cyrilzakka/clinical-trials huggingface dataset:
Spinal Cord Injury Virtual Coach RCT

The SCI Virtual Coach study has developed an on-screen, human-like character that will provide support, education and coaching to adults with spinal cord injury (SCI) to aid in the prevention of serious secondary conditions like pressure ulcers. In a randomized controlled trial, participants assigned to "the Coach" intervention will have a touch-screen computer placed in their homes and be asked to interact with the Coach on a daily basis for 2 months. Participants will be asked to complete surveys at baseline and 2 months.

The SCI Virtual Coach study aims to measure how accessible and usable participants feel the Coach is, as well as participants' adherence to the Coach's instructions. It will also gauge how effective the Coach is in changing self-care knowledge, health care behaviors, self-efficacy for self-care, and perception of social support in participants.


Eligibility Criteria:
Inclusion Criteria:

* Self-report of physician-confirmed chronic spinal cord injury diagnosis
* Injured within the last 6 months -10 years
* Speaks and understands conversational English
* Lives within approximately 1 hour of Boston, MA

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Expected to live less than 1 year
Observational Study to Investigate the Effectiveness and Safety of Olostar Tab in Patients With Essential Hypertension and Dyslipidemia

The purpose of this study is to investigate the effectiveness and safety of Olostar Tab in patients with essential hypertension and dyslipidemia


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 19
* Patients have record of blood pressure (SBP/DBP) and LDL-C after prescription of Olostar Tab.

Exclusion Criteria:

* Patients that have participated clinical trials or PMS with Olostar Tab.
Vascular Endothelial Growth Factor (VEGF) in Uveitis

This study will look for the presence in blood of a substance called vascular endothelial growth factor (VEGF) in patients with uveitis (eye inflammation). It will also look for this substance in eye fluid samples taken from patients with uveitis who are undergoing eye surgery.

Some patients with uveitis experience some vision loss during an inflammatory attack because of swelling (edema) in a particular area of the retina called the macula, which is involved in visual acuity. It may be that VEGF is involved in the development of macular edema.

Patients with uveitis who participate in this study will have about 10 cc (2 teaspoons) of blood drawn to be examined for VEGF. They will also undergo a procedure called fluorescein angiography to look at the blood vessels of the eye. A dye called sodium fluorescein is injected into the blood stream through a vein. After the dye reaches the blood vessels of the eye, photographs are taken of the retina.

In addition, patients with uveitis who are undergoing eye surgery will have a tissue specimen (either aqueous fluid or vitreous gel) collected for examination for the presence of VEGF.

Increased intraocular and systemic levels of the angiogenic factor vascular endothelial growth factor (VEGF) is associated with new vessel growth in the eye, such as diabetic retinopathy. Recent work using immunopathologic techniques have shown that VEGF is upregulated in both experimentally induced uveitis and in uveitic eyes as well, with no evidence of neovascularization. This pilot study will evaluate the level of VEGF in the blood of uveitic patients with and without macular edema. This level will be determined also in the ocular fluid of those patients that are undergoing ocular surgery. These levels will be compared with age and sex matched controls.

Eligibility Criteria:
For Uveitis Patients:

Evidence on ocular examination in the past or presently of intraocular inflammation, with cells and haze in the vitreous for the intermediate and posterior uveitis patients.

In order to demonstrate the presence or absence of macular edema, a fluorescein angiogram will be attempted on all patients. However, if the patient is unable or not willing to undergo the test, then if two observers from the LI can substantiate independently that there is or is not evidence of cystoid edema, the patient may be included.
An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1D

This is an open-label, multicenter, Phase 1 study evaluating the safety and tolerability of VCTX210A combination product in patients with T1D

VCTX210A combination product (unit) comprises 2 components: (1) allogeneic pancreatic endoderm cells (PEC210A) genetically modified using Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9 (CRISPR/Cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain the PEC210A cells.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of T1D for a minimum of 5 years
* Stable, optimized diabetic regimen for at least 3 months prior to enrollment

Exclusion Criteria

* Medical history of islet cell, kidney, and/or pancreas transplant
* Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment
* Known causes of diabetes other than T1D
* Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study
* Prior treatment with gene therapy or edited product
Venous Sinus Stenting for Idiopathic Intracranial Hypertension Refractory to Medical Therapy

Idiopathic Intracranial Hypertension (IIH) is a disease that affects mainly young people, and is associated with headache and loss of vision. The medical and surgical management of IIH is problematic and many patients are not treated effectively. Some cases of IIH are associated with severe stenosis of the large veins of the brain and various researchers have recently reported significant improvement in patients with IIH after the narrow veins of the brain were treated with a stent. Our project aims to evaluate the safety and long-term efficacy of venous sinus stenting in patients with severe IIH refractory to medical management.


Eligibility Criteria:
INCLUSION CRITERIA

1. Age \> 18 years
2. Established diagnosis of Idiopathic Intracranial Hypertension according to the criteria of the 2004 International Classification of Headache Disorders (Table 3).
3. Visual field loss: One of criteria A, B or C must be fulfilled.

   A. Severe visual function loss, defined as grades 4 and 5 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at initial presentation.

   B. Moderate visual function loss, defined as grade 3 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at presentation and failure of treatment with acetazolamide (Diamox) given at efficient dose (2g/d or maximum tolerated dose) or Topiramate (Topamax) given at efficient dose (maximum 150mg daily). Failure is defined by the absence of visual function improvement after 1 month of treatment and/or medication intolerance.

   C. Mild visual function loss, defined as grades 0,1 or 2 on the Humphrey Visual Field Analyzer SITA Standard 24-2 Test grading scale (Table 4) at presentation and a worsening to moderate or greater visual function loss, defined as grades 3-5, after 1 month of treatment and/or medication intolerance.
4. Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV) demonstrating bilateral transverse sinus stenosis or unilateral transverse sinus stenosis with contralateral transverse sinus hypoplasia or atresia. At least one of the stenoses must cause ≥ 50% reduction of the sinus lumen diameter.
5. Signed informed consent obtained from the patient.
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients

This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for unilateral cataract surgery

Exclusion Criteria:

* Ocular, topical, or oral corticosteroids within 7 days of Day 0
Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid

To assess Collagen Drink on skin condition and sleep quality improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing
* Constant drug use
* Received facial laser therapy, chemical peeling or UV overexposure (\>3 hours everyday) in the past 4 weeks.
* Students taught by the PI
Reinforced Feedback in Virtual Environment

The aims of the study is to explore whether the rehabilitation of the upper extremity performed in interaction with a virtual environment could improve motor function in post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the traditional neuromotor rehabilitation treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients affected by a stroke occurring in the period no longer than 1 year before the enrolment
* both first ischemic and hemorrhagic stroke
* subjects who did not had RFVE treatment previously
* scoring higher than 24 points in the Mini-Mental State Examination test

Exclusion Criteria:

* upper extremity complete hemiplegia
* upper limbs sensory disorders
* clinical evidence of cognitive impairment
* neglect
* apraxia
* comprehension difficulties
* post-traumatic injury of the upper limb
A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain

This trial aims to compare two training programs for children suffering functional abdominal pain. These two programs are comparable in number of sessions and group sizes, but show differences in content (very focused on pain management vs. more general information and support). Focus of the trial is the evaluation of "Stop the pain", which has shown high effectiveness in one first trial. This time, five clinics, experienced in diagnosis and treatment of childhood chronic abdominal pain, will take part. Children aged 7-12 years are eligible. The programs imply six weekly group sessions for the children and 2 parent evenings. The study group assumes that participation in "Stop the pain" will reduce pain experience and will improve the children's quality of life and coping strategies - up to 12 months after training.

The trial aims to assess the efficacy of a cognitive-behavioral self-management program (intervention group, IG) compared to an equally extensive information-only control group (CG). The interventions contain 6 weekly group sessions and 2 parent meetings according to the cognitive-behavioral, manualized program "Stop the pain with Happy Pingu". Follow up per patient: 3- and 12 months. Children aged 7-12 years suffering functional abdominal pain (according to Rome III criteria H2a, H2b, H2d, H2d1) are eligible. Our primary hypothesis is that for patients in the IG the frequency and intensity of pain will be reduced more successfully and more sustainable than for children in the CG. Secondary hypotheses state that the IG will experience a higher increase in quality of life and psychosocial well-being compared to the active CG.

Eligibility Criteria:
Inclusion criteria for medical screening:

* aged 7-12 years
* abdominal pain for at least 2 months
* abdominal pain at least once per week
* unclear cause for abdominal pain

exclusion criteria for medical screening:

* very limited German language skills
* mental retardation
* adjuvant psychological treatment at point of medical screening
* participation in a trainingsprogram for abdominal pain in the 6 months prior to medical screening
* participation in a clinical trial which possibly may have effects on abdominal pain in the 4 weeks prior to medical screening
* at point of medical screening: therapy or medication for abdominal pain
* presentation of sibling aged 7-12 years

Inclusion Criteria for study participation:

* pain-predominant functional gastrointestinal disorders according to Rome-III
* criteria (H2a, H2b, H2d, H2d1)
* informed consent for study particiaption
* informed consent for audiotaping of trainings sessions
* no time constraints for participation in training groups

Exclusion Criteria for study participation:

* psychiatric disorder (internalizing) with primary treatment indication
* severe externalizing disorder
Natural History and Outcomes in X-Linked Hypohidrotic Ectodermal Dysplasia

The proposed natural history study will enroll male and female patients, ages 36 months and younger, who have a diagnosis of XLHED based on genetic testing and who have not received an investigational study drug. The study protocol will include collection of all relevant medical history and documentation of clinical outcomes using age-appropriate, minimally invasive technologies. Data will be collected both retrospectively, back to pregnancy assessments that may be available, and prospectively through age 5 yrs.

Important to the development and regulatory approval of therapies for XLHED will be the collection of data on the clinical history and prospective health of those affected by XLHED. The proposed natural history study will enroll male and female patients, ages 36 months and younger, who have a diagnosis of XLHED based on genetic testing and who have not received an investigational study drug. The study protocol will include collection of all relevant medical history and documentation of clinical outcomes using age-appropriate, minimally invasive technologies. Data will be collected both retrospectively, back to pregnancy assessments that may be available, and prospectively through age 5 yrs. Genotype-phenotype correlations in XLHED, based on well-documented health records and prospective assessments on genetically-confirmed individuals, may now provide new and clinically-predictive information for the benefit of patients, families, health care providers and clinical investigators designing trials for therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled in this study:

1. Confirmed genetic diagnosis of XLHED
2. Written informed consent of both parents (if reasonably available)

Exclusion Criteria:

Subjects who meet any of the following criteria cannot be enrolled in this study:

1. Medically-significant complications or congenital anomalies outside of those considered to be associated with the diagnosis or status of XLHED
2. Having received an investigational study drug prior to enrollment. For subjects less than 6 months of age, the mother cannot have taken an investigational drug during her pregnancy.
3. Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists
4. Presence of pacemakers
Biomechanical Parameters of Gait in Patients with Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.

The aim of this study is to compare biomechanical walking parameters between patients with symptomatic lumbar spinal stenosis and healthy elderly.


Eligibility Criteria:
Inclusion Criteria:

Patients with lumbar spinal stenosis

* Having a diagnosis of lumbar spinal stenosis (at least 1 level)
* Having neurologic claudication due to the lumbar spinal stenosis

Healthy elderly

* Being over 50 years old of age
* No back or leg pain during walking

Exclusion Criteria:

* Symptomatic hip or knee Ostearthritis
* Not able to give their free consent
* Being in a wheelchair (not able to walk 30 meters)
The Feasibility and Efficacy of an Extremely Brief Mindfulness Practice

This study will assess the efficacy of brief mindfulness practices on improving mental health in adults who are currently in treatment for mental health concerns. From online instructional videos, each participant will learn a thirty-second or three-minute mindfulness practice that is to be performed at least three times daily over two weeks.

Mindfulness meditation and mindfulness-based therapies have been shown to improve many aspects of psychological functioning in individuals with mental health problems.

The purpose of this study is to assess the feasibility, acceptability, and efficacy in improving mental health of brief mindfulness practices in adults currently in treatment for mental health concerns. The entire study will be administered online. From online instructional videos, each participant will learn a thirty-second or three-minute mindfulness practice that is to be performed at least three times daily over two weeks. A delayed-treatment control group will begin the intervention after a two-week waiting period.

Eligibility Criteria:
Inclusion Criteria:

* Regular internet access
* Able to listen to audio files
* Currently receiving outpatient care
* No change in type of psychotherapy during the past month
* If taking medications, a stable, unchanging prescription for the previous month
* Willingness to sign release of mental health care information
* Capacity to provide informed consent

Exclusion Criteria:

* Does not speak and read English
Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion

Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops.

Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops. Patients will be studied with ultrasound for 4 weeks after PICC insertion, one visit a week. The final outcome of PICCs will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Peripherally Inserted Central Catheter insertion

Exclusion Criteria:

* Pre-existing Deep Vein Thrombosis
CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening （CITRUS Study）

The aim of this study is to assess efficacy of the screening with concurrent liquid-based cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 30-64 years old
2. Participants provided written informed consent

Exclusion Criteria:

Women who

1. will receive planed HPV DNA testing by local governmental cervical cancer program next six years
2. have had cervical invasive cancer before
3. have undergone cervical conization
4. have undergone hysterectomy
5. have had or have the cytological abnormalities and are under follow-up
6. are pregnant
7. are judged ineligible for this trial by physician
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations

BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles.

Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643.

Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.

BH-30643 is a novel, orally available, reversible, mutant selective, macrocyclic OMNI-EGFR inhibitor that targets mutations in the EGFR kinase domain, including EGFR classical, atypical (also called uncommon or nonclassical), and ex20ins mutations, and a variety of EGFR resistant mutations (eg, ex19del/T790M, ex19del/C797S, ex19del/T790M/C797S, L858R/T790M, L858R/C797S, and L858R/T790M/C797S), as well as HER2 mutations including ex20ins mutations. In addition, BH-30643 has demonstrated good selectivity over wildtype EGFR and HER2. This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years or legal adult.
* Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
* Had received standard therapies.
* Has at least 1 measurable target extracranial lesion according to RECIST v1.1.
* Eastern Cooperative Oncology Group Performance Status ≤ 1.
* Has a life expectancy of ≥ 3 months.
* Has adequate hematologic, hepatic, and renal function. \*The above are a summary; other Inclusion Criteria details may apply.

Exclusion Criteria:

* History of any concurrent malignancy within the previous 2 years.
* Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).
* Unresolved toxicities from prior therapies.
* Any significant and uncontrolled medical condition, such as infection.
* History of interstitial lung disease from any cause
* Clinically significant cardiovascular event within 6 months or significant history of major organ.
* Actively receiving investigational therapy(ies) in another clinical study. \*The above are a summary; other Exclusion Criteria details may apply.
Study on Ocular Blood Flow and the Orbital Cerebrospinal Fluid Pressure in Glaucoma

Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in flow velocities in the retrobulbar arteries in what appears to be related to the degree of the glaucomatous disease.

The anatomic pathway of the several arteries into the eye is intricately complicate, with at least one of them (the central retina artery) penetrating the optic nerve before entering the eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central nervous system, this central retinal artery has also to cross this CSF containing compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial pressure at the orbital level - the possibility exists that this pressure around the optic disc could affect the blood flow of the arteries that go through it.

The investigators will try to detect if a correlation exists between the optic nerve sheath diameter and the blood flow in the retrobulbar vessels of glaucoma patients.

1. Visual field testing will be performed.
2. Structural analysis of the retinal nerve fiber layer (through confocal microscopy)will be performed.
3. Color Doppler Imaging of the retrobulbar vessels will be performed. Peak and end diastolic velocities, resistivity index will be calculated from the Doppler waveform.
4. B-scan ultrasound of the optic nerve sheath diameter will be performed. the measure will take place at 3mm behind the globe.

Eligibility Criteria:
Inclusion Criteria:

* individuals over 18 years old
* willing to sign an informed consent and able to comply with the requirements of the study
* having no other ocular diseases besides glaucoma

Exclusion Criteria:

* history of ocular trauma
* intraocular surgery (except for cataract surgery)
* eye disease (except glaucoma)
* systemic diseases with ocular involvement like diabetes