cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality for Fibromyalgia

Fibromyalgia is a frequent chronic pain syndrome almost often affecting women and associating diffuse chronic musculoskeletal pain (for more than 3 months), fatigue and sleep disturbances. Other varied functional symptoms are associated with it, in particular cognitive disorders and a feeling of unrested awakening.

Technological advances in virtual reality have led to recognition by the medical community as a way to improve pain and quality of life for patients.

There is a growing body of evidence supporting the use of virtual reality as an adjunct therapy to reduce acute pain in patients during medical procedures in hospital settings. There may also be a role for virtual reality in patients with chronic pain.

Current treatments for fibromyalgia (FM) include pharmaceutical pain medications as well as psychological programs with components of cognitive therapy, and activity management. However, pain medications are not fully effective, can be addictive, and can cause hyperalgesia. Non-pharmacological treatments for chronic pain may be associated with limiting side effects, technology-based interventions using virtual reality (VR) may be a promising alternative treatment option.

There is evidence which shows that VR can be an effective treatment for pain reduction. However, most studies which utilize VR as a method of pain reduction focus on acute pain and studies looking at VR for chronic pain are scarce.

Investigator will analyze the pain reduction and impact on behavioral mechanisms and cognition with repetitive active VR on Fibromyalgia

Eligibility Criteria:
Inclusion Criteria :

* Patients able to understand and sign the informed consent form for the study
* Adults aged 18 to 65 years
* Followed in algology for fibromyalgia pain \> 6 months
* With mean pain intensity ≥ 4

Exclusion Criteria :

* History of epilepsy or hypersensitivity to flashing light to limit the risk of virtual reality-induced seizures
* Previous use of VR for pain (possible bias)
* Refusal to participate
* Therapeutic modifications for pain management related to fibromyalgia during the first month of participation
Home-based Transitional Telerehabilitation in Cardiac Recovery

The main aim is to determine the impact of home video-based cardiac rehabilitation program on elderly patients' health-related quality of life and therapeutic self-care post-coronary revascularization

Over the past decade, the efficacy of coronary artery bypass graft (CABG) surgery in treating coronary artery disease (CAD) has significantly advanced, particularly in improving symptom relief and survival rates among older adults. Remarkably, CAD stands as the foremost cause of global mortality, contributing to a staggering 16% of all deaths, with a notable surge of more than 2 million additional fatalities recorded in 2019, reaching a total of 8.9 million. This escalating incidence is particularly pronounced in the Middle East and North Africa, where CAD has witnessed a 160% increase, signifying a critical healthcare concern with a mortality rate of 120 per 100,000 individuals.

In the realm of cardiovascular diseases, individuals aged 75 years and above face substantial threats, with CAD posing a significant threat to both morbidity and mortality. Despite the acknowledged benefits of CABG, older adults' post-CABG commonly grapple with a spectrum of musculoskeletal and neurological challenges stemming from the surgical procedure. This encompasses incisional sternotomy pain, respiratory issues, weakness, leg swelling, sleeping difficulties, wound healing complications, poor appetite, dissatisfaction with postoperative supportive care, and difficulties with eating. Psycho-socially, these individuals often experience distress, depression, a sense of loss of control, concerns about surgery success, social dysfunction, and fear of death.

The postoperative period necessitates an in-hospital stay of approximately one week, with depressed functional capacity immediately following CABG, potentially linked to fear of activity and pain exacerbated by movement. This is followed by a convalescence period of 2 to 6 weeks for recovery after discharge and the resumption of daily activities. The healing process for chest and leg wounds typically spans 4 to 6 weeks, with pulmonary function and lung capacity decreasing one week following CABG up to 4-6 months after surgery compared to pre-surgery levels.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older
* diagnosed with CAD and were recommended to undergo elective CABG by a cardiologist
* intact cognitive function
* agree to be visited by the researchers at home
* didn't have previous experiences with CABG.

Exclusion Criteria:

* Have an experience with CABG
* demonstrates cognitive dysfunctions.
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study

The goal of this clinical trial is to learn how doing mechanical insufflation (MI) using a mechanical insufflator-exsufflator (MI-E) device affects breathing in early amyotrophic lateral sclerosis (ALS). This will be a single-center, single-arm study of MI in 20 patients with ALS at Penn.

Based on prior research, we believe that 6-months of MI may slow decline in cough strength, measured as peak cough flow (PCF).

Participants will perform MI using a device designed for mechanical insufflation-exsufflation (MI-E) known as the BiWaze Cough system. The BiWaze Cough is used for mucus clearance . It is connected to tubing and mouthpiece (or mask). The device will use programmed pressure and timing settings. An insufflation includes inflating the lungs for a maximal size inhalation before exhaling. The daily routine for the device includes 5 sets of 5 insufflations twice daily.

Researchers will compare how use of MI in early ALS affects peak cough flow compared to 20 subjects who did not use MI in early ALS.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age ≥18 years.
4. Diagnosed with amyotrophic lateral sclerosis using the Gold Coast Criteria.
5. Have an able and willing caregiver to assist with mechanical insufflation on a daily basis.
6. Willingness and ability to participate in study procedures.

Exclusion Criteria:

1. Age \<18 years old.
2. Inability to perform a cough peak flow or spirometry manuever
3. Current use of non-invasive ventilation (NIV), bi-level positive pressure ventilation, or "Bi-PAP" or physician prescribing NIV on day of potential enrollment.
4. Current use of MI-E (also known as a "cough assist device") for airway clearance. Please note that patients can start use of a MI-E device subsequent to enrollment while currently being followed for the study.
5. Active enrollment in hospice.
6. Current tracheostomy.
7. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician.
8. Absence of an able and willing caregiver to assist with MI twice daily as specified in the protocol.
9. Pregnancy
10. Medical history of any of the following:

    1. Recent hemoptysis
    2. Recent barotrauma
    3. History of emphysema of any kind (including bullous emphysema)
    4. History of or known susceptibility to pneumothorax
    5. History of or known susceptibility to pneumomediastinum
    6. Chronic obstructive pulmonary disease
    7. Uncontrolled asthma (defined as recent exacerbation requiring corticosteroids in the previous 30 days)
    8. Symptomatic cardiomyopathy (heart failure) with left ventricular ejection fraction less than 50%
    9. History of right heart failure or pulmonary hypertension
11. Current smoker or tobacco use within the last 30 days.
Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures

The primary aim of this study is to detect incidence of mesh infection in cases presented with obstructed or strandulated hernia.A prospective controlled study will be carried out after obtaining written informed consent from all patients and approval of the ethics committee of the faculty of medicine, Assuit University.

There is controversy regarding the use of prolene mesh in cases of obstructed and strangulated hernia. The main aim and objective of this prospective study is to evaluate the outcomes and incidence of mesh infection in hernioplasty in emergency situations like obstructed and strangulated hernia .Hernioplasty is the most common surgery for hernia repair with Propylene mesh,but the use of synthetic prosthesis is associated with increase risk of developing a prosthetic infection that may manifest after time as subtle symptoms in the form of fever, myalgia, erythema of overlying skin and in some cases as chronic discharging sinus(1). clinicians have been challenged in the past few years by an increasing variety of novel non-infectious and infectious complications following the widespread use of meshes after open repair of hernias this incidence is influenced by underlying co-morbidities, the type of mesh, the surgical technique and the strategy used to prevent infections. An approach that combines medical and surgical management is necessary for cases of mesh infection.(2)

Eligibility Criteria:
Inclusion Criteria:

* All adult patients aging above 21 years old, who presented with obstructed or strangulated hernia with viable bowel loops by clinical examination or detected by preoperative ultrasound or computed tomography CT imaging.

Exclusion Criteria:

* Uncomplicated hernia.
* patients who will underwent rescection and anastmosis
* patient cannot withstand anethesia.
* Decompensated liver patients.
* Pregnancy.
* Immunosuppressed patients e.g.: under chemotherapy or steroids.
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)

The Phase II study consisted of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni. Part 2 investigated efficacy and safety with the selected formulation and dosage in S. mansoni infected children aged between 3 months - 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2)
* S. mansoni positive diagnosis defined as positive egg counts in stool (greater than \[\>\]1 egg/1 occasion) according to World Health Organization (WHO) classification : light (1-99 eggs per gram of faeces), moderate (100-399 eggs per gram of faeces) and heavy (greater than or equal to \[\>=\]400 eggs per gram of faeces) infections
* Minimum weight of 8.0 kg in 2- to 6-year-old children and of 4.0 kg in 3- to 24-month infants

  • Parents/legal representative ability to communicate well with the Investigator, to understand the protocol requirements and restrictions, and willing their children to comply with the requirements of the entire trial, i.e.
* To be examined by a study physician at screening and 14-21 days after treatment
* To provide stool and urine samples at screening, 24 hours and 8 days after treatment, as well as 14-21 days after treatment
* To provide finger prick blood samples for Pharmacokinetics (PK) studies and blood samples for safety assessments

Exclusion Criteria:

* Treatment in the 4 weeks prior to study screening with Praziquantel (PZQ) , other anti-helminthic, antimalarial or anti-retroviral compounds or any other medication that might affect the PK of PZQ such as certain antiepileptics (e.g., carbamazepine or phenytoin), glucocorticosteroids (e.g., dexamethasone), chloroquine, rifampicin or cimetidine
* For children being breast fed, treatment of the mothers/wet nurses with PZQ in the 3 days prior to administration of Investigational medicinal product
* Previous history of adverse reactions associated with PZQ treatment
* Marked increases of the liver transaminases (alanine aminotransferase and/or aspartate aminotransferase) above 3x Upper Limit of Normal (ULN)
* History of acute or severe chronic disease including hepato-splenic schistosomiasis
* Fever defined as temperature above 38.0 degree centigrade
* Debilitating illnesses such as tuberculosis, malnutrition, etc. as well as a medical history of seizures
* Mixed S. haematobium and S. mansoni infections
* Findings in the clinical examination of schistosome-infected children participating in the study as performed by the study clinician on the treatment day, that in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation
* Unlikelihood to comply with the protocol requirements, instructions and trial-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial
Randomized, Double-Blind Phase 1 Safety and Tolerability Study of Pafuramidine Maleate (DB289) in Healthy Subjects

This is a phase 1 study to establish the safety and tolerability profile of pafuramidine maleate 100 mg BID administered orally for 14 days to healthy subjects

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel treatment single center safety and tolerability study. Subjects who meet all inclusion criteria and none of the exclusion criteria will be randomized in a 4:1 fashion to receive either pafuramidine maleate 100 mg tablets or matching placebo tablets administered twice daily for 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female volunteers a minimum of 18 years to 75 years of age
2. Female must be non-lactating and either be of non-child-bearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation) or if of child-bearing potential, must have a negative human chorionic gonadotropin (hCG) pregnancy test and be practicing effective dual barrier contraceptive method from consent to 42 days after initiation of study drug administration.
3. Negative test for hepatitis B surface antigen, Hepatitis C antibody and HIV 1 and 2 antibody within 14 days prior to admission to this study
4. The subject has provided written informed consent prior to admission into this study.

Exclusion Criteria:

1. History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically-mediated disorders
2. History of drug or alcohol abuse, (\* 10 drinks weekly)
3. Blood donation within 30 days prior to dosing
4. History of drug allergies, anaphylaxis or laryngeal edema
5. Use of any medication within 7 days before dosing with study medication or anticipated need for any medication during the study conduct
6. Use of any investigational medication within 6 weeks prior to dosing with study medication or scheduled to receive an investigational drug other than pafuramidine maleate during the course of this study
7. Clinically significant abnormal laboratory value at screening including CBC, blood chemistry or urinalysis
8. Clinically significant anomalies noted on physical examination or ECG
9. Resting pulse rate of \> 100 beats per minute or \< 45 beats per minute during the screening period, either supine or standing.
10. Any condition, which compromises ability to give informed consent or to communicate with the Investigator as required for the completion of this study
11. The subject has been previously enrolled in this study. -
A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients

The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.


Eligibility Criteria:
Inclusion Criteria:

* \>20% TBSA burn with anticipated operation need on admission as determined by attending physician
* age \>18 years
* Admission within 96 hours of injury

Exclusion Criteria:

* \<18 years of age
* pregnancy
* inability or unwillingness to receive blood products
* history of chronic anemia (hemoglobin \<9.0 g/dL one month prior to enrollment)
* preexisting need for hemodialysis
* brain death or imminent brain death
* non-survivable burn as determined by the attending burn surgeon
* angina or acute myocardial infarction
* preexisting hematologic disease
* Length of hospital stay anticipated to be \< 2 weeks
* Transfusion administered at outside hospital before admit
The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain

Low back pain is a common disorder that every individual in the society is likely to meet throughout his/her life. Low back pain lasting longer than 12 weeks is defined as chronic low back pain and causes serious disability in the community. Conservative, pharmacological, interventional and surgical treatment options are available in its treatment. In this study, it was aimed to determine the effects of ultrasound-guided deep paravertebral periforaminal ozone injection treatment on physical examination, functional independence, quality of life and pain scores in patients with chronic low back and leg pain and to compare it with transforaminal epidural steroid injection treatment.

A total of 50 patients were included in the study. Deep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week. In the transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy. The patients in both groups were offered a home exercise program for therapeutic waist and abdominal muscles to do during the treatment follow-up period. Patients\&#39; quality of life was evaluated with SF-36(Short Form-36), pain scores with VAS(Visüel Analog Scala) and functional evaluations with ODI(Oswestry Disability Index) at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Back and leg pain lasting longer than 3 months
* Diagnosis of lumbar disc herniation with advanced imaging techniques after anamnesis, - physical examination and laboratory examinations
* Continuation of complaints despite conservative treatment before
* Regular participation in the study voluntarily

Exclusion Criteria:

* Being pregnant and breastfeeding
* History of lomber surgery
* Peripheral neuropathy (diabetes, alcoholism...)
* Cauda equina syndrome or progressive neurologic deficit in the lower extremity
* Neurogenic bladder/bowel syndrome
* Arterial vascular disease-Vascular claudication
* Spinal stenosis, spondylolysis, spondylolisthesis
* Local infection at the injection site
* Presence of bleeding diathesis
* Neuro-degenerative diseases
* Uncontrolled diabetes, hypertension
* History of malignancy
* Uncontrolled psychiatric illness
* BMI over 40
* Allergy to injection substances
A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients ≥18 years of age
2. Histologically confirmed epithelial ovarian cancer and documented disease.
3. Patients must have platinum-resistant disease
4. Patients must have disease that is measurable according to RECIST 1.1 and require chemotherapy treatment.
5. ECOG PS 0-1.
6. Adequate hematological functions:

   * ANC ≥ 1000/mm3
   * PLT ≥ 100,000/mm3
   * PT and PTT (seconds) \< 1.2 X ULN. Patients who are anticoagulated do not need to meet criteria for PT and PTT.
7. Patients who are known to carry a BRCA mutation may be enrolled only after (following PARP inhibitor treatment failure, or being intolerant of, or ineligible for PARP inhibitor treatment).

Exclusion Criteria:

1. Non-epithelial tumors (Carcino-sarcomas are excluded)
2. Ovarian tumors with low malignant potential (i.e. borderline tumors) clear cell carcinomas, grade 1 serous tumors or mucinous tumors.
3. History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma, adequately controlled, non-metastatic squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
4. Previous ovarian cancer treatment with \>5 anticancer regimens.
5. Any prior radiotherapy to the pelvis or whole abdomen.
6. Inadequate liver function, defined as serum creatinine \> ULN, unless calculated creatinine clearance \> 50ml/min (by Cockroft \& Gault formula):

   * Serum (total) bilirubin \> ULN (Exception: documented Gilbert's disease patients can be enrolled)
   * Alkaline phosphatase, AST/SGOT or ALT/SGPT ≥2.5 x ULN (or ≥ 5 x ULN in the presence of liver metastases).
7. Inadequate renal function, defined as:

   * Serum creatinine \> ULN OR
   * Calculated creatinine clearance \< 50ml/min (by Cockroft \& Gault formula)
8. New York Heart Association (NYHA) Grade II or greater congestive heart failure
9. History of myocardial infarction or unstable angina within 6 months prior to day of randomization.
10. History of stroke or transient ischemic attack within 6 months prior to day of randomization.
11. Patient with proliferative and/or vascular retinopathy
12. Known brain metastases
13. History of hemoptysis or active GI bleeding within 6 month prior to day of randomization
14. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
15. History of abdominal fistula or gastrointestinal perforation.
16. Current signs and symptoms of bowel obstruction
17. Uncontrolled active infection
18. Patients who had evidence of disease progression during or up to 90 days from the last dose of the first line of platinum based therapy
Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps

Neurologically-impaired individuals may have significant neurologic morbidity related to epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures, and potentially reversing the epileptogenic process, is of paramount importance in improving the lives of those with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Thad E. Saleeby Center
* Epilepsy or seizure disorder
* At least one year of detailed seizure reporting prior to study starting date

Exclusion Criteria:

* Severe hearing impairment