linjc16/ctgov huggingface dataset:
Treatment of Microscopic Colitis

Study Overview
=================
Brief Summary
-----------------
The study compares the effect of Budesonide, Bismuth and fiber in patients with microscopic colitis

Detailed Description
-----------------
This randomized, controlled, open study compares the effects of 8 weeks' treatment with Budesonide, Bismuth and fiber on symptoms and histological findings in patients with microscopic colitis (both collagenous colitis and lymphocytic colitis).

Official Title
-----------------
Treatment of Microscopic Colitis (Collagenous Colitis and Lymphocytic Colitis) With Budesonide, Bismuth or Fiber

Conditions
-----------------
Colitis

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Bismuth
* Drug: Fiber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Microscopic colitis verified with biopsies from the colon Symptoms to such an extent that treatment is indicated Age > 17 years Informed consent Exclusion Criteria: Previous treatment with any of the investigational drugs Patients treated with ketoconazole Pregnant and breast-feeding females

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide<br>Budesonide 9mg | Drug: Budesonide<br>* Budesonide 9 mg<br>|
| Experimental: bismuth<br>Bismuth mixture | Drug: Bismuth<br>* Bismuth mixture<br>|
| Sham Comparator: Fiber<br>Fiber preparation | Drug: Fiber<br>* Fiber for control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms: Stool frequency and consistency | September 2010: Patient's enrollment completed. Data analysis ongoing. | 2001 - 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological findings in biopsies from colon | Patient's enrollment completed. Data analysis ongoing. | 2001 - 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microscopic colitis, Drug treatment, Diarrhoea
Verification of Saliva MMP-1 as a Diagnostic Marker of Oral Cavity Cancer

Study Overview
=================
Brief Summary
-----------------
The study is designed to measure salivary matrix metalloproteinase-1 (MMP-1) using the enzyme-linked immunosorbent assay (ELISA) we developed previously in patients with oral potentially malignant disorders (OPMD), oral squamous cell carcinoma (OSCC), and healthy participants. The purpose of this study is to evaluate the potential of the newly developed salivary MMP-1 ELISA as an adjunctive tool to aid in diagnosis of OSCC.

Official Title
-----------------
Verification of Saliva MMP-1 as a Strong Diagnostic Marker of Oral Cavity Cancer

Conditions
-----------------
Oral Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group OSCC: patients with lesions of OSCC Group OPMD: patients with lesions of OPMD Group HC: healthy subjects who are not suffering from any oral lesions and having behaviors of smoking, and/or betel nut chewing Exclusion Criteria: Subjects having personal history of other cancers or severe diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Group OSCC<br>Patients with Oral Squamous Cell Carcinoma (OSCC) | Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)<br>* The MMP-1 ELISA is to measure salivary MMP-1 levels of participants<br>|
| Group OPMD<br>Patients with oral potentially malignant disorders (OPMD) | Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)<br>* The MMP-1 ELISA is to measure salivary MMP-1 levels of participants<br>|
| Group HC<br>Healthy Control | Diagnostic Test: MMP-1 Enzyme Linked Immunosorbent assay (ELISA)<br>* The MMP-1 ELISA is to measure salivary MMP-1 levels of participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity (both range from 0 to 1, the higher the better) of salivary MMP-1 levels as a diagnostic marker for OSCC |  | 30 days from initial sample obtained for this study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROC analysis of non-cancer group versus OSCC patients to find the optimal cutoff as the maximum of Youden's index (calculated as sensitivity + specificity - 1 and ranges from 0 to 1, the higher the better) |  | 30 days from initial sample obtained for this study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mouth Neoplasms, Head and Neck Neoplasms
Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to analyse eating rate in comparison to other aspects of eating habits in women suffering from severe/massive obesity.

Detailed Description
-----------------
Eating rate is associated with BMI and weight gain in various populations and is a factor modulating the risk of complications after bariatric surgery. The aim of the present study is to determine whether common difficulties to change eating rate in subjects with obesity candidate to bariatric surgery could be due to more extensive abnormalities in eating behaviour.

Official Title
-----------------
Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria : BMI ≥ 35 kg/m responses to a self-administered questionnaire distributed between November 2011 and March 2014 to female patients attending a nutrition consultation for overweight, or attending an outpatient visit prior to bariatric surgery, both within the Champagne-Ardenne Specialized Obesity Clinic, at the University Hospital Robert Debré in Reims, France Patients who agree to participate to the study Major patient exclusion criteria : Patient under law protection Minor patient Patients with uncontrolled diabetes (HbA1c ≥ 8.0% at inclusion) or those treated with glucagon-like peptide-1 (GLP-1) receptor antagonists, as well as patients treated by glucocorticoids (their current treatment was systematically reported)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| cases<br>women suffering from severe/massive obesity | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Rate | Eating Rate was assessed by using an analog scale from 1 (slowest eating) to 10 (fastest eating) | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obese, Food behaviour, Eating rate
Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device

Study Overview
=================
Brief Summary
-----------------
The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline. Secondary objectives are to establish which indications lead to treatment with IRE Nanoknife® setting and safety assessment measured by number of complications and adverse events.

Detailed Description
-----------------
This is an international prospective observational multi-center study in which data on consecutive patients for 5 years with prostate cancer who undergo IRE are collected. Data from each patient will be collected at participating centers over a 5-year period. Patients' data at baseline visit (pre-IRE), peri-operative data and follow up for 5 years will be recorded. Follow up data will be collected according to the following schedule: 1 - 2 weeks after surgery st year: every 3 months nd year: every three months rd year: every 6 months th and 5th year: once a year. Data from participating centers will be collected through electronic Case Report Forms (eCRFs), with use of an online Data Management System (DMS), which is located and maintained at the CROES Office. The data collection or patient participation in this study does not interfere with the choice of treatment, sample collection, procedures and the treatment itself, which should entirely follow standard hospital practices, including the follow up.

Official Title
-----------------
Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device; A Multi-Center, International Registry to Evaluate the Treatment of Prostate Cancer in Terms of Recurrence, Functional Outcomes and Safety.

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is diagnosed with histologically confirmed prostate cancer Is scheduled for IRE Nanoknife® Has signed informed consent form Exclusion Criteria: No specific exclusion criteria are defined.
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to establish which indications lead to treatment with IRE Nanoknife® setting |  | 5 years | 
| safety assessment measured by number of complications and adverse events |  | 5 years |
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol

Study Overview
=================
Brief Summary
-----------------
Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin

Official Title
-----------------
Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: Ketokonazol 2% cream
* Radiation: UVB-radiation 311nm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 18- 80 diagnosis of psoriasis vulgaris (mild- middle) no other current antipsoriatic therapy (systemic/topical) at least 5 psoriatic areas of 5x5 cm Exclusion Criteria: pregnancy/nursing mothers women in reproductive age without adequate contraception severe and acute forms of psoriasis vulgaris patients receiving systemic or topical antipsoroatic treatment in past 3 month UV-therapy in past 3 month patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma epilepsy

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketokonazol 2% cream|twice a day at 2 times,2 out of 5 areas have to be treated for 4 weeks/7 days a week|
|Radiation: UVB-radiation 311nm|3 out of 5 areas are radiated for 4 weeks every MO/DI/DO/FR starting MED orientated, intensified everytime 0,03 J/qcm|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI, PGA |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT/ultrasound- thickness of epidermis/ dermis |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis vulgaris,, vitamin D, UVB-phototherapy, ketokonazol,, Optical Coherence Tomography,, local PASI, Nizoral
Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to better understand why some women with breast cancer develop chronic pain.

Detailed Description
-----------------
Women with breast cancer who either have chronic pain or who do not have chronic pain will be asked to enroll. Those who participate will have pictures taken of their brain using MRI when they are lying still and also when pressure is being applied to their thumbnails. These pictures will be compared to patients without breast cancer who do not have pain and to those who have other types of pain, such as fibromyalgia. By taking and analyzing these pictures the investigators hope to understand more about why breast cancer survivors develop pain after their diagnosis and treatment. In the future the investigators hope to better treat the pain or possibly even prevent the pain from occurring in the first place.

Official Title
-----------------
Pilot Functional Imaging Study to Evaluate Mechanisms Underlying Chronic Pain in Breast Cancer Patients

Conditions
-----------------
Pain, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast Cancer Survivor with and without chronic pain Able to undergo MRI

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 |
| --- | --- | --- |
| Determination of differences in pain sensitivity and functional MRI in different groups of patients. | The primary objective of this pilot trial is to determine if there may be differences in mechanical pain sensitivity and functional MRI brain activation patterns in breast cancer survivors with chronic pain as compared to breast cancer patients without chronic pain, to patients with fibromyalgia, or to healthy controls. | 6 months |
Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, real world study.The objective is to observe the diagnosis and first-line treatment of Chinese patients with cancer of unknown primary, and collect the clinicopathological characteristics, treatment outcomes, survival and other data of the patients.

Official Title
-----------------
Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China

Conditions
-----------------
Cancer of Unknown Primary Site

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation . Prepared to receive first-line therapy for CUP Exclusion Criteria: Patients who had previously received systemic therapy for CUP Previous history of other cancers, except cervix cancer or basal cell carcinoma of the skin that has been cured The investigator considered that there were contraindications to treatment or were not appropriate to participate in this study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|The patient's treatment is determined by the physician in charge according to the patient's clinical situation and relevant guidelines, without additional intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | 8 months |
Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.

Official Title
-----------------
Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients

Conditions
-----------------
Systolic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 years old or older Scheduled to undergo left ventricular assist device implantation at Thomas Jefferson University Exclusion Criteria: Unable or unwilling to provide informed consent Unable to complete baseline frailty assessment

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Older, left ventricular assist device<br>Older heart failure patients undergoing left ventricular assist device implantation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frailty following left ventricular assist device implantation | Frailty will be assess based on the domains initially described by Fried and colleagues: weakness, low physical activity, unintentional weight loss, slowness and exhaustion. Additional frailty measures include the Short Physical Performance Battery (SPPB), as well as gait speed and hand grip strength as single item measures. | Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle size as measured by ultrasonography |  | Baseline (prior to surgery); 10 days and 3 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventricular Assist Device, Skeletal Muscle, Frailty, Older adults
ReNEW Clinic Cohort Study

Study Overview
=================
Brief Summary
-----------------
This is an ongoing, prospective cohort study of children and young adults who are evaluated in the Reversing the Negative Effects of Weight on the Heart (ReNEW) Clinic at Johns Hopkins University. Demographic and clinical data of patients who agree to participate are obtained via chart review and entered into a longitudinal clinic registry.

Official Title
-----------------
Reversing the Negative Cardiovascular Effects of Weight (ReNEW) Clinic Cohort Study

Conditions
-----------------
Hypertension, Prehypertension, Obesity, Overweight, Left Ventricular Hypertrophy, Elevated Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Children and young adults with overweight or obesity referred for evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University are eligible. Exclusion Criteria: Children who are wards of the state or who are non-English speaking without an in-person interpreter accompanying them to the clinic visit.

Ages Eligible for Study
-----------------
Maximum Age: 22 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 |
| --- | --- | --- |
| Demographic and clinical data obtained via chart review | This is a clinic based registry of cardiovascular disease risk data from participants to be collected over time. | 20 years |
Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the new Boussignac-system of non-invasive ventilation is as good as the conventional non-invasive System in patients presenting with acute hypercapnic respiratory failure.

Official Title
-----------------
Prospective Trial of the Bilevel Positive Airway Pressure (by Boussignac) in Emergency Department of Non-invasive Patients Presenting With Acute Hypercapnic Respiratory Failure

Conditions
-----------------
Acute-on-chronic Respiratory Failure

Intervention / Treatment
-----------------
* Other: non- invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7,25 ≤ pH ≤ 7,35 PaCO2 ≥ 45 mmHg Exclusion Criteria: pH < 7,24 incapable of collaboration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-invasive ventilation<br> | Other: non- invasive ventilation<br>* non-invasive bi-level ventilation with IPAP and EPAP.<br>* Other names: Boussignac;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinking pCO2 |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasion ventilation, Boussignac