linjc16/ctgov huggingface dataset:
SLNM in Endometrial Cancer Combined With OSNA

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with histological ultrastaging examination in the sentinel lymph node assessment in patients with endometrial cancer. The molecular biologic method OSNA is a modern way of metastatic spread detection in lymphatic nodes using quantitative reverse transcription polymerase chain reaction. Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker (detected by OSNA). The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could help to improve the standards of care in endometrial cancer patients.

Detailed Description
-----------------
Method: After the sentinel lymph node detection (ICG, 99m Tc or Bleu Patente) and sentinel node/nodes removal is performed, the node/nodes is/are cut in 2-mm slices parallel to short axis of the node. The odd-numbered blocks will be examined by the OSNA method and the even-numbered blocks will be examined by conventional histopathological methods including immunohistochemistry. Statistical analysis to identify differences will be performed subsequently.

Official Title
-----------------
Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (OSNA)

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Device: RD-100i, OSNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometrial cancer Signed informed consent Exclusion Criteria: Inclusion criteria not met Pregnant patients Patients participating in other clinical studies Patients who have been judged to be an inappropriate candidate by any medical care provider

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| RD-100i, OSNA<br>SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging | Device: RD-100i, OSNA<br>* quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of CK 19 copies detected by OSNA | Number of CK 19 copies will be assessed: 250-5000 micrometastasis, more than 5000 copies macrometastasis. This result will be compared to histological ultrastaging examination. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSNA, sentinel, lymph, node, endometrial, cancer
Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Detailed Description
-----------------
Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

Official Title
-----------------
Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Conditions
-----------------
Myopic Choroidal Neovascularization

Intervention / Treatment
-----------------
* Drug: Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopic CNVM, Exclusion Criteria: Patients with poor compliance Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients). Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved. Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery. Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods. Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR. Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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: 1<br>Myopic eyes with retinal neovascularization | Drug: Injection<br>* Intravitreal injection of 1.25 mg bevacizumab<br>|

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
-----------------
Bevacizumab, Myopia, Complications, Neovascularization, OCT
Bioavailability of the Fixed Combination of Amodiaquine and Artesunate Under Fed & Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
Primary Objective: to evaluate the interaction with food after a single oral dose of a fixed combination of amodiaquine (AQ) and artesunate (AS) (COARSUCAM™) in healthy male subjects Secondary Objective: to assess the clinical and biological safety and tolerability of Coarsucam™

Official Title
-----------------
A Randomized, Open-Label, Cross-Over Study, to Compare the Bioavailability of the Fixed Combination of Amodiaquine and Artesunate (COARSUCAM™) After Single Oral Administration Under Fed and Fasted Conditions in Healthy Subjects

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Artesunate + Amodiaquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Caucasian subjects Weight between 50 kg and 90 kg. 18 ≤ Body Mass Index ≤ 28 kg/m2. 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: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Artesunate + Amodiaquine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics/Time course of the plasma concentrations of AS, AQ & their pharmacologically active metabolites dihydroartemisinin (DHA) & desethylamodiaquine (DSA), used to determine:Tmax, Cmax, t1/2, AUC(0-t) & AUC(0-Inf) for AS, DHA & AQ |  | During all the study conduct | 
| Tmax, Cmax, Truncated AUC(0-10d) for DSA |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability/Adverse events, physical examinations, vital signs including heart rate and blood pressure, ECG and laboratory parameters. |  | From the signature of the informed consent up to the end of the study |
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure

Study Overview
=================
Brief Summary
-----------------
Localization of small femur lesions for resection can be challenging and may be associated with the need for significant fluoroscopic imaging and tissue dissection.

Detailed Description
-----------------
This study was performed to evaluate the use of a radiopaque localizer grid along with methylene blue staining for resection of small femur lesions in children, and to determine this technique's effectiveness at reducing radiation exposure and tissue injury.

Official Title
-----------------
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure in Resection Small Femur Lesions

Conditions
-----------------
Bone Diseases

Intervention / Treatment
-----------------
* Radiation: surgical treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with lesions <20.0 mm Exclusion Criteria: patients with lesions >20.0 mm

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 9 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: surgery group<br>The dissection was continued into the deeper layers until the bone lesion was visualized, and the bone lesion was then thoroughly resected. | Radiation: surgical treatment<br>* Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The times of C-arm fluoroscopy used |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incision length |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiopaque localizer grid, methylene blue, reduce radiation exposure
Amount of Lactose Causing Symptoms in Lactose Intolerant People

Study Overview
=================
Brief Summary
-----------------
The hypothesis underlying this study is that failure to recognise the role of lactose intolerance among patients has led to inappropriate dietary advice and treatment with drugs that contain lactose as a filler. These failures exacerbate symptoms and lead to the unnecessary use of immune suppressant drugs. This study will identify the threshold at which symptoms of lactose intolerance develop, to provide appropriate advice and treatment in the management of patients.

Official Title
-----------------
A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People.

Conditions
-----------------
Lactose Intolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed lactose intolerance demonstrated with a lactose intolerance test. Adherence to a lactose free diet for at least four days before the start of the study. Exclusion Criteria: Failure to adhere to a lactose free diet. People who are on lactose containing medications. Pregnancy. Unwillingness to comply with study outline.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactose Intolerance, Lactose, Threshold
the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake

Study Overview
=================
Brief Summary
-----------------
safe study of Chinese Herbs to Treat Thyroid Diseases With Different Iodine

Detailed Description
-----------------
Based on the previous studies, the research choose the patients with different iodine intake,and improve our original Chinese Herbs thyroid III formula, in order to provide the patients the best individual treatment plan.

Official Title
-----------------
the Effect of Chinese Herbs to Treat Thyroid Diseases With Different Iodine Intake

Conditions
-----------------
Thyroid Diseases

Intervention / Treatment
-----------------
* Drug: chinese herbs-I
* Drug: chinese herbs-II


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with thyroid diseases Exclusion Criteria: not meet the diagnostic criteria,women with pregnancy or lactation ,drug allergy ,need surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high Iodine intake<br> | Drug: chinese herbs-I<br>* two agent per day, twice a day<br>|
| Active Comparator: low Iodine intake<br> | Drug: chinese herbs-II<br>* two agent per day, twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diameter，number of the tumor |  | 3 months |
Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

Study Overview
=================
Brief Summary
-----------------
This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Detailed Description
-----------------
The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Official Title
-----------------
Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: medical abortion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: desires abortion Exclusion Criteria: medically ineligible for procedure

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: medical abortion|medical abortion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability | adverse events | 1 year |
A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin

Study Overview
=================
Brief Summary
-----------------
This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.

Official Title
-----------------
A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects

Conditions
-----------------
Cachexia

Intervention / Treatment
-----------------
* Drug: PF-05230901
* Drug: PF-05230901


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: History of seizures, including childhood seizures. History of movement disorders or related neurological conditions. History of head trauma associated with loss of consciousness.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose<br>6 treated, 3 placebos | Drug: PF-05230901<br>* Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.<br>* Other names: TAM-153;Drug: PF-05230901<br>* Single dose SC<br>* Other names: TAM-163;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events. |  | 35 days | 
| Incidence and severity of clinical laboratory abnormalities. |  | 35 days | 
| Mean change from baseline in vital signs. |  | 35 days | 
| Mean change from baseline in 12-lead electrocardiogram (ECG) parameters. |  | 35 days | 
| Incidence and severity of findings during the neurological examination. |  | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations |  | 14 days | 
| Anti-drug antibodies |  | 35 days | 
| Appetite and food consumption |  | 13 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia
Reducing Indoor Allergen Exposures in Northern Manhattan and the South Bronx

Study Overview
=================
Brief Summary
-----------------
Controlled trial of an intervention to reduce indoor exposures to cockroach allergens among asthmatic children in NYC.

Conditions
-----------------
Asthma, Allergy

Intervention / Treatment
-----------------
* Procedure: Integrated Pest Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Ages 6-18 Doctor-diagnosed asthma Skin-test reactivity to cockroach antigen Daily cockroach sitings in home

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Integrated Pest Management|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
-----------------
Asthma, Allergen, Cockroach
Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.

Detailed Description
-----------------
After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.

Official Title
-----------------
Nasal Intermittent Positive-Pressure Ventilation vs Nasal Continuous Positive Airway Pressure for Twin Infants With Respiratory Distress Syndrome

Conditions
-----------------
Neonatal Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Device: nIPPV
* Device: nCPAP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Twins Clinical diagnosis of mild-moderate respiratory distress syndrome requiring a fraction of inspired oxigen (FiO2 ) <0.40 to keep oxygen saturation of 90%-95% a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram) Exclusion Criteria: pneumothorax pneumomediastinum surgical diseases cardiac diseases intraventricular hemorrage major congenital defects

Ages Eligible for Study
-----------------
Minimum Age: 30 Minutes
Maximum Age: 6 Hours

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nIPPV<br>the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV) | Device: nIPPV<br>* one of the twins was randomly allocated to nIPPV<br>* Other names: nIPPV:Nasal Intermittent Positive Pressure Ventilation;|
| Active Comparator: nCPAP<br>the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP) | Device: nCPAP<br>* another of the twins was allocated to nCPAP<br>* Other names: nCPAP:Nasal Continuous Positive Airway Pressure;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of intubation |  | 48h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of BPD |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory distress syndrome, Nasal Intermittent Positive-Pressure Ventilation, Nasal Continuous Positive Airway Pressure, twin