louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00429689: Hormonal Levels in Men With Major Depressive Disorder
Official title: Hormonal Levels in Men With Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Depression
Keywords: Male, MDD, Testosterone, DHEA-S,Cortisol
Male
18-65
Major Depression
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-02-01
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men diagnosed with Major depression disorder

Brief summary: Subjects will be 1000 men meeting the following inclusion criteria: 1) male, age 18-65 years; 2) meeting DSM-IV criteria for major depressive disorder within the past one year, with a HAM-D score \>12.

Subjects will be excluded if they exhibit 1) a substance abuse or dependence disorder within the past year; 2) current psychotic symptoms; or 3) a history of bipolar disorder.

Procedure

After informed consent, eligible patients will have blood drawn for serum hormone levels; cortisol, DHEA-S and testosterone or they will provide a salivary sample for measurement of hormone levels.

We will also test hormone level form 1000 healthy males (from blood or saliva) at the same age for comparison.


Eligibility criteria: Inclusion Criteria:

* Male
* Major Depression Disorder
* 18-65

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West End Medical Associates
name: Stuart Seidman,, MD
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Revital Amiaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04995289: Prone Position During ECMO in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Hypoxaemic Patient
Official title: Prone Position During ECMO in Covid Hypoxaemic Patient :A PROCESS-compliant Case Series From the Eastern Morocco
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
Hypoxemic Respiratory Failure
Keywords: ECMO
ARDS
Prone position
COVID
compliance
Lead sponsor: Mohammed VI University Hospital
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 23 patients admitted to the intensive care unit of different genders and ethnicities were included.

Brief summary: Introduction:

The main manifestation of COVID-19 pneumonia is acute respiratory distress syndrome (ARDS), which in some cases can be more severe than intubation, extracorporeal membrane venous oxygenation (VV-ECMO) to ensure hematosis. Despite support from VV-ECMO, some patients may remain hypoxemic. One possible therapeutic procedure for these patients is the application of the prone position.

Objective:

The main aim of this study was to investigate the modification of the PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO with refractory hypoxemia. The secondary objective was to evaluate the safety and feasibility of the inclined position for ECMO.

Methods:

the investigators reviewed the electronic records and lists of all 23 COVID-19 patients. were placed for the first time in PP with an average duration of 16 h . patient characteristics, pre-ECMO characteristics, ventilator/ECMO settings, and changes in ventilator/ECMO settings and blood gas analysis before and after PP.

Detailed description: The main objective of the current study was to investigate the change in PaO2/FiO2 ratio, the compliance of the respiratory system in VV-ECMO patients with persistent hypoxemia. Measurements were taken before PP, 1 h after the start of the PP, at the end of the PP cycle.

The secondary objective of this study was to assess the safety and feasibility of emergency positioning for patients with severe ARDS during ECMO treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of SARS COV 2 infection complicated by ARDS, and needed a VV ECMO.
* patient who presented refractory hypoxemia during VV ECMO.

Exclusion Criteria:

* patient who has received ECMO V-A or ECMO VV for reasons other than ARDS.

Primary outcomes:
measure: amelioration of PaO2/FiO2
timeFrame: through study completion, an average of 1 yea
Secondary outcomes:
Other outcomes:
Locations:
city: Berkane
country: Morocco
facility: younes Oujidi
Study officials:
References:
Clinical trial NCT05573789: Tumor Molecular Profiling in Patients With Prostate Cancer
Official title: Investigation of Mutations in DNA Damage Repair Genes and Other Actionable Molecular Aberrations as Biomarkers in Patients With Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Metastatic Prostate Adenocarcinoma
Keywords: tumor molecular profiling
Mutations
homologous recombination repair
BRCA2
Prognostic
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: NIPD Genetics
First posted: 2022-10-10
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent locally advanced, metastatic and/or high-grade operable prostate cancer

Brief summary: The aim of the study was to evaluate the prevalence, the prognostic and predictive value of gene alterations in unselected patients with prostate cancer. Patients with histologically confirmed prostate cancer, treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments, were included. The presence of gene alterations was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic.

Detailed description: Data on tumor molecular profiling of European patients with prostate cancer is limited. The aim of the study was to evaluate the prevalence, the prognostic and predictive value of gene alterations in unselected patients with prostate cancer. Patients with histologically confirmed prostate cancer, treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments, were included. The presence of gene alterations was assessed using the ForeSENTIA® Prostate panel developed by NIPD Genetic. The primary endpoint was the prevalence of gene alterations in homologous recombination repair (HRR) genes. Secondary endpoint was overall survival.

Eligibility criteria: Inclusion Criteria:

Metastatic prostate cancer Recurrent prostate cancer Locally advanced prostate cancer High-risk operable prostate cancer Available FFPE tumor tissue

Exclusion Criteria:

Absence of tumor tissue available for analysis Lack of informed consent Lack of clinicopathological data

Primary outcomes:
measure: Overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Prevalence of somatic mutations in clinically relevant genes
timeFrame: 3 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Cooperative Oncology Group
Study officials:
References:
Clinical trial NCT05750589: Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections
Official title: Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Retinal Disease
Lead sponsor: iRenix Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to IRX-101 or Providone-Iodine
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.


Eligibility criteria: Inclusion Criteria:

1. Capable of giving informed consent
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes

Exclusion Criteria:

1. Current or past diagnosis of endophthalmitis
2. Current diagnosis of uveitis
3. Monocular patients (vision 20/100 or worse in one eye) who are receiving injections in the better seeing eye
4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT
5. Currently receiving intravitreal steroid injections
6. Concurrent participation in another clinical trial
7. Females who are pregnant, planning to become pregnant or lactating

Primary outcomes:
measure: Assessment of post-intravitreal injection eye pain
timeFrame: Demonstrate a reduction in mean 1-hr post-injection pain scores
Secondary outcomes:
measure: Change in post-IVT corneal epitheliopathy as evaluated by corneal fluorescein staining scores
timeFrame: Immediately following intraviteral injection
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: R. Gary Lane, II MD
state: Texas
Study officials:
affiliation: Founder
name: Stephen Smith, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01326689: A Comparative Study of KW-2246
Official title: Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer Related Pain (Breakthrough Pain)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of KW-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Have been treated with opioid analgesic on a fixed-schedule at a stable daily dose
* Receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled
* ECOG PS =\< 3

Exclusion Criteria:

* Currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics
* Severe respiratory dysfunction
* Asthma
* Severe bradyarrhythmia
* Severe hepatic function disorder
* Severe renal function disorder
* Severe psychoneurotic disorder
* Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor

Primary outcomes:
measure: Pain intensity difference
timeFrame: 30 minutes after each dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
citation: Shimoyama N, Gomyo I, Katakami N, Okada M, Yukitoshi N, Ohta E, Shimoyama M. Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. Int J Clin Oncol. 2015 Feb;20(1):198-206. doi: 10.1007/s10147-014-0697-z. Epub 2014 May 20.
Clinical trial NCT00849589: Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
Official title: Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alcohol Abuse
Risk Behavior
Keywords: Screening
Brief intervention
Underage drinking
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Cambridge Health Alliance
name: Dartmouth-Hitchcock Medical Center
name: Fallon Clinic
name: Tufts Medical Center
name: University of Vermont
First posted: 2009-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).

Detailed description: The specific aims of the proposed multisite RCT are:

1. To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;
2. To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;
3. To identify moderators, mediators, and optimal responders to the SBA/TE interventions;
4. To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.

Eligibility criteria: Inclusion Criteria:

* 12-21 years old
* patients arriving for routine medical care
* provide informed assent (for those \<18) or informed consent (for those 18-21)

Exclusion Criteria:

* medically or psychologically unstable at time of visit
* receiving behavioral health services
* cannot read or understand English at a 6th grade reading level
* unavailable for follow-up assessments

Primary outcomes:
measure: Initiation of underage drinking
timeFrame: Baseline, 3-months, 6-months, 12-months
Secondary outcomes:
measure: Cessation of underage drinking
timeFrame: Baseline, 3-months, 6-months, 12-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R. Knight, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01205789: EXCEL Clinical Trial (Universal Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Coronary Occlusion
Left Main Coronary Artery Disease
Stent Thrombosis
Vascular Disease
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Keywords: Drug eluting stents
Stents
Angioplasty
Left Main Coronary Artery Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 1000
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: Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions

Brief summary: The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.

Detailed description: Approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended PCI, CABG or medical treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry

Primary outcomes:
measure: This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study.
timeFrame: At the time of enrollment into the study
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Abbott Vascular
state: California
Study officials:
affiliation: Columbia University
name: Gregg W Stone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Patrick W Serruys, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinical Main Campus
name: Joseph Sabik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: A. Pieter Kappetein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06638489: Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence
Official title: Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence: A Pilot for Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the impact of High-Intensity Focused Electromagnetic Therapy (HIFEM) combined with Pelvic Floor Muscle Training (PFMT) versus PFMT alone on urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence. Women aged 30 years or older exhibiting symptoms of stress urinary incontinence were randomized into two treatment groups. The experimental group received both HIFEM and PFMT, while the control group received only PFMT. The treatment continued for 6 weeks. Evaluations measured at baseline and post-intervention included the 1-hour Pad Test, the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), and sonography to assess bladder neck movement.


Eligibility criteria: Inclusion Criteria:

* Primipara or Multipara women aged 30 years or older with symptoms of stress urinary incontinence;

Exclusion Criteria:

* Those who had any contraindication for High-Intensity-Focused-Electromagnetic-Therapy (HIFEM);
* prior surgery for incontinence;
* taking drugs for bladder dysfunction or diuretics;
* hormone therapy;
* urgent or mixed urinary incontinence;
* incontinence associated with a neurologic condition;
* inability to perform voluntary pelvic floor muscle contractions;
* cognitive impairment or dementia, major neurological disorders (such as stroke, cerebral palsy, multiple sclerosis);
* inability to carry out the treatment or evaluation;
* uncontrolled hypertension.

Primary outcomes:
measure: 1-hour pad test
timeFrame: Baseline and the end of the 6-week intervention
Secondary outcomes:
measure: International Consultation on Urinary Incontinence questionnaire (ICIQ-UI-SF)
timeFrame: Baseline and the end of the 6-week intervention
measure: Bladder neck movement
timeFrame: Baseline and the end of the 6-week intervention
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Metropolitan University
state: Hong Kong
Study officials:
References:
Clinical trial NCT02900989: Validation of the French Version of Ask Suicide-Screening Questions (ASQ) in Adolescents Managed in Pediatric Emergency Unit
Official title: Etude de Validation de la Version française d'un Questionnaire " Ask Suicide-Screening Questions " (ASQ) Dans Une Population de Patients Adolescents Pris en Charge en unité d'Urgences pédiatriques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Keywords: Psychiatry
Pediatrics
Suicide
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use of this brief valid screening instrument could assess the risk for suicide in pediatric patients and then improve the prevention of suicidal tendencies in this population.

Detailed description: ASQ-Fr is a prospective, cross-sectional instrument-validation study evaluated 5 candidate screening questions assessing suicide risk in adolescents between 10 and 18 years of age managed in two urban, pediatric emergency departments associated with tertiary care hospitals.

ASQ-Fr questionnaire is conducted by a psychologist before or after the French version of the SIQ/SIQ Junior (Suicidal Ideation Questionnaire), depending on the randomisation in the unit. SIQ is composed of 30 items and valid for adolescents aged 15 years or more. SIQ Junior is composed of 15 items and valid for children up to 14 years old.

Questionnaires are followed by an interview in adolescents and parents separately by the psychologist to evaluate perceptions, feasibility and acceptability of questionnaires.

It is planned a convenience sample of 200 patients aged 10 to 18 years who presented with either medical or surgical chief concerns to the emergency department.

Eligibility criteria: Inclusion Criteria:

* patient with informed consent of adolescents and at least one of parents or a guardian
* patient with social protection cover
* in adequation with emergency management

Exclusion Criteria:

* patients with mental disorder
* minor without parent/gardian at the emergency unit

Primary outcomes:
measure: Proportion of adolescents detected at suicide risk by the French version of Ask Suicide-Screening Questions and by the SIQ or SIQ Junior
timeFrame: 6 months
Secondary outcomes:
measure: Type and proportion of answers about perceptions by parents of a questionnaire on suicidal ideation conducted in their child
timeFrame: 6 months
measure: Type and proportion of answers about perceptions by adolescent of the questionnaires
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: Centre Hospitalier Universitaire de La Réunion
Study officials:
affiliation: INSERM U1178
name: Erick Gokalsing, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01735929: Combination of Ultrasound Treatment and Neck Liposuction for Skin Tightening
Official title: Evaluating the Combined Skin Tightening Benefit of Non-Invasive Ultrasound Treatment and Neck Liposuction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin Laxity
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the effectiveness of ultrasound treatment and liposuction combined on skin tightening around the neck.


Eligibility criteria: Inclusion Criteria:

* Women 35-60 years old
* Exhibit mild to moderate neck skin laxity on clinical examination
* No other serious health problems, including psychiatric illness.

Exclusion Criteria:

* Prior neck surgery or face lift.
* Bleeding disorders or coagulopathy.
* Botulinum toxin or filler injections to neck area within past 6 months.
* Severe neck skin laxity or sagging
* Other serious medical conditions that in the opinion of the surgeon could compromise safety

Primary outcomes:
measure: Change from baseline in photo ratings at 8 weeks.
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: