cyrilzakka/clinical-trials huggingface dataset:
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease

We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
* American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)
* For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
* Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
* Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)

Exclusion Criteria:

* History of any of the following:

  * Prior gastric or esophageal surgery, including lap banding or bariatric surgery
  * Bowel obstruction
  * Gastric outlet obstruction
  * Diverticulitis
  * Inflammatory bowel disease
  * Ileostomy or colostomy
  * Gastric or esophageal cancer
  * Achalasia
  * Esophageal diverticulum
* Active Dysphagia or Odynophagia
* Active medication use for any gastrointestinal conditions
* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
Detection of PPROM With AmniSure PAMG-1 Rapid Immunoassay

The investigators will test the hypothesis that in a preterm population with a gestational age of 16+0 and 36+6 weeks AmniSure PAMG-1 rapid immunoassay will be more accurate than conventional methods (speculum examination for combination of pooling, nitrazine and ferning) for the detection of Preterm Prelabour Rupture of Membranes (PROM).

Prior studies of AmniSure have included a heterogeneous population of women with preterm and term pregnancies.10-12 No study to date has specifically addressed and been powered to detect the efficacy of AmniSure in pregnancies between 16+0 and 36+6 weeks. The objective of the proposed research is to evaluate the usefulness of AmniSure PAMG-1 rapid immunoassay in the evaluation of preterm prelabour rupture of membranes (PPROM) compared to standard detection of PPROM with a speculum examination for combination of pooling, nitrazine and ferning.

Eligibility Criteria:
Inclusion Criteria:

* women presenting to assessment at the labour and delivery unit at RUH with suspected PPROM between 16+0 and 36+6 weeks gestation
* consent to enrollment

Exclusion Criteria:

* vaginal bleeding
* active labor (cervical dilation \> 2 cm or effacement \> 80%)
* multiple pregnancy
* fetal anomalies
* placenta previa
* fluid loss per vagina \> 7 days
* prior inclusion in the study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

In this study, the investigators will prospectively collect, analyze and integrate information regarding vaginal microbiome composition and HPV presence in women with cervical pathologies (high-grade CIN and CC) and controls, to construct a large dataset from patients with pre-cancerous cervical lesions and healthy women, to evaluate the personalized contribution of the vaginal microbiome to the CIN-CC sequence.

Infection with high-risk Human Papillomavirus (HPV) genotypes constitutes a well-recognized risk factor for cervical-carcinoma (CC). High-risk HPV features 10-15% persistence rate, consequently driving precancerous cervical-intraepithelial-neoplasia (CIN) and subsequent progression to CC. Multiple factors are believed to play permissive roles in the progression of CIN/CC , yet a molecular mechanism driving carcinogenesis across the CIN-CC continuum following persistent HPV infection remains elusive. The vaginal microbiome may play a role in the development of CIN-CC carcinogenesis, by modulation of host-immune-response and alteration of cervical microenvironment to become tumor-permissive. While suggested vaginal microbiome contributions include induction of altered epithelial cell adhesion and downregulation of DNA damage responses, no clear mechanism has been proven to date. The loss of Lactobacillus genus dominancy, and the switch to dysbiotic, high-diversity, high-pH, Bacterial Vaginosis (BV) is thought to play a key-role in HPV infection, persistence and carcinogenesis.

the investigators hypothesize that specific vaginal microorganisms may promote HPV persistence, chronic inflammation and progression through the CIN-CC sequence, and the elimination of harmful bacteria or supplementation of beneficial microbes, could possibly reverse HPV persistency and inhibit CIN-CC progression.

The current study consists of recruitment of a human cohort of healthy, CIN and CC patients including vaginal samples and comprehensive metadata collection. The investigators plan to conduct an in-depth characterization of vaginal microbiome to identify associations with HPV, CIN and CC.

Eligibility Criteria:
Inclusion Criteria:

* Age 25-70
* Attended the clinic for a Pap smear or colposcopy

Exclusion Criteria:

* Patient does not approve sample collection
* Usage of antibiotics in the month prior to clinic visit
* Usage of any vaginal preparation or medication in the week prior to sample collection (anti-fungal, spermicides, lubricant etc.)
* Menstruation
* Pregnancy
Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

The purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil.

Despite their high toxicity, antimonials and amphotericin B deoxycholate are commonly used for treating visceral leishmaniasis (VL). Few studies showing conflictive data about their efficacy and adverse events in pediatric population are available. This study aimed to evaluate efficacy and safety of amphotericin B deoxycholate vs. that of N-methylglucamine antimoniate in treating pediatric VL in Brazil. This was a randomized, open-label, 2-arm and controlled pilot clinical trial. Treatment naïve children and adolescents with VL without signs of severe illness were treated with N-methylglucamine antimoniate or amphotericin B deoxycholate. All patients were diagnosed with positive direct examination and/or positive PCR for Leishmania spp. performed in bone marrow samples. The primary efficacy end-point was VL cure determined after 180 days of completion of treatment. The analysis was performed using intention-to-treat (ITT) and per protocol (PP) analyses.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms of visceral leishmaniasis: fever plus hepatomegaly or splenomegaly
* Diagnosis of visceral leishmaniasis confirmed through parasite visualization in bone marrow smears or positive serology (indirect immunofluorescent antibody test or rK39 rapid test)or positive kDNA PCR test

Exclusion Criteria:

* Any of the following laboratory findings

  * Total serum bilirubin higher than 2,5 mg/dL
  * Serum SGOT higher than 5 times the upper normal level
  * Serum SGPT higher than 5 times the upper normal level
  * Prothrombin time concentration lower than 70%
  * Abnormal serum creatinine
* Any of the following signs or symptoms

  * Generalized edema
  * Severe malnutrition
  * Systemic inflammatory response syndrome
* Any of the following conditions

  * HIV infection/disease
  * Diabetes
  * Corticoid or immunosuppressive drugs use
  * Symptomatic heart diseases
  * Chronic hepatic or renal diseases
  * Lupus erythematosus
Yoga for Stress Management in Health Care Personnel

The purpose of this study is to investigate if yoga can be an effective stress management technique for health care personnel.

Stress, both job related and personal, is an increasing problem in the health care sector. Yoga is said to have a good stress-reducing effect.

The participants will provide blood, urine, and saliva samples. They will take part in two different stress tests. They will also fill in various qualitative questionnaires, including the Swedish questionnaire on health related quality of life (SWEDQUAL), Antonovsky's sense of coherence scale (KASAM), and the Job stress survey (JSS), both before the study starts and after 3 months of participation.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30
* healthy
* work in the health care sector

Exclusion Criteria:

* medication, including contraceptives and all medications or topical skin preparations with cortisone in any form (exception: hormone replacement therapy for hypothyroidism were included if their hormone levels were within the normal range)
Physical Therapy Trial for Pelvic Pain

The purpose of this study is to determine if a randomized trial of physical therapy for pelvic pain is feasible.

This is a pilot study wherein eligible participants will be randomly assigned to receive either myofascial tissue manipulation or global therapeutic massage. Those receiving myofascial tissue manipulation will have targeted internal and external connective tissue manipulation focusing on the muscles and connective tissues of the pelvic floor, hip girdle, and abdomen. Those receiving global therapeutic massage will have non-specific somatic treatment with full-body Western massage.

Eligibility Criteria:
Inclusion Criteria:

* female and male patients who have failed to respond to previous therapies for interstitial cystitis/painful bladder syndrome
* male patients who have failed to respond to previous therapies for chronic prostatitis/chronic pelvic pain syndrome

Exclusion Criteria:

* neurologic disorder affecting bladder
* bladder cancer, prostate cancer, or urethral cancer
A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042)

Patients undergo 4-week placebo lead-in and diet period, and 12-week treatment period. Clinical efficacy and safety is evaluated at weeks 4, 8 and 12. This study takes approximately 18 weeks for an individual patient to complete including post-visit at week 14.


Eligibility Criteria:
Inclusion Criteria:

* Korean males or females at least 18 years of age with hypercholesterolemia
Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery

The objective of the study was to improve protein intake after the implementation of a dietary workshop performed on the 15th postoperative day following bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Over 18 years of age
* Scheduled for bariatric surgery such as sleeve gastrectomy or bypass surgery.
* Able to give informed consent to participate in the research.
* Enrolled in a Social Security system.

Exclusion Criteria:

* Inability to travel to participate in the workshop.
* Patients with a diet excluding animal proteins (vegetarians, vegans).
* Pregnant and lactating women.
* Inability to comply with protocol recommendations.
* Incapacitated patients.
* Major deprived of liberty
* Refusal to participate.
Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems

Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers.


Eligibility Criteria:
Inclusion Criteria:

1. Patients- naïve in CareLink®:

   * First implant patients, who initiate in CareLink®
   * Replacements patients who initiate in CareLink.
2. Long term users in CareLink®: patients in CareLink for more than a year.
3. Both male and female
4. More than 18 years old.
5. Be at the disposal of using CareLink monitoring system.
6. Complete informed consent and accept the conditions of CareLink system.

Exclusion Criteria:

1. Less than 18 years old
2. Suffer from any menthal pathology who prevents the patient to collaborate in the study.
3. Be unable to understand or answer questionnaires in Spanish.
4. Deny to continue in the study.
CREATION Health Readmission Risk Assessment Tool

This study occurs in two phases. Phase 1 involves initial item development and measurement validation of a new tool for identifying hospitalized patients at high risk for preventable readmission. Primary tasks include item construction and content validation, data collection, analysis, and instrument refinement. Phase 2 involves administering the refined instrument to a new group of patients to determine final item content for the instrument, its factor structure, and its predictive validity.

Participants will complete the instrument on an electronic device provided by research staff in the hospital room. If an individual is unable to complete the instrument, the participant may have another individual input answers on the electronic device. Hospitalized patients (n = 1240: 620 in Phase 1 and 620 in Phase 2) with a variety of chronic diseases will be recruited into the study. Study coordinators will recruit participants with the following diagnoses: heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, coronary artery bypass graft, pneumonia, total knee or hip replacement, and stroke. These diagnoses were chosen because of the frequency with which patients are readmitted after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary admission diagnosis of heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, coronary artery bypass graft, pneumonia, total knee or hip replacement, or stroke.
* Age 21 and over
* Able to provide informed consent
* Able to speak and read English
* Able to complete an electronic survey or relay answers to questions to another party who may complete the survey for the participant
* Resides in Central Florida and anticipates continued residence in Central Florida for the next 120 days
* Planned discharge to a non-hospital or residential care environment

Exclusion Criteria:

* Under age 21
* Does not speak or read English
* Permanent residence is outside Central Florida
* Not of cognitive capacity to provide valid responses
* Dementia or cognitive impairment that renders subject unable to provide informed consent
* Prescribed a known psychoactive medication that might reasonably affect the ability of the participant to provide valid responses
Bone Ultrasound to Access Fracture Healing

The purpose of this study is to evaluate sequential fracture healing with radius/ulna fractures or clavicle fractures and compare ultrasound to radiographs.

Investigators will recruit 60 pediatric and adult patients with complete radius, ulna and/or clavicle fractures and obtain ultrasound data from the fractured bones and the contralateral intact bone (as control) at each clinical visit. Ultrasound will be compared to radiographs. Completion of this aim will validate the concept and correlate clinical healing with ultrasound findings. For the ultrasound method, investigators will use ultrasound energy to produce a secondary mechanical vibration in bone that can be used to characterize the integrity of the bone. (This is in contrast with conventional sonography where ultrasound echoes are used to image the tissue.) The proposed method is based on the use of Ultrasound Radiation Force (URF) to excite the bone. URF is a "pushing" force exerted by ultrasound on an object. This force can be static, transient (pulse), or harmonic. Harmonic URF can be generated by modulating the amplitude of the ultrasound beam at a desired frequency. This force initiates bone vibration, where the frequency and amplitude of such vibrations depend on bone geometry and elastic properties. Hence, any fracture (or fracture repair) will alter the vibration pattern, thus enabling us to monitor fracture and fracture healing by analyzing such patterns.

Eligibility Criteria:
Inclusion Criteria:

* Forearm fractures and no patients with hemiplegia -OR-
* Clavicle fractures

Exclusion Criteria:

* Non-English speakers
* Known pregnancy
Clozapine IM and Aggression in Schizophrenic Patients

Aggressive, persistent aggression and impulsive behavior are frequently observed in schizophrenic patients. According to some researchers "more than 50% of all psychiatric patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening behavior and agitation to assault"(1). It is a common cause of psychiatric admission and is a therapeutic issue. The treatment of these symptoms is a clinical problem for both patients and staff. Violent behavior, a major detrimental factor in stigmatization of the mentally ill, also poses physical danger for the patients themselves. Current pharmacotherapy of pathologic aggression involves the use of multiple agents (typical and atypical antipsychotics, benzodiazepines, mood stabilizers, beta-blockers, antiandrogenic hormones, and selective serotonin reuptake inhibitors) on empiric basis, with varying degrees of response (2-6). Unfortunately, these approaches lead to numerous side effects. Poor or noncompliance with pharmacotherapy makes it difficult to choose the appropriate preparation. Currently, typical neuroleptics are still the first choice in treating acute aggressive symptoms, while risperidone and olanzapine could be alternatives (5-7). Typical depot neuroleptics should be considered in cases where medication compliance is a problem. Most clinical information on treating of aggression has been collected about atypical neuroleptics, particularly regarding clozapine.

Clozapine is indicated in psychotic state and/or in drug-resistant schizophrenic patients. According to the FDA - it is the drug of choice in suicidal and aggressive patients, due-to psychotic state. It was found helpful in nearly 30% of resistant schizophrenic patients. Concerning the parenteral administration of clozapine - very little data is available today.

This study aims to investigate efficacy and safety (psychopathology, and side effects) of parenteral clozapine in treatment of aggressive behavior in schizophrenic patients in a double-blind trial.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenic, schizoaffective, or schizophreniform according to DSM-IV
* treatment-resistant
* presenting pathologic violent-aggressive behavior on admission
* at risk for self damage
* age: 18-65
* patient is not participating in any other study at time of this study
* minimal score of 70 on PANSS
* prior resistance to at least 2 different classes of neuroleptics
* OAS scores of at least 4 points in physical aggression sections and at least 2 points in verbal aggression section

Exclusion Criteria:

* neutropenia or any other abnormal CBC result
* myeloproliferative disease
* chronic physical diseases such as liver, renal or cardiac diseases
* history of alcohol or drug abuse
* history of drug induced granulocytopenia/agranulocytosis
* alcoholic/drug psychosis or intoxication
* carbamazepine or other bone marrow suppressor treatment
* uncontrolled epilepsy
* paralytic ileus
* hypersensitivity to clozapine
Quantitative EEG During Anesthesia Emergence in Children

Most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. In this process, various side effects may occur.

Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. Previous EEG studies reported that this phenomenon is related to hyperexcitation of the brain, and occurrence of epileptiform discharges during anesthesia induction may indicate an increased vulnerability for the development of a functional brain disorder in these children.

However, to the best of our knowledge, there is no studies concern evaluating quantitative EEG parameters for prediction of this postoperative negative behavior in children.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2 and 10 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive surgery under general anesthesia

Exclusion Criteria:

* If the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder
* with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc
* refusal of consent
* Recent history (within a month) of received general anesthesia or surgery
* presence of congenital or other genetic conditions thought to influence brain development
Measurement of Total Hemoglobin by Pulse Oximetry in Neonatal Population

Assess ability of Masimo SpHb sensor to demonstrate robust performance on various sensor application sites on neonates/infants


Eligibility Criteria:
Inclusion Criteria:

* Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care.
* Ages: Newborn infants less than 16 weeks postnatal age.
* Weight: Range from 500 g to 10 kg.
* Able to obtain written informed consent from parents or legal guardians

Exclusion Criteria:

* Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.