linjc16/ctgov huggingface dataset:
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS

Study Overview
=================
Brief Summary
-----------------
To analyse false positives in breast cancer screening with tomosynthesis versus 2D mammography. The Avellino Breast Tomosynthesis Screening Trial is a observational population-based study that analyze souspicious findings in tomosynthesis slice images. This study is based on two years screening and tomosynthesis was analzyed by two expert breast radiologists.

Official Title
-----------------
FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS: An Analysis of Findings Leading to Recall and Work-up in ASL Avellino Screening

Conditions
-----------------
Breast Cancer Screening

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer screening population Exclusion Criteria: previous cancer breast prostheses

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recall rate |  | 15 days |
Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants for finger arthritis. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device

Detailed Description
-----------------
The purpose of this IRB approved study is to allow patients to undergo surgery with the SR™ PIP (Proximal Interphalangeal) Implants. This is NOT a research study, but rather, a requirement by the FDA for humanitarian use of device. Use of the SR™ PIP is approved for humanitarian use by the FDA when either the patient is in need of a revision of failed PIP prothesis(es) or the patient expects to place his/her hand under loading situation which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint.

Official Title
-----------------
Humanitarian Use of AVANTA Orthopaedics Proximal Interphalangeal Joint

Conditions
-----------------
Arthroplasty of the PIP Joint

Intervention / Treatment
-----------------
* Device: SR™ PIP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is in need of a revision of failed PIP prosthesis(es) patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic PIP joint Exclusion Criteria: patient is not in need of a revision of a failed PIP prothesis(es) patient is eligible to use an alternative implant

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 |
| --- |
|Device: SR™ PIP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma

Study Overview
=================
Brief Summary
-----------------
This single-center, open-label, phase 2 study will evaluate the anti-tumor activity, as well as the safety and pharmacokinetics, of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Colloidal Dispersion (NCD) administered in patients with recurrent glioblastoma multiforme (GBM)

Official Title
-----------------
A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme

Conditions
-----------------
Recurrent Glioblastoma Multiforme

Intervention / Treatment
-----------------
* Drug: Panzem Nanocrystal Colloidal Dispersion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of a 1st or 2nd recurrent/progressive primary WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma). 18 years or older An interval of at least 2 weeks between prior surgical resection or any major surgery or 4 weeks between prior radiotherapy or chemotherapy (except nitrosoureas which require 6 weeks) Karnofsky performance score equal to or greater than 70% Hematocrit greater than 29%, absolute neutrophil count greater than 1,500 cells/micro liters, platelets greater than 100,000 cells/ micro liters Serum creatinine less than 1.5 X upper limit of normal (ULN), serum SGOT less than 2.5 X ULN; and bilirubin less than 1.5 times ULN Signed informed consent form and authorization for use and disclosure of protected health information approved by the IRB prior to patient entry Agree to use effective contraceptive methods Exclusion Criteria: Current, active systemic bleeding or excessive risk of bleeding Be pregnant or lactating; not employing effective birth control Concurrent severe and/or uncontrolled medical disease Impairment of gastrointestinal (GI) function/disease Requirement for therapy with coumadin (warfarin sodium) Patient is less than 5 years free of another primary malignancy Patients unwilling to or unable to comply with the protocol Grade 2 or greater peripheral sensory neuropathy

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: Panzem Nanocrystal Colloidal Dispersion|Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month progression free survival and median overall survival |  | time of progression; survival |
AI for Colorectal Polyp Detection in Endoscopy

Study Overview
=================
Brief Summary
-----------------
Linked color imaging (LCI) has shown its effectiveness in multiple randomized controlled trials for enhanced colorectal polyp detection. Most recently, artificial intelligence (AI) with deep learning through convolutional neural networks has dramatically improved and is increasingly recognized as a promising new technique enhancing colorectal polyp detection. Study aim was to evaluate a new developed deep-learning computer-aided detection (CAD) system in combination with LCI for colorectal polyp detection.

Official Title
-----------------
Artificial Intelligence Combined With LCI for Colorectal Polyp Detection

Conditions
-----------------
Focus of the Study is to Evaluate a New Developed Deep-learning Computer-aided Detection System in Combination With LCI for Colorectal Polyp Detection

Intervention / Treatment
-----------------
* Other: CAD with LCI for colorectal polyp detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full endoscopy withdrawal videos with LCI of patients ondergoing screening or surveillance endoscopy Exclusion Criteria: non adequate bowel preparation no full length withdrawal in LCI mode

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

| Intervention/Treatment |
| --- |
|Other: CAD with LCI for colorectal polyp detection|Polyps within fully recorded endoscopy videos with LCI mode, covering the whole spectrum of adenomatous histology, are used to evaluate the efficacy of CAD with LCI for polyp detection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal polyp detection rate in comparison to traditional detection rate |  | 2019-2020 |
Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas

Study Overview
=================
Brief Summary
-----------------
Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.

Detailed Description
-----------------
Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.

Official Title
-----------------
A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: Ethyol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed squamous cell head and neck cancer inclusion of at least 75% of both parotid glands within radiation fields that would receive at least 40 Gy Neutrophils ≥ 2000 / mm, Platelets ≥ 100,000 / mm3, Creatinine < 130 / mmol.L-1, Transaminase ≤ 3 x upper limit Exclusion Criteria: Distant metastases Prophylactic use of pilocarpine Concomitant chemotherapy

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

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late xerostomia rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and Neck cancer, Radiotherapy, Xerostomia, Randomized trial
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients

Study Overview
=================
Brief Summary
-----------------
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Denosumab treatment in osteoporotic patients
* Drug: Teriparatide treatment in osteoporotic patients
* Drug: Denosumab and teriparatide treatment in osteoporotic patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporotic patients Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 120 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab and/or teriparatide treatment<br>Denosumab and/or teriparatide treatment in osteoporotic patients | Drug: Denosumab treatment in osteoporotic patients<br>* To examine the effectiveness of denosumab in osteoporotic patients<br>Drug: Teriparatide treatment in osteoporotic patients<br>* To examine the effectiveness of teriparatide in osteoporotic patients<br>Drug: Denosumab and teriparatide treatment in osteoporotic patients<br>* To examine the effectiveness of denosumab and teriparatide in osteoporotic patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of bone mineral density | Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug. | every 4-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of bone turnover markers | Bone turnover markers will be examined every 3-6 months to evaluate the suitability of the drug. | every 3-6 months |
Intravenous Levodopa for the Diagnosis of Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Patients with Parkinson's disease have low levels of the neurotransmitter dopamine. Dopamine is responsible for motor function and normal physical activity. Patients with Parkinson's disease typically suffer from tremors, rigid muscles, stooped postures, and walk with a shuffle. The drug levodopa acts as a replacement for dopamine and has been has been used effectively for over 30 years as treatment for Parkinsons disease. Because of its effectiveness, levodopa has been used to distinguish Parkinson's disease from other conditions that may resemble Parkinson's disease. Traditionally, levodopa has been given as a pill. In this study, researchers would like to inject levodopa directly into a vein (intravenous) in order to diagnose cases of Parkinson's disease. This method provides immediate results and allows doctors to adjust the dose of levodopa very carefully. Because the intravenous method of giving levodopa is less practical than oral medication, it is not an available alternative for the routine treatment of Parkinson's disease. However, it may be useful for faster diagnosis of the disease and for determining effective doses of oral medication.

Detailed Description
-----------------
A positive response to levodopa is now considered a condition sine qua non for the diagnosis of idiopathic Parkinson's disease. Under this protocol, patients with parkinsonism of uncertain etiology will be tested for their motor response to intravenous levodopa to aid in the diagnosis of Parkinson's disease. This protocol regulates and stipulates the acute administration of intravenous levodopa and associated safety issues.

Official Title
-----------------
Intravenous Levodopa in Parkinsonism

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

Participation Criteria
=================
Eligibility Criteria
-----------------
All patients will have parkinsonism of undetermined etiology. Males and females between the ages of 18 and 85 are eligible for the study. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risks, specifically those who have the following: a history of convulsive, hepatic, or renal disorders; currently receiving treatment for myocardial infarction, arrhythmia or cardiac failure; and pregnant women or anyone not practicing an effective means of birth control.
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, Infusion, Parkinsonism
Why Still in Neurosurgical Ward After Tumor Craniotomy?

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective observational study is to identify the specific reasons that prolong a hospital stay after elective tumor craniotomy. Optimal postoperative in-hospital stay is considered to be two days from surgery to discharge from the neurosurgical ward. However, a variable length of stay at a neurological department for follow-up of late recognized deficits of neurological consequences of the surgical procedure are common.

Detailed Description
-----------------
The concept of fast-track surgery and later enhanced recovery after surgery (ERAS) was first imputed in 1990s. Since then, ERAS protocols have been successfully adopted in many surgical fields, often with dramatic benefits for the patients. Length of hospital stay is one of the main questions addressed in many ERAS studies, as it by a simple approach address many of the complications encountered by the patients or the case flow in the perioperative period. Why patients have prolonged hospital stay after surgery has been investigated by Husted et al. in 2011 after hip and knee arthroplasty and P. Munk-Madsen et al. in 2019 after laparoscopic colorectal surgery. Both studies could isolate dominating factors prolonging hospital stay, some of them preventable. Existing length of stay studies on tumor craniotomy patients have focused on specific variables affecting hospital duration, but never explored the true cause of prolonged hospitalization.

Official Title
-----------------
Factors Associated With Prolonged In-hospital Stay After Elective Tumor Craniotomy.

Conditions
-----------------
Surgery--Complications, Brain Tumor

Intervention / Treatment
-----------------
* Diagnostic Test: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective brain tumor craniotomy Exclusion Criteria: Stereotactic biopsy, pituitary surgery and laser interstitial thermal therapy (LITT)

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 |
| --- | --- |
| Tumor craniotomy patients<br>Patients undergoing elective brain tumor craniotomy | Diagnostic Test: No intervention<br>* This is an observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Length of stay is defined as the length of inpatient stay, based on number of nights spent at the neurosurgical ward, calculated from the day of surgery to the day of discharge from the neurosurgical ward. | Patients are followed for a maximum of 6 months. |
Observational Study to Assess a 6-months Treatment With Gladem

Study Overview
=================
Brief Summary
-----------------
Evaluation of a 6-months treatment with Gladem Experiences with the internet for performing a postmarketing study (PMS) trial

Official Title
-----------------
Observational Study Via Internet to Assess a 6-months Treatment With GLADEM

Conditions
-----------------
Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Gladem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women at least 18 years old De novo prescription of Gladem Treatment with Gladem intended for at least 6 months Depressive disorders Exclusion Criteria: Known hypersensitivity against sertraline Concomitant treatment with monoamine oxidase (MAO)-inhibitors, selegiline, moclobemide (washout for at least 14 days necessary) Concomitant treatment with other serotoninergic substances like tryptophan or fenfluramine Instable epilepsy According to product information (October 1998) Gladem prescription was possible with precautions in the following cases: Patients with stable epilepsy Patients with restricted liver functions Suicidal patients Patients in emotional state and marked sleeping disorders According to product information (October 1998) Gladem should only be prescribed during pregnancy and lactation period, if the expected benefit was greater than the risk. Women of childbearing age should use Gladem only in combination with sufficient contraception.

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 |
| --- | --- |
| Depressive patients<br> | Drug: Gladem<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Scale (HAMD-6) |  | 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of efficacy on a 4-point scale |  | up to 6 months | 
| Global assessment of compliance on a 4-point scale |  | up to 6 months | 
| Global assessment of tolerability on a 4-point scale |  | up to 6 months | 
| Clinical global impression score |  | up to 6 months | 
| Number of responders | >= 50 % reduction in HAMD-6 score | up to 6 months | 
| Change in HAMD subscores |  | baseline, 6 months | 
| Number of patients with adverse drug reactions |  | up to 6 months |