cyrilzakka/clinical-trials huggingface dataset:
Clonidine - Ropivacaine in Peribulbar Anesthesia

This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine.

The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.

The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* patients who have given written informed consent
* any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia

Exclusion Criteria:

* persons without National Health Insurance
* pregnant or breast-feeding women, patients \< 18, patients who cannot give their consent, patient's refusal of Loco-Regional Anesthesia, patients who cannot remain in dorsal decubitus dorsal for at least 1h
* contra-indication for Loco-Regional Anesthesia
* hypersensitivity to the study drugs (ropivacaine, clonidine), to the corresponding excipients or hypersensitivity to local anaesthetics other than amide-type ropivacaine.
* disorders of periorbital or oculomotor sensitivity, patients with glaucoma, patients with chronic pain and on morphines
* uncontrolled arterial hypertension, clonidine per os at home, arterial hypotension before the intervention (SAP \< 90 mmHg)
* Surgery for diabetic retinopathy, patients with unbalanced diabetes, eye with prior posterior segment surgery
* Contra-indications mentioned on the summary of product characteristics for clonidine (known hypersensitivity to the active ingredients or one of its excipients, Heart rate below 60bpm, severe Bradycardia due to sinoatrial node disease or second or third degree atrioventricular block, Depression, Sultopride).
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria
* Disease duration of \</= 60 months (defined as time from first non-Raynaud phenomenon manifestation)
* \>/= 15 and \</= 40 mRSS units at screening
* Active disease, as defined by protocol
* Uninvolved skin at injection sites
* Negative pregnancy test for a female subject of childbearing potential

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment
* Rheumatic autoimmune disease other than systemic sclerosis
* Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
* Previous treatment with tocilizumab
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Severe cardiopulmonary disease
* Known active current or history of recurrent infections
* Use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol
* As specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the Principal Investigator to pose a significant safety risk to any subject while participating in the study
* Primary or secondary immunodeficiency
The STAPLE International Post-Market Registry

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

The Aptus Endosystems STAPLE International Post-Market Registry is intended to expand the clinical knowledge base by including 'real world' subjects.

All subjects diagnosed with a qualifying AAA suitable for elective endovascular repair, who meet the inclusion/exclusion criteria for the registry, are eligible for enrollment and should be offered informed consent to participate.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 18 years old
2. Patient has given written informed consent
3. Patient has a life expectancy \> 1 year
4. Patient is willing to comply with follow-up evaluations
5. Patient's AAA meets at least one of the following criteria:

   * ≥ 4.5cm in diameter
   * Increased in size by 0.5cm in last 6 months
   * Maximum diameter exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment
   * Saccular aneurysm larger than 3cm in maximal diameter
6. Patient has a proximal aortic neck diameter measured inner wall to inner wall between 19mm and 29mm
7. Patient has a proximal aortic neck length of at least 12mm
8. Patient has a patent iliac or femoral artery that allows endovascular access to the aneurysmal site with 16Fr (5.3mm) or 18Fr (6.0mm) delivery system.
9. Patient has bilateral iliac artery distal fixation site ≥ 10mm in length with an internal diameter between 9mm and 20mm

Exclusion Criteria:

1. Patient is participating in a concurrent clinical study which may confound STAPLE-International Registry results
2. Patient has a symptomatic AAA
3. Patient's AAA has a proximal aortic neck angle that is \> 60 degrees between the infrarenal neck and the long axis of the aneurysm
4. Patient has irregularly-shaped plaque that would inhibit sealing stent apposition
5. Patient has aortic mural pathology that is ≥ 2mm in thickness over ≥ 50% of the circumference of the proximal fixation site
6. Patient has an active, or known history of, bleeding diathesis or hypercoagulable condition
7. Patient has a contraindication to any materials to which he or she will be exposed during the EVAR procedure (i.e., Fortevo Endograft or Heli-FX EndoAnchor System materials, contrast agents)
8. Patient has a genetic connective tissue disorder (e.g., Marfan's or Ehlers-Danloe Syndromes)
Open-label Pilot Study to Assess the Use of Magic Foot™ in the Improvment of Parameters in Subject With Foot Symptoms

This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened . Subjects meeting inclusion criteria will sign informed consent and enrolled. All 30 subjects will be treated with the Magic Foot™.

