linjc16/ctgov huggingface dataset:
Botulinum Toxin (BOTOX) for Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.

Detailed Description
-----------------
This trial will test the effectiveness of BTX injections versus placebo to reduce plantar-flexor spasticity and improve function and mobility in children with spastic diplegia, a common form of cerebral palsy. The study will evaluate the effects of the treatment across five domains that relate to disability: pathophysiology, impairment, functional limitation, disability, and societal limitation. Forty children, ages 4 to 12 years, will be recruited and randomized into one of two groups. Group A will receive BTX. Group B will receive a placebo injection. Participants will be assessed at the beginning of the trial and at Weeks 3, 8, 12, and 24. Assessments include quantitative electromyographic kinesiology measurements, electromechanical measurement of joint torque across the ankle joint using the Spasticity Measurement System, Gross Motor Function Measure, physical exam parameters, energy expenditure using the Energy Cost Index, kinematic gait analysis, and the Canadian Occupational Performance Measure. Participants are followed for a total of 6 months. Participants initially randomized to Group B will have the opportunity for BTX treatment after 24 weeks.

Official Title
-----------------
Botulinum Toxin for Spasticity in Cerebral Palsy

Conditions
-----------------
Cerebral Palsy, Muscle Spasticity

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spastic diplegic cerebral palsy Community or independent ambulators Expressive communication skills at age 3 or above Stable social environment Reasonable proximity to the medical center Physical therapy at least once per week No other serious health problems that would interfere with the study Exclusion Criteria: Other forms of cerebral palsy Previous treatment with botulinum toxin Musculoskeletal contractures greater than 15 degrees Unstable social environment

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BOTOX, Cerebral Palsy, Spasticity, Botulinum toxin
Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste

Study Overview
=================
Brief Summary
-----------------
Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica', the famous 'Toothbrush Tree' used for centuries. The astringent and anti-bacterial properties of Meswak helps reduce tooth decay , fight plaque and prevent gum diseases. Miswak Herb is a rare, potent, priceless, wonder herb that delivers incredible Dental Care benefits.

Detailed Description
-----------------
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate antibacterial effect miswak toothpaste compared to fluoride toothpaste in high caries risk patients.

Official Title
-----------------
Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste in High Caries Risk Patients: Randomized Clinical Trial

Conditions
-----------------
Caries

Intervention / Treatment
-----------------
* Other: Miswak toothpaste
* Other: Fluoride toothpaste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High caries risk patients. At least one carious tooth according to CAT caries risk assessment model. Patient compliance Exclusion Criteria: Participant in another trial. Using another antimicrobial agents since one month of sampling. Systemic diseases or concomitant medication affecting salivary flow. Parafunctional habits. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miswak toothpaste<br>Dabur meswak herpal toothpaste | Other: Miswak toothpaste<br>* Dabur Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica'<br>* Other names: Dabur meswak;|
| Active Comparator: Fluoride toothpaste<br>Signal fluoride toothpaste, containing 1450 ppm of fluoride | Other: Fluoride toothpaste<br>* 1450 ppm fluoride toothpaste<br>* Other names: Signal toothpaste;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| streptococcus mutans count | Counting streptococcus mutans, Measurement: Mitis-Salivarius agar plate, Unit: CFUs/mL | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibacterial, streptococcus mutans, miswak, fluoride
Epidemiology of Young Lung Cancer - Survey

Study Overview
=================
Brief Summary
-----------------
This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.

Official Title
-----------------
This is a 100% Virtual (Remote) Study (Survey, and Voluntary Blood Donation) to Explore Potential Environmental, Lifestyle and Genetic Factors That May be Associated With Driver Mutations of Young Lung Cancer in the USA.

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Other: Online Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment Documentation of primary NSCLC, any stage Less than 50 years of age at the time of NSCLC diagnosis Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer Willingness to undergo all study procedure Provision of written informed consent Exclusion Criteria: Male or female aged less than 18 years; or less than the age of majority for their residential state Greater than or equal to 50 years of age at the time of NSCLC diagnosis No documentation of mutation testing Unwilling to undergo all study procedures Unable or unwilling to provide consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EGFR<br> | Other: Online Survey<br>* Epidemiological Survey (approx 200 questions)<br>|
| ROS1<br> | Other: Online Survey<br>* Epidemiological Survey (approx 200 questions)<br>|
| ALK<br> | Other: Online Survey<br>* Epidemiological Survey (approx 200 questions)<br>|
| KRAS<br> | Other: Online Survey<br>* Epidemiological Survey (approx 200 questions)<br>|
| NSCLC Other<br> | Other: Online Survey<br>* Epidemiological Survey (approx 200 questions)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory epidemiology correlates | Exploratory correlations between all questionnaire variables (demographic factors, medical history, smoking history, early life exposures (child and mother), residential history, occupational history, menstrual and reproductive history, diet, and physical activity. | 1 month |
Vitamin D and Type 2 Diabetes - a Cross Sectional Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to describe vitamin D status among patients with type 2 diabetes and to determine the association between serum 25-hydroxyvitamin D and glycemic control, markers of inflammation and blood pressure

Detailed Description
-----------------
It has been estimated that 1 billion people worldwide have vitamin D deficiency or insufficiency. It is well known that vitamin D deficiency causes osteoporosis, increases the risk of fracture and causes muscle weakness. But there is now evidence that calcium malnutrition and hypovitaminosis D are predisposing conditions for various common chronic diseases such as malignancies (particularly colon, breast and prostate) chronic inflammatory and autoimmune disease (inflammatory bowel disease, multiple sclerosis) as well as metabolic disorders (metabolic syndrome, hypertension). It has also been reported that vitamin D deficiency may predispose to glucose intolerance, altered insulin secretion and type 2 diabetes mellitus. The purpose of this study is to determine vitamin D status among type 2 diabetics in our outpatient clinic and examine the relationship between vitamin D status , calcium and phosphorous metabolism, inflammatory markers, glycemic control, blood pressure and lipid profile. Moreover the patients are asked to answer a questionnaire regarding lifestyle, exercise, sun exposure and food intake.

Official Title
-----------------
Vitamin D and Type 2 Diabetes - a Cross Sectional Study

Conditions
-----------------
Hypovitaminosis D, Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Patients of Danish extraction Written consent Exclusion Criteria: Renal failure (Urea > 12 mmol/l) Age < 18 years malabsorption

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 |
| --- | --- |
| A<br>The cohort consists of type 2 diabetics from the outpatient clinic at Silkeborg Hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D status and its association with inflammation, glycemic control, lipids and blood pressure. |  | December 08 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle (exercise, sun exposure, food intake) |  | December 08 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypovitaminosis D, Type 2 diabetes, Glycemic control, Inflammation, Blood pressure
Prospective Evaluation of the Preoperative Lymph Node Staging in Patients With Cancer of the Esophagogastric Junction and Stomach

Study Overview
=================
Brief Summary
-----------------
This prospective study includes patients with histologically proven cancer of the esophagogastric junction (Siewert Type II and III) and the stomach. Aim of the study is to evaluate the accuracy of PET-CT for the preoperative assessment of lymph node metastasis. The evaluation includes a combination with standard diagnostic tools (endoluminal ultrasound, CT and diagnostic laparoscopy prior to neoadjuvant therapy). Standardized D2-lymphadenectomy is performed and individual lymph node stations (Nr 1-12 according to the Japanese classification) are histopathologically examined. Furthermore we evaluate the role of the PET-CT for early metabolic response evaluation in patients receiving neoadjuvant chemotherapy. Trial with surgical intervention

Conditions
-----------------
Adenocarcinoma, Stomach Cancer, Cancer of Esophagogastric Junction

Intervention / Treatment
-----------------
* Procedure: FDG-PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Histological prove of adenocarcinoma of the stomach. Exclusion criteria: Recurrent gastric carcinoma No informed consent Previous malignancy (exception: thyroid, bladder in situ, Cervix in situ)

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: all patients<br>all patients with Adenocarcinoma | Procedure: FDG-PET-CT<br>* Radiologic standard procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of PET-CT |  | preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenocarcinoma of the stomach and esophagogastric junction
Monitoring of Safety and Tolerance of PICOPREP in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
A Confirmation of Safety, Tolerance and Efficacy of PICOPREP in Clinical Practice.

Official Title
-----------------
A Study of PICOPREP in Patients Needing to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery

Conditions
-----------------
Bowel Cleanliness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for treatment with PICOPREP® for bowel cleansing prior to endoscopic examination or surgery Exclusion Criteria: Patients in which prescription of PICOPREP® is contraindicated

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PICOPREP treatment<br>PICOPREP powder for oral solution according to standard clinical practice | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Frequency of Adverse Events |  | 2 days | 
| The Severity of Adverse Events |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy measured by assessment of the quality of colon cleaning |  | 2 days |
A Study of GFH018 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is the first in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.

Official Title
-----------------
A Phase I Study With Single/Multiple Dose Administered to Explore the Safety/Tolerability and Pharmacokinetics of GFH018 in the Treatment of Patients With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Drug: GFH018


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible subjects must meet all the inclusion criteria listed below: Voluntarily participate in this clinical trial, and are willing to sign informed consent forms. Male or female aged from 18-75 years old (inclusive). Diagnosed with histologically or cytologically confirmed advanced solid tumors. Evaluable lesions defined by RECIST v1.1. Eastern Cooperative Oncology Group performance status of 0 to 1. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study. Exclusion Criteria: Eligible subjects should not meet any of the exclusion criteria listed below: With clinically significant cardiac diseases. With clinically significant digestive disorders. Other severe disease. Pregnant or lactating women. Other unfavorable situations for subjects to participate in the study judged by Investigators.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GFH018<br>The duration of the first cycle is 31 days and the subsequent periods are 28 days. Subjects will receive treatment with GFH018 until disease progression (clinically- or radiologically-confirmed), occurrence of intolerable toxicity, or subjects discontinue from the study treatment for other reasons. | Drug: GFH018<br>* Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I：Incidence of dose-limiting toxicity (DLT) events |  | 31 days after the first dose |
A Study of Taspoglutide in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Official Title
-----------------
A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: taspoglutide
* Drug: taspoglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-65 years of age; type 2 diabetes mellitus; treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening. Exclusion Criteria: type 1 diabetes mellitus; type 2 diabetes duration of <3 months; treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months; treatment with insulin for >7 days within 6 months prior to screening.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Placebo<br>* sc for 4 days<br>Drug: taspoglutide<br>* 300micrograms/day sc for 2 days<br>Drug: taspoglutide<br>* 800 micrograms/day sc for 2 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under insulin concentration time curve relative to basal insulin concentration |  | First 10 minutes after glucose bolus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under insulin concentration time curve relative to basal insulin concentration |  | 10-120 minutes after glucose bolus | 
| Adverse events, laboratory parameters |  | Throughout study |