louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00592332: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
Official title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-01-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.

Detailed description: Due to the fundamental importance of glucose as a cerebral fuel, a complex and redundant counterregulatory response to hypoglycemia exists in man. Some studies have shown that prior activation of GABA(A) receptors may result in blunting of counterregulatory responses during next day hypoglycemia.

The Specific Aim is to determine if repeated activation of GABA(A) receptors using Alprazolam will result in blunting of neuroendocrine, ANS and metabolic counterregulatory mechanisms during next day hypoglycemia in T1DM and healthy man.

Eligibility criteria: Inclusion Criteria:

* 16 (8 males, 8 females) Type 1 diabetes patients aged 18-45 yr.
* 16 (8 males, 8 females) healthy controls aged 18-45 yr.
* HbA1c \> 7.0% (Type 1 diabetes patients)
* Had diabetes for 2-15 years (Type 1 diabetes patients)
* No clinical evidence of diabetic tissue complications (Type 1 diabetes patients)
* Body mass index 21-30 kg · m-2
* Normal bedside autonomic function
* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
* Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

* Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
* Hemoglobin of less than 12 g/dl
* Abnormal results following screening tests
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with known liver or kidney disease
* Subjects taking steroids
* Subjects taking beta blockers
* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases

Primary outcomes:
measure: Catecholamine levels
timeFrame: Comparative study performed every 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Stephen N Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312832: Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
Official title: A Randomized Open Label Study Comparing the Impact of Reducing the Dose of Stavudine Versus Switching to Tenofovir on Plasma Lipids, Body Composition and Mitochondrial Function in HIV-Infected Patients Receiving Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lipoatrophy
Keywords: HIV
d4T
TDF
lipoatrophy
treatment experienced
HIV-infection
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2006-04-11
Enrollment: 60
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: Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared to switching to tenofovir or maintaining the standard dose of stavudine.

Methods: Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg bid with a plasma HIV RNA \<200 copies/mL for at least 6 months were randomized to maintain stavudine 40 mg bid (d4T40 arm), to reduce to 30 mg bid (d4T30 arm), or to switch from stavudine to tenofovir-DF (TDF arm) while preserving the remaining drugs. Fasting metabolic parameters were assessed at baseline and at weeks 4, 12, and 24. Mitochondrial parameters in peripheral blood mononuclear cells and body composition were measured at baseline and at week 24.


Eligibility criteria: Inclusion Criteria:

Study eligibility criteria included documented HIV infection, age 18 years or older, moderate to severe clinical lipoatrophy in at least one region upon physical examination (17,18), viral load \<200 copies/mL for at least 6 months prior to inclusion in the study, and a stable triple antiretroviral therapy including d4T 40 mg bid for at least the 6 preceding months, and no prior TDF use.

Exclusion Criteria:

Prior TDF use, viral load\>200 copies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose Maria Gatell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02321332: Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis
Official title: Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palmar Hyperhidrosis
Keywords: Palmar hyperhidrosis
Endoscopic thoracic sympathectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 400
Sex: ALL
Minimum age (years): 8
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.


Eligibility criteria: Inclusion Criteria:

* Patients suffering palmar hyperhidrosis

Exclusion Criteria:

* Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis

Primary outcomes:
measure: Number of participants developing compensatory hyperhidrosis (reflex sweating) following sympathectomy.
timeFrame: one year
Secondary outcomes:
measure: Number of patients who will be satisfied or unsatisfied regarding the procedure.
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura Faculty of Medicine
name: tamer youssef, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04049032: Perinatal Opioid Use
Official title: MUSC Women's Reproductive Behavioral Health Program for Opioid Use During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Pregnancy
Keywords: pregnancy
prescription opioids
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort derived from a prospectively collected database including 94 women receiving perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed until 6-8 weeks postpartum from September, 2017 to December, 2018.

Brief summary: To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine versus in-person.

Detailed description: Participants: Pregnant women with OUD.

Intervention: Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine.

Design: A cohort derived from a prospectively collected database including 98 women receiving perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed until 6-8 weeks postpartum from September, 2017 to December, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables.

Setting: Four outpatient obstetric practices in the southeast.

Eligibility criteria: Inclusion Criteria:

* Adult females, any race or ethnicity, age 18-45 years
* Currently pregnant
* Opioid Use Disorder (OUD)
* received in person or telemedicine treatment for OUD in their obstetrician's office

Exclusion Criteria:

* Not currently pregnant or receiving perinatal care
* Not in agreement with Patient-Physician Agreement

Primary outcomes:
measure: Number of individuals retained in treatment
timeFrame: 6-8 weeks postpartum
measure: Percent of infants born with Neonatal Abstinence Syndrome (NAS)
timeFrame: At Delivery
Secondary outcomes:
measure: Positive urine drug screens
timeFrame: At delivery and 6-8 weeks postpartum
measure: Length of newborn hospital stay and birth weight
timeFrame: Assessed up to 6 months following delivery
Other outcomes:
Locations:
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: Guille C, Simpson AN, Douglas E, Boyars L, Cristaldi K, McElligott J, Johnson D, Brady K. Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial. JAMA Netw Open. 2020 Jan 3;3(1):e1920177. doi: 10.1001/jamanetworkopen.2019.20177.
Clinical trial NCT01091532: A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.
Official title: A Double Blind, Randomized 3rd Party Open, Placebo Controlled, Parallel Group Multiple Oral Escalating Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UK-396,082 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Phase 1
Multiple Dose
Safety
Toleration
Pharmacokinetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study in healthy people is to investigate the safety, toleration and time course of UK-396,082 concentration in the blood and any changes in relevant markers of drug effects, following multiple doses given twice daily by mouth for 14 days.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Primary outcomes:
measure: safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
timeFrame: 14 days
Secondary outcomes:
measure: Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, Rac (=AUCtau (Day 14)/AUCtau (Day 1)), CL/F, Vz/f, Cmin, Cav Urine pharmacokinetics: Aetau & Aetau%, CLR on Day 14
timeFrame: 14 days
measure: Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations.
timeFrame: 14 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01926132: High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Fatigue
Keywords: ascorbic acid
fatigue
mitochondrial DNA
patient for more than 6 months
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reactive Oxygen Species (ROS) can cause oxidative damage, resulting in oxidation of lipids, proteins and DNA. In fatigue patients, there are some evidences of oxidative damage to DNA. Ascorbic acid was known to protect mitochondrial injury against oxidative stress by depolarizing the mitochondrial membrane. The copy number of mitochondrial DNA(mtDNA) was suggested mitochondrial gene stability and biogenesis and reflected mitochondrial function. There is no evidence ascorbic acid would decrease the mtDNA damage in fatigue patients. The investigators hypothesized that decreasing in mtDNA copy number in salivary and blood sample may be reversed by high-dose vitamin C intravenous injection in fatigue patients. The investigators will compare the mtDNA copy number and fatigue scale between moderate-severe fatigue patients and control group that had not malignant and chronic illness by a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

1. Adults with above 18 years old and 6 month fatigue duration
2. Moderate to severe fatigue scale (Brief fatigue inventory-Korean version scale ≥ 4)
3. Normal limit values in the screening test (White blood cell count, Hemoglobin, Creatinine, SGOT/SGPT, Thyroid stimulating hormone, Urinalysis)
4. Normal limit values in glucose 6 phosphate dehydrogenase level
5. Agree the subjects explanation

Exclusion Criteria:

1. pregnancy and lactation
2. acute common cold, acute gastroenteritis, uncontrolled diabetes, uncontrolled hypertension, liver disease or renal disease
3. previous medical history, affectable by high-dose ascorbic acid (gout, renal calculi and glucose 6 phosphate dehydrogenase deficiency)
4. hypersensitivity from ascorbic acid
5. vitamin supplement intake until 2 days ago
6. drug interactions with ascorbic acid ( aspirin, Fe, phenytoin, estrogen, tetracycline, coumarin, corticosteroid)
7. Do not read a consent fom

Primary outcomes:
measure: fatigue scale
timeFrame: 2 weeks after 10g ascorbic aicd intravenous injection
Secondary outcomes:
measure: mitochondrial DNA copy number on blood and salivary samples
timeFrame: 2 weeks after 10g ascorbic aicd intravenous injection
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT01824732: A Registry Study on Tanreqing（a Chinese Medicine Injection）Used in Hospitals in China
Official title: a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Tanreqing(a Chinese Medicine Injection)in Hospitals in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia;
Bronchitis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An anticipated sample size was caculated in this study, about 3000 Patients using Tanreqing injection from January to March 2013 in hospitals.

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.

The purpose of this study is to make a event monitoring to see whether Tanreqing injection is safe and the characteristic and mechanism of anaphylactic reaction used Tanreqing injection in hospitals in China.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Tanreqing injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.

Eligibility criteria Patients who will use Tanreqing injection in selected hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients using Tanreqing injection from January to March 2013

Exclusion Criteria:

-

Primary outcomes:
measure: Number of participants with anaphylactic reaction;the blood of participants with anaphylactic reaction
timeFrame: to assess Tanreqing's 'anaphylactic reaction' .during patients' hospital stay, administration information of Tanreqing will be registered every day. The registry procedure will last 3 month only for patients using Tanreqing
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Basic Research in Clinical Medicine
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Xie Y Ming, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00115232: Inflammatory Profiles of Children at High Risk for Atherosclerosis
Official title: Inflammatory Profiles of Children at High Risk for Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Metabolic Syndrome X
Hypercholesterolemia
Inflammation
Keywords: cardiovascular disease
metabolic syndrome
hypercholesterolemia
child
family history
inflammation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Sandra A. Daugherty Foundation
First posted: 2005-06-22
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primarily children referred to preventive cardiology clinic.

Brief summary: The purpose of this study is to evaluate levels of inflammatory mediators in children at risk for cardiovascular disease due to family history. We are measuring inflammatory markers in two groups of children and their parents: children with a family history of early atherosclerotic heart disease (cases), and healthy children without such a family history (controls). The design is a cross-sectional study, gathering a fasting blood sample and clinical and behavioral data on children and a parent.

Detailed description: Family history is a well known risk factor for early atherosclerosis. Whether inflammation plays a role in the increased risk of family history is not known. In this prospective single-center study, we are recruiting children with and without a family history of premature atherosclerotic disease, defined as occurring \< 55 years in males and \<65 years in females. Children are recruited primarily from a pediatric preventive cardiology clinic at Children's Hospital Boston. We measure anthropomorphic characteristics, fasting lipid profiles and inflammatory marker levels, including high sensitivity C-reactive protein (hsCRP), intracellular adhesion molecule 1 (ICAM-1), P-selectin, and tumor necrosis factor alpha receptor 2 (TNFαR2).

In this sample of high-risk overweight children, Lp(a) and inflammatory markers could reflect cardiovascular risk outside lipid profiles.

Eligibility criteria: Inclusion Criteria:

* Age 8-21 years
* Parent able to participate
* Fasting state
* Live locally

Exclusion Criteria:

* Taking medication that may alter cholesterol levels or inflammatory state
* Past or present inflammatory illnesses

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sarah D. de Ferranti, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05349032: Assessing the Bioavailability of Leading Phytonutrient Products
Official title: Assessing the Bioavailability of Leading Phytonutrient Products
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Keywords: infalmmation
bioavailability
Lead sponsor: Epiceutical Labs
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 15
Sex: MALE
Minimum age (years): 21
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. The study will secondarily look at inflammatory markers in the urine to determine any change.

Detailed description: This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. 120 mg of curcumin from brands Meriva, CurcElite, Lonvida, UltraCur, NovaSol. The study will secondarily look at inflammatory markers in the urine to determine any change.

Eligibility criteria: Inclusion Criteria:

* Age and gender

Exclusion Criteria:

* Cannot take any phytonutrient or curcumin supplement five days prior to commencement.

Primary outcomes:
measure: Bioavailability
timeFrame: 0, 1, 2, 4, and 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: David Roberts
state: Virginia
Study officials:
References:
citation: Jamwal R. Bioavailable curcumin formulations: A review of pharmacokinetic studies in healthy volunteers. J Integr Med. 2018 Nov;16(6):367-374. doi: 10.1016/j.joim.2018.07.001. Epub 2018 Jul 4.