linjc16/ctgov huggingface dataset:
The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application

Study Overview
=================
Brief Summary
-----------------
This mixed methods study aims to answer the question: What is the work of being a patient with type 2 diabetes mellitus? .

Detailed Description
-----------------
This study will describe how much time persons with type 2 diabetes mellitus spend on health management and the burden they experience from these activities.

Official Title
-----------------
The Work of Being a Patient: A Mixed Methods Characterization of the Work of Being a Patient With Type 2 Diabetes Mellitus Using Real-time Data Collection Via a Smartphone Application

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: none, observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: receiving medical care at Mayo Clinic endocrine subspecialty clinic diagnosis of type 2 diabetes Exclusion Criteria: unable to provide consent patients who reside in an extended care of intermediate care facility

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 |
| --- | --- |
| Participants with Type 2 Diabetes<br>Adults with type 2 diabetes will be enrolled in this mixed methods observational study. | Other: none, observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Score on Burden of Treatment Questionnaire | The 48-item version of the Patient Experience with Treatment and Self-Care (PETS) | Baseline |
Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap

Study Overview
=================
Brief Summary
-----------------
Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.

Conditions
-----------------
Complex Digital Injuries

Intervention / Treatment
-----------------
* Procedure: Composite Flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a neurocutaneous defect at the proximal phalanx a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect. Exclusion Criteria: an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers a nerve injury that is able to be repaired by primary neurorrhaphy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgical flap<br>The flap includes the nerve for repair of the soft tissue and nerve defects | Procedure: Composite Flap<br>* nerve transfer with the dorsal branch of the digital nerve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static 2-point discrimination test | The test points are at the center of the radial or ulnar portion of the pulp. Each area is tested 3 times with a Discriminator. The investigators stop at 4mm as a limit of 2PD and consider this normal. | 18 months to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cold Intolerance Severity Score (CISS) questionnaire. | The maximum score is 100 and is grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively. | 18 months to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft tissue loss, nerve defect, dorsal branch of the proper digital nerve, heterodigital arterialized nerve pedicle flap, Composite Flap, nerve flap, nerve transfer
Debulking Effect of Curretage on Basal Cell Carcinomas - a Histological Assessment.

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare histologically observed tumour infitration of basal cell carcinoma (bcc) lesions before and after curretage.A significant reduction of tumour depth would enable further bcc's included for superficial non-invasive treatment modalities such as topical photodynamic therapy.

Official Title
-----------------
Relation of Basal Cell Carcinoma Tumour Thickness, Histologically Estimated, in Punch Biopsies Performed Before and After Curretage.

Conditions
-----------------
Carcinoma, Basal Cell

Intervention / Treatment
-----------------
* Procedure: Curretage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bcc with tumour depth two mm.or more Exclusion Criteria: bcc tumours smaller than three mm in mean diameter.

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?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curettage<br> | Procedure: Curretage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of tumour thickness 0,5mm or more after curretage |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of tumour thickness in punch biopsies performed on referral, before and after curretage. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cytoreduction Surgical Procedures, Curretage, Photochemotherapy
Central Blood Volume in Hypotensive Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test whether hypotensive episodes during dialysis - caused by withdrawal of fluid drom the circulation - can be predicted by means of two harmless monitoring techniques.

Official Title
-----------------
Registration of Central Blood Volume in Hypotensive Dialysis Patients - a Comparison of Thoracic Impedance and Central Venous Saturation Monitoring

Conditions
-----------------
Intradialytic Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hemodialysis patients with central vascular access Exclusion Criteria: Patients below 18 years of age Patients unable to give informed consent

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System

Study Overview
=================
Brief Summary
-----------------
Observational trial to evaluate the effectiveness of the TEG6s DOAC cartridge to detect and classify the presence of DOAC drugs in a subject.

Official Title
-----------------
Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System

Conditions
-----------------
DOAC Eligible Subjects

Intervention / Treatment
-----------------
* Device: TEG6s DOAC Cartridge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old DOAC administered for a minimum of 7 days Exclusion Criteria: Genetic Bleeding disorders. Known or subsequently discovered inherited defects of coagulation (e.g. hemophilia or Von Willebrand disease) Not known when last two DOAC doses were administered prior to blood draw DOAC first administered (or resumed after temporary cessation) less than 7 days prior to blood draw DOAC dosage outside of manufacturer's recommended range (e.g. study subject with renal impairment and supratherapeutic dose) Heparin or LMWH administered within 7 days prior to blood draw On any medications known to affect coagulation status and listed below Bruising, wounds or scarring in the area of venipuncture List of medications known to affect coagulation status Vitamin K Antagonists [VKAs] Warfarin Phenprocoumon Acenocoumarol Tecarfarin [ATI-5923] Phenindione Anisindione Elinogrel Vorapaxar Atopaxar Heparin and Heparins Unfractionated Heparin [UFH] LMWH Fondaparinux Idraparinux Danaparoid Vasopressin Analogues DDAVP Direct Thrombin [IIa] Inhibitors Hirudin Lepirudin Bivalirudin Argatroban Defibrinating Agents Ancrod

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 |
| --- | --- |
| Reference Range<br>Healthy Subjects | Device: TEG6s DOAC Cartridge<br>* Testing subjects for presence of DOAC<br>|
| DOAC Pivotal<br>DOAC Eligible Subjects | Device: TEG6s DOAC Cartridge<br>* Testing subjects for presence of DOAC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence / Absence of DOAC Drug |  | 1 week |
Improving the Diagnosis of Traveller's Fevers in Point Of Care (POC)

Study Overview
=================
Brief Summary
-----------------
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of traveller's fever caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC traveller's fever tests . The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a rectal swab would improve the etiological diagnosis of traveller's fever of at least 10%.

Conditions
-----------------
Traveller's Fever

Intervention / Treatment
-----------------
* Other: Rectal Swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted for traveller's fever requiring a microbiological examination with a Traveller's fever POC kit Patient who freely signed the informed consent form Patient affiliated to a social security regime Exclusion criteria Pregnant or breastfeeding women Adult patient under guardianship Patient deprived with liberty under court order Patient refusing or unable to sign the informed consent form
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients admitted for traveller's fever<br> | Other: Rectal Swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients admitted for traveller's fever with a confirmed etiological diagnosis |  | 1 day |
Outcomes of the Intradural Extramedullary Tumors Resection

Study Overview
=================
Brief Summary
-----------------
The intradural extramedullary tumors remain curable diseases. Our aim in this study is to evaluate the postoperative status after the tumor resection and compare it to the preoperative status

Detailed Description
-----------------
Meticulous microscopic excision without nerve root or dural injuries

Official Title
-----------------
Professor of Neurosurgery

Conditions
-----------------
Spinal Cord Tumor

Intervention / Treatment
-----------------
* Procedure: Spinal cord tumor resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neurological deficit back pain Exclusion Criteria: old age above 80 years immunocompromised patients

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 66 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: spinal cord tumors<br> | Procedure: Spinal cord tumor resection<br>* Excision of intradural tumors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete excision | delicate dissection | 7 years |
Pregabalin In Adolescent Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin

Official Title
-----------------
A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions. Exclusion Criteria: Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br> | Drug: pregabalin<br>* Oral capsule 75-450 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pain Numeric Rating Scale by Week | The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement. | Baseline, Weeks 3, 8, 16, 24 and Last Visit. |
Sudarshan Kriya Yoga and Cardiac Autonomic Control in Patients With Anxiety-Depression Disorders

Study Overview
=================
Brief Summary
-----------------
The effects of Sudarshan Kriya Yoga (SKY) on autonomic function in patients with anxiety-depression disorders is unknown. Thus, the authors will investigate cardiac autonomic control in a population of patients with anxiety-depression disorders which will undergo a specific SKY treatment.

Detailed Description
-----------------
Several studies have demonstrated that adjuvant therapies as exercise and breathing training are effective in improving cardiac autonomic control (CAC) in patients with affective spectrum disorders. However, the effects of Sudarshan Kriya Yoga (SKY) on autonomic function in this population is unknown. To test the hypothesis that SKY training improves CAC, cardiorespiratory coupling and adaptive response of sympatho-vagal balance to orthostatic changes were evaluated in patients with anxiety and/or depression disorders. The authors will enroll patients with a diagnosis of anxiety and/or depression disorders (DSM-IV) and they will divide them in two groups: 1) conventional therapy (Control) and 2) conventional therapy associated with SKY (Treatment) for 15 days. Anxiety and depression levels will be determined using quantitative questionnaires. For the assessment of CAC and cardiorespiratory coupling, cardiorespiratory traces will be analyzed using monovariate and bivariate autoregressive spectral analysis, respectively.

Official Title
-----------------
Effects of Sudarshan Kriya Yoga on Cardiac Autonomic Control and Anxiety/Depression Levels in Patients Affected by Anxiety-Depression Disorders

Conditions
-----------------
Anxiety, Depression

Intervention / Treatment
-----------------
* Other: SKY therapy
* Drug: usual drug therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of anxiety-depression disorder Exclusion Criteria: absence of sinus rhythm on ECG absence of any cardiovascular and metabolic disorder

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sky<br>Sky treatment foe 15 days | Other: SKY therapy<br>* slow breathing<br>|
| Sham Comparator: control<br>standard medical therapy | Drug: usual drug therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in autonomic control | Parameter derived from heart rate variability: LF/HF (marker of sympatho-vagal balance) | 1 month |
Comparing Cardiac Output Measurements in Critically Ill Children Using USCOM and Transthoracic ECHO

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the accuracy and precision of two non-invasive methods of measuring cardiac output in critically ill children (<18 yrs). The participants will include any patient admitted to Pediatric intensive care unit (PICU) requiring a trans-thoracic ECHO (TTE) as part of their treatment plan. Measurements of intermittent cardiac output will be obtained and compared on participants using standard 2-D TTE and Ultrasound Cardiac Output Monitor (USCOM).

Official Title
-----------------
Comparing Cardiac Output Measurements in Critically Ill Children Using Ultrasonic Cardiac Output Monitor and Transthoracic Echocardiography.

Conditions
-----------------
Critical Illness, Pediatrics

Intervention / Treatment
-----------------
* Device: Ultrasonic Cardiac Output Monitor (USCOM).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any UNC PICU patient <18 yrs requiring a transthoracic ECHO (TTE) as standard of care. Gestational age >36 weeks Wt > 2 kg Written informed parental permission Exclusion Criteria: Any patient with known unrepaired intracardiac shunt lesion (ASD,PDA,VSD) any post operative patient with delayed closure of chest parental refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 17 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 |
| --- | --- |
| USCOM Cardiac index<br> | Device: Ultrasonic Cardiac Output Monitor (USCOM).<br>* This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.<br>* Other names: USCOM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index |  | measured at the time of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care units, pediatric, cardiac index, Doppler Ultrasonography
Phase I Study to Investigate the Alcohol Interaction of SK3530

Study Overview
=================
Brief Summary
-----------------
This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.

Detailed Description
-----------------
This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.

Official Title
-----------------
Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: SK3530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 20 to 50 body weight of IBM ± 20% Exclusion Criteria: cardiovascular disease color-blindness or weakness no availability to intake 0.5 g/Kg alcohol abnormal supine blood preesure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SK3530|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters - AUC, Cmax |  | 24hr after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Vital signs, Adverse events) |  | until post-study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SK3530, alcohol, pharmacokinetics, safety