linjc16/ctgov huggingface dataset:
The Use of a Language Toolkit for Toddlers

Study Overview
=================
Brief Summary
-----------------
To investigate whether young children with isolated expressive language delay benefit from early intervention with a simple language toolkit and brief instructions provided to their caregivers. We hypothesize that children whose families are provided the language toolkit will develop more words over the subsequent 3 months.

Official Title
-----------------
Two to Talk: The Use of a Language Toolkit for Toddlers

Conditions
-----------------
Language Acquisition

Intervention / Treatment
-----------------
* Behavioral: Language toolkit
* Behavioral: Safety counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 14.5 to 18.5 months Below average expressive language Otherwise normal development Exclusion Criteria: Other developmental delay Non-English primary language

Ages Eligible for Study
-----------------
Minimum Age: 14 Months
Maximum Age: 19 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Language Toolkit<br>Language toolkit composed of simple tools that parents can use to interact with child and help language acquisition. | Behavioral: Language toolkit<br>* Simple toolkit of interactive things to stimulate language.<br>|
| Placebo Comparator: 2<br>Safety counseling and smoke detector | Behavioral: Safety counseling<br>* Smoke detector and general safety counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Language/Words acquisition |  | 3 months |
Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
This research will provide data on thermal condition of medical workers who use personal protective equipment from biological hazards. Aquired data will be used to define acceptable period of use for these protective costumes. This research will recruit 6 volunteers. During 6 hours each subject will perform their work using protective costume. Heart rate, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations.

Official Title
-----------------
Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients

Conditions
-----------------
Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients

Intervention / Treatment
-----------------
* Other: Personal protective equipment from biological hazard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals (based on medical screening) Exclusion Criteria: endocrinological diseases and disorders health deviations at the time of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Health workers<br> | Other: Personal protective equipment from biological hazard<br>* Includes: isolation clothing, mask, eyewear, overshoes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin thermometry | DS1923-F5 Thermochron iButtons | 6 hours | 
| Hygrometry under costume | DS1923-F5 Thermochron iButtons | 6 hours | 
| Heart rate | A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research | 6 hours | 
| Air thermometry | Meteoscop - M | 6 hours | 
| Air hygrometry | Meteoscop - M | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thermophysiology, Personal protective equipment from biological hazards, Medical workers, COVID-19
Feasibility and Functionality of fPAM Imaging in Melanoma

Study Overview
=================
Brief Summary
-----------------
Melanoma is a cutaneous malignancy that has the potential for local (skin) and regional (lymph node) recurrence. These recurrences may be difficult to detect in their earliest stages. We are attempting to use novel form of skin imaging that uses ultrasound combined with laser to identify these recurrences early, when they may be most amenable to treatment. This imaging will detect melanoma pigment below the surface of the skin and in the draining lymph nodes, as well as new blood vessel formation that occurs with these loco-regional metastases.

Detailed Description
-----------------
recruiting healthy individuals with pigmented lesions and individuals with melanoma and pigmented lesions

Official Title
-----------------
Determine the Feasibility and Functionality of fPAM Imaging for the in Vivo Characterization and Early Diagnosis of Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 yrs of age) with recently diagnosed or a history of, Stage I - III melanoma who are able to give informed consent. Exclusion Criteria: Patients with melanomas < 1mm. Pregnant females. Children and young adults < 18 yrs of age and patients who are unable to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| fPAM is a hybrid imaging technique that detects absorbed diffuse photons ultrasonically through the photoacoustic (PA) effect | Evaluate pigmented lesions for depth, width, total hemoglobin saturation, melanin distribution, and melanin concentration using fPAM in vivo and ex vivo | baseline |
A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women

Study Overview
=================
Brief Summary
-----------------
This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.

Official Title
-----------------
A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women

Conditions
-----------------
Effect of Diet on Breast Milk Composition

Intervention / Treatment
-----------------
* Other: Mediterranean Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≤4.5 months postpartum BMI 30 - 50 kg/m2 ≥ 18 years of age Singleton pregnancy Exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum Mother has a breast pump Mother is willing to collect breast milk for a 24 hour period. Exclusion Criteria: Pre-existing conditions (e.g. diabetes, hypertension, heart disease) Use of recreational drugs, tobacco, or alcohol Use of medications or supplements for which breastfeeding is contraindicated Child has internal metal which may be an NMR safety concern

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

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

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

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: Mediterranean Meal Plan<br>This is a single arm study in which participants will receive meals that follow a Mediterranean diet plan for 4 weeks. Breast milk samples will be collected before, during, and after the intervention period. | Other: Mediterranean Diet<br>* Participants will be provided with meals that follow a Mediterranean meal plan.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breast milk fat concentration by mid-infrared spectroscopy | The primary aim is to test whether the dietary intervention modifies the breast milk fat concentration of obese mothers. | The change in breast milk fat concentration will be assessed by mid-infrared spectroscopy by measuring the concentration before the participants begin the dietary intervention, 2 weeks into the intervention, and at the end of the 4-week intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Milk, Mediterranean Diet
Epidermoid Cancer Development in Esophageal Achalasia

Study Overview
=================
Brief Summary
-----------------
Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

Detailed Description
-----------------
In order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. The local institutional review board approved using the database from the division of thoracic surgery for research purposes. Clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.

Official Title
-----------------
Incidence and Risk Factors for Development of Epidermoid Carcinoma in Esophageal Achalasia

Conditions
-----------------
Achalasia, Epidermoid Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Clinical instrumental examinations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry Exclusion Criteria: pseudoachalasia
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Clinical instrumental examinations|Achalasia patients were periodically submitted to clinical assessment, barium swallow (esophageal diameter and residual barium column were measured), endoscopy. Mucosal esophageal biopsies were taken in order to diagnose dysplasia or epidermoid carcinoma.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of epidermoid carcinoma of the esophagus | Detection of epidermoid carcinoma of the esophagus by means of upper GI endoscopy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of achalasia treatment by investigating dysphagia and gastro-esophageal reflux | Result of achalasia treatment assessed by means of semiquantitative grading scales of dysphagia and gastro-esophageal reflux | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidermoid carcinoma, esophageal achalasia, risk factors
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.

Official Title
-----------------
Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: imatinib mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with age between 18 and 80 years diagnosis of GIST not previously treated Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function) Exclusion criteria: presence of metastatic disease use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy) Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imatinib<br> | Drug: imatinib mesylate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response using the RECIST criteria |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 16 weeks | 
| Time and duration of response |  | 16 weeks | 
| Time to treatment failure |  | 16 weeks | 
| Overall survival |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stromal,, Gastrointestinal,, neoadjuvant,, imatinib,, mesylate,, pre-operatory
Trial of PED-1 in Male Patients With Premature Ejaculation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.

Detailed Description
-----------------
This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be > or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Fixed Dose, Parallel Grouped, Multi-center Clinical Study to Evaluate the Safety and Efficacy of PED-1 in Male Patients With Premature Ejaculation

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: Clomipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent for subjects and partners Men 20-65 ages Stable monogamous relation at least for 6 mo Premature Ejaculation Diagnosis Tool (PEDT) more than 9 At least 6 mo of premature ejaculation Hx IELT of =< 2 min in >= 75% of evaluable events during 4 week screening period Exclusion Criteria: History of medical or psychiatric illness Erectile dysfunction (<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction Partner sexual dysfunction Known hypersensitivity to clomipramine and contraindications for clomipramine

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| Experimental: PED-1<br>PED-1 (Clomipramine 15 mg) | Drug: Clomipramine<br>* Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks<br>* Other names: PED-1;|
| Placebo Comparator: placebo<br> | Drug: Clomipramine<br>* Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks<br>* Other names: PED-1;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravaginal ejaculation latency time (IELT)(seconds) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug coitus interval time (hours) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PE, IELT, DCIT
Professional Bladder Cancers and the Profession of Painter

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study on bladder cancer in French painters' population. The French agency ANSES collected data from all occupational and environmental diseases center in a specific database called RNV3P. We selected cases of bladder cancer in painters in four centers from 01/01/2010 to 31/12/2019. Those cases were analyzed in terms of occupational exposure, histology and sociodemographics data. Comparison between different histologic types of cancer, workplaces and occupational diseases process will be done.

Official Title
-----------------
Professional Bladder Cancers and the Profession of Painter: Retrospective Study of the RNV3P Database Files

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: painters age> 18 years data from one of the French occupational diseases centers approval letter Exclusion Criteria: non-approval letter age < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| histological type of bladder cancer | international classification of bladder cancer TNM and histology | Inclusion ( Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occupational exposures | chemical exposures and workplaces during occupational painting activities | Inclusion (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
painter, occupational cancer
Olfactory Function Following Endoscopic Endonasal Skull Base Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a subject's sense of smell before and after endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory process, fracture, defect, etc.) and use the information collected to validate approaches to surgery that will minimize side effects to the sense of smell function. Data will be collected using a smell identification test along with two questionnaires. In addition, demographic, medical history, treatment, outcome, and follow-up information will be collected.

Official Title
-----------------
Olfactory Function Following Endoscopic Endonasal Skull Base Surgery: Clinical and Histological Outcomes

Conditions
-----------------
Skull Base Pathology

Intervention / Treatment
-----------------
* Procedure: endoscopic endonasal surgery with UPSIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with skull base pathologies requiring endonasal surgery at The Ohio State University Wexner Medical Center 18 years or older Able to consent for self Negative serum pregnancy test for women of childbearing potential Exclusion Criteria: Patient unable to return to clinic at specific follow-up times Pregnant or nursing Prisoners

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endoscopic endonasal surgery with UPSIT<br>endoscopic endonasal surgery with UPSIT prior to surgery and at months 1, 3, 6, and 12 after surgery. | Procedure: endoscopic endonasal surgery with UPSIT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with decreased olfactory function after endoscopic endonasal surgery | The subject will complete 2 questionnaires and the University of Pennsylvania Smell Identification Test (UPSIT) at baseline (pre-surgery) and at 1, 3, 6, and 12, months post surgery to determine if the sense of smell has been altered from surgery. | up to 12 months post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tumor, inflammatory process, fracture, defect