If there is any significant improvement in ICG or foot symptoms as obtained from self evaluation questionnaire, a further 30 subjects will be enrolled.

This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened and enrolled. Subjects meeting inclusion criteria will sign informed consent. They will undergo a full examination including blood pressure measurement, heart rate and ECG.

A self evaluation questionnaire relating to foot and sleep disorder symptoms will be completed.

A baseline screening ICG will be performed to measure total peripheral resistance CO (Cardiac Output) and SV (Stroke Volume).

ABI will be performed. The investigational product will be used for 30 minutes and ICG will be repeated.

Each subject will be provided with a size appropriate pair of Magic Foot™ to use at home.

Magic Foot™ will be used for thirty minutes daily for 30 days. This will be done at rest in the evening prior to bedtime. A diary to report compliance will be provided to the subjects. The subject will provide the completed diary to the site staff at day 14 and day 30. Subjects will be reassessed at Day 14. Self evaluation questionnaire will be completed. Subjects will continue with daily use of Magic Foot™. Subject will be reassessed at day 30. ICG, ABI (Ankle Bracial Index) and a final self assessment questionnaire will be repeated at day 30.

At the end of the study the Magic Foot™ will remain with the subjects. In consultation with the treating physician a decision will be made whether to continue with treatment or not.

Eligibility Criteria:
Inclusion Criteria:

1. Subject over the age of 18 with Type 1 / Type 2 diabetes or with PVD (Peripheral vascular disease) or ABI \< 0.9 with foot symptoms.
2. Subject able and willing to comply with the requirements of the protocol.
3. Subject able to understand and sign written informed consent to participate in the study.

One or more of the following foot symptoms:

* Pain at rest
* Pain on activity
* Nocturnal feet pain
* Burning sensations
* Loss of sensation
* Cold feet
* Recurrent ulcers , wounds , injuries - longtime to heal

Exclusion Criteria:

1. Active foot infection
2. Open ulcer in shoe area
3. Subjects with unstable or lifethreatening conditions
4. History of malignancy
5. Active Charcot arthropathy
6. Impaired cognitive function -unable to sign informed consent
7. History of drug or alcohol abuse
8. Subject currently enrolled or has not yet completed other investigational device or drug study or subject is receiving other investigational agents.
9. Other conditions based on Principle Investigators judgement
Randomized Study of Velcade-based Regimen With Autologous Stem Cell Transplantation in Newly-diagnosed Myeloma Patients

The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then patients will be randomized into standard group which will receive a single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and the study group which will receive single autologous hematopoietic stem cell transplantation with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone as consolidation.

The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. Newly-diagnosed myeloma patient enrolled will receive 4 cycles of velcade and Dexamethasone as front-line induction therapy. All patients finished the induction therapy will be randomized into standard group and the study group. All patients will mobilized by cyclophosphamide with G-CSF to collect a target of 2x106 CD34+/kg and then undergo autologous stem cell transplantation. For standard group, patients will receive single auto-SCT with standard conditioning of melphalan 200mg/m2. The patients in the study group will receive single auto-SCT with conditioning of melphalan 200mg/m2 added with 4 dose of velcade at 1.0mg/m2 during the transplantation procedure and then followed by 3 more cycles of velcade alone as consolidation.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman between age 18-65 with newly diagnosed Multiple Myeloma for whom stem cell transplantation is considered appropriate
* Measurable serum and/or urinary paraprotein
* European Cooperative Oncology Group performance status 0-3
* Serum bilirubin \< 1.5x the upper limit of normal (ULN) Serum alanine transaminase (ALT)/aspartate transaminase values \< 2.5 x ULN
* Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Woman of child bearing potential
* Non-secretory MM
* Serum creatinine \> 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy
* Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
* Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure
Cardiac Arrest Registry of the Lombardia Region (Lombardia CARe)

The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region with a follow-up up to ten years after the event.

The registry is an observational study which enroll all the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region The follow-up of the patients is at 1 month after the event, 6 month and every year up to five years after the event.

Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest of any etiology in the Lombardia Region

Exclusion Criteria:

* In-hospital cardiac arrest
Study of Stored Tumor Samples in Young Patients With Brain Tumors

This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

The overall objective of this non-therapeutic protocol is to develop and molecularly characterize patient-derived orthotopic xenografts (PDOXs), organoids and in vitro models derived from medulloblastomas, High Grade Neuroepithelial Tumors (HGNET), CNS embryonal tumors, Atypical Teratoid Rhabdoid Tumors (ATRTs), Choroid Plexus Carcinomas (CPCs), ependymomas, and gliomas. The investigators will characterize the genome-wide mutation, expression and epigenetic signatures of these models and compare them with the primary tumors from which they were derived, thus creating a well-characterized and invaluable resource for research on these rare and deadly pediatric brain tumors. This will also provide important insights into intratumoral heterogeneity, and molecular abnormalities that may influence the selective pressures driving evolution, and tumor growth as in PDOXs, organoids or in vitro cultures and define the relationship between these abnormalities and tumor histologic and clinical characteristics. This objective will be achieved by applying state-of-the-art DNA, RNA and epigenome analysis tools to the study of fresh frozen and/or cryopreserved, fixed and cultured tumor cells, PDOXs and organoids. The establishment of patient-derived orthotopic xenografts, organoids and cell cultures from each tumor sample will also allow for in vitro and in vivo analysis of tumor cell growth, signaling and therapeutic response.

Eligibility Criteria:
Inclusion Criteria

* Tumor may be primary, progressive or recurrent CNS tumor including brain and/or spine. All tumor types will be included with a focus on medulloblastoma, HGNET, CNS embryonal tumors, gliomas, ependymoma, CPC and ATRT tumors. Low grade gliomas are currently very challenging to culture and implant but if techniques mature these will also be included. Although rare, patients with ATRT may present with a primary renal and CNS tumor. In these instances samples will be collected from both the kidney and CNS tumor for analysis if available.
* Tumor may be collected at surgery prior to histologic confirmation
* Age less than 40 years at the time of initial diagnosis.
* Enrollment in the current version of the institution's banking protocol

Exclusion Criteria

* Diagnosis of tumor outside the central nervous system.
* Age greater than or equal to 40 years at the time of diagnosis
Impact Evaluation of CyberRwanda: a Digital Health Intervention for Adolescents

This protocol describes an evaluation of the CyberRwanda program, a digital health tool designed with and for adolescents in Rwanda, with a focus on successful futures, broadly, and family planning and reproductive health, more specifically. CyberRwanda is a tablet-based system that provides information on family planning and reproductive health through a set of vignettes. The program also allows users to order and purchase contraceptives, with pick up at nearby participating pharmacies. The program will be implemented in schools in eight districts in Rwanda. The investigators will conduct a 3-arm, cluster, randomized controlled trial to evaluate the impact of CyberRwanda on three primary outcomes: uptake of a contraceptive method, initiation of childbearing, and HIV testing. The investigators will compare two implementation models (facilitated and self-service) to a control arm at the school (cluster) level. The study will enroll 60 schools (20 per arm) and 100 students per school, and follow students for 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Attending a study school at baseline in secondary school levels S1 or S2;
* Between 12 and 19 years of age;
* If \<18 years of age: Assent and parental consent to participate in the study;
* If ≥ 18 years of age, informed consent to participate in the study;
* Willingness to provide valid contact information for study follow-up purposes.

Exclusion Criteria:

-
Food Groups Associated With Anaemia in Pregnant Women

This study investigates the association between locally consumed food items with anemia among pregnant women, in Addis Ababa city, Ethiopia.

Prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda in Ethiopia. Anemia is a significant contributor to poor pregnancy outcomes, including low birth weight and maternal mortality. Anemia is of multiple influences, which in most of the cases include dietary factors. Consumption food items rich in iron and other nutrients involved in red blood cell production promotes optimal hemoglobin level. Dark green leafy vegetables, meat, and beans are some of the food groups reported to be associated with lesser risk of anemia. Studies on the relation of indigenous food items with health outcome are limited in developing countries. For example, teff, consumed only in Ethiopia and parts of Eritrea, is traditionally believed to be protective of anemia because of its high iron content, but Khat chewing, a pervasive social practice in Ethiopia, has been associated with restrictive eating pattern and anemia. In this study, the association of locally consumed food groups with anemia was investigated among pregnant Ethiopian women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Age 18 years and above
* Residence in Addis Ababa city

Exclusion Criteria:

* Serious medical illness
Effect of Resistance Training on Microvascular, Hemodynamic and Physical Parameters in Obese Adolescents

The purpose of this study is to investigate the effect os resistance training on microvascular reactivity, endothelial functions, inflammatory markers, blood pressure, heart rate, body composition and physical fitness in obese adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Tanner pubertal stage of development between three and five
* age between 13 up to 17 years old

Exclusion Criteria:

* presence of chronic diseases (diabetes mellitus, nephropathy and/or hypertension),
* musculoskeletal injury,
* smoking and
* to be in use of any medication.
Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)

This is a prospective, patient blinded, randomized, clinical trial enrolling patients with symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose of this study is to compare two different surgical methods, both of which are already in common use, for the treatment of nasal obstruction in patients with inferior turbinate hypertrophy.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of chronic nasal obstruction with an exam finding of turbinate hypertrophy, with or without septal deviation will be eligible for the study.
* Failed medical treatment
* Have failed medical treatment for at least 1 month, and will be offered surgery
* Patients having Septoplasty at the same time as their turbinate reduction surgery.

Exclusion Criteria:

* Patients who have had previous turbinate reduction surgery will be excluded.
* Patients that have nasal polyps, chronic rhinosinusitis, adenoid hypertrophy, nasal tumors, or any other exam finding that would explain their symptoms of nasal obstruction other than enlarged inferior turbinates with or without septal deviation will be excluded.
* Patients who are diagnosed with purely bony inferior turbinate hypertrophy as discussed below.
* Patients on hormone or anticoagulation therapy and those who have a history of head and neck radiation therapy will be excluded.
* All study candidates will be assessed for external nasal valve collapse via the modified Cottle maneuver, and will be excluded if they exhibit significant external or internal nasal valve collapse as their primary cause of their nasal obstruction.
* All patients will complete the Visual Analog Scale (VAS) on nasal obstruction before and after decongestion at their preoperative visit. Patients that fail to report a score less than 5 after decongestion are likely to have bony rather than soft tissue hypertrophy. In these patients MAIT is unlikely to be an adequate surgical option, and they would derive a greater amount of benefit from SMR. Therefore these patients will be excluded from the study, and offered only SMR.
Ketamine for Multiple Sclerosis Fatigue

The proposed study is a single-center, phase II, randomized, double-blind, parallel-group, active-placebo-controlled trial of intravenous low-dose ketamine in patients with MS fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be a man or woman, 18 to 65 years of age, inclusive.
* Subject must be medically stable based on physical examination, medical history, and vital signs
* Subject must meet McDonald 2017 diagnostic criteria for multiple sclerosis based on the PI review of the medical records
* Subject must complain from fatigue as one of their main symptoms and have a screening MFIS score equal or higher than the cutoff based on gender, age, and education displayed in Table-226
* Subject must be ambulatory (able to walk at least 20 feet using bilateral assistance)
* Subject must have internet and email access and ability to use a computer or tablet or smartphone
* Subjects that are currently taking medication for alleviating fatigue (such as amantadine, modafinil and armodafinil, and amphetamine-like psychostimulants) at Screening are eligible to participate unless the medication is one of the disallowed therapies (Table 3). Subjects taking a fatigue medication at the Screening visit must have been receiving a stable dose for at least four weeks before the Screening visit and be willing to continue the medication at the same dose for the duration of the study.

Exclusion Criteria:

* BDI-II score of more than 29 (indicating severe depression)
* Having a known clear cause for secondary fatigue, such as untreated sleep apnea, untreated hypothyroidism, chronic liver disease, history of moderate to severe anemia (hemoglobin concentration of less than 9 gr/dl in men or less than 8 gr/dl in women).
* Neurodegenerative disorders other than relapsing or progressive MS
* Breastfeeding or pregnant
* History of coronary artery disease or congestive heart failure
* Uncontrolled hypertension at Screening (history of high blood pressure and screening systolic blood pressure \>160 or diastolic blood pressure\>100)
* History of severe liver disease, including cirrhosis
* Terminal medical conditions
* Currently treated for active malignancy
* Alcohol or substance abuse in the past year (except marijuana or other cannabinoids)
* A history of intolerance or allergic or anaphylactic reaction to ketamine or midazolam
* Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI
* History of severe or untreated coronary artery disease or history of congestive heart failure
* History of prior ischemic or hemorrhagic stroke and cerebral vascular aneurysms.
* History of recurrent seizures or epilepsy
* Taking any disallowed therapy(ies), as noted in the protocol.