cyrilzakka/clinical-trials huggingface dataset:
The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury

Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. In this study, our aim is to compare the effects of robot-assisted hand therapy and conventional physiotherapy on hand functions and quality of life in patients with spinal cord injury.

Spinal cord injury (SCI) is considered one of the most devastating injuries that cause lifelong disability.Among the impaired functions, upper extremity function is one of the most important goals of rehabilitation for these individuals.Hand functions are among the most important determinants of independence.Some studies have reported that in more than half of people with tetraplegia, restoring arm and hand function will improve quality of life.Therefore, small improvements in upper extremity function can make a clinically significant difference in feeding, bathing, transferring and other functional activities.Given that the majority of individuals with spinal cord injuries are in their most productive years and life expectancy approaches that of the healthy population, more aggressive treatment strategies that focus on improving peripheral muscle control and recovery of the central nervous system (CNS) are needed.Recently, treatment based on the 'motor learning theory' has been reported to be effective in the recovery of impaired upper extremity function.It has been shown that by repetitive movements as intense as possible to help achieve the ultimate goal of optimum movement, patients are able to learn motor skills that lead to CNS recovery.It has also been suggested that repetitive and activity-based exercise may facilitate recovery after spinal cord injury by inducing practice-dependent brain and spinal cord plasticity.Therefore, repetitive, intensive, and activity-based upper extremity rehabilitative therapy can help improve impaired upper extremity function.In this context, robotic therapy (RT) may be an alternative way of delivering rehabilitative therapy to patients with tetraplegia, as RT can deliver consistently high-intensity, high-repetition, and task-specific training with less effort compared to conventional therapy.

Eligibility Criteria:
Inclusion criteria:

* Mini mental test score \>15
* Able to understand the commands
* Had a function between 1 and 4 in at least one of the key muscle strengths in at least one hand.

Exclusion Criteria:

* Patients with persistent pain in the upper extremity (VAS\>40)
* Patients with severe spasticity in the hand (MAS≥3)
* Patients with severe limitation of joint range of motion / contracture in the hand
* Patients who had fractures or operations in the upper extremity in the last 6 months
* Patients who received botulinum toxin injection to the upper extremity in the last 6 months
* Patients with skin ulcers
* Patients with severe visual impairment and severe depression
* Patients who cannot sit in a chair for more than 30 minutes
* Patients with a history of stroke or progressive neurodegenerative disease
* Patients with neuromuscular disease
* Patients with uncontrolled epilepsy
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

The purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (Lamictal) which is frequently used to treat bipolar depression in the clinical setting. At present, memantine is approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the treatment of bipolar depression. Subjects will be asked to participate because they are suffering from bipolar depression associated and have had an inadequate response to lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.

Hypothesis/Objectives:

H1: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement on the Hamilton Depression Rating Scale (HDRS) and Clinical Global Improvement (CGI) scale compared to patients augmented with placebo.

H2: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement of scores on the Selective Reminding Test (SRT), the Digit Span Test, the Stroop Test, and Trail Making Test (TMT) than patients augmented with placebo.

Study Population:

We will study 40 bipolar disorder depressed (BDD) outpatients (20 in each arm) recruited from the outpatient Mood Disorders Clinic and by advertisement.

Eligibility Criteria:
Inclusion Criteria:: 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder and Major Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treated with at least 100 mg of lamotrigine for at least 4 weeks but 17 item HDRS rating \> 15; 4) give informed consent as approved by local IRB; 5) if on other antidepressants or mood stabilizers on stable dose for the past 4 weeks.

Exclusion Criteria:1) comorbid psychotic disorder such as schizophrenia or schizoaffective disorder; 2) significant suicidal or homicidal risk; 3) clinically significant medical illness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning to be pregnant or not using adequate contraception; 6) satisfy criteria for substance dependence within 6 months prior to start of the study; and 7) on any medication with significant adverse interaction with either lamotrigine or memantine.
Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT

The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up.

150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT).


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspected recurrence of breast cancer
* Blood glucose level less than 8,0 mmol/L

Exclusion Criteria:

* Disqualified patients
* Other malignancies
* \< 18 years
* \< 50 kg
* \> 90 kg
* Pregnant or lactating
* Patients with permanent address outside of the Region of Southern Denmark
* Estimated inability to collaborate
The Effect of Somatosensory Cue on Postural Stability in Blinded Persons

Blind Adults that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate in the movement and Rehabilitation Laboratory at Ben-Gurion University. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). the subjects will be tested in 3 task conditions (eyes blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible.


Eligibility Criteria:
Inclusion Criteria:

* Blind persons
* Able to stand safely for 30 seconds
* Able to walk independently
* Hip OA prior THA

Exclusion Criteria:

* Stroke or other neurological diseases
* Orthopedic surgery at the past year
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers

The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures
* Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lb)

Additional Inclusion Criteria for Participants with Normal Hepatic Function:

* Healthy male or female participants
* No known or suspected hepatic disease

Additional Inclusion Criteria for Participants with Impaired Hepatic Function:

* Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days prior to the Screening visit
* No other ongoing clinically significant abnormalities based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests except for the abnormal findings that are related to the participant's hepatic impairment.
* Satisfy the criteria for Class A or Class B of the Child-Pugh classification (mild: Child-Pugh Scores 5-6 points, and moderate: Child Pugh Scores 7-9 points), within 28 days of investigational product administration.

Exclusion Criteria:

* Has active acute or chronic infection requiring treatment or history of systemic infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis
* Infection with hepatitis B, hepatitis C or HIV
* Any condition affecting drug absorption, distribution, metabolism and excretion (eg, status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal resection)
* Has malignancy, lymphoproliferative disorder, surgery or other condition not allowed per protocol

Additional Exclusion Criteria for Participants with Normal Hepatic Function:

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease

Additional Exclusion Criteria for Participants with Impaired Hepatic Function:

- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score \>9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol
Rotator Cuff Surgery in Athletes: From Rehabilitation to Return to Sport

The main goal of this project is to study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport made by a set of objective shoulder evaluation indicators that are easy to use in clinical context. Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo four evaluation at different times. Healthy subjects will undergo evaluations with the same timing as patients.

Clinical, kinematic and shoulder muscle strength assessments to collect data useful to define objective criteria for progression between rehabilitation phases will be performed according to the following times:

* T1 - 4-6 weeks after surgery: PROM assessment, pain assessment at rest and during PROM, Constant-Murley score (CMS).
* T2 - 6-12 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during PROM and AROM tasks, scapular humeral rhythm, CMS.
* T3 - 12-16 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during PROM and AROM tasks, scapular humeral rhythm, isometric strength assessment, CMS; joint proprioception assessment (joint position sense).
* T4 - 16-24 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), scapular humeral rhythm, isometric strength assessment, CMS, joint proprioception assessment (joint position sense), movement speed and smoothness.

Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo the evaluations. Healthy subjects will undergo evaluations with the same timing as patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Mini Mental Status Examination (MMSE)\> 24
* Acceptance and signature of informed consent

Exclusion Criteria:

* Presence of other pathologies that can compromise the standard post-operative course (shoulder instability; reoperation for failed rotator cuff repair; neurological and cognitive problems)
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients

In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.


Eligibility Criteria:
Inclusion Criteria:

* ages 7-17 years old
* child able to provide assent, and a legal guardian able to provide informed consent
* current diagnosis of pediatric cancer
* undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
* prescribed or expected to be prescribed opioids during inpatient perioperative period
* sufficient mental capacity to comprehend and interact with the game in English or Spanish.

Exclusion Criteria:

* the inability to play with the SpellBound app from English or Spanish instructions
* daily opioid use within 30 days prior to surgery
* any concerns from the treatment team.
Study of Metformin Pharmacogenetics in Twins

The trough concentration of metformin will be examined in monozygotic and dizygotic twins. Current twin study will determine the total weight of genetics on the trough concentration of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Both twins has to be included
* Dizygotic twin pairs has to be same sex
* Informed consent given
* Healthy condition

Exclusion Criteria:

* Chronical/daily alcohol abuse
* Hypersensitivity to metformin
* Ingestion of drugs containing topiramate or x-ray contrast fluids
* For women: Positive pregnancy test/breastfeeding at the beginning of the trial. No use of safe anticonceptives
A Retrospective Study to Evaluate NeuroStar® Advanced Therapy in Adolescents

To assess the real-world effectiveness of transcranial magnetic stimulation (TMS) for depression in large adolescent and young adult samples.

This is a retrospective analysis. The purpose of this study is to collate real world data (RWD) from existing medical records of patients aged 12 to 21 years who received treatment with NeuroStar Advanced Therapy for Major Depressive Disorder (MDD) as determined by scores on the PHQ-9 and CGI-S assessment tool into a central registry database.

Eligibility Criteria:
Inclusion Criteria:

1. Primary diagnosis of Major Depressive Disorder (MDD), according to DSM-4/ICD-9 or DSM-5/ICD-10 criteria applicable on the date treatment with NeuroStar Advanced Therapy begins.
2. 12 to 21 years of age.
3. Male or female.
4. Treatment with NeuroStar Advanced Therapy.
5. Treatment start-date of November 1, 2008, or later.
6. Treatment end date on or before the date on which the retrospective study sample is extracted from the TrakStar database.
7. a) Per Protocol Subjects: Subject received a course of a minimum of 20 treatments with NeuroStar Advanced Therapy.

   b) Intent-to-Treat (ITT) Subjects: Subject received at least one treatment with NeuroStar Advanced Therapy.
8. Treatment with NeuroStar Advanced Therapy to the left dorsolateral prefrontal cortex (DLPFC) only.
9. Treatment with NeuroStar Advanced Therapy according to standardized NeuroStar Advanced Therapy treatment protocols of DASH and/or Standard per the current FDA clearance.
10. Each of GAD-7 and PHQ-9 scores available at each of pre-treatment (defined as the closest score available within 7 days prior to administration of the first treatment) and post-treatment (defined as the closest score available within ± 7 days of the date of the last treatment) evaluations for the single NeuroStar Advanced Therapy course.
11. Subjects with moderate or greater depression prior to NeuroStar Advanced Therapy (pre-treatment), defined as a score on the Physician Health Questionnaire-9 (PHQ-9) ≥ 10 within 7 days prior to the first treatment.

Exclusion Criteria:

- 1. Gap in NeuroStar Advanced Therapy treatment \> 14 continuous days, where applicable.

2. More than one DLPFC treatment session on the same day.
Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease

The goal of this observational study is to learn about the changes in coagulation factor VIII and IX levels in patients undergoing liver transplantation to help guide future management of coagulation factor replacement in patients with hemophilia and liver disease. The question we aim to answer is: should the recommendations for factor replacement in patients with hereditary bleeding disorders be altered in the setting of end stage liver cirrhosis?

Participants will be asked to provide two blood samples, one at the beginning of their liver transplant, and one after their liver transplant.

Current guidelines for management of hemophilia B suggest replacement of factor IX to 100% prior to major abdominal surgery. However, in patients with concurrent liver cirrhosis where the liver does not produce Factor IX, is it worth considering adjusting the factor replacement strategy? We recently had a case of a patient with Hemophilia B and end-stage liver disease (ESLD) who underwent orthotopic liver transplantation and received the standard pre-operative recombinant factor IX replacement. His case was complicated by intra-cardiac thrombus and hypotension. We conduct a small study to assess the pre-operative thromboelastography (TEG) and factor levels in ESLD patient which we hope will help guide clinical decision making in future hemophilia B patients with cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* participants who have end stage liver disease who are listed for liver transplantation and have an accepted organ offer
* age \> 18+
* MELD \> 25

Exclusion Criteria:

* undergoing multi-organ transplant
* tumor MELD exception points
* has hereditary coagulation disease
* currently on therapeutic blood thinner or anti-platelet medication (ie. aspirin, plavix, warfarin, heparin)
The Effect of Yoga on Sleep and Quality of Life in Epilepsy Patients

Determining the sleep quality and quality of life of epilepsy patients and offering solutions can be effective in their success both in their professional and social lives.

Therefore, in this study, it was aimed to evaluate the effectiveness of yoga therapy on sleep quality and quality of life in epilepsy patients.

Yoga is an ancient Hindu practice with documented therapeutic effect in western countries and means perfect control of the body, emotions and mind. It consists of breathing exercises, asanas (posture), relaxation and meditation exercises. Through breathing exercises, various postures, and meditation in yoga, the connection between mind and body is established and a balanced health is assisted.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with epilepsy for at least six months,
* Does not have any disease that causes insomnia and does not use sleeping pills
* Have not participated in a similar regular exercise program in the last 6 months,
* Seizures are under control,
* Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given

Exclusion Criteria:

* Epilepsy patients who do not agree to participate in the study
Phacoemulsification vs SLT as Initial Treatment for Pseudoexfoliation Glaucoma

The Canadian Pseudoexfoliation Glaucoma Study 1 is a randomized clinical trial that aims to compare two initial treatment options - Selective Laser Trabeculoplasty (SLT) and Phacoemulsification (PHACO) - in newly diagnosed patients with pseudoexfoliation and need to lower the intraocular pressure. Patients with pseudoexfoliation and a recent decision to lower the intraocular pressure, who also have early asymptomatic lens opacification will be recruited and randomized to receive either SLT or PHACO. Patients will be followed for 2 years according to a target IOP protocol based on the Canadian Ophthalmological Society Glaucoma guidelines. Patients who do not achieve the target IOP with the initial randomization procedure will receive IOP lowering medications. The main outcome of interest will be the proportion of subjects who need IOP lowering medications after 2 years. Secondary outcomes include IOP reduction, time to need medications, patient reported outcomes in terms of visual function, and occurrence of adverse effects. To obtain longer follow-up information beyond two years, a chart review will be done 5 and 10 years after randomization.


Eligibility Criteria:
Inclusion Criteria:

1. Pseudoexfoliation syndrome, detected at slit-lamp examination by exfoliative material on anterior capsule, pupil, or anterior chamber angle
2. Clinical decision to lower the IOP, as assessed by the investigator who is treating the subject, based on the presence of PXG or with IOP elevated enough to warrant treatment, even without clear evidence of optic nerve damage or visual field defect
3. Presence of asymptomatic early cataract

Exclusion Criteria:

1. Age less than 50 years old
2. Anterior chamber angle closure at gonioscopy, defined as pigmented trabeculum visible in less than 180º
3. Previous IOP lowering procedure such as trabeculoplasty, trabeculectomy, or minimally invasive glaucoma surgery
4. Previous use of IOP lowering medication for more than 6 months
5. Presence of ocular or systemic pathology or medication that could significantly influence the IOP, such as: uveitis, neovascular or traumatic glaucoma, corneal pathology influencing tonometry, use of oral steroids
6. IOP at baseline visit higher than 36 mmHg
7. Visual field damage at baseline visit with mean deviation worse than -15 dB
8. Not able or willing to provide voluntary, informed consent to participate in the study