louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02745678: Localized Therapeutics for the Treatment of Gastrointestinal Disorders II
Official title: Localized Therapeutics for the Treatment of Gastrointestinal Disorders II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colitis, Ulcerative
Keywords: Enema
Ulcerative Colitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 3
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Voluntarily sign written informed consent.
* Male or non-pregnant and non-lactating females at least 8 years of age.
* Confirmed diagnosis of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge. Typically, baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild to moderate disease).

Exclusion Criteria:

* Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens
* 5-aminosalicylic acid (5-ASA) intolerance
* Current or recent (3 weeks) oral or rectal steroids
* History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for colitis
* Abnormal creatinine
* Previous small bowel or colonic resection,
* Anal sphincter incompetence,
* Current smokers.
* History or current diagnosis of Crohn's disease or indeterminate colitis.
* History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
* Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
* Hemoglobin levels \< 7.5 g/dL.
* History of sclerosing cholangitis, cirrhosis, or hepatic impairment
* Pregnant or at risk of pregnancy.
* Some medications to treat UC are prohibited during participation in the study, including laxatives and anti-diarrhea medications; oral 5-ASA agents and daily fiber supplements are allowed.

Primary outcomes:
measure: Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)
timeFrame: Between 4-6 weeks post-administration
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT00958178: A Novel Method of Preoxygenation Using a Bain Circuit
Official title: A Novel Method of Preoxygenation Using Partial Rebreathing Via a Coaxial Mapleson D Breathing System (Bain Circuit)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: National Health Service, United Kingdom
Sponsor class: OTHER_GOV
First posted: 2009-08-13
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether rebreathing for a short time (a bit like breathing into a paper bag) will stimulate faster breathing and thus make the giving of Oxygen more effective.

The hypothesis is that the investigators method (rebreathing) will be faster than the current method of administering Oxygen.

Detailed description: It is standard practice for patients to breathe oxygen before receiving a general anaesthetic. This is called preoxygenation. It is done by using a mask which fits snugly onto the face. But for how long should patients breathe oxygen? Is taking deep breaths a good idea? What is the best oxygen flow rate? These questions are important because preoxygenation is one of the things which makes anaesthesia safe, so finding the best way of doing it might help save lives. Previous research has attempted to identify the best way to give oxygen before anaesthesia. It seems that breathing pure oxygen for three minutes is enough, or if you are in an urgent situation, then taking deep breaths of pure oxygen for a minute will do. However, there is another possible way of doing it which has not yet been looked at.

Asking someone to breathe back in the air they have just exhaled seems, on the face of it, to be pointless at best. But doing just that for a very short time will make the person breathe harder. Then when you give them pure oxygen, they will breathe it in really deeply and this might make the preoxygenation quicker. That's the theory. To test it we plan to ask 40 healthy people to do the standard preoxygenation, then try our new way. We won't be giving anaesthetic, just the oxygen.

The hypothesis is that our new method will be quicker than the existing one.

Eligibility criteria: Inclusion Criteria:

* BMI 18-27
* Non-smoker
* No chronic cardiorespiratory or neuromuscular illness
* No intercurrent illness

Exclusion Criteria:

* Unable/unwilling to consent

Primary outcomes:
measure: Time to end-tidal oxygen of 90%
timeFrame: 5 minutes
Secondary outcomes:
measure: Level of discomfort as assessed by questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Victoria Infirmary
Study officials:
affiliation: UK National Health Service
name: John Glen, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03744078: A Randomized Trial of Induction Methods in Premature Rupture of Membranes
Official title: A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Premature Rupture of Fetal Membranes
Induction of Labor Affected Fetus / Newborn
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.


Eligibility criteria: Inclusion Criteria:

1. singleton pregnancy,
2. gestational age ≥34 weeks,
3. rupture of membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,
7. a category II or III fetal heart rate pattern,
8. anomalous fetus,
9. fetal demise
10. women with immediate delivery indications -

Primary outcomes:
measure: induction-to- delivery time
timeFrame: an average of one year
Secondary outcomes:
measure: tachysystole
timeFrame: an average of one year
measure: chorioamnionitis
timeFrame: an average of one year
measure: postpartum hemorrhage
timeFrame: an average of one year
measure: neonatal outcome
timeFrame: an average of one year
measure: admission to neonatal intensive care unit
timeFrame: an average of one year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Doga
state: Kucukcekmece
city: Istanbul
country: Turkey
facility: Zeynep Kamil Education and Research Hospital
state: Uskudar
Study officials:
affiliation: Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
name: ahmet eser
role: STUDY_DIRECTOR
References:
Clinical trial NCT02116478: Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis
Official title: Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fasciitis
Keywords: plantar fasciitis
gastrocnemius recession
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the clinical results for patients suffering from plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.

Detailed description: All patients will be instructed in stretching exercises. Half of the patients will be randomized to proximal medial gastrocnemius recession. All patients will be followed for 1 year. Additional long term follow-up will be 6 years after inclusion

Eligibility criteria: Inclusion Criteria:

* Symptoms of plantar fasciitis lasting more than 12 months.
* Isolated gastrocnemius contracture

Exclusion Criteria:

* No previous surgery to foot or ankle
* No active arthritis

Primary outcomes:
measure: Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
timeFrame: 1 year and 6 years postoperative
Secondary outcomes:
measure: 0-10 points Visual analog pain score
timeFrame: 1 year and 6 years postoperative
Other outcomes:
measure: Short form-36 (SF-36)
timeFrame: 1 year and 6 years postoperative
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Marius Molund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02280278: Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy
Official title: The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stage III Colon Cancer
Keywords: colon cancer
cytokine-induced killer cell immunotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 550
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: We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
* Stage III colon cancer
* undergone complete resection of primary tumor
* Completed standard adjuvant chemotherapy
* within 120 days of completion of standard therapy
* ECOG performancer status 0-2
* Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
* ANC ≥ 1.0 x 109/L
* Platelets ≥ 100 x 109/L
* Creatinine clearance ≥ 30 mL/min
* Total bilirubin ≤ 2.0 x the upper limit normal
* AST \& ALT ≤ 5 x the upper limit normal
* Completed the following investigations
* Completed the following investigations

Exclusion Criteria:

* HIV positive or other Immunodeficiency disease
* recently use of high dose glucocorticoid
* Uncontrolled hypertension (untreated systolic blood pressure \> 160 mmHg, or diastolic blood pressure \> 95 mmHg)
* History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
* Patient having known allergy to capecitabine or Oxaliplatin
* Pregnant, lactating

Primary outcomes:
measure: Disease free survival
timeFrame: 3 years
Secondary outcomes:
measure: survival rate
timeFrame: 5 years
measure: toxin-side effect
timeFrame: 1 year
Other outcomes:
Locations:
city: Guagzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Xiao-Jun Wu, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01648478: IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker
Official title: Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: IRAP
insulin sensitivity marker
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Cisbio Bioassays
First posted: 2012-07-24
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin. The extracellular domain of IRAP is cleaved and released in the bloodstream.

Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.

In this study the investigators seek to confirm this hypothesis by using the gold standard of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.

It is a multicenter descriptive study.


Eligibility criteria: Inclusion Criteria:

* Men and women (sex ratio = 1)
* Aged from 18 to 35 years
* Fasting glycemia \< 6mmol/L
* Total cholesterol \< 7mmol/L
* Triglycerides \< 1.5 mmol/L
* CRPus \< 5 mg/L
* Creatinine clearance \< 80mL/min according to Cockroft formula
* Liver enzymes (ALanine AminoTransférase and ASpartate AminoTransférase) \< 1.5 times normal values

Exclusion Criteria:

* Subject not in compliance with the recommendations of French National Law in force
* Medical history of metabolic disease (diabetes, dyslipidemia), endocrine disease, renal insufficiency
* Drug use that could affect glucose metabolism and the renin angiotensin aldosterone system
* Blood pressure \> 140/90mmHg
* Tea and coffee consumption more than 5 cups per day
* Subject who smoke more than 5 cigarettes per day

Primary outcomes:
measure: IRAP plasma concentration during the hyperinsulinemic euglycemic clamp
timeFrame: 30 min before the clamp and during the clamp every 10 min for a duration of 240 min.
Secondary outcomes:
measure: Glucose Infusion Rate (GIR)
timeFrame: at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes
measure: Oxydative stress markers
timeFrame: at T0, T120 and T240 min
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre de recherche en nutrition humaine Rhone-Alpes
Study officials:
affiliation: Centre de recherche en nutrition humaine Rhone-Alpes
name: Martine LAVILLE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03103178: Spanish Version of the KBILD Questionnaire
Official title: Translation Into Spanish of an Interstitial Lung Disease Quality of Life Questionnaire (KBILD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Fibrosis
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects over 18 years of age diagnosed with diffuse interstitial lung disease for which they are being followed up at the respiratory department of the Santa Creu i Sant Pau Hospital.

Brief summary: The purpose of the present study is to advance in the knowledge of quality of life in patients with ILD by translating a ILD quality of life questionnaire.

There are no specific tools validated in Spanish to evaluate the quality of life in patients with ILD, although these measures are useful for an comprensive evaluation of these patients.

Patients with ILD have a significant impact on their health. If we improve our Knowledge of the different domains affected by the disease, and not only in the pathophysiological ones, we will be able to develop tools to improve their management.


Eligibility criteria: Inclusion criteria

1. Subjects older than 18 years.
2. Diagnosis of ILD, established according to the consensus documents of the ATS and ERS \[1,2\].
3. Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits.

Exclusion criteria

1. Another chronic respiratory disease other than EPID.
2. Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).

Primary outcomes:
measure: Validation of a specific quality of life questionnaire for patients with ILD
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT06211478: Role of Vitamin E in Gaucher Disease Patients
Official title: Role of Vitamin E as an Adjuvant Therapy for Patients With Gaucher Disease Under Enzyme Replacement Therapy in Relation to Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gaucher Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: gaucher disease (GD) can be classified into three clinical types .type 1,the most common type ,is the chronic non neuronpathic form of the disease,which shows gighly variable signs and symptoms and variable course,with visceral,skeletal and hematologic involvement among others.the neurologocal involvement can be observed in types 2 and 3

Detailed description: enzymatic defeciency in gaucher disease patients may induce a cascade of events that result in side effects, such as the production of reactive oxygen species(ROS) and reactive nitrogen species(RNS) that can then generate the oxidative stress whereas in body of healthy individuals,the production and degradation of ROS and RNS are generally balanced.

neurochemical abnormalities in patients with gaucher disease might be related to oxidative stress and inflammation in the brain.

oxidative stress induces peroxiredoxin-2 as cytoprotective response against RNS .it is able to detoxify a vast range of organic peroxides.

vitamin E well accepted nature most effective lipid soluble chain breaking antioxidant .

Eligibility criteria: Inclusion Criteria:

children and adolescents aged fron 2 to 18 years old with gaucher disease both type 1 and type 3 diagnosed clinically and confirmed by laboratory analysis patients who are on stable enzyme replacement therapy for at least 6 months -

Exclusion Criteria:

patients with infection or another inflammatory condition patients on multivitamin therapy known chronic liver disease (viral hepatitis,HIV) patients with renal impairement defined as creatinine level greater 1.2 for female and greater than 1.4 for male.

-

Primary outcomes:
measure: effect of vitamin E on oxidative stress and antioxidant markers in gaucher disease patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasia
Study officials:
affiliation: Ain Shams University
name: Amira A Adly, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pacheco N, Uribe A. Enzymatic analysis of biomarkers for the monitoring of Gaucher patients in Colombia. Gene. 2013 May 25;521(1):129-35. doi: 10.1016/j.gene.2013.03.044. Epub 2013 Mar 21.
citation: Kartha RV, Terluk MR, Brown R, Travis A, Mishra UR, Rudser K, Lau H, Jarnes JR, Cloyd JC, Weinreb NJ. Patients with Gaucher disease display systemic oxidative stress dependent on therapy status. Mol Genet Metab Rep. 2020 Dec 9;25:100667. doi: 10.1016/j.ymgmr.2020.100667. eCollection 2020 Dec.
Clinical trial NCT04838678: Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN)
Official title: Sympathetic Neural Patterns and Transduction in Obesity-associated Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hypertension
Obesity
Keywords: NPY
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand how the nervous system communicates to blood vessels to increase blood pressure during stress. The study will also investigate how hypertension and obesity influence the nervous system and vascular function. The study will involve measuring sympathetic nervous system activity and blood flow during common laboratory physiological stress protocols (e.g. hypoxia, exercise), and in response to infusion of drugs that cause vasodilation or vasoconstriction.


Eligibility criteria: Inclusion Criteria:

* Control - BMI\<30, age 18-55
* Hypertensive - BMI\<30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring Obese- BMI\>30, age 18-55 Obese-hypertensive- BMI\>30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring

Exclusion Criteria:

All groups - presence of other significant cardiovascular disease, renal disease, history of smoking, diabetes,

Primary outcomes:
measure: Blood flow measured by doppler ultrasound
timeFrame: Acutely on the day of study
measure: Muscle sympathetic nervous system activity
timeFrame: Acutely on the day of study
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: