louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00065104: Dehydroepiandrosterone Effects on HIV-1 Replication
Official title: Dehydroepiandrosterone Effects on HIV-1 Replication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
DHEA
immune system
hormones
body composition
quality of life
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study's purpose is to learn how dehydroepiandrosterone (DHEA) affects the HIV virus, the immune system, hormone levels, body composition and quality of life.


Eligibility criteria: Inclusion criteria:

* Evidence of HIV-1 infection
* HIV RNA \<50 copies/mL
* Stable antiretroviral treatment regimen for at least 8 weeks
* Age 18 years or older
* Normal pap smear and mammograph within 1 year (females)
* Normal prostate-specific antigen level with in one year, age adjusted (males)

Exclusion criteria:

* Active opportunistic infections or malignancy other than localized cutaneous KS lesions
* Concurrent or prior use within the past 8 weeks of DHA, testosterone, other anabolic steroids, corticosteroids, megestrol acetate, growth hormone, IL-2, or thalidomide
* Diagnosis of AIDS Dementia Complex (stage II or higher)
* Active substance abuse (e.g., alcohol or injection drugs)
* Evidence of severe liver dysfunction or hepatic transaminases greater than 3x the upper normal limit
* Pregnant or breast-feeding
* History of endocrinologically-responsive tumors (e.g., breast, ovarian, uterine, or prostatic cancer, or malignant melanoma)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Community Consortium
state: California
Study officials:
References:
Clinical trial NCT00728104: The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS)
Official title: Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cyclic Vomiting Syndrome
Keywords: Learn
L-Carnitine
Co-enzyme Q10
Effective
These supplements
Compared
Standard
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2008-08-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cyclic Vomiting Syndrome (CVS) is a condition where children and adults have repeated attacks of severe vomiting, nausea, abdominal pain, headaches, and tiredness. These episodes can last from several hours to several days.

Brief summary: This is a study with the principle goal being to learn about the use of L-Carnitine and CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting Syndrome, largely initiated by parents. We want to learn how effective these supplements are compared to standard treatment, at what dose, and what onset of action in order to initiate future prospective study on these supplements.


Eligibility criteria: Inclusion Criteria:

* 3 discrete episodes of vomiting
* normal health between episodes
* stereotypical clinical pattern
* no abnormal test results to account for vomiting (see exclusion criteria)

Exclusion Criteria:

* abnormal UGI with small bowel follow-through revealing an anatomic anomaly, inflammatory or obstructive
* Significantly abnormal endoscopic biopsies (moderate to severe esophagitis, H. pylori)
* Abnormal abdominal ultrasound revealing hydronephrosis, cholelithiasis, pancreatitis
* Positive screening for endocrine disorder (diabetic ketoacidosis, Addison's)
* Positive screening for inborn errors of metabolism (hypoglycemia, lactic acidosis, hyperammonemia, organic acidemia, amino aciduria, elevated beta-ALA, porphobilinogen)

Primary outcomes:
measure: How two vitamin supplements are being used to treat cyclic vomiting syndrome
timeFrame: Two years
Secondary outcomes:
measure: How effective these supplements appear to be compared to standard treatment
timeFrame: Two years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wiconsin
name: B Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00459004: Japanese Dose-Response Study of Rimonabant in Obese Patients
Official title: A Dose-Response Relationship Study of SR141716 in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: weight loss
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-11
Enrollment: 527
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to verify the dose-response relationship of rimonabant on body weight change.

The secondary objectives are to compare the effect of 3 doses of SR141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of SR141716.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index ≥25 kg/m²
* Viceral Fat Area ≥ 100 cm²
* Diet therapy for more than 8 weeks before start of the placebo observation period
* Stable weight (variation \< ±3kg within 8 weeks before start of observation period)
* At least 2 criteria of the following 3 comorbidities: Impaired Glucose Tolerance or Type 2 diabetes, Dyslipidemia (hypertriglyceridemia and/or low HDL-choresterol), Hypertension

Primary outcomes:
measure: absolute change in body weight from baseline to Week 24
Secondary outcomes:
measure: Efficacy: body weight, visceral fat area, waist circumference, fasting plasma glucose, HbA1c, triglyceride, HDL-cholesterol, blood pressure
measure: Safety:adverse events, laboratory tests, ECGs
measure: Pharmacokinetics: SR141716 plasma trough concentrations
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Toho University Sakura Medical Center, Japan
name: Kohji SHIRAI, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00186004: Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes
Official title: Correlation Between Continuous Glucose Monitoring and Intermittent Glucose Monitoring Values and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Health & Hospital System
First posted: 2005-09-16
Enrollment: 21
Sex: FEMALE
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: Pregnant patients 18 years or older, less than 28 weeks gestation without pregestational diabetes.

Brief summary: We wish to find out if in non-diabetic pregnancies, as well as diabetic pregnancies, additional data obtained by Continuous Glucose Monitoring improves perinatal risk prediction.

Detailed description: Patients are recruited for 3 day continuous glucose monitoring (CGM) plus self-blood glucose monitoring followed by routine diabetes screening at 26-28 weeks gestation to determine if maternal blood glucose excursions correlate with deviation from optimized birth weight.

Eligibility criteria: Inclusion Criteria:

- Pregnant patients under 28 weeks gestation

Exclusion Criteria:

- Pre-gestational diabetes

Primary outcomes:
measure: Birthweight centile
timeFrame: Delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Yehia El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00117104: Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis
Official title: A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease (ESRD)
Kidney Disease, Dialysis
Aranesp®, rHuEPO
Anemia, Hemoglobin
Dosing, Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).


Eligibility criteria: Inclusion Criteria: - Subjects with end stage renal disease (ESRD) on hemodialysis Exclusion Criteria: - Known hypersensitivity to Aranesp® (darbepoetin alfa) or any of its excipients - Participating in an investigational drug or device trial - Patient will not be available for follow-up assessment - Patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures

Primary outcomes:
measure: Target hemoglobin (Hgb)
Secondary outcomes:
measure: Distribution of hemoglobin (Hgb) values by week
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04710004: Electrophysiological Biomarkers in MTLE Patients.
Official title: Electrophysiological Biomarkers During Invasive Monitoring of Mesial Temporal Lobe Epilepsy Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mesial Temporal Lobe Epilepsy
Keywords: Epilepsy
Biomarkers
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 1
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: BASIC_SCIENCE

Brief summary: The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.

Detailed description: This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male or female, aged 18-65
3. Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
4. Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays

Exclusion criteria:

1. Any patient who is unwilling or unable to provide consent
2. Women who are pregnant
3. Patients under 18 years
4. Incarcerated persons

Primary outcomes:
measure: Change in Intracranial EEG Recording: Spectral Power From Baseline
timeFrame: Baseline, up to 6 weeks postintervention
measure: Change in Intracranial EEG Recording: Synchrony From Baseline
timeFrame: Baseline, up to 6 weeks postintervention
Secondary outcomes:
measure: Changes in Memory During Brain Stimulation From Baseline
timeFrame: Baseline, up to 6 weeks postintervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Epilepsy monitoring unit (EMU) at Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Robert Gross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01495104: A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers
Official title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE VALPROATE ON THE PHARMACOKINETICS OF RO4917838 AND VICE VERSA IN HEALTHY MALE VOLUNTEERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, 18 to 65 years of age inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Healthy as determined by the investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs, and a 12-lead electrocardiogram (ECG)
* Non smoker or smoker of fewer than 10 cigarettes per day

Exclusion Criteria:

* History of alcoholism, drug abuse or addiction within the last year prior to Day -1 of the study
* Alcohol consumption averaging more than 24 g of alcohol per day
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
* Any major illness within the 4 weeks prior to dosing or any acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of study Day -1
* Any confirmed allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Involvement in other investigational studies of any type within 90 days of first study drug administration or within 5 times the elimination half-life of the tested drug, whichever is longer

Primary outcomes:
measure: Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC)
timeFrame: Period 2, day 10 and day 15
measure: Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC)
timeFrame: Period 1, day 5 and Period 2, Day 15
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 16 days
Other outcomes:
Locations:
city: Rueil-Malmaison
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03465501: Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates
Official title: Interstitial Brachytherapy Boost for Treatment of Anal Canal Cancers, Comparison of Two Dose Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Canal Cancer
Keywords: Anal Canal Cancer
brachytherapy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with anal canal brachytherapy for boost, between 2008 and 2016.

Brief summary: Comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting \[low dose rate (LDR) and high dose rate (HDR)\]

Detailed description: Efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate, Tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.

Eligibility criteria: Inclusion Criteria:

* Patients treated by brachytherapy anal canal to boost.

Exclusion Criteria:

* Patients below age of 18 years

Primary outcomes:
measure: Evaluation of the efficacy of interstitial brachytherapy of the anal canal
timeFrame: 1 year
measure: Evaluation of the tolerance of interstitial brachytherapy of the anal canal
timeFrame: 1 year
Secondary outcomes:
measure: Estimation of local control
timeFrame: 1 year
measure: Estimation of disease free survival
timeFrame: 1 year
measure: Estimation of overall survival
timeFrame: 1 year
measure: Comparison of the incidence of toxicities (CTCAE v4) between the 2 groups
timeFrame: 1 year
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Leonel VARELA GAGETTI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordoba A, Escande A, Leroy T, Mirabel X, Coche-Dequeant B, Lartigau E. Low-dose-rate interstitial brachytherapy boost for the treatment of anal canal cancers. Brachytherapy. 2017 Jan-Feb;16(1):230-235. doi: 10.1016/j.brachy.2016.07.007. Epub 2016 Sep 3.
citation: Boukhelif W, Ferri-Molina M, Mazeron R, Maroun P, Duhamel-Oberlander AS, Dumas I, Martinetti F, Guemnie-Tafo A, Chargari C, Haie-Meder C. Interstitial pulsed-dose-rate brachytherapy for the treatment of squamous cell anal carcinoma: A retrospective single institution analysis. Brachytherapy. 2015 Jul-Aug;14(4):549-53. doi: 10.1016/j.brachy.2015.03.006. Epub 2015 Apr 29.
Clinical trial NCT03754101: Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants
Official title: Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized patients with cardiomyopathy will be enrolled in this study

Brief summary: Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the present study, we intend to identify new related variants or genes. From March, 2003 to November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole exome sequencing was used to find out the variants associated with the onset of cardiomyopathy and its prognosis.


Eligibility criteria: Inclusion Criteria:

· Patients diagnosed as cardiomyopathy according to the definition of American Heart Association

Exclusion Criteria:

* Uncontrolled hypertension significant valvular disease
* Mild ischemic heart disease
* Significant systemic infection
* Thyroid-induced cardiomyopathy
* Excessive alcohol consumption
* Precious cancer treatment including irradiation
* Refusal to participate in the study

Primary outcomes:
measure: Cardiovascular death confirmed by death comfirmation or interview with the relatives
timeFrame: up to 24 months
measure: Heart transplantation confirmed by medical record
timeFrame: up to 24 months
Secondary outcomes:
measure: All cause death confirmed by death comfirmation or interview with the relatives
timeFrame: up to 24 months
measure: Heart failure recurring confirmed by medical record
timeFrame: up to 24 months
Other outcomes:
measure: Readmission because of cardiovascular diseases confirmed by medical record
timeFrame: up to 24 months
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital,Wuhan, Hubei, China, 430030
name: Dao Wen Wang, Doctor
role: STUDY_CHAIR
References:
citation: Li S, Sun Y, Hu S, Hu D, Li C, Xiao L, Chen Y, Li H, Cui G, Wang DW. Genetic risk scores to predict the prognosis of chronic heart failure patients in Chinese Han. J Cell Mol Med. 2020 Jan;24(1):285-293. doi: 10.1111/jcmm.14722. Epub 2019 Oct 31.
Clinical trial NCT00755001: Clinical Study on BiHapro Total Hip System With Different Surface Coatings
Official title: Clinical Study on BiHapro Total Hip System With Different Surface Coatings
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Keywords: Total Hip Replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet Spain Orthopaedics S.L.
First posted: 2008-09-18
Enrollment: 40
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total Hip Arthroplasty

Brief summary: This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.

Detailed description: The efficacy of the prosthesis will be evaluated comparing the pain, the function and the range of motion measured preoperatively and postoperatively using recognized clinical outcomes Harris Hip Score. The secondary efficacy measurement is based on X-rays to measure the mineral bony thickness in the areas of Gruen zones of the proximal femur.

Eligibility criteria: The patients who are selected for this study must fit the following criteria.

* Candidate for a Total Hip Arthroplasty
* Less than 80 years of age.
* A pre-operative level of pain and function the same as for conventional joint replacement.
* A likelihood of obtaining relief of pain and improved function.
* Full skeletal maturity.
* Ability to follow instructions.
* Good general health for age.
* Willing to return for follow-up evaluations.
* No bias to sex.

Primary outcomes:
measure: Harris Hip Score
timeFrame: annual at least to 5 yr
Secondary outcomes:
measure: Radiographic Assessment
timeFrame: Annual; At least to 5 yr
Other outcomes:
Locations:
city: Aviles
country: Spain
facility: University Hospital of Aviles
city: Oviedo
country: Spain
facility: University Central Hospital of Asturias
Study officials:
References: