linjc16/ctgov huggingface dataset:
New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow earlier and more detection of drug response in advanced NPC than RECIST method, in patients with previously untreated advanced NPC who will receive platinum-based chemotherapy. This study will also determine if this new method can predict survival in these patients. This study may have far-reaching impact on drug development in NPC as it may offer a more optimal way of evaluating drug efficacy in clinical trials and also in clinical management.

Official Title
-----------------
Prospective Evaluation of Plasma EBV DNA Half-life and PET-CT Scanning as a New Tool in Assessing Early Response to Chemotherapy in Patients With Advanced Nasopharyngeal Carcinoma

Conditions
-----------------
Advanced Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergo chemotherapy for any one of the following settings: Setting 1: Neoadjuvant chemotherapy prior to cheom-RT Setting 2: Palliative chemotherapy in Chemonaive patients Setting 3: Palliative chemotherapy in previously treated patients (i.e. 2nd line or 3rd line chemo) Age >= 18 years (ECOG) performance status of 0-2 have detectable levels of pEBV DNA at baseline have measurable tumor sites by RECIST criteria have adequate bone marrow, renal and hepatic functions

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 |
| --- | --- |
| advanced nasopharyngeal carcinoma<br> | Drug: Chemotherapy<br>* platinum-based chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if measuring tumor metabolic response during chemotherapy can predict survival |  | 3 years | 
| To determine if measuring plasma EBV DNA (half-life) early during chemotherapy can predict survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New method of assessing drug response (measuring tumor metabolic response via FDG-PET & plasma EBV DNA (half-life) after 1 course of chemotherapy) can better predict survival, than the conventional method |  | 3 years | 
| To determine if plasma EBV DNA (half-life) correspond with best response rate based on the conventional 'Response Evaluation Criteria in Solid Tumors' - RECIST criteria. |  | 3 years | 
| overall survival |  | 3 Years | 
| progression free survival |  | 3 Years |
A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

Study Overview
=================
Brief Summary
-----------------
Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives are to assess effects on the signs and symptoms of this disorder. Individuals greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.

Official Title
-----------------
A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Chicory root extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be 50 years of age or older and may be of either gender. Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee. Patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study). Patients must be able and willing to give informed consent. Exclusion Criteria: Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study. Patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. Ambulatory aids such as canes and walkers are acceptable. Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded. Patients requiring any dose of glucocorticoids within the past 30 days are excluded.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Chicory root extract|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma

Study Overview
=================
Brief Summary
-----------------
Endometrial carcinoma represents the most common gynaecological cancer and the sixth most frequent cancer among women worldwide. The 5-year survival of patients with stage I endometrial carcinoma is 75%-88% versus 50% for stage III or 15% for stage IV disease. Therefore, early detection could improve survival rates. Specifically, in the most prevalent, type 1 endometrial cancer develops from hyperplastic endometrium. The aim of the study was to evaluate the utility of cancer gene mutations from endometrial biopsies towards predicting synchronous or metachronous development of malignant lesions. The aim of the study was to evaluate whether endometrial biopsies could already carry mutations in cancer genes useful for predicting or anticipating subsequent cancer development

Official Title
-----------------
Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma: A Pilot Study

Conditions
-----------------
Cancer of Endometrium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years old patients subjected to endometrial biopsies with previous histopathologically negative and subsequent histopathologically positive for endometrial carcinoma patient informed consent Exclusion Criteria: - Endometrial carcinoma patients without a previous non-tumour biopsy were excluded

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 |
| --- | --- | --- |
| Mutation analyses on matched samples from female patients with a previous endometrial biopsy negative for cancer, followed by a subsequent biopsy positive for cancer | Mutation analyses performed on DNA isolated from formalin fixed, paraffin embedded samples retrieved for each patient by sequencing a panel of fifty genes (ABL1, AKT1, ALK, APC, ATM, BRAF, CDH1, CDKN2A, CSF1R, CTNNB1, EGFR, ERBB2, ERBB4, EZH2, FBXW7, FGFR1, FGFR2, FGFR3, FLT3, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, JAK2, JAK3, KDR, KIT, KRAS, MET, MLH1, MPL, NOTCH1, NPM1, NRAS, PDGFRA, PIK3CA, PTEN, PTPN11, RB1, RET, SMAD4, SMARCB1, SMO, SRC, STK11, TP53, VHL) both on non-cancerous biopsies and on matched endometrial carcinoma biopsies. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Integration of molecular results with clinico pathological data | Integration of molecular results with clinico pathological data | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers, cancer gene mutations, endometrial cancer
FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy

Study Overview
=================
Brief Summary
-----------------
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.

Official Title
-----------------
Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy

Conditions
-----------------
Kidney Calculi

Intervention / Treatment
-----------------
* Procedure: Floseal
* Procedure: Cope Loop
* Procedure: Fascial Stitch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has kidney stones that require treatment (tx) with percutaneous stone removal 18 years of age or over Exclusion Criteria: Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain Patient taking coumadin Pre-existing percutaneous nephrostomy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Floseal | Procedure: Floseal<br>* Bioglue that seals the kidney<br>|
| Active Comparator: 2<br>Cope-Loop/Nephrostomy Tube | Procedure: Cope Loop<br>* Nephrostomy tube for fluid drainage from the kidney<br>|
| Active Comparator: 3<br>Fascial Stitch | Procedure: Fascial Stitch<br>* Stitch that closes the kidney<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine which method of treatment causes the least pain to the patient. |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney stone removal surgery
Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia

Study Overview
=================
Brief Summary
-----------------
There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.

Official Title
-----------------
Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: Blood pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA status 1-3 0-10 years of age Undergoing surgical procedure with planned arterial cannula placement Exclusion Criteria: ASA status >3 Older than 10 years of age Patient unable to have BP taken on 1 upper and 1 lower extremity

Ages Eligible for Study
-----------------
Maximum Age: 10 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 |
| --- | --- |
| Arterial line<br>Children undergoing surgical procedure with planned arterial cannula placement. | Other: Blood pressure measurement<br>* Blood pressure will be measured in both upper and lower extremities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deviation >5 mmHg in MAP | Deviation >5 mmHg in MAP between one of the non-invasive measurements compared to invasive BP measurement at any point during the study. | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deviation >10 mmHg | Deviation >10 mmHg between the non-invasive and invasive measurements. | 45 minutes |
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Patients undergoing lung resection due to pulmonary cancer can be compromised in their postoperative period due to atrial fibrillation. A retrospective analysis performed at our institution indicates that 30 % of the population develope atrial fibrillation in the postoperative period. Amiodarone is known to diminish the occurence of postoperative atrial fibrillation after heart surgery, why this drug is chosen as a prophylactic agent for the mentioned population. Amiodarone is administrated twice a day for 5 days at a dose of 600 mg oral treatment after an initial loading bolus og 300 mg intravenously.

Official Title
-----------------
Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial

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

Intervention / Treatment
-----------------
* Drug: Amiodarone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resection of the lung due to confirmed diagnosis of cancer pulmones. Elective operation (scheduled operation for at least one day) Ready to be randomized Patient must be at least 18 at time of operation Exclusion Criteria: Former operation of the lung Former heart surgery Bradycardia below 40 beats/ min Hypotension with systolic blood pressure below 80 mmHg AV-blockage of any degree or sick sinus node QTc interval above 440 ms for men or above 460 ms for women Paroxysmal, persistent or permanent atrial fibrillation or flutter Former atrial fibrillation or flutter for more than a month. Pregnant or positive pregnancy test Breastfeeding ALAT of more than twice the normal over limit Treatment with monoamineoxidase inhibitors (MAOI) Allergy to one or more components in amiodarone

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Amiodarone<br>* intravenous bolus of 300 mg oral treatment og 600 mg twice a day for five days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free of atrial fibrillation |  | 31082009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-benefit analysis of amiodarone prophylactic |  | 31082009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, amiodarone
a 3.0T Magnetic Resonance Imaging Study

Study Overview
=================
Brief Summary
-----------------
Glaucomatous damage not only occurred to retinal ganglion cells in the eyes, but went across optic nerves, visual chiasm, lateral geniculate nucleus (LGN) and finally the visual cortex; the neural degenerations could be identified through the whole visual tract, which suggests the central nerve system may play a vital role in the progression of glaucoma. The investigators used MRI to investigate changes of visual pathway in vivo.

Official Title
-----------------
The Central Nerve System Injury in Patients With Primary Open Angle Glaucoma

Conditions
-----------------
Primary Open Angle Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma diagnosed on the basis of glaucomatous optic disc cupping ratio (in particular, thinning of the inferior and/or superior rim, cup-to-disc ratio asymmetry of >0.2) matching glaucomatous visual field defects (European Glaucoma Society (2008) Perimetry ) Exclusion Criteria: optic neuropathy neurological disorder other diseases and use of systemic medications which affect optic nerve or the visual ﬁeld underwent complete eye examination and visual-field testing.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19

Study Overview
=================
Brief Summary
-----------------
The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).

Official Title
-----------------
Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19

Conditions
-----------------
Covid 19

Intervention / Treatment
-----------------
* Other: patients COVID 19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years, patients with confirmed SARS-Cov2 infection (RT PCR positive) or patients suspected (evocative chest scanner) OR patients exposure to SARS-CoV2 but no symptoms (patient's family, caregivers) OR patients Non exposure to SARS-Cov2 volunteer subjects (general population) Exclusion Criteria: pregnant or breastfeeding female

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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: COVID-19 patients will be selected in the 4 participating centres Contact subjects and healthy volunteers will be selected only in the coordinating centre (Centre Hospitalier Universitaire de Nice)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Samples With DNA<br>Nasopharyngal swab and blood samples | Other: patients COVID 19<br>* Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgA specific cells of SARS | Proportion of subjects with IgA-specific cells of SARS-CoV-2's Spike 1 protein at inclusion and 7 +/-2 days later | At 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OMS progression scale | The scale is 7-point ordinal. | At 7 days |
The Effect of Education Based on Roy Adaptation Model for Infertile Individuals on Adaptation and Coping With Stress

Study Overview
=================
Brief Summary
-----------------
Psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health. It appears that learning adaptation strategies in infertile couples is concurrent with health promotion. In addition to medical treatments, it is aimed to add training to be given in accordance with the Roy Adaptation model, to adapt to the process and infertility, and to control stress in infertile individuals in the management of the process. The study was planned to examine the effect of education based on the roy adaptation model for infertile individuals on adaptation and coping with stress.

Official Title
-----------------
Hasan Kalyoncu University Health Sciences Institute

Conditions
-----------------
Health Education

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45age difference Primary infertility Exclusion Criteria: - Secondery infertility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: receiving health education<br> | Other: Education<br>* Patients will be educated to determine their level of coping with stress and their adaptation.<br>|
| Experimental: Level of compliance<br> | Other: Education<br>* Patients will be educated to determine their level of coping with stress and their adaptation.<br>|
| Experimental: Coping with stress<br> | Other: Education<br>* Patients will be educated to determine their level of coping with stress and their adaptation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training effectiveness | The education given will increase adaptation to infertility and coping with existing stress. | 3 months |