cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Knowledge and Practice About Prostate Cancer in Male Employees

Analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of a pharmaceutical company.

In Brazil, there are still few published and current studies that explore man's attention and awareness of health. Historically, women attend medical appointments and perform routine tests more frequently than men. For this is very important Analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of Libbs Farmacêutica (a pharmaceutical company in Brazil).

Eligibility Criteria:
Inclusion Criteria:

* Male individuals included in the Libbs workforce;
* Age 18 years or older;
* Subjects who agree to participate in the study after reading and signing the Informed Consent Form.

Exclusion Criteria:

* There is no exclusion criteria
Disclosing a Cystic Fibrosis Diagnosis to a Dating Partner

This study will examine the experience of disclosing a cystic fibrosis (CF) diagnosis to a dating partner. CF has implications for potential life partners (issues of fertility, decreased life span and an increasing need for medical management with age) that may make disclosure particularly sensitive. An understanding of the disclosure process may provide insight into ways health care practitioners can support their patients during this process.

People between 21 and 35 years of age with CF who have been in at least one dating relationship may be eligible for this study.

Participants are interviewed by telephone about their experiences living with cystic fibrosis and telling dating partners about their diagnosis. The interview includes questions about:

* Past experiences disclosing their CF diagnosis to a dating partner
* What information was disclosed versus what was not disclosed
* Why certain information was disclosed or not disclosed
* Positive and negative implications of the disclosure or non-disclosure

The interview lasts about 60 minutes and is tape-recorded for later review and analysis.

Cystic fibrosis (CF) is an autosomal recessive chronic medical condition. As medical treatment is improving more persons with CF are living into adulthood and are entering into serious dating relationships. A diagnosis of CF has medical implications of concern to potential life partners including infertility, decreased life span and an increasing need for medical management with age. In addition, there is a small but non negligible possibility of future children inheriting the condition. These implications may make this type of disclosure a particularly important event in one's life and may affect one's disclosure decisions. Little research has been done on the process of disclosure in this population, and research specifically on disclosure to dating partners is lacking.

This study seeks to gain insight into the experience of disclosing a CF diagnosis to a dating partner through semi-structured in-depth phone interviews with approximately 30 persons who have CF and who vary in gender, age, ethnicity, and severity of their condition. The interviews will explore general experiences of disclosure to dating partners, will focus on selective disclosure of certain information to certain recipients, and will explore the implications of the disclosure or non-disclosure experiences. The qualitative interviews will be transcribed and subjected to thematic analysis, which will identify common themes across interviews. An understanding of the disclosure process experienced by persons with cystic fibrosis may provide insight into ways health care practitioners can support their patients during this process.

Eligibility Criteria:
* INCLUSION CRITERIA:

Self-reported to have been diagnosed with cystic fibrosis.

Self-reported to be in or have been in at least one dating relationship

English speaking.

EXCLUSION CRITERIA:

Younger than 21 years of age; Older than 35 years of age.
Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.

OBJECTIVES: I. Determine the maximum tolerated dose of fludarabine that can be given during the sixth and seventh weeks of radiotherapy in patients with locally advanced squamous cell carcinoma of the oral cavity, pharynx, or larynx, based on the systemic toxicity of the drug and the acute mucosal reactions in the irradiated fields. II. Document the qualitative and quantitative toxicity of this combination therapy in this patient population.

OUTLINE: This is a dose escalation study of fludarabine. Patients receive radiotherapy on days 1-5 for 7 weeks. Patients receive fludarabine IV on days 1-5 of weeks 6 and 7 of radiotherapy. Fludarabine is administered 3-4 hours prior to daily radiotherapy. Cohorts of 3 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose that produces a severe toxicity rate nearest to 20%. Patients are followed every 4 weeks after the completion of treatment until acute reactions have resolved, then every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 1.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx for which surgery would result in significant functional impairment Stage III or IV (T3-4 or N2-3) No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT less than 4 times upper limit of normal PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other concurrent acute illness or infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery

This study evaluates the safety and efficacy of ketorolac for post-operative pain management after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing the requirements for morphine during the (immediate) 24-hour post-operative period.

