louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00434434: A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Asthma
Keywords: AQUA
anti-CD11
CD11a
Asthma
Allergy
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 61
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 was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Meet criteria for the diagnosis of allergic asthma
* Be between the ages of 18 to 65 years
* Have a normal chest X-ray within 2 years of screening

Exclusion Criteria:

* Need daily controller medication for asthma
* History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
* Have a documented medical history of anaphylaxis
* Have lung disease other than mild allergic asthma
* Have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
* Are unable or unwilling to comply with study procedures and visits
* Are pregnant or lactating
* Have significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia
* Have been treated with omalizumab within 12 months prior to screening
* Currently smoke or have a history of smoking more than 10 pack-years
* Have a history of drug or alcohol abuse, which, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study

Primary outcomes:
measure: Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
timeFrame: From baseline to Week 16
Secondary outcomes:
measure: Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge
timeFrame: From baseline to Week 16
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Dennis Wong, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00348634: Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
Official title: The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Constipation
Keywords: Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Temple University
name: University of Michigan
First posted: 2006-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.


Eligibility criteria: Inclusion Criteria:

* Male \& Females aged 65 and older
* Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
* Patients must have had a colonoscopy within the past 5 years
* Patients must pass a balloon expulsion test at screening
* Patients must be able to comply and understand the use of a diary

Exclusion Criteria:

* Patients with a clinically significant medical condition that would interfere with the patient completing the trial
* Patients with loose stools at least once per week
* Patients with IBS
* Known allergies to the same class of drug and/or allergies to eggs
* Patients who require the use of manual maneuvers to have a bowel movement

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
Secondary outcomes:
measure: Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology, PA
state: Arizona
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple
name: Henry Parkman, MD
role: STUDY_CHAIR
affiliation: University of Michigan
name: William Chey, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01386034: Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2)
Official title: Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure : a Prospective, Randomized, Double-blind, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intestinal Failure
Keywords: Nutrition, protein metabolism, stable isotopes, mass spectrometry, intestinal failure
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. The investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis.


Eligibility criteria: Inclusion Criteria:

* Adult between 18 and 75 years
* Patient with short bowel syndrome
* Patient with an incompetent small intestine after intestinal resection
* Patient fed orally and beyond more than 6 weeks after surgery
* Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol®
* No current artificial feeding (parenteral)
* No low-sodium diet- No renal, cardiac, respiratory or hepatic insufficiency
* No chronic inflammatory disease (intestinal or other)
* No current corticosteroid treatment
* Fasting blood glucose below 6mmol/L
* Patient able to understand benefits and risks of protocol
* Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 15 days following the end of the study
* Signed informed consent

Exclusion Criteria:

* Subject not fulfilling inclusion criteria
* Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique"
* Pregnancy

Primary outcomes:
measure: whole body protein synthesis
Secondary outcomes:
measure: nitrogen balance
measure: Measure of insulin
measure: Measure of insulin-like-growth factor 1 (IGF-1)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Clinique Saint Yves
Study officials:
affiliation: Nantes University Hospital
name: Dominique DARMAUN, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jirka A, Layec S, Picot D, Bernon-Ferreira S, Grasset N, Flet L, Thibault R, Darmaun D. Effect of oral citrulline supplementation on whole body protein metabolism in adult patients with short bowel syndrome: A pilot, randomized, double-blind, cross-over study. Clin Nutr. 2019 Dec;38(6):2599-2606. doi: 10.1016/j.clnu.2018.12.030. Epub 2019 Jan 2.
Clinical trial NCT01795534: Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia
Official title: Beetroot Juice as a Potential Ergogenic Aid During Exercise in Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Bangor University
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. It is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial.


Eligibility criteria: Inclusion Criteria:

- Trained athletes with personal best performances for a 10km run of sub 40 minutes

Exclusion Criteria:

- Unable to give informed consent Unstable medical condition.

Primary outcomes:
measure: Time to Complete a 10 km Run
timeFrame: Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Bangor University
state: Gwynedd
Study officials:
affiliation: Bangor University
name: Jamie H Macdonald, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03945734: Expressive Helping for Chinese-Speaking Cancer Patients and Survivors
Official title: Feasibility of Expressive Helping for Chinese-Speaking Cancer Patients and Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Cancer
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines the feasibility, cultural-sensitivity, and health effects of the expressive helping intervention by conducting a single-arm trial with Chinese-speaking cancer patients and survivors.

Detailed description: This study examines whether expressive helping is feasible and culturally-sensitive for Chinese American cancer patients and survivors. For 20 minutes each week over four weeks, participants choose to write or voice-record their thoughts about cancer by following specific prompts designed to help them process their cancer experiences. During the last week of this reflection exercise, participants write or voice-record an anonymous letter to another Chinese cancer patient by sharing their cancer experience and providing advice and encouragement. Health outcomes are assessed at baseline, 1-month, and 3-month follow-ups. A subset of the participants will be invited to share their experiences with the study through qualitative interviews after the last writing/voice-recording session. This research study provides an opportunity for Chinese American cancer patients and survivors to express their feelings without the fear of burdening others, and give them an opportunity to help others by sharing their cancer experiences.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer (any type)
* Of Chinese descent
* Over the age of 18
* Can speaking and read Mandarin Chinese

Exclusion Criteria:

* Completed primary cancer treatment more than five years ago

Primary outcomes:
measure: Number of participants screened
timeFrame: through study completion, an average of 1 year
measure: Compliance rate
timeFrame: through study completion, an average of 1 year
measure: Retention rate
timeFrame: through study completion, an average of 1 year
measure: Meaningfulness of the study
timeFrame: This will be assessed approximately four weeks after the baseline
Secondary outcomes:
measure: Change in quality of life as assessed by the Functional Assessment of Cancer Therapy Scale (FACT).
timeFrame: Baseline; 1-month follow-up; 3-month follow-up
measure: Change in depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D).
timeFrame: Baseline; 1-month follow-up; 3-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
Clinical trial NCT06904534: Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate
Official title: Comparison of Fetal Cardiac Functions in Pregnant Women Using Nifedipine and Magnesium Sulfate for Tocolysis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4
Keywords: Nifedipine
MgSO4
Fetal echocardiography.
Lead sponsor: Sanliurfa Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with preterm labor indication at 24-34 weeks of gestation who are treated with nifedipine or MgSO4 for tocolysis

Brief summary: The potential unexpected effects of nifedipine and MgSO4, the tocolytic agents used for the indication of preterm labor, on fetal heart will be determined. In this study, the fetal echocardiographic findings of nifedipine and MgSO4 will be compared.

Detailed description: This study will include pregnancies at 24-34 weeks of gestation that are using nifedipine and MgSO4 for tocolysis. Fetal echocardiographic findings of these pregnancies will be recorded

Eligibility criteria: Inclusion Criteria:-Patients with preterm labor indication at 24-34 weeks of gestation

-Treated with nifedipine or MgSO4 for tocolysis

Exclusion Criteria:

* Multiple pregnancy
* premature rupture of membranes
* Chorioamnionitis
* Placental abruption
* Severe fetal growth restriction
* Congenital anomalies of the fetus
* Preeclampsia
* Oligohydramnios
* Maternal diabetes
* Contraindications for the use of nifedipine and/or MgSO4 in the mother

Primary outcomes:
measure: Use of nifedipine or MgSO4 as tocolytic agents
timeFrame: Fetal echocardiographic findings after 48 hours the use of nifedipine or MgSO4
Secondary outcomes:
Other outcomes:
Locations:
city: Sanliurfa
country: Turkey
facility: Şanlıurfa Training and Research Hospital
Study officials:
References:
Clinical trial NCT01178034: Early Identification of Warfarin Maintenance Dosage
Official title: Early Identification of Warfarin Maintenance Dose in Patients With Atrial Fibrillation: a Randomized Trial Evaluating a New Genotype-based Versus Usual Care Initiation of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Warfarin
Dose
Pharmacogenetic
INR
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value at day five after four days of 5 mg/day warfarin. To this end patients with atrial fibrillation starting warfarin are randomized in two arms.

Detailed description: The objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. In patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of VKORC1 genotype and patient's body weight.The second day warfarin maintenance dose is calculated on the basis of surface area and CYP2C9, CYP4F2 e VKORC1 genotype. In the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (Pengo V, Am J Cardiol 2001). INR is checked on day 0, 5, 7, 9, 12, 15 and 19. Primary end-point of the trial is the number of INR outside the therapeutic range of 2.0 to 3.0. Secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Indication to warfarin with INR between 2.0 and 3.0

Exclusion Criteria:

* Pregnancy
* Drug interactions
* Basal INR \> 1.2

Primary outcomes:
measure: International Normalized Ratio (INR)
timeFrame: Day 0, 5, 7, 9, 12, 15, 19.
Secondary outcomes:
measure: Number of changes in warfarin dosage
timeFrame: Day 0-19
measure: Difference between predicted and actual warfarin maintenance dose
timeFrame: Day 19
measure: Thromboembolic and Bleeding complications
timeFrame: Day 0-30
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Thrombosis Centre
Study officials:
affiliation: University of Padova
name: Vittorio Pengo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pengo V, Zambon CF, Fogar P, Padoan A, Nante G, Pelloso M, Moz S, Frigo AC, Groppa F, Bozzato D, Tiso E, Gnatta E, Denas G, Padayattil Jose S, Padrini R, Basso D, Plebani M. A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naive Patients with Non-Valvular Atrial Fibrillation. PLoS One. 2015 Dec 28;10(12):e0145318. doi: 10.1371/journal.pone.0145318. eCollection 2015.
Clinical trial NCT02654834: Oxidative Stress in OR Personnel
Official title: Oxidative Stress Status During Anesthesia in Pediatric Surgical Room Staff Versus Non-operating Room Personnel: Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Oxidative Stress
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty operating room staff and twenty intensive care unit staff (40 Total Participants)

Brief summary: The purpose of this study is investigate to the effect(s) of chronic occupational exposure to N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the generation of the biochemical markers) in operating room staff, with different levels of exposure to halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care Staff), and to determine the relationship between the degree of oxidative stress and psychological stress, as assessed by validated psychometric measures.

Detailed description: This is a single blinded randomized, controlled and prospective clinical trial comparing oxidative stress status in two groups.

Subjects in two groups will be matched for gender, age, smoking habit and employment duration and will be randomized into one of the two groups of:

1. Pediatric OR Staff, and
2. control (e.g; ICU staff)

Biomarkers of oxidative stress will be measured in two different time points in each subject, (Monday Morning and, Friday afternoon of that same week-\>40 hours in Operating room or Intensive Care Unit).

The relationship between oxidative stress and psychological stress will also be assessed by validated psychometric measures.

Eligibility criteria: Inclusion Criteria:

1. CHOR-Staff who work \> 40 hours per week in the operating rooms (Anesthesiologists, CRNA, Surgeons, Nurses)
2. NOR- Intensive Care Unit Staff who work \> 40 hours per week in Intensive care unit (Physicians, Nurses, APN'S)

Exclusion Criteria:

Staff with the following history will be excluded:

1. Therapeutic exposure to radiation
2. On chemotherapeutic agents
3. History of General Anesthesia during the past two years

Primary outcomes:
measure: Oxidative Stress
timeFrame: During exposure to volatile anesthetics over the course of a week in the work-place
Secondary outcomes:
measure: Psychological Stress
timeFrame: During exposure to volatile anesthetics over the course of a week in the work-place
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Haleh Saadat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03363334: Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
Official title: Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Immune Thrombocytopenic Purpura
Keywords: ITP
Immune Thrombocytopenia
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-12-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: C-935788-055 is an open-label, multi-center, expanded access (EAP) study.

Detailed description: The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.

Eligibility criteria: Inclusion Criteria:

1. Adult patient with chronic or persistent ITP.
2. Must have failed or are unable to receive standard of care treatments for ITP.
3. Must have at least two platelet counts \< 30,000/µL during the last 2 months prior to screen date.

Exclusion Criteria:

1. ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
2. Subject has uncontrolled or poorly controlled hypertension.
3. Any of the following laboratory abnormalities: neutrophil count of \< 1,500/µL, or transaminase levels (ALT, AST) \> 1.5x ULN, total bilirubin \> 2.0 mg/dL.
4. Active HBV or HCV infection.
5. Current or recent enrollment in an investigational drug or device study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rigel Pharmaceuticals, Inc., Chief Medical Officer
name: Anne-Marie Duliege, M.D.
role: STUDY_DIRECTOR
References: