cyrilzakka/clinical-trials huggingface dataset:
Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.

The goal of this study is to compare the effectiveness and safety of two hemoglobin F inducer. This is single centered interventional pilot study is to compare the efficacy and safety parameters in beta thalassemia patients. As this is a pilot study, the investigator took a small number of patients. The Sample size was calculated by the World health organization sample size calculator. After screening 39 patients and 24 patients were eligible for enrollment in this study.

The main objective was to evaluate safety of both drugs in genetic disorder like thalassemia. for safety evaluation, hematological parameters were evaluated that includes total bilirubin , indirect bilirubin, Serum Glutamate Pyruvate Transaminase, serum glutamic-oxaloacetic transaminase, urea, creatinine and lactate dehydrogenase were monitored . Moreover to evaluate the efficacy of drug, hematological parameters that includes hemoglobin, red blood cells , nucleated red blood cells , reticulocytes count, Red blood cells indices ( mean corpuscular hemoglobin, mean corpuscular volume and mean corpuscular hemoglobin concentration) , white blood cells and platelets were done. Another important parameters to evaluate the efficacy of hemoglobin F inducer is transfusion frequency.

Test were done at baseline and after completion of study means after 06 months.


Eligibility Criteria:
Inclusion Criteria:

* Know case of beta thalassemia age between 10-30 years

Exclusion Criteria:

* Patients on any other haemoglobin F inducer or erythropoietin.
* Patients with co-morbidities like cardiopulmonary and neurological disease
* Pregnant, lactating women.
* Patient did not willing to take contraceptive measures.
* Participants with history of thrombosis.
Helmet Continuous Positive Airway Pressure (CPAP) Versus Oxygen Venturi in Severe Acute Respiratory Failure in Pneumonia

The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of achievement of criteria for endotracheal intubation during severe acute respiratory failure caused by pneumonia

Pneumonia is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up to 30%.

Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration by Venturi mask for the treatment of severe acute respiratory failure in patients with pneumonia. .

Eligibility Criteria:
Inclusion Criteria:

* men and women of any ethnic group;
* age ≥18 years;
* dyspnoea at rest with respiratory rate (RR) ≥30 breath/min or sign of respiratory distress
* PaO2/FiO2 ratio≤250 evaluated during oxygen therapy supplied at least 1 hour through a Venturi mask with FiO2 ≥0,50
* diagnosis of pneumonia as unique cause of severe acute respiratory failure
* informed consent from each patient or from the closest relative in case of the patient's incapacity to give it

Exclusion Criteria:

* diagnosis of other causes of severe acute respiratory failure
* unstable angina or acute myocardial infarction;
* acute respiratory acidosis with pH \<7,35 and PaCO2 \>45 mmHg;
* systolic BP \<90 mmHg despite fluid resuscitation or vasopressors;
* severe arrhythmias;
* convulsions;
* degree of consciousness, Kelly score\>3;
* swallowing disturbance with increasing risk of aspiration pneumonia;
* inability to protect the airway;
* recent facial trauma or burn;
* non-collaborative patient;
* presence of open wounds (head, thorax, abdomen);
* respiratory arrest or need of intubation;
* pregnancy or suspect of pregnancy
Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency

The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletal Class II relationship (ANB \> 4°).
2. Mandibular retrognathy (SNB \< 78°).
3. Overjet ≥ 5 mm.
4. Minimal crowding in dental arches (≤4 mm).
5. Class II molar relation.
6. Growing female patients.
7. Patients with CMV3 maturation stage of the cervical verbrae.

Exclusion Criteria:

1. No history of orthodontic treatment either prior to or during functional Appliance therapy.
2. Posterior cross bites or severe maxillary transverse deficiency.
3. Severe facial asymmetry determined by clinical or radiographical examination.
4. Poor oral hygiene.
5. Systemic diseases that may affect the orthodontic treatment results.
6. Patients past their peak growth spurt.
Proper Extent of Maze Intercaval Lesion

It's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible could be entered into the study if they meet the inclusion/exclusion requirements.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years male or female
* Scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
* Subjects willing and able to provide written informed consent

Exclusion Criteria:

* Subjects receiving surgery with non-sternotomy access
* Presence of or history of transvenous pacing leads
* Subjects receiving a re-do cardiac surgery
* Subjects with a history of pericarditis
* Subjects who are in atrial fibrillation or atrial flutter and cannot be converted out of it.
* Any medical condition or finding for which the Investigator used medical discretion to determine the subject should be excluded
* Subject is currently participating in another clinical trial.
* Subject is unable to provide written informed consent.
A Randomized, Double-Blind, Active Control Trial Comparing Effects of Telmisartan, Candesartan and Amlodipine, Alone or Plus Metformin, on Non-Diabetic, Obese Hypertensive Patients

The epidemic of obesity is associated with a considerable rise in the incidence of the metabolic syndrome, type 2 diabetes mellitus, and hypertension. Insulin resistance plays an important role in the pathogenesis of obesity related hypertension. These patients are at high risk to suffer from cardiovascular events. However, current guidelines for treatment of hypertension do not provide specific recommendation for the pharmacotherapy of obese hypertensive patients due to lack of prospective randomized intervention studies in non-diabetic obese hypertensive patients.

Aside from their antihypertensive effects, angiotensin II receptor blockers (ARB) were shown to improve insulin sensitivity. Furthermore, metformin is commonly used to treat the obese type 2 diabetes mellitus. Metformin can also lower body weight and increase insulin sensitivity. In a prospective, double-blind, double-dummy, randomized, parallel-group study, we will evaluate the effects of ARB (telmisartan and candesartan) or amlodipine combination with metformin on weight gain, visceral fat, and metabolic parameters in obese hypertensive patients without diabetes mellitus compared with obese hypertensives on ARB or amlodipine treatment alone. This study will help to develop future comprehensive treatment strategies and guidelines for obesity related hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Grade 1 or 2 hypertension: 140mmHg≤SBP\<180mmHg, and/or 90mmHg≤DBP\<110mmHg
* Waist circumference higher than 90cm in men, 80cm in women

Exclusion Criteria:

* Diabetes
* Grade 3 hypertension: SBP≥180mmHg, or DBP≥110mmHg
* known allergy or hypersensitivity to trial drugs
* Myocardial infarction or cerebrovascular accident in the year preceding the trial
* Clinical Congestive Heart Failure
* History of hepatitis or cirrhosis
* History of kidney disease
Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)

The purpose of this study is to understand how to prevent COVID-19 spread in a school like the Mary Cariola Center (MCC) in Rochester, NY by answering questions like these: how do activities in the school alter chances of infection? Are there people infected with the COVID-19 virus who have no symptoms? How is spread of COVID-19 affected by vaccination rates? Is there any hesitancy to get the vaccine and what are the reasons? This information will be used to help keep the school open and the students and staff safe.

Eligible participants are those that work at the Mary Cariola Center (MCC) and interact with the students at MCC who have a high risk of infection from COVID-19.

The study lasts for up to 16 months.


Eligibility Criteria:
Inclusion Criteria:

Students:

* IDD Student of the Mary Cariola Center
* Age 3 - 18
* Have a parent/guardian who can give informed consent
* In the judgement of the Mary Cariola Medical Staff will be able to safely participate in the study procedures (nasal swab, phlebotomy)

Staff

* Age 18 - 72
* Able give informed consent
* Anticipated duration of remaining employment less than 1 month (e.g. retiring)
* Must be willing to participate in RT-PCR and antibody testing

Exclusion Criteria:

Students

* Contraindication to nasal swab
* Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)

Staff

* Contraindication to nasal swab
* Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL

The goal of this clinical trial is to determine effect of arginine and glutamine on outcome of COVID-19 patients. The main questions it aims to answer are:

-to test the effect of oral nutritional supplements containing arginine and glutamine on covid-19 patients outcome Dr. M. Djamil General Hospital Padang

Participants will given ONS containing arginine and glutamine. Researchers will compare intervention group with control group to see if ONS affected outcome of COVID-19 patients


Eligibility Criteria:
Inclusion Criteria:

* Patients confirmed positive for COVID-19
* Age over 17 years
* The patient can take food orally

Exclusion Criteria:

* Patients with restricted fluid intake
* Patients who cannot take food orally
* suffering from diabetes mellitus and kidney failure
Prognostic Factors in Epiretinal Membrane Surgery

Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected visual acuity appeared to be reliable prognostic factors. Combining these factors with analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical coherence tomography provides a predictive score to estimate individual chances of good visual recovery


Eligibility Criteria:
Inclusion Criteria:

* symptomatic idiopathic epiretinal membrane operated on between April 2009 and September 2012 at the university hospital of Dijon, France.
* All patients signed informed consent for the surgical procedure.

Exclusion Criteria:

* Patients were excluded if they presented any cause of secondary epiretinal membrane (including diabetic retinopathy, vein occlusion, ocular inflammation, retinal detachment, or previously vitrectomized eye), high myopia (axial length ≥ 26 mm or spherical equivalent ≥ 6 diopters), severe media opacities with weak SD-OCT signal strengths, or any macular or optic nerve disease. Patients with a follow-up of less than 12 months were excluded and only one eye was included in those with bilateral epiretinal membranes.
Glymphatic MRI Study

This study aims at identifying neuroimaging markers of glymphatic function in humans.


Eligibility Criteria:
Inclusion Criteria:

* Ability to undergo MRI without anesthesia
* Calculated GFR greater or equal to 60 mL/min/1.73 m2

Exclusion Criteria:

* Inability to obtain consent
* Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant
* Known allergic or hypersensitivity reactions to gadolinium
* Three or more drug allergies from separate drug classes
* Recent or expected beed for imaging with iodinated contrast
* Contraindications to MRI: claustrophobia, weight greater than maximum MRI scanner capacity, presence of metallic foreign body, or implanted devices not documented as MRI safe
* History of neurosurgical procedure or cervical surgery
* Current use of anticoagulation medications
* Contraindication to lumbar puncture (creatinine or INR elevated above laboratory standard cutoffs)
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.

Subjects will be followed per Institution's standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be ≥ 18 years of age and ≤80 years of age
2. Subject must have an intracranial aneurysm (IA),
3. Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
4. For ruptured aneurysm, Subject with Hunt \& Hess Score ≤ III

Exclusion Criteria:

1. Subject has an IA with characteristics unsuitable for endovascular treatment
2. Subject's index IA was previously treated
3. Subject has stroke-in-evolution within the prior 30 days
4. An additional aneurysm must be treated during the procedure
Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer

Simultaneous radiotherapy followed by adjuvant immunotherapy is the standard treatment modality of unresectable stage III NSCLC. Our preliminary study confirmed that the treatment of CTV-omitted IMRT regimen did not compromise the PFS or OS and significantly reduced the incidence of severe radiation pneumonia and radiation esophagitis.

The purpose of this study was to observe the role of radiotherapy modalities that omit CTV in the context of immunotherapy for NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* •Patients with advanced (Stage IIIA or IIIB AJCC 7) NSCLC that was histologically or cytologically inoperable

  * ECOG whole body status (performancestatus,PS) level 0 or 1
  * The estimated survival time is more than 12 weeks, 18 \~80 years old
  * Laboratory results within 2 weeks prior to radiotherapy met the following criteria: ① Neutrophil count \> 1,500/ MCL Heathko-Pilot Oncology Research Fund; ② Platelet \> 50,000/ MCL; ③ Total bilirubin \< 1.5 times of the normal upper limit value; ④AST(SGOT)/ALT(SGPT) \< 2.5 times of the normal upper limit; ⑤ Serum creatinine \< 1.5 times of the normal upper limit value; ⑥ The results of coagulation function examination were within the normal range
  * Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy tests (serum or urine) within 7 days before admission, and the results are negative, and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug
  * Understand and voluntarily sign written informed consent
  * The investigator judged that the patient had good compliance

Exclusion Criteria:

* Malignant pleural/pericardial effusions, previous thoracic radiotherapy or chemotherapy
* Uncontrolled concurrent diseases, including but not limited to symptomatic congestive heart failure, unstable angina pectoris and myocardial infarction, uncontrolled grade III hypertension, liver insufficiency, renal insufficiency, uncontrolled diabetic blood sugar, arrhythmia, mental illness or social condition, etc.
* Pregnant or nursing women
* The patient has no history of intracranial hemorrhage or spinal cord hemorrhage
* HIV-positive patients receiving combination antiretroviral therapy
* Active tuberculosis
* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Prior allogeneic stem cell or solid organ transplantation
* Researchers determine other conditions that may affect the conduct of clinical studies and the determination of their findings
Evaluation of the Ulthera System for the Treatment of the Decolletage

This is prospective, multi-center clinical trial. Enrolled subjects will receive one Ulthera® treatment on the decolletage. Follow-up visits will occur at 90 and 180 days following treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Female, aged 35 to 70 years.
* Subject in good health.
* Moderate to severe skin lines and wrinkles on the décolletage; grade of ≥4 on a chest wrinkle scale.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements.
* Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating.
* Absence of physical conditions unacceptable to the investigator.
* Willingness and ability to provide written consent for study-required photography.
* Willingness and ability to provide written informed consent.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in areas to be treated.
* Tattoos in the areas to be treated.
* Patients with ports or defibrillators.
* Any open wounds or lesions in the area.
* Active and severe inflammatory acne in the region to be treated.
* Patients who have a history with keloid formation or hypertrophic scarring.
* Inability to understand the protocol or to give informed consent.
* Retinoid, microdermabrasion, or prescription level glycolic acid treatments to the décolletage area within two weeks prior to study participation or during the study.
* Marked décolletage asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
* History of chronic drug or alcohol abuse.
* History of autoimmune disease.
* Concurrent therapy that would interfere with the evaluation of the safety or effectiveness of the study device.
* Subjects who anticipate the need for surgery or overnight hospitalization during the study.
* Subjects who have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
* Concurrent enrollment in any study involving the use of investigational devices or drugs.
* Current smoker or history of smoking in the last one year.
* History of using the following prescription medications:

  1. Topical Retinoids to the area within the past two weeks;
  2. Antiplatelet agents/anticoagulants (Coumadin, Heparin, Plavix).
  3. Psychiatric drugs that would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Clinical Effectiveness Of High Frequency Chest Wall Oscillation (HFCWO) In A Bronchiectasis Population

The primary objective is to compare the patient's baseline QoL prior to HFCWO use against the patient's QoL at various study timepoints over a one-year period of HFCWO use.

This study will use a prospective interventional comparative study design using the patient's quality of life (QoL) as the primary study endpoint to determine HFCWO affect. The study will compare the patient's QoL baseline (established at enrollment prior to HFCWO treatment) to the QoL measured at various timepoints (enrollment, 2 months, 6 months and 12 months) over a one-year period whilst receiving HFCWO treatment. In addition, a baseline for the secondary endpoints will established at enrollment for comparison to measurements taken at various timepoints over a one-year period whilst receiving HFCWO treatment. The patient's medical records will be used to establish prior histories of exacerbation rates for comparison to exacerbation rates experienced after one year of HFCWO treatment. Patients will serve as their own control.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Previous diagnosis of bronchiectasis confirmed by HRCT within the last 6 months
3. Patients must have at least 6 months of medical records related to bronchiectasis
4. Patients must be stable and currently on a standard of care regimen for bronchiectasis such as hypertonic saline and/or PEP
5. Patients with 1 or more exacerbations within the last 12 months
6. Previous and existing productive cough
7. No previous HFCWO use

Exclusion Criteria:

1. Patients who are known to have cystic fibrosis
2. Patients who are known to have primary ciliary dyskinesia (PCD)
3. Patients with chronic obstructive pulmonary disease (COPD) without bronchiectasis
4. Patients breathing via an artificial airway
5. Severe bronchospasm based on exam or history
6. Any comorbidity(ies) or contraindications that would normally complicate tolerating HFCWO treatment