cyrilzakka/clinical-trials huggingface dataset:
Nativis Voyager for Newly Diagnosed GBM

This feasibility study will assess the effects of the Nativis Voyager therapy in patients newly diagnosed with GBM. The study will enroll and treat up to 32 subjects and will be combined with standard of care radiotherapy and temozolomide.


Eligibility Criteria:
Inclusion Criteria:

* There is pathological evidence of GBM using World Health Organization (WHO) classification.
* Subject received maximal debulking surgery. Patients may enroll in the study if received Gliadel wafers before entering the trial. Any additional treatments received prior to enrollment will be considered an exclusion.
* Subject must have at least one measurable lesion per RANO.
* Subject is at least 18 years of age.
* Subject has a Karnofsky Performance Scale (KPS) ≥ 60.
* Subject has life expectancy \> 3 months.
* Subject has adequate organ and marrow function; see note 1.
* Subject able to start treatment at least 28 days from tumor resection surgery.
* Subject has provided signed informed consent.

Exclusion Criteria:

* Subject has progressive disease per RANO. If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
* Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
* Subject is currently being treated with Optune.
* Subject is currently being treated with other investigational agents.
* Subject has not sufficiently recovered from prior surgery in the opinion of the investigator.
* Subject has significant co-morbidities at baseline which would prevent radiotherapy and/or temozolomide treatment.
* Subject has history of hypersensitivity reaction to temozolomide or a history of hypersensitivity to dacarbazine (DTIC).
* Subject has a clinically significant electrolyte abnormality.
* Subject has an active implantable (e.g., neurostimulator, pacemaker) or other electromagnetic device that is incompatible with MRI. Subjects with programmable shunt are excluded from the study.
* Subject has a metal implant, including a stent, in the head or neck that is incompatible with MRI.
* Subject is known to be HIV positive.
* Subject is pregnant, nursing or intends to become pregnant during the study period.
* Subject is participating in other potentially confounding investigational research.
* Subject has any condition that at the discretion of the investigator would preclude participation in the study.
* Subject is unable or unwilling to comply with the protocol-required follow-up schedule.
Diagnostic Utility of Exercise Cardiac Magnetic Resonance in the Assessment of Cardiac Dyspnea.

Researchers are examining the diagnostic utility of an exercise cardiac MRI (eCMR) in the assessment of cardiac dyspnea (shortness of breath).


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged ≥18 years years with suspected cardiac dyspnea who are scheduled to undergo right heart catheterization as dictated by a comprehensive examination and echocardiography will be included for enrollment.

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Mechanical ventilation
* Acute or chronic renal failure (creatinine clearance \<30 ml/min or requiring renal replacement therapy)
* Inability to perform MRI (i.e. claustrophobia, severe obesity (\>150 kg), device incompatible with MRI)
* Inability to exercise
* Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)
* Prior heart or lung transplantation
* Left ventricular systolic (ejection fraction \<50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)
* Significant left-sided valvular disease (≥moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery
Gradual vs. Abrupt Cessation Treatment for Smoking

This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.

For cigarette smokers who intend to stop smoking, most treatment guidelines recommend abrupt cessation. There is evidence from some small studies that gradually reducing the number of cigarettes per day smoked may increase success in quitting. In this study, we will randomize smokers who want to quit smoking in the next 30 days to one of three groups: gradual reduction, abrupt cessation, and minimal intervention.

Eligibility Criteria:
Inclusion Criteria:

* Interested in quitting gradually
* At least 18 years old
* Daily cigarette smoker
* Smoke at least 15 cigarettes per day (CPD)
* No change greater than 20% in CPD in the last month
* Interested in quitting in next 30 days
* Must agree to not use non-cigarette tobacco during study
* No use of smoking cessation medication in last month
* Have phone with voice mail
* Willing to use nicotine lozenge
* No other person in household in study
* Fluent/literate in English

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Currently using medication for depression or asthma
* Heart disease requiring medication
* Heart attack in last month
* Irregular heartbeat
* High blood pressure not controlled by medication
* Stomach ulcers
* Diabetes
Study on the Preventive Effect of Establishing an Integrated Working Group of Doctors and Nurses in Operating Room

To explore the preventive effect and clinical enlightenment of establishing an integrated working group of doctors and nurses in operating room on incision infection in orthopedic surgery.

Surgery is the most used treatment in orthopedics. During orthopedic surgery, the integrity of the skin barrier is compromised, resulting in direct exposure of sterile tissue to the external environment and the potential impact of surgical instruments on local tissue. Additionally, orthopedic surgery procedures often entail prolonged duration, extensive surgical areas, and significant blood loss, all of which contribute to an elevated risk of surgical site infections. However, there are some limitations in the practical application of the conventional nursing model in the operating room. Against this backdrop, numerous new nursing models have emerged to meet contemporary demands. Among them, the integration of medical and nursing staff (MANS) in the operating room has garnered significant attention. Presently, this integrated model is predominantly employed in critical care settings and for postoperative infection prevention. However, the establishment and effectiveness of an integrated working group comprising both MANS in the operating room remains in its nascent stage of exploration, warranting further investigation into its clinical impact and implications.

Eligibility Criteria:
Inclusion Criteria:

* (1) All selected cases met the relevant diagnostic criteria outlined in the orthopedic disease guidelines. Diagnosis was confirmed through imaging methods.

  (2) The patients ranged in age from 18 to 70. (3) All individuals underwent surgery in the orthopedic department of our hospital.

  (4) The vital signs of the patients were essentially stable. (5) Patients possessed normal cognitive function before the operation and demonstrated the ability to listen, speak, read, and write.

Exclusion Criteria:

* (1) Orthopedic patients with multiple injuries in other locations (such as craniocerebral trauma, chest trauma, etc.); (2) Patients with severe internal diseases, such as severe anemia, severe diabetes, liver insufficiency; (3) Patients with chronic infectious diseases; (4) Patients with malignant tumor; (5) Patients with pathological fracture, such as bone tumor; (6) Patients with mental diseases and cognitive impairment.
Efficacy of MND-2119 in Participants With Hypertriglyceridemia

The purpose of this study is to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in participants with hypertriglyceridemia.

MND-2119 is a new formulation of Icosapent. This is a phase 3 study to evaluate the efficacy and safety of MND-2119 compared to EPADEL CAPSULES 300 in subjects with hypertriglyceridemia.

The study period is a total of 22 weeks and is comprised of 8 weeks run-in period, 12 weeks treatment period and 2 weeks follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Participants diagnosed with hypertriglyceridemia.
2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.

Exclusion Criteria:

1. Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
2. Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
3. Participants with, or with a history of, pancreatitis.
4. Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
5. Participants taking both anti-coagulants and anti-platelets.
6. Participants receiving dual antiplatelet therapy.
7. Participants taking direct oral anticoagulants.
Flap Preconditioning by Intermittent Negative Pressure

A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.

Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.

Exclusion Criteria:

* Infection of skin of planned flap.
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation

The study will investigate the cardiovascular effects of sildenafil on patients with Fontan circulation. Recent studies suggest that sildenafil may improve exercise in patients with Fontan circulation. However, why this occurs is not known. The study will used specialized catheters to measure pressure and volume. The measure of pressure and volume leads to more detailed analysis of heart function. Patients will receive either sugar pill or sildenafil prior to catheterization. It is believed that sildenafil will improve relaxation and contraction of the heart.

Modifications to surgical procedures and medical treatment have led to a rapidly declining mortality rates in patients with single-ventricle heart disease (SV). However, SV patients still suffer from lower quality of life, decreased exercise capacity, worse neurodevelopmental outcomes and many other morbidities. While patients with SV circulation only make a small portion of all congenital heart diseases, 2-4 %, they require a great deal of resource utilization.

Standard medical treatments for adult heart failure have not had the same success in the SV population. Phosphodiesterase 5 (PDE5) inhibitors have recently become a frequently used medication class in patients with SV heart disease to treat pulmonary hypertension, heart failure, as well as "Fontan" failure (i.e., plastic bronchitis and protein-losing enteropathy). While there have been findings of improved measures of exercise capacity and some reports of improved symptoms of heart failure, the physiologic mechanisms behind these findings are not completely understood. There have been reports, indicating that the phosphodiesterase five inhibitors improve ventricular function in biventricular circulation patients and animal models. The aim of our study was to investigate the effect of acute PDE5 inhibition on ventricular function in SV patients after the final palliative surgery, the Fontan procedure.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a congenital heart defect that leads to single ventricle physiology
* Previously performed Fontan surgery

Exclusion Criteria:

* The use of phosphodiesterase type 5 (PDE5) inhibitors at the time of catheterization of within 1 month of catheterization

  * Unstable arrhythmia at the time of catheterization
  * History of unstable arrhythmia within 2 months of catheterization
  * Venous, arterial or cardiac malformation that precludes the proper placement of a microconductance catheter
  * Allergy to sildenafil or previous significant adverse reaction to sildenafil (e.g. hypotension)
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy

Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 18.
* Patient suffering of pharmacoresistant epilepsy.
* Frequency of epilepsy crisis : minimum 4 per month.
* Antiepileptic drug on a stable dose for at least 2 months.
* SA-SDQ score ≥ 25.
* Written informed consent obtained.
* Patient affiliated with a social security regimen.

Exclusion Criteria:

* Pregnant females (female subjects who are lactating are not excluded).
* Anterior CPAP treatment.
* Central apnea \>20% during the initial polysomnography.
* Mental retardation or severe cognitive impairment.
* Presence of pseudo-crisis.
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck \&Co, pepcid 40 mg famotidine tablets under fasting conditions.

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia

This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.

Objective: To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia.

Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.

Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit

Eligibility Criteria:
Inclusion Criteria: Patients with a diagnosis of parastomal hernia and indication for surgical treatment -

Exclusion Criteria: None

-
Decision Aid - Extreme Prematurity

The purpose of this study is to assess in a pilot randomized controlled trial the following PICOT question: In parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? Furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?


Eligibility Criteria:
Inclusion Criteria:

* physicians who counsel women at the limits of viability
* women who are receiving counseling at the limits of viability

Exclusion Criteria:

* Known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.
Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study

The investigators long-term goal is to demonstrate the effectiveness of acupuncture for the treatment of adults with chronic pain due to sickle cell disease (SCD), a debilitating pain syndrome characterized by acute and chronic pain. The objective of this study is to explore the feasibility and acceptability of acupuncture with adult patients with SCD. All participants will receive acupuncture treatments twice per week for 5 weeks. Subjects will complete measures at baseline and post-treatment, and a measure of study acceptability at post-treatment. The investigators will describe the procedures and potential challenges to implementing the acupuncture protocol, and expect to identify and rectify any procedural problems that subjects report regarding the 10-session study protocol.

The investigators will conduct the study with adults with chronic pain from SCD, 18 years old or greater. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will complete measures that include pain, fatigue, anxiety, depressive symptoms, injustice experience, and pain catastrophizing. Subjects will also complete a measure of study acceptability, the Protocol Acceptability Scale for Treating SCD with Acupuncture at post-treatment. The investigators will describe the procedures and potential challenges to implementing the acupuncture protocol and the range in the subjects' Acceptability Scale scores. The investigators will expect to identify and rectify any procedural problems that subjects will report regarding the 10-session study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Adults with Sickle Cell Disease
* Receiving care at the University of Illinois Sickle Cell Disease clinic
* Moderate to severe level of pain (3 or higher on a 0-10 scale) within the last 3 months

Exclusion Criteria:

* Pregnancy
* Physically or cognitively unable to complete the study procedures
Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases

This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Maximum user weight of 35 kg
* Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
* Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
* Pelvis width (between greater trochanters) from 24 to 35 cm.
* Ability to achieve ankle dorsiflexion to 90˚
* 20º or more hip flessum.
* 20º or more knee flessum.
* No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
* Informed consent signed by legal guardians.
* Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
* Stable medical condition with no changes in disease-specific medication in the last 6 months, and additional medication in the last month.
* Patient being followed according to the recommended standards for his or her illness
* Ability to maintain, spontaneously or with a brace, the head and trunk while standing and walking.
* No need for daytime ventilation (have an oxygen saturation and PCO2 with normal ambient oxygen
* Score on the FAC scale between 1 and 4 points
* Not being able to walk without assistance

Exclusion Criteria:

* Patient's inability to follow simple instructions and/or communicate discomfort.
* Invasive or non-invasive daytime ventilation.
* Orthostatic hypotension.
* 20º or more hip flessum.
* 20º or more knee flessum
* Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
* Severe skin injury to the lower extremities.
* Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
* History of fracture without trauma.
* History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
* Not receiving regular standing rehabilitation sessions.
* Absence of control of the head or trunk in an upright position without the possibility of wearing a corset during the use of the exoskeleton
* Refusal of the patient or legal guardian to include the child in the study.
* Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the skin of patients.