louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02886052: Internet-based Cognitive Behavior Therapy for Insomnia for Parents Who Have Lost a Child
Official title: Therapist Guided Internet Cognitive Behavioral Therapy (ICBT) for Insomnia for Bereaved Parents: a Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Bereavement
Keywords: Cognitive behavior therapy
Internet treatment
Self-help treatment
Insomnia
ICBT
CBT-i
Bereavement
Lead sponsor: Ersta Sköndal University College
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Region Stockholm
First posted: 2016-09-01
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to evaluate changes in symptoms of complicated grief and depression.


Eligibility criteria: Inclusion Criteria:

* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-5
* Enough Swedish language skills

Exclusion Criteria:

* Other sleep disorders that require other treatment (e.g. sleep apnea)
* Somatic or psychiatric conditions requiring acute care

Primary outcomes:
measure: Change (from baseline) in Insomnia Severity Index, ISI
timeFrame: 0, 9 and 18 months after treatment
Secondary outcomes:
measure: Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
timeFrame: 0, 9 and 18 months after treatment
measure: Change (from baseline) in Prolonged Grief Disorder, PG-13
timeFrame: 0, 9 and 18 months after treatment
measure: Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5
timeFrame: 0, 9 and 18 months after treatment
measure: Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7
timeFrame: 0, 9 and 18 months after treatment
measure: Change (from baseline) in Utrecht Grief Rumination Scale, UGRS
timeFrame: 0, 9 and 18 months after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01101152: Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Volunteers
Official title: Effectiveness of the Dual Serotonin Norepinephrine Reuptake Inhibitor Desvenlafaxine Succinate in Healthy Females and Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Antidepressant
healthy volunteers
desvenlafaxine succinate
norepinephrine reuptake
serotonin reuptake
tyramine test
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: DVS is the main metabolite of the antidepressant/anxiolytic medication Venlafaxine (Effexor). Like parent compound, DVS is an antidepressant inhibiting both serotonin (5-HT) and norepinephrine (NE) reuptake. However, no studies to date describe the in vivo potency of this drug on monoamines reuptake. Consequently, it appears essential to determine the potency of DVS in human subjects using a wide dose range in order to determine at which dose(s) it starts inhibiting 5-HT and NE reuptake. The investigators are interested in learning whether there is a gender difference in the dose of the study medication at which NE reuptake inhibition occurs.


Eligibility criteria: Inclusion Criteria:

* Female subjects between 18 and 40 years of age, including those on oral contraceptive pills
* Male subjects between 18-40 years of age
* Written informed consent signed by the subject.

Exclusion Criteria:

* Life-time personal history of diagnosis of major depression according to the DSM-IV (American Psychiatry Association, 1994) using the MINI (Sheehan et al. 1998)
* Blood pressure greater than 140/90 and a pulse rate greater than 90bpm
* Evidence of significant physical illness contraindicating the use of DVS, found on physical or in the laboratory data obtained during the first week of the study
* Obvious mental retardation rendering the response to investigators unreliable
* Pregnancy, or absence of adequate contraceptive method.
* Concurrent use of psychotropic medication such as antipsychotics, mood stabilizers or regular use of benzodiazepines.
* Participation in a clinical trial within 30 days of entry into the current study
* Intolerance to Desvenlafaxine

Primary outcomes:
measure: The degree of norepinephrine reuptake in response to the increasing levels of the study medication will be assessed and compared between genders
timeFrame: 1 month
Secondary outcomes:
measure: The degree of serotonin reuptake in response to the increasing levels of the study medication will be assessed and compared between genders
timeFrame: 1 month
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Institute of Mental Health Research
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Pierre Blier, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946452: Symbicort SMART Satisfaction From Patient Perspective 2009
Official title: Symbicort SMART Satisfaction From Patient Perspective 2009
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Control
Satisfaction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in Malaysia.


Eligibility criteria: Inclusion Criteria:

* Have been prescribed Symbicort SMART (1 or 2 inhalation twice daily) by their Dr's for the past 3 months
* Informed consent

Exclusion Criteria:

* Symbicort SMART treatment \< 3 months
* Patients requiring short courses of oral steroids more than twice in a month

Primary outcomes:
measure: Score level of Satisfaction in Asthma Treatment Questionnaire (SATQ)
timeFrame: After 3 months on SMART - once
measure: Score level of Asthma Control Test (ACT)
timeFrame: After 3 months on SMART - once
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Research Site
state: Selangor
Study officials:
affiliation: UMMC
name: Liam Chong Kin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03123952: Expanded Access to ABT-414
Official title: Expanded Access to ABT-414
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-04-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABT-414 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* Participant must have epidermal growth factor receptor (EGFR) amplification or EGFRvIII mutation.
* Health Care Provider (HCP) must have prior clinical trial experience with ABT-414.
* The participant must not be eligible for an ABT-414 clinical trial.
* Pediatric participants may be evaluated on a case by case basis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02841852: Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients?
Official title: Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients Over 75 Years Old ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatric Disorder
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 280
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients aged 75 and over hospitalized in acute geriatric medicine

Brief summary: Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in the world and the most effective drugs available to reduce gastric acid secretion. However, studies have shown that PPIs are not always prescribed with a clear indication. Indeed, between 25% and 86% of older individuals taking a PPI have been overprescribed these medications. In older patients, overprescribing of a PPI is associated with increases in morbidity, adverse drug events, hospitalization, and mortality. The hypothesis is that overprescription of PPIs is associated with the individual multimorbidities in older patients evaluated using the multimorbidities group criteria included in the CIRS. The aim of the present study was to establish a relationship between overprescribing of PPIs and multimorbidities in older patients.


Eligibility criteria: Inclusion Criteria:

* Patients of 75 years or more
* Patients hospitalized in geriatric short stay
* Patients with an inhibitor therapy proton pump short geriatric entry
* Patients who have given their written consent

Exclusion Criteria:

* Patients who have expressed their inability or refusal to sign an informed consent

Primary outcomes:
measure: Burden of comorbidities
timeFrame: 48 hours after the entry into acute geriatric medicine
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Nazaire
country: France
facility: Centre Hospitalier de St Nazaire
Study officials:
affiliation: Nantes University Hospital
name: Laure De DECKER, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02748252: Prognosis of a First-Ever Stroke in Persons Living With HIV
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebrovascular Accident, Acute
HIV
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-04-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to a Stroke Unit for the first occurrence of an ischemic stroke

Brief summary: With aging of the persons living with HIV, cardiovascular diseases now account for substantial mortality and morbidity. Stroke frequency grows exponentially with aging and its incidence doubles every decade over 55 years of age.

The prognosis of ischemic stroke depends mainly on the care in Stroke Units in the acute phase of the disease (thrombolysis/thrombectomy). It is important that HIV patients are referred to these units in the first hours of a stroke and not to their infectious disease units which is a loss of chance.

It would also be important to know whether HIV patients need specific protocols for stroke emergency management.

The study aims to compare the functional prognosis after the first occurrence of an ischemic stroke, in patients admitted to a Stroke Unit, whether they are infected or not infected by HIV.


Eligibility criteria: Inclusion Criteria:

* Patients unexposed to HIV: HIV-1 seronegative OR patients exposed to HIV: HIV seropositive for over 6 months with or without antiretroviral treatment. Confirmed by Elisa and Western blot tests
* admitted for ischemic stroke, defined as a sudden cerebrovascular event confirmed by MRI
* at least 18 years of age
* paired with patients unexposed to HIV, admitted for ischemic stroke, same gender and age

Exclusion Criteria:

* antecedents of a symptomatic ischemic or hemorrhagic cerebrovascular event
* no social security benefits;
* Absence of signed informed consent for the study
* Patients currently pregnant or breast-feeding

Primary outcomes:
measure: degree of disability measured with the modified Rankin Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Study officials:
References:
Clinical trial NCT04928352: Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Official title: Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cleft Palate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we introduce a potent local anesthetic; bupivacaine 0.5% in two different doses by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.

Detailed description: A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive; Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 (Group B1) or Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 (Group B2) or same volume of saline placebo (Group C).

Eligibility criteria: Inclusion Criteria:

* Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
* Elective cleft palate repair ± cleft lip surgery under general anesthesia .

