linjc16/ctgov huggingface dataset:
Minocycline to Reduce Pain After Carpal Tunnel Release

Study Overview
=================
Brief Summary
-----------------
The investigators are looking at whether peri-operative minocycline will reduce the duration of pain after minor hand surgery: carpal tunnel release and trigger finger release. The investigators' hypothesis is that minocycline will reduce post-operative pain.

Detailed Description
-----------------
This is a double blinded randomized controlled trial. Patients are given 100mg of minocycline 2 hours prior to their procedure and then 100mg two times a day for 5 days. The subjects are then contacted daily to check their level of pain. The investigators' outcome of interest is time to pain resolution. The investigators will perform a futility analysis to assess if a larger trial would be a reasonable next step after this pilot study.

Official Title
-----------------
A Trial of Minocycline for Pain After Carpal Tunnel and Trigger Release

Conditions
-----------------
Chronic Pain, Post-operative Pain

Intervention / Treatment
-----------------
* Drug: Minocycline
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, Veteran, Exclusion Criteria: Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to understand survery

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minocycline<br>perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID | Drug: Minocycline<br>* RCT blinded placebo trial<br>* Other names: Minocycline Hydrochloride;|
| Placebo Comparator: Placebo<br>PLacebo | Drug: placebo<br>* RCT blinded placebo trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Pain Resolution | the time until patient answers no pain at surgical site for three consecutive days | up to 365 days |
Health-related Quality of Life in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
This study investigates health-related Quality of life in colon cancer patients in Västmanland, Sweden, at diagnosis, at 6 months, 1, 2 and 3 years after diagnosis, measured by the well-validated EORTC QLQ-C30 questionnaire.

Detailed Description
-----------------
See above.

Official Title
-----------------
Health-related Quality of Life in Colon Cancer Patients

Conditions
-----------------
Health Related Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed with colon cancer in Region Västmanland 2012-2016. Exclusion Criteria: Language problems, declined inclusion,
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 |
| --- | --- | --- |
| Health-related Quality of Life | The EORTC QLQ-C30, a HRQoL questionnaire was used. It consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain). Six single items are also included (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). The final two items in the questionnaire assess global health and overall QoL. Raw data were transformed to standardized scores ranging from 0 to 100 using the EORTC scoring manual. A high score on the functional scale represents a high level of functioning (i.e., higher is better), whereas a high score on the symptom scale represents a high level of symptoms (i.e., lower is better). | 2012-2016 |
Rule-Based Closed Loop System for Type 1 Diabetes Control

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. Ten subjects will be enrolled and they will participate in a cross-over study with a control night, using their usual insulin pump pattern, and with a experimental night, being controlled for the closed loop system. Each night includes the overnight control and prandial control of the breakfast. The system proposes an insulin dose every 5 minutes according with the value of glucose displayed by the continuous glucose monitoring system.

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Algorithm for insulin administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes Insulin pump treatment Undetectable C-Peptide Exclusion Criteria: Autonomous system neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Algorithm for insulin administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent with glucose in the target range |  |  |
Glulisine Pre- and Postmeal

Study Overview
=================
Brief Summary
-----------------
To investigate in type 1 diabetic patients the glucodynamic response to HMR1964 insulin and RHI (HOE31HPR100) injected subcutaneously before and after a standard meal

Official Title
-----------------
Glucodynamic Response to Pre- and Postmeal Subcutaneous Injection of 0.15 IU/kg HMR1964 Insulin and RHI in Type 1 Diabetic Subjects in an Open, Randomized, Four-way Crossover Study

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

Intervention / Treatment
-----------------
* Drug: Insulin glulisine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin glulisine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measures: Post-prandial glucose and insulin concentrations. Outcome: In T1DM, insulin glulisine provides a better mimic of the physiological postprandial glucose disposal than RHI. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin glulisine, Diabetes mellitus Type 1, Postprandial Period, Pharmacokinetics, Glucodynamics
Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias

Study Overview
=================
Brief Summary
-----------------
Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans, but there is no standardized CT protocol for the diagnosis and follow-up of hepatic candidiasis. The investigators compared the size of the fungal lesions in the chest and abdomen CT. The current analysis aimed to increase the value of CT for the diagnosis and the follow-up of hepatic candidiasis in daily routine.

Official Title
-----------------
Verbesserung Der Radiologischen Diagnose Von Hepatolienaler Candidiasis während Der Therapie Der Leukämie

Conditions
-----------------
Leukemia, Infection

Intervention / Treatment
-----------------
* Behavioral: Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Chest and Abdomen CT with fungal lesion in patients with leukemia Exclusion criteria: Other liver pathologies

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Imaging|CT image validation and lesion measurement, as well as comparison of different CT phases|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point was IFI according to the EORTC/MSG 2008 definitions and bacteraemia |  | 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Computed tomography
Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare observed neuraxial (Epidural, spinal, combined spinal-epidural) insertion attempts with actual documented attempts in anesthesia providers (staff, residents and fellows) at one maternal hospital. Trained research staff will document the number of neuraxial attempts before the operation, and compare this with the attempts recorded in the patient's chart. The definition of a neuraxial attempt will be determined before the study begins through a thorough literature review.

Official Title
-----------------
Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)

Conditions
-----------------
Neuraxial Anesthesia Charting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy parturients receiving any neuraxial procedure Exclusion Criteria: Patient refusal of observation Provider refusal of observation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent accuracy of recorded neuraxial attempts | Charted neuraxial attempts divided by observed neuraxial attempts | 1 day post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent accuracy of recorded neuraxial redirections | Charted neuraxial attempts divided by number of observed attempts and redirections | 1 day post-operatively | 
| Define a neuraxial attempt | Use thorough literature review to establish a working definition of a neuraxial attempt | 1 month before recruitment starts | 
| Define a neuraxial redirection | Use thorough literature review to establish a working definition of a neuraxial redirection | 1 month before observations start | 
| Departmental consensus on a neuraxial attempt | Survey the department to understand how staff define a neuraxial attempt | One week after observations conclude | 
| Completeness of documentation | Percentage completion of requisite charting prompts on anesthesia record | 1 day post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuraxial attempts, anesthetic charting, anesthetic documentation
Screening for Atrial Fibrillation, After Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the incidence of patients suffering from ischemic stroke or transient ischemic attacks who have underlying asymptomatic paroxysmal atrial fibrillation. Patients who have suffered an ischemic stroke or transient ischemic attack, without a history of atrial fibrillation, are planned to be included. Starting within 14 days of the ischemic stroke, participating patients are asked to perform 10 second ECG recordings using a handheld ECG device twice daily (mornings and evenings) during 30 days. These recordings are transmitted via telephone to a secure encrypted Internet site. Within these 30 days the participants also perform an ambulatory 24 hour Holter recording. Handheld ECG recordings are evaluated continuously. In case of atrial fibrillation the patient is informed and offered treatment with anti coagulant medication (Warfarin). The investigation is a comparison between 24 hour continuous ECG recordings and short intermittent ECG recordings twice daily over a longer time period to determine which method is the best to detect atrial fibrillation in this patient group. Hypothesis: Short Intermittent ECG recordings over a longer time period is more efficient, compared with continuous 24 hour ECG recordings, in detecting silent paroxysmal AF in patients with an ischemic stroke and without a history of atrial fibrillation.

Official Title
-----------------
Improving Screening for Silent Atrial Fibrillation, After Ischemic Stroke

Conditions
-----------------
Atrial Fibrillation, Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No previously diagnosed atrial fibrillation. Acute ischemic stroke or transient ischemic attack verified by computed tomography or clinical diagnosis using the National Institute of Health Stroke Score within 14 days of enrollment. Ability to understand study instructions both verbal and written. Ability to perform and transmit ECG recordings according to study design. Exclusion Criteria: Previously diagnosed atrial fibrillation. Hemorrhagic stroke Low compliance Pacemaker carrier
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ischemic stroke, no atrial fibrillation<br>Patients who have suffered ischemic stroke or transient ischemic attack without known atrial fibrillation | |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silent paroxysmal atrial fibrillation, stroke, tele ECG
INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

Study Overview
=================
Brief Summary
-----------------
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

Detailed Description
-----------------
This is a single-center, non-randomized, prospective interventional pilot study. Feasibility of intraoperatively visualizing tumour (margins) in penile and tongue tumours using EMI-137 will be investigated. Patients, ≥ 18 years of age, with ≥T1 penile or tongue cancer undergoing primary tumour surgery will be included. All patients will receive an intravenous bolus injection of EMI-137 prior to surgery. Main study parameters/endpoints are: Intraoperative visualization of primary penile or tongue tumours using a dedicated clinical fluorescence camera. The in vivo detected fluorescence signal will be correlated to ex vivo measurements and pathological assessment of the ex-cised tissue.

Official Title
-----------------
INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

Conditions
-----------------
Head and Neck Cancer, Penile Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent, prior to performing any protocol related procedures. Age ≥ 18 years at time of study entry. ≥ T1 penile or tongue squamous cell cancer Scheduled for surgical primary tumour resection Exclusion Criteria: Involvement in the planning and/or conduct of the study. Pregnant woman Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days. Severe kidney insufficiency

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 |
| --- | --- | --- |
| tumour visualization by means of c-MET targeted fluores-cence imaging | The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry. | peri-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph node visualization by means of c-MET targeted fluores-cence imaging | Detection and visualization of lymph node metastases in penile and tongue tumour patients | peri-operative | 
| Dysplasia or Cis by means of c-MET targeted fluores-cence imaging | Identification of dysplasia or carcinoma in situ in penile and tongue tumours. | Peri-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, fluorescent c-met tracer, penile, tongue
FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)

Study Overview
=================
Brief Summary
-----------------
This study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5 years, in order to evaluate the effects of continuing or discontinuing alendronate treatment on bone mineral density and biochemical markers of bone turnover.

Official Title
-----------------
A 5-year, Double-blind, Randomized, Placebo-controlled Extension Study to Examine the Long-term Safety and Efficacy of Oral Alendronate in Postmenopausal Women Who Previously Received Alendronate in Conjunction With the Fracture Intervention Trial

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: MK0217, alendronate sodium / Duration of Treatment : 5 Years
* Drug: Comparator : placebo (unspecified) /Duration of Treatment : 5 Years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible to participate in this study, women needed to have previously participated in the Fracture Intervention Trial (FIT) and to have been part of the group treated with alendronate in FIT They needed to have received at least 3 years of treatment with alendronate in the FIT trial In addition, their bone mineral density (BMD) at the hip needed to be better than it was at the start of FIT Exclusion Criteria: Patients were excluded if they had conditions that contraindicated alendronate therapy and if they might have used other medications for the treatment of osteoporosis Women were also excluded if BMD at the hip was below a certain level (T-score <=-3.5); that is, if it were 3.5 standard deviations or more lower than the average for young adult women

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 86 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0217, alendronate sodium / Duration of Treatment : 5 Years|nan|
|Drug: Comparator : placebo (unspecified) /Duration of Treatment : 5 Years|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hip bone mineral density (BMD) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD of femoral neck, trochanter, and lumbar spine |  |  | 
| Biochemical markers of bone turnover |  |  |
Serum Clozapine and Cognition

Study Overview
=================
Brief Summary
-----------------
This study aim to investigate the relationship between serum levels of clozapine and cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine monotherapy. The hypothesis is that higher serum levels of clozapine are associated with cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine are studied. The design is cross-sectional.

Official Title
-----------------
Serum Clozapine and Cognition

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with clozapine for minimum 6 months. Fixed dosage of clozapine last month before inclusion. Exclusion Criteria: Substance misuse. Depression (Calgary Depression score ≥7). Somatic disease that interfere with cognitive performance. Treatment with benzodiazepines (half-lives >15 hours not allowed up 14 days prior inclusion and during study. Half-lives < 15 hours not allowed 3 days prior cognitive testing). Electroconvulsive therapy. Treatment with other antipsychotics. Withdrawal of informed consent. Compulsory measures. Treatment with anticholinergics except for atropine drops administered sublingually. Changes in use of tobacco last month before inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Cognitive function measured by CANTAB |  | once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-wave morphology |  | Once | 
| Sedation VAS,ACES and SWAI scale |  | once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clozapine, schizophrenia, cognition, t-wave morphology