linjc16/ctgov huggingface dataset:
Threatened Preterm Birth and Time of Subsequent Delivery -a Prediction Model

Study Overview
=================
Brief Summary
-----------------
This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.

Detailed Description
-----------------
Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. These women are often overtreated. In this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor. Differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth.

Official Title
-----------------
Threatened Preterm Birth and Time of Subsequent Delivery; Prediction Model Based on Biomarkers and Maternal/Obstetrical Characteristics

Conditions
-----------------
Preterm Birth, Immunologic Activity Alteration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes Age > 18 years Swedish-speaking (understanding study information) Exclusion Criteria: Multiple gestation Blood borne infections

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| threatened preterm birth<br>Women with either preterm labor or preterm prelabor rupture of the membranes. Blood samples taken at time of inclusion in the study. | |
| Controls<br>Women with normal pregnancies. Blood samples taken at time of inclusion in the study, either prelabor (during pregnancy) or during active phase of labor. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of delivery | Delivery before 34 weeks of gestation or after 34 weeks of gestation | Outcome noted at delivery |
Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?

Study Overview
=================
Brief Summary
-----------------
Inhaled corticosteroids are largely used in patients with asthma or chronic obstructive lung diseases. The purpose of this study is to determine if the use of inhaled corticosteroids is associated with suppression of endogenous cortisol production, as seen in patients treated with pharmacologic doses of oral or parenteral steroids.

Detailed Description
-----------------
The normalcy of the hypothalmic-pituitary-adrenal (HPA) axis of enrolled subjects will be assessed by low dose (1mcg) corticotropin (ACTH)stimulation test. Serum cortisol levels will be measured before , 30 minutes and 60 minutes after 1 mcg ACTH intravenous injection.

Official Title
-----------------
Low Dose(1mcg) ACTH Stimulation Test for Assessment of the Hypothalamus-pituitary-adrenal Axis in Patients Treated With Inhaled Busedonide or Fluticasone.

Conditions
-----------------
Adrenal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving inhaled busedonide or fluticasone at daily dose of 200-800 mcg ' for at least 4 weeks Exclusion Criteria: patients receiving any corticosteroid therapy, except inhaled busedonide or fluticasone.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stimulated serum cortisol levels |  | within 30 days of treatment |
WheezoMeter® Correlation Study

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.

Official Title
-----------------
Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.

Conditions
-----------------
Asthma, Bronchiolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients <= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation. Control: Patients <= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam. Exclusion Criteria: Medical problems that would contraindicate Wz% measurement.

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- |
| Active Wheezing - age 5-12<br> | |
| Active Wheezing - under age 5<br> | |
| No Wheezing<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK Tangerine Mix

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 18 and 60 years old; Phototype Skin II and III; Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or gestation Use of Antiinflammatory and/or immunossupression drugs 15 days before the selection; Diseases which can cause immunity decrease, such as HIV, diabetes; Use of drug photosensitizer; History of sensitivity or irritation for topic products; Active cutaneous disease which can change the study results; History of photodermatosis active; Family or personal antecedent of cutaneous photoinduced neoplasias; Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium; Intense solar exposure in the study area; Use of new drugs or cosmetics during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactic Acid | Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)<br>* Lactic Acid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. |  | Throughout the study | 
| The sensibility will be evaluated according to the skin type. |  | Throghout the study |
Search for Restenosis Markers in Lower Limb Arteritis

Study Overview
=================
Brief Summary
-----------------
The initial hypothesis of this work is that the genesis and the evolution of the atheromatous plaque are partly controlled at the molecular level and in particular by the microRNAs through their role as regulator of the genes. The study of the tissue and serum profile over time of specific microRNAs involved in the regulation of atheromatous plaque correlated with clinical data and restenosis imaging will allow to define biological markers of restenosis in the patient with an arteritis of the lower limbs . This study is a pioneer in the field and it would be imprudent to conclude that a biomarker would be used clinically at the end of this work alone. Nevertheless this study will make a major advance in this topic, in vivo intervention studies with inhibition or over-expression of microRNA will obviously be necessary to confirm the use of these as biomarkers of arteritis of the lower limbs. Regular assay of reliable biomarkers in arterial patients will ultimately suggest early management to best adapt surgical and medical treatment.

Official Title
-----------------
Search for Restenosis Markers in Lower Limb Arteritis

Conditions
-----------------
Restenosis, Lower Limb Arteritis

Intervention / Treatment
-----------------
* Other: To look for serum microRNA profiles associated with restenosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any person to be surgically treated for arteritis on the femoropoplitetic stage, affiliated to a social security scheme, informed of the study and not opposed to it. Exclusion Criteria: Any person taken in charge for an arteritis on the femoro-popliteal floor refusing to participate in the study, or not being able to express its 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Person to be surgically treated for arteritis<br> | Other: To look for serum microRNA profiles associated with restenosis<br>* To look for serum microRNA profiles associated with restenosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of the tissue and serum profile of microRNAs by quantification by real-time PCR |  | 3 years |
Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort study designed to evaluate the treatment effect as well as predictive and prognostic factors with special emphasis on the clinical utility of ctDNA in plasma in patients with gastroesophageal cancer. Patients with gastroesophageal cancer are included in 5 separate cohorts scheduled for Surgical resection + perioperative chemotherapy (cohort 1) Neoadjuvant chemoradiotherapy followed by surgical resection (cohort 2) Definitive chemoradiotherapy with curative intent (cohort 3) Systemic therapy with the intent to prolong survival (cohort 4) Palliative treatment without the use of chemotherapy (cohort 5)

Official Title
-----------------
Clinical Utility of Circulating Tumor DNA in Gastro-Esophageal Cancer

Conditions
-----------------
Esophageal Cancer, Gastric Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Circulating tumor DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroesophageal cancer Age 18 years or older Able to understand and sign written informed consent Exclusion Criteria: Patients not providing informed consent

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Surgical resection + perioperative chemotherapy<br> | Diagnostic Test: Circulating tumor DNA<br>* Measurement of circulating tumor DNA from plasma over a period of 2 years.<br>|
| Cohort 2: Neoadjuvant chemoradiotherapy followed by surgery<br> | Diagnostic Test: Circulating tumor DNA<br>* Measurement of circulating tumor DNA from plasma over a period of 2 years.<br>|
| Cohort 3: Definitive chemoradiotherapy<br> | Diagnostic Test: Circulating tumor DNA<br>* Measurement of circulating tumor DNA from plasma over a period of 2 years.<br>|
| Cohort 4: Chemotherapy with the aim to prolong life expectancy<br> | Diagnostic Test: Circulating tumor DNA<br>* Measurement of circulating tumor DNA from plasma over a period of 2 years.<br>|
| Cohort 5: Non-chemotherapeutic palliation<br>E.g. Palliative radiotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | 1 year | 
| Overall survival |  | 5 year | 
| Response rate RECIST 1.1 |  | through study completion, an average of 1 year | 
| Response duration RECIST 1.1 |  | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating Tumor DNA
Inappropriate Sinus Tachycardia Registry

Study Overview
=================
Brief Summary
-----------------
The primary objective of this registry is to capture the real-world data on the outcome of AtriCure Isolator® Synergy™ Surgical Ablation system (or future iterations) when used to ablate cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS) using sinus node sparing hybrid ablation procedures. This is an observational, retrospective and prospective, multicenter, open-label patient registry.

Official Title
-----------------
A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment

Conditions
-----------------
Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome

Intervention / Treatment
-----------------
* Device: AtriCure Isolator® Synergy™ Surgical Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is age>=18 years Subject has been scheduled by physician to undergo or has undergone hybrid sinus node ablation procedure using the AtriCure Isolator® Synergy™ device or future iterations of that device for IST or POTS Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements Exclusion Criteria: Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager Subject with exclusion criteria required by FDA or local governance

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 |
| --- |
|Device: AtriCure Isolator® Synergy™ Surgical Ablation System|A sinoatrial (SA) node sparing, endoscopic epicardial and endocardial hybrid ablation approach used to treat the IST or POTS using the AtriCure Isolator® Synergy™ Surgical Ablation System and Isolator® pen devices as applicable.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of AtriCure Isolator® Synergy™ Clamp System used to treat IST or POTS | The data associated with the SA node sparing hybrid ablation procedure using the AtriCure Isolator® Synergy™ Clamp system to treat patients diagnosed with IST or POTS will be captured and assessed in this registry study. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome;, Sinus Node Sparing Hybrid Procedure
Drug-Drug Interaction Study With Aricept® (Donepezil)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time

Official Title
-----------------
A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: Donepezil
* Drug: BMS-708163


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and postmenopausal women Exclusion Criteria: Medical History and Concurrent Diseases Gastrointestinal disease Gastrointestinal bleeding disorders History of peptic ulcer disease History of cholecystectomy History of seizure disorder History of asthma History of Chronic Obstructive Pulmonary Disease History of cardiac conduction abnormalities, including but not limited to sick sinus syndrome and those with unexplained syncopal episodes Inability to tolerate oral medication Inability to be venipunctured and/or tolerate venous access

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donepezil and BMS-708163<br> | Drug: Donepezil<br>* Tablets, Oral, 5 mg, Once Daily, Days 1-28<br>* Other names: Aricept®;Drug: BMS-708163<br>* Capsule, Oral, 125 mg, Once Daily, Days 15-28<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28 |  | Days 14 and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs |  | Days 7, 14, 21, 29 and study discharge |
The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey

Study Overview
=================
Brief Summary
-----------------
Collect the real clinical background of advanced colorectal cancer c of China.

Detailed Description
-----------------
The Primary Objectives of this study is collect the real clinical background of advanced colorectal cancer treatment situation of China. The Secondary Objectives is the mutation of K-ras , targeting therapy , use present situation of cetuximab and liver metastases treatment situation of colorectal cancer patients.

Official Title
-----------------
The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey

Conditions
-----------------
Advanced Malignant Neoplasm, Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically or cytologically confirmed diagnosis of metastatic colorectal cancer. Exclusion Criteria: Patients with histologically or cytologically confirmed diagnosis other than metastatic colorectal cancer.
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
-----------------
Advanced, Colorectal Cancer, Targeted chemotherapy, Surgery, Radiotherapy
Quality of Awakening and Impact on Cognitive Function After Administration of Sugammadex in Robotic Radical Cystectomy

Study Overview
=================
Brief Summary
-----------------
With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted using continuous intravenous infusion of curare, which ensures maximum neuromuscular relaxation until the end of the intervention. Sugammadex, administered for the reversal of deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a positive effect also on the recovery of cognitive function, psychomotor coordination and mental ability, effects undocumented in Literature. The aim of the investigators study was to assess whether the reversal with sugammadex after intraoperative continuous infusion of rocuronium, can improve the quality of awakening.

Conditions
-----------------
Anesthesiology Management

Intervention / Treatment
-----------------
* Drug: sugammadex
* Drug: Neostigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA score ≤ III Patients underwent robotic cystectomy Exclusion Criteria: Cerebrovascular disease BMI ≥ 30

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sugammadex<br>this arm will receive sugammadex at the end of the surgery | Drug: sugammadex<br> <br> |
| Active Comparator: neostigmine<br>this arm will receive neostigmine at the end of the surgery | Drug: Neostigmine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average score obtained on awakening according to specific test | cognitive function as assessed by the Mini Mental State Exam; quality of awakening as assessed by the Observer's Assessment of Alterness/sedation | 16 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Curare, Sugammadex, Delayed Emergence from Anesthesia, Robotic Surgical Procedures