linjc16/ctgov huggingface dataset:
Side Effects After Direct-acting Antiviral Treatment

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.

Detailed Description
-----------------
Direct-acting antiviral (DAA)-based treatments are today very effective The objective of this study was to assess the incidence of side effects after DAA therapy in patients with chronic hepatitis C virus infection.

Official Title
-----------------
Side Effects After Direct-acting Antiviral Treatment in Patients With Chronic Hepatitis C. The EFINO-C Study.

Conditions
-----------------
Chronic Hepatitis c

Intervention / Treatment
-----------------
* Drug: DAA treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Hepatitis C virus infection Treatment by direct-acting antiviral combination Exclusion Criteria: HIV coinfection

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

| Intervention/Treatment |
| --- |
|Drug: DAA treatment|Direct-acting antiviral-based treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of side effects | Incidence of side effects occurring during treatment duration. Treatment duration may be of 8 weeks, 12 weeks or 24 weeks depending on treatment combination. | Within treatment duration, i.e. 8, 12 or 24 weeks after treatment initiation |
Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

Study Overview
=================
Brief Summary
-----------------
Several surgical techniques are used for the treatment of acute acromioclavicular joint dislocations. The investigators investigate a new method using arthroscopic repair using the Tightrope fixation device.

Detailed Description
-----------------
The Tightrope consists of a suspension system with a strong suture thread intertwined between an oval button and a round button, which is inserted through drilling holes in the clavicula and the coracoid. The investigators want to prospectively evaluate the results in a series of 25 patients.

Official Title
-----------------
Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).

Conditions
-----------------
Acromioclavicular Joint Dislocation

Intervention / Treatment
-----------------
* Procedure: Tightrope fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute acromioclavicular joint dislocation 18 years or older Exclusion Criteria: Unable to sign informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acromioclavicular joint dislocation<br>Surgery: Arthroscopic repair using the Tightrope fixation device | Procedure: Tightrope fixation<br>* Arthroscopic repair<br>* Other names: Tightrope (R) (Arthrex, Naples, Florida);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant score | Shoulder outcome score | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plain radiographs |  | 1 Year | 
| VAS Pain | Visual analogue acale 1-10 | 1 Year | 
| VAS Satisfaction | Visual analogue acale 1-10 | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromioclavicular, Injury, Dislocation, Surgery
Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures

Study Overview
=================
Brief Summary
-----------------
This study compares the effect of infusion of two types of modern hydroxyethyl starch on the renal function and acid-base in patients undergoing urologic surgery.

Official Title
-----------------
The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions

Conditions
-----------------
Urologic Surgical Procedures

Intervention / Treatment
-----------------
* Drug: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)
* Drug: Tetraspan, B. Braun, Melsungen, Germany


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group above 18 years, ASA І and ІІ, Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement Exclusion Criteria: A known allergy to HES, Renal insufﬁciency (serum creatinine of >2.5 mg/dL), Signiﬁcant hepatic disease (liver function tests more than three times the upper limit of normal), Coagulation disorders (INR > 1.5).

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOL group<br>patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany) | Drug: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)<br> <br> |
| Experimental: TET group<br>patient will receive 6% HES 130/0.42 in a balanced electrolyte containing Na+140 mmol/L, Cl- 118 mmol/L, K +4 mmol/L, Ca++ 2.5 mmol/L, Mg++ 1 mmol/L, acetate- 24 mmol/L and malate-- 5 mmol/L | Drug: Tetraspan, B. Braun, Melsungen, Germany<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative volume replacement therapy | volume of the study drug in milliliters that will be needed for hemodynamic stabilization until the end of surgery (ie, the cumulative volume of the study drug in milliliters administered up to this time point). | From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acid base and Renal function | differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups | 24 hours after randomization |
Reversal of Obesity Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to determine if weight loss is beneficial for obese patients with diastolic heart failure.

Official Title
-----------------
Reversal of Obesity Cardiomyopathy After Gastric Bypass

Conditions
-----------------
Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects will have obesity and have a BMI > 35kg/m2. Subjects must be between the ages of 35 and 65 years, in order to limit the confounding affect of age on our endpoints. To determine if potential subjects meet these criteria, they will: be interviewed, their clinical charts reviewed, by the research study coordinator and/or the PI, and undergo a history and physical by a physician (Study Day 2). Subjects who are to undergo gastric bypass surgery will be in the intervention arm. They will be matched with control subjects. We will attempt to have no more than one control subject for each gastric surgery subject. Exclusion Criteria: Subjects who have a condition that may masquerade as diastolic heart failure will be excluded (see Research and Design). Subjects who are < 35 or > 65 years, > 400lbs (the weight limit of the MRI table) not obese, unstable, not able to lie flat for the imaging studies, not ambulatory, unable to give informed consent, pregnant, lactating, with atrial flutter or fibrillation, current smokers, or who will undergo a different type of bariatric surgery (not Roux-en-Y gastric bypass) will be excluded from participation. Those who have evidence of other major systemic diseases (e.g., cancer, significant lung disease, creatinine > 2.0mg/dL, hemoglobin < 10g/dL, and liver function tests twice the normal range) will be excluded. Subjects who have > class I hypertension will be excluded. The investigators will exclude patients with an LV ejection fraction < 45% and those with significant pulmonary hypertension (peak artery pressure > 55mmHg).

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- | --- |
| Cardiac function, myocardial fat deposition |  | the time frame of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver fat metabolism, plasma lipidomics |  | the time frame of the study |
Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to perform a prospective multicentric study to determine predictive ED score and D-dimer level in the evaluation of the thromboembolic event recurrence after anticoagulant treatment cessation. The patients are included in the study from the anticoagulant treatment cessation. An ED score and a blood sample are performed at this time and one month later. Then, the patients are followed up by phone for 2 years.

Detailed Description
-----------------
DDimer levels are centralized in University Hospital of Grenoble at the end of the study

Official Title
-----------------
Study of Predictive Echo Doppler Score and D-dimer Level in Evaluation of the Thromboembolic Event Recurrence After Anticoagulant Treatment Cessation.

Conditions
-----------------
Previous Vka Treatment, Previous Proximal VTE

Intervention / Treatment
-----------------
* Other: ED, DDimers and phone follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 and <80 years old First or second treated proximal VTE event (+/- Pulmonary embolism) Signed informed consent Exclusion Criteria: Active cancer or currently treated Previous VTE>2 Long term anticoagulant treatment for VTE diseases Long term anticoagulant treatment for other diseases Pregnancy, parturient or breast feeding Person deprived of freedom by judicial or administrative decision Consent unsigned

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Follow up<br>ED score and DDimer level of patients who have stopped their VKA treatment (after the first or the second previous proximal VTE). Phone follow up for 2 years. | Other: ED, DDimers and phone follow up<br>* ED score, DDimers level and phone questionnary<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE event recurrence |  | 0-2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VTE, VKA treatment, VKA treatment cessation
Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting

Study Overview
=================
Brief Summary
-----------------
The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments. This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.

Official Title
-----------------
Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection age > 18 treatment with rilpivirine, elvitegravir, or dolutegravir (for exposed patients) treatment with none of these drugs (for non exposed patients) capacity of reading French language Exclusion Criteria: drugs addiction (except for amyl nitriles (poppers) and cannabis) alcoholism co-infection with hepatitis C virus pregnant or breast feeding patient

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 |
| --- | --- |
| exposition to the drugs<br>patients treated with at least one of the following drugs: dolutegravir, elvitegravir and rilpivirine | Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir<br>* chemical dosage ARV<br>|
| patients non exposed to the drugs<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with neurologic and/or psychiatric adverse events |  | 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine |
Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare and evaluate the response to treatment with intravenous human immune globulin (IVIG) or placebo in previously untreated patients with chronic inflammatory demyelinating polyneuropathy.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a double blind, randomized, controlled study. Patients receive either intravenous human immune globulin (IVIG) or placebo infused at a rate of 40 mL/hr, increasing every 30 min to a maximum of 100 mL/hr daily over 6 to 8 hours for 2 days. On day 2, infusions of IVIG or placebo are delivered at the highest dose tolerated on day 1. On day 21, patients receive another IVIG or placebo infusion. Following day 42, patients may choose to continue infusions of IVIG every 21 days for 2 doses. Patients not receiving additional treatment are released from study. Patients are evaluated on days 10, 21, and 43.

Conditions
-----------------
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention / Treatment
-----------------
* Drug: immune globulin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Chronic inflammatory demyelinating polyneuropathy (CIDP) characterized by: Progressive or relapsing disease or chronic stable course with elevated cerebrospinal fluid protein with normal cell counts Acquired demyelination on electrophysiologic studies Segmental demyelination on nerve histology --Patient Characteristics-- Not pregnant No significant medical disorders

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: immune globulin|nan|

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
-----------------
demyelinating neuropathy, neurologic and psychiatric disorders, rare disease
Systematic Chart Review of Carotidynia Patients

Study Overview
=================
Brief Summary
-----------------
Systematic retrospective study of medical charts and medical imaging files, of patients consulting for acute neck pain and presenting unclassified abnormalities on dedicated vessel imaging.

Official Title
-----------------
Systematic Chart Review of Carotidynia Patients

Conditions
-----------------
Carotidynia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute cervical tenderness or neck pain fulfilling the characteristics of an idiopathic neck pain syndrome as defined by the International Headache Society in 1988 the performing of a diagnostic imaging like MRI, CT or US of the cervical area with a dedicated vessel analysis unilateral or bilateral abnormalities of common carotid, carotid bifurcation or internal carotid arteries on dedicated vessel imaging. Exclusion Criteria: patients without imaging, or without dedicated vessel analysis patients presenting with pain caused by a clearly identified vascular disease on dedicated vessel analysis imaging such as carotid occlusion, carotid dissection, vasculitis like giant cell arteritis. patients with no abnormality on cervical or vessel imaging

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 |
| --- | --- | --- |
| Presence or absence of perivascular carotid artery enlargement on dedicated vessel imaging |  | Within 1 week following admission |
The Effects of Functional Action-Observation Training on Gait Ability in Patients With Chronic Stroke

Study Overview
=================
Brief Summary
-----------------
This study aimed to examine the effects of functional action observation training on gait ability in chronic stroke patients.

Official Title
-----------------
Main Researcher for the Effects of Functional Action-observation Training on Gait Ability

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Functional action observation training
* Other: General action observation training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis with stroke through computed tomography or magnetic resonance imaging, more than six months ago. determination not to have cognitive disability, based on the score(>24 point) of mini mental state examination-Korea version. determination not to have visual abnormalities including the unilateral neglect through the motor-free visual perception test(MVPT) ability to independently gait longer than 10m in the room and to keep standing up without help. Exclusion Criteria: surgery in the last three months participating any other research
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional action observation training<br> | Other: Functional action observation training<br>* the Four Square Step Test (FSST) performance video for enhancing the dynamic balance and the video including participants' daily activities to increase the gait ability such as walking in a corridor, walking around the hospital, walking to the therapy room, coming out of the ward after opening and closing the door of it, coming in and out of toilet, shifting their blue plate. and bringing something from a refrigerator were produced and watched.<br>|
| Other: General action observation training group<br> | Other: General action observation training<br>* step 1, looking at the front, while walking comfortably; step 2, looking left and right, while walking; step 3, looking up and down, while walking; step 4, looking at the front, left and right, up and down while walking. After 15 minutes of watching the video, the exercise program with a therapist was conducted to increase the gait ability, for 15 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| temporal gait variables | gait velocity | 8 weeks |