linjc16/ctgov huggingface dataset:
Tooth Wear:m Tooth Wear : Diagnosis- Treatment Decision

Study Overview
=================
Brief Summary
-----------------
Tooth wear is a physiological process occurring from normal functioning of the dentition throughout lifetime.

Detailed Description
-----------------
The studies in the current literature indicated that both techniques of tooth preparation and the materials used are appropriate for the treatment of this condition, but the tendency is to reduce tooth preparation as reasonably possible. In this clinical trial, the investigators will compare the outcomes of direct resin composite and indirect polymer-infiltrated-ceramic-network.

Official Title
-----------------
Tooth Wear : Diagnosis- Treatment Decision- Management- Monitoring- Randomized Clinical Trial

Conditions
-----------------
Dental Wear

Intervention / Treatment
-----------------
* Device: Clearfil Majesty TM
* Device: Vita-Enamic®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or older, in good general health, willing to participate in the study and accepting to come to regular controls in the future. Patients representing any type of significant tooth wear (≥ 1 mm depth) with dentine exposure in at least 4 teeth: localized tooth wear anterior or posterior teeth and generalized tooth wear anterio and posterior teeth. Patients having posterior support with at least 4 molars in occlusion, 1 pair per side, excluding third molar. Exclusion Criteria: Patients wearing removable partial prosthesis Patients presenting skeletal Cl III occlusal Relationship Patients with remaining clinical crown of ≤ 3 mm in height and presenting tooth anomaly in shape and number in addition to anterior diastemas. Patients with symptomatic temporomandibular joint disorders.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Composite resin<br>Restoration with composite resin has shown good clinical performance and limited occlusal wear. The Clearfil Majesty will be used in the present study. | Device: Clearfil Majesty TM<br>* Tooth wear - composite resin<br>|
| Active Comparator: Polymer-infiltrated-ceramic-network<br>This hybrid material seems to be a promising material that imitates natural tooth properties. The VITA-Enamic® will be used in this study. | Device: Vita-Enamic®<br>* Tooth wear - polymer-infiltrated-ceramic-network<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration | by modified USPHS criteria | up to 3 years |
Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.

Study Overview
=================
Brief Summary
-----------------
A fever and a non-blanching rash is a relatively common reason for a child to attend an emergency department. A fever and a non-blanching rash can be an early sign of a life-threatening infection known as meningococcal disease. The aim of the PIC study is to determine how best to diagnose early meningococcal disease in children. In particular the investigators are interested in researching how quick bedside tests can be used to do this.

Detailed Description
-----------------
A fever an a non-blanching rash is a relatively common presentation the the emergency department. A minority of children with a fever and a non-blanching rash with have a life-threatening infection. Currently it is very difficult to determine those children that require urgent treatment from those that have a simple viral illness. The aim of the PIC study is to research how to better diagnose those serious infections earlier. Data from the study will be used to test the effectiveness of current practice and to identify areas where current practice could be improved.

Official Title
-----------------
Petechiae In Children (PIC) Study

Conditions
-----------------
Meningitis, Meningococcal, Meningococcal Sepsis, Meningococcal Disease, Meningococcal Infections, Sepsis, Meningitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fever (recorded or reported) 38 degrees Centigrade or higher and a non-blanching rash (at the time of presentation) Features of meningococcal sepsis/meningitis Exclusion Criteria: Known haematological conditions such as haematological malignancy, idiopathic thrombocytopenic purpura and coagulopathy

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| Confirmation of meningococcal infection | Blood and Cerebrospinal fluid (CSF) culture or quantitative Polymerase Chain Reaction (PCR) will be used to confirm meningococcal infection | 72 hours from testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meningococcal, neisseria meningitidis, sepsis, meningitis, procalcitonin, PCT, LAMP, loop-mediated-isothermal AMPlification
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.

Official Title
-----------------
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients, 18 years and older Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months. Exclusion Criteria: Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline. Current or history of erosive esophagitis confirmed by EGD Heartburn occurring 3 or more days a week. Other protocol-defined inclusion/exclusion criteria may apply

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

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

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly assessment of satisfactory relief of dyspepsia. |  |  | 
| Daily assessment of percentage of patients responding on average severity score. |  |  | 
| For each week assessment of average daily severity score. |  |  | 
| Percentage of days with satisfactory relief of dyspepsia during each week. |  |  | 
| Weekly global assessment of change in dyspepsia condition. |  |  | 
| Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting. |  |  | 
| Quality of life at end of treatment compared to baseline. |  |  | 
| Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyspepsia, gastrointestinal, tegaserod
The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of acupuncture protocol involving in Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Other: Weizhong and Huantiao
* Other: A-shi point


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible adult (≥18 years of age) patients had a diagnosis of AS for at least 3 months defined as definite by the 1984 modified New York criteria Eligible patients also had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of ≥4 (0-10 cm scale) A visual analogue scale (VAS) score for total back pain of ≥4 (0-10 cm scale) Exclusion Criteria: Had received prior Acupuncture therapy With complete ankylosis of the spine, defined as the presence of bridging syndesmophytes at all intervertebral levels of the cervical and lumbar spine on lateral view spinal radiographs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weizhong and Huantiao<br>Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points | Other: Weizhong and Huantiao<br> <br> |
| Active Comparator: A-shi point<br>Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points | Other: A-shi point<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks |  | At 0 week, 6 weeks, 12 weeks | 
| Change from Baseline in Visual Analog Scale at 12 weeks |  | At 0 week, 6 weeks, 12 weeks |
Two Different Surgical Techniques on Postoperative Circumcision Pain

Study Overview
=================
Brief Summary
-----------------
To compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain.

Detailed Description
-----------------
Two different circumcision techniques result in different kinds of pain.This research aims determine which is more beneficial to the patient.

Official Title
-----------------
Comparison of Two Different Circumcision Surgical Technique on Postoperative Pain

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Other: Dorsal slit
* Other: Double incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children Exclusion Criteria: Patients with any bleeding

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dorsal slite<br>Skin and mucosa insicion made together | Other: Dorsal slit<br>* Skin and mucosa incision made together<br>|
| Experimental: Double incision<br>Skin and mucosa incision made separately | Other: Double incision<br>* Skin and mucosa incision made separately<br>* Other names: Surgical technique;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses postoperative pain scores on Modified Objective Assessment Scale (MOAS) |  | Postoperative first two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circumcision, postoperative pain
SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

Study Overview
=================
Brief Summary
-----------------
The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.

Official Title
-----------------
SuperSTAT Noninvasive Blood Pressure Monitor Evaluation

Conditions
-----------------
Non-Invasive Blood Pressure

Intervention / Treatment
-----------------
* Device: GE DINAMAP with SuperSTAT algorithm monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Signed informed consent Ability to single or dual monitor NIBP, ECG, and/or SpO2, whether or not already being monitored for any or all of these parameters. Exclusion Criteria Any subject deemed too unstable, at the clinician's discretion, to participate in the study Any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery. Any subject who cannot tolerate, in the opinion of the clinician, multiple blood pressure measurements Known disease state or medical condition that A) compromises circulation to the extremity (ies), B) compromises musculo-skeletal integrity, or C) otherwise contraindicates use of a NIBP cuff and/or SpO2 sensor on an extremity or ECG patches on skin Excessive movement or excitability causing false values or no determinations (SP10 accuracy study only)

Ages Eligible for Study
-----------------
Maximum Age: 3 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GE DINAMAP with SuperSTAT algorithm monitor|Apply cuff on a limb, cuff is inflated and deflated, monitor will displays non-invasive blood pressure values (systolic, diastolic, MAP, and pulse rate)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of one of the GE DINAMAP NIBP Monitor algorithms, SuperSTAT NIBP, in neonatal and/or infant subjects. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-invasive Blood Pressure (NIBP), GE Dinamap, SuperSTAT
Safety and Tolerability of Transcranial Direct Current Stimulation (tDCS)

Study Overview
=================
Brief Summary
-----------------
Testing safety and tolerability of transcranial direct current stimulation (2 mA, 20 minutes) in four different protocols: saline-soaked sponges electrode with electrode gel tap-water-soaked sponges tap-water-soaked-sponges + sham stimulation Outcome measures are tolerability (comfort rating questionnaire), impedances, skin elasticity

Official Title
-----------------
Safety and Tolerability of Transcranial Direct Current Stimulation (tDCS)

Conditions
-----------------
Best Comfort and Lowest Skin Irritation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no neurological or psychiatric illness written informed consent Exclusion Criteria: dermatologic diseases medication with corticoids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Treatment Patterns and Clinical Outcomes Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1st Line) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Medical Chart Review (RENALISTIC Study).

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about the treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world. Study participants must be: At least 18 years of age or older. Confirmed renal cell carcinoma Received first line treatment

Official Title
-----------------
Clinical Outcomes and Therapy Management Among Patients With Advanced Renal Cell Carcinoma (aRCC) Receiving Systemic First-line (1L) Anti-cancer Treatment Under Daily Routine in Germany: Retrospective Chart Review (RENALISTIC Study)

Conditions
-----------------
Carcinoma, Renal Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants diagnosed with locally advanced or metastatic renal cell carcinoma Participants with full medical information is available regarding all treatments before, during and after 1st line Exclusion Criteria:

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 |
| --- | --- | --- |
| Progression Free Survival |  | 01 Jan 2020-01 July 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 01 Jan 2020-01 July 2022 | 
| Proportion of different drug regimen |  | 01 Jan 2020-01 July 2022 | 
| Best response rate (RR) |  | 01 Jan 2020-01 July 2022 | 
| Duration of Response (DoR) |  | 01 Jan 2020-01 July 2022 | 
| Time to progression (TTP) |  | 01 Jan 2020-01 July 2022 | 
| Time to next treatment (TTNT) |  | 01 Jan 2020-01 July 2022 | 
| Number of participants with dose modifications |  | 01 Jan 2020-01 July 2022 | 
| Number of participants with an interim/permanent discontinuation of one or all drugs of a therapy |  | 01 Jan 2020-01 July 2022 | 
| Number of participants continuing therapy after dose modification |  | 01 Jan 2020-01 July 2022 | 
| Number of participants continuing therapy after temporary/permanent discontinuation of single drugs |  | 01 Jan 2020-01 July 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Real World Chart Review, Retrospective, Germany
Feasibility Clinical Study of NLA Tool

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.

Official Title
-----------------
Evaluate the Feasibility of the NLA Tool, a Combined Assessment of Nutritional and Physical Functional Status, to Provide Personalized Advice for the Independence and Mobility of Elderly.

Conditions
-----------------
Healthy Elder People

Intervention / Treatment
-----------------
* Behavioral: Nutrition Status Questionnaires and Physicial Function Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 65 and 90 years, able to walk with or without walking aid, having obtained the subject's written informed consent free of cognitive impairment, Exclusion Criteria: restricted by a doctor to exercise. unable to carry out performance tests and questionnaires correctly, lower or upper extremity surgery or fracture in the last 3 months having history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 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 |
| --- | --- |
| Nutrition Status and Physical Function<br>Nutrition questionnaire will be administered Physical functional status will be tested | Behavioral: Nutrition Status Questionnaires and Physicial Function Test<br>* Nutrition status questionnaires will be administered, Physical functional status will be tested<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NLA Feasibility | Determining the proportion of elderly subjects (by statistical approach) who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status | Day 1 of Study | 
| The Segmentation of Target Population | Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength (By measuring upper and lower extremity strength) and endurance performance (By measuring 6 minutes walking distantce) (33% +/- 10% of target group) | Day 1 of Study |