cyrilzakka/clinical-trials huggingface dataset:
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)

Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant \>18 yrs of age
* Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
* Subjects meeting the clinical prediction rule

Exclusion Criteria:

* Subjects with an allergy/intolerance to caspofungin or echinocandin analog
* absolute neutrophil count \<500/mm3 at study entry or likely to develop such a count during therapy
* acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
* moderate or severe hepatic insufficiency
* subjects who are pregnant or lactating
* unlikely to survive \< 24 hours
* subjects who have received systemic antifungal therapy within 10 days prior to study entry
* Documented active proven or probable invasive fungal infection upon enrollment
* previously enrolled in this study
* Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.
Study to Evaluate the Safety and EffIcacy of PRX-102 on Gastrointestinal Symptoms in Naïve Fabry Disease

The study will be a randomized, double blind, placebo-controlled study of the safety and efficacy of PRX-102 in ERT naïve male patients randomized 1:1. Patient age will be 14 to 45 years. Patients must have diarrhea defined as ≥ 3 stools a day with an average consistency of ≥ 5.5 on the Bristol Stool Form Scale (BSFS) by patient electronic diary and moderate to severe gastrointestinal symptoms as defined by the Irritable Bowel Symptom Severity Score (IBSSS) Part 1 average \> 175 derived from at least two IBSSS assessments during screening period. Patients will receive intravenous infusions of PRX-102 1 mg/kg or placebo every two weeks for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Males, age 14-45 years, naïve to enzyme replacement therapy (ERT) or off ERT or off chaperone treatment for at least 6 months and negative for anti-PRX-102 antibodies
* A documented diagnosis of Fabry disease: Plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than lower limit of normal (LLN)
* eGFR by CKD-EPI \> 30 ml/min/1.73 m2
* Moderate to severe gastrointestinal symptoms as defined by:

  * Average score of \> 175 from at least two Irritable Bowel Symptom Severity Score (IBSSS) Part 1 assessments before randomization.
  * Average stool consistency of ≥ 5.5 on the Bristol Stool Form Scale (BSFS) by patient diary during 2 weeks prior to randomization out of the 4 week of screening period and
  * ≥ 3 stools a day with a consistency of ≥ 5 on the BSFS during the week before randomization.
* Completed electronic BSFS diary on at least 6 of the 7 days during the week prior to randomization AND at least 11 of the 14 days during the 2 weeks prior to randomization.

Exclusion Criteria:

* Patients will be evaluated to rule out other gastrointestinal comorbidity than Fabry disease as responsible for the gastrointestinal symptoms by:

  i. Medical History for non Fabry gastrointestinal comorbidity ii. Occult blood in stool iii. Stool culture for bacteria and parasites iv. Calprotectin in stool v. Sigmoidoscopy
* Use of any kind of laxatives
* Initiation of anti-diarrheal medications during the screening period
* History of renal dialysis or transplantation
* Use of, or change in dose of, angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) for less than 4 weeks prior to screening
* Cardiovascular event (myocardial infarction, unstable angina) in the 6 month period before randomization
* Congestive heart failure NYHA Class IV
* Cerebrovascular event (stroke, transient ischemic attack) in the 6 month period before randomization
* Known history of hypersensitivity to Gadolinium contrast agent
* Known allergies to ERT
* Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study
The Use of Injectable Plasma Versus the Use of Simvastatin Gel in Surgical Management of Bony Defect in Dentistry

Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with a concentration of 1.2% (SMV) approximately, can have a significant decrease in the pocket depth, regain the clinical attachment loss (CAL), and improve the bone level.

and the platelets concentrate has been introduced which is the injectable plasma rich fibrin (I-PRF), as it contains platelets and leukocytes, stem cells and endothelial cells that why it is called "blood concentrate ". So, it is proposed as treatment option in different periodontal procedures such as treatment of intra-bony defects,

Group I ( Experimental group): will include 12 patients undergoing open flap debridement (OFD) followed by single application of I-PRF. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.

Group II (Control group): will include 12 patients undergoing open flap debridement (OFD) followed by application of 1.2% simvastatin gel. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them.

* Oral hygiene instructions will be given to all patients.
* Full mouth Scaling and root planing (SRP) will be performed under local anesthesia.
* 4 to 8 weeks after the non-surgical periodontal therapy patients will be reassessed clinically and radiographically For all patients who are suitable for the study the following clinical and radiographic evaluation parameters will be measured: (All parameters will be recorded Pre-operatively (base line) and 6 months Post operatively by an examiner who will be masked to the type of treatment received by the individuals).

Eligibility Criteria:
Inclusion Criteria:

* • Age range between 25 and 40 years

  * Patients with severe chronic periodontitis having probing depth (PD) ≥6 mm and clinical attachment loss (CAL) ≥5 mm , or Stage III periodontitis
  * Patient having vertical bone loss ≥3 mm (distance between alveolar crest and base of the defect as confirmed by preoperative intraoral periapical radiographs using standardized parallel technique.)
  * Good compliance with the plaque control instructions following initial therapy
  * Availability for follow up and maintenance program.

Exclusion Criteria:

* • Patient with any systemic disease or conditions

  * Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of trial and during the study.
  * Patients who have undergone any periodontal treatment in the last 6 months
  * Pregnant and Lactating.
  * Reported allergy to any type of statins
  * Subjects who were tobacco or alcohol users
  * Vulnerable group of patients (e.g.: prisoners , handicapped , or decisionally impaired individuals )
The Effect of Progressive Relaxation Exercises in University Students

The aim of this randomized controlled study is to determine the effect of progressive muscle relaxation exercise on mental health and quality of life in university students. The research was carried out with the 1st and 2nd year students of Tokat Gaziosmanpaşa University Reşadiye Vocational School Health Care Services Department Elderly Care Program. The data of the study were collected using the Introductory Information Form, Brief Symptom Inventory, and Quality of Life Scale. University students in the intervention group were given progressive muscle relaxation exercise at least 4 times a week for 6 weeks.

The aim of this randomized controlled parallel group single-center study is to determine the effect of progressive muscle relaxation exercise on mental health and quality of life in university students. The research was conducted online with Tokat Gaziosmanpaşa University Reşadiye Vocational School Health Care Services Department Aged Care Program 1st and 2nd grade students. The research was carried out with a total of 86 students, 43 of which were in the intervention group and 43 in the control group. The data of the study were collected using the Introductory Information Form, Brief Symptom Inventory, SF-36, Progressive Muscle Relaxation Exercise Follow-up Form. University students in the intervention group were given progressive muscle relaxation exercise at least 4 times a week for 6 weeks. No intervention was made in the control group. University students in the control group were asked to continue their daily lives. Ethics committee permission, institutional permission, scale usage permission and written consent of the participants were obtained for the research.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being 18 years or older,
* Having the necessary technology to participate in the study online (Smartphone, computer, etc.)

Exclusion Criteria:

* Presence of any diagnosed musculoskeletal disease
Effects of Exercise Prediabetic Individuals

The aim of this study was to determine the effects of two different exercise protocols on body composition, aerobic capacity, blood lipid profile, some biomarkers, quality of life and exercise beliefs in participants at risk of diabetes.

After being informed about the study and possible risks, all participants who gave written informed consent and met the eligibility requirements will be randomly assigned to 2 separate groups.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18-60 years old
* HbA1c value between 5.7%-6.4%
* BMI\>24,9 kg/m²
* Being sedentary
* Not on any diet

Exclusion Criteria:

* Insulin and derivative drug use
* Uncontrolled hypertension
* History of heart disease
* History of MI or stroke
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA

The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on fetal DNA isolated from maternal blood.

The primary purpose of this study is to collect family triads from families affected by a genetic or microdeletion/duplication (MD/D) syndrome to further develop non-invasive prenatal testing based on fetal DNA isolated from maternal blood. To assist with the development of the test, we will need to collect blood samples from women whose child was diagnosed with a genetic or MD/D syndrome, a blood sample from that child as well as a blood sample from their confirmed unaffected siblings. Since the test is based on Natera's Parental Support™ technology, buccal or blood samples from the biological fathers will also be requested.

A recent abstract from a five year study on prenatal microarray testing revealed that 1.6% of women who present for routine prenatal indications have a positive microarray test. With the frequency of microdeletions and microduplications (MD/D) now known to be higher than previously thought, the field is likely to move toward offering invasive testing for microarray abnormalities to all pregnant women. Although non-invasive prenatal testing for aneuploidy is now clinically available, it has become clear that non-invasive prenatal testing for MD/D is equally important. However, access to these samples is made difficult as the standard of care for offering microarray analysis to all pregnant women will take time to come to fruition. We would like to develop this non-invasive as the standard of care so that less women will have to undergo invasive testing for the diagnosis of microarray abnormalities. Thus, there is an unmet need for the development of novel tests that would increase the scope of non-invasive prenatal screening.

Eligibility Criteria:
Inclusion Criteria:

* Couples who have a child diagnosed with an autosomal chromosome abnormality (e.g. Down syndrome, Edwards syndrome, Patau syndrome).
* Couples who have a child diagnosed with a sex chromosome abnormality (e.g. Turner syndrome, Klinefelter syndrome, Triple X syndrome, 47, XYY).
* Couples who have a child diagnosed with a microdeletion/duplication syndrome (a positive microarray test).

Exclusion criteria:

* Not an English language or Spanish language speaker
* Genetics report is not available
Enhancing Recovery in Early Schizophrenia

Current antipsychotic treatments of schizophrenia are only partially effective, and their use is often associated with serious side effects. Cannabidiol is a natural counterpart of the psychoactive component of marijuana, delta-9- tetrahydrocannabinol and has no psychotomimetic or addictive properties. In a controlled clinical trial of cannabidiol versus amisulpride in acute paranoid schizophrenia we showed a statistically significant clinical improvement in all symptoms clusters of schizophrenia compared to baseline with either treatment. Cannabidiol displayed a significantly superior side-effect profile in particular regarding prolactin elevation, extrapyramidal symptoms and weight gain. The favorable side-effect profile and potentially novel mechanism of action identify this molecule as a potential antipsychotic. However, long-term safety and efficacy data is still lacking. This study is to evaluate the efficacy and safety of the novel compound cannabidiol in the maintenance treatment of schizophrenia in comparison to placebo as an add-on to an established treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone, in a 12-months, double-blind, parallel-group, randomized, placebo-controlled clinical trial. Thereby, relevant data on cannabidiol's antipsychotic potential will be gained.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent given by the subject
* DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90)
* First documented diagnosis of schizophrenia must not be no older than seven years.
* Patients must receive a stable dose of amisulpride, aripiprazole, olanzapine, quetiapine or risperidone (TAU: treatment as usual) at least 4 weeks prior to inclusion in the study to ensure that the maximal effect of the previous medication has been received.
* Initial PANSS total score of ≤ 75 at baseline.
* proper contraception in female patients of childbearing potential
* body mass index between 18 and 40.

Exclusion Criteria:

* Lack of accountability
* positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
* serious suicidal risk at screening visit
* other relevant interferences of axis 1 according to diagnostic evaluation (MINI) including residual forms of schizophrenia.
* other relevant neurological or other medical disorders
* pregnancy or lactation.
A Study for Tecfidera (Dimethyl Fumarate) Capsules in Korean Participants With Relapsing-Remitting Multiple Sclerosis

The primary purpose of this study is to evaluate the overall safety and efficacy of Tecfidera (Dimethyl Fumarate) as an oral treatment for Korean participants with relapsing-remitting multiple sclerosis (MS) under routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. The decision by the treating physician to prescribe Tecfidera is made before participating in the post marketing surveillance (PMS)
2. A participant data release consent form is signed and dated by the participant and/or legal representative
3. A Korean participant is diagnosed as relapsing-remitting MS per approved Korean label

Exclusion Criteria:

1. Participants with hypersensitivity to active ingredient or any of the excipients of Tecfidera according to the approved Korean label
2. Participants with unresolved serious infection
3. Participants who are participating in another study
Trial of Myocet in Metastatic Breast Cancer

The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic Her2+ Breast cancer by FISH analysis
* No prior chemotherapy for metastatic disease
* Measurable disease
* normal left ventricular ejection fraction

Exclusion Criteria:

* prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
* relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
A Study Evaluation the Safety and Efficacy of Hormone Replacement Therapy With North Star Compared to Levothyroxine in Patients With Primary Hypothyroidism

The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary hypothyroidism
* On continuous thyroid replacement therapy for at least 6 months before Study Entry
* On a stable daily dose of LT4 for a minimum of 12 weeks prior to Screening
* Agree to practice a method of contraception
* Female patients not pregnant or lactating at Screening
* Agree to practice a method of contraception of greater than 90% reliability
* Willing to give written informed consent for the Study
* Provide written authorization for use and disclosure of protected health information

Exclusion Criteria:

* Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star or levothyroxine
* Hospitalization for a major illness within 4 weeks prior to Screening
* Anticipated initiation or change in concomitant medications
* Concomitant use of prohibited medications or supplements
* Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration.
* For female subjects, be pregnant, nursing or planning to become pregnant during the study
Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.


Eligibility Criteria:
Inclusion Criteria:

* Included patients had uncomplicated arthroscopic ACL reconstruction
* Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm visual analogue scale (VAS) and moderate to severe pain on a categorical scale by 23:00 hours on the day of surgery and prior to being discharged from the surgical facility
* Subjects could not have received any medication or additional procedures that would confound the interpretation of the study results.

Exclusion Criteria:

* the patient was admitted to or retained in the surgical center/hospital for \>23 hours;
* the patient underwent any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone;
* the patient used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery, during surgery, or subsequent to the end of surgery;
* the patient received oxaprozin or piroxicam within 1 week prior to randomization;
* the patient had a pain pump or indwelling catheter during surgery that administered local or intraarticular anesthetics or narcotics at the index joint, or had such an intra-articular injection at the end of surgery;
* the patient had been treated with patient-controlled analgesia or NSAIDs subsequent to the end of anesthesia;
* patient had a history of clinically significant GI disease or renal disease, or history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would suggest it was not in the subject's best interest to enroll in the trial.
YOga for Patients with Chronic BACK Pain and Poor PROgnosis

The goal of this clinical trial is to investigate the effectiveness of yoga for patients with chronic low back pain and high risk of poor prognosis. The main question it aims to answer is:

- In patients with back pain and high risk of poor prognosis, what is the effectiveness of yoga plus education on reducing pain and disability compared to a control group receiving education alone?

A total of 110 patients with chronic low back pain and classified as high risk of poor prognosis according to the Orebro Musculoskeletal Pain Screening Questionnaire (i.e. score ≥ 50 points out of 100) will be recruited for this study. Participants will be randomized into two groups: yoga and control. The yoga group will receive a 3-month course of yoga program consisting of two sessions per week and 3 educational classes. The control group will receive 3 educational classes over a 12-week period. Outcome measures will be assessed at baseline, at post-intervention (i.e. 3-months post randomization) and at 6-month follow up (i.e. 6-months post randomization).


Eligibility Criteria:
Inclusion Criteria:

* report chronic nonspecific LBP, defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration.
* score ≥ 50 points (out of 100) in the Orebro Musculoskeletal Pain Questionnaire.
* have an average back pain intensity of 3 points or more on a 0-10 numerical pain rating scale.

Exclusion Criteria:

* serious spine pathology (e.g. tumors, fractures, and inflammatory diseases).
* nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve).
* previos spinal surgery.
* pregnancy or having given birth within the previous 3 months.
* any medical condition that prevented being physically active (e.g., serious cardiovascular, kidney or neurological diseases).
* any other musculoskeletal condition that may affect activity and movement participation in a Yoga program during the last year.
* not currently receiving other physical activity-based intervention (e.g., Pilates, physical therapy, aquatic exercise).
* inadequate Portuguese literacy for the study's questionnaires and instructions.