linjc16/ctgov huggingface dataset:
Value of Pleural Lavage Cytology in Resectable Esophageal Carcinoma Eastern Cooperative Thoracic Oncology Projects 2005, ECTOP-2005)

Study Overview
=================
Brief Summary
-----------------
Disease recurrence and metastasis are common after curative treatment for patients with esophageal cancer. Thus, it is important to identify the risk factors to predict disease recurrence and metastasis. Pleural lavage cytology (PLC) is reported to be associated with disease recurrence and patient survival in lung cancer, but the value is unclear in esophageal cancer. The aim of this study is to evaluate the value of PLC in esophageal cancer patient in terms of frequencies, association with patient survival, and efficacy of postoperative treatment.

Detailed Description
-----------------
Pleural lavage cytology will be performed before esophageal resection, and after resection, respectively. Frequency of positive pleural lavage cytology will be determined, and the value of pleural lavage cytology for patients with resectable esophageal cancer will be studied.

Official Title
-----------------
A Prospective Study for Pleural Lavage Cytology in Patients With Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Other: pleural lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: esophageal cancer with histological confirmation before treatment. resectable esophageal cancer with clinical T1-4a/N0-3/M0 staging potential R0 resection no history of other malignancies Exclusion Criteria: severe major organ dysfunction (American society of anesthesiologisits score >3 ) patients underwent ESD or EMR pleural lavage is unavailable due to adhesions
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pleural lavage|pleural lavages before tumor resection and after tumor resecion, respectively|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who had positive pleural lavage cytology | Frequency of positive pleural lavage cytology in resectable esophageal squamous cell carcinoma | July 2022 to July 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time period from date of surgery to the date of death | value of pleural lavage cytology in predict patient survival | July 2022 to July 2026 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous cell carcinoma, Esophagectomy, Pleural Lavage
Advice Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)

Study Overview
=================
Brief Summary
-----------------
A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.

Official Title
-----------------
Prospective Evaluation of the Effectiveness of a Counseling Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)

Conditions
-----------------
Metallic Trace Elements, Metal-type Environmental Pollutants

Intervention / Treatment
-----------------
* Diagnostic Test: Toxseek test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 years old Patient with desire to conceive 1st trimester of pregnancy Patient having been informed of the study and not opposing the use of the data collected Affiliate or beneficiary of a social security scheme Exclusion Criteria: Women under 18 years old 2nd and 3rd trimester of pregnancy Patient objecting to the use of the data collected Protected patient: adult under tutorship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women or woman in desire for conception<br>Towseek test : hair taking different questionnaires : environmental questionnaire, compliance questionnaire | Diagnostic Test: Toxseek test<br>* Hair taking<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice. | The patient will be considered successful for the reduction of the exposure level, if all the metals with a risky exposure level during the 1st screening have gone to an exposure level to be monitored or acceptable during the 2nd screening. | 4 months |
VX-770 Expanded Access Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this expanded access program is to provide VX-770 prior to its commercial availability to people with cystic fibrosis (CF) who have at least one copy of the G551D-CFTR mutation and who are in critical medical need and who are not eligible for participation in other Vertex-sponsored studies.

Detailed Description
-----------------
VX-770, a compound being developed by Vertex Pharmaceuticals Incorporated (Vertex) for the treatment of CF, is an orally bioavailable small molecule that targets the underlying defect in CF, the dysfunctional CFTR protein. In Phase 3 studies of VX-770 in patients with CF and a G551D CFTR mutation, improvements in CFTR function (measured by reduction in sweat chloride concentration) and improvements in lung function were observed. Patients who are interested in the VX-770 Expanded Access should contact their CF physician about participation. Physicians interested in participating as a site should contact 800-745-4484.

Official Title
-----------------
VX-770 Expanded Access Program (EAP)

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: VX-770


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female with confirmed diagnosis of CF, with a sweat chloride >60 mmol/L OR 2 CF-causing mutations AND chronic sinopulmonary disease OR gastrointestinal/nutritional abnormalities. Have the G551D-CFTR mutation in at least 1 allele Will be aged 6 years or older on the date of signed informed consent form Highest FEV1 in the 6 months prior to screening is ≤ 40% predicted value or patient is documented to be active on the lung transplant wait list Exclusion Criteria: If female, currently pregnant Abnormal liver function, at screening on recent clinical laboratory testing, defined as >3 × upper limit of normal (ULN), of any 3 or more of the following: AST, ALT, GGT, serum alkaline phosphatase, total bilirubin Is currently requiring invasive mechanical ventilation Is currently participating, or has participated in the past 30 days in another therapeutic or clinical study

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VX-770|150 mg tablet, oral use, twice daily every 12 hours (q12h)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Correlation Between Visual Field Defects on FORESEE HOME and on Optical Coherence Tomography in Choroidal Neovascularization Subjects

Study Overview
=================
Brief Summary
-----------------
The FORESEE HOME is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee HOME demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV. The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices. The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Official Title
-----------------
Correlation Between Visual Field Defects on Home Macular Perimeter (FORESEE HOME) and on OCT in Eyes of Patients With CNV Before and After Treatment

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable and willing to sign a consent form and participate in the study Subjects diagnosed with CNV Did not perform more then 4 anti- VGEF injections VA with habitual correction better then 6/45 in the study eye Ability to understand instructions Familiar with computer usage Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye Participation in another study with the exclusion of AREDS study

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| CNV subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size and location of lesions |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HMP, CNV, AMD, PHP, HPHP, foresee home
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema

Study Overview
=================
Brief Summary
-----------------
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Icatibant subcutaneous injection 30 mg syringe and to check if Icatibant subcutaneous injection 30 mg syringe improves acute attacks of HAE. During the study, pediatric participants with HAE will take Icatibant subcutaneous injection 30mg syringe according to their clinic's standard practice. The study doctors will check for side effects from Icatibant subcutaneous injection 30 mg syringe for 3 months.

Official Title
-----------------
Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects With Hereditary Angioedema (All-Case Investigation)

Conditions
-----------------
Hereditary Angioedema (HAE)

Intervention / Treatment
-----------------
* Drug: Icatibant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All participants with HAE who are 2 to <18 years of age, treated with Icatibant subcutaneous injection 30 mg syringe for the first time. Exclusion Criteria: - Participants who have been treated with Icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| Icatibant<br>Participants will be recieved Icatibant 10 to 30 mg injection subcutaneously. | Drug: Icatibant<br>* Icatibant, 10 to 30 mg, Subcutaneous injection<br>* Other names: FIRAZYR Subcutaneous Injection 30mg Syringe;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) |  | Up to 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from Onset of Seizure to Start of Treatment | Time from onset of seizure to the first drug administration will be assessed. | Up to 3 Months | 
| Time from First Drug Administration to Symptom Resolution | Time from the first drug administration to complete resolution of all symptoms of HAE will be assessed. | Up to 3 Months | 
| Duration of Seizure | The time from the start of the seizure to the disappearance of all symptoms will be assessed. | Up to 3 Months |
Cutaneous Squamous Cell Carcinoma Staging Study

Study Overview
=================
Brief Summary
-----------------
Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer, and one of the most common cancers worldwide. The majority of CSCCs are easily removed by surgery and have excellent prognosis. However, a small subset has poor outcomes, including secondary spread in the body (metastasis) and death. The investigators will look at existing CSCC in people from two UK dermatology centres. The investigators will then evaluate the accuracy of current staging systems in predicting risk of poor outcomes in people. The investigators hope that this project will improve the management of patients with CSCC by validating the predictive power of currently available histological staging classifications for cSCC. In the second stage of the study, The investigators will see whether better prediction tools can be found.

Official Title
-----------------
Comparison of the Prognostic Capacity of Existing Staging Systems for Cutaneous Squamous Cell Carcinoma

Conditions
-----------------
Cutaneous Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Other: This is not an interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old with diagnosis of CSCC Exclusion Criteria: Patients who decline for their data to be used for research purposes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: This is not an interventional study|This is not an interventional study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence or metastasis | Proportion of patients developing cutaneous squamous cell carcinoma locoregional recurrence, nodal or distant metastases | 4 years |
Study Evaluating Multiple Oral Doses of PPM-204 in Healthy Japanese Male Subjects

Study Overview
=================
Brief Summary
-----------------
A study evaluating the safety and pharmacokinetics of multiple oral doses of an investigational oral diabetic agent when given to healthy Japanese male volunteers.

Official Title
-----------------
A Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Ppm-204 Administered Orally to Healthy Male Japanese Subjects

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: PPM-204


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, aged 20 to 45 years, inclusive Body mass index in the range of 17.6 to 26.4 kg/m2 Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG) Exclusion Criteria: History of cardiac, thyroid, muscle, and kidney abnormalities History of NSAID induced bronchospasm or asthma History of any clinically important allergies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PPM-204|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics/Pharmacodynamics |  |  |
Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify and confirm new blood and tissue markers for prognosis and tumor hypoxia. Tumor hypoxia, or the condition of low oxygen in the tumor, has been shown to increase the risk of tumor spread and enhance tumor resistance to the standard treatment of radiation and chemotherapy in head and neck and lung cancers. We have recently identified several proteins or markers in the blood and in tumors (including osteopontin, lysyl oxidase, macrophage inhibiting factor and proteomic technology) in the laboratory that may be able to identify tumors with low oxygen levels or more aggressive behaving tumors.

Detailed Description
-----------------
The endpoints of the study are To validate the prognostic significance of OPN in H&N and lung cancer patients and to monitor its level during active therapy and follow up for cancer surveillance. To identify a gene and protein signature for hypoxia in H&N and lung cancer patients.

Official Title
-----------------
Identification of Secreted Markers for Tumor Hypoxia in Patients With Head and Neck or Lung Cancers

Conditions
-----------------
Head and Neck Cancer, Lung Cancer, Lip Cancer, Lip Neoplasms, Head and Neck Cancers

Intervention / Treatment
-----------------
* Procedure: Tumor biopsy
* Procedure: Phlebotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck sites or non-small cell lung cancer, or relatives of patients with histologically confirmed squamous cell carcinoma of the head and neck. Able to sign a Stanford IRB approved consent form Exclusion criteria: Refuse or unable to sign an IRB approved consent form. Refuse to be contacted in the future for 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

| Intervention/Treatment |
| --- |
|Procedure: Tumor biopsy|For patients who undergo tumor biopsy or resection at Stanford, approximately 500 mg of the tumor will be removed from the resection specimen|
|Procedure: Phlebotomy|Blood draw (approximately 20 cc) prior to any anticancer therapy Weekly blood draw (approximately 20cc) only for patients who are undergoing radiation treatment at Stanford University|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Secreted Markers for Tumor Hypoxia through tissue collection |  | before therapy, weekly during therapy |
A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether metronidazole 10% ointment , applied topically three times a day in and around the anus, on the reduction of pain following haemorrhoidectomy.

Official Title
-----------------
Phase 2 Study Evaluation of Topical 10% Metronidazole Ointment for the Reduction of Pain After Haemorrhoidectomy

Conditions
-----------------
Haemorrhoidectomy

Intervention / Treatment
-----------------
* Drug: Metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have Grade 3 or 4 haemorrhoids (external disease with or without significant internal component) Be scheduled for diathermy haemorroidectomy with ≥2 quadrant involvement Be medically fit for surgery Subjects must be aged 18 years or over and of the legal age of consent. If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study. Must have provided written informed consent to participate. Exclusion Criteria: They have had surgery to the anus or rectum in the past 8 weeks Suffer from a chronic pain syndrome which requires regular narcotic analgesia Have anal fissures Have diagnosed Crohn's disease Allergic to metronidazole Are taking any prohibited medication. Deemed mentally incompetent Considered by their physician unlikely to be able to comply with the protocol. Taken part in an experimental drug study in the preceding three months.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole<br> | Drug: Metronidazole<br>* 10% ointment, three times daily for 14 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Metronidazole<br>* 10% ointment, three times daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to evaluate the efficacy of 10% metronidazole ointment in reducing post-operative pain associated with haemorrhoidectomy as compared to placebo. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate and compare the expected pain following haemorrhoidectomy in the treatment and placebo groups. overall patient satisfaction with the operation. the number of analgesics required post-operatively the time taken to return to work and/or |  | 56 days |