cyrilzakka/clinical-trials huggingface dataset:
Growth Hormone Use in Adults With Prader-Willi Syndrome

The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months.

The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months. Specific outcomes to be evaluated are as follows:

• Increased IGF-1 as a function of human growth hormone dosage compared with baseline.

1. Improvement of indicators or risk factors for co-morbid diseases \[diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function\] in participants.
2. Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants.
3. Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants.
4. Increased energy expenditure as determined by whole-room calorimeter measures (8 hour energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors and strength measures.

Eligibility Criteria:
Inclusion Criteria:

* 16 to 60 years old
* Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR)
* Low IGF-1 level (e.g.,≤25%) at baseline
* Ability to provide informed consent or availability of a suitable legally authorized representative

Exclusion Criteria:

* Pregnancy
* Previous treatment with growth hormone
* Uncontrolled endocrine disease, (i.e. diabetes or thyroid)
* History of severe scoliosis
* Heart disease
* Uncontrolled high blood pressure or history of stroke
* Morbid obesity (using PWS growth charts)
* Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results
Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)

Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.

The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6 months preceding the screening visit.

Exclusion Criteria:

* Patients with a limited level of motivation.
* Other participant in a household enrolled in the study.
* Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product more than 3 days within the 3 months preceding the screening visit.
* Patients dependent to alcohol or illicit drugs.
* Patients with a diagnosis of Psychotic Disorder or currently presenting with a Depressive Episode.
* Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past 6 months prior to screening.
* Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.

The investigator will evaluate whether there are other reasons why a patient may not participate.
ED Overcrowding Validation Study

The aim of this study is to externally validate a new emergency department overcrowding estimation tool (SONET) developed at John Peter Smith Health Network (JPS).

In recent years, emergency department (ED) overcrowding has become more and more common in regional and tertiary referral hospitals. ED overcrowding status significantly affects ED operational efficiency, resulting in ambulance diversion, increased ED 72h return visits, patient satisfaction, and left without being seen (LWBS) rates.

Several estimation tools were derived to determine ED overcrowding status using various operational parameters such as, but not limited to, total number of ED patients, total ED admission holds, nursing staff, and patient injury severity. However, these tools cannot precisely evaluate ED overcrowding status, nor show strong correlations with ED operational inefficiency. The National Emergency Department Overcrowding Study (NEDOCS) is a widely used estimation tool to determine ED overcrowding status with relatively high consistency rates. However, the study was not able to evaluate interrater reliability since no standard definition of overcrowding existed.

An ED overcrowding estimation tool, SONET, was developed and internally validated at JPS and showed more consistency and accuracy when compared to estimation rates utilizing NEDOCS. All things considered, it is worthwhile to perform a survey study to determine the interrater variability between different evaluators for an ED overcrowding evaluation tool, one utilizing all possible collectible operational variables. In order to minimize the bias and further determine the accuracy of evaluating ED overcrowding status, a multi-center external validation study is warranted. This study will extend to six sites for the purpose of externally validating JPS' novel ED overcrowding estimation tool, SONET, by comparing its overcrowding estimation rates with those derived utilizing NEDOCS.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients visiting the emergency department or urgent care clinic at any one of the six participating sites during the allocated one month time period

Exclusion Criteria:

* those who do not meet inclusion criteria
Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed carcinoid tumors
* Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible

Exclusion Criteria:

* Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible)
* Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment
* Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer
* Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus)

Other protocol-defined inclusion/exclusion criteria may apply.
Stapes Footplate Thickness Measured With UHR-CT

The aim of this study is to compare the thickness of the stapes footplate measured with ultra high resolution CT in control patients, otosclerosis patients and chronic otitis media patients.

Stapes footplate thickness will be measured under its anterior crus, its posterior crus and at its midpoint, in both the stapes axial plane and the laletral semi-circular canal planes.

Eligibility Criteria:
Inclusion Criteria:

* Ultra high resolution CT of the temporal bone available

Exclusion Criteria:

* previous surgery
Benzydamine HCl for Postoperative Sore Throat

To evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.

The investigators will assign patients into either the benzydamine hydrochloride or the control group. The whole ETT cuff will be either dripped with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing 5 minutes prior to anesthesia induction. The incidence and severity of POST at 0, 2, 4, 6, 12 and 24 hours postoperatively will be assessed. The potential adverse effects of benzydamine hydrochloride (throat numbness, throat burning sensation, dry mouth and thirst) will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years
* ASA status I-II
* Mallampati grade I-II
* Duration of surgery less than 4 hours
* Patients placed in the supine position

Exclusion Criteria:

* Undergoing oral, cervical spine or thyroid surgery
* More than one attempt of ETT intubation or intubated with a technique of rapid sequence induction with cricoid pressure
* Insertion of nasogastric/orogastric tube or esophageal stethoscope
* Complaint of sore throat or hoarseness
* Presence of upper respiratory tract infection within 7 days prior to the operation
* Gastroesophageal reflux
* Known allergy to benzydamine hydrochloride or other nonsteroidal anti-inflammatory drugs (NSAIDs)
Interest in Spirituality and Oncology: Is It An International Phenomenon?

Primary Objective:

-To assess correlations between spiritual and religious beliefs and physician burnout using the Work Related Stress Inventory.

Secondary Objectives:

* To assess relationships between a physician's spiritual/religious beliefs and age, race, sex, marital status, and nationality.
* To explore differences in survey responses among oncologists from different countries: Duke University Religion Index (DUREL), Hoge (Intrinsic religiosity scale), Templer's Death Anxiety Scale, Locus of Control Scale, Work Related Strain Inventory, and non-validated case scenarios.
* To correlate survey responses to management of specific patient case situations.

Few studies have explored the spiritual/religious beliefs of physicians and almost none have been done outside of the United States until the last two years. Therefore, this is the first study of its kind to evaluate this subject internationally.

In the next few weeks individuals will be receiving an on line survey from Survey Monkey.

The purpose of the survey is to explore the spiritual/religious beliefs of oncologists from a world side perspective, to identify areas in which spiritual/religious beliefs may affect medical decision making, and to explore any correlation that may exist between spiritual/religious beliefs of oncologists and physician burn out.

The surveys will take about 30 to 40 minutes to complete. Survey results will be encrypted even in transmission and sent to a secure server for anonymity. Even if one chooses not to fill out the surveys investigators ask that each person complete the demographic questionnaire.

Without input, investigators will lose the opportunity to further an understanding of how spirituality and religious beliefs impact patient care and physician well being.

Investigators welcome any feed back.

Eligibility Criteria:
Inclusion Criteria:

* Physician members of the International Gynecologic Oncologists Society or the Society of Gynecologic Oncologists

Exclusion Criteria:

* None
Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors

This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
2. At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
3. Age ≥20 years old
4. World Health Organization (WHO) Performance Status of ≤2
5. Patients must have the following laboratory values as defined in protocol
6. Life expectancy of ≥ 12 weeks
7. Written informed consent obtained

Exclusion Criteria:

1. Patients with evidence of CNS tumor or metastasis
2. Patients with pleural effusion and/or ascites to be drained
3. Patients with any peripheral neuropathy ≥ CTCAE grade 2
4. Impaired cardiac function defined in protocol
5. Acute or chronic liver or renal disease
6. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
7. Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication
8. Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes

This is a Phase 3 trial of cadisegliatin in participants with Type 1 Diabetes Mellitus.

Study TTP399-302 is a 52-week, Phase 3 trial designed to measure the relative efficacy of treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 hypoglycemia in participants with Type 1 Diabetes Mellitus compared to placebo over 26 weeks of continuous therapy.

Eligibility Criteria:
Inclusion Criteria:

* Individuals ≥18 years
* Diagnosed T1DM with a minimum of 5 years since diagnosis
* Has had at least 1 hypoglycemic event of Level 2 (glucose level \<54 mg/dL or \<3 mmol/L, \[CGM or SMBG confirmed\]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening
* HbA1c value of \<9.5% at Screening
* Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study
* Must have used a CGM device for at least 3 consecutive months prior to Screening

Exclusion Criteria:

* Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease
* Has been hospitalized for DKA within 3 months prior to Screening
* Has uncontrolled hypothyroidism or hyperthyroidism
* History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight
* Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ
* Has used any of the following medications within the specified time periods - any non- insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, or pramlintide within 90 days prior to the Screening or weight loss medications within 30 days prior to the Screening
* Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 1 month prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study.
* Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening
* Has persistent, uncontrolled hypertension prior to Screening
The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.

This project designed a large-scale, single-center, prospective randomized controlled clinical trial to explore the impact of antibiotics on the incidence of biliary tract infections after PTCD with malignant obstructive jaundice. This study will provide evidence-based medical evidence for the need for routine use of antibiotics to prevent biliary tract infections after PTCD with malignant obstructive jaundice, and provide references for clinicians to prevent patients from PTCD infections.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old;
2. ECOG score 0-1 before operation;
3. Patients diagnosed as pancreatic head cancer and periampullary cancer according to preoperative imaging, including ampullary cancer, extrahepatic bile duct cancer and duodenal papillary cancer;
4. Bilirubin\>200 mmol/L before PTCD , and the duration of PTCD continuous drainage \>2 weeks;
5. Volunteer to participate and sign the informed consent form;

Exclusion Criteria:

1. Decompensated liver cirrhosis, acute and chronic hepatitis and other diseases before surgery;
2. A history of other malignant tumors before surgery;
3. Duration of preoperative PTCD drainage\<2 weeks;
4. Jaundice caused by other reasons besides cancer around the ampulla and cancer of the head of the pancreas;
A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.


Eligibility Criteria:
Inclusion Criteria:

* Participants with Type 2 Diabetes Mellitus (T2DM) for at least 3 months
* Have Glycated hemoglobin (HbA1c) level of 6.5 percent (%) to 9.5% at screening
* Have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²)
* Participants are insulin naïve or have been without insulin treatment for at least 3 months prior to screening

Exclusion Criteria:

* Have had a severe hypoglycemia in the past 6 months
* Have a history of renal impairment
* Have had a blood transfusion or severe blood loss within last 90 days
* Have had a significant weight gain or loss of approximately 6% or more within 3 months prior to screening.
* Have a history of an active or untreated malignancy
* Are receiving or received systemic glucocorticoid therapy
* Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product
Development and Validation of an Instrumented Ankle-foot Orthosis

Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.

TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.


Eligibility Criteria:
Inclusion Criteria for Patients questionnaire:

* Having foot drop

Inclusion Criteria for Clinician questionnaire:

* Being a clinician who treats foot drop patients

Inclusion Criteria for Gait analysis:

* Having foot drop

Exclusion Criteria for Gait analysis:

* Not being able to walk without a cane or a walker
* Having lower extremity spasticity
Fluarix/ FluLaval/ Fluarix Quadrivalent/ FluLaval Quadrivalent Vaccine Pregnancy Registry

The purpose of this pregnancy registry study is to detect and describe abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with any of GlaxoSmithKline (GSK) Biologicals' seasonal Inactivated Influenza Vaccines (sIIVs): Fluarix, FluLaval, Fluarix Quadrivalent and FluLaval Quadrivalent.

This study is a transition of existing ongoing pregnancy registries for Fluarix/ FluLaval/Fluarix Quadrivalent/ FluLaval Quadrivalent into one post-authorization safety study (PASS).

Pregnancy outcome data will be collected using questionnaires within 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births) to ascertain the presence of birth defects not diagnosed before, from Q2 2014 to Q2 2019.

The intent of the Registry is to prospectively collect data such as vaccination with GSK sIIVs during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy.

Eligibility Criteria:
Inclusion Criteria:

A subject will be included in the Registry if all of the following criteria are met:

* Exposure to GSK sIIVs occurs during pregnancy or within 28 days preceding conception.
* Subject is a US resident.
* A HCP is identified (name, address and phone number).
* Subject can be identified (by GSK or HCP).

Data from registered subjects will be included in the analyses if the following criterion is met:

• Pregnancy is ongoing and the outcome is unknown at the time of initial report.

Exclusion Criteria:

Data from registered subjects will not be included in the analyses if the following criterion is met:

• Outcome of pregnancy is known at the time of initial report. Types of known outcomes include prenatal testing reports in which the results are abnormal or outside the reference range, indicating possible abnormality in the fetus.
Recurrence Monitoring in NSCLC Using Circulating Tumor DNA

This research study is investigating the role of cell free tumor DNA profiling in determining disease relapse and/or progression for patients with advanced NSCLC.

The objective of this study is to determine the ability of cell free tumor DNA genomic profiling to predict disease relapse or progression while on therapy for advanced stage NSCLC in comparison to current standard objective measures of disease relapse or progression.

This study is a prospective observational study. The investigators will assess whole genome sequencing from patient blood samples collected alongside routine blood draws with each treatment cycle to determine the tumor load score at each timepoint while on therapy. CT images will be obtained at routinely ordered timepoints throughout therapy and will be used in the assessment for standard clinical or radiographic evidence of disease progression. These methods of measuring disease progression will be compared in a lead time analysis.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve biopsy confirmed not surgically resectable stage III or greater NSCLC
* Baseline CT imaging available

Exclusion Criteria:

* Patients unable to undergo biopsy for initial tissue diagnosis
* Patients who do not wish to pursue standard of care therapy
* Patients with another diagnosis of malignancy
The Gut and Skin Microbiome in Vitiligo Disease Progression

Investigators plan to perform a pilot study that aims to characterize the microbiome of human vitiligo patients with both active and stable disease and compare this to the microbiome of age and sex matched controls. The investigators aim to answer the question whether the gut and skin microbiome of patients with vitiligo differs from the general population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with and/or without vitiligo lesional expansion over the past year.
* Age/sex-matched controls who do not have a diagnosis of vitiligo
* Subjects who are age 18-89 years of age at time of enrollment
* Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443)

Exclusion Criteria:

* Subjects who are younger than 18 years of age or 90 years of age or older
* Subjects who are unable to give consent