linjc16/ctgov huggingface dataset:
Safety and Efficacy Study of the Z-Lig Medical Device Compared to Allograft

Study Overview
=================
Brief Summary
-----------------
The purpose of this Trial is to demonstrate the safety and efficacy of the Investigational Device for the treatment of ruptured Anterior Cruciate Ligament (ACL) of the knee compared to Allograft.

Detailed Description
-----------------
Current techniques to reconstruct ruptured ACLs utilize either autologous tissue or allograft (cadaver) tissue. Both treatments have well-documented shortcomings (i.e., autologous tissue exposes patients to increased morbidity and allograft tissue use is limited by global availability and quality). There are currently no effective artificial materials or xenograft tissue substitutes widely available. The purpose of this multicenter clinical trial is to evaluate the safety and efficacy of the Z-Lig in Subjects who require reconstruction of primary ruptured anterior cruciate ligaments and compare those results to allograft.

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Z-Lig Medical Device Compared to Allograft for the Reconstruction of Ruptured Anterior Cruciate Ligaments

Conditions
-----------------
Ruptured Anterior Cruciate Ligaments

Intervention / Treatment
-----------------
* Device: Z-Lig
* Device: allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Contact Sponsor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Z-Lig<br>Z-Lig Anterior Cruciate Ligament Reconstruction (ACLR) graft implantation performed under anesthesia during an arthroscopic procedure. | Device: Z-Lig<br>* ACL replacement<br>|
| Active Comparator: Allograft<br>Allograft bone/tendon graft implantation performed under anesthesia during an arthroscopic procedure. | Device: allograft<br>* ACL replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KT-1000 | Contact Sponsor | baseline, 3,6, 12 & 24 monhts | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Z-Lig, allograft, ACL, Anterior Cruciate Ligament, ACLR, Anterior Cruciate Ligament Reconstruction, EU, European Union, S. Africa, Reconstruction of ruptured anterior cruciate ligaments
Efficacy of QAX576 in Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with QAX576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.

Official Title
-----------------
A Multi-center, Randomized, Double Blind, Placebo-controlled, 'add-on' Study to Investigate the Efficacy and Safety of 24 Weeks Intravenous Treatment With QAX576 in Patients (≥18-75 Years) With Persistent Asthma Not Adequately Controlled With Inhaled Corticosteroids and Long Acting β2-agonists

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Biological: QAX576
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients Female patients must be surgically sterilized or postmenopausal Male patients must use two forms of contraception Body mass index must be between 18 and 39 kg/m2 Diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists Exclusion Criteria: Smoking history >10 pack-years Patients with a diagnosis of chronic obstructive pulmonary disease (COPD) Patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening Patients who have had a respiratory tract infection within 6 weeks prior to screening History of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QAX576<br>QAX576 | Biological: QAX576<br>* every 3 weeks via intravenous infusion<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* every 3 weeks via intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of clinically significant asthma exacerbations |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, QAX576
Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease

Official Title
-----------------
A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.

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

Intervention / Treatment
-----------------
* Drug: K0706
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give written, and dated, informed consent (or legally acceptable representative/impartial witness when applicable) and is available for the entire study Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (in the Investigator's opinion), and be accessible for follow-up Male or female aged 18 to 65 years (both inclusive) Diagnosed with Parkinson's disease Exclusion Criteria: Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced parkinsonism Diagnosis of Parkinson's disease Dementia (probable, possible) Presence of severe dyskinesias History of brain surgery for Parkinson's disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K0706<br>K0706 will be administered once a day | Drug: K0706<br>* Once a day administration after fast<br>|
| Experimental: Placebo<br>Placebo will be administered once a day | Drug: Placebo<br>* Once a day administration after fast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration |  | 4 weeks | 
| Area under the plasma concentration versus time curve |  | 4 weeks | 
| Time of observed peak plasma concentration |  | 4 weeks |
68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)

Study Overview
=================
Brief Summary
-----------------
To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

Detailed Description
-----------------
This is an expanded access study with a total of 300 participants with NET and suspected SSTR positive tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATATE and will undergo a PET/CT imaging study. All patients referred by Oncologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate.

Official Title
-----------------
68Ga-DOTATATE Imaging in Neuroendocrine Tumors

Conditions
-----------------
Carcinoid Cancer, Neuroendocrine Tumors, Medullary Thyroid Cancer, Cancers Expressing Somatostatin Receptors

Intervention / Treatment
-----------------
* Drug: 68Ga DOTATATE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years the time of radiotracer administration Provides written informed consent Known diagnosis of NET or suspected SSTR positive tumors Women of childbearing age must have a negative pregnancy test at screening/baseline Able to remain still for duration of each imaging procedure (about 30 minutes) Exclusion Criteria: Less than 18 years-old at the time of radiotracer administration Pregnant or nursing Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 68Ga DOTATATE|Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTATATE PET/CT.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ultrasound After Total Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound. We believe ultrasonography imaging to be a comparable and efficacious modality to evalute tenotomy healing rates and diagnose rotator cuff failure after total shoulder arthroplasty. In addition, we believe ultrasonography to be a cost-effective modality to asses the rotator cuff after total shoulder arthroplasty. Our population would consist of patients that received total shoulder arthroplasty within the last 5 years.

Official Title
-----------------
Advanced Imaging for Shoulder and Elbow Arthroplasty

Conditions
-----------------
Total Shoulder Arthroplasty, Rotator Cuff Tears, Rotator Cuff Injuries

Intervention / Treatment
-----------------
* Procedure: Ultasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary or revision total shoulder arthroplasty with or without subscapularis tenotomy Primary or revision reverse shoulder arthroplasty with or without subscapularis tenotomy English speaking patients only Shoulder arthroplasty within the last 5 years Exclusion Criteria: Revision shoulder arthroplasty for infection 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 |
| --- | --- |
| Post-operative patients who had total shoulder arthroplasty<br>Patients who have had a total shoulder replacement will be scheduled for an ultrasound at Duke Radiology. An ultrasound will be completed on the shoulder that has been replaced, which takes no more than an hour. This ends all study involvement. | Procedure: Ultasound<br>* Evaluation of post-operative patients who have had total shoulder arthroplasty and will assess the integrity of the rotator cuff using ultrasound.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of confirmed healed rotator cuff tear as measured by ultrasound |  | time of procedure, up to 1 hour | 
| Number of confirmed non-healed tenotomy |  | time of procedure, up to 1 hour | 
| Number of confirmed rotator cuff tears |  | time of procedure, up to 1 hour |
Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
Neoadjuvant chemoradiotherapy is recommended as standard therapy for resectable esophageal cancer. The recurrence rate after surgery following neoadjuvant chemoradiotherapy is about 35%. Whether achieving pathological complete response after neoadjuvant chemoradiotherapy is significantly associated with recurrence after surgery. It is reported that immunotherapy combined with chemotherapy improved survival compared with chemotherapy alone in first line therapy of advanced esophageal cancer. We hypothesize that the addition of immunotherapy to neoadjuvant chemoradiotherapy is helpful to improving pathologic complete response and survival.

Official Title
-----------------
Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by Surgery for Thoracic Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Pilot Study

Conditions
-----------------
Esophagus Cancer, Neoadjuvant Therapy

Intervention / Treatment
-----------------
* Drug: Tislelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Pathologically diagnosed as esophageal squamous cell carcinoma Initially diagnosed as thoracic esophageal cancer resectable or potantially resectable II-IVA according to AJCC 8th edition； KPS≥70 Adequate organ function

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tislelizumab arm<br>Radiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg per square meter of body-surface area weekly) and Caboplatin (area under the curve of 2 mg per milliliter per minute weekly) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks) | Drug: Tislelizumab<br>* neoadjuvant immunotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response rate | Pathologic complete response rate | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival | 2 years after first medication of Tislelizumab | 
| overall survival | overall survival | 2 years after first medication of Tislelizumab |
Analysis of T Cell Metabolism in Acute Myeloid Leukemia Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to analyze the T cell metabolism and immune phenotype in AML patients during the course of the disease before and after allo-HCT.

Detailed Description
-----------------
Patients who experience relapse of acute myeloid leukemia (AML) after allogeneic hematopoietic cell transplantation (allo-HCT) have a dismal prognosis. Infusion of donor T cells can induce graft-versus-leukemia (GVL) effects, indicating the importance of intact T cell function for leukemia control. Recent studies have shown the importance of metabolic fitness for an effective T cell response. In this study we have analyzed the T cell metabolism and immune phenotype in AML patients at different time points before and after allo-HCT.

Official Title
-----------------
Analysis of T Cell Metabolism and Immune Phenotype During the Course of Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed diagnosis of AML age ≥ 18 years peripheral blood sample available written informed consent ability to understand the nature of the study and the study related procedures and to comply with them Exclusion Criteria: age < 18 years lack of informed consent patients that cannot be classified in one of the 3 groups

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Primary Diagnosis<br>Analysis of patient blood at primary diagnosis of AML | |
| Relapse<br>Analysis of patient blood at time point of relapse after allo-HCT | |
| Remission<br>Analysis of patient blood during remission after allo-HCT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell metabolism | Extracellular acidification rate (ECAR) and oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer | 4 years | 
| T cell phenotype | T cell cytokine and effector molecule production | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite abundance in serum | Serum metabolites as measured by mass spectrometry | 4 years |
Meclizine Plasma Levels in Responders and Non-responders

Study Overview
=================
Brief Summary
-----------------
Motion sickness is a debilitating condition that can effect many crew members. Meclizine has long been known as an effective anti motion sickness drug. The response to the drug is variable - some are responders, while others are resistant to the drug. The aim of the present study is to examine whether there is a correlation between meclizine plasma levels and clinical response.

Official Title
-----------------
Meclizine Plasma Levels in Responders and Non-responders

Conditions
-----------------
Seasickness, Meclizine

Intervention / Treatment
-----------------
* Drug: Meclizine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seasickness questioner (WIKER) score of 7. Subjective functioning at 1 meter sea voyage - 5/10 and lower. Subjects who were prescribed 25mg of meclizine. Subjects who did not take any other drugs 48 prior to their participation in the study. Exclusion Criteria: Known hearing loss or any vestibular impairment Vertigo complains Any ear infection Use of Scopolamine based anti-seasickness drugs. Use of meclizine 50mg.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meclizine responders<br> | Drug: Meclizine Hydrochloride<br>* Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.<br>* Other names: Bonine;|
| Active Comparator: Meclizine non responders<br> | Drug: Meclizine Hydrochloride<br>* Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.<br>* Other names: Bonine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meclizine plasma levels | ng/dl | 2 hours after meclizine administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seasickness, Plasma Levels, Meclizine
Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation

Study Overview
=================
Brief Summary
-----------------
As the result of our last study Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression

Official Title
-----------------
Status and Develepment Mental Quality of Life in Lung Fibrosis in Comparison of COPD Inpatients Before and After Pulmonary Rehabilitation

Conditions
-----------------
Idiopathic Pulmonary Fibrosis and COPD

Intervention / Treatment
-----------------
* Procedure: Pulmonary rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD GOLD III-IV IPF according Pulmonary Guidelines Exclusion Criteria: < 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD patients (GOLD stage III-IV)<br> | Procedure: Pulmonary rehabilitation program<br>* 3 weeks, ...<br>|
| Active Comparator: IPF patients<br> | Procedure: Pulmonary rehabilitation program<br>* 3 weeks, ...<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score | Hospital Anxiety and Depression scale | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score | Hospital Anxiety and Depression scale | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary fibrosis, COPD, pulmonary rehabilitation, mental status (anxiety and depression), quality of life, physical activity