louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01211717: The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
Official title: The Effects of Orally Ingesting Branched Chained Amino Acids on Delayed Onset Muscle Soreness in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Healthy Individuals
Keywords: Branched Chained Amino Acids
Delayed Onset Muscle Soreness
Diabetes
Muscle Damage
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effectiveness of the 3 Branched Chained Amino Acids (isoleucine, leucine, and valine) on treating Delayed Onset Muscle Soreness, a type of muscle pain which usually develops after exercising.

Detailed description: Delayed Onset Muscle Soreness is a common painful sensation experienced by individuals who have been recently inactive and begin with an unaccustomed exercise protocol. Branched Chained Amino Acids have been found as a useful supplement for promoting muscle recovery following exercise; however the effects of this supplement have not been investigated amongst individuals with diabetes.

Eligibility criteria: Inclusion Criteria:

* The subjects with diabetes must have been diagnosed with diabetes at least one year before the onset of the study
* At least 6 weeks of physical inactivity in the upper body
* BMI less than 40

Exclusion Criteria:

* For the Diabetics, hemoglobin A1c levels over 13
* Pregnant
* Have Cardiovascular diseases
* Have Hepatic diseases
* Are diagnosed with Rhabdomyolysis
* Recent upper limb injuries
* Upper limb neuropathy
* Blood Pressure levels over 140/90, or lower than 90/60
* Are on High doses of alpha or beta agonist/antagonists, and take any types of NSAID's, Cox 2 inhibitors, Calcium channel blockers, Pre-Gabalin's, or Pain reducers

Primary outcomes:
measure: Measuring Pain, using the short form McGill pain questionnaire
timeFrame: 5 days following the initial exercise
Secondary outcomes:
measure: Measuring Muscle strength of the studied muscle
timeFrame: 5 days following the initial exercise
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University, School of Allied Health Professions
state: California
Study officials:
affiliation: Loma Linda University, School of Allied Health Professions
name: Jerrold Petrofsky, Doctoral PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06331117: Effect of RAS/MAPK Pathway Hyperactivation on Growth' and Bone' Profile of the RASopathies
Official title: The Impact of Ras/MAPK Pathway Hyperactivation on Bioenergetic Metabolism and Its Effect on Growth Profile and Bone Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: RASopathy
Costello Syndrome
Noonan Syndrome
Cardio-Facio-Cutaneous Syndrome
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Costello syndrome (CS) and cardio-facio cutaneous syndrome (CFCS) belongs to RASopathies, a group of multisystemic disorders caused by unregulated signalling through the RAS/MAPK pathway, an intracellular signalling pathway regulating multiple processes such as cellular proliferation, differentiation, survival, apoptosis and also contributing to oncogenesis. They share a recognizable facial appearance, aged appearance, growth delay, muscle-skeletal anomalies, heart defects, neuropsychological features, skin and ocular abnormalities, and cancer predisposition.

Even though life expectancy of individuals with CS and CFCS has increased in the last years due to the improvement of patients' care and a more effective prevention of comorbidities, some of the most challenging aspects impacting on everyday living such as growth failure, accelerate senescence and skeletal-muscle defects, still need to be fully understood. This statement underlies the need to improve clinical research protocols with more innovative techniques (multi-omics profiling) in order to better understand the effect of RAS/MAPK pathway hyperactivations on different systems and to define possible personalized treatments.

Detailed description: Multiomics profiling of the RASopathies

Eligibility criteria: Inclusion Criteria:

* Clinical and molecularly confirmed diagnosis of a RASopathy

Exclusion Criteria:

* Only clinical diagnosis of a RASoapthy

Primary outcomes:
measure: Metabolomic profile of the RASopathies
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli, IRCCS
name: Chiara Leoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824017: Validation of an RLIP76 Assay in Humans
Official title: Validation of RLIP76 Assay and Exploratory Study of RLIP76 Correlation Among Patients With Type 2 Diabetes and Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
metabolic syndrome
oxidative stress
GSH
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The current proposal extends work done in mouse models evaluating the consistency of measuring RLIP76 in a clinical cohort (Aim 1) by using guidelines provided by the NIH for validating biomarkers. We will also proceed to estimate the effect size of a potential correlation of RLIP76 with standard MsY treatment measures such as hgbA1c, LDL, and triglyceride levels in a longitudinal prospective study ( Aim 2) that will follow a cohort of patients with MsY who seek care at the City of Hope Endocrine clinic over a 12 month period..


Eligibility criteria: Inclusion Criteria:

* Registered patient of City of Hope and followed in the Endocrine Clinic. Must have documentation of a diagnosis of diabetes identified by the problem list in the patient's electronic health record.
* Must demonstrate features of MsY by possessing any of the following characteristics and/or receiving treatment for diabetes, hyperlipidemia, and/or hypertriglyceridemia.

  * Central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches (female)
  * Dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl)
  * Dyslipidemia: HDL-C \< 40 mg/dL (male), \< 50 mg/dL (female)
  * Blood pressure ≥ 130/85 mmHg
  * Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)

Primary outcomes:
measure: The consistency of an ELISA-based RLIP76 assay in the serum of human subjects with metabolic syndrome.
timeFrame: 12 months
Secondary outcomes:
measure: Effect size of correlation of RLIP76 levels with treatment measures of metabolic syndrome such as hemoglobin A1c, LDL, and triglyceride levels.
timeFrame: 12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Raynald Samoa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02931617: Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
Official title: Comparison of Two Modes of Respiratory Physiotherapy in Cardio-thoracic Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Postoperative; Dysfunction Following Lung Surgery
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University of Technology
First posted: 2016-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Two forms of pre and postoperative physiotherapy are compared in three cohorts of patients undergoing cardio-thoracic surgery: Minor thoracic surgery (biopsy), major thoracic surgery (lobectomy etc, open or VATS) and cardiac surgery

Detailed description: Inspiratory force calibrated training is applied in a controlled randomized trial

Eligibility criteria: Inclusion Criteria:

* cardiothoracic operation,
* informed consent

Exclusion Criteria:

* reduced co-operation (such as psychiatric diagnosis),
* severe neurologic disease affecting respiratory function,
* alcohol or drug abuse at hospital entry,
* tuberculosis or other contagious lung infection,
* severe respiratory insufficiency SpO2 \< 90 or blood pO2 \<8 or rep.rate \> 25/min at rest or supplementary oxygen required at home,
* cardiac pacemaker.

Primary outcomes:
measure: Change in FEV1
timeFrame: Preop + 1-3 postoperative days
measure: Number of patients with atelectasis
timeFrame: Preop + 1-3 postoperative days
measure: Change in peripheral oxygen saturation
timeFrame: Preop + 1-3 postoperative days
measure: Postoperative lung complications
timeFrame: Preop + 1-30 postoperative days
Secondary outcomes:
measure: Compliance to Chest physiotherapy
timeFrame: Preop + 1-3 postoperative days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital, Heart Center
Study officials:
affiliation: Tampere Univeristy Hospital
name: Jari O Laurikka, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02965417: Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients
Official title: An Open-label, Multicenter, Phase 2 Trial Investigating Sym004 in Patients With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies and Documented Mutation of Extra Cellular Domain of EGFR (ECD-EGFR)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Resistance to anti-EGFR monoclonal antibodies
Mutation of ECD-EGFR
Lead sponsor: Symphogen A/S
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR (ECD-EGFR).


Eligibility criteria: Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.

Primary outcomes:
measure: Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01661517: Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting
Official title: Brief Intervention and Referral to Treatment With Substance Use Disorders in the Emergency Room Setting (Screening and Brief Treatment for Substance Use Disorders in the Emergency Room Department)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Substance Use
Keywords: substance use treatment
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 5271
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. This study will consist of a chart review of the results of the screens performed by substance use counselors and correlating them to institutional variables such as wait time in the emergency room and length of stay as well as to patient variables obtained by chart review such as medical diagnosis and sociodemographic variables.


Eligibility criteria: Inclusion Criteria:

* Age 19 and older Presentation to UAB Emergency Department

Exclusion Criteria:

* Younger than 19 Prisoners

Primary outcomes:
measure: substance use
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT02796417: The Efficacy of REHACOP Program in Schizophrenia
Official title: Implementation of REHACOP Cognitive Training Program in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University of Deusto
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to improve cognition, social cognition, clinical symptoms and functional outcome in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* diagnostic criteria for Schizophrenia according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

Exclusion Criteria:

* evidence of alcohol or drug abuse in the last 30 days
* previous history of significant lack of consciousness
* mental retardation
* relevant neurological or medical condition

Primary outcomes:
measure: Change in functional competence after receiving cognitive remediation
timeFrame: 4 months
measure: Change in global functioning after receiving cognitive remediation
timeFrame: 4 months
measure: change in verbal memory after receiving cognitive remediation
timeFrame: 4 months
measure: change in processing speed after receiving cognitive remediation
timeFrame: 4 months
Secondary outcomes:
measure: change in emotion perception after receiving cognitive remediation
timeFrame: 4 months
measure: change in clinical symptoms after receiving cognitive remediation
timeFrame: 4 months
measure: change in social perception after receiving cognitive remediation
timeFrame: 4 months
measure: change in theory of mind after receiving cognitive remediation
timeFrame: 4 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: University of Deusto
state: Biskai
Study officials:
affiliation: University of Deusto
name: Natalia Ojeda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pena J, Ibarretxe-Bilbao N, Sanchez P, Uriarte JJ, Elizagarate E, Gutierrez M, Ojeda N. Mechanisms of functional improvement through cognitive rehabilitation in schizophrenia. J Psychiatr Res. 2018 Jun;101:21-27. doi: 10.1016/j.jpsychires.2018.03.002. Epub 2018 Mar 6.
citation: Pena J, Ibarretxe-Bilbao N, Sanchez P, Iriarte MB, Elizagarate E, Garay MA, Gutierrez M, Iribarren A, Ojeda N. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial. NPJ Schizophr. 2016 Nov 9;2:16037. doi: 10.1038/npjschz.2016.37. eCollection 2016.
Clinical trial NCT02636517: Fecal Microbiome Transplant
Official title: Fecal Microbiome Transplant in Pediatric C. Difficile
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Clostridium Difficile
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Fecal Microbiota transplant
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD)

The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
2. Age ≥ 3 years old.
3. Recurrent C. difficile or Moderate to Severe C. difficile.
4. Satisfactory completion of the medical interview and physical exam conducted by a study team member
5. Participants must be between 3 and 21 years of age (inclusive)
6. Signed informed consent form, and assent (if applicable)

Exclusion Criteria:

1. Patients \<3 years old
2. Patients with other co-morbid intestinal infectious processes
3. Recipients with a history of severe (anaphylactic) food allergy
4. If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled.
5. Patients with severe IBD.
6. Ongoing/anticipated antibiotic use for non-CDI indication
7. Adverse event attributable to a previous FMT
8. Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
9. Any other condition for which the treating physician thinks the treatment may pose a health risk
10. Predicted death within time period of follow-up
11. Patients who are on supraphysiologic doses of corticosteroids

Primary outcomes:
measure: Number of subjects with a recurrence of C. difficile (CDI)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Judith Kelsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595517: Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer
Official title: A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer
Duodenal Ulcer
Rheumatoid Arthritis
Osteoarthritis
Lumbago
Keywords: gastrointestinal
GI
NSAID
Japan
Japanese
Gastric ulcer
duodenal ulcer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 395
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.


Eligibility criteria: Inclusion Criteria:

* Medical history of gastric and/or duodenal ulcer
* A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

* Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
* History of esophageal, gastric or duodenal surgery
* Having severe liver disease or chronic renal disease

Primary outcomes:
measure: Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
timeFrame: up to 4 weeks after treatment
measure: Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
timeFrame: up to 12 weeks after treatment
measure: Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
timeFrame: up to 24 weeks after treatment
Other outcomes:
Locations:
city: Oita
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Naotsugu Oyama
role: STUDY_DIRECTOR
References:
citation: Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs. BMC Gastroenterol. 2013 Mar 26;13:54. doi: 10.1186/1471-230X-13-54.