louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03654144: Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
Official title: Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adenomyosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adenomyosis was first described as endometrial glands in the myometrium of the uterus. The current definition of adenomyosis is provided in 1972 'the benign invasion of endometrium into the myometrium, producing a diffusely enlarged uterus which microscopically exhibits ectopic non-neoplastic, endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium


Eligibility criteria: Inclusion Criteria:

* symptomatic adenomyosis
* irregular menstrual bleeding and dysmenorrhea .

Exclusion Criteria:

* asymptomatic patients -
* non-lactating patient
* not desire for pregnancy
* no hormonal treatment more than 6 month even contraception e.g IUD
* no focal lesion of uterus (malignancy ,fibroid or adenxal mass )

Primary outcomes:
measure: The mean pain score after receiving treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05684744: Roflumilast Versus Methotrexate in Psoriasis
Official title: Roflumilast Versus Methotrexate in the Treatment of Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psoriasis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 30
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: Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis

Detailed description: Phosphodiesterase (PDE-4) activity was found to be greater in psoriatic skin than in healthy skin. Inhibition of PDE-4 inhibits the hydrolysis of cyclic AMP in inflammatory cells, which increases intracellular cAMP and results in down-regulation of immune modulators, including tumor necrosis factor (TNF)- α, interferon-γ, interleukin (IL)-17, and IL-23. Roflumilast is a potent and selective inhibitor of PDE-4 which is already approved in its oral form for chronic obstructive pulmonary disease. Regarding Roflumilast's topical form, it is currently also approved in the treatment of psoriasis. Lebwohl et al., 2020 found that roflumilast cream was efficacious in reducing the severity of psoriasis in a 12-week, randomized, double-blind, placebo vehicle-controlled trial.

Eligibility criteria: Inclusion Criteria:

1. Patients with psoriasis vulgaris
2. Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study
3. Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study

Exclusion Criteria:

1. Erythrodermic or pustular psoriasis
2. Pregnant and lactating females
3. Patients with autoimmune diseases e.g. systemic lupus erythematosus
4. Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.

Primary outcomes:
measure: Psoriasis Severity Index (PASI) before and after Roflumilast
timeFrame: 12 weeks
measure: Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05219344: Tissue Flossing and Lower Limb Neuromuscular Function
Official title: Effects of Different Volumes of Tissue Flossing Around Thigh Muscle on Neuromuscular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Performance
Neuromuscular Function
Tissue Flossing
Ischemic Preconditioning
Keywords: Physical Performance, Neuromuscular Function, CMJ, TMG, PAP
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: There is no study investigating different volumes, that is various sets of the configuration of tissue flossing on neuromuscular function. Previously, investigators found that 3 sets of TF impaired neuromuscular function assessed with TMG. Therefore, the aim is to compare the effects of one and two sets of TS on countermovement jump (CMJ) performance and muscle contractile properties.

Detailed description: The primary purpose of the study will be to examine the differences in one and two sets of applying tissue flossing to the thigh muscles on neuromuscular function using tensiomyography (TMG) and CMJ, while considering several measurement points after flossing application (i.e., +0.5min, +3min, +6min, +9min, +12min, +15min). A better understanding of the effects of flossing on acute performance enhancement as well as on individual muscle contractile properties could help practitioners to develop specific pre-conditioning activities and consequently improve athletic performance on the field. The investigators hypothesized that: (i) the application of tissue flossing will improve the contraction time of the vastus lateralis muscle as well as the maximal jumping performance, regardless of sets of configuration.

Eligibility criteria: Inclusion Criteria:

* healthy and physically active male subjects

Exclusion Criteria:

* Subjects who have latex allergy, hypertension, venous thrombotic disease, cardio-respiratory disease, or neurological disorders, acute and or chronic neuromuscular injuries i.e., with a history of serious lower limb injuries in 12 months period prior to study began will be excluded.

Primary outcomes:
measure: Tensiomyography
timeFrame: 20 seconds per single measurement
measure: Countermovement jump
timeFrame: 30 seconds per single measurement
Secondary outcomes:
measure: Rate of perceived exertion
timeFrame: 5 seconds
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Faculty of Sport
Study officials:
affiliation: Faculty of Sport
name: Armin Paravlic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paravlic AH, Segula J, Drole K, Hadzic V, Pajek M, Vodicar J. Tissue Flossing Around the Thigh Does Not Provide Acute Enhancement of Neuromuscular Function. Front Physiol. 2022 Apr 27;13:870498. doi: 10.3389/fphys.2022.870498. eCollection 2022.
Clinical trial NCT00593944: Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
Chronic Lymphocytic Leukemia
B cell
leukemia
lymphocyte
antibody
monoclonal
cancer
blood
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.

Detailed description: Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.

Eligibility criteria: Inclusion Criteria:

* relapsed/refractory CD19-positive CLL
* At least 28 days since prior treatment for CLL
* ECOG PS 0-2
* Screening laboratory values must be met

Exclusion Criteria:

* No prior anti-CD19 antibody tx
* No active, uncontrolled infection
* No prior allogeneic bone marrow transplant
* No autoimmune disease

Primary outcomes:
measure: incidence and severity of treatment-emergent adverse events
timeFrame: all events will be followed to resolution
Secondary outcomes:
measure: response
timeFrame: 12 weeks
measure: clinical laboratory tests
timeFrame: study duratation - each visit
measure: physical examination
timeFrame: study duration - each visit
measure: electrocardiogram
timeFrame: at screening and study completion
measure: diagnostic testing
timeFrame: at screening and study completion
measure: pharmacokinetics sampling
timeFrame: at each dosing visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Houston
country: United States
facility: Oncology Consultants, PA
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00889044: Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI
Official title: Chewing Clopidogrel in Addition to Regular Oral Clopidogrel Treatment to Improve Platelets Aggregation in Patient With NON ST ELEVATION MI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Platlet Aggregation
Major Bleeding Outcomes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Since the absorption of clopidogrel through the gastrointestinal tract is limited, we want to examine whether adding clopidogrel by chewing will overcome the limited gastrointestinal absorption, and hence will improve the prevention of platelet aggregation.


Eligibility criteria: Inclusion Criteria:

* Male and Female older than 18 years old with non-ST myocardial infarction

Exclusion Criteria:

* Current treatment with anticoagulation medication, any type of cerebro vascular event in the past, active bleeding, active peptic ulcer disease, pregnant women, any inability to sign an informed consent of participate in the study

Primary outcomes:
measure: Platelet aggregation and bleeding events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba_medical_center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center, Cardiac Institute
Study officials:
References:
citation: Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. doi: 10.1161/01.CIR.0000072771.11429.83. Epub 2003 Jun 9.
citation: Matetzky S, Shenkman B, Guetta V, Shechter M, Beinart R, Goldenberg I, Novikov I, Pres H, Savion N, Varon D, Hod H. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Circulation. 2004 Jun 29;109(25):3171-5. doi: 10.1161/01.CIR.0000130846.46168.03. Epub 2004 Jun 7.
Clinical trial NCT02904044: Sport Injuries During Physical Activity Lessons in Secondary School in South of Reunion Island
Official title: Etude Des Traumatismes Sportifs Lors Des Cours d'éducation Physique et Sportive Chez Les collégiens Dans le Sud de l'Ile de La Reunion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletic Injuries
Keywords: School
Sport
Injuries
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Reunion Island secondary school pupils

Brief summary: TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.

Detailed description: Sport injuries during physical activities lessons are the first etiology of traumatism in secondary school. Epidemiological studies on individual determinants of sport injuries are very scarce and most focused on contextual or mixed determinants.

TsColEPS is a multicenter case control study with one control paired to one case.

A convenience sample of 500 pupils in each group was planned on the base of a range of expected odds ratios.

Eligibility criteria: Inclusion Criteria:

* in secondary public school classroom in south of Reunion Island
* no age limited

Exclusion Criteria:

* none

Primary outcomes:
measure: Individual determinants of sport injuries during physical activity lessons in secondary school measured by a series of questionnaires at school (nurse interview), at home (family interview) and at the doctor's office for diagnosis
timeFrame: 2 years with 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: Centre Hospitalier Universitaire
state: île de La Réunion
Study officials:
References:
Clinical trial NCT06928844: Role of Low Dose Injectable Progesterone in Triggering Ovulation
Official title: Role of Low Dose Injectable Progesterone in Triggering Ovulation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Dose
Progesterone
Triggering Ovulation
Lead sponsor: The General Authority for Teaching Hospitals and Institutes
Sponsor class: NETWORK
First posted: 2025-04-15
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation.

Detailed description: Infertility affects approximately 10-15% of couples attempting pregnancy, with no readily identifiable cause found in 15-30% of these patients, resulting in a diagnosis of unexplained infertility.

Kol and Itskovitz-Eldor stated that when using GnRH agonist to trigger ovulation in IVF cycles, the LH surge is associated with a rapid rise of progesterone and the attainment of peak E2 levels through the first 12 h after GnRH agonist administration which is followed by a temporary suppression of progesterone biosynthesis and a gradual drop in E2 levels during the 24 h before follicle aspiration. After oocyte retrieval, a second rise in progesterone and continuous fall in E2 are noted, reflecting transitions from follicular to luteal phase in ovarian steroidogenesis.

Letrozole (LE) is a nonsteroidal, highly selective oral aromatase inhibitor (AI) that inhibits the synthesis of oestrogen and increases the secretion of endogenous gonadotropin by diminishing negative feedback to stimulate ovulation. Currently, letrozole is widely used as an adjunct for IVF cycles.

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 35 years.
* Infertile women.
* Basal follicle-stimulating hormone (FSH) level \<10 mIU/ml.

Exclusion Criteria:

* Poor ovarian reserve.
* Immunological disease.
* Endometriosis.
* Uterine abnormality.
* Body mass index (BMI) \>30 kg/m2.
* Endometrial thickness \<8 or \>12 mm on the day of triggering.

Primary outcomes:
measure: Incidence of ovulation rates
timeFrame: 10-12 days of the menstrual cycle
Secondary outcomes:
measure: Follicle stimulating hormone (FSH)levels
timeFrame: 10-12 days of the menstrual cycle
measure: Luteinizing hormone (LH)levels
timeFrame: 10-12 days of the menstrual cycle
measure: Estradiol (E2) levels
timeFrame: 10-12 days of the menstrual cycle
measure: Progesterone levels
timeFrame: 10-12 days of the menstrual cycle
measure: Number of oocytes
timeFrame: 8 days of the menstrual cycle
measure: Mature oocytes
timeFrame: 16 days of the menstrual cycle
measure: Clinical pregnancy rate.
timeFrame: One week late from the previous menstrual cycle
measure: Biochemical pregnancy
timeFrame: 16 days of the menstrual cycle
measure: Early miscarriage rate
timeFrame: 16 days of the menstrual cycle
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Teaching Hospitals and Institutes
Study officials:
References:
Clinical trial NCT00652444: Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)
Official title: Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization.


Eligibility criteria: Inclusion Criteria:

* Patients with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, who are being treated with simvastatin 20mg. Simvastatin consumption meant that subjects must be currently taking simvastatin 20mg daily, and by history have taken at least 80% of daily evening doses for the preceding 6 weeks prior to baseline visit
* Age of at least 18 years and 75 years or less
* Calculated LDL-C concentration of at least 2.6 and 4.1mmol/l or less using the Friedewald equation, and triglyceride of less than 3.99 mmol/l

Exclusion Criteria:

* Congestive heart failure (defined as New York Heart Association class III or IV heart failure)
* Uncontrolled cardiac arrhythmias
* Acute coronary syndrome, coronary bypass surgery or coronary angioplasty within 3 months of study entry
* History of unstable or severe peripheral artery disease within 3 months of study entry
* Uncontrolled hypertension at study entry
* Uncontrolled or newly diagnosed diabetes mellitus (within 3 months of study entry)
* Uncontrolled endocrine or metabolic diseases known to influence serum lipids and lipoproteins; known impairment of renal function
* Active or chronic hepatic and hepatobiliary disease
* Disorders that would limit study evaluation or participation

Primary outcomes:
measure: Percentage reduction of LDL-C after 6 weeks of treatment.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):688-93. doi: 10.2459/JCM.0b013e3282f3a1b1.
Clinical trial NCT00020644: Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
Official title: Phase I Study of Continuous Infusion Gemcitabine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer.

Detailed description: OBJECTIVES:

* Determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies.
* Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1. Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks 1-3. Courses repeat every 2 weeks (for patients on dose levels 1-5) and every 4 weeks (for patients on dose levels 6 and 7) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of an advanced metastatic malignancy for which no curative therapy exists

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.0 mg/dL

Renal:

* Creatinine no greater than 2.0 mg/dL

Pulmonary:

* Corrected DLCO at least 60% expected

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Prior short-infusion gemcitabine allowed

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Lutheran General Cancer Care Center
state: Illinois
Study officials:
affiliation: Advocate Lutheran General Hospital
name: Brian L. Samuels, MD
role: STUDY_CHAIR
References: