louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06034938: DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)
Official title: DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hiv
Keywords: doravirine
M184 mutation
Maintenance therapy
PLWH
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-09-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, non-comparative, single arm pilot trial
Primary purpose: TREATMENT

Brief summary: The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.


Eligibility criteria: Inclusion Criteria:

* Adult living with HIV
* Receiving stable antiretroviral treatment for at least 3 months
* HIV RNA VL\<50cp/mL for at least 6 months
* Presence of the M184V/I mutation in at least one previous genotype performed on plasma HIV RNA but absent from the genotype on current standard pro-viral DNA (Sanger technique)
* Signed informed consent

Exclusion Criteria:

* History of genotypic mutation associated with resistance to DOR or TDF according to the ANRS version 32 algorithm, i.e. :
* For DOR : V106A/M; Y188L; G190E/S; M230L; L100I + K103N; K103N + Y181C; K103N + P225H; F227C; At least 3 amongst: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
* For TDF : At least 3 mutations among: M41L, E44D, D67N, T69D/N/S, L74V/I, L210W, T215A/C/D/E/G/H/I/L/N/S/V/Y/F; K65R/E/N ; Insertion at codon 69; K70E
* Contraindications to the use of DOR/TDF/3TC
* Hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients (lactose in particular)
* Current or recent treatment with a strong CYP3A4 inducer
* Breast-feeding
* Patients already on DOR
* Pregnant or breast-feeding women
* Patients under guardianship or trusteeship

Primary outcomes:
measure: Plasma HIV-RNA at 24-week
timeFrame: 24 weeks from the switch to DOR/3TC/TDF
Secondary outcomes:
measure: Plasma HIV-RNA at 48-week
timeFrame: 48 weeks from the switch to DOR/3TC/TDF
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: Orléans
country: France
facility: CHU Orléans
city: Rouen
country: France
facility: CHU Rouen
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
References:
Clinical trial NCT02861638: Action Observation in Hip Replacement
Official title: Effects of Action Observation Therapy in Patients Recovering From Total Hip Arthroplasty: A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Keywords: Total hip replacement
Action observation treatment
Rehabilitation
Arthroplasty
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative rehabilitation is required for a successful outcome following total hip arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to strengthen quadriceps, to restore normal gait, and to recover independence in activities of daily living. In the last decade action observation treatment, in addition to conventional physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is growing evidence of the applicability of action observation training in rehabilitative medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of cerebral palsy and of aphasia.

Nevertheless those are small studies and one of them included a mixed population of hip and knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Primary total hip replacement.

Exclusion Criteria:

* bilateral hip replacement
* previous total hip replacement.
* pre-existing motor impairment (i.e. hemiparesis, poliomyelitis, lumbar sciatica);

Primary outcomes:
measure: Change of Pain intensity
timeFrame: Baseline and immediately post-intervention
measure: Change of Range Of Motion (ROM)
timeFrame: Baseline and immediately post-intervention
Secondary outcomes:
measure: Barthel index
timeFrame: Baseline and immediately post-intervention
measure: Short Form-36 motor
timeFrame: Baseline and immediately post-intervention
measure: Tinetti scale
timeFrame: Baseline and immediately post-intervention
measure: Lequesne index
timeFrame: Baseline and immediately post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: JORGE H VILLAFAÑE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villafane JH, Pirali C, Isgro M, Vanti C, Buraschi R, Negrini S. Effects of Action Observation Therapy in Patients Recovering From Total Hip Arthroplasty Arthroplasty: A Prospective Clinical Trial. J Chiropr Med. 2016 Dec;15(4):229-234. doi: 10.1016/j.jcm.2016.08.011. Epub 2016 Oct 5.
Clinical trial NCT01387438: The Incidence,Factors,and Importance of Brown Adipose Tissue in Chinese Adults
Official title: Cross-sectional Study on the Incidence,Factors,and Importance of Brown Adipose Tissue in Adult Chinese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: Brown Adipose Tissue
Cross sectional study
Chinese Adults
Factor
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who underwent scanning PET-CT at Huashan Hospital Medical Centre from 2009 to 2013

Brief summary: Previous studies have shown that active brown adipose tissue (BAT) is present in adults and may play important roles in material and energy metabolism. However, most of these studies were tumor-based populations and retrospective study. Due to the large amount in our cohort, the investigators are able to promote a cross-sectional study of the incidence and factors of BAT in adult chinese. In addition, the investigators can analyse the metabolic profiles in healthy adults with active BAT.

Detailed description: The investigators will perform a cross sectional analysis on the chinese adults who use 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) to scan the whole body at Huashan Hospital from 2009 to 2013. BAT activity will be measured by PET/CT. Not only demographic data on sex, age, medication and medical history,but also data on body composition and physical examination will be collected for all subjects. Imaging date,outdoor temperature and fasting blood samples will be collected as well. In addition, the investigators will analyse the metabolic profiles in healthy adults with active BAT and their negative controls,such as lipid profiles,fasting glucose and insulin sensitivity, adipokines and other biochemical markers.

Eligibility criteria: Inclusion Criteria:

* Subjects with detectable brown adipose tissue
* Negative controls,consisting of one subject who underwent PET/CT scans at the same day but without detectable BAT

Exclusion Criteria:

* Younger than 18 years
* Pregnant women
* With implantable medical electronic instrument

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Yiming Li, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01846338: The Effect of「GTT-EGCG」on Acne Women
Official title: The Effect of「GTT-EGCG」on Acne Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Lesion Counts
Keywords: acne, EGCG, green tea
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Taipei City Hospital
First posted: 2013-05-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial.

Detailed description: change in acne lesions counts, hormone, quality of life

Eligibility criteria: Inclusion Criteria:

* Female patient
* 20 to 45 years of age
* moderate or severe acne vulgaris as defined by the Investigator's Global Assessment (IGA; score of 3 or 4 on a scale from 0 to 5)

Exclusion Criteria:

* Received systemic retinoid or hormone treatment in the previous 3 months.
* Abnormal liver enzymes or kidney function tests (1.5 times higher than the upper normal limit)
* abnormal blood chemistry
* Pregnant or breast feeding women or the intention of becoming pregnant
* Concurrent systemic illness
* PCOS
* Very severe acne(IGA score5)

Primary outcomes:
measure: acne lesion counts
timeFrame: four weeks
Secondary outcomes:
measure: quality of life, SF-12
timeFrame: four weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
References:
citation: Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
citation: Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.
Clinical trial NCT02636738: Vela China Study: in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese Population
Official title: A Prospective, Multicenter, Single-arm, Non-controlled Study to Evaluate The Safety and Utility of VelaTM XL Thulium Laser in Cutting And Hemostasis For Gastrointestinal Epithelial Neoplasia In Chinese Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Indication for Modification of Patient Physical Status
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, single-arm, non-controlled, 60 subjects enrolled and 14 days follow up for evaluate the safety and utility of VelaTM XL thulium laser.

Detailed description: This study aimed to evaluate the safety and utility of VelaTM XL thulium laser in cutting and hemostasis for gastrointestinal epithelial neoplasia in Chinese population.

Vela China study will enroll at least 60 patients. Follow up points are 72 ±3 hours post procedure, 7±2 days post procedure, 14 days(±2 days) post procedure.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent to participate in the study and comply with the study procedures.
* Diagnosed as gastrointestinal epithelial neoplasia and admitted to hospital for gastrointestinal ESD procedure.
* EUS and/or CT are performed to confirm the absence of regional lymph node or distant metastasis.

Exclusion Criteria:

* Endoscopic techniques or treatment are contraindicated.
* Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
* Based on doctor's evaluation, the patient's medical condition doesn't fit for this study.

Primary outcomes:
measure: Technique success
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Beijing Friendship Hospital
name: Shutian Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03524638: Visbiome Effect on Colorectal Anastomosis and Local Recurrence
Official title: Visbiome Effect on Colorectal Anastomosis and Local Recurrence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Determine whether the administration of Visbiome after colorectal surgery has any effect on anastomotic leak and local recurrence

Detailed description: Randomized study of Visbiome after colorectal surgery. Subjects will be randomized 1:1 to either VSL3 or no VSL3.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Diagnosis of biopsy proven rectal cancer (CT/MRI)
* Willing and able to comply with protocol requirements
* Able to tolerate surgery
* Able to comprehend and have signed the Informed Consent
* Absence of metastatic disease
* Clinical performance status of ECOG 0 or 1
* Life expectancy of greater than 3 months
* Planned ileostomy as part of their routine care

Exclusion Criteria:

* Severe or refractory ulcerative colitis defined as Mayo Score of greater than or equal to 10, endoscopic disease activity score 3
* Untreated enteric infection (positive stool test for any of the following: clostridium difficile, salmonella, shigella, yersinia, campylobacter, enteropathogenic E. coli or other enteric infection at the discretion of the Investigator
* Severe immunodeficiency, inherited or required (e.g. HIV, chemotherapy or radiation therapy)
* Patients with the following laboratory abnormalities: absolute neutrophil count \<1000/ul, platelets \<50 x 10\^9/L, hemoglobin \<6.5g/dL
* History of anaphylaxis (severe allergic reaction) to food allergens (e.g. tree nuts, shellfish)
* Active intestinal obstruction
* Non-steroidal anti inflammatory medications (NSAIDs) as long-term treatment, defined as for at least 4 days per week each month
* Cholestyramine use
* Any condition in which the Investigator thinks VSL3 administration may pose a health risk (e.g. severely immunocompromised)
* Simultaneous participation in another interventional clinical trial
* Patients who are pregnant, breast feeding or planning pregnancy during study trial period
* Patients with any other signification medical condition that could confound or interfere with evaluation of safety, tolerability or prevention compliance with the study protocol at the discretion of the Investigator

Primary outcomes:
measure: Development of Anastomotic Leak
timeFrame: Hospital discharge, 2 and 4 weeks post-treatment. Then every 3 months for 1 year.
measure: Local Recurrence
timeFrame: Every three months for 1 year post hospital discharge.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02361138: The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers
Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Multiple Dose of SHR3824 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.


Eligibility criteria: Inclusion criteria:

* Chinese male and female subjects aged 18 to 45 years.
* BMI:18 -25 kg/m2.
* Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria:

* History of or current clinically significant medical illness as determined by the Investigator.
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose.
* Pregnancy or breastfeeding . Significant acute or chronic medical illness, including renal impairment, or recent surgery.
* Donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.

Primary outcomes:
measure: AUC(Area under the curve) of SHR3824.
timeFrame: day1 and day11 to day 13.
measure: Cmax(the maximum concentration) of SHR3824.
timeFrame: day1 and day11 to day 13.
measure: Tmax(the time reaching maximum concentration) of SHR3824.
timeFrame: day1 and day11 to day 13.
measure: Halflife of SHR3824.
timeFrame: day1 and day11 to day 13.
measure: CL/F of SHR3824.
timeFrame: day1 and day11 to day 13.
measure: V/F of SHR3824.
timeFrame: day1 and day11 to day 13.
measure: Accumulation ratio of SHR3824
timeFrame: Up to day 13.
measure: Urine glucose concentration of SHR3824.
timeFrame: day1 and day11
measure: Plasma glucose concentration of SHR3824.
timeFrame: day1 and day11
Secondary outcomes:
measure: Adverse events, vital signs, physical exams , ECG, clinical labs
timeFrame: Days -14 to -1, 0, 13.
measure: Serum creatinine
timeFrame: Days -14 to -1, 0, 2, 9, 13.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04344938: Covid 19 Pandemic. Emerging Legal and Ehical Disputes Over Patient Confidentiality
Official title: Covid 19 Pandemic. Emerging Legal and Ehical Disputes Over Patient Confidentiality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid 19 Pandemic From Ethical View
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Doaa M.EL Shehaby
First posted: 2020-04-14
Enrollment: 874
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: medical and non medical personel

Brief summary: Many critical ethical questions arise in pandemic covid 19planning, preparedness and response. These include: Who will get priority access to medications, vaccines and intensive care unit beds, given the potential shortage of these essential resources? In the face of a pandemic, what obligations do health-care workers have to work not withstanding risks to their own health and the health of their families? How can surveillance, isolation, quarantine and social-distancing measures be undertaken in a way that respects ethical norms? What obligations do countries have to one another with respect to pandemic covid 19 planning and response efforts?


Eligibility criteria: Inclusion Criteria:

* adult aged 18 years to 60 years
* medical personel graduated from egyptian faculty of medicine.
* non medical personel live in egypt

Exclusion Criteria:

* personel less than 18 years old .
* medical personel not graduated from egyptian faculty of medicine.
* non medical personel live outside egypt

Primary outcomes:
measure: Evaluate the ethical requirement of controlled disrupts of patients In case of infectious disease pandemic
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05938738: PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action
Official title: A Portable Dyspnea Relief Device for Episodic Breathlessness in COPD (PEP-buddy): Effect on Dyspnea Severity and Mechanism of Action
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic dyspnea is the most characteristic symptom of patients with Chronic Obstructive Pulmonary Disease (COPD), with intermittent increases during exercise and other events.Despite optimal standard therapy, episodic dyspnea is a common occurrence in COPD. Recently, the PEP buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (PEP). Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. More research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. Therefore, the aim of our study is to explore the potential of this device for patients with COPD and episodic breathlessness.


Eligibility criteria: Inclusion Criteria:

1. Age ≥40 years
2. Read, understood and signed Informed Consent
3. COPD Gold class II-IV/ B or E (FEV1\<60% of predicted, CAT ≥10 points)

5. Optimized standard therapy according to the study physician 6. Episodic breathlessness requiring intervention (i.e. taking rest during physical activities, as needed inhalation medication, breathing techniques, as needed opioids) at least three days per week

Exclusion Criteria:

1. Other severe disease causing episodic breathlessness
2. Life expectancy ≤ 3 months
3. Exacerbation of COPD 4 weeks prior to inclusion
4. Change in COPD management targeted at breathlessness 8 weeks prior to inclusion
5. Inability to use the PEP buddy device
6. Currently participating in another interventional clinical study
7. Any other conditions, which, in the opinion of the investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.

Primary outcomes:
measure: Dyspnea severity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
References: