louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02956278: The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Official title: The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Gout
Hyperuricemia
Keywords: allopurinol
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Open Medicine Institute
First posted: 2016-11-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects will undergo a placebo and allopurinol phase to better understand the effects of the reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.


Eligibility criteria: Inclusion Criteria:

* self-identified as Asian/European ancestry
* generally healthy with approved lab values for CBC,HFP,RFP, and uric acid
* Subjects with the ABCG2 genotype, homozygous, heterozygous or homozygous for the major allele of rs2231142 will be recruited

Exclusion Criteria:

* vascular disease
* renal impairment
* medications/supplements that affect uric acid levels
* pregnant or lactating women
* prior history of allergic reaction to allopurinol or testing positive for HLA-B\*5801 allele
* risk of urinary or gastric retention or narrow-angle glaucoma
* impaired hepatic function
* evidence of anemia
* evidence or diagnosis of congestive heart failure
* smokers
* subjects with a mutation other than rs2231142 in the ABCG2 genotype
* subjects taking hormonal contraceptives or other hormonal medications
* evidence of recreational drug use as determined by questionnaire

Primary outcomes:
measure: Oxypurinol Renal Clearance
timeFrame: 24 hours (Urine collected 0-4 hrs,4-8 hrs,8-10 hrs,10-24 hrs post-dose)
measure: Percent Change Uric Acid
timeFrame: 24 hours
Secondary outcomes:
measure: Oxypurinol AUC
timeFrame: 24 hours (Collections at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24 hours post-dose)
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Open Medicine Institute
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kathleen Giacomini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05980078: Interactive Informed Consent and Decision Conflict
Official title: A Computer-Based Interactive Informed Consent for Surgery Does Not Reduce Decision Conflict
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Problem
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Informed consent for surgery can address the legal aspects while also being simple, informative, and empathic. It can help people confirm that the potential harms are acceptable in light of the potential benefits. Standard consent forms just document this process, while a computer-based, interactive consent process can also standardize and potentially enhance it.

Detailed description: It's not clear that the current informed consent process adequately addresses common misconceptions and adequately confirms patient understanding of potential harms and potential benefits. Thoughtful patient consideration of potential benefits and potential harms of surgery might be facilitated by a step-by-step, iterative, interactive electronic consent process designed to help patients: 1) become aware of their values, 2) understand the actual and potential harms of surgery, 3) understand the potential benefits of surgery, and 4) guide people away from common misconceptions and towards decisions based on their values.

Eligibility criteria: Inclusion Criteria:

1. English and Spanish-speaking adults
2. Older than 18 years of age
3. One of six common upper extremity conditions including carpal tunnel release, cubital tunnel release, trigger finger release, plate and screw fixation of a distal radius fracture, removal of a benign lump including a ganglion cyst, and Dupuytren contracture release.

Exclusion Criteria:

People with cognitive deficits were excluded.

Primary outcomes:
measure: Decision Conflict Scale
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Jefferson Scale of Patient's Perceptions of Physician Empathy
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas Health Austin (UTHA)
state: Texas
Study officials:
affiliation: Professor of orthopedic surgery at The university of Texas at Austin
name: David Ring, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184778: Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
Official title: Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore Throat
Hoarseness
Keywords: postoperative
Tube size
Patient experience
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2019-12-04
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: How tube size affect patient's experience of postoperative sore throat and hoarseness

Detailed description: A randomised controlled study studying how tube size affect patient's experience of postoperative sore throat and hoarseness.

The patients are randomised on the basis of gender. Men are randomized to tube size 8.0 (usual) or 7.0. Women are randomized to tube size 7.0 (usual) or 6.0.

Eligibility criteria: Inclusion Criteria:

* Need for intubation
* Elective surgery
* ASA Group I and II
* Understands and speaks Danish
* give one's consent

Exclusion Criteria:

* Known dementia
* SARI score \>4
* BMI \> 35
* Acute intubation
* attempt intubation \> 2
* known with previously difficult intubation

Primary outcomes:
measure: Sore throat after intubation
timeFrame: 7 days
measure: Hoarseness after intubation
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: North Denmark Regional Hospital
city: Thisted
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Regionshospital Nordjylland
name: Dorte M Kristensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04451278: RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy
Official title: RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-06-30
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 6 to 18 years old receiving an MRI as part of a preoperative assessment of lesion epilepsy

Brief summary: Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness.

To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 6 and 18 years
* Receiving an MRI for lesional drug-resistant epilepsy
* Affiliated or beneficiary of a social security plan
* Whose parents or guardians have received information about the study and have given their express consent to participate in the study

Exclusion Criteria:

* Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding women)
* History of intracranial surgery
* MRI performed under general anesthesia

Primary outcomes:
measure: Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A De Rothschild
Study officials:
affiliation: Adolphe de Rothschild Fondation Hospital
name: Sidney KRYSTAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04889378: Change of Body Composition and Functional Status Following Short-term Pre-habilitation Among Morbidly Obese Patients Before Bariatric Surgery
Official title: Change of Body Composition and Functional Status Following Short-term Pre-habilitation Among Morbidly Obese Patients Before Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Term Pre-habilitation Before Bariatric Surgery
Keywords: obesity
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, Malaysia
First posted: 2021-05-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: morbidly obese patients

Brief summary: Observational study is conducted in patient under short term pre-habilitation before bariatric surgery.

Detailed description: Observational study is conducted in patient under short term pre-habilitation before bariatric surgery. Data on anthropometry (waist circumference), body compositions (weight, muscle mass, fat free mass, fat mass, fat percentage and basal metabolic rate (BMR)), and functional status (handgrips strength) are collected.

Eligibility criteria: Inclusion Criteria:

* Obese or severe obese patients
* Candidates for short term pre-habilitation among morbid obese patients before bariatric surgery
* Aged more than 18 years old
* Malaysian
* Provided and signed informed consent

Exclusion Criteria:

* Not a candidate for short term pre-habilitation among morbid obese patients before bariatric surgery
* Aged \<18 years old
* Non-Malaysian
* Not able to provide informed consent
* chronic renal failure

Primary outcomes:
measure: anthropometry (waist circumference in cm)
timeFrame: baseline and after 2 weeks
measure: body composition (weight in kg)
timeFrame: baseline and after 2 weeks
measure: body composition (muscle mass in kg)
timeFrame: baseline and after 2 weeks
measure: body composition (fat free mass in kg)
timeFrame: baseline and after 2 weeks
measure: body composition (fat mass in kg)
timeFrame: baseline and after 2 weeks
measure: body composition (fat percentage in percentage)
timeFrame: baseline and after 2 weeks
measure: functional status (hand-grips strength in kg)
timeFrame: baseline and after 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Putrajaya
country: Malaysia
facility: National Cancer Institute
Study officials:
References:
Clinical trial NCT06051578: Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
Official title: Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hernia, Ventral
Hernia, Abdominal
Hernia Abdominal Wall
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of 50 patients who have been evaluated by a surgeon and will undergo a hernia repair without component separation.

Brief summary: The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation.

1. What is the abdominal wall tension for hernias repaired without a component separation?
2. What patient factors contribute to greater abdominal wall tension?
3. Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes?

Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.

Detailed description: This is a prospective cohort study. Patients who undergo hernia repair without component separation will have their abdominal wall tension measured using a tension scale. The scale is an investigational (experimental) device that works by attaching to surgical clamps during surgery to measure the tension on the abdominal wall. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.

Eligibility criteria: Inclusion Criteria:

1. Patients who are planned to undergo ventral hernia repair without component separation
2. Midline hernia

Exclusion Criteria:

1. Mesh excision for reasons other than mesh infection
2. Prior component separation
3. Isolated flank hernia
4. Patients under the age of 18 years
5. Pregnant patients

Primary outcomes:
measure: Abdominal wall tension in patients hernia repair without component separation
timeFrame: 2 year
Secondary outcomes:
measure: Patient factors that contribute to greater abdominal wall tension
timeFrame: 2 year
measure: Association between abdominal wall tension and patient outcomes
timeFrame: 2 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Benjamin Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02180178: Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry
Official title: Mainzer IntraCoronAry daTabase (MICAT). Das Coronary Slow Flow- Syndrom Und Koronare Mikrozirkulationsstörungen- Register.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Microvascular Dysfunction
Keywords: microvascular disease
coronary artery disease
Coronary artery disease, with or without microvascular dysfuntion
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical indication for coronary angiography.

Brief summary: Primary goal of the registry is to collect prospective data on patients undergoing coronary angiography in Mainz. Following amendment of the procol, this study will also include patients who received an Aborb bioresorbable scaffold for the therapy of de novo stenoses.

Detailed description: Patients included in the registry will be contacted by telephone at 3,6,9, 12 months and 2, 5, 10 years after the procedure. In case coronary slow flow is shown at the index procedure, 39ml of blood will be drawn for further studies.

According to the regulations of the Province Rheinland-Pfalz, national law, and with the approval of the Ethic commission of the Landesärztekammer Rheinland Pfalz, patients (n=1000) will also be retrospectively entered in the database in an anonymous way. For these patients, no specific study procedure is foreseen and the MICAT database will be only used as a platform (database of anonymous data collected during routine clinical practice).

Eligibility criteria: Inclusion Criteria:

* clinical indication to coronary angiography

Exclusion Criteria:

* none

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: baseline to 10 years
Secondary outcomes:
measure: Individual endpoints
timeFrame: baseline to 10 years
measure: Other cardiovascular endpoints
timeFrame: baseline to 10 years
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center Mainz - 2 Medizinische Klinik
Study officials:
affiliation: University Medical Center Mainz
name: Tommaso Gori, PhD Dott Med e Chirurgia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gori T, Weissner M, Gonner S, Wendling F, Ullrich H, Ellis S, Anadol R, Polimeni A, Munzel T. Characteristics, Predictors, and Mechanisms of Thrombosis in Coronary Bioresorbable Scaffolds: Differences Between Early and Late Events. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2363-2371. doi: 10.1016/j.jcin.2017.08.020.
citation: Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016 Mar 1;67(8):921-931. doi: 10.1016/j.jacc.2015.12.019.
Clinical trial NCT04464278: Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization
Official title: Predictive Value of Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization (Suite Care and Rehabilitation)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Body Weight Changes
Keywords: Geriatric
Suite Care and Rehabilitation
Body composition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: INSERM UMR S 1136
First posted: 2020-07-09
Enrollment: 360
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Geriatric population hospitalized in geriatric department at Rothschild and Emile-Roux hospitals

Brief summary: The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population

Detailed description: Weight loss in obese adults confers health benefits, while weight loss in the elderly is associated with an increased risk of mortality.

There are a large number of studies associating weight loss and mortality but the relationships between changes in body composition (ratio between fat mass and lean mass) and mortality are often contradictory and poorly understood in elderly subject. The aim at this study is to request at this question.

Eligibility criteria: Inclusion Criteria:

* Patient ≥70 years old
* Hospitalized in SSR for less than 7 days
* No patient opposition

Exclusion Criteria:

* patient with a pacemaker
* lake of nutritional assessment on admission
* lake of assessment of autonomy at admission
* Patient under guardianship or curatorship
* Patient participating in another clinical research
* Patient for whom a short stay (\<21 days) is planned in SSR

Primary outcomes:
measure: The prognosis value of variation of weight on mortality
timeFrame: 3 months
measure: Mortality rate
timeFrame: 3 months
Secondary outcomes:
measure: The pprognosis value of variation of weight on unscheduled readmission in SSR
timeFrame: Between D0 and D21
measure: Unscheduled readmission in SSR
timeFrame: during 15 days after the end of hospitalization
measure: Lean mass pronostic value
timeFrame: 3 months after the inclusion
measure: In fat mass pronostic value
timeFrame: 3 months after the inclusion
measure: fat / lean mass ratio
timeFrame: 3 months after the inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christine FORASASSI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00249678: Behavioral Therapy Development for Methamphetamine Abusers
Official title: Behavioral Therapy Development for Methamphetamine Abuse
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: The Study Was Designed to Develop a Cognitive Behavioral Approach to Treating Methamphetamine Abuse in HIV Primary Care Settings
Keywords: Behavior Therapy
methamphetamine
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-07
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is...to assess whether placing a substance abuse intervention for HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.


Eligibility criteria: Inclusion Criteria:

1. HIV-seropositive, GBM receiving medical treatment for HIV for at least 30 days prior to signing informed consent at the UCLA CARE clinic, aged 18-65
2. Willing to give informed consent and comply with study procedures;
3. Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications;
4. Diagnosed with current methamphetamine abuse as determined by MINI; and
5. Interested in seeking treatment for their methamphetamine abuse and in participating in this research project.

Exclusion Criteria:

1. Unwilling to give, or withdrawal of, informed consent;
2. Inability to understand nature of study;
3. A psychiatric condition that, in the principal investigator's judgment, warrants additional intervention to ensure participant safety (e.g., meets DSM-IV-TR criteria for current bipolar disorder or a psychotic disorder);
4. Current suicidal ideation or suicide attempt within the past 3 months; and
5. Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI.
6. Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.

Primary outcomes:
measure: Craving
measure: Medication compliance
measure: Addiction severity
measure: Psychiatric interview
measure: Sex-risk behavior
Secondary outcomes:
measure: Depression
measure: Quality of Life
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA, Integrated Substance Abuse Programs
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Clinic
state: California
Study officials:
affiliation: University of California, Los Angeles
name: James Peck, Other
role: PRINCIPAL_INVESTIGATOR
References: