linjc16/ctgov huggingface dataset:
Thickness of Retinal Layers in Amblyopia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine retinal layer thickness in amblyopia.

Detailed Description
-----------------
Amblyopia is a visual disorder characterized by a reduction of vision that cannot be immediately improved by refractive correction or accounted for by clinically determined anatomic defects of the eye or visual pathway. Evidence for direct retinal changes in eyes with amblyopia has been controversial. It has been hypothesized that amblyopia may affect the postnatal maturation of the retina including the postnatal reduction of retinal ganglion cells. However, although some studies have found incrased retinal nerve fiber layer thickness in amblyopic eyes, others have found no significant differences. This sutdy will examine the retinal layer thickness in amblyopia and compare the retinal layer thickness between amblyopic eyes and nonamblyopic fellow eyes.

Official Title
-----------------
Analysis of Spectral Domain Optical Coherence Tomography Measurements in Amblyopia

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Other: Optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Amblyopia Exclusion Criteria: Other retinal disease Anisometropia Neurologic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 19 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 |
| --- | --- |
| Retinal layer thickness analysis<br>Optical coherence tomography will be conducted to analyze retinal layer thickness (safe examination) | Other: Optical coherence tomography<br>* Spectral domain optical coherence tomography will be conducted once when patients are enrolled.<br>* Other names: Spectralis Optical coherence tomography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal layer thickness | Optical coherence tomography scan will be conducted to analyze retinal layer thickness, when the patient are enrolled. | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amblyopia, Retinal layer thickness
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.

Detailed Description
-----------------
The primary objective of this study is to demonstrate the safety of the use of intra-operative ultrasound contrast (Definity®) administration. The secondary objective of this study is to demonstrate the improved image quality and conspicuity of known liver tumors using contrast enhancement.

Official Title
-----------------
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors

Conditions
-----------------
Liver Tumors

Intervention / Treatment
-----------------
* Drug: Definity®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor: ≥ 18 years of age If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits. IRB-approved informed consent, signed by the subject or the subject's legally authorized representative. ≥ 18 years of age Exclusion Criteria: 1. Not a suitable candidate for operation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Definity Contrast Dye<br>During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors | Drug: Definity®<br>* Definity® injections given both pre-ablation and post-ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 6-weeks post surgery | 
| identification of liver tumors |  | intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved ablation of liver tumors |  | 6-weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Definity, liver tumors, intra operative contrast, liver cancer, hepatic tumors, identify liver tumors, surgery liver tumors, Patients with known hepatic tumors
Discordant HER2/Neu Status of Breast Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine discordant HER2/neu status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.

Detailed Description
-----------------
HER2/neu status of primary breast tumor and axillary lymph nodes were tested by IHC staining. In the cases of equivocal result of IHC, FISH test were performed. The result of HER2/neu status between primary breast tumor and axillary lymph node were analyzed.

Official Title
-----------------
Discordant HER2/Neu Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.

Conditions
-----------------
Malignant Neoplasm of Breast.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients stage I,II and III with axillary lymph nodes metastasis. Exclusion Criteria: Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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 |
| --- | --- |
| Primary Breast Tumor<br>Primary breast tumor were test for HER2/neu status. | |
| Axillary Lymph Nodes.<br>Axillary Lymph Nodes were tested for HER2/neu status. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of HER2/neu status between primary breast tumor and axillary lymph nodes | Association of HER2/neu status between primary breast tumor and axillary lymph nodes was analyzed by using the χ2 test | up to 1 year |
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether simvastatin is effective in the improvement of IVF-ICSI outcome in Pcos patients.

Detailed Description
-----------------
simvastatin reduces cardiovascular risks by improving hypercholesterolemia, reducing vascular smooth muscle proliferation, ameliorating inflammation, limiting theca-interstitial proliferation & decreasing steroidogenesis (production of progesterone & testosterone).Polycystic ovary syndrome (pcos) is associated with increased cardiovascular risks and is characterized by ovarian theca-interstitial hyperplasia& hyperandrogenism .This study will test the hypothesis that simvastatin improves biochemical parameters& IVF-ICSI outcome in Pcos patients.

Official Title
-----------------
Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients : A Prospective Randomized Double Blind Placebo Controlled Trial

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: SIMVASTATIN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pcos patients Age <40 years FSH<10 IU/L Exclusion Criteria: Endometriosis grade 3 &4 History of tubal surgery Hydrosalpinx History of mellitis diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: SIMVASTATIN<br>* 20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used<br>|
| Placebo Comparator: B<br> | Drug: SIMVASTATIN<br>* 20 mg/day,po,for two months until the day of hCG injection placebo pills as like as simvastatin will be used<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ivf-et outcomes |  | 14-20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical parameters baseline and 8weeks Biochemical parameters |  | baseline and 8weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pco, simvastatin, ivf, embryo transfer
Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent chemo-radiotherapy is necessary if the patients have high-risk factors, including positive surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.

Detailed Description
-----------------
In the present study, the patients with stage Ib2-IIa2 cervical cancer will receive either neoadjuvant chemo/brachytherapy or neoadjuvant chemotherapy before radical hysterectomy and pelvic+/- para-aortic lymph node dissection. According to the surgical findings, post-operative chemo-radiotherapy will be performed.

Official Title
-----------------
Comparative Study of Neoadjuvant Chemo/Brachytherapy and Chemotherapy Alone Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Radiation: combination group
* Drug: chemotherapy group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histology confirmed cervical cancer Clinical stage Ib2 or IIa2 (FIGO 2009) Exclusion Criteria: Patients who not suitable for surgery Personal history of pelvic radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemo/brachytherapy<br>Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) and brachytherapy before radical hysterectomy. | Radiation: combination group<br>* chemotherapy (paclitaxel/cisplatinum) and brachytherapy<br>|
| Active Comparator: chemotherapy<br>Patients in this arm will receive neoadjuvant chemotherapy (paclitaxel/cisplatinum) before radical hysterectomy. | Drug: chemotherapy group<br>* chemotherapy: (paclitaxel/cisplatinum)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of post-operative chemo-radiotherapy |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease-free survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoadjuvant chemotherapy, brachytherapy, radiotherapy
A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)

Study Overview
=================
Brief Summary
-----------------
A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a) levels.

Conditions
-----------------
Elevated Lp(a)

Intervention / Treatment
-----------------
* Drug: TA-8995
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels Exclusion Criteria: Clinically significant medical history Abnormal laboratory results (other than lipid levels) or vital signs Receiving any other drug therapy

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10mg TA-8995<br>10mg TA-8995 once daily | Drug: TA-8995<br> <br> |
| Experimental: 2.5mg TA-8995<br>2.5mg TA-8995 once daily | Drug: TA-8995<br> <br> |
| Placebo Comparator: Placebo to TA-8995<br>Placebo to TA-8995 once daily. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 12 weeks |
Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma

Study Overview
=================
Brief Summary
-----------------
The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy. This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.

Official Title
-----------------
A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Previously untreated follicular NHL Stage III or IV disease requiring treatment Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin) Able to provide tumor sample adequate for Id-KLH manufacture ≥ 18 years of age At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of the Effect of Output on Skin Covered by a New Adhesive

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive

Official Title
-----------------
Evaluation of the Effect of Output on Skin Covered by a New Adhesive

Conditions
-----------------
Ileostomy - Stoma

Intervention / Treatment
-----------------
* Other: New adhesive strip
* Other: Standard adhesive strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had an ileostomy for more than one year Have intact skin on the area used in the evaluation Has an ileostomy with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) - Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) Participating in other interventional clinical investigations or have previously participated in this evaluation

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 9<br>This is a sub-study testing the effect of real output applied under two adhesive strips on the skin. Standard adhesive strip and a strip with a newly developed adhesive (new adhesive strip) | Other: New adhesive strip<br>* This is a strip made of a newly developed adhesive. This adhesive might in the future be part of an ostomy product.<br>Other: Standard adhesive strip<br>* this is a standard adhesive strip (hydrocolloid). This adhesive is currently used in marketed ostomy devices.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans epidermal water loss | The condition of the skin is measure by trans epidermal water loss after removing the adhesive strip. | 6 hours |
Sniper Intubation for Training of Undergraduate Medical Student

Study Overview
=================
Brief Summary
-----------------
Students trained to focus on vocal cord before intubation

Detailed Description
-----------------
Student trained to spray vocal cords with 3 ml normal saline over 30 seconds before intubation then allow them to introduce endotracheal tube

Official Title
-----------------
Sniper Intubation for Training of Undergraduate Medical Student Randomized Controlled Trial

Conditions
-----------------
Intubation;Difficult

Intervention / Treatment
-----------------
* Other: Intubation on manikin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medical student Exclusion Criteria: previous training on endotracheal intubation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group S<br>Spray before intubation | Other: Intubation on manikin<br>* Training of medical student to focus on manikin vocal cord before intubation<br>* Other names: Simulator;|
| Group C<br>Intubation directly | Other: Intubation on manikin<br>* Training of medical student to focus on manikin vocal cord before intubation<br>* Other names: Simulator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful intubation |  | Less than 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts |  | 120 seconds | 
| Time to intubation |  | 120 seconds |
Buprenorphine Combination Tablet Feasibility - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine target dose range of buprenorphine/naloxone combination tablet that provides therapeutic response in opiate addicts with low to moderate dependence, and to identify appropriate initial induction dose in opiate addicts with low to moderate dependence.

Official Title
-----------------
Buprenorphine Combination Tablet Feasibility

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine/naloxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males/Females ages 21-50, opiate dependence according to DSM-IV criteria, self-reported use within the last 30 days, agreeable to conditions of study and signed informed consent Exclusion Criteria: Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine/naloxone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal symptoms |  |  | 
| Opiate use |  |  | 
| Opiate craving |  |  |