linjc16/ctgov huggingface dataset:
Dermatological Evaluation of Topic Compatibility-Dermacyd Delicata Pocket BR

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Pocket BR.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Delicata Pocket BR.

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

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin I,II, III e IV Integral skin test in the region Exclusion Criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs Personnel history of atopy History of sensitivity or irritation for topic products Active cutaneous disease Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactic acid (Dermacid)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermal irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hygiene
Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke

Study Overview
=================
Brief Summary
-----------------
Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.

Official Title
-----------------
A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Vivistim System
* Other: Rehab Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior Age > 18 years and < 80 years Right or left sided weakness of upper extremity Major Exclusion Criteria: Hemorrhagic stroke Any deficits in language or attention that interferes with reasonable study participation Presence of significant apraxia Profound Sensory loss Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VNS<br>VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System. | Device: Vivistim System<br>* The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.<br>* Other names: VNS, vagus nerve stimulation, paired VNS;|
| Active Comparator: Rehab Only<br>Rehabilitation only (no implant, no VNS) | Other: Rehab Only<br>* Rehabilitation without device implant and VNS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Assessment of adverse events and serious adverse events. | 6-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper, Limb, Deficits, Rehabilitation, VNS
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 Years of Age

Conditions
-----------------
Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: General good health, other than perennial allergic rhinitis History and diagnosis of perennial allergic rhinitis by skin prick test Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.) Main Exclusion Criteria: Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial Use of any prohibited concomitant medications as defined by the study protocol Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ciclesonide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Total Nasal Symptom Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety, changes in symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
Added Value of inReach Software on Performance Characteristics of Standard Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
The study is aimed to evaluate and describe the added value of inReach planning software on performance characteristics of standard bronchoscopy.

Official Title
-----------------
Open Label, Randomized, Comparative, Single Center, Pilot Study to Assess the Added Value of inReach Technology Software on Performance Characteristics of Standard Bronchoscopy.

Conditions
-----------------
Lung Disease

Intervention / Treatment
-----------------
* Device: inReach bronchoscopy planning software
* Device: Standard lung CT viewer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for non-emergency bronchoscopy Must provide signed informed consent Male or female above 18 years old Lung lesions up to 3 cm in size (in largest diameter), non-visible by standard bronchoscope Exclusion Criteria: CT done over a month before the bronchoscopy 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inReach (A)<br>Bronchoscopy procedure is planned using inReach planning software | Device: inReach bronchoscopy planning software<br>* inReach planning software creates three-dimensional lung CT reconstruction, enabling rapid virtual endoscopic depiction of the airways that allows to plan bronchoscopy virtually.<br>|
| Active Comparator: Control (B)<br>Bronchoscopy procedure is planned using standard CT viewer software | Device: Standard lung CT viewer<br>* CT viewer, used for standard bronchoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoscopy Diagnostic Yield, compared between two study groups and calculated as percentage of true diagnoses from total number of bronchoscopy procedures. |  | Until the definitive diagnosis is obtained | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchoscopy Safety Profile, compared between two groups and calculated as percentage of bronchoscopy-related adverse events. |  | At discharge from bronchoscopy unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Known or suspected lung disease, Candidates for non-emergency bronchoscopy
Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer. Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques. The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.

Official Title
-----------------
Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.

Conditions
-----------------
Breast Cancer, Radiotherapy Side Effect

Intervention / Treatment
-----------------
* Radiation: Simultaneous integrated boost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Invasive breast cancer or ductal carcinoma in situ Breast conserving surgery Complete tumor resection Treatment with adjuvant radiotherapy of the breast Indication for boost Irradiation Given informed consent Exclusion Criteria: Incomplete tumor resection Mastectomy Distant metastases at diagnosis Unable to give informed consent

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simultaneous integrated boost arm<br> | Radiation: Simultaneous integrated boost<br>* Adjuvant breast cancer irradiation including simultaneous integrated boost<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Radiation induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement at the last 1 day of radiotherapy | 
| Acute Radiation induced toxicity (grade 2 or higher) | Toxicity score using Common Terminology for Adverse Events (CTCAE) | Measurement 3 months after completion of radiotherapy |
Characterization of the Charcot Foot

Study Overview
=================
Brief Summary
-----------------
The project concerns a type of very debilitating diabetic foot complications called Charcots osteoarthropathy (COA). This disease is characterized by a rapidly progressing destruction of the load bearing joints, primarily in the feet, resulting in loss of structure and remodeling. Untreated this cascade leads to the collapse of the bones, meaning severe pain and walking disability for the patient. Reconstruction is often very difficult or impossible, and furthermore the collapse can lead to chronic foot ulcers and infections, which in the worst case can be fatal. Treatment options are currently limited to early diagnosis and physical offloading (immobilisation), assisted wound healing and surgical intervention. The purpose of this project is to investigate and describe the bone-related factors, which separate COA from other, less acute, diabetic foot changes. The investigators wish to describe the long term consequences of COA - both anatomically, physiologically and biochemically. The investigators will be doing this in a follow-up investigations on a group of COA patients tested 8 years ago. Little is known of the long term changes to the bone structure after acute COA, and the investigators want to visualize to what extend the bone damage is permanent. To do this the investigators will be using DXA-scans, x-ray, blood tests including bone markers, neurophysiological tests and occlusion plethysmography.

Detailed Description
-----------------
please see above

Official Title
-----------------
Follow-up on Cross-sectional Study of Known Population With Charcot Osteoarthropathy - Metabolic, Physiologic and Pathologic Changes

Conditions
-----------------
Charcot's Joint, Complications of Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Followed in the previous study Exclusion Criteria: Unable to attend 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Charcot foot<br>Patients with Charcot foot and diabetes mellitus 1 or 2 | |
| No charcot foot<br>patients with diabetes mellitus type 1 or 2 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression in the previously affected foot |  | initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density of os. calcaneus |  | initiation | 
| Peripheral neuropathy in the feet |  | initiation | 
| Peripheral blood supply |  | initiation | 
| Altered levels of bone resorption markers |  | initiation |
Dasatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate effectiveness of Dasatinib as the first line therapy for patients with newly diagnosed chronic myeloid leukemia in chronic phase in Japan.

Official Title
-----------------
Phase II Clinical Trial of Dasatinib First Line Therapy for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Conditions
-----------------
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelogenous Leukemia, Chronic, Chronic Phase

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase 20 years old over ECOG performance status (PS) score 0-2 Adequate organ function (hepatic, renal and lung) Signed written informed consent Exclusion Criteria: A case with the double cancer of the activity Women who are pregnant or breastfeeding The case of Pleural effusion clearly Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction whithin 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Months

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 |
| --- | --- | --- |
| Rate of complete molecular response (CMR) after treatment with dasatinib | The rate(%) of patients who achieve complete molecular response (CMR) by 18 months after the dasatinib therapy will be measured to evaluate the efficiency of dasatinib. | by 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete molecular response (CMR) |  | by 3,6,12,24, 36 months | 
| Major Molecular Response(MMR) |  | by 3,6,12,18,24,36 months | 
| Complete Cytogenetic Response(CCyR) |  | by 6,12 months | 
| Expansions rate of large granular lymphocyte |  | by 12 months | 
| Progression free survival |  | at 36 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | by 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic myelogenous leukemia, chronic phase, Phase II, dasatinib
A Study of KRN23 in X-linked Hypophosphatemia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.

Official Title
-----------------
A Phase I, Double-blind, Randomized, Placebo-controlled, Single-dose, Dose-escalation Study of KRN23 in X-linked Hypophosphatemia

Conditions
-----------------
X-linked Hypophosphatemia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: KRN23


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Clinical diagnosis of XLH TmP/GFR is less than 2.0 mg/dL GFR is 60 mL/min or above Exclusion Criteria: Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening History of known immunodeficiency Lactating females, female patients who are pregnant or planning to become pregnant during the study Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing Receipt of live (attenuated) vaccine within 3-months prior to screening Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KRN23<br>Single IV or SC administration on day 1 | Drug: KRN23<br>* Single IV administration on day 1: 0.003, 0.01, 0.03, 0.1 and 0.3 mg/kg and Single SC administration on day 1: 0.1, 0.3, 0.6 and 1.0 mg/kg<br>|
| Placebo Comparator: Placebo<br>Single IV or SC administration on day 1 | Drug: Placebo<br>* single dose IV or SC administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | AEs, etc | Up to 7 weeks after dosing (maximally 11 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect to pharmacodynamic parameter | Change in Serum Phosphate | Up to 7 weeks after dosing (maximally 11 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
XLH