linjc16/ctgov huggingface dataset:
Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors

Study Overview
=================
Brief Summary
-----------------
Multi-centric, observational, prospective study, designed for pts with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma.

Detailed Description
-----------------
Patients will undergo basal blood sample exams regarding blood cell count, renal and liver function, tumor markers, inflammatory and metabolic state, along with a screening (and, if needed, a more in-depth laboratory analysis) for viral hepatitis infections. Information will be collected about radiological, clinical and pathological features of the neoplasm at time of diagnosis, as well, at a later time, about its natural history. A two-step data analysis will be performed: Task-1 analysis will define the risk factors landscape, Task-2 analysis will examine the influence of etiology on clinical outcomes. Anonymized data will be stored in a central database, kept at the Leading Centre.

Official Title
-----------------
Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors

Conditions
-----------------
Cholangiocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntary, written, dated and signed informed consent; age ≥ 18 years; histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma. Exclusion Criteria: Dementia or altered mental status leading to inability to understand or render the informed consent. Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about BI-CAUSE - Study Protocol Version 1.0 Oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. Performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.

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 |
| --- | --- | --- |
| assessment the prevalence of a broad pool of medical or non-medical (e.g. life-style) conditions among Italian patients with cholangiocarcinoma, in order to evaluate their potential role as a risk factor |  | 36 months |
Role of Laparoscopy in Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
In this randomized controlled trial the investigators were looking for the best policy for management of women with unexplained infertility after normal hysterosalpingogram (HSG). The investigators test the hypothesis that postponing or even bypassing laparoscopy does not affect the outcome of management of women with apparently unexplained infertility.

Official Title
-----------------
Role of Laparoscopy in Unexplained Infertility

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: laparoscopy
* Other: ovarian stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: failure of conception for at least one year no pathology demonstrated after the standard infertility work-up including semen analysis, mid-luteal serum progesterone for confirming ovulation and hysterosalpingography for documenting tubal patency diagnosed as having unexplained infertility

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

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

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 |
| --- | --- |
| Other: laparoscopy group<br>laparoscopy | Procedure: laparoscopy<br>* subjected to laparoscopy<br>|
| Active Comparator: ovarian stimulation group<br>ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles | Other: ovarian stimulation<br>* ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome measure was the occurrence of clinical pregnancy and miscarriage. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, unexplained infertility
Idiopathic Pulmonary Fibrosis and Serum Bank

Study Overview
=================
Brief Summary
-----------------
Idiopathic pulmonary fibrosis (IPF) is the most common form of chronic idiopathic diffuse interstitial lung disease (DILD) in adults. It is a fibroproliferative, irreversible disease of unknown cause, usually progressive, occurring mainly from the age of 60 and limited to the lungs. IPF is a serious disease with a median survival rate at diagnosis of 3 years. The aim of the study is to set up a biocollection of serum from patients in a context of idiopathic DILD and a possible or confirmed diagnosis of common interstitial lung disease by chest CT. Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF.

Detailed Description
-----------------
This study will initially focus on circulating serum CD163 markers, but a broader proteomics approach could be considered in a second phase to look for other markers of lung diseases.

Official Title
-----------------
Idiopathic Pulmonary Fibrosis and Serum Bank

Conditions
-----------------
Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial

Intervention / Treatment
-----------------
* Biological: Blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen on an outpatient basis and in stable or acute condition Patient over 18 years of age. The inclusion criteria will be those edited by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) to diagnosis IPF Exclusion Criteria: Patients who are unable or unwilling to sign the consent.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with DILD<br>Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF. | Biological: Blood sample collection<br>* Three additional blood tubes (3 x 8mL) will be collected for this study. They will be added to the traditional diagnostic assessment carried out for their IPF, during their consultation at the competence centre for rare lung diseases. These samples will be taken by a registered nurse in the presence and under the responsibility of the investigator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of circulating CD163 serum concentration | Serum CD163 levels in patients with possible or certain DILD will be performed by ELISA technique (R&D Systems kit, Minneapolis, MN). | Through study completion, an average of 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, CD163
Study of CP-461 in Patients With Advanced Renal Cell Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.

Official Title
-----------------
Phase II Study of CP-461 in Patients With Advanced Renal Cell Cancer

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: CP-461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Measurable metastatic or locally advanced disease. Histologically confirmed renal cell cancer. No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy. Expected remaining life span > or = three months. ECOG performance status 0-2. > or = 18 years of legal age. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal. Negative serum pregnancy test, if fertile female. Willingness and ability to sign an informed consent document. Exclusion Criteria: Uncontrolled or symptomatic brain metastases. Use of an investigational medication or device within one month of initiating study therapy. Absolute granulocyte count < or = 1500/mm3; Platelet count < or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine > or = 2.2 mg/dL; AST/ALT > 2.5 ULN. Any condition or any medication which may interfere with the conduct of the study. Current active malignancy other than renal cell cancer.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-461|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
-----------------
renal, renal cell cancer, renal cell carcinoma, kidney cancer
Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to study the value and feasibility of magnetic resonance imaging in detection of bone marrow metastases

Detailed Description
-----------------
The patient was diagnosed as bone metastasis by pathology. CT showed no bone marrow biopsy site metastasis (anterior iliac spine or posterior iliac spine). After functional magnetic resonance examination, bone marrow biopsy was performed. Functional magnetic resonance imaging includes conventional SE sequence, T2W SPAIR, e-THRIVE,DWI,IVIM. With bone marrow biopsy as the gold standard, the sensitivity, specificity and coincidence rate of functional MRI in the diagnosis of bone marrow metastasis were evaluated.

Official Title
-----------------
Detection of Bone Marrow Metastases With Magnetic Resonance Imaging

Conditions
-----------------
Bone Marrow Metastases, Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Diagnostic Test: magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with malignant tumors (solid tumors or hematological malignancies) were definitely diagnosed by pathology or cytology. patients with bone metastases confirmed by more than two imaging examinations. Age 18-75. ECOG score: 0-2. The expected survival time is more than 3 months. Sign the informed consent. Exclusion Criteria: Imaging findings suggest that bone metastases are present at the bone marrow puncture site. The patient refused bone marrow puncture. Puncture site with infection. Severe coagulation dysfunction. There are implanted instruments in the body, so magnetic resonance imaging can not be performed.

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 |
| --- | --- |
| Experimental: magnetic resonance imaging<br>Detection of bone marrow metastases with magnetic resonance imaging | Diagnostic Test: magnetic resonance imaging<br>* Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity | With bone marrow biopsy as the gold standard, the sensitivity of functional MRI in the diagnosis of bone marrow metastasis | through study completion, an average of 1 year | 
| specificity | With bone marrow biopsy as the gold standard, the specificity of functional MRI in the diagnosis of bone marrow metastasis | through study completion, an average of 1 year |
Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to develop a reliable method to obtain habitual iodine intakes from spot urinary iodine concentration (UIC) and to assess the prevalence of inadequate iodine intake in school-age children and women of reproductive age. We will evaluate different methods to estimate iodine intake from UIC and estimate the prevalence of inadequate and excess iodine intake in UIC studies conducted in populations with low, adequate and high iodine intakes using the the established estimated average requirement (EAR)/Tolerable Upper Intake Level (UL) cut-point method.

Official Title
-----------------
Estimating the Usual Iodine Intake From Spot Urinary Iodine Concentrations to Obtain the Prevalence of Inadequate or Excess Iodine Intake in School-aged Children and Adults

Conditions
-----------------
Iodine Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lived in study area >= 12 months no reported intake of Amiodarone no history of thyroid dysfunction / goiter (past & present) no exposure to iodine containing contrast agents within the last 12 months Second arm: Women aged 18 - 49, exclusion / inclusion criteria apply, plus non-pregnant, non-lactating.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 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 |
| --- | --- |
| St. Petersburg: School aged children<br>Generally healthy 9 to 12 years old children | |
| St. Petersburg: Women of reproductive age<br>Generally healthy non-pregnant, non-lactating women between 18 and 44 years of age | |
| Papua New Guinea: School aged children<br>Generally healthy 9 to 12 years old children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated iodine intake | Estimated daily iodine intake of the study population derived from urinary iodine and creatinine concentrations measured in spot urine samples | 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary iodine concentration | Measured in spot urine samples and 24 h urine collections | 17 months | 
| Urinary creatinine concentration | Measured in spot urine samples and 24 h urine collections | 17 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iodine
Bariatric Surgery and Pharmacokinetics of Chlorprothixene

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on chlorprothixene.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics of Chlorprothixene: BAR-MEDS Chlorprothixene

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Chlorprothixene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chlorprothixene|Patients are tested for their normal prescription chlorprothixene medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chlorprothixene concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Chlorprothixene
Cardiac Computarized Tomography in Infective Endocarditis

Study Overview
=================
Brief Summary
-----------------
The diagnosis of infective endocarditis is based on the results of blood culture and findings on transeosophageal echocardiography. Cardiac computarized tomography is a new modality, mainly used for the imaging of coronary arteries. Its use in the diagnosis of infective endocarditis is not well known.The purpose of this study is to establish the use of cardiac CT in infective endocarditis.

Official Title
-----------------
The Use of Cardiac Computarized Tomography in Infective Endocarditis

Conditions
-----------------
Infective Endocarditis

Intervention / Treatment
-----------------
* Device: Cardiac CT 0BRILLIANT 64


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with infective endocarditis Exclusion Criteria: Allergy to contrast agent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,1<br> | Device: Cardiac CT 0BRILLIANT 64<br>* Cardiac CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic capacity of cardiac CT in comparison with TEE in the diagnosis of infective endocarditis |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of cardiac function in patients with infective endocarditis |  | 1 year |
The Cholelithiasis in Adults With Short Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
Short-term studies have shown that patients with short bowel syndrome (SBS) often develop cholestasis or cholelithiasis. In this retrospective cohort study, we aimed to define the incidence, risk factors, and clinical consequences of cholelithiasis in adults with SBS over an extended time period.

Detailed Description
-----------------
However, only limited data are available regarding cholelithiasis in patients with SBS. The prevalence of cholelithiasis in patients with SBS has been reported only in two studies. Furthermore, few studies have focused on identifying the risk factors for cholelithiasis in patients with SBS. Considering the marked improvements in medical care and nutrition support during the last 2 decades, the current incidence and risk factors for cholelithiasis in patients with SBS are unknown. The aim of the current study was to provide comprehensive, longitudinal, and long-term data on the incidence of symptomatic and asymptomatic cholelithiasis in a cohort of patients with SBS, in order to identify the prevalence, risk factors, and clinical consequences of cholelithiasis in patients with SBS to aid in the development of protective interventions.

Official Title
-----------------
Prevalence, Risk Factors, and Complications of Cholelithiasis in Adults With Short Bowel Syndrome

Conditions
-----------------
Short Bowel Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All eligible adults diagnosed with SBS Exclusion Criteria: age <18 years; history of cholelithiasis before SBS diagnosis; cholecystectomy; biliary tract obstruction or no abdominal imaging (CT, MRI, or ultrasound) after SBS diagnosis.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of cholelithiasis in patients with SBS | the incidence of symptomatic and asymptomatic cholelithiasis in a cohort of patients with SBS | 2010/1/1-2019/12/31 | 
| risk factors | the risk factors of cholelithiasis in patients with SBS | 2010/1/1-2019/12/31 | 
| complications | the clinical consequences of cholelithiasis in patients with SBS | 2010/1/1-2019/12/31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Short bowel syndrome, Cholelithiasis, Prevalence, Risk factors