cyrilzakka/clinical-trials huggingface dataset:
Quality of Life With Arcoxia in Women With Dysmenorrhea (0663-094)

Allow gynecologists to gain experience with arcoxia for treatment of dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women older than 18 years old and younger than 25 years old
* Voluntary agreement to participate in the study and signature of informed consent
* Women with clinical diagnosis of dysmenorrhea

Exclusion Criteria:

* Diagnosis of secondary dysmenorrhea due to: endometriosis, adenomyosis, malformations of Muller's conducts, uterine fibromyomas, ovarian cystic, pelvic varicocoele, inflammatory pelvic disease, adherences, intrauterine devices, cervical channel stenosis, etc.
* Patients with diagnosis of acute inflammatory abdomen
* Patients with diagnosis of congestive heart disease, stroke (1 year), unstable angina, and history of myocardial infarction
* Women auto prescribing rescue medication for dysmenorrheal pain during the study
* Women with a diagnosis of mild dysmenorrhea
Comparison of 2 Hemostasis Techniques After Transradial Coronary

Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.

Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.

Interventions: Radial hemostasis with TerumoBand® and Radial hemostasis with a standardized compressive dressing

Eligibility Criteria:
Inclusion Criteria:

* Adult patients submitted to elective or urgent coronary catheterization who presented with a A, B or C curve on oximetry test before the procedure

Exclusion Criteria:

* Inability to understand the study and sign the informed consent form
A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia

To conduct a pilot study of cluster randomized clinical trial of an practice intervention to improve the quality of care for suspected lower respiratory and and urinary tract infections among 60 nursing home residents with advanced dementia living in 4 facilities (2 matched intervention/control pairs) for 12 months. We hypothesize that 1. In the intervention compared to the control facilities there will be a trend towards a greater proportion of infections for which antimicrobials were initiated appropriately, and 2. in the intervention compared to the control facilities there will be a trend towards higher proxy satisfaction with decision-making, fewer hospital transfers, and lower antimicrobial exposure.


Eligibility Criteria:
Inclusion Criteria:

Resident eligibility criteria include: 1) Age \> 65, 2) Dementia, 3) Global Deterioration Scale score of 7,59 and 4) a proxy is available who can speak in English. Features of Global deterioration stage 7 include: profound memory deficits (cannot recognize family), total functional dependence, speech \< 5 words, incontinence, and inability to ambulate.

Eligibility criteria for providers in the intervention nursing homes include: Medical Doctor,a. nurse, nurse practitioner, physician assistant identified by a senior administrator as an individual who cares for residents with advanced dementia, and is 2. able to communicate in English because on-line course and algorithms are in English., and 3. over 21 years of age.

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Exclusion Criteria:

Residents with cognitive impairment due to causes other than dementia (e.g., head trauma) and in short-term, sub-acute SNFs will be excluded. -
Cutaneous Diphtheria in France : Observational, Retrospective Study of Patient Characteristics

Toxigenic cutaneous diphtheria is a notifiable disease that is re-emerging in the world and particularly in France. A better description of the epidemiological characteristics, as well as a refinement of the clinical characteristics of patients with cutaneous diphtheria, are essential to better understand this pathology, which has important public health issues and whose diagnosis absence can have catastrophic consequences for the patient and their contacts. Microbiological data (species identification, toxigenicity or not, resistance profile...) will be transmitted by the national reference center for corynebacteria of the diphtheriae complex and then caregivers who have managed the corresponding patients with cutaneous diphtheria will be contacted.


Eligibility Criteria:
Inclusion Criteria:

* Culture or PCR positive skin samples for corynebacteria diphtheria, ulcerans, pseudotuberculosis, belfantii or rouxii
* Patient living in metropolitan France

Exclusion Criteria:

- Patient opposition
Relationship Between Skeletal Muscle Mass and Interventricular Septum Thickness in Apparently Healthy Overweight and Obese Subjects

The study was aimed at investigating the relationship between skeletal muscle mass and interventricular septum thickness in overweight and obese subjects (BMI≥25)

Subjects were enrolled at the first examination whether they were not taking any medication, including oral contraceptives or drugs for osteoporosis, and free of significant medical illnesses, except obesity. Exclusion criteria were history of endocrinological diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), chronic inflammatory diseases, stable known hypertension, angina pectoris, stroke, transient ischemic attack, heart infarction, congenital heart disease, malignancies, chronic inflammatory diseases, renal and liver failure, angina pectoris, myocardial infarction, heart failure, congenital heart diseases, minor and major stroke, and inherited thrombocytopenias and other major malignancies. Subjects were examined by means of the medical history, hormonal, metabolic and routine hematochemical parameters. The investigators provided for a clinical baseline evaluation that included extemporaneous ambulatory blood pressure (BP), echocardiography, bioimpedance and a physical assessment of body weight, Body Mass Index (BMI) and Waist Circumference (WC) as anthropometric parameters.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug
* Hypertension
* Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.),
* Chronic inflammatory diseases
* Renal failure
* Liver failure
* Angina pectoris
* Myocardial infarction and heart failure
* Genetic heart diseases
* Thrombocytopenias
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
* Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Exclusion Criteria:

* Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Significant liver function test abnormalities or physical symptoms of hepatotoxicity
* Significant infection
* Gastrointestinal intolerance
* Cancer
Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents

The trial studies the efficacy of subcutaneous (SQ) testosterone compared to intramuscular (IM) testosterone therapy during the first 6 months of pubertal induction in transgender male adolescents. Describes rate of adverse effects, masculinizing effects and quality of life while receiving testosterone. Evaluates clinic utilization required for testosterone therapy.

Objectives:

1. Determine the efficacy of SQ testosterone compared to IM testosterone therapy. Hypothesis: SQ testosterone is equally efficacious to IM testosterone in achieving mid-pubertal testosterone levels and masculinizing physical changes in transgender male adolescents after 6 months.
2. Determine the rate of adverse reactions of SQ and IM testosterone during the first 6 months of treatment.

   Hypothesis: SQ testosterone results in equal or fewer adverse reactions than IM testosterone.
3. Evaluate quality of life (QOL) and satisfaction of injection technique for SQ and IM testosterone.

   Hypothesis: Subjects receiving SQ testosterone will report equal or superior quality of life and satisfaction with injection technique compared to IM testosterone as SQ is less painful and easier to administer at home.
4. Evaluate and compare the number of clinical visits required for testosterone injections by transgender male patients receiving SQ and IM therapy.

Hypothesis: Subjects using SQ testosterone will have fewer clinic visits than those using IM testosterone. This may impact healthcare-related costs.

Study Outline:

6 month study consisting of three study visits at baseline, 3 months and 6 months. Optional cross over of injection modality from 6-9 months. At each visit subjects complete blood work and questionnaires to determine testosterone peak and trough levels as well as biochemical adverse effects, quality of life, masculinizing effects and medication experience.

Eligibility Criteria:
Inclusion Criteria:

* Testosterone naive
* Transgender male
* 14-19 years old

Exclusion Criteria:

* Transgender males who have received testosterone therapy in the past
Comparison of Electronic Cigarettes and Tobacco Cigarettes on Cardiovascular Function and Oxidative Stress

Background: Electronic cigarettes (e-cigarettes) are battery-powered devices heating a liquid (e-liquid) composed of propylene glycol and/or vegetable glycerin, and most commonly, nicotine to form an aerosol (vapor) that is inhaled (i.e. "vaped"). Scarce and conflicting data are available regarding the cardiovascular toxicity of e-cigarettes. We wish to determine the acute effects of propylene glycol/vegetable glycerin and nicotine vaporization at high temperature in comparison to tobacco cigarette smoking on several advanced cardiovascular parameters in healthy chronic e-cigarettes users and tobacco smokers. Furthermore, a large range of plasma, urine and respiratory oxidative stress markers will be quantified. By this way, we aim to demonstrate that e-cigarettes-induced systemic oxidative stress could be linked to cardiovascular toxicity. To the best of our knowledge, this is the first project that evaluates the effects of e-cigarettes vaping in comparison to tobacco cigarette smoking on the cardiovascular system in relation to vaporization temperature, nicotine delivery and oxidative stress.

Aims of the study: This study tests the following hypotheses: 1) acute high temperature vaporization of propylene glycol and vegetable glycerin has no deleterious effects on cardiovascular parameters in comparison to tobacco smoking; 2) Tobacco smoking rises plasma and urine oxidative stress biomarkers. On the contrary, acute and chronic e-cigarettes vaping don't rise these biomarkers. At a cellular level, plasma of smokers but not vapers increases superoxide anion production.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Any form of cardiovascular disease
* Any form of pulmonary disease like asthma or COPD
* Any form of systemic or chronic disorder
* Active allergy within 4 weeks of the study
* Symptoms of infection or inflammation within 4 weeks of the study
* Pregnancy
The Effects of Tele-Yoga in Ankylosing Spondylitis Patients

The aim of this study is to investigate the effect of tele-yoga on functional level, disease activity, spinal mobility, balance, aerobic capacity, sleep quality, anxiety, depression, stress, mindfulness and quality of life in patients with ankylosing spondylitis

Yoga is an ancient discipline that emerged in India thousands of years ago, designed to bring balance and health to the physical, mental, emotional and spiritual dimensions of the individual.Due to its therapeutic effects, yoga can be considered as an alternative approach for those with rheumatic disease. Because of Covid-19, which has changed the world and the lifestyle of people, tele-yoga practice can be considered as an alternative instead of traditional face-to-face yoga classes. The use of online platforms provides a good environment for yoga training at home. The aim of this study is to investigate the effects of tele-yoga on functional level, disease activity, spinal mobility, balance, sleep quality, depression, mindfulness and quality of life in patients with ankylosing spondylitis.

60 AS patients who meet the inclusion criteria will be assigned to the tele-yoga or waiting list control group by the block randomization method. Patients in the tele-yoga group will participate in tele-yoga sessions with a maximum of 5 people in each group by video-conference method for 8 weeks, 3 days a week. Assessments will perform just before starting to study and after the 8-week tele-yoga program. Patients in the waiting list control group will be asked to continue their normal physical activities during the 8-week study, not to start a new exercise program, and to report any changes in the drug or dosage used. Control group's assessments will be performed when they are included in the study and at the end of 8 weeks. After these assessments, patients who wish will participate in the tele-yoga program.

Eligibility Criteria:
Inclusion Criteria:

* Ankylosing spondylitis(AS) patients diagnosed according to modified New York criteria
* To be volunteer
* To have the necessary equipment to provide internet access and connection

Exclusion Criteria:

* Presence of systemic, orthopedic neurological or cognitive disease other than ankylosing spondylitis
* Regular exercise in the last 3 months
* Pregnancy
* Not attending 4 consecutive yoga sessions
* Changing the drug during the study
* Has an acute attack during the study
Role of Cryobiopsy in Diagnosis of Pleural Effusion

The purpose of this study is to evaluate the feasibility, size and quality of the specimens obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during medical thoracoscopy in diagnosis of pleural effusion.

* Medical thoracoscopy with single-port-of-entry technique will be performed in the bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg) or pethidin.
* vertical incision will be made with the scalpel (usually near the midaxillary line), through the skin and subcutaneous tissue, appropriate to the size of the trocar to be used, usually of approximately 10 mm, parallel with and in the middle of the selected intercostal space.
* Then the trocar will be inserted until the sudden release of resistance (after passing the costal pleura) is felt.
* Under direct vision with the thoracoscope, introduction of pneumothorax will be performed, and all pleural fluid will be removed, and the pleural cavity will be inspected.
* Suspicious areas will be biopsied through the working channel of the thoracoscope.
* two to six biopsies of a suspicious pleural lesion will establish the diagnosis.

Technique of pleural biopsy using cryotechnique:

* The probe (ERBE Elektromedizin GmbH( Gesellschaft mit beschränkter Haftung) , Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.
* The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch.
* carbon dioxide will be used as the cryogen gas for cryobiopsy
* The frozen tissue is going to be extracted by gently pulling of the probe.
* Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.

Eligibility Criteria:
Inclusion Criteria:

- 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural biopsy using Abram's needle.

3. Age\>18 years old

Exclusion Criteria:

1. Transudative pleural effusion.
2. Exudative pleural effusion less than one third of hemithorax.
3. Presence of hemorrhagic diathesis (prothrombin concentration \<50% and platelet count \<80,000/mm 3).
4. Poor performance state (ECOG performance status \>4) as recommended in BTS (British thoracic society) guidelines 2010.
5. Sever uncontrollable cough, hypercapnia and sever respiratory distress.
6. Fibrothorax, excessive pleural adhesion.

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A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female, aged 10 to below 18 years at the day of randomisation
* HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive)
* Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with:
* stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or
* stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or
* stable dose of basal insulin

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Maturity onset diabetes of the young (MODY)
* Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
Self-management EdUcation and SuPport to Promote PsychOsocial Health Among StRoke Survivors and Informal Caregivers in a VirTual Stroke Community (SUPPORT)

The purpose of this study is to create a virtual stroke community for stroke survivors and informal caregivers of stroke survivors by customizing an existing VE intervention to incorporate real-time, stroke-specific, psychosocial self management education (SME) and social interactions, to test feasibility, acceptability, and usability of the customized intervention for stroke survivors and informal caregivers of stroke survivors and to obtain and explore data to derive evidence-based hypotheses and properly design and conduct a future, larger trial to demonstrate treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Stroke survivors that have experienced an ischemic or hemorrhagic stroke event and their caregivers
* can read, write, and speak English
* are able to provide written consent
* are computer literate (have used a computer for ≥1 month)
* have access to a computer with broadband internet at home
* understand how to use the Internet (accessed the Internet on ≥2 occasions)

Exclusion Criteria:

* reside outside of the home
* Montreal Cognitive Assessment score of \<9 indicating moderate to severe impairment
* Caregivers that provide long-distance care. I
Protection From Pulmonary Embolism With the Permanent OptEase™ Filter (PROOF)

The main objective of this study is to monitor the safety and effectiveness of the OptEase™ Permanent Vena Cava (IVC) Filter


Eligibility Criteria:
Inclusion Criteria:

* · Pulmonary thromboembolism when anticoagulants are contraindicated.

  * Failure of anticoagulant therapy in thromboembolic diseases.
  * Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
  * Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Exclusion Criteria:

* · Patients with risk of septic embolism.

  * Patients with uncontrolled infectious disease.
  * Patients with an IVC diameter \> 30 mm.
  * Patients contraindicated for procedures under fluoroscopy.
  * Patients with demonstrated hypersensitivity to one or more of the components of the OptEase™ filter
Comparison of Modified Post-Anesthetic Discharge Scoring System (PADSS) Between 4 and 24 Hours in Patients Undergoing Laparoscopic Cholecystectomy

This study is compare of Modified Post-Anesthetic Discharge Scoring System (PADSS) between 4 and 24 hours in patients undergoing laparoscopic cholecystectomy


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing laparoscopic cholecystectomy
* 20-60 years old
* American Society of. Anesthesiologist physical status classification I-III

Exclusion Criteria:

* Turn to open cholecystectomy
Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

Eligibility Criteria:
Inclusion Criteria:

Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

Exclusion Criteria:

Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.