cyrilzakka/clinical-trials huggingface dataset:
The Caffeine Therapy in the Fetal to Neonatal Transition

Introduction: The caffeine is used in the treatment for apnea of prematurity and it has several positive effects in the neurodevelopment of preterm babies. There are innumerable observational studies suggesting that initiating caffeine in the first hours of life may offer more benefits in the reduction of the necessity of intubation and in ventilation time. It is necessary to expand further research on the best time to start caffeine, which may improve the quality of care for premature infants.

Objective: To evaluate the benefits of caffeine administration in the first two hours of life compared to administration at 24 hours of life in premature patients on noninvasive mechanical ventilation with birth weights less than 1250 grams.

Methodology: Preterm newborn patients with birth weight \< 1250 grams born at Hospital de Clínicas de Porto Alegre who are not intubated in the delivery room will be included. Patients will be randomized into two groups. One arm of the study will receive caffeine at 2 hours of age and the other arm will receive caffeine at 24 hours of age (control). Patients in the control group will receive 0.9% SF at 2 hours of life in order to keep the study blinded. The following outcomes will be evaluated: need for intubation, time on invasive and non-invasive mechanical ventilation, BPD, necrotizing enterocolitis, need for ROP treatment, PDA with hemodynamic repercussions, peri-intraventricular hemorrhage, leukomalacia and death. The sample size calculation is 50 patients, 25 in each arm.

Expected Results: It is expected to find a 43% reduction in the need for intubation in preterm infants who receive caffeine in the first two hours of life compared to administration at 24 hours of life. It is also expected to find a reduction in mechanical ventilation time, in addition to a possible reduction in negative outcomes associated with prematurity.


Eligibility Criteria:
Inclusion Criteria:

* Premature newborns with birth weight less than 1250 grams
* Who are not intubated in the delivery room

Exclusion Criteria:

* Premature newborns from other hospitals
* Presence of a major congenital malformation or genetic syndrome
Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers

Investigation of arginine and NO metabolism in healthy subjects is important as a reference for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the changes during aging and gender-related differences. Although data on arginine metabolism exist in literature, data are limited to young healthy male subjects. Since patients with suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly and also women, knowledge of arginine metabolism in these groups is needed.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-25 years (young); 50-70 years (middle aged/elderly)

Exclusion Criteria:

* Diabetes mellitus type I
* Livercirrhosis, pancreatitis, malignancies
* Hypertension (diastolic blood pressure \>95 mmHg or systolic blood pressure \>160 mmHg)
* History of gastrointestinal complaints
* Recent involuntary weight loss (more than 10 % in 6 months or more than 5 % in one month)
* Pregnancy (pregnancy test is done in female subjects)
* Use of medication that can affect arginine metabolism (nitrovasodilators and corticosteroids)
* Subjects with "high activity level"
Active Health Education to Increase HPV Vaccine Coverage in Youth: A Stepped-wedge, Cluster, and Randomized Trial

This study aims to evaluate the impact of active health education methodologies on increasing adherence to the HPV vaccine among schoolchildren. The project will involve 80 schools across Brazil, encompassing a total of 5,000 students.

A stepped-wedge implementation design will be applied, with clusters being randomized every two months to one of four interventions.

Each intervention will be implemented in 20 schools.

The adherence to the HPV vaccine among young people has declined recently, particularly in Brazil. While previous studies have shown that interventions such as text messaging can increase vaccination coverage, there is still a lack of robust data on the effectiveness of direct interventions in school populations using active health education methods. This study aims to evaluate the impact of active health education methodologies on increasing adherence to the HPV vaccine among schoolchildren.

The project will involve 80 schools across Brazil, including a total of 5,000 students. These schools will be randomized into clusters of five.

The study will apply a stepped-wedge implementation design, with clusters being randomized every two months to one of four interventions:

Education for students and teachers training + Basic Health Unit action in schools Education for students without teachers training + Basic Health Unit action in schools Only Basic Health Unit activities Usual control

Eligibility Criteria:
Criteria for students

Inclusion Criteria:

* Students of both sexes aged 9 to 14 years old.

Exclusion Criteria:

* Students with a complete HPV vaccination (two doses) received.

Criteria for Clusters

Inclusion Criteria:

* The school has enrolled students aged 9 to 14 years old.

Exclusion Criteria:

* Schools that do not have students aged between 9 and 14;
* Schools that provided only distance education
Stents, Drug Eluting Stents, and CABG- Financial and Clinical Impact.

Options for coronary revascularization include stent implantation and coronary bypass surgery. Both modalities have their unique advantages and disadvantages in terms of clinical outcomes as well as financial impact on the medical system. We wish to investigate the late results of patients undergoing coronary revascularization, the need for re-hospitalization, re-intervention, patient satisfaction as well as the financial burden on the medical system. The study will be conducted by historical prospective review of hospital records in conjunction with records of the medical insurance companies ("HMO's").

Cardio-vascular disease is the second leading cause of death in the western world. Two modes of treatment are currently used:

Coronary Artery Bypass Graft (CABG) Percutaneous Interventions (PCIs) i.e: balloon angioplasty and stents\[ bare metal (BMS) and drug eluting (DES)\].

CABG is a major operation but is considered to be safe and with good quality of life in the years to follow. The initial cost of CABG is high but usually stays low thereafter.

PCI is less invasive but its downfall is a high rate of restenosis hence leading to the return of angina. The initial cost is low but due to the return of symptoms the cost increases.

The goal of DES is to lower the rate of restenosis thus reducing the need for repeat hospitalizations and procedures. The initial cost of this stent is higher than that of the BMS but still lower than that of CABG.

The goal of this study is to assess and compare the average annual cost of treatment for patients with multi-vessel disease who underwent one of the following procedures:

1. CABG
2. DES
3. BMS

The information for the study is derived from the data bases of the cardiology and cardio-thoracic surgery departments at Shaarey-Zedek hospital and from those of Clalit Health Services and Kupat Holim Meuhedet.

The study design is historical prospective. The participants are insured by the above mentioned HMOs and were treated during 2000-2004.

The final sample's size will be decided on according to a pilot study with 15 patients from each of the treatment groups.

To our knowledge no studies comparing CABG and DES have yet been published. We believe that our study could become a mile stone in the process of choosing the most suitable treatment for the patient and for the health system.

Eligibility Criteria:
Inclusion Criteria:

* Patients which are insured in the relevant HMO's and suffer from a multi-vessel coronary disease with occlusion of at least 70% of at least two of the main coronary vessels.

Exclusion Criteria:

* Non multi- vessel Disease
* Any additional cardiac disease

  1. Valvular
  2. Low EF (\<30%)
* Liver disease - according to liver enzymes
* Other cardiac treatment (past or immediate future)

  1. Active MI (24hrs before revascularization)
  2. Previous revascularization before beginning of follow up.
Is Acne a Skin Disease Affecting the Brain Functions? Neurocognition in Patients With Acne Vulgaris

Acne vulgaris usually causes psychological distress, depression, and anxiety disorders that may impair neurocognitive functions such as memory, attention, psychomotor speed, and executive functions, which are also common psychiatric disorders in patients with acne.

The purpose of this study is to determine cognitive functioning in treatment naive acne patients, without a history of any psychiatric disorder.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

The participants that had a symptom or a history of mental retardation (IQ \< 70), serious head trauma, seizures or any other mental disorder, and participants on any medical treatment will be excluded. Participants with a family history (first degree relatives) of schizophrenia, bipolar disorder or schizoaffective disorder will also be excluded to avoid the negative effect of these disorders on cognitive functions. The same exclusion criteria will also be applied to the control group.
Biobehavioral Intervention in Gynecologic Oncology Patients

Baseline self-report outcome measures will be completed and additional assessments will occur mid-treatment , post-treatment , 3 months following completion of all sessions, and 6 months following completion of all sessions. Patients and therapists will complete the evaluation measures in private (at home, in an office).

At the University of Kentucky Markey Cancer Center, BBI treatment is offered in group and individual formats. The course of individual treatment varies and group treatment consists of 10 1.5-hour weekly sessions in the "intensive" phase, followed by 2 1.5-hour bi-weekly maintenance sessions. Individual treatment is one-on-one. In group treatment, there are typically 6-12 patients per group and 1 or 2 therapists. The intervention helps patients to learn adaptive coping strategies and how to apply them to daily stressors. Additional content discusses use of seeking information, enhancing social support, enhancing body esteem and intimacy, and maintaining positive changes.


