louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00561132: Study of Vanadium Supplement in Patients With Impaired Glucose Tolerance
Official title: Effect of Vanadium on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prediabetic State
Keywords: vanadium
insulin sensitivity
impaired glucose tolerance
triglycerides
Lead sponsor: Unidad de Investigacion Medica en Epidemiologia Clinica
Sponsor class: OTHER
Collaborators: name: Fondo para el Fomento a la Investigacion Medica
name: Doctorado en Farmacologia de la Universidad de Guadalajara
First posted: 2007-11-20
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate if the vanadium can improve the insulin sensitivity in patients with impaired glucose tolerance. Secondary purpose of this study was to assess changes on metabolic profile, weight and blood pressure.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of impaired glucose tolerance
* Body mass index from 25 to 35 kg/m2
* History of type 2 diabetes mellitus in the first branch

Exclusion Criteria:

* Taking medication with known effects on carbohydrate or insulin metabolism
* Thyroid diseases
* Hepatic diseases

Primary outcomes:
measure: Changes on insulin sensitivity assessed with a euglycemic-hyperinsulinemic clamp technique
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes on metabolic profile
timeFrame: 4 weeks
measure: Changes on anthropometrical measures
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion Medica en Epidemiologia Clinica, Hospital de Especialidades, UMAE, Centro Medico Nacional de Occidente
state: Jalisco
Study officials:
affiliation: Unidad de Investigacion Medica en Epidemiologia Clinica
name: Omar Jacques-Camarena, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Investigacion Medica en Epidemiologia Clinica
name: Manuel González-Ortiz, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de Investigacion Medica en Epidemiologia Clinica
name: Esperanza Martínez-Abundis, MD, MSc, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00861432: Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy
Official title: Evaluation of Quality of Life of Tumor Patients With and Without Additive Homeopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tumor
Keywords: Life quality
questionnaire
tumor patients
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 400
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: Tumor patients receiving conventional tumor therapies are included into this study. The patients are randomized into two groups receiving either additive homeopathic therapy or not. Two questionnaires referring to subjective feeling and life quality are filled out by the patients with each visit to the outpatients Department. One of them is the QLQC30 questionnaire of the EORTC. The results of the questionnaires of the two groups are compared.

Detailed description: Quality of life is an important issue for cancer patients, especially during the periods of chemotherapy and radiation. Preliminary results have revealed positive effects of add-on homeopathy on quality of life as well as subjective well-being. Patients are receiving classical homeopathy with administration of either globules and/or dilutions. With each appointment, patients complete two questionnaires.

Eligibility criteria: Inclusion Criteria:

Tumor patients between 18 and 100 years old

Exclusion criteria: Patients younger than 18 years, patients having completed less than 3 questionnaires.

Primary outcomes:
measure: Difference with regard to subjective feeling and life quality with or without homeopathic treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Med. Univ. Vienna, Dept. Internal Med. I
Study officials:
affiliation: Medical University Vienna
name: Michael Frass, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frass M, Friehs H, Thallinger C, Sohal NK, Marosi C, Muchitsch I, Gaertner K, Gleiss A, Schuster E, Oberbaum M. Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial. Complement Ther Med. 2015 Jun;23(3):309-17. doi: 10.1016/j.ctim.2015.03.004. Epub 2015 Mar 23.
Clinical trial NCT07019532: Machine Learning-Based Risk Stratification for Fistula Formation After Perianal Abscess Drainage
Official title: A Prospective Cohort Study for Machine Learning-Based Prediction of Anal Fistula Formation After Perianal Abscess Drainage Based on Drainage Setting, Provider Experience, and MRI Interpretation (PRISM)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Perianal Abscess
Anal Fistula
Keywords: Artificial Intelligence
MR Imaging
Colorectal Surgery
Surgical Outcomes
Drainage
Fistula Prediction
Lead sponsor: Gumushane State Hospital
Sponsor class: OTHER_GOV
First posted: 2025-06-13
Enrollment: 450
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 (≥18 years old) undergoing surgical drainage for their first perianal abscess at a university or state hospital. Participants must not have a history of anal fistula, Crohn's disease, or be under immunosuppressive therapy. Follow-up duration is 6 months after drainage.

Brief summary: This prospective cohort study investigates the influence of provider experience and drainage location on fistula formation within 6 months following perianal abscess drainage. Additionally, the study explores the role of artificial intelligence (AI)-based interpretation of magnetic resonance (MR) images in early identification of fistula development.

Detailed description: Perianal abscess drainage is a common surgical procedure. However, subsequent fistula formation remains a significant complication. This study aims to determine whether the procedure setting (operating room, emergency department, or outpatient clinic) and the experience level of the performing clinician affect fistula development rates.

Furthermore, the study evaluates the use of AI-assisted analysis of selected MR images to identify early signs of fistula formation. Selected image slices will be labeled based on radiological reports, and a machine learning model will be trained to predict fistula risk. The study will also compare AI-generated interpretations with expert radiologist assessments to validate performance.

The ultimate goal is to create a risk stratification tool to support clinical decision-making in surgical management of perianal abscesses.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* First-time perianal abscess
* Surgical drainage performed

Exclusion Criteria:

* Existing anal fistula history
* Crohn's disease
* Immunosuppressive treatment
* Incomplete 6-month follow-up

Primary outcomes:
measure: Fistula formation within 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between drainage location and fistula rate
timeFrame: 6 months
measure: Correlation between provider experience and fistula complexity
timeFrame: 6 months
measure: Diagnostic accuracy of AI-based MR analysis vs radiologist
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06998732: BCD to Measure the ED95 of Remimazolam-Assisted Sedation in Arteriovenous Fistula Creation Surgery
Official title: Using Biased Coin Design (BCD) to Measure the ED95 of Remimazolam-Assisted Sedation in Arteriovenous Fistula Creation Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Uremia
Keywords: Biased Coin Design
uremia
remimazolam
ED95
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study intends to measure the ED95 of remimazolam-assisted sedation in arteriovenous fistula creation by BCD.

Detailed description: Operative venous fistula (AVF) under local anaesthesia is a common surgical procedure for long-term haemodialysis patients. A common surgical procedure for patients with renal failure on dialysis. However, due to the long duration of the procedure, patients are prone to anxiety and nervousness that Especially if it is difficult to keep quiet during the operation, it may lead to blood pressure fluctuation and other complications, affecting the operation's smooth progress of the procedure. Moderate sedation is particularly important in this type of surgery, as it can effectively relieve the patient's tension and stabilise vital signs, It can effectively relieve the patient's tension, stabilise vital signs and reduce the patient's discomfort, thus contributing to the successful completion of the operation.This study intends to measure the ED95 of remazolam-assisted sedation in arteriovenous fistula creation by BCD. This will provide a scientific basis for anaesthetic drug selection in uremic patients.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old (including borderline values).
* Elective surgical patients under local anaesthesia for operation of AVF
* Voluntary participation in this study and signing of informed consent.
* American Society of Anesthesiologists (ASA) classification \< Grade IV.
* BMI range: 18-28kg/m2 (including borderline values).

Exclusion Criteria:

* hypersensitivity to remimazolam or benzodiazepines.
* patients with severe cardiac, pulmonary, neurological diseases or liver failure. -- Preoperative use of sedative drugs, anticonvulsants, etc.
* patients who cannot cooperate with postoperative recovery or follow-up.
* vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc.

Primary outcomes:
measure: ED95
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04396132: The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
Official title: The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Nerve Diseases
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system.

Detailed description: Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics).

Eligibility criteria: Inclusion Criteria:

* No ear disease
* No neurologic disease
* No surgery for ear, brain or musculoskeletal system

Exclusion Criteria:

* Diabetes mellitus
* Drug use effective on central nervous system

Primary outcomes:
measure: Subjective Visual Vertical
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Department Of Otolaryngology
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152632: Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study
Official title: Acupuncture Treatment for Migraine: a Functional Magnetic Resonance Imaging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: acupuncture
migraine
specific acupoints
brain network
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods.

Detailed description: Every participants in the four intervention groups will go through functional magnetic imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be performed when the 4 courses end; the 4th scan will be operated after three-month enrollment.

Volunteers in waiting list group will undergo the above scans at the same time points in exception of acupuncture treatment.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004

Exclusion Criteria:

* people with other types of headache
* people with organic cerebral disorders
* people with primary disorders
* people in moderate or severe anxiety or depression
* people in pregnancy

Primary outcomes:
measure: improvement of headache frequency
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Fanrong Liang, Master
role: STUDY_CHAIR
References:
citation: Li Z, Zhou J, Lan L, Cheng S, Sun R, Gong Q, Wintermark M, Zeng F, Liang F. Concurrent brain structural and functional alterations in patients with migraine without aura: an fMRI study. J Headache Pain. 2020 Dec 7;21(1):141. doi: 10.1186/s10194-020-01203-5.
Clinical trial NCT00345332: A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2006-06-28
Enrollment: 31
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Detailed description: A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.

Eligibility criteria: Inclusion Criteria:

* Female subjects 21-90 years of age
* subjects has urinary incontinence on 3 day bladder diary
* subject has severe incontinence
* urine dipstick or urine culture negative for urinary tract infection
* cystometrogram without stress urinary leakage
* must have failed at least one anti-cholinergic medication
* negative urine pregnancy test on day of administration of study medication

Exclusion Criteria:

* history of carcinoma of the bladder
* presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance
* gross fecal incontinence
* known allergy to sulfa or ciprofloxacin or to lidocaine
* any medical condition that may put the subject at increased risk with exposure to Botox
* females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential
* known allergy to any of the components in the study medication
* prior documented resistance to Botox
* evidence of recent alcohol or drug abuse
* concurrent participation in another investigational drug or device study within 30 days

Primary outcomes:
measure: Incontinent Episodes Per Day
timeFrame: week 13
Secondary outcomes:
measure: Number of Incontinence Pads Used Per Day
timeFrame: week 13
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California at Davis
state: California
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: University of Rochester
name: Michael K Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flynn MK, Webster GD, Amundsen CL. The effect of botulinum-A toxin on patients with severe urge urinary incontinence. J Urol. 2004 Dec;172(6 Pt 1):2316-20. doi: 10.1097/01.ju.0000143889.00681.3f.
Clinical trial NCT05061732: Helicobacter Pylori Eradication and Follow-up
Official title: Helicobacter Pylori Eradication and Follow-up in Zhongshan Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 4447
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility criteria: Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.

Exclusion Criteria:

* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: 6 weeks
Secondary outcomes:
measure: Eradication rate of Helicobacter pylori resistant strains
timeFrame: 6 weeks
measure: Eradication rate of Helicobacter pylori susceptible strains
timeFrame: 6 weeks
Other outcomes:
measure: Adherence rate
timeFrame: 2 weeks during therapy
measure: Frequency of adverse events
timeFrame: 2 weeks during therapy
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Taotao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01207232: The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates
Official title: The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Influenza
Keywords: seasonal influenza
behavioral economics
implementation intentions
planning prompt
nudge
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Yale University
name: Stanford University
First posted: 2010-09-22
Enrollment: 3272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates.

Detailed description: Seasonal influenza causes 20,000 hospitalizations and 36,000 deaths in the U.S. each year. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. This type of planning prompt is a "nudge" in the direction of desired behavior that can be implemented at minimal expense and does not restrict individual autonomy. We conducted a 3-arm randomized controlled trial to test whether a low-cost planning intervention could increase influence vaccination rates. We show that planning prompts can be successfully applied to improve health behaviors.

Eligibility criteria: Inclusion Criteria:

* Vaccine indications according to fall 2009 CDC criteria (age \>= 50 or chronic disease
* Employee at partner corporation that implemented the study

Exclusion Criteria:

* None

Primary outcomes:
measure: Receipt of 2009 Seasonal Influenza Vaccination
timeFrame: up to 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine L Milkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: