linjc16/ctgov huggingface dataset:
Genetic Study of Insulin-Like Growth Factor-I Receptor Mutations in Patients With Intrauterine Growth Retardation

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo blood draw. Insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) are measured. Patients whose IGF-I and IGFBP-3 levels are average or above are tested for the presence of mutation in the insulin-like growth factor-I receptor.

Conditions
-----------------
Intrauterine Growth Retardation

Participation Criteria
=================
Eligibility Criteria
-----------------
Intrauterine growth retardation (IUGR), defined as birth weight less than 2 standard deviations below the mean by Usher and McLean Deficient catch-up growth (stature less than 5th percentile on growth chart after age 18 months) Normal or elevated circulating concentrations of insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) IGF-I or IGFBP-3 within or above the 95th percentile confidence interval for age No other clinical explanation for poor prenatal and postnatal growth No IUGR due to maternal toxemia, endocrine disease, gastrointestinal disease, significant heart disease, or chromosomal abnormalities No other condition known to retard growth

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum 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
-----------------
endocrine disorders, intrauterine growth retardation, rare disease
Prevalence of Pulmonary Embolism in ICU

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. The secondary objectives were to assess the association between PE and DVT, to identify risk factors for VTE, and to determine the outcome of VTE.

Detailed Description
-----------------
Background: Pulmonary embolism (PE) produces nonspecific or minimal symptoms in mechanically ventilated (MV) patients, leading to underdiagnosis. We estimated the prevalence of PE and associations with deep vein thrombosis (DVT) among MV patients. Methods: Consecutive MV patients who required thoracic computed tomography (CT) in a single ICU. Compression ultrasound of the four limbs was performed within 48 hours of inclusion. Curative anticoagulation therapy was given immediately after PE diagnosis.

Official Title
-----------------
Pulmonary Embolism in Mechanically Ventilated Patients Requiring Computed Tomography: Prevalence, Risk Factors and Outcome

Conditions
-----------------
Pulmonary Embolism, Deep Venous Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients requiring invasive MV and thoracic contrast-enhanced CT for any reason Exclusion Criteria: a diagnosis of PE before ICU admission, allergy to contrast agents, and age younger than 18 years.

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 |
| --- | --- |
| pulmonary embolism, deep venous thrombosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Find a pulmonary embolism on the CT scan | TO estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. | CT scan at the day of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To find thrombus on compression ultrasound (CUS) of the four limbs |  | CUS within 48 hours after the CT scan |
Eucapnic pH Compared With Arterial pH and Base Deficit

Study Overview
=================
Brief Summary
-----------------
Neonatal asphyxia per partum can be complicated by severe neurologic sequelae and can lead to neonatal death. Of the 0.2% of live births to cerebral palsy, 10 to 28% would be secondary to neonatal acidosis. Only metabolic acidosis plays a neurotoxic role, explaining the recent interest of Racinet et al. in the development of a new biochemical marker, more specific than pH or base deficit, of neonatal asphyxia per partum at risk of anoxo-ischemic encephalopathy. This eucapnic neonatal pH raises the hope of a biochemical marker of situations at risk of poor prognosis, with high diagnostic value, prognostic and forensic. Our hypothesis is that eucapnic pH is more efficient than cord blood arterial pH and base deficit in the prediction of adverse neurologic outcomes.

Official Title
-----------------
Umbilical Cord Arterial Eucapnic pH Compared With Arterial pH and Base Deficit as Predictor of Severe Adverse Outcomes Among Term Neonates

Conditions
-----------------
Neurologic Complication

Intervention / Treatment
-----------------
* Other: Eucapnic pH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All birth more than 37 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016 Exclusion Criteria: Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant Children with congenital anomalies or without valid arterial and venous umbilical cord samples
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hôpital Femme Mère Enfants births<br> | Other: Eucapnic pH<br>* Collection of Biological marker (proposed by Racinet): eucapnic pH<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with at least one of these criteria including neonatal seizure, neonatal hypotonia requiring intensive care unit admission, neonatal encephalopathy, and/or neonatal death. |  | Between 2000 and 2016 |
Sexual Function in Male Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Sexual dysfunction is common in male patients with chronic renal failure on dialysis and after renal trasnplantation. Multiple factors play a role in this important clinical problem. Recent studies suggest that certain immunosuppressive medication used for solid organ transplant may affect male sexual function. The purpose of this study is to compare the sexual function of male renal transplant patients on sirolimus and those patients not on sirolimus immunosuppression.

Detailed Description
-----------------
All male renal transplant recipients with a functioning allograft 1 month post transplant will be eligible to participate in this prospective serial observation study. As roughly half of renal transplant patients are assigned to rapamycin immunnosuppression clinically and half are not, we plan to assess routine clinical perameters, sex hormone levels, subjective sexual function as measured by standardized questionnaire and semen analysis in 55 patients on sirolimus treatment and 55 patients not on this treatment. Assessment will be made at baseline (1 mo post transplant) and 6 and 12 months later. All adult male renal transplant recipients ages 21-65 off dialysis 1 mo post transplant will be eleigible. Exclusion criteria will be female gender, patients requiring testosterone therapy, patients on dialysis, and those unwilling to give informed consent.

Official Title
-----------------
Sexual Function in Male Renal Transplant Patients

Conditions
-----------------
Renal Transplant Recipients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:male renal transplant recipients off dialysis by 1 month post transplant, ages 21-65,willing to give informed consent - Exclusion Criteria: female gender, patients requiring testosterone replacement treatment, patients with neglibile renal function requiring dialysis, unwilling to give informed consent -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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
-----------------
renal, transplant, sexual dysfunction, male, dialysis free
Modulation of Lactase Expression by a New PPARgamma Ligand in Duodenal Biopsies

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut

Official Title
-----------------
Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies

Conditions
-----------------
Lactose Intolerance

Intervention / Treatment
-----------------
* Drug: GED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing gastroduodenal endoscopy for digestive cancer screening Subjects undergoing gastroduodenal endoscopy for ulcerative gastroduodenal diseases Subjects undergoing gastroduodenal endoscopy for epigastric pains Subjects undergoing gastroduodenal endoscopy for gastroesophageal reflux diseases Exclusion Criteria: Subjects with macroscopic duodenal lesions detected at endoscopy Subjects suffering from coeliac disease Subjects suffering from atrophic gastritis Subjects who use anticoagulant Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactase expression induction by GED<br> | Drug: GED<br>* Four duodenal biopsies will be collected. Two biopsies will stimulated with GED (PPARgamma modulator) ex vivo during 6 hours. Two biopsies will be unstimulated (control).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LCT mRNA expression measured by quantitative RT-PCR in duodenal biopsies stimulated ex-vivo with a new PPARgamma agonist (GED, 1mM) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LCT mRNA expression measured by quantitative RT-PCR in primary intestinal epithelial cells (isolated from duodenal biopsies) stimulated with a new PPARgamma agonist (GED, 1mM) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PPARgamma, Lactose intolerance, Lactase
LVA on Serum Profiling in Patients With Lymphedema

Study Overview
=================
Brief Summary
-----------------
The correlation between oxidative stress and increased lymphedematous limb volume lacks supporting evidence. Lymphedema patients are prone to cellulitis. This study aims to investigate the link between oxidative stress, limb volume, and cellulitis after supermicrosurgical lymphaticovenous anastomosis (LVA).

Detailed Description
-----------------
In this study, we focused on the changes in serum antioxidant biomarkers before and after LVA, detected by isobaric tags for relative and absolute quantitation (iTRAQ)-based quantitative proteomic analysis, enzyme-linked immunosorbent assay (ELISA), and Oxidative Stress Panel Kit. For clinical correlation, magnetic resonance (MR) volumetry was implemented for precise lymphedematous limb volume measurements. Correlations were made between changes in oxidative stress, limb volume, and cellulitis before and after LVA.

Official Title
-----------------
The Impact of Lymphaticovenous Anastomosis on Serum Profiling in Patients With Lymphedema

Conditions
-----------------
Lymphedema

Intervention / Treatment
-----------------
* Other: pre-LVA
* Other: post-LVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with lower limb lymphedema confirmed with lymphoscintigraphy unilateral lower limb lymphedema lymphedema duration > 2 years no active infection no prophylactic antibiotic use for at least one month before LVA no tumor recurrence or metastasis no consumption of antioxidants, such as vitamin E or ascorbic acid Exclusion Criteria: Patients with upper limb and bilateral lower limb lymphedema

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Patients underwent supermicrosurgical LVA<br>Patients underwent supermicrosurgical LVA between June 2018 and May 2019. | Other: pre-LVA<br>* Venous serum samples were collected from patients before LVA.<br>Other: post-LVA<br>* Venous serum samples were collected from patients one-month after LVA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between post-LVA volume reduction | The primary outcome was determined whether post-LVA volume reduction < 40% | 6 months after surgery |
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

Study Overview
=================
Brief Summary
-----------------
The study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein. Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-OP.

Official Title
-----------------
The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit

Conditions
-----------------
Pain, Ponv, Fatigue

Intervention / Treatment
-----------------
* Device: music pillow
* Device: pillow without music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients going for laparoscopic cholecystectomy Exclusion Criteria: Age below 18, Use of NSAID, morphine, steroids Disability Previous surgery in the past month Pregnancy

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: music<br> | Device: music pillow<br>* according to randomisation patients will receive with/without music.<br>|
| Placebo Comparator: Pillow without music<br> | Device: pillow without music<br>* According to randomisation patients will receive a pillow with/without music<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant reduction in post operative VAS score |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant reduction in Stress hormone level (Cortisol and C reactive protein) |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic cholecystectomy, pain, PONV, music, therapy, fatigue after elective laparoscopic cholecystectomy
Immunotherapy of Chronic Kidney Failure

Study Overview
=================
Brief Summary
-----------------
Kidney failure can result from inflammatory renal disease in the context of autoimmunity because the kidney is targeted by host's immune response against self. There are many causes to this, but abnormal kidney function tests, i.e., BUN and creatinine, can reveal the disease. Oral delivery of kidney cells is ought to produce the immune tolerance - phenomenon is known as oral tolerance. Preliminary studies produced convincing evidence that this hypothesis holds true and has not produced any adverse side effects. Intended open label Phase II aims to confirm these findings.

Official Title
-----------------
Phase II Trial of V8 in Treating Kidney Failure

Conditions
-----------------
Renal Failure Chronic

Intervention / Treatment
-----------------
* Biological: V8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Baseline level of creatinine twice above normal Exclusion Criteria: Baseline level of creatinine normal
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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V8 850 mg<br>Arm 1: Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of V8 | Biological: V8<br>* one pill per day either V8 or placebo<br>* Other names: Placebo;|
| Placebo Comparator: Placebo 850 mg<br>Arm: 2 Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of placebo | Biological: V8<br>* one pill per day either V8 or placebo<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on creatinine | Change in serum creatinine level from baseline | 1 month |
Capsule Endoscopy in Obscure GI Bleeding

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted

Detailed Description
-----------------
The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted. Patients randomized 1:1.

Official Title
-----------------
An Economic Evaluation of Capsule Endoscopy for Obscure Gastrointestinal Bleeding

Conditions
-----------------
Obscure Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Device: Wireless capsule endoscopy
* Other: standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Obscure overt GI bleeding No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding Exclusion Criteria: Known or suspected swallowing disorders Known or suspected small bowel obstruction Multiple comorbidities precluding surgery Patients with implantable electromagnetic devices Pregnant women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Wireless capsule endoscopy | Device: Wireless capsule endoscopy<br>* wire less capsule endoscopy<br>|
| Active Comparator: 2<br>Standard care | Other: standard care<br>* standard diagnostic evaluation as decided by treating physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sf36 |  | 48 weeks | 
| giqli |  | 48 weeks | 
| eq50 |  | 48 weeks | 
| diagnostic yield |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusions |  | 48 weeks |