louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06911983: Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
Official title: Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitis
Keywords: genetics
polymorphysm
supplements
berberine
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center for New Medical Technologies, Novosibirsk, Russia
First posted: 2025-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot 12-week randomized open-label study compares metformin and berberine in newly diagnosed type 2 diabetes patients stratified by the TCF7L2 (rs7903146) genotype (TT vs. CC). The primary goal is to assess changes in HbA1c between metformin and berberine treated groups within each genotype. Secondary outcomes include fasting and postprandial glucose, insulin levels, HOMA-IR, body weight/BMI, lipid profile and adverse events.

The central hypothesis is that berberine, through its additional effect on TCF7L2-linked pathways, will provide superior glycemic control in high-risk TT carriers compared to metformin, whereas both treatments will yield comparable results in CC carriers. By enrolling only TT and CC genotypes, this study aims to estimate effect sizes and feasibility, guiding a future, larger-scale trial on genotype-tailored diabetes therapies.


Eligibility criteria: Inclusion Criteria:

* Adults aged 30-65 years;
* Newly diagnosed T2DM ≤1 year;
* Baseline HbA1c: 7.0-9.0% (53-75 mmol/mol);
* No prior use of antihyperglycemic agents or ≤4 weeks of usage;
* Willing to sign informed consent and undergo TCF7L2 genotyping;
* TT or CC genotype (rs7903146)

Exclusion Criteria:

* Severe comorbidities (hepatic, renal, cardiac dysfunction);
* Pregnancy or lactation;
* Known allergy or intolerance to metformin or berberine;
* Participation in another clinical trial within the last 3 months;
* TC genotype (excluded).

Primary outcomes:
measure: Change in HbA1c
timeFrame: 12 weeks
measure: Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin)
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting Plasma Glucose change (FPG)
timeFrame: 12 weeks
measure: Postprandial Glucose (PPG) change
timeFrame: 12 weeks
measure: Serum Insulin Levels
timeFrame: 12 weeks
measure: HOMA-IR change
timeFrame: 12 weeks
measure: Body Weight in kg change
timeFrame: 12 weeks
measure: Total Cholesterol change
timeFrame: 12 weeks
measure: Triglycerides change
timeFrame: 12 weeks
measure: LDL-C change
timeFrame: 12 weeks
measure: HDL-C change
timeFrame: 12 weeks
measure: Number of any adverce events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center for New Medical Technologies
Study officials:
References:
Clinical trial NCT00495183: Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence
Official title: Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cocaine Dependence
Keywords: cocaine dependence
cocaine use
CNS stimulants
caffeine
biperiden
placebo
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2007-07-02
Enrollment: 108
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 aim of this study is to assess the efficacy of caffeine compared to placebo as a maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be also studied.

Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 10 days in an in-hospital setting.


Eligibility criteria: Inclusion Criteria:

* diagnosis of cocaine dependence, according to DSM-IV-TR criteria
* age between 18 and 60 years
* current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.
* demonstrated capacity to grant informed consent and sign the pertinent informed consent form.
* place of residence compatible with attendance at the center.
* for women, willingness to use effective contraceptive measures during the study.

Exclusion Criteria:

* diagnosis of a severe medical disorder that could interfere with the study
* presence of an organic pathology for which methylxanthines or biperidene administration is contraindicated
* serum liver transaminase levels 3 times higher than normal values
* pregnancy and breast-feeding
* neuroleptic medication treatment in the past 6 weeks
* current treatment, or anticipation that the patient may need to initiate treatment during the study, with drugs that may interact with study medication.
* current diagnosis of a major mental disorder.
* awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)
* current participation in another research project.

Primary outcomes:
measure: survival
timeFrame: 22 weeks
measure: cocaine use
timeFrame: 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Catalonia
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain
name: Miquel Casas, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00870883: N-acetylcysteine Plus Deferoxamine for Patients With Hypotension
Official title: Prospective, Randomized, Double-blinded, Placebo-controlled Study of N-acetylcysteine Plus Deferoxamine for Patients With Hypotension as Prophylaxis for Acute Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypotension
Acute Renal Failure
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2009-03-27
Enrollment: 81
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: Oxidative stress is associated with kidney damage in several different situations, including hypotension. In animal models it has been shown that the combination of n-acetylcysteine plus deferoxamine is superior to its isolate use in the treatment of several diseases. Thus the investigators aimed to determine if the administration of n-acetylcysteine plus deferoxamine could prevent renal failure in critical ill patients who develops hypotension.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU
* Presenting hypothesion (MAP \< 60mm Hg or the needing to use vasoactive drugs) for at least 30 min in the last 12h before study inclusion

Exclusion Criteria:

* Age lower than 18 years old
* Chronic renal failure
* A known history of allergy to any of the study drugs
* Using n-acetylcysteine to paracetamol overdose
* Pregnant women
* Patients who used iodinated contrast medium
* Hemoglobin less than 6.5 mg/dl
* Cancer patients

Primary outcomes:
measure: Development of acute renal failure
timeFrame: 28 days
Secondary outcomes:
measure: 28 day-mortality
timeFrame: 28 days
measure: Decrease on plasma oxidative damage and inflammatory parameters
timeFrame: at the end of drug infusion
Other outcomes:
Locations:
city: Criciuma
country: Brazil
facility: São José Hospital
state: SC
Study officials:
References:
citation: Fraga CM, Tomasi CD, Damasio DC, Vuolo F, Ritter C, Dal-Pizzol F. N-acetylcysteine plus deferoxamine for patients with prolonged hypotension does not decrease acute kidney injury incidence: a double blind, randomized, placebo-controlled trial. Crit Care. 2016 Oct 17;20(1):331. doi: 10.1186/s13054-016-1504-1.
citation: Fraga CM, Tomasi CD, Biff D, Topanotti MF, Felisberto F, Vuolo F, Petronilho F, Dal-Pizzol F, Ritter C. The effects of N-acetylcysteine and deferoxamine on plasma cytokine and oxidative damage parameters in critically ill patients with prolonged hypotension: a randomized controlled trial. J Clin Pharmacol. 2012 Sep;52(9):1365-72. doi: 10.1177/0091270011418657. Epub 2011 Nov 1.
Clinical trial NCT02005783: Study of Danggui Buxue Decoction in Preventing Neutropenia
Official title: Adjuvant Treatment of EC/TC Versus EC/TC Plus Danggui Buxue Decoction in Breast Cancer：A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Grade 3/4 Neutropenia
Febrile Neutropenia
Keywords: incidence of grade 3/4 neutropenia
incidence of febrile neutropenia
time to neutropenia recovery
safety
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate EC/TC (epirubicin and cyclophosphomide or docetaxel and cyclophosphomide) with EC/TC plus DBD (Danggui Buxue Decoction) in adjuvant treatment of breast cancer patients. The aim is to evaluate whether DBD can decrease the incidence of grade 3/4 neutropenia induced by EC/TC regimen during chemotherapy.


Eligibility criteria: Inclusion Criteria:

Women aged ≥18 years and \< 70 years; Histologically confirmed invasive breast cancer by core needle biopsy, suggested to receive EC/TC regiments for adjuvant chemotherapy by MDT; Leukocyte ≥ 3\*109/L; Neutrophil ≥ 1.5\*109/L; PLT ≥ 100\*109/L; Serum AST/SGOT or ALT/AGPT ≤ 2.5 times of upper limit of normal (UNL) range Serum creatinine/BUN ≤ upper limit of normal (UNL) range; No dysphagia, be able to take the Danggui Buxue Decoction(DBD) Written informed consent according to the local ethics committee requirements. Has ECOG Performance Score 0-1;

Exclusion Criteria:

Metastatic breast cancer; Family history of endometrial cancer or any other kind of gynecologic cancer; Patients with severe co-morbidity that indicate intolerant to adjuvant chemotherapy; patients with psychiatric disorder or other diseases leading to incompliance to the therapy; Known severe hypersensitivity to any drugs in this study; Prior adjuvant chemotherapy of any kind cancer; Hematologic disorders relative to aplasia

Primary outcomes:
measure: incidence of grade 3/4 neutropenia
timeFrame: 3 weeks
Secondary outcomes:
measure: times of grade 3/4 neutropenia per cycle of chemotherapy
timeFrame: 3 weeks
measure: incidence of febrile neutropenia
timeFrame: 3 weeks
measure: the time to neutropenia recovery
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Kunwei Shen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896583: A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety and Tolerability, of ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Lead sponsor: Seldar Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Men or women aged 18-75 years
* Patient has IBS with diarrhea (IBS-D)
* Ability to communicate with the investigator

Exclusion Criteria:

* IBS with constipation (IBS-C) or mixed IBS (IBS-M)
* Other significant disease or condition that may interfere with trial completion
* Untreated lactose intolerance
* History of alcohol or drug abuse in past two years
* Participation in other clinical trials within prior month

Primary outcomes:
measure: Abdominal pain
timeFrame: 4 weeks
Secondary outcomes:
measure: Stool consistency
timeFrame: 4 weeks
measure: Stool frequency
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Encino
country: United States
facility: Shahram Jacobs, M.D., Inc.
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: Santa Ana
country: United States
facility: Probe Clinical Research Group
state: California
city: Miami
country: United States
facility: San Marcus Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Las Vegas
country: United States
facility: OM Medical
state: Nevada
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: San Antonio
country: United States
facility: DCT - Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
Study officials:
References:
Clinical trial NCT04187287: Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis
Official title: Comparison of Effects of Radial Extracorporeal Shock Wave Therapy and Deep Friction Massage on Individuals With Chronic Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Lateral Epicondylitis
Tendinopathy
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of Radial Extracorporeal Shockwave Therapy (rESWT) treatment and Deep Friction Massage (DFM) treatment on pain, functionality, grip strength (GS), edema, range of motion (ROM) of the elbow and quality of life in individuals with chronic lateral epicondylitis (CLE).

