linjc16/ctgov huggingface dataset:
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.

Study Overview
=================
Brief Summary
-----------------
Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of AGC. The aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (CAPOX) in HER2-positive AGC.

Official Title
-----------------
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study

Conditions
-----------------
Advanced Gastric Carcinoma

Intervention / Treatment
-----------------
* Drug: Trastuzumab
* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and fluorescence in situ hybridization (FISH)+ with no history of previous treatment. Exclusion Criteria: -

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tras-Capox<br> | Drug: Trastuzumab<br>* Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).<br>Drug: Oxaliplatin<br>* Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.<br>Drug: Capecitabine<br>* Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco-regional and Distant Tumor Control After Completion of Treatment | Response Evaluation Criteria in Solid Tumors was used to measure outcome: Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | 28 months | 
| Overall survival (OS) |  | 28 months |
Investigating Participation Patterns Among Recurrent Ovarian Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Clinical trials, with a particular focus on recurrent ovarian cancer, play a crucial role in assessing the safety and efficacy of novel treatments for this condition. These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to support their widespread adoption. By actively participating in recurrent ovarian cancer observational study serves pivotal role in expanding the boundaries of medical knowledge and advancing the quality of care provided to those enduring the same condition.

Official Title
-----------------
Delving Into the Patterns of Patient Engagement and Trends in Participation Within Recurrent Ovarian Cancer Clinical Trials

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old Able to comprehend the investigational nature of the protocol and provide informed consent Diagnosis of recurrent ovarian cancer Exclusion Criteria: No diagnosis of recurrent ovarian cancer confirmed Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form

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

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

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 patients who decide to participate in a recurrent ovarian cancer clinical trial |  | 3 months | 
| Rate of patients who remain in recurrent ovarian cancer clinical research to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent Ovarian Cancer
Obinutuzumab in Chinese Real-world Patients With iNHL

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.

Detailed Description
-----------------
This study was a prospective, multicenter, non-interventional, real-world study. The study will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and < 60 years at the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of treatment). Patients in this study will receive obinutuzumab-contained regimens according to the investigators' clinical opinion.

Official Title
-----------------
Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.

Conditions
-----------------
Lymphomas Non-Hodgkin's B-Cell

Intervention / Treatment
-----------------
* Drug: Obinutuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Age ≥ 18 years at the start of treatment; Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma; Previously untreated or relapsed or refractory patients; Patients who started treatment with otuzumab between June 2021 and April 2023. Exclusion Criteria: Patients currently participating or planning to participate in any interventional clinical trial; Patients who, in the opinion of the investigator, are Discomfort for any other reason to participate in this study.

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 |
| --- | --- |
| Cohort 1<br>the younger cohort (aged ≥ 18 and < 60 years at the start of treatment) | Drug: Obinutuzumab<br>* obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.<br>|
| Cohort 2<br>the older cohort (aged ≥ 60 years at the start of treatment) | Drug: Obinutuzumab<br>* obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoints | The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoints | All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters. | 12 months |
Preoperative Inflammatory Status and Postoperative Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) is a common complication during the early postoperative period after noncardiac surgery. Patients with AKI are at an increased risk of developing chronic kidney disease, prolonging hospitalization, and experiencing higher rates of morbidity and mortality. Identifying preoperative risk factors for postoperative AKI can significantly contribute to the development of preventive strategies and improved perioperative care in this vulnerable patient population. The goal of this retrospective study is to investigate the predictive value of preoperative inflammatory status, as measured by complete blood count-derived inflammatory markers, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), derived neutrophil-to-lymphocyte ratio (dNLR), neutrophil-to-lymphocyte*platelet ratio (NLPR), systemic immune-inflammatory index (SII), systemic inflammatory response index (SIRI), and aggregate index of systemic inflammation (AISI), on postoperative AKI in elderly patients undergoing non-cardiac surgery.

Official Title
-----------------
Prognostic Significance of Preoperative Inflammatory Status for Postoperative Acute Kidney Injury in Elderly Patients Undergoing Non-cardiac Surgery

Conditions
-----------------
Postoperative Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged ≥ 65 years. general, gynaecological, neurosurgery, orthopaedic, or thoracic surgery. surgery duration lasting longer than one hour. Exclusion Criteria: patients with an American Society of Anesthesiologists (ASA) physical status V. those with concurrent cardiac, vascular, transplant or urological surgeries. those with end-stage renal disease (i.e. a glomerular filtration rate of 15 mL/min/1.73 m2 or receiving haemodialysis) or a history of kidney transplantation.. those did not have sufficient data required for calculation for inflammatory markers or AKI evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 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 participants with acute kidney injury after surgery | In accordance with the KDIGO creatinine criteria: a serum creatinine increases of 26.5 mmol/L within 48 hours or 1.5 times baseline within 7 days after surgery. | Within 7 days after surgery |
Discovering Factors in the Clinical Study Journey of Patients With OCD

Study Overview
=================
Brief Summary
-----------------
This research aims to collect comprehensive data on the clinical trial experience of OCD patients. Its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. Clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. Therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future OCD patients.

Official Title
-----------------
Understanding the Patient Perspective: An Observational Study on Experiences of OCD Clinical Trial Patients

Conditions
-----------------
OCD, Obsessive-Compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. Participant has a diagnosis of OCD. Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. Exclusion Criteria: Pregnant or lactating woman Enrolled in another research study Any mental or medical condition that prevents the patient from giving informed consent or participating in the 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants who decide to enroll in a OCD clinical study. |  | 3 months | 
| Number of OCD patients who remain in clinical trial until completion. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCD, Obsessive-Compulsive Disorder
Brief Mindfulness Intervention for Orthopedic Patients

Study Overview
=================
Brief Summary
-----------------
This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

Official Title
-----------------
Brief Mindfulness Intervention for a Heterogenous Mix of Orthopedic Patients

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Pain Coping Information
* Behavioral: Mindful Pain Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 Seeking foot or ankle treatment at the Tallahassee Orthopedic Center Exclusion Criteria: • Cognitive impairment preventing completion of study procedures. Current cancer diagnosis, Other unstable illness judged by medical staff to interfere with study involvement.

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pain Coping Information<br> | Behavioral: Pain Coping Information<br>* A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).<br>|
| Experimental: Mindful Pain Management<br> | Behavioral: Mindful Pain Management<br>* A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Unpleasantness Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable. | Immediately before to after 4-minute audio recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable. | Immediately before to after 4-minute audio recording | 
| Change in Anxiety Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety. | Immediately before to after 4-minute audio recording | 
| Change in Depression Numeric Rating Scale | Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 indicating severe depression. | Immediately before to after 4-minute audio recording] |
The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the possible prognostic performance of RV dysfunction, as assessed by TAPSE, in non-cardiac patients with septic shock.

Detailed Description
-----------------
The objective is to investigate the prognostic performance of right ventricular dysfunction, as assessed by tricuspid annular plane systolic excursion (TAPSE), in non-cardiac patients with septic shock.

Official Title
-----------------
The Prognostic Role of Tricuspid Annular Plane Systolic Excursion in Critically Ill Patients With Septic Shock

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Radiation: tricuspid annular plane systolic excursion (TAPSE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (18 - 64 years old) with septic shock after admission according to 2016 consensus definition (Sepsis-3). Exclusion Criteria: Pregnant females Trauma Documented coronary heart disease History of myocardial infarction Myocarditis Thrombo-embolic pulmonary disease Valvular heart disease Corpulmonale Arrhythmia Known left ventricular ejection fraction < 40% Poor echocardiographic window

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survivors<br>Patients who survived after day 28. | Radiation: tricuspid annular plane systolic excursion (TAPSE)<br>* Echocardiography<br>|
| Non-survivors<br>Patients who died at or before day 28. | Radiation: tricuspid annular plane systolic excursion (TAPSE)<br>* Echocardiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Mortality rate after at day 28. | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Care, Septic Shock, Echocardiography, RV dysfunction
Early Access Program for ALXN1840 in Patients With Wilson Disease

Study Overview
=================
Brief Summary
-----------------
This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.

Detailed Description
-----------------
To provide access to ALXN1840 treatment, an investigational medicinal product (IMP) that has not yet been granted marketing authorization, to participants who complete Studies ALXN1840-WD-205, WTX101-301, or ALXN1840-WD-302, or other studies with ALXN1840 who, in the opinion of the Treating Physician, may benefit from continued treatment with ALXN1840, and who meet the eligibility criteria described in this protocol.

Official Title
-----------------
Early Access Program for ALXN1840 in Patients With Wilson Disease

Conditions
-----------------
Wilson Disease

Intervention / Treatment
-----------------
* Drug: ALXN1840


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840. Confirmed diagnosis of WD. Has completed one of the following ALXN1840 clinical studies: ALXN1840-WD-205 WTX101-301 ALXN1840-WD-302 Other ALXN1840 studies In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant. Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP. Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance. Exclusion Criteria: Eligible for and able to participate in an Alexion-sponsored study of ALXN1840. Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason. Has decompensated hepatic cirrhosis. Model for End-Stage Liver Disease (MELD) score > 13. Modified Nazer Score > 7. End-stage renal disease on dialysis (chronic kidney disease stage 5 [CKD 5]) or creatinine clearance < 30 mL/min. Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840. Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALXN1840|bis-choline tetrathiomolybdate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wilson Disease, ALXN1840
Effectiveness of Mobilization With Movement Along With Sensory Motor Training in Patients With Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
to find out the Effectiveness of Mobilization With Movement Along With Sensory Motor Training in Patients With Knee Osteoarthritis

Official Title
-----------------
Effectiveness of Mobilization With Movement Along With Sensory Motor Training in Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Diagnostic Test: Sensory Motor Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders between age of 45 and 70 with knee pain more than 3 months of presentation in outpatient department. They were also required to stand independently from sitting and prone lying Exclusion Criteria: Patients with any lower limb fractures, any neurological condition, contraindication to manual therapy, post traumatic Knee osteoarthritis, total knee replacement, uncontrolled hypertension, and radiating leg pain

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobilization With Movement<br>Mobilization With Movement | Diagnostic Test: Sensory Motor Training<br>* Mobilization With Movement Along With Sensory Motor Training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Scale | Effectiveness of Mobilization With Movement Along With Sensory Motor Training using Oxford Scale | 6 Months | 
| Numeric Pain Scale | Effectiveness of Mobilization With Movement Along With Sensory Motor Training using Numeric Pain Scale | 6 Months |