louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00935415: Time-Effect of Montelukast Protection
Official title: Time-Effect of Montelukast on Protection Against Exercise-Induced Bronchoconstriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Exercise-Induced Asthma
Asthma
Keywords: asthma
exercise-induced bronchoconstriction
montelukast
clinical protection
children
time effect
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 69
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration.

Detailed description: Within few days after a baseline exercise challenge, children was randomized to a double blind, placebo-controlled, three day doses, crossover study design. In practice each eligible patient was randomized by a computer-generated schedule to receive in sequence double-blind treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out of seven groups in order to perform the exercise challenge at different time intervals from drug administration which occurred always at 8.00 A.M. On day one the challenge was performed in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration, respectively. Then treatment was continued as a single day dose for three consecutive days and a third challenge was then performed at the same time of the day.

Eligibility criteria: Inclusion Criteria:

* children with exercise-induced asthma

Exclusion Criteria:

* viral infections
* montelukast treatment

Primary outcomes:
measure: maximal percentage fall in FEV1 after exercise test from the baseline value
timeFrame: at the first and at the third day of single day drug administration
Secondary outcomes:
measure: clinical protection
timeFrame: at the first and at the third day of single day drug administration
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Pediatric Dept Hospital of Bolzano
Study officials:
affiliation: Universita di Verona
name: Attilio Boner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02599415: Anti-psoriatic Effect of TL01 Light Therapy
Official title: Studying the Effect of Narrow Band Ultraviolet B Phototherapy on Skin Dendritic (DCs) Cells in Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis patients referred to receive TL01 NB-UVB therapy
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2015-11-06
Enrollment: 6
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: DIAGNOSTIC

Brief summary: This is a pilot study to investigate the effect of TL01 narrow band UVB therapy on the resident dermal dendritic cells characterized by expression of CD1c and CD141. These cells were reported to have a role in induction of tolerogenic regulatory T cells and production of IL-10. The investigators proposed to investigate the effect of NB-UVB on these subsets of cells after two weeks of treatment to provide better understanding of the mechanism of action of light treatment.

Detailed description: Six patients with plaque psoriasis were recruited from the phototherapy unit. These patients were referred by their dermatologist to receive narrow-band UVB (TL01) light treatment. Two 6 mm lesional skin punch biopsies were taken at baseline and 2 weeks after commencing the light treatment to study the effect of light on innate immune cells involved in psoriasis pathogenesis.

Eligibility criteria: Inclusion Criteria:

* Male and female psoriasis patients in whom the decision to treat with NB-UVB therapy, as part of their routine clinical care, has been taken by their dermatologist in the age range of 18-70 years.

Exclusion Criteria:

* patients currently on antipsoriatic treatment.

  * Patients with immunosuppressive diseases
  * Patients on immunosuppressive therapies
  * Pregnant or lactating female patients
  * Patients unable to provide a written consentProcedure

Primary outcomes:
measure: determination of the effect of TL01 NB-UVB on numbers of CD1c and CD141 cells
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen
Study officials:
References:
Clinical trial NCT01776515: Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
Official title: A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Back Pain
Keywords: Low back pain
Wontran
Wontran SR Tab.
Tramadol Hydrochloride/Acetaminophen
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-01-28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.


Eligibility criteria: Inclusion Criteria:

1. Adult males/Females aged over 20 years
2. Patient with low back pain who needs analgesic administration
3. Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification
4. Pain VAS Value over 40 mm
5. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

1. Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension
2. Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease)
3. Patients who had taken back surgery within 24 weeks from the screening point
4. Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point
5. Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point

Primary outcomes:
measure: Changes in '100 mm pain VAS' value from baseline
timeFrame: 0, 1, 7, 14, 28 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00208715: Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.
Official title: A DOUBLE-BLIND PILOT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PROVIGIL® (MODAFINIL) AT FIXED/FLEXIBLE DOSES, IN CONJUNCTION WITH IDENTIFIED SSRIs FOR THE TREATMENT OF EXCESSIVE SLEEPINESS IN PATIENTS WITH MILD TO MODERATE DEPRESSION WITH ATTENDANT SYMPTOMS OF SLEEPINESS AND FATIGUE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Mental Health
Keywords: Depression
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Cephalon
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective for treating symptoms of sleepiness and fatigue associated with Major Depressive Disorder when added to a SSRI.

Detailed description: Approximately 100 male and female outpatients, who are between the ages of 18 and 65, will be enrolled at four sites in the United States. This study consists of two parts. The first part consists of 6 weeks of open label treatment with a selected SSRI \& double blind treatment with Provigil or placebo (inactive medication).

After the six week double blind treatment phase all patients will enter a four week open label treatment phase with Provigil. The dose of Provigil is not to exceed 400 mg and cannot be less than 100 mg per day. They will continue taking the prescribed SSRI.

Eligibility criteria: Inclusion Criteria:

* Major Depressive Disorder
* MADRS score ≥ 15 at both screen \& baseline.
* Significant fatigue as evidenced by FSS ≥4 at both screen \& baseline.
* Excessive sleepiness as evidenced by ESS ≥ 10 at both screen \& baseline.

Exclusion Criteria:

* Treatment refractory depression
* Serious or unstable medical condition.
* Pregnancy
* Primary diagnosis of another Axis I or II disorder
* Alcohol or substance abuse or dependence within the past 12 months.

Primary outcomes:
measure: Epworth Sleepiness Scale (ESS)
Secondary outcomes:
measure: Hamilton Depression Scale (HAM-D 31 item)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Philip T Ninan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06743815: The Percent of AKI Occurred in Patient with Comorbidities Undergoing Colonoscopy
Official title: Predictors of AKI in Patient Undergoing Colonoscopy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injuries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patient \>18 years old with eGFR.30ml/min

Brief summary: observation the percent AKI in patient with comorbidities undergoing colonoscopy

Detailed description: recording the data of the patient if there are any comorbidities like DM or HTN and observation of the kidney functions before and after the colonoscopy to record the percent of the AKI in patient undergoing colonoscopy

Eligibility criteria: Inclusion Criteria:

* Adult patient aged \>18 years old Patient with eGFR\>30ml/min

Exclusion Criteria:

* patient with eGFR \<30ml/min patient with serum electrolytes abnormalities patient with heart diseases (uncontrolled heart failure, unstable angina, myocardial infarction, coronary intervention within the previous 3 months) patients with ascites

Primary outcomes:
measure: incidence of acute kidney injury
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Florentin M, Liamis G, Elisaf MS. Colonoscopy preparation-induced disorders in renal function and electrolytes. World J Gastrointest Pharmacol Ther. 2014 May 6;5(2):50-4. doi: 10.4292/wjgpt.v5.i2.50.
Clinical trial NCT06656715: Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure
Official title: Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will approach cancer participants with solid tumors and with a concurrent diagnosis of heart failure who are followed at MD Anderson for HF management. In fiscal year 2023, of the more than 20,000 hospital discharges, approximately 6% of those discharges have a concurrent diagnosis of heart failure. Investigators will enroll 100 participants who meet the inclusion criteria.

Brief summary: To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).

Detailed description: The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).

The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the measure of Quality of Life Short Form-12 (SF-12).

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Individuals with a concurrent solid tumor cancer diagnosis
* Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)\[Tamoxifen\], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists \[Leuprolide\], Androgen deprivation therapy for prostate cancer
* Completed cancer treatment at least 3 months and up to 3 years before study enrollment.

Therapy

* Able to read, speak and consent in English
* Ability to understand and the willingness to sign a written informed consent document
* Diagnosis of heart failure, confirmed by echocardiogram, MUGA, or cardiac catheterization
* Internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the Fitbit App and 2) complete electronic study assessments via REDCap.

Exclusion Criteria:

* Participants undergoing active cancer treatment.
* Inability to provide consent in the medical record, such as cognitively impaired individuals.

Primary outcomes:
measure: Heart Failure
timeFrame: Through study completion, an average of 3 years
measure: Heart Failure
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas of MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT00936715: Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
Official title: A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: prevention of chronic hepatitis B recurrence
post orthotopic liver transplant
prevention of chronic hepatitis B recurrence in patients who have undergone orthotopic liver transplant
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2009-07-10
Enrollment: 24
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: TREATMENT

Brief summary: The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.


Eligibility criteria: Key Inclusion Criteria:

* Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if applicable) for the GS US 203 0107 study.
* A negative pregnancy test is required for female individuals at the end of study visit for GS US 203 0107 (unless surgically sterile or greater than two years post-menopausal).
* All sexually active female individuals who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
* Male individuals who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants Who Had Access to, and Received the Intervention
timeFrame: Up to 240 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Miami
country: United States
state: Florida
city: New York
country: United States
state: New York
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03629015: Safety Study of Stemchymal® in Acute Liver Failure
Official title: The Safety Study of Stemchymal® (Allogeneic Adipose-Derived Mesenchymal Stem Cells) Treating on Acute Liver Failure - An Open-Label, Single-Center Phase I Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Stem Cells
Adult Stem Cells
Acute Liver Failure
Acute-On-Chronic Liver Failure
Steminent
Lead sponsor: Steminent Biotherapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2018-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To investigate the safety of Stemchymal® via intravenous (IV) infusion in acute liver failure (ALF) and acute on chronic liver failure (ACLF) patients.


Eligibility criteria: Inclusion Criteria:

1. ALF or ACLF patients.
2. Subjects are between 20 and 70 years of age.
3. MELD scores meet 17 ≤ MELD ≤ 26.
4. Subjects who had completed signing informed consent.

Exclusion Criteria:

1. Subjects who had been enrolled in any other cell therapy within six months.
2. Females with a positive pregnancy test result.
3. Subjects have contraindication for liver transplantation.
4. Subjects with psychiatric illnesses.
5. Subjects who are diagnosed as active tuberculosis (TB).
6. Subjects with immunological disorders (e.g. autoimmune hepatitis) or using immunosuppressive drugs (e.g. steroid for immunosuppression) within six months prior to screening visit.
7. Subjects with unstable illnesses or contraindication for this clinical trial according to investigator's judgment.

Primary outcomes:
measure: The incidence of adverse events (AEs) and suspected unexpected serious adverse reaction (SUSAR)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Changes of Model for End-Stage Liver Disease score
timeFrame: 12 months
measure: Changes of Child-Pugh score
timeFrame: 12 months
measure: Changes of Eastern Cooperative Oncology Group performance scale
timeFrame: 12 months
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT05684315: Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
Official title: Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Muscle Strain, Lower Leg
Keywords: health behavior
hamstring flexibility
fascial shearing
delayed onset muscle soreness
muscle disorder
treatment
blood flow restriction training
myotonometer
muscle stiffness
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study will be conducted in two rounds over 4 weeks. In the first round, subjects will have one leg threaded during the fatigue protocol, and after a four-week rest after full recovery, they will have the other leg threaded during the fatigue protocol.
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess whether soft tissue flossing therapy will alleviate eccentric muscle-destroying influences. Men aged 20-25 will be tested. Suddenly taking up activity in untrained people and performing the fatigue protocol is a heavy burden for the body, and its effects may have a negative impact on the body. The assessment of the processes taking place in the body under the influence of this type of physical activity with the use of soft tissue flossing will broaden the scope of knowledge about this therapeutic method and will allow assessing whether it has an impact on accelerating regeneration after intense physical exertion.


Eligibility criteria: Inclusion Criteria:

* men aged 20-25
* BMI (body mass index) at the level of 20-35

Exclusion Criteria:

• chronic diseases, musculoskeletal injuries, mental disorders, surgery or hospitalization

Primary outcomes:
measure: Isokinetic muscle strength
timeFrame: 40 days
Secondary outcomes:
measure: Soft tissue assessment
timeFrame: 40 days
measure: Range of motion
timeFrame: 40 days
measure: Visual Analogue Scale (1-100 mm)
timeFrame: 40 days
measure: Pain assessment - Algometer
timeFrame: 40 days
measure: Triple hop jump test
timeFrame: 40 days
Other outcomes:
Locations:
city: Biała Podlaska
country: Poland
facility: Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
Study officials:
affiliation: Jozef Pilsudski University of Physical Education in Warsaw Faculty in Biala Podlaska
name: Szczepan Wiecha, Phd
role: STUDY_DIRECTOR
References: