louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00046722: Marijuana for HIV-Related Peripheral Neuropathy
Official title: Effects of Marijuana on Neuropathic Pain in HIV-Related Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Nervous System Diseases
HIV Infections
Keywords: treatment experienced
complementary therapies
Neuropathy
Peripheral Neuropathy
HIV-Related Peripheral Neuropathy
HIV
Lead sponsor: Center for Medicinal Cannabis Research
Sponsor class: OTHER
First posted: 2002-10-03
Enrollment: 50
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: To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.

Detailed description: The study will include subjects with peripheral neuropathy caused either by HIV-disease or antiretroviral medication for the treatment of HIV. A neurologist will conduct a neurological and pain evaluation to determine eligibility for the study. Subjects who meet all eligibility criteria will be admitted to the General Clinical Research Center at San Francisco General Hospital for seven days. Subjects will be randomized (like a toss of a coin) to smoke marijuana or a placebo (cigarettes with no THC).

Eligibility criteria: INCLUSION CRITERIA:

* HIV positive.
* Be 18 years or older.
* Diagnosis of HIV-related painful neuropathy.
* Stable antiretroviral therapy or no antiretroviral therapy for at least 8 weeks.
* Prior use of marijuana, at least 6 occasions in their lifetime prior to enrollment.

EXCLUSION CRITERIA: (Not allowed)

* Current use of smoked tobacco products.
* Current methadone treatment.
* Use of smoked marijuana within 30 days of enrollment.
* Diagnosis of diabetes mellitus.
* Currently receiving treatment with corticosteroids.
* Use of INH, dapsone or metronidazole within 8 weeks prior to enrollment.
* Severe heart disease, uncontrolled high blood pressure or lung disease.
* Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Change in level of HIV-related neuropathic pain as recorded on a 100mm Visual Analog Scale.
Secondary outcomes:
measure: Change in level of experimentally-induced pain.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Community Consortium
state: California
Study officials:
affiliation: UCSF Community Consortium
name: Donald I Abrams, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
Clinical trial NCT00960622: Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
Official title: Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Keywords: treatment experienced
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2009-08-18
Enrollment: 17
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: Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after randomization to either continuing on trizivir or combivir, or to switching to Truvada. Measurements include maximal or peak oxygen consumption, lactate production and clearance, subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction in several organ systems.

Detailed description: None different from the summary description above.

Eligibility criteria: Inclusion Criteria:

* infection with human immunodeficiency virus (HIV) with undetectable viral load
* on Combivir or trizivir
* able to exercise and sign consent

Exclusion Criteria:

* other active illness
* contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.

Primary outcomes:
measure: Change in Peak Oxygen Uptake.
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: St Luke's Roosevelt Hospital New York City
name: Donald P Kotler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SLRHC
name: Gabriel Ionescu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05318222: Genetic Inclusion by Virtual Evaluation
Official title: Virtual Platforms for Genetics Evaluation in the Medically Underserved
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Birth Defects
Multiple Congenital Anomaly
Neurodevelopmental Disorders
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to transform the current clinical practice paradigm by leveraging an internally designed web-based model of delivery of care called Consultagene to provide remote evaluation and genomic sequencing for improving genetic health of less resourced children with rare disorders living along the Texas-Mexico border.

Detailed description: Inadequate access to genetics evaluation and genomic testing in the Hispanic minorities living along the Texas-Mexico has marginalized the most vulnerable pediatric group. In this study, we will (1) implement a virtual web-based service, called Consultagene for simplifying patient pathways and deliver virtual genetics evaluation in Rio Grande Valley (RGV) (2) provide rapid genetic diagnoses through whole genome sequencing and interpretation of diagnostic studies for medical decision-making and improving health outcomes for the minorities, and (3) build genomic competency of front-line healthcare providers through education and machine learning to expedite referral of pediatric patients with suspected rare diseases for shortening diagnostic odyssey.

Eligibility criteria: Inclusion Criteria:

Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley and El Paso in Texas

Exclusion Criteria:

Children with known genetic diseases

Primary outcomes:
measure: Time to diagnosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburg
country: United States
facility: University of Texas Rio Grande Valley
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Seema Lalani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404922: Multiple Ascending Dose Study in Healthy Volunteers
Official title: A Phase I Single Center, Double-Blind, Placebo-Controlled, Multiple Dose-Ascending Study to Evaluate the Pharmacokinetics and Tolerability of CTP-730 Immediate Release at Steady State in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety/Efficacy Study
Randomized
Double Blind
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males and females between 18 and 50 years of age.
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2

Exclusion Criteria:

* Medical, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety
* Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions.
* PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug.
* Liver function tests greater than the upper limit of normal.
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
* Urinalysis positive for protein or glucose.
* A positive screen for alcohol, drugs of abuse, or tobacco use.
* Inability to comply with food and beverage restrictions during study participation.
* Donation or blood collection or acute loss of blood prior to screening.

Primary outcomes:
measure: Pharmacokinetic Profile
timeFrame: 96 hours
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Ginny Braman
role: STUDY_DIRECTOR
References:
Clinical trial NCT04213222: Radiomics Assess of Bevacizumab Plus Chemo in Colorectal Cancer Liver Metastases
Official title: A Radiomics Approach to Predict the Effect of Bevacizumab Plus Chemotherapy in Patients With Liver Metastases of Colorectal Cancer: A Prospective Multi-Centers Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Rectal Cancer
Liver Metastases
Keywords: colorectal cancer
liver metastasis
bevacizumab
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of colorectal carcinoma with liver metastasis

Brief summary: Colorectal carcinoma with liver metastasis is one of the major problems bothering physicians worldwide. Bevacizumab combined with chemotherapy is the standard treatment recommended by several guidelines. Despite the high cost, a certain portion of patients couldn't benefit from this therapy. This study is aiming to find out the specific type of patients who would respond to bevacizumab by Radiomics approach, and evaluate the prediction value of this imaging model with clinical and genetic factors.


Eligibility criteria: Inclusion Criteria:

1. Colorectal carcinoma confirmed by pathological result.
2. Liver metastasis confirmed by imaging studies.
3. Treatment of bevacizumab combined with chemotherapy chosen by MDT team.
4. ECOG: 0-2.
5. Normal laboratory studies including liver\\renal\\bone marrow functions.
6. Expected lifespan more than 3 months.

Exclusion Criteria:

1. Previous treatment of colorectal cancer with liver metastasis.
2. Diagnosed with other malignancies.
3. Couldn't finish the trial due to several reasons such as allergy to chemotherapy drugs\\pregnancy or lactation\\chronic heart disease\\unable to sustain further treatment.

Primary outcomes:
measure: estimated ORR
timeFrame: 6-8 weeks
Secondary outcomes:
measure: estimated PFS
timeFrame: 3 years
measure: estimated OS
timeFrame: 3 years
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05799222: Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
Official title: Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight
PreDiabetes
Diabetes Type 2
Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with overweight or obesity and pre-diabetes or diabetes and low income

Brief summary: This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income.

Detailed description: The Medically Intensive Nutritional Therapy (MINT) program at Massachusetts General Hospital (MGH) Weight Center is a low-calorie nutrition plan that may offer a solution for those who have difficulty implementing a low-calorie dietary plan on their own. This study examines the effects of MINT on weight loss and blood sugar control specifically in a low-income population and explores potential reasons for discontinuing the program.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Body mass index (BMI) greater than or equal to 27 kg/m\^2
* HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months
* Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022

Exclusion Criteria:

* Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment
* HbA1c greater than or equal to 10 percent
* Plans to pursue bariatric surgery over the 6 months post-study enrollment
* Weight loss of greater than 5 kg within the previous 3 months
* Current active eating disorder, with the exception of binge eating disorder
* Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention
* Active illicit substance abuse
* Pregnant, breastfeeding, or considering pregnancy within the next 6 months
* Current participation in another clinical research trial deemed by investigator to conflict with current study

Primary outcomes:
measure: Body weight reduction
timeFrame: 3 months
measure: Hemoglobin A1c reduction
timeFrame: 3 months
Secondary outcomes:
measure: Program adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass General Brigham
name: Chika V Anekwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644839: Study Examing The Effect Of Omeprazole On Safety, Tolerability And How The Body Processes An Experimental Drug
Official title: A Phase 1, Open-Label, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Omeprazole On The Single Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Experiment in the test tube indicated that CP-945,598 becomes less soluble with increase of pH (less acidity). Changes in stomach acid levels may affect the solubility of CP-945,598, therefore, alters its availability in the blood. Omeprazole decreases acid levels in stomach. This study will compare the time course of drug concentrations in the body, safety, and tolerability of CP-945,598 given with and without omeprazole.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Body Mass Index (BMI) of 26.6 to 40.5 kg/m2.

Exclusion Criteria:

* Non-prescribed use of drugs or abuse of recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure measurements falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits; medically important health conditions; recent use of prescription or non-prescription medications.

Primary outcomes:
measure: Measurement of drug concentrations in serum from blood samples collected at 4 days before given omeprazole, and after second single dose of CP-945,598 on days 1-6, 8.
timeFrame: 1 day
measure: Measurement of drug concentrations in serum from blood samples collected at various times after first single dose of CP-945,598 on days 1-6, 8, 15.
timeFrame: 1 day
Secondary outcomes:
measure: ECGs on the first and last day of the study
timeFrame: 2 days
measure: Saftey laboratory tests (chemistry, hematology, urinalysis) on the first and last day of the study
timeFrame: 2 days
measure: Vital signs (blood pressure, heart rate and respiratory rate) on the first and last day of the study
timeFrame: 2 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02596139: Reliability and Validity of the Taiwan-version of Multidimensional Fatigue Inventory and Fatigue Severity Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatigue
Taiwan-version Questionnaire
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy people

Brief summary: The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity.

Fatigue Severity Scale (FSS) contains nine statements that rate the severity of fatigue symptoms. The purposes of this study are to translate fatigue questionnaires of -MFI- and -FSS- to Taiwan-version, and to examine the reliability and validity of the scales.

A hundred adult people without diagnosed physical nor mental disabilities will be recruited. Subjects will fill out the Taiwan-version of MFI, FSS, SF-36 and Pittsburg Sleep Quality Index (PSQI) to establish the validity. Subjects will re-fill the MFI and FSS one week later to evaluate the test-retest reliability.

Another twenty people who are familiar with both English and Chinese will be recruited to evaluate the translation reliability. Subjects will fill out the English version of MFI and FSS and, then, fill out the Taiwan-version of the MFI and FSS with at least ten minutes apart. The translation reliability will be evaluated by paired t test and the intraclass correlation coefficient.


Eligibility criteria: Inclusion Criteria:

* No cognition or mental disorders

Primary outcomes:
measure: Assessing the reliability and validity of Taiwan-version Multidimensional Fatigue Inventory questionnaire
timeFrame: 1 week
measure: Assessing the reliability and validity of Taiwan-version Fatigue Severity Scale questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: SF-36 questionnaire
timeFrame: Baseline
measure: Pittsburg Sleep Quality Index questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT06516939: The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin
Official title: The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sensitive Skin
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin


Eligibility criteria: Inclusion Criteria:

1. Sensitive skin with a diagnosis of persistent erythema and a lactate irritation test score of 2-3
2. No related skin care products including bovine alkaline fibroblast growth factor were used within 1 month before participating in the experiment, and photoelectric treatment measures were not carried out
3. Physical sunscreen should be strict during enrollment

Exclusion Criteria:

1. Children
2. Have serious heart, liver, kidney, and blood system diseases, and severe immunocompromise
3. Patients with mental illness or cancer
4. Those who have received glucocorticoids, calcineurin inhibitors, topical small molecule drugs, antibiotics or tretinoin within 3 months
5. Those who are allergic to basic fibroblast growth factor gel and its components
6. Acute dermatitis of the face and perifolliculitis

Primary outcomes:
measure: erythema index
timeFrame: 0、1、2、4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
Study officials:
References: