linjc16/ctgov huggingface dataset:
Pediatric Obesity Research Registry

Study Overview
=================
Brief Summary
-----------------
The Pediatric Obesity Research Registry will function to collect and catalog historical and medical chart related clinical data of patients presenting with pediatric obesity and who agree to participate.

Detailed Description
-----------------
Individuals between age 1 and 18 years who present to the endocrinology clinic for management of elevated BMI/Obesity (Body Mass Index≥95th percentile of age and gender), will be given the opportunity to read the consent form, have any questions/ concerns addressed prior to obtaining informed consent from the research team (consisting of the PI and the Co-investigators) who are also part of the child's clinical care team. The child's clinician will introduce the study to the parents. The Investigator will obtain written informed consent from the child's parents. The clinical care team/research registry investigators will address any questions and concerns prior to obtaining written informed consent and any future questions and concerns. In this manner, Patients seen at the Phoenix Children's Hospital (PCH) Division of Endocrinology and Diabetes with an obesity diagnosis will be asked to provide their written informed consent to allow their past, current and future identifiable medical record information related to their obese condition to be placed in the Pediatric Obesity Research Registry. For individuals who respond to Potential advertisement or who contact the research team over the phone, a verbal explanation will be given over the phone and an offer to send a copy of the consent via mail/fax/email, and if interested scheduling a follow up appointment. At the clinic visit, the above noted procedure will be followed.

Official Title
-----------------
Pediatric Obesity Research Registry

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals between age 1 and 18 years who present to the endocrinology clinic for management of elevated BMI/Obesity Individuals between age 1 and 18 years who respond to advertisement or who contact the research team over the phone, for management of elevated BMI/Obesity (Body Mass Index ≥ 95th percentile of age and gender) Exclusion Criteria: A Body Mass Index less than 95th percentile of age and gender

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese Children<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Determinants of Formate Concentrations

Study Overview
=================
Brief Summary
-----------------
Formate is an important metabolite, serving as a donor of one-carbon groups to the intracellular tetrahydrofolate pool. However, little is known of its circulating concentrations or of their determinants. This study seeks to define formate levels and their determinants in a young, healthy population. Serum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects, males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate levels will be compared with other one-carbon metabolites, vitamin status, potential formate precursors, genetic polymorphisms, and lifestyle factors.

Official Title
-----------------
Lifestyle, Metabolite and Genetic Determinants of Formate Concentrations in a Cross-sectional Study of Young, Healthy Adults

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trinity College Dublin students with Irish grandparents Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|Cross-sectional study requiring a single serum sample|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formate concentrations | Formate concentrations in study population | Single baseline measurement; cross sectional, observational study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
formate, one-carbon metabolism
Central Hypothyroidism and Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medica Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk factors. The hypothesis is that subtle central hypothyroidism is associated with adverse cardiac risk factors, such as body composition and serum lipids, and that improved T4 replacement will eliminate this increased risk, independently of other pituitary hormone replacements.

Detailed Description
-----------------
Retrospective trial of 300 patients with pituitary insufficiency treated in Department of Medical Endocrinology, Rigshospitalet, Copenhagen University concerning levothyroxine (T4) replacement and cardiovascular risk profile. The patient files are recruited among hypopituitary patients treated with growth hormone from the period 1993 to 2008. The trial is a retrospective assessment of data already collected for routine purposes and thus an audit of daily clinical practice. All information on the patients is obtained from the paper and electronic files existing in the department and no new measurements are foreseen.

Official Title
-----------------
Central Hypothyroidism and Cardiovascular Risk Factors

Conditions
-----------------
Hypopituitarism

Intervention / Treatment
-----------------
* Other: levothyroxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with pituitary hypopituitarism Exclusion Criteria: Unavailability of data
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypopituitarism<br>group of patients with hypopituitarism | Other: levothyroxine<br>* titration of T4 according to biochemical values<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cholesterol |  | March 2002 - March 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
levothyroxine replacement, lipids, body composition, central hypothyroidism, hypopituitarism
VDR SNPs & 25OHD Correlated With Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
The project was aimed to explore the associations of single nucleotide polymorphisms (SNPs) of vitamin D receptor gene with specific circulating lipids in adult Chinese. The circulating 25-hydroxyvitamin D concentration was also tested to explore its interactions with SNPs in the associations.

Conditions
-----------------
Dyslipidemias, Single Nucleotide Polymorphism

Intervention / Treatment
-----------------
* Other: No intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) ≥ 20 years old Han Chinese; 2) living in Shenzhen for > 2 years; 3) free of liver diseases, renal diseases, and any cancers in the past 6 months; and 4) not in pregnancy for women. Exclusion Criteria: 1) had severe organic diseases, 2) had acute infection symptoms, allergic diseases, and malignant tumors, 3) had a family history of genetic diseases, 4) took VD supplements in the past 6 months, 5) took medicines to control lipid levels within 12 hours, or 6) took diuretics, did strenuous exercise, or overate within 24 hours before the test.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 81 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention.|No intervention.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNPs of VDR | Polymorphisms of vitamin D receptor gene: Cdx2, Fok1, Apa1, and Taq1 | 6 months | 
| lipid profiles | Serum concentrations of TG, TC, LDLC, and HDLC | 6 months | 
| 25OHD | Plasma 25-hydroxyvitamin D concentration | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene polymorphism, vitamin D receptor, vitamin D, lipid, dyslipidemia
Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections

Study Overview
=================
Brief Summary
-----------------
Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.

Official Title
-----------------
Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections

Conditions
-----------------
Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years of age) managed within a study center for high-grade cephalosporinase-producing bacteremia Not objecting to the reuse of their health data for scientific research purposes. Exclusion Criteria: Patient who has expressed opposition to the reuse of their data for scientific research purposes. Resistance to Cefepime or carbapenems Multiple bacteremia Treatment with a molecule other than Cefepime or carbapenem.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality |  | 30 days after infection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bacteremia, Cefepime, carbapenems, AmpC β-lactamase, enterobacteriaceae bloodstream infections
Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliative Care Unit

Study Overview
=================
Brief Summary
-----------------
Even if most patients in palliative care units presented with well-recognized risks factors of venous thromboembolism (VTE) (eg: active cancer, bed rest, previous history of venous thrombosis), the incidence of VTE in palliative setting is unknown. By consequence, the efficacy and safety of antithrombotic prophylaxis in such a population is not established. Indeed, patients admitted in palliative care units were not included in trials evaluating the potential effect of antithrombotic drugs in regard to their poor prognosis at short term. In addition, the main role of prophylaxis is to prevent sudden death from pulmonary emboli and is thus a life prolonging therapy which is viewed as counterintuitive to palliative care philosophy and inappropriate on grounds of futility. Nevertheless, the current use of Low Molecular Weight Heparin in palliative care units seems to increase particularly in patients with advanced malignancy. The identification of high hemorrhagic risks in palliative care patients could help the decision of antithrombotic prophylaxis initiation. For this, the investigators conducted a multicenter prospective longitudinal study.

Official Title
-----------------
Predictive Factors for Major Bleeding Risk in Patients Admitted in a Palliativecare Unit - Etude RHESO - Etude Monocentrique

Conditions
-----------------
Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years admitted in a palliative care unit for a cancer, a pulmonary, a cardiac or a neurologic advanced disease Exclusion Criteria: life prognosis less than 48 hours patients treated with curative doses of antithrombotic therapy patients with follow up of 3 months is not possible

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>Patients admitted in a palliative care unit | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the symptomatic occurrence of major and clinical relevant bleeding during the three months study period. |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive factors for major bleeding |  | 3 month | 
| Incidence of venous thomboembolic symptomatic disease |  | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
palliative care unit, bleeding, thromboembolic, hemorrhagic risk, antithrombotic prophylaxis
Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator

Study Overview
=================
Brief Summary
-----------------
People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.

Detailed Description
-----------------
Data pending

Official Title
-----------------
Dynamic Vocal Fold Abduction for Bilateral Paralysis

Conditions
-----------------
Vocal Cord Paralysis

Intervention / Treatment
-----------------
* Device: pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breathing difficulties from vocal cord paralyses Tracheostomy tube Ability to understand the purpose of the research Appropriate hand motor coordination Exclusion Criteria: Lack of understanding the research Poor hand motor coordination Non-acceptance of tracheostomy Inability to passively move the paralyzed vocal cords

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: pacemaker|Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of implanted device |  | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bilateral vocal cord paralyses, Implanted laryngeal stimulator, vocal cord opening, pulmonary function tests
FGR Diagnostic Criteria in Predicting Adverse Neonatal Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard).

Official Title
-----------------
Accuracy of the Recent Consensus Based Definition of FGR Encompassing Biometric and Doppler Parameters in Predicting Adverse Neonatal Outcomes

Conditions
-----------------
FGR

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasound diagnostic criteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants included in this study will have the following criteria: Pregnancies complicated with FGR (EFW <10th percentile). Singleton pregnancy. Exclusion Criteria: • Fetal structural malformations or chromosomal abnormalities as detected by neonatal examination and anomaly scan during pregnancy. Identified infectious etiologies detected during immediate postnatal examination or during pregnancy. Gestational age cannot be calculated accurately. Missing antenatal or perinatal outcome data.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: ultrasound diagnostic criteria|evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | neonatal outcome | 30 days after delivery |
Impact of Sperm DNA Integrity on Artificial Reproductive Treatment (ART)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a new criteria with which to judge the quality of sperm samples submitted for artificial reproductive treatments. It is believed that this type of testing can compliment the traditional semen analysis to better drive patient care.

Official Title
-----------------
Impact of Sperm DNA Integrity on ART Treatment

Conditions
-----------------
Sperm DNA Impact on ART Outcomes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: needs interventions through artificial reproductive treatment to achieve a pregnancy Exclusion Criteria: severly oligozoospermic patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IUI patients<br>Patients undergoing routine semen analysis as part of their infertility treatment pertaining to success or failure with intrauterine insemination, based upon their sperm DNA integrity | |
| IVF patients<br>Couples undergoing routine screening prior to IVF retrievals to assess their reproductive treatment outcomes as compared to the sperm DNA integrity | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm DNA integrity |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| achievement of a successful pregnancy |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sperm DNA integrity, Toluidine blue staining
Effectiveness of Cannabis in the Treatment of Tinnitus Patients

Study Overview
=================
Brief Summary
-----------------
The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as experienced by the patients.

Official Title
-----------------
Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Drug: Cannabis
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tinnitus lasting more than 3 months Tinnitus Handicap Inventory score over 58 Treated previously for tinnitus (2 modalities) Exclusion Criteria: Prior use of drugs Current use of Cannabis Neurologic or Psychiatric disease Heart Failure Ischemic Heart Disease Immune Deficiency Acoustic Neuroma

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabis<br>Treatment with a Cannabis capsule | Drug: Cannabis<br>* Cannabis capsules given once daily for a month<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus handicap inventory score | Patients will be monitored during a month (treatment time) and a month later | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinnitus Cannabis