cyrilzakka/clinical-trials huggingface dataset:
Improving Insulin Sensitivity by Non-invasive Brain Stimulation

Efforts in curing and preventing obesity and type 2 diabetes (T2D) have been elusive thus far. One reason for that is the lack of understanding of the role of the brain in the development and treatment of the disease. In recent studies, the hypothalamus was identified as part of a brain network including higher cognitive regions that is particularly vulnerable to insulin resistance. Furthermore, the central insulin response in this network predicted food craving and hunger. In this project, transcranial direct current stimulation (tDCS) is implemented as a tool to stimulate brain networks. The investigators hypothesize that stimulating the hypothalamus-cognitive network will enhance insulin sensitivity and reduce food intake, food craving and hunger. Furthermore, the project will provide the unique opportunity to investigate novel mechanisms of insulin resistance in participants who have been extensively metabolically characterized.

Objectives The overarching aim of the study is to stimulate the hypothalamus-cognitive brain network to improve insulin sensitivity and eating behavior.

Specific Objectives

1. Implement tDCS stimulation compared to sham stimulation in overweight and obese adults to assess the impact on eating behavior, cognition and metabolism.
2. Evaluate whether 3-day non-invasive brain stimulation of the hypothalamus-cognitive network has a causal effect on metabolism.
3. Evaluate whether 3-day non-invasive brain stimulation has a significant effect on brain functional connectivity and diffusion parameters.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 25.5 and 39.5 kg/m2
* Age between 20 to 66 years of age
* Waist circumference ≥ 80 cm for women, ≥ 94 cm for men

Exclusion Criteria:

* Insufficient knowledge of the German language
* Persons who cannot legally give consent
* Pregnancy or lactation
* History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures)
* Taking psychotropic drugs
* Previous bariatric surgery
* Acute infection within the last 4 weeks
* Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men
* Current participation in a lifestyle intervention study or a pharmaceutical study
* Contradictions to a MRI measurement (e.g. metal implants)
Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent to participate in this study in accordance with local regulations
* Have a confirmed diagnosis of cystic fibrosis (sweat test and/or genotype)
* Be aged \>6 years (6-11 for paediatrics, 12-17 for adolescents and 18 years for adults)
* Have FEV1 \> 30 % and \< 90% predicted

Exclusion Criteria:

* Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
* Be considered "terminally ill" or listed for lung transplantation
* Have had a lung transplant
* Be using nebulised hypertonic saline
* Have had a significant episode of haemoptysis (\> 60 mL) in the three months prior to enrolment
* Have had a myocardial infarction in the three months prior to enrolment
* Have had a cerebral vascular accident in the three months prior to enrolment
* Have had major ocular surgery in the three months prior to enrolment
* Have had major abdominal, chest or brain surgery in the three months prior to enrolment
* Have a known cerebral, aortic or abdominal aneurysm
* Be breast feeding or pregnant, or plan to become pregnant while in the study
* Be using an unreliable form of contraception (female patients at risk of pregnancy only)
* Be participating in another investigative drug study, parallel to, or within 4 weeks of study entry (except inhaled mannitol)
* Not able to maintain a mannitol free diet from Day -2 until Day 8 of the treatment phase.
* Have a known allergy to mannitol
* Be using beta blockers
* Have uncontrolled hypertension - systolic blood pressure \> 190 and / or diastolic blood pressure \> 100
* Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
* Be MTT positive.
Early Reversal of Defunctioning Stoma Trial

In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.

Eligibility Criteria:
Inclusion Criteria:

* Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6.

Exclusion Criteria:

* Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.
Study of E3810 for Healthy Japanese Male (Under Fasting Condition)

The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting condition.

The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.

Eligibility Criteria:
Inclusion criteria:

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19.

Exclusion criteria:

Subjects with allergy
Lung Perfusion Measured With Dual-Energy CT in Patients With Chronic Thromboembolic Pulmonary Hypertension: Comparative Study With Right Heart Catheterization and V/Q

A comparative, observational, cross-sectional and prolective diagnostic test study, including patients that have had a right heart catheterization and were referred for a CT pulmonary angiography as part of their imaging workup protocol for pulmonary hypertension.

Dual-energy computed tomography (DECT) pulmonary angiography was performed on each patient to obtain perfusion maps and do a quantitative analysis. Segments with and without perfusion defects according to significant differences in the quantitative values, were defined as compatible or not with chronic thromboembolism.

To assess the accuracy of the method and evaluate its performance, these results were compared with the sole results from the right heart catheterization, known to be the gold standard diagnostic tool.

a comparative, observational, cross-sectional and prolective diagnostic test study is conducted, including consecutive patients from the pulmonary hypertension clinic at our institution, from March 2017 to October 2018. Patients that have had a right heart catheterization and were referred for a CT pulmonary angiography as part of their imaging workup protocol. (The minimum sample size calculated is 26 patients).

DECT pulmonary angiography (256-slice and double-source CT scanner) was performed on each patient. Obtaining perfusion maps and doing a quantitative analysis by circular regions of interest (ROI) and iodine-related attenuation values (IRA) on each lung segment. Then, according to the finding in right heart catheterization, a comparison will be made between to groups: segments with and without perfusion defects, in order to find significant differences in the quantitative.

To assess the accuracy of the method and evaluate its performance, these results were later compared with the sole results from the right heart catheterization.

ROC curves were plotted to extract possible decision thresholds of the IRA values to classify perfusion as normal or deficient with this technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients from the pulmonary hypertension clinic at our institution who have had right heart catheterization and were referred for a pulmonary CT angiography as part of their imaging workup protocol.

Exclusion Criteria:

* creatinine \> 1.5 mg/dL
Correlation Between Body Weight and Foot Progression Angle in Adolescents

Obesity is associated with functional decline , altered spatiotemporal gait parameters (e.g. lower gait speed, shorter strides, and increased step width), and a significantly higher metabolic cost of walking compared to people with normal body weight. Obesity also negatively affects balance control.This study will investigate foot progression angle in adolescents related to their weight and category classification based on the CDC (Centers for Disease Control and Prevention) growth charts.


Eligibility Criteria:
Inclusion Criteria:

* All children have normal stature for age percentile according to CDC chart.
* The sample will include both sex and will be divided in to 4 groups according to the CDC (Centers for Disease Control and Prevention) growth charts.
* All children are normal \&perform all activities of daily living
* They were able to understand and follow verbal commands and instructions included in the testing procedures.

Exclusion criteria:

* All of them could be part of recreational activities in their public schools but no competitive sports. Children who participated in any regular sport activities involving the lower extremities will be excluded.
* None of them had any surgical intervention in the lower extremities.
* None of them had any history of musculoskeletal deformities or neuromuscular disorders.
* They had neither visual, auditory defect.
Check It! Positive Psychology Intervention to Improve Adherence in Adolescents With T1D

Problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. Therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. This intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. In addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes.

Participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. Clinical measures of diabetes management will be collected from participants' electronic medical records.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 diabetes for at least 6 months
* HbA1c between 8-12%
* Speak and read English
* Caregiver living with child

Exclusion Criteria:

* Other uncontrolled health conditions
Electric Stimulation on Nausea and Vomit Chemotherapy Induced

Chemotherapy induces nausea and vomit for some large patients. But, some chemotherapy protocol has a high indices of the incidence as observed in a combination of Anthracycline and Cyclophosphamide (AC). To prevent this symptoms, some medication can be used as Ondansetron. By other hands, the traditional acupuncture on Chinese Medicine have been used a PC6 point to avoid nausea and vomit. More recently, a transcutaneous electric nerve stimulation (TENS) also has been used for this application. Our study will test the TENS applied on PC6 point with two different frequencies (high and low) to evaluated the nausea and vomit inhibition effects.

We will enroll 84 women that being starts a chemotherapy protocol with a Anthracycline and Cyclophosphamide (AC) as a part of breast cancer treatment. All volunteers will be submitted a 30 minutes TENS prior to chemotherapy administration. Three different TENS treatment will be test: 1) placebo; 2) high frequency and 3) low frequency. The self-adhesive electrodes will be positioned in the same position for all different TENS treatment (opposite arm to the chemotherapy infusion). The eletctrodes will be positioned as follows: the first electrode at the PC6 point which is located proximal to the flexion fold of the wrist in the middle of the anterior face of the forearm, between the tendons of the long palmar and radial flexor muscles of the carpus and the second electrode at any point in the hand. After that, all volunteers will receipt a formulary to self-complete a nausea and vomit symptoms record during the next 24 hours. Number of incidence and magnitude of the symptoms will express the accumulated indices the occurrence and severity of the symptoms, as further describe in this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Having breast cancer diagnosed through anatomopathological investigation;
* Indication of neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with Ondasetron used as a routine of the Santa Rita Hospital chemotherapy service;
* Present Karnofsky score (KPS) higher than 70 points;
* Being female;
* Be between 18 and 65 years of age and be able to participate in outpatient chemotherapy.

Exclusion Criteria:

* Patients with breast cancer treated with chemotherapeutic regimens other than anthracycline and cyclophosphamide;
* Inability to report nausea and vomiting due to neurological changes, difficulty understanding and / or lack of caregivers that may contribute to the completion of the report;
* Be submitted to radiation therapy concomitant with chemotherapy;
* Presence of gastrointestinal and cerebral metastases;
* Presence of cardiac pacemaker;
* Presence of active skin infection in PC6;
* Nausea and vomiting caused by electrolyte disturbances or intestinal;
* Presence of intra-cranial hypertension.
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns

A randomised controlled trial comparing volume-targeted ventilation to pressure-limited ventilation in infants born at or near term.

Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for preterm infants in comparison to pressure-limited ventilation. It is not known whether the same is true in the case of infants born at term. This study aims to compare pressure-limited to VTV in term-born infants.

Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated infants 34 weeks or more gestational age at birth were recruited and randomly allocated to receive either pressure-limited or VTV. Adjustments to ventilator settings were made according to the trial protocol. Infants were deemed to have met failure criteria if they required HFOV or peak pressures of more than 30 cm of water. Analysis will be by intention-to-treat.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated
* Born at gestation 34 weeks and above

Exclusion Criteria:

* Congenital diaphragmatic hernia
* Congenital heart disease
Digital Glucose Monitoring in Gestational Diabetes

Assessing blood glucose control in women with gestational diabetes can be challenging. The standard of care remains visual inspection of blood glucose paper diaries of self-performed capillary monitoring during regular meeting in High Risk pregnancy clinics.

The researchers are interested in preforming a randomized control trial comparing women with the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital monitoring using an application in a Smart-phone and submitting those values via email in addition to the regular clinic appointments.

The Primary outcome of the trial is to assess the compliance of the research group as compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* gestational diabetes

Exclusion Criteria:

* pre-gestational diabetes
Bone Status and Insulin Resistance in Hirsutism

The purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. The change in hormone content in the blood will also be investigated. The study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women.

Hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. Their blood tests often show changes reminding of the ones seen in diabetic patients.

All hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. The investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition).

The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. They are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.


Eligibility Criteria:
Inclusion Criteria:

Hirsute subjects:

* Belonging to group 1 or 2.
* Age: 20-46
* Hirsute score: \>7
* Written informed consent

Control group:

* Age: 20-46
* Hirsute score: 0 (without razing)
* Regular menses
* Written informed consent

Exclusion Criteria:

* Previous cosmetic treatment for hirsutism.
* Use of contraceptive pill (within the past 6 months)
* Systemic steroid treatment \> 6 weeks (ever)
* Age above 46 years/post menopause (increased FSH)
* Recognized diabetes mellitus or other endocrine disease
* Eating disorder
* Serious, treatment demanding disease
Male Stress Urinary Incontinence and Sexual Health

The purpose of this study if to demonstrate if post-prostatectomy incontinence is a barrier to sexual satisfaction/frequency/desire and if surgical correction of incontinence will improve these aspects of sexual health.


Eligibility Criteria:
Inclusion Criteria:

* Adult men age 18-80 who have had an open or laparoscopic radical prostatectomy more than 6 months ago who have bothersome urinary incontinence.

Exclusion Criteria:

* Any significant cardiac or pulmonary co-morbidities that would preclude the patient from another surgical procedure as they would be too high risk for general anesthesia.
* They will also be excluded if based on their anatomy or urodynamics, they will most likely not benefit from a surgical incontinence procedure (e.g. poor bladder contractility, bladder neck contracture, etc).
Zinc to Treat Tinnitus in the Elderly

There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group.

There is widespread belief and some evidence to indicate that zinc can successfully treat tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of this study is to establish the effectiveness of zinc for the treatment of tinnitus in individuals 60 years of age and older. Subjects will be randomly assigned to either receive zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed over to the other group. 116 patients were tested. Tinnitus loudness and the Tinnitus Handicap Questionnaire are the outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Tinnitus for 6 months or more
* Normal copper levels
* Be generally healthy

Exclusion Criteria:

* Have a treatable otological disorder
* Involved in litigation
* Have or are suspected of having a serious psychiatric problem
* Involved in other treatments for tinnitus
* Are taking drugs which might interact with zinc and result in tinnitus
* Have copper deficiency
* Have Zinc levels above normal
* Are cognitively impaired.
Study of Cost-effectiveness of the Airway Management in Thoracic Surgery

The investigators want to carry out a study to determine the role of Doble Lumen Tubes with built-in camera Viva Sight-DL (VDLT) in thoracic surgery. With this study the investigators want to study and enlarge the information in the different surgical approaches, including robotic surgery.

The objective of this study is report a single-center experience using individual data costs to compare the cost effectiveness of VDLT Viva Sight versus the use of conventional Doble Lumen Tubes (cDLT) together with fiberoptic bronchoscope in patients undergoing thoracic surgery, in order to generate information for future decision making related to both devices.

The investigators want to carry out a comparative clinical study on the use of conventional double-lumen endobronchial tubes (cDLT) or video double-lumen endobronquial tubes Vivasight DL (VDLT) during intubation in thoracic lung resection surgery, to study their possible advantages and disadvantages.

This will be a prospective, single-center cohort study of Thoracic Surgery in which the VivaSight-DL (n = 55 patients) or conventional DLT (n = 55 patients) is used for lung isolation in elderly patients (≥ 18 years), thoracic surgery procedures of the "lung resection" type: wedge resection, transegmental resection, lobectomy, bilobectomy or pneumectomy by the different surgical approaches: VATS, robotic surgery and thoracotomy.

The objective of this study is to find out if the use of VDLT reduces the need for fiberoptic bronchoscope (FBS) to verify the positioning of the endobronchial tube during intubation and intraoperatively. Reducing the need for FBS could improve the quality of care provided to the patient and reduce costs to the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients of legal age (≥18 years).
* Patients who require one-lung collapse in Thoracic Surgery procedures.

Exclusion Criteria:

* Patients with predicted difficult airway.
* Left main bronchus anomalies.
* Previous thoracic surgery.
* BMI\> 40.
* Patients with tracheostomy.