Current practice at this institution does not include routine use of ketorolac for post-operative pain management of patients undergoing cardiac surgery. The investigators hypothesize that using Ketorolac as an adjunct to IV morphine can positively impact patient outcomes and reduce the occurrence of possible side effects.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \> 18 years of age at the screening visit.
* Undergoing coronary artery bypass graft or single valve repair or replacement requiring cardiopulmonary bypass.
* American Society of Anesthesiology (ASA) Physical Class 3, or 4.
* Willing able to use a PCA Pump
* Willing to receive iv morphine for 24 hours post initial ketorolac dose to control pain.
* Capable of speaking and understanding English sufficiently to provide written informed consent and responses to pain assessment scales and neurological questionnaires.

Exclusion Criteria:

* Allergy or sensitivity to nonsteroidal anti-inflammatory drugs
* History of gastrointestinal bleeding or peptic ulcer
* Serum creatinine = 2.0 mg/dl or rise in serum creatinine of = 0.5 mg/dl or 25% within the preceding 10 days if known with the exception of patients with Dialysis Dependent End Stage Renal Disease (ESRD).
* Hepatic dysfunction
* Patients with low cardiac output syndrome (cardiac index \< 2.0) after cardiopulmonary bypass or pre-op ejection fraction \< 30%
* Inability to operate PCA pump
* Cardiothoracic reoperations
* Bleeding disorder
A Phase III Trial Assessing the Pharmacodynamic Effect and the Tolerability of Grazax Treatment

The study assess the pharmacodynamic effect and the tolerability of Grazax treatment initiated in the grass pollen season in subjects with seasonal grass pollen induced rhinoconjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick test to Phleum pratense
* Positive IgE to Phleum pratense
* signed informed consent
* A clinical history of moderate to severe persistent rhinoconjunctivitis symptoms

Exclusion Criteria:

* No uncontrolled asthma in the past 12 months
* No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
* No history of an IgE mediated systemic reaction due to food, insect venom, any kind of medication or induced by exercise, where there are symptoms both from the skin and the respiratory system with or without hypotension
Neuroimaging Changes in Hereditary Ataxia

This study aim to investigate the neuroimaging changes of hereditary ataxia patients, especially in the SCA3 patients in preclinical or mild stage.


Eligibility Criteria:
Inclusion Criteria:

* genetically diagnosed as Spinocerebellar ataxia

Exclusion Criteria:

* deny to follow-up
Home Monitoring After Primary Total Knee Arthroplasty

Home monitoring technologies have recently emerged in many different areas of healthcare. These technologies are being used to provide rehabilitation to patients, and to prevent, identify, and manage complications. The investigators are proposing a method to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty (TKA) using an electronic home-based patient monitoring system with unique connectivity capabilities and prescriptive controls. The investigators will prospectively, electronically capture range of motion and gait parameters at specified intervals using Bluetooth sensors worn by the patient. The unique in-home patient monitoring platform will be utilized by 10 TKA patients once they return home following surgery. The investigators hypothesize that the use of an internet based home patient monitoring technology platform will reliably provide information related to the patients' pain and function and enhance patient feedback and communication after TKA. The hypothesis will be tested with the following aim: 1) To test the reliability of all technology utilized within the patient's home including but not limited to the sensors, the communication controller, the patient interface (Android tablet) and the internet by prospectively comparing between data collected through the home monitoring technology and traditional clinical measurements taken during physical therapy and surgical follow-up visits.

