louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06226701: EFFECT OF CRYOLIPOLYSIS ON HORMONAL PROFILE AND MENSTRUAL REGULARITYIN OBESE WITH PCOS
Official title: EFFECT OF CRYOLIPOLSIS IN HORMONAL PROFILE AND MENSTRUAL REGULARITY IN OBESE WOMEN WITH PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Women With PCOS
Keywords: obesity, pcos ,cryolipolysis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Impact of cryolipolsis on hormonal Profile in obese women with Pcps
Primary purpose: TREATMENT

Brief summary: The effecting study to determine the impact of cryolipolysis on obese women with pcos

Detailed description: Polycystic ovary syndrome(PCOS) is the most common endocrine disorder in women of reproductive age. Women with this syndrome may have infrequent menstrual periods or amenorrhea and excess androgen levels. The ovaries develop numerous small follicles and fail to ovulate on a regular basis, with subsequent subfertility in those women that wish to conceive.The etiology of PCOS is unclear. Early diagnosis and treatment may reduce the risk of long-term complications such as type 2 diabetes and heart disease ,PCOS affects 5-20% of women of reproductive age worldwide. The condition is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovarian morphology (PCOM) with excessive androgen production by the ovaries being a key feature of PCOS. PCOS is classified into four separate phenotypes (A-D), according to the presence or absence of three characteristics: hyperandrogenism (either biochemical or clinical), ovulatory dysfunction and polycystic ovarian morphology. Only phenotype A requires all three features of PCOS to be present. The various diagnostic criteria currently available for PCOS include a greater or fewer number of PCOS phenotypes. AE-PCOS, Androgen Excess-PCOS Society; NIH, National Institutes of Health ,the trial made on 2group ,control group and study group for 3 months

Eligibility criteria: Inclusion Criteria:

All patient age from 18to 30 Waist hip ratio \>.9

Exclusion Criteria:

* thyroid disorders. Hepatic diseases. Skin or bleeding disorders. Chronic disease or illnessCardiovascular and pulmonary disease,Cancer diseases., Renal failure disease. Recent surgery. hose with pacemakers or surgical implants. Musculoskeletal problems that would limit WBV.Raynaud's phenomenon. A rare condition in which cold temperatures can impede blood flow to the fingers and toes. Other conditions that pose a risk include,Pregnancy or breast-feeding,Inflammatory skin disorders,Skin conditions caused by immune system disorders, such as eczema or psoriasis

Primary outcomes:
measure: Weight
timeFrame: Up to 3months
measure: Hormones
timeFrame: 3months
Secondary outcomes:
measure: waist hip ratio
timeFrame: 3months
Other outcomes:
Locations:
city: Bilbeis
country: Egypt
facility: Sabrin mohamed taha abdelwahab
state: Sharqia
Study officials:
References:
Clinical trial NCT05991401: Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
Official title: An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 3-period
Primary purpose: TREATMENT

Brief summary: This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteer 19 years to 50 years
* Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
* In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
* The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion Criteria:

* Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease, sexual disorder, ophthalmologic or history of such disease
* Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid surgery)
* Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
* Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
* Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test
* Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items

Primary outcomes:
measure: Peak Plasma Concentration of DA-8010 (Cmax)
timeFrame: 0~48hours
measure: Area under the plasma concentration versus time curve of DA-8010 (AUClast)
timeFrame: 0~48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02420301: Effect of Self-administered Exercises on PRMD
Official title: Effects of Self-administered Exercises Based on Tuina Techniques on Musculoskeletal Disorders of Professional Orchestra Musicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 69
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: Objective: To study the effects of self-administered exercises based on tuina techniques on the pain intensity caused by playing related musculoskeletal disorders (PRMD) of professional orchestra musicians, using numeric visual scale (NVS).

Method: The investigators performed a prospective, controlled, single-blinded, randomized study with musicians suffering from PRMD. n= 69 musicians were randomly distributed into the experimental and into the control group. After an individual diagnostic assessment, specific tuina self-administered exercises were developed and taught to the participants. Musicians were instructed (educated) to repeat the exercises every day during 3 weeks. Pain intensity was measured by NVS before the intervention and after the 1st, 3rd, 5th, 10th, 15th and 20th days of self-exercising. The procedure was the same for the control group, however the Tuina exercises were executed in non-acupuncture points


Eligibility criteria: Inclusion Criteria:

* Professional orchestra musician presenting playing related musculoskeletal pain during at least 3 weeks

Exclusion Criteria:

Primary outcomes:
measure: Verbal numeric scale
timeFrame: At the baseline
measure: Verbal numeric scale
timeFrame: After one day
measure: Verbal numeric scale
timeFrame: After 3 days
measure: Verbal numeric scale
timeFrame: After 5 days
measure: Verbal numeric scale
timeFrame: After 10 days
measure: Verbal numeric scale
timeFrame: After 15 days
measure: Verbal numeric scale
timeFrame: After 20 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03075501: Interactions Between Drug Effects and Environments II
Official title: Drug Contextual Conditioning With in Humans: Causes and Consequences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Substance-Related Disorders
Keywords: drug cues
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-03-09
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to determine how associations between drugs and the places where they are experienced influence drug seeking, mood and acute drug responses.

Detailed description: Learned associations between drug effects and the people, places, and paraphernalia (cues) linked with drug experiences are a major barrier to the treatment of drug addiction. These links are remarkably persistent and can cause relapse to drug taking even after long periods of abstinence. They are also key features in some of the foremost theories of addiction, yet there is little clinical evidence of how these associations are formed and how they come to profoundly control behavior. The long-term goal of this research is to understand how drug cues become powerfully linked with drug experiences and their influence on mood and behavior. In the proposed project, the investigators will use a de novo conditioning paradigm to examine the influence of drug contexts on drug seeking, mood and acute drug responses. The hypothesis is that drug-paired contexts gain motivational salience, induce approach, and alter acute subjective responses to the drug.This knowledge will lead to novel treatment strategies to counteract the effects of drug cues on mood and behavior, and also to prevent relapse.

Eligibility criteria: Inclusion Criteria:

* past use of stimulants
* bmi 19-26
* hormonal birth control for women

Exclusion Criteria:

* current or recent (Past year) history of major axis I disorder

Primary outcomes:
measure: Change in Time Spent in Drug-paired Room
timeFrame: Measured through study completion (maximum 5 weeks).
Secondary outcomes:
measure: Subjective Drug Effects
timeFrame: Self-reported drug effects are measured 30min before drug administration and at 30min intervals after drug administration for 4h during each drug administration session.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Emma Childs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04163601: Liposomal Amikacin Inhalation in M.Abscessus Patients
Official title: NTM-net Study: Liposomal Amikacin Inhalation in M.Abscessus Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: M.Abscessus Pulmonary Disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: European network (http://www.ntm-net.org/index.php/ntm-net)
First posted: 2019-11-15
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with M. abscessus disease

Brief summary: Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results.

The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes


Eligibility criteria: Inclusion criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* ATS diagnostic criteria for M.abscessus pulmonary disease
* \> 12 years
* Patients with CF/COPD or other underlying disease
* LAI use for more than 3 weeks

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Extra-pulmonary or disseminated disease

Primary outcomes:
measure: culture conversion
timeFrame: 1 day
Secondary outcomes:
measure: clinical cure
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Raphael CHIRON, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06334601: Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness
Official title: Diurnal Evaluation of Obstructive Sleep Apnea (OSA) Upper Airway Collapsibility and Muscle Responsiveness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Collapsibility of upper airways
Muscle responsiveness
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients evaluated for sleep disorders in our Institution, who present an at home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index \>14)

Brief summary: In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness.


Eligibility criteria: Inclusion Criteria:

* Obstructive Sleep Apnea (OSA)
* At home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index \>14).

Exclusion Criteria:

* OSA treatment ongoing during two weeks before PSG
* Unstable cardio-respiratory disease in the 3 months before enrollment
* Subjects in O2 treatment

Primary outcomes:
measure: Upper airway collapsibility
timeFrame: During the diagnostic test
measure: Upper airway muscle responsiveness
timeFrame: During the diagnostic test
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Auxologico Italiano,Ospedale San Luca
Study officials:
References:
Clinical trial NCT01668901: Warfarin Versus Aspirin in Patients With Atrial Fibrillation and Chronic Kidney Disease
Official title: A Randomized Controlled Prospective Trial of Warfarin Versus Aspirin for Stroke Prevention in Patients With Atrial Fibrillation and Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Chronic Kidney Disease
Keywords: warfarin
aspirin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.

Detailed description: randomised open labelled prospective study

We enroll patients with CHADS2 score 1 non-valvular AF with chronic kidney disease, and analyze all thromboembolic event or major bleeding event during follow-up period. Warfarin group take dose adjusted warfarin (target INR 2.0-3.0) and aspirin group take aspirin 100mg daly.

Thromboembolic events: Ischemic stroke or systemic arterial occlusion Major bleeding: gastrointestinal bleeding or intracranial bleeding (code 430, code 431, code 432 by ICD-9-CM codes)

-\> Only the first event of each case will be used for the analysis

Eligibility criteria: Inclusion Criteria:

* CHADS2 score 1 nonvalvular atrial fibrillation patients with chronic kidney disease

Exclusion Criteria:

* HAS-BLED ≥30
* History of syncope or seizure within 1 year
* History of major bleeding event within 6 months
* BP\>180/100
* Abnormal prothrombin time
* Hypersensitivity of aspirin or warfarin
* Folstein mini mental state examination score \<26
* Taking or had taken other anticoagulants

Primary outcomes:
measure: Thromboembolic event
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Major bleeding
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Nationap University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul , Korea
name: Seil Oh, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01735201: AGN-199201 for the Treatment of Erythema With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Erythema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 357
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: This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.


Eligibility criteria: Inclusion Criteria:

* Redness of the skin caused by rosacea

Exclusion Criteria:

* ≥3 inflammatory lesions
* Laser light-source or other energy based therapy in the last 6 months
* Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days

Primary outcomes:
measure: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
timeFrame: Baseline, Day 28-hours 2 to 12
Secondary outcomes:
measure: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28
timeFrame: Baseline, Day 28-hour 0.5
measure: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28
timeFrame: Baseline, Day 28-hour 1
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03248401: Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
Official title: Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Carotid Atherosclerosis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Age between 30 and 80 years
* Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
* Carotid plaque on 3D ultrasound

Exclusion Criteria:

* Acute bleeding or bleeding tendency
* Diagnosed with heart failure
* Suggestive of ischemia on ECG
* Uncontrolled hypertension
* Recently diagnosed with peptic ulcer disease
* Taking other antiplatelet agents
* Hypersensitivity to salicylic acid
* Aspirin induced asthma
* Severe kidney, liver, heart disease

Primary outcomes:
measure: Change of carotid artery atherosclerosis
timeFrame: 6 months
Secondary outcomes:
measure: Change of carotid artery atherosclerosis 1
timeFrame: 6 months
measure: Change of carotid artery atherosclerosis 2
timeFrame: 6 months
measure: Change of carotid artery atherosclerosis 3
timeFrame: 6 months
Other outcomes:
measure: Glucose metabolism 1
timeFrame: 6 months
measure: Diabetic complication
timeFrame: 6 months
measure: Glucose metabolism 2
timeFrame: 6 months
measure: Body composition
timeFrame: 6 months
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
citation: Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation. 2010 Jun 15;121(23):2584-91. doi: 10.1161/CIRCULATIONAHA.109.892414. Epub 2010 Jun 1.
citation: Huh JH, Seok H, Lee BW, Kang ES, Lee HC, Cha BS. Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event. Endocrine. 2014 Sep;47(1):138-45. doi: 10.1007/s12020-013-0120-y. Epub 2014 Jan 1.
citation: Lee DH, Chun EJ, Moon JH, Yun HM, Lim S. Effect of cilostazol on carotid plaque volume measured by three-dimensional ultrasonography in patients with type 2 diabetes: The FANCY study. Diabetes Obes Metab. 2020 Dec;22(12):2257-2266. doi: 10.1111/dom.14147. Epub 2020 Sep 17.