cyrilzakka/clinical-trials huggingface dataset:
Reward Mechanisms in Obesity

The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes).

According to the study protocol, 70 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.

All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session while being presented with gustatory stimuli. Second, participants will complete behavioural tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated with food intake. Third, metabolic parameters and hormones involved in appetite regulation will be assessed and studied in relation to fMRI.

These measurements will be repeated after 16 weeks in obese individuals. The control group of normal body weight individuals will be evaluated once at Baseline.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 kg/m2 and \< 40 kg/m2
* right-handed
* current non-smokers
* with stable body weight (\<5% reported change during the previous 3 months)

Exclusion Criteria:

* History of any psychiatric, neurological, cardiovascular, renal or liver disease, malignancies, type 1 and type 2 diabetes mellitus
* use of centrally acting medication, glucocorticoides, insulin, orlistat
* any substance abuse
* food allergies
* deficits of smell and taste
* history of pancreatitis
* family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
* pregnancy
* contraindications for fMRI
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.


Eligibility Criteria:
Inclusion Criteria:

-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

Exclusion Criteria:

* History of glaucoma, ocular hypertension or optic nerve head change
* Any active bacterial, viral, parasitic, or fungal infections in either eye
* Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start
* History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start
* Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start
* Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start
* Use of topical ophthalmic corticosticosteroids within 2 weeks of study start
Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)

To assess the diagnostic validity and cost-effectiveness of an infrared thermography system in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).

AIMS: To assess the diagnostic validity and cost-effectiveness of an infrared thermography system, integrated in an expert diagnostic algorithm (TIS), to determine the sleep stages and identify respiratory events, compared to conventional polysomnography (PSG) in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).

METODOLOGY: DESIGN: Prospective, unicentric, randomized and blinded study carried out into two phases: Phase I: Development of the tool in 99 full valuable adults with suspected OSA (PSG recruitment, coordination and quality control, image capture, Information and development of the expert system); Phase II: Validation of the tool compared with the PSG in another group of 99 full valuable adults with suspected OSA. INSTRUMENTALIZATION: a) Clinical history and anthropometric variables; b) Sleep and quality of life questionnaires; c) PSG; d) TIS; e) Cost-effectiveness study.

ANALYSYS : The validity of the results of the TIS will be analyzed compared with the results of the PSG. The agreement measure will be established according to the different categories of the Apnea-Hypopnea Index (AHI), using ROC (Receiver Operating Characteristic) curves and the area under the curve. The investigators will also validate the therapeutic decisions made with PSG compared to those performed with the TIS. Finally, a cost-effectiveness study will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years to 75 years old, with clinical suspicion of OSA
* Written informed consent signed

Exclusion Criteria:

* Place of residence more than 100 km from the hospital
* Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies
* Presence of insomnia, depressive syndrome or epilepsia
* Patients diagnosed of any acute inflammatory episode of the cranium-maxillo-facial area or any systemic infection that develops with fever\> 38 ºC at the time of testing
* Patient with malformation syndromes, Down syndrome and neuromuscular diseases
* Patient on active treatment with Positive continuous pressure (CPAP )
Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur. Some women will experience no symptoms at all. However, it is important to treat this condition since it may increase and cause important scarring and deformity. In less than 5% of cases, cancer may develop.

Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical corticosteroids are the usual treatment for this condition. Though this treatment is generally well tolerated, some patients may not present a sufficient response or may develop mainly local and rarely systemic side effects. In this perspective, an alternative treatment would be beneficial.

Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing the usual side effects seen with the prolonged use of topical corticosteroids.

This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar lichen sclerosus by comparing it with the standard topical corticosteroid treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female, 2 years or older
* Medical diagnosis of vulvar lichen sclerosus
* Received no treatment during the last 4 weeks

Exclusion Criteria:

* Who have received topical steroids, tacrolimus or pimecrolimus during the 4 last weeks.
* Who are immunocompromised
* Who have history of intra-epithelial neoplasia or anogenital carcinoma
* Who have active vulvar infections (herpes,condylomas,vaginitis)
* Who are hypersensitive to tacrolimus, pimecrolimus or corticosteroids
* Who have physical limitations that cause difficulty in applying the cream
* Who wear diapers
* Who present Hyperkeratotic Vulvar Lichen Sclerosus
Efficacy of Granulocyte Colony Stimulating Factor (GCSF) In Patients With Dystrophic Epidermolysis Bullosa

This is a feasibility study to see if Granulocyte Colony Stimulating Factor (GCSF) is effective as a treatment of Dystrophic Epidermolysis Bullosa (EB). Patients will receive one course of treatment with the study drug. The course will be 7 days in length. After receiving GCSF, patients will be followed at 7 and 30 days following the discontinuation of the drug. Thirty day follow up can be done via telephone communication with the patient or family.

Each patient will be given 10 micrograms per kilogram per day of G-CSF subcutaneously for 6 consecutive days. On day 7 each patient will be seen and evaluated in the same manner as on day 0. Patients or their parents (if children are too young to reliably respond themselves) will also be asked to rate the following via a visual analog scale of 1-9- oral pain, pruritus, oral pain, swallowing, and overall sense of well-being. A telephone follow-up will be conducted on all patients 28 days after G-CSF so as to evaluate if the effect noted on day 7 was sustained.

Eligibility Criteria:
Inclusion Criteria:

* Each patient must have the diagnosis of severe generalized recessive dystrophic EB (formerly known as Hallopeau-Siemens RDEB) confirmed by clinical criteria and either of the following:

  1. transmission electron microscopy
  2. immunofluorescence antigenic mapping and type VII collagen monoclonal antibody staining
  3. COL7A1 mutational analysis

Exclusion Criteria:

* The patient must not have a history of squamous cell carcinoma or any internal malignancy.
* Female patients who are pregnant.
* Patients with active signs and symptoms of infection.
Fecal Helicobacter Pylori Gene Detection for Gastric Cancer

This is a prospective, multicenter, cross-sectional study. The efficacy of fecal H. pylori gastric cancer susceptibility testing in predicting gastric cancer was evaluated by comparing fecal H. pylori gastric cancer susceptibility testing with the "gold standard" imaging tests, such as CT, gastroscopy, and/or pathology, in the enrolled population.

Primary study objective: to assess the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility locus-based testing applied to predict gastric cancer.

Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal H. pylori gastric cancer susceptibility locus test applied to predict gastric cancer; 2. whether the predictive ability is significantly higher than that of the conventional tumor markers, such as CA19-9, CEA, and CA72-4, etc.; and 3. combined with fecal methylation detection Predictive ability assessment.

The "fecal H. pylori-based gastric cancer susceptibility locus test" was compared with the "gold standard" CT, gastroscopy and/or pathology, and the results were analyzed for consistency.

Eligibility Criteria:
Inclusion Criteria:

1. Be ≥40 years of age, male or female.
2. Have or will have gastroscopy and/or pathology results.
3. Have no contraindications to endoscopy and be able to cooperate with endoscopy.
4. Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Exclusion Criteria:

1. Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
2. A previous history of upper gastrointestinal malignancy.
3. Women during pregnancy.
4. Those whose pathology is not clear.
5. Those with unsatisfactory sample retention (e.g., too small a sample size).
BMD Alterations and Bone and Muscle Parameters During Menstrual Cessation With GnRH

The investigators aim to investigate the effect of menstrual cessation in women with endometriosis treated with GnRH analogs for 6 months on bone mineral density and bone and muscle metabolism parameters and subsequently the effects of menstrual restoration after GnRH analogs discontinuation on the above measured parameters

Prospective, open-label, controlled 12month observational study

Premenopausal women with surgically verified endometriosis will receive goserelin 1 injection per month for 6 months. Subsequently goserelin will be discontinued and patients will be monitored for another 6 months after menstrual restoration. Age- and BMI-matched premenopausal, health women will serve as controls. Controls will receive no treatment.

Eligibility Criteria:
Inclusion Criteria:

Premenopausal women with surgically verified endometriosis

Exclusion Criteria:

1. Secondary osteoporosis
2. diseases or conditions that could affect bone and/or muscle metabolism
3. any medications that could affect bone and/or muscle metabolism
Defining the Mechanisms Underlying Adrenal Insufficiency in Cirrhosis

This study aims to define the prevalence and potential pathophysiologic mechanisms underlying relative adrenal insufficiency (RAI) in outpatients with decompensated cirrhosis. Patients will be followed prospectively for up to two years to determine incidence of RAI, whether RAI represents a permanent or dynamic physiologic state in cirrhosis, and to determine whether RAI in this setting is associated with important clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18y
* Diagnosis of cirrhosis by biopsy or compatible clinical picture
* Experienced at least one portal decompensating event in the past and currently have a Child-Pugh B or C classification

Exclusion Criteria:

* Pregnant women
* Prisoners
* Not been treated with medication known to affect the adrenal axis within the past 4 weeks (oral or IV steroids, ketoconazole, etomidate)
* Hospitalized at time of enrollment
Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients

Dementia is a common problem for older patients presenting to emergency departments and for the family caregivers who often lack support, understanding, and skills to manage the problems related to the need for emergency department visits. The purpose of Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED-CPCIP, here on referred to as POISED) randomized controlled trial is to use previously established quality improvement methods of root cause analysis to uncover reasons for emergency department use and to focus on caregiver activation within a program of dementia care management.

The goals of this study are to reduce recurrent emergency department visits and improve caregiver symptoms of depression, anxiety and need for social support.


Eligibility Criteria:
Inclusion Criteria:

* Must be in the emergency department for care at the point of recruitment
* Must be English- or Spanish-speaking
* Must have a family member or friend who provides caregiving assistance
* Must have a plan to be discharged to home (ESI = 4 or 5)
* Must have score \<3 on the MiniCog or if using caregiver assessment by IQCODE must be \>3.4
* Must have capacity to consent or have a proxy.

Exclusion Criteria:

* Care recipient (CR) is a resident of a nursing home or other supportive facility
* CR scores \> 3 on the MiniCog or the caregiver assessment by IQCODE was \< 3.4
* Caregiver (CG) declines participation
* CR is not being discharged to home
Institutional Registry of Hip Fracture in the Elderly

The purpose of this study is to create an institutional and population-based registry of Hip fracture in the elderly with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

All patients over 65 years old who are admitted to the orthopedic and traumatology ward diagnosed with hip fracture will be assessed.

The generation of the list of potentially evaluable patients will be performed daily.

Once defined patient inclusion, an intern take oral informed consent and will proceed to complete the CRF.

Cohort will be followed at 3 months and a second follow-up at year.

Variables to be measured:

Patient Data Comorbidities Charlson score Scales functionality Factors prior to the fall Medications Trauma variables Complications Mortality

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 65 with hip fracture.
2. Admission to HIBA
3. Followed by any health care provider. -

Exclusion Criteria:

1 Patient refuses to participate in the registration or informed consent process

-
Children's Susceptibility to Enterovirus 71 in Different Areas of Taiwan

EV71 has caused large epidemics with lots of fatal cases and cases with sequelae. However, the clinical syndromes and severity of the same EV71 strain are very diverse, ranging from asymptomatic (71%) to fatal (0.05%) disease, and the pathogenesis remains unknown. In addition, the severe or fatal case incidence varies significantly differently in different areas of Taiwan. Although some viral virulence studies were performed, no clear viral virulence factor has been found. Therefore, host factors may be important to the clinical outcomes of EV71 infections. In addition, there were significantly different incidences of severe or fatal cases in different areas of Taiwan, for example, significantly more fatal or severe cases occurred in the central or southern Taiwan in comparison with in northern Taiwan. Whether this is related to host factors, social, behavioral or environmental factors remains unanswered. To find the most important factors associated with EV71 susceptibility, a thorough study involving genetics, social, behavioral or environmental factors among different areas of Taiwan is warranted and the findings will provide future prevention of EV71 and give help on early precaution and treatment of EV71.

The specific aims are to find factors associated with different severe/fatal incidences in different areas of Taiwan. We will do

1. Comparison of gene variants in EV71 cases with different severity and normal children in different areas of Taiwan to find susceptible genes and genetic polymorphism related to the clinical outcomes
2. Social, behavioral and environmental factors related to EV71 infections in different areas of Taiwan

Eligibility Criteria:
Inclusion Criteria:

- Enterovirus type 71

Exclusion Criteria:

- not Enterovirus type 71
USG-guided M-TAPA vs OSTAP Block in Patients Undergoing Laparoscopic Cholecystectomy

In this study, the postoperative analgesic effect of ultrasound-guided modified thoracoabdominal nerves blocks through perichondrial approach (M-TAPA) and oblique subcostal transversus abdominis plane block(OSTAP) will be searched in patients recruiting for laparoscopic cholecystectomy (LC) and the two groups will be compared in terms postoperative opioid consumption.

The primary aim of this study is to compare the effects of ultrasound-guided (M-TAPA) and OSTAP blocks on opioid consumption after LC surgery. It is hypothesized that M-TAPA will reduce opioid consumption of the patients more than the OSTAP block.

Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC).

Oblique subcostal transversus abdominis plane (OSTAP) block is a regional anesthesia technique defined for abdominal surgeries. Previously, several studies have reported that ultrasound-guided OSTAP blocks reduce postoperative pain scores after LC. M-TAPA block is performed by applying local anesthetic to the lower surface of the chondrium. This technique provides effective analgesia in the abdominal wall.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, M-TAPA and OSTAP blocks will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, vital parameters, nausea and vomiting, antiemetic, opioid consumption, and Quality of Recovery score will be blinded to group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study

Exclusion Criteria:

* presence of coagulation disorder
* infection at the injection site of the block
* known allergy to local anesthetics
* advanced hepatic or renal failure
* can not communicate in Turkish
* history of abdominal surgery or trauma
* conversion of laparoscopic to open surgery
* consumption of any pain killers within the 24 h before the operation
* chronic opioid consumption
* pregnancy
* alcohol or drug abuse
* body mass index (BMI) ≥ 35 kg m-2.
China Evera MRI® Study

The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.

The purpose of the China Evera MRI® study is to confirm safety of the Evera MRI ICD System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body). Long-term device effects, such as long-term lead integrity, will not be assessed in the China Evera MRI® study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are indicated for implantation of an ICD at the time of study enrollment.
* Subjects who are able to undergo a pectoral implant.
* Subjects who are able and willing to undergo elective MRI scanning without sedation , .
* Subjects who are geographically stable and available for follow-up at the study site for the length of the study.
* Subjects who are at least 18 years of age (or older, if required by local law).

Exclusion Criteria:

* Subjects with a history of significant tricuspid valvular disease that precludes the ability to place the RV lead. .
* Subjects who may be contraindicated to the dexamethasone sodium phosphate and/or dexamethasone acetate.
* Subjects who require a legally authorized representative to obtain informed consent.
* Subjects with abandoned or capped leads.
* Subjects who require an indicated MRI scan, other than those specifically described in the China Evera MRI® study, before the one-month post-MRI follow-up (approximately 4 months post-implant).
* Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys).
* Subjects with medical conditions that preclude the testing required by the CIP or limit study participation.
* Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the China Evera MRI® study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
* Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant
* Subjects with exclusion criteria required by local law (e.g., age, breastfeeding).
* Subjects who are diagnosed with terminal disease with life expectancy less than 4 months.