cyrilzakka/clinical-trials huggingface dataset:
General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

This study compare general anesthesia versus locoregional anesthesia for evacuation of chronic subdural hematoma. Half of participant will be operated under general anesthesia, while the other half will be operated under locoregional anesthesia.

General anesthesia is the most common technique for this surgery. The local anesthesia is less common but it allows to obtain the same surgical result. This last technique being more recent little study compared these two techniques in terms of complications and postoperative consequences.

The investigators will randomize patients into two groups (a general anesthesia group and a locoregional anesthesia group).

General anesthesia provides complete immobility and optimal surgical comfort but is a source of multiple complications, especially in a population of polypathological and polymedicated elderly patients (which is the population affected by chronic subdural hematomas).

Locoregional anesthesia requires special technical training, leads to complete analgesia of the surgical procedure but does not involve complete immobility of the patient, however this technique probably leads to less postoperative complications and allows a more early rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* subdural chronic hematoma uni or bilateral
* Obtaining an oral consent
* french speaker
* affilliation to French social security

Exclusion Criteria:

* Patients agitated or not cooperating, not allowing the realization of a locoregional anesthesia
* Patients with other intracranial lesions
* Patients with underlying neurological pathology with a modified Rankin score greater than 1
* Pregnant or lactating women
* Patients under guardianship / curatorship
A Clinical Trial of Metformin to Decrease Glucocorticoids Side Effects in Patients With Autoimmune Uveitis

This project is designed to evaluating the use of combination therapy of glucocorticoid and metformin to decrease glucocorticoid side effects in participants with autoimmune uveitis.This study also aims to evaluate the anti-inflammatory and immunosuppressive effects of combination therapy.

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All participants were provided with written informed consent and received a thorough explanation of the study design, aims, and the side effect of metformin. This is a multicenter, randomized, controlled clinical trial research. According to 1:1 ratio, all participants are randomly divided into two groups, the metformin group and placebo group.

According to the fasting blood glucose (FBG), triglycerides (TG),total cholesterol (TC) and body mass index (BMI), the investigators compared experimental group with control group to evaluate whether the use of combination therapy of glucocorticoid and metformin decrease glucocorticoid side effects in participants with autoimmune uveitis.

According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, fluorescence fundus angiography (FFA), electroretinogram (ERG) and so on, the investigators evaluate the anti-inflammatory and immunosuppressive effects of metformin in treatment of autoimmune uveitis.

Eligibility Criteria:
Inclusion Criteria:

1. Attending Tianjin Medical University Eye Hospital, ophthalmology department of Peking Union Medical College Hospital, ophthalmology department of Peking University First Hospital and Zhongshan Ophthalmic Center Sun Yat-sen University from January 2018 to January 2022.
2. Chronic and non-infectious autoimmune uveitis with systemic glucocorticoids treatment (Initiation dosage ≥ 1 mg/kg/d or ≥ 50 mg/d).
3. FBG \< 6.1 mmol/L, HbAlc\<6.O%, TC \<6.2 mmol/L(240 mg／d1) and TG \<2.3 mmol/L(200 mg／dl).
4. All genders, age ≥ 18 years old.
5. Ready for systemic glucocorticoids treatment.
6. Willing to follow all study requirements and sign the informed consent.
7. Without history of cancer and serious systemic diseases.

Exclusion Criteria:

1. Participate in other clinical trials within the preceding one years
2. Planning ophthalmologic surgery over the next three months.
3. With other sight-threatening diseases except cataract, such as glaucoma, diabetic retinopathy, retinal detachment, and so on.
4. Taking or will take immunosuppressants which affecting glycometabolism and lipid metabolism except methotrexate,mycophenolate and azathioprine.
5. Any known history of a serious infection (e.g., HIV, hepatitis, pneumonia, syphilis or tuberculosis).
6. Any known history of diabetes mellitus, severe hepatic, renal or heart disease.
7. Any known history of drug addiction, drug abuse and malignant tumor.
8. Presence of a transplanted solid organ.
9. Pregnant women and nursing mothers.
10. Any known history of mental disorders.
Promoting Physical Activity for Persons With Multiple Sclerosis

The purpose of this study was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis.

Evidence from this study shows that both interventions were effective in improving health and physical activity in persons with multiple sclerosis. The results also show that participants may benefit more physically from individualized physical rehabilitation and more mentally from group wellness interventions. Interventions that combine individualized therapeutic exercise with group health education might be most effective for persons with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* A physician-confirmed diagnosis of MS
* Between the ages of 18 to 75 years
* Ability to ambulate 25 meters with or without the use of an adaptive aide

Exclusion Criteria:

* Pregnant
* Cardiovascular disease
* Had fallen more than twice in the past month
* Significant cognitive deficits
FoxBioNet Pilot Project: SAVE (Synuclein Assay Validation Effort)

The overall objective of this study is to compare the performance of available oligomeric and phosphorylated a-synuclein assay in cerebrospinal fluid and blood.

Specific aims to accomplish this objective are:

1. Assess the reliability of oligomeric and phosphorylated a-synuclein concentration between two different oligomeric and three phosphorylated asynuclein assays.
2. Assess the reliability of the oligomeric and phosphorylated a-synuclein concentrations between laboratories
3. Assess the correlation of oligomeric and phosphorylated a-synuclein concentrations between cerebrospinal fluid and blood.

1.2. Secondary Objectives

1. To assess the ability of the network of pilot sites to efficiently conduct a study involving biosample collection for PD research. Efficiency will be assessed using measures of the time taken to meet specific milestones within the study.
2. To assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols.
3. To gauge the willingness of participants to participate in subsequent Fox BioNet studies

Eligibility Criteria:
Inclusion Criteria:

Parkinson's Disease Subjects

* Patients must meet the MDS criteria for Parkinson's disease.
* Disease duration: any
* Male or female age 30 years or older at time of PD diagnosis.

Control Subjects

* Male or female age 30 years or older at Screening.

Exclusion Criteria:

Parkinson's Disease Subjects

* Inability to provide informed consent
* Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.
* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
* Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.

Control Subjects

* Inability to provide informed consent
* Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.
* Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
* Participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans.
* The presence of rest tremor, bradykinesia or rigidity.
* The presence of any other neurological sign that in the opinion of the site investigator raises suspicion for an atypical parkinsonian syndrome (e.g. supranuclear gaze palsy)
Impact of the Characteristics of Acute Renal Failure in Intensive Care on the Long-term Renal Prognosis: Prospective Multicenter Cohort Study

The purpose of this study is to assess the impact of Acute Kidney Injury (AKI) characteristics on long-term renal prognosis in Intensive Care Unit (ICU) patients.

This study will be a multicentre prospective observational study. The MAKE evaluation after different kind of Acute Kidney Injury (MAKI) study will be conducted in 4 Intensive Care Units (ICU) in Clermont-Ferrand, France.

An information form about the study will be given to each ICU patients hospitalized more than 24 hours. This form will be given to their support person if it is not possible. Data during ICU stay related to renal function of patients included in the study will be collected. If available data related to their baseline kidney function (before ICU hospitalisation) will be collected.

The patients will be classified into 3 groups based on the occurrence of AKI and its duration: 1) patients without AKI during their stay, 2) patients who had a transient AKI episode (defined as recovery within 48 hours of onset), and 3) patients who had a persistent AKI episode during their stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are hospitalized for more than 24 hours in ICU will be eligible to participate in the study.

Exclusion Criteria:

* patients who are younger than 18 years,
* those who are pregnant,
* those who have chronic extrarenal epuration before their admission to the ICU,
* those who are admitted for kidney transplantation,
* those under the safeguard of justice, and those who refuse to participate in the study.
Pradaxa or Warfarin for Prevention of Recurrent VTE in Patients With Angiographically Confirmed Acute Massive Pulmonary Embolism undergoIng Endovascular Mechanical Fragmentation and Thrombolytic Therapy

A prospective randomised controlled study to evaluate outcomes of the treatment with pradaxa or warfarin for prevention of recurrent DVT in patients with angiographically confirmed acute massive pulmonary embolism undergoIng endovascular mechanical fragmentation and thrombolytic therapy. \[RE-SPIRE study\]


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \> 18 years
* Angiographically confirmed acute massive pulmonary embolism with involvement of Central pulmonary arteries.
* endovascular mechanical thrombus fragmentation + thrombolytic therapy (using recombinant tissue activator of plasminogen), performed for treatment of the above-mentioned pulmonary embolism in less than 48 hours before randomization. The patient should be randomized no earlier than 24 hours after procedures endovascular mechanical thrombus fragmentation + thrombolytic therapy
* Written informed consent signed by patient.

Exclusion Criteria:

* Signs of hemodynamic instability (i.e. systolic blood pressure \<100 mm Hg.St. or episode of systolic blood pressure fall for ≥40 mm Hg. / or heart rate \> 110 lasting more than 15 min) or need for ventilatory support within 12 hours prior to randomisation.
* The indication for oral anticoagulation, associated with others disease.
* malignant neoplasm of any location
* Contraindications to warfarin or pradaxa according to Russian Instructions for medical use of these drugs
* Indications for concomitant treatment with antiplatelet agents
* Any stroke within 6 months before randomization
* Intracranial hemorrhage in anamnesis
* Active bleeding, bleeding diathesis.
* Clinically significant bleeding within the last 30 days.
* Trauma or extensive surgery within 1 month before randomization or surgery planned in the next 6 months after randomization.
* Intracranial pathology: tumor, arteriovenous fistula or aneurysm.
* Gastrointestinal bleeding in the previous 3 months.
* Gastric ulcer or duodenal ulcer with clinical manifestations or endoscopically identified acute ulcer without signs of scarring during previous 30 days.
* Uncontrolled hypertension (systolic blood pressure\> 180 mm Hg. and / or diastolic blood pressure\> 100 mm.hg in patients receiving antihypertensive drugs).
* Pregnancy, lactation.
* Life expectancy \<6 months.
* Clinically significant liver disease.
* Creatinine clearance (estimated by Cockcroft-Gault) \<30 ml / min.
* hemoglobin level \<90 g/l), thrombocytopenia \<100x10\^9 / L.
* Patients who, in the opinion of the researcher, are not suitable for inclusion in the study, for example, due to the low likelihood of doctor's recommendations following.
* Long-term use of NSAIDs
* Current participation in another clinical study.
* Allergic to contrast substance or radioisotope drugs used in procedures to assess endpoints of the study, which according to researchers, may be a contraindication to the implementation of these research methods.
Erythropoietin in the Prevention of Acute Mountain Sickness

Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.

In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.

However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.

The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.

In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* History of serious illness
* Current smoker or Hemoglobin \>15.5gm/dL
* Uncontrolled hypertension
Psychosocial Support for Pre-operative Pain and Distress

The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking males or females
* 18 years old or older
* patients within the University of Utah Hospital system
* patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery

Exclusion Criteria:

* Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni

The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.

Schistosomiasis remains an important parasitic disease in the tropics, including Kenya. In the absence of a vaccine, the major control strategy is the reduction of morbidity by chemotherapy using Praziquantel. Evidence from laboratory studies and field trials continue to show that schistosome worms have developed reduced susceptibility to Praziquantel. These observations indicate the need for research to monitor the trends in efficacy of praziquantel and the need for research to develop novel antischistosomal drugs. Randomized controlled trials have also shown that Artemisinin derivatives (artesunate, artemether) have antischistosomal activity against S. mansoni, S. haematobium and S. japonicum. We propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of 212 school children infected with S.mansoni in Rarieda district in western Kenya. To do this we will screen about 1000 school children by examination of stool for schistosome eggs. Eligible children will be randomized to receive either artesunate plus sulfamethoxypyrazine-pyrimethamine over 3 days or a single dose of Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction.Our study may provide vital information regarding an alternative treatment for S. mansoni infection in children.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 6 and 15 years old
* Study participants appear healthy at enrollment, as assessed by the study clinician
* Suffering from S. mansoni infection, excreting eggs in stool
* Residing in Uyoma area, near Lake Victoria
* Able to receive oral treatment
* Parent/legal guardian gives informed written consent for the child to participate in the study
* Child assent to participate in study

