linjc16/ctgov huggingface dataset:
Metabolic Response to Food in Advanced Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This goal of this study is to describe how unintentional weight loss influences fasting and post-prandial metabolic flexibility in participants with advanced non-small cell lung cancer.

Official Title
-----------------
Metabolic Response to Food in Advanced Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Other: Weight loss (%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Diagnosis of non-small-cell lung cancer that is locally advanced and inoperable Reported weight stability or loss after cancer diagnosis Body mass index less than or equal to 35 kilograms per meter squared Ability to provide written informed consent Willing and able to comply with all scheduled visits, treatment plans, lab tests, and other study procedure Allow the collection and storage of biospecimens and data for future use Exclusion Criteria: Prior diagnosis of diabetes mellitus (type 1 or type 2) Currently pregnant or breastfeeding Contraindication to consuming the liquid mixed meal Any medications affecting gastric motility Any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol

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 |
| --- |
|Other: Weight loss (%)|Change in body weight from cancer diagnosis to study enrollment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory quotient | The respiratory quotient will be measured by indirect calorimetry before and after consumption of a liquid mixed meal | Difference between pre- to post-prandial conditions over four hours |
A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced solid tumors.

Official Title
-----------------
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: QLP2117


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion) Eastern Cooperative Oncology Group Performance Status of 0 or 1 Agree to provide archived tumor tissue samples of primary or metastatic lesions. Have adequate organ function as described in the protocol. Exclusion Criteria: Women who are pregnant or breastfeeding HBsAg/HBcAb positive and HBV-DNA>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment Has an active autoimmune disease that has required systemic treatment in past 2 years. Has an active infection requiring systemic therapy Has received a live vaccine wihtin 30 days of planned start of study treatment Has know history of, or any evidence of interstitial lung disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ia： QLP2117 Dose escalation and PK expansion<br> | Drug: QLP2117<br>* Specified dose on specified days<br>|
| Experimental: Ib：QLP2117 Dose expansion<br> | Drug: QLP2117<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity(DLT) |  | 21days | 
| Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 |  | up to 96 weeks | 
| Objective Response Rate for phase 1b |  | up to 96 weeks |
Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage

Study Overview
=================
Brief Summary
-----------------
Conventional open surgery often requires extensive dissection of the muscle insertion points of the suboccipital muscle group during the insertion position and direction of the atlas axis screw, resulting in sustained postoperative occipital neck pain and movement dysfunction. In order to overcome the shortcomings of the prior art mentioned above, the present invention provides a self stabilizing fusion cage with a wing plate. During surgery, a thinner and smaller screw through the wing plate is used to achieve a secure connection between the atlas axis and the fusion cage. Due to the smaller screw size, the screw placement has higher safety. The purpose of this study is to compare the advantages of using this new fusion cage compared to traditional surgical instruments.

Official Title
-----------------
Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage: a Cohort Study

Conditions
-----------------
Atlantoaxial Dislocation

Intervention / Treatment
-----------------
* Device: New type of self stabilizing atlantoaxial fusion cage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atlantoaxial dislocation Agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible Sign an informed consent form; Exclusion Criteria: Atlantoaxial dislocation without surgical treatment Patients who refuse to participate in this project
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Using the new type of self stabilizing atlantoaxial fusion cage<br>Use the new type of self stabilizing atlantoaxial fusion cage to treat atlantoaxial dislocation. | Device: New type of self stabilizing atlantoaxial fusion cage<br>* Using the above-mentioned new fusion cage for the treatment of atlantoaxial dislocation<br>|
| Using other fusion systems<br>Use screw and plate system or other existing models of fusion cages. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fusion rate | Postoperative atlantoaxial fusion conditions | 12 month follow up | 
| neural functions | Postoperative neurological function recovery conditions | 12 month follow up | 
| complications | Short or long-term postoperative complications | 12 month follow up |
Impact of Surgical Mask, FFP2 Mask and FFP3 Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy. In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.

Official Title
-----------------
Impact of Surgical Mask, FFP2 (Filtering Face Piece Class 2) Mask and FFP3 (Filtering Face Piece Class 3) Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy

Conditions
-----------------
Face Mask, Longterm Oxygen Therapy

Intervention / Treatment
-----------------
* Diagnostic Test: 6-MWT
* Diagnostic Test: Spiroergometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known lung disease and LTOT informed consent Exclusion Criteria: Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure) Acute exacerbation of lung disease

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 known lung disease and LTOT (long term oxygen therapy)<br>Patients with i.e. interstitial lung, emphysema, pulmonary hypertension or COPD with the need for LTOT | Diagnostic Test: 6-MWT<br>* Measurement of saturation and blood gas parameters under 6-MWT with different masks.<br>* Other names: Six minutes walk test;Diagnostic Test: Spiroergometry<br>* Measurement of saturation and blood gas parameters under spiroergometry with different masks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of capillary pO2 |  | At the end of 6-MWT or spiroergometry | 
| Increase of capillary pCO2 |  | At the end of 6-MWT or spiroergometry |
A Combinatorial Biomarker for Infection Diagnosis in Children

Study Overview
=================
Brief Summary
-----------------
To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and CRP) is used, and to compare them with control patients without BV measurement. Secondary objectives: Qualitative evaluation of indication as well as adherence to the test result. Comparison of antimicrobial therapy, performed diagnostics, hospitalization, and outcomes between patients with high BV score (bacterial) and patients with low BV score (viral).

Official Title
-----------------
A Combinatorial Biomarker for Infection Diagnosis in Children

Conditions
-----------------
Respiratory Tract Infections, Fever

Intervention / Treatment
-----------------
* Diagnostic Test: BV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspicion of acute bacterial or viral infection Requirement of at least one BV test during medical presentation Exclusion Criteria: lack of informed consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BV use cases<br>cases in whom BV was ordered | Diagnostic Test: BV<br>* The use of the BV test, ordered at the discretion of the treating physician<br>|
| BV non-use cases<br>cases in whom BV was not ordered | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotics | Number of participants treated with antibiotics | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibiotic duration | Length of antibiotic treatment per participant | up to 30 days | 
| Hospitalization | Number of participants admitted to the hospital | up to 30 days | 
| Complications | Rate of complications per participant | up to 30 days | 
| Tests | Rate of ancillary tests per participant | up to 30 days |
Paravertebral Block vs no Block in Open Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.

Official Title
-----------------
Paravertebral Block vs no Block in Open Pancreaticoduodenectomy: Prospective Randomized Controlled Trial

Conditions
-----------------
Pancreaticoduodenectomy

Intervention / Treatment
-----------------
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients willing and have signed consent. Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB) Exclusion Criteria: Not able or unwilling to sign consent. Currently pregnant or lactating. Patients with chronic pain, requiring daily opiate use at time of surgery. Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral Block Pre Procedure<br>Subject will receive a preoperative paravertebral block only | Drug: Ropivacaine<br>* Paravertebral at the T7-10 levels bilaterally with 5 cc of 0.5% ropivacaine at each level<br>|
| No Intervention: No Paravertebral Block<br>Subject will receive no paravertebral block. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean post-operative pain score | Measured using pain visual analog scale, with pain scale ranging from 0 to 10 (0=no pain; 10=worst possible pain) | First 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | Total number of days subjects were admitted to the hospital following surgery | Approximately 2-4 days | 
| Number of subjects with a bowel obstruction | Number of subjects to experience a bowl obstruction following surgery | Approximately 2-4 days |
A Detailed Look At What Patients Experience When They Take Part In Hypertension Clinical Trials

Study Overview
=================
Brief Summary
-----------------
This research study aims to identify the obstacles faced by specific demographic groups of hypertension patients during their engagement in clinical trials. The study will collect in-depth information from participants and identify common factors that impede their enrollment or successful completion of these trials. By examining data from various demographic perspectives, the study aims to identify patterns impacting future hypertension patients' experiences.

Official Title
-----------------
An In Depth Study Exploring Patient Experiences of Individuals Participating in Hypertension Clinical Trials

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age Diagnosis of hypertension Ability to understand the study procedures, benefits and risks, and sign a written informed consent document. Exclusion Criteria: Enrolled in another research study Inability to provide written informed consent Women of childbearing potential without a negative pregnancy test; or women who are lactating.

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 |
| --- | --- | --- |
| Number of hypertension patients who decide to join in a clinical study |  | 3 months | 
| Rate of patients who remain in a hypertension clinical study to completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Intradialytic Aerobic Exercise in CKD Patient

Study Overview
=================
Brief Summary
-----------------
Intradialytic aerobic exercise is not effective in increasing hemodialysis adequacy but is effective in improving physical performance in twice-weekly hemodialysis patients.

Detailed Description
-----------------
Uremic myopathy occurs in 60-75% of Chronic Kidney Disease (CKD) patients undergoing hemodialysis, which causes a decrease in muscle strength and physical performance. Increasing dialysis adequacy is beneficial in reducing the impact of uremia on muscles. Intradialytic aerobic exercise in thrice-weekly hemodialysis patients has improved dialysis adequacy and physical performance. This study aims to determine the effect of intradialytic aerobic exercise on improving dialysis adequacy and physical performance in twice-weekly hemodialysis patients.

Official Title
-----------------
Intradialytic Aerobic Exercise in CKD Patient

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Behavioral: Aerobic Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD patients undergoing hemodialysis two times per week Exclusion Criteria: Hemoglobin level < 8mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Thirty-four participants receiving hemodialysis were randomized to the intervention and control groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>subjects in the treatment group underwent routine hemodialysis by committing to an intradialysis aerobic exercise program | Behavioral: Aerobic Exercise<br>* Intradialytic aerobic exercise for eight weeks<br>|
| No Intervention: Control Group<br>subjects in the control group underwent routine hemodialysis without a physical exercise program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kt/V | Dialysis adequacy (Kt/V) and physical performance test with a Short Physical Performance Battery (SPPB) were evaluated before and after the intervention | eight weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic kidney disease, intradialytic aerobic exercise, physical performance
Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation

Study Overview
=================
Brief Summary
-----------------
Determine echocardiographic predictors of atrial fibrillation recurrence post radiofrequency Ablation and evaluate markers of low voltage areas on 3D mapping.

Official Title
-----------------
Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paroxysmal or persistent ablation Exclusion Criteria: previous AF ablation previous left atrial ablation refusal to give informed consent congenital cradiomiopathy

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 |
| --- | --- |
| No recurrence<br>No recurrence of AF | Procedure: Ablation<br>* Radiofrequency AF ablatoon<br>|
| Recurrence<br>Recurrence of AF | Procedure: Ablation<br>* Radiofrequency AF ablatoon<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low voltage areas |  | At procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Radiofrequency ablation