linjc16/ctgov huggingface dataset:
A Study of SHR-A1811 in Subjects With Gynaecologic Oncology

Study Overview
=================
Brief Summary
-----------------
This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.

Official Title
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Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies

Conditions
-----------------
Gynaecological Malignancies

Intervention / Treatment
-----------------
* Drug: SHR- A1811


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subjects voluntarily joined the study and signed the ICF. Measurable disease, as defined by RECIST v1.1. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. Life expectancy ≥ 12 weeks. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer. Exclusion Criteria: Symptomatic, untreated or active central nervous system metastases. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc.. Have uncontrolled or severe cardiovascular disease. With any active autoimmune disease or history of autoimmune disease. Patients with active hepatitis B or hepatitis C. Severe infections within 28 days prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm study of SHR-A1811
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group with SHR-A1811<br> | Drug: SHR- A1811<br>* Subjects with gynaecological malignancies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | 12 months | 
| Objective response rate (ORR) |  | 12 months | 
| Disease control rate (DCR) |  | 12 months | 
| Duration of response (DOR) |  | 12 months | 
| Overall survival (OS) |  | 12 months | 
| Incidence and severity of adverse events (AEs) |  | From Day 1 to 90 days after last dose |
The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to investigate in elderly with hypertension . The main question it aim to answer is: • Investigate the effect of inspiratory muscle training on inspiratory muscle strength, blood pressure and physical capacity Participants will be random in to 2 group and measure baseline. Control group will advise to maintain normal daily life activity. and Intervention group will receive inspiratory muscle training (IMT) with 60% of Maximal inspiratory pressure. Intervention group will perform IMT 30 breaths/day, 5 days a week for 6 weeks. after 6 weeks both group will remeasure variable again as post test

Official Title
-----------------
The Effect of Inspiratory Muscle Training on Blood Pressure and Functional Capacity in Elderly With Hypertension

Conditions
-----------------
Elderly, Hypertension

Intervention / Treatment
-----------------
* Other: Inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly with hypertension BMI 18.5 - 29.9 kg/m2 Exclusion Criteria: Unstable angina Resting heart rate more than 120 bpm Resting blood pressure more than 180/100 mmHg Other abnormality with contribute to IMT and variable measurement

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control group | |
| Experimental: Intervention<br>IMT group | Other: Inspiratory muscle training<br>* Inhale against 60% of Maximal inspiratory pressure 30breaths/day 5days/week for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Inspiratory pressure |  | baseline, pre-intervention and 6 weeks | 
| Systolic and diastolic blood pressure | blood pressure will include systolic and diastolic blood pressure | baseline, pre-intervention and 6 weeks | 
| Six-minute walk distance |  | baseline, pre-intervention and 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Elderly, Hypertension, Inspiratory muscle training
Autonomic Monitoring in Neurocardiogenic Syncope

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational pilot study of suitability of autonomic monitoring via the VU-AMS device for prediction of neurocardiogenic syncope (NCS) in children referred to cardiopulmonary exercise testing (CPET) for a diagnosis of syncope. The study population is children referred for CPET to evaluate for neurocardiogenic syncope. The purpose is to describe autonomic function during rest and exercise and determine the positive predictive value of autonomic function measurements against the gold standard for diagnosis of neurocardiogenic syncope, the CPET. Children presenting for CPET with chest pain or who are status post orthotopic heart transplantation will serve as positive and negative controls respectively.

Official Title
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Comparing Phenotypic and Autonomic Physiologic Determinants of Neurocardiogenic Syncope

Conditions
-----------------
Syncope, Chest Pain, Dyspnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent/Legal guardian able to provide informed consent Verbal participant assent Undergoing clinically indicated CPET. Diagnosis of either syncope, chest pain/dyspnea or status post OHT Participant willing and able to participate in study procedures Age 7-24 years Exclusion Criteria: Participant unwilling or unable to participate Contraindication to adhesive placement, eg, epidermolysis bullosa Cancellation of the subject's planned CPET procedure. Tracheostomy tube presence (this will prevent proper placement of impedance cardiogram lead)

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 24 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 |
| --- | --- | --- |
| Autonomic data respiratory sinus arrhythmia among patients with chest pain | Subjects will wear an ambulatory monitor during testing | Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes. | 
| Autonomic data respiratory sinus arrhythmia among patients with syncope | Subjects will wear an ambulatory monitor during testing | Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes. | 
| Autonomic data respiratory sinus arrhythmia among patients post heart transplant | Subjects will wear an ambulatory monitor during testing | Data collected throughout cardiopulmonary exercise testing. Up to 90 minutes. |
Weight-loss Treatment Program in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effect of an existing hospital-based obesity treatment in children and adolescents in relation to weight loss and motivation. This is to ensure that children who have developed obesity have the possibility to obtain a healthier lifestyle, including a healthier body weight during their school years. This study will test whether an obesity treatment program designed for school children can reduce the degree of overweight in children and adolescents with overweight and obesity.

Official Title
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Healthy Weight Development Among Children and Adolescents in the Central Denmark Region

Conditions
-----------------
Childhood Obesity, Health Behavior, Weight Loss, Motivation

Intervention / Treatment
-----------------
* Behavioral: ROS chubby and healthy - a multidisciplinary family-based weight-loss treatment program


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 2-18 years old BMI SDS above the 90th percentile Exclusion Criteria: Reached a BMI SDS below the 75th percentile Attained 19 years of age

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 19 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: ROS chubby and healthy - a multidisciplinary family-based weight-loss treatment program|The weight-loss treatment program ROS is family-based and delivered by a multidisciplinary team of physicians, nurses, dieticians, and psychologists. The treatment is based on an individualized tailored plan made together with the family. The plan consists of dietary changes, more physical activity, regular weight checks, and motivational conversations. The program includes options of cooking classes, group session with a psychologist and participation in structured physical activity called ROS sports twice a week. Follow up visits are scheduled every 2-3 months at the different health care professionals.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BMI during weight-loss program of childhood overweight and obesity | The primary objective is to investigate the changes in BMI z-score among children and adolescents with overweight or obesity who participated in a hospital-based weight-loss program, and whether existing characteristics of the child and parents at baseline modify this association. In addition we also want to characterize those who do not respond to treatment either because they gain or regain BMI z-score, or drop-out of the weight-loss program. | December 2022 - December 2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood obesity treatment
Accuracy of IVCCI as a Measure of CVP

Study Overview
=================
Brief Summary
-----------------
The primary aim of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI.

Detailed Description
-----------------
Hemodynamic monitoring is important in the management of patients in the intensive care unit (ICU) Assessment of the intravascular volume, infusion of fluids or vasoactive drugs and maintenance of an adequate systemic perfusion is essential for reduction of the risk of organ failure and/or mortality. The use of CVP through central venous catheter is a gold standard method that is extensively used in the ICU as it reflects the filling pressure of the right ventricle (RV) and RV preload. Central venous cannulation has significant complications such as pneumothorax, hemothorax, arterial puncture, catheter malposition, cardiac arrhythmias, venous embolism, subcutaneous hematoma, and catheter related infection, and it is difficult to use this method in an emergency situation as it requires skilled personnel. Measurement of IVC index by bedside ultrasound is widely used to assess the intravascular volume in adult patients and has the advantage of being non-invasive, rapid, and reliable for assessing the volume status. Besides, related measures such as IVC diameter, IVC collapsibility, and IVC to aorta (AO) diameter have been applied clinically to assess the volume status and have been related to CVP.

Official Title
-----------------
Accuracy of Inferior Vena Cava Collapsibility Index as a Measure of Central Venous Pressure

Conditions
-----------------
IVC Collapsibility Index

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥18 years. Sex: Both sexes. BMI: <35 Patient in whom central venous cannulation is needed for management. Spontaneously breathing patients. Exclusion Criteria: Patients with increased intra abdominal pressure. Patients who not able to lie supine. Patients on mechanical ventilation.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Derivation Sample<br>80 patients will be recruited as a derivation sample to calculate the regression equation | |
| Validation Sample<br>80 patients will be recruited as a validation sample to test the performance of the equation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the current study is to examine the accuracy of IVCCI for measurement of CVP and to derive equation or formula to predict CVP from IVCCI. |  | 18 months |
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia

Study Overview
=================
Brief Summary
-----------------
To determine if the novel regimen of PT/FLU+CY promotes cord blood engraftment in children's leukemia HSCT cohort

Detailed Description
-----------------
PTCy is a well-established haploidentical transplant regimen strategy. Moreover, unrelated cord blood (UCB) plays a critical role in the effects of GVL. However, the engraftment of grafts is unpredictable in the setting of a haplo-cord subsequent transplant. Therefore, applying a novel post-transplant regimen of PT/CY+FLU may selectively promote UCB engraftment in the setting of haplo-cord transplant.

Official Title
-----------------
A Novel Post-transplant Regimen of PT/FLU+CY for Selectively Promoting Unrelated Cord Blood Engraftment in Haploidentical-cord Transplantation in Childhood Leukemia: a Single-arm, Multi-center Trial

Conditions
-----------------
Leukemia, Stem Cell Transplant, Cord Blood

Intervention / Treatment
-----------------
* Procedure: applying of FLU+CY post-HSCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children acute leukemia Exclusion Criteria: MODS

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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: PT/FLU+CY<br>The group consisted of fludarabine (40mg/m2, day-5 to day-3 and day+3, day+4), busulfan (100mg/m2, day-6 to day-3), haplo-PBSC (day0), cyclophosphamide (50mg/kg, day+3, day+4) , and UCB (day+6) | Procedure: applying of FLU+CY post-HSCT<br>* The conditioning regimen (PT-Cy/Flu group) consisted of fludarabine (40mg/m2, d-5 to d-3 and d+3, d+4), busulfan (100mg/m2, d-6 to d-3), haplo-PBSC (d0), PTCy (50mg/kg, d+3, d+4) and UCB (d+6).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of UCB engraftment | evaluate the regimen if it promotes UCB engraftment | initiate STR detection from day+15 thereafter weekly up to 1 year post-HSCT | 
| rate of leukemia free survival | determine the leukemia status post-HSCT | 3 years post-HSCT | 
| rate of overall survival | determine the overall survival status post-HSCT | 3 years post-HSCT |
Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
This was a retrospective real-world evidence cohort study.

Official Title
-----------------
Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

Conditions
-----------------
BRAF Positive Metastatic Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of melanoma (The International Classification of Diseases, 9th Revision [ICD-9] 172.x & 10th revision [ICD-10] C43 or D03x). Pathologic stage IV at initial diagnosis on or after 01 January 2011. First-line treatment with IO monotherapy or combination therapy (nivolumab, pembrolizumab, ipilimumab + nivolumab) or TT combination therapy (dabrafenib + trametinib, vemurafenib+cobimetinib, encorafenib+binimetinib) on or after 01 January 2014. Evidence of a BRAF test. Evidence of a BRAF-positive result prior to or up to 30 days after first-line (1L) therapy initiation. At least 18 years of age at the time of initiation of 1L treatment. Exclusion criteria: Documented receipt of a clinical trial treatment for cancer at any time on or after 01 January 2014. Diagnosis of a second primary cancer or secondary cancer following initiation of 1L metastatic melanoma (MM) treatment.

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 |
| --- | --- |
| Immunotherapy (IO) Cohort<br> | |
| Targeted Therapy (TT) Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean age |  | Baseline | 
| Number of male patients |  | Baseline | 
| Race |  | Baseline | 
| Mean Charlson comorbidity index (CCI) score | Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. | Baseline | 
| Eastern Cooperative Oncology Group performance status (ECOG PS) | The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled. | Baseline | 
| Number of patients with study-related biomarkers | Study-related biomarkers included BRAF and PD1/PDL1 test dates and results. | Baseline | 
| Number of metastatic sites |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS was defined as the time from the initiation of a line of therapy until the date of progression or death. | 6 months and 1, 1.5, and 2 years | 
| Overall survival (OS) | OS was defined as the time from the initiation of a line of therapy until death from any cause. | 6 months and 1, 1.5, and 2 years |
Somatic Symptoms in Autism Spectrum Disorder: Data Integration

Study Overview
=================
Brief Summary
-----------------
Autistic patients have higher chances commorbid somatic symptoms. Therefore, it leads to more health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular disease, autonomic disorders. On average, autistic patient's life span is 16 years shorter than non-autistic patients. Furthermore, autistic patients are not able to convey or communicate their somatic symptoms in a clear and comprehensive manner. This leads to unable to receive proper health care in a timely manner.

Official Title
-----------------
Somatic Symptoms in Autism Spectrum Disorder: Data Integration

Conditions
-----------------
Autism Spectrum Disorder, Somatic Symptom Disorder

Intervention / Treatment
-----------------
* Other: No intervention involved


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASD group: diagnosed with DSM-5 autism spectrum disorder clinical group: anxiety, depression, somatic disorder who are non-psychotic and non-organic control group: healthy control without psychiatric disorder or chronic somatic symptoms age between 15 and 70 Exclusion Criteria: psychiatric disorders such as schezophrenia, mood disorder. major physical disorder which can be potentially lethal who cannot read or comprehend the survey and questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| ASD<br>Diagnosed with DSM-5 autism spectrum disorder | Other: No intervention involved<br>* No intervention involved<br>|
| Clinical<br>Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic | Other: No intervention involved<br>* No intervention involved<br>|
| Control<br>Healthy control without psychiatric disorder or chronic somatic symptoms | Other: No intervention involved<br>* No intervention involved<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient health questionnaire-15, PHQ-15 | range from 0 to 2 for each item, total score range from 0 to 30. Higher the score, worse the level of somatization | 8 years | 
| Health assessment questionnairse, HAQ | range from 0 to 3 for each item. Higher the score, worse the disability | 8 years | 
| Beck depression inventory, BDI | range from 0 to 3 for each item. Higher the score, worse the depression | 8 years | 
| Beck anxiety inventory | range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety | 8 years |