linjc16/ctgov huggingface dataset:
An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan

Study Overview
=================
Brief Summary
-----------------
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 participants will be enrolled in Japan. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 64 weeks. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Official Title
-----------------
A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan

Conditions
-----------------
Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with moderately to severely active Crohn's disease (CD). Has been prescribed upadacitinib for CD as per most current local approved label after its approval for CD in Japan. Within 14 days from the commencement of upadacitinib induction treatment for CD at the participating institution. Exclusion Criteria: Currently participating in another interventional clinical research. Participants for whom upadacitinib is contraindicated. Has been treated with upadacitinib for CD before and continue treatment with upadacitinib for CD at the participation to this study.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Upadacitinib<br>Participants will receive upadacitinib as prescribed by their physician according to local label. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Drug Related Serious Infections | Pecentage of participants with serious infections. | Up to 64 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's disease, Upadacitinib
Evaluation of Study Experiences of Neuroendocrine Tumor Patients

Study Overview
=================
Brief Summary
-----------------
Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This research will admit a wide range of data on the clinical study experience of neuroendocrine tumor patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with neuroendocrine tumor.

Official Title
-----------------
Investigating the Clinical Trial Journey and Engagement of Neuroendocrine Tumor Patients

Conditions
-----------------
Neuroendocrine Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age Diagnosis of neuroendocrine tumor Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Enrolled in another research study Patients with psychiatric illness/social situations that would limit compliance with study requirements Pregnant or lactating woman

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who decide to join in a neuroendocrine tumor clinical research |  | 3 months | 
| Number of neuroendocrine tumor patients who remain in clinical trial until completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroendocrine tumor
Familial Hyperlipidemia Family Registry

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to identify children and families that are at risk for cardiovascular disease because of a condition known as familial hyperlipidemia. This condition may increase the risk of cardiac events such as hardening of the arteries anywhere in the body which can result in heart attacks, strokes, and death over ten fold. Children have already been assessed in the Healthy Hearts screening program and identified as having elevated cholesterol. A buccal smear will identify whether the familial hyperlipidemia condition exist in your child. If the child's test shows that they have the specific gene for familial hyperlipidemia and shows a genetic tendency towards premature heart disease, we would encourage genetic testing for as many blood family members as possible. The study plan is to determine whether the Healthy Hearts screening program is a more effective way of identifying students at risk since it is estimated that less than 10% of those individuals with the problem have been identified. If it is effective, then it will be incorporated as part of the standard screening process in the Healthy Hearts program. Aim 1: Is a school screening program a more effective method to identifying those at risk for familial hyperlipidemia? Aim 2: What percent of children with elevated cholesterol ≥ 200 mg/dl have familial hyperlipidemia?

Official Title
-----------------
Familial Hyperlipidemia Family Registry

Conditions
-----------------
Familial Hyperlipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Primary family member of child from school screening program with documented FH variant Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 60 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 |
| --- | --- | --- |
| FH Determination for Family members of School children with elevated Cholesterol and docmented FH variant | Genetic evaluation for FH variants in family member of children with elevate Cholesterol on baseline screening | Evaluation of family members over a defined 5 year period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Hearts, Children, Cholesterol, School based, Biometric Screening, Genetic
Awareness of Parents About Management of Dental Avulsion

Study Overview
=================
Brief Summary
-----------------
Aim of the study: assessment of level of awareness of parents about emergency management of permanent teeth avulsion in children

Detailed Description
-----------------
our study asses level by awareness of parents about emergency management of dental avulsion through questionnaire , the study will be done in diagnosis clinic of faculty of oral and dental medicine Cairo university

Official Title
-----------------
Awareness of Emergency Management of Permanent Teeth Avulsion in Children Among a Group of Egyptian Parents: a Cross Sectional Study.

Conditions
-----------------
Dental Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parents who have children aged from 6 to 12 years Exclusion Criteria: parents who refused to participate in questionnaire parents who have children above or below this age

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| parents who have children aged from 6 to 12 years<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of awareness of parents about emergency management of avulsed permanent teeth | outcome will be assessed through a questionnaire that include binary and multiple choice questions | 2 months |
Predictive Value of Early Changes of Chromogranin A Levels in Patients With Neuroendocrine Tumours Treated With PRRT

Study Overview
=================
Brief Summary
-----------------
The results of the study suggest that an early change in CgA levels might serve as a prognostic factor in NET patients treated with PRRT.

Official Title
-----------------
Predictive Value of Early Changes of Chromogranin A Levels in Patients With Neuroendocrine Tumours Treated With PRRT

Conditions
-----------------
Early Release of Chromogranin A (CgA)

Intervention / Treatment
-----------------
* Diagnostic Test: early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed NET peptide receptor radionuclide therapy (PRRT) Exclusion Criteria: lack of patient consent to a clinical trial

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 |
| --- | --- |
| patients with neuroendocrine tumours<br>We aimed to assess the predictive value of early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT). | Diagnostic Test: early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).<br>* early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The CgA level change | We aimed to assess the predictive value of early release of chromogranin A (CgA) in patients with neuroendocrine tumours (NET) treated with peptide receptor radionuclide therapy (PRRT). | 2016-2023 |
PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

Study Overview
=================
Brief Summary
-----------------
This is a non-intervention, prospective, one-arm, observational real-world clinical trial. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study was to establish a population pharmacokinetic model of Pamiparib and to explore the correlation between its pharmacokinetic parameters and adverse reactions.

Detailed Description
-----------------
In recent years, the advent of poly(ADP-ribose) polymerase(PARP) inhibitors is one of the important breakthroughs in the field of tumor-targeted therapy, and its therapeutic effect on ovarian cancer is quite significant Pamiparib is a potent, selective, oral PARP 1/2 inhibitor. In preclinical models, pamiparib demonstrated PARP-DNA complex trapping, brain penetration, antitumor activity, and inhibition of PARylation. Therefore, at least 50 patients using pamiparib will be included. Before and after treatment, the laboratory examination data ，blood concentration ，combined medication and adverse events of the patients will be collected. The population pharmacokinetic model of pamiparib was established to evaluate the correlation between pharmacokinetic parameters and adverse reactions.

Official Title
-----------------
PPK Study Based on Quantitative Pharmacology in Patients With Pamipril

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The age of the patient is ≥ 18 years old and less than 80 years old. Receive treatment with pamipalil. The patient signed a written informed consent form. Exclusion Criteria: The expected survival time may be less than the treatment cycle. Is being treated with other systemic trial drugs. There are other factors that the researchers think are not suitable for joining the group.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood drug concentration | After treating with Pamipali, blood samples were collected at different time periods | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between blood drug concentration and adverse events | Try to find the relationship between pharmacokinetic parameters and adverse events | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Cancer, Pamiparib
Analysis of the Persistence, Reservoir and HIV Latency

Study Overview
=================
Brief Summary
-----------------
The APRIL study aims at analyzing HIV reservoirs, latency and persistence on antiretroviral therapy. It enrolls HIV-infected adults providing blood samples of which peripheral blood mononuclear cells are stored. The frequency, phenotype and inducibility of HIV-infected cells are then analyzed. These parameters may vary across the different clinical and therapeutic settings.

Official Title
-----------------
APRIL Study: Analysis of the Persistence, Reservoir and HIV Latency

Conditions
-----------------
Informed Consent, HIV Infected Individuals

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infection Adults (>18 years) Social insurance Informed consent Exclusion Criteria: HIV-uninfected <18 years Lack of social insurance Lack or withdraw of consent

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-Flow |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Reservoir, Latency, Persistence
Root Resorption After Maxillary Expansion

Study Overview
=================
Brief Summary
-----------------
The aim of this study will to evaluate the root resorption after RME by hyrax and hybrid hyrax appliances by using of cone beam computed tomography .

Official Title
-----------------
A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances (Expanders)

Conditions
-----------------
Maxillary Expansion

Intervention / Treatment
-----------------
* Device: maxillary expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: skeletal maxillary transvers deficiency unilateral or bilateral posterior crossbite negative buccal corridor patient with good oral hygiene patient with no previous orthodontic treatment no systemic disease Exclusion Criteria: craniofacial congenital anomalies a history of periodontal disease incomplete treatment records

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyrax group<br> | Device: maxillary expansion<br>* Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances<br>|
| Experimental: hybrid hyrax group<br> | Device: maxillary expansion<br>* Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in root resorption after maxillary expansion | A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances | 12 weeks following end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
expanders
Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women

Study Overview
=================
Brief Summary
-----------------
The study is aim to establish 95th and 99th percentile for healthy pregancy women for antiphospholipid antibodies(aPLs), such as aCL IgG/M/A, B2GP1 IgG/M/A, aPS/PT IgG/M. The outcome of the study is expected to aid Antiphospholipid syndrome patients diagnosis and managment. We also include some obstetirc Antiphospholipid syndrome(APS) patients to analysis the correlation between antiphospholipid antibodies and pregancy outcome, also want to know the prevalenc of aPLs, which can be guide for clinical application for APS diagnosis and treatment.

Official Title
-----------------
Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss

Conditions
-----------------
Focus Health Pregancy Women

Intervention / Treatment
-----------------
* Diagnostic Test: Draw blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 120 non-pregnant healthy women, Age 18-45, with at least 1 successful pregnancy , no history of adverse pregnancy outcome, no abortion, still birth, premature delivery, preeclampsia 120 pregnant women, Age 18-45, follow through the pregnancy and successful delivery without any adverse pregnancy outcome during the pregnancy process, no abortion, still birth, premature delivery, preeclampsia, no drug treatment 60 APS pregnant patients diagnosed by clinical department Exclusion Criteria: Thrombosis history Rheumatic immune disease Use oral contraception or biological inhibitors History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1: non-pregancy health women.<br> | Diagnostic Test: Draw blood<br>* Draw blood from human body and make into serum to test<br>|
| Group 2:Pregancy health women.<br> | Diagnostic Test: Draw blood<br>* Draw blood from human body and make into serum to test<br>|
| Group 3: Diagnosed Antiphospholipid syndrome patients<br> | Diagnostic Test: Draw blood<br>* Draw blood from human body and make into serum to test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 95th and 99th pencentile data of pregancy and non-pregancy women | 95th and 99th pencentile data of pregancy and non-pregancy women, and the prevalence of aPLs | Oct. 2023 |
Mother-Baby Study - Caloric Compensation Index (COMPX)

Study Overview
=================
Brief Summary
-----------------
The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

Detailed Description
-----------------
This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 240 participants (120 mothers and 120 children). In this trial only data from the children is collected and therefore only 120 participants are listed.

Official Title
-----------------
Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad

Conditions
-----------------
Eating Behavior

Intervention / Treatment
-----------------
* Behavioral: Caloric Compensation Index (COMPX)


Participation Criteria
=================
Eligibility Criteria
-----------------
The child is a participant in the observational study (NCT06039878).

Ages Eligible for Study
-----------------
Minimum Age: 0 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caloric Compensation<br>The researchers will enroll 120 children from the long-term observational study, NCT06039878. | Behavioral: Caloric Compensation Index (COMPX)<br>* Researcher gives child opportunity to consume high- and low-calorie preloads and then free access to a palatable snack<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in energy intake of palatable snack following a high-calorie versus low-calorie preload |  | Up to approximately 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eating behavior