cyrilzakka/clinical-trials huggingface dataset:
Cryptococcal Antigen Screening Plus Sertraline

Cryptococcal meningitis or "Crypto" is a life threatening fungal infection around the brain that requires hospitalization for treatment for 14 days and then continued therapy. Crypto causes 15-20% of HIV/AIDS-related deaths worldwide. However, this infection can be detected before one develops symptoms and becomes ill. People can be screened for infection by a blood test to detect "cryptococcal antigen," (called CrAg), which is part of the fungus, in blood. The World Health Organization and over 22 countries worldwide recommend CrAg screening of all persons with advanced AIDS entering or re-entering into HIV care.

However, it is not known how best to treat people with cryptococcal antigen in their blood, who don't otherwise yet have symptoms of infection around their brain. If no treatment is given, almost all people will develop infection of the brain and/or die. International guidelines suggest using both HIV medicines and an anti-fungal medicine, called fluconazole, to treat this early infection. However, despite this treatment approximately 1 in 4 people may get sick and/or die.

Researchers have recently discovered another medicine that may work against the Cryptococcus fungus. This medicine is called Sertraline, and it is actually a medicine that has been used for more than 25 years to treat depression (sadness). Sertraline is one of the most commonly used medicines worldwide.

The purpose of this research clinical trial is to determine if standard fluconazole antifungal therapy plus a high dose of Sertraline, will be better than standard fluconazole therapy alone for treating early disseminated cryptococcal infection in persons who are asymptomatic and do not yet have infection of the brain (i.e. meningitis).

This study seeks to test if Sertraline will improve survival through 6-months. Prior studies have shown that \>90% of those who survive 6-months will survive \>5 years.

This is a double-blind, randomized placebo-controlled clinical trial testing sertraline as an antifungal medicine in combination with fluconazole for treatment of HIV-infected persons with AIDS and asymptomatic cryptococcal antigenemia (CrAg+).

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Cryptococcal antigen (CrAg) positive in blood
* Age \>=18 years
* Written informed consent
* Women of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use one reliable method of contraception while receiving fluconazole \>=400mg/day

Exclusion Criteria:

* Prior history of cryptococcal meningitis
* Suspected meningitis or mania
* Suspected/known cirrhosis, jaundice, or alanine aminotransferase (ALT) \>5x upper limit of normal
* Receiving an antidepressant medicine
* Receiving antifungal therapy, \>1 week
* Pregnant or Breastfeeding
* Contraindication to sertraline or fluconazole
* Current rifampin use or other prohibited medication
* Electrocardiogram corrected QT interval (QTc) \>450ms
The Effectiveness of Mindfulness-based Intervention on Smoking Cessation

The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking.

The present study will carry out a workplace health promotion via MBI to help smoking workers to quit smoking. The study will adopt a longitudinal research design with randomized quasi-experimental trial. The smoking workers will recruited and be randomly assigned to Group A (one lesson of health education on smoking cessation and six lessons of MBI) or Group B (one lesson of health education on smoking cessation and six lessons of physical fitness). There will be 50 participants in each group. Data will be collected five times.

Eligibility Criteria:
Inclusion Criteria:

* volunteered employees with heavy smoker
* Full-time paid workers

Exclusion Criteria:

* Age \< 20y or \> 65y
* Part-time workers
* The workers are not willing to take part in the study
Safety Evaluation of Adverse Reactions in Diabetes

The purpose of this study is to assess the effects of incretin-based antidiabetic therapies (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system and to detail the mechanisms underlying their action in these systems.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Metformin monotherapy - stable dose during last 3 months
* HbA1C 48-75 mmol/mol (IFCC)
* BMI 25-40 kg/m2
* Age 35-70 years (women postmenopausal)
* Use of ACE inhibitors or ATII receptor blockers for at least 3 months before enrollment

Exclusion Criteria:

* eGFR\<30 ml/min/1.73m2 (MDRD)
* Treatment with incretin mimetics during 3 months before enrollment
* Chronic insulin therapy
* Chronic use of loop diuretics, glucocorticoids, NSAID, immune suppressants, antimicrobial agents, chemotherapeutics, bile acid sequestrants (colestyramin, colesevelam)
* History of pancreatic disease or impaired pancreatic function (defined as the need to use pancreatic enzymes)
* Active liver disease or a 3-fold elevation of liver transaminases (ALT, AST)
* Active malignancy
* History of severe cardiovascular disease including acute coronary syndrome, stroke or transient ischemic neurologic disorder during previous 6 months, atrial fibrillation or other arrhythmia requiring chronic antiarrhythmic medication, chronic heart failure (New York Heart Association grade III/IV)
* History of alcohol abuse, defined as \>4 units of alcohol/day (32 g or 40 ml of 100% alcohol)
* History of allergy for GLP-1 receptor agonists or DPP-4 inhibitors
* Any disease that could interfere with study procedures (e.g. decreased mobility, mental incapacity)
* Inability to give informed consent
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients

The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85
* Histologically or cytologically confirmed advanced or metastatic solid tumors
* Patients will be received femoral venepuncture for apheresis by cell separator, which is the necessary process to perform following adoptive cell immunotherapy.
* Estimated life expectancy \> 3 months
* Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR \<1.5 (unless patient is receiving warfarin in which case PT-INR must be \<3), PTT \<1.5X ULN
* Adequate renal and hepatic function, with serum creatinine \< 1.5 mg/dL, bilirubin \< 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.

Exclusion Criteria:

* known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis
* Platelet count \< 50 000 G/L
* Active bleeding
* Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
* Patients with obstructive jaundice
* Patients with Spleen hyperfunction
* Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
* Pregnant or breast-feeding women，or lack of effective contraceptive treatment for women of childbearing age.;
Memory During Anesthesia: the Role of Stress Hormones

1. To investigate whether the auditory stimulation causes changes in hormones levels (cortisol+prolactin) during general anesthesia.
2. To determine if there is a correlation between hormones levels (cortisol+prolactin) and dreams recall.
3. To investigate whether, in patients receiving auditory stimulation, there is a correlation between hormones levels (cortisol+prolactin), serum remifentanil concentration and detection of implicit memory.
4. To investigate the presence of primary auditory cortex activation (temporal lobe) in patients with implicit memory and in those with dreams recall using the EEG-ERP 128 channels GES300 EGI system.

Patients from group A, during maintenance of anesthesia, at the time of trocar insertion, will listen (via MP3) a piece of one of two stories, "Puss in Boots" and "Pinocchio", each followed by four keywords. In group B, patients will be isolated from the sounds of the operating room using specific headphones.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old
* Class-ASA Physical Status I-II

Exclusion Criteria:

* Psychiatric or neurological disorders and/or hearing disorders
* Obesity (Body Mass Index \> 30)
* Drug addiction, alcoholism
* Patients with an education level below middle school
* Patients with difficulty in understanding the Italian language
* Patients treated with corticosteroids and/or estrogens, pregnant patients and patients suffering from hypercorticism
Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study

Summary

Reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital self-management program during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.

Description of the project

This project is about investigating the effect of a digital self-management program to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The self-management program has been developed with patients and researchers and consists of existing high-quality technology that provides support for setting and following goals. The people who use the self-help program also receive support from a physiotherapist to set goals for reduced sedentary time and get to choose which activities will replace the time spent sedentary.

The goal of the project

The goal of the project is to investigate the effects of a digital self-management program on reduced sedentary and well-being during ongoing cancer treatment, both in the short and long term. In addition, the project will study the health-economic effects, and climate benefits of using the digital self-management program. By focusing on reducing a sedentary lifestyle and replacing it with daily activities and/or physical activity, the health of individuals is expected to be positively affected in the short term through, for example, increased well-being and reduced side effects from cancer treatment, and the long term through a reduced risk of developing complications and new illness related to the cancer treatment, such as cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in Uppsala and Västerås, Sweden.

Exclusion Criteria:

* Individuals diagnosed with dementia.
* Individuals diagnosed with severe psychiatric disease.
* Individuals with severe loss of vision, or communicative ability.
* Individuals who cannot walk independently indoors with or without a walking aid.
* Individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.
Comparison of Active and Passive Static Stretching in Delayed Onset of Muscle Soreness of Recreational Body Builders

To find out the better treatment options from active and passive static stretching in delayed onset of muscle soreness in recreational body players.

After registering participant's randomization will be done through sealed envelope method and will be allocated in both groups equally. Group 1 will receive passive static stretching while group 2 will receive active static stretching. All subjects will be assessed before the intervention through likert muscle soreness scale, Numeric Rating Pain Scale and range of motion for Shoulder, elbow, and wrist by a Goniometer. After that all subjects will perform eccentric exhaust weight exercises in the gym of all mentioned joints, three sets at each joint. Before giving the intervention they will assess of all mentioned parameters. Group 1 groups will perform passive static stretching and group 2 will perform active static stretching. At the end of the intervention participants will be assessed again using the same parameters. Statistical analysis will be carried out to compare the outcomes measures of both groups.

Eligibility Criteria:
Inclusion Criteria:

* Recreational Body Builders are Included

Exclusion Criteria:

* Individuals with disc herniation and
* Acute muscle soreness are excluded
Anal Fistula Plug Versus Endorectal Advancement Flap

The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or more)
* Single anal fistula
* Surgically treated with anal fistula plug or endorectal advancement flap

Exclusion Criteria:

* Children or adolescents
* Pregnancy
* Patients treated with setons alone
MyDiaText Text Messaging Intervention for Diabetes

To test a text messaging intervention using MyDiaText and financial incentives to determine whether such an intervention will improve self-reported self-care behaviors in children 12 to 18 years old. The intervention will consist of daily text messages sent to the subject's personal mobile device. Subjects will be incentivized to respond to text messages via a lottery financial incentive. Previously developed text messages based on the American Diabetes Association (ADA) behavior goals will be used for this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 diabetes for more than 1 year
* HbA1c greater than or equal to 8% but less than 14%.
* Have been seen in diabetes clinic in the last 6 months
* Owns a personal mobile device with unlimited text messaging plan

Exclusion Criteria:

* Non-English speaking
* Significant cognitive disability or major organ illness
* Hemolytic anemia
Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg

The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).

This was a randomized, open label, two-period, two-sequence, crossover study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Pramipexole 0.25 mg produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals) or one tablet of the reference drug (Sifrol® 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).

Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug. The plasma concentrations of pramipexole were determined by validated ultra performance liquid chromatography with mass spectrometry detector (UPLC-MS/MS).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects
* Preferably non-smokers or smoke less than 10 cigarettes per day
* Body mass index within 18 to 25 kg/m2
* Normal vital signs (after 10 minutes rest): systolic blood pressure 100 - 120 mmHg, diastolic blood pressure 60 - 80 mmHg, pulse rate 60 - 90 bpm

Exclusion Criteria:

* Personal / family history of allergy or hypersensitivity or contraindication to pramipexole or allied drugs
* Pregnant or lactating women
* Any major illness in the past 90 days or clinically significant ongoing chronic medical illness
* Any clinically significant abnormal values of liver function test (ALT, alkaline phosphatase, total bilirubin \>= 1.5 upper limit normal), renal function test (serum creatinine \> 1.4 mg/dL), etc
* Positive Hepatitis B surface antigen (HbsAg), anti-HCV, or anti-HIV
* Clinically significant hematology abnormalities
* Clinically significant ECG abnormalities
* Any surgical or medical condition (present or history) which might significantly alter the pharmacokinetics of the study drug
* History of anaphylaxis or angioedema
* History of drug or alcohol abuse within 12 months prior to screening
* Participation in any clinical trial within the past 90 days
* History of any bleeding or coagulative disorders
* History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
* A donation or loss of 300 mL (or more) of blood within 3 months before the study's first dosing day
* Intake of any prescription, non-prescription drug, food supplement or herbal medicine within 14 days of the study's first dosing day
Pain Control for Laser Epilation in Pilonidal Disease

It's unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure. This study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo.

Patients presenting to a dedicated Pilonidal Care Clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study. Patients will be randomized to topical lidocaine or placebo, which will be applied for 30 minutes prior to the laser procedure, before which it will be removed. Laser technicians will be unaware of which cream the patient received and will record a post-procedure Likert pain score, from 0 to 10.

Patients will return in 6 to 8 weeks at which time they will crossover to the other group. Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream. Cream removal and laser follicle ablation, with post-procedure pain score recording, will be conducted as during the first visit.

Twenty patients will be recruited and each patient will act as their own control.

Eligibility Criteria:
Inclusion Criteria: undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments -

Exclusion Criteria: Unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser

-
Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

The mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. Consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. The aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.

Method: Monocentric prospective study with diagnostic and prognostic expectations.

Primary objective:

Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.

Secondary objective:

Research of clinical and biological prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* Patient from oncology or hematology with a septic shock
* Patient aged 18 years and older
* Inclusion within the 24 hours of the septic shock in the intensive care unit
* Signed consent according to the emergency reglementation

Exclusion Criteria:

* Pregnancy, breast feeding
* Patient with decision of care limitation
* Patient with legal protection
A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.


Eligibility Criteria:
Inclusion Criteria:

- Patients with CKD and hyperphosphatemia must meet the following criteria for study entry:

* Age ≥18 years
* On thrice-weekly hemodialysis for at least 3 months prior to screening
* Not having changed dialysis prescription within 4 weeks prior to screening for dialyzer, calcium concentration in dialysate, or dry weight more than 1 kg
* Receiving stable doses of treatments affecting serum phosphorus for at least 4 weeks prior to screening and willing to discontinue these treatments

Exclusion Criteria:

- Patients with CKD and hyperphosphatemia who meet any of the following criteria will be excluded from study entry:

* Uncontrolled diabetes and/or hypertension in the opinion of the investigators
* Uncontrolled chronic constipation and/or diarrhea in the opinion of the investigators
* Hospitalization for cardiac disease in previous 3 months
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN)
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold

To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease

Patients with coronary artery disease receive bioabsorbable vascular scaffolds. Patients are clinically followed during a period of 10 years.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease
* implantation of at least one bioresorbable vascular scaffold

Exclusion Criteria:

* no written informed consent
Behavioral Management and Psychological Well-Being

The aim of present study is to evaluate whether a program of behavioral and cognitive procedures for emotional control, and assertive training, produces well-being and improvement in quality of life of healthy volunteers.

Healthy volunteers,not presenting neurologic or psychiatric disorders, 18 years or older,both genders, were selected, after a medical examination, to participate in the study. In a randomized controlled trial, the volunteers were submitted to sessions of muscle relaxation (autogenic method), progressive self-focus meditation, and cognitive-behavioral training in self-control of negatives feelings. They were also trained to determine goals and to determine each step to reach them (plan of action).The volunteers have to apply this strategy to control emotional behavior and improve interpersonal relationship. Anxiety and depression scores will be determined using the Beck self evaluation scales (BDI and BAI); quality of life will be determined using WHO-QOL inventory and the Ryff Scale will be used to measure Psychological Well-Being.

Eligibility Criteria:
Inclusion Criteria:

* Healthy people, without neurological or psychiatry disorders, according to the results of a medical examination
* 18 years or older
* high school degree

Exclusion Criteria:

* Severe neurological or psychiatric disorders