linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.

Official Title
-----------------
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Focalin XR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of ADHD Males and females aged 6-12 Exclusion Criteria: Inability of understand or follow instructions Is pregnant Diagnosis of tic disorder History of seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Focalin XR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in attention and deportment measured at 2 hours post-dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose |  |  | 
| Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline |  |  | 
| Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, children
Outcome of Proximal Humerus Fractures :Anatomic Neck Fractures vs Surgical Neck Fractures

Study Overview
=================
Brief Summary
-----------------
From April ,2014 to April 2015,31 patients with fractures of the proximal humerus were treated in our hospital. According to anatomic neck fractures (ANF) and surgical neck fractures (SNF), we divided the patients into two groups. All the patients were followed at least 1 year.

Conditions
-----------------
Humeral Fracture, Proximal, Internal Fixation; Complications, Mechanical, Bones of Limb

Intervention / Treatment
-----------------
* Procedure: Locking plates were used for proximal humeral fractures.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -From May ,2013 to April 2015, patients with fractures of the proximal humerus who were treated with locking plate. Exclusion Criteria: Patients had pathologic fractures, Patients had previous surgery on the affected shoulder, Patients were treated with shoulder arthroplasty. Patients were treated with intramedullary nail.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| ANF<br>anatomic neck fractures of proximal humerus | Procedure: Locking plates were used for proximal humeral fractures.<br> <br> |
| SNF<br>surgical neck fractures of proximal humerus | Procedure: Locking plates were used for proximal humeral fractures.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of head-shaft angle at 12months from 6months in two groups |  | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Offset at 12months from 6months in two groups |  | 12 months | 
| Constant-Murly scores at 3 months, 12 months and last follow-up |  | 3 months,12 months,last follow-up (last follow-up means recent evaluation before database lock, it is more than 12months ) | 
| change of the distance between the screw tip and the subchondral surface(TSD) at 12months from 6months in two groups |  | 12 months |
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation is to gather data to evaluate the impact of using Eeva with traditional morphology grading on implantation rates.

Detailed Description
-----------------
The purpose of this clinical investigation is to gather data to evaluate the impact of implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (from a concurrent control group).

Official Title
-----------------
US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. IVF cycle attempts ≤ 2. Egg age ≤ 40 years. Planned Day 3 embryo transfer. At least 4 normally fertilized eggs (2PN). All 2PN embryos must be imaged by Eeva. Ejaculated sperm or sperm from the epididymis (fresh or frozen). Willing to comply with study protocol and procedures. Willing to provide written informed consent. Exclusion Criteria: Planned preimplantation genetic diagnosis or preimplantation genetic screening. Planned freeze all cycle (oocytes or embryos). Sperm retrieved from testicular tissue. Abnormal uterine cavity as evaluated by standard methods. Gestational carrier. Endometriosis Hydrosalpinx. History of cancer. Concurrent participation in another clinical study.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eeva Test Group<br>Day 3 embryo transfers that used Eeva with morphology grading (Test Group). | |
| Matched case control group<br>Day 3 embryo transfers using morphology grading only (from concurrent Control Group). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of implantation | To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group). | 5-6 gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate clinical pregnancy rates from the Eeva Test group to the Control group |  | 5-6 weeks gestational age | 
| Ongoing pregnancy rate |  | Gestational age week 8-12 | 
| Multiple pregnancy rate |  | Gestational age weeks 5-6 and 8-12 | 
| Spontaneous miscarriage rate |  | Gestational age week 8-12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

Study Overview
=================
Brief Summary
-----------------
In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing. Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.

Official Title
-----------------
Metabolomics Pilot Study on Postoperative Intensive Care Acquired Muscle Weakness (MIRACLE-I Study)

Conditions
-----------------
Metabolomics, Critical Care, Critical Illness, Critical Illness Myopathy, Critical Illness Polyneuropathy, Intensive Care (ICU) Myopathy, Muscle Weakness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: invasive mechanically ventilated critically ill patient with expected intensive care unit stay > 3 days postoperative patient ≥ 18 years old American Society of Anesthesiology (ASA) classification ≥ III Exclusion Criteria: moribund patient non-curative care (comfort care)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive Care Patients<br>Postoperative high-risk patients who have been admitted to intensive care after surgery | |
| Operative Control patients<br>Elective operative patients where control blood samples and muscle ultrasound will be measured. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomics | Blood Metabolome will be isolated from blood samples. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) using mass spectrometry. | a median of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle histology | Immunohistochemistry will be done in muscle samples. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes. | a median of 14 days | 
| Phosphoproteomics | Phosphoproteomics will be done in muscle samples using mass spectrometry. All samples will be screened for influence of Intensive Care Unit Acquired Weakness (ICUAW) and correlation with blood metabolome changes. | a median of 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pilot trial, muscle biopsy, blood metabolome
Energy Specific Far Infrared Radiation Treatment for Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
A study to determine the possibility of using far infrared radiation to treat Hyperparathyroidism.

Detailed Description
-----------------
Overactive parathyroid glands secrete an excess of parathyroid hormones, resulting in increased levels of calcium in the blood stream, which can lead to weakening of the bones and to kidney stones. We are postulating that the non-invasive energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to stop the over secretion of the parathyroid hormones and normalize the body's metabolic functions.

Official Title
-----------------
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Hyperparathyroidism.

Conditions
-----------------
Hyperparathyroidism

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with parathyroid disease Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Radiation: Far Infrared Radiation<br>* Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is to determine the therapeutic effects of far infrared radiation on Hyperparathyroidism. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of far infrared radiation treatment on other immune deficiency diseases like thyroidism and diabetes |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRIMARY HYPERPARATHYROIDISM, PARATHYROID NEOPLASMS, SECONDARY HYPERPARATHYROIDISM, HYPOCALCEMIA
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.

Study Overview
=================
Brief Summary
-----------------
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults with Generalized Anxiety Disorder.

Official Title
-----------------
A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL Treatment (up to 16 mg/Day) in Adults With Generalized Anxiety Disorder.

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: Gabitril


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects who have completed 10 weeks of double-blind treatment and the subsequent taper period in 1 of the 3 previous double-blind studies (studies C6671/3030/AX/US, C6671/3031/AX/US, or C6671/3032/AX/US).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gabitril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Electronic Cigarette and Surgery (ECigarSurg)

Study Overview
=================
Brief Summary
-----------------
Since decades, literature has shown that smoking has negative effect on postoperative outcome. Recent systematic review and meta-analysis on clinical impact of smoking and smoking cessation showed that postoperative healing complications occur more often in smokers compared with nonsmokers. The use of electronic cigarette (e-cigarette) is spreading through the world. Despite this fact, the health risk assessment studies on e-cigarette are limited and scientific evidences are inconsistent. This prospective multicenter study aimed at assessing the use of e-cigarette whether patient undergoing elective surgery. The main objective of this study was to evaluate the prevalence of e-cigarette consumer in perioperative period. Secondary objectives were to analyze when patients consume e-cigarette in regard of surgery, how many dose they consume and if they also consume nicotine cigarette.

Detailed Description
-----------------
this study used a standardized questionnaire that was filled in preoperative period

Official Title
-----------------
Electronic Cigarette and Perianesthesia : a Prospective Multicentric Survey

Conditions
-----------------
Smoke Inhalation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: protocol approval patients scheduled for elective surgery Exclusion Criteria: < 18 ans refusal not speaking emergency surgery

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| electronic cigarette<br>patient using electronic device, electronic cigarette | |
| control<br>patient not smoking nor using electronic cigarette | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electronic cigarette | incidence of electronic cigarette that are used by patients | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electronic, surgery, outcome, anesthesia, cigarette
Undifferentiated Embryonal Sarcoma of the Liver: Evaluation of the Relapse Profile According to the Therapies Administered

Study Overview
=================
Brief Summary
-----------------
Undifferentiated embryonal sarcoma of the liver is the 3rd most common malignant liver tumor after hepatoblastoma and hepatocellular carcinoma with a peak incidence between 6 and 10 years of age. Historically, it is a tumor treated only by surgery with a poor prognosis. In the last decade, the combination of more intensive chemotherapy and, more randomly, radiotherapy, has significantly improved the survival rate of these patients. Due to its low incidence, there are few series reported in the literature and to date there is no specific treatment protocol for the management of these tumors. It seems appropriate to review the management of these tumors in France in order to discuss the best therapeutic strategy.

Official Title
-----------------
Undifferentiated Embryonal Sarcoma of the Liver

Conditions
-----------------
Hepatic Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Any patient aged 0 to 25 on the date of inclusion in the study Treatment carried out in France (included in NRSTS 2005, in the childhood cancer registry or in an SFCE center) Start of treatment from 01/01/2008 to 31/12/2018 Diagnosis of undifferentiated embryonal sarcoma of the liver defined by a compatible histological analysis Adult subject who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research Minor subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research Exclusion criteria: Refusal to participate in this research Diagnosis of rhabdoid tumor, rhabdomysarcomas, angiosarcomas, PNET Absence of histological and/or molecular documentation.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 25 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the relapse profile of children with undifferentiated hepatic sarcoma according to the therapies received | the primary endpoint is event-free survival (progression, death, relapse) at 3 years. | 3 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embryonal Sarcoma, Embryonic Sarcoma, Hepatoblastoma, Hepatocarcinoma, Hepatic Sarcoma, Undifferentiated (Embryonal) Sarcoma
Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).

Official Title
-----------------
Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Biological: CG1940/CG8711


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of <60%. Exclusion Criteria: Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms) Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment. Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.|
|Biological: CG1940/CG8711|Immunotherapy allogeneic GM-CSF secreting cellular vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Pathological Complete Response. | CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen | The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy. |