linjc16/ctgov huggingface dataset:
Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases

Study Overview
=================
Brief Summary
-----------------
The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult to have histology of these tumors as the samples taken during ERCP were performed under  blind  radiology control. So the diagnostic accuracy was insufficient. The arrival of A new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost. A new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability. The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.

Official Title
-----------------
Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial  EASYSPY 

Conditions
-----------------
Lesions of Biliary or Wirsung Ducts, Biliary Tract Diseases, Common Bile Duct Diseases, Pancreatic Duct Disorder

Intervention / Treatment
-----------------
* Procedure: cholangio-pancreatoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥ 18 years Patients with biliary duct stenosis with undetermined etiology Patients with pancreatic duct stenosis with undetermined etiology Patients with pancreatic duct distension with undetermined etiology Patients with biliary or pancreatic gallstones after failure to endoscopic treatment Exclusion Criteria: Patients with haemorrhagic disease or hemostasis and coagulation disorders (TP < 60%, TCA> 40 sec. and platelets < 60000/mm3). Patients treated with anticoagulant or platelet aggregation inhibiting drugs that could not be temporarily interrupted. Patients with biliary duct diameter < 3 mm Patients with pancreatic duct diameter <3 mm

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 |
| --- |
|Procedure: cholangio-pancreatoscopy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the diagnostic accuracy of the Spyglass to distinguish a benign lesion from a malignant lesion of the biliary or Wirsung ducts. |  | 4 YEARS |
Platelet Concentrate in Achilles Tendon Repair

Study Overview
=================
Brief Summary
-----------------
People operated for a rupture of the Achilles tendon receive a concentrate of their own platelets injected into the operated area. The study is randomized and single-blinded, with 20 treated patients and 20 controls, who get no injection. The primary endpoint is a mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a special type of radiography. This radiography uses 0.8 mm metal markers, which are injected into the tendon. The tendon is mechanically loaded during radiography and its strain can be measured as increased distance between the markers. Other mechanical variables at 6, 12 and 52 weeks are secondary variables, as well as a validated patient-administrated questionaire at 1 year.

Conditions
-----------------
Achilles Tendon Rupture, Soft Tissue Injury, Tendon Injury

Intervention / Treatment
-----------------
* Biological: Autologous platelets
* Biological: no injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Achilles tendon rupture, age 18-65. Exclusion Criteria: Any counterindication for surgical treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Injection of autologous platelet concentrate into repair site | Biological: Autologous platelets<br>* Local injection 10mL, about 2.5 x 10E10 platelets.<br>|
| Placebo Comparator: 2<br>No injection | Biological: no injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulus of elasticity |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelets tendon ligament
The Cytogenetic Constitution of Embryos Resulting From Immature Oocytes (M1)

Study Overview
=================
Brief Summary
-----------------
To examine the chromosomal number content in the blastomeres of embryos achieved from fertilization of immature oocytes at MI stage recruited following COH for IVF. comparison of the genetic number content of embryos and their quality in terms of cleavage rate and morphological score reached after fertilization of immature oocytes at MI stage whether arrested at the MI stage or extruded the polar body, after in vitro maturation for a variable length of time.

Detailed Description
-----------------
Patients undergoing routine IVF, following informed consent, donated some of their unusable, immature- MI stage oocytes for our research. Following in vitro maturation for up to 2, 4, 8 and 24 hours after harvest, all immature oocytes in these 4 study groups underwent intracytoplasmic donor sperm injection (ICSI), whether they extruded their polar body (MI-PB or rescued MI) or not (arrested MI). Oocyte fertilization rate after 24 hours and embryonic development in terms of cleavage rate and morphology were assessed, for another 48 hours. Then the whole embryo was prepared for molecular cytogenetic evaluation using FISH (Fluorescence in situ hybridization) analysis of chromosomes x, y and 18.

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with presence of immature oocytes after ART stimulation Exclusion Criteria: Patients with less than total 7 oocytes

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MI oocytes, FISH,chromosomal aberrations
Acute Regulation of Parathyroid Hormone by Dietary Phosphate

Study Overview
=================
Brief Summary
-----------------
Patients with end stage renal disease often have secondary hyperparathyroidism due to high phosphorus and low calcium levels in the blood. Preliminary animal studies and our initial human study indicate that the parathyroid hormone levels may change quickly based on the ingestion of phosphorus, prior to any change in the blood levels of calcium or phosphorus. This follow-up study will attempt to determine if the effect is independent of an increase in the blood glucose level. If so, this would suggest an as yet unidentified gastrointestinal receptor that mediates parathyroid hormone levels. This may affect the timing of administration and the type of phosphate binder used in treating patients with secondary hyperparathyroidism. The knowledge that parathyroid hormone levels can change acutely may also affect the recommended timing of blood samples

Detailed Description
-----------------
This study is observational and no drugs or other interventions will be used. The population targeted in this study will be adult patients already on chronic hemodialysis with a diagnosis of secondary hyperparathyroidism. Experimental design will involve the use of a glucose clamp to maintain a constant, mild increase in blood glucose levels. Frequent, scheduled lab tests will be obtained during the period of hyperglycemia to evaluate phosphorous, calcium, and glucose levels and the relationship of any change in their values to changes in the parathyroid hormone level. The primary outcome will be to evaluate for any change in the parathyroid hormone level in the presence of hyperglycemia and to compare these results to that of our initial study

Official Title
-----------------
Acute Regulation of Parathyroid Hormone by Dietary Phosphate

Conditions
-----------------
Secondary Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients 21 years of age or older Receiving treatment with hemodialysis for at least 90 days. Serum parathyroid hormone level greater than 200 pg/ml Serum phosphorus level greater than 4 mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study

Study Overview
=================
Brief Summary
-----------------
In this randomized trial surgical therapy and surveillance of ureteropelvic junction obstruction will be compared, regarding partial renal function.

Official Title
-----------------
Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance in Children With Scintigraphically Prooved Obstruction. A Prospective, Randomized, Controlled Multi-Center Study

Conditions
-----------------
Unilateral Ureteropelvic Junction Obstruction

Intervention / Treatment
-----------------
* Procedure: Pyeloplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral ureteropelvic junction obstruction diameter of renal pelvis greater 12 mm partial renal function of 35%-55% proofed by scintigraphy urodynamically relevant decrease in renal drainage proofed by diuresis scintigraphy at the age of 4 weeks up to 6 months Abscence of clinical symptoms Healthy contralateral kidney Exclusion Criteria: Global decrease in renal function renal dystopia megaureter vesico-ureteral reflux progressive hydronephrosis oligohydrammnion voiding dysfunction bilateral hydronephrosis severe chronical illness decrease of partial renal function of more then 5% during allocation

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 6 Months

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pyeloplasty|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial renal function |  |  |
Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs. All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks were included

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Fluvastatin, Tacrolimus, Mycophenolat Mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal transplant patients (18 - 65 years, inclusive) cadaver and living renal transplants(1. Ntx, 2. Ntx) Immunsuppression: Tacrolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months writen informt consent by the patient Exclusion Criteria: contraindications for statins pregnancy or lactating elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluvastatin, Tacrolimus, Mycophenolat Mofetil|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal transplantation, pharmacokinetics, Fluvastatin, Mycophenolat mofetil, tacrolimus
Cosopt Versus Xalatan

Study Overview
=================
Brief Summary
-----------------
To compare the 24-hour efficacy and safety, measured every three hours, of the dorzolamide/timolol fixed combination given twice daily versus latanoprost and placebo each given once daily.

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: timolol maleate 0.5%
* Drug: dorzolamide/timolol maleate fixed combination
* Drug: latanoprost 0.005%
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with primary open-angle, pigmentary, or exfoliation glaucoma, or ocular hypertenstion intraocular pressure should be 22 to 30 mm Hg inclusive on timolol BID at the 08:00 H ETDRS visual acuity must be 1.0 or better in both eyes Exclusion Criteria: any contraindications to study medications any anticipated change in systemic hypertensive therapy during the trial

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

| Intervention/Treatment |
| --- |
|Drug: timolol maleate 0.5%|nan|
|Drug: dorzolamide/timolol maleate fixed combination|nan|
|Drug: latanoprost 0.005%|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Blood Pressure Monitor Clinical Test

Study Overview
=================
Brief Summary
-----------------
To monitor the blood pressure level of the patient

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - IEC 60601-1-2 Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| monitor the diastolic and systolic |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
normal
Treatment of Self Harm Scars With Fraxel Laser

Study Overview
=================
Brief Summary
-----------------
Treatment of self harm scars with fractionated laser.

Detailed Description
-----------------
Fractionated resurfacing lasers have been shown to be useful for scars including acne scars, burns scars and striae. We will treat self harm scars with 3 to 4 treatments using a Fraxel fractionated laser. Patients will be screened to ensure they are not actively engaged in self harm behaviors.

Official Title
-----------------
Treatment of Self Harm Scars With Fraxel Laser

Conditions
-----------------
Self Harm

Intervention / Treatment
-----------------
* Device: Fractionated laser resurfacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self harm scars Exclusion Criteria: Active self harm behaviors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fractionated laser resurfacing|Patients will receive 3-4 treatments with fractionated laser resurfacing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of scars | Patients will be assessed with pre and post treatment photography. Photographs will be taken at baseline and 1 month after the final treatment. After the final treatment both the investigator and patients will rate appearance of scarring as worsened, unchanged or improved as compared to baseline. | 6 months |
Tolerance of a Probiotic Formula

Study Overview
=================
Brief Summary
-----------------
Evaluate the tolerance of a probiotic formula in infants

Official Title
-----------------
Tolerance of a Probiotic Formula Containing Lactobacilli

Conditions
-----------------
Safety Issues

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Full term healthy infant aged 3-95 days Exclusion Criteria: Prematurity Low birth weight Congenital anomalies Chronic disease Failure to thrive Allergy or atopic disease Recent exposure to antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 95 Days

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic formula<br>Lactobacillus strains | Dietary Supplement: Probiotics<br> <br> |
| Placebo Comparator: Placebo formula<br>Placebo | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (g) |  | 8 weeks | 
| Body length (cm) |  | 8 weeks | 
| Head circumference (cm) |  | 8 weeks |
Video Documentation of Localized Complications

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.

Official Title
-----------------
Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology

Conditions
-----------------
Vascular Access

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 18 years of age or older Must be considered in good health by investigator Must be able to read and understand English Exclusion Criteria Less than 18 years of age Known allergy to Heparin History of HIT (Heparin-induced thrombocytopenia) Unable to read and understand English

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Valve and Refill Confirmation | Using VeinViewer, the clinician will be able to view valves and refill. It will be confirmed using Ultrasound. | Immediately after flush-Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Video Documentation of localized vascular access complications | Using VeinViewer, the user will be able to detect hematomas and infiltrations. | Immediately after attempt-Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Veins, Vascular Access, IV complications, VeinViewer Vision
Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to improve the detection of endometriosis using F-18 FES PET/MRI imaging.

Official Title
-----------------
Pilot Study Evaluating Endometriosis With 16α-(18)F-fluoro-17β-estradiol ([F-18] FES) PET/MRI

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: F-18 FES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Premenopausal women (18-50) with endometriosis Exclusion Criteria: Postmenopausal women AP diameter when lying supine greater than 32 cm (too large for PET/MRI) Unable to undergo PET/MRI for any reason (metal implants, severe claustrophobia) Unable to receive IV Gadolinium contrast for any reason (renal failure eGFR < 60, contrast allergy) Pregnant (Urine test will be provided for all patients)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: F-18 FES PET/MRI<br>16α-(18)F-fluoro-17β-estradiol ([F-18] FES) | Drug: F-18 FES<br>* F-18 FES PET/MRI for detection of endometriosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Endometriosis | Comparisons will be made descriptively between conventional MRI imaging, FES PET/MRI imaging and surgical/pathologic findings. Outcome data include number of detected lesions, differences in the accuracy for detection of active disease versus inactive fibrosis, and confidence score. | 24 months |