linjc16/ctgov huggingface dataset:
Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement. Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (<12 weeks duration) and high basal C-peptide >0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 [1,25-(OH)2D3] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.

Official Title
-----------------
Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Calcitriol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines; age at presentation between 11 and 35 years; duration of clinical disease (since the beginning of insulin therapy) <12 weeks; baseline C-peptide >0.25 nmol/l; no medical contra-indications or any other major chronic disease; willingness and capability to participate in a regular follow-up. Exclusion Criteria: cardiovascular disease; renal disease; liver disease; neurological disorders; allergic diathesis; hyperparathyroidism; neoplasia.

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 40 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 |
| --- | --- |
| Experimental: Calcitriol<br> | Drug: Calcitriol<br> <br> |
| Placebo Comparator: placebo<br> | Drug: Calcitriol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C peptide | evaluation of baseline and stimulated C peptide |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycometabolic control | To measure insulin requirement and HbA1c |  |
Evaluation of Diaphragm Movement

Study Overview
=================
Brief Summary
-----------------
Precise measurement of diaphragm function is difficult. Several methods exist. No are sufficiently validated. With this study, the investigators wish to investigate the validity of different ultrasound and radiological methods and compare them with inspiratory pressure measurements.

Official Title
-----------------
Vurdering af Diafragmas Funktion. Et Metodestudie og et Klinisk Studie

Conditions
-----------------
Diaphragm Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Diaphragm evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed informed consent one of the following conditions: Healthy participants, control group Lung disease group. COPD or Ideopatic pulmonary fibrosis. Heart disease group. Heart disease that lead to: heart transplantat or left ventricular assist device. Exclusion Criteria: Known diaphragm dysfunction. Neuromuscular disease. Pleural effusion. Pneumothorax. In the healthy group: Significant comorbidity that affect heart og lung function (arterial hypertention, mild valve disease and COPD without symptoms are accepted). In the healthy group and in the lung disease group: Previous thorax surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Healthy participants<br>Participants without any known cardiac or pulmonary disease. | Diagnostic Test: Diaphragm evaluation<br>* Ultrasound and radiographic evaluation of diaphragm function<br>|
| Heart disease participants<br>Participants with heart disease. | Diagnostic Test: Diaphragm evaluation<br>* Ultrasound and radiographic evaluation of diaphragm function<br>|
| Lung disease participants<br>Participants with lung disease. | Diagnostic Test: Diaphragm evaluation<br>* Ultrasound and radiographic evaluation of diaphragm function<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm function | Movement of diaphragm measured with ultrasound and radiography. Ultrasound measures: Diaphragm excursion in centimeters with M-mode, in B-mode and with the area method. Radiographic measures: Craio-caudal movement in centimeters with flouroscopy. | immediately after intervention |
Identifying New Genetic Causes to Development Disorders

Study Overview
=================
Brief Summary
-----------------
Disorders of growth, puberty and sex development can have genetic causes. The exome analysis could detect new mutations responsible for these disorders and the frequency of these mutations in these disorders, their association with other malformations.

Official Title
-----------------
Identifying New Genetic Causes to the Disorders of Growth, Puberty and Sex Development

Conditions
-----------------
Disorders of Sex Development, Growth Disorders, Puberty Disorders

Intervention / Treatment
-----------------
* Genetic: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital growth hormone deficiency puberty disorder gonadal dysgenesis or anorchia primary ovarian failure disorder of sex development subjects related to a patient with one of the above criteria Exclusion Criteria: environmental or auto-immune cause
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: blood sample|search for genetic mutations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mutation research | frequency of genetic mutation | baseline |
Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

Study Overview
=================
Brief Summary
-----------------
To investigate headache score and accompanying symptoms during and after infusion of carbachol.

Detailed Description
-----------------
To investigate headache score and accompanying symptoms during and after infusion of carbachol. Changes in regional cerebral blood flow (rCBF) in the area supplied by middle cerebral artery (MCA), blood flow in MCA, diameter of the superficial temporal artery (STA) and radial artery (RA)

Official Title
-----------------
Basic Research on Carbachol´s Headache Inducing Characteristics and Effects on the Cerebral Blood Flow in a Humane Experimental Headache Model

Conditions
-----------------
Headache

Intervention / Treatment
-----------------
* Drug: carbachol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Aged 18-40 50-100 kg Fertile women must use safe contraceptives (IUD, oral contraceptives, surgical sterilisation and long lasting gestagen. Exclusion Criteria: Tension type headache more than once/month Other primary headaches Daily medication except contraceptives Drug taken within 4 times the halflife for the specific drug except contraceptives Pregnant or lactating women Exposure to radiation within the last year Headache within the last 24 hours before start of trial Hypertension Hypotension Respiratory or cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carbachol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

Study Overview
=================
Brief Summary
-----------------
The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.

Official Title
-----------------
Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block

Conditions
-----------------
Knee Replacement Surgery

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: - Exclusion Criteria: ASA IV, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 |
| --- | --- |
| Femoral block preoperative<br>In one group (T1) with performance of femoral block before general anesthesia and administration of bolus of local anesthetic through stimulating catheter (combined anesthesia) | |
| Femoral block postoperative<br>In second group (T2) with a administration of local anesthetic through stimulating femoral catheter until awareness of patient (balanced anesthesia). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sevoflurane requirements | Combined ( femoral block and general anesthesia) or balanced anesthesia ( intravenous analgesics and general anesthesia) is evaluated on the requirements of inhalational hypnotics during surgery. Schedule time when BIS has to be in proper range (40-60): T1 T2 T3 T4 T5 T6 T1 Induction T2 Inflated cuff ischemia T3 Incision T4 Unlocking cuff ischemia T5 End surgery T6 Time to wake the patient from the close of the sevoflurane vaporizer Each time include a period of adjustment in 5 minutes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative and postoperative opiates requirements and relations with CVI |  | Time surgery and 24,48 and 72 h postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Trauma patients
24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the relationship between intraocular pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This device has previously been investigated and shown to be safe and well tolerated.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is able to comply with the study procedures 18-80 years old Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment. Subject has consented to be in the trial Visual acuity of 20/200 or better Presence of cataract requiring phacoemulsification with lens exchange Ability to understand the character and individual consequences of the study For women of childbearing potential, adequate contraception Exclusion Criteria: Subjects presenting with any of the following criteria will not be included in the trial: Subjects with contraindications for wearing contact lenses Severe dry eye syndrome Keratoconus or other corneal abnormality Conjunctival or intraocular inflammation Eye surgery prior to and throughout the study. Full frame metal glasses during SENSIMED Triggerfish® monitoring Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine) Pregnancy and lactation Simultaneous participation in other clinical studies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| cataract patients with glaucoma<br> | Device: Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish<br>* Phacoemulsification (standard cataract extraction surgery)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-h IOP patterns |  | 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relationship, IOP fluctuations, glaucoma, cataract surgery, SENSIMED Triggerfish
STRAIN - Work-related Stress Among Health Professionals in Switzerland

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify work stressors, stress reactions and long-term consequences among nurses, physicians, medical-technical and medical-therapeutic professions in Switzerland and to reduce those factors by an educational intervention for the supervisors.

Detailed Description
-----------------
Methods: This study is a cross-sectional design and randomly selected hospitals, nursing homes and home care organizations. The study sample included nursing staff and midwives, physicians, medical-technical and medical-therapeutic professionals at all hierarchical levels. Data were collected using self-report questionnaires and analysed using multiple regression models.

Official Title
-----------------
STRAIN - Work-related Stress Among Health Professionals in Switzerland

Conditions
-----------------
Stress, Health Care Professionals, Work-Related Condition

Intervention / Treatment
-----------------
* Other: educational intervention for the supervisors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Employee within a participating health organization in Switzerland Health care professional (nurse, medical-technical medical-therapeutical profession, physician) Exclusion Criteria: Health professionals without an fixed employment contract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention group (IG) An educational intervention for the supervisors | Other: educational intervention for the supervisors<br>* The educational intervention is based on a systematic literature review as well as focus-group interviews with health care professionals. It will be developed until the end of 2018<br>|
| No Intervention: Control<br>control group (CG) | |
| No Intervention: Non-Intervention<br>group without intervention (GWI) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effort reward imbalance model (ERI) | The model defines threatening job conditions as a mismatch between high workload (high demand) and low control over long-term rewards | Changes in self reported results of the ERI from t1 to t2 (1 year) |
Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug

Study Overview
=================
Brief Summary
-----------------
Prolonged Collagen/Epinephrine - closure time (CEPI-CT) indicates platelet dysfunction in CKD patients taking antiplatelet agent. The synthetic vasopressin derivative, Desmopressin (DDAVP) shortens the prolonged bleeding time and improves platelet dysfunction measured by in vitro closure time: CEPI-CT in uremic patients. Desmopressin also antagonizes the in vitro platelet dysfunction induced by GPIIb/IIIa inhibitors, clopidogrel and aspirin. The investigators designed a prospective study to evaluate the effect of desmopressin on platelet function, as measured by in vitro collagen/epinephrine - closure time, in uremic patients who were taking antiplatelet drugs.

Official Title
-----------------
Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis

Conditions
-----------------
Bleeding, Tachycardia, Dyspnea

Intervention / Treatment
-----------------
* Drug: Desmopressin administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult uremic patients with one or more antiplatelet medication, prolonged collagen/epinephrine (CEPI) closure time, need for emergent hemodialysis and subsequent catheter insertion Exclusion Criteria: acute coronary syndrome, hemophilia, and nephrogenic diabetes insipidus, allergy against desmopressin

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmopressin<br>Twenty five patients with chronic kidney disease and who were taking antiplatelet agents and needed an emergent catheter insertion for hemodialysis | Drug: Desmopressin administration<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collagen-epinephrine closure time | In vitro closure time (CT), measured using a platelet function analyzer (PFA)-100, is a relatively new tool for investigation of primary hemostasis. This system has been shown to be efficacious in evaluating abnormalities of primary hemostasis. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding after procedure | we observe incidence of bleeding complication after procedure | 1-4 hr after procedure |
Xtract™ Aspiration Catheter Registry Study

Study Overview
=================
Brief Summary
-----------------
Intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous coronary and other vascular interventional techniques. The Xtract™ Aspiration Catheter is a single use device designed to remove fresh, soft emboli and thrombi from the arterial system using standard catheter techniques, compatible with 6 Fr guide catheters and 0.014 guidewires. The purpose of this registry study is to validate the design and demonstrate the performance of the Xtract Aspiration Catheter as a thrombectomy catheter during percutaneous intervention of vessels in the arterial system. Subjects will be enrolled during percutaneous intervention when the Interventional Physician decides a thrombectomy catheter is needed to remove thrombus during the procedure.

Official Title
-----------------
Xtract™ Aspiration Catheter Registry Study

Conditions
-----------------
Fresh Soft Emboli or Thrombi in the Arteries.

Intervention / Treatment
-----------------
* Device: Xtract Aspiration Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion Angiographic evidence of thrombus.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Xtract Aspiration Catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study will be to evaluate the performance of the Xtract Aspiration Catheter. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thrombus, aspiration catheter