cyrilzakka/clinical-trials huggingface dataset:
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).

Eligible patients will receive Doxil 20 mg/m2 IV over 1 hour every 2 weeks. Treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.

Eligibility Criteria:
Inclusion Criteria:

* Thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes.
* Failure to respond to initial treatment with steroids, IV immune globulin, splenectomy and post splenectomy steroids.
* Platelet count of 30,000 or less.
* Performance status score of 2 or less.
* Adequate organ function: \*bilirubin\< 2; \*AST \< 3 times normal; \*creatinine \< 2.
* No prior treatment with anthracycline or chemically related drugs.

Exclusion Criteria:

* Pregnant or lactating women.
* Presence of a malignancy other than basal cell carcinoma of the skin.
Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury

The purpose of this study is to determine if memantine can improve cognitive and neuropsychiatric outcomes after severe traumatic brain injury.

This is a pilot/feasibility study of memantine in severe traumatic brain injury (TBI) persons, employing a randomized, double-blind, placebo-controlled, design. Outcome evaluations will occur after 24 weeks of treatment (on medication) and 4 weeks after treatment discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old of age at time of enrollment
* Severe traumatic brain injury (TBI)
* Feeding access (e.g., orogastric (OG), nasogastric (NG), or percutaneous endoscopic gastrostomy (PEG) tube) permitting delivery of memantine or placebo
* Availability of legally-authorized representative (LAR) to provide consent and participate in some study activities (e.g., monitoring for side effects, providing information about the patient)

Exclusion Criteria:

* Pre-existing history of serious neurological disorder
* Pre-existing history of serious psychiatric disorder (e.g., schizophrenia)
* Anticipated poor prognosis, based on the presence of bilaterally fixed and dilated pupils, severe hemodynamic instability, severe elevations in intracranial pressure refractory to interventions, or other factors leading to a determination of a probable non-survivable injury
* Primarily penetrating mechanism of injury (e.g., gunshot wound to the head)
* Isolated epidural hematoma with anticipated good prognosis
* Low probability of participant being compliant or being able to finish study procedures (e.g., present for outcome rating) in the judgment of the investigator
* Not English speaking (due to inability to complete outcome measure)
* Medical contraindications to memantine: Severe hepatic impairment (defined as albumin \> 15gm/dL, Alk Phos \> 375 U/L, ALT \> 150 U/L, AST \> 120 U/L or bilirubin \> 3mg/dL). Moderate-to-Severe renal impairment (defined as creatinine clearance \< 60)
* Pregnancy or breastfeeding
Medipore Tape Study

This is a prospective, single-blinded, two-arm, randomized, parallel, pragmatic, effectiveness trial that will enroll patients undergoing arthroscopic anterior cruciate ligament reconstruction in order to evaluate the efficacy of using Medipore tape to improve cosmetic wound healing and scaring.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing arthroscopic ACL reconstruction with bone-patella-tendon-bone autograft at the Ambulatory Surgical Center and Hospital for Joint Diseases will be eligible for enrollment.
* Patient is indicated for ACL reconstructive surgery with bone-patella-tendon-bone autograft

Exclusion Criteria:

* Subjects/Parents who are mentally impaired and are unable to give consent
* Patients with prior vertical anterior knee incisions
* Patients with known skin reactions to adhesive
* Patients with high risk for abnormal scar formation and keloids
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers

The objective of this study is to assess the safety and tolerability of Risdiplam (RO7034067) in healthy people. The study will assess what the body does to Risdiplam (RO7034067) and what Risdiplam (RO7034067) does to the body. Risdiplam (RO7034067) will be given by mouth in gradually increasing doses. The data from this study will help to define the dose to further explore Risdiplam (RO7034067) in patients with Spinal Muscular Atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men, aged 18 to 45 years of age, inclusive
* Body Mass Index (BMI) of 18 to 30 kilograms/meter square, inclusive

Exclusion Criteria:

* History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
* History of malignancy in the past 5 years
* A history of clinically significant hypersensitivity (e.g. drugs, excipients) or allergic reactions
* Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first study drug administration
* History or presence of clinically significant electrocardiogram (ECG) abnormalities or cardiovascular disease
* Clinically significant abnormalities in laboratory test results
* Confirmed resting pulse rate (PR) greater than 100 or less than 40 bpm
* Confirmed systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
* Positive result on HIV1 and HIV2, hepatitis C (HCV) or hepatitis B (HBV)
* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmological, dermatological, hematological or allergic disease, metabolic disorder, hypofertility, cancer or cirrhosis
* History or evidence of (neuro)muscular disorders
* Hypersensitivity to itraconazole, to any of the other ingredients, or to any other triazole antifungal
* Any other known contraindications to itraconazole
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial

A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. The intervention strategy focuses solely on the promotion of drinking tap water. The study was conducted in 32 elementary schools including about 3000 children in two German cities over 1 school year.

Soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. The intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. The environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. These lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. For the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. Body weight and height to calculate BMI as primary outcome were assessed at baseline and after the intervention period of 1 school year. As secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. The water flow of the dispenser was measured at regular intervals. In addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting.

To analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.

Eligibility Criteria:
Inclusion Criteria:

* All children in 2nd and 3rd grade of selected elementary schools

Exclusion Criteria:

* parental consent
Bioequivalence Study of Levothyroxine Sodium Tablets 150 mcg

The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.

Levothyroxine (T4) is used to treat patients with hypothyroidism and may often result in lifelong therapy. Its physiologically active metabolite is tri-iodothyronine (T3). Levothyroxine is also endogenously produced in the body. Since small changes in levothyroxine administration (e.g. change in brand or formulation) can cause significant changes in serum thyroid stimulating hormone (TSH) concentrations, precise and accurate TSH control is critical to avoid potential adverse iatrogenic effects. Tecnoquimicas modified its Levothyroxine tablets formulation in order to comply with new pharmacopeical specifications. It will then evaluate the impact on drug product performance based on pharmacokinetic (PK) measures of total serum T4 and total serum T3 of the new formulation of levothyroxine (Test formulation) relative to the reference formulation from Merck (Reference formulation)

This will be a single-center, open-label, two-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 80 healthy adults will be randomized to receive a single dose (4 x 150 mcg tablets = 600 mcg) of the test formulation of levothyroxine and reference formulation of levothyroxine separately in each treatment period. There will be two treatment sequences (AB, BA) and a 42 day washout between the two treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women from 18 to 50 years old
* Diagnosed as healthy after a clinical examination
* BMI from 18 to 30 kg/m2
* Not smoking for at least 3 months
* To sign the informed consent
* Not having participated in a similar study for at least 4 months

Exclusion Criteria:

* Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition
* Hematologic disorders, specially anemia and polycythemia
* Permanent or temporal pharmacological therapy, prescribed or not
* Smoking for the last 3 months
* Alcohol drinker more than once a week
* Drug abuse
* Drug hypersensitivity
* Angioedema or anaphylaxis history
* Pregnancy or breast-feeding
* HIV o Hepatitis B diagnosed
* Blood donor in the past 30 days
Female Acl Prevention Study Where we Look at Landing Techniques Pre/Post Nine Week Strenghtening Program

To make reading this consent form easier, the word "participant" refers to you or your child (if a minor) throughout the consent form. This research is being done to study the effects of an eighteen-session strengthening program and to see if there is a relationship between the female athletes improving their landing techniques which has been proven to decrease anterior cruciate ligament injuries.

Participants have been asked to take part in a research study because you are a female athlete involved in a sport that has an increased anterior cruciate ligament injury rate. The purpose of this research study is to find out if an eighteen-session strengthening program will decrease your anterior cruciate ligament injury rate.

There will be approximately ninety-four (94) people in this research study at Henry Ford Health System (HFHS).

The purpose of this research program is to use Dartfish technology and Functional Movement Screen to assess female athletes pre- and post injury prevention program.The study will include ninety-four females: forty-seven who complete a nine week program focusing on neuromuscular and proprioceptive exercises to improve landing techniques, and forty-seven who go about their normal preseason training regimen. This program has no more risk than if each athlete were to work out at their own gym. Each athlete will be given two questionnaires before and after completing the program in order to determine their level of activity has changed as well as uncover any underlying knee issues. Participants will also go through a series of functional and movement tests to reveal any imbalances, and determine whether or not they have improved by going through the prevention program.

All functional and movement tests will be video recorded. These recordings will only be used for the purpose of conducting this research study and will only be viewed by the HFHS investigators participating in the study. We will follow-up with each athlete one year later to see if there are any lasting effects from the program and re-test each athlete at that time to validate any results

Eligibility Criteria:
Inclusion Criteria:females only age 13-16 -

Exclusion Criteria:all males females younger than 13 and older than 16

-
Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Augmentation

The aim of this study was the radiographic and clinical comparison of Algipore with decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique using piezoelectric instruments.

Vertical and horizontal bone resorption of the alveolar ridge are common in edentulous jaws. In the distal area of the maxilla, an adequate bone volume is often lacking because of the proximity of the sinus cavities to crestal bone. Sinus floor augmentation is an established way of increasing the height and volume of bone in the posterior region of the maxilla, which increase the stability of dental implants. For this purpose various materials, including auto grafts, allografts, alloplasts, and xenografts have been used.

Eligibility Criteria:
Inclusion Criteria:

* physically healthy patients
* ridge bone height of less than 5 mm

Exclusion Criteria:

* any past medical history of systemic or localized diseases that were contraindications for sinus or implant surgery
Adalimumab in Alleviating Inflammation in Patients With Axial Spondyloarthritis

Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the spine and the sacroiliac joints. Inflammatory pathways are likely the central link from axial spondyloarthritis to the known increased risk of atherosclerotic morbidity. Positron emission tomography (PET) is the most sensitive method to detect inflammatory foci in clinical practice. A few small studies have demonstrated that PET imaging together with computed tomography (PET/CT) detects inflamed tissues in relevant patient groups. One study suggested that antirheumatic treatment diminishes the inflammation detected in PET/CT. No study so far has disclosed whether aortic inflammation is present in patients with spondyloarthritis, and whether the inflammation would wane with efficient antirheumatic treatment. The current study is aimed to grade the articular and aortic inflammatory signals in the PET/CT imaging before and after antirheumatic treatment of clinically active axial spondyloarthritis.

Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as detected either by MRI or X-ray will be recruited. Twenty of those are DMARD-naive, and 40 patients have axial spondyloarthritis resistant to sulfasalazine or other conventional antirheumatic drug. In addition, approximately 30 patients without spondyloarthritis but with stable coronary heart disease and approximately 20 healthy controls will be taken as historical controls. All the axial spondyloarthritis patients are PET/CT scanned after inclusion in the study. The DMARD-naive patients (n=20) are started sulfasalazine-based regimen for 12 weeks, which is the time point for a second PET scan for this subgroup. Adalimumab will be commenced for those without remission at 12 weeks. After another 16 weeks, those with adalimumab will be scanned with PET/CT for the third time. The subgroup with active disease in spite of prior conventional treatment (n=40) is also scanned with PET/CT right after the enrolment and after 16-week treatment with adalimumab. The first 15 patients form a pilot group, which is used to check the validity of the power calculation.

The project will give essential new information on PET-detectable inflammation in the patients with axial spondyloarthritis. The results will be published in international publication series. The publications will form the basis for a doctoral thesis. Funding for the project comes from Abbvie Ltd.


Eligibility Criteria:
Inclusion Criteria:

* Axial spondyloarthritis (ASAS criteria) and radiologic sacroiliitis as detected either by MRI or X-ray.

Exclusion Criteria:

* Psoriasis or psoriasis arthropathy
* Inflammatory bowel disease
* Unwillingness to participate in the study with additional imaging protocols
* Expected life-span less than \<1 year
* Diabetes (to improve the PET imaging quality)
* Probable noncompliance
* Pregnancy
* Age \<18 years or \>75 years
* Contraindication for adalimumab
* Methotrexate used within the previous 6 months
* A biologic medicine used within the previous 6 months
Sargramostim With Ipilimumab Containing Therapy in Patients With Solid Tumors

This open label, randomized study will evaluate safety and tolerability of sargramostim when combined with an ipilimumab-containing regimen received as part of standard of care therapy. The study will evaluate 2 sargramostim administration schedules. Patients will be randomized 1:1 to the sargramostim administration schedules and stratified based on planned dose of ipilimumab (1 mg/kg, 3 mg/kg).

Sargramostim will be administered for the first 12 weeks following the assigned treatment schedule or until disease progression, intolerable toxicity, consent withdrawal, pregnancy, or death, whichever comes first. Checkpoint inhibitor therapy will be administered in accordance with institutional standard of care guidelines, at the Investigator's discretion.

Patients will be followed up for to 24 weeks following end of sargramostim treatment for safety, efficacy, and survival.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with solid tumors that will start an ipilimumab-containing therapy (with or without anti-PD-1, such as nivolumab) as part of standard of care in approved ipilimumab indication
* Recovery from any toxicities related to prior therapies
* Ability and willingness to self-administer or have a caregiver administer a SC injection of sargramostim
* Women of child-bearing potential willing to use birth control

Exclusion Criteria:

* Recent radiation therapy for cancer that has spread to bones or to the brain
* History of a severe reaction to prior immune checkpoint inhibitors
* Pleural or pericardial effusion, or history of recurrent pleural or pericardial effusion.
* Heart rhythm with symptoms within the last 12 months
* Known or suspected intolerance or hypersensitivity to sargramostim or any product component or diluent
* Use drugs that can suppress the immune system
* Women who are pregnant or breastfeeding
* Live virus vaccine within 28 days prior to study treatment and for 4 weeks after study treatment.
* Have other active cancers
* Participation in another clinical trial
* Any other medical condition or laboratory abnormality that would put patient at risk or confound interpretation of trial results
Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children

Ultrasound Guided Posterior Versus Lateral Transversus Abdominis Plan Block for Prolonged Postoperative Analgesic Effect in Children

the investigators will compare the effect of posterior Transversus abdominis plan block versus the effect of lateral transversus abdominis plan bock regarding the duration of analgesia and patients satisfaction the study will be conducted on 69 children aged from 1 to 7 years presented for lower abdominal surgery.

Eligibility Criteria:
Inclusion Criteria:

* children from 1- 7 years
* scheduled to undergo lower abdominal surgery

Exclusion Criteria:

* bleeding disorders
* emergency surgery
* skin lesion at site of needle insertion
Power Mobility Training for Persons With Stroke

To test the hypothesis that persons with stroke can safely and effectively learn to use power mobility devices. The primary objective of this project is to test the hypothesis that, with formal wheelchair skills training, people who have had a stroke and have been prescribed a power wheelchair will have a larger improvement in performance and safety scores on the wheelchair skills test than people who have not received wheelchair skills training.


Eligibility Criteria:
Inclusion Criteria:

* be an inpatient at the Nova Scotia Rehabilitation Centre with a primary diagnosis of stroke within the previous 6 months;
* be competent to provide informed consent;
* have permission of the attending physician to participate;
* require no more than minimal assistance for verbal/non-verbal communication and auditory comprehension as evaluated by a therapist or by chart review of the baseline CIHI evaluation;27
* be able to attend during a 20-minute therapy session as evaluated by the occupational or physical therapist;
* use a manual wheelchair for at least 1 hour per day;
* be able to be safely seated in the power wheelchair that we will be using for the study;
* have no significant visual impairment (such that a subject would be unable to see barriers) as evaluated by his/her therapist based on his/her performance during functional tasks;
* Not currently be using a power wheelchair
* have no physical or mental health condition (as determined by the health-care team) that would make participation dangerous.

Exclusion Criteria:

* none
Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).

This work was designed as a prospective case series clinical study. Patients imaging was evaluated with Cone-Beam Computed Tomography and Nuclear Magnetic Resonance at the beginning of the treatment and after the last arthrocentesis.

Eligibility Criteria:
Inclusion Criteria:

* TMJ pain
* TMJ noises and click
* history of unsuccessful conservative management (NSAID and occlusal bite)
* occlusal bite still present

Exclusion Criteria:

* degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)
* history of condylar fractures or previous TMJ trauma
* TMJ surgery