linjc16/ctgov huggingface dataset:
The Effect of Ruboxistaurin on Small Fiber Function

Study Overview
=================
Brief Summary
-----------------
To determine the effect of Ruboxistaurin on small fiber function.

Official Title
-----------------
The Effect of Ruboxistaurin Mesylate (LY333531) on Small Fiber Function as Measured by Microvascular Skin Blood Flow, C-Fiber Quantitations in Skin and Quantitative Sensory Testing of Cold and Heat.

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: Ruboxistaurin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have Type 1 or Type 2 diabetes mellitus Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus Patients must have blood glucose control measured as HbA1c=<11% Patients must be 18 years of age or older. Patients must be able to return to all follow-up visits Exclusion Criteria: Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy. Patient currently has uncontrolled high blood pressure You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems You are a woman of childbearing age and unwilling or unable to use effective contraceptive.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy. |  |  |
A Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)

Study Overview
=================
Brief Summary
-----------------
The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.

Official Title
-----------------
A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)

Conditions
-----------------
End Stage Liver Disease, Infection

Intervention / Treatment
-----------------
* Drug: Antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decompensation of liver cirrhosis: ALB <35 g / L; A / G <1.0 TBIL> 35μmol / L; ALT> 1 × ULN and / or AST> 1 × ULN PTA <60% Ascites or hepatic encephalopathy or esophageal variceal bleeding Acute-on-chronic liver failure: Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis onset time: <4 weeks Hepatic encephalopathy: with or without Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L Chronic liver failure: The basis of chronic liver disease: decompensated cirrhosis onset time: - Hepatic encephalopathy: with or without Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infection Group<br>Patients with end stage liver disease with infection | Drug: Antibiotics<br>* This is an observation study, no specific antibiotics will be indicated during treatment<br>|
| Non-infection Group<br>Patients with end stage liver disease without infection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate to empirical antibiotic treatment | The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-liver transplant survival | Non-liver transplant survival rate at 30 days, 60 days and 6 months after empirical antibiotic treatment | 6 months | 
| Hospitalization time | Days of hospitalization after empirical antibiotic treatment | 6 months |
Irritable Bowel Syndrome Hypnotherapy

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study was whether gut focused hypnotherapy, in a group format, was successful in reduction of symptoms in patients with irritable bowel syndrome. The secondary goal was to see if any outcome predictors could be determined.

Detailed Description
-----------------
Patients with Irritable Bowel Syndrome entering a group hypnotherapy program are asked to complete a series of questionnaires at the outset, and repeat a symptom severity scale at intervals over the one year period after termination of treatment. Eligibility was limited to patients with age greater than 20. Outcome measures were improvement in symptom score. Outcome predictors studied included quality of relationships, measured with a Quality of Relationship Inventory and attribution of IBS to physical or emotional cause, measured with a Mind-Body IBS Questionnaire, both administered before onset of hypnotherapy.

Official Title
-----------------
Outcome Effectiveness Predictors of Irritable Bowel Syndrome Hypnotherapy

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: gut focused hypnotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of irritable bowel syndrome by Rome II criteria, age 20 and older Exclusion Criteria: Age below 20

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: gut focused hypnotherapy|7 session hypnotherapy protocol designed for irritable bowel syndrome|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Group Hypnotherapy in Irritable Bowel Syndrome | assessed by symptom severity scale given before treatment began and after 7 bi-weekly sessions, at 3 months, 6 months and 12 months | one year | 
| Percentage of Patients With Significant Reduction in Their IBS Symptom Severity Score One Year After Completion of Therapy. | The IBS Symptom Severity Scale has four components, severity of abdominal pain, number of days with pain in past 10 days, abdominal distension, bowel habit and interference with life in general. Maximum score is 500, minimum score is 0. The lower the score, the lower the symptom severity. Participants are considered clinically improved if they have a reduction in score of 50 points or greater. | One year after termination of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Predictors | to determine whether relationship quality, or attribution of symptoms to physical or emotional causation correlated with result | one year |
Clinical Evaluation of Pink Esthetic Score

Study Overview
=================
Brief Summary
-----------------
Clinical evaluation of pink esthetic score in delayed implants in thin gingival biotype with and without temporization in the esthetic zone

Detailed Description
-----------------
Clinical evaluation of the pink esthetic score with and withiut temporization in thin gingival biotype in the maxillary esthetic zone with subepithelial connective tissue graft in bith groups

Official Title
-----------------
Clinical Evaluation of Pink Esthetic Score Following Delayed Implant Placement With Connective Tissue Graft With and Without Temporization in the Maxillary Esthetic Zone With Thin Gingival Biotype

Conditions
-----------------
Thin Gingiva

Intervention / Treatment
-----------------
* Procedure: Connective tissue graft and implant placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with missing teeth in the maxillary esthetic zone with thin gingival biotype and adequate arch space Exclusion Criteria: deficient ridge , crowns on the adjacent teeth
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 |
| --- | --- |
| Other: implant with immediate temporization<br>Immediate nonfunctional loading | Procedure: Connective tissue graft and implant placement<br>* Augmenting soft tissue with connective tissue graft<br>|
| Other: Delayed implant without temporization<br>Conventional loading protocol | Procedure: Connective tissue graft and implant placement<br>* Augmenting soft tissue with connective tissue graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pink esthetic score | Clinical assessment accotding to furhausser et al | 1 year from the base line |
Fish Intervention and Learning Abilities

Study Overview
=================
Brief Summary
-----------------
In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish.

Detailed Description
-----------------
Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural development during pre- and postnatal development.

Official Title
-----------------
Fish Intervention and Learning Abilities in German Youths

Conditions
-----------------
Cognitive Enhancement

Intervention / Treatment
-----------------
* Dietary Supplement: Fish Meals
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4-6 years Exclusion Criteria: severe illness child dislikes fish

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish Meals<br>3 Fish meals per week for 4 months | Dietary Supplement: Fish Meals<br>* Meals containing salmon<br>|
| Placebo Comparator: Placebo<br>Habitual diet | Dietary Supplement: Placebo<br>* No fish meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Performance |  | Change from baseline at 4 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage |  | Change from baseline at 4 months later | 
| Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3 |  | Change from baseline at 4 months later | 
| Change of iodine levels in urine |  | Change from baseline at 4 months later | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Test, Omega-3 Fatty acids
Young Smokers Have Impaired Airway Defense

Study Overview
=================
Brief Summary
-----------------
Background: Smoking is a key factor for development and progression of chronic obstructive pulmonary disease (COPD). Although persons with COPD often have concomitant nasal disease, there are few studies that report physiological or inflammatory changes in the upper airways in young asymptomatic smokers. The investigators investigated physiologic and inflammatory changes in the nasal and lower airways of young smokers and if these changes were related to smoking history. Methods: Seventy-two subjects aged ≤ 35 years (32 healthy nonsmokers and 40 young smokers) participated in this study. The investigators measured nasal mucociliary clearance (MCC), nasal mucus physical properties, cell count, myeloperoxidase and cytokines concentrations in nasal lavage fluid, exhaled breath condensate (EBC) pH and lung function.

Official Title
-----------------
Young Smokers Have Impaired Airway Defense That is Not Associated With Pulmonary Function

Conditions
-----------------
Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy nonsmokers asymptomatic smokers after obtaining written informed consent Exclusion Criteria: inability to understand and follow commands previous nasal surgery respiratory infection in the previous 30 days reported or diagnosed asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Nonsmokers<br>Young healthy nonsmokers | |
| Smokers<2.5 pack years<br>Young healthy or asymptomatic smokers (aged < 35 y.o.) with smoking history <2.5 pack years | |
| Smokers≥ 2.5 pack-years<br>Young healthy or asymptomatic smokers (aged < 35 y.o.) with smoking history ≥ 2.5 pack-years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Breath Condensate pH |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mucociliary clearance by saccharine transit time test |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, nasal lavage, exhaled breath condensate, mucociliary transport
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

Study Overview
=================
Brief Summary
-----------------
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients

Official Title
-----------------
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse

Conditions
-----------------
Anterior Vaginal Wall Prolapse, Vaginal Apex/Uterine Prolapse

Intervention / Treatment
-----------------
* Device: SRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has signed the informed consent form and is willing to participate in the clinical study and data collection. Patient age is between 18 and 75 years old POP-Q: Aa and/or Ba is at least -1 Exclusion Criteria: Patient is pregnant or breastfeeding Patient suffering from active infection (on antibiotic therapy) Patient planning vaginal delivery Patient had Previous vaginal mesh surgery Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases). Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results. Malignancy . Known hypersensitivity to PEEK and polypropylene materials. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation. Tendency for hyper-scaring reaction Diagnosed with mental or emotional disturbance.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: SRS-I<br>Implantation of SRS-I | Device: SRS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No device related serious adverse events |  | up to 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications) |  | up to 12 months | 
| Improvement in POP-Q: points Aa and Ba |  | up to 12 month | 
| Improvement in POP-Q point C |  | up to 12 months | 
| Achieving normal urinary function |  | up to 12 months |
Neoadjuvant Database

Study Overview
=================
Brief Summary
-----------------
The NEOADJ Database base contains data collected during the regular clinical patient management (sociodemographic, clinical, pathological, radiological, biological, disease evolution...). This database allows easy access to information in a centralized and structured way. This cohort is used to gather insights for research purposes. All data collected come from medical files of patients managed at Centre Georges Francois Leclerc, Dijon, France.

Official Title
-----------------
Prospective and Retrospective Neoadjuvant Breast Cancer Database

Conditions
-----------------
Neoadjuvant Treatment in Breast Cancer

Intervention / Treatment
-----------------
* Drug: Neoadjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women followed for breast cancer in Georges Francois Leclerc Center Neoadjuvant chemotherapy Age >= 18 Exclusion Criteria: Males Metastatic breast cancer

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neoadjuvant Breast Cancer<br>Patients undergoing neoadjuvant therapy for breast cancer | Drug: Neoadjuvant therapy<br>* Neoadjuvant therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | Overall survival and evolution over years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patient and treatment characteristics | Collection of patient and treatment characteristics over years, to set up prospective and retrospective studies | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer; Breast, Neoadjuvant
A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is therefore to investigate the efficacy of the PEG-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.

Official Title
-----------------
A Phase II Open-label, Intra-individual Controlled, Single-center Study to Investigate the Efficacy, Safety and Tolerability of a Polyethylene Glycol-formulation and the Viral Shedding in Patients Suffering From Genital Herpes

Conditions
-----------------
Genital Herpes

Intervention / Treatment
-----------------
* Drug: PEG-Formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent 18 - 65 years Positive for HSV-1 and/or -2 (as determined by serology testing in course of study) Initial infection > 1 year ago ≥ 6 recurrences in the last year (or in the year prior to a recent prophylactic therapy) ≥ 2 recurrences during the six-month baseline period Exclusion Criteria: Known or suspected allergy or intolerability to PEG Prophylactic antiviral drugs, virostatic agents, cytostatics, immunomodulatory drugs and steroids within less than 14 days prior to baseline period, or plan to take such drugs during the trial Pregnancy and/or breast-feeding History of malignant diseases (described in chapter 7.2) Known or suspected non-compliance to study protocol Participation in another investigational drug study in the last 30 days prior to baseline period

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-Formulation<br>PEG-Formulation, applied twice daily during the treatment period (duration: 6 months) | Drug: PEG-Formulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of number of genital herpes recurrences during the treatment period as compared to the baseline period. | The number of genital herpes recurrences will be counted during the baseline period (6 months) and during the treatment period (6 months) and then be compared. | Baseline and Treatment period (6 months each). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of the PEG-formulation via reporting of AEs. |  | Baseline and Treatment period (6 months each). |