cyrilzakka/clinical-trials huggingface dataset:
Shunt Outcomes of Post-Hemorrhagic Hydrocephalus

This multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts. The study is being conducted by the Hydrocephalus Clinical Research Network (HCRN), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

Intraventricular hemorrhage and post-hemorrhagic hydrocephalus remain a leading cause of mortality and long-term morbidity in premature infants. The two most common temporary cerebrospinal fluid (CSF) diversion procedures are the ventriculosubgaleal shunt (SGS) and an implanted ventricular reservoir (RES) for intermittent CSF removal. These methods are physiologically very different and their comparative effectiveness in treating hydrocephalus and possibly reducing the need for an eventual permanent CSF shunt is currently not known. The goal of this pilot study is to obtain information critical for planning and executing a future randomized trial comparing SGS and RES. Specifically, this pilot study will establish inclusion criteria, define the primary outcome, and standardize the interventions in preparation for initiating a comparative trial between the SGS and RES procedures. In addition, the importance of examining the neurodevelopmental outcomes for these patients has been recognized within the neurosurgical and neuropsychological settings. Therefore, the scope of this study has been extended to include an examination of the neurodevelopmental outcomes at 18 to 22 months and at 36 to 42 months in patients who undergo BSID-III testing at their clinical centers.

Eligibility Criteria:
Inclusion Criteria:

* premature neonates with birth weights less than 1500 grams
* Grade III or IV intraventricular hemorrhage
* Fronto-occipital horn ratio greater than or equal to 0.50

Exclusion Criteria:

* Less than 72 hour life expectancy from other medical problems
Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke

Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Have severe upper extremity motor deficit after a single stroke
* Stroke onset at least 12 months ago

Exclusion Criteria:

* Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
* Untreated depression
* History of multiple strokes
* History of seizure
* History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
* Positive pregnancy test or being of childbearing age and not using appropriate contraception
* Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
* Cardiac or neural pacemakers or implanted medication pumps
* Receptive aphasia
Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)

The purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
2. Subject should have had cervical or lumbar radicular pain for at least two months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
3. Subject has a pain score of 4 or above (Visual Analog Scale (VAS): 0 - 10 from no pain to worst pain).
4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.
5. For controls, healthy subjects without radicular pain for at least three months will be recruited. \*We are no longer accepting healthy volunteers.\*

Exclusion Criteria:

1. Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease, and severe liver or kidney disorders.
2. Subject has scar tissue, infection, or acute injury at the site of QST.
3. Subject is on anticoagulation therapy.
4. Subject is pregnant.
5. Subject is tested positive on illicit drugs.
BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent;
2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane BCMA expression；
4. All genders, ages: 18 to 75 years；
5. The expect time of survive is above 3 months;
6. KPS\>60；
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
12. With single or venous blood collection standards, and no other cell collection contraindications;
13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD；
5. The patients treatment by inhibitor of T cell；
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
The Utility of Positive Psychology in Military TBI Rehabilitation

Service members and veterans (SMVs) report more persisting symptoms following traumatic brain injury (TBI) compared to civilian populations (Ommaya, Ommaya, Dannenber, \& Salazar, 1996). Therefore, it is important to utilize interventions that reduce psychological impairments and increase resiliency during military TBI rehabilitation. Unlike traditional behavioral health treatments that focus on reducing maladaptive behaviors and negative thoughts, positive psychological treatments focus on increasing positive emotions to increase well-being. There is substantial growing evidence demonstrating that cultivating positive emotions is preventative and improves resiliency and psychological (Bolier et al., 2013; Sin \& Lyumbomirsky, 2009), cognitive (Estrada, Isen, \& Young, 1997; Ashby \& Isen, 1999; Isen \& Daubman, 1984; Isen, Daubman, \& Nowicki, 1987; Fredrickson \& Branigan, 2001), and health outcomes (Pressman \& Cohen, 2005). This study will examine the effectiveness of traditional behavioral health treatment versus behavioral health treatment with an added positive psychological group treatment in terms of psychological, cognitive, and health outcomes during TBI rehabilitation. The hypothesis is that SMV's with TBI will experience improved outcomes with added positive psychological treatment compared to traditional behavioral health treatment alone.

There will be about 100 people taking part in the study, randomly assigned to either a traditional behavioral health treatment group or an alternative behavioral health treatment group (therefore, up to 50 people will be enrolled in each) at the Fort Belvoir Intrepid Spirit Center over a period of 30 months. Study participants will be randomly assigned to groups, and over 3 months the study procedures include participating in group behavioral health treatment and/or individual behavioral health treatment and completing pre/post-treatment questionnaires focusing on psychological, cognitive, and health outcomes. The behavioral health intervention has not been well-studied; thus, the behavioral health intervention is considered experimental for the treatment of psychological symptoms. Additionally, the impact on other areas of functioning (i.e., cognitive functioning and overall health) is currently unknown.


Eligibility Criteria:
Inclusion Criteria:

* Documented mild TBI or moderate TBI.
* Individual is recommended to have a Behavioral Health provider at ISC Fort Belvoir for general TBI-related psychological impairments.
* Individual has decision making capacity for informed consent based on medical provider clinical judgement and initial evaluation.
* Individual scored a 14 or lower on the Patient Health Questionnaire-9, indicating no worse than moderate depressive symptoms.
* Individual is 18 years or older.
* Individual is Defense Enrollment Eligibility Reporting System-eligible.

Exclusion Criteria:

* Individuals with severe depressive symptoms (PHQ-9 score above 14).
* Documented severe traumatic brain injury.
* Minors and pediatric populations.
Effect of Myofascial Release Technique Applied to in Patients With Temporomandibular Dysfunction

We aim to compare the effectiveness of MFR and exercise therapy on mobility and function by investigating the effectiveness of the Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection in participants with temporomandibular dysfunction (TMD) and low back pain.

We aim to compare the effectiveness of MFR and exercise therapy on mobility and function by investigating the effectiveness of the Myofascial Release Technique (MFR), which we will apply to the muscles we choose related to the facial system connection in participants with temporomandibular dysfunction (TMD) and low back pain.

Method and Material Working group (Group A): Myofascial release technique will be applied. A total of 10 sessions will be applied for 4 weeks, 3 times a week for the first 2 weeks, and 2 times a week for the next 2 weeks.

Exercise group (Group B): The stretching exercises that we planned to give to the exercise group were planned for the muscles to which we will apply myofascial technique.

• Control group (Group C): No application will be made to the control group. Evaluations will be made at the beginning of the study and at the end of 4 weeks. The evaluation parameters to be used are as follows; Oswestry Low Back Disability Survey, Algometer and Myotonometry.

Inclusion Criteria: Participants aged 18-50 years diagnosed with TMD,Persons with a score of 20% or more on the Oswestry waist index, and People with low back pain for more than 3 months,Persons with mechanical low back pain and lumbar disc herniation without neurological deficits will be included in the study.Persons with acute or chronic temporomandibular dysfunction will be included. Exclusion Criteria; Neurological problems,Presence of extruded and sequestered lumbar disc herniation,Cardiovascular symptoms and circulation problems,Infection,Fibromyalgia, Acute arthritis conditions,Those with spinal abnormalities,Fracture history, presence of dislocation / subluxation will be excluded

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-50 years diagnosed with TMD
* Persons with a score of 20% or more on the Oswestry waist index, and
* People with low back pain for more than 3 months
* Persons with mechanical low back pain and lumbar disc herniation without neurological deficits will be included in the study.
* Persons with acute or chronic temporomandibular dysfunction will be included

Exclusion Criteria:

* Neurological problems,
* Presence of extruded and sequestered lumbar disc herniation
* Cardiovascular symptoms and circulation problems,
* Infection,
* Fibromyalgia, Acute arthritis conditions
* Those with spinal abnormalities,
* Fracture history, presence of dislocation / subluxation will be excluded
Efficacy of the Aussie Current in Patients With Knee Osteoarthritis.

Introduction: Osteoarthritis (OA) of the knee is a musculoskeletal disorder and is associated with significant implications related to public health and socioeconomic factors resulting in leave from work. Currently, there are several types of conservative treatment for this pathology, such as medications and mainly muscle strengthening, recommended by international guidelines. It can be associated with neuromuscular electrostimulation (NMES) as with the Aussie Current, for example, which aims to increase strength and function earlier. Objective: To determine whether the effectiveness of adding NMES to the Aussie Current in patients with knee OA who receive treatment based on the principles of conventional physiotherapy, in relation to pain relief, improvement of functional disability and muscle strength. Materials and Method: Forty individuals will be randomly distributed in two groups, with group 1 (G1) exercises and placebo application of electrostimulation and group 2 (G2) exercises and application of NMES with the Aussie current in the quadriceps femoris muscle. In the treatment, 24 sessions will be carried out in a period of 12 weeks based on the gold standard for the treatment of knee OA. Clinical outcomes of pain intensity, functional disability and muscle strength will be measured at baseline, immediately after 12-week treatment and after 24-week follow-up by a single blinded evaluator at all stages. All statistical procedures will be carried out following the principles of "intention to treat" and the comparison between groups will be carried out through the test of Mixed Linear Models. Expected Results: It is expected that there will be improvement in the variables: pain, functional capacity and strength in both the groups, however in the group that carried out the application of the Aussie Current, the gains would be more precocious, when compared to the group that did not carry out the NMES.


Eligibility Criteria:
Inclusion Criteria:

* medical diagnosis of OA in the knees,
* pain for another 06 months
* both genders
* age between 45 and 80 years
* Grade I to III, according to Kellgren-Lawrence.

Exclusion Criteria:

* bearers of severe spine, hip and ankle diseases (fractures and tumors and inflammatory pathologies)
* neurological impairment
* Severe cardiorespiratory diseases
The Effect of Mukbang on the Desire to Eat

Mukbang is an online eating broadcast where a host (Asian mukbangs generally feature a young and slim female host) consumes a large amount of food while chatting with audiences. Since some dieters watch mukbang to get satiation and control their appetites, the current study is aimed at testing the effect of mukbang on the desire to eat.

Two randomized and controlled trails are conducted. The first randomized and controlled trail is conducted online using the Amazon Mturk. Participants (n=286) were randomly assigned to watch one of the following 3 videos: ramen mukbang (n=98), donut mukbang (n=97) and a non-food content video (n=91). The other study is a in person study. Participants (n=234) were randomly assigned to watch one of the following 3 videos: hotpot mukbang (n=79), hotpot cooking show (n=76) and a non-food content video (n=79).

The investigators used the self-report survey to test whether the mukbang affects the desire to eat, and participants' satiation and disgust.


Eligibility Criteria:
Inclusion Criteria:

* Female, age at least 18

Exclusion Criteria:

-
Fascial Distortion Model Manual Therapy and Painful Shoulder Syndrome

Relatively new method of diagnosing and treating dysfunction of the musculoskeletal system is Fascial Distortion Model. It is manual therapy developed by emergency physician and an osteopath Stephen P. Typaldos.

Disfunction are diagnosed based on verbal and physical descriptions, palpations, anamnesis. As a result of examination, It can be found one or more of six different distortions. The aim of the study is to examine the effectiveness of FDM manual therapy in comparison to manual therapy using the Mulligan Concept method and traditional physiotherapy in patients with shoulder dysfunction who have undergone previous rehabilitation and who have not achieved satisfactory results. Patients will receive five treatments with one day brake between each treatment. The patient's condition will be evaluated before the first treatment, two weeks after the last treatment, and also after three months. As a outcome of the occurring phenomenon, structural changes are planned at the level of the fascial system in the studied region. The obtained results may influence the current views on diseases of the musculoskeletal system, as well as on the method of diagnosing and treating shoulder joint dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of dysfunction in the shoulder joint based on an orthopedic and/or physiotherapeutic examination confirmed by X-ray and ultrasound imaging,
* patients undergoing prior rehabilitation / pharmacotherapy / surgical intervention without satisfactory results,
* limitation of mobility and / or pain in the shoulder complex,

Exclusion Criteria:

* coexistence of neoplastic diseases,
* symptoms from the cervical spine
* pregnancy,
* aneurysms,
* osteitis,
* arthritis
* deep veins thrombosis of upper limbs,
* resignation from the study / therapy,
* skin damage, hematomas.
Non-invasive Evaluation of Volume Status Using Exhaled Carbon Dioxide and Pulse Contour Analysis

The investigators hypothesize that changes in blood circulation can be reflected by exhaled CO2 provided CO2-production in the tissues and ventilation from the lungs are stable. The investigators want to explore changes in cardiac output (the amount of blood being pumped out of the heart each minute) in patients using different devices: an esophagus ultrasound device measuring cardiac output, a finger cuff measuring blood pressure and cardiac output, and exhaled carbondioxide in the patients' breath measured by the ventilator.

The investigators investigate patients after bypass surgery or heart valve replacement, and induce changes in cardiac output with passive leg raise or ventricular pacing.

Measurements with the finger cuff (pulse contour analyses) were aborted due to technical difficulties.

Eligibility Criteria:
Inclusion Criteria:

* Persons 18 years or older scheduled to undergo arteriocoranary bypass surgery or aortic valve replacement.

Exclusion Criteria:

* Esophageal pathology, EF \<40%
A Study of the Safety and Pharmacology of MEGF0444A in Combination With Bevacizumab With or Without Paclitaxel in Patients With Locally Advanced or Metastatic Solid Tumors

This is a Phase Ib, open-label, dose-escalation study of MEGF0444A in combination with bevacizumab, and in combination with bevacizumab and paclitaxel as therapy for locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on or failed to respond to regimens or therapies known to provide clinical benefit

Specific to Arm A:

* For patients undergoing optional or mandatory exploratory MRI, at least one tumor lesion that represents a liver, fixed peritoneal, neck, extremity, or pelvic lesion measuring \>/= 3 to 10 cm (for liver lesions) or \>= 2 to 10 cm (for all other lesion locations) to be used for MRI

Specific to Arm B:

* Maximum of two prior chemotherapy regimens for metastatic disease

Exclusion Criteria:

* Anti-cancer therapy within 3 weeks prior to initiation of study treatment
* Patients who had to discontinue prior bevacizumab therapy due to intolerable toxicity
* Leptomeningeal disease
* Active infection or autoimmune disease
* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis
* Known primary central nervous system (CNS) malignancy or untreated or active CNS metastases
* Inadequately controlled hypertension; history of hypertensive crisis or encephalopathy; congestive heart failure (New York Heart Association Class II or greater); history of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment
* History of hemoptysis; evidence of bleeding diathesis or significant coagulopathy
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment
* Serious, non-healing wound, active gastrointestinal ulcer, or untreated bone fracture

Specific to Arm B:

* Known significant hypersensitivity to paclitaxel or other drugs using the vehicle cremophor
* Previous intolerance to paclitaxel
* Grade \>= 2 sensory neuropathy