linjc16/ctgov huggingface dataset:
Early Skin to Skin in Neonatal Reanimation

Study Overview
=================
Brief Summary
-----------------
In the reanimation neonatal department of the Nice's hospital, 34% of newborns admitted have an umbilical vein catheter (KTVO). Their parents are admitted 24h/24h by their side, where everything is done to set up the Attachment (participation in care, skin to skin, support of breastfeeding, ...). The benefits of skin to skin described in developmental care of the newborn in the neonatal health services are well established. Nevertheless, for supposed risks (infectious and displacement of the catheter), registered in the memory of the teams, this care is not currently carried out when the newborns are carrying an umbilical venous catheter. Sometimes, because of the presence of an umbilical venous catheter, parents and their newborns could not enjoy this moment of well-being in the first days of life. We therefore propose a study evaluating the current risks of skin to skin with an umbilical venous catheter by reflecting on a new protocol for laying and fixing this medical device.

Official Title
-----------------
Early Skin to Skin in Neonatal reanimation_Risk Assessment in the Newborn With an Umbilical Venous Catheter

Conditions
-----------------
Infant, Premature

Intervention / Treatment
-----------------
* Other: Skin to skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn of gestational age less than 37SA Admitted in neonatal reanimation department at Nice's hospital Born in the maternity ward of the Nice's hospital Carriers of an umbilical venous catheter. Exclusion Criteria: All newborns with medical contraindications from skin to skin: Controlled hypothermia protocol Newborn under HFO (High Frequency Oscillation) Carrying a diaphragmatic hernia Thoracic drain holder With major PAH (hypertensive pulmonary artery) Symptomatic mother of acute infectious disease Mother whose physical or psychiatric capacity is not compatible with travel to the neonatal reanimation service within 3 days of delivery. Minor mother
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin to skin<br>Implement of skin to skin | Other: Skin to skin<br>* 3 sessions of skin to skin will be made on newborn wearing an umbilical venous catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteremia | Occurrence of a bacterial blood infection concomitant with Umbilical venous catheter and up to 48 hours after its withdrawal | 48h |
Anesthesia Type on Percutaneous Nephrolithotomy in Aging Male

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in terms of safety and effectiveness in elderly men.

Detailed Description
-----------------
Data recorded since 2003 will be analyzed retrospectively. Elderly men with PNL will be divided into two groups according to the type of anesthesia. The results determined in both arms will be compared with appropriate statistical methods.

Official Title
-----------------
The Effect of Anesthesia Type on the Outcomes of Percutaneous Nephrolithotomy in Aging Male

Conditions
-----------------
Kidney Stone, Anesthesia

Intervention / Treatment
-----------------
* Procedure: Percutaneous nephrolithotomy surgery (PNL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Renal Stone Disease Above 65 years of age Male sex Exclusion Criteria: Having low hemoglobin level before surgery Presence of hematology disease causing bleeding diathesis Presence of stones in an ectopic or transplanted kidney

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| combined spino-epidural anesthesia (CSEA)<br>Percutaneous nephrolithotomy under combined spino-epidural anesthesia | Procedure: Percutaneous nephrolithotomy surgery (PNL)<br>* Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study.<br>* Other names: general anesthesia (GA);|
| general anesthesia (GA)<br>Percutaneous nephrolithotomy under general anesthesia | Procedure: Percutaneous nephrolithotomy surgery (PNL)<br>* Percutaneous nephrolithotomy (PNL) surgery was performed in all arms of the study to remove the renal stones. This surgery was performed with 2 anesthesia methods, CSEA and GA. These formed the groups of the study.<br>* Other names: general anesthesia (GA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rates | These are the success percentages depending on the outcome of the surgical procedure in both groups. | Post-surgery day 1 | 
| Complication rates | These are the complication percentages depending on the outcome of the surgical procedure in both groups. | During surgery to 24 hours after surgery |
The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester.

Study Overview
=================
Brief Summary
-----------------
The investigators speculate that ultrasound examination in the first trimester can accurately detect placental location. By performing both transabdominal ultrasound and later hysteroscopy on women with a first trimester missed abortions and comparing the ultrasound findings to those of the hysteroscopy the investigators will evaluate the performance of the ultrasound in detecting the placenta location.

Detailed Description
-----------------
All women with a first trimester missed abortion who will sign an informed consent form will undergo an ultrasound examination. During the examination, the operator will assess the location of the placenta/sac insertion. After the performance of the ultrasound, the women will undergo hysteroscopy with a different operator who will be blinded to the results of the previous exam result. During the hysteroscopy the second operator will assess again the location of the sac insertion .The investigatorswill then compare the results of the two tests using the histeroscopy as the gold standard and evaluate the performance of abdominal ultrasound exam in the evaluation of placenta/ sac inserion.

Official Title
-----------------
The Accuracy of Ultrasound in the Detection of Placenta Site in the First Trimester When Compared to Hysteroscopy in Early Abortions

Conditions
-----------------
Placenta; Implantation

Intervention / Treatment
-----------------
* Other: ultrasound exam
* Procedure: hysteroscopy diagnostic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women . Clinical diagnosis of first trimester spontaneous abortion. Exclusion Criteria: viable pregnancy women below 18 years women with chronic disease

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: women with first trimester missed abortion<br> | Other: ultrasound exam<br>* An abdominal ultrasound exam to assess the placenta implantation site.<br>Procedure: hysteroscopy diagnostic<br>* Diagnostic hysteroscopy to asses the placenta implantation site.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of placental site/ gestational sac implantation with ultrasound in the first trimester | Transabdominal ultrasonography detection of gestational sac insertion location will be compared with gestational sac location diagnosed with hysteroscopy. | up to 12 weeks |
An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement in Senior Men

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect and support the tolerance of orally ingested formulation containing Eurycoma longifolia dietary supplement (Euryco-10) on a cohort of senior men.

Detailed Description
-----------------
This is a single-center, single arm, open label study in senior men. This study will investigate the effect and tolerance of oral ingestion of Euryco-10. Subjects meeting all inclusion and none of the exclusion criteria will be enrolled and provided with study dietary supplement. Subjects will be instructed to take 2 capsules per day for 35 days. Administration and any adverse events will be recorded in the subject diary. At each clinic visit (Day 0, Day 21 and Day 35) the Subject will complete the AMS Questionnaire.

Official Title
-----------------
An Open Label Study to Assess the Effect of Euryco-10® Oral Dietary Supplement on Total Testosterone, Sex Drive and Energy Level in Senior Men

Conditions
-----------------
Healthy Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male ≥ 55 years of age Exclusion Criteria: Severe lower urinary tract symptoms. Current use of any herbal and/or nutritional supplements that can interfere with testosterone. A history of cancer except melanoma skin cancer. Currently receiving treatment with cancer chemotherapy or antiandrogens. Chronic use of systemic glucocorticoids (use within >14 days up to the 3months prior to screening); use of non-testosterone anabolic steroids within12 months prior to screening. History of frequent opioid use >1 time/week during any week within 30 days prior to screening. Have a history of known angina. Have a history of severe liver disease or clinical evidence of hepatic impairment at screening. Untreated severe obstructive sleep apnea. Allergies to any of the ingredients in Euryco-10® or BioPerine. Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results

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

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

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 |
| --- | --- | --- |
| Change in serum total testosterone concentration compared to baseline |  | Day 0, Day 21 and Day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Q 9 of the AMS Questionnaire |  | Day 0, Day 21 and Day 35 | 
| Change in Q17 of the AMS Questionnaire |  | Day 0, Day 21 and Day 35 |
Barrett's Esophagus - 315 - 3 Way Cross-Over

Study Overview
=================
Brief Summary
-----------------
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.

Official Title
-----------------
A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Drug: Esomeprazole Magnesium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months Exclusion Criteria: A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer. History of various gastrointestinal diseases - please see investigator for full list. Evidence of any malignant disease in the last 5 years, except minor superficial skin disease. Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>40mg twice daily | Drug: Esomeprazole Magnesium<br> <br> * Other names: Nexium;|
| Experimental: 2<br>40mg three times daily | Drug: Esomeprazole Magnesium<br> <br> * Other names: Nexium;|
| Experimental: 3<br>20mg three times daily | Drug: Esomeprazole Magnesium<br> <br> * Other names: Nexium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily. |  | pH measured on Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period. |  | pH measured | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nexium, Barrett's esophagus
Sensory Mapping Following Video-assisted Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational cohort study on changes in sensory mapping.

Official Title
-----------------
Sensory Mapping Following Video-assisted Thoracic Surgery

Conditions
-----------------
Pain, Paresthesia, Dysesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 18 years old Elective lung cancer surgery (VATS) Exclusion Criteria: does not understand Danish cognitive reduction bilateral procedure planned previous thoracic surgery pregnant or nursing known nerve affection from other cause alcohol/substance abuse inability to cooperate to pain scoring/sensory examination > 5 mg methylprednisolone/day

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 |
| --- | --- |
| lung cancer surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area (cm2) | Size of sensory dysfunction | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain intensity /numerical rating scale) | 3 months |
Effects of Blueberry Juice Consumption on Cognitive Function in Healthy Older People

Study Overview
=================
Brief Summary
-----------------
Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective. The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse. We therefore investigated whether 12 weeks of blueberry concentrate supplementation improved cognitive function in healthy elderly via increased brain activation and perfusion.

Official Title
-----------------
Effects of Blueberry Juice Consumption on Brain Activation and Perfusion in Healthy Older People

Conditions
-----------------
Cognitive Aging

Intervention / Treatment
-----------------
* Dietary Supplement: Blueberry
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 60-80y Addenbrooke's Cognitive Examination III questionnaire > 88 Consuming 5 or less portions of fruit per day Exclusion Criteria: Addenbrooke's Cognitive Examination III questionnaire < 88 Contraindications for MRI Consuming more than 5 portions of fruit per day

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blueberry<br>Blueberry concentrate consumed daily for 12 weeks. | Dietary Supplement: Blueberry<br> <br> |
| Placebo Comparator: Placebo<br>Placebo concentrate consumed daily for 12 weeks. | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain perfusion | MRI - arterial spin labelling | Change from baseline to 12 weeks dietary supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activation | fMRI whilst performing modified Stroop task | Change from baseline to 12 weeks dietary supplementation | 
| Cognitive function tests | Cogstate battery of tests | Change from baseline to 12 weeks dietary supplementation | 
| Blood biomarkers of inflammation | CRP, IL6, | Change from baseline to 12 weeks dietary supplementation | 
| Blood biomarkers of oxidative stress | protein carbonyls, glutathione | Change from baseline to 12 weeks dietary supplementation | 
| Blood biomarkers of neurogenesis | BDNF | Change from baseline to 12 weeks dietary supplementation |
Dyslipidemia-related Risk Factors in Dialysis

Study Overview
=================
Brief Summary
-----------------
In this study, we studied lipoprotein abnormalities-related variables as risk factors for the development of cardiovascular disease in patients on renal replacement therapies.We studied 96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24 healthy controls.We concluded that metabolic acidosis activating the inflammation and lipoprotein oxidation influences the dyslipidemia and cardiovascular morbidity of patients on renal replacement therapies.Dialysis adequacy was positively associated to cardioprotective HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized lipids than hemodialysis modalities.

Detailed Description
-----------------
Blood samples were obtained by venipuncture in the peritoneal dialyzed patients and control group in a twelve hours fasting state.In hemodialyzed patients blood was drawn just before the start of the mean weekly dialysis session also in a twelve hours fasting state from the vascular access. All samples were received once at baseline time ( in the start of the study ). Peripheral systolic and diastolic blood pressures were calculated as an average of 10 measurements during a renal replacement treatment month in the starting time of the study. Also, electrocardiographic examination, echocardiography and the calculation of ankle-brachial blood pressure index became once in the start of the study.

Official Title
-----------------
Dyslipidemia-related Variables as Risk Factor for Cardiovascular Disease in Patients on the End-stage of Renal Disease

Conditions
-----------------
Chronic Renal Disease, Cardiovascular Disease, Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: permanent renal replacement therapy more than 6 months and accurate dry body weight Exclusion Criteria: acute illness, significant infection, malignancy, Kt/V for urea <1.2.

Ages Eligible for Study
-----------------
Minimum Age: 24 Years
Maximum Age: 87 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 |
| --- | --- | --- |
| Associations between dyslipidemia with cardiovascular disease on patients on renal replacement therapy |  | February 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis, dyslipidemia, cardiovascular disease
Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy

Study Overview
=================
Brief Summary
-----------------
Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality. In general, the patients are already malnourished, and early postoperative enteral nutrition is recommended. However, there is no consensus concerning the best enteral access route in these cases.

Detailed Description
-----------------
A prospective randomized trial with patients undergoing esophagectomy, total gastrectomy or pancreaticoduodenectomy to asses the outcomes of either jejunostomy placement or catheter placement

Official Title
-----------------
Randomized Clinical Trial: Nasoenteric Catheter or Jejunostomy as a Route For Nutrition After Major Upper Gastrointestinal Operations

Conditions
-----------------
Postoperative Complications After Gastrointestinal Operations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18, gastrointestinal resections Exclusion Criteria: age under 18, no gastrointestinal procedure

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 |
| --- | --- |
| Jejunostomy<br>Patients who received a jejunostomy | |
| Nasojejunal catheter<br>Patients who received a nasojejunal catheter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Follow up patients after undergoing operation up to 30 days | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of hospital stay in both groups | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal surgery, complications, length of hospital stay, mortality