cyrilzakka/clinical-trials huggingface dataset:
Corneal Endothelium After Glaucoma Surgery

The purpose of this trial is to study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Change in corneal endothelial cell density, hexagonality, and coefficient of variation of cell area will be analyzed and compared to the baseline and between the types of the surgeries.

To study the change in corneal endothelial cell after glaucoma surgery, non-contact specular microscopic examination is performed for the patients who underwent glaucoma surgery; trabeculectomy and Ahmed glaucoma valve implant surgery prospectively. Specular microscopy using non-contact type specular microscope (Noncon Robo SP-8000, Konan Medical Inc., Tokyo, Japan) was performed by one experienced examiner before surgery and 1, 6, 12, 18, and 24 months after surgery. All examinations were done at the center, superior, superonasal, and superotemporal area of the cornea, while the patient maintain fixation at the target in the equipment. The follow-up was stopped if serious complication requiring surgical treatment was developed or additional intraocular pressure lowering surgery is needed, and the data before the second surgery were collected.

Eligibility Criteria:
Inclusion Criteria:

* Patients who need glaucoma surgery for intraocular pressure control

Exclusion Criteria:

* congenital glaucoma
* Pre-existing corneal abnormality
* lost from follow up without any ocular problem within 6 months from surgery
Cognitive Stimulation in Daily Activities for People Living With Early to Middle Stage Dementia

The goal of this study is to test the effect of CS-ADL is on people living with early to middle stage dementia. The study also aims to evaluate the feasibility of conducting larger-scale research of CS-ADL.

The main questions it aims to answer are:

* What is the effect of CS-ADL on the ability of people with early to middle stage dementia to carry out their everyday activities?
* What is the effect of CS-ADL on the memory, mood, communication, and quality of life of people living with early to middle stage dementia? What is the feasibility of conducting large-scale research of CS-ADL?

Participants will take part in a group program that lasts 7 weeks, with one session per week, lasting two hours. Participants will take part in rewarding and stimulating activities, for example discussion, reminiscence, music, and practical activities such as baking, cooking, gardening. Participants will be asked to complete a variety of questionnaires before and after taking part in the group.

Researchers will compare a group receiving CS-ADL to a group receiving their usual care, to explore whether CS-ADL works well in comparison to typical treatment provided by the health services.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a formal diagnosis of major neurocognitive disorder (dementia) as per the DSM-V criteria.
* Participants must have a mild-to-moderate cognitive impairment as classified by the Montreal Cognitive Assessment (MoCA).
* Participants must have some ability to communicate and understand communication, determined by a score of 1 or 0 on questions 12 and 13 of the Clifton Assessment Procedures for the Elderly-Behaviour Rating Scale.
* Participants must be able to see and hear well enough to participate in the group.

Exclusion Criteria:

* Individuals with severe dementia, i.e., an MMSE\<10, will be excluded as most CS interventions are not applicable for those with severe cognitive impairment.
* Participants will be excluded if they have significant uncontrolled disruptive behaviours.
* Premorbid diagnosis of a learning disability.
* A significant physical illness/disability that may affect participation during intervention sessions or assessments.
Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes

This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female subjects who are ≥ 18 and ≤ 80 years old
* Subjects diagnosed with type 2 diabetes at least one year prior to Screening and receiving a stable, therapeutic dose of metformin \> 1500 mg/day according to local prescribing information for at least 3 months prior to Screening or the highest tolerated dose \> 1000 mg/day documented in the subject's history
* HbA1c \> 7.0% and \< 10.5% at Screening
* C-peptide \> 0.8 ng/mL at Screening
* Body mass index (BMI) \> 22 and \< 45 kg/m2 at Screening
* Body weight \< 150 kg at Screening

Key Exclusion Criteria:

* Prior participation in any stem cell study
* Women who are pregnant, intending to become pregnant during the study period or currently lactating
* History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of \>3 alcoholic beverage. Current cigarette smoking \> 10 cigarettes per day
* Severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (\> 2 episodes/week) within one month prior to Screening
* Patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of Screening except if used transiently for \< 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of Screening
* Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), renal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease, or other disorder which in the Investigator's opinion would interfere with the subject's ability to complete the trial, would require administration of treatment that could affect the interpretation of the safety and efficacy variables or would preclude safe involvement in the study.
Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines

The purpose of this research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.

The purpose of this prospective, randomized, double-blinded study is to compare the relative efficacy and safety of intravenous magnesium in conjunction with intravenous prochlorperazine in the treatment of migraines. Participants will be patients presenting to the Emergency Department with primary diagnosis of migraine.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or older
* Able to provide informed consent
* English speaking
* Primary diagnosis of migraine. Patient with a previous diagnosis of migraine, who experience headaches with typical migraine features (e.g at least 2-3 of the following: recurrent, unilateral, pounding or throbbing in nature, associated with nausea), AND with a clinical exclusion of migraine mimics

Exclusion Criteria:

* Pregnancy defined as a positive urine HCG
* Allergy or sensitivity to study drug
* Stated history of renal insufficiency
* Documented history of myasthenia gravis
* Consumption of study drug within 48 hours prior to enrollment
* Previously enrolled in this trial during a different patient encounter
Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon 18.
* Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRα gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting.
* Cohort 3: Participants must have a confirmed diagnosis of unresectable GIST without mutations in the PDGFRα gene exon 18, KIT gene exon 13, and KIT gene exon 14.

Exclusion Criteria:

* Participants who have participated and may participate in any other interventional clinical trail in the future.
* Participants with any comorbidities not suitable for avapritinib (other TKIs, Cohort 4) treatment assessed by researchers.
DermACELL in Subjects With Chronic Wounds of the Lower Extremities

The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).

This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers.

DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment;
* If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days;
* Have a DFU that has been present for at least 30 days or have a VSU that has been present for at least 60 days;

Exclusion Criteria:

* Have a DFU or VSU that is infected;
* Are pregnant or lactating;
* Have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin;
* Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol;
* Have had a HbA1c level greater than 12% within the past 90 days;
* Have liver function tests or kidney function tests that are very elevated;
* Have a known or suspected disease of the immune system;
* Have had surgery in the past 30 days to increase blood flow into your leg or foot;
* Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis);
* Have undergone wound healing treatment with a living skin equivalent (i.e., Dermagraft®, Apligraf®, TheraSkin®, Oasis®, GraftJacket®, Integra®, Alloderm®) or topical growth factors in the last 4 weeks;
* Have active Charcot disease, a weakening of the bones in the foot that can occur in people who have significant nerve damage (neuropathy);
Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial

The study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* cigarette smoker
* wanting to quit in the next 30 days
* preference to quit gradually (vs. abruptly) or having no preference
* access to an iPhone (iOS only)
* completion of a run-in period

Exclusion Criteria:

* no major change in number of cigarettes per day in the past month (+/- 20%)
* no major health diagnoses that could impact study attrition
Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.

To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Aged 18-70 years.
* Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
* Expecting lifetime is over 2 months.
* Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.

Exclusion Criteria:

* Severe drug allergic history or anaphylaxis.
* Severe problems in other vital organs(e.g. the heart, renal or lungs)
* Severe problems in psychiatric disease,such as Schizophrenia,et al
* Severe bacteria infection.
* Malignancies.
* Alcoholism or drug abuse.
* Plan to have liver transplantation in 3 months.
* Pregnancy
* Candidates who are participating in other study.
Reliability and Validity Study for SWE of Shoulder Muscles in Persons After Stroke.

This study aims

1. To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke.
2. To assess if differentiation can be made between the hemiplegic (HP) and non-hemiplegic (NHP) side and between stroke patients and matched healthy volunteers (discriminative validity).
3. To assess if an immediate effect on the pectoralis major and minor can be measured after applying transversal stretch technique to the pectoralis major muscles (response validity).

Stroke patients will be assessed on 2 days with an interval of 3 days (Friday - Monday).

Day 1 (Friday): shear wave velocity (SWV) will be assessed by 2 assessors in randomised order. Each assessor will evaluate SWV of 6 shoulder muscles (m. supraspinatus, m. infraspinatus, m. rhomboid major, m. deltoideus, m. pectoralis major, m. pectoralis minor).

At the end of the assessment secondary outcome measures will be assessed.

Day 2 (Monday): SWV will be reassessed by assessor 1 to measure test-retest reliability.

Position of the patient will be changed. SWV of the pectoralis major and minor muscle will be reassessed.

Assessor 2 will perform a transversal stretch of the m. pectoralis major or a passive mobilisation of the hand at the hemiplegic arm of the stroke patients. Assessor 1 will reassess the SWV of the pectoralis major and minor muscle to assess if there is an immediate effect of the intervention. Assessor 1 will be blinded for the intervention.

Healthy controls (matched for age, gender and BMI):

Only one test day to assess SWV of 6 shoulder muscles. Secondary outcome measures will be assessed after SWE assessment.

Eligibility Criteria:
Stroke group

Inclusion:

* Stroke patients in the subacute phase after stroke (\< 6 months post stroke)
* Able to sit independently with support of the back, but without support of the arms
* With upper-limb (UL) impairment: i.e. no maximum score (36) on the shoulder elbow part of the Fugl-Meyer UL (FM UL)

Exclusion Criteria:

* Other neurologic disorders
* Shoulder or neck surgery before stroke onset
* Arthroscopic surgery in the last year before stroke onset.
* Shoulder or neck pain in the last year before stroke onset.
* Severe cognitive or language deficits that inhibit the participants of understanding simple commands or providing valuable information regarding the outcome measures - measured with the Ability Q.
* Participants who are not able to maintain the test position.
* Pregnancy

Healthy controls can participate if they

* Have not suffered a stroke or other neurological disorders
* Did not have surgery at the shoulder and/or neck
* Did not have arthroscopic surgery in the last year before stroke
* If they do not suffer any shoulder or neck pain
A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study

This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences).

Subjects will attend three study visits. During Visit 1, subjects will be screened for participation \[i.e., medical history, routine blood work, background baseline diet\]. During Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency). Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation, respectively, with the probiotic dietary supplement or placebo.


Eligibility Criteria:
Inclusion Criteria:

* all participants were required to be between 30-60yr
* score ≥12 on the GSRS
* have a body mass ≥120 pounds (54.5kg)
* body mass index (BMI) between 20.0-34.99kg/m2
* normotensive (\<140/\<90mmHg)
* normal resting heart rate (\<90bpm)

Exclusion Criteria:

* Female participants who were pregnant or nursing
* history of unstable or new-onset cardiovascular or cardiorespiratory disease;
* stroke, diabetes, or other endocrine disorder;
* use of any nutritional supplement known to alter the gut microbiota/microflora;
* use of probiotic supplements or prebiotic supplements in the previous 4 weeks and for the duration of the study;
* use of any antibiotics, antifungals, antivirals, or antiparasitic within 8 weeks of the start of the study or throughout the study;
* any changes in diet within 4 weeks of study start date or throughout study duration;
* if the participant was unwilling to abstain from gut altering supplements for the study;
* malignancy in the previous 5yr except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin);
* prior gastrointestinal bypass surgery (i.e., Lapband);
* any known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism \[e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU)\];
* any chronic inflammatory condition/disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.);
* known sensitivity to any ingredient in the test formulations as listed in the certificates of analysis.
* currently participating in another research study with an investigational product or had participated in another research study in the past 30 days
* any other diseases/conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Improving Sleep in Cancer Patients: A Feasibility Trial

The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.

This research study is a single arm feasibility trial in which all eligible participants receive five weekly sessions of CBT-I (cognitive behavioral therapy for insomnia) delivered before or during their cancer treatments. CBT-I is a non-drug behavioral treatment for insomnia and is considered the most effective treatment for insomnia. However, CBT-I is not routinely offered to cancer patients due to unknowns about its feasibility in this population. Data will be obtained at pre- and post-CBT-I and at eight-week follow-up, and will focus on acceptability, implementation, and efficacy in order to assess feasibility. The study will focus on cancer patients who are diagnosed with gastro-intestinal (GI) cancer.

Eligibility Criteria:
Inclusion Criteria:

1. 18+ years of age
2. have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments)
3. are diagnosed with gastro-intestinal cancer;
4. have life expectancy \> 6 months;
5. are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure;
6. will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I;
7. are English-speaking and able to provide voluntary, written consent.

Exclusion Criteria:

1. unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment;
2. other sleep disorders;
3. bipolar disorder;
4. unmanaged serious mental illnesses;
5. suicidal ideation/intent/plan;
6. unstabilized pharmacological treatment for insomnia;
7. night-shift employment.
Femoral Cartilage Thickness In Patients With Lower Limb Amputation

The aim of the study to investigate any relation with functional parameters and femoral cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.

In this prospective observational study, subjects approached Tertiary Rehabilitation Clinics for prothesis recipe or long term outpatient follow up was 150 people. Among them 76 subjects accepted to enroll study. Informed consent was taken. Subjects firstly performed clinical parameters at the first doctor's control. Knee radiography has been performed.

Eligibility Criteria:
Inclusion Criteria:

* Being a single lower limb amputation
* At least one year after the amputation operation
* Prosthesis use for the last 6 months
* Being traumatic or vascular
* Not having stump infection
* Muscle strength over stump should be at least 3/5

Exclusion Criteria:

* Doing quadriceps exercise in the last 3 months
* Trauma, surgery, and knee injections within 6 months (PRP, hyaluronic acid), Chondroitin-glucosamine use.

Being any of the active synovitides, Rheumatoid arthritis, spondyloarthritis, pseudogout, coxarthrosis, neuromuscular diseases

* Having an additional disease that will cause psychiatric adjustment problem
* Subjects are younger than 18 years
* Bilateral amputated
Enhancing the Outcomes of a Behavioral Parent Training Intervention

This study is a feasibility trial, testing the hypothesis that among sedentary mothers of behaviorally at-risk preschool-aged children, those who receive behavioral parent training (BPT) programs and concurrently increase their physical activity levels will demonstrate improved parenting and child behavior outcomes compared to those who receive BPT but remain sedentary.

The investigators will randomly assign 20 participants to two groups: behavioral parent training plus contingency management to increase steps (BPT+CM) or behavioral parent training alone (BPT). Contingency management procedures will involve monetary rewards for meeting weekly step-count goals.

The specific aims of the proposed project are to: 1) assess the feasibility of the study design and procedures, 2) assess the acceptability of the BPT+CM condition to participants, and 3) determine whether a signal of an effect of increased physical activity exists (via preliminary comparisons of measures of fatigue, perceived energy, parenting behaviors, parenting sense of competence, parenting stress, and child behavior ratings between participants in the two conditions).

This innovative pilot study will prepare us for a fully powered trial to test the efficacy of this approach.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 years or older
* Custodial caregiver of a child aged 2-5 years who lives full-time in the caregiver's home
* Reports that her child has behavioral problems
* Never or rarely engages in regular physical activity
* Able to understand, speak, and read English

Exclusion Criteria:

* The child has been diagnosed with a severe developmental condition (e.g., extreme developmental delay, severe autism, debilitating neurological conditions)
* Participant reports a condition that may contraindicate physical activity (e.g., asthma)