linjc16/ctgov huggingface dataset:
3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery

Study Overview
=================
Brief Summary
-----------------
Despite the shift from 2D towards 3D virtual treatment planning of orthognathic surgery, traditional plaster cast are still gold standard. The investigators aimed to compare the overall reliability and time efficiency of an digital workflow using 3D printed models, in comparison to the conventional plaster workflow. Twenty real-life cases were planned according to both workflows and timed by a single resident.

Official Title
-----------------
Evaluation of Implementation of 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery

Conditions
-----------------
Orthognathic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned for orthognathic surgery planning by a single resident planning based on 3D virtual workflow Exclusion Criteria: not eligible according to abovementioned criteria
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 |
| --- | --- | --- |
| time efficiency: duration of the complete workflow, measured in seconds with a digital chronometer | duration of the complete workflow, measured in seconds with a digital chronometer | preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reliability of the workflow through registration of problems, difficulties that occur | evaluation of the reliability of the workflow through registration of problems, difficulties that occur | preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traditional plaster model, 3D printed model, digital workflow, reliability, time efficiency
Safety and Efficacy Registry of Yinyi Stent (SERY-II)

Study Overview
=================
Brief Summary
-----------------
Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.

Official Title
-----------------
Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Yinyi stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-80 years old both gender native coronary lesion narrowing > 70% vessel size 2.5-4.0 in diameter Exclusion Criteria: without informed consent, ST elevation myocardial infarction within 7 days, patient with ≤ 70% coronary narrowing at target lesion, left main lesion, multivessel narrowing need more than 3 stent implantations, by-pass graft, abnormal liver function before randomization, active hepatitis or muscular disease, impaired renal function with serum creatinine level > 3mg/dl, impaired left ventricular function with LVEF < 30%, participate in other studies.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yinyi stent<br> | Device: Yinyi stent<br>* subjects with Yinyi stent implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss | Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events | including cardiac death, re-infarction, and target vessel revascularization | 12 months |
Role of Antibiotics Post Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
morbidity after tonsillictomy remains asignificant problem therefore they recommend prophylactic antibiotics to reduce it.in the other hand, the overuse of antimicrobial agents can lead to antimicrobial resistance ,adverse drug events,and unnecessary cost.so,the effectiveness and necessity of antibiotic following tonsillictomy needs to be studied .

Official Title
-----------------
Study Of The Antibiotic Role In Post Tonsillectomy Complications

Conditions
-----------------
Tonsillectomy

Intervention / Treatment
-----------------
* Drug: Amoxicillin/clavulanate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 200 patients who are scheduled for tonsillectomy with or without adenoidectomy, and their age are less than 18 years old of either gender will be included in our study Exclusion Criteria: 1-Patients age ≥ 18 years. 2-Trials in which antibiotics was administrated locally or used in the immediate preoperative period (within seven days before surgery). 3. Medical comorbidity requiring treatment with antibiotics e.g. Rheumatic heart disease 4-Patients undergoing the following procedures: Unilateral tonsillectomy or biopsy. Tonsillectomy for known carcinoma. Tonsillectomy in conjunction with palatal surgery. Hot tonsillectomy for tonsillar abscess

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tonsillictomy with antibiotics<br> | Drug: Amoxicillin/clavulanate<br>* after tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it.<br>|
| No Intervention: tonsillictomy Without Antibiotics<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the morbidity after tonsillectomy between the group which receive antibiotics and the other group which not receive antibiotics | A questionnaire will be given to the parents on discharge to fill in the type of post-tonsillectomy morbidity of main concern including: fever, secondary bleeding, number of days with throat pain and the number of days to resume normal diet, incidence of abdominal pain, nausea & vomiting. | 2 years |
Cryptosporidium Species in Sohag Governorate

Study Overview
=================
Brief Summary
-----------------
Cryptosporidium species are increasingly recognized as important enteric pathogens that infect a broad range of hosts including human, domestic and wild animals worldwide, causing asymptomatic or mild-to-severe gastrointestinal disease in their host species. There are 38 species of Cryptosporidium that have been described, going from amphibian parasites to mammals ones, with over 40 genotypes infecting mammals, although Cryptosporidium parvum and Cryptosporidium hominis are the two species predominantly reported in human infections. In Cairo and Sharkyia governorates in Egypt, Cryptosporidium is a common intestinal parasite among children, especially in diarrheic, preschool-aged children, with a predominance of C. hominis indicates anthroponotic rather than zoonotic transmission. Also in the sohag governorate, Cryptosporidium infection is a common intestinal parasite, as in the last five years its prevalence about 35% but there is no study clarify predominant genotype of Cryptosporidium in sohag.

Official Title
-----------------
Genetic Diversity of Cryptosporidium Species Infecting Human in Sohag Governorate

Conditions
-----------------
Cryptosporidiosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: any age Sex: male -female Residence: rural-urban Animal contact. Immune status: immunocompetent - immunocompromised Clinical manifestations: diarrhea -abdominal pain- fever- vomiting. Exclusion Criteria: patients taking treatment for cryptosporidiosis
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 |
| --- | --- | --- |
| estimate the prevalence and clarify the species and genotypes/subtypes of Cryptosporidium spp. in sohag. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clarify the relationship of them in a phylogenetic context and to provide additional information on the molecular epidemiology of this parasite in our locality |  | 24 weeks | 
| clarify the predominant clinical manifestation of each genotypes/subtypes of Cryptosporidium spp |  | 24 weeks | 
| clarify the relationship between genotypes/subtypes of Cryptosporidium spp. and different risk factors. |  | 24 weeks |
A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family

Study Overview
=================
Brief Summary
-----------------
The proposed study will evaluate whether the use of non-pharmaceutical methods, such as surgical masks, isolation of patients and personal hygiene, are acceptable and effective in preventing the spread of influenza within the family.This will be achieved by conducting a randomized, controlled, unblinded, clinical trial. Family members of an index case with influenza like illness, will be randomly allocated to two groups. In the intervention group, family members will receive comprehensive guidance about sanitation and hygiene, as well as surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In addition, they will be asked to isolate the index case as much as possible. In the control group, family members will receive only standard guidance about sanitation and hygiene relevant for reducing the transmission of influenza. The primary end-point of the study will be secondary infection of influenza of at least one of the family members in order to asses the efficacy of the interventions. In addition, the compliance to those interventions will be evaluated. The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50%.

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Behavioral: sanitation and personal hygiene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Family members of an index case with influenza-like illness (ILI) during the first two days of his illness. No limitations will be given regarding the number of family members. Exclusion Criteria: Presence of another household member with ILI during the previous two weeks.
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: sanitation and personal hygiene|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary infection of influenza within the family |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compliance of non-pharmaceutical interventions |  |  |
Controlling and Lowering Blood Pressure With The MOBIUSHD™

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Detailed Description
-----------------
This is an open-label, multicenter, first-in-man clinical trial to be conducted inside the United States. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system. Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.

Official Title
-----------------
CALM-FIM_US -Controlling and Lowering Blood Pressure With the MobiusHD™ - A Prospective Multicenter Safety Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: MobiusHD™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Office cuff SBP ≥ 160 mmHg measured per protocol instructions (Appendix IV) following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic. Any combination medications will be counted per the active ingredient. (For example, Zestoretic (Lisinopril +HCTZ) equals two (2) anti-hypertensive medications) Exclusion Criteria: Known or clinically suspected baroreflex failure or autonomic neuropathy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MobiusHD™<br>MobiusHD™ | Device: MobiusHD™<br>* Implant that is placed in the carotid sinus to control hypertension.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of Participants with Adverse Events | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Office Blood Pressure (OBP) | Change in Systolic Office Blood Pressure (OBP) compared to baseline. | 3 years | 
| Change in Systolic Ambulatory Blood Pressure (ABPM) | Change in Systolic Ambulatory Blood Pressure (ABPM) measured at 3 and 6 months compared to baseline values. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Carotid Sinus
Ventricular Wall Motion Characterization

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate feasibility of using new technologies to characterize ventricular wall motion in patients indicated for mapping and ablation procedures. Echo will be performed preoperatively and patients will receive a 1-month followup telephone call.

Official Title
-----------------
Characterization of Normal and Abnormal Ventricular Wall Motion

Conditions
-----------------
Atrial Fibrillation, Tachycardia, Ventricular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be in sinus rhythm Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations Be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (VT) or atrial fibrillation (AF) according to HRS (Heart Rhythm Society)/ESC (European Society of Cardiology)/German National guidelines. The patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) Symptomatic sustained monomorphic VT (SMVT), or b) Frequent PVCs, non-sustained VT, or VT that is presumed to cause ventricular dysfunction, or c) Bundle branch reentrant or interfascicular VTs, or d) Symptomatic AF with indication for ablation per current HRS/ESC/German National guidelines in a patient who is either 1) refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy Exclusion Criteria: Have permanent AF Exhibit Cheyne-Stokes respiration Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures Have had a recent CVA or TIA within 3 months prior to enrollment Be less than 18 years of age Be pregnant Be currently participating in any other clinical investigation

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 |
| --- | --- | --- |
| Feasibility of Ventricular Wall Motion Characterization |  | Mapping and Ablation Procedure |
12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019

Official Title
-----------------
A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: CP-526,555 (varenicline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have smoked an average of at least ten cigarettes per day during the past year No period of abstinence greater than three months in the past year Exclusion Criteria: Subjects with history of clinically significant cardiovascular disease Subjects with uncontrolled hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-526,555 (varenicline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 . |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence rate from target quit date to end of treatment (Week 12) |  |  | 
| 7-day point prevalence of abstinence at Week 12 |  |  | 
| Number of cigarettes smoked per day |  |  | 
| Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale |  |  | 
| Rewarding effects of smoking assessed by Smoking Effects Inventory |  |  | 
| weight change from baseline |  |  |
Creatine Supplementation in Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
Autism Spectrum Disorder (ASD) is accompanied by reduced levels of total creatine in right temporal-parietal junction and other brain regions of interest, and addressing this deficit by exogenous administration of creatine may have beneficial effects on brain metabolism and disease-specific clinical symptoms in patients suffering from ASD.

Official Title
-----------------
The Effects of Creatine Supplementation in Autism Spectrum Disorder: a Randomized Placebo-controlled Trial

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Creatine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 10 years and above Informed consent signed by a parent or legal guardian or legal representative Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD. Exclusion Criteria: Pregnant or nursing female patients Non-pharmacologic therapy Current diagnosis of other mental disorder

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine<br>Twenty grams per day b.i.d. | Dietary Supplement: Creatine<br>* Creatine monohydrate (20 g per day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain creatine change | Monitor change in brain creatine levels by magnetic resonance imaging | Change from Baseline Brain Creatine Levels at 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain N-acetylaspartate change | Monitor change in brain N-acetylaspartate levels by magnetic resonance imaging | Change from Baseline Brain N-acetylaspartate Levels at 6 Months | 
| Autism Treatment Evaluation Checklist (ATEC) score | Monitor changes in ASD severity | Change from Baseline ATEC Scores at 6 Months |