Over one million primary total hip and total knee arthroplasty (TKA) surgeries are being performed annually in the U.S. and this number is expected to increase over the next seven years, along with a simultaneously projected shortage of trained orthopaedic surgeons to care for these patients. This proposal addresses the optimization of the surgeons' clinical time through utilization of innovative home based technologies to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty. This will be accomplished by establishing home monitoring connectivity with novel technology and measure validated patient-reported outcomes, knee ROM and gait parameters in a postoperative TKA patient's native living environment. It will allow the investigators to prospectively, electronically capture clinically relevant TKA outcomes at the patient's home and provide insight into postoperative rehabilitation progress, predictors of suboptimal clinical outcomes, and guide future randomized controlled trial development to improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary TKA
* Surgery is performed at Cleveland Clinic Main Campus or at Lutheran Hospital
* Patient must reside within 75 miles (driving distance) from Cleveland Clinic Main Campus
* Patient expected to utilize Cleveland Clinic Home Care Services after surgery

Exclusion Criteria:

* Revision or simultaneous bilateral TKA
* English is not the patient's preferred language for healthcare discussions
* Currently participating in any other research study
Study to Assess the Efficacy and Safety of "Pílulas de Lussen®" Compared to the Pyridium® in the Symptomatic Control of Dysuria

Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a total of 80 patients, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo.

Phase III Clinical Study, prospective, multicenter, double-blind, randomized, double-dummy to assess the efficacy and safety of "Pílulas de Lussen®" compared to the Pyridium® in the symptomatic control of dysuria in 80 patients of either sex or race, older than 18 years, with symptoms of dysuria, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo to evaluate the effectiveness and tolerability of 'Pílulas de Lussen' for symptomatic relief of dysuria.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years;
* Patients with symptoms of dysuria characterized by pain/burning sensation in the lower urinary tract and discomfort in urination;
* Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.
* Patients who consent to participate in the study.

Exclusion Criteria:

* Patients with sensitivity to any component of the formula;
* Patients pregnant or lactating;
* Patients with a history of glaucoma, heart failure, cardiac arrhythmias, prostatic hypertrophy, paralytic ileus or pyloric stenosis;
* Patients with menorrhagia or heavy menstrual periods;
* Patients who need to use antibiotics or chemotherapy;
* Patients who can not follow the procedures shown in this Clinical Protocol.
Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function

Benzodiazepine sedative hypnotics are commonly used intravenous anesthetics in clinical practice. Remimazolam is a new benzodiazepine with the characteristics of rapid onset, short maintenance and recovery time, no accumulation, metabolism independent of liver and kidney function, and no serious side effects, which has a good prospect for clinical application. Now we will study the effects of remimazolam on EEG and postoperative cognitive function ，in order to further understand the clinical application of remimazolam.


Eligibility Criteria:
Inclusion Criteria:

* ASAⅠ-Ⅱ
* Patients undergoing elective surgery under general anesthesia.
* Age, sex, and weight were not limited.

Exclusion Criteria:

* Allergic or contraindication to remimazolam/midazolam/remifentanil;
* Abnormal liver and kidney function; Alcohol abuse;
* Long-term use of sedative, analgesic or anxiolytic drugs;
* Hearing and language communication disorders;
* Complicated with severe cardiovascular lesions or neurological diseases.
Fistula Reintegration Pilot

This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility and acceptability assessment.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery for female genital fistula
* Age 18 or above, or emancipated minor per Ugandan law

Exclusion Criteria:

* No further criteria
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels

This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three dose strengths.

There are three parallel groups each with 24 healthy male and female subjects (with a minimum of 10 subjects per gender). Each group receives one dose strength.

The study utilizes a partial replicate cross-over design with three periods and each subject receives the same strength of either the FDC or SET formulation twice.

Screening takes place within 21 days before admission and subjects are admitted on Day -1. Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each dose administration.

Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11 for outpatient assessments.

An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Male subject must agree to not donate semen from the day of first dosing until 3 months after last discharge and practice an effective contraceptive method with female sexual partners to prevent pregnancy.
* Female subject must be of non-child bearing potential, i.e. postmenopausal, surgically sterilized, hysterectomy in medical history, or practicing highly effective non-hormonal birth control.

Exclusion Criteria:

* Female subject who is pregnant, has been pregnant within 6 months before screening or breast-feeding within 3 months before screening.
* Known or suspected hypersensitivity to solifenacin succinate, mirabegron or any components of the formulations used.
* The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit.
* Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
Aggressive Driving and Road Rage: A Driving Simulation Experiment.

Driving a car is the most dangerous behavior most people engage in every day. According to the World Health Organization, about 1.25 million people die each year as a result of road traffic crashes, and they are the leading cause of death among 15 to 29 year olds. According to the National Highway Traffic Safety Administration, 37,461 Americans were killed in motor vehicle crashes in 2016 - about 103 per day. Although there are several causes of traffic crashes (e.g., texting, alcohol consumption, inclement weather), the leading cause is aggressive driving. In the United States, aggressive driving accounts for more than half of all traffic fatalities. Thus, aggressive driving is an important applied health topic, especially for young drivers.

Experimental studies are needed to draw inferences about the causes of aggressive driving. Only six driving simulation experiments have been conducted, and one of these experiment was conducted by the investigators (Bushman, Kerwin, Whitlock, \& Weisenberger, 2017).

The proposed research will test the effects of seven situational risk factors: (1) racing video games (Experiment 2), (2) racial bumper stickers (i.e., "Black Lives Matter" bumper stickers for white motorists vs. "All Lives Matter" bumper stickers for black motorists; Experiment 3), (3) political bumper stickers (i.e., "Donald Trump for President 2016" for Democrat motorists vs. "Hillary Clinton for President 2016" for Republican motorists; Experiment 4), (4) alcohol-related cues (i.e., a case of beer vs. water on the passenger seat; Experiment 5), (5) music with violent lyrics (Experiment 6), (6) music with an upbeat tempo (Experiment 6), and (7) roadside trash (Experiment 7). The proposed research will also test the effects of five situational protective factors: (1) racial bumper stickers (i.e., "Black Lives Matter" for black motorists vs. "All Lives Matter" for white motorists; Experiment 3), (2) political bumper stickers (i.e., "Donald Trump for President 2016" for Republican motorists vs. "Hillary Clinton for President 2016" for Democrat motorists; Experiment 4), (3) music with prosocial lyrics (Experiment 6), (4) music with a calm tempo (Experiment 6), and (5) roadside vegetation (Experiment 7).

Eligibility Criteria:
Inclusion Criteria:

* Participants will be adults recruited from Central Ohio (Franklin County) through advertisements (e.g., newspaper, Internet).
* Participants' ages will vary depending on the experiment. 18 and older for Experiment 1; 18-21 for Experiments 2-4 and 6-7; 21+ for Experiment 5
* All participants must have a current driver license.

Exclusion Criteria:

• Participants who have motion sickness will be excluded.
Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.

Vitiligo is a pigmentation disorder in which white patches of skin appear on different parts of the body. Histologically it is characterized by absence of melanocytes along the epidermal basal layer.

Using cell suspension with non-cultured melanocytes which injected into blister of depigmented lesion, a success rate of 85% was reported for repigmentation. However there are some limitations in this technique: the induction of blister is limited to several sites of the body, hypo-pigmentation around the recipient area due to cryodamage of peripheral melanocytes and leakage of suspension out of the blister. To reduce these problems, in this study we will inject melanocytes directly to epidermis.

A shaved biopsy specimen (about 1 cm2) is taken from the patient's normally pigmented area under local anesthesia (lidocaine hydrochloride 20 mg/ml). The specimens are incubated in 0.25% trypsin solution for 15 minutes at 37°C 0.02% EDTA solution for 10 minutes. Then epidermal sheets are gently manipulated with forceps to dissociate the epidermal cells and to yield a cell suspension, followed by treatment with 0.5% trypsin/versene solution at 37C for 3-5 minutes. Well-dispersed cell suspension is aspirated into 1 ml syringes and injected directly in epidermis.

Eligibility Criteria:
Inclusion Criteria:

* Age over 12 years
* Stable form of vitiligo (no increase in the size of the lesion for at least one year)
* No use of immunosuppressive \& cytotoxic drugs at least for past 6 months

Exclusion Criteria:

* Pregnant patients
* Patients with active disease
* Infection at the recipient site
* Evidence of köebner in the past
* Keloidal tendencies