cyrilzakka/clinical-trials huggingface dataset:
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5

The objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.

In this prospective cohort study, the participants (children with predominantly spastic CP, GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators evaluated level of spasticity using the modified Ashworth scale (MAS) and other related measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural ability scale (PPAS) were performed.

Eligibility Criteria:
Inclusion Criteria:

- cerebral palsy with spastic disease, GMFCS 3-5.

Exclusion Criteria:

* other disorders affecting the sensorimotor functions without spasticity,
* implanted electric medical devices,
* BMI\>35
* other severe concomitant diseases such as cancer, cardiovascular, inflammatory, psychiatric disease, medical dysregulated epilepsy or hypertension.
Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function

The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Stable Renal Function defined as ≤20% (25% for normal renal function) difference between 2 measurements of serum creatinine obtained on 2 occasions separated by at least 2 weeks.
* Body Mass Index (BMI) of approximately 18 to 40 kg/m2 inclusive.
* Total body weight \>50 kg (110 lbs).
* Male or female subjects between the ages of 18 and 85 years.

Exclusion Criteria:

* Subjects with acute renal disease and/or history of renal transplant.
* Supine BP at Screening ≥160 mm Hg systolic or ≥95 mm Hg diastolic.
* Supine BP at Screening ≤80 mm Hg systolic or ≤40 mm Hg diastolic.
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have provided informed consent prior to any study specific procedures.
* Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
* Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
* Verified previous manic or mixed episode.
* Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
* Participants with a HAMD-17 item 1 score ≥ 2.
* Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

* Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
* Women who are pregnant or breast feeding
* Participants with Young Mania Rating Scale (YMRS) total score \> 10
* Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.
Study of Endoscopic Sphincterotomy With Needle Knife Papillotome in Patients of Ampullary Impacted Stone

Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies were performed in difficult cannulation cases. In a prospectively collected database, we investigate the complications of those with ampullary impacted stone.

The endoscopic sphincterotomy with needle knife papillotome is a well-established advanced endoscopic technique in difficult cannulation cases. Choledocholithiasis impacted at the ampulla of Vater is occasionally seen. Inflammed surrounding mucosa frequently accompanies. Whether sphincterotomy with a needle knife increases the bleeding complications is to be elucidated in this study.

Eligibility Criteria:
Inclusion Criteria:

* choledocholithiasis patients and an ampullary impacted stone

Exclusion Criteria:

* patients with liver cirrhosis , pregnancy, history of abdominal malignancy, bleeding diathesis, ileus, renal failure
Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study

Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period, despite the ongoing opioid crisis in the United States. While opioid-free multimodal pathways have shown promising results, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. This study aims to evaluate post-operative pain following the use of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.

Despite the presence and increased understanding of the opioid crisis in the United States, orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during the postoperative period. In an effort to minimize narcotic analgesia and its potential side effects, opioid-free multimodal pathways have been developed in many orthopaedic sub-specialties with promising results. There have been early studies reporting the results of non-narcotic protocols during the intra-operative period. Likewise, there have been several studies reporting the results of inpatient non-narcotic pain protocols in select foot and ankle surgeries. However, there remains a lack of published literature evaluating opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries. Currently, our practice utilizes an opioid-free post-operative pain protocol for patients undergoing elective outpatient foot and ankle surgery. The goal of this study is to evaluate post-operative pain using this opioid-free multimodal pain protocol at days 1,3, and 8 following elective outpatient foot and ankle surgery.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Outpatient, elective, primary foot and ankle surgery not due to infection including:
* Bunion or bunionette surgery, hammertoe surgery, ankle fracture, Achilles tendon surgery (primary mid-substance repair, Haglund's deformity correction with debridement), ankle arthroscopy

Exclusion Criteria:

* \<18 years of age
* Undergoing revision surgery
* Allergic to more than 1 medication listed in protocol
* Creatinine clearance \>1.5
* Known end-stage renal, stage 2 or higher
* History of GI bleed, ulcer, NSAID-induced gastritis, and/or gastric bypass
* History of active liver disease or Child-Pugh Class 2 liver failure or above
* History of pain syndromes including: fibromyalgia, complex regional pain syndrome/reflex sympathetic dystrophy, hyperalgesia
* Inability to undergo regional anesthesia due to inability to obtain nerve block, prior nerve damage or anatomy, or anesthesiologic best judgement
* Currently pregnant
Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.

A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA\* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (\*TREXIMET)

Eligibility Criteria:
Inclusion Criteria:

* At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month
* Typically experiences moderate to severe migraine pain preceded by a mild pain phase
* Differentiate between mild migraine pain and other headache types
* Women of childbearing potential must be on adequate contraception

Exclusion Criteria:

* Pregnant and/or nursing mother
* History of cardiovascular disease
* Uncontrolled hypertension
* Basilar or Hemiplegic migraine
* History of stroke or transient ischemic attacks (TIA)
* History of epilepsy or treated with anti-epileptics within past 5 years
* Impaired hepatic or renal function
* History of gastrointestinal bleeding or ulceration
* Allergy or hypersensitivity to aspirin or any other NSAID
* Allergy or hypersensitivity to triptans
* Participated in an investigational drug trial in the previous 4 weeks
Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia

The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease
2. Female patients \>18 years old.
3. Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.
4. Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue).

Exclusion Criteria:

1. Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody
2. Participant must not be simultaneously enrolled in any interventional clinical trial.
3. Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
4. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
Optic Nerve Sheath Diameter and Intracranial Pressure (ICP) in Children

The use of optic nerve sheath diameter (ONSD) measurements as a non invasive test for raised ICP has many potential benefits. This includes having assessments that can be made at the bedside instead of requiring patient transport to CT or MRI, which in itself can cause a rise in ICP. If ONSD represents an acute and sensitive measurement of elevated ICP, it may prove useful in the emergency department (ED) setting in the evaluation of shunts used for cerebrospinal fluid (CSF) diversion. The investigators hypothesize that ONSD will correlate with measured ICP and thus be a reliable tool for the bedside assessment of ICP. The investigators further hypothesize that ONSD changes will correlate with changes in ICP, making it a useful bedside tool for assessing ICP changes over time. This is a prospective, observational study using a convenience sample. Children who are 0 - 18 years old who have an invasive intracranial ICP monitoring device admitted to the hospital Pediatric Intensive Care Unit (PICU) are eligible for participation in the study. Children who are 0-18 years old who are determined to require a shunt revision following evaluation in the ED will also be included in the study. 10. After the invasive intracranial pressure monitoring device is placed, for every recruited patient, ONSD measurements will be taken and the ICP will be recorded 8 hours post placement and then repeated 3 times a day until the intracranial pressure monitoring device is removed.12. For ventriculoperitoneal (VP) shunt revision patients, the investigators will obtain a measurement just before surgery, immediately post-op, and then 12 hours, 24 hours, and 36 hours post-op. If the patient is otherwise ready for discharge prior to 36 hours, the measurement may be omitted or done early so as to not unnecessarily prolong the hospitalization


Eligibility Criteria:
Inclusion Criteria:

* Children between 0 years and 18 years of age
* Children who are determined to need an invasive intracranial monitoring device in the ED and admitted to the PICU
* Children who undergo VP shunt revisions at the study site

Exclusion Criteria:

* Children with an invasive intracranial monitoring device that is malfunctioning
* Prior adverse reactions to ultrasound gel
* Pre-existing ophthalmologic conditions that could cause a baseline increase in ONSD, including glaucoma or severe ocular trauma
* Children with ocular or facial trauma that would impede ONSD measurements
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone

The purpose of this research study is to measure how many of the dopamine receptors lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective disorder and over what time period the occupancy occurs. This is research because lurasidone is an investigational medication that has not yet been approved by the Food and Drug Administration (FDA). Dopamine receptors have key roles in many processes, including the control of motivation, learning, and fine motor movement. The degree of occupancy and the transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent relapses is a controversial area that this study will address.

In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand 18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use of these receptors. Researchers hope that quantifying the amount of receptors being occupied by the medication will help them to determine the best dose of study medication in terms of improvement and least side effects related to body size and gender as well as in preventing relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also be performed. MRI is a scanning method which makes pictures of parts of the brain using a large magnetic field. This study will use a particular kind of MRI called fMRI, or functional MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task. fMRI will allow the researchers to investigate patients regional brain activation during cognitive (mental) and emotional tasks.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible to participate in this study if they:

* are 18 to 60 years of age at the day of first dosing.
* are diagnosed with schizophrenia or schizoaffective disorder.
* are female, subject must be using an acceptable method of birth control or be surgically sterile or postmenopausal. Postmenopausal is defined as no period for at least 12 months. Acceptable methods of birth control include oral, injectable or implanted contraceptives, and barrier methods such as condoms, diaphrams, and spermicides.
* are able to provide written informed consent.
* can safety have an MRI (no metal in the body, not claustrophobic).

Exclusion Criteria:

Subjects are not eligible to participate in this study if they:

* are treatment resisitant or intolerant to lurasidone.
* have had extensive radiation exposure (the study doctor will discuss this with the subject).
* if they have tremors or shaking of the limbs.
* are pregnant or trying to become pregnant or breastfeeding.
* are colorblind.
* have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant (any abnormal lab values will be discussed with the subject).
* are taking certain medications. The study doctor will discuss these medicines with the subject.
* have a history of alcohol, cannabis or cocaine abuse within two weeks prior to the study.
Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse

The purpose of this study is to evaluate the long-term success rate of the colpocleisis procedure and its effect on quality of life in women who have this surgery. We want to see if women who have this surgery have problems with recurrent pelvic organ prolapse, urinary incontinence, or bowel problems after the surgery. We also want to see how the surgery affects women's sexuality.


Eligibility Criteria:
Inclusion Criteria:

* women who underwent either total colpectomy with colpocleisis or partial colpectomy with LeFort-type colpocleisis performed by the Urogynecology service between 1/2000 and 12/2007 at Strong Memorial Hospital

Exclusion Criteria:

* women who are not undergone colpocleisis or colpectomy
Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients of age 18 years or above
* Patients diagnosed with stage 1 or stage 2 essential hypertension
* Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

* Secondary hypertension or severe hypertension
* Clinically significant cardiovascular disease or heart failure
* A medical contraindication to discontinuing a current antihypertensive therapy
* History of Type 1 diabetes mellitus
The Heidelberg Engineering ANTERION Anterior Segment Metrics Precision and Agreement Study

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess anterior segment metrics with the ANTERION


Eligibility Criteria:
Inclusion Criteria:

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. With at least one of following eye status for the corresponding eye population:

A. Eye with Open Angle (defined by Spaeth gonioscopy grading)

B. Eye with Narrow Angle (defined by Spaeth gonioscopy grading)

Exclusion Criteria:

1. Subjects which were enrolled in the B-2018-1 study
2. Active infection or inflammation in either eye
3. Insufficient tear film or corneal reflex
4. Physical inability to be properly positioned at the study devices or eye exam equipment
5. Rigid contact lens wear during 2 weeks prior to day when study device acquisitions take place
6. Soft lenses worn within one hour prior to study device acquisitions
Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation

Some patients with brain tumors receive standard radiation to help prevent tumor growth. Although standard radiation kills tumor cells, it can also damage normal tissue in the process and lead to more side effects. This research study is looking at a different form of radiation called proton radiotherapy which helps spare normal tissues while delivering radiation to the tumor or tumor bed. Proton techniques irradiate 2-3 times less normal tissue then standard radiation. This therapy has been used in treatment of other cancers and information from those other research studies suggests that this therapy may help better target brain tumors then standard radiation.

- Participants will receive proton radiotherapy at the Francis H. Burr Proton Therapy Center which is located at the Massachusetts General Hospital. They will receive the proton radiotherapy 5 days per week. The number of weeks the participant will be receiving proton radiotherapy depends upon the tumor type and location and how well they are tolerating the treatment. Participant's will have a physical exam weekly during proton radiotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven low grade glioma or astrocytoma, ependymoma, craniopharyngioma, meningioma, neurocytoma, medulloblastoma or gangliogliomas or other rare tumor requiring tumor bed or tumor irradiation. Patients with a presumed diagnosis of optic glioma or gliomas based on imaging and clinical characteristics will also be allowed on this trial.
* Patients with biopsy proven high grade glioma (excluding GBM) and a gross total resection and patients with non-disseminated atypical teratoid rhabdoid (ATRT) may also be included.
* Pathologic diagnosis must be based on pathology or pathology review by Department of Pathology at MGH or another DF/HCC institution.
* Age between 1-25 years.
* Life expectancy of greater than 1 year.
* ECOG Performance Status 0, 1, 2 or 3 or Lansky performance status 30 or greater.
* Girls and women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

* Participants who have had radiotherapy to the site to be treated.
* Participants with known spinal or distant metastases. Patients with ependymoma, medulloblastoma or germinoma must have metastatic workup including spine MRI to rule out metastases.
* Uncontrolled intercurrent illness that would limit compliance with study requirements.
* Pregnant or breastfeeding women.
* Patients who cannot participate in contributing to the neurocognitive outcomes due to severe neurologic impairment or language barrier (ie not English or Spanish speaking) will be excluded from this study.
Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination

The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.

The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) of both sexes without upper age limit
* Willingness to sign written informed consent form
* Basic vaccination plus one booster (minimum) of TBE-vaccine,

Exclusion Criteria:

* Age: \< 18 years
* Pregnancy or breast feeding
* Prior TBE infection
* Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study
* Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study
* History of autoimmune disease
* Drug addiction
* Plasma donators
* Administration of other vaccines 4 weeks before/after day 0
* Administration of immunoglobulins 6 weeks prior to any vaccination or blood donation during the entire study period
* Specific Immune Therapy (Hypo-/Desensibilization) within 14 days before and after the 2 study vaccination doses.
* History of any malignant disease 5 years prior to the study entry
* Any contraindication for the administration of the TBE- or influenza vaccine according to the manufactures information.