Exclusion Criteria:

* Weighing more than 50 kg
* Pregnant or lactating at the time of the study
* Presence of infection with Plasmodium falciparum or other Plasmodium spp.
* Presence of severe illness, such as cerebral cysticercosis
* Signs of severe malnutrition (defined as children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
* Hypersensitivity to As, sulfonamides or PZQ.
* Use of another anti-malaria or anti-schistosomal drug during the study, or within 28 days before the administration of treatment.
* Previous participation in this study.
Biochemical Alterations of Stored Erythrocyte Membranes

The investigators will define procoagulant properties of packed red blood cells and investigate whether packed red blood cells from certain donor populations are prone to induce procoagulant states.


Eligibility Criteria:
Inclusion Criteria:

* group 1: healthy female volunteers 18-35 y.o.
* group 2: healthy male volunteers 18-35 y.o.
* group 3: healthy female volunteers 36-60 y.o.
* group 4: healthy male volunteers 36-60 y.o.
* group 5: female volunteers 36-60 y.o., BMI 26-45
* group 6: male volunteers 36-60 y.o., BMI 26-45

Exclusion Criteria:

* age below 18 years
* age above 60 years
Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study

An open, randomized, parallel-group, comparative, multicentre study. Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A or sulphasalazine. Patients enter the study if considered refractory to corticosteroids (prednisolone equivalent ≥10 mg/day) at the time of randomization.

The randomized phase of the study will be followed by an open-label extension (OLE) phase, to follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment with anakinra or one of the study DMARDs or a combination of study drugs for additional 28 weeks.

Product: Kineret (anakinra) Comparative agents: Methotrexate or azathioprine or leflunomide or cyclosporin A or sulphasalazine Protocol title: An open, randomized study treating refractory adult-onset Still's disease with IL-1ra anakinra (Kineret, compared to an established, single anti-rheumatic treatment Target Disease: Adult-onset Still's disease Patients: 23 patients diagnosed with AOSD, living in the four Nordic countries.

Study Objectives: To follow the changes in clinical status and disease activity in patients receiving anakinra, compared to those treated with an established DMARD, in addition to corticosteroids in patients with refractory AOSD. To compare the changes in disease-related parameters (global health, patient's assessment on disease, laboratory values) in the two randomized groups. To assess the safety of anakinra in AOSD. To follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment in AOSD (open phase).

Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with AOSD according to preliminary classification by Yamaguchi (1992).
* Other diseases with similar symptoms must be excluded. Has been exposed to a corticosteroid for ≥2 months prior to randomization for AOSD.
* Needs a prednisolone dose ≥10 mg/day or equivalent, yet unacceptable disease activity determined by the investigator.
* Anti-TNF agents must be discontinued 4 to 8 weeks prior to commencing study medication.

Exclusion Criteria:

* Use of corticosteroids (prednisolone equivalent \<10 mg/day.
* History of recurrent or chronic infection, including:

  * tuberculosis
  * any malignancy
  * any other major chronic inflammatory disease syndrome
  * drug or alcohol abuse
  * known positivity for hepatitis B, C or HIV.
* Use of anti-TNF agents during ≤4 weeks (etanercept) or≤8 weeks (infliximab or adalimumab) prior to randomization.
Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.


Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 years or older
* Undergoing craniotomy for a brain tumor
* Intra-axial tumor location
* Supratentorial tumor location

Exclusion Criteria:

* Documented seizure history or epilepsy diagnosis
* Currently taking an antiepileptic medication
* Unable to take levetiracetam (e.g. allergy, inability to swallow)
* Inability to obtain consent from participant or substitute decision maker prior to surgery
* Renal impairment with eGFR less than 50
* Pregnancy