linjc16/ctgov huggingface dataset:
The Investigation of the Depression in Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
Studies have reported that the patient's psychological state such as anxiety, depression and other emotion affect the therapeutic effect of osteoarthritis, also may be the important reason for the poor knee joint osteoarthritis efficacy. The aim of this study are firstly to investigate the depression status of patients with osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression will affect depression status, ultimately, provide reference for clinical.

Official Title
-----------------
The Investigation of the Depression in Osteoarthritis

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: There is no intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis and the 2010 Chinese Medical Association clinical criteria for knee osteoarthritis. Exclusion Criteria: Patients with rheumatoid arthritis patients with a history of depression before osteoarthritis pathogenesis patients who can't cooperate with related inspection and assessment Patients with mental illness

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 |
| --- | --- |
| Kellgren and Lawrence classification I<br>Grade I Kellgren and Lawrence radiographic changes. | Other: There is no intervention.<br> <br> |
| Kellgren and Lawrence classification II<br>Grade II Kellgren and Lawrence radiographic changes. | |
| Kellgren and Lawrence classification III<br>Grade III Kellgren and Lawrence radiographic changes. | |
| Kellgren and Lawrence classification IV<br>Grade IV Kellgren and Lawrence radiographic changes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster OA index (WOMAC) |  | Day 1 | 
| American knee society knee score |  | Day 1 | 
| Hamilton Depression Scale-17（HAMD-17） |  | Day 1 |
Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury

Study Overview
=================
Brief Summary
-----------------
Myocardial injury after noncardiac surgery (MINS) is common, silent, and strongly associated with morbi-mortality. There are some evidences in the littérature showing that troponin elevation pre and/or postoperatively and surgical Apgar score are strongly and independently associated with postoperative morbi-mortality. In this cohort study of orthopedic surgery patients (> 50years), the aim is to determine MINS incidence and to assess wich peri-operative factors are associated with the occurrence of MINS. The final objective is to create a score to better identified the patients with a MINS and a poor outcome.

Official Title
-----------------
Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study

Conditions
-----------------
Perioperative Complication, Myocardial Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 50 years orthopedic surgery (hip, knee, spine) written consent Exclusion Criteria: no troponin measurement prior surgery sepsis acute coronary syndrome pulmonary embolism refusing to participate guardianship

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative MINS incidence | Troponin elevation > 5ng/l compared to previous measurement OR troponin elevation > 65 ng/l | 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with cardiac arrest | Cardiac arrest | 3 months | 
| Number of Participants with an episode of acute pulmonary oedema | Acute pulmonary oedema | 3 months | 
| Number of Participants with coronary angioplasty | Coronary angioplasty | 3 months | 
| Number of Participants with myocardial infarction | Myocardial infarction | 3 months | 
| Number of Participants with stroke | Stroke | 3 months | 
| Number of Participants with transient stroke | Transient stroke | 3 months | 
| Mortality rate | Death | 3 months | 
| Revised Cardiac Risk Index for Pre-Operative Risk (Lee score) | Minimum value = 0 Minimum value = 0, maximum value = 6, higher scores mean a worse outcome (higher peri operative mortality risk) | Inclusion | 
| Metabolic Equivalent of Task (MET) | Minimum value = 1, Maximum value= 10, a low score (MET <4) is associated with a capacity to do some light intensity activities and is associated with cardiovascular risk. | Inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non cardiac surgery
PACMAN Ultrasound Recording Data Collection

Study Overview
=================
Brief Summary
-----------------
Study to collect videos of ultrasound recordings during peripheral nerve block procedures.

Official Title
-----------------
Prospective, Multicenter, Single Arm Feasibility Study to Collect Patient and Imaging Data for Avanos Medical Ultrasound Guided Regional Anesthesia System Development

Conditions
-----------------
Anesthesia, Local

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years and older with underlying pathologies requiring surgical intervention facilitated by a specific regional nerve block Informed consent executed Exclusion Criteria: Patients unable to understand and provide written consent Infection at the injection site Allergy to local anesthetic agents Medical condition obscuring visualization Known neuropathy at or around target nerve for the PNB Inability to communicate with the investigator or hospital staff

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 |
| --- | --- |
| Interscalene<br> | |
| Supraclavicular<br> | |
| Infraclavicular<br> | |
| Transversus Abdominus Plane<br> | |
| Paravertebral Space<br> | |
| Fascia Iliaca<br> | |
| Femoral Nerve<br> | |
| Saphenous Nerve via Adductor Canal<br> | |
| Popliteal Sciatic Nerve<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of ultrasound recordings | Collection of 100 ultrasound recordings for each group | 6 months |
The Incidence of Difficult Intubation in Obese Versus Non-obese Patients

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to identify the incidence of difficult endotracheal intubation in patients with normal BMI undergoing surgery under general anaesthesia in our hospital and compare it to that of obese patients.

Official Title
-----------------
The Incidence of Difficult Intubation in Obese Versus Non-obese Patients

Conditions
-----------------
Airway Obstruction

Intervention / Treatment
-----------------
* Other: ET Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery BMI< 30 for Normal BMI group BMI > 30 for Obese group Exclusion Criteria: Known previous difficult airway Pediatric patients. Emergency patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese<br>Patients with a BMI of greater than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia | Other: ET Tube<br>* Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia<br>|
| Non-Obese<br>Patients with a BMI of less than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia | Other: ET Tube<br>* Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of difficulty in airway management | Assessment of Cormack Lehanne grading (intubation difficulty scale) IDS. | two years |
Online Program for Social Anxiety

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy of an online program in reducing symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative evaluations and improving quality of life in students with above-average social anxiety.

Detailed Description
-----------------
While there are many benefits to online programs in treating a variety of health issues (i.e., implementation in remote areas, cost-effectiveness, etc.), the primary challenge for online formats is to imitate real-life interactions while promoting a reduction in symptoms. This will be attempted in a six-month online program for social anxiety. The present study will assess the efficacy of a six-month online program through measures of social anxiety, fear of negative evaluations, unhelpful thoughts, avoidance behaviours and quality of life. This information will be collected from students at baseline and upon completion of the online program.

Official Title
-----------------
Online Cognitive Behavioural Therapy Program for Social Anxiety

Conditions
-----------------
Social Anxiety

Intervention / Treatment
-----------------
* Behavioral: Online Program for Social Anxiety


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered UBC student Achieve an above-average score on a validated screening tool for social anxiety Exclusion Criteria: Not a registered UBC student Clinical diagnosis of a mental illness
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>These participants will be given access to a six-month online program for social anxiety. | Behavioral: Online Program for Social Anxiety<br>* This program will be completed from participants' homes using their own computers. This online format is based on a Cognitive Behaviour Therapy framework (CBT) and involves seven modules that ask participants to engage in a variety of thinking exercises and activities.<br>|
| No Intervention: Wait List Control<br>These participants will not be given an intervention until after they have completed the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Anxiety | A self-report measure that assesses symptoms of distress experienced when socializing with others. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Social Anxiety, Cognitive Behaviour Therapy, Online Program
Safety and Efficiency of γδ T Cell Against Hepatocellular Liver Cancer

Study Overview
=================
Brief Summary
-----------------
In this study, effects of γδT cells on human hepatocellular liver cancer in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

Detailed Description
-----------------
Liver tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

Official Title
-----------------
γδ T Cell Immunotherapy for Treatment of Hepatocellular Liver Cancer

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Biological: DC-CIK cells
* Biological: γδ T cells
* Biological: γδ T/DC-CIK cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-75 Karnofsky performance status >50 Diagnosis with hepatocellular carcinoma cancer based on histology or the current accepted radiological measures. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, gd Tcells/ DC-CIK. Life expectancy: Greater than 3 months Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease and diabetes

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>DC-CIK cells will be used against tumor cells. | Biological: DC-CIK cells<br>* DC-CIK cells will be used against tumor cells.<br>|
| Experimental: Group B<br>γδ T cells will be used against tumor cells. | Biological: γδ T cells<br>* γδ T cells will be used against breast tumor.<br>|
| Experimental: Group C<br>Combination of γδ T cells/ DC-CIK be used against tumor cells. | Biological: γδ T/DC-CIK cells<br>* γδ T/DC-CIK cells will be used against breast tumor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced size of the tumors |  | Up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, γδ T Cell, heptocellular liver cancer
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells

Study Overview
=================
Brief Summary
-----------------
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion &prednisolone & LMWH

Detailed Description
-----------------
patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion begin in the cycle before embryo transfer &prednisolone begin with the start of lipid emulsion & LMWH begin with the day of ET

Official Title
-----------------
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial

Conditions
-----------------
Unexplained Infertility

Intervention / Treatment
-----------------
* Combination Product: combination therapy for high peripheral NK cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with high peripheral NK cells > 10% unexplained infertility cases cases with endometriosis Exclusion Criteria: uterine factors poor responders< 3 MII oocytes severe male factor & Azospermia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 37 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid | Combination Product: combination therapy for high peripheral NK cells<br>* lipid emulsion & prednisolone & LMWH<br>|
| Experimental: study<br>regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid but the investigators add in this arm lipid emulsion & prednisolone & LMWH | Combination Product: combination therapy for high peripheral NK cells<br>* lipid emulsion & prednisolone & LMWH<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chemical pregnancy rate | quantitative serum test | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | gestational sac and fetal echo by ultrasound | 6 weeks of pregnancy |
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections

Study Overview
=================
Brief Summary
-----------------
Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1 gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be measured at different time points. Safety labs will also be checked on a regular basis to assess the safety of dalbavancin.

Official Title
-----------------
A Phase 1, Open Label, Single Dose Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Dalbavancin In Hospitalized Adolescents, Aged 12 Through 17 Years Receiving Standard Intravenous Anti-Infective Treatment For Bacterial Infections

Conditions
-----------------
Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Dalbavancin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 to 17 year old adolescents hospitalized for the treatment of bacterial infections. Exclusion Criteria: Patients being treated with vancomycin. Patients with liver and kidney failure. Pregnant female subjects.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dalbavancin<br>* Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Plasma - Cmax, Tmax, AUClast, AUCinf, AUC(48) (as data permit), t1/2 (as data permit), CL, Vss. Urine - Ae48, Ae48% and CLR. |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments: adverse event monitoring; clinical laboratory tests (hematology, serum chemistry, and urinalysis); ECGs; blood pressure and pulse rate determinations; weight and physical examination. |  | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dalbavancin adolescent subjects
Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients

Detailed Description
-----------------
An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole. The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.

Official Title
-----------------
Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients: a Longitudinal Follow-up of Trough Levels

Conditions
-----------------
Critically Ill Patients

Intervention / Treatment
-----------------
* Other: Sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Treatment with fluconazole Admitted to an ICU ward Exclusion Criteria: < 18 years DNR 2 or 3

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

| Intervention/Treatment |
| --- |
|Other: Sample collection|Plasma and urine sample collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to fluconazole (trough levels) | To document the trough levels (Cmin) of fluconazole in an ICU cohort over multiple days of treatment | On the day of sampling | 
| Exposure to fluconazole (trough levels) | Determine if the Cmin target levels are attained. | June 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability in fluconazole trough levels | To determine the intra-and intersubject variability of the fluconazole trough levels | June 2020 | 
| Influencing covariates | Determine possible covariates that might explain the fluconazole variability | June 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Fluconazole, Variability, Target attainment