louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05840367: Mothers' Experience of Category 1 Cesarean Section
Official title: Mothers' Experience of Category 1 Cesarean Section - in a Hospital Where the Partner is Present in the Operating Room. A Qualitative Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cesarean Section Complications
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark, Department of Regional Health Research
First posted: 2023-05-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study aims to include all mothers who undergoes a category 1 cesarean section in Kolding Hospital, Denmark, during a 1-year period. Mothers will be approached for inclusion in the study regardless of the outcome of the infant.

Brief summary: The aim of this qualitative prospective study is to investigate how mothers experience a category 1 cesarean section in a hospital where the partner is present in the operation room during the entire process (induction of general anestesia, cesarean section, possible resuscitation of newborn).

Mothers will be included in the study, if they wish to participate, on day 1 or 2 following the cesarean section and a brief, structured interview will be held concerning her experience of the cesarean section.

Clinical baseline data regarding the mother, the cesarean section and the infant will be collected from patients files.

Mothers will be contacted again three months after the cesarean section, and a semi-structured interview will be held via telephone. At the end of the interview a screening for posttraumatic stress will be performed, using the PTSD-8 tool. The interviews will be recorded and transscribed verbatim.

Content of interviews will be analysed using manifest content analysis. NVivo software will be used for coding interviews.


Eligibility criteria: Inclusion Criteria:

* Mothers who had a category 1 cesarean section in Kolding Hospital, Denmark during a 1-year period

Exclusion Criteria:

* Not speaking/understanding Danish

Primary outcomes:
measure: Mothers' experience of the category 1 cesarean section
timeFrame: Three months after the cesarean section
Secondary outcomes:
measure: PTSD
timeFrame: Three months after the cesarean section
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Lillebaelt Hospital, Kolding
Study officials:
affiliation: Lillebaelt Hospital Kolding, Department of Anesthesiology and Intensive Care, and University of Southern Denmark, Department of Regional Health Research
name: Anne C Brøchner, MD, Associate Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06992167: Caregiver Depression in a Low-Resource Setting: Socio-Demographic Predictors of Major Depressive Disorder Among Family Caregivers of Breast Cancer Patients in Pakistan
Official title: Caregiver Depression in a Low-Resource Setting: Socio-Demographic Predictors of Major Depressive Disorder Among Family Caregivers of Breast Cancer Patients in Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Rahmah Health Foundation
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 402
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of primary caregivers of breast cancer patients receiving treatment in public or private healthcare facilities in low-resource settings of Pakistan. Caregivers include family members or individuals who are directly involved in providing physical, emotional, or financial support to the patient.

Brief summary: This cross-sectional study aims to assess the prevalence of depression among primary caregivers of breast cancer patients within low-resource country like Pakistan. Caregiving for individuals with breast cancer can be physically and emotionally demanding, often leading to psychological distress, including depression. However, there is limited data from low- and middle-income countries, including Pakistan, where caregivers may face additional socioeconomic and systemic burdens. This study seeks to quantify the burden of depression in this population and explore associated sociodemographic and caregiving-related factors. Findings will help inform psychosocial support strategies and interventions to improve caregiver well-being in resource-constrained environments.


Eligibility criteria: Inclusion Criteria:

1. Primary caregiver of a patient diagnosed with breast cancer at any stage
2. Male or female caregiver
3. Aged 15 years or older
4. Providing physical, emotional, or financial support to the patient
5. Willing to give informed consent

Exclusion Criteria:

1. Paid caregivers (professional or hired help)
2. Age under 15 years
3. Unwilling to provide consent or participate in the study
4. Incomplete or missing essential data required for analysis

Primary outcomes:
measure: Prevalence of depression among caregivers of breast cancer patients
timeFrame: At a single time point during caregiver recruitment (cross-sectional assessment within 6 months of study initiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: Ayub Teaching Hospital
state: Pubjab
city: Multan
country: Pakistan
facility: Nishtar Medical University and Hospital
state: Punjab
city: Karachi
country: Pakistan
facility: Jinnah Postgraduate Medical Center
state: Sindh
city: Rawalpindi
country: Pakistan
facility: Benazir Bhutto Hospital
Study officials:
References:
Clinical trial NCT06903767: Automated V Manual Impactor Study
Official title: Do Quantifiable Differences in Physiologic Stress Exist in Surgeons When Comparing the Use of a Powered Femoral Impactor Versus Manual Impaction in Total Hip Arthroplasty?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Total Hip Arthroplasty (THA)
Impaction
Physiological Strain
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: UCLA Health - Santa Monica Medical Center
name: University of Virginia
name: Orthopedic + Fracture Specialists, Portland, OR
First posted: 2025-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates the use of an automated impactor device in total hip arthroplasty versus manual malleting method and the physiological strain on the surgeon. This study will be a randomized, prospective, multicenter study involving fellowship-trained arthroplasty surgeons. Each participating surgeon will contribute data from 50 primary, elective THA cases, using the HAMMR powered impactor in 25 cases and manual impaction in 25 cases.


Eligibility criteria: Inclusion Criteria:

Patients undergoing primary elective THAs Participants over the age of 18 Patients with compatible implants

Exclusion Criteria:

Attending orthopaedic surgeons with pre-existing cardiorespiratory or musculoskeletal conditions Use of cemented or hybrid THA Patients undergoing a conversion or revision THA Patients undergoing a non-elective THA (i.e., for fracture) Participants lacking cognitive capacity to consent Participants who are pregnant

Primary outcomes:
measure: Physiological strain in the surgeon
timeFrame: 1 day
Secondary outcomes:
measure: Patient Adverse Events
timeFrame: 6 weeks
measure: F-NRS
timeFrame: 1 day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
affiliation: Rothman Orthopaedic Institute
name: Camilo Restrepo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05313867: Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects
Official title: Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress
trace elements
voice parameters
Lead sponsor: Laboratoires Pronutri
Sponsor class: INDUSTRY
Collaborators: name: Clin-Experts
name: Plateforme Cocolab
First posted: 2022-04-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Preliminary data obtained by the company Pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters.

Trace elements are pure minerals essential to the functioning of our body, present in very small quantities. They have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments.

No scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. The present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years of age
* Healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months)
* Affiliated to the social security system
* Signed consent

Exclusion Criteria:

* Voice disorders: aphasia, dysphonia, aphonia...
* Presence of a cardiac pacemaker
* Person intolerant to lactose, or to any excipient present in the VX 1 product
* Person under legal protection or unable to give consent
* Minor
* Pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception
* Person deprived of liberty by a judicial or administrative decision or under psychiatric care

Primary outcomes:
measure: F0 voice frequency
timeFrame: Change from baseline at 5 minutes after the intake
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est, 24, avenue des Diables Bleus, Campus Saint Jean d'Angély
Study officials:
affiliation: Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est
name: Alice GUYON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03583567: Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine
Official title: A Randomized Controlled Study Comparing the Prophylactic Effect of histamine1 and Histamine 2 Receptor Blocker in Prevention Systolic Hypotension After Protamine Administration in Cardiac Patient Having Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Protamine Adverse Reaction
Keywords: protamine
antihistamine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Protamine remains the anticoagulant of choice for cardiopulmonary bypass (CPB). The process of protamine neutralization of heparin came with the side effects sometimes; it can be life threatening or fetal reaction. The adverse cardiopulmonary response of protamine has been observed during entire history of clinical cardiac surgery. The true mechanism reaction is difficult to defined and the complexity of the clinical situation The classification of protamine reaction has been divided in to main 3 types (transient systemic hypotension secondary to rapid administration, anaphylactic and anaphylactoid reaction and catastrophic pulmonary vasoconstriction.

The reaction from pharmacologic histamine release is the most common type of reaction. Protamine was believed to induce hypotension by this mechanism, and it was demonstrated to release histamine by degranulation of isolated mast cells From the hypothesis that the systemic hypotension cause by the released of histamine. The investigators will measure the serum tryptase which is the enzyme that released from degranulation of human mast cell. Comparing the serum tryptase level of the patient at baseline, 30 min and 60 min after protamine was given.

There for the hypothesis of this study is administrating of H1 and H2 blocker helps attenuate the drop in MAP after protamine is given.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-3
* Schedule for open heart surgery

Exclusion Criteria:

* History of allergy to the study drugs or protamine
* History of previous cardiac surgery or received protamine
* History of diabetes with insulin therapy

Primary outcomes:
measure: Blood pressure
timeFrame: 37 minutes
Secondary outcomes:
measure: Serum tryptase
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02824367: Evaluation of Clinical Perfectionism in Parkinson Disease
Official title: Evaluation of Clinical Perfectionism in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Perfectionism
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety.

Detailed description: Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety. Also, clinicians reported that they exhibit specific personality traits (e.g., rigidity and perfectionism).

To date, few studies used Cognitive Behavioural Therapies (CBT) in people with Parkinson's disease showing promising results. Recently, perfectionism has received particular attention because of it association with many emotional disorders. Thus, some psychometric tools have been developed in order to evaluate different aspects of perfectionism. Yet, none of them has been used in people with Parkinson's disease.

The objective of this study is to investigate whether there is a direct link between Parkinson's disease and perfectionism by using psychometric tools from the CBT literature. Identifying such link would allow to justify the use of CBT in people with Parkinson's disease with the goal in mind to improve their care and quality of life.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Score Mini Mental Scale (MMS) greater than 23
* For Parkinsonian, Parkinson disease be defined according to the criteria of the Unified Parkinson Disease Rating Scale (UPDRS), with a Hoehn and Yahr stage 1, 2 or 3
* The control patients present dystonias not within the scope of Parkinson
* Informed Consent Form signed
* Patient covered by social insurance

Exclusion Criteria:

* Proven Presence of neuropsychological disorders
* Patients with deep brain stimulation
* Diagnosis of somatic pathology diagnosed
* Private Patient freedom or protected adult (under guardianship)

Primary outcomes:
measure: Perfectionism evaluation 1
timeFrame: Day 0
measure: Perfectionism evaluation 2
timeFrame: Day 0
Secondary outcomes:
measure: Depression and anxiety evaluation 1
timeFrame: Day 0
measure: Depression and anxiety evaluation 2
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Pierre KRYSTKOWIAK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745667: The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction
Official title: The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction by Upper Laparotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforated Peptic Ulcer
Keywords: laparoscopic
peptic ulcer
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Gastrostart
First posted: 2008-09-03
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction will be discharged 3 days sooner due to less postoperative pain and complications.

Detailed description: as written above

Eligibility criteria: Inclusion Criteria:

* All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria:

* Pregnancy
* Younger than 18 years
* Unable to sign consent form

Primary outcomes:
measure: days of discharge
timeFrame: 7 days
Secondary outcomes:
measure: postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)
timeFrame: follow up 1 year
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Diaconessenhuis
Study officials:
affiliation: Erasmus university hospital
name: Johan Lange, PhD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01546467: Cognitive Remediation in Early Phase Psychosis
Official title: Cognitive Remediation in Early Phase Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Psychosis NOS
Keywords: Schizophrenia
Schizoaffective disorder
Psychosis
Early phase
Cognitive remediation
Functional outcome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
name: South-Eastern Norway Regional Health Authority
First posted: 2012-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effect of a 30 hour cognitive remediation program for young patients with early phase schizophrenia spectrum disorders on cognitive, clinical and functional outcome measures. The remediation program is integrated with whatever active rehabilitation the participant is currently attending (school, work, day program etc).


Eligibility criteria: Inclusion Criteria:

* Early phase schizophrenia, schizoaffective disorder, psychosis NOS
* Less than 5 years since start of adequate treatment for psychotic disorder
* Age between 18-40
* Norwegian speaking (sufficiently to understand and complete assessments)

Exclusion Criteria:

* Traumatic brain injury
* Neurological disorder as determined by medical history
* IQ below 70

Primary outcomes:
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: Change in MCCB performance from baseline to 4 months and 9 months
measure: UCSD Performance Based Skilled Assessment Brief Version (UPSA-B)
timeFrame: Change in UPSA-B performance from baseline to 4 months and 9 months
measure: Cognitive Assessment Interview (CAI)
timeFrame: Change in CAI scores from baseline to 4 months and 9 months
measure: Social Functioning Scale (SFS)
timeFrame: Change in SFS scores from baseline to 4 months and 9 months
Secondary outcomes:
measure: Calgary Depression Scale
timeFrame: Change in CDS scores from baseline to 4 months and 9 months
measure: Global Assessment of Function (GAF)- split version
timeFrame: Change in GAF scores from baseline to 4 months and 9 months
measure: event related fMRI
timeFrame: Change in BOLD fMRI signal from baseline to 4 months
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: Change in RSES scores from baseline to 4 months and 9 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital.
Study officials:
affiliation: Psychosis Research Unit, Division of Mental Health and Addiction, Oslo University Hospital
name: Torill Ueland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00249067: Retrospective Evaluation of Carvedilol Versus Captopril in CHF Patients
Official title: The Retrospective Evaluation of Carvedilol Versus Captopril and Digoxin/Lasix Therapy in Congestive Heart Failure Due to Left-to-Right Shunt Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Heart Murmurs
Keywords: Congestive Heart Failure, Left-to-Right Shunt
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children's Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study.

We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

Detailed description: This is a retrospective chart review examining our experience with carvedilol in CHF secondary to left-to-right heart shunt lesions. The treatment group will be children who have received carvedilol. The control or comparison groups will be patients who have received either digoxin/furosemide or captopril for this indication. Charts will be reviewed of patients who have been treated at Children's Healthcare of Atlanta and as outpatients by Sibley Heart Center Cardiology between September 2000 and October 2005. Patients will have been started on carvedilol prior to April 1, 2005 and only information up to October 1, 2005 will be used for this study. We will review approximately 50 charts for this study.

We will evaluate the effectiveness of these medications at reducing symptoms of CHF.

Eligibility criteria: Inclusion Criteria: Children aged 0-18 years with a cardiac defect resulting in a left-to-right shunt (i.e. ventricular septal defect) who develop congestive heart failure. Patient must have been treated with one of the study medications: carvedilol, digoxin, or furosemide.

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Exclusion Criteria: Patients who are not between 0-18, who do not have a defect resulting in left-to-right shunt, who do not have congestive heart failure and who have not been treated with one of the study medications: carvedilol, digoxin, or furosemide.

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Resident-Emory Department of Pediatrics
name: Jeffrey D Dayton, MD
role: PRINCIPAL_INVESTIGATOR
References: