linjc16/ctgov huggingface dataset:
Clinical Utility of the SPEAC® System: A Case Series

Study Overview
=================
Brief Summary
-----------------
The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.

Official Title
-----------------
Clinical Utility of the SPEAC® System: A Case Series

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: SPEAC System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement. The subject's first reported seizure must be within the last 5 years. Male or Female between the ages 22 and 99. If female and of childbearing potential, subject must agree to not become pregnant during the trial. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments. Subject or Primary Caregiver must be competent to follow all study procedures. Subject must be willing to use the Seizure Monitoring and Alerting System for a long period of time (up to 90 days), for a minimum of 30 hours/ week. Exclusion Criteria: The subject cannot be pregnant, or nursing. The subject cannot be sensitive or allergic to adhesives or tapes.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 99 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: SPEAC Treatment Arm<br>All study participants will be provided with a SPEAC System to use in their home environment. | Device: SPEAC System<br>* A lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.<br>* Other names: Brain Sentinel Seizure Monitoring and Alerting System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Seizure Frequency | We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System. | 1 year |
Impact of Cooking Process on Meat Protein Digestion and Metabolism

Study Overview
=================
Brief Summary
-----------------
Few is known on meat protein digestibility in humans and the impact of cooking process, while excessive intake of processed meat has been suggested to increase the risk of colorectal cancer. This study aims to measure in vivo in humans the real digestibility of beef meat proteins depending 2 cooking processes, using ileal tubes and stable isotopes.

Conditions
-----------------
Physiology, Digestive Tract, Heating Process

Intervention / Treatment
-----------------
* Dietary Supplement: Test meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy BMI between 18 an 27 Age between 18 and 45 years Exclusion Criteria: Gastrointestinal or liver pathology Diabetes Pregnancy Vegetarian

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intense cooking process<br>Test meal: 150g of beef cooked at intense temperature. Beef proteins are intrinsically labelled with 15 N protein | Dietary Supplement: Test meal<br>* test meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N.<br>|
| Experimental: mild cooking process<br>Test meal: 150 g of beef cooked at moderate intensity. Beef proteins are intrinsically labeled with 15N. | Dietary Supplement: Test meal<br>* test meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| protein digestibility | From ileal recovery of the ingested tracer during 8 h after the meal | single measure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nitrogen metabolism | Distribution of dietary nitrogen throug metabolic pools | single measure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ileal digestibility, metabolism, stable isotopes
COVID-19 and Pregnancy Outcomes

Study Overview
=================
Brief Summary
-----------------
This is a multicenter prospective study that aims to investigate the clinical impact of SARS-CoV-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

Detailed Description
-----------------
This is a cohort study of pregnant women confirmed positive for SARS-CoV-2 infection. Data will be collected in Portuguese maternities that agreed to collaborate in this study. Pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for SARS-CoV-2 RT PCR as part of a universal testing policy. Maternal demographic data (age, comorbidities, parity, smoking habits), COVID-19 related data (symptoms, diagnostic tests, therapy used and ICU admission), gestational age at SARS-CoV-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and Apgar score, RT PCR neonate results) and breastfeeding strategies will be evaluated.

Official Title
-----------------
COVID-19 and Pregnancy Outcomes: a Portuguese Collaboration Study

Conditions
-----------------
Coronavirus Infection, Pregnancy Complications, Vertical Transmission of Infectious Disease, Breastfeeding, Neonatal Infection

Intervention / Treatment
-----------------
* Diagnostic Test: RT PCR SARS-CoV-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women infected with Sars-Cov-2. Delivery at Portuguese maternities. Exclusion Criteria: RT PCR SARS-CoV-2 negative. -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: RT PCR SARS-CoV-2|Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 Neonatal Infection | Positive Sars-Cov-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perinatal mortality | stillbirths and deaths in the first week of life | 35 weeks | 
| ICU maternal admission | maternal ICU admission due to COVID-19 | 35 weeks | 
| 5 minute Apgar Score < 7 | Newborn 5 minute Apgar Score < 7 | 1 day | 
| Preterm labour | Delivery between 24 and 36 weeks | 35 weeks | 
| PPROM | Preterm premature rupture of the membranes between 24 and 36 weeks | 35 weeks | 
| Miscarriage | spontaneous pregnancy loss before 24 weeks | 14 weeks |
Disulfiram for Cocaine-Alcohol Abuse - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate disulfiram for cocaine-alcohol abuse.

Official Title
-----------------
Disulfiram for Cocaine-Alcohol Abuse

Conditions
-----------------
Alcohol-Related Disorders, Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Disulfiram


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  |  | 
| Cocaine effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cocaine-Related Disorders
Causes and Consequences of Primary Ovarian Insufficiency

Study Overview
=================
Brief Summary
-----------------
100 women with primary ovarian insufficiency will be included for extensive diagnostic workup to improve diagnostic precision by extended autoantibody screening and genetic and toxicological testing.

Official Title
-----------------
Causes and Consequences of Primary Ovarian Insufficiency

Conditions
-----------------
Primary Ovarian Insufficiency, Premature Menopause

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Women 40 years or younger, more than 4 months amenorrhea, more than 2 FSH measurements in menopausal range (drawn at least 2 months apart), ability to provide informed concent - Exclusion Criteria:History of oophorectomy, chemotherapy or radiation -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Autoimmune | Prevalence of primary ovarian insufficiency (POI) with autoimmune etiology based on positive autoantibodies toward steroidogenic cells | one day | 
| Genetic | Prevalence of POI with genetic etiology defined by detection of genetic defects in a NGS panel | one day | 
| Endocrine disrupting chemicals | Characterize the cohort of women with POI, including testing for environmental factors | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotype description | Describe phenotypical characteristics including menstrual characteristics, hormone profile, BMD | one day |
Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness of RaPID/BSI by testing its performance compared to blood cultures collected prospectively from consented subjects.

Official Title
-----------------
Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

Conditions
-----------------
Bacteremia, Candidemia

Intervention / Treatment
-----------------
* Diagnostic Test: RaPID/BSI Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Determined to have a positive blood culture. 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Suspected of Bloodstream Infection<br>No intervention(s) to be administered. | Diagnostic Test: RaPID/BSI Test<br>* RaPID/BSI Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity compared to Blood Culture (comparator method) | The primary endpoint of sensitivity (detection of on panel pathogen) and specificity will be determined by comparing blood culture results with the RaPID/BSI results from the prospective clinical specimens. | Up to 24 hours following blood collection |
Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI

Study Overview
=================
Brief Summary
-----------------
With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management. Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity. We aim to build and test three predictive models (clinical, radiomic and combined models).

Official Title
-----------------
Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI

Conditions
-----------------
Prostatic Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18yo Patients underwent radical prostatectomy High-risk prostate cancers: at least 1 criteria (pt3a/pT3b/pT4, R1, Gleason score > 7) Exclusion Criteria: No available pre-operative MRI No analyzable pre-operative MRI proof of lymph-node involvement (cN1/2 or pN1/2) post-operative PSA > 0.04ng/mL

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

Sexes Eligible for Study
-----------------
Male

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of biochemical failure | Comparison of AUCs between each predictive model | From the date of surgery until data collection (up to 100 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of survival without biochemical failure | Survival analysis: comparison of Kaplan-Meier curves | From the date of surgery until data collection (up to 100 months) |
Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between January 2000 to present. Based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or without chemotherapy.

Official Title
-----------------
A Multicenter Analysis of Definitive (Chemo)Radiotherapy With or Without Chemotherapy for Patients With Esophageal Cancer - 3JECROG-R01

Conditions
-----------------
Chemoradiation, Esophagus Cancer, Chemotherapy Effect, Radiotherapy Side Effect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1b, without visceral metastasis, according to AJCC 6th) based on standard primary staging by EUS and CT Age>18 years No distant metastasis other than supraclavicular lymph nodes No prior history of thoracic radiation Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits Exclusion Criteria: Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer during 5 years before diagnosis of esophageal cancer Pregnant or lactating females Contraindication for radiotherapy or chemotherapy

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 |
| --- | --- |
| Chemoradiotherapy<br> | |
| Chemoradiotherapy following chemotherapy<br> | |
| Chemoradiotherapy followed by chemotherapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| Overall survival |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival |  | 1 year | 
| Progress free survival |  | 2 year | 
| Locoregional recurrence free survival |  | 1 year | 
| Locoregional recurrence free survival |  | 2 year | 
| Distant metastasis free survival |  | 1 year | 
| Distant metastasis free survival |  | 2 year |
Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research

Study Overview
=================
Brief Summary
-----------------
This study aims to determine effectiveness of Gefitinib (Iressa) in recurrent glioblastoma after standard treatment (surgery, radiationtherapy and at least a first line chemotherapy). Gefitinib is a specific inhibitor of the epidermal growth factor receptor (EGFR). EGFR is elevated in more than 50% of malignant gliomas. At recurrence, secondary surgery and pre- and postoperative Gefitinib is offered to patients in good performance status. Clinical outcome of patients and correlation to translational research will be evaluated.

Detailed Description
-----------------
Glioblastoma (GBM) patients who relapse and are in good performance status, without serious neurological deficits are offered secondary surgery and participation in the trial. Eligible patients must have had standard treatment including primary surgery, radiation therapy and at least a first line chemotherapy. Patients on cytochrome P450 isoenzyme CYP3A4-inducing antiepileptic drugs (EIAE) are excluded due to ensuing interactions of these drugs with gefitinib metabolism, reducing systemic availability. After giving written informed consent, patients receive gefitinib 500 mg daily starting at least 5 days prior to re-operation, allowing a steady state condition.Treatment continues until tumor progression or occurrence of intolerable side effects.The specimens collected at surgery will undergo translational research, aiming to correlate drug accumulation and molecular signatures of GBM samples with clinical outcome.

Official Title
-----------------
A Phase II Open Label Study of the Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research

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

Intervention / Treatment
-----------------
* Drug: Gefitnib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent glioblastoma informed consent reoperation planned fresh frozen sample obtainable Exclusion Criteria: enzyme inducing antiepileptic drugs pregnancy or breast feeding

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: Gefitnib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| molecular signature of EGFR responsiveness to ZD1839 |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent Glioblastoma, Gefitinib
Multiple-Center Retrospective Study of Severe and Critical COVID-19 in Shanghai

Study Overview
=================
Brief Summary
-----------------
This study is to clarify the clinical characteristics of severe and critical COVID-19 from March 1st ,2022 to June 9th, 2022 in Shanghai and to explore the relationship between the characteristics and prognosis in these patients.

Detailed Description
-----------------
To Describe the clinical characteristics of severe and critical COVID-19. To analyze the relationship between the clinical characteristics and their clinical prognosis; To analyze the relationship between clinical intervention and their clinical prognosis.

Official Title
-----------------
Multiple-Center Retrospective Study of Severe and Critical COVID-19 in Shanghai

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe and critical covid-19 patients who met the Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition) admission time more than 24 hours Exclusion Criteria: admission time less than 24 hours
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| severe and critical COVID-19<br>hospital admission time more than 24 hours meet the standard of definition of severe and critical COVID-19 in Diagnosis and Treatment Plan for new Coronavirus Pneumonia (Ninth Edition) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | 28-day mortality of severe and critical COVID-19 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60-day mortality | 60-day mortality of severe and critical COVID-19 | one year | 
| ICU length of stay | ICU length of stay | one year | 
| the percentage of organ failure | the percentage of organ failure include respiratory，circulatory failure and so on | one year | 
| time for virus to turn negative | time for COVID-19 from positive to negative | one year | 
| The overall description | The overall description of the clinical characteristics in severe and critical covid-19 | one year |