linjc16/ctgov huggingface dataset:
Anxiety and Symptom Burden in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Anxiety has been identified as a prevalent and significant co-morbid condition in patients with End Stage Renal Disease (ESRD) being treated with hemodialysis. In particular, anxious sensitivity to symptoms commonly experienced by dialysis patients may lead patients to prematurely terminate their dialysis sessions and may have consequences on their dialysis adequacy and overall quality of life. The proposed study will examine the relationships between anxiety, depression, quality of life, symptom burden and dialysis prescription adherence. The primary regression analyses will be used to predict the influence of anxiety and depression (independently and together) on measures of adherence behaviors.

Detailed Description
-----------------
Additional analyses will examine the relationship of elevated anxiety and depression scores on symptom burden, QOL, and other measures of dialysis adherence. Retrospective data of the preceding three months will be used to calculate measures of dialysis adherence (shortening and skipping) and clinical parameters.

Official Title
-----------------
Anxiety, Symptom Burden, and Dialysis Adherence in In-center Hemodialysis Patients

Conditions
-----------------
Anxiety, ESRD

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving In-center hemodialysis Exclusion Criteria: Non-English speaking

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: Survey|For our primary analysis (multiple regression) scores on the GAD-7, BAI and PHQ-9 will be used to predict dialysis adherence, as defined as minutes reduced (total dialysis prescribed -total actual time on machine) while controlling for age and gender.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder-7 (GAD-7) | Anxiety measure - higher scores indicate more anxiety | This is a cross-sectional study, with anxiety scores being correlated with previous 6 months of adherence data |
Coagulation Parameters During Pregnancy in Amniotic Fluid

Study Overview
=================
Brief Summary
-----------------
Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Detailed Description
-----------------
Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Official Title
-----------------
Coagulation Parameters During Pregnancy in Amniotic Fluid

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing amniocentesis during 15-35 weeks of gestation. Exclusion Criteria: A history of venous thromboembolism Systemic disease i.e.; diabetes, hypertension, hypo or hyper-thyroidism, Anticoagulant treatment Abnormal embryo

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amniotic fluid, D-dimer, coagulation, factor X activation
Preventing Propofol-associated Injection Pain

Study Overview
=================
Brief Summary
-----------------
Injection of propofol is associated with discomfort in subsets of patients. Local anesthetics have been shown to attenuate this response in some patients. This randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. Both groups are expected to be superior to placebo.

Official Title
-----------------
Propofol Mixed With Lidocaine Versus Lidocaine Pretreatment With Tourniquet for Alleviation of Pain Associated With Propofol Injection

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

Intervention / Treatment
-----------------
* Drug: Saline
* Drug: Lidocaine / propofol admixture
* Drug: lidocaine pretreatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: weight >40kg, <100kg ambulatory surgery Exclusion criteria: allergy to propofol or lidocaine taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (NSAIDs)

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline pretreatment, saline admixture | Drug: Saline<br>* 3.3 mL normal saline<br>|
| Active Comparator: Lidocaine pretreatment<br>Lidocaine pretreatment / saline-propofol admixture | Drug: lidocaine pretreatment<br>* lidocaine 50 mg iv under tourniquet-control<br>|
| Active Comparator: Lidocaine-Propofol admixture<br>saline pretreatment / Lidocaine-propofol admixture | Drug: Lidocaine / propofol admixture<br>* lidocaine 50 mg plus propofol 50 mg intravenous (iv)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Pain Score | 11 point verbal pain score (VPS) 0=no pain; 10=worst imaginable pain | Immediately after injection of study drug. One time assessment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Alleviation of Injection Pain | Total subjects within the arm versus those subjects who had no pain with injection (VPS=0) | Immediately after injection of study drug. One time assessment | 
| Satisfaction With Anesthetic Technique | Were you satisfied with the anesthetic technique? Yes/No | Prior to discharge. One time assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, lidocaine, injection pain
Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !?

Study Overview
=================
Brief Summary
-----------------
a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles

Detailed Description
-----------------
a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome (oocyte quality, fertilization rate, implantation rate, clinical pregnancy rate as well as the incidence of OHSS) in ICSI- antagonist cycles

Official Title
-----------------
Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !? a Prospective Randomized Controlled Comparative Study

Conditions
-----------------
IVF

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients <40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol Exclusion Criteria: age: > 40 years BMI > 30 , long agonist protocol were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DUAL TRIGGERING<br>PATIENTS WILL RECEIVE DUAL TRIGGERING | |
| URINARY HCG<br>PATIENTS WILL RECEIVE URINARY HCG | |
| RECOMBINANT HCG<br>PATIENTS WILL RECEIVE RECOMBINANT HCG | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate, |  | 4 WEEKS | 
| implantation rate, |  | 2 WEEKS | 
| incidence of OHSS. |  | 1 WEEK | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dual trigger implantation,, HCG, OHSS, ANTAGONIST
Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.

Detailed Description
-----------------
Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.

Official Title
-----------------
Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus

Conditions
-----------------
Periodontal Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed as type 1 diabetes mellitus Age between 7 and 14 years Exclusion Criteria: Having another systemic problem except type 1 diabetes mellitus Children carrying orthodontic appliances

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 diabetes with gingivitis<br>Children with type 1 diabetes mellitus and gingivitis | Diagnostic Test: ELISA<br>* Enzim linked immunoabsorbant assay<br>|
| Type 1 diabetes with healthy gingiva<br>Children with type 1 diabetes mellitus and healthy gingiva | Diagnostic Test: ELISA<br>* Enzim linked immunoabsorbant assay<br>|
| Healthy patients with gingivitis<br>Systemically healthy patients with gingivitis | Diagnostic Test: ELISA<br>* Enzim linked immunoabsorbant assay<br>|
| Healthy patients with healthy gingiva<br>Systemically healthy patients with healthy gingiva | Diagnostic Test: ELISA<br>* Enzim linked immunoabsorbant assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-18 level | IL-18 | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tnf-alpha level | Tnf-Alpha | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interleukin-18, gingival crevicular fluid, tumor necrosis factor alpha
Weight Cycle Post Intervention

Study Overview
=================
Brief Summary
-----------------
The aim of this follow-up (FU) study is to examine trajectory of body weight impacted by self-reported diet patterns and physical activities in 6 months at 3 monthly intervals from treatment cessation among patients who completed a pharmacotherapy trial. In addition, patient self-reported diet patterns and physical activities at respective time points will be described.

Detailed Description
-----------------
This is a real-world prospective observational study with primary data collection. All participants with a background be recommended to adopt lifestyle intervention as chronic weight management in China clinical practice. This FU study will enroll patients who completed SURMOUNT-CN trials, with planed study duration of 6 months. No investigational medicine is applied in this prospective follow-up study. Patients are requested to report body weight, waist circumferences, blood pressure, diet, physical activities, and laboratory results if available, at 3 monthly intervals during the 6-month follow-up period. Patients are also asked if they receive any Anti-Obesity medication (AOM) or participate in any interventional clinical trials indicated for weight management during study period. Summary statistics will be respectively applied to examine changes from trial baseline (time at trial randomization, week 0) and study baseline (time at 52 weeks from trial randomization, week 52) to each scheduled follow-up (at week 65 and week 78) by study arms in SURMOUNT-CN trial.

Official Title
-----------------
Weight Cycle Impacted by Health Lifestyle Post Pharmacotherapy Intervention

Conditions
-----------------
Weight Gain

Intervention / Treatment
-----------------
* Drug: investigational medicine product (IMP)
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants. Exclusion Criteria: Those in the SURMOUNT-CN trial who denied to participant.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: investigational medicine product (IMP)|Investigational medicine product (IMP) received at SURMOUNT-CN trial|
|Other: placebo|Placebo received at SURMOUNT-CN trial|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in body weight |  | at week 65 and week 78 from study baseline |
Pre and Post Arthrogram Ultrasound Images of Joints

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the usefulness of contrast in ultrasonography of the joints.

Detailed Description
-----------------
To determine if using intra-articular contrast (contrast injected into a joint) will provide clearer, more precise ultrasound images of the joints then an ultrasound done without the use of a contrast agent.

Official Title
-----------------
An Evaluation of Pre and Post Arthrogram Ultrasound Images of Joints: Does Arthrography Have a Role in Ultrasonography?

Conditions
-----------------
Joint Abnormalities

Intervention / Treatment
-----------------
* Procedure: Ultrasound
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically ordered arthrogram Exclusion Criteria: pregnant women children under the age of 18

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound Pre-Arthrogram<br>Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s) | Procedure: Ultrasound<br>* Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s)<br>|
| Experimental: Ultrasound Post-Arthrogram<br>Ultrasound of the joint(s) after the clinically scheduled arthrogram of the same joint(s), performed while the body still has a contrast agent in it from the arthrogram. The contrast agent varies with different joint areas, but is usually iodine based (like Ultravist.) | Procedure: Ultrasound<br>* Ultrasound of the joint(s) after a clinically scheduled arthrogram is performed. Ultrasound images will then be compared to the arthrogram findings, other imaging findings such as MRI and surgical pathological findings such as arthroscopy (if any.)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To add to the general knowledge of the researchers and to possibly benefit future patients in the diagnosis and treatment of joint abnormalities. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthrogram, Contrast, Joint, Ultrasound
Low Back Motor Control in Rhythmic Gymnasts During Hip Extension

Study Overview
=================
Brief Summary
-----------------
CONTEXT: Low back pain (LBP) is a common complaint in gymnasts. A deficit in the control of lumbopelvic movement has been related to low back pain. OBJECTIVE: This study aims to examine the effectiveness of an education session about low back motor control during hip extension in the lumbopelvic sagittal movement control of elite gymnasts. DESIGN: single-group, pretest-posttest clinical trial. PARTICIPANTS: 70 Elite Rhythmic Gymnasts INTERVENTION: One standardized theoretical practical session of 15 Min that includes anatomical issues and one practical exercise in quadruped position for controlling the movement of lumbar spine during hip extension and flexion.

Official Title
-----------------
Low Back Motor Control in Rhythmic Gymnasts During Hip Extension

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Theoretical practical educational session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pre-established level of practice: minimum 13 hours taking part in the Italian federal championship sign an informed consent form Exclusion Criteria: not fulfill Inclusion Criteria had surgery in the low back pain or the hip joint

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: single-group, pretest-posttest clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Performing after session<br>LB control during hip extension after intervention | Other: Theoretical practical educational session<br>* 1 Theoretical practical educational session of 15 Min about the importance of low back control during hip extension. Includes anatomical issues and one practical exercise in quadruped position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- spinal movement control in 10º of hip extension | Preintervention movement control of the spine in 10º of hip extension | Min 0 - Min 15 | 
| Post- spinal movement control in 10º of hip extension | Postintervention movement control of the spine in 10º of hip extension | Min 30 - Min 45 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gymnastics, low back pain, Physical Therapy Specialty
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.

Official Title
-----------------
Assessment of Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction, Erectile Dysfunction With Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Tadalafil 5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients with ED. Exclusion Criteria: Patients with history of pelvic trauma. Patients with major pelvic surgical intervention. Patients with hypogonadism and hyperprolactinemia. Patients with chronic liver disease. Patients with cardio vascular system diseases. History of chronic intake of central nervous system, anti androgen drugs or other drugs as Tramadol. Smokers patients. Patients with non-vasculogenic Erectile dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tadalafil group<br>Each patient will be treated by tadalafil 5mg daily for 3months | Drug: Tadalafil 5mg<br>* Estimate serum level of serum YKL-40, total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3months. Penile color Doppler ultrasound examination before and after treatment<br>|
| No Intervention: control group<br>Estimation of serum YKL-40, platelet indices and serum total testosterone in healthy individuals in camparing with tadalafil group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum YKL-40 and platelets indices in erectile dysfunction | Measurement of YKL-40 and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of tadalafil on Erectile dysfucntion patients | To show the therapeutic effect of tadalafil in dose 5 mg daily on Erectile dysfucntion patients and assess their response by international index of erectile function (IIEF-5) | 3 months |