linjc16/ctgov huggingface dataset:
Cosmetic Dermatology Study

Study Overview
=================
Brief Summary
-----------------
This study aims to understand the impact of VeinViewer technology during routine cosmetic and dermatologic procedures.

Detailed Description
-----------------
This study was designed as an observational study to determine if VeinViewer technology helped to improve the efficiency of certain dermatological procedures namely botox injections and schlerotherapy for varicose veins. The device was used to identify veins but clinical decisions were ultimately left the physician.

Official Title
-----------------
Evaluation of VeinViewer in Cosmetic Dermatology

Conditions
-----------------
Cosmetic Procedures

Intervention / Treatment
-----------------
* Device: VeinViewer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and up Male or Female Receiving cosmetic dermatological injection Willing to participate Exclusion Criteria: Aged younger than 18 years Prior history of known light sensitivity Other reasons as determined by investigator

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VeinViewer<br>VeinViewer will be used in conjunction with routine cosmetic dermatology procedures. Patients and physicians will complete questionnaires. | Device: VeinViewer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perception of the use of the device | Small questionnaires will be used to assess how the patient perceives the use of the device (i.e., did the patient have a positive attitude towards the device?) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician perception of the use of the device | Physicians will complete a small questionnaire to understand what their perception of the use of the device to be (i.e, did the physician have a positive attitude towards the device while using it). | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cosmetic dermatology, near-infrared, patient preference, physician preference
N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the study will be as follows: comparison of the mortality rates, and length of hospitalization among patients treated with N-acetylcysteine compared to the control group.

Conditions
-----------------
Drug Induced Nephrotoxicity

Intervention / Treatment
-----------------
* Drug: Oral N-Acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized with presumptive gram-negative infection, as assessed by the treating house staff and requiring gentamycin therapy according to an infectious disease specialist decision. Aged between 18 and 90. Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours. Signed informed consent. Exclusion Criteria: Any known allergy or intolerance to one of the medications in the AG group. Any known allergy or intolerance to N-acetylcysteine. Any immunosuppressive therapy excluding steroid therapy. Pregnancy. HIV infection. Non-sepsis-related neutropenia. An estimated creatinine clearance of less than 30 mL/min. Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral N-Acetylcysteine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease in glomerular filtration rate (GFR) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aminoglycosides
Validation of the HYPONUT Product

Study Overview
=================
Brief Summary
-----------------
The HYPONUT product was previously validated in a laboratory setting (Procédé de préparation d'aliment hypoallergénique, n° FR1250977) on 2012. A international patent was then obtained on 2013. Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. In vitro tests are also performed (i.e. IgE levels for peanut and peanut components). The follow-up of patients consists in regular yearly or semestral evaluations. During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.

Official Title
-----------------
Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product

Conditions
-----------------
Peanut Allergy

Intervention / Treatment
-----------------
* Other: Hyponut


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients aged more than 6 Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France) Exclusion criteria: Pregnancy, or patients breast-feeding Patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines) Patients presenting with dermographism Patients not fluent in French

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyponut<br> | Other: Hyponut<br>* Prick tests with hyponut<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Prick Tests evaluation |  | day patient enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral food challenge evaluation |  | day patient enrolled | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peanut Allergy, Skin Prick Test, Oral Food Challenge, Hyponut
Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.

Study Overview
=================
Brief Summary
-----------------
This is a multicentric, randomized, single-blinded clinical trial to evaluate the efficacy and safety of 3D printing for the planification and simulation of orbital decompression surgery for thyroid-associated orbitopathy.

Official Title
-----------------
Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.

Conditions
-----------------
Thyroid Associated Ophthalmopathy, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Device: 3D printing model/guide.
* Procedure: Standard surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of inactive thyroid-associated orbitopathy requiring bilateral orbital decompression (moderate-severe in EUGOGO classification). Volunteers older than 18 years old. Ability to read. Acceptation to participate and signature of informed consent. Exclusion Criteria: Younger than 18 years old. Previous orbital surgery. Any coexisting disease preventing follow-up.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control grup<br>Conventional surgery. | Procedure: Standard surgery<br>* Orbital decompression surgery will be previously planned and simulated using the actual standard methods.<br>|
| Experimental: Intervention group<br>Surgery planned, simulated and guided by 3D printing. | Device: 3D printing model/guide.<br>* Orbital decompression surgery will be previously planned and simulated using 3D-printed individualized models. In the operating room, surgery will be assisted with 3D-printed individualized guides.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complications | Intraoperative complications | 6 months | 
| Postoperative complications | Postoperative complications | 6 months | 
| Exophthalmos | Exophthalmos measured in millimeters | 6 months | 
| Diplopia | Diplopia correction | 6 months |
Salvage mFOLFOX in BTC After Failure of Gemcitabine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.

Official Title
-----------------
Phase II Study of Salvage mFOLFOX(5-fluorouracil, Leucovorin, Oxaliplatin) in Patients With Unresectable Biliary Tract Cancer (BTC) Who Had Failed Gemcitabine

Conditions
-----------------
Unresectable Biliary Tract Cancer

Intervention / Treatment
-----------------
* Drug: 5-fluorouracil, leucovorin, oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age : older than 18 Histologically confirmed adenocarcinoma of the biliary tract Metastatic or unresectable biliary cancer Prior exposure to gemcitabine chemotherapy for biliary cancer Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT Adequate bone marrow, liver, renal function Exclusion Criteria: Pregnancy and breast-feeding. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics). Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix. Symptomatic or uncontrolled brain metastasis

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5-fluorouracil, leucovorin, oxaliplatin|D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety | Clinically assessed every cycle (2weeks) | 1 year | 
| To estimate the time to progression |  | 1 year | 
| To estimate overall survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biliary Tract Cancer, Salvage therapy, FOLFOX
Dermatologic Patterns of Tuberous Sclerosis Patients and Somatic Mutation Relationship

Study Overview
=================
Brief Summary
-----------------
Tuberous Sclerosis is a rare genetic disorder that affects about one in 15,000 individuals. It is part of the phacomatoses: a germline mutation of the gene Tuberous Sclerosis Complex 1 (TSC1) or TSC2 causes a protein dysfunction, hamartin and tuberin respectively, leading to mTOR signaling pathway activation, thus tumors rise on the skin but also brain, eyes, kidneys, heart. Thanks to the advent of sequencing techniques of the human genome, genes involved were found twenty years ago. Most commonly, these are de novo private mutations and autosomal dominant Mendelian transmission. About 15% of patients have a phenotype corresponding to the disease but no mutation is found. Although the initial clinical description was in 1880, publications regularly describe new signs in Tuberous Sclerosis, especially for skin. Cutaneous manifestations are important in the diagnostic criteria of the disease and often even the first sign of appeal. However, no data is available on the relationship between genotype and dermatological phenotype. Therefore the investigator intend to review all cutaneous finding in Tuberous Sclerosis patient and try to link with their mutation.

Official Title
-----------------
Dermatologic Clinical Patterns Study of Tuberous Sclerosis Complex Patients Related With Their Somatic Mutation

Conditions
-----------------
Tuberous Sclerosis Complex

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Diagnosis of Tuberous Sclerosis Complex established of confirmed by a geneticin, with a genetic study done or processing, patients accepting to be exanimated 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 |
| --- | --- | --- |
| Phenotype | Phenotype : Dermatological signs observed | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype | Genotype : TSC1, TSC2, mosaicism | 1day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberous Sclerosis Complex, MTOR associated protein, Neurocutaneous Syndromes, High-Throughput Nucleotide Sequencing
Study of XL999 in Adults With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.

Official Title
-----------------
A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: XL999


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced solid tumor Cancer that has progressed on currently available therapies Life expectancy of >3 months Adequate bone marrow, liver, and kidney function Willing to use accepted method of contraception during the course of the study Negative pregnancy test (females) Written informed consent Exclusion Criteria: Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy) Radiotherapy within 4 weeks of the start of treatment Subjects with known brain metastasis Uncontrolled medical disorder such as infection or cardiovascular disease Subjects known to be HIV positive Pregnant or breastfeeding 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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: XL999|XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors |  | Inclusion until 30 days post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors |  | Various timepoints from pre-dosing until 48 hours post dose. | 
| To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg. |  | At various timepoints from pre-dosing until 48 hours post dosing |
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement.

Detailed Description
-----------------
Clinical randomized controlled double-blind study with healthy subjects to investigate the effect of low and high fat of meal on absorption of vitamin D supplement. Participants were randomly in two groups according to sex and BMI. In the same date, each group of participants received a meal and dietary supplement of vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples were collected in the seventh and fourteenth day after intake the supplement.

Official Title
-----------------
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal

Conditions
-----------------
Deficiency, Vitamin D

Intervention / Treatment
-----------------
* Dietary Supplement: colecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Residents of the hospital clinics of Porto Alegre Exclusion Criteria: Don't drink milk Obesity Malnutrition Liver disease Kidney disease or diabetes Use of dietary supplements containing calcium and vitamin D Medications Anticonvulsants Barbiturates, or steroids. Having performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low fat meal<br> | Dietary Supplement: colecalciferol<br>* 50.000UI single oral dose<br>|
| Experimental: Hight fat meal<br> | Dietary Supplement: colecalciferol<br>* 50.000UI single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Level of Vitamin D3 |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, colecalciferol, absorption by Vitamin D