cyrilzakka/clinical-trials huggingface dataset:
Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

In this study, which will be performed as a randomized clinical trial, all patients with macular edema with central involvement (central macular thickness greater than 300 μm) and corrected vision less than or equal to 20/40 and better than 20/400 were included in the study. After a thorough eye examination, people are randomly divided into two groups. The first group was treated with intravitreal injection of Bevacizumab in three injections one month apart with receiving oral Acetazolamide tablets of 250 mg twice a day, and the second group was treated with intravitreal injection of Bevacizumab for three Loads are spaced one month apart. Ophthalmologic examinations and corrected visual acuity, as well as macular thickness examination, are repeated with Spectral-domain Optical coherence tomography (SD-OCT) at the beginning of treatment and at the end of the first, second, and third months. At the end of the study, the rate of changes in visual acuity and macular thickness in the eyes in the two groups will be compared and will be statistically analyzed.


Eligibility Criteria:
Inclusion Criteria:

* 20 / 400≤ Best Corrected Visual Acuity ≤20 / 40
* Central macular thickness \<300 μm
* The onset of the disease is less than three years
* No other eye diseases that affect the evaluation and process of this study.

Exclusion Criteria:

* It is not possible to provide informed consent.
* Patients who are prohibited from taking oral acetazolamide (renal failure, hepatic failure, history of allergies)
* Other eye diseases that affect the evaluation and process of this study. Including diabetes retinopathy
* History of retinal laser photocoagulation
Acute Effects of Leg Heating on Skeletal Muscle Blood Flow

The purpose of this study is to apply local heat to the legs, thighs and buttocks of patients with peripheral arterial disease and use PET/CT imaging with an injectable stable radiotracer to study direct measurement of blood flow in the legs pre and post heat treatment.

Cilostazol is the only effective medication available to treat walking pain (intermittent claudication) and it has multiple side effects. Overall improvement in walking performance in patients who use cilostazol is small. Endovascular and surgical interventions are effective alternatives for patients who don't respond to medical therapy, however, these procedures are costly and only applicable to patients with certain lesions types and carry a high risk of restenosis.

Heat therapy (HT) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. The objective of this study is to test the hypothesis that a single session of heat therapy will increase local muscle tissue blood flow in the calf of patients with PAD as assessed by PET/CT imaging of generator-based 62Cu-ETS.

Subjects who have met inclusion criteria will volunteer for a single experimental visit. Participants will wear the water circulating pants and asked to rest supine for 30 minutes inside the scanner. Water at 43 degrees C will be perfused through the pants for 90 minutes with the goal to increase skin temperature in the calf to 39 degrees C. IV injections of 62Cu-ETS and subsequent perfusion imaging will be performed at the end of the 30 minute baseline period, after 45 minutes of heat therapy and at the end of the intervention (90 minutes). Due to the short half life of 62Cu, radioactivity from the prior administrations will not interfere with acquisition of a subsequent PET scan at this timing interval.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with a stable symptomatic claudication for \>/= 6 months
* Ankle brachial index \< 0.9

Exclusion Criteria:

* Uncontrolled diabetes
* Heart failure
* COPD
* Critical limb ischemia
* Prior amputation
* Exercise-limiting co-morbidity
* Recent (\< 3 months) intra-inguinal revascularization or planned in study period
* Plans to change medical therapy during duration of study
* Active cancer
* Chronic kidney disease (eGFR \< 30)
* HIV positive, active HBV or HCV disease
* Presence of an clinical condition that makes the patient not suitable to participate in the trial
* Peripheral neuropathy, numbness or paresthesia in the legs
* Morbid obesity BMI \> 36 or unable to fit into water-circulating pants
* Open wounds or ulcers on the extremity
* Claustrophobia/unable to tolerate PET/CT scanning
* Women of child-bearing age
Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.

Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 years of age
* Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months
* Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed
* If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment
* Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

* Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab
* Subject has a history of acute inflammatory joint disease of different origin other than RA
* Subject has been treated with any investigational biologic agents
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
An Open Label Study for Participants With Rheumatoid Arthritis

The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

Week 16 non-responders (NR) are participants with \<20% improvement from baseline in both tender and swollen joint counts when assessed at Week 16 of Studies BCDO, BCDV and BCDM.

Eligibility Criteria:
Inclusion Criteria:

* Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
* Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion Criteria:

* Current presence of a serious disorder or illness
Prevention of Photoparoxysmal Abnormalities by Mozart K448

The purpose of this clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. by specific music) can result in significant reductions, or even complete termination of epileptiform activity and/or seizures across a broad range of individuals with epilepsy. A hypothesis is generated that specific music activation would beneficially effect photoparoxysmal based epileptiform abnormalities.

Non-pharmacologic, non-surgical treatments for seizures and epilepsy are of increasing importance, given the potential side effects as well as lack of complete seizure control with such treatments. Based on previous studies demonstrating an anti-convulsant and anti-epileptiform effect achieved in subjects by music exposure, it is proposed that specific musical stimuli may causally result in widely distributed cortical activation in such a fashion as to effectively prevent or terminate epileptiform abnormalities in subjects with photosensitive epilepsy. We will investigate the effect of specific musical stimulation (Mozart K448) to reduce or prevent photoparoxysmal abnormalities in subjects.

Primary outcome will be evaluated in 3 groups, assessing alteration/cessation of photic-induced abnormalities during:

1. Treatment: music exposure to Mozart K448, vs.
2. Placebo: music exposure to Beethoven's Für Elise for piano, vs.
3. Control: no music exposure.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-17 years, inclusive
* Female or male with photoparoxysmal epilepsy clinical history, and at least one seizure, as defined by the International League Against Epilepsy (International Classification of Epilepsies and Epileptic Syndromes; Commission on Classification and Terminology of the International League Against Epilepsy 1989)
* Abnormal EEG consistent with features of photoparoxysmal epilepsy: occipital based epileptiform abnormalities with otherwise normal background interictal EEG;
* On \< or equal to 2 anti-seizure medications \[range 0-2 AEDs\]

Exclusion Criteria:

* History of a generalized convulsion provoked by photic stimulation;
* Inability to complete and/or comply with study protocol
CoreValve Advance International Post Market Study

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe aortic valve stenosis requiring treatment
* Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context
* Patient is above the minimum age as required by local regulations to be participating in a clinical study
* The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")

Exclusion Criteria:

* Currently participating in another trial
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Pregnancy
Adapted Physical Activity Program After Sleeve Gastrectomy

This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only

This study will assess prospectively and objectively the potential benefits of a personalized and specific rehabilitation program designed for patients who undergone sleeve gastrectomy. This strategy will help to reduce fat mass and to limit lean mass loss, in order to prevent in the short term the overweight recurrence. Also,the improvement of physical and metabolic status is expected.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 kg/m² or BMI\>35kg/m² with comorbidities qualifying for bariatric surgery
* Stable obesity or obesity evolving for more than 5 years
* Patient cleared by the surgeon for sleeve gastrectomy one month before recruitment
* Absence of contraindication for a sub-maximal stress test
* Performance of a polysomnography before surgery
* Signed informed consent
* Patient benefiting from Health Care Coverage

Exclusion Criteria:

* Absence of preliminary and regular medical check-ups mandatory before sleeve gastrectomy
* Anticipated difficulty for patient follow-up
* Mental diseases (psychosis, depression, suicidal behavior or history)
* Eating disorders
* Lack of informed consent or cooperation
* Unsufficient patient commitment
* Patient under judiciary protection
* Patient not able to comply with any or all the research procedures over time including physical activity
* Patient excluded from the french database of volunteers for clinical trials
Bumblebee Breath Effect on Tinnitus in Older Patients

Tinnitus is a condition in which the person hears sound, which isn't coming from the external environment, often, described as ringing in the ears.

Patients describe the condition as an annoyance and disturbance and in turn this correlates with increased levels of anxiety and depression. Currently, there is no single effective treatment for tinnitus so research continues to look for new ways to treat and manage the condition.

Bumblebee Breath starts by finding a relaxed, supported posture, either laying supine or in seated and then bringing the minds attention to the space between the eyebrows (or third eye in yoga terms). With the eyes close the thumbs are placed over the tragus of the ears, the first finger gently rests on eye lids, middle finger touches the sides of the nose and then the index and pinkie rest just above and below the closed lips. Next, a sound is created by inhaling deeply through the nose and exhaling with a low-pitched humming sound. The result sounds very much like a bee buzzing to the person performing the breath and a sensation of vibration is experienced inside the head and over the face. this study is designed to assess Bumblebee Breath on tinnitus.

two groups (28 for each) will included. One tinnitus group will receive half an hour of Bumblebee Breath training (daily) for one month. The second one will receive nothing

Eligibility Criteria:
Inclusion Criteria:

* elderly males and females
* Tinnitus complaints

Exclusion Criteria:

* cardio(respiratory) symptoms, any local (within ear) problem(s).
Resistance Training in Cardiovascular Disease Patients

In this study coronary artery disease patients and patients with heart failure will be randomly assigned to three training groups: combined aerobic interval training with high intensity resistance training, combined aerobic interval training with low intensity resistance training and aerobic interval training.

Exercise-based cardiac rehabilitation programmes have predominantly used aerobic-dynamic exercise modalities, whereas resistance training have been discouraged in patients with cardiovascular disease, due to safety concerns related to cardiovascular response (heart rate and blood pressure) during the exertion. Contrary to such concerns, recent hemodynamic studies have reported lower blood pressure and heart rate during higher intensity resistance training (\>70 % 1-RM) compared to lower intensity resistance training (\>40 % 1-RM). Furthermore, the latest meta analysis have demonstrated that combined resistance training with standard aerobic interval training has been superior than aerobic training alone in several aspects of health.

However, there is still huge heterogeneity in training intervention design, also there still lacks studies to further elucidate the effects of high intensity resistance training combined with aerobic training on physical performance (aerobic capacity, muscle strength, balance), body composition, quality of life, morbidity, mortality, etc. Therefore, the aim of this study was to examine the effects of high (70%-80 % 1-RM) versus low loads (30%- 40 % 1-RM) resistance training in combination with aerobic interval cycling (50 % -80% of baseline peak Power output) in coronary artery disease patients and patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Stable patients with documented CAD with clinical event (\>1 month after acute coronary syndrome and/or percutaneous coronary intervention) or coronarography and/or
* Stable Heart Failure patients with documented reduced ejection fraction (\>40-45 %)
* age \>18 years
* NYHA class I-III
* Cardiopulmonary exercise test without ECG abnormalities

Exclusion Criteria:

* Unstable CHD
* Decompensated HF
* Uncontrolled arrhythmias
* Severe and symptomatic aortic stenosis
* Acute myocarditis, endocarditis, or pericarditis
* Aortic dissection
* Marfan syndrome
* Musculoskeletal limitations
Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units

The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.

In spring 2020 four regions of France faced a surge of severe Coronavirus (COVID) patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded ICUs to other French regions and neighbouring countries. The study aims at assessing the impact of these inter-ICU transfers on the short and medium term physical and psychological outcomes in this population of severe COVID 19 patients.

All transferred patients between ICUs outside the origin region are invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (+/-4 days of transfer date). Clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients diagnosed biologically or by imaging
* Admission in ICU between 03/13/2020 and 04/10/2020

Exclusion Criteria:

* none
Biomarkers in Tissue Samples From Patients With High-Risk Wilms Tumor

This research study is studying biomarkers in tissue samples from patients with high-risk Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer.

OBJECTIVES:

I. To assess genomic gains and losses in high risk renal tumors, including up to 80 favorable histology Wilms tumors that relapse (RFHWT), 50 anaplastic Wilms tumors (UHWT), 15 clear cell sarcomas of the kidney (CCSK), and 40 rhabdoid tumors (RT) using a high density genetic platform to survey for recurrent copy number variations and allelic imbalances. II. To define transcription patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform for global gene expression. III. To define DNA methylation patterns within 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using a high throughput platform. IV. To identify genetic mutations involved in the pathogenesis of Wilms tumor, and in the development of relapse and anaplasia through the study of 80 RFHWT, 50 UHWT, 15 CCSK, and 40 RT using next generation sequencing tools.

V. To facilitate the integration of the above databases and allow meaningful access by investigators through the infrastructure provided by TARGET, including its data portal and associated caBIG tool.

OUTLINE: This is a multicenter study.

Archived tumor tissue samples are analyzed for DNA copy number determination, gene expression, DNA methylation, and genomic re-sequencing by array-based methods, including PCR analysis, methylation-specific reverse transcriptase-PCR (RT-PCR), and quantitative RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of high-risk Wilms tumor meeting ≥ 1 of the following criteria:

  * Relapsed disease
  * Anaplastic disease
  * Clear cell sarcomas of the kidney
  * Rhabdoid tumors
* Registered on NWTS-4, NWTS-5 (now COG-Q9401), or participation in AREN03B2 protocols with clinical follow-up \> 3 years
* Banked frozen tumor samples and paired normal DNA available with clinical data points, including the following:

  * Age, race, and gender
  * Stage and reason for stage
  * Tumor weight
  * Associated precursor lesions (rests)
  * Histologic subtype
  * Site and time of recurrence
  * Days of follow-up
  * Time and reasons for death (e.g., tumor, toxicity, infection, or other)
Phase I Study of S64315 Administred Intravenously in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years;
* Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia (APL, French-American British M3 classification):

  * with relapsed or refractory disease without established alternative therapy or
  * secondary to MDS treated at least by hypomethylating agent or
  * \> 65 years not previously treated for AML and who are not candidates for intensive chemotherapy nor candidates for established alternative chemotherapy Or Patients with cytologically confirmed and documented MDS), in relapse or refractory after previous treatment line including at least one hypomethylating agent and have ≥10% bone marrow blasts;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Circulating white blood cells \< 10\^9 /L (with or without use of hydroxycarbamide).
* Adequate renal function defined as:

  • Serum creatinine ≤ 1.5 x ULN (upper normal limit) or calculated creatinine clearance (determined by MDRD) \> 50 mL/min/1.73m2.
* LDH \< 2 x ULN
* Adequate hepatic function defined as:

  * AST and ALT ≤ 1.5 x ULN
  * Total bilirubin level ≤ 1.5 x ULN, except for patients with known Gilbert's syndrome (confirmed by the UGT1A1 polymorphism analysis), who are excluded if total bilirubin\>3.0 x ULN or direct bilirubin \> 1.5 x ULN
* Serum CK/CPK ≤2.5 x ULN.

Exclusion Criteria:

* Unlikely to cooperate in the study.
* Participant already enrolled in the study who has received at least one S64315 infusion.
* Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
* Participation in another interventional study requiring investigational treatment intake within 2 weeks or at least 5 half-lives (whichever is longer) prior to first dose of S64315 (participation in non-interventional registries or epidemiological studies is allowed).
* Presence of ≥ CTCAE grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.03)
* Unresolved ≥ CTCAE grade 2 diarrhoea or medical conditions associated with chronic diarrhoea (such as irritable bowel syndrome, inflammatory bowel disease)
* Known carriers of HIV antibodies
* Known history of significant liver disease
* Uncontrolled hepatitis B or C infection
* Known active or chronic pancreatitis
* History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.