cyrilzakka/clinical-trials huggingface dataset:
Effect of Sensorimotor Training on Upper Extremity in Parkinson's Patients

There are many factors affecting the upper extremity such as tremor, bradykinesia, rigidity, and postural instability in Parkinson's patients. According to the International Classification of Functioning, Disability and Health (ICF) model, there are restrictions on people's activities and participation in life due to structural and functional disorders affecting the upper extremity in PD.

In PD, integrating and using proprioceptive feedback, sensorimotor integration and peripheral sensory functions are reported to be impaired. Numerous studies show that the main source of motor problems in PD is dysfunction of sensorimotor integration. Since the cervical region contains a dense concentration of proprioceptive organs such as muscle spindles, it plays an important role in providing afferent proprioceptive information for postural control. Therefore, sensorimotor training targeting the cervical region gains importance. In this study, we aim to reduce PD-specific upper extremity disorders and related activity and participation limitations by increasing motor control in the cervical region with sensorimotor training. Patients with Parkinson's disease will be included in the study and randomly divided into 2 groups. While the general physiotherapy program will be applied to the control group, sensorimotor training will be given in addition to the exercise group.


Eligibility Criteria:
Inclusion Criteria:

* Having idiopathic Parkinson's disease over the age of 40
* Meets the diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank
* Hoehn-Yahr Staging \<3
* Mini mental test score of 24 and above
* In the "on" period
* Receiving oral therapy only

Exclusion Criteria:

* Patients receiving device-assisted therapy
* Patients receiving apomorphine therapy
* Patients with mini mental test scores below 24
* Patients who use drugs (antidepressants, etc.) that will affect cognitive functions
* Patients with hearing and speech problems
* Patients with orthopedic, neurological and vestibular problems other than Parkinson's that may prevent them from completing the tests and treatment
Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

The objective of this study was to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke/transient ischemic attack with intracranial atherosclerosis etiology.

In this study, 416 patients with minor strokes or transient ischemic attacks due to symptomatic intracranial atherosclerotic stenosis within one week of the onset of last ischemic symptoms from 20 centers in China were enrolled. The observation group received early submaximal balloon angioplasty, while the control group received only medical therapy. Two groups will be followed up for 1 year to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke / transient ischemic attack with intracranial atherosclerosis etiology.

Eligibility Criteria:
Inclusion Criteria:

1. age range of 30-80 years;
2. symptomatic ICAS (C4-C7 segments of ICA, M1 segment of the MCA, V4 segment of the VA, and BA) with 70%-99% stenosis confirmed by DSA;
3. minor stroke (NIHSS score ≤5) within 1 week of onset or from symptom exacerbation (NIHSS score increased by ≥2 points) or intermediate- to high-risk TIA, defined as ABCD2 score ≥4 within 1 week of the last symptom episode;
4. diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;
5. mRS ≤ 2 before endovascular treatment；
6. no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8)；
7. written informed consent obtained from the patient or legally responsible person.

Exclusion Criteria:

1. allergy to contrast media;
2. non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
3. penetrating branch lesion ipsilateral to the target lesion (infarction caused by penetrating branch occlusion is defined as stenosis of the MCA or BA, but only with simple basal ganglia or brainstem/thalamic infarction);
4. presence of severe stenosis of the extracranial segment on the side of the target lesion;
5. previous endovascular treatment of the ipsilateral vessel;
6. presence of intracranial aneurysms, tumors, and vascular malformations;
7. any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks;
8. presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year;
9. hemoglobin ≤ 100g/L, platelet count ≤ 100×10\^9/L, INR\> 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
10. uncontrollable hypertension: systolic blood pressure \>185 mmHg and/or diastolic blood pressure \>110 mmHg;
11. poor glycemic control (random blood glucose \> 22.2 mmol/L);
12. history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
13. pregnancy or lactation;
14. other conditions that the researchers think make the patient unsuitable for the study.
Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with AMI.

Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves were estimated by Kaplan-Meier method. In addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.

Eligibility Criteria:
Inclusion Criteria:

* Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.

Exclusion Criteria:

* Renal insufficiency defined as serum creatinine \> 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase \> 50 IU/L, alanine aminotransferase \> 50 IU/L and total bilirubin \> 1.2 mg/dl.
Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs

The true incidence and risks of intracranial hemorrhage (ICH) in patients on various antithrombotic treatments remain unknown. Here a nationwide study is conducted to investigate the risk for and incidence rates of ICH in users and non-users of various oral antithrombotic drugs in Norway between 2008 through 2014.

Hopefully, this study will contribute to a more responsible prescription pattern of antithrombotic medications.

The most serious adverse effect of antithrombotic therapy is bleeding. Combinations of antithrombotic agents are now frequently used (e.g. after use of drug eluting stents or after ischemic stroke), and this may lead to an increased frequency of significant bleeding complications. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage (ICH) may have particularly devastating consequences with high morbidity, disability and even mortality rates. Intracerebral hemorrhage (hemorrhagic stroke) is generally associated with a higher risk for death and incurs greater loss of health over a lifetime than ischemic stroke.

This makes antithrombotic therapy a double-edged sword. Although a certain risk for bleeding may be acceptable in the context of even greater protection against ischemic events, it is important to quantify the magnitude of bleeding risk. So far the efficacy and safety profile of antithrombotic agents are generally assessed in randomized controlled trials (RCT). However, extrapolating the results from randomized clinical trials to the general patient population in this context is challenging. Patients who participate in clinical trials are frequently highly selected and therefore somewhat unrepresentative. In addition, their numbers are limited and the treatment period is often much shorter than in routine management of a chronic disease or condition. Finally, patients in clinical trials are often monitored more closely than in routine practice.

The incidence of intracranial hemorrhage due to antithrombotic therapy could theoretically be monitored by post-marketing surveillance by including spontaneously reported events. Unfortunately, it seems this does not provide more reliable estimates. A recent study from Finland has shown that bleeding complications due to oral anticoagulation with Warfarin are underreported in daily clinical practice. Further, it has been shown that reporting rates of side effects following medical therapy tend to decrease over time indicating that it is more likely that adverse events to a newer drug are reported than to a drug that has been available for many years. This is why population-based large-scale pharmaco-epidemiological studies are needed, in which cohorts of patients exposed to antithrombotic medications are monitored to determine a valid and reliable risk of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* hospitalization due to intracranial hemorrhage (ICH)
* residential address in Norway

Exclusion Criteria:

* Traumatic (high-energy) intracranial injury
* Parenteral antithrombotic treatment
* ICH related to tumor or vascular malformation
Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System

The study will be an open label laboratory study with all subjects receiving HFCWO with The Monarch® System

Objective:

Assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume

Methodology:

Subjects will receive HFCWO using The Monarch® System at multiple frequency / intensity combinations on a single visit day. Frequency / intensity combinations will be evaluated to determine which settings produce highest airflow and highest oscillating volume.

The study will be an open-label, laboratory study. All enrolled subjects will receive HFCWO therapy with the Monarch® system. The study will be conducted at one (1) site in the US.

The study will evaluate oscillating airflow and oscillating volume induced during therapy with the Monarch® system. Subjects will also rate the comfort of the therapy. Patients with cystic fibrosis (CF) who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study.

Therapy with the Monarch® system will be delivered using multiple frequency/intensity combination settings. The order of settings will be randomized for each study subject. During therapy oscillating flow and volume measurements will be obtained for each frequency/intensity combination. Following each frequency/intensity combination, subjects will respond to a subjective assessment of the comfort of the therapy by rating the comfort on a visual analogue scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CF (by sweat test and/or genetics
* Age \> 15 years
* Require regular home airway clearance therapy
* Current user of The Monarch® System with a minimum of 4 weeks experience with the device
* Signed informed consent. If patient is a minor, parents/guardians must give written informed consent and patient must give written assent
* Patient must be on a stable regimen of CF medication

Exclusion Criteria:

* History of pneumothorax within the past 6 months prior to study visit
* History of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of \> 100 ml within a 24-hour period within the past 30 days
* History of lobectomy
* Recent chest surgery or chest trauma
* Inability to perform The Monarch® System therapy as directed
* Pregnant or lactating female
* Have a pacemaker or implantable cardioverter defibrillator (ICD)
* Requirement for oral or IV antibiotics that are not part of the subject's usual course of treatment within the past 14 days prior to screening
Neuromodulation for Hypothalamic Obesity

The balance between hunger and satiety is imperative for an individual's survival and overall health.). Without this balance, individuals can become morbidly obese or lack adequate nutrition for survival. Craniopharyngioma (CP) is a benign tumour that occurs at the base of the brain in children. Unfortunately, pediatric neurosurgeons sometimes inadvertently destroy a child's satiety centre during CP tumour removal surgery. This leaves the child with a post-operative complication: an insatiable appetite. This form of obesity is called "hypothalamic obesity". This study is designed to investigate Deep Brain Stimulation for hypothalamic obesity in n=6 young adults who have stabilized tumours.

For young adults with destroyed satiety centres due to childhood CP surgery, we believe directly re-balancing the brain's control of hunger and satiety is necessary for sustained and long-term therapy. n=6 patients will be recruited in this Phase 1 DBS trial. The proposed research will hope to improve personal health among the young adults involved in this study by improving quality of life and avoiding long-term cardiovascular morbidities. Furthermore, this study will elucidate what brain regions drive excessive hunger and develop a treatment that attempts to reverse these abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hypothalamic obesity following craniopharyngioma tumour removal
* Treatment refractory to pharmacological interventions such as growth hormone therapy and anti-obesity medications

Exclusion Criteria:

* Unable to give consent or unmanaged psychiatric condition
The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19

This study will explore how a well-known probiotic strain L. reuteri DSM 17938 impacts SARS-CoV-2 specific antibody response upon and after infection in healthy adults.

After giving their informed consent, the study subjects will complete screening procedures to assess their eligibility for the study (Visit 1). Participants deemed suitable for the study will be randomized into two study arms (placebo, probiotic) before undergoing a baseline visit (Visit 2) before the start of the intervention period. During the 6-month intervention period, the participants will attend study visits at 3 months (Visit 3) into the intervention as well as at the end of intervention (at 6 months, Visit 4). Blood, saliva, and faecal samples will be collected at visits 2-4. In addition to sampling, during the whole intervention period, the participants will fill out a weekly questionnaire in which they are asked to record any possible symptoms of COVID-19. The participants' dietary habits are assessed via a food frequency questionnaire (FFQ) before the start of the intervention period. Also, the participants are asked to maintain their habitual diet and lifestyle as well as not to consume any other probiotic or prebiotic supplements.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age between 18-60

Exclusion Criteria:

1. Previous diagnosis of COVID-19 (by positive PCR) or previous confirmation of seropositivity to SARS-CoV-2
2. Body Mass Index over 35 or under 16
3. Current diagnosis of cancer or ongoing cancer treatment in the last 12 months
4. Diabetes mellitus
5. Cardiovascular disorder in need of pharmaceutical treatment
6. Chronic kidney disease
7. Chronic lung disease with decreased lung capacity
8. Chronic liver disease with liver cirrhosis
9. Current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
10. Chronic neurological/neurodegenerative disease (e.g. Parkinson's disease)
11. Decreased function of the adrenal cortex (e.g. Addison's disease)
12. Autoimmune disease (e.g. rheumatoid arthritis)
13. Chronic pain syndromes (e.g. fibromyalgia)
14. Pregnancy or breast-feeding
15. Immunodeficiency due to disease or ongoing medical treatment
16. Regular intake of anti-inflammatory and/or other immunosuppressive medication within the last 3 months
17. Use of anti-depressants within the last 3 months
18. Antimicrobial treatment within the last 12 weeks before baseline sampling
19. Regular intake of probiotics, as well as nutritional supplements or herb products that might affect intestinal function within the last 4 weeks if the investigator considers that those could affect study outcome
20. Inability to maintain current diet and lifestyle during the study period
21. Alcohol or drug abuse
22. Any clinically significant present or past disease/condition which the investigator considers to possibly interfere with the study outcome or increase the risk for severe form of COVID-19
Assessment of the Psychosocial Sexual Health Competencies of Young Adults Born in France (including Those Whose Parents Were Born Abroad), and Proposal of a Sexual Health Promotion Model Adapted to the Needs Identified.

Every year, between 4,000 and 6,000 people discover their seropositivity to the human immunodeficiency virus (HIV). The dynamics of new discoveries vary according to sexual orientation and birthplace. MSM born in France show the sharpest improvement, while heterosexuals born in France show a more moderate decline, and intravenous drug users (IDUs) are still at a low ebb.

There is little fine-grained data available on a national scale to explain these dynamics among people living with HIV (PLHIV).

The acquisition of Psychosocial Competencies in sexual health is a prerequisite for good sexual health. It is important for all young people, and all the more so for young people from immigrant backgrounds, whom we hypothesize, despite the limited existing literature, to be more vulnerable due to the influence of their origins, their parents' culture or language barrier, or even religion.

The primary research question: What psychosocial skills should be included in a sexual health education program for young people born in France (including those born to migrant parents), to enable them to enjoy good sexual health in adulthood?


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 29 years
* Born in France or its territories,
* Be able to read and write French.

Exclusion Criteria:

* They are under guardianship,
* They refuse to take part in the study.
Calf Muscle Contraction During Walking

Walking is the most familiar form of exercise, the calf muscle plays an important role in the stance phase of the normal gait cycle of gait. The relative contribution of the calf muscle to the total positive work of the lower extremities during walking is approximately 51% and 73% in the elderly and younger people respectively. This study will explore the different types of calf muscle activation during normal gait cycle based on the previous literature and will introduce a new proposition in the biomechanics of calf muscle contraction..Also, this study will address the role of this muscle during gait and the effects of calf muscle weakness on the lumbar spine.

400 patients with a history of calf muscles' weakness throughout the last 3 years will be included in the study. The patients suffered from unresolved CLBP with radiculopathy contralateral to their calf muscle atrophy (i.e., an ipsilateral calf muscle weakness induces contralateral lumbar radiculopathy) that did not respond to physical therapy or any medication for long patients in an out-patient clinic in Egypt (2016 to 2022) are screened for calf muscle weakness secondry to ankle injury. Patients with lumbar disc herniation (confirmed by MRI) and radiculopathy contralateral to the calf muscle weakness are recruited to participate in this study A better understanding of the calf muscle contraction can provide a valuable insight into how the calf muscle works during walking, predict calf muscle injuries and develop specific exercise to enable the patients with calf muscle dysfunction. .................................................................................................................................

Eligibility Criteria:
Inclusion Criteria:

* The patients suffered from unresolved CLBP with radiculopathy contralateral to their calf muscle atrophy (i.e., an ipsilateral calf muscle weakness induces contralateral lumbar radiculopathy) that did not respond to physical therapy or any medication for long

Exclusion Criteria:

* any spinal deformity or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness
Sepantronium Bromide for the Treatment of High-grade B-cell Lymphoma

This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma

This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL.

Cohorts of three patients will be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.

Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.

An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma
* Relapse or refractory disease after at least one previous line of therapy
* Measurable disease as defined by 2014 Lugano classification
* ECOG performance status of 0-2
* Acceptable coagulation parameters

Exclusion Criteria:

* Allogeneic transplant within 3 months
* Autologous transplant without resolution of post-transplant cytopenias
* Known CNS involvement
* Average QT/QTc interval duration \> 450 msec
* Inadequate marrow, hepatic or renal function
* Unresolved Grade 2 or greater toxicities from prior anticancer therapy
* Radiotherapy within prior 4 weeks
* Requires systemic immunosuppressive therapy
* Positive for Hepatis B or Hepatis C
* Seropositive for HIV