Exclusion Criteria:

* Coronary artery disease
* Hypertension
* Developmental delay
* Allergy to study drug

Primary outcomes:
measure: the total postoperative consumption of rescue analgesics
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: Postoperative FLACC score
timeFrame: 24 hour postoperative
measure: The time to first request for rescue analgesics
timeFrame: 24 hour postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: Assuit
Study officials:
affiliation: Assiut University
name: Omar Soliman, MD
role: STUDY_DIRECTOR
References:
citation: Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.
Clinical trial NCT04769752: Beta Blocker Use in Cardiac Surgery and Association With Postoperative Course
Official title: Use and Prescription of Beta-blockers Before Cardiac Surgery With Cardiopulmopnary Bypass: Multicenter Observational Analysis of Practices and Its Association With Postoperative Morbidity-mortality.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery With Cardiopulmonary Bypass
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 1789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive cardiac surgical patients who meeet inclusion criteria with cardiopulmonary bypass

Brief summary: The objective of this study is to describe in a cohort of cardiac surgery patients the use of beta-blockers before surgery and their maintenance or withdraw according to international recommendations in order to compare patients who receive a beta-blocker with maintenance during the surgical period (international recommendation) to those for whom prescription and maintenance are not respected. Patients are treated according to standard practice and this protocol does not change patient management. No additional information or data is required by the study other than the data usually collected in the patient record (drug treatment, medical history, operating data, postoperative data, complications, length of stay).

The objectives of this research are :

* To evaluate the proportion of patients receiving beta-blocker treatment prior to cardiac surgery.
* To evaluate the proportion of patients receiving beta-blocker treatment before cardiac surgery and complying with international recommendations for its maintenance/stop in perioperative cardiac surgery.
* To evaluate the incidence of complications and length of hospital stay in patients receiving beta-blockers based on compliance or non-compliance with recommendations.


Eligibility criteria: Inclusion Criteria:

* Major patient ≥ 18 years
* Patient operated cardiac surgery with cardiopulmonary bypass
* Patients who have given oral consent to participate after full information

Exclusion Criteria:

* Off pump cardiac surgery

Primary outcomes:
measure: Number of patients treated with beta-blocker in accordance with international guidelines
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT06314152: 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
Official title: A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Chronic Pain
Seroma
Recurrent
Infections
Hematoma
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Guang'an People's Hospital
name: Pengan County People's Hospital
name: People's Hospital of Yilong County
name: Nanbu Hospital of County Chinese Medicine
name: Langzhong People's Hospital
name: Langzhong Traditional Chinese Medicine Hospital
First posted: 2024-03-15
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.


Eligibility criteria: Inclusion Criteria:

* Unilateral inguinal hernia according to preoperative physical examination and imaging examination.

The inclusion criteria were as follows: primary inguinal hernia.

Exclusion Criteria:

* Age below 18 years or older than 80. recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias.

Patients not suitable for general anesthesia. Patients requiring open surgery; patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.

Primary outcomes:
measure: Rate of postoperative pain
timeFrame: 6 months
measure: Rate of recurrence
timeFrame: 1 month,3 months,6 months and 12 months after surgery
Secondary outcomes:
measure: Rate of postoperative complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Yunhong Tian
state: Sichuan
Study officials:
References:
Clinical trial NCT02644252: Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer
Official title: Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 79
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: There is a need for improving the effect of first-line chemotherapy for lung cancer patients, preferably by using an approach with none or very few side effects.

In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement on top of standard chemotherapy for patients with advanced non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer, including squamous cell carcinomas, adenocarcinomas and non-neuroendocrine large cell carcinomas
* Patients with advanced stages of NSCLC who are candidates to first-line platinum-based doublet chemotherapy
* Measurable disease by RECIST 1.1
* Age ≥ 18 years.
* Performance status 0-2.
* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

  * White blood cells (WBC) ≥ 3.0 \* 10\^9/l or neutrophils (ANC) ≥ 1.5 \* 10\^9/l
  * Platelet count ≥ 100 \* 10\^9/l
  * Hemoglobin ≥ 6 mmol/l
  * Serum bilirubin \< 2.0 \* upper level of normal (ULN)
  * Serum transaminase ≤ 2.5 \* ULN
  * Serum creatinine ≤ 1.5 ULN
* Written and orally informed consent.

Exclusion Criteria:

* Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
* Patients who have received prior chemotherapy for NSCLC
* Patients with NSCLC who are candidates to neoadjuvant chemotherapy or curative chemoradiotherapy
* Underlying disease not adequately treated (diabetes, cardiac disease)
* Allergy to the active substance or any of the auxiliary agents
* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.

Primary outcomes:
measure: Progression free survival
timeFrame: From date of randomization until date of first documented progression; assessed up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Christa H Nyhus, MD
role: STUDY_CHAIR
References: