cyrilzakka/clinical-trials huggingface dataset:
Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke

This pilot study will examine a combination therapy for adults with chronic, severe motor impairment of an arm after stroke. The intervention will combine brain stimulation with physical rehabilitation of the arm on the side of the body more-affected by stroke.

The overarching goal of this program of research is to develop a therapy that produces meaningful and persistent improvements in function of the more-affected arm in stroke survivors with severe, chronic hemiparesis. No treatment with an established evidence base is available now for this large group, who have barely perceptible voluntary movement of the more-affected fingers and wrist. The lab of E. Taub and G. Uswatte has developed an expanded version of Constraint-Induced Movement therapy (CIMT) for this population that has evidence of efficacy for improving use in daily life of the more-affected arm from a case series and small randomized controlled trial (RCT). The original version of CIMT is a form of physical rehabilitation that has evidence of efficacy from multiple RCTs for improving use in daily life of the more-affected arm in adults with mild to moderate hemiparesis after stroke. CIMT has also been shown to produce neuroplastic changes in both grey and white matter structures. Expanded CIMT (eCIMT) combines CIMT with neurodevelopmental techniques (NDT) for managing tone. Studies from by J. Szaflarski and by others suggest that priming CNS tissue for training by electrically stimulating the brain regions that control the target function with excitatory intermittent theta burst stimulation (iTBS) augments the benefits of neurorehabilitation. This pilot study will evaluate the feasibility of combining eCIMT with brain stimulation by iTBS and, on a preliminary basis, will evaluate whether this combination therapy boosts treatment outcomes relative to eCIMT alone.

Eligibility Criteria:
Inclusion Criteria:

* stroke
* \> 12 months after stroke onset
* severe hemiparesis of more-affected arm

Exclusion Criteria:

* substantial use of the more-affected arm in daily life
* frailty or insufficient stamina to carry out the requirements of the therapy
* other neurological or musculoskeletal problems, including pain, affecting the more-affected arm
* severe cognitive deficits
The Effects of Rifampin on the Pharmacokinetics of Rosuvastatin

The effect of transporter inhibition by rifampin on the pharmacokinetics of rosuvastatin will be studied in clinical trial in White and Asian healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Asian volunteers of Han-Chinese/Japanese/Korean descent whose parents and grandparents are Han-Chinese/ Japanese/ Korean.
* Healthy Caucasian volunteers of White/Caucasian/European-born descent whose parents and grandparents are White/Caucasian/European.
* Male or female, ages 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam, and laboratory evaluations.
* Subjects who take no other medications two weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications, dietary supplements, or drugs of abuse.
* Subjects with the following genotype: SLCO1B1\*1a and ABCG2 421CC.
* Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use.
* Subjects able to abstain from grapefruit, grapefruit juice, oranges, orange juice, caffeinated beverages and/or alcoholic beverages from 7am the day before the study to completion of that study day.
* Participants determined to have normal liver and kidney function as measured at baseline
* BMI between 18.0 - 30 kg/m2
* Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing.
* Be able to read, speak, and understand English.
* Subjects capable of providing informed consent and completing the requirements of the study.

Exclusion Criteria:

* Subjects with active medical problems
* Subjects on chronic prescription or OTC medication that cannot be stopped 2 weeks prior to and during the study.
* Subjects incapable of multiple blood draws (HCT \< 30mg/dL)
* Subjects with a history of rhabdomyolysis
* Subjects with a history of drug-related myalgias
* Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias
* Subjects with a history of GI bleed or peptic ulcer disease
* Subjects who smoke tobacco or have ongoing alcohol or illegal drug use
* Subjects who are pregnant, lactating, or trying to conceive during the study period
* Subjects allergic to rosuvastatin or rifampin or any known component of the medications
* Anyone who in the opinion of the study investigators is unable to do the study
Long Term Clinical and Functional Outcome in Rotationplasty Patients

Rotationplasty is a very special surgical technique. In its most frequent variant it allows, in the bone sarcomas of the distal femur, to remove all the thigh tissues including the knee joint keeping intact the innervation of the leg and the foot that are transplanted proximally after a 180 ° rotation and joined to the proximal femoral stump.

It is currently the first choice in children under the age of 6 with a bone sarcoma localized to the distal femur but also finds indication in all age groups in cases of extremely voluminous and extended to the entire thigh with the oncological need to remove in block femur, knee and all the muscular involved. The objective of the study is to obtain information about the clinical and functional status of the limb operated in long-term surviving patients. In particular in this study the problem of the possible degenerative pathology of the hip on the operated side will be addressed. Moreover the psychic and psychological well-being of this population with particular reference to gender and motherhood will be tested.

30 long term survivors of rotationplasty patients at the IOR will be welcomed by the research team. They will be introduced to the aims of the research and the methodology and timing of the assessment.

The two-day agenda will be communicated to perform in a coordinated manner so that each patient performs all the exams:

* X ray pelvis
* Physiatric, orthopedic and prosthetic examination
* Proprioceptive test with Delos system
* Psychological questionnaires

Eligibility Criteria:
Inclusion Criteria:

- Rotationplasty patients operated at IOR

Exclusion Criteria:

- Disagreement of patient to participate to the study (or of part of it)
Open Label, Continuation Study of Cholic Acid in Subjects With Inborn Errors of Bile Acid Synthesis

The primary purpose of the study is to evaluate the therapeutic efficacy and safety of cholic acid in subjects with identified inborn errors of bile acid synthesis.

This is a Phase 3, open-label, single center, nonrandomized study. This continuation protocol will consist of eligible subjects who have previously received cholic acid through the Cincinnati Children's Hospital Medical Center (CCHMC) Compassionate Use (91-10-10), CAC-001-01 study protocols and newly diagnosed subjects.

New subjects will be infants, children, adolescents identified from urine samples obtained from the clinical services of programs across the U.S., Canada, South America, Europe, and Asia. Subject or their legal representative will receive information regarding the study, and the principle investigator (PI) or designee will obtain informed consent. Serum and urine samples will be collected and sent to CCHMC to measure complete bile acid profile analysis. Clinical records including medical history, physical exams, vital signs, and laboratory assessments performed as standard of care will be reviewed to ensure subject eligibility and determine baseline values.

Subjects who have participated in Protocols conducted under IND 45,470 will be consented to continue to receive cholic acid capsules under this continuation protocol. Subjects will serve as their own controls and no placebo will be utilized.

Eligibility Criteria:
Inclusion Criteria:

Subjects who received cholic acid through CCHMC protocols 91-10-10 or CAC-002-01 and meet the following criteria are eligible for study participation.

1. The subject and/or parent/legal guardian must have provided informed consent prior to study start.
2. The subject must have a diagnosis of an inborn error of bile acid synthesis.
3. The subject must be willing and able to comply with all study assessments and procedures.
4. Subjects with other organ dysfunction will not be excluded
Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms

A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also

MEN1 patients are eligible:

* PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 \<5%, or:

  * PNET \< 2cm with Ki-67 \<10% that has shown progression during surveillance, or:
  * PNET 1.5-2 cm with Ki-67 \<10% in patients age \< 60 years of age, whether progression is detected or not.
* Distance from the main pancreatic duct ≥2 mm, or \<2mm with a prophylactic stent in the main pancreatic duct.
* Patient in good general condition, ECOG performance status 0-2 (see Appendix)
* Signed written informed consent

Exclusion Criteria:

* Pregnancy.
* Life expectancy \< 1 year
* Severe hemostasis disorders
* Pancreatic and/or biliary ductal dilation
* Evidence of active pancreatitis
* Metastatic disease, including local lymph node metastases
* Use of anticoagulants that cannot be discontinued
* INR \>1.5 or platelet count \<50.00
* Distance from the main pancreatic duct \<1 mm, and placement of a pancreatic stent is not possible
* Patient being managed for another malignant lesion which is progressive or under treatment
Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty

The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.

The study will randomize patients between an uncemented and cemented stem

Eligibility Criteria:
Inclusion Criteria:

* Acute Displaced femoral neck fracture
* Subject is aged between 65-79 years
* Independent walker with or without walking aides
* Subject is able and capable of providing consent to participate in the study

Exclusion Criteria:

* Patients with Rheumatoid Arthritis
* Patients with an impaired cognitive dysfunction
* Patients with Pathological fractures
* Patients with substance abuse
* Patients with fracture older than 36-hours on arrival at the A\&E
* Patients suffering from cancer
* Patients determined by principal investigator to be unsuitable for inclusion
Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum

This study is intended to be an evaluation of the properties of human sputum collected from patients with COPD. It is hypothesized that cationic airway lining modulators will have beneficial effects on the rheological properties of sputum derived from patients with COPD. Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be collected and tested in laboratory tests.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical and spirometric diagnosis of COPD
2. Smoking history of at least 10 pack yrs
3. Sputum production of greater than 2 tablespoons per day by patient report.

Exclusion Criteria:

1. a primary diagnosis of asthma or bronchiectasis
2. a COPD exacerbation within 4 weeks
3. Inability to comply with study procedures.
Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain

The purpose of this study is to study the effect of a physical exercise program on patients suffering from migraine and co-existing tension-type headache and neck pain. The investigators hypothesized that migraine patients are ofte physically inactive because of their headache and that they will benefit from a specific exercise program.

Migraine and tension-type headache are among the most common neurological diseases and are causing reduced quality of life, private and socio-economic consequences in terms of medical consumption and work-related absenteeism. The clinical experience shows that physical activity, like cycling and brisk walking, can prevent migraine attacks, but the evidence of the efficacy is sparse.

The primary aim of the study is to investigate the acute and the long term effect of exercise on patients suffering from migraine and co-existing tension-type headache and neck pain.

The project will be the first of its kind that explores the effect of an exercise program on patients who both suffer from migraine, tension-type headache and neck pain. We expect that the participants from the exercise program will achieve a reduced pain impact on everyday life, an improved fitness and quality of life, and a decrease of absence days and medication use.

Eligibility Criteria:
Inclusion Criteria:

* Migraine
* Tension-type headache
* Neck pain

Exclusion Criteria:

* Whiplash injury or other significant neck trauma
* Nerve root compression
* Post traumatic headache
* Medication overuse headache
* Cluster headache
* Trigeminal neuralgia
* Pregnancy and breast feeding
* Severe physical and psychological illnesses
* Alcohol and or drug abuse
* Current insurance claim owing to headache
* Persons not able to speak or understand Danish
* Persons deemed not to implement the program because of musculoskeletal pain or physical limitations
Hearty Meals for Mom- Pilot Study of Meal Delivery for Cardiometabolic Health During Pregnancy

This study is being done to assess the feasibility, acceptability, and preliminary impact of a meal delivery intervention designed to improve diet quality and promote appropriate gestational weight gain among predominantly Black and low-income pregnant women with overweight or obesity. This will be done by 1) assessing the feasibility and acceptability of the meal delivery intervention; 2) investigating changes in patient-reported diet quality, barriers to healthy eating, and food security; and 3) exploring the preliminary impact of the meal delivery intervention on gestational weight gain and blood pressure and estimate the effect size of the intervention relative to a de-identified non-randomized control group that will be derived from de-identified hospital records.

Subjects will receive 10 home-delivered meals per week from about 20 weeks gestation until 40 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* Medicaid eligible and/or have a household income at or below 185 percent of the federal poverty line
* 18 years of age or older
* \<= 19 weeks gestation
* Currently experiencing a singleton pregnancy
* Receiving prenatal care at a University of Alabama at Birmingham clinic
* Planning to deliver at the University of Alabama at Birmingham
* Residing within the meal company's delivery radius
* Body mass index \>= 25
* Willing to consent

Exclusion Criteria:

* Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 diabetes)
* Current treatment for severe psychiatric disorder (such as schizophrenia)
* Current substance abuse
* Self-reported diagnosis of anorexia or bulimia
* Known fetal anomaly
* Current use of medication expected to significantly impact body weight
* Planned termination of the current pregnancy
* Participation in another dietary and/or weight management intervention during the current pregnancy
* Unwilling or unable to understand and communicate in English
* Unwilling or unable to consume study meals
Umbilical Vessel Catheterization Under ECG Monitoring and Guidance

Umbilical venous catheters (UVC) are typically places with poor guidance and some radiological confirmation. Misplacement of the catheter could lead to its placement in other unintended anatomical areas such as the liver or the spleen, which could be detrimental in critically-ill infants. Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram (ECG) tracings.


Eligibility Criteria:
Inclusion Criteria:

* Neonate pediatric patient
* 2 - 6kg
* Require or currently have UVC

Exclusion Criteria:

* Participants who do not consent or have parental consent
* Patients who are clinically unstable
Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up

Background: A real challenge faces practitioners in dealing with permanent molars in young patients starting from proper selection of endodontic treatment system till the type of final coronal restoration. For permanent molars in young age patients, which system should be followed to guarantee better performance and enhance the integrity of such weakened teeth? The question most commonly asked.

Purpose: To evaluate two-year clinical performance of endocrowns as permanent restorations for endodontically treated molars in young age.

Endodontic treatment will be done for all patients using ProTaper Next rotary files and iRoot SP sealer. Then patients were randomly divided into two groups;

Gr 1: Conventional group (CG), the coronal cavity will be restored directly with bulk-fill nanohybrid composite restorations.

Gr 2: Endocrown group (EG), the coronal cavity will be restored with IPS e.max CAD endocrown restorations.

* First step: Endodontic treatment protocol will be used as the following:

  1. Biomechanical preparation using; 2.6% NaOCl for irrigation, ProTaper Next rotary files for instrumentation and 17% EDTA gel for lubrication.
  2. Obturation of root canal using; ProTaper gutta-percha and iRoot SP sealer.
* Second step: Endocrown restoration protocol will be used as the following:

  1. Occlusal Butt joint design for Endocrown preparation.
  2. Putty-wash technique for taking impression.
  3. IPS e.max CAD for Endocrown construction.
  4. G-CEM self-adhesive resin cement for Endocrown cementation.
* Follow up visits: The patients will be recalled every 6 months for evaluation.
* Evaluation methods:

  * Endodontic treatment evaluation: The outcome will be evaluated clinically and radiographically.
  * Endocrown restoration evaluation: The outcome will be evaluated clinically in terms of; marginal adaptation, marginal discoloration and surface alteration.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were systemic free.
2. Mature lower permanent first molar needs conventional endodontic treatment.
3. The remaining coronal tooth structure after endodontic treatment is not less than 50%.
4. Presence of teeth in opposite arch with normal occlusion.
5. Absence of para-functional habits.
6. Supra-gingival margin after preparation.
7. No known allergies.
8. Complaint patient (parent/ guardians)

Exclusion Criteria:

1. Immature lower permanent first molar.
2. Presence of teeth, whose coronal anatomy does not allow use of rubber dam for optimum bonding.
3. Lack of cooperation of the patients to perform a postoperative radiograph and use a rubber dam for bonding.
Fluid Oriented Therapy During Major Abdominal Surgery

In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 patients

Exclusion Criteria:

* Severe Caridiac Disease
* Renal Failure
FILtration of Subarachnoid Hemorrhage Via SpinaL CAtheteR Extension

The objective of this study is to further demonstrate safety and characterize effectiveness of the Neurapheresis™ System (extracorporeal system and catheter) to remove red blood cells (RBCs) and lysed blood by-products from hemorrhagic cerebrospinal fluid (CSF) following aneurysmal subarachnoid hemorrhage (aSAH).

The PILLAR-XT study is designed to further confirm safety and characterize efficacy of Neurapheresis therapy. The study works in tandem with the current SOC treatments for SAH and does not detract from the established care pathways, or deny enrolled subjects proven therapies. The PILLAR-XT study utilizes the established skill sets of chosen Investigators who are already trained in the treatment and care of SAH patients and insertion/management of lumbar drains.

Eligibility Criteria:
Inclusion Criteria:

* Modified Fisher Grade 2, 3 or 4
* Hunt \& Hess I-IV
* First aneurysmal SAH
* Patient is ≤ 48 hours post bleeding event
* World Federation of Neurosurgeons (WFNS) Grades I-IV

Exclusion Criteria:

* Pregnancy
* Patients with a SAH due to mycotic aneurysm or AV malformation
* Patients who present with an acute MI or unstable angina
* Imaging demonstrates supratentorial mass lesions \> or = 15 cc
* Imaging demonstrates \> or = 2 mm of mid-line-shift associated with infarction and or edema
* Effacement of the basilar cisterns
* Vasospasm on admission as defined by angiographic evidence
* Patients with a coagulopathy that cannot be reversed
* Thrombocytopenia def. platelet count \< 100,000
* Patients on low molecular weight heparin such as Lovenox
* Non-communicating Obstructive hydrocephalus
* Existing hardware that prevents accurate CT imaging
* Pre-existing Lumbar Drain
* Local skin infections or eruptions over the puncture site
* Signs of CNS systemic infection, sepsis or pneumonia
Confirmatory Study of MT-2412 in Japanese Patients With Type 2 Diabetes (Add-on Study of Canagliflozin)

The purpose of this study is to evaluate the efficacy and safety of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 24 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Men or women who are 20 - 75 years old
* HbA1c of ≥7.0% and \<10.5%
* FPG of ≤ 270 mg/dL
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before run-in period

Exclusion Criteria:

* Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
* Patients with serious diabetic complications
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with severe hepatic disorder or severe renal disorder.