louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01994343: Pain in Women With Chronic Pelvic Pain
Official title: Musculoskeletal Disturbances in Women With Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pelvic pain, women, pain, posture.
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pelvis pain is very common between adult women. Significant progress is made in clarifying the multifactorial model of chronic pain pathogenesis, but a more complete assessment is important in order to improve the therapeutic approach. The purpose of this study is stablish a clinical and symptomatological profile of women with chronic pelvic pain.

Detailed description: Chronic pelvic pain is defined as non-menstrual or noncyclic pelvic pain with duration of at least 6 months. This pain interfere with habitual activities and requires clinical or surgical treatment. It is a complex interaction between the gastrointestinal, urinary, gynecologic, musculoskeletal, neurologic and endocrine systems influenced by psychological factors. Its prevalence range between 3 and 8% among women aged 15-73 years, ranging from 14 to 24% among women of reproductive age. It is very important a multidimensional approach in order to stablish a more specific profile.

Eligibility criteria: Inclusion Criteria:

* Women.
* Clinical diagnosis of chronic pelvic pain.
* More than eighteen years.
* Non-menstrual or noncyclic pelvic pain.
* Duration of pain of at least 6 months.

Exclusion Criteria:

* Duration of pain less than 6 months.
* Women who were pregnant in the last 12 months

Primary outcomes:
measure: Change in postural control
timeFrame: Change from baseline postural control at 8 weeks
Secondary outcomes:
measure: Nervous assessment
timeFrame: baseline
measure: Spinal assessment
timeFrame: baseline
measure: Balance under dual task conditions
timeFrame: Baseline, 8 weeks
measure: Trigger points evaluation
timeFrame: baseline
measure: Self perceived health status
timeFrame: Baseline, 8 weeks.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Torres J, Lopez-Lopez L, Cabrera-Martos I, Prados-Roman E, Granados-Santiago M, Valenza MC. Effects of an Individualized Comprehensive Rehabilitation Program on Impaired Postural Control in Women With Chronic Pelvic Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Aug;101(8):1304-1312. doi: 10.1016/j.apmr.2020.02.019. Epub 2020 Apr 20.
citation: Fuentes-Marquez P, Valenza MC, Cabrera-Martos I, Rios-Sanchez A, Ocon-Hernandez O. Trigger Points, Pressure Pain Hyperalgesia, and Mechanosensitivity of Neural Tissue in Women with Chronic Pelvic Pain. Pain Med. 2019 Jan 1;20(1):5-13. doi: 10.1093/pm/pnx206.
Clinical trial NCT02298543: Coronary Spasm Presenting Aborted Sudden Cardiac Death, the Multicenter Registry
Official title: The Multicenter Registry to Evaluate the Natural Course of Coronary Spasm Patients Presenting Aborted Sudden Cardiac Death
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Vasospasm
Cardiac Death
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with coronary spasm

Brief summary: The purpose of this study is to evaluate the natural course of coronary spasm patients presenting aborted sudden cardiac death and analyze risk factors.


Eligibility criteria: Inclusion Criteria:

* Age 18 and more
* Coronary spasm

Exclusion Criteria:

* Life expectancy less than 2years
* Coronary stenosis 50% and more
* Structural abnormalities of the heart leading to ventricular arrhythmia

Primary outcomes:
measure: all cause death
timeFrame: 1 year
measure: myocardial infarction
timeFrame: 1 year
measure: ventricular tachycardia
timeFrame: 1 year
measure: ventricular Fibrillation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References:
Clinical trial NCT06437743: Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery
Official title: Monitoring Nociception Using NoL Index and Its Implications in Reducing Opioid-Related Complications in Laparoscopic Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Opioid-related Complications
Keywords: Nociception, NoL Index, Opioids, Postoperative Complications, Laparoscopic Surgery
Lead sponsor: Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
Sponsor class: NETWORK
First posted: 2024-05-31
Enrollment: 282
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: The study population includes adult patients scheduled for elective laparoscopic abdominal surgery at participating hospitals. The population will consist of individuals who meet the inclusion criteria and have consented to participate in the study.

Brief summary: This study aims to determine if optimal intraoperative nociception monitoring using the NoL index can reduce postoperative complications related to opioid use in laparoscopic abdominal surgery. The hypothesis is that guided nociception monitoring decreases opioid-related complications and improves postoperative outcomes.

Detailed description: The study is a prospective, observational cohort study conducted across multiple centers. It aims to evaluate the impact of intraoperative nociception monitoring on postoperative opioid-related complications. The study will involve two groups of patients undergoing laparoscopic abdominal surgery: one group with visible NoL monitoring and another with non-visible NoL monitoring.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Scheduled for laparoscopic abdominal surgery
* Undergoing balanced general anesthesia
* ASA physical status I-III
* Signed informed consent

Exclusion Criteria:

* Refusal to participate
* Communication barriers
* Multimodal, opioid-free, or regional epidural anesthesia
* ASA IV or V
* Pregnant or breastfeeding women
* Open or emergency abdominal surgery
* Post-surgery transfer to ICU or Recovery Unit

Primary outcomes:
measure: Reduction in Postoperative Opioid-Related Complications
timeFrame: From the end of surgery up to 48 hours postoperatively
Secondary outcomes:
measure: Intraoperative Opioid Consumption
timeFrame: During the surgical procedure
measure: Postoperative Pain Scores
timeFrame: At 1, 6, 12, 24, and 48 hours postoperatively
measure: Length of Hospital Stay
timeFrame: From admission to discharge, up to 7 days postoperatively
Other outcomes:
measure: Patient Satisfaction with Pain Management
timeFrame: At 48 hours postoperatively
Locations:
Study officials:
affiliation: Miguel Servet University Hospital
name: Ana Pascual-Bellosta, M.D, Ph.D, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Miguel Servet University Hospital
name: Cristian Aragón-Benedí, M.D, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00000443: Ondansetron Treatment for Alcoholism
Official title: Pharmacological Treatment for Alcoholism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 1999-11-03
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.


Eligibility criteria: Inclusion Criteria:

* Meet criteria for alcohol dependence.
* Subjects with early onset alcoholism must also have a diagnosis of antisocial personality disorder.
* Understand the requirements of the study and be able to complete the questionnaires and rating scales.

Exclusion Criteria:

* Current diagnosis of substance dependence or self-report of having used narcotics (opiates, cocaine, amphetamine-like substances, and hallucinogens) in the 30 day period prior to study.
* Positive urine drug screen test for narcotics, barbiturates, or benzodiazepines.
* Receiving current psychotropic medications.
* Current history of other psychiatric disorders excluding nicotine dependence.
* Hepatocellular disease.
* Pregnant females.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Substance Abuse Research Center, University of Texas Health Science Center
state: Texas
Study officials:
References:
Clinical trial NCT05899543: Determining Clinical Study Experiences of Chronic Lymphocytic Leukemia Patients
Official title: Exploring Patient Experiences of Individuals Joining Chronic Lymphocytic Leukemia Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic lymphocytic leukemia patients who are actively participating in a clinical study, but have not yet completed enrollment and randomization.

Brief summary: This research study aims to address the limited understanding of the challenges faced by specific demographic groups of chronic lymphocytic leukemia patients in their participation in clinical trials.

This trial will scrutinize the experiences of patients diagnosed with chronic lymphocytic leukemia as they take part in a separate medical intervention clinical trial. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future chronic lymphocytic leukemia patients.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with chronic lymphocytic leukemia
* Patient is a minimum of 18 years or older
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patients who are currently receiving any other investigational drug
* Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial

Primary outcomes:
measure: Number of chronic lymphocytic leukemia patients who decide to join in a clinical study
timeFrame: 3 months
measure: Rate of patients who remain in an chronic lymphocytic leukemia clinical study to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Nabhan C, Rosen ST. Chronic lymphocytic leukemia: a clinical review. JAMA. 2014 Dec 3;312(21):2265-76. doi: 10.1001/jama.2014.14553.
citation: Iskierka-Jazdzewska E, Robak T. Investigational treatments for chronic lymphocytic leukemia: a focus on phase 1 and 2 clinical trials. Expert Opin Investig Drugs. 2020 Jul;29(7):709-722. doi: 10.1080/13543784.2020.1770225. Epub 2020 May 27.
citation: Molica S. The clinical safety of ibrutinib in chronic lymphocytic leukemia. Expert Opin Drug Saf. 2015 Oct;14(10):1621-9. doi: 10.1517/14740338.2015.1084286. Epub 2015 Sep 11.
Clinical trial NCT01136343: Comparison of Predictive Factors Related to Coronary Artery Disease
Official title: Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: women
middle age
risk factor
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 130
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment and proper management of risk factors may reduce the prevalence rate of CAD. In the past decade, despite increased attention to CAD in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of CAD among middle-aged women in three menopausal statuses. At the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study.


Eligibility criteria: Inclusion Criteria:

* diagnosis of CAD by coroangiography
* LVEF \>30%

Exclusion Criteria:

* impairment of physical activity
* history of psychiatric disorder, vital arrhythmia

Primary outcomes:
measure: lifestyle
Secondary outcomes:
measure: metabolic
timeFrame: 6 months
measure: biomarkers
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University College of Nursing
name: Chii Jeng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06969443: Evaluation of Rehabilitation Practices in the Intensive Care Unit
Official title: Evaluation of Rehabilitation Practices in Patients Undergoing Invasive Mechanical Ventilation in French-speaking Critical Care Units
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Invasive Mechanical Ventilation
Rehabilitation Exercise of ICU Patients
Keywords: ICU
Rehabilitation
Mechanical ventilation
Observationnal
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
First posted: 2025-05-13
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: Adult patients undergoing mechanical ventilation (MV) via an endotracheal tube for less than five days, in French-speaking intensive care units in three countries (France, Belgium and Switzerland), in whom MV is scheduled to last more than 48 hours.

Brief summary: This observational study aims to describe the number of rehabilitation procedures performed per patient during their stay in French-speaking adult intensive care units undergoing invasive mechanical ventilation (average rehabilitation ratio). The study aims to determine the actual rehabilitation ratio, i.e. the number of rehabilitation procedures divided by the number of critical care hospital days (censored at day 28 from the start of invasive mechanical ventilation), provided to patients undergoing invasive mechanical ventilation. The rehabilitation procedure will remain the same, and ICU teams will only record the number of procedures performed per day.


Eligibility criteria: Inclusion criteria:

* Foreseeable invasive ventilation lasting more than 48 hours.
* Included within the first five days of an intensive care stay.

Exclusion criteria:

* Participation in an interventional study on early rehabilitation in the ICU
* Moribund patient
* Pregnant or breastfeeding woman
* A person deprived of liberty by court order
* Not being affiliated to a social security scheme

Primary outcomes:
measure: Rehabilitation Ratio
timeFrame: On Day 28 of study participation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06176443: Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass on Metabolic Outcomes Type 2 Diabetes.
Official title: Impact of an Increased Restrictive Factor of One Anastomosis Gastric Bypass Using a "FundoRing" Fundoplication on Metabolic Outcomes in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Diabetes Mellitus, Type 2
Keywords: Obesity
Metabolic Surgery
FundoRing
One anastomosis gastric bypass
Fundoplication
Diabetes Mellitus, Type 2
Lead sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus. The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.

Detailed description: The randomized controlled trial compared two interventional procedures: one group - using the original fundoplication procedure to enhance the restrictive effect and another group without fundoplication in the standard version of the OAGB.

The purpose of the study is to evaluate the effect of an increased restrictive factor of one gastric anastomosis (OAGB) using a "FundoRing" fundoplication on metabolic outcomes in type 2 diabetes mellitus.

The main hypothesis is that an increase in the restrictive effect will lead to an increase in the metabolic effect and an increase in its persistence over time.

Eligibility criteria: Inclusion Criteria:

* BMI 25-55 kg/m2
* Patients with Diabetes Mellitus, Type 2

Exclusion Criteria:

* BMI \<25 and \>55 kg/m2
* Patients without Diabetes Mellitus, Type 2
* History of surgery on the stomach
* Less than 18 or more than 60 years of age
* Psychiatric illness
* Patients unwilling or unable to provide informed consent

Primary outcomes:
measure: Metabolic improvements of type 2 diabetes
timeFrame: Baseline, at 12, 24, 36 months after surgery
Secondary outcomes:
measure: Change of body mass index
timeFrame: Baseline, at 12, 24, 36 months after surgery
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Oral Ospanov
state: Aqmola
Study officials:
affiliation: Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)
name: Oral Ospanov, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00626743: Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
Official title: Clinical Trial to Investigate the Influence of SK3530 on the Blood Pressure of Patients With Hypertension Taking Amlodipine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 13
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.


Eligibility criteria: Inclusion Criteria:

* Male subjects 19-65 years of age inclusive
* Subjects with hypertension as defined 100 mmHg ≤ SBP\<140 mmHg and 65 mmHg ≤ DBP \< 90 mmHg after more than 5 minutes in the supine position
* Written informed consent
* Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subjects with acute or chronic disease within 4 weeks of study initiation.
* Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.)
* Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors
* Subjects with clinically significant abnormalities on laboratory tests
* Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position
* Subjects with abnormal QTc interval(≥440ms)
* Subjects with color-blindness or weakness
* Subejcts with alcohol, drug or caffeine abuse
* Diet known to alter drug absorption, distribution, metabolism or elimination processes
* Subjects who participated in other clinical studies within 2 months before an administration
* Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators

Primary outcomes:
measure: Maximal Change From Baseline in Standing SBP
timeFrame: within 8 hrs after SK3530 or placebo
Secondary outcomes:
measure: Maximal Change From Baseline in Standing DBP
timeFrame: within 8 hrs after SK3530 or placebo
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: INJE University Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Inje University
name: Jae Gook Shin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: