cyrilzakka/clinical-trials huggingface dataset:
Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome

The purpose of this research study is to learn about brain development in very young girls with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain development.

Studies in older children and adults have found that IQ (intelligence quotient) in individuals with Turner syndrome (TS) and the general population are similar. However, many individuals with TS have a nonverbal learning disability which may cause problems with imagining and working with objects in space (for example: building blocks, working puzzles, copying designs, driving a car) as well as problems in planning, paying attention, and getting along with people their own age. Studies of brain structure have found changes in the size and function of specific areas of the brain that are involved in these nonverbal processes. However, there are no data published on brain structure or function in girls with Turner Syndrome in the first few years of life when brains are learning and growing most rapidly.

In a recent study, very young, short girls with Turner Syndrome (TS)(averaging 2 years in age) were treated with Growth Hormone (GH) and almost reached an average height after 2 years. The risks of GH for the young girls in that study appeared to be the same as those for older girls. Therefore, it is now recommended that GH therapy be considered as soon as a child with TS has growth failure. Growth failure often occurs during infancy; therefore, more children with TS are now receiving GH therapy as young as 12 months of age. In this study, the investigators wish to start understanding what effect GH has on learning and brain growth when given between the ages of 12 and 24 months. In this study, the girls with TS will have developmental studies, a physical examination, magnetic resonance imaging (MRI), and blood drawn at one and two years of age. Some of the girls in this study will receive GH from 12 until 24 months of life, while others will not. Brain growth and development will be compared between those who have been treated with GH and those who have not. This is a pilot study in which the investigators will gather data to design a larger study that can answer these questions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Turner syndrome
* Less than the 50th percentile for length for the general female population

Exclusion Criteria:

* Prior Growth Hormone (GH) therapy
* Diabetes
* Allergy to metacresol (a preservative in the GH liquid that is injected)
* Contraindications for Magnetic Resonance Imaging (MRI) (such as metal in the body)
* Part of a Y chromosome in child's karyotype
* Parent/guardian is not willing for child to be randomized to be in the treatment group (receives Growth Hormone injections for one year) or the control group (receives no Growth Hormone during the study)
* Parent/guardian is not willing for child to have some of her developmental testing digitally recorded for scoring
Surgical Approach of Hemiarthroplasty After Femoral Neck Fracture: Posterolateral or Direct Lateral

Rationale: In the Netherlands the two main surgical approaches for hemiarthroplasty are the posterolateral and the direct lateral approach. Currently there is no conclusive evidence which of these two approaches results in better patient outcomes.

Objective: Assessing the patient outcome comparing the posterolateral with the direct lateral approach in patients being treated with cemented hemiarthroplasty after femoral neck fractures.

Study design: A randomised controlled multi-center superiority trial and natural experiment with an economic evaluation alongside.

Study population: All patients older than 18 years with a femoral neck fracture whereby treatment with cemented hemiarthroplasty is recommended according the national guidelines.

Intervention: Treatment with cemented hemiarthroplasty using the posterolateral approach.

Standard intervention to be compared to: Treatment with cemented hemiarthroplasty using the direct lateral approach.

Main study parameters/endpoints: The primary outcome is the patient-rated quality of life (EQ-5D-5L) at 6 months after surgery.

Secondary outcomes are: ADL functionality (KATZ), Balance test (SPPB), Tendency to Fall (FES-I), Pain (NRS), Re-interventions, Mobility, Discharge destination, Complications, and cost-effectiveness.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The different approaches in the two treatment arms of the randomised controlled trial are widely used techniques in the Netherlands and many of the outcome measures are part of the standard clinical follow-up after hip fracture. Therefore, there is no extra risk or burden for participating patients, except for the time to complete some additional follow-up measurements. The primary outcome measurement and secondary outcomes, will be assessed through questionnaires online, by hardcopy or by phone at baseline, 4 weeks, 3 and 6 months postoperatively. The assessment of the Short Physical Performance Battery (SPPB) balance test, will be performed by one of the study researchers or nurse practitioner to protect continuity and feasibility.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years at time of trauma
* Acute hip fracture
* Hemiarthroplasty as recommended treatment according the national guidelines
* Dutch or English fluency and literacy
* Informed consent or by proxy in patients with mental impairment

Exclusion Criteria:

* Multi-trauma-patient (ISS \> 15)
* Secondary surgery after failed internal fixation
* Patients with a known metastatic disease and a confirmed pathological fracture of the hip
* Fracture \> 7 days at time of surgery
* High risk of non-compliance/adherence to study procedures (e.g. no Dutch residency during follow-up period, or other factors that impair follow-up data collection)
Impact in Quality of Care of the "STructural heARt NURSE" as New Interventional Cardiology Nursing Role in Spain.

The hypothesis is that patients with structural heart disease who are treated by STructural heARt nurses obtain better results in indicators of quality of care, compared with the usual practice (or not assisted) by this type of new interventional cardiology's nursing role.

Valvular disease is the future epidemic structural heart disease of developed countries. To slow or alter the course of the disease, cardiac valve repair or replacement is necessary. Transcatheter treatment has become a safe alternative to surgery. The United States and Canada developed the TAVI (Transcather Aortic Valve Implantation) program and TAVI Nurse is strongly supported by scientific societies as a key leadership role in the aortic stenosis care process. This nursing role is not implemented in Spain.

The objective of this study is to develop a new nursing role in interventional cardiology, similar to TAVI Nurse but including all the structural heart diseases, through conceptual definition and competencies, and evaluate its impact on the quality of care after of its implementation.

The new nursing role of a hemodynamics and interventional cardiology unit in Spain will be based on the model existing in other countries.

This study consists of three phases:

Phase I) Integrative review to explore and identify the definition and competencies of TAVI Nurse or another similar figure outside Spain, as well as identify quality of care indicators.

Phase II) The competences of these nurses will be contextualized in Spain, and indicators of quality of care will be defined through the consensus of experts using a Delphi methodology.

Phase III) Quasi-experimental pre / post study to assess the quality of care, through the indicators developed, of the implementation of the new nursing role.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years) who have been or will undergo any procedure of structural heart disease in the hemodynamic and interventional cardiology unit of the Hospital de la Santa Creu i Sant Pau.
* Patients who accept to participate in the study.

Exclusion Criteria:

* Patients with cognitive impairment, mental disability or other serious difficulty communicating.
* Patients with insufficient fluency of the main languages.
Benefit of Scarf Support on Skin-to-skin Time and Portage in Neonatology and at Home

Carrying (or kangaroo carrying) is known to reduce neonatal and child morbidity and mortality and improves the quality of survival of premature and term children during the most fragile growth period, the first thousand days of life. Carrying is also a growing brain protection technique and becomes a routine of care in all neonatal units around the world.

In University hospital of Saint-Etienne, the developmental care program has been developed since 2002 in all neonatology units and advocates the practice of skin-to-skin carrying between the parent (father or mother) and his baby, from the time of the hospitalization. Professionals in units who have long been thinking about the concept of attachment and the benefits of skin-to-skin, wish to validate the use of the wearing scarf as a tool for the practice of skin -in-skin in neonatology then back home by performing a randomized monocentric prospective longitudinal study.

This study it's a single-center, prospective, randomized study to evaluate the benefit of the scarf in the practice of skin-to-skin and portage (PAPSE Group) compared to a Skin-to-Skin and Carry Without Scarf (PAP group).

Eligibility Criteria:
Inclusion Criteria:

For the child:

* Any newborn regardless of gestational age and postnatal age hospitalized in the neonatology department of the University Hospital of Saint-Etienne

For the parent (father or mother):

* Be a parent of a child eligible for the research protocol

Exclusion Criteria:

For the child:

* Need for sedation or analgesia for the duration of the study
* Orthopedic pathology incompatible with the practice of carrying
* Other medical contraindications to carriage
* Absence of parents

For the parent (father or mother):

* Family, social or psychological situation compromising the evaluation
* No fluency in the French language
Prediction and Secondary Prevention of Fractures

The purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs.

A standardized treatment program of osteoporosis will be introduced successively at 7 hospitals in Norway from April 2015 to January 2016. This Project is named NoFRACT (Norwegian Capture the Fracture Initiative https://clinicaltrials.gov/show/NCT02536898). Patients above 50 years of age, who recently have suffered a fragility fracture, will be offered examination of osteoporosis and treatment if indicated. Some of these patients will be asked to participate in this consent-based sub-study (NoFRACTsub). At baseline, the patients will be asked to answer a questionnaire, collect blood-sample for to outline possible causes for osteoporosis, in addition to Dual X-Ray Apsopiometry (DXA) scan including bone mineral density(BMD), trabecular bone score(TBS) and vertebral fracture assessment (VFA). At 1-year follow-up there will be a brief questionnaire and measuring of BTM. At 2-year follow-up there will be a brief questionnaire in addition to repeated measurement of DXA including BMD, TBS and VFA. All data will be stored securly at the designated server at the University of Oslo, Service of sensitive data, TSD.

Eligibility Criteria:
Inclusion Criteria:

* Patients participating in NoFRACT
* Recent low-trauma vertebral or non-vertebral fracture
* Written patient consent

Exclusion Criteria:

* Fractures of scull, face, toes or fingers
* Short life expectancy
* Patients not competent or willing to give consent
* Patients having difficulties in answering questionairies, undergoing a DXA scan, and show up on the follow-ups,
A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants

This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of primary hypothyroidism made \>= 12 months prior to Screening.
* Be on continuous thyroid replacement therapy of synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit.
* Be on a stable FDA-approved daily dose of synthetic T4 prior to the Screening visit, and must be taking synthetic T4 dose of at least 25 mcg at Screening visit. Must enter the study using the same stable dose to determine dose conversion.
* Documentation of 1 in-range thyroid-stimulating hormone (TSH) (i.e., within 0.45 - 4.12 mIU/L, inclusive) at Screening and at least 1 additional in range TSH (i.e., within 0.45 - 4.12 mIU/L, inclusive) taken at a minimum of 6 weeks and a maximum of 12 months prior to Screening.

Exclusion Criteria:

* Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4.
* History of alcohol or other substance abuse within the previous 6 months prior to the Screening.
* Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, synthetic T4, other thyroid replacement medications, or pork products.
Frailty in Patients With Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of Multifactorial Intervention

This study evaluate Frailty syndrome (FS) as a common syndrome in patients with cirrhosis and it is an independent predictor of hospitalizations, falls and mortality. Identifying, treating and preventing FS can improve the prognosis and quality of life of these patients and reduce health costs.

Substudy I. The phase angle (PA) determined by electrical bioimpedance is an index of FS with prognostic value in outpatients with cirrhosis, but its usefulness in hospitalized patients has not been studied. Objective: To analyze the prognostic value of PA in hospitalized patients with cirrhosis. Patients and Methods: 100 hospitalized patients with cirrhosis will be consecutively included and PA will be determined by bioimpedance at admission. The correlation between PA and liver function and frailty markers, and the evolution during hospitalization, as well as the incidence of falls, hospitalizations and mortality during follow-up will be analyzed. Substudy II. Given the multidimensional nature of the FS, we propose a multifactorial non-pharmacological intervention based on evidence from previous studies that could be implemented in daily clinical practice. Objective: To evaluate if a multifactorial intervention can improve the FS and decrease the related events (hospitalizations, falls and mortality) in patients with cirrhosis. Patients and Methods: 150 outpatients with cirrhosis will be included and evaluated using the Liver Frailty Index. Frail and pre-frail patients will be randomized into two groups: one group that will receive a multifactorial intervention, consisting of exercise at home, branched-chain amino acids and multispecies probiotic for one year, and one control group. The evolution of the Liver Frailty Index and other parameters (muscle and cognitive function, bioimpedance, risk of falls, quality of life) and biomarkers (miostatin, immune response, microbiota) of FS, and the incidence of hospitalizations, falls and mortality in both groups will be prospectively analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients
* Aged \>18 years old, with cirrhosis diagnosed by clinical, analytical and ultrasound criteria or liver biopsy
* Conscious and oriented in time and space and able to understand and follow the indications of the study.

Exclusion Criteria:

* Liver cirrhosis with poor prognosis (MELD \[Model for End Stage Liver Disease\]\> 25)
* Hepatocellular carcinoma or other active neoplastic disease
* Expected survival \<6 months
* Acute and/or chronic hepatic encephalopathy
* Neurological disorder that hinders the performance of the tests
* Active alcoholism in the previous 3 months
* Severe comorbidities
* Hospitalization in the previous month
* Contraindications to exercise or probiotic treatment (immunosuppression)
* Refusal to sign informed consent.
Brief Online Study Abroad Alcohol Intervention

This study involves a randomized controlled trial that builds upon a successful pilot intervention study to address problematic and dangerous drinking among young adult college students studying abroad in foreign environments. Despite universities and colleges citing alcohol misuse as the most concerning issue for their students abroad, most institutions offer no empirically-based prevention efforts tailored to this at-risk population. The proposed intervention attempts to fill a major gap for the nearly 333,000 students completing study abroad programs each year by addressing empirically-based and theoretically-informed risk and protective factors of correcting misperceived peer drinking norms and promoting cultural engagement abroad. In addition to preventing heavy and problematic drinking, the intervention seeks to prevent risky behaviors and experience of sexual violence victimization, which are strikingly common among study abroad students and have the potential for lasting physical and psychological effects upon return home.

The investigators will conduct a randomized controlled trial of a developed intervention with a sample of 1,200 college students studying abroad from 35 U.S. universities and colleges. The brief, online intervention is text and video based and contains evidence-based components of personalized normative feedback to correct students' misperceived drinking norms, content to promote engagement with the cultural experience abroad and addressed difficulties adjusting to life in the foreign environment, and tips and strategies to prevent risky sexual behaviors and sexual violence victimization abroad. Participants will complete online surveys at five time points (predeparture, first month abroad, last month abroad, one-month post-return, and three-months post-return) to assess for intervention effects on drinking, risky sex, and sexual violence outcomes. The investigators will examine whether the mechanisms targeted by the intervention (changes in perceived norms, engagement in the cultural experience abroad) serve as mediators of intervention efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 25
* Signed up to study abroad in one of the 12 most popular destinations (i.e., United Kingdom, Italy, Spain, France, Germany, China, Ireland, Australia, Costa Rica, Japan, South Africa, and Mexico
* Plan to study abroad for between 8 and 21 weeks (approximately one quarter/semester)
* Have a working email address

Exclusion Criteria:

* None except not meeting eligibility criteria
Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Purpose:

With the existing biologic anti-inflammatory product patents expiring and the FDA approval of new biosimilar and innovator biologics, patients with rheumatologic (RA), psoriatic (PsO-PsA-AS), and gastrointestinal (GI) conditions will have additional therapeutic options. This observational study will describe the patient characteristics of new users of Tumor Necrosis Factor-α (TNF) antagonists, non-TNF- α antagonists, oral DMARD, and non-biologic agents. It will describe in the treatment cohorts outcomes of serious infections that require hospitalization. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator anti-inflammatory biologics.

Additional information:

To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with baseline period of 365 days with continuous medical and pharmacy coverage preceding the first prescription fill
* new and users of the following exposures

  * TNF -α antagonists (including adalimumab, certolizumab, etanercept \[not included for IBD\], golimumab, infliximab, and natalizumab \[IBD only\])
  * Non-TNF-alpha antagonist biologics in RA only (abatacept, rituximab, and tocilizumab)
  * Non-biologic medications (after any use of methotrexate in the previous year includes RA: hydroxychloroquine, leflunomide, or sulfasalazine; IBD: 6- mercaptopurine or azathioprine; PsO-PsA-AS: methotrexate, leflunomide, or sulfasalazine).

Exclusion Criteria:

* During baseline 365 days, any patient with

  * Active cancer or a history of non-melanoma cancer\*
  * Any immunocompromising conditions (organ transplantation, HIV, and advanced kidney/liver disease)\*
  * \*if occur during the follow-up period, patients also will be censored.
* During baseline 183 days, any patient with hospitalization for any infection
Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care

Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity and mortality between low- and middle- income countries (LMICs) and high-income countries. Individuals present with advanced stage disease resulting in minimal chance for cure or long-term survival.

The Potlako project will implement and evaluate a multifaceted intervention to test the hypothesis that a package of enhanced coordination of care including an electronic messaging, transportation support, and training targeted at generalist clinicians at primary and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for HIV-infected individuals with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Citizen of Botswana
* Suspected or diagnosed cancer

Exclusion Criteria:

* Involuntary incarceration