cyrilzakka/clinical-trials huggingface dataset:
Impact of Virtual Reality Physiotherapy on Multiple Sclerosis Patients

The goal of this clinical trial is to learn if virtual reality combined with conventional physiotherapy intervention works to treat moderate to severe multiple sclerosis persons. The main questions it aims to answer are:

* Does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in motor aspects of patients with multiple sclerosis?
* Does the application of a virtual reality-based program along with conventional physiotherapy produces improvements compared to the application of conventional physiotherapy and placebo virtual reality in cognitive aspects of patients with multiple sclerosis

Researchers will compare a virtual reality-based program along with conventional physiotherapy with a placebo virtual reality to see if virtual reality improve motor and cognitive aspects of multiple sclerosis.

Participants will:

* Visit the clinic twice a week for 10 weeks to receive a 1-hour session of virtual reality and conventional physiotherapy.
* Be assessed using various scales and questionnaires at three different times: at the start of the study, at the end of the treatment, and 4 weeks after the study ends.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with an evolution time of more than two years.
* All patients with Multiple Sclerosis are included according to the Kurtzke Multiple Sclerosis Disability Status Scale (EDSS) (ANNEX II) with a score greater than or equal to 6.5 (Need of two types of support to walk -two canes, walker...- about 20 meters without resting).
* Stable medical treatment for at least six months prior to intervention.
* Absence of cognitive impairment, with ability to understand instructions and to obtain a score equal to or greater than 24 on the Minimental Test.

Exclusion Criteria:

* Diagnosis of another neurological disease or musculoskeletal disorder other than MS.
* Diagnosis of any cardiovascular, respiratory or metabolic disease, or other conditions that may interfere with this study.
* To have suffered an exacerbation or hospitalization in the last 3 months before starting the assessment protocol, nor during the therapeutic intervention process.
* To have received a course of steroids, intravenously or orally, 6 months prior to the start of the assessment protocol and within the intervention period of the study duration.
* Visual disturbances not corrected by ocular devices.
Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of aTTP

The objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in Germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in iTTP-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. The rational is to develop new treatment algorithms that optimize overall patient outcome and reduce treatment cost.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of an acute episode of acquired thrombotic thrombocytopenic purpura
* Treatment with at least one single dose of caplacizumab (10 mg i.v. or s.c.)
* Male or female patients ≥ 18 years of age
* signed written informed consent

Exclusion Criteria:

* Hereditary thrombotic thrombocytopenic purpura
* disability to give informed consent
Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.

The purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Histologically confirmed prostate cancer
* Triptorelin to be initiated in its labelled indication for a planned total duration of at least 12 months; decision to start triptorelin was made voluntarily by the physician as part of routine medical practice, prior to the inclusion in the study
* Ability to understand and complete questionnaire,

Exclusion Criteria:

* Previously received a hormonal therapy during the last 6 months before inclusion,
* Simultaneously participates in a clinical trial.
Sorafenib/Docetaxel Dose Escalation Trial

The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Advanced histological or cytological documentation of cancer
* At least one evaluable lesion
* ECOG Performance Status of 0 or 1
* No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
* Life expectancy of at least 12 weeks
* No previous exposure to docetaxel or sorafenib
* Adequate bone marrow, liver and renal function as assessed by the following:

  * Hemoglobin greater than or equal to 9.0 g/dL
  * Absolute neutrophil count (ANC) greater than or equal to 2,500/mm3
  * Platelet count greater than or equal to 100,000/mm3 Hepatic
  * Total Bilirubin less than or equal to ULN
  * AST, ALT and Alkaline Phosphatase less than 1.5x ULN.
  * PT-INR/PTT less than 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or heparin will be allowed to participate provided that the INR less than 1.5. In addition, these patients must be monitored at appropriate intervals throughout study)
  * Serum creatinine less than or equal to 1.5 x upper limit of normal

Exclusion Criteria:

* Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
* Active clinically serious infections (\> Grade 2 NCI-CTCAE Version 3.0)
* Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
* Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Peripheral neuropathy \> Grade 1
* Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to screening
* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
* Pregnant or breast feeding women
The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation

The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the accuracy of clinician interpretation.


Eligibility Criteria:
Inclusion Criteria:

* Current residents and attending physicians in the University of Utah Department of Anesthesiology who have a range of experience and exposure to thromboelastography

Exclusion Criteria:

* Refusal to consent or no longer an active member of the University of Utah Department of Anesthesiology
Freezie Remedy to Alleviate Morning Sickness

The primary objective of this study is to assess the effectiveness of Lillipops in the improvement of morning sickness symptoms. Secondary objectives are to assess if there are any changes to concurrent symptoms that may intensify NVP, such as metallic taste or gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas), as well as preference for freezie flavours.

Nausea and vomiting of pregnancy (NVP) is the most common medical condition of pregnancy, also known as morning sickness which affects up to 80% of pregnant women. Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger. The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours are chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.

This study hypothesizes that using Lillipops Iced Soothies will reduce the severity of NVP symptoms according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy. In addition, we hypothesize concurrent symptoms that may intensify NVP, such as metallic taste or gastrointestinal disorders (e.g. heartburn, acid reflux, indigestion and gas), will be alleviated. We hypothesize that improvements to NVP and concurrent symptoms will be greater with Lillipop freezies compared to another commercially available freezie.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy between 4 and 12 weeks gestation.
* Pregnant women with NVP, regardless of treatment (if any) for their NVP.
* Provide the signed informed consent form prior to initial interview.
* Able to come in person to Sick Kids or meet at an agreed location.

Exclusion Criteria:

* Gestational age beyond 12 weeks of pregnancy.
* Pregnant women less than 18 years of age.
* Women who are not proficient in the English language.
* Unable to consume any of the ingredients listed in Lillipops or Mr. Freeze freezies due to allergies, medication interactions or other reasons.
* Women refusing to avoid sources of ginger products for the duration of the study.
A Trial Evaluating Vitamin D Normalization on Major Adverse Cardiovascular-Related Events Among Myocardial Infarction Patients

This study evaluates whether achieving 25-hydroxyvitamin D (25\[OH\] Vit D) levels (\>40 ng/mL) among myocardial infarction patients will result in a reduction of cardiovascular-related adverse events. Half of the patients will be randomized to receive standard of care and half will receive clinical management of 25\[OH\] Vit D levels.

Low 25\[OH\] Vit D levels have become a public epidemic with increasing recognition of its widespread insufficiency both in the United States and worldwide. Epidemiologic studies have associated low 25\[OH\] Vit D levels with coronary risk factors and adverse cardiovascular outcomes. However, randomized trials are needed to establish the relevance of 25\[OH\] Vit D status to cardiovascular health. While a few randomized trials have evaluated vitamin D supplementation, none have "treated to target" (i.e., individual dosing so that adequate 25\[OH\] Vit D levels are obtained), but have rather given "blanket" doses regardless of 25\[OH\] Vit D level.

Eligibility Criteria:
Inclusion Criteria:

1. Patients, both male and female, \>18 years old
2. Undergone angiography for a MI (troponin positive \[\>0.04 ng/mL\] and ACS diagnosis) within the past month
3. Receive follow-up care at an Intermountain Healthcare facility
4. Not taking or taking \<1000 IU of vitamin D daily within the last 3 months
5. Willing to provide informed consent and participate in follow-up visits

Exclusion Criteria:

1. Hypersensitivity to vitamin D products
2. History of previous vitamin D supplementation of \>1000 IU daily within the past 3 months (i.e., \>40% of the days during the past 3 months).
3. Systemic disease (including terminal cancer, cirrhosis, end stage COPD, etc) with a reduced (\<12 months) life expectancy
4. Hypercalcemia (calcium levels \>10.6 mg/dL)
5. Subject participation in previous investigational interventional studies within 30 days of the current study.
6. History of psychiatric illness/condition that would interfere with their ability to understand or complete the requirements of the study, a condition that in the opinion of the investigator or their designee places the subject at an unacceptable risk as a participant.
7. Pregnant and/or lactating women and women of child bearing potential who are not using acceptable means of contraception as determined by the clinical investigators.
Ventilation in Cardiac Arrest Resuscitation Study

Out-of-hospital cardiac arrest (OHCA) is a major public health problem, with around 40,000 victims each year in France. Their survival rate remains dramatically low, at less than 10%.

In the event of pre-hospital cardiac arrest, rescuers perform resuscitation techniques using equipment for which they have been trained. They perform cardiopulmonary resuscitation (CPR) by alternating 30 chest compressions with 2 insufflations (30/2) with a manual insufflator bag.

In basic life supports, insufflations should result in chest rise, but guidelines do not specify a precise volume.

Recently, medical devices have been developed that enable precise measurement of ventilatory volumes. In simulation, these devices show hyperventilation in volume and frequency in mannequins. But no clinical study has analyzed insufflator bag ventilation maneuvers in real-life situations on pre-hospital cardiac arrest patients.

The aim of this study is to analyze ventilation parameters in current practice in relation to standards, and the factors influencing the quality of ventilation maneuvers.


Eligibility Criteria:
Inclusion Criteria:

* Out of hospital cardiac arrest with CPR performed by the Firefighters
* Age 18 and over
* BLS team on site before arrival of physician staffed ALS means
* CPR ventilation initially provided with Bag-valve- mask
* Measuring device records ventilatory parameters

Exclusion Criteria:

* trauma related OHCA
* airway obstruction during CPR
* OHCA on hanging
* tracheostomized patient
* obstacle to using the Bag-valve-mask
* CPR time less than 2 minutes
RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases.

The purpose of this study is to assess the outcome of a new bone level tapered implant when inserted either following an immediate placement protocol or an early placement approach and restored with single crowns out of two different ceramic materials adhesively cemented on a titanium bonding base.


Eligibility Criteria:
Inclusion Criteria:

Subjects must require extraction and replacement of a tooth in the maxillary or mandibular anterior or premolar region with an implant reconstruction.

* ≥22 years of age
* Patient in a good general health
* Adequate bone quality and quantity for one-stage implant placement
* Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5)
* Adequate bone height of at least 1mm longer than the length of the study implant
* Capable of providing written informed consent.
* Obtained informed consent from the patient and committed to the study and the required follow-up visits.

Exclusion Criteria:

* Patients with a high lip line / smile line

  * Thin mucosal biotype
  * Anatomically not sufficient bone volume or height at implant site to achieve primary stability of the implant
  * Pronounced esthetic expectations
  * Lack of keratinized mucosa at implant site (\< 2mm oral and buccal)
  * Women of childbearing potential with a positive urine pregnancy test
  * Patients with inadequate oral hygiene or persistent intraoral infection
  * Smokers exceeding 10 cigarettes / day, or equivalent; patients chewing tobacco
  * Severe bruxism or clenching habits
  * Presence a systemic disease or allergy (e.g. conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids, history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.)
  * Presence or history of receiving intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
  * Presence of mucosal diseases (e.g. erosive lichen planus) in the localized area around the study implant
  * Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, leucocyte dysfunction and deficiencies, neoplastic disease requiring the use of radiation or chemotherapy, etc.
  * Patients with alcohol or drug abuse
  * Participation in any other clinical trial (drug or device) less that 30 days before implant insertion
Interaction Between Benralizumab and Basophils in Eosinophilic Asthma

In this study, investigators want to evaluation of the impact of benralizumab (Fasenra®, Astra Zeneca) on different cell populations, including basophils and innate lymphoid cells, and several biomarkers, such as miRNAs, cadena α dek receptor pra la interleukin % (IL5Rα) and soluble IL5Rα in patients with severe eosinophilic asthma. For this, basophil and innate cells type 2 (ILC2) populations will be monitored in different point-time of treatment: 8 week (V1), 6 months (V2) and 1 year (V3) in blood and sputum samples. Also, follow-up IL5Rα expression on a cell surface of eosinophils, basophils and ILC2 from peripheral blood and sputum of patients treated with or or without benralizumab. Determination of IL5Rα levels will be performed by flow cytometry

For this:

1. Investigators will monitor basophil miRNAs changes with benralizumab analyzing miRNAS profile of isolated basophil before and after benralizumab treatment.
2. Also, in vitro characterization of benralizumab effects on functionality of human basophils (isolated from allergic asthmatic patients) and human cell line KU812, measuring apoptosis, activation, degranulation and histamine release will be performed.

Eligibility Criteria:
Inclusion Criteria:

* .It is mandatory that all patients can comprehend the study requirements and provide informed consent for their participation in MEGA.

Group A:

* Adult people (≥ 18 and ≤ 80 years old) with eosinophilic severe asthma requiring high-dose inhaled corticosteroids plus long-acting beta agonists (with or without long-acting muscarinic antagonist or Montelukast or oral corticosteroids)
* Benralizumab treatment approved.

Group B:

.Patients with allergic asthma (prick test or RAST positive).

Exclusion Criteria:

* Patients with continuous OCS treatment
* Patients with Immunosuppressive drugs
* Patients with primary or secondary immune deficiency,
* Patients with chronic or/and concomitant disease, presence of severe systemic disease or cancer,
* Patients with possible infestation by parasites.
* Patients with other acute or chronic active lung disorders Patients with significant psychiatric disorders
* Patients with biological treatment will be excludes for group B
Non-Immunoglobulin E-mediated Food Allergies in Children

Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food protein-induced enteropathy (FPE), food protein-induced allergic proctocolitis (FPIAP), and food protein-induced allergic dysmotility disorders (gastroesophageal reflux disease (GERD), colic and constipation) (FPIMD).

Despite the prevalence and clinical impact of these conditions, the pathogenesis as well as the natural history and the best management of these disorders are still poorly defined. These limitations could be responsible for diagnostic delays and errors, and suboptimal clinical management. We aim to evaluate clinical features, natural course and pathophysiology of non-IgE-GIFA in the pediatric age.


Eligibility Criteria:
Inclusion Criteria:

* subjects aged between 0-14 years
* suggestive history of food allergy

Exclusion Criteria:

* age \>14 years-
* chronic systemic diseases,
* malignancy,
* immunodeficiency,
* infectious diseases,
* autoimmune diseases,
* inflammatory bowel diseases,
* celiac disease,
* metabolic and genetic diseases,
* cystic fibrosis,
* chronic pulmonary diseases,
* gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,
* neurologic and/or neuropsychiatric disorders,
* gastrointestinal tract eosinophilic disorders,
* use of immunomodulating drugs, steroids, pre-pro-synbiotics, antibiotics in the previous 4 months
Feasibility Study of Short-Term Effects of Chiropractic Manipulation on Older Adults With Impaired Balance

To study the effect of chiropractic care and a specific exercise program on balance in older adults.

Fall prevention in older adults is a significant public health issue that all health care providers must address. At this time, chiropractors, the most commonly used complementary and alternative medicine (CAM) practitioners, have not been systematically involved in either interventions for or research related to fall prevention and risk factor reduction. However, it is possible that body-based CAM practitioners such as chiropractors might make important contributions to decreasing fall risk through affecting musculoskeletal function and managing chronic pain, factors which may affect balance, an important risk factor for falls.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 65 or older
2. Able to stand steadily without assistance on one leg for no more than 5 seconds (determined by averaging the time for both legs)
3. Able to attend all scheduled sessions (by self-report.)

Exclusion Criteria:

1. Non-ambulatory (that is, wheelchair bound); this precludes required balance testing; however, potential patients requiring assistive devices such as canes and walkers are not excluded.
2. received chiropractic care, physical therapy or any other manual care procedure within the past three months (by self report)
3. began an exercise program targeting balance and/or lower body strength within past month (by self report)
4. contraindications to CMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications included but are not limited to: unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", ie.e. persons with known cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease
5. absence of indications for CMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for CMT include identification of decreased or increased joint mobility usually accompanied by tenderness and muscle tension and spasm.
6. unable to understand English or Spanish adequately to complete study forms and questionnaires, since for this study we do not have study personnel fluent in other languages.
Quintex® Follow-up After One Year Minimum

Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a Quintex plate for stabilisation


Eligibility Criteria:
Inclusion Criteria:

- all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end 2018 (minimum Follow-up is one year) in the study center

Exclusion Criteria:

* Patient informed consent not signed
* Patients living outside a radius of 80 km around the study center