linjc16/ctgov huggingface dataset:
Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test

Study Overview
=================
Brief Summary
-----------------
In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.

Official Title
-----------------
Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test: Study of Practices in the Grand-Est

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 50 and 75 years old at the time of the colonoscopy With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR Patient whose follow-up has ended Patient living in the Grand-Est region and in the department of the site concerned Examination carried out by a gastroenterologist from the Grand-Est region Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research Exclusion criteria: Age ≥ 76 years at the time of colonoscopy Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity) Colonoscopy performed before the fecal immunological test Gastroenterologist performing the examination practicing outside the Grand-Est region Subject not able to understand the objectives of this research Subject under judicial control Subject under tutorship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test |  | Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Colorectal cancer, Immunological test
Pelvic Floor Physical Therapy-Biomarkers Project

Study Overview
=================
Brief Summary
-----------------
This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points.

Detailed Description
-----------------
Collection points will be baseline, and at the last PT visit.

Official Title
-----------------
Women's Urology Center-Physical Therapy-Biomarkers Project

Conditions
-----------------
Pelvic Pain

Intervention / Treatment
-----------------
* Other: Pelvic floor PT with biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center. Exclusion Criteria: all others

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Women with Pelvic Pain<br>Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center | Other: Pelvic floor PT with biomarkers<br>* Pelvic floor physical therapy and collection of urine for biomarker analysis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in biomarkers pre- and post-pelvic floor PT | Interim Analysis to be done as PI determines. | pre- and post- pelvic floor PT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of biomarkers in relation to clinical findings | Clinical data and biomarkers will be analyzed. | pre- and post- pelvic floor PT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic Pain, Pelvic Floor Physical Therapy, Biomarkers
Effects of St. John's Wort on the Effectiveness of Oral Contraceptives

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of a common herbal remedy, St. John's Wort, on the effectiveness of birth control pills. St. John's Wort has recently been shown to increase metabolism of some drugs. If it could increase metabolism of oral contraceptives as well, it may increase the risk of contraceptive failure and unintended pregnancy. Study participants will be evaluated for risk of ovulation on oral contraceptives before and during simultaneous therapy with St. John's Wort.

Detailed Description
-----------------
See Brief Summary

Official Title
-----------------
Effects of Hypericum Perforatum on Effectiveness of Oral Contraceptives

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: hypericum perforatum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women taking or willing to take low dose oral contraceptives for 5 months No contraindications to hormonal contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hypericum perforatum|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
-----------------
contraception, hormonal contraception, herbal remedies, hypericum perforatum, contraceptive effectiveness
Mucin Glycosylating Enzymes in Head and Neck Cancers

Study Overview
=================
Brief Summary
-----------------
Head and neck squamous cell carcinoma(HNSCC) is the fourth common malignancy in Taiwan. It accounts for 5.8% of all cancers and causes 2,463 deaths per year. Aberrant glycosylation is the hallmark of most human cancers, including HNSCC, and affects many cellular properties. This study is aimed at exploring the role of mucin glycosylating enzymes in HNSCC.

Detailed Description
-----------------
Glycosylation is the most common post-translational modification of proteins. Aberrant glycosylation is the hallmark of most human cancers and affect many cellular properties, including cell proliferation, apoptosis, differentiation, transformation, migration and immune response. Though widely explored in various human cancers, the role of mucin glycosylating enzymes in HNSCC has not been elucidated. Our aims is to analyze the expression patterns of mucin glycosylating enzymes in HNSCC tissues. Furthermore, we will correlate the expression levels of mucin glycosylating enzymes with clinical characteristics of HNSCC patients.

Official Title
-----------------
Expression of Mucin Glycosylating Enzymes in Head and Neck Cancers and Its Correlation With Clinico-pathological Parameters.

Conditions
-----------------
Glycosyltion Enzymes and Function Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck cancer patients receiving operation in National Taiwan University Hospital Exclusion Criteria: Recurrence or non-operable patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Stage I, II, III, IV HNSCC<br>Stage I, II, III, IV HNSCC reveive treatment in NTUH | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the expression of mucin glycosylating in head and neck cancer |  | 1 5 years after patient received surgery |
Pre-analytical Sample Handling Conditions and Their Effects on the Human Serum Metabolome

Study Overview
=================
Brief Summary
-----------------
This study evaluates how blood serum handling conditions can affect the concentrations of  1,000 serum metabolites and attempts to quantify the degree of attenuation and/or potential bias in epidemiologic associations that may result from less than optimal sample handling conditions.

Detailed Description
-----------------
Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of metabolites simultaneously in a biological matrix, is a versatile analytical technique capable of accelerating biomarker-based discoveries in nutritional science. Recently, metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic studies (2) to identify dozens of novel potential dietary biomarkers. Several large prospective cohort studies, many of which are collaborating in a metabolomics consortium led by the National Cancer Institute, have recently applied metabolomics to banked samples. This has made nutrition-related biomarkers suddenly available for tens of thousands of participants with follow-up for disease endpoints, enabling truly large-scale nutritional biomarkers and disease studies.

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 65 years at beginning of study. BMI between 18.5 and 35.0 kg/m2. Exclusion Criteria: Presence of cardiovascular disease, kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes. Unable or unwilling to give informed consent or communicate with study staff. Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight. | Serum metabolomics profiling will be conducted at Metabolon, Inc. after the serum has been handled in a number of different ways (refrigerated for different lengths of time and frozen and thawed various numbers of times) | on day one |
Copper Histidinate Treatment for Menkes Disease

Study Overview
=================
Brief Summary
-----------------
This study investigates the clinical effects and safety of subcutaneous Copper Histidinate treatment for newly diagnosed Menkes disease patients under 6 years of age.

Official Title
-----------------
Copper Histidinate Treatment for Menkes Disease

Conditions
-----------------
Menkes Disease

Intervention / Treatment
-----------------
* Drug: Copper Histidinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must be a newly diagnosed Menkes disease patient in the United States. Must sign and date an informed consent form by parent or legal guardian for this study prior to any assessment being done in this study. Male or female, aged 0 to <6 years of age. Confirmed diagnosis of Menkes disease based on the following clinical and/or biochemical and/or molecular characteristics: Clinical: Abnormal hair color and/or texture, and/or seizures, and/or hypotonia, and/or developmental delay; or Biochemical: Low serum copper levels (< 75 mcg/dL) and/or ceruloplasmin and/or abnormal plasma catecholamine levels; or Molecular: Mutation(s) in the ATP7A gene (deletion/duplication, nonsense, missense, or canonical or non-canonical splice junction mutations). For newly diagnosed Menkes disease patients, whose molecular ATP7A gene mutation confirmation is pending these patients should have serum copper levels < 75 mcg/dL. Ability to adhere to the prescribed subcutaneous Copper Histidinate injection regimen. Willingness to comply with all study visits and procedures. Exclusion Criteria: Pre-existing liver (e.g., hepatitis, biliary atresia, cirrhosis) or kidney disease (e.g., serum creatinine >1.0 mg/dL). History of bleeding diatheses. Diagnosis of Wilson disease. Any disease or condition that, in the opinion of the Investigator, has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 6 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Copper Histidinate|Restoring Copper Histidinate levels normally found in the blood to assist in the maintenance of copper homeostasis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Conservative Treatment For Ventral Hernia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate on which indication patients are offered operative treatment for their ventral hernia, and to investigate the natural course of ventral hernia in the population of patients not offered operation.

Official Title
-----------------
Conservative Treatment For Ventral Hernia

Conditions
-----------------
Ventral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients (older than 18 years) referred to the Surgical Department of Køge University Hospital from 2009 - 2014 with the diagnosis ventral hernia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| Conservatively treated ventral hernias<br> | |
| Surgically treated ventral hernias<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of conservatively treated ventral hernias that undergo surgery | Percentage of conservatively treated ventral hernias at the primary surgical consultation, that undergoes surgery (acute or elective) later on | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient with ventral hernia that are treated conservatively | Percentage of patient referred to Køge Surgical Department with ventral hernia that are treated conservatively instead of surgically | 5 years |
Epidemiology of Cardiotoxicity in Children With Cancer

Study Overview
=================
Brief Summary
-----------------
To provide a comprehensive analysis of risk factors for the development of clinical cardiotoxicities in over 6,000 children with cancer who had been treated on standardized protocols involving the use of anthracyclines alone or in combination with other potentially cardiotoxic therapies or with no use of anthracycline therapy.

Detailed Description
-----------------
DESIGN NARRATIVE: The data were analyzed to estimate the incidence of clinical cardiotoxicity as measured by sudden death, congestive heart failure, or discontinuation of therapy based on cardiac function. Evaluation of patient characteristics (age, anemia) and treatment factors such as drug, dose level, dosing schedule, exposure to irradiation and/or cyclophosphamide identified groups at particularly high risk for development of clinical cardiotoxicity and provided estimates of this risk for future treatment planning. Such estimates of high risk groups should make possible future trials to test the feasibility of using cardioprotectors or alternate dosing schedules to prevent cardiotoxicity. The incidence of clinical cardiotoxicity was calculated using Kaplan- Meier estimates as a function of total cumulative anthracycline dose and also as a function of the time since the end of treatment stratified by dose levels. The estimates were stratified by exposure to cyclophosphamide and radiation therapy. Multivariate methods were used to evaluate the prognostic significance of selected patient characteristics and treatment parameters and to provide estimates of the relative risk of each variable. The method of recursive partitioning was used to identify subpopulations at elevated risk for clinical cardiotoxicity. The data and analytic techniques were accessible through SAS data sets and procedures available to the study at the Pediatric Oncology Group (POG) Statistical Office. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Death, Sudden, Cardiac, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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 |
| --- | --- | --- |
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma

Study Overview
=================
Brief Summary
-----------------
Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities. But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens. GemOx has been reported to be effective and have very favorable toxicity profiles.

Official Title
-----------------
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin Un-fit Advanced Urothelial Carcinoma: Randomized Phase II Study

Conditions
-----------------
Advanced Urothelial Carcinoma

Intervention / Treatment
-----------------
* Drug: GCb
* Drug: GemOx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cytologically of histologically confirmed urothelial carcinoma Locally advanced or metastatic disease Measurable disease according to RECIST v.1.1 ECOG PS 0-2 Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2) Adequate organ function Chemotherapy-naive Exclusion Criteria: Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed CNS metastases Peripheral neuropathy grade 2 or worse Serious medical or surgical conditions

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 |
| --- | --- |
| Active Comparator: GCb<br>Gemcitabine plus Carboplatin | Drug: GCb<br>* Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks<br>|
| Experimental: GemOx<br>Gemcitabine plus Oxaliplatin | Drug: GemOx<br>* Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate based on RECIST 1.1 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety according to NCI CTCAE v.4.03 | 12 months | 
| Progression-free survival |  | 1 year | 
| Overall survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cisplatin-unfit condition