linjc16/ctgov huggingface dataset:
Impact of Clinical Pharmacist on the Quality and Cost of the Therapeutic Management of Patients in Two Medical Services of a Teaching Hospital

Study Overview
=================
Brief Summary
-----------------
Incomplete information or poorly communicated to the transitional stages of the patient's drug therapy hospitalized cause medication errors. These steps are the admission, transfer within the institution and hospital discharge to home or another institution. The adequacy of the prescription recommendations of good practice is not always optimal. The cost of taking drug therapy and iatrogenic risks preventable drug-related weighs more and more heavily in health spending and in the prolongation of hospitalization or re hospitalization. Clinical pharmacy widely practiced in the Anglo-Saxon countries has demonstrated its effectiveness on these three themes; it seems appropriate to assess this practice in the environment of the French health system.

Conditions
-----------------
Admitted to Infectiology or Internal Medicine Wards

Intervention / Treatment
-----------------
* Other: Pharmacist consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients admitted in in infectious and tropical diseases unit or the internal medicine unit Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BMO<br> | Other: Pharmacist consultation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of prescriptions |  | 11 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cost study, clinical pharmacist
Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine expression of chaperones proteins from the endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared to healthy controls. Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic patients and healthy controls

Official Title
-----------------
Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study

Conditions
-----------------
Bipolar Disease Type I

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar Disease type I manic phase YMRS > 14 HDRS < 9 Exclusion Criteria: Use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BP I patients manic phase<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
mHealth Intervention to Promote Cancer Survivors' Physical Activity

Study Overview
=================
Brief Summary
-----------------
The Primary Goal is to conduct a 5-10 week randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mHealth app. The target population will be childhood cancer survivors 14-18 years old recruited from Seattle Children's Hospital. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This study will provide initial proof of concept and allow for further customization of the intervention for childhood cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.

Official Title
-----------------
mHealth Intervention to Promote Cancer Survivors' Physical Activity

Conditions
-----------------
Physical Activity, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Fitbit
* Behavioral: Facebook group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in remission for childhood cancer and previously treated for childhood cancer at Seattle Children's Hospital ≥1-year post-cancer therapy ambulatory without any known medical contraindications to participation able to complete surveys in English agree to install and share data from the FitBit smart phone app with the investigators Exclusion Criteria: currently or previously used a wearable physical activity sensing device to improve physical activity

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fitbit + Facebook<br>Participants will use the Fitbit device and join the Facebook group. | Behavioral: Fitbit<br>* Participants will use the FitBit device to track their physical activity<br>Behavioral: Facebook group<br>* Participants will receive and post messages and receive badges on the Facebook group<br>|
| No Intervention: Usual care control<br>No intervention provided. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention physical activity (measured by accelerometers) |  | up to week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-intervention health related quality of life (measured by questionnaire) |  | up to week 10 |
Astaxanthin Supplementation in Cyclists

Study Overview
=================
Brief Summary
-----------------
Background of the study: Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in animals and humans. Exercise enhancing effects have been shown in animals via enhancement of fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on fat oxidation and cycling performance in trained cyclists Objective of the study: To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat oxidation and improve exercise performance in trained cyclists Study design: Double blind, placebo controlled study. Study population: Well trained cyclists between 18-30 years old Intervention (if applicable): astaxanthin (20 mg/day) or placebo for 4 weeks Primary study parameters/outcome of the study: performance on a time trial after 90 min steady state exercise. Secundary study parameters/outcome of the study (if applicable): substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): The risks involved in participating in this experiment are minimal. Astaxanthin has been shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is of a small local haematoma.

Conditions
-----------------
Athletic Performance

Intervention / Treatment
-----------------
* Dietary Supplement: astaxanthin
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male Age between 18 and 30 years Endurance trained (≥3 sessions of endurance exercise per week) VO2 max ≥ 50 ml/kg/min Training history of more than one year of ≥3 sessions of endurance exercise per week BMI <25 kg/m2 Exclusion Criteria: Use of medication Smoking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: astaxanthin<br> | Dietary Supplement: astaxanthin<br>* astaxanthin<br>|
| Placebo Comparator: placebo<br> | Dietary Supplement: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time trial performance | time trial performance | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substrate use |  | 4 weeks |
Bio-logical Carbon Fiber Intramedullary Nail Biomechanical Test and Preliminary Clinical Results

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to present a novel Intramedullary Nail (IMN) made of CFR - PEED composite, that is biomechanically tailored to closely match cortical bone. This IMN should promote fracture healing and prevent stress shielding osteopenia. Case records of patients with humurus shaft fracture will be retrospectively reviewed to determine whether the implant promotes bone healing.

Conditions
-----------------
Fractures, Bone

Intervention / Treatment
-----------------
* Device: Carbon fiber intramedullary nail (PEEK-CF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Broken humerus shaft Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Broken humerus shaft<br>Patients presenting with broken humerus shaft | Device: Carbon fiber intramedullary nail (PEEK-CF)<br>* Carbon fiber polyether-ether-ketone (PEEK-CF) PICCOLE Nail - produced by Carbofix, Herzlyia, Israel.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone healing | Observed imaging proof of callus will indicate quality of bone healing. | 6 months |
Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies

Detailed Description
-----------------
This is an open-label, non-randomized, dose escalation/expansion phase I study, SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Official Title
-----------------
A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

Conditions
-----------------
Tumor

Intervention / Treatment
-----------------
* Drug: SHR-1316


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥18 years of age Subjects with confirmed advanced malignancies (histologically or cytologically) ECOG Performance status of 0 or 1 Adequate organ functions Life expectancy ≥12 weeks; Exclusion Criteria: Subjects with active autoimmune disease. Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment Previous received PD-1 or PD-L1 therapy Known Active central nervous system (CNS) metastases Known Clinically significant cardiovascular condition Active infection or an unexplained fever >38.5°C History of immunodeficiency

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escalation<br>SHR-1316 administrated intravenously(IV) at protocol defined dose levels | Drug: SHR-1316<br>* Monotherapy<br>* Other names: HTI-1088;|
| Experimental: Expansion<br>SHR-1316 administrated IV in advanced solid tumors and selected tumor type | Drug: SHR-1316<br>* Monotherapy<br>* Other names: HTI-1088;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | incidence and severity of treatment-related adverse events | at the end of cycle one(each cycle is 21 days) | 
| Dose-limiting toxicities (DLTs) | Number of participants with DLTs | at the end of cycle one(each cycle is 21 days) |
Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication

Study Overview
=================
Brief Summary
-----------------
Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.

Official Title
-----------------
Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: Transcranial Magnetic Stimulation (TMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as suffering from treatment resistant major depression Right laterality Exclusion Criteria: other major axis I diagnosis severe axis II diagnosis risk factors to convulsions history of drug abuse in the past year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep TMS stimulation<br> | Device: Transcranial Magnetic Stimulation (TMS)<br> <br> |
| Experimental: DTMS with positive cognitive-emotional provocation<br> | Device: Transcranial Magnetic Stimulation (TMS)<br> <br> |
| Experimental: DTMS with negative cognitive-emotional provocation<br> | Device: Transcranial Magnetic Stimulation (TMS)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMILTON RATING SCALE FOR DEPRESSION 24 items |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TMS, drug resistant depression
Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

Study Overview
=================
Brief Summary
-----------------
The link between epigenetic changes as an effect of psychotherapy has been investigated recently. Genes investigated in these studies were brain-derived neurotrophic factor (BDNF), NR3C1, FKBP51, MAOA and GLUT1. Change in methylation of these genes could be a biomolecular mechanism of psychotherapy induced changes. This study project aims at providing evidence for a biological mechanism of personality disorder interventions in adolescence by investigating the link between epigenetic changes as an effect of psychotherapy. It investigates the correlation between changes in the methylation of the FKBP5 gene and psychotherapy induced changes in symptoms and functioning.

Official Title
-----------------
Epigenetic Changes in Psychotherapy of Adolescents With Borderline Personality Pathology

Conditions
-----------------
Borderline Personality Disorder (BPD)

Intervention / Treatment
-----------------
* Other: routine psychotherapy for Borderline Personality Disorder (BPD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adolescents presenting 3 or more criteria for BPD in the Structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) axis II personality disorders (SCID-II) Exclusion Criteria: difficulties to understand or comply with instructions psychotic disorders pervasive developmental disorders severe somatic or neurological disorders severe and persistent substance addiction elevated risk for complications related to blood sampling

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: routine psychotherapy for Borderline Personality Disorder (BPD)|Routine psychotherapy as treatment for patients with Borderline Personality Disorder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in methylation of the FKBP5 gene | change in methylation of the FKBP5 gene | after 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in methylation of the FKBP5 gene | change in methylation of the FKBP5 gene | at month 3 and at month 12 after baseline. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epigenetic changes, Psychotherapy, epigenetic regulation, methylation patterns, change in methylation of genes, FKBP5 gene
Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional

Detailed Description
-----------------
Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.

Official Title
-----------------
Left Atrial Volume and Function in Patients With Obstructive Sleep Apnea Assessed by Real Time Three Dimensional Echocardiography

Conditions
-----------------
Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 30 to 70 Apnea-hypopnea index > 5 by polysomnography Exclusion Criteria: Any cardiac disease Poor imaging quality by mean of echocardiography non-sinusal Rhythm

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>The subjects for this group are matched for age, gender, body mass index. The presence of obstructive sleep apnea will divide the cohort in 02 subgroups: non-Obstructive Sleep Apnea and Obstructive Sleep Apnea | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Atrial enlargement |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea Syndromes diastolic disfunction left atrium