linjc16/ctgov huggingface dataset:
Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
At present, there is no agreement on the effect of vitamin D level in serum and follicular fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology. This project intends to make a prospective cohort study with large sample, based on a complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET pregnancy outcome. This study is also the first to study the relationship between maternal vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.

Official Title
-----------------
Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer

Conditions
-----------------
Infertility, Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female with only fallopian tube factor or male factor infertility,first IVF/ICSI cycle,18 years old≤age≤35 years old,take a long protocol or super-long protocol,18≤BMI≤25, menstrual regularity(periodic change < 7 days) Exclusion Criteria: Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥2.0 cm, and/or Uterine fibroids located within the endometrium≤1cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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 |
| --- | --- | --- |
| clinical pregnancy rate |  | Until 28 day after embryo transferred |
Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

Detailed Description
-----------------
This is an open-label study to provide expanded access to TAS-102 prior to its commercial availability for patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an anti-epidermal growth factor receptor (EGFR) therapy. Serious adverse event information (whether or not related to TAS-102) as well as reports of pregnancy, overdose, or medication error will reported. In addition, all grades of adverse drug reactions (ADRs, adverse events related to study medication) and any adverse event that results in treatment discontinuation will be recorded as study data on CRFs.

Official Title
-----------------
An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy

Conditions
-----------------
Colorectal Cancer Metastatic

Intervention / Treatment
-----------------
* Drug: TAS-102


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has provided written informed consent Has adenocarcinoma of the colon or rectum Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer ECOG performance status of 0 or 1 Is able to take medications orally Has adequate organ function (bone marrow, kidney and liver) Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control. Exclusion Criteria: Certain serious illnesses or medical condition(s) Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration Has received TAS-102 Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies Is a pregnant or lactating female

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TAS-102|At a dose of 35 mg/m2 administered orally twice daily for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest (1 treatment cycle)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

Study Overview
=================
Brief Summary
-----------------
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.

Detailed Description
-----------------
This study is to determine if intra-operative use of Amnio-Fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.

Official Title
-----------------
A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery

Conditions
-----------------
Larynx Cancer, Pharynx Cancer, Pharyngocutaneous Fistula

Intervention / Treatment
-----------------
* Biological: Dehydrated human amnion/chorion membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication Subject is age 18 or older Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study Exclusion Criteria: Subjects currently enrolled in or planning to enroll in another clinical trial Subjects with a known history of poor compliance with medical treatments Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation Subject has undergone previous pharyngeal reconstructive surgery Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment with Dehydrated Human Amnion Chorion Allograft<br> | Biological: Dehydrated human amnion/chorion membrane<br>* Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft<br>|
| Standard of Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pharayngocutaneous Fistula Development (PCF) | Incidence of PCF developement necessitating intervention within the 60 day time point. | 60 days |
Volumetric Analysis in the Assessment of Therapy Response by CT

Study Overview
=================
Brief Summary
-----------------
To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

Detailed Description
-----------------
To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.

Official Title
-----------------
Volumetric Analysis in the Assessment of Therapy Response by CT

Conditions
-----------------
Multiple Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered and being treated on one of the following therapeutic protocols: 06-043, 07-052, 07-057, 07-112, 07-116, 08-093, and 08-054 Have at least one measurable lesion* as per RECIST criteria situated in lung, liver or lymph node meeting RECIST criteria noted on a baseline CT scan. Baseline** and at least one follow-up CT scan to likely to be obtained at an MSKCC facility All patients must be > or = to 18 years old The measurable lesions are metastatic in the liver, lung and lymph nodes. The algorithms do not distinguish between primary and metastatic disease, therefore, in selected cases, a primary lesion such as in the liver or lung may also be assessed. Baseline CT are prefer but if not able to obtain for volumetric reconstructions follow up studies will still be use for other objectives if the study. Exclusion Criteria: Pregnant or lactating women

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 |
| --- | --- | --- |
| To compare volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Volumetric Analysis, Multiple Diseases
Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Study Overview
=================
Brief Summary
-----------------
Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.

Official Title
-----------------
Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Lapatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HER2 overexpressing inoperable or recurrent breast cancer Exclusion Criteria: Patients with hypersensitivity to lapatinib or any components Pregnant women and women suspected of being pregnant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed TYKERB<br>Patients with HER2 overexpressing inoperable or recurrent breast cancer | Drug: Lapatinib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice |  | 1 year |
The Method to Reduce Displacement of Double-lumen Tube

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to devise the method to reduce displacement of a left-sided double-lumen tube during patient positioning.

Official Title
-----------------
The Method to Reduce Displacement of Double-lumen Tube During Patient Positioning

Conditions
-----------------
Double-lumen Tube Displacement

Intervention / Treatment
-----------------
* Procedure: pillow
* Procedure: neutral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes Exclusion Criteria: intraluminal lesion of left bronchus very distorted anatomy of tracheobronchial tree

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pillow<br>confirmation of double-lumen tube position with a head on a pillow | Procedure: pillow<br>* bronchoscopic confirmation of double-lumen tube position with a head on a pillow<br>|
| Experimental: neutral<br>confirmation of double-lumen tube position in neutral position of a head | Procedure: neutral<br>* bronchoscopic confirmation of double-lumen tube position in neutral position of a head<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tracheal displacement |  | up to 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchial displacement |  | up to 5 minutes |
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.

Official Title
-----------------
A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: atorvastatin
* Drug: dalcetrapib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, 18 to 55 years of age, inclusive Exclusion Criteria: Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient Clinically significant abnormal laboratory values

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>RO5317116/F01 bilayer tablet | Drug: atorvastatin<br>* single dose of atorvastatin on day 1<br>Drug: dalcetrapib<br>* single dose of dalcetrapib on day 1<br>|
| Experimental: B<br>RO5317116/F03 bilayer tablet | Drug: atorvastatin<br>* single dose of atorvastatin on day 1<br>Drug: dalcetrapib<br>* single dose of dalcetrapib on day 1<br>|
| Experimental: C<br>RO5317116/F04 active-coated tablet | Drug: atorvastatin<br>* single dose of atorvastatin on day 1<br>Drug: dalcetrapib<br>* single dose of dalcetrapib on day 1<br>|
| Experimental: D<br>RO4607381/F49 tablet | Drug: atorvastatin<br>* single dose of atorvastatin on day 1<br>Drug: dalcetrapib<br>* single dose of dalcetrapib on day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Dalcetrapib Active Form |  | 3 days | 
| Plasma Concentration of Atorvastatin |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Atorvastatin Metabolites | Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma. | 3 days | 
| Safety: Incidence of Serious Adverse Events |  | 9 weeks |
Predictors of Teen Smoking-cessation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program. It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.

Official Title
-----------------
Predictors of Smoking Cessation Among Teen Smokers

Conditions
-----------------
Cigarette Smoking

Intervention / Treatment
-----------------
* Behavioral: Not-On-Tobacco smoking cessation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages of 13 and 19 Enrolled in the NOT program offered by Nationwide Children's Hospital Currently smoke at least one cigarette per day Exclusion Criteria: Adolescents must be English speaking

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Not-On-Tobacco smoking cessation program|Adolescent quit-smoking program; Not-On-Tobacco|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adolescents that quit/reduce smoking and those who do not quit/reduce. | Primary outcomes will be the number of adolescents who quit or reduced smoking and the number of adolescents who did not quit or reduce. | 8.5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescent quit-smoking program.
Colonic Resections in Patients With Suspected Appendicitis

Study Overview
=================
Brief Summary
-----------------
Although many reports have been published on colonic resections in patients with suspected appendicitis and the diseases that cause the decision to resect the colon have been identified and their proper treatments have been established, there is no report on the risk factors present in converting a simple appendectomy into a major colonic resection. The investigators aimed to identify the risk factors that lead the surgeon to perform a colonic resection in patients undergoing surgery for initially suspected acute appendicitis.

Official Title
-----------------
Risk Factors for Colonic Resections in Patients With Suspected Acute Appendicitis

Conditions
-----------------
Colectomy, Appendicitis

Intervention / Treatment
-----------------
* Procedure: Right hemicolectomy with or without primary anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 15 years of age Male or female Suspected of having acute appendicitis Converted to right hemicolectomy Exclusion Criteria: Patients in whom a right hemicolectomy was planned initially Right hemicolectomy for causes other than suspected acute appendicitis

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Cohort: Patients with colonic resections<br>Colonic resections in patients submitted to appendicectomy for suspected acute appendicitis | Procedure: Right hemicolectomy with or without primary anastomosis<br>* During open classic appendectomy (McBurney incision) the surgeon decided to convert to midline extended laparotomy to perform a right hemicolectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term survival |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute appendicitis, Colonic diverticulitis, Colonic tumors, Colonic resections
Multifunctional Substrate for Early Detection of Oxidative Stress Susceptibility and Application to Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The proposed work is based on the detection of a novel molecule for sensitivity to oxidative stress in humans in venous blood

Detailed Description
-----------------
Since alterations in mitochondrial functions in platelets and lymphocytes have been detected in Parkinson's disease we plan to monitor the metabolism a a new molecule (LTG) in the blood samples of Parkinson's disease patients and compare them to controls. We shall use 10 cc of venous blood and analyze serum, white blood cells and platelets. We shall not extract nor use DNA.The main purpose is to develop a marker for Parkinson's disease in venous blood.

Official Title
-----------------
Multifunctional Substrate for Early Detection of Oxidative Stress Susceptibility and Application to Parkinson's Disease

Conditions
-----------------
Parkinson's Disease, Oxidative Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease Healthy control - Exclusion Criteria: None -

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?
-----------------
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
-----------------
Marker, Parkinson's disease, Oxidative stress