louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05880550: PCOS and US Cavitation
Official title: Response of Menstrual Irregularity and Infertility- Related Stress to Ultrasound Cavitation Combined With Aerobic Exercise in PCOS: Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. Recent research stated that interventions aiming to improve QoL among infertile women with PCOS should focus on alleviating infertility-related stress, especially among women with high BMI. So, the purpose of this study is to investigate the effect of ultrasound cavitation combined with aerobic exercise on menstrual irregularity and infertility related stress in women having PCOS.


Eligibility criteria: Inclusion Criteria

All women in this study will be on the following criteria:

* Their ages will range from 20-35 years.
* They will be diagnosed with PCOS by Gynecologist.
* Doesn't receive any treatment for menstrual regularity and fertility during the study.
* BMI above 25kg/m²and less than 35kg/m².
* Waist /hip ratio \<.88.

Exclusion Criteria

Women will be excluded if they have one of the following criteria:

* Skin diseases that prevent the application of cavitation.
* Severe cardiovascular disease.
* Other endocrine disordered (hypothyroidism hyperprolactinemia).
* Patients that who take hormonal treatment within the last 3 months before the study.

Primary outcomes:
measure: Infertily related Stress level
timeFrame: change from base line at 12 weeks.
measure: cortisol level
timeFrame: change from base line at 12 weeks.
Secondary outcomes:
measure: Anthrometric measurement (body mass index and waist-hip ratio)
timeFrame: change from base line at 12 weeks.
measure: Hormonal profile
timeFrame: change from base line at 12 weeks.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Marwa Shafiek Saleh
Study officials:
References:
Clinical trial NCT00754650: A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
Official title: ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, ≥ 18 years of age.
* B-chronic lymphocytic leukemia not yet requiring treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* No previous treatment of chronic lymphocytic leukemia (CLL) by chemotherapy, radiotherapy, or immunotherapy.
* Life expectancy \> 6 months.

Exclusion Criteria:

* Central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression.
* Computed tomography (CT) scan based evidence of tumor invading major blood vessels.
* Gastrointestinal (GI) tract involvement by CLL.
* Active viral, bacterial, or fungal infection.
* Uncontrolled hypertension, cerebrovascular accident/stroke (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months prior to randomization), unstable angina (≥ New York Heart Association (NYHA) Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II congestive heart failure, or serious cardiac arrhythmia requiring ongoing medication.

Primary outcomes:
measure: Bone Marrow Response
timeFrame: Baseline to the end of treatment (up to 24 weeks)
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: Baseline to the end of treatment (up to 24 weeks)
Other outcomes:
Locations:
city: Salzburg
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06570850: Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
Official title: Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infection Due to Carbapenem Resistant Acinetobacter
Keywords: carbapenem resistant Acinetobacter baumanni
CRAB
Colistin
Fosfomycin
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 188
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:

1. Which group has better clinical response at end of treatment
2. Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment

Detailed description: Participants will be randomized in a 1:1 ratio to receive a combination of intravenous colistin plus intravenous fosfomycin (combination group) or colistin alone (monotherapy group) to determine if monotherapy or combination therapy has a better outcome.

Eligibility criteria: Inclusion Criteria:

* ≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)
* Able to provide informed consent or having a legal proxy who can provide informed consent in case the subject is unable to provide consent on his own

Exclusion Criteria:

* Minimum inhibitory concentration (MIC) of colistin \> 2 mg/L
* Complicated infection with inadequate source controlled
* Intracranial infection
* Infective endocarditis
* Intraabdominal infection
* Bone and joint infection
* Allergic to or have contraindication(s) to any treatment regimen in the study
* Polymicrobial infection with Carbapenem-resistant Psuedomonas aeruginosa, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE)
* Pregnancy
* Previous treatment with colistin or fosfomycin more than 96 hours
* Life expectancy of 24 hour or less
* Refusal to participate in the study
* Hospice treatment

Primary outcomes:
measure: Number of participants with clinical response after completion of therapy
timeFrame: Baseline, day 10-14 (end of therapy)
Secondary outcomes:
measure: Number of participants with clinical response at 72 hours of therapy
timeFrame: Baseline, day 3
measure: Number of participants with microbiological cure at 72 hours of therapy
timeFrame: Baseline, day 3
measure: Number of participants with microbiological cure after completion of therapy
timeFrame: Baseline, day 3
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Faculty of medicine, Chiang Mai university
Study officials:
affiliation: Chiang Mai University
name: Athitaya Luangnara
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00508950: Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay
Official title: Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Pneumococcal Opsonophagocytic Assay Development.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Vaccines
Pneumococcal Conjugate Vaccine
Adult
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The study will identify healthy adults who have been vaccinated against pneumococcus, and collect blood for the purpose of developing laboratory assays.

Detailed description: Collect serum with antibody levels capable of killing pneumococcal bacteria from healthy prevaccinated adults to develop OPA assays for the 13 serotypes in 13-valent pneumococcal conjugate vaccine.

Eligibility criteria: Inclusion Criteria:

* Healthy adults 18-70 years of age
* Must have received 23vPS pneumococcal vaccine

Exclusion Criteria:

* Bleeding diathesis
* Pregnancy
* Chronic disease which could be worsened by donating blood
* Receipt of blood, blood products or immune globulin within six months

Primary outcomes:
measure: To identify potential serum donors and obtain unit volumes of blood from these donors for use in pneumococcal opsonophagocytic assay development.
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: Frontage Clinical Services Inc.
state: New Jersey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01093950: White Light Scanning to Aid Body Contouring: A Pilot Project
Official title: White Light Scanning to Aid Body Contouring: A Pilot Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lipodystrophy
Body Dysmorphic Disorders
Keywords: anthropometric
white light scanner
extraction profiles
Body lipodystrophy
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: Novaptus Systems Incorporated
First posted: 2010-03-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, prospective, surgical candidates for body contouring surgery, including: lipoplasty, abdominoplasty, breast reduction, breast augmentation, thigh lift,and brachioplasty are being asked to participate in this research project.

Brief summary: A white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods.

Detailed description: A 3-D digital body camera that employs non-intrusive white light phase profilometry and 24 coordinated charge-coupled cameras scans and produces a "point cloud" image of the subject. The result of the two-minute scan process is an accurate three-dimensional body model of the subject, consisting of over 1.2 million surface points. The point cloud is compressed to provide programmable measurement extraction profiles (MEP's) that automatically extracts linear and circumferential measurements. Subjects are scanned and anthropometrically measured pre-operatively, and at 3, 6 and 9 months post-op.

Eligibility criteria: Inclusion Criteria:

* All healthy preoperative body contouring subjects between 18-65 years old are potentially included in this study.

Exclusion Criteria:

* Pregnant, nursing,or have a history of epilepsy.
* Individuals under 18 years old;
* Problems reading or understanding spoken instructions;
* Are in jail or in a "locked ward";
* Are a student or an employee of EVMS; or
* Are chemically-dependent.

Primary outcomes:
measure: To study whether the scanner was faster and more accurate than anthropometric measurements.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: The Hague Center
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: David A Gilbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01716650: A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle
Official title: A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Joint Disease of the Ankle
Keywords: ankle
saphenous nerve block
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degenerative joint disease of the ankle evaluated in the orthopedic department

Brief summary: To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle


Eligibility criteria: Inclusion Criteria:

* Patients evaluated with osteoarthritis who are surgical candidates for ankle fusion or total ankle replacement.
* Registered patients at Mayo Clinic in Florida with scheduled visit to see Dr.Whalen

Exclusion Criteria:

* Patients with lower extremity diabetic neuropathy
* History of prior trauma of ankle with residual nerve injury
* Current medication of pregabalin or gabalin
* Allergy to lidocaine.

Primary outcomes:
measure: Ankle pain
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
References:
Clinical trial NCT01343550: Creativity Group for Borderline Personality Disorder
Official title: Creativity Group for Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
Borderline Personality
Borderline
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that a creativity skills group for Borderline Personality Disorder can reduce symptoms of BPD, depression, and anxiety.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* participant self-reports clinical diagnosis of Borderline Personality Disorder
* currently seeing an individual therapist on a regular basis

Primary outcomes:
measure: Borderline Evaluation of Severity Over Time (BEST)
timeFrame: baseline, 5th week, post-intervention (week 8)
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: baseline, week 5, week 8
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Blake Bazel, M.S.
role: STUDY_DIRECTOR
affiliation: State University of New York - Upstate Medical University
name: Robbi Saletsky, Ph.D.
role: STUDY_DIRECTOR
affiliation: State University of New York - Upstate Medical University
name: Roger Greenberg, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Gunderson JG. Borderline personality disorder: ontogeny of a diagnosis. Am J Psychiatry. 2009 May;166(5):530-9. doi: 10.1176/appi.ajp.2009.08121825.
citation: Jacob GA, Gabriel S, Roepke S, Stoffers JM, Lieb K, Lammers CH. Group therapy module to enhance self-esteem in patients with borderline personality disorder: a pilot study. Int J Group Psychother. 2010;60(3):373-87. doi: 10.1521/ijgp.2010.60.3.373.
Clinical trial NCT00603850: Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP)
Official title: Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: HMP, PHP, AMD, CNV, HPHP
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed as intermediate AMD in at least one eye

Brief summary: Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

Detailed description: The pilot study purpose is to demonstrate that the tutorial which is a part of the device software, is giving sufficient training for the intended users.

Eligibility criteria: Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed as intermediate AMD in at least one eye
* Age \>50 years
* VA with habitual correction \>20/60 in the study eye
* Ability to speak, read and understand instructions in Hebrew
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
* Patients diagnosed with geographic atrophy (GA)

Primary outcomes:
measure: Proportion of subjects who manage to use the device as in a daily testing
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat
state: North Carolina
Study officials:
affiliation: Charlotte Eye Ear Nose & Throat
name: Justin Mr Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771250: A Study of Insulin Peglispro and Glargine on Fats in Participants With Type 1 Diabetes
Official title: Assessment of the Effects of LY2605541 on Triglyceride Metabolism, Compared to Insulin Glargine, in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study has two parts. Each participant will receive a daily injection of insulin peglispro during one treatment period and a daily injection of insulin glargine during the other treatment period. Each treatment period is 3 to 4 weeks and is followed by procedures to look at how the body uses or stores fats while taking each study drug.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) of less than 8.5%
* Otherwise fit and healthy
* Non smoker

Exclusion Criteria:

* Taking medication or supplements other than insulin to control diabetes.
* Suffered a hypoglycemic event in the last 12 months that required hospitalization or have poor awareness of hypoglycemia
* Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic corticosteroids

Primary outcomes:
measure: Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations
timeFrame: Day 22: 240 minutes (min) to 420 min
measure: VLDL-TG Secretion Rate
timeFrame: Day 22: 240 min to 420 min
measure: VLDL-TG Oxidation Rate
timeFrame: Day 22: 240 min to 420 min
measure: VLDL-TG Clearance Rate
timeFrame: Day 22: 240 min to 420 min
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04434950: Promoting Repeated HIV Self-testing Among MSM in Hong Kong
Official title: A Longitudinal Study for Promotion and Implementation of Repeated HIV Self-testing With Online Real-time Counseling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavior, Health
Keywords: HIV testing
HIV self-testing
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will be exposed to an online video-based intervention promoting HIV testing in general and real-time HIV self-testing with online counselling service (HIVST-online) in particular. Participants will receive intervention at baseline, Month 6 and Month 12.

Detailed description: 500 MSM will be recruited via venue-based, online outreach, and NGO referrals. At baseline, Month 6 and Month 12, participants received online intervention promoting HIV testing in general and HIV testing with online real-time counseling service. Free HIV self-testing kits will be mailed to participants at baseline, Month 6 and Month 12. Upon appointment, a testing administrator will provide online real-time pre-test and post-test counseling service for HIV self-testing users.

Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese speaking men
* ≥18 years old
* Anal intercourse with at least one man in the last six months
* Access to online face-to-face communication tools (e.g., Line, Skype, WhatsApp)

Exclusion Criteria:

* Self-reported to be HIV positive

Primary outcomes:
measure: HIV testing of any type
timeFrame: 14 months
Secondary outcomes:
measure: HIV self-testing
timeFrame: 14 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Zixin Wang
role: PRINCIPAL_INVESTIGATOR
References: