linjc16/ctgov huggingface dataset:
A Study to Test the Pain-relieving Effect of Laughing Gas in Infants

Study Overview
=================
Brief Summary
-----------------
Our proposal is to study infants in the Neonatal Intensive Care Unit (NICU) who are undergoing a heel stick for blood sampling, a standard procedure in patient care. Currently, these infants do not get any pain relief for this procedure. Several recent clinical studies have shown the usefulness of nitrous oxide (laughing gas) for treating pain for minor procedures in children 0 to 18 years, but these effects have not been exclusively studied in the newborn and infant populations. Animal studies have questioned the anti-nociceptive (pain-blocking) effect of nitrous oxide in very young animals. It is unclear if this also applies to humans. The reason for this difference may be due to an immaturity of the neural pathways that modulate pain in the very young. The purpose of this study is to investigate whether or not nitrous oxide has an analgesic (pain-relieving) effect in infants undergoing minor procedures in the neonatal period (less than 3 months).

Official Title
-----------------
Analgesic Effect of Nitrous Oxide in Neonates Undergoing Heel Stick

Conditions
-----------------
Analgesic Affect

Intervention / Treatment
-----------------
* Drug: Nitrous Oxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Full-term babies up to three months old scheduled for heel stick blood draw. Exclusion Criteria: preterm, difficult airway (micrognathia, cranio-facial malformation, choanal atresia, Pierre Robin syndrome, or Treacher Collins syndrome), sedated, intubated (including tracheostomy), have an oxygen requirement (FiO2>40%), anemia, bone marrow suppression, or cardiac defect

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 3 Months

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nitrous Oxide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIPS scale |  |  | 
| salivary cortisol level |  |  |
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled clinical trial with three parallel arms. This trial aims to evaluate the effectiveness of electroacupuncture on P6 acupoint for patients with hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.

Official Title
-----------------
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Procedure: Sham acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients above 18 years old Have not recently had any changes in anti-hypertensive medications Have not recently been discharged from hospital/are stable Is not having any acute infection. Exclusion Criteria: Trypanophobia Below 18 years of age Is currently having an acute infection Is unstable or have been discharged recently from hospital Changes made to anti-hypertensive medications

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral electroacupuncture of p6 acupoint<br> | Procedure: Acupuncture<br>* In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device.<br>|
| Experimental: Bilateral electroacupuncture of p6 acupoint<br> | Procedure: Acupuncture<br>* In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device.<br>|
| Sham Comparator: Sham acupuncture of p6 acupoint<br> | Procedure: Sham acupuncture<br>* Sham acupuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of blood pressure. | It is expected that both blood pressure and heart rate will be reduced during the electroacupuncture of P6 acupoint. | up to 6 months | 
| Reduction of Heart Rate | Heart Rate is also expected to be reduced with the stimulation of p6 acupoint. | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture
Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

Study Overview
=================
Brief Summary
-----------------
Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system. The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase. Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.

Official Title
-----------------
Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL

Conditions
-----------------
Acute Lymphoblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained Exclusion Criteria: No allergic reactions to PEG-asparaginase

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| treatment every 6th week during 6 months<br> | |
| treatment every 2nd week during 6 months<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the coagulation parameters | The study is a prospective and descriptive study. Levels of coagulation parameters will be analyzed using Two Sample T-Test and the levels of asparaginase in serum will be analyzed by Chi2 test. | December 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALL, PEG-asparaginase, prolonged treatment, Thrombosis, Central venous line, Echocardiography
Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies

Study Overview
=================
Brief Summary
-----------------
This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

Detailed Description
-----------------
Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Design: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited. Methods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting. Statistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

Official Title
-----------------
Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies

Conditions
-----------------
Prenatal Diagnosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal. only singleton were included Exclusion Criteria: women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease. Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.
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 |
| --- | --- | --- |
| accuracy of NIPT for prenatal diagnosing chromosomal anomalies | sensitive, false negative rate, and false positive rate of NIPT compared with CMA | July,2016-July, 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prenatal diagnosis, non-invasive prenatal tests, chromosome microarray analysis
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.

Official Title
-----------------
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Levodopa-Carbidopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or female subjects at least 30 years old; Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days; Body mass index range from 18.0 to 30.0 kg/m2 Exclusion Criteria Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator; Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments; Subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Levodopa-Carbidopa<br>* Intestinal Gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation. | 5mins, then every 30 minutes up to 8 hours (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8 hour), 12, 16 (immediately after flushing the tube), 17, 18, and 19 hours. | 
| Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam) | Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring (Screening, Day -1, Day 1, Day 2), clinical lab testing and physical exam (Screening and Day 2) | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, levodopa, carbidopa, Duodopa, intestinal gel
Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.

Official Title
-----------------
Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome

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

Intervention / Treatment
-----------------
* Drug: Letrozole
* Procedure: ovarian drilling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of at least one year of infertility either primary or secondary. Body mass index: 25-35 Normal fallopian tubes Normal semen analysis of the husband Women who will accept to participate in the study Exclusion Criteria: Body mass index above 35 Contraindication to general anesthesia Previous laparoscopic drilling Presence of other causes of infertility Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months Women who intended to start a diet program Women who will refuse to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: letrozole<br>letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day | Drug: Letrozole<br>* oral tablets 2.5 mg<br>* Other names: femara;|
| Active Comparator: laparoscopic drilling<br>laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle | Procedure: ovarian drilling<br>* laparoscopic electrocauterization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ovulation rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mid-cyclic endometrial thickness |  | one day |
Efficacy and Safety of 3% Minoxidil Lotion for Chest Hair Enhancement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for chest hair enhancement.

Official Title
-----------------
Efficacy and Safety of 3% Minoxidil Lotion for Chest Hair Enhancement : A Randomized, Double-blind, Placebo-controlled Study

Conditions
-----------------
Chest Hair Enhancement

Intervention / Treatment
-----------------
* Drug: 3 % minoxidil lotion
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male Exclusion Criteria: serious underlying diseases history of chest/ hair treatment before 6 months history of surgery or trauma on chest area. history of minoxidil allergy

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

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

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: Minoxidil<br>3% Minoxidil lotion is applied twice daily to the chest. | Drug: 3 % minoxidil lotion<br> <br> |
| Placebo Comparator: Placebo<br>Placebo lotion is applied twice daily to the chest. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of global photographic assessment after 20 weeks from baseline |  | baseline and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in number of hairs after 20 weeks from baseline |  | baseline and 20 weeks |
Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of a urine test strip in diagnose schistosoma mansoni in areas of Kenya where the rate of infections are low. The hypothesis is that the urine strip test is a superior tool to the conventional parasitological tools used to diagnose schistosomiasis mansoni infections in area where there is low transmission

Detailed Description
-----------------
The study will compare the use of the urine test strip with the conventional method used and with a golden standard methode, in an area of Kenya where the infection transmission is low. Furthermore will the urine test strip be evaluatied in its ability to monitor the intensity of infections in school children before and after they are been treated for the infections. A total of 1100 school children in the age between 10 and 18 years will be included in the study. Children have to submitt a stool and a urine sample on three consecutive days. Children who are found to be infected with the schistosomiasis parasite will be offered treatment.

Official Title
-----------------
Evaluation of Applicability of Urine Based Schistosomiasis Test Strip in the Epidemiologic Mapping and Sampling of Schistosoma Mansoni Infection in Low Endemic Areas of Kenya

Conditions
-----------------
Schistosomiasis Mansoni, Circulating Cathodic Antigen Urine Based Dipstick

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children in the age between 10 and 18 years Exclusion Criteria: Children younger then 10 years of age and children whos parent/guardians did not give informed consents for their participation in the study

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schistosomiasis, Schistosoma mansoni, Circulating cathodic antigen urine dipstick
WHODAS-II for Patients With Nonspecific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with low back pain (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).

Official Title
-----------------
WHODAS-II for Patients With Nonspecific Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Set of questionnaires (respondent)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen for nonspecific low back pain, with or without referred pain Able to read and write Have signed the informed consent form Exclusion Criteria: Central nervous system pathology (with or without treatment) Diagnosis of rheumatic inflammatory disease or fibromyalgia Red flags for underlying systemic disease Criteria for diagnosis of symptomatic herniated disc or symptomatic spinal stenosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule) | Other: Set of questionnaires (respondent)<br>* To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement characteristics of WHODAS-II |  | At baseline and at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in nonspecific low back pain |  | At baseline and at 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nonspecific low back pain, disability, fear avoidance beliefs, quality of life