Eligibility Criteria:
Inclusion Criteria:

* Females
* Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
* Undergoing active treatment or in remission and undergoing active surveillance; age ≥21 and ≤80
* Able to speak/read English.

Exclusion Criteria:

* Concurrent diagnosis of organic brain syndrome, dementia, mental retardation
* Non-English speaking, or significant sensory deficit
* Major mental illness (e.g., schizophrenia, psychotic disorder).
Diabetes Resolution and Hormone Changes After BPDLL and LSG

To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.

Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)\> 50kg/m2) will undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose tolerance test. The investigators aim to investigate the effects of surgery on diabetes resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin, glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated according to the criteria of American Diabetes Association with an OGTT. The effects on appetite and satiety will be also evaluated with the use of visual analog scores.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>50kg/m2 to undergo BPDLL
* BMI 40-50kg/m2 to undergo LSG
* Diabetes mellitus type 2

Exclusion Criteria:

* Chronic medical illness
* Psychiatric illness
* Substance abuse
* Previous gastrointestinal surgery
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
* Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
* Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

* Prior treatment with vismodegib
* Known hypersensitivity to any of the study drug excipients
* Any metastatic basal cell carcinoma
* Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
* Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
* Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
* Recent, current, or planned participation in another experimental drug study
The Anti-fibrotic Therapeutic Effects of Resveratrol for Discharged COVID-19 Patients

A randomized controlled trial (RCT) will be conducted to evaluate the anti-fibrotic therapeutic effects of resveratrol on the clinical symptoms in discharged COVID-19 patients.

The proposed study will be a randomized controlled trial (RCT) to evaluate the anti-fibrotic therapeutic effects of resveratrol on the clinical symptoms in discharged COVID-19 patients. The target population will be post-discharge patients recovering from COVID-19. Eligible participants will be recruited from the ongoing special Chinese Medicine program for discharged patients collaborated with Hong Kong Hospital Authority. Thirty (30) participants will be randomly assigned to resveratrol group and placebo group with 1:1 ratio. The participants will receive six months of treatment (1 g, orally and once daily) and three months of follow-up. The total duration of the clinical study is 9 months. The study protocol will be submitted to the Ethics Committee for review and approval. Participants will be enrolled and signed written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be the patients aged 18-65 years old who have been previously diagnosed to be infected with COVID-19 and discharged from local hospitals after treatment with western medicines, and with negative results from COVID-19 virus detection. The subjects will be evaluated for potential pulmonary fibrosis and those who present with the condition resulting from COVID-19 infection will be included.

Exclusion Criteria:

* Participants will be excluded if they have one or more of the followings: 1) inability to communicate (e.g. cognitive impairment); 2) history of Chinese medicine allergies; 3) incompetent in giving consent.
Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea

The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
* Signed informed consent

Exclusion Criteria:

* IBS-D
* evidence of cathartic colon or history laxative abuse
Targeting Worry to Improve Sleep

The purpose of this study is to test an app-based mindfulness training program for worry to see if it can help individuals decrease worry and improve sleep.

In this study, 80 individuals with worry interfering with sleep will be randomized to receive Unwinding Anxiety or to Treatment as Usual (50/50 chance). The active intervention period will last 2 months, with an optional 2-month follow-up period in which the intervention remains available. Changes in mindfulness, emotional reactivity, cognition and sleep behavior at specified time points will be measured. The primary engagement targets will be non-reactivity and worry. The primary behavioral outcome target will be sleep.

Eligibility Criteria:
Inclusion Criteria:

* Score \> 40 on the Penn State Worry Questionnaire (PSWQ)
* Score ≥ to 40% on Worry Interfering with Sleep Scale (WISS)
* Owns a smartphone
* Willing to wear a sleep tracker for at least 1 week

Exclusion Criteria:

* Any usage of psychotropic medication: not on a stable dosage 6+ weeks
* Medical disorder of the severity that would interfere with ability to attend visits and complete study milestones
* Use of benzodiazepine or hypnotic sleep aid on as needed (i.e. prn)
* Known sleep disorder
* Psychotic disorder
* Post-traumatic Stress Disorder
* Severe depression (Score \> 3 on PHQ-2)
* Current shift work employment
* BMI \> 35
* Evening caffeine use
* Pregnant women
Clinical Evaluation of Monolithic Zirconia Crowns

The objectives of the present study are to compare the survival rates and possible biological and technical complications of metal-ceramic, and monolithic third-generation zirconia posterior crowns. The null hypothesis is that no diﬀerences would be found between the parameters studied for each type of restoration.

Seventy patients requiring at least one crown in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Seventy posterior crowns were produced and allocated in parallel and randomly to either monolithic third-generation zirconia, or metal-ceramic (MC) restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the crowns were designed using speciﬁc software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 70 crowns were examined at 1week (baseline),1, 2 and 3 years by 2 researchers who were not involved in the restorative treatment.

Eligibility Criteria:
Inclusion Criteria:

* One posterior tooth (molar or premolar) to be crowned
* Vital abutment or abutment with an adequate endodontic treatment
* Abutment not crowned previously
* Periodontally healthy abutment with no signs of bone resorption or periapical disease.
* Adequate occlusogingival height ≥ 4 mm.
* Stable occlusion and the presence of natural antagonist tooth.

Exclusion Criteria:

* Patients who present reduced crown length (less than 4 mm occlusogingival height).
* Poor oral hygiene, high caries activity, or active periodontal disease
Comparative Bioavailability Study of Two Misoprostol Formulations

The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour.

Prostaglandin E2 (dinoprostone) given vaginally or intra-cervically, and oxytocin have been the most commonly used preparations for induction of labour. Misoprostol is a synthetic prostaglandin E1 analogue. Misoprostol has anti-secretory and mucosal protective properties and was originally developed in the 1970s for the prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers. It is now used much more widely for 'off-label' indications like medication abortion, medical management of miscarriage, cervical ripening before surgical procedures, treatment of postpartum hemorrhage, and induction of labour. The lack of a specific license for Cytotec® to be used in obstetrics and gynecology has led to a number of problems regarding correct dose and dose regime.

The study is an open-label, randomized, single-dose, comparative, parallel design, bioavailability study followed by repeat dosing of of two formulations misoprostol in healthy adult females being induced to go into labour.

The drug shall be administered orally or sublingually.

Eligibility Criteria:
Inclusion Criteria:

* Adult females
* Women wanting to participate and having given informed consent
* Known to have reached week 37 + 0 days to week 42 + 2 days of gestation
* With a viable fetus in a vertex position
* Age above or equal to 18 years old
* Women opting for vaginal delivery
* BMI between 20 and 30 kg/m2

Exclusion Criteria:

* Women with known allergy to misoprostol or other prostaglandins
* Women with prior caesarean section
* Women with dead or anomalous fetus
* Women with twin pregnancy
* Women with known liver or renal dysfunction
Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)

This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.

The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection

Eligibility Criteria:
Inclusion Criteria:

* • Male or female over 18 years of age at the time of enrollment

  * Current symptoms of COVID-19 ; fever alone or fever and at least one of the following symptoms need to be present

    * Dry cough
    * Sore throat
    * Shortness of breath
    * Chills
    * Muscle pain
    * Headache
    * New loss of taste or smell
    * Chills with repeated shaking

Exclusion Criteria:

* • Unwilling to provide informed consent

  * Unwilling to undergo bi-weekly serological test during the 1-month enrollment
Measurement of Relaxin Peptide in Multiple Sclerosis (MS)

This study will evaluate relaxin (RLX) levels in patients with multiple sclerosis.

The goal of this study is to obtain baseline information on serum and cerebrospinal fluid (CSF) relaxin levels in patients with MS, as well as to further study RXFP-1 receptor binding affinity for RLX in patients with active and clinically stable MS.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with suspected MS, who have had a clinical attack within the last 12 weeks, have at least one gadolinium-enhancing lesion on brain or spinal cord MRI taken within the prior 4 weeks, and for which they have not received any immunomodulating or immunosuppressant medication.
* Subjects with clinically stable definite MS, with no evidence of clinical relapse for at least the past 12 weeks, and have no gadolinium enhancing lesions on MRI in the prior 4 weeks. These subjects will fulfill the Revised (2010) McDonald's Criteria for the Diagnosis of MS.
* Subjects without evidence of inflammatory systemic or inflammatory central nervous system disease, who require CSF removal for some other cause, such treatment of benign intracranial hypertension or as part of the procedure for insertion of an intrathecal medication delivery system.

Exclusion Criteria:

- Pregnancy