louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00297505: Serotonin, Impulsivity, and Cocaine Dependence Treatment
Official title: Serotonin, Impulsivity, and Cocaine Dependence Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: Cocaine; citalopram; impulsivity; serotonin
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2006-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.

Detailed description: Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.

Eligibility criteria: Inclusion Criteria:

* male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
* female subjects: a negative pregnancy test

Exclusion Criteria:

* current or past DSM-IV Axis I disorder other than substance abuse/dependence
* any serious non-psychiatric medical illness requiring ongoing medical treatment
* substance dependence other than cocaine within the last 3 months
* negative urine drug screen for cocaine at time of testing
* for female subjects: a positive pregnancy test

Primary outcomes:
measure: The presence of cocaine metabolites in urine weekly.
Secondary outcomes:
measure: Retention rate and cocaine cravings weekly.
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - Houston Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Frederick G Moeller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moeller FG, Schmitz JM, Steinberg JL, Green CM, Reist C, Lai LY, Swann AC, Grabowski J. Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2007;33(3):367-78. doi: 10.1080/00952990701313686.
Clinical trial NCT03409705: Effect of Skate Skin Extract on Body Fat in Overweight Adults
Official title: Effect of Skate Skin Extract on Body Fat in Overweight Adults: A RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults

Detailed description: Our aim is to investigate the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults by a randomized, double-blind, and control-group study.

Eligibility criteria: Inclusion Criteria:

* BMI 23\~30 kg/m2

Exclusion Criteria:

* Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
* Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
* Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
* Those who are treated with hypothyroidism or hyperthyroidism
* Creatinine levels: more than twice the normal upper limit
* AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
* Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
* Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
* Participated in the commercial obesity program within the last 3 months.
* If you have participated or are planning to participate in another clinical trial within the past month If yes
* Alcohol abuser
* Smoking abstinence within 3 months
* If they are pregnant or lactating or have a pregnancy plan during the clinical trial
* Those with allergic reactions to the constituent food
* Any person deemed inappropriate by the researcher for other reasons

Primary outcomes:
measure: Body fat percent
timeFrame: Change from baseline body fat percent at 6, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02107105: Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
Official title: Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Adenocarcinoma
Stage I Rectal Cancer AJCC v8
Stage II Rectal Cancer AJCC v8
Stage IIA Rectal Cancer AJCC v8
Stage IIB Rectal Cancer AJCC v8
Stage IIC Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IIIA Rectal Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8
Stage IV Rectal Cancer AJCC v8
Stage IVA Rectal Cancer AJCC v8
Stage IVB Rectal Cancer AJCC v8
Stage IVC Rectal Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 430
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: Patient with stave I-IV rectal adenocarcinoma at the Colorectal Clinic at M D Anderson Cancer Center

Brief summary: This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.

SECONDARY OBJECTIVES:

I. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.

II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.

III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.

OUTLINE:

Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment
* Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English

Exclusion Criteria:

* Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer
* Patient has a concurrent cancer diagnosis at the time of consent
* Patient has recurrent disease

Primary outcomes:
measure: Health state utilities
timeFrame: At 24 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: George J Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04016805: Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Official title: A Phase 2 Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: umbralisib
ublituximab
venetoclax
ibrutinib
CLL
acalabrutinib
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.

Detailed description: This is a Phase 2 open label, two treatment cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with CLL, who fail to achieve MRD negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.

Eligibility criteria: Inclusion Criteria:

* Participants with Chronic Lymphocytic Leukemia (CLL) who have been on treatment for at least 6 months
* Minimal Residual Disease positive at screening
* Adequate organ system function as specified in the protocol
* Ability to follow protocol procedures.

Exclusion Criteria:

* Participants receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1.
* Participants with a known histological transformation
* Active Hepatitis B or Hepatitis C.

Primary outcomes:
measure: Rate of Undetected Minimal Residual Disease (U-MRD)
timeFrame: Up to approximately 23 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 34 months
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
timeFrame: Up to approximately 34 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Massachusetts
city: Hackensack
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: New York
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
Study officials:
References:
Clinical trial NCT01936805: ROsuvastatin LOading and Clinical Outcomes Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 299
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 aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel revascularization (TVR), or stroke.


Eligibility criteria: Inclusion Criteria:

* statin-naive patients
* stable ischemic heart disease
* de novo lesions appropriate for PCI

Exclusion Criteria:

* current statin use
* statin allergic patients
* acute coronary syndromes
* lesions not appropriate for PCI
* refusal for participation
* statin quitting during follow- up

Primary outcomes:
measure: all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke
timeFrame: 4 year
Secondary outcomes:
measure: all cause death
timeFrame: 4 year
measure: composite of death or myocardial infarction from CV causes, TVR, or stroke
timeFrame: 4 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yuksek Ihtisas Hospital
state: Altindag
Study officials:
References:
Clinical trial NCT01216605: Oxytocin and Emotion Recognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Health
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study was designed to investigate the effects of a single dose of synthetic oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary the level of awareness. In a randomized placebo-controlled between-subject design, recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition. We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed with limited awareness.


Eligibility criteria: Inclusion Criteria:

* Males
* 18 to 40 years of age

Exclusion Criteria:

* Any psychiatric diagnosis life-time
* Somatic disease
* IQ \< 85
* Smoker
* Psychoactive medication

Primary outcomes:
measure: Performance on a facial emotion recognition task
timeFrame: 45 min. following drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Department of PSychiatry University of Rostock
state: D
Study officials:
affiliation: University of Freiburg
name: Gregor Domes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518505: Assessing Outcomes After Surgery for Gastroesophageal Reflux Disorder
Official title: Long and Short Term Outcomes After Laparoscopic Surgery for Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux Disorder
Keywords: GERD, laparoscopic surgery
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2007-08-20
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. This will allow us to evaluate how patients have benefited from the procedure.

Detailed description: This study will include all patients who have laparoscopic surgery for gastroesophageal reflux disorder. Patients who participate will be asked to answer questionnaires regarding symptoms of reflux before and after surgery. In addition medical charts will be reviewed for relevant data.

Eligibility criteria: Inclusion Criteria:

* patients must have GERD and must plan to have laparoscopic surgery for GERD.
* patients must be at least 18 years of age

Primary outcomes:
measure: The objective of this study is to review pre-operative studies and evaluation reports and compare those with post-operative studies and evaluation reports to evaluate outcome following laparoscopic surgery for GERD.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital/University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Alexander S Rosemurgy, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03981705: Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
Official title: Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TN ER-/PR-/HER2- Breast Cancer
Triple Negative Breast Cancer
HER2-positive Breast Cancer
ERany/PRany/HER2+ Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 8
Sex: FEMALE
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: Study entry is open to women 18 years of age and older regardless of race or ethnic background. While there will be every effort to seek out and include minority patients, the patient population is expected reflect those at the University of Minnesota with triple negative or HER2+ breast cancer.

Brief summary: This is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned
* A biopsy clip placed at the time of diagnostic biopsy
* 18 years of age or older
* Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation
* Able to provide written consent prior to any research related activities

Exclusion Criteria:

* Stage IV breast cancer
* T4 breast cancer
* Previous ipsilateral breast cancer
* Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery

Primary outcomes:
measure: Complete Pathologic Response (pCR)
timeFrame: 6 Months Post Surgery
Secondary outcomes:
measure: Complications and Side Effects of the Needle Biopsy Procedure after NAC
timeFrame: 6 Months Post Surgery
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: Department of Surgery, University of Minnesota
name: Todd Tuttle, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693705: Outcome Evaluation of Patients After Percutaneous Tracheostomy Due to Respiratory Failure in an Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Insufficiency
Keywords: Tracheostomy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-09-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with respiratory failure who were mechanically ventilated in the critical care unit

Brief summary: To determine the morbidity and mortality of patients who have undergone percutaneous tracheostomy due to respiratory failure in the critical care unit and after intensive care in the internal medicine department, including follow-up of quality of life of these patients.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated critical care patients

Exclusion Criteria:

* All others

Primary outcomes:
measure: Number of patients with tracheostomy due to respiratory failure who died
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT01879605: Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery
Official title: Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Ileus
Surgery
Keywords: Spinal surgery
Bowel preparation
Ileus
Constipation
Well-being
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.

Detailed description: This was a randomised clinical trial with one control group and two treatment groups.

Forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing spinal fusion surgery
* Age 15 years or older
* The patients had to understand oral and written Norwegian.
* Postoperative pain management via epidural catheter should have been planned.
* Exclusion Criteria:
* Constipation
* Regularly use of enema

Primary outcomes:
measure: Defecation within 72 hours postoperatively
timeFrame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Secondary outcomes:
measure: Postoperative constipation
timeFrame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Other outcomes:
measure: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
timeFrame: Nausea
measure: Pain
timeFrame: The study's outcome measures were recorded every evening between 17.00 and 21.00 hours
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus
Study officials:
affiliation: University of Oslo, Institute of Health and society
name: Ida T Bjork, MNSc, PhD,
role: PRINCIPAL_INVESTIGATOR
References: