cyrilzakka/clinical-trials huggingface dataset:
ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.

OBJECTIVES:

* Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839.
* Determine the median time to objective progression in these patients receiving this drug.
* Determine the toxic effects of this drug in this patient population.
* Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage IV or recurrent renal cell carcinoma not amenable to potentially curative surgery
* Evidence of disease progression
* Measurable disease

  * At least 20 mm with conventional techniques OR
  * At least 10 mm with spiral CT scan
* No brain metastases
* Malignant tissue available

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2 OR
* Karnofsky 60-100%

Life expectancy:

* More than 2 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN

Cardiovascular:

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other:

* No prior allergy to compounds of similar chemical or biologic composition to ZD 1839
* No ongoing or active infection
* No other uncontrolled illness or psychiatric condition that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunotherapy

Chemotherapy:

* No more than 1 prior chemotherapy regimen
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No prior therapy for metastatic disease
* No other concurrent investigational agents
* No concurrent oral retinoids
Prospective, Multicenter HCCIS Evaluation Study

With this prospective, multicenter trial the investigators aim to establish the Hepatocellular Immune Score (HCCIS), a score that has been developed in a retrospective study, as a new tool for risk stratification of patients after resection of hepatocellular carcinoma that can be widely used in the clinical practice. The investigators expect to show that this score is a prognosticator for overall survival and also disease free survival. Further, it should be demonstrated that the HCCIS is a risk stratification tool that is independent from clinical or descriptive parameters. Additionally, the investigators plan to elucidate that the respective HCCIS risk groups are not only different with respect to immunological infiltration but are also different with respect to tumor biology. The finding, that tumors of the respective risk groups show different tumor biology leads to the assumption that different therapy strategies need to be applied. Therefore, in a translational approach we aim to build up a data base with HCC tumor organoids and test the effect of CD8+IL-33+ effector-memory cells on HCC tumor organoids of the respective HCCIS risk groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old who are receiving primary liver resection in curative intent for HCC after informed consent is obtained.

Exclusion Criteria:

* Patients who have not given informed consent or who have withdrawn their consent will be excluded from this analysis. In case there is not enough liver tissue for a histological analysis or the remaining liver tissue is not enough to perform a routine pathological analysis patients have to be excluded from the further analysis. In case of an R1 or R2 resection, patients have to be excluded from further analysis. However, these patients will remain in the study as an intention to treat analysis.
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.

The objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.

The objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.

The following evaluations will be assessed as "yes" or "no":

* Cold flow (dark ring formed around the patch)
* Patch movement/displacement
* Patch wrinkling
* Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.

AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).

As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.

Exclusion Criteria:

* Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
* History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
* History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
* History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.
A Study to Evaluate Absorption, Metabolism, and Excretion of 14C-JNJ26489112 in Healthy Male Participants

The purpose of this study is to evaluate the absorption, the metabolic pathways (a series of metabolic reactions) and the excretion of JNJ26489112 in healthy male adult participants after administration of a single oral dose of 1000 mg of 14C-JNJ26489112.

This is a single-dose, 1-arm (group), open-label study (all people know the identity of the intervention) in healthy adult male participants. On Day 1, after completing a 10-hour overnight fast, participants will receive a single oral dose of 14C-JNJ-26489112 1,000 mg as a 10-mL suspension. Participants will be recruited in 2 cohorts. The 6 participants in the first cohort were dosed in error with doses less than 1000 mg. So, an additional cohort of 4 participants will be enrolled to receive a single oral dose of 1000 mg 14C-JNJ 26489112. Total 10 participants will receive the study medication. Safety will be assessed by monitoring vital signs, physical examinations, electrocardiograms, and clinical laboratory tests throughout the study. The total duration of the study for each participant will be approximately 5 weeks (including up to 3 weeks for screening and 11 to 15 days of study) or up to 1 additional week for participants who excrete 14C-JNJ26489112 more slowly.

Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent document indicating they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing to adhere to the prohibitions and restrictions specified in the protocol
* Had consistent bowel movement habit (approximately once per day) within 30 days before dosing
* Blood pressure (after the participant is supine for 5 minutes) is between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
* A 12-lead electrocardiogram consistent with normal cardiac conduction and function

Exclusion Criteria:

* Exposure to radiation for professional or medical reasons with the exception of up to 2 standard diagnostic radiographs (eg, dental X-rays, plain chest X-ray) or participation in any investigational study involving radioactivity within 1 year before study drug administration on Day 1
* History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center
* Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram at screening or at admission to the study center
* Clinically significant ocular deficits, including retinal disorders
Optimisation of Monitoring for Clinical Research Studies

OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the classic standards of quality assurance, and the other one being a priori "optimized" on the main scientific and regulatory principles.

There is no validated standard of monitoring strategy for clinical research studies. Optimon will compare two monitoring strategies - a classical strategy based on the practices of the pharmaceutical industry, and an optimized strategy based on patient's risk level - on their ability to produce exact data, focusing on the main quality criteria: regulatory requirements and scientific validity of results. Optimon is a non inferiority randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Research Studies: risk level A, B, or C in the Optimon risk-assessment scale, with or without a sponsor and the advice of an ethical committee, starting in 2008 and ending before the end of 2010, with a foreseen accrual of 20 patients or more, multicentric with at least 4 clinical sites, with a paper or electronic CRF, with the participating agreement of the coordinating investigator and the sponsor.
* Clinical sites: Sites with a foreseen accrual of 5 patients at least, with the participating agreement of the principal investigator.
* Clinical Research Units: with the label of an institution, with at least 2 years of experience in multicentric studies, with SOPs finalized before 2008, willing to participate in Optimon.

Exclusion Criteria:

* N/A
Prevalence and Variables Associated With Depression in Subjects With Chronic Wounds Using PHQ-9 as a Screening Tool

The objective of the study is to complete a retrospective chart review of subjects who were treated at the Wound Care Clinic at Methodist Dallas Medical Center, presented for treatment between June 2018 and February 2019, and were administered the PHQ-9. The study aims to measure the prevalence of depression in this sample, feasibility of using PHQ-9 in this patient population, and identifying variables and functional impairment associated with clinically significant depression.

The study will review medical records of new patients who presented to the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019. These patients were all administered PHQ-9 as part of a quality improvement project. The medical records included for analysis will be from male and female patients aged 18 years or older. The medical records will be reviewed for the following information: general demographics, information including age, sex, ethnicity, race, PHQ-9 score (total and individual items), medical conditions, wound history, past medical history, general symptoms, abuse and suicide risk, activities of daily living, motivation assessment, mental status, and pain ratings. This information will be used to measure the prevalence of clinically significant depression in the sample, which is the primary aim. We will also use the data to establish factors and variables correlated with the presence and severity of clinically significant depression.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Received care at the Wound Care Center at Methodist Dallas Medical Center between June 2018 and February 2019
3. Completed a PHQ-9 form at the time of initial evaluation/examination

Exclusion Criteria:

1. Patients less than 18 years of age will be excluded from the study
ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry

This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.


Eligibility Criteria:
Inclusion Criteria:

- Potential subjects must satisfy all of the following criteria to be enrolled in the study:

* Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses.
* A minimum age of 18 years, with no maximum age.
* The registrant must read and sign the Informed Consent form.
* The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

- Potential subjects who meet any of the following criteria will be excluded from participating in the study:

* Current participant in another research study.
* Employee or relative of site, or family member of Recruiting Practitioner or Johnson \& Johnson.
* Non-spherical contact lens wearers, i.e. toric or multifocal lenses.
Manual Therapy Force Perception Scale

The objective of this observational study is to pilot a scale designed to assist clinicians in evaluating the force they perceive during manual therapy.

The main question it aims to answer is:

- Are clinicians able to evaluate the force they use when delivering manual therapies to their patients using a scale?

For the pilot test, licensed chiropractors administer manual therapies on a manikin.

The aim of this observational study is to pilot test an ordinal scale (the Manual Therapy Force Perception \[MTFP\] scale) intended to enable clinicians to assign ordinal rankings to their patients based on their perception of the force they applied during manual therapy . This involved evaluating the agreement between the force applied by clinicians during spinal manipulations and mobilizations delivered on a manikin and their subjective perception of force, as determined using the MTFP scale. Additionally, the pilot study aimed to seek feedback on the MTFP scale from clinicians who are its potential users.

Eligibility Criteria:
Inclusion Criteria:

* Licensed chiropractors with a private practice within the province of Quebec, Canada.

Exclusion Criteria:

* Having a condition that prevents the execution of approximately 50 manual therapies over a 1-hour period.
Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial

The first objective is to determine the efficacy of calcium and vitamin D supplementation at doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in non-institutionalized elderly people.

The second objective is to measure and compare treatment groups (calcium and vitamin D vs placebo) as regards muscle strength and musculoskeletal function, bone mineral density, calcidiol level and treatment safety.

Background:

There are many studies that associate vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. However, current evidence is insufficient to make a general recommendation for administrating calcium and vitamin D to older persons. The objective of this study is to determine the effectiveness of calcium and vitamin D supplementation in improving musculoskeletal function and decreasing the number of falls in person aged over 65 years.

Design:

Phase III, randomized, double blind, placebo-controlled trial to evaluate the efficacy of already marketed drugs in a new indication. It will be performed at Primary Care doctor visits at several Healthcare Centers in different Spanish Health Areas. A total of 704 non-institutionalized subjects aged 65 years or older will be studied (sample size calculated for a statistical power of 80%, alpha error 0.05, annual incidence of falls 30% and expected reduction of 30% to 20% and expected loss to follow up of 20%). The test drug containing 800 IU of vitamin D and 1000 mg of calcium will be administered daily. The control group will receive a placebo. The subjects will be followed up over two years. The primary variable will be the incidence of spontaneous falls. The secondary variables will include: consequences of the falls (fractures, need for hospitalization), change in calcidiol plasma levels and other analytical determinations (transaminases, PTH, calcium/phosphorous, albumin, creatinine, etc.), change in bone mass by densitometry, change in muscle strength in the dominant hand and change in musculoskeletal strength, risk factors for falls, treatment compliance, adverse effects and socio-demographic data.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 65 years with normal renal function
* Normal transaminase levels
* Normal calcium blood levels
* Not homebound (not immobilized) nor in socio-healthcare institutions.

Exclusion Criteria:

* Need for medical treatment with calcium or vitamin D
* Hypersensitivity to or contraindication for calcium or vitamin D
* Medical treatment that includes calcium or vitamin D
* Physical disability that impedes their collaboration
* Taking thiazide diuretics
* Oral anticoagulants
* Hormone replacement therapy
* Digitalis drugs
* Anticonvulsants or barbiturates
* Having any of the following diseases:

  * Lithiasis
  * Renal impairment (serum creatinine \>1.4 mg/dl)
  * Hypo or hyperthyroidism
  * Paget's disease
  * Chronic liver disease
  * Tumors
  * Sarcoidosis
  * Impaired intestinal absorption or chronic alcoholism (\>40 g/day).
Bipolar Scissors for Circumcision

comparing the outcomes of using bipolar scissors for male circumcision to the classic scalpel method

A prospective, randomized study, comparing two different techniques for pediatric male circumcision: the bipolar diathermy scissors technique with that of a classic scalpel technique. Study included male infants from 40 days old up to 18 month old. They were reviewed regarding Operative time, bleeding, complications, postoperative pain and morbidity. Differences in the outcome were compared.

Eligibility Criteria:
Inclusion Criteria:

* Male infant between 40 days and 18 month old
* parents' request and approval of circumcision

Exclusion Criteria:

* previous attempts of circumcision or revision cases
* bleeding tendency
* congenital anomalies involving genitalia
* age below 40 days (expected Vit. K deficiency) or above 18 month old.
The Effect of Calisthenic Exercises

This study will investigate the effects of physical activity in young adults. With the increase in physical activity, the change in smartphone addiction, pain and sleep quality parameters will be evaluated.

This study aims to increase physical activity with a calisthenic exercise program. An answer will be sought to the question of whether increased physical activity causes changes in phone addiction, pain and sleep quality parameters.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study.
* Being between the ages of 15-35.

Exclusion Criteria:

* Individuals with an orthopedic and/or neurological disease that will affect their sleep health and/or pain level,
* Individuals with physical disabilities,
* Individuals who have undergone any surgical procedure in the last 6 months.
Virtual Reality Intervention for Speech Anxiety

Exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate whether mood state moderates outcome to a brief VR exposure intervention.

The goal of this clinical trial is to compare outcomes of VR exposure therapy for college students with public speaking anxiety following a positive or negative mood induction. The overarching aim of the present study is to determine whether mood state prior to engaging in a brief VR exposure therapy session for public speaking anxiety impacts treatment outcomes.

The study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing VR based exposure therapy. Public speaking and social anxiety outcomes are measured immediately post-intervention and one week later.

Researchers will compare participants given a positive mood induction to participants given a negative mood induction to see if public speaking anxiety outcomes differ.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of 18 years of age or older
* Current student at Boston University
* Ability to read English to provide informed consent
* Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet).
* For Phase 2: speech anxiety scale score of ≥ 14 on the Personal Report of Communication Apprehension, Public Speaking Subscale (PRCA-PS)

Exclusion Criteria:

* Previous participation (i.e., no participant may take the survey more than once).