louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000447: Behavioral/Drug Therapy for Alcohol-Nicotine Dependence (Naltrexone/Nicotine Patch)
Official title: Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Smoking
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol and nicotine dependence.
* Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.
* Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.
* Motivated to quit smoking.
* Willing and able to participate in the 12 week outpatient treatment.
* Acceptable health.
* Able to provide a collateral informant.
* Willing to be followed for 6 months after treatment ends.
* Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up.

Exclusion Criteria:

* Current diagnosis of dependence on other substances except nicotine and alcohol.
* Having moderately severe or severe alcohol withdrawal symptoms.
* Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).
* History of opioid abuse.
* Recent use of cocaine.
* Not desiring to quit smoking.
* Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems.
* History of psychosis.
* Current suicidality, homicidally or psychiatric symptoms requiring other medications.
* Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy.
* Current treatment with psychotropic medications.
* Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Joy Schmitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310347: Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake
Official title: Influence of a Medicinal Cannabinoid Agonist on Behavioural Responses to Food Images and Food Intake: Role of Gut Peptides
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Appetite Regulation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the influence of a medicinal cannabinoid agonist versus placebo on behavioural and gut peptide responses to food images and food intake.


Eligibility criteria: Inclusion Criteria:

For healthy volunteers:

1. 20 ≤ BMI ≤ 25
2. Age 18-60
3. Right handed
4. Stable body weight for at least 3 consecutive months at start of study and no history of behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain

For obese subjects:

1. BMI \> 30
2. Age 18-60
3. Right handed
4. Stable body weight for at least 3 consecutive months at start of the study and no behavioural, therapeutic or surgical treatment aiming at or leading to weight loss/gain for at least 3 consecutive months

For FD patients:

1. FD diagnosis according to 'Rome III' criteria
2. Age 18-60
3. Right handed
4. 5% weight loss since onset of symptoms

Exclusion Criteria:

1. Medical conditions (current or history):

   * Abdominal/thoracic surgery except appendectomy
   * Gastrointestinal, endocrine (especially diabetes), or neurological diseases
   * Cardiovascular, respiratory, renal or urinary diseases
   * Hypertension
   * Food or drug allergies
   * Head trauma with loss of consciousness
2. Psychiatric disorders:

   * Eating disorders
   * Psychotic disorders
   * Major depressive disorder
   * Somatoform disorder
3. Medication use:

   * No history of cannabis use or any other drug of abuse for at least 12 months prior to the study
   * All medication except oral contraception;
4. Known allergy to dronabinol and/or sesam oil
5. Pregnancy, plans to conceive or refusal to take adequate precaution to avoid pregnancy
6. Subjects who refuse to abstain from driving during the study

Primary outcomes:
measure: Behavioural responses to food images and food intake
timeFrame: 2 years
measure: Gut peptide responses
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, campus Gasthuisberg
Study officials:
affiliation: University Hospitals Leuven, campus Gasthuisberg
name: Lukas Van Oudenhove, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weltens N, Depoortere I, Tack J, Van Oudenhove L. Effect of acute Delta9-tetrahydrocannabinol administration on subjective and metabolic hormone responses to food stimuli and food intake in healthy humans: a randomized, placebo-controlled study. Am J Clin Nutr. 2019 Apr 1;109(4):1051-1063. doi: 10.1093/ajcn/nqz007.
Clinical trial NCT00472147: Selection of Shock Energy in Out-Of-Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sudden Cardiac Death
Arrhythmia
Survival
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2007-05-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sudden cardiac death is the most frequent cause of death in industrialized countries. The most efficient interventiont in ventricular fibrillation is defibrillation in an appropriate timely manner. But since the intervention of defibrillation the optimal shock energy is unknown. As a too low energy is not able to terminate ventricular fibrillation a too high energy may cause asystole wich jeopardizes survival itself. We study the efficacy of different shock energies on the termination of ventricular fibrillatiion and survival.


Eligibility criteria: Inclusion Criteria:

* out of hospital sudden cardiac death
* ventricular fibrillation

Exclusion Criteria:

* non cardiac death
* asystole

Primary outcomes:
measure: termination of vf survival
Secondary outcomes:
measure: resulting rhythm CPC score
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité campus Benjamin Franklin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Dirk Müller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03967847: Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Official title: Oral Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rotator Cuff Tear
Postoperative Pain
Keywords: Rotator Cuff Tear
Postoperative Pain
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following arthroscopic rotator cuff repair.
2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following arthroscopic rotator cuff repair.


Eligibility criteria: Inclusion Criteria

1. Patients between the ages of 18 and 89 years old, male or female
2. Patients undergoing primary shoulder arthroscopic rotator cuff repair

Exclusion Criteria

1. Patients below the age of 18 or above the age of 89
2. Illiterate or non-English speaking patients
3. Patients with contraindications to Ketorolac
4. History of alcohol of drug abuse
5. Chronic use of analgesic or psychotropic drugs
6. Known peptic ulcer disease or bleeding diathesis
7. Renal dysfunction

Primary outcomes:
measure: Postoperative Visual Analog Scale Scores
timeFrame: participants were assessed at one single time point up to 8 weeks.
Secondary outcomes:
measure: Number of Participants With Retear of Rotator Cuff Repair
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00664547: Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
Official title: Reduction in Cardiovascular Risk Factors and Visceral Adipose Tissue in Men: Separate Effects of Diet- and Exercise-Induced Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity, exercise, diet, insulin resistance
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2008-04-23
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial was to examine the independent effects of equivalent diet- or exercise-induced weight loss on obesity and related cardiovascular health risk factors. We hypothesized that exercise would result in greater reductions in obesity and health risk factors that equivalent diet (caloric restriction).


Eligibility criteria: Inclusion Criteria:

* Men between 20 and 60 yrs

Exclusion Criteria:

* Smokers and diabetics

Primary outcomes:
measure: Abdominal obesity
timeFrame: 3 months
measure: Insulin Resistance
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert Ross, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross R, Dagnone D, Jones PJ, Smith H, Paddags A, Hudson R, Janssen I. Reduction in obesity and related comorbid conditions after diet-induced weight loss or exercise-induced weight loss in men. A randomized, controlled trial. Ann Intern Med. 2000 Jul 18;133(2):92-103. doi: 10.7326/0003-4819-133-2-200007180-00008.
Clinical trial NCT06414447: Electrocardiogram (ECG) Validation Study
Official title: SANSA Electrocardiogram (ECG) Validation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arrythmia
Lead sponsor: Huxley Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects willing to participate in an ECG diagnostic evaluation

Brief summary: Comparison of diagnostic Electrocardiogram (ECG) signals


Eligibility criteria: INCLUSION CRITERIA

* 18 years of age of older
* Able to read, understand, and sign informed consent documentation willing to wear the Sansa device and 3-lead or 5-lead Holter monitor simultaneously for 24- hours
* In the opinion of the investigator, subject is willing to comply with the protocol

EXCLUSION CRITERIA

* Noted deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would Interfere with sensor placement
* broken or injured skin that would interfere with sensor placement, are known to experience adverse reactions to medical-grade adhesive
* pacemaker dependent
* females who are pregnant (self-reported)

Primary outcomes:
measure: Comparison of the diagnostic Electrocardiogram (ECG) signal quality of the P, QRS and T wave deflections of the Sansa device to a reference standard Holter monitor
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02732847: Trial of Post-Dated Delayed Antibiotic Prescriptions
Official title: Post-Dated Versus Voluntary Delayed Antibiotic Prescriptions for Acute Respiratory Infections in Primary Care: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Upper Respiratory Tract Infections
Keywords: Respiratory infections
Primary care
Antibiotics
Delayed prescriptions
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral).

This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.

Detailed description: 6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether the prescription is cashed, and when.

It is hypothesised that post-dating the prescription will result in a reduced cashing rate.

Each arm of the study (Usual v Post-Dated) will contain 75 subjects. This sample will have the power to detect a 25% change in prescription use.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older
* Adults with an untreated upper respiratory tract infection
* Adults presenting for the first time to a family physician or a nurse practitioner

Exclusion Criteria:

* Less that 18 years
* Having a clear indication for antibiotic therapy

Primary outcomes:
measure: Number of Participants That Filled a Prescription in 20 Days
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: St John's
country: Canada
facility: Memorial University
state: Newfoundland and Labrador
Study officials:
References:
Clinical trial NCT01861847: 7-Keto DHEA for the Treatment of PTSD
Official title: 7-Keto DHEA for the Treatment of PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Lead sponsor: Humanetics Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-24
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing symptoms of Post-Traumatic Stress Disorder (PTSD).

Detailed description: The main purpose of the study is to investigate the possible effect of 7-Keto Dehydroepiandrosterone (7-Keto DHEA) on decreasing Post Traumatic Stress Disorder Symptoms (PTSD) in a Veteran population. The study proposes, based on a 2006 report, that the use of the drug will show significant reduction in overall PTSD symptoms, a decrease in physiological stress response and higher patient-reported quality of life compared to placebo. This is a Phase 2, randomized, double-blind, crossover design with a placebo control. The sponsor for this study is Humanetics Corporation

Eligibility criteria: Inclusion Criteria:

* Veteran status and enrolled for care in the Veteran Health Administration
* Ages 18-64
* Primary diagnosis of PTSD as assess by the clinician administered PTSD scale and independent clinical mental health evaluation

Exclusion Criteria:

* psychosis
* Dementia
* Active alcohol and/or substance abuse or dependence
* Active suicidal or homicidal ideation
* Medical concerns that would exclude use of 7-Keto DHEA

Primary outcomes:
measure: Psychological benefits of 7-Keto DHEA (Dehydroepiandrosterone) in Veterans suffering from PTSD participating in the intervention through questionnaires and corresponding measurement of blood work for amounts of DHEA.
timeFrame: Four months
measure: Physiological benefits of 7-Keto DHEA (Dehydroepiandrosterone) in Veterans suffering from PTSD participating in the intervention through questionnaires and corresponding measurement of blood work for amounts of DHEA.
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
Study officials:
affiliation: Bay Pines VAHCS
name: Alina Gonzalez-Mayo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02323347: Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
Official title: Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progesterone
Fertilization in Vitro
Infertility
Pregnancy
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 1901
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing IVF-ICSI ad fresh embryo transfer

Brief summary: At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program should fresh embryo transfer (ET) be cancelled?

Detailed description: There is still an ongoing debate on the effect of subtle increased P-hCG concentration on pregnancy outcome after fresh ET. No consensus on the cut-off value to define increased P-hCG seems to exist. It is accepted that high P advances endometrium, leading to asynchrony between the implanting embryo and the endometrium, and resulting in implantation failure. A freeze all embryos policy and postponement of ET in subsequent frozen-thawed cycle has been proposed.

Eligibility criteria: Inclusion Criteria:

* Fresh embryo transfer
* Progesterone value on day HCG (Human choriogonadotrophin hormone)

Exclusion Criteria:

* Clinical indication for delaying embryo transfer

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 6 weeks after embryo transfer procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Martinez F, Rodriguez I, Devesa M, Buxaderas R, Gomez MJ, Coroleu B. Should progesterone on the human chorionic gonadotropin day still be measured? Fertil Steril. 2016 Jan;105(1):86-92. doi: 10.1016/j.fertnstert.2015.09.008. Epub 2015 Oct 9.
Clinical trial NCT05988047: Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia
Official title: Analysis of CMTM6 Expression in Patients With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia, Adult
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AML at primary diagnosis ≥ 18 years of age

or

healthy probands ≥ 18 years of age

Brief summary: In this study, we aim to investigate the expression of CKLF like MARVEL transmembrane domain containing 6 (CMTM6) in leukemia cells of patients with acute myeloid leukemia (AML). We will use peripheral blood samples and assess CMTM6 expression by flow cytometry and Western Blot.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* primary diagnosis of acute myeloid leukemia
* diagnosis results available
* written informed consent
* ability to understand the nature of the study and the study related procedures and to comply with them

Exclusion Criteria:

* age \< 18 years
* lack of informed consent

Primary outcomes:
measure: CMTM6 expression (FC)
timeFrame: At primary diagnosis
measure: T cell activation (FC)
timeFrame: At primary diagnosis
Secondary outcomes:
measure: CMTM6 expression (WB)
timeFrame: At primary diagnosis
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Medical Center- University of Freiburg
state: CA
Study officials:
References: