linjc16/ctgov huggingface dataset:
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

Study Overview
=================
Brief Summary
-----------------
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.

Official Title
-----------------
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: polyethyleneglycol3350


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients between the ages of 4 to 16 years. Adolescent female patients must not be pregnant or lactating. constipated according to ROME I definition Two or fewer bowel movements during the initial observation week. Absence of a stool impaction Bowel movement after receiving enema Are otherwise in good health, as judged by a physical examination. Parent or guardian is mentally competent to sign an instrument of informed consent Exclusion Criteria: Patients with heme positive stool at baseline exam. Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam Patients with known or suspected perforation or obstruction other than fecal impaction. Patients who are breastfeeding, pregnant or intend to become pregnant during the study. Female patients of childbearing potential who refuse a pregnancy test. Patients with a known history of organic cause for their constipation. Patients with congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases). History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy. Use of concomitant medications that cause constipation Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures. Patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications. Patients with clinically significant elevations of TSH or abnormal plasma electrolytes. Patients who, within the past 30 days have participated in an investigational clinical study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: polyethyleneglycol3350|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greater than 2 bowel movements per week |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of individual ROME I criteria |  |  | 
| Safety (adverse event and laboratory testing) |  |  |
Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors For The Treatment Of Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.

Detailed Description
-----------------
The primary objective of the protocol is to evaluate the toxicity and tolerability of this mixed chimerism matched unrelated donor allogeneic transplant approach for patients with multiple myeloma. Response, toxicity, survival and graft-versus-host disease will be evaluated.

Official Title
-----------------
Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors for the Treatment of Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Autologous followed by non-myeloablative allogeneic transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:a) Multiple myeloma which is responsive to therapy. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease. Patients who have relapsed following autologous transplantation may be eligible for this protocol. b) Age <= 60 years. c) No prior therapy which would preclude the use of low-dose total body irradiation. d) Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or amyloidosis will be excluded from this study. e) Patients must have a Karnofsky performance status > 70%. f) DLCO >= 60% predicted. g) ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl. h) Serum creatinine < 2.0 or 24-hour creatinine clearance >= 50 ml/min. i) Patients must be HIV negative. j) Pregnant or lactating women will not be eligible to participate. k) Patients must provide signed, informed consent. Exclusion Criteria:a) Severe psychological or medical illness b) Patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study. c) Patients who have an HLA-identical sibling donor will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Autologous followed by non-myeloablative allogeneic transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants. |  |  |
Understanding of Genetic Risk Information for Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This research study is being conducted to learn about how health and genetic literacy (i.e., how well a person understands health and genetic information) affects a person's ability to understand genetic risk information for Type 2 diabetes and whether that person chooses to change their lifestyle and health behaviors to reduce their risk. The investigators also want to learn if the manner in which the genetic risk information is communicated affects the level of understanding and potential behavior changes. Participants will be tested for genetic risk of developing Type 2 diabetes and will received results either via a web-based computer program, or in-person from a genetic counselor.

Official Title
-----------------
Implications of Health and Genetic Literacy for Genomic Medicine

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Receiving results via genetic counselor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 or older Speak fluent English Have an email address and access to the internet Not diagnosed with type 2 diabetes Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving results via web-based program<br>participants will receive genetic risk results for Type 2 diabetes via a web-based program that they access on their own | Behavioral: Receiving results via genetic counselor<br>* participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor<br>* Other names: genetic counseling;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accurate understanding of genetic risk information |  | assessed at follow-up 1 week, 3 months and 6 months after receiving results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on behavior change |  | assessed upon follow-up (3 mon, 6 mon) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, health literacy, genetic literacy, genetic risk
Comparison of the Performance of an Optimized 3D EPI SWI Sequence and a Non-EPI QSM SWI Sequence in Detecting the Central Vein Sign in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which four additional 20-minute sequences will be added. MRI of routine care in the context of MS includes at least the following sequences: 3D T1 TFE (2 minutes) T2 TSE (2 minutes) 3D FLAIR (3 minutes) SWI EPI 0.6 iso (7 minutes) The sequences added by the search are: SWI non EPI QSM 6 echo (10 minutes) SWI EPI in resolution equivalent to non-EPI SWI (3 minutes) SWI EPI to TR equivalent to SWI non EPI (6 minutes) These sequences will be acquired before or after the injection of gadolinium (if present in the examination of routine care). For examinations carried out with injection, the order of carrying out the 4 post-injection SWI sequences will be random.

Official Title
-----------------
Comparison of the Performance of an Optimized 3D EPI SWI Sequence and a Non-EPI QSM SWI Sequence in Detecting the Central Vein Sign in Patients With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: cerebral MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 With MS defined according to the McDonald's revised clinical or radiological spatial and temporal dissemination criteria, with onset of symptoms <5 years To benefit as part of care from an MRI with or without injection of gadolinium Express consent to participate in the study Affiliate or beneficiary of a social security scheme Exclusion Criteria: Patient benefiting from a legal protection measure Pregnant or breastfeeding woman

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: cerebral MRI|MRI of routine care in the context of MS includes at least the following sequences: 3D T1 TFE (2 minutes) T2 TSE (2 minutes) 3D FLAIR (3 minutes) SWI EPI 0.6 iso (7 minutes) The sequences added by the search are: SWI non EPI QSM 6 echo (10 minutes) SWI EPI in resolution equivalent to non-EPI SWI (3 minutes) SWI EPI to TR equivalent to SWI non EPI (6 minutes)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of lesions showing the central vein sign with the SWI EPI sequence that also show the central vein sign with the candidate sequence |  | 1 day | 
| percentage of lesions which do not present the sign of the central vein with the SWI EPI sequence but which present it with the candidate sequence |  | 1 day |
Smart Phone Atrial Fibrillation Application

Study Overview
=================
Brief Summary
-----------------
Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices

Official Title
-----------------
Assessing Management of Patients With Atrial Fibrillation Through a Smart Phone Application

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paroxysmal or persistent atrial fibrillation Exclusion Criteria: unable to provide informed consent unable to have 1 year of follow-up for any reason

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Atrial fibrillation recurrence | Clinical episodes of atrial fibrillation, hospitalisation for atrial fibrillation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke incidence | Ischemic or hemorrhagic stroke | 1 year | 
| Major bleeding incidence | GI bleeding, urinary bleeding necessitating hospitalisation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, mobile technology
Improving Patient Understanding of Preeclampsia

Study Overview
=================
Brief Summary
-----------------
Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.

Official Title
-----------------
Improving Patient Understanding of Preeclampsia

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Behavioral: ACOG education pamphlet on preeclampsia
* Behavioral: Preeclampsia education tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-40 weeks pregnant No significant hearing or vision impairment English speaking Exclusion Criteria: Active diagnosis of preeclampsia Significant hearing or vision impairment Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Active Comparator: 2<br> | Behavioral: ACOG education pamphlet on preeclampsia<br>* The ACOG pamphlet on preeclampsia will be offered to this group<br>|
| Experimental: 3<br> | Behavioral: Preeclampsia education tool<br>* The newly created preeclampsia educational tool will be offered to this group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved understanding of preeclampsia | Understanding of preeclampsia will be assessed through a questionnaire that asks a series of closed ended questions about preeclampsia as well as a single open ended question. This questionnaire has been used in a prior study and has proven to be a useful assessment of patient knowledge. | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient understanding and counseling
Two Treatment for a Mallet Finger of Tendinous Origin

Study Overview
=================
Brief Summary
-----------------
A randomized clinical trial, with patients treated either by a custom thermoplastic orthosis or by the Kirschner wire with the distal interphalangeal (DIP) joint extended. Evaluating the treatment efficacy of the operation management compared with a conventional orthosis.

Official Title
-----------------
A Prospective, Randomized Controlled Trial of Two Treatment for a Mallet Finger of Tendinous Origin

Conditions
-----------------
Mallet Finger

Intervention / Treatment
-----------------
* Procedure: custom thermoplastic orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a mallet finger, with or without fracture; Age≥18 years Exclusion Criteria: Open lesions Mallet fractures with subluxation of the DIP Delays in treatment >2 weeks DM RA

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery<br> | Procedure: custom thermoplastic orthosis<br>* extended the DIP by a custom thermoplastic orthosis or the Kirschner wire through the joint<br>* Other names: Kirschner wire;|
| Active Comparator: custom thermoplastic orthosis<br> | Procedure: custom thermoplastic orthosis<br>* extended the DIP by a custom thermoplastic orthosis or the Kirschner wire through the joint<br>* Other names: Kirschner wire;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion(ROM) of the DIP joint from the first week up to the 16th week after the treatment completed | Use a Protractor to measure the maximum degree of active flexion of the DIP joint at the first visit and at the end treatment; Use a Protractor to measure the maximum degree of active extension of the DIP joint at the start of immobilization and end of treatment. (If the maximum degree of active flexion of two time periods are 40° and 40°，respectively; the maximum degree of active extension of two time periods are 20° and -10°，respectively. We could get the range of motion of the DIP joint of two time periods are 20° 40° and -10° 40°，respectively. The maximum extension angle increased by 30 degrees).To assess whether there was a statistical difference in ROM changes between the two groups before and after treatment. | The first visit(Enrolled and completed treatment), 8 weeks after first visit(two weeks after 6 weeks fixation), 16 weeks(4 weeks after six weeks Rehabilitation) |
Tranexamic Acid in Dacryocystorhinostomy

Study Overview
=================
Brief Summary
-----------------
Single dose tranexamic acid (TA) before dacryocystorhinostomy (DCR) operation: a prospective, double blind, placebo controlled study. The study hypothesis: TA in DCR might reduce the intraoperative and postoperative bleeding in DCR surgery, and might reduce the duration of the surgery.

Official Title
-----------------
Single Dose Tranexamic Acid for Dacryocystorhinostomy

Conditions
-----------------
Nasolacrimal Tract Obstruction

Intervention / Treatment
-----------------
* Drug: Tranexamic acid
* Drug: saline solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstruction of nasolacrimal pathway eligible for DCR surgery 18 years of age or older Exclusion Criteria: warfarin treatment renal insufficiency pregnancy mental retardation tendency to bleed thromboembolic disease thrombophilia

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid single dose of 500mg<br> | Drug: Tranexamic acid<br>* Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.<br>|
| Placebo Comparator: Saline<br> | Drug: saline solution<br>* 5cc saline solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of DCR surgery in minutes and amount of blood loss in milliliters during surgery. |  | Blood loss will be measured at the end of DCR operation from the suction bowel. Duration of surgery will be caculated by registering time of operation start and end. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late onset postoperative epistaxis or periorbital hematoma |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, dacryocystorhinostomy, operative duration
Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen

Study Overview
=================
Brief Summary
-----------------
To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics each treatment beeing allocated by randomization

Detailed Description
-----------------
240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics : paracetamol 1 gr ketoprofen 100 mg the association of both Postprocedure pain was recorded, by nurse, using a visual analog scale (VAS), 7 times before and after the procedure, until the discharge of the patient. if VAS was above 40 on two consecutive measurements a morphine injection was given. the number and total amount of morphine was recorded. satisfaction was recorded within the 3 postoperative day by a telephone inquiry.

Official Title
-----------------
Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen

Conditions
-----------------
Abortion, Induced

Intervention / Treatment
-----------------
* Drug: paracetamol
* Drug: ketoprofen
* Drug: ketoprofen + paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women medical abortion performed in day case surgery under local anesthesia informed written consent Exclusion Criteria: under 18 year old

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paracetamol|nan|
|Drug: ketoprofen|nan|
|Drug: ketoprofen + paracetamol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain rating |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption |  |  | 
| patient satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical abortion, analgesia