linjc16/ctgov huggingface dataset:
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice

Study Overview
=================
Brief Summary
-----------------
Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance. The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).

Official Title
-----------------
An Open Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice

Conditions
-----------------
Head Lice

Intervention / Treatment
-----------------
* Drug: 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 6 months of age or older. Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005. Agree not to use any other pediculicides or medicated hair grooming products during the duration of the study. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form. Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language. Subject is willing to participate in the study, and abide by the protocol requirements. - Exclusion Criteria: Participation in any clinical study, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days. Known hypersensitivity to any ingredient in the product formulation.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation

Study Overview
=================
Brief Summary
-----------------
Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.

Official Title
-----------------
Value of Target-controlled Intravenous Anaesthesia (TCIVA) to Optimize Coverage of the Low Back Pain Territory in Patients With Chronic Refractory Postoperative Multifocal Low Back and Legpain

Conditions
-----------------
Failed Back Surgery Syndrome

Intervention / Treatment
-----------------
* Procedure: Target-controlled intravenous anaesthesia
* Procedure: Total anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years and ≤ 80 years FBSS Radicular leg et lumbar pain For more than 3 months after one or many spine surgeries Mixt pain (radicular leg et lumbar) with Neuropathic status Failure of conservative treatment Severe uni or bilateral radicular pain > 5 / 10 Exclusion Criteria: Age <18 years and> 80 years. BMI > 30 kg/m2. Back pain that can be treated by surgery (discogenic, vertebral instability, …) Contraindication to TCIVA anesthesia under propofol remifentanil Psychiatric status Cancer No signature of informed consent. Women of childbearing without contraception

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Target-controlled Intravenous Anaesthesia<br>Patients have a target controlled intravenous anaesthesia to implant the spinal cord stimulation lead with active cooperation during the surgery. | Procedure: Target-controlled intravenous anaesthesia<br> <br> |
| Active Comparator: Total anesthesia<br>Patients have a total anaesthesia to implant the spinal cord stimulation lead without active cooperation during the surgery. | Procedure: Total anaesthesia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative paresthesia coverage >= 50% of the lower lumbar determined using a paresthesia cover mapping |  | 6 months. |
Gingivitis and Periodontitis as a Risk Factor for Stroke

Study Overview
=================
Brief Summary
-----------------
Periodontitis and gingivitis are one of the most infectious diseases in humans. Several studies have been carried out on the dependence of periodontitis and stroke. The aim of this study was to investigate gingivitis and periodontitis as risk factors for stroke in the Pakistani population.

Detailed Description
-----------------
Epidemiologic studies have shown that cerebrovascular accident (CVA) is the 3rd cause of death in developed countries with 0.8 % prevalence in the whole population. Although, the prevalence rate of stroke is reduced yet is one of the most important health problems in the United State. Periodontitis and gingivitis are the two most infectious man diseases. Today, it is estimated that about 35% of people over 30-year-old in America and 50-55% of people in developing countries are involved with these diseases. These diseases are due to the practice of chronic bacterial infection and the inflammatory response of the host. The relationship between periodontitis and CVA was first introduced by Mackenzi and Millard in 1963 but the importance of this issue was not understood. Periodontal infection can be a complex multiphase disease by associating this infection with organ systems such as cardiovascular, endocrine, reproductive, and respiratory systems. Nowadays, periodontitis is considered a risk factor for atherosclerosis and thromboembolic disease.

Official Title
-----------------
Gingivitis and Periodontitis as a Risk Factor for Stroke

Conditions
-----------------
Stroke, Gingivitis, Periodontitis

Intervention / Treatment
-----------------
* Diagnostic Test: Periodontal Probing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed stroke by using brain imaging from magnetic resonance imaging and/or computerized tomography. Exclusion Criteria: Not willing to participate Neurological complications other than stroke
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Periodontal Probing|with the help Michigan probe, periodontal pocket measurement was done.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis | Measurement of bleeding site while probing and this was done with gingival index | baseline | 
| Periodonitis | Measurement of periodontal pockets while probing and this was done with community periodontal idex | baseline |
Study of Docetaxel and Gemcitabine in Metastatic Esophageal Squamous Cell Cancer

Study Overview
=================
Brief Summary
-----------------
Gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of DNA synthesis.Docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits microtubule depolymerization. In this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100 mg/m2 on day 8 with G-CSF support every 3 week.

Official Title
-----------------
Phase II Study of Docetaxel and Gemcitabine in Previously Treated Metastatic Esophageal Squamous Cell Cancer

Conditions
-----------------
Metastatic Carcinoma, Recurrent Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Gemcitabine/Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma Age > 18 years ECOG performance status 0 - 2 At least one measurable lesion(s) by RECIST 1.1 criteria Life expectancy ≥ 3 months At least one cytotoxic chemotherapy regimen (adjuvant chemotherapy will be considered as one regimen if administered within 6 months from the date of study entry) (upto three prior regimens will be allowed) Prior radiotherapy must be completed 2 weeks before study entry. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl) Adequate renal function (≤ serum creatinine 1.5 mg/dl or CCr ≥ 50 ml/min) Adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 upper normal limit) Written informed consent Exclusion Criteria: Evidence of serious gastrointestinal bleeding Serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia) Serious metabolic disease such as severe non-compensated diabetes mellitus History of significant neurologic or psychiatric disorders Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease Pregnant or lactating 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine/Docetaxel<br>Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days | Drug: Gemcitabine/Docetaxel<br>* Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 1years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 1years | 
| overall survival |  | 1years | 
| Number of Adverse Events |  | 1years |
Global Syphilis Sequencing

Study Overview
=================
Brief Summary
-----------------
Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches allow the whole genetic sequence of Treponema pallidum to be obtained from a swab. In this study residual DNA collected as part of routine patient care of patients seen at sexual health clinics in the UK will be used for sequencing. No patient contact is involved in the study which is limited to whole genome sequencing using residual material from samples. By better understanding the genome of the T.pallidum insights will be gained in to the pathogenesis of this important sexually transmitted disease.

Official Title
-----------------
Whole Genome Sequencing of Syphilis Using Routine Clinical Samples

Conditions
-----------------
Syphilis

Intervention / Treatment
-----------------
* Diagnostic Test: Whole Genome Sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of syphilis Exclusion Criteria: No PCR positive clinical sample

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 |
| --- | --- |
| Syphilis<br>Patients with syphilis and detectable Treponema pallidum DNA in a routinely collected clinical sample | Diagnostic Test: Whole Genome Sequencing<br>* Residual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage | Whole genome sequencing of UK and global syphilis samples combined with phylogenomic and population genomic analyses to determine the population structure and diversity of Treponema both regionally and in global context. Diversity will be assessed by measuring nucleotide diversity between samples and reference genomes. | Measured at baseline - time of enrollment. There are no further samples or visits in the study. |
Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates

Study Overview
=================
Brief Summary
-----------------
A multicenter Prospective Study to assess the screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.

Official Title
-----------------
A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates

Conditions
-----------------
Non-small Cell Lung Cancer, Bone Metastases

Intervention / Treatment
-----------------
* Drug: bisphosphates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18, either sex Histologically confirmed non-small cell cancer One bone metastasis at least confirmed by image(X ray,CT or others) Without receiving zoledronic acid Life expectancy > 6 M ECOG <= 2 Signed ICF Exclusion Criteria: Women who are pregnant or in lactation Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br> | Drug: bisphosphates<br>* any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeleton-related event |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 24 months |
Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.

Official Title
-----------------
A Randomised, Multi-center, Evaluator-blinded Study in China to Evaluate the Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

Conditions
-----------------
Nasolabial Folds in Chinese Population

Intervention / Treatment
-----------------
* Device: Restylane Perlane
* Device: Restylane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese origin Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side. Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period. Singed Informed Consent Exclusion Criteria: Subjects with traumatic scars or ongoing active skin disease in the area to be treated Permanent inplant or filler, including fat injection placed in the area to be treated Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane Perlane<br>Single injection and optional touch up injection with Restylane Perlane in NLF | Device: Restylane Perlane<br>* Intradermal injection<br>|
| Active Comparator: Restylane<br>Single injection and optional touch up injection with Restylane in NLF | Device: Restylane<br>* Intradermal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months | The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyaluronic acid, comparative study, NLF
BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes

Study Overview
=================
Brief Summary
-----------------
The landmark study Diabetes Control and Complication Trial (DCCT) clearly showed that intensive insulin management delays the onset and progression of longterm complications in adolescents with type 1 diabetes mellitus (T1DM). The same clinic trial also showed increased rate of severe hypoglycemia which required assistance. The risks of severe hypoglycemia, defined as loss of consciousness or seizure associated with hypoglycemia, include lower HbA1C, younger age, higher insulin dose, male sex, lower parental socioeconomic status, non-Hispanic white ethnicity, longer duration of disease, the presence of psychiatric disorders, and underinsurance. The purpose of this protocol is to explore the relationship between hypoglycemic seizures and BMI.

Detailed Description
-----------------
This is a retrospective study using questionnaire/survey/interview. We will give subjects a letter stating the purpose and describing the study. We will answer all questions they have about the study. Once the parents and patient verbally agree to participate in the study, we will proceed with the survey.

Official Title
-----------------
BMI and Its Relationship to Hypoglycemic Seizures in Children With Insulin-requiring Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1DM 2-17 years old Exclusion Criteria: T2DM Known seizure disorder

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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 |
| --- | --- |
| Type 1 diabetes<br>children with type 1 diabetes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).

Official Title
-----------------
Psychopharmacology of Adolescents With AUD and ADHD

Conditions
-----------------
Substance Use Disorders, Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents, ages 13-18 Meets criteria for alcohol and/or substance use disorder and attention deficit hyperactivity disorder. Exclusion Criteria: Adolescents who are pregnant. Have a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk. History of pervasive development disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders. Currently on other psychotropic medications from which discontinuation would present a significant risk. A current episode of major depressive disorder or a diagnosis of bipolar disorder. Diagnosis of dependence for any substance other than marijuana. Adolescents with a full-scale IQ below 80.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in ADHD symptoms |  |  | 
| decrease in the quantity and frequency of alcohol and other substance use |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Substance Use