linjc16/ctgov huggingface dataset:
Genetic Determinants and Clinical Consequences of Early-onset Severe Obesity

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to identify new obesity-related genetic defects and determine their association with clinical manifestations in families with childhood-onset severe obesity. The investigators hypothesize that by exploring children with severe early-onset obesity they can find new obesity-related genetic defects and by exploring obesity-associated clinical manifestations the investigators can elucidate the outcomes of severe childhood obesity.

Detailed Description
-----------------
Obesity is a complex disorder with many contributing genetic and environmental factors. The genetic causes and mechanisms for severe childhood obesity are still incompletely understood. It is acknowledged that obesity in some individuals could be a consequence of rare genetic variants with strong effect - these rare variants might be population specific. The aims of this study are to determine inheritance patterns of early-onset obesity new obesity-related genetic variants and disease-causing gene mutations the association between obesity-related genetic defects and clinical manifestations the association between obesity-related genetic defects and psychiatric symptoms in patients with early-onset obesity and their first-degree relatives Significant advancements in genetic methodology provide new tools to explore genetic defects underlying obesity. Family-based approach provides several advantages compared to cohort studies to investigate genetic determinants of complex diseases.The unique genetic composition of the Finnish population enables identification of novel genetic entities. Discovery of genetic defects associated with severe childhood-onset obesity will increase the investigators understanding of the pathogenesis of obesity and allows early detection, by genetic testing, of those at increased risk and optimal targeting of preventive measures.

Official Title
-----------------
Genetic Determinants and Clinical Consequences of Early-onset Severe Obesity

Conditions
-----------------
Childhood Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children and adolescents age 10-18 years height-adjusted weight >60 % before the age of 7 years. Finnish descent Exclusion Criteria: patients with a known endocrine or genetic disorder underlying obesity (e.g. Prader-Willi syndrome, hypercortisolism, hypothyroidism)

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
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 |
| --- | --- | --- |
| Number of patients with gene mutations or genetic variants in children with early-onset severe obesity |  | Baseline, first day of enrollment |
Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment

Study Overview
=================
Brief Summary
-----------------
To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.

Conditions
-----------------
Infertility, Pertubation, Insemination

Intervention / Treatment
-----------------
* Procedure: Pertubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration >15 million spermatozoa/ml and total sperm number >39 million/ml according to WHO criteria Exclusion Criteria: the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pertubation performed<br>Study group had pertubation and insemination | Procedure: Pertubation<br>* a lavage procedure of the intrauterine cavity and bilateral fallopian tubes<br>|
| No Intervention: Pertubation not performed<br>Study group had insemination only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Pregnancy rate at 6 month-follow-up | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination
Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

Study Overview
=================
Brief Summary
-----------------
This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders

Detailed Description
-----------------
The study uses non-thermal atmospheric pressure plasma to treat target conditions. The patients are monitored at set intervals for efficacy and adverse effects using investigator's assessment and imaging techniques

Official Title
-----------------
Using a Cold Atmospheric Plasma Device to Treat Skin Disorders

Conditions
-----------------
Actinic Keratosis, Acne/Rosacea, Verruca Plana, Tinea, Molluscum Contagiosum, Bowen's Disease, Warts

Intervention / Treatment
-----------------
* Device: Non-thermal, atmospheric plasma to treat skin lesions and acne
* Device: Indirect non-thermal, atmospheric plasma to treat hair loss and acne


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnoses of target conditions ability to complete study protocol Exclusion Criteria: based on specific condition

Ages Eligible for Study
-----------------
Minimum Age: 4 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-thermal atmospheric plasma treatment<br>Device treatment | Device: Non-thermal, atmospheric plasma to treat skin lesions and acne<br>* Non-thermal, atmospheric plasma treatment of affected area or lesions using a nanosecond dielectric barrier discharge plasma device<br>|
| Experimental: Indirect non-thermal atmospheric plasma treatment<br>A compound of non-thermal atmospheric plasma and medium is used to treat the target by direct application or by on-site generation of the compound | Device: Indirect non-thermal, atmospheric plasma to treat hair loss and acne<br>* A compound of non-thermal, atmospheric plasma and medium is delivered to or generated at the target area. Plasma is generated using either microsecond dielectric barrier discharge plasma device or PiezoBrush (a helium jet plasma). The medium is an aqueous alcohol solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | The outcome is the presence or lack of clinical improvement in the investigator's global assessment and reviewing photo-documentation as well as reflectance confocal microscopy study investigator's global assessment and reviewing photo-documentation | 1-12 months |
Tailored Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
The study is intended to examine the safety and efficacy of computerized mobilization of the neck for the treatment of patients with chronic neck pain. This is a third continuation study aimed at examining the Occiflex Robotic System. This time we will be studying tailored or personalized three dimensional movement of the neck.

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Device: Occiflex Robotic Intervention System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain Exclusion Criteria: Patients with cervical radiculopathy Myelopathy Discopathy Malignancy involving the neck or cervical spine Severe Osteoporosis Severe skin disorder Psychiatric disorders Cervical disc herniation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive Mobilization Cervical Spine<br>Patients with chronic neck pain according to the International Association of the Study of Pain criteria of the following types: facet joint disorder, post-whiplash injury, myofascial pain syndrome. | Device: Occiflex Robotic Intervention System<br>* Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occiflex Device Safety | A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as Per the NDI-Neck Disability Index | The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Neck Pain, Occiflex, Computerized Mobilization
Study of the Electrocardiographic Effects of TA-8995

Study Overview
=================
Brief Summary
-----------------
A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.

Official Title
-----------------
A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects

Conditions
-----------------
Dyslipidaemia

Intervention / Treatment
-----------------
* Drug: TA-8995
* Drug: Moxifloxacin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or females of non-child bearing potential Exclusion Criteria: Receiving any other drug therapy Clinically significant medical history Abnormal ECGs or vital signs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-8995<br>Single oral dose of 150mg TA-8995 | Drug: TA-8995<br> <br> |
| Experimental: Placebo<br>Single oral dose of placebo to TA-8995 | Drug: Placebo<br> <br> |
| Active Comparator: Moxifloxacin<br>Single open-label oral dose of 400mg moxifloxacin | Drug: Moxifloxacin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between plasma levels of TA-8995 and the QTcF effect |  | 4 days |
Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes

Study Overview
=================
Brief Summary
-----------------
Evaluating the percentage of patients that suffer from eye allergies and determining whether they also have dry eyes.

Official Title
-----------------
Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome

Conditions
-----------------
Dry Eyes, Allergic Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to give informed consent Males and females at least 18 years of age Personal history of allergic disorders including but not limited to allergic conjunctivitis, allergic rhinitis, contact dermatitis and other eczema, and asthma Diagnosis of allergic conjunctivitis Presence of any of the following signs including conjunctival redness and papillae, chemosis, red edematous eyelids, reduced tear clearance, reduced TBUT, vital staining, stringy discharge, and/or symptoms including ocular itching, burning and tearing, runny nose or itchy throat Exclusion Criteria: Active ocular or systemic infection History of ocular infection within past 6 months Presence of punctal plugs Recent ocular surgery within past 6 months Current use of chemotherapeutic agents Presence of ocular trauma Inability to give informed consent Women who are pregnant, nursing or lactating

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 |
| --- | --- |
| Dry Eyes, Eye Allergies<br>Patients with ocular allergies and those with dry eyes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dry eye in an allergic population presenting to a high volume optometry practice |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of allergic patients with moderate to severe ocular signs and symptoms |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burning, Dryness, Itching, Blurry Vision
Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
EFFECTS OF CYTOTOXIC CHEMOTHERAPY AND PARP INHIBITION ON THE GENOMIC CONTEXTURE OF OVARIAN CANCER: TR_NACT_OV/17 In order to approach the above open questions, ultimately aiming in understanding the effects of cancer drugs on tumor biology and hence in selecting the proper drugs for the patients in the context of Precision Medicine, the objective of this study is to study the genomic characteristics of ovarian tumors before and after treatment with classic neoadjuvant chemotherapy (NACT) and with the more recently approved PARP inhibitor olaparib.

Official Title
-----------------
Effects of Cytotoxic Chemotherapy and PARP Inhibition on the Genomic Contexture of Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ovarian cancer eligible for neoadjuvant chemotherapy Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| assesment of genomic characteristics of ovarian tumors at the diagnosis |  | 4 years | 
| assesment of genomic characteristics of ovarian tumors after treatment with neoadjuvant platinum-based chemotherapy |  | 4 years |
Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi

Study Overview
=================
Brief Summary
-----------------
The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected. The study will also determine the effect of these vaginal gels on genitourinary symptoms.

Detailed Description
-----------------
This is a phase 3, randomized, double masked, two arms study conducted in Malawi, Southeast Africa. The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age. Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment. Women receive assigned product every three months for one year.

Conditions
-----------------
Bacterial Vaginosis, Trichomonas Vaginitis, Urogenital Diseases

Intervention / Treatment
-----------------
* Drug: Metronidazole gel versus placebo gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nonpregnant HIV-Uninfected HIV-Infected Exclusion Criteria: Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metronidazole gel versus placebo gel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of bacterial vaginosis |  |  | 
| Reported genitourinary symptoms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genitourinary symptoms
Left Atrial Volume and Function in Children Assessed by Echo 3DRT: Reference Values for Normal Children

Study Overview
=================
Brief Summary
-----------------
The investigators study is trying to find the normal value to left atrial volume and left atrial function in healthy children by tridimensional real time echocardiography avaluation.

Official Title
-----------------
Left Atrial Volume and Function in Healthy Children Assessed by Three Dimensional Echocardiography

Conditions
-----------------
Left Ventricular Function Good

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: research murmur Exclusion Criteria: any congenital heart disease any systemic disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 13 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left atrial, three-dimensional echocardioraphy, left atrial function
Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Study Overview
=================
Brief Summary
-----------------
We will evaluate the bioavailability of naproxen 375 mg in two formulations

Official Title
-----------------
Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Drug: PN400
* Drug: Naproxen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non-pregnant female subjects between 18-55 years as well as other standard inclusion criteria for a study of this nature Exclusion Criteria: Standard exclusion criteria for a study of this nature

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PN400 | Drug: PN400<br>* naproxen 375 mg / esomeprazole 20 mg<br>|
| Active Comparator: 2<br>naproxen 375 mg | Drug: Naproxen<br>* naproxen 375 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess and compare the pharmacokinetics bioavailability of a single oral dose of naproxen administered in two formulations |  | 72-hour PK | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of the two treatments |  | entire study duration |