36 individuals diagnosed with CLE will be randomly divided into two equal groups. rESWT treatment will be applied to Group 1 and DFM treatment to Group 2. Visual analogue scale will be used to assess pain severity, functionality with Patient-Rated Elbow Evaluation Turkish version (PRTEE-T), GS with digital dynamometer, ROM of the elbow joint with goniometer, edema with environmental measurement, and quality of life with Short Form 36 (SF-36).


Eligibility criteria: Inclusion Criteria:

* Individuals with pain on the lateral epicondyle or proximal musculotendinous area of the forearm extensor muscles for at least 3 months,
* Individuals with a positive Thomsen Test ,

  - Individuals who have not received physical therapy for lateral epicondylitis,
* Individuals with a positive Maudsley Test will be included.

Exclusion Criteria:

* Individuals who have received any physical therapy,
* Individuals with reflected pain due to cervical and shoulder pathologies,
* Individuals with elbow osteoarthritis,
* Individuals with previous elbow fractures or elbow joint operations,
* Individuals with a history of systemic inflammatory disease,
* Individuals with osteoporosis,
* Individuals with cardiovascular problems will not be included in the study.

Primary outcomes:
measure: Elbow and Forearm Pain
timeFrame: Change from Baseline elbow and forearm pain at 3 weeks
Secondary outcomes:
measure: Functionality
timeFrame: Change from baseline functionality at 3 weeks
measure: Grip Strength
timeFrame: Change from baseline grip strength at 3 weeks
measure: Change in the level of elbow and forearm edema
timeFrame: Change from baseline edema at 3 weeks
measure: Range of motion of elbow joint
timeFrame: Change from baseline range of motion at 3 weeks
measure: Change in the level of quality of life
timeFrame: Change from baseline quality of life level at 3 weeks
Other outcomes:
Locations:
city: Famagusta,
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Mediterranean University
name: Ozge Gokalp, Asst. Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00314587: Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children
Official title: Treatment of Unstable Both-Bone Midshaft Forearm Fractures in Children: A Randomized Trial Between 1 and 2 Elastic Stable Intramedullary Nails
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture
Keywords: fracture
forearm
midshaft
child
treatment
Lead sponsor: Colaris, Joost, M.D.
Sponsor class: INDIV
First posted: 2006-04-14
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators created a randomized clinical trial between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.

Detailed description: Children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial.

If the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 ESIN will be done.

The aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. Outpatient clinic visits till a follow-up of 9 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.

Eligibility criteria: Inclusion Criteria:

* Stable both-bone forearm fracture
* Age \< 16 years old
* Dislocation
* Unstable

Exclusion Criteria:

* Fracture older than 1 week
* No informed consent
* Refracture
* Open fracture (Gustillo 2 and 3)

Primary outcomes:
measure: pronation and supination
Secondary outcomes:
measure: complications, function, esthetics, complaints in daily living, X-rays
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: HAGA, Juliana Children's Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre, Sophia Children's Hospital
state: Zuid Holland
Study officials:
affiliation: HAGA/Erasmus Medical Centre
name: Joost W Colaris, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04653987: The Impact of Puncture Angle on Total Fluoroscopy Time Reduction During Percutaneous Biliary Drainage
Official title: Ultrasound and Fluoroscopy Guided Percutaneous Transhepatic Biliary Drainage in Patients With Malignant Bile Duct Obstruction - Impact of Puncture Angle on Total Fluoroscopy Time Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interventional Radiology
Keywords: biliary drainage, fluoroscopy time, puncture angle
Lead sponsor: Institut za Rehabilitaciju Sokobanjska Beograd
Sponsor class: OTHER
Collaborators: name: Klinički centar Srbije
First posted: 2020-12-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with malignant biliary obstruction who underwent PTBD performed by right sided intercostal approach (US and fluorocopy guided).

Brief summary: The purpose of this study is to retrospectively assess the importance of initial bile duct puncture angle on total fluoroscopy time and overall efficacy during ultrasound and fluoroscopy guided percutaneous transhepatic biliary drainage (PTBD) performed for patients with malignant biliary hilar obstruction.

Detailed description: Data used for this study will be collected from medical records of patients who underwent PTBD at the Interventional radiology department. Only patients who received percutaneous biliary drainage performed with right sided intercostal approach will be included in study. The initial puncture was ultrasound-guided in all patients. Any subsequent step of the procedure was performed under fluoroscopy. The cumulative fluoroscopy time (the total time of the exposure to X rays during intervention) after the US guided puncture was recorded. It will be used as an indirect measure of the complexity of the intervention and as an important parameter of radiation exposure. The patients will be divided into two groups based on the puncture angle: ≤30° group and \>30° group. The two groups will be retrospectively analysed for technical success, fluoroscopy time and complications.

Eligibility criteria: Inclusion Criteria:

* pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1.

Exclusion Criteria:

* terminally ill patiens, performance status ˃2, hepatic decompensation (including ascites), severe underlying cardiac or renal diseases and coagulation disorders

Primary outcomes:
measure: Total fluoroscopy time
timeFrame: during intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Centre of Serbia
name: Dragan M Masulovic, Phd
role: STUDY_DIRECTOR
References: