louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00247117: Metformin in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
Official title: Study of the Effect of Metformin in Patients With Non-Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Keywords: non-alcoholic fatty liver disease
insulin resistance
metformin
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of metformin on biochemical and histological findings in NAFLD patients with insulin resistance syndrome.

Detailed description: Study population:

30 patients will be included who meet all the following criteria: ALT \> 2 times normal range; liver histology revealing NASH (type 2-4), without cirrhosis; clinical characteristics of the metabolic syndrome as defined by the NCEP, but no overt diabetes; negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week.

All patients will undergo liver biopsy and only patients with type 2-4 (steatosis + inflammation, or steatosis plus ballooning degeneration, or steatosis plus fibrosis and/or Mallory bodies) but without cirrhosis will be included.

Patients who received lipid lowering medications or anti hypertensive drugs prior to study will continue the treatment. Patients who will develop overt type 2 DM with HbAic \> 7% during study will be withdrawn.

Intervention:

All patients will have dietary intervention by a dietician and will be encouraged to increase physical activity. Patients will be receiving metformin 850 mg tid for 12 months.

Outcome:

* Improvement of liver enzymes (ALT, AST, GGT)
* Improvement of metabolic profile: lipid profile, fasting and post-load glucose and insulin levels, HOMA.
* Liver histology (repeated liver biopsy after 1 year).
* Soluble TNF receptors- TNF-receptor P55 and P75.

Eligibility criteria: Inclusion Criteria:

* ALT \> 2 times normal range.
* Liver histology revealing non-alcoholic steatohepatitis \[NASH\] (type 2-4), without cirrhosis.
* Clinical characteristics of the metabolic syndrome as defined by the National Cholesterol Education Program (NCEP), but no overt diabetes.
* Negative work-up for other causes of liver diseases including alcohol intake \< 40 g/week.

Exclusion Criteria:

* Diabetes mellitus.
* Alcohol intake \> 40 g per week.

Primary outcomes:
measure: histological and biochemical changes
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Institute of Endocrinology, Kaplan Medical Center
Study officials:
affiliation: Kaplan Medical Center
name: Stephen D Malnick, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05588817: Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis
Official title: Expression of IRAK1 Gene rs1059703-related Single- Nucleotide Polymorphisms in Egyptian Patient With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 90
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Rheumatoid arthritis (RA) is known as a long-lasting inflammatory autoimmune disease affecting the diarthrodial joints, which is diagnosed by inflammation and hyperplasia in synovium, generation of RF and anti-citrullinated protein antibody (ACPA), deformity of cartilage and bone, systemic injuries involving cardiovascular, pulmonary, psychological, and skeletal disorders (McInnes and Schett., 2011).


Eligibility criteria: Inclusion Criteria:

* approval to sign an informed written consent, patient diagnosed rheumatoid arthritis, patient age range 17-85 year and both sexes are included.

Exclusion Criteria:

* Refusal to sign an informed written consent and patient with other autoimmune disease.

Primary outcomes:
measure: rs1059703 PCR polymorphism in rhomatoid arthritis patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
References:
Clinical trial NCT04188717: Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation
Official title: Incidence, Risk Factors, Predictors and Survival for Neurological Complications After Liver Transplantation- A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Neurologic Complication
Postoperative Complications
Keywords: liver transplantation
neurological complications
postoperative complications
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent liver transplant surgery for the specified time period were included in the study.

Brief summary: Liver transplantation is the definitive treatment in patients with chronic liver disease. Neurological complications (NC) occur commonly after liver transplantation. The investigators aim to evaluate the incidence, risk factors and predictors of neurological complications in both living donor and deceased donor transplantation done in the hospital. Between January 2011 to December 2016, 253 liver transplant recipients were recruited for this study. The investigators recorded the incidence of neurological complications, their median time of onset, their relationship with etiology of chronic liver disease, and the risk factors for the complications. The investigators also studied the relationship of neurological complications with duration of hospital and ICU stay, and survival. Using multivariate forward regression analysis , the investigators developed a scoring system for prediction of neurological complications in liver transplantation.


Eligibility criteria: Inclusion Criteria:

* patients undergoing liver transplant surgery
* 18-65 years

Exclusion Criteria:

* pregnant patients
* Acute Liver Failure, Acute on Chronic Liver Failure

Primary outcomes:
measure: Neurological complications
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: ILBS
name: Karthik T Ponnappan, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367717: Effect of Creatine on Serum and Urine Creatinine
Official title: Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Creatine
Creatinine
Serum Creatinine
Urine Creatinine
Creatine Monohydrate
Creatine Ethyl Ester
Acute Kidney Injury
Renal
Kidney
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Background: Creatinine (Crn) concentration is used to assess renal function via calculation of GFR (Glomerular Filtration Rate). By RIFLE (Risk, Injury, Failure, Loss, End Stage Kidney Disease) criteria, acute kidney injury (AKI) and acute renal failure (ARF) are defined by a two-fold and three-fold increase in serum Crn, respectively. Crn is a breakdown product of proteins and circulating creatine, and it is generally a benign product present in serum. Creatine is a nutritional supplement that has been available since 1993, and it is widely used among athletes today.

Methods: In an IRB approved, blinded crossover trial, 25 human volunteers ingested 2 creatine supplements to determine any associated statistically significant increase in serum Crn and clinically significant increase in serum Crn to a degree associated with AKI or ARF. Urine samples were also collected to examine excretion patterns after an ingested sample. Participants ingested 10 gm of creatine ethyl ester (CEE) or creatine monohydrate (CrM) and had serum Crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. Urinary Crn levels were assayed at 0, 1.5, 3, 5 and 24 hours. Exclusion factors were any history of renal disease or use of creatine within the last month. Statistical analysis was performed by Wilcoxon Matched-Pair Signed Ranks Test and descriptive summary statistics were performed.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Human

Exclusion Criteria:

* Use of any form of creatine within 4 weeks prior to participation in study.
* Pregnancy
* History of elevated creatinine or renal insufficiency
* History of PKU

Primary outcomes:
measure: Serum Creatinine
timeFrame: 24 Hours
measure: Urine Creatinine
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Kristopher K Hunt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Medical Center
name: Robert J Hoffman, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01353417: Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
Official title: A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Insufficiency
Keywords: Grafting, kidney
Transplantation, kidney
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2011-05-13
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after renal transplantation who are treated in the general hospital of Vienna on an outpatient basis

Brief summary: This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18
* Post renal transplantation time: ≥ 6 months
* Stable kidney function ( serum creatinine \< 3.0mg/dl; variation \< 0.5mg/dl at 2 appointments in minimum distance of 6 days)
* Stable Tacrolimus Sandoz© dose \> 2 weeks before inclusion in this Non Interventional Study (NIS)
* Written and oral informed consent

Exclusion Criteria:

* Well-known poor compliance with immunosuppressives
* Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months

Primary outcomes:
measure: Changes in Adport Sandoz© trough level
timeFrame: Observation time: 26 weeks
Secondary outcomes:
measure: Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels
timeFrame: Observation time: 26 weeks
measure: Incidence of serious adverse drug reactions
timeFrame: Observation time: 26 weeks
measure: Incidence of adverse drug reactions
timeFrame: Observation time: 26 weeks
measure: Incidence of serious adverse events
timeFrame: Observation time: 26weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital
Study officials:
References:
Clinical trial NCT03442517: The LATCHING Pilot Project
Official title: Learning About Techniques to Create Healthy Infants Through Nutrition and Proper Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: group-based counseling
phone counseling
conference calls
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn if group-based phone counseling is effective for increasing breastfeeding rates, reducing the early introduction of solids and increasing maternal weight loss after pregnancy.


Eligibility criteria: Inclusion Criteria:

* Women who are 9-30 weeks in gestation that have not previously met breastfeeding recommendations
* Speak and understand English

Exclusion Criteria:

* Women with pregnancies conceived using fertility treatments, those at high risk for pre-term delivery, those with multiple gestation (ie. twins, triplets, etc), or pregnancies complicated by morbid obesity (BMI\>40), diabetes (pre-gestational or gestational), hypertension, metabolic dysfunction, etc.
* Women who have previously exclusively breastfed an infant for three or more months

Primary outcomes:
measure: Differences in infant feeding progression
timeFrame: Month 6
measure: Proportion of women exclusively breastfeeding
timeFrame: Month 6
measure: Proportion of women who introduce solids
timeFrame: Month 4
Secondary outcomes:
measure: Subject satisfaction and acceptability of intervention
timeFrame: Week 24
measure: Intervention compliance
timeFrame: Week 24
measure: Study Retention
timeFrame: Month 6
Other outcomes:
measure: Differences in infant feeding progression
timeFrame: Week 2
measure: Differences in infant feeding progression
timeFrame: Month 2
measure: Differences in infant feeding progression
timeFrame: Month 4
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Priority Care Pediatrics, LLC
state: Missouri
city: Liberty
country: United States
facility: Northland Obstetrics & Gynecology, Inc.
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Holly Hull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cauble JS, Herman A, Wick J, Goetz J, Daley CM, Sullivan DK, Hull HR. A prenatal group based phone counseling intervention to improve breastfeeding rates and complementary feeding: a randomized, controlled pilot and feasibility trial. BMC Pregnancy Childbirth. 2021 Jul 22;21(1):521. doi: 10.1186/s12884-021-03976-2.
Clinical trial NCT02455817: REWARDS-Angina at Follow up Post Stenting
Official title: REWARDS-Angina at Follow up Post Stenting
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rate of Angina
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients male or female, 18 years or older who have received at least one commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents

Brief summary: Single center, retrospective registry to collect data regarding the rate of angina (any and CCS clas III/IV) within 12 months post stent implantation. In addition, the target vessel revascularization rate within 12 months post stent implantation.

Detailed description: The objective of this study is to retrospectively identify the rate of angina (any as well as CCS class III/IV) up to one (1) year following stent implantation. The following drug eluting stents will be evaluated in addition to bare metal stents; Cypher, Taxus Express, Xience V, Resolute and Promus Element. The target vessel revascularization rate will also be compared for the 6 stent types within one (1) year.

Eligibility criteria: Inclusion Criteria:

* Patients, male or female, \> 18 years of age,
* Patients who received at least one (1) commercially available Drug Eluting Stent or Bare Metal Stent: Cypher, Taxus Express, Xience V, Promus Element, Resolute, or Bare Metal Stents

Exclusion Criteria:

* Received more than one type of DES as listed above or both a BMS and DES (as listed above)

Primary outcomes:
measure: Rate of Angina
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04231617: The Hemodynamic Effects of CGRP After Glibenclamide Administration in Healthy Volunteers
Official title: The Hemodynamic Effects of CGRP After Glibenclamide Administration in a Randomized Double-blind Cross-over Placebo-controlled Study With Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamics of Cranial Arteries
Headache
Cerebral Blood Flow
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Primary purpose: OTHER

Brief summary: To investigate the hemodynamic effects of CGRP after glibenclamide administration.

Detailed description: 20 healthy participants will randomly be allocated to receive CGRP infusion followed by glibenclamide or placebo on two different days.

The aim of the study is to investigate the vascular effect of CGRP after glibenclamide administration.

Repeated measurements covering the arteria radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA) before and after glibenclamide/placebo administration and CGRP infusion.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception

Exclusion Criteria:

* A history of serious somatic disease
* Migraine or any other type of headache (except episodic tension-type headache less than once a month)
* Daily intake of any medication except contraceptives

Primary outcomes:
measure: Changes in the arterial radialis (RA), superficiel temporal artery (STA) and middle cerebral artery (MCA)
timeFrame: Time of measurements is baseline and repeatedly every 20 min for 240 min.
Secondary outcomes:
measure: Headache
timeFrame: Time of headache measurements is from before (-20 min) and after (12 hours) glibenclamide/placebo administration.
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish headache center
state: Copenhagen
city: København S
country: Denmark
facility: Mohammad Al-Mahdi Al-Karagholi
state: Danmark
Study officials:
References:
Clinical trial NCT04035317: Aesculus Hippocastanum L. on Fontan Circulation
Official title: Effect of Aesculus Hippocastanum L. (Sapindaceae, "Horse Chestnut") on Fontan Circulation - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Univentricular Heart
Keywords: Fontan operation
Aesculus hippocastanum
mesenteric artery resistance
Lead sponsor: Casa Espirita Terra de Ismael
Sponsor class: OTHER
Collaborators: name: Hospital das Clínicas de Ribeirão Preto
First posted: 2019-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomized to receive Aesculus hippocastanum or placebo for 4 months, followed by 4 weeks of washout and crossover.
Primary purpose: TREATMENT

Brief summary: Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial. The primary outcome will be the mesenteric artery resistance measured by Dopple sonography.


Eligibility criteria: Inclusion Criteria:

* Underwent Fontan surgery

Exclusion Criteria:

* Severe adverse reaction
* Personal or parental request

Primary outcomes:
measure: Mesenteric artery resistance
timeFrame: After 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
state: Sao Paulo
Study officials:
References:
Clinical trial NCT01586117: A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Official title: A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: rectal cancer
amifostine
pre-operative chemo-radiation
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Detailed description: To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Eligibility criteria: Inclusion Criteria:

* pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
* tumor distance from anus less than 12 cm.
* KPS score not less than 70
* can be tolerated chemotherapy and radiotherapy.
* pelvic who had no history of radiation therapy.
* Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
* blood pressure can be controlled by drugs in the normal range (90 ≤ systolic blood pressure ≤ 140,60 ≤ diastolic blood pressure ≤ 90).
* a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent.

Exclusion Criteria:

* other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
* pregnant or lactating patients.
* fertility but did not use contraceptive measures.
* existing active infection.
* merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
* concurrent treatment with other anticancer drugs.
* can not complete treatment or follow-up.

Primary outcomes:
measure: Acute radiation-induced toxicity: daily diarrhea frequency
timeFrame: about 3 months from chemo-raditherapy to operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Radiation Oncology Depratment, Cancer Hospital, CAMS
state: Beijing
Study officials:
affiliation: Chinese Acedemy of Medical Scinences
name: Jing Jin, M.D
role: PRINCIPAL_INVESTIGATOR
References: