linjc16/ctgov huggingface dataset:
An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers

Study Overview
=================
Brief Summary
-----------------
Military personnel face intense physical and cognitive demands. Diminished iron status affects physiologic responses to these challenges. Both cross-sectional and longitudinal studies indicate a significant decrement in iron status in enlisted female military personnel immediately following basic combat training (BCT). Decrements in iron status are associated with diminished cognitive and physical performance, and may affect body composition. The primary objective of this randomized, placebo controlled study is to assess the utility of an iron-containing food product for maintaining iron status during BCT. This study will provide insight into the utility and efficacy of an iron-containing food product for the maintenance of iron status during military training. Furthermore, it will provide novel scientific data regarding the relationship between iron status and physical and cognitive performance in female Soldiers.

Official Title
-----------------
Utility of an Iron-containing Food Product for the Prevention of Diminished Iron Status During Basic Combat Training

Conditions
-----------------
Iron Deficiency, Iron Deficiency Anemia

Intervention / Treatment
-----------------
* Other: Iron-containing food product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female US Army Recruit Participating in Basic Combat Training Exclusion Criteria: Male Pregnancy Diagnosed hemochromatosis Diagnosed thalassemia History of ulcerative colitis Allergy to chocolate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Iron-containing food product|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
-----------------
Iron, Iron status, Iron deficiency, Iron deficiency anemia
Prostate-specific Membrane Antigen Antibody-Drug Conjugate in Subjects With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Prostate-specific Membrane Antigen Antibody-Drug Conjugate (PSMA ADC) 1301 is an open-label, dose-escalation phase 1 study of PSMA ADC administered IV in subjects with progressive, castration-resistant, metastatic prostate cancer that has progressed after prior taxane therapy. For all subjects, PSMA ADC will be administered in four repeating cycles.

Official Title
-----------------
A Phase 1 Dose-escalation Study of PSMA ADC in Subjects With Progressive, Castration-resistant, Metastatic Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: PSMA ADC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of progressive, castration-resistant, metastatic prostate cancer. Prior chemotherapy regimens, one of which contains taxane. Eastern Cooperative Oncology Group status of 0 or 1 Exclusion Criteria: Clinically significant cardiac disease or severe debilitation pulmonary disease Evidence of an active infection requiring ongoing antibiotic therapy Any prior treatment with any other therapy targeting PSMA History of drug and/or alcohol abuse

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: PSMA ADC<br>* PSMA ADC administered IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the maximum tolerated dose of PSMA ADC |  | 13 weeks |
Treatment Study for Actinic Cheilitis Comparing Imiquimod 5% and Photodynamic Therapy

Study Overview
=================
Brief Summary
-----------------
Actinic cheilitis is a common precancerous lesion of the lip. The purpose of this study is to compare imiquimod 5% therapy and photodynamic therapy. The data will include effect data, histology (skin analysis), epidemiological data and follow-up data.

Detailed Description
-----------------
Randomized study comparing imiquimod 5% with photodynamic therapy for actinic cheilitis. Histological, efficacy, epidemiological and clinical data will be collected.

Official Title
-----------------
Randomized Prospective Study Comparing 5% Imiquimod and Photodynamic Therapy for Actinic Cheilitis

Conditions
-----------------
Actinic Cheilitis

Intervention / Treatment
-----------------
* Drug: Imiquimod 5%
* Procedure: Photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical findings of actinic cheilitis. Histological findings demonstrating epithelial changes equal to or greater than mild epithelial dysplasia in severity (mild - moderate - severe). Age above 18. Willingness to take post-treatment biopsy. Exclusion Criteria: Disorders predisposing to photosensitivity (porphyria, SLE). Pregnancy or nursing. Known allergy to any excipients in the study creams. prescribed topical retinoids, 5-fluorouracil, cryodestruction, surgical excision and curettage.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Imiquimod 5%<br>Patients randomized to this arm will receive treatment with imiquimod 5% | Drug: Imiquimod 5%<br>* Imiquimod 5% cream used three days a week for 4 weeks<br>* Other names: Aldara;|
| Other: Photodynamic therapy<br>Patients will be randomized to receive photodynamic therapy twice at a 2 week interval to the affected area. | Procedure: Photodynamic therapy<br>* Photodynamic therapy involves applying Metvix cream to the affected area followed by illumination. It will be done twice during the study at a 2 week interval.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and pathological complete cure rates. |  | 3 and 12 months after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical, safety, epidemiological and histopathological data | Through collecting patient data and post-treatment biopsy | post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Actinic cheilitis, Imiquimod 5%, Photodynamic therapy
Meta-analysis of Stannous Fluoride and the Effects on Enamel Erosion

Study Overview
=================
Brief Summary
-----------------
The aim of this 5 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices to assess enamel erosion protection in-situ using surface profilometry.

Official Title
-----------------
Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion

Conditions
-----------------
Enamel Erosion

Intervention / Treatment
-----------------
* Drug: Stannous fluoride dentifrice
* Drug: Positive control dentifrice
* Drug: Negative control dentifrice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stannous Fluoride Dentifrice<br>Twice daily use | Drug: Stannous fluoride dentifrice<br>* Stannous fluoride (0.454%) dentifrice<br>|
| Positive control dentifrice<br>Twice daily use | Drug: Positive control dentifrice<br>* Positive control dentifrice containing potassium nitrate or arginine.<br>|
| Negative control dentifrice<br>Twice daily use | Drug: Negative control dentifrice<br>* Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Surface profilometry | Enamel samples will be measured via profilometry after 10 days of study use. | 10 days |
Cognitive Remediation for Cocaine Dependence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate treatments designed to improve cocaine treatment success by combining medications that target cocaine-related cognitive impairments.

Official Title
-----------------
Cognitive-enhancing DA Medications for Cocaine Dependence

Conditions
-----------------
Cocaine Dependence

Intervention / Treatment
-----------------
* Drug: levodopa/carbidopa
* Drug: Ropinirole 2 mg/d
* Drug: Placebo
* Drug: Ropinirole 4 mg/d


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: meet criteria for cocaine dependence seeking treatment for cocaine dependence be in acceptable health based on medical history and physical exam Exclusion Criteria: dependent on drugs other than cocaine, nicotine, marijuana have a medical condition contraindicating treatment with study medications having conditions of probation or parole requiring reports of drug use to officers of the court

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ldopa + ropinirole low dose<br>levodopa/carbidopa 800/200 mg/d plus ropinirole 2 mg/d | Drug: levodopa/carbidopa<br>* 800/200 mg/d<br>* Other names: ldopa;Drug: Ropinirole 2 mg/d<br>* 2 mg/d<br>* Other names: Requip;|
| Active Comparator: ldopa + ropinirole high dose<br>levodopa/carbidopa 800/200 mg/d plus ropinirole 4 mg/d | Drug: levodopa/carbidopa<br>* 800/200 mg/d<br>* Other names: ldopa;Drug: Ropinirole 4 mg/d<br>* 4 mg/d<br>* Other names: Requip;|
| Active Comparator: ldopa<br>levodopa/carbidopa 800/200 mg/d | Drug: levodopa/carbidopa<br>* 800/200 mg/d<br>* Other names: ldopa;|
| Placebo Comparator: placebo<br>Placebo | Drug: Placebo<br>* sugar pill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Use Based on Urine Drug Screening | The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed the 10 Week Trial |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine, cognition, medication, treatment
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
the present randomized placebo-controlled study aimed to evaluate the effect of green tea extract administration on the clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy.

Official Title
-----------------
Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy A Randomized Controlled Trial

Conditions
-----------------
Diabetic Peripheral Neuropathy

Intervention / Treatment
-----------------
* Dietary Supplement: Green tea
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with peripheral neuropathy Exclusion Criteria: Patients under treatment of diabetic peripheral neuropathy. Patients with other causes of peripheral neuropathy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green tea extracts<br>Patients in this arm received green tea extract capsules | Dietary Supplement: Green tea<br>* Green tea extract capsules<br>|
| Placebo Comparator: Placebo<br>Patients in this arm received placebo treatment | Other: Placebo<br>* Placebo containing inert material.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Clinical Scoring System | Improvement describes the difference between baseline and post-intervention outcome parameters | three months |
Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

Detailed Description
-----------------
Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.

Official Title
-----------------
Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Drug: Chlorhexidine gel
* Drug: Placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients in PICU requiring mechanical ventilation Above the age of 3 months Oro or nasotracheal intubation Exclusion criteria: Known hypersensitivity to chlorhexidine Inability to access the oral cavity for any reason Patients with tracheostomy Mechanical ventilation for more than 24 hours prior to PICU admission. Death or extubation within 24 hours of ICU admission.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 15 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Chlorhexidine gel | Drug: Chlorhexidine gel<br>* Oral mucosal application of chlorhexidine gel<br>|
| Placebo Comparator: 2<br>Placebo gel | Drug: Placebo gel<br>* Oral mucosal application of placebo gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic sensitivity of organism cultured |  | 21 days | 
| Duration of hospital stay |  | 21 days | 
| Duration of ICU stay |  | 21 days | 
| In hospital mortality rate |  | 21 days |
18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy. Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy. Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Detailed Description
-----------------
Background: Although 99mTc MDP bone scintigraphy is a sensitive tool for screening metastatic bone status, it is not a satisfactory imaging modality in evaluating residual disease after therapy. 18F-FDG PET has been an effective imaging tool for many malignancies including breast cancer, not only in diagnosis and staging, but also in monitoring response and following up disease status after therapy. Purpose: This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy. Method: Breast cancer patients with bone metastases, age 20-90 year-old, will be included in this study. Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy. Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Official Title
-----------------
The Effectiveness of 18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.

Conditions
-----------------
Breast Cancer, 18F-FDG PET

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age：20-90 years old Histological proven breast cancer, with known metastatic bone lesion(s) written informed consent signed Exclusion Criteria: pregnant or intend to be pregnant other malignancies known

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Histological proven breast cancer with bone lesion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The uptake of 18F-FDG PET. |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer; bone metastases; 18F-FDG PET; 99mTc bone scintigraphy; therapy response monitoring; prognosis
Pharmacogenetic and Antidepressant Treatment in Elderly

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the therapeutic benefits of the adaptation of the antidepressant dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients. Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the action time and the after effects.

Official Title
-----------------
Pharmacogenetic in the Therapeutic Strategy in Depressed Elderly

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Biological: urine analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current major depressive disorder antidepressant treatment Exclusion Criteria: dextromethorphan contra-indication other psychiatric disorder kidney failure liver failure mini mental State Examination (MMSE)<18

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adapted treatment<br>the treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis | Biological: urine analysis<br>* a sample of urine is collected during 8 hours.<br>|
| Experimental: non-adaptated treatment<br>the treatment dose is adapted to the metabolic capacity of the patient. intervention: urine analysis | Biological: urine analysis<br>* a sample of urine is collected during 8 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient remission | remission is defined by a Montgomery and asberg depression rating (MADRS) score<10. | 6 months |