cyrilzakka/clinical-trials huggingface dataset:
Prasugrel Versus Placebo in Adult Sickle Cell Disease

The purpose of this trial is to assess the safety of Prasugrel in adult patients with sickle cell disease (SCD) by monitoring the rate and severity of hemorrhagic events requiring medical intervention compared to placebo for 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Adults with Sickle Cell Disease (SCD).
* Are greater than or equal to 50 kilograms (kg) at time of screening.
* Are not currently being treated with an investigational drug (use of hydroxyurea, which is not an investigational drug, is permitted under this protocol if the patient has been on a stable dose for at least 30 days prior to randomization and has no signs of hematological toxicity at screening.
* Agree to use a reliable method of birth control during the study or are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.

Exclusion Criteria:

* Acute painful crisis (requiring medical attention) within 30 days prior to screening.
* Have a concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period (approximately 30 days).
* Severe hepatic dysfunction (cirrhosis, portal hypertension, or aspartate aminotransferase (AST) greater than or equal to 3x upper limit of normal \[ULN\]).
* Renal dysfunction requiring chronic dialysis.
* Contraindication for antiplatelet therapy.
* History of intolerance or allergy to approved thienopyridines.
* Have signs or symptoms of an infection.
* Hypertension (systolic blood pressure \>180 millimeters of mercury (mm Hg) or diastolic blood pressure \>110 mm Hg) at the time of screening or randomization.
* Hematocrit \<18%.
* Any history of bleeding diathesis, bleeding requiring in-hospital treatment, or papillary necrosis.
* Active internal bleeding.
* History of spontaneous gastrointestinal (GI) bleeding requiring in-hospital treatment.
* Gross hematuria. Microhematuria, common in SCD patients, is not a contraindication.
* Platelet count \<100,000 per cubic millimeter.
* Any history of intraocular hemorrhage.
* Prior history of transient ischemic attack (TIA), ischemic stroke, hemorrhagic stroke, or other intracranial hemorrhage.
* Known history of intracranial neoplasm, arteriovenous malformation, or aneurysm.
* Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
* Have an international normalized ratio (INR) of greater than 1.5 at screening.
* Have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days.
* History of menorrhagia requiring medical intervention.
Dose-dependent FODMAP Reintroduction in IBS

The aim of this study is to evaluate whether symptom recurrence, after successful FODMAP elimination, is dose-dependent in patients with IBS. The effect of a blinded reintroduction of FODMAP powders fructans and mannitol will be investigated in a crossover dose-escalation scheme for the identification of the eliciting dose in individual patients. The reintroduction of FODMAPs is performed after a successful elimination by the LFD.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
3. Patients with irritable bowel syndrome according to Rome IV diagnostic criteria
4. Patients ages between 18 and 70 years old

Exclusion Criteria:

1. Participant has a history of any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years

1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
5. Patients presenting with predominant symptoms of functional dyspepsia (FD) and of gastro-oesophageal reflux disease (GERD)
6. Patients following a diet interfering with the study diet in opinion of the investigator
7. Patients who already followed the low FODMAP diet under guidance of a trained dietitian without success.
Treatment Outcomes in Patients With Muscular Temporo-mandibular Joint Disorders

The aim of the present study was to assess the treatment outcomes in patients affected by M-TMDs in terms of pain scores assessed with pressure pain threshold (PPT). The levels of de-pression, anxiety and the Oral-Health Impact profile were also assessed and compared to healthy controls. Patients with a clinical diagnosis of M-TMDs and a control group of healthy subjects were enrolled. At baseline, OHIP-14, PHQ-9 and GAD-7 were administered. PPT was registered at the level of masseter and temporalis muscles. The patients were then treated with oral splints and physio-kinesiotherapy following a standardized treatment protocol. At 6-months follow-up, PPT was registered, and the questionnaires were re-administered to compare treatment outcomes.

Consecutive patients referred to the Unit of Dentistry and Oral Surgery for suspected TMD between January 2022 and December 2022 were enrolled. All the study participants signed an informed consent form to be included in the study.

Two study groups were identified:

* M-TMD group, including patients with a diagnosis of muscular TMDs;
* A control group of subjects with a negative history for TMDs. The inclusion criteria for patients in the M-TMD group were i) males or females \&amp;gt;18 years, ii) systemically healthy patients, iii) clinical examination revealing a diagnosis of muscular TMD and/or positive history of muscular TMD, iv) patients willing to give informed consent, and v) compliance to the study follow-up. Patients with i) articular TMDs, ii) chronic diseases, iii) any psychiatric diagnosis under medication, iv) pregnant or lactating, and v) not willing to comply with the study protocol were excluded.

The subjects included in the control group were enrolled among the patients referred to the Unit of Oral Surgery of the Unit of Dentistry and Oral Surgery. The patients in the control group were i) males or females of age \&amp;gt; 18 years, ii) systemically healthy patients, iii) clinical examination negative for pain in the masticatory muscles and negative for history of TMDs, and iv) patients willing to give informed consent and to be administered the study questionnaires.

After diagnosis confirmation of M-TMD according to the DC/TMD criteria, the patients were treated with the application of an oral splint on the upper dental arch associated with physio-kinesiotherapy.

The patients were administered OHIP-14, PHQ-9, and GAD-7 questionnaires to compare scores in the M-TMD patients versus healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* males or females \>18 years of age
* systemically healthy patients
* clinical examination revealing a diagnosis of muscular temporo-mandibular joint disorder (TMD) and/or positive history of muscular TMD
* patients willing to give informed consent, and v) compliance to the study follow-up.

Exclusion Criteria:

* articular TMDs
* chronic diseases
* any psychiatric diagnosis under medication
* pregnant or lactating females
* not willing to comply with the study protocol
The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head

The purpose of this study is to assess the clinical and x-ray results of patients who are treated with core decompression of the hip and the injection of a bone marrow concentrate and the use of the Bone Graft Substitute Genex®.

Avascular necrosis (AVN) or osteonecrosis (ON) of the femoral head refers to a condition in bone metabolism when cells of the trabecular bone (porous bone found at the end of long bones like the femur) in the hip spontaneously die. Depending on the amount of femoral head involvement, parts of the surface, like the articular surface that do not have blood vessels may collapse as the disease advances. Although the exact common occurrence of AVN or ON is unknown, the incidence is estimated to be between 20,000 to 30,000 newly diagnosed patients each year in the US.

Core decompression of the hip is a minimally invasive surgical technique performed to manage symptoms in early stages (precollapse) of the condition. The procedure involves drilling holes into the femoral head to relieve pressure and create channels for new blood vessels to nourish the affected areas. Multiple adjuncts to core decompression, such as structural bone grafts, bone marrow concentrates, and bone proteins have been developed to accelerate the healing process in these patients. In recent years, considerable research activity has also been expanded to find new bone substitutes with osteoconductive properties (where bone grows on a surface) for the use in the treatment of surgically created defects.

Genex® Bone Graft Substitute is a catalyst for bone healing. It complements the body's natural healing processes and encourages normal bone structure to be restored at a steady rate. Over 12 months, the graft matrix is completely absorbed and replaced by bone. No foreign artifacts are left behind to impair structural integrity.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years or older with osteonecrosis of the femoral head
* Surgeon considers the patient appropriate for the core decompression procedure of the hip
* Subject provides voluntarily signature on the IRB approved Informed Consent Form
* Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete the study protocol and follow ups

Exclusion Criteria:

* Subject is pregnant at the time of surgery
* Subject is incarcerated
* Subject is not comfortable with speaking, reading and understanding questions and providing responses in an available language for the questionnaires provided for the study
Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study

Pilot study to evaluate efficacy of Keppra (levetiracetam) for seizure control in patients with alcohol related seizures.


Eligibility Criteria:
Inclusion Criteria:

* No trauma
* Not pregnant
* No other cause for seizure (hypoglycemia, CNS causes, trauma)
* Good family support
* Working telephone contact

Exclusion Criteria:

* Pregnancy
* Renal failure (creatine \> 2mg/dl
* Fever or illness
* Hypotension
* Any trauma
Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery

Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed.

Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. The investigators registered presence of varicose veins, type of previous invasive procedure and availability of saphenous trunks as possible grafts

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 Years

Exclusion Criteria:

* Those unwilling to sign an informed consent were also included.
Effects of Home-based Resistance Exercise on Body Composition, Muscle Strength and Glycemic Control in People With Type 2 Diabetes.

This study investigates the effects of home-based resistance exercise training, compared to a control group, on body composition, muscle strength and glycaemic control in people with type 2 diabetes.

Half participants will be in the home-based exercise group and half in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed type 2 diabetes
* No changes in anti-diabetic medication in the last 3 months

Exclusion Criteria:

* Not currently or in the past year participating in any vigorous aerobic activity (\>1h per week) or any resistance exercise.
* BMI of 45 or higher
* Blood pressure of 160/100mmHg or higher
* Currently receiving insulin therapy
The MiDAS ENCORE Study

Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.


Eligibility Criteria:
Inclusion Criteria:

1. 65 years or older and a Medicare beneficiary.
2. Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics.
3. LSS with neurogenic claudication diagnosed via:

   1. Symptomatic diagnosis and
   2. Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum \>2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit.
4. Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced.
5. Available to complete 6 month and one year follow-up visits.

Exclusion Criteria:

1. ODI Score \< 31 (0-100 ODI Scale).
2. NPRS Score \< 5 (0-10 NPRS Scale).
3. Prior surgery at any treatment level.
4. History of recent spinal fractures with current related pain symptoms.
5. Patients with Grade III or higher spondylolisthesis.
6. Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
7. Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance.
8. Patients previously randomized and/or treated in this clinical study.
9. Patients that have previously received the MILD procedure.
10. ESI during eight weeks prior to study enrollment.
11. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician).
12. On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
EVENT - Evaluation of the Influence of hTEE

Compromised tissue oxygenation during surgery may negatively influence patient outcome. Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative pericardia effusion and/or tamponade may further compromise cardiac function. Today, hemodynamically instable patients are often monitored by means of pulmonal artery catheters or transpulmonary thermodilution. However, these methods only allow quantification of functional limitations. Underlying causes may be investigated by relatively recent technology through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that also provide the possibility of continuous monitoring. It has been reported that a training program consisting of six hours may enable physicians who are unexperienced in the field of echocardiography to apply this new method. Up to now, there is no evidence whether this methods is associated with improved postoperative outcome.

Therefore we hypothesize that continuous hemodynamically focussed transesophageal echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its application may decrease hospital expenses (secondary hypothesis).


Eligibility Criteria:
Inclusion Criteria:

* elective, cardiac surgery
* hemodynamic instability or placement of hTEE/PICCO (Pulse Contour Continuous Cardiac Output) /PAC (Pulmonary Arterial Catheter) within 12 hours of ICU admission

Exclusion Criteria:

* pregnant/breastfeeding women
Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain

This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain.

This is a prospective, open label, non-controlled Pilot study in which the safety and feasibility of umbilical cord Wharton's Jelly (WJ) allograft will be evaluated in participants suffering with lumbar pain. The participants will receive a series of lumbar injections described in the protocol.

As this is a Pilot study primarily designed to evaluate safety, no control will be used. The dosing will consist of 10cc WJ Allograft with 100 total participants. In addition to baseline outcome instruments along with imaging and laboratory studies, participants will be followed for one year for evaluation of safety, pain relief and functional improvements.

Eligibility Criteria:
Inclusion Criteria:

• Patient must

* Be over age 20.
* Suffering from chronic lumbar pain
* Body Mass Index (BMI) \<50 Kilograms/m2.
* Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS).
* Female participants must be abstinent, surgically sterilized or postmenopausal.
* Premenopausal females must be on contraceptive measures and do not anticipate pregnancy during the duration of the study.
* Be willing and capable of giving written informed consent to participate in English.
* Be willing and capable of complying with study-related requirements, procedures and visits.

Exclusion Criteria:

• Patient must not

* Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
* Use anticoagulants have a substance abuse history, and fail to agree not to take any lumbar symptom modifying drugs during the course of the study without discussing and reporting the use to the site Clinical investigator and study team.
* Known allergy to penicillin, sulfa or amphotericin medications.
* Have had any lumbar injections (at all) of any drug in lumbar spine in the past 6 months.
* Have had surgery on the lumbar spine within the past 6 months.
* Had a traumatic injury to the lumbar spine with the past 3 months.
* Planned elective surgery during the course of the study.
* A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
* Be on immunosuppressive medications.
* Have a diagnosis of carcinoma with the past 5 years.
* Have a lumbar infection or have used antibiotics for lumbar infection within the past 3 months.
* Have participated in any other clinical study or treatment (not just for the lumbar spine, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
* Female participants who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
* Contraindications to radiographic or MRI imaging.
* Serious neurological, psychological or psychiatric disorders.
* Injury or disability claims under current litigation or pending or approved workers compensation claims.
Sensitivity and Specificity of Aridol Challenge for a Diagnosis of Asthma by a Specialist Pulmonologist

The purpose of this study is to estimate the sensitivity, specificity and positive and negative predictive values of a positive Aridol challenge with respect to a specialist pulmonologist diagnosis of asthma in corticosteroid naive subjects with asthma-like symptoms and no previous diagnosis of asthma. The comparator is methacholine provocation


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Provisional or possible asthma diagnosis
* FEV1 at least 70% of predicted at inclusion

Exclusion Criteria:

* Contraindications for bronchial provocation challenge or spirometry
* Respiratory tract infection within previous 6 weeks
* Significant co-morbidity
* \> 10 pack year smoking history
* Other lung diseases
* Pregnancy, lactation
Ologen (OculusGen)-Glaucoma MMC Control Trial in India

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
2. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with ologen (OculusGen) implant or trabeculectomy with mitomycin-C.
3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over.
* Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
* Subject able and willing to cooperate with investigation plan.
* Subject able and willing to complete postoperative follow-up requirements.
* Subject willing to sign informed consent form.

Exclusion Criteria:

* Known allergic reaction to mitomycin-C or porcine collagen.
* Subject is on warfarin and discontinuation is not recommended.
* Normal tension glaucoma.
* Participation in an investigational study during the 30 days preceding trabeculectomy.
* Ocular infection within 14 days prior to trabeculectomy.
* Pregnant or breast-feeding women.
"Ecological Program Changes Pelvic Kinematics in Soccer Players: Pilot Study on Hamstring Injury Implications"

The present pilot study aimed to investigate whether a 6-week multicomponent intervention, comprising a structural lumbopelvic and sprint technique program, could reduce anterior pelvic tilt in soccer players who regularly participated in soccer practice.

This pilot study aimed to evaluate the impact of a 6-week multicomponent intervention combining lumbopelvic control exercises and running technique training on pelvis structure and lower limb kinematics in semi-professional soccer players. Seventeen players were randomly assigned to a control group (CG) or an intervention group (IG). Data on static anterior pelvic tilt (APT) and three-dimensional kinematics during high-speed running (HSR) and high-speed soccer running (HSSR) were collected before (PRE) and after (POST) the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for both groups were: (a) being between 18 and 40 years old, and (b) being available for their teams

Exclusion Criteria:

* Exclusion criteria for both groups included (a) not having suffered any musculoskeletal injuries in the previous 3 months and (b) not being involved in any additional strength program outside of their regular team training.