linjc16/ctgov huggingface dataset:
Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

Study Overview
=================
Brief Summary
-----------------
Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic differences of therapeutic effect of chloroquine and search the cause of these ethnic differences. For this purpose, chloroquine will be administered to four ethic groups of Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be measured. The result of this study will be helpful in finding more adequate dosing regimen of chloroquine in patients with malaria.

Official Title
-----------------
Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: chloroquine phosphate 1000 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 20 - 50 male subjects (6 Koreans, 6 Caucasians, 6 Africans and 6 Southeast Asians) Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9. Exclusion Criteria: Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study. Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Southeast Asians<br> | Drug: chloroquine phosphate 1000 mg<br>* 1000 mg, 1day<br>|
| Experimental: Korean<br> | Drug: chloroquine phosphate 1000 mg<br>* 1000 mg, 1day<br>|
| Experimental: Caucasians<br> | Drug: chloroquine phosphate 1000 mg<br>* 1000 mg, 1day<br>|
| Experimental: Africans<br> | Drug: chloroquine phosphate 1000 mg<br>* 1000 mg, 1day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic evaluation | maximum of concentration(Cmax) | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic evaluations | Area under the time-concentration curve(AUC) | within 30 days |
Using Cumulase for Denudation of Cycles With ≤ 8 Cumulus-oocytes Complexes

Study Overview
=================
Brief Summary
-----------------
The cumulus-corona-oocyte complex (COCs) surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (ICSI). This is traditionally achieved with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. A human recombinant hyaluronidase (Cumulase) has been developed to circumvent the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. whether cumulase offers a higher chance for success after ICSI for women with 8 COCs or lower remains an open question.

Official Title
-----------------
Can Cumulase Reduce the Shear Stress During Denudation for ICSI Cycles of ≤ 8 Cumulus-oocytes Complexes

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Cumulase denudation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICSI indicated partcipants Exclusion Criteria: severe medical disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cumulase denudation<br> | Other: Cumulase denudation<br>* Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve<br>|
| No Intervention: Hyaluronidase denudation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Continued pregnancy after 12 weeks of gestation | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy | Positive b-hCG at two weeks or more after embryo transfer | Two weeks | 
| Clinical pregnancy rate | Detection of gestational sac with a heartbeat on ultrasound at 7 weeks of gestation | 7 weeks | 
| Embryo developmental rate | fertilized oocytes per injected oocytes and developed embryos per fertilized oocytes | 6 days of culture |
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia. N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.

Official Title
-----------------
Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis

Conditions
-----------------
Endometriosis, Chronic Pelvic Pain

Intervention / Treatment
-----------------
* Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 50 years; pain visual analog scale (VAS) score>4 laparoscopic diagnosis of endometriosis (performed in the last three years), no assumption of any drugs (in particularly estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists) persistence of symptoms by at least one month Exclusion Criteria: presence of other associated diseases assumption of drugs menopause pregnancy unable or unwilling to give written consent patients adverse reaction or hypersensitivity to active substance or excipients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: Endometriosis<br>Symptomatic patients with laparoscopic diagnosis of endometriosis | Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin<br>* Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pelvic pain as measured by visual analogue scale |  | Change from Baseline Pelvic Pain at 90 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pelvic pain as measured by visual analogue scale |  | Change from baseline Pelvic Pain after 30 days from the suspension of the therapy |
Effects of Emotional Stimulation on the Stress Levels of Healthy Persons

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of a short-term emotional stimulation on the mood of healthy persons.

Detailed Description
-----------------
The trial assesses the effects of a emotion-centered stimulation on the mood of healthy persons. The outcomes will be evaluated with standard questionnaires.

Official Title
-----------------
Evaluation of the Effects of a Body-centered Emotional Stimulation in Healthy Persons

Conditions
-----------------
Depression, Somatization Disorder, Anger, Anxiety

Intervention / Treatment
-----------------
* Other: Emotional stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 45 Ability to speak German Exclusion Criteria: Physical or psychiatric disorders Consume of drugs or alcohol 24 previous to the test

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: Emotional stimulation<br>* Increase of the physical correlates of an emotion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Depression scores will be evaluated with the BDI | After 10 days | 
| Somatization | Somatization will be assessed with the SOMS7 questionnaire | After 10 days |
Magnetic Resonance Imaging Studies of Motor and Thought Processes

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). MRI is especially useful when studying the brain, because it can provide information about certain brain functions. In addition, MRI is much better than standard X-rays at showing areas of the brain close to the skull and detecting changes in the brain associated with neurological diseases. In this study researchers will use MRI to gather information about the processes that control human movement and sensory processing. The purpose of the study is to investigate how the brain is activated when remembering, thinking, or recognizing objects. Researchers would like to determine what happens to brain functions when patients have trouble remembering, thinking, or recognizing objects following the start of disorders in the brain and nervous system. In addition, this study will investigate the processes of motor control in healthy volunteers and patients with disease.

Detailed Description
-----------------
The main purpose of the studies presented in this protocol is to investigate the physiology of motor control in health as well as the pathophysiological modifications taking place during disease. Patients and normal volunteers will be scanned at rest and during different tasks, either while making repetitive movements or undergoing sensory stimulation. These studies should provide new insight concerning the processes that control human movement and sensory processing. The studies described in this protocol will be conducted by systems operating on 1.5 Tesla up to 4 Tesla, including a system at 3 Tesla which is going to be installed in near future.

Official Title
-----------------
Central Nervous System Motor and Cognitive Processes: Nuclear Magnetic Resonance Imaging at 1.5 to 4 Tesla

Conditions
-----------------
Cerebrovascular Disorder, Healthy, Movement Disorder, Nervous System Disease, Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with movement disorder and normal volunteers.
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
-----------------
Movement Disorders, Sensory Processing, Stroke, Spinal Cord Injury, Blood Flow, Blood Volume, Cognitive Function, Neurobehavioral Deficits, Neurological Disorders, Magnetic Resonance Imaging, Plasticity, Normal Volunteer
Evaluation of Factors Affecting Diaper Dermatitis

Study Overview
=================
Brief Summary
-----------------
Diaper dermatitis is one of the most common skin problems in infants and children.It is a skin disorder in the perineal , perianal and surrounding area .It frequently occurs also in areas immediately adjacent to the diaper area . Diaper dermatitis is caused by lack of fresh air,dampness and irritation.With prevelance from 7-35 % in newborns.This skin disorder typically develops between nine and twelve months of age .

Detailed Description
-----------------
The development of diaper dermatitis is multifactorial . Newborn skin exhibits a cutaneous immaturity and an increased susceptibility toward skin barrier disruption or percutaneous absorption. The epidermal barrier function resides in the outermost epidermal layer , the stratum corneum , which is the region of terminal skin differnatiation and is composed of corneocytes . The hydrophobic components of the lipid matrix provide the epidermal permeability barrier and protect against excessive water loss and irritant penetration , whereas the corneocytes and the cornified envelope provide mechanical strength to the stratum corneum. The skin in the diaper area is predisposed to irritation by the prolonged contact with irritants , such as urine and feces as well as by diaper occlusion, with leads to an increase in hydration and skin ph. Overhydration promotes degradation of the brick and mortar structure of stratum corneum, contributing to impraired barrier function.

Official Title
-----------------
Evaluation of Factors Affecting Diaper Dermatitis

Conditions
-----------------
Diaper Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age <2 years whether male or female. having diaper dermatitis Exclusion Criteria: age > 2 years .

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- | --- |
| The percentage of patients with risk factors for Diaper dermatitis | The percentage of patients with breastfeeding, presence of diarrhea, and frequency of diaper change | One week |
Trunk Strength Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure abdominal wall strength both preoperatively and postoperatively in patients undergoing ventral/incisional hernia repairs. The investigators hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate the rectus musculature to the midline. Abdominal wall strength measurements would be obtained utilizing various abdominal strength testing.

Official Title
-----------------
Abdominal Wall Hernias and Abdominal Wall Function: A Quantitative Study of Trunk Strength.

Conditions
-----------------
Ventral/Incisional Hernia Repairs

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled for hernia repair. Exclusion Criteria: Pregnant females.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with abdominal wall hernias<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS

Study Overview
=================
Brief Summary
-----------------
children ; autonomic nervous mediated syncope； vitamin D ; symptom score ; renin-angiotensin-aldosterone-system

Detailed Description
-----------------
children with autonomic nervous mediated syncope have seriously affects children's physical and mental health and quality of life, and the incidence rate is also increasing year by year. But the current treatment measures are not ideal, Therefore, we need to look for new biological indicators, according to different biological indicators to develop different treatment options, so as to improve the current situation of poor treatment of children with NMS

Official Title
-----------------
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope（NMS） Child and it 's RAAS

Conditions
-----------------
Vitamin D

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Device: Full automatic chemiluminescence measuring instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed with OI; Compliance with the diagnostic guidelines for Syncope in children (2016 edition) and 2018 syncope in children and adolescents in the cardiovascular group of the Society of Pediatrics, Chinese Medical Association The diagnostic criteria of Oi in the Diagnostic and therapeutic guidelines. Exclusion Criteria: Taken 3 months prior to admission Vitamin D or hormone drugs; Heart, brain, nerves, metabolism, blood and other apparatus Syncope or aura of syncope caused by a qualitative disease;

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 Years

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

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

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 |
| --- | --- |
| Other: Clinical Study of Vitamin D in Children With NMS<br>Correlation between vitamin D and symptoms severity of autonomic nervous mediated syncope child and it 's RAAS | Drug: Vitamin D<br>* Clinical Study<br>* Other names: Vitamin D drops;Device: Full automatic chemiluminescence measuring instrument<br>* Chemiluminescence immunoassay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels | Vitamin D levels after supplementation | 3 months after taking the drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAAS levels | RAAS levels after vitamin D supplementation | 3 months after taking the drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children ; VVS； vitamin D ; symptom score ; RAAS
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this protocol is to provide fluconazole for the treatment of individual patients who require therapy for serious or life-threatening systemic fungal infection, who have failed on conventional antifungal therapy or have had unacceptable reactions to conventional antifungal therapy, and who are ineligible for other established fluconazole clinical trial protocols.

Official Title
-----------------
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy

Conditions
-----------------
Candidiasis, Mycoses, HIV Infections

Intervention / Treatment
-----------------
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole. A patient will be excluded if he/she has previously had an unacceptable adverse effect due to fluconazole. AMENDED: 900207 Open only to unapproved indications and/or age ranges. Original design: Patients with clinically established serious or life-threatening systemic fungal disease will be considered if conventional fungal therapy is not an acceptable alternative. Unacceptability of conventional therapy is defined as: Failure of conventional therapy to control or eradicate infection after appropriate trial(s) of generally accepted regimen(s). Serious and unacceptable untoward reaction(s) to conventional antifungal therapy. OR A major contraindication to the use of conventional antifungal therapy. The patient must be ineligible or have no access to other established fluconazole investigational protocols. The final judgment of patient acceptability for inclusion lies with the Pfizer Clinical Monitor.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluconazole|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
-----------------
Mycoses, Drugs, Investigational, Fluconazole