linjc16/ctgov huggingface dataset:
A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections

Study Overview
=================
Brief Summary
-----------------
On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin.

Official Title
-----------------
A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections

Conditions
-----------------
Intra-abdominal Infection

Intervention / Treatment
-----------------
* Drug: moxifloxacin
* Drug: ampicillin/sulbactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed of complicated intra-abdominal infection need surgical treatment Exclusion Criteria: patients diagnosed of intra-abdominal infection receive non-operative management patients with known allergic history of fluoroquinolone Severe, life threatening disease with a life expectancy of < 48 h or APS and APACHE scores of > 35
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients with intra-abdominal infection treated with moxifloxacin 400mg once daily | Drug: moxifloxacin<br>* moxifloxacin 400mg once daily (IV form, 60minutes)<br>|
| Active Comparator: 2<br>patients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily | Drug: ampicillin/sulbactam<br>* ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response at test-of-cure visit |  | test of cure: 10-14 days after initial treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra-abdominal infection, moxifloxacin, ampicillin/sulbactam
Mind-Body Program for Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if Mind-Body groups can help improve the physical and emotional well-being of people facing cancer or its treatment.

Detailed Description
-----------------
Pain, fatigue, anxiety, depression, nausea, sexual impairment, body image disturbance, relationship strains, existential distress and role losses are all potential side-effects of living with cancer and its treatment. Behavioral interventions have shown some success in mitigating distress and QOL impairment among cancer patients. The purpose of this randomized-controlled study is to compare the effects of Mind-body group interventions on the quality of life of patients with advanced cancer. Patients are randomized to one of two psychotherapy groups, which occur weekly for eight weeks. Quality of life assessments are conducted at baseline and two and four-month intervals.

Official Title
-----------------
Evaluation of Mind-Body Groups on the Quality of Life of Cancer Patients

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Mind-Body Psychotherapy Group
* Behavioral: Mind-Body Psychotherapy Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On Active Treatment for: Breast Cancer Stage IV, Colorectal Cancer Stage IV, Lung Cancer Stages III & IV, or All Other Cancers (ANY stage on treatment) Language is English or Spanish Exclusion Criteria: Patient is currently attending other support/psychotherapy group Significant Cognitive Impairment ECOG performance status = 3 or 4 Current major untreated psychiatric disorder Unable to attend intervention in following 8 weeks due to medical or practical restrictions

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Psycho-educational / Stress Management group | Behavioral: Mind-Body Psychotherapy Group<br>* Psycho-educational group<br>* Other names: Stress Management Group;|
| Active Comparator: 2<br>Spiritual-Existential Support Group | Behavioral: Mind-Body Psychotherapy Group<br>* Spiritual-Existential Group<br>* Other names: Spiritual Support Group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy |  | baseline to 2 months and 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplasms, Needs Assessment, Adaptation Psychological, Minority Groups, Psychotherapy, Group, Program Evaluation, Spirituality, Spiritual Therapies
Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma

Study Overview
=================
Brief Summary
-----------------
To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study

Official Title
-----------------
Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma

Conditions
-----------------
Scleroderma, Systemic

Intervention / Treatment
-----------------
* Other: questionnaires online


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with systemic scleroderma according to the ACR / EULAR 2012 criteria Patient with one or more active digital ulcers Patient with internet access and camera or smartphone Exclusion Criteria: Minor patients Patient deprived of liberty or subject to a court order Patient subject to a legal protection measure Pregnant or lactating woman Patient unable to complete the questionnaires

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| questionnaires online<br>Each month, the nurse will contact the patients included, by mail or telephone, to fill out their questionnaires online or by mail, and to make a photo of the ulcer if it is healed. | Other: questionnaires online<br>* Each month, the nurse will contact the patients included, by mail or telephone, to fill out their questionnaires online or by mail, and to make a photo of the ulcer if it is healed. A dedicated telephone line and e-mail address will be used as a support if necessary (for questionnaires, emails or sending photos). The referring nurse and the clinical research assistant of the service will be in charge of centralizing the data collected.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of digital ulcers | Number of digital ulcers healed at the end of the study | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scleroderma - Digital Ulcers
Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether New Touch Digital (NTD) NeuroRPM software installed on wearable devices can objectively measure and track symptoms in patients with Parkinson's disease.

Official Title
-----------------
Monitoring Movement Disorder Symptoms With a Mobile Medical App on Off-the-shelf Consumer Mobile Devices

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: Monitoring Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years of age or older Subject is able to provide informed written consent Subject has been clinically diagnosed with Parkinson's Disease Subject is mentally and physically capable of performing tasks on the mobile device and related physical activities herein described Exclusion Criteria: Inability to give informed consent Presence of additional neurological disease aside from the diseases being studied Inability to understand and follow the directions for the study

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 |
| --- | --- |
| Parkinson's patients<br>Cohort of patients with clinical diagnosis of Parkinson's diseases with varied symptoms and severity. | Device: Monitoring Device<br>* Monitoring Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NeuroRPM UPDRS predicted score vs. clinical raters' UPDRS | We will compare symptom severity as predicted by NeuroRPM to UPDRS scores from clinical raters. Statistical significance will be evaluated by intraclass correlation and kappa-statistic. | Comparison will be performed upon completion of the study, approximately in 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease
Cronic Pressure Wounds and Relation With Gender

Study Overview
=================
Brief Summary
-----------------
There is no exact scientfic data about gender relationship with cronic pressure wounds (CPW). This research is aimed first to reveal gender relationship with CPW and aimed secondarily to reveal the gender related couse(es).

Detailed Description
-----------------
There is no exact scientific data about gender relationship with cronic pressure wounds (CPW). Researches about this subject is generally related to prevention and management of the process. But gender difference is not exactly researched in the literature. This research is aimed first to reveal gender relationship with CPW and aimed secondarily to reveal the gender related couse(es).

Official Title
-----------------
Cronic Pressure Wounds and Relation With Gender

Conditions
-----------------
Wound

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cronic pressure wound patients Exclusion Criteria: Operated cronic pressure wounds

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gender
Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the occurrences of respiratory symptoms risk factors and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic diseases at presentation (before treatment) and up to 3 years follow-up (study period).

Detailed Description
-----------------
Pulmonary function tests (PFTs) are a part of the routine follow-up of patients receiving anti-cancer treatment. Treatment is frequently associated with diverse pulmonary damage which may become functionally and clinically evident many years later. PFTs may help to quantify the damage in the lungs; help to evaluate the point at which lung function deviates from normal to allow early intervention before irreversible lung damage occurs and thereby to reduce morbidity and mortality. Reliable PFTs in the preschool age have traditionally been difficult to perform, but recent publications have demonstrated that the majority of preschool children can produce reproducible forced expiratory flow volume (FEVC) curves with proper coaching techniques. This recent development may enable studying the long term effect (years) of treatment on lung function in young children suffering from hemato-oncologic diseases.

Official Title
-----------------
Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years

Conditions
-----------------
Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Solid Tumors,, Hodgkin's Disease, Non-Malignant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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 |
| --- | --- |
| 1<br>all were in a single group | |

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
-----------------
acute lymphoblastic leukemia, long-term lung function
Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry

Study Overview
=================
Brief Summary
-----------------
A retrospective and prospective registry will evaluate demographic and angiographic data in patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive coronary angiography, intravascular imaging and/or computed multislice coronary tomography. The type of treatment applied during index hospitalization (i.e., clinical management, percutaneous coronary intervention or coronary artery bypass grafting) will be evaluated. Long-term follow-up (up to 10 years) will be also reported.

Official Title
-----------------
Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry: Epidemiological Data, Clinical Results and Long-Term Follow-up (SCALIBUR Registry).

Conditions
-----------------
Coronary Artery Dissection, Spontaneous

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with coronary manifestations due spontaneous coronary artery dissection Angiographic findings of SCAD in coronary angiogram or coronary tomography Agreement between two or more invasive cardiologists (adjudicated committee) for the diagnosis. Exclusion Criteria: Non-agreement for SCAD diagnosis Coronary dissections due other mechanisms: unstable atherosclerotic plaque or trauma-induced.
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 |
| --- | --- | --- |
| Long-term clinical outcomes in patients presented with spontaneous coronary artery dissection | All major adverse cardiac events will be collected | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multimodality intravascular imaging findings in patients with spontaneous coronary artery dissection. | Multimodality intravascular imaging will be recorded | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spontaneous coronary artery dissection, acute coronary syndrome, coronary angiography, coronary tomography
Post-Marketing Surveillance of TISSUCOL for Hemostasis in Subjects Undergoing Vascular Reconstruction With Polytetrafluoroethylene (PTFE) Prosthesis

Study Overview
=================
Brief Summary
-----------------
This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs.

Official Title
-----------------
Non- Interventional Study of Tissucol® for Hemostasis in Subjects With Femoral Vascular Anastomosis Undergoing Vascular Reconstruction With PTFE Prosthesis

Conditions
-----------------
Femoral Vascular Anastomosis

Intervention / Treatment
-----------------
* Drug: Tissucol®
* Procedure: Control: Conventional treatment, i.e. compression with swabs


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tissucol®|nan|
|Procedure: Control: Conventional treatment, i.e. compression with swabs|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
-----------------
Vascular reconstruction, Polytetraflouroethylene (PTFE) prosthesis
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Prospective pilot study to determine if changing the phosphate binder to sucroferric oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in peritoneal dialysis patients.

Official Title
-----------------
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients

Conditions
-----------------
Peritoneal Dialysis Complication, Hyperphosphatemia, Hypoalbuminemia

Intervention / Treatment
-----------------
* Drug: Sucroferric Oxyhydroxide Chewable Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7 Use of Automated Peritoneal Dialysis Serum phosphate > 5.5 mg/dL or <5.5 mg/dL on a binder other than velphoro Serum albumin ≤ 3.7 g/dL Able to provide consent Ability to complete self-reported questionnaire Exclusion Criteria: Inadequate dialysis Current use of sucroferric oxyhydroxide Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 6 months Active malignancy Recent episode of peritonitis Pregnancy or planning to become pregnant Anticipated kidney transplantation within 6 months Factors judged to limit adherence to interventions Known adverse side effect to sucroferric oxydroxide

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Open-label, one arm study. Patients receive sucroferric oxyhydroxide three times daily and dose is titrated to keep serum phosphate at goal. | Drug: Sucroferric Oxyhydroxide Chewable Tablet<br>* Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Phosphate at Baseline | Serum phosphate at baseline | Baseline | 
| Serum Phosphate at 6 Months | Serum phosphate at end of study (6 months) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Albumin | Changes in serum albumin from baseline to 6 months | Baseline, 6 months | 
| Serum FGF23 | Change in serum FGF23 from baseline to 6 months | 6 months | 
| Serum PTH | Change in serum PTH (perathyroid hormone) from baseline to 6 months | Baseline, 6 months | 
| Serum Prealbumin | Change in prealbumin from baseline to 6 months | 6 months |
Differential Study of Muscle Transcriptome

Study Overview
=================
Brief Summary
-----------------
To isolate biomarkers of ALS in muscle

Detailed Description
-----------------
At present, there is no validated biological diagnostic marker for amyotrophic lateral sclerosis (ALS). The main objective of the study is to isolate a set of genes that are specifically dysregulated in muscle from ALS patients. Gene profiling in muscle will be compared between ALS patients and patients with other motor neuron diseases (SMA and SBMA)

Official Title
-----------------
Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects

Conditions
-----------------
ALS, SMA, SBMA

Intervention / Treatment
-----------------
* Procedure: Muscle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : - Patient with ALS, SMA, or SBMA Exclusion criteria : Indication against biopsy (allergy to anesthetics local haemostasis disorders) Treatments that can affect muscle metabolism

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: disease (ALS, SMA or SBMA)<br>muscle biopsy | Procedure: Muscle biopsy<br>* open muscular biopsy of the deltoid under local anaesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression levels | Gene expression levels in muscle as determined By microarrays (transcriptome analysis) | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle denervation | Severity of muscle denervation as determined by histological analysis of muscle | day 1 | 
| Functional evaluation | ALSFRS-R, Manual Muscle Testing and Slow Vital Capacity | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS, Motor neuron diseases, Transcriptome