cyrilzakka/clinical-trials huggingface dataset:
A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

The purpose of this study is to assess the safety and effectiveness of \[S,S\]-Reboxetine in patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
* At screening and randomization, patients must have a score of \>/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).

Exclusion Criteria:

* Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
* Patients with severe hepatic impairment.
Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events

Background: Recent observational studies have reported possible arrhythmogenic effects with long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object of a recent signal in trials of LABAs submitted for marketing approval.

Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two long-acting bronchodilators as well as from monotherapy use of each of the long-acting bronchodilators.

Methods: A series of population-based cohort studies, using both cohort and nested case-control analyses will be conducted using data from the United Kingdom's Clinical Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting bronchodilators from Jan 2002 until Aug 2012, age \>= 55 with chronic obstructive pulmonary disease (COPD) and at least two years of baseline medical history information. The high-dimensional propensity score technique will be used to match new users of each long-acting bronchodilator and new users of two bronchodilators with comparable subjects from the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke, heart failure, arrhythmia and community acquired pneumonia. Data will be analysed using time-dependent Cox proportional hazard regression models and conditional logistic regression models.

Purpose:

Eligibility Criteria:
Inclusion criteria:

* New users of long-acting bronchodilators, either a LABA or tiotropium, between January 2002 and August 2012
* Age \>= 55 years

Exclusion criteria:

- Use of LABA or tiotropium in the two years prior to cohort entry
Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases

The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir, the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.

The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to the blood oxygenation during exercise testing. Given that the "endurance time" is very sensitive for little changes in exercise capacity, this test will be used to show the difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration at 70% of peak Watt and oxygenation.

The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and heart rate.


Eligibility Criteria:
Inclusion Criteria:

* COPD IV
* interstitial lung disease
* long-term oxygen therapy with oxygen flow rate \>= 2 L/min

Exclusion Criteria:

* acute cardial decompensation
* usual kontraindication for exposure test (higher-grad Hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)
Safety and Effect of Oral Doses of 5mg or 10mg of SLx-2101 for 14 Days in Patients With Hypertension

The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on systolic, diastolic pressures and heart rate in patients with hypertension.

1. Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate
2. 24 hour ambulatory blood pressure and heart rate
3. Safety and tolerability

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 70 years old, inclusive
* Moderate to severe hypertension
* Body weight within a body mass index of 18-32kg/m2

Exclusion Criteria:

* The subject is receiving more than three antihypertensive agents
* A history of drug abuse
* Exposure to a new chemical entity within 3 months prior to the first day of dosing
Evaluation of PerioMonitor for Detection of Oral Inflammatory Load (OIL) in Human Subjects.

The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases.

PerioMonitor is an IVD device for the rapid, semi-quantitative detection of neutrophil enzyme activity in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.

The purpose of this multicenter, prospective, single arm Study is to evaluate the efficacy and safety of PerioMonitor as an aid to the detection of oral inflammation associated with periodontal diseases.

PerioMonitor is an IVD device for the rapid, semi-quantitative detection of neutrophil enzyme activity in oral samples. This test is intended for prescription use at Point-of-Care ("POC") settings by health care professionals.

The primary objective of this Study is to evaluate the Positive Percent Agreement (PPA)PPA and the Negative Percent Agreement (NPA)NPA of PerioMonitor for semi-quantitative detection of neutrophil enzyme activity in human oral specimens, to detect oral inflammation associated with periodontal diseases (subjects having more than 50 000 neutrophils/mL in their oral specimen or having more than 10% of bleeding sites when tested with the BOP method).

The secondary objective is to validate the claim that PerioMonitor can be used in POC settings (i.e., representative of the intended users and under conditions similar to the conditions of use), at the time of the consultation, with instant availability of results, by healthcare professionals (HCP) working in a dental clinic (i.e. with the background, education, and training of those who will perform the test in its intended environment) that are not qualified laboratory technicians, to make immediate and informed decisions about patient care.

Eligibility Criteria:
Inclusion Criteria:

* subject \> 18 years old;
* subject fluent in English; and
* subject has signed the ICF

Exclusion Criteria:

* Subject with altered mental status/inability to provide informed consent or follow the procedure of the Study; and
* Subject using immunosuppressants including biologics such as adalimumab (Humira) and infliximab (Remicade); or calcineurin inhibitors such as tacrolimus (Envarsus XR or Protopic) and cyclosporine (Gengraf, Neotal or Sandimmmune); or corticosteroids (Prednisone); or azathioprine (Imuran)
* Oral rinse specimens received 5 days or more after PerioMonitor testing by the clinical laboratory
* Previous enrolment into the current Study.
Effects of Stretching on Strength of Proximal and Distal Group of Muscles - A Comparative Study

Muscular flexibility is believed to prevent injuries and improve movement therefore most coaches include stretching exercises in their pre-competition and pre-exercise warm-up routines. One question arises here, should sports persons avoid stretching exercises prior to sporting events thereby exposing themselves to musculoskeletal injuries, or should they continue stretching exercises prior to sporting events and risk losing the maximal performance? The aim of this study is to compare the effects of 2, 4, and 8 min of static stretching (SS) on isometric maximum voluntary contraction (MVCF) force between proximal (Hamstrings) and distal group (Calf) of muscles.

OBJECTIVE: To compare the effects of 2, 4, and 8 min of static stretching (SS) on isometric maximum voluntary contraction (MVCF) force between proximal (Hamstrings) and distal group (Calf) of muscles.

DESIGN: Two-group pretest-posttest experimental design. METHODS: Each subject visited the Rehabilitation center on three days: On day-I for static stretching for 2 minutes (SS2), day-II for 4 minutes (SS4), and day-III for 8 minutes (SS8). Isometric Maximum Voluntary Contraction Force (MVCF) measurement was done prior (Pre), 0-min, 10-min, and 20-min post-intervention (i.e. stretching). Each visit was separated by a gap of at least 3-4 days. On each visit, each subject underwent (a). Pre-intervention evaluation, (b). Intervention, (c). Post-intervention evaluation. Subjects performed stretching exercises under the supervision of expert Physical Therapist. The outcome assessor who was kept blind to study protocol did all measurements.

Eligibility Criteria:
Inclusion Criteria:

For group A: subjects performed active knee extension test and those lacking at least 20 degrees of active knee extension range, with hip in 90 degree of flexion were selected. For group B (Calf): Subjects performed active foot dorsiflexion in long sitting position with back supported against the wall and those having not more than 20-degree range of motion were selected.

Selected subjects used to engage in 1-5 hours of regular physical activity per week (recreationally active) that does not involve stretching exercise

Exclusion Criteria:

Subjects reporting any current or ongoing neuromuscular disease, injury specific to lower limb joints, any apparent limit in knee or ankle ROM and competitive/professional athletes were excluded from study.
A Coordinated Parent/Child Dyad Weight Loss Intervention: Dyad Plus (Feasibility)

The purpose of this research is to develop a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Participation in this study will involve participation in six, one-hour sessions in addition to those required by your weight loss program. These sessions will work to facilitate an increase in self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs. Joint goal setting and tracking will be enabled by commercially available devices and apps. Each caregiver and child will receive an activity monitor, activity app, and a food app (digital food diary) that allows self-monitoring of consumption and "social accountability," which will allow caregivers and the Brenner FIT team to monitor and encourage. Furthermore, two home visits will be conducted to evaluation the home food and activity environments to inform tailored feedback to families.

Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity.11-14 By Design is an adult (\>18yrs) weight loss clinic that includes tailored dietary and physical activity behavioral counseling. The preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least one adult caregiver who is eligible and would benefit from enrollment in By Design Essentials.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for enrollment in Brenner FIT and/or By Design Essentials
* Caregiver who lives in the house with a BMI \> 30
* No contraindication for physical activity or caloric restriction
* Must be able to read and write English

Exclusion Criteria:

* Over the age of 65
* BMI \< 30
* Contraindication for physical activity or caloric restriction
* Cannot read or write English
Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)

This study aims to learn about the long-term safety and effectiveness of the Chocolate Balloon Catheter in patients with blocked leg arteries (peripheral artery disease, or PAD). The Chocolate Balloon is a special type of balloon used during minimally invasive procedures to open narrowed arteries while potentially causing less damage to the blood vessel.

The main question it aims to answer is:

Does the Chocolate Balloon keep the treated artery open after 12 months without needing repeat procedures? Patients with PAD who are already scheduled to undergo an artery-opening procedure (angioplasty) with the Chocolate Balloon as part of their standard care will answer the question about the safety and effectiveness of the Chocolate Balloon Catheter


Eligibility Criteria:
Inclusion Criteria:

* Participant or legal guardian provides written informed consent.
* Age ≥18 and ≤80 years, regardless of gender.
* De novo target lesion located in the native superficial femoral, popliteal, or infrapopliteal artery.
* Life expectancy \>1 year as assessed by the investigator.
* Candidate suitable for endovascular angiography and intervention per investigator judgment.
* Willingness to undergo Chocolate Balloon Catheter PTA.

Exclusion Criteria:

* Active systemic infection or uncontrolled coagulation disorder within 14 days prior to procedure.
* Planned major amputation of the target limb (at or above the ankle).
* Renal insufficiency (MDRD eGFR ≤30 mL/min/1.73 m²) or serum creatinine ≥2.5 mg/dL within 30 days, or dialysis dependence.
* Contraindication to antiplatelet therapy (aspirin/clopidogrel), low-molecular-weight heparin, vasodilators, or contrast agents.
* Uncontrolled systemic comorbidities (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, uncorrected coagulopathy).
* History of cerebral hemorrhage, symptomatic stroke, myocardial infarction, or gastrointestinal bleeding within 6 months.
* Pregnancy, lactation, or planned pregnancy (men or women).
* Participation in another interventional clinical trial with unmet primary endpoint.
* Investigator-determined medical, social, or psychological contraindications.
* Life expectancy \<1 year.
Study of Brimonidine Tartrate Nanoemulsion Eye Drops in Patients With Ocular Graft-vs-Host Disease

This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will receive Brimonidine and one third will receive ophthalmic buffered saline (placebo).

Ocular GVHD (oGVHD) is a common complication that occurs in 40-60% of patients who have undergone allogeneic bone marrow transplants. Driven by inflammation, oGVHD can result in damage to the ocular surface and tear-producing glands, which over time significantly diminishes quality of life and restricts daily activities due to visual impairment.

Early studies in animals and humans indicate that Brimonidine nano-emulsion, also known as OCU300, may relieve the signs and symptoms of oGVHD. These symptoms include blurry vision, foreign body sensation, burning sensation, severe light sensitivity, chronic conjunctivitis (pink or red eye), dry eyes and eye pain.

This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 15 centers. Upon meeting the eligibility criteria, enrolled subjects with a diagnosis of definite oGVHD will be randomly assigned in a 2:1 (test: control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.18% investigational product (test) or ophthalmic buffered saline (placebo).

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years of age
* Diagnosis of definite oGVHD using the International Chronic Ocular GVHD Consensus Group Revised Diagnostic criteria in at least one eye.
* Ocular Discomfort score ≥ 3
* Validated Bulbar Redness score ≥ 40 in both eyes
* Subjects who are capable and willing to provide informed consent and follow study instructions
* Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
* Women who are not pregnant or lactating or post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

* Allergic to brimonidine or any similar products, or excipients of brimonidine
* Currently receiving any brimonidine or other treatment for glaucoma
* Receiving or have received any investigational drug or device within 30 days of screening
* Current use of contact lenses 14 days prior to screening
* Active ocular infection or ocular allergies
* Any history of eyelid surgery or ocular surgery within the past 3 months
* Corneal epithelial defect larger than 1 mm (squared) in either eye
* Received corticosteroid-containing eye drops within 14 days prior to screening or planned use during the study
* Any change in corticosteroid-containing eye drops, systemic corticosteroids/immunosuppressives, topical ocular antibiotics, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa®) or lifitegrast ophthalmic solution 5% (Xiidra®), or autologous serum tears within 30 days prior to screening or planned change during the study
Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI

Women with urinary stress incontinence who underwent surgical treatment by either TVTO or TVTS will be enrolled. The investigators will collect data from charts and use a telephone questionnaire to check the outcome of these women. Physical examination findings will also be incorporated.


Eligibility Criteria:
Inclusion Criteria:

* Women with USI who underwent TVTS or TVTO procedure, more than 6 months ago

Exclusion Criteria:

* Women who have not undergone TVT procedure
Empagliflozin for No-reflow Phenomenon in PCI for STEMI

Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects.

Consequently, this randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo.

Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a standar treatment. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group. Patients will be monitored weekly during the first month and bi-weekly during the second and third months.

The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction with ST-segment elevation
* Presentation to the institute within 12 hours of symptom onset
* Coronary angioplasty chosen as the reperfusion treatment for the subject
* Known diagnosis of diabetes or admission glucose \>180 mg/dl.
* Informed consent signed

Exclusion Criteria:

* Hemodynamically unstable subjects
* Subjects undergoing thrombolysis treatment in the current event
* History of coronary revascularization surgery
* Known allergy or hypersensitivity to Sodium-glucose co-transporter-2 (SGLT2) inhibitors
* History of recurrent urinary tract infections
* Known chronic kidney disease and estimated glomerular filtration rate (eGFR) \< 20
* Ongoing treatment with any SGLT2 inhibitor
* Participation in another clinical trial or having participated in the week prior to recruitment
* For women of childbearing age: Current or planned pregnancy or lactation.
Glycaemic Load and Pre-meal Insulin Doses in Type 1 Diabetes Patients

The aim of this study is to compare the feasibility and the efficacy on short-term glucose control of pre-meal insulin doses adjustment made on the bases of the glycemic load or of the carbohydrates content of the meal in patients with type 1 diabetes mellitus treated with insulin pump


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes treated by insulin pump

Exclusion Criteria:

* Preganncy
* HbA1c \> 9%

  * Any serious acute or chronic illness a part diabetes
Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
* Serum 25OHD levels \< 40 ng/ml

Exclusion Criteria:

* Severe or debilitating musculoskeletal pain
* Known metastatic disease
* History of renal stones
* History of hypercalcemia or hyperthyroidism
* Currently receiving adjuvant or neoadjuvant chemotherapy
* Currently receiving other investigational agents
Validation of the French Version of the Back Belief Questionnaire

The goal of this study is to carry out a transcultural validation of the Back Belief Questionnaire in order to assess its appropriateness for French-speaking populations.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has had back pain for at least 3 months

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding