linjc16/ctgov huggingface dataset:
Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Photo Evaluation.

Study Overview
=================
Brief Summary
-----------------
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINLYN Sweet Flower.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd PH_DETINLYN (Lactic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin II and III; Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection; Diseases which can cause immunity decrease, such as HIV, diabetes; Use of drug photosensitizer; History of sensitivity or irritation for topic products; Active cutaneous disease which can change the study results; History of photodermatosis active; Family or personal antecedent of cutaneous photoinduced neoplasias; Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium; Intense solar exposure in the study area; 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd PH_DETINLYN (Lactic Acid) | Drug: Dermacyd PH_DETINLYN (Lactic Acid)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale |  | Throughout the study | 
| The sensibility will be evaluated according to the skin type. |  | Throughout the study |
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.

Official Title
-----------------
A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea

Conditions
-----------------
Haemophilus Influenzae Type B Infection

Intervention / Treatment
-----------------
* Biological: Haemophilus influenza type b conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female children 2 months to 5 years of age scheduled to receive vaccination Exclusion Criteria: Contraindications to Vaxem™Hib Korean Prescribing information

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 5 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br> | Biological: Haemophilus influenza type b conjugate vaccine<br>* Primary series is 3 doses given to infants beginning at 2 months of age with an interval of 2 months apart (i.e. 2, 4 and 6 months of age). Booster vaccination consists of 1 dose and is given to toddlers 16 to 20 months of age. In this study, subjects will receive vaccination from routine primary care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events 28 days following vaccination |  | 29 days to 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilus influenza type b, children, Korea, vaccine, Prevention of haemophilus influenza type b
Novel Screening Modality for Early Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for pathology analysis, per standard clinical practice.

Detailed Description
-----------------
Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for histologic analysis, with planned study of the diagnostic yields of each method.

Official Title
-----------------
Initial Analysis of Wide-area Transepithelial Sampling for the Detection of Gastric Neoplasia

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is informed of the investigational nature of this study and given verbal and written informed consent in accordance with local, U.S., and international guidelines. Both males and females at least 18 years. Patients with clinical indications for upper endoscopy Exclusion Criteria: Patients should not have an advanced medical or psychiatric conditions which that may limit their ability to participate in the study, as judged by the physician.

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 |
| --- | --- | --- |
| Diagnostic yield of the WATS approach versus standard gastric biopsy mapping | To compare the diagnostic yield of the WATS approach versus standard gastric biopsy mapping (per the updated Sydney system). | 1-3 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric intestinal metaplasia, gastric neoplasia
Bacteriological Study of Diabetic Foot and Antibiotic Sensitivity Pattern in Eastern India

Study Overview
=================
Brief Summary
-----------------
The pattern of organism causing diabetic foot infection are presumed to vary from location to location depending on the antibiotic prescription practice, geographical locations, environmental variations and therapeutic interventions for various patients. Our hypothesis is look to finding out common similarities with diversified subgroups spread across various geographical locations of eastern part of India, thus to create a data base for treating patient with diabetic foot infections.The sensitivity pattern is anticipated to be different from institution to institutions and place to place but the gross sensitivity data of local pathogen could guide physician for choosing right empirical antibiotic. Practice guideline could be postulated from the collated data of distribution of pathogens, their sensitivity pattern as well as co-morbid conditions of the sufferers.

Official Title
-----------------
An Observational, Prospective, Multicentre Study in Eastern India to Understand the Bacteriological Epidemiology in Diabetic Foot and Sensitivity Pattern of Antibiotics Along With the Pattern of Empirical Therapy

Conditions
-----------------
Diabetic Foot

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic foot patients with Wagner's grade 2 or more foot infection.
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 |
| --- | --- | --- |
| Epidemiological pattern of diabetic foot infection in eastern India |  | One year | 
| Sensitivity of isolated organisms to antibiotics |  | one year | 
| Risk factors associated with different grades of severity of DFI |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To record prevailing management practices of diabetic foot infection in terms of disease, antibiotic practice, practice of supportive and surgical care. |  | one year | 
| Common empiric antibiotic therapies used in management of DFI |  | one year | 
| Percentage sensitivity to different empiric antibiotics |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eastern India, Diabetic foot, Bacteriological epidemiology, Wagner's Grading
Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).

Official Title
-----------------
Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Drug: YAM80


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged between 25 and 65 years ALS patients who can visit the clinic for six months Forced Vital Capacity (FVC) > 70% Patients who can walk by themselves Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration Patients who are willing to give informed consent Exclusion Criteria: Tracheotomy and invasive ventilation Pregnant or possibly pregnant female patients Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases. Patients who are being treated with investigational drugs Patients who are treated with other ALS drugs within 2 weeks prior to the first administration

Ages Eligible for Study
-----------------
Minimum Age: 25 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: YAM80|Oral administration, 2 to 6 mg, once a day.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALSFRS-R |  | 24w + follow-up period | 
| Safety |  | 24w and the follow up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual Muscle Testing |  | 24w + follow-up period | 
| Grip/pinch strength |  | 24w + followup period | 
| Pulmonary function (forced vital capacity) |  | 24w + follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALS
Behavioral Couples Therapy for Female Drug-Abusing Patients

Study Overview
=================
Brief Summary
-----------------
In treating drug addiction, many studies of male patients show Behavioral Couples Therapy (BCT) helps the whole family (the drug abuser, the relationship partner, and their children) and is more effective than typical individual and group counseling. Only one study of BCT has been done with female drug-abusing patients, and results were promising but not definitive. The proposed study will test with married or cohabiting female drug-abusing patients whether BCT will produce more positive outcomes for the women, their male partners, and their children than standard individual counseling for the patient alone.

Official Title
-----------------
Behavioral Couples Therapy for Female Drug-Abusing Patients

Conditions
-----------------
Drug Abuse

Intervention / Treatment
-----------------
* Behavioral: Behavioral Couples Therapy
* Behavioral: Individual Drug Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients with primary drug abuse diagnosis & their relationship partners patient married or cohabiting with relationship partner partner without current alcohol or drug problem Exclusion Criteria: both patient and partner without severe mental health disorders

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Couples Therapy<br> | Behavioral: Behavioral Couples Therapy<br>* Behavioral Couples Therapy<br>|
| Experimental: Individual Drug Counseling<br> | Behavioral: Individual Drug Counseling<br>* Individual Drug Counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent days abstinent from illicit drugs |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Abuse, Female Patients
Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.

Detailed Description
-----------------
The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.

Official Title
-----------------
Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Drug: Gemcitabine plus rapamycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent signed before any trial test Age equal or less than 80 years Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum Measurable disease, acoording to RECIST criteria ECOG 0-2 Exclusion Criteria: Patients who have been irradiated on target lesions ECOG >2 Bilirubin levels over normal values. Creatinine over 1.6 mg/dL History of other cancers except basal cell cancer or cervical cancer adequately treated Serious cardiovascular disease

Ages Eligible for Study
-----------------
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>6 cycles of gemcitabine plus rapamycin | Drug: Gemcitabine plus rapamycin<br>* Gemcitabine and rapamycin given in combination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) rate |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response according to RECIST |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteosarcoma
Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome

Study Overview
=================
Brief Summary
-----------------
There might be a correlation between gastric mucosal microbiome and mucosal pattern visualized by confocal laser endomicroscope.

Detailed Description
-----------------
The gastric mucosal microbiome plays a pivotal role in a series of diseases, such as the H.pylori infection. We hypothesized that mucosal patterns, here visualized by confocal endomicroscopy, may constitute specific microbiome niches.

Official Title
-----------------
Association Between Confocal Laser Endomicroscopic (CLE) Features and Gastric Mucosal Microbiome

Conditions
-----------------
Mucosal Microbiome, H.Pylori, Intestinal Metaplasia, Gastric Neoplasia

Intervention / Treatment
-----------------
* Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients scheduled for gastroendoscopy examination Aged between 18 and 80 years old Exclusion criteria: Antibiotic, probiotic or prebiotic usage within 2months Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium Pregnant or breast-feeding (for females) Impaired renal function

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| endomicroscopy<br> | Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The operational taxonomy units in gastric mucosal microbiome |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of endomicroscopy compared to pathology. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mucosal microbiome, H.pylori, intestinal metaplasia, gastric neoplasia, endomicroscopy
Functional MRI Use in Prostate Radiation Treatment Planning

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate the use of MRI during radiation treatment planning to identify areas of tumor within the prostate to aid in future treatment planning and targeting of prostate cancer. This study will be conducted at the University of Pennsylvania Health System. The study is projected to run for 18 months. Subjects will be male 18 or older with a prostate cancer diagnosis and treatment plansat the Department of Radiation Oncology.

Official Title
-----------------
A Prospective Study Evaluating Non-Endorectal Coil Functional MRI Identification of Intraprostatic Tumor During Radiation Treatment Planning

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Male Biopsy proven prostate cancer without evidence of metastatic disease Planned definitive external beam RT with daily ERB and implanted Visicoil fiducial markers. Prior fMRI-ec documenting an IPL 25 mm2 in axial bidimensional diameter product, concordant with intraprostatic tumor location as documented on transrectal ultrasoundbiopsy Subject capable of giving informed consent for standard external beam RT and for the study. No current contraindication that would prevent MRI or gadolinium contrast. Exclusion Criteria: Metastatic disease Lack of fMRI-ec documeneting an IPL 25 mm2 in axial bidimensional product, concordant with intraprostatic tumor location as documented on transrectal untrasound biopsy Neoadjuvant androgen deprivation therapy greater than 10 weeks, defined from date of LHRH analog injection to date of fMRI-sim Contraindication that would prevent MRI or gadolinium contrast GFR 30 mL/min/1.73m2 per Crockoft-Gault formula.

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

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

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 |
| --- | --- |
| Other: Functional MRI<br>Subjects in this arm receive functional MRI during radiation therapy treatment planning. | Device: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 2 years |