louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05915416: The Effect of Child Abuse and Neglect Prevention Program on Awareness Levels and Child Abuse Potential of Pregnant Women
Official title: The Effect of Child Abuse and Neglect Prevention Program on Awareness Levels and Child Abuse Potential of Pregnant Women: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse
Keywords: child abuse
awareness
pregnant
nurse
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the effect of the Child Abuse and Neglect Prevention Program (CANPP) based on Social Cognitive Theory (SCT) on the awareness levels and child abuse potential of pregnant women. This randomized controlled study was conducted between July and December 2022 in a family health center of Aydin/Turkey with the participation a total of 30 pregnant women, who were then distributed into two groups as 15 experiment group and 15 control group pregnant women.The participants in the experiment group were applied SCT-based CANPP whereas no intervention was applied to the control group. Research data were collected before the intervention, one month after the intervention, and three months after the intervention using the Pregnant Data Collection Form, Child Neglect and Abuse Awareness Scale for Parents (CNAASP) and Child Abuse Potential Inventory (CAPI). Chi-Square and Fisher exact tests, independent groups t-test and repeated measures ANOVA test were used in the statistical analysis of the research data.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who agree to participate in the study
* are 18 years of age or older
* who can read and understand Turkish
* who have either a smart phone or a computer
* are between 28+0 and 33+0 weeks of pregnancy

Exclusion Criteria:

* Pregnant women with high risk pregnancy
* who have visual or auditory problems
* who have been diagnosed with mental disorders.

Primary outcomes:
measure: Child Neglect and Abuse Awareness Scale for Parents
timeFrame: one month after the intervention
measure: Child Neglect and Abuse Awareness Scale for Parents
timeFrame: three months after the intervention
Secondary outcomes:
measure: Child Abuse Potential Inventory
timeFrame: one month after the intervention
measure: Child Abuse Potential Inventory
timeFrame: three month after the intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
Study officials:
References:
Clinical trial NCT05881616: Study on Serum Metabolomics of GDM
Official title: Serum Metabolomics Analysis for Early Diagnosis and Pathogenesis of Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GDM
Pathogenesis
Diagnosis
Keywords: Metabolomics
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Women's Hospital School Of Medicine Zhejiang University
First posted: 2023-05-31
Enrollment: 480
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to recruit pregnant women undergoing routine prenatal examinations and healthy women undergoing routine physical examination.

Brief summary: This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. This study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of GDM.


Eligibility criteria: Inclusion Criteria:

* No obvious abnormalities in all inspection items
* No history of diabetes
* No particular dietary habits
* No previous history of other mental illnesses
* No history of drug abuse or allergies
* No history of smoking or drinking

Exclusion Criteria:

* Pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome
* Critical illnesses such as cardiovascular disease or abnormal liver/kidney function
* Personal history of syphilis, HIV positive, and other infectious diseases
* Artificial insemination or IVF pregnancy
* Multiple pregnancy (twins or more)
* Patients participating in other clinical studies
* Other reasons that researchers think are inappropriate

Primary outcomes:
measure: Content of serum metabolomics
timeFrame: Second trimester (24-28 gestational weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06033716: Development and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors
Official title: Exploring the Developmental Changes and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors: Based on Latent Growth Modeling and Cross-lagged Modeling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resilience
Anxiety
Depression
Keywords: gastric cancer
resilience
anxiety
depression
trajectory
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 412
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: select elderly gastric cancer patients who had undergone cancer surgery and were receiving medical treatment at a tertiary hospital

Brief summary: This study will explore the dynamic interaction between mental resilience, anxiety and depression in elderly patients with gastric cancer 1 year after surgery, in order to better understand the role of these two factors in patients' mental health, and provide accurate insights for clinical practice and targeted psychological support strategies.


Eligibility criteria: Inclusion Criteria:

* diagnosed with gastric cancer by endoscopy or pathology
* age ≥60 years old
* radical gastrectomy was proposed
* be able to communicate simply in writing and verbal

Exclusion Criteria:

* received preoperative radiotherapy or chemotherapy;
* combined with other sites of malignant tumors;
* combined with severe heart, liver, lung and renal insufficiency;
* recent using hormones, immunosuppressants;
* with physical disabilities.

Primary outcomes:
measure: resilience
timeFrame: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)
measure: anxiety
timeFrame: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)
measure: depression
timeFrame: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yinning Guo
state: Jiangsu
Study officials:
References:
Clinical trial NCT01460316: Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny
Official title: Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conotruncal Cardiac Defects
Keywords: Conotruncal cardiac defects
methylation
genotype
cobalamin
folates
nutrition
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Besancon
name: University Hospital, Strasbourg, France
name: Centre Hospitalier Universitaire Dijon
name: CHU de Reims
First posted: 2011-10-26
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Conotruncal cardiac defects population and theirs mothers

Brief summary: The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.


Eligibility criteria: Inclusion Criteria:

* Conotruncal cardiac defects patients and theirs mothers
* Weight: \> 3750 g

Exclusion Criteria:

* Syndromic conotruncal cardiac defects
* 22q11 deletion Holder's
* Patients whose mother's took anti-folates before and during first pregnancy semester

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: Service de Cardiologie Pédiatrique, CHU Brabois Enfants
Study officials:
affiliation: CHU de Nancy- Hôpital Brabois Enfants
name: François FEILLET, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01331616: Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
Official title: A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Glioblastoma
Optic Neuropathy
Keywords: Prospective study
Glioblastoma
Avastin
Visual Evoked Potential
Optic neuropathy
Chemo-radiotherapy
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Does treatment with bevacizumab (Avastin) in combination with prior or current radiotherapy lead to optic neuropathy?

Detailed description: The investigators research will focus on patients prior to them beginning treatment with bevacizumab (Avastin), by undergoing a baseline visual examination with Visual evoked Potentials testing. This will allow testing of the patient's optic nerve function bilaterally. Patients will then begin their normally scheduled treatment with avastin, and other chemotherapeutic agents, as well any radiation treatments scheduled. Once patients have completed their treatment with avastin for 6-8 weeks, they will then undergo their second Visual Evoked Potential testing, with both studies then being compared for any changes within the optic nerves. Patients will also be recommended to have stringent follow up with an Ophthalmologist to include confrontational visual field testing, external and anterior segment examination, and dilated fundus examination. The investigators main objective is to assess whether or not bevacizumab causes a direct toxic effect on patient's optic nerves leading to an acute/subacute optic neuropathy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed w Glioblastoma grade IV, and scheduled to begin chemo radiotherapy with Avastin

Exclusion Criteria:

* No diagnosis of GBM, not scheduled to begin treatment with avastin in combination with radiotherapy.

Primary outcomes:
measure: Measurement of Visual Evoked Potentials (optic nerve function and visual processing) and optic nerve function in 10 patients.
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients diagnosed with optic neuropathy following treatment with chemo and radiation in combination with avastin treatment
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02548416: Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Official title: Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Keywords: Atelectasis
Positive End-Expiratory Pressure
Oxygenation
Anaesthesia
Computed tomography
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned.

The investigators hypothesize that the use of PEEP as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero PEEP.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects, American Society of Anesthesiology (ASA) I-II.
* Patients scheduled for non-abdominal day case surgery under general anaesthesia.

Exclusion Criteria:

* ASA class III or higher.
* Body Mass Index (BMI) 30 or higher.
* Arterial oxygen saturation (SpO2) \<96% breathing air.
* Chronic Obstructive Pulmonary Disease (COPD).
* Ischaemic heart disease.
* Known or anticipated difficult airway.
* Active smokers and ex-smokers with a history of more than 6 pack years.
* Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

Primary outcomes:
measure: Area of atelectasis expressed as centimeter^2
timeFrame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.
measure: Measurement of aeras with different aeration in the particular CT scan.
timeFrame: Within 1-2 hours, just before emergence from anesthesia.The outcome measure (atelectasis) will be investigated at just one point i.e. end of surgery but before emergence from anaesthesia.
Secondary outcomes:
measure: Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
timeFrame: Within 1-2 hours, just before emergence from anesthesia. At end of surgery but before emergence from anaesthesia, at the same time as the lungs are investigated by computed tomography.
measure: Oxygenation, oxygen tension in arterial blood expressed in kilo Pascal (kPa)
timeFrame: Within 2 hours perioperatively, 15 minutes after extubation.
Other outcomes:
Locations:
city: Köping
country: Sweden
facility: Region Västmanland
Study officials:
affiliation: Region Västmanland
name: Lennart Edmark
role: STUDY_DIRECTOR
References:
Clinical trial NCT06590116: Perspectives on Spinal Manipulative Therapy for Low Back Pain
Official title: Patient and Physical Therapist Perspectives on Spinal Manipulative Therapy for Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Brooks Rehabilitation
First posted: 2024-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to better understand how the thoughts and beliefs of patients with low back pain and their physical therapist influence how much patients benefit from physical therapy. Participants will receive physical therapy as determined by their physical therapist including spinal manipulative therapy, exercise, and education. Participants with low back pain and their physical therapists will complete forms about their thoughts and beliefs about low back pain and treatment.


Eligibility criteria: Inclusion Criteria:

* Pain between 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region.
* Meets NIH Task Force criteria for chronic low back pain

Exclusion Criteria:

* Prior surgery to the lumbosacral spine
* Currently pregnant
* Not currently receiving spinal manipulative therapy or exercise interventions from another healthcare provider such as a chiropractor or massage therapist.
* No neurogenic signs indicating radiculopathy
* No "red flags" of a potentially serious condition (e.g., cauda equina syndrome, fracture, cancer, infection, etc.)

Primary outcomes:
measure: PROMIS-29
timeFrame: Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks
measure: NIH Chronic LBP Impact Score
timeFrame: 12 weeks and 26 weeks
Secondary outcomes:
measure: Patient Acceptable Symptom State
timeFrame: Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT01889316: Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Official title: Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Fetal Anoxia
Keywords: Fetal monitoring
ECG
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii (a newer device also created by Monica Healthcare) using the same technology with different monitor placement.

Detailed description: This study has one arm, in which Both the FDA - Approved AN24 (Fetal Monitoring device marketed by Monica Healthcare) and the new device (Novii, being investigated in this clinical trial) will be placed on the patient's abdomen. After delivery of the patient's infant, the data will be abstracted from the second device. This data will be compared to the data from the first device for accuracy.

Eligibility criteria: Inclusion Criteria:

* Term Laboring Patients

Exclusion Criteria:

* Preterm Labor
* Fetal Anomaly
* Imminent cesarean

Primary outcomes:
measure: Efficacy of the Novii when compared to the AN24
timeFrame: duration of the patient's labor
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Meg Hill, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956016: Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment
Official title: Open-label Randomized Comparative Study of the Effects of a Classic High-frequency rTMS Treatment Versus a Deep rTMS Treatment in the Management of Resistant Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder, Treatment-Resistant
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 152
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: The main objective is to demonstrate that dTMS is more efficient than high frequency rTMS with a conventional coil.

The patient will receive treatment arm A or B :

Arm A : classic rTMS treatment (use of the 8-shaped coil) and standard therapy Arm B: treatment with deep rTMS (use of the H-shaped coil (helmet)) and standard therapies.

20 rTMS sessions are planned (5 sessions per week) and 3 follow-up visits : at Day 30, Day 60 and Day 90.


Eligibility criteria: Inclusion Criteria:

* Volunteer subjects over 18 years old
* Having signed a free and informed consent
* Having a diagnostic of caracterised depressive episod recurrent or isolated according to DSM IV criteria (A.P.A 1994).
* Having an antidepressant treatment not modified since 3 weeks
* Score to MADRS scale ≥ 21
* Subject affiliated to a social security regimen

Exclusion Criteria:

* Depression with psychotic caracteristics
* Co-morbid diagnosis according to axis I (DSM IV) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime)
* Patient who has already undergone seismotherapy for current episode and non-responder to this treatment
* Patient hospitalized under duress or under legal protection (guardianship, curatorship)
* Patient with a high risk of suicide (item 10 of MADRS \> 4) in the absence of hospitalization.
* Contra-indication for IRM exam or rTMS : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip
* Pregnancy
* Simultaneous participation to another interventionnal study

Primary outcomes:
measure: A 50% change of MADRS score
timeFrame: Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: Ghina HARIKA-GERMANEAU, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03618316: Effect of Cimetidine on the PK of Imeglimin
Official title: An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Drug-drug interaction
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.


Eligibility criteria: Inclusion Criteria:

* BMI : 18.5-29.9
* Body weight ≥ 60 kg
* willing to use reliable contraception
* able to give fully informed written consent.

Exclusion Criteria:

* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
* Clinically relevant abnormal findings at the screening assessment
* Clinically significant vital signs outside the acceptable range at screening
* Clinically relevant abnormal medical history, surgery or concurrent medical condition
* Acute or chronic illness
* Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
* Severe adverse reaction to any drug or sensitivity to the trial medication or its components
* Significant food allergy; vegetarian or vegan
* Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
* Drug or alcohol abuse
* Smoking of more than 5 cigarettes daily
* Possibility that subject will not cooperate
* Positive test for hepatitis B \& C, HIV
* Objection by a General Practitioner

Primary outcomes:
measure: PK parameters of imeglimin
timeFrame: At Day 1
Secondary outcomes:
measure: PK parameters of imeglimin
timeFrame: From day 1 to day 3
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: from day 1 to day 17
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research (HMR)
Study officials:
References: