louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01830218: Obstetric Anesthesia and Analgesia Month Attributes in Czech Republic
Official title: A National Survey on Obstetric Anesthesia and Analgesia Care in Czech Republic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Anesthesia Care
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Masaryk University
name: General University Hospital, Prague
name: Brno University Hospital
First posted: 2013-04-12
Enrollment: 1940
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in labor

Brief summary: A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic.

Detailed description: A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic.

Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.

Eligibility criteria: Inclusion Criteria:

Women in labor undergoing anesthesia care

Primary outcomes:
measure: A national survey of current practice of obstetric anesthesia and analgesia in Czech Republic
timeFrame: Parturition period, up to 24 hours after labor
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: University Hospital Brno
Study officials:
affiliation: ESPAA
name: Petr Stourac, MD, PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT02633618: Analgecine for the Treatment of Neuropathic Pain
Official title: The Clinical Study of Analgecine for the Treatment of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropathic Pain
Lead sponsor: VanWorld Pharmaceutical (Rugao) Company Limited
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 135
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: A randomized, open-label , positive drug controlled (Neurotropin,Japan organs Pharmaceutical Co., Ltd. ), multi-center study to evaluate Analgecine's efficacy and safety for the treatment of neuropathic pain.

Detailed description: The study was designed to evaluate the efficacy and safety of Analgecine for the treatment of neuropathic pain for 2 weeks. It was a randomized, open-label , positive drug controlled, multi-center study phase III clinical trial. Patients were recruited with age between 18 and 80 and visual analysis scale (VAS) between 3 and 8. After randomization, subjects were divided into 2 groups: 1) Treatment with Analgecine as experiment group; 2) Treatment with Neurotropin as positive control group. There are 3 measurement time points on day 0, 7, 14 after treatment to score patients pain with VAS. The changes of the VAS score at day 14 were compared between groups.

Eligibility criteria: Inclusion Criteria:

1. Patients with the established medical records;
2. Patients with age of 18 years to 80 years old.
3. Patients with neuropathic pain
4. Patients at child-bearing age with negative pregnancy tests and contraceptive measures ( oral or injectable contraceptives) taken throughout the course of the experiment
5. Patients with signed informed consent.

Exclusion Criteria:

1. Patients younger than 18 years old or older 80 years old
2. Patients of dementia who can not determine efficacy
3. Patients who was pregnant, nursing or who may become pregnant in the study course and did not take effective contraceptive measures.
4. Patients with the history of allergic reactions
5. Patients suffering from tuberculosis, cancer and other organic disease
6. Patients who are alcoholics and drug addicts
7. Others who were determined by physician not to be a candidate for this clinical observation

Primary outcomes:
measure: Change of visual analog scale on pain
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Lu-Ning Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT03717818: Mechanisms of Change in Brief Treatment for Borderline Personality Disorder
Official title: Mechanisms of Change in Brief Treatment for Borderline Personality Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present two-arm randomized controlled study aims at testing the effects (i.e., symptom reduction) and the underlying mechanisms of change associated with a brief psychiatric treatment (10 sessions over 4 months), compared with treatment as usual. Participants undergo assessments at four points (intake, 2 months, discharge and 12 month follow-up). In addition to symptom measures, all individuals undergo a two-step assessment for the potential mechanisms of change (i.e., emotion and socio-cognitive processing): a) behavioural and b) neurofunctional. We hypothesize that change in the mechanisms explains the treatment effects. The present study uses an innovative treatment of BPD and at the same time a sophisticated assessment procedure to demonstrate the critical role of psychobiological change in emotion and sociocognitive processing in brief treatments. It will help increase the effectiveness of initial treatment phase for BPD and help diminish the societal burden of disease related with BPD. This study is funded by the Swiss National Science Foundation (SNSF).


Eligibility criteria: Inclusion Criteria:

* Borderline Personality Disorder
* age between 18 and 35

Exclusion Criteria:

* non-mastery in French
* neurological disorders
* schizophrenia (according to DSM-5)

Primary outcomes:
measure: ZAN-BPD (Zanarini Borderline Personality Disorder Scale; Zanarini, 2003)
timeFrame: 4 months
Secondary outcomes:
measure: OQ-45 (Outcome Questionnaire-45.2, Lambert et al., 2004)
timeFrame: 4 months
measure: BSL-23 (Borderline Symptom List, Short Version; Bohus et al., 2009)
timeFrame: 4 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Psychiatry-CHUV, University of Lausanne
state: VD
Study officials:
References:
citation: Kramer U, Kolly S, Maillard P, Pascual-Leone A, Samson AC, Schmitt R, Bernini A, Allenbach G, Charbon P, de Roten Y, Conus P, Despland JN, Draganski B. Change in Emotional and Theory of Mind Processing in Borderline Personality Disorder: A Pilot Study. J Nerv Ment Dis. 2018 Dec;206(12):935-943. doi: 10.1097/NMD.0000000000000905.
citation: Kramer U, Grandjean L, Beuchat H, Kolly S, Conus P, de Roten Y, Draganski B, Despland JN. Mechanisms of change in brief treatments for borderline personality disorder: a protocol of a randomized controlled trial. Trials. 2020 Apr 16;21(1):335. doi: 10.1186/s13063-020-4229-z.
Clinical trial NCT01074918: Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients
Official title: Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients; Role of Natriuresis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Pre-hypertension
Hypertension
Keywords: Pre-hypertension
Hypertension
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.


Eligibility criteria: Inclusion Criteria:

* Age greater than 21 years
* BMI \> 18.5 kg/m2 and \< 40 kg/m2
* Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg
* Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial.

Exclusion Criteria:

* Taking blood pressure lowering medication
* Diabetes mellitus
* Renal disease
* Active cardiac disease
* Active liver disease
* Chronic diarrhea
* Chronic NSAID use
* Active or suspected drug use
* Uncontrolled psychiatric disease
* HIV infection
* Missed more than 20% of clinic visits in the last yr
* Prescription of diuretics for any reason
* A patient taking nutritional supplements including multivitamins that is unwilling to discontinue them,\\
* Consumption of greater than 14 alcoholic beverages per week

Primary outcomes:
measure: Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT02508818: Cardiovascular Response to Orthostatic Fractional Gravity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There are no equivalent experiment setups to create comparable changes of gravitation such as during parabolic flights. To determine the initial orthostatic responses of the cardiovascular system under the gravitational conditions of mars and moon is an essential step for a better understanding of 1) the fundamental functions of the human cardiovascular system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels in a spaceflight-context 3) approaches for countermeasure development against orthostatic intolerance on moon and mars (applied research).

Non-invasive measurement methods will be used to achieve the cardiovascular key values of the study: stroke volume (SV) and cardiac output determination by pulse contour analysis, impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure measurement, heart rate and heart rate variability determination by ECG. All of these methods have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and impedance cardiography are known to provide only relative SV and CO values. Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to absolute values. Success of this procedure was shown during former parabolic flights.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 55
* Affiliated to a Social Security System
* Who accepted to take part in the study
* Who have given their written stated consent
* Who already participated in parabolic flights or performed a centrifuge run up to 4 G with head movements without occurrence of serious nausea or vomiting or cardiovascular discomfort.
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women
* Medication with beta blockers, ACE inhibitors, calcium channel blockers or diuretics.

Primary outcomes:
measure: systolic finger blood pressure
timeFrame: baseline
measure: Heart rate
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT00691418: Docosahexaenoic Acid (DHA) Administration and Length of Gestation: a Feasibility Study
Official title: DHA Administration and Length of Gestation: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Premature Birth
Keywords: perinatal
premature
pregnancy
gestation
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2008-06-05
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a feasibility study to determine if it will be possible to conduct a larger study of the effect of docosahexaenoic acid (DHA), an omega fatty acid, on increased length of gestation among women who have had a previous preterm delivery.

Detailed description: We propose to conduct an 18-month feasibility study to determine (a) how many women we could approach during a 4-month period, (b) how many of these women would be eligible for a future RCT, (c) how many would consent to participate in the RCT, and (d) how many would be subsequently rendered ineligible due to poor compliance. Women enrolled during the 4-month recruitment period would be followed until 1 month after delivery using telephone contact (for assessing compliance) and scanning of KPMCP electronic databases (for quantifying outcomes). We hope to enroll 50 to 75 women during our fixed time (4 months) recruitment period. Half of these 50-75 women would receive DHA; half would receive placebo.

We will identify potential subjects based on their response to the Preterm Birth Prevention Program questionnaire (a screening instrument administered by the Regional Perinatal Service Center \[RPSC\] to all women in the KPMCP entering prenatal care). Eligible women are those pregnant women entering prenatal care who, based on their response to the abovementioned RPSC questionnaire, are identified as having had a previous preterm delivery (delivery prior to 37 completed weeks of gestation).

Results of this study will (a) permit us to determine whether an RCT is feasible at a reasonable cost, and (b) assuming the answer to (a) is positive, it would then be possible for us to design an RCT that could address our primary study question.

Eligibility criteria: Inclusion Criteria:

* Previous preterm delivery (delivery prior to 37 completed weeks of gestation)

Exclusion Criteria:

* None

Primary outcomes:
measure: Is daily intake of 600 mg per day of docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid, beginning at 22-24 weeks gestation, associated with increased length of gestation among women who have had a previous preterm delivery?
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Gabriel Escobar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02963818: Smartphone Technology: Young Adult Drinking
Official title: Smartphone Technology Effects on Alcohol Drinking Among Young (STEADY) Adults Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alcohol Use
Alcohol Drinking
Drinking Behavior
Keywords: Brief intervention
Harm reduction
Young adult
College Student
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-11-15
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Exploring technology based tools to reduce drinking is important. The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment. Participation in this study will last approximately two months.


Eligibility criteria: Inclusion Criteria:

* Be able to read/write English and complete study assessments
* Drink alcohol regularly

Exclusion Criteria:

* Test positive on a urine test for use of certain illegal drugs
* Undergraduate student enrolled at the University of Florida
* Graduate students from the College of Health and Human Performance at the University of Florida
* Pregnant, or currently breast feeding

Primary outcomes:
measure: Quantity of alcohol consumption
timeFrame: During one alcohol drinking session, an average of 2 hours
Secondary outcomes:
measure: Quantity of alcohol consumption
timeFrame: two-week field period
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: EDGE Laboratory
state: Florida
Study officials:
affiliation: University of Florida
name: Robert F Leeman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leeman RF, Berey BL, Frohe T, Rowland BHP, Martens MP, Fucito LM, Stellefson M, Nixon SJ, O'Malley SS. A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Psychol Addict Behav. 2022 Sep;36(6):710-723. doi: 10.1037/adb0000780. Epub 2021 Nov 11.
Clinical trial NCT00280618: Oxaliplatin in Unresectable Hepatocellular Carcinoma
Official title: Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-01-23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary:

* To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin

Secondary:

* Safety and tolerability of this regimen in these patients


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed hepatocellular carcinoma
* Patients must have measurable disease by CT scan
* Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.
* The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.
* WHO performance status: 0 to 2
* Patients must have adequate organ and marrow function as defined below:

  * Leukocytes : ≥ 3,000/μl
  * Absolute neutrophil count :≥ 1,500/μl
  * Platelets : ≥ 80,000/μl
  * Total bilirubin : \< 3.0g/dl
  * ASAT/ALAT : ≤ 3 times the upper normal limits of the institute
  * Creatinine : \< 120μmol/l
* Patients with no evidence of clinically significant neuropathy.

Exclusion Criteria:

* Documented allergy to platinum compound or to others study's drugs
* Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
* Hematological disorder or malignancies
* Metastasis to central nervous system
* Other serious illness or medical conditions:

  * Active infectious disease
  * Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.
* Concurrent treatment with any other anticancer therapy
* Concurrent treatment with other experimental drugs.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST
timeFrame: During the Study Conduct
Secondary outcomes:
measure: Adverse Events collections and evaluation
timeFrame: From the signature of the informed consent up to the end of the study
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Pingkuan Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05862818: Can Food Timing Reduce Your Diabetes Risk?
Official title: Can Food Timing Reduce Your Diabetes Risk?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dietary Habits
Keywords: Glucose tolerance
Diet-induced thermogenesis
Fat tolerance
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants.

Participants will:

* complete 2 inpatient stays
* be provided with test meals
* have frequent blood draws

Detailed description: The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.

Eligibility criteria: Inclusion Criteria:

* Healthy with no acute or chronic medical and psychiatric disorders
* BMI: 18.5-29.9 kg/m2

Exclusion Criteria:

* Smokers, current tobacco or e-cigarette use
* Drug or alcohol dependency
* Pregnant

Primary outcomes:
measure: Difference in glucose tolerance between Meal Conditions and Shift Work
timeFrame: 24 hours
measure: Difference in diet-induced thermogenesis between Meal Conditions and Shift Work
timeFrame: 24 hours
measure: Difference in plasma triglyceride level between Meal Conditions and Shift Work
timeFrame: 24 hours
Secondary outcomes:
measure: Difference in insulin sensitivity between Meal Conditions and Shift Work
timeFrame: 24 hours
measure: Difference in beta-cell function between Meal Conditions and Shift Work
timeFrame: 24 hours
measure: Difference in 24-h glycemia between Meal Conditions and Shift Work
timeFrame: 24 hours
measure: Difference in postprandial incretin level between Meal Conditions and Shift Work
timeFrame: 24 hours
measure: Difference in substrate oxidation between Meal Conditions and Shift Work
timeFrame: 24 hours
measure: Difference in plasma free fatty acids level between Meal Conditions and Shift Work
timeFrame: 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References: