cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing

The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

The study design is to validate the pulse rate accuracy. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Subjects must be 18 years or older
* Ability to comprehend written consent and provide informed consent
* Ability to commit to and complete study related paperwork and activities (i.e. subject forms, have de-identified pictures taken, comply with periods of no movement, etc.)

Exclusion Criteria:

* Pregnant women
* Diagnosis of essential tremor or any medical condition causing tremors of the head or hands
* Facial tattoos, scars, large moles, beards/hair growth, birthmarks, vitiligo, skin conditions, facial discoloration, or heavy makeup within the areas of interest
* Inability for subject to avoid extreme movement during measurement reading windows
* Inability for subject to raise their hand during measurement reading windows
* No heart arrythmias
* Discretion of the Principal investigator or clinical study staff
Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients

Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells showed promising results in regulating immune system and promoting some degree of disease control. The aim of our study is to determine the safety and efficacy of intravenous infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.

Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. First, bone marrow derived adult mesenchymal stem cells are collected from a first degree relative and cultured. After that, the patient receive 4 intravenous infusions 1 week apart followed by 4 infusion 4 months apart.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
* Less than 6 weeks from diagnosis

Exclusion Criteria:

* Previous diabetic ketoacidosis
* Pregnancy
* Severe psychiatric disorder
* Severe organic impairment (renal, hepatic, cardiac, pulmonary)
* Active infectious disease
* Previous or present neoplastic disease
Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

The aim of this non-dispensing study is to evaluate the fitting performance of MyDay™ 8.4 base curve, especially for flatter corneas, and compared it with 1-DAY ACUVUE® TruEye® 9.0 base curve and DAILIES TOTAL1® 8.8 base curve in a range of spherical powers.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft spherical contact lens wearer
* Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
* Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Patient contact lens refraction should fit within the available parameters of the study lenses
* Is willing to comply with the wear schedule
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Is not a habitual wearer of soft spherical contact lenses
* Has a contact lens prescription outside the range of the available parameters of the study lenses
* Has a contact lens prescription outside the range of the inclusion power range
* Has a spectacle cylinder ≥1.00D of cylinder in either eye
* Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
* Presence of clinically significant (grade \> 2) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Moderate to severe dry eye
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study
Duration of Postop Analgesia After Inguinal Hernia Surgery Treated with TAP Block Vs II/IH Nerve Block

Comparing Postop Analgesia after Inguinal Hernia Surgery treated with TAP Block Vs Ilioinguinal/ Iliohypogastric Nerve Block

Comparison of Mean Duration of Postoperative Analgesia in Patients undergoing Inguinal Hernia Surgery treated with Transversus Abdominal Plane Block Versus Ilioinguinal/ Iliohypogastric Nerve Block

Eligibility Criteria:
Inclusion Criteria:

* Patients giving written informed consent
* Patients undergoing Inguinal Hernia surgery
* patients with ages 18-60 years
* ASA 1 and 2 patients

Exclusion Criteria:

* INR \> 1.0 (patients with bleeding tendency)
* EF \< 45 % (patients with cardiac dysfunction)
* FEV1 \< 80 % of normal (patients with pulmonary dysfunction)
* patients with renal disease
Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)

The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to quantify the possible deleterious effect on the cardiac autonomic nervous system control of two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.

This is a cross-over study with randomization in terms of 4 treatments: two long-acting muscarinic antagonists (tiotropium and glycopyrronium), one long-acting beta-adrenoceptor agonist(indacaterol) and placebo.

Each subject will pass 4 experimental random sessions, separated by at least 48 hours given the pharmacokinetic properties of the drugs tested. During each of the 4 sessions, blood pressure will be measured. Drugs inhaled by the patient will be prepared and administered by the nurse according to the randomization schedule. Patients and investigators will be blinded regarding the administered drug/placebo (anonymized inhaler). After 15 minutes (at rest, at neutral temperature), patients will have continuous measurement of blood pressure and heart rate (by a sphygmomanometer) (1) in supine position and (2) after a passive tilt test on a tilt test table.

A flow-volume loop (BDV) will be performed after the tilt table test (measurement of Forced expiratory volume in 1 second (FEV1) and FVC).

Eligibility Criteria:
Inclusion Criteria:

* patients with FEV1 / FVC \<70%

Exclusion Criteria:

* beta blocker
* supraventricular rhythm disorder
* previous history of respiratory disease other than COPD
* diabetes
* autonomic dysfunction
* dysautonomia
* renal failure
* long-term oxygen therapy
* history of psychiatric illness
Pelvic Floor Muscle Training With and Without Hypopressive Exercises in Postmenopausal Females.

To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females

In this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,UTIs and neoplasm). This study will be conducted in Jinnah hospital , Lahore. Sample size of 36 will be taken according to inclusion criteria. Study will be completed in 10 months after approval of synopsis. Non-Probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the Pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. Treatment period will be 12 weeks 3 days per week. The participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). All subjects will be assessed before and after treatment by POP-Q, pelvic floor impact questionnaire and P-QOL. Data will be analyzed by using SPSS 25 statistical software.

Eligibility Criteria:
Inclusion Criteria:

* Multigravida
* Previous spontaneous vaginal deliveries
* Diagnosed Stage 1 and 2 pelvic organ prolapse
* Post-menopausal females

Exclusion Criteria:

* History of cesarean section
* History of ovarian cysts
* History of UTIs
* History of neoplasm
* Instrumental deliveries
Observational Study of Synovian® Inj. in Patients With Osteoarthritis in the Knee

This is an observational study to evaluate the injection site reactions of Synovian® Inj. in patients with osteoarthritis in the knee


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patient of over 19 years of age
* A patient diagnosed with knee osteoarthritis
* A patient who has been informed of the purpose, method of the study and signed the written informed consent form.

Exclusion Criteria:

* A patient who shows hypersensitive reaction to the Synovian® Inj. or to the ingredients of Synovian® Inj.
* A patient with infection at the joint
* A patient with skin infection or skin disease at the injection area
* A patient diagnosed with osteoarthritis with the Kellgren \& Lawrence Grade IV in X-ray within 12 months before enrollment of this study.
A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. We hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). We anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. This new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. Further, it could be applied to other chronic illnesses affecting disadvantaged populations.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma
* Persistent asthma (criteria based on NHLBI guidelines).
* Age \>12 and \<15 years.
* Attending school in the Rochester City School District.
* Signed physician permission to enroll the child.
* Current prescription of a daily preventive asthma medication
* Parent or caregiver and the adolescent must consent to the intervention.

Exclusion Criteria:

* Inability to speak and understand English.
* No access to a working phone for follow-up surveys
* The family planning to leave the school district within fewer than 6 months.
* The teen having other significant medical conditions
* The teen having a diagnosed developmental condition per parent report.
* Adolescents in foster care or other situations in which consent cannot be obtained from a guardian.
* Adolescents that were previously enrolled in our School-Based Asthma Study
Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma

The goal of this study is to determine the utility of cerebrospinal fluid (CSF) cell-free DNA (cfDNA) as a prognostic biomarker in glioblastoma (GBM).


Eligibility Criteria:
Inclusion Criteria:

Cohort A

* Participants must be able to understand and be willing to sign a written informed consent document
* Age ≥ 18 years
* MRI with contrast-enhancing lesion concerning for high-grade glioma in absence of known systemic malignancy
* Clinical consensus of presumed diagnosis of high grade glioma between (1) neuroradiology (2) neurosurgery; and (3) principal investigator
* No prior tumor directed therapy
* Planned radiation therapy for glioblastoma
* Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast
* Patients must be willing to consent to MSK IRB#12-245

Cohort B

* Participants must be able to understand and be willing to sign a written informed consent document
* Age ≥ 18 years
* Histologic confirmed glioblastoma (WHO grade IV), IDH wild type per IHC
* No prior tumor-directed therapies except surgical resection or biopsy
* Patients who have gliadel wafers placed during upfront surgery are excluded
* Planned radiation therapy for glioblastoma
* Patients must be willing and able to tolerate MRI scans and/or CT scans w/ contrast
* Patients must be willing to consent to MSK IRB#12-245

Exclusion Criteria:

Cohorts A and B

* Any case for which there is a medical contraindication or safety concern regarding a lumbar puncture under standard medical guidelines at MSK
* Refusal to undergo serial lumbar punctures
A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Immunosuppressant therapy.
* Antiviral therapy such as zidovudine.
* Prophylaxis for Pneumocystis carinii pneumonia.

Concurrent Treatment:

Allowed:

* Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

* No prior systemic antifungal therapy for cryptococcosis.
* Relapse after prior therapy.
* Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

Prior Medication:

Allowed:

* Immunosuppressant therapy.
* Antiviral therapy (such as zidovudine).
* Prophylaxis for Pneumocystis carinii pneumonia.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
* Moderate or severe liver disease.
* Comatose.
* Unlikely to survive more than 2 weeks.
* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Medication:

Excluded:

* Coumadin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications.
* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
* Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.

Concurrent Treatment:

Excluded:

* Lymphocyte replacement.

Patients with the following are excluded:

* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
* Moderate or severe liver disease.
* Comatose.
* Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded:

* Coumadin-type anticoagulants.
* Oral hypoglycemics.
* Barbiturates.
* Phenytoin.
* Immunostimulants.
* Investigational drugs or approved (licensed) drugs for investigational indications.
* Excluded within 4 weeks of study entry:
* Greater than 1 mg/kg/wk amphotericin B.

Prior Treatment:

Excluded:

* Lymphocyte replacement.
Study to Evaluate the Feasibility of Community-based Test and Treat Strategies Among Men Who Have Sex With Men and Transgender Women to Increase the Uptake of HIV Testing and Treatment Services in Thailand

HIV counseling and testing, risk reduction counseling, provision of condoms and lubricants Same-day result HIV testing along with pre-test and post-test counseling, including risk reduction counseling, will be provided according to the standard practice at each study site at enrollment and every 6 months in HIV-negative participants. HIV-negative participants can also access non-occupational post-exposure prophylaxis service and symptomatic STD service if these are available at study sites. HIV-positive participants will also receive risk reduction counseling every 3 months. Condoms and lubricants will be provided free of charge.

This study is a prospective observational cohort study that will enroll up to 6,000 Thai MSM and TG from drop-in centers in Bangkok, Chiang Mai, Chonburi and Songkhla. Each participant will have HIV testing at baseline and will be followed up for 18 months.

HIV-negative participants will be asked to have HIV re-testing every 6 months. HIV-positive participants will have POC CD4 testing and ART initiation regardless of CD4 count will be offered. Those who accept ART will be followed up at week 2, week 4, month 2, month 3 and every 3 months thereafter. Those who deny ART will be followed up every 3 months.

Uptake of HIV re-testing will be determined. Access to POC CD4 testing and acceptability of ART initiated at HIV diagnosis regardless of CD4 count along with ART adherence will also be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Thai national
2. Age \>18 years
3. Men or transgender women who report unprotected anal intercourse with a man at least one time in the past 6 months
4. Not known to be HIV-positive, i.e., never tested for HIV or previous HIV test(s) negative
5. Willing to participate in the study
6. Provide written informed consent

Exclusion Criteria:

1. Known HIV-positive serostatus
A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer

In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of NSCLC
* Locally advanced or metastatic disease (Stage IIIB or IV).
* Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
* Disease status must be that of measurable disease as defined by RECIST criteria
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.

Exclusion Criteria:

* Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
* Concurrent administration of any other tumor therapy.
* History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
* Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
* Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone