cyrilzakka/clinical-trials huggingface dataset:
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* HIV disease related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.

Concurrent Medication:

Excluded:

* Zidovudine (AZT) therapy during the double-blind phase of study.

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease.
* HIV disease related dementia.
* Uncontrolled hypertension (diastolic blood pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.
* Zidovudine (AZT) therapy and during the double-blind phase.

Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia.

* Clinical diagnosis of AIDS or ARC.
* Clinically stable for 1 month preceding study entry.
* Patients should preferably be transfusion dependent.

Substance abuse.
Effect of an Exercise Bout in Plasma and Fecal Profile

The aim of this project is to study the effect of a bout of exercise on the metabolomic profile of plasma and feces as well as its influence on the intestinal microbiota.

The practice of physical exercise has numerous health benefits, preventing the appearance and development of cardiovascular diseases and various types of cancer. Exercise causes changes in the vascular, muscular and pulmonary systems, etc. One of the benefits that can result from exercise modification of the intestinal microbiota and its metabolic profile. In order to identify the potential changes that exercise has on the intestinal microbiota and its metabolic profile, the purpose of this study is to identify changes in the plasma and fecal metabolome and in fecal microbiota associated with a bout of exercise

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* high physical condition (VO2 ≥ 55 ml/kg/min)
* BMI 18-25 kg/m2

Exclusion Criteria:

* antibiotics intake during 3 months prior to the study,
* smoking
* nutritional complements
* ergogenic complements
* prebiotics
* probiotics
* vegetarian or vegan diet
* chronic medication
* gastrointestinal surgery
* Any diagnosed disease
A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers

The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties and safety profile of alefacept in Caucasian and Japanese healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Caucasian or Japanese healthy subject with a body mass index (BMI) of 18 to 29 kg/m2, inclusive
* Japanese subject is first generation, born in Japan from parents of Japanese decent, and has resided outside of Japan for 5 years or less OR Caucasian subject is Hispanic or non-Hispanic, born of parents of European decent (not Mestizo or mixed race)
* Subject must have clinical laboratory test results within the normal therapeutic range or, if abnormal, the results are not clinically significant as determined by the investigator

Exclusion Criteria:

* CD4+ lymphocyte count outside normal limits at Screening
* Received vaccine within 60 days prior to study drug administration
* History of drug or alcohol abuse within the 2 years prior to the study drug administration
* Treatment with any systemic immunosuppressant agent within 6 months prior to study drug administration
* Treatment with any antibody or biologic product within 6 months prior to study drug administration
* Treatment with any systemic steroid or steroid inhaler within 2 months prior to study drug administration
* A smoking habit of greater than 10 cigarettes a day
The Effect of Motivational Interviewing in Women's Health

The behaviour of healthcare demand procrastination constitutes an obstacle for individuals to lead a healthy life, and an example of this is the low participation rate of women in pap-smear screening programs compared to the target population. It is known that motivational interviews are frequently used and effective in studies planned to change health behavior. According to the results of the power analysis, at least 104 women, 52 experimental and 52 control, should be included in the study. Data will be collected with the "Personal Information Form", "Healthcare Demand Procrastination Scale", "Health Belief Model Scale for Cervical Cancer and Pap Smear Test" and "Evaluation Form for Cervical Cancer Screening Participation". Motivational interviews will be given to the women in the experimental group.

The behaviour of healthcare demand procrastination constitutes an obstacle for individuals to lead a healthy life, and an example of this is the low participation rate of women in pap-smear screening programs compared to the target population. It is known that motivational interviews are frequently used and effective in studies planned to change health behavior. This study aims to evaluate the effectiveness of motivational interviewing on behaviour of healthcare demand procrastination, health beliefs regarding cervical cancer screenings, and screening participation in women. According to the results of the power analysis, at least 104 women, 52 experimental and 52 control, should be included in the study. Data will be collected with the "Personal Information Form", "Healthcare Demand Procrastination Scale", "Health Belief Model Scale for Cervical Cancer and Pap Smear Test" and "Evaluation Form for Cervical Cancer Screening Participation". Motivational interviews will be given to the women in the experimental group by the researcher once a week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The ages of 30-65,
* Having not had cervical cancer screening before,
* Having not had a hysterectomy operation,
* Being literate,
* Volunteering to participate in the study

Exclusion Criteria:

* Those who have communication problems,
* Those with psychiatric and mental illnesses,
* Those who have previously attended any training on cervical cancer screening,
* Pregnant women
A Trial of Camrelizumab in Combination With Nab-paclitaxel and Famitinib as a First Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer(FUTURE-C-PLUS)

The study is being conducted to evaluate the efficacy, safety of camrelizumab in combination with nab-paclitaxel and famitinib in Patients with unresectable locally advanced or metastatic immunomodulatory triple negative breast Cancer..


Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status of 0-1
* Expected lifetime of not less than three months
* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
* Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
* Adequate hematologic and end-organ function, laboratory test results.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
* Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

Exclusion Criteria:

* Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
* A history of bleeding, any serious bleeding events.
* Important blood vessels around tumors has been infringed and high risk of bleeding.
* Coagulant function abnormality
* artery/venous thromboembolism event
* History of autoimmune disease
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Uncontrolled pleural effusion and ascites
* Known central nervous system (CNS) disease.
* Long-term unhealing wound or incomplete healing of fracture
* urine protein ≥2+ and 24h urine protein quantitative \> 1 g.
* Pregnancy or lactation.
* Thyroid dysfunction.
* Peripheral neuropathy grade ≥2.
* People with high blood pressure;
* A history of unstable angina;
* New diagnosis of angina pectoris.
* Myocardial infarction incident ;
* Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency
Reliability and Validity of the Turkish Version of the Stroke Exercise Preference Inventory

With this study, it will be proven whether the Turkish version of the Stroke Exercise Preference Inventory is valid and reliable in evaluating the exercise preferences of individuals who have had a stroke.

Version, validity, and reliability studies are frequently encountered in the literature. However, there is no scale that evaluates the exercise preferences of individuals who have had a stroke among the measurement tools whose Turkish version, validity, and reliability studies have been carried out. The Stroke Exercise Preference Inventory is an outcome scale for questioning exercise preferences in individuals who have had a stroke. It is functional for the development and planning of exercise programs for individuals who have had a stroke. This scale will both fill the gap in the Turkish literature in terms of the parameters it evaluates and will be the first in this context. In terms of its application, it is a useful inventory in this field. Considering the absence of a measurement tool developed in Turkish or adapted to Turkish for the assessment of exercise preferences of individuals with stroke, the aim of this study is to evaluate the validity and reliability of the Turkish version of the self-administered Stroke Exercise Preference Inventory, designed to question exercise preferences in Turkish individuals with stroke, to perform cross-cultural adaptation study, and to question the suitability of the Turkish version for Turkish society and the effectiveness of its clinical use.

Eligibility Criteria:
Inclusion Criteria:

* Who have had a stroke,
* Good cognitive status,
* Can speak, read, write Turkish.

Exclusion Criteria:

* Pregnant,
* Who cannot speak, read or write Turkish.
A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment.

To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Painful distal diabetic neuropathy

Exclusion Criteria:

* Must have an average pain intensity of ≥ 4 on an 11-point Likert scale
Polk COVID-19 and Flu Response

Study Objectives:

To perform COVID-19 diagnostic and serologic testing on emergency medical personnel in Polk County to determine:

1. COVID-19 prevalence
2. Rate of convalesced personnel (+antibodies)
3. Rate of asymptomatic carriers

This observational study involves a community wide program offering free COVID-19 testing to county front line workers, including EMS personnel, board of county commissioners and sheriffs' office personnel. These personnel will also be asked to fill out a survey that asks about their medical history and which of any symptoms they have experienced in the prior three weeks. The survey is voluntary and written informed consent is obtained . EMS personnel can still get the free testing even if they do not want to fill out the survey.

The primary objective of the study is to describe the prevalence of COVID-19 antigen and IgM and IgG markers amongst our county/EMS workers.

The secondary objective is to describe whether the antigen/antibody markers are significantly correlated to the presence of a set of symptoms in the prior 3 weeks, and/or to the baseline demographics such as age, sex, and presence of co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

Polk County (FL) emergency personnel including EMS, Fire Rescue, Board of County Commissioners, and Sheriff's office

Exclusion Criteria:

Age \< 18
Patient Engagement Initiative

A no-cost intervention may improve adherence with a recommendation for higher-quality, lower-cost care for patients with critical illness endorsed by a collaborative of critical care societies. The investigators propose prompting consideration of functional outcomes. This trial will help establish the impact of the intervention on practice patterns including proxy engagement and elements of shared decision-making.


Eligibility Criteria:
Inclusion Criteria:

* Licensed physicians
* At least 4 weeks of clinical work in an I.C.U. in the U.S.A. during the past 12 months

Exclusion Criteria:

* \<25 years old
* Non-English speaking
* Primarily practicing medicine outside the U.S.A.
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder.

PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 66 years or older, with a documented clinical diagnosis of Generalised Anxiety Disorder (GAD).
* Absence of current episode of major depression.

Exclusion Criteria:

* The presence of dementia or other mental disorder than GAD.
* Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse.
* A current diagnosis of cancer or current or past diagnosis of stroke.
Effects of Exercise Training in Patients With Permanent Atrial Fibrillation

Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with increased vagal tone. Patients with AF have poor exercise capacity that may contribute to decreased atrial effective refractory period, and decreased cardiac output and heart rate reserve, and may result in poor quality of life. Poor endothelial function had been noted in patients with AF, associated with increased risks of cerebrovascular and cardiovascular disease. Exercise training has been noted to improve exercise capacity and quality of life in patients with AF only in some studies. Endothelial function can be improved by exercise training in patients with cardiovascular disease, but no report in patients with AF. Evidence of exercise training is still needed in patients with AF. The purpose of this study is to investigate the effect of exercise training on

1. endothelial function
2. heart rate variability
3. exercise capacity
4. quality of life.

A randomized controlled study was implemented to examine :(1) the effect of interval aerobic exercise training combined with resistance training on endothelial function, heart rate variability (HRV), exercise capacity, and quality of life (QoL); (2) the influential factors related to exercise capacity, and the relationship between exercise capacity and quality of life in patients with permanent atrial fibrillation (AF).

Eligibility Criteria:
Inclusion Criteria:

* Permanent atrial fibrillation≥ 1 year aged 40-76 years
* Recurrence AF after ablation
* Under antiarrhythmia medication control

Exclusion Criteria:

* CAD or myocardial infrarction history
* NYHA≥ III-IV, or LVEF≤45%
* Mitral or aortic valve regurgitation ≥ Gr. II
* Mitral valve or aortic valve stenosis
* Pacemaker
* Cardioversion by ablation
* Pulmonary artery hypertension
* Any surgery in previous 3 months
* Any neurological disorders
* Cancer
* Severe musculoskeletal disorder
* Hyperthyroidism
* Premenopausal women
A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis


Eligibility Criteria:
Inclusion Criteria:

1. Females ≥18 and ≤75 years old;
2. Clinical diagnosis with VVC episodes at screening, signs and symptoms score of ≥ 7, with a documented positive potassium hydroxide (KOH) or Gram staining;
3. Subjects of childbearing potential must have a negative pregnancy test result at screening and agree to use highly effective contraceptive measures throughout the study;
4. Willing to sign the informed consent form to participate in this study.

Exclusion Criteria:

1. Have recurrent vulvovaginal candidiasis (RVVC) as defined by 4 or more confirmed VVC episodes in the past 12 months or history of RVVC;
2. Presence of concomitant vulvovaginitis caused by other pathogens;
3. History of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening;
4. Moderate to severe hepatic and/or renal disorders;
5. Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, or vulvovaginal corticosteroids within 7 days prior to randomization;
6. Have received any estrogen replacement therapy or vaginal topical products within 7 days prior to randomization;
7. Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
8. Presence of significant laboratory abnormalities at screening;
9. QTc interval greater than 470 ms or other clinically significant ECG abnormalities at screening;
10. Have planned surgeries or other medical procedures that may impact compliance with the protocol;
11. Known history of hypersensitivity or intolerance to azole antifungal drugs;
12. Being in the menstrual period, pregnant, or lactating at screening, or planning to become pregnant during the study period;
13. History of narcotic or drug abuse or alcoholism within 6 months prior to screening;
14. Have participated in another clinical study and received the investigational drug containing active ingredient within 30 days prior to screening;
15. Other conditions unsuitable for participation in the study per investigator's judgment.
Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2

Methadone is a drug that offers significant therapeutic benefits to opiate dependent women who are pregnant. Currently, it is the treatment of choice for this group of people. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.

Methadone is a drug that is commonly used to treat opiate addiction, usually as part of a detoxification and maintenance program. Methadone offers significant therapeutic benefits to pregnant women who are opiate dependent, and it is currently the treatment of choice for this group of people. In general, breast milk is beneficial for infants. However, there is some concern as to whether it is safe for women who are taking methadone to breastfeed their babies. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.

Participants will be assigned to one of two groups: women taking methadone who will breastfeed their babies or women taking methadone who will bottle-feed their babies. On Days 1, 2, 3, 4, 14, and 30, following infant delivery, plasma will be collected from both groups and breast milk will be collected from the breastfeeding group. These samples will be quantitatively analyzed for methadone. Infants will undergo neurobehavioral assessments on Days 3, 14, and 30, following birth. Rates and severity of neonatal abstinence syndrome will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy methadone-maintained women electing to either exclusively breastfeed or bottle-feed their infants for 1 month after delivery

Exclusion Criteria:

* Relapse to illicit drugs or alcohol at any time during the study
* Positive maternal or infant urine toxicology test at birth
* Serious medical or psychiatric illness requiring medication or medical intervention
* HIV infected
* Currently dependent on alcohol
* Major birth defect in the infant
* Significant medical problems in the infant, including premature birth, sepsis, or other infections
Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis

The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be more than or equal to 20 years of age
* Restenosis after drug-eluting stents (\>50% by visual estimate)
* Any Lesion length including focal in stent restenosis or diffuse in stent restenosis
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* The patient has a known hypersensitivity or contraindication to any of the following medications:

  * Heparin
  * Aspirin
  * Both Clopidogrel and TIclopidine
  * Sirolimus eluting stent
  * Stainless steel and/or
  * Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled)
* Systemic (intravenous) Everolimus use within 12 months.
* Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period