cyrilzakka/clinical-trials huggingface dataset:
Oral Antidiabetic Agents in Pregnancy

The aim of this study is to determine the efficacy of oral treatment with glyburide and metformin controlling excessive fetal growth in women with gestational diabetes, using insulin as a ransom on no response to oral treatment .

It is randomized with women who seek care at the Outpatient Diabetes in Pregnancy in our hospital trial Eligible women between 18 - 45anos diagnosed with gestational diabetes , according to the WHO criteria , ratified the public network for prenatal care at the Clinic for Diabetes and Pregnancy HCPA .

Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of enrollment.

Pregnant women with indication for pharmacological treatment will be invited to randomization to use of oral , glyburide or metformin antidiabetic .

At regular intervals of 2 - 3 weeks fetal growth will be measured with obstetric ultrasonography , until birth.

The primary outcomes will be :

( 1 ) weight and gestational age at birth and the index of large for gestational age fetuses ( ≥ 90th percentile for gestational age ) ( 2 ) the use of insulin to achieve glycemic targets according to fetal growth , as an indirect measure of the inefficiency of oral medications .

The procedures for monitoring metabolic and obstetrical control , assessments of fetal well -being and indications for interruption are usually adopted in the Outpatient Diabetes and Pregnancy of the institution.

- Patients will be followed since their first appointment in our hospital, around the 20th week of pregnancy- until 8 weeks after labor and delivery. That being said, patients will be followed by an average of 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Eligible women between 18-45 years diagnosed with gestational diabetes, according to the WHO criteria (19), ratified the public network for prenatal care at the Clinic for Diabetes and Pregnancy.
* Women with singleton pregnancy and gestational age not exceeding 30 weeks at the time of enrollment, calculated from ultrasound (U.S.) Obstetric performed before the 20th week of pregnancy will be enrolled.

Exclusion Criteria:

* Women who present enrollment in the diagnosis of chronic hypertension, heart disease or chronic lung disease intrauterine restricted or preterm labor, growth, or even chronic diarrhea will be excluded
A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma

The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.

The purpose of this randomized, double-blind, placebo-controlled, parallel-group, multi-center designed trial is to determine the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of persistent asthma for at least 6 months
* Require use of beta-agonists at least four times per week

Exclusion Criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD)
Evaluation of D-chiro-inositol Treatments

Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.


Eligibility Criteria:
Inclusion Criteria:

* Good state of health;
* Regular menstrual cycle.

Exclusion Criteria:

* pregnancy;
* delivery in the previous 6 months;
* currently breastfeeding;
* menopause;
* alcohol or drug abuse;
* insulin resistance defined as HOMA-IR index greater than or equal to 2.5;
* other medical morbidities, such as hypertension, PCOS, or diabetes;
* oligomenorrhea or amenorrhea;
* current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin);
* use of GnRH analogues, SERMs, or SPRMs within the previous 6 months.
I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia

The Hit-IT study is based on an internet-based cognitive behavioral therapy program tailored to patients with different types of cardiovascular diseases and insomnia. A randomized controlled trial design is used. A 9 weeks internet-based cognitive behavioral therapy intervention vs a 3 weeks sleep hygiene education.

DESIGN: Randomized controlled trial with 1-year follow-up. All patients with cardiovascular disease (i.e., myocardial infarction, heart failure, atrial fibrillation and angina) from 4 primary care centers will be screened for insomnia and during a clinical examination diagnosed by a physician specialized in sleep medicine. INTERVENTION: 9 weeks internet-based cognitive behavioral therapy for insomnia (1 week introduction, 2 weeks psycho education on cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction) vs 3 weeks internet-based sleep hygiene education. QUESTIONNAIRES: Sleep (Pittsburgh Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive- and cardiac symptoms (Patient Health Questionnaire-9, Cardiac Anxiety Questionnaire) and Quality of Life (SF-12) at baseline, during and after intervention (after 6 and 12 months).

Eligibility Criteria:
Inclusion criteria:

* age over 18 years
* having a clinical diagnose of insomnia
* being treated for heart failure, coronary artery disease or atrial fibrillation
* access to a computer with an Internet connection, access to a mobile phone and was willing to participate in a treatment for their insomnia.

Exclusion criteria:

* no access to internet, computer or cellphone.
* not understanding the Swedish language
* suffering from cognitive disabilities, severe psychiatric disease, severe somatic disease or sleep apnea
* suffering from drug abuse
* been hospitalised for heart failure, coronary artery disease or atrial fibrillation in the last four weeks
* expected survival less than 12 months
The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

This is a study to assess the ability of SinoFresh Nasal \& Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* The volunteer is able to adhere to the study requirements and study visits.
* Agrees to abstain from use of other nasal sprays for length of study.
* Diagnosis of an MRSA carrier by PCR testing

Exclusion Criteria:

* History of chronic nose bleeds.
* History of intranasal steroids in the last 2 months
* Nasal obstruction severe enough to prohibit effective delivery of a nasal spray
* Epistaxis
* Significant excoriation in the opinion of the Investigator.
* Known hypersensitivity to any ingredients
ImPACT Online Clinical Study

The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.


Eligibility Criteria:
Inclusion Criteria:

* Age: 12-59
* Primary English speaking or fluent in English.
* No known special education diagnosis excluding a 504 designation.
* Currently not suffering from a concussion or being treated for a concussion.
* No known physical or psychological impairment that would affect their ability to perform the test.
* An average or above average score on the RIST (Reynolds Intellectual Screening Test).

Exclusion Criteria:

* Documentation of a known special education diagnosis other than a 504 designation.
* English is not their primary language nor are they proficient in the English language.
* Currently suffering from a concussion or being treated for a concussion.
* A below average score on the RIST.
Improvement of Transient Elastography Applicability and Diagnostic Accuracy to Identify Significant Fibrosis by Experienced Operators Using the M and XL Probe.

Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%. The aim of this study is to evaluate the applicability and diagnostic accuracy of TE performed by trained operators (\<500 explorations), after a second evaluation by experienced explorers (\>500 explorations) and after a third exploration using XL probe. Inadequate LSM will be re-evaluated by experienced operators with the M (standard size) probe. A third register will be performed with XL (obese size) probe in those patients with inadequate M probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic liver disease evaluated with TE by trained operators (experience \<500 explorations).
* Signed inform consent.
* Aged between 18-90.

Exclusion Criteria:

* Patients with ascites.
* Pregnancy.
The CSF Shunt Entry Site Trial

The purpose of the study is to compare the survival time (time to first shunt failure) of ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted through a posterior entry site in children. Shunt entry site is the location on the head that the shunt catheter enters the brain on its path to the fluid-filled spaces in the brain, the ventricles. Entry sites can be anterior or posterior.

The study is a multi-centered, randomized, controlled trial comparing two commonly used CSF shunt insertion techniques, anterior and posterior entry site. There is conflicting information and opinions in the pediatric hydrocephalus literature regarding entry site's effect on shunt survival. This trial is designed to detect a 10% or more difference in the rate of shunt survival at one year between the two techniques.

The trial will be conducted by the Hydrocephalus Clinical Research Network and the Hydrocephalus Association. It is a four year study with an estimated sample size of 448 patients. Patients will be randomized in the operating room. Subjects will be followed for a minimum of 18 months.

Eligibility Criteria:
Inclusion Criteria:

1. Less than 18 years of age at the time of shunt insertion; AND
2. Clinical evidence of hydrocephalus that requires a simple ventriculoperitoneal shunt as determined by a pediatric neurosurgeon; AND
3. No prior history of shunt insertion (a history of an external ventricular drain, ventricular reservoir, subgaleal shunt, and or endoscopic third ventriculostomy with or without choroid plexus coagulation is permissible); AND
4. Ventriculomegaly on imaging.

Exclusion Criteria:

1. Need of a shunt that is not a simple ventriculoperitoneal shunt. For example: Patients who require more than one intracranial catheter are excluded. Patients who require a ventricular shunt that terminates in the atrium of the heart, the pleural cavity, the gallbladder, or any other terminal location that is not the peritoneal cavity are excluded. Patients who require a subdural to peritoneal or a cyst to peritoneal shunt are excluded.
2. Active CSF or abdominal infection;
3. CSF leak without hydrocephalus;
4. Pseudotumor cerebri;
5. Hydranencephaly;
6. Loculations within the ventricular system (e.g. large intraventricular cysts or ventricular adhesions which create compartments that distort the ventricular anatomy; isolated trapped lateral ventricle). A small cyst within the ventricle does not meet these criteria;
7. Other difficulties that would preclude follow up at one year (e.g. terminal illness with life expectancy less than 18 months; family plans to move out of region or country);
8. A bilateral scalp, bone, or ventricular lesion that makes placement of either an anterior or a posterior shunt impracticable (e.g. cutis aplasia);
9. Bilateral slit like frontal horns or trigones defined as the widest distance between the medial and lateral walls less than 3 millimeters.
10. Patient is scheduled to have an intra-ventricular procedure (e.g. ETV, endoscopic biopsy, arachnoid cyst fenestration, fenestration of septum pellucidum) in addition to possible or definite VP shunt.
Comparison of Two Immunosuppressive Regimens in Kidney Transplant Recipients With Deceased Donors With the Aim of Preventing the Development of Fibrosis / Atrophy of Reducing the Incidence of Cytomegalovirus Infection

The aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. The investigators will also the evaluate the reduction in the incidence of cytomegalovirus the and improvement of renal function of the everolimus after 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI below 30,
* first transplants with PRA \< 30,
* no contraindication for induction Thymoglobuline,
* age 18 years or younger than 70 years.

Exclusion Criteria:

* patients with a BMI above 30
* retransplantation
* patients hypersensitized with PRA \> 30
* compared with Thymoglobulina indication for induction
* age under 18 or over 70 years
Effectiveness of Physical Therapy Program to Treat Rotator Cuff Disorders Among Nursing Professionals

The program of stretching, strengthening and proprioception is more effective than stretching and strengthening program in nursing, with rotator cuff disorder, according to indicators of quality of life and job satisfaction.

The study will be conducted at the Rehabilitation Centre of the Hospital of the Medical School of Ribeirão Preto, University of São Paulo (USP-HCFMRP).

The study will be conducted with nursing staff (nurses, technicians and nursing assistants) HCFMRP-USP.

The sample will consist of nursing workers sent by request for referral to a medical diagnosis of rotator cuff disorder in the period May 2010 to August 2011.

There was no sample size calculation for this study because the number of subjects directly depends on the demand of patients referred to the Department of Physical Therapy Rehabilitation Center (CER) in the period of data collection. All patients who met the study inclusion criteria were invited to participate.

So, once met the inclusion criteria of the sample, the subjects were randomly allocated to Group 1 (control) or 2 (experimental).

Group 1 was formed by the subjects in the control group in which they were performed stretching exercises, cryotherapy and strengthening the shoulder.

Group 2 was formed by the subjects in the experimental group were performed in which stretching exercises, strengthening, and cryotherapy proprioceção shoulder.

Eligibility Criteria:
Inclusion Criteria:

* working as a nurse
* technician or nursing assistant in the hospital
* make medical diagnosis of disorder in the rotator cuff (impingement, injury or rupture of the cuff)
* does not make a medical diagnosis of cognitive impairment
* were receiving no another type of treatment for shoulder pain (eg medicines,acupuncture, massage)
* availability and interest in participating in therapy and accept to participate in the survey.

Exclusion Criteria:

* patients with pain that would prohibit their participation in the program with a medical diagnosis of cognitive impairment,
* associated with debilitating diseases,
* previous surgery of the shoulder,
* other specific conditions of the shoulder joint (adhesive capsulitis,
* degenerative osteoarthritis of the glenohumeral joint,
* tendon calcification) and do not accept to join the study.
Measuring Endometrial Blood Flow Using Laser Doppler: Acceptability & Reproducibility

35 participants will be recruited from a list of patients who are scheduled, as part of their routine NHS care, to have a clinically-indicated outpatient hysteroscopy for assessment of their uterine cavity. The participants will be women from the age of 18 up to the age of 40 who are undergoing hysteroscopy investigation. All participants included in the study require at least one ultrasound scan, within the preceding 5 years, demonstrating the presence of a normal uterine cavity devoid of uterine anomalies such as a septate uterus or intrauterine fibroids (which may affect endometrial blood flow measurements). It is usual for a patients to have an ultrasound assessment prior to hysteroscopy therefore we do not anticipate this requirement limiting the number of eligible participants available.

Patient registry: Recruited patients will be registered on 'Edge', a secure, password-protected, database for study participants.

All the investigators will comply with the requirements of the GDPR 2018 with regards to the storage, processing and disclosure of personal information and will uphold the Act's core principles.

Access to patient-identifiable data will be restricted to the core patient-facing members of the research team at Birmingham Women's and Children's Hospital. The patient-facing members will be the Chief Investigator (ME), the Principal Investigator (JC), and co-investigator (HH).

The study involves depersonalised data and the data will be maintained within secure servers. The Birmingham Women's Hospital Research and Development department will hold an archived copy of the study data.

The Chief Investigator (ME) and the Principal Investigator (JC) will act as data custodians and keep the site file locked away securely with restricted access to study data for 25 years. Only the aforementioned members of the research team will have access to the site file for the purpose of quality control, audit and analysis.

Coded, depersonalised data will be created and used for study documents, in place of participant-identifying information. The participant data within the study and the code linking this data to the individual's true identity and identifiable data will be kept in separate locations using encrypted digital files within password-protected folders and storage media

Eligibility Criteria:
Inclusion Criteria:

* Women from the age of 18 up to the age of 40 who have consented to hysteroscopy investigation as part of their standard NHS care.
* Women who have had an ultrasound scan, within the preceding 5 years, demonstrating a normal uterine cavity with no gross anatomical abnormalities (e.g. uterine septum).
* Women who have given informed consented to take part in the study

Exclusion Criteria:

* Inability to tolerate vaginal examinations
* Women who are pregnant
* Women who do not have regular menstrual cycles
* Women who have not given consent to the study.
Implementing Internet-Assisted Treatment for Non-Cardiac Chest Pain

This study aims to test Implementation of Internet-Assisted Treatment for Non-Cardiac Chest Pain at the Cardiac Department at Sørlandet Hospital. The internet-assisted treatment will be delivered by personnel working at the department. Effectiveness will be tested in an randomized controlled trial (RCT). The intervention has been tested in an RCT where the intervention was delivered by a cognitive behavioral therapy (CBT) specialist who also participated in developing the intervention. Presently the investigators will test if personnel working at the department, with minimal training in CBT, can deliver the intervention effectively.

Most patients with chest pain referred to hospital do not have a cardiac illness. Non-cardiac chest pain (NCCP) is often followed by persistent distress and reduced quality of life, and societal costs are nearly equal to those of cardiac patients. Research suggests that face-to-face CBT is effective, but this has not been implemented as standard treatment. The investigators plan to test an easily implementable internet-assisted treatment for NCCP patients delivered by personnel already working at the department.

Patients will be recruited at the chest pain unit at Sørlandet Hospital, Kristiansand, and will be recruited after they have finished their cardiac examination.

The intervention group will receive six web-based sessions, comprising information, exposure to physical activity, how worry can excess pain, physical reactions to pain and worry, consequences of avoidance, and specific panic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non-Cardiac Chest Pain

Exclusion Criteria:

* Language difficulties
* Unable to perform at least moderate physical activity due to physical constraints
* Obvious cognitive impairment (e.g mentally retarded, psychotic, dementia or intoxicated)
* no regular access to a computer/tablet computer with internet connection
Transcatheter Aortic Valve Implantation With Sapien 3 Transcatheter Heart Valve for Pure Aortic Regurgitation

The hypothesis is that TAVI using a SAPIEN 3 THV is feasible and safe for the treatment of pure AR.

Up to now, the balloon-expandable valves have been considered contraindicated for patients with pure AR due to the absence of calcium which is considered necessary for the anchoring of the prosthesis. Nonetheless, several cases report have suggested the feasibility of TAVI using the SAPIEN XT THV, in patients with no calcified valves suggesting that an appropriate degree of oversizing might compensate the lack of calcium for the anchoring of these prostheses.

The new generation balloon-expandable SAPIEN 3 THV has incorporated changes in the stent frame geometry, leaflets configuration and an external sealing skirt resulting in an increased stability and outstanding control during its implantation, a greater radial force, a reduced rate of paravalvular leaks and a covering of a wider range of annulus dimensions. These characteristics of the SAPIEN 3 THV might translate into a safer use of this device in patients with pure AR and non-calcified valves.

Significant AR occurs in 2.0% of individuals of \>75 years, 13.3% of patients referred for intervention, being severe in 5% of these patients. As for aortic stenosis, its prevalence increases with age and the most frequent cause is degenerative although rheumatic and endocarditis are present. Although patients with severe AR have an excess risk of mortality and aortic valve replacement reduces mortality, only 1/3 of patients with significant AR finally undergo intervention. Reasons for no intervention are unknown.

Even if it has been suggested that AR might be underestimated and the prevalence of this disease might be higher than previously reported, and a percent of patients with indication for aortic valve replacement are denied for surgery, pure AR is a small niche of patients for TAVI. In terms of cost-effectiveness, both the development of a dedicated device and the investment in the training of operators in the implantation technique might lack of interest. However, performing TAVI with a device used in the routine practice might be appealing and, importantly, safer. A preliminary case series including 3 patients have suggested the feasibility of TAVI with the SAPIEN 3 device for pure AR (Urena M, Himbert D. JACC, 2016 ). In this study we aim to evaluate the feasibility and long-term safety of the SAPIEN 3 THV in patients with pure AR.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic (at least dyspnoea NYHA class III or acute heart failure requiring hospitalisation) and pure AR
* Contraindication or high risk for surgical aortic valve replacement
* Echocardiography and computed tomography findings suitable for TAVI using a SAPIEN 3 THV

Exclusion Criteria:

* Contraindication for TAVI (active endocarditis, aortic dissection, annuloectasia..)
* Patients' refusal