linjc16/ctgov huggingface dataset:
Performance Evaluation Study for a New Meconium Detection Test

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect amniotic fluid samples from pregnant women. Amniotic fluid samples will be tested for meconium with a new assay. The results will be correlated with other laboratory tests.

Detailed Description
-----------------
Female volunteers will be recruited locally in a single medical center. After the occurrence of amniotic membranes rupture, amniotic fluid samples will be collected extracorporeally. Meconium concentration levels will be measured by the new test. Other laboratory tests will be employed in order to determine the accuracy of the new test.

Official Title
-----------------
Performance Evaluation Study for a New Meconium Detection Test

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written or oral informed consent to participate in the study and agree to comply with study procedures. Pregnant. Intend to seek medical care during pregnancy. Exclusion Criteria: Amniotic fluid samples are mixed with urine.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meconium concentration in amniotic fluid |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meconium, concentration, level
Mederma to Reduce Appearance of Post Surgical Scars

Study Overview
=================
Brief Summary
-----------------
This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N&I to Mederma Ultra Gel on the appearance of post-surgical scars.

Detailed Description
-----------------
This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest. Inclusion Criteria: Healthy male and non pregnant female subjects ≥18 years of age have seborrheic keratoses on the right and left chest and/or back Exclusion Criteria: -Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.

Official Title
-----------------
The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars

Conditions
-----------------
Scars

Intervention / Treatment
-----------------
* Other: Mederma N&I
* Other: Mederma Ultra Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be 18-70 years of age, of any race or sex. Subjects must be Fitzpatrick skin type I-VI. Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study. Exclusion Criteria: Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine. Subjects with known history of keloids or hypertrophic scars.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mederma Ultra Gel<br> | Other: Mederma Ultra Gel<br>* Topical gel applied once daily for eight weeks.<br>|
| Active Comparator: Mederma N&I<br> | Other: Mederma N&I<br>* Topical gel applied three times a day for eight weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry. |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical, scars, Mederma
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Testicular Injury and Oligospermia

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Testicular Injury and Oligospermia

Detailed Description
-----------------
This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Testicular Injury and Oligospermia. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Testicular Injury and Oligospermia

Conditions
-----------------
Testicular Injury, Oligospermia

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Testicular Injury or Oligospermia Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Previous organ transplant Hypersensitivity to sulfur
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: Treatment Group (AlloRx)<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oligospermia, Testicular Injury, stem cell treatment
Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.

Official Title
-----------------
Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome in Lambaréné, Gabon

Conditions
-----------------
Immune Reconstitution Inflammatory Syndrome, Opportunistic Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Informed consent ART naive Exclusion Criteria: No informed consent History of ART use Pregnancy

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 |
| --- | --- |
| Starting ART<br>Adult patients starting anti retroviral therapy for the first time | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IRIS | Development of immune reconstitution inflammatory syndrome | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to IRIS | Time to development of immune reconstitution inflammatory syndrome | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Immune reconstitution inflammatory syndrome, Biomarkers, ART, predictive factors, epidemiological pattern, Gabon
Effect of Glucosamine on Intraocular Pressure

Study Overview
=================
Brief Summary
-----------------
In this double blind clinical trial 92 patients suffering from rheumatoid arthritis are included. Those with the history of intraocular and corneal surgery, diabetic and heavy smokers are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam, corneal biomechanical properties assessment by Ocular Response Analyzer (ORA) and corneal thickness measurement. Patients are randomly assigned to treatment and placebo groups. Those in the treatment groups receive glucosamine sulfate 1500 mg three times a day. Those in placebo arm receive alike capsule with the same schedule. At month 3 and 6 IOP(intraocular pressure), ORA and pachymetry would be checked again.

Conditions
-----------------
Intraocular Pressure Changes After Glucosamine Sulfate Consumption.

Intervention / Treatment
-----------------
* Drug: Placebo three times a day
* Drug: glucosamine sulfate 1500 mg three times a day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of rheumatoid arthritis based on ACR (American College of Rheumatology)FC(functional classes). No history of using drugs tested in the study. Exclusion Criteria: History of any kind of corneal surgery. History of intraocular surgery. History of diabetes mellitus. Heavy smokers. Unwillingness to participate in the study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Administration of the Placebo<br>Placebo three times a day. | Drug: Placebo three times a day<br> <br> * Other names: oral consumption;|
| Placebo Comparator: Administration of the glucosamine sulfate<br>glucosamine sulfate 1500 mg three times a day | Drug: glucosamine sulfate 1500 mg three times a day<br> <br> * Other names: oral consumption;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure changes | : Goldmann applanation tonometry | until 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal biomechanical changes | Ocular Response Analyzer (ORA) | until 6 months |
Epigenetic Modifications of Diabetes Mellitus Type I

Study Overview
=================
Brief Summary
-----------------
This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes.

Official Title
-----------------
Epigenetic Modifications Induced by Glycemic Variability

Conditions
-----------------
Type I Diabetes

Intervention / Treatment
-----------------
* Procedure: Oral glucose tolerance test for Phase I


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old Diagnosis of Type I diabetes Willing to wear continuous blood glucose monitor as specified in protocol Exclusion Criteria: Pregnant or planning to become pregnant during the study Healthy control group Inclusion: 18-65 years old Willing to wear continuous blood glucose monitor as specified in protocol Exclusion: Pregnant or planning to become pregnant during the study Diagnosis of Type I or II Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase I<br> | Procedure: Oral glucose tolerance test for Phase I<br>* Oral glucose tolerance test for Diabetic patients in phase I<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate blood sugar variability in Type I diabetics for differences in epigenetic signatures between Type I diabetics with little glycemic variability as compared to those with more pronounced glycemic changes. |  | 7 days |
Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World

Study Overview
=================
Brief Summary
-----------------
To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.

Official Title
-----------------
Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World

Conditions
-----------------
Respiratory Infectious Diseases

Intervention / Treatment
-----------------
* Drug: Pudilan Xiaoyan Oral Liquid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ; (2)Aged between 18 and 80. Exclusion Criteria: Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pudilan Xiaoyan Oral Liquid|In the respiratory and emergency departments of the hospitals under surveillance, the medication of Pudilan Xiaoyan Oral Liquid is observed for those aged 18-80 years who strictly follow the prescription of the instructions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Drug Reaction | Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ratio of Body Temperature to Normal | The Ratio of Body Temperature to Normal(Lower Than 37.3ºC) | 7 days | 
| Change of liver function | Observation of liver function in at least 3000 patients before and after medication.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase.To observe whether the above liver function indexes appear abnormal once after medication. | 7 days | 
| Change of renal function | Observation of renal function in at least 3000 patients before and after medication.The renal function includes creatinine,usea nitrogen.To observe whether the above renal function indexes appear abnormal once after medication. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pudilan Xiaoyan Oral Liquid, Safety monitoring
Assess the Effects of Infant Formula on Infant Stool Characteristics, Behaviour and Parental Experience in Everyday Situations

Study Overview
=================
Brief Summary
-----------------
A prospective, multi-country, open label study to describe the stool characteristics and behaviour as well as the parents' experience in infants receiving a recently launched infant formula in a real life situation.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy term infants, gestational age up to and including 37 weeks and 42 weeks and below. Healthy is defined as no supervision or medical treatment by a medical specialist. Further more to be determined by HCP. Birth weight between 2.5 - 4.5 KG (within normal range for gestational age and sex) Infants up to 6 weeks of postnatal age (Including day 42) Receiving exclusively or at least 1 complete infant formula feeding per day at study inclusion (retrospectively exclusively or partly formula fed) Willingness to change from their regular infant formula to study product Parents' or legal guardians' aged up to and including 18 years, written, informed consent. Exclusion Criteria: Infants with a congenital condition and / or previous or current illness and (or) medication that could interfere with the study Infants with established or suspected cows milk allergy, lactose intolerance, galactosaemia or infants on a prescribed fibre free (e.g. prebiotic oligosaccharides) diet Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study Investigator's uncertainty about the willingness of the parents / legal guardians to comply with the protocol requirements.

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 6 Weeks

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: Healthy infants: fully or partly formula fed<br> | Other: Infant formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency measured by Amsterdam Stool Scale. | Will be reported in diaries completed by the parents. | 15 months | 
| Crying time | Will be reported in diaries completed by the parents. | 15 months | 
| Stool frequency | Will be reported in diaries completed by the parents. | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating behaviour | Baby Eating Behaviour Questionnaire | 15 months | 
| Parental experience of child behaviour | PedsQL, | 15 months | 
| Impact on family life | FamPedsQL | 15 months |
Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
In patients with acute rejection after lung transplantation the peptide profile in broncho-alveolar lavage (BAL) and urine should be compared in order to identify a paradigm that allows an non-invasive rejection therapy.

Detailed Description
-----------------
Goal of the study is the establishment of biomarkers for early diagnosis of acute rejection, followed by a late validation of the paradigm with prospectively collected samples, which will be examined blinded.

Official Title
-----------------
Proteomics Analysis for Recognition of Acute Cellular Rejection After Lung Transplantation

Conditions
-----------------
Rejection, Lung Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable graft function Patients with acute rejection Exclusion Criteria: Acute infection BOS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| 1<br>30 patients with stable graft function | |
| 2<br>30 patients with acute rejection after lung transplantation | |

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
-----------------
Proteomics, Lung Transplantation