linjc16/ctgov huggingface dataset:
Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

Study Overview
=================
Brief Summary
-----------------
Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography. The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.

Official Title
-----------------
Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women who choose to have a ultrasound done in the early second trimester. Exclusion Criteria: More than one fetus, No agreement to participate in the study, Malformative fetus.
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 |
| --- | --- |
| 1 - transabdominal sonography<br>Women who will have a transabdominal sonography done in the early second trimester. | |
| 2 - transvaginal sonography<br>Women who will have a transvaginal sonography done in the early second trimester. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nuchal cord entanglement |  | at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SGA |  | at birth | 
| Admission to intensive care unit |  | at birth | 
| meconium |  | at birth | 
| fetal distress |  | at birth | 
| low APGAR score |  | 1 minute, 5 minutes after birth | 
| need for c section |  | at birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outcome, Pregnancy, Ultrasonography, adverse
COVID-19 in Home Healthcare

Study Overview
=================
Brief Summary
-----------------
Assessment of cause of Death in home Healthcare residents in Östergötland County, Sweden, who had a positive COVID-19 diagnosis and died between March and September 2020. Our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive COVID-19 diagnoses who had a fatal outcome, and a second aim is to assess the contribution of COVID-19 to those fatal outcomes.

Official Title
-----------------
COVID-19 in Home Healthcare and Mortality

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult (< 18 years) individuals and cared for in home healthcare in Östergötland county and positive COVID-19 diagnosis and diseased between March and September 2020 Exclusion Criteria: none
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 |
| --- | --- | --- |
| Frailty | Frailty is classified i four groups: None or mild frailty: no restrictions in daily life. Moderate frailty: mobile and independent but unable to handle physically demanding activities or work. Considerable frailty: able to perform activities of daily living but confined at times to bed or chair. Severe frailty: unable to perform activities of daily living and/or confined to bed or chair. Dementia necessitating care. | Up to one month before death | 
| Comorbidity | Comorbidity is classified in three Groups: none or mild comorbidity (0-1 diagnosis), moderate comorbidity (2 diagnoses), and severe comorbidity (3 or more diagnoses) | Up to one month before death |
Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Tissue characterization will be performed, from different regions of the gastrointestinal tract in healthy volunteers.

Detailed Description
-----------------
During an endoscopic examination tissue samples will be taken from different regions of the gastrointestinal mucosa. The tissue samples will be used to characterize bacterial markers in the various intestinal segments.

Official Title
-----------------
Tissue Characterization From Various Parts of the Gastrointestinal Tract in Healthy Volunteers

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, Age: 20-60 years, Consent to perform endoscopic examination. Exclusion Criteria: Antibiotics - a month prior to participation in the study, A chronic health condition.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Healthy volunteers<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial markers in different intestinal segments. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endoscopy, Gastrointestinal tract, Bacterial markers, volunteers
MMP-7 Modulation by Short and Long Term Radiotherapy in Rectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.

Official Title
-----------------
Effect of Long and Short Radiotherapy on MMP-7 Levels in Rectal Cancer Treatment

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Radiation: Neoadjuvant radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adenocarcinoma of the rectum, ability to understand written and oral information, written consent. Exclusion Criteria: Colon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No radiotherapy<br>Surgery only | |
| 25 Gray radiotherapy<br>Surgery after short term radiotherapy | Radiation: Neoadjuvant radiotherapy<br>* Neoadjuvant radiotherapy prior to rectal cancer surgery<br>|
| 50 Gray radiotherapy<br>Surgery after long term radiotherapy | Radiation: Neoadjuvant radiotherapy<br>* Neoadjuvant radiotherapy prior to rectal cancer surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Matrilysin levels | Inflammatory markers | 1 - 6 weeks |
Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

Study Overview
=================
Brief Summary
-----------------
Impact of unilateral modulation of deep brain stimulation of the subthalamic nucleus on freezing of gait in Parkinson's disease

Detailed Description
-----------------
Unilateral modulation of subthalamic stimulation and its impact on freezing of gait in Parkinson's disease will be studied. In a cross-over, doubleblind, randomized study, a 30% reduction of stimulation intensity of the less impacted side will be compared with chronic treatment with regard to frequency and duration of freezing of gait episodes.

Official Title
-----------------
Subthalamic Nucleus Stimulation Effect on Gait Symmetry and Freezing of Gait

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

Intervention / Treatment
-----------------
* Procedure: Unilateral reduction of stimulation
* Procedure: Chronic Subthalamic nucleus stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affiliated to social security Patient with idiopathic parkinson's disease, with deep brain stimulation since at least one year Freezing of gait Able to give inform consent Exclusion Criteria: Patient under guardianship, legal guardianship Psychosis Severe depression Severe cognitive troubles (Mattis < 130) Other neurologic or medical pathology interfering with gait

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chronic Subthalamic nucleus stimulation<br>This arm is the reference, with the best stimulation parameters | Procedure: Chronic Subthalamic nucleus stimulation<br>* This arm is the reference, with the best stimulation parameters<br>|
| Experimental: Unilateral reduction of stimulation<br>30% unilateral reduction of Subthalamic nucleus stimulation | Procedure: Unilateral reduction of stimulation<br>* 30% unilateral reduction of Subthalamic nucleus stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of Freezing of gait | the improvement will be measure with a composite score of items 12 + 13 on UPDRS II and items 10+11 on UPDRS III, | 1 month after new stimulation parameters | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson disease, Deep brain stimulation, Freezing of Gait
Molecular Quantification of Insulin mRNA

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to: quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects, determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects, determine the identity of the white cell responsible for expression of insulin mRNA and determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.

Detailed Description
-----------------
Indicators of active immune or chemically mediated beta cell destruction would be helpful for predicting the development and severity of autoimmune diabetes and monitoring the success of islet transplants. Currently there are no reliable indicators readily available. Insulin mRNA in the white cell fraction of blood has been detected or elevated under several circumstances including: normal animals after islet cell transplantation hyperglycemic induced expression and during induction of diabetes with streptozotocin The investigators propose that quantitative measurement of insulin mRNA may be an accurate, innovative and minimally invasive indicator of beta cell destruction.

Official Title
-----------------
Prediction of Type 1 Diabetes: Molecular Quantification of Insulin mRNA in the While Cell Fraction of Whole Blood

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects ages 1 to 17 years of age Subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity Subjects with new onset type 1 diabetes Non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes Unrelated nondiabetic controls with no family history of type 1 diabetes Of sufficient size to donate 10ml of blood Exclusion Criteria: None if subjects meet above inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 diabetes mellitus, Insulin mRNA
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fed conditions

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions

Conditions
-----------------
Dry Mouth

Intervention / Treatment
-----------------
* Drug: Cevimeline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to cevimeline or any comparable or similar product.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cevimeline first, the Evoxac<br>Single dose 30 mg cevimeline capsule, then single dose 30 mg Evoxac capsule (after washout period) | Drug: Cevimeline<br> <br> * Other names: Evoxac;|
| Active Comparator: First Evoxac, then cevimeline<br>Single dose 30 mg Evoxac capsule, then single dose 30 mg cevimeline capsule (after washout period) | Drug: Cevimeline<br> <br> * Other names: Evoxac;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 33 Days |
Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the Enteric Nervous System During the Syndrome of the Irritable Bowel

Study Overview
=================
Brief Summary
-----------------
Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate: paracellular permeability in colonic biopsies of IBS patient the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations

Official Title
-----------------
Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the entérique Nervous System During the Syndrome of the Irritable Bowel

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Procedure: Colic biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients needing coloscopy Exclusion Criteria: Disrupted coagulation results Cancer even healed Known food allergy. Alcohol consumption >30g/day

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>patient with chronic inflammatory intestinal disease | Procedure: Colic biopsies<br>* colic biopsies and analysis<br>* Other names: endoscopic biopsy;|
| Other: 3<br>patient having no symptoms | Procedure: Colic biopsies<br>* colic biopsies and analysis<br>* Other names: endoscopic biopsy;|
| Experimental: 1<br>patient with irritable bowel syndrome | Procedure: Colic biopsies<br>* colic biopsies and analysis<br>* Other names: endoscopic biopsy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Para-cellular permeability |  | at time=0 | 
| Gap junction protein expression |  | at time=0 | 
| Inflammation molecule expression |  | at time=0 | 
| Digestive discomfort degree |  | at time=0 |
Urgent-SQ in Treatment of Overactive Bladder Syndrome: 9-yr Follow up

Study Overview
=================
Brief Summary
-----------------
Long term open label study on safety and durability of the Urgent-SQ tibial implant device for refractory overactive bladder syndrome (OAB).

Detailed Description
-----------------
This is a follow-up study of the study by van der Pal et al. (see reference). The Urgent-SQ is an ankle (tibail) implant that is used for on demand electical stimulation that stimulates the tibial nerve for the treatment of overactive bladder syndrome (OAB). The implant is placed via an minimal invasive surgical procedure. The implant can be activated with an external pulse generator. This study by van de Pal et al. was conducted with the approval of the local Medical Ethical Committee and with a one year systematic follow-up of eight patients. Since then, follow-up up and use of the device was open-label. This study reports on the long-term (9yrs) the safety and durability of the Urgent-SQ implant in these eight patients. Parameters evaluated were local pain and discomford at the site of the implant, AE's related to the implant or the use of the implant. Current use of the treatment and effectivity of the treatment. van der Pal F, van Balken MR, Heesakkers JP, Debruyne FM, Bemelmans BL.Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up. Neuromodulation. 2006 Apr;9(2):163-71. doi: 10.1111/j.1525-1403.2006.00056.

Official Title
-----------------
Urgent-SQ Implant in Treatment of Overactive Bladder Syndrome: Nine-year Follow-up Study

Conditions
-----------------
Overactive Bladder, Urinary Frequency or Urgency Adverse Event, Urinary Incontinence, Urge

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory overactive bladder syndrome that have an Urgent-SQ tibial nerve implant in 2003-2004 Exclusion Criteria: Patient who had the implant removed before the first year after implantation.

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAB, Overactive bladder, Urgency, Incontinence
Effect of Short-term Oxygen During CPET in COPD

Study Overview
=================
Brief Summary
-----------------
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with chronic obstructive pulmonary disease.

Official Title
-----------------
Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise (CPET) Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: Oxygen application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic obstructive pulmonary disease on optimized medical therapy and in stable condition for at least 4 week desaturate in the 6 minute walking test by at least 4% to values <92% Exclusion Criteria: unstable conditions pregnant women patients with relevant concomitant lung disease and severe daytime hypoxemia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplemental oxygen<br>Supplemental oxygen will be applied via a mask during CPET | Procedure: Oxygen application<br>* Supplemental oxygen via mask<br>|
| Sham Comparator: Sham room air<br>Room air will be applied similarly to oxygen | Procedure: Oxygen application<br>* Supplemental oxygen via mask<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Watt |  | 1 day | 
| Exercise time |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Oxygen uptake |  | 1 day | 
| Respiratory Exchange ratio |  | 1 day | 
| Ventilatory equivalent of carbon dioxide (VE/VCO2) slope |  | 1 day | 
| End-tidal pressures of carbon dioxide (PET CO2) |  | 1 day | 
| Changes in arterial blood parameters |  | 1 day |