linjc16/ctgov huggingface dataset:
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing. Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages. The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing. Clinical information related to subjects' pregnancy and foetal health is also collected.

Official Title
-----------------
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring

Conditions
-----------------
Foetal Wellbeing

Intervention / Treatment
-----------------
* Device: TMSi Porti
* Device: Bloomlife sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Gestational age of at least 20 weeks Singleton pregnancy Willingness to participate in the study Exclusion Criteria: Multiple pregnancy Implanted pacemaker or any other implanted electrical device History of allergies to silicone-based adhesives

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase I<br>Data collections are performed with TMSi Porti system and CTG (reference) | Device: TMSi Porti<br>* Data collections<br>|
| Experimental: Phases II-III-IV<br>Data collections are performed with the Bloomlife sensor and CTG (reference) | Device: Bloomlife sensor<br>* Data collections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy and reliability in the detection of foetal heart rate | Foetal heart rate is extracted from the collected electrophysiological data and compared to the reference | Throughout the subject's participation in the study, from inclusion until delivery | 
| Accuracy and reliability in the detection of foetal movements | Foetal movements are detected from the collected sensor data and compared to the reference | Throughout the subject's participation in the study, from inclusion until delivery |
Pattern of Genitourinary Fistula in Upper Egypt

Study Overview
=================
Brief Summary
-----------------
the pattern of genitourinary fistula in upper egypt

Detailed Description
-----------------
A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems. The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries. The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus. These four types are further subclassified by the size of the fistula, extent of associated scarring, vaginal length or special considerations: Type 1: Distal edge of fistula > 3.5 cm from external urinary meatus Type 2: Distal edge of fistula 2.5-3.5 cm from external urinary meatus Type 3: Distal edge of fistula 1.5 - < 2.5 cm from external urinary meatus

Official Title
-----------------
the Genitourinary Fistula Experience in Upper Egypt

Conditions
-----------------
Data Collection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - any female with genitourinary fistula Exclusion Criteria: no
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 |
| --- | --- | --- |
| prevalence of genitourinary fistula in upper egypt | to detect how many numbers of cases of genitourinary fistula in upper egypt . | 5 years |
Stem Cell Therapy in Chronic Ischemic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).

Detailed Description
-----------------
Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality. The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure. 35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.

Conditions
-----------------
Myocardial Ischemia, Heart Failure, Congestive

Intervention / Treatment
-----------------
* Procedure: Bone marrow transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs), Stable left ventricular ejection fraction < 40%, CCS class 2-3 and/or NYHA class 2-3, and Signed informed consent. Exclusion Criteria: Implantation of pacemaker (including implantable cardioverter defibrillator [ICD] and biventricular pacing), Acute myocardial infarction within 3 months, Atrial fibrillation, or Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)
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 |
| --- |
|Procedure: Bone marrow transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in left ventricular ejection fraction from baseline to 12 months' follow-up |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone Marrow Transplantation
Non-invasive Measurement of Cerebral Dynamic Autoregulation

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to evaluate the use of diffuse correlation spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with vascular risk factors. Optical cerebral blood flow measurements will be correlated with changes in arterial blood pressure to assess how CBF is maintained in response to changes in ABP, and will be compared to transcranial doppler reference measurements.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Thigh Cuff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 50 years Positive history of at least one of the following vascular disk factors: hypertension, diabetes, hyperlipidemia, coronary artery disease, atrial fibrillation, prior myocardial infarct, transient ischemic attack, or history of smoking Exclusion Criteria: Vascular risk factor subjects: Pregnant women Prisoners Prior neurosurgical procedure or traumatic brain injury, including hemicraniectomy or other skull defect Prior history of ischemic or hemorrhagic stroke Prior lower extremity amputation Peripheral vascular disease

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population. | Device: Thigh Cuff<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD | Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation. | 1.5 hours | 
| dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical | Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation. | 1.5 hours |
DPBRN Prevalence of Questionable Occlusal Caries Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the process involved when making decisions about the diagnosis and treatment of questionable lesions, as well as determine if there is any association between lesions progression (or depth, if opened) and clinical characteristics and baseline risk assessment.

Detailed Description
-----------------
The termquestionable is defined as a tooth with no cavitation (no continuity break in the enamel) and no radiographic radiolucencies, but the presence of caries is suspected due to roughness, surface opacities, or staining. The characteristics of these lesions and the patient's baseline caries risk were examined. There have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions. Since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.

Official Title
-----------------
Prevalence of Questionable Occlusal Caries Lesions

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients needed to have at least one permanent tooth with a questionable lesion. This means that subjects were at least 6 years old because that is when the permanent first molar typically erupts. Exclusion Criteria: patients under 6 years old patients 6 years old and older who do not have a questionable lesion

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Questionable occlusal lesions<br> | |

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
-----------------
Assessment, Questionable Caries
International Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.

Detailed Description
-----------------
Primary objective: To describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass pollen season in real-life settings. Secondary objectives: - To describe the patient's perceived effectiveness of ORALAIR® in allergic rhinoconjunctivitis management in terms of disease intensity, satisfaction and rescue medication

Official Title
-----------------
An International Non-Interventional Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis Treated With Oralair®.

Conditions
-----------------
Allergic Rhinitis Due to Grass Pollens

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of 5 years of age and older at the date of the screening visit Patient with proven allergic rhino-conjunctivitis due to grass pollen Patient eligible for a grass-pollen Allergen ImmunoTherapy (AIT) Patient whose physician prescribed ORALAIR® independently of the study, before the beginning of the grass-pollen season Exclusion Criteria: Patient participating in a clinical trial or in an epidemiological study

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| allergic rhino-conjunctivitis<br>Patient with proven allergic rhino-conjunctivitis due to grass pollen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | The primary objective is to describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass-pollen season in real-life settings. | patients will be followed for the duration of the treatment, an expected average of 6 months/year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Effectiveness | To describe the patient's perceived effectiveness of ORALAIR® in allergic rhino-conjunctivitis management in terms of disease intensity, satisfaction and rescue medication | patients will be followed for the duration of the treatment, an expected average of 6 months/year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic, rhinitis, conjunctivitis, grass pollen, Allergen ImmunoTherapy (AIT), grass mix
Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study

Study Overview
=================
Brief Summary
-----------------
Background. Pancreatic cancer surgery is associated with very high risk of postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC). Purpose. The investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after pancreatic surgery

Official Title
-----------------
Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Other: pts operated for pancreatic cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing all different kinds of pancreatic surgery in elective setting for cancer with a pancreatic anastomosis performed. Exclusion Criteria: age < 18 years pregnant women patients undergoing pancreatic surgery for benign disease, other kinds of pancreatic surgery without an anastomosis being performed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| pts operated for pancreatic cancer<br>all pts operated of pancreatic resection for cancer in the involved units | Other: pts operated for pancreatic cancer<br>* measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery | Sensitivity: % of patients corrected identified by the biomarkers having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak | 2 yrs | 
| Specificity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery | Specificity: % of pts corrected identified by the biomarkers not having AL; PCT: procalcitonin, CRP: C-reactive protein, AL: anastomic leak | 2 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCT and CRP cuts-off in 3rd POD with a good NPV for AL | PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value | 2 yrs | 
| PCT and CRP cuts-off in 5th POD with a good NPV for AL | PCT: procalcitonin, CRP: C-reactive protein, NPV: negative predictive value | 2 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cancer, procalcitonin
Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for survival prolongation compared to chemotherapy only.

Conditions
-----------------
Stomach Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed gastric adenocarcinoma Patients were diagnosed during 2006-2013 HER2 expression status was evaluated in primary gastric cancer or metastatic lesion. Exclusion Criteria: Patients with second primary cancer within 5 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 |
| --- | --- |
| gastric adenocarcinoma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of HER2 overexpression in gastric cancer patients |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric cancer specific survival according to HER2 expression in each stage |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genes, erbB-2, Prognosis
Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions

Study Overview
=================
Brief Summary
-----------------
Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin lesions. The study will also measure blood levels of the drug and examine the potential anti-tumor activity of the cream.

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: 852A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have melanoma cutaneous metastasis or lentigo maligna melanoma unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Have a life expectancy of 4 months Have normal organ and bone marrow function Exclusion Criteria: Need for non-steroidal anti-inflammatory drugs (NSAIDs) during the study Have a body mass index (BMI)> 30 kg/m2 Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements Have a history of disease requiring ongoing steroid treatment Have a history of seizure disorder (other than febrile seizures in childhood) Have a history of clinically significant coagulation or bleeding disorders or abnormalities Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.

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: 852A|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
-----------------
Advanced Metastatic Melanoma