louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00478322: Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: Diabetes;
Type II diabetes;
Non-insulin dependent diabetes;
Obesity
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.


Eligibility criteria: Inclusion Criteria:

1. Have an established diagnosis of Type 2 Diabetes as determined by the investigator.
2. Females will be postmenopausal for at least 1 year with documented FSH \> 30 IU/L.

Exclusion Criteria:

1. Hypertriglyceridemia \> 500 mg/dL at screening.
2. BMI \> 40 kg/m2.
3. Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
4. History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
5. Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.

Primary outcomes:
measure: Changes in lipid profile laboratory values
timeFrame: Measured at baseline and weekly for four weeks
measure: Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
timeFrame: Measured at baseline and weekly for four weeks
measure: Assessment of pharmacodynamics of INCB013739 through analysis of blood samples
timeFrame: Measured at baseline and weekly for four weeks
measure: Assessment of ECGs, physical examinations and laboratory values for adverse events
timeFrame: Measured at baseline through study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
city: Bronx
country: United States
state: New York
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Incyte Corporation
name: Richard Levy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06264622: ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension
Official title: Dose Response Study of the Effects of a Daily Supplementation With a Black Garlic Extract, ABG+/GarlACE on Cardiovascular Disease Risk Factors in Subjects With Grade I Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Grade I Hypertension
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
Collaborators: name: Pharmactive Biotech Products S.L.U
First posted: 2024-02-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:

* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
* If the changes in lipid profile are in a dose-response manner

Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks


Eligibility criteria: Inclusion Criteria:

* Men and women with Grade I Hypertension (systolic blood pressure between 130 and 139 mmHg; and diastolic blood pressure between 80 to 89 mmHg) without taking any antihypertensive drug

Exclusion Criteria:

* Acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- -
* Hypothyroidism
* Having previously suffered a myocardial infarction or stroke
* Pharmacological treatment with insulin, sulfonylureas, protease inhibitors
* Chronic gastrointestinal disease
* Pregnancy or intention to become pregnant during the study period.
* Breastfeeding
* Allergy or intolerance to garlic
* High alcohol consumption (\>14 units per week)
* Smokers

Primary outcomes:
measure: Blood Pressure
timeFrame: Pre-treatment and 12 weeks post-treatment
Secondary outcomes:
measure: Blood Lipid Profile
timeFrame: Pre-treatment and 12 weeks post-treatment
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: University of Lleida
Study officials:
References:
citation: Serrano JCE, Castro-Boque E, Garcia-Carrasco A, Moran-Valero MI, Gonzalez-Hedstrom D, Bermudez-Lopez M, Valdivielso JM, Espinel AE, Portero-Otin M. Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients. 2023 Aug 23;15(17):3691. doi: 10.3390/nu15173691.
Clinical trial NCT05528822: Study of H-FICB ＆ PENG Block in Elderly Patients' THA on the Post-operative Quality of Recovery
Official title: Comparative Prospective Randomized Study of Modified Fascia Iliaca Compartment Block Versus Pericapsular Nerve Group Block in Elderly Patients' Total Hip Arthroplasty on the Post-operative Quality of Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Quality of Recovery
Keywords: modified fascia iliaca compartment block
pericapsular nerve group block
the post-operative quality of recovery
HHS score
VAS score
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total joint replacement is projected to become the most common elective surgical procedure in the coming decade; the prevalence of total hip arthroplasty (THA) was estimated as more than 2.5 million individuals in the entire United States population. Orthopedic procedures involving the hip have remained challenging for regional anesthesia given the complex innervation, painful nature contributing to difficulty positioning, and a desire to maintain mobility to hasten postoperative recovery.

Detailed description: By comparing the intraoperative and postoperative rehabilitation indexes of high fascia iliac nerve block and hip pericapsular nerve block, we can choose a more suitable analgesic method for this operation.

Eligibility criteria: Inclusion Criteria:

* Aged 65 to 80 years male and female
* Scheduled for elective single-incision laparoscopic cholecystectomy
* The patients volunteered to participate in the study and signed the informed consent

Exclusion Criteria:

* Preexisting neuropathy
* Coagulopathy
* Local skin infection
* Hepatic, renal or cardiorespiratory failure
* Local anesthetic allergy
* Pregnancy
* Complications of gallstone with gallbladder perforation
* Diffuse peritonitis
* Acute pyogenic cholangitis

Primary outcomes:
measure: Change from Baseline visual analogue scale
timeFrame: one day before the operation.
measure: Harris Hip Score
timeFrame: At one week, one month, and three months post-operatively.
Secondary outcomes:
measure: The mini-mental State Examination
timeFrame: one day before the operation.
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Chair
name: Xingguo Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03165422: A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan
Official title: A Real-World Study of Ipilimumab Treatment After Nivolumab Treatment in Melanoma in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2017-05-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with melanoma who are patients at the participating centers in Japan will be enrolled.

Brief summary: This is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in Japan


Eligibility criteria: Inclusion Criteria:

* Adult patients \> 18 years of age or older
* Diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection
* Treated with ipilimumab between 31-Aug-2015 and 31-Mar-2017 before or after nivolumab treatment

Exclusion Criteria:

* Patients enrolled in any clinical trials at any time
* Overlapping use of nivolumab and ipilimumab

Primary outcomes:
measure: Incidence of ipilimumab treatment after nivolumab treatment
timeFrame: Approximately 19 months
measure: Incidence of nivolumab treatment after ipilimumab treatment
timeFrame: Approximately 19 months
measure: Duration of nivolumab treatment
timeFrame: Approximately 19 months
measure: Duration of ipilimumab treatment
timeFrame: Approximately 19 months
measure: Duration of interval between nivolumab treatment and ipilimumab treatment
timeFrame: Approximately 19 months
Secondary outcomes:
measure: overall response rate (ORR)
timeFrame: Approximately 19 months
measure: best overall response rate (BORR)
timeFrame: Approximately 19 months
measure: overall survival (OS)
timeFrame: Approximately 19 months
measure: progression-free survival (PFS)
timeFrame: Approximately 19 months
measure: incidence of treatment-related adverse events (AEs)
timeFrame: Approximately 19 months
measure: severity of treatment-related adverse events (AEs)
timeFrame: Approximately 19 months
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04313322: Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
Official title: Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Use of Stem Cells for COVID-19 Treatment
Keywords: Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,
Lead sponsor: Stem Cells Arabia
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients positively diagnosed with COVID-19
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the potential use of Wharton's Jelly Mesenchymal stem cells (WJ-MSCs) for treatment of patient diagnosed with Corona Virus SARS-CoV-2 infection, and showing symptoms of COVID-19.

Detailed description: COVID-19 is a condition caused by infection with Coronoa Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates. causing a worldwide pandemic. Patients diagnosed with COVID-19 and confirmed positive with the virus, will be given three IV doses of WJ-MSCs consisting of 1X10e6/kg. The three doses will be 3 days apart form each other.

Patients will be followed up for a period of three weeks to assess the severity of the condition and measure the viral titers.

Eligibility criteria: Inclusion Criteria:

COVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.

Exclusion Criteria:

* Participants in other clinical trials
* patients with malignant tumors
* pregnant and lactating women
* co-infection with other infectious viruses or bacteria
* History of several allergies
* Patients with history of pulmonary embolism
* any liver or kidney diseases
* HIV positive patients
* Considered by researchers to be not suitable to participate in this clinical trial
* Chronic heart failure with ejection fraction less than 30%.

Primary outcomes:
measure: Clinical outcome
timeFrame: 3 weeks
measure: CT Scan
timeFrame: 3 weeks
measure: RT-PCR results
timeFrame: 3 weeks
Secondary outcomes:
measure: RT-PCR results
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Stem Cells Arabia
Study officials:
References:
Clinical trial NCT00162422: Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo
Official title: The Effect of β2 Genetic Polymorphisms on the Brochodilatation Effect of Albuterol ex-Vivo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 150
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 role played by ß2AR polymorphisms in determining the bronchial response to ß2AR agonist drugs, has been confirmed by several studies.

The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and drug responsiveness. An ex-vivo model (organ bath technique) will be used to investigate association between polymorphisms in the coding region of ß2AR and the response of bronchial rings derived from human lung tissue to the respective agonists (i.e. salbutamol).

In the second part of the study the same bronchial rings will be incubated for 24 hours in a solution containing fixed concentration of albuterol. A second dose response curve for rising concentrations of albuterol will be constructed and a relationship between β2 genetic polymorphisms and the extent of desensitization to albuterol will be investigated.

In addition, through specifically designed receptor binding assay the bronchial tissue will be used to define the affinity (Kd) and expression (Vmax) of the ß2 receptor. These data will enable to enhance our understanding regarding the mechanism responsible for the association noted between ß2AR polymorphism and altered drug effect.


Eligibility criteria: Inclusion Criteria:

* Macroscopically normal pulmonary tissue

Exclusion Criteria:

* The presence of pathological finding in the pulmonary tissue

Primary outcomes:
measure: The extent of bronchial dilatation ex-vivo
measure: The extent of decrease in brochial dilatation after prolonged incubation with albuterol
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05894122: Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)
Official title: Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Phenylketonuria
Metabolic Diseases
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population

Brief summary: The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.

Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.


Eligibility criteria: Inclusion Criteria:

* Children aged 3 months to 18 years
* suffering from phenylketonuria or hyperphenylalaninemia
* who have had a capillary and blood test including a phenylalanine assay at CHUGA
* Whose parents or legal guardians are affiliated to the social security system.
* For whom parents or legal guardians have not objected to the MitrAlanine study.

Exclusion Criteria:

* Parents or legal guardians opposed to the MitrAlanine study

Primary outcomes:
measure: Comparison of phenylalanine concentrations
timeFrame: Day 1
Secondary outcomes:
measure: Ease of use of research device
timeFrame: Day 1
measure: sample conformity
timeFrame: Day 1
measure: comparison of concentrations of tyrosin
timeFrame: Day 1
measure: comparison of concentrations of total leucin
timeFrame: Day 1
measure: comparison of concentrations of methionin
timeFrame: Day 1
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
References:
Clinical trial NCT05745922: Acute Effects of Endurance Exercise on Breast Milk Composition in Women With Overweight/Obesity
Official title: Acute Effects of Endurance Exercise With Moderate and High Intensity on Breast Milk Composition Among Women With Overweight/Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Milk Collection
Overweight and Obesity
Keywords: Exercise
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2023-02-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Sequential assignment
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will determine the acute effect of exercise on breastmilk composition. Participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. The conditions will be randomly allocated to each participant. Breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. Dietary intake will be standardized on the test days.


Eligibility criteria: Inclusion Criteria:

* 6 weeks postpartum
* Exclusively breastfeeding
* Term birth
* Singleton baby

Exclusion Criteria:

* Known cardiovascular disease
* Known type 1 or type 2 diabetes
* Limited ability to exercise

Primary outcomes:
measure: Breastmilk metabolite composition
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Secondary outcomes:
measure: Complex lipids composition
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
measure: Adiponectin
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
measure: Leptin
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
measure: Insulin Growth Factor-1
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
measure: Insulin
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
measure: Ghrelin
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
measure: Cytokine profiling (Multiplex 27)
timeFrame: Change from before exercise to after exercise (+0 hour, +1 hour, and +4 hours)
Other outcomes:
measure: Cardiorespiratory fitness
timeFrame: At baseline
measure: Body mass in kg
timeFrame: At baseline
measure: Fat mass in kg
timeFrame: At baseline
measure: Muscle mass in kg
timeFrame: At baseline
measure: Height in metres
timeFrame: At baseline
Locations:
city: Trondheim
country: Norway
facility: Department of circulation and medical imaging , NTNU
Study officials:
References:
Clinical trial NCT02246322: A Clinical Trial With a New Needle Device Comparing Two Needles for EUS_FNA of Solid Lesions.
Official title: A Randomized Clinical Trial With a New Needle Device Comparing 25G and 22G Needle in Endoscopic Ultrasound Fine-needle Aspiration of Solid Lesions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Neuroendocrine Tumors
Lymphadenopathies
GIST
Gastric Wall Tumor
Keywords: Pancreatic cancer
Neuroendocrine tumors
Lymphadenopathies
GIST
Gastrointestinal wall neoplasia
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNA) is a reliable, safe, and effective technique for obtaining samples from the GI wall lesions and from organs adjacent to the GI tract (pancreas, nodes...).Needles available for EUS-FNA include 25G, 22G and 19G. Some studies have suggested that the 25G needle could be equal or even better than the 22G needle.

The BXN system and neddles are is a newly developed for EUS-FNA. This trial is developed for testing the accuracy of the new neddle system for EUS-FNA and for comparing the two needles types, 25G and 22G.


Eligibility criteria: Inclusion Criteria:

* endosonographic appearance of a solid lesions
* age \>18 years
* informed consent.

Exclusion Criteria:

* alteration of the coagulation (INR \>1.5, PLT \<50 x 103 /µL)
* inability to express consent

Primary outcomes:
measure: Clinical performance of 22G and 25G needles
timeFrame: 18 months
Secondary outcomes:
measure: Ease of needle pass
timeFrame: 18 months
measure: Needle malfunction
timeFrame: 18 months
measure: Number of passes
timeFrame: 18 months
measure: Number of crossovers
timeFrame: 18 months
measure: Major complications
timeFrame: 18 months
Other outcomes:
Locations:
city: Rozzano, Milan
country: Italy
facility: Humanitas Research Hospital
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Silvia Carrara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
citation: Siddiqui UD, Rossi F, Rosenthal LS, Padda MS, Murali-Dharan V, Aslanian HR. EUS-guided FNA of solid pancreatic masses: a prospective, randomized trial comparing 22-gauge and 25-gauge needles. Gastrointest Endosc. 2009 Dec;70(6):1093-7. doi: 10.1016/j.gie.2009.05.037. Epub 2009 Jul 28.