linjc16/ctgov huggingface dataset:
Testing the Efficacy of Different Dosages of Lercanidipine to Reduce Hypertensive Blood Pressure in Normal Weight and Obese Patients

Study Overview
=================
Brief Summary
-----------------
A double blind study to examine the safety and efficacy of different dosages of lercanidipine in normal weight and obese patients with hypertension

Official Title
-----------------
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Dose-Titration Study to Assess the Efficacy of Lercanidipine 10 mg and 20 mg Once Daily p. o. in Hypertensive Subjects (I or II WHO) With Elevated Body Weight.

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

Intervention / Treatment
-----------------
* Drug: Lercanidipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI): 18.0 - 24.9 or 30.0 - 39.9 kg/m2 (extremes included); Essential hypertension I or II WHO: 140 mmHg ≤ BPs ≤ 179 mmHg and BPd ≤ 109 mmHg at the end of the placebo run-in phase; Exclusion Criteria: Secondary hypertension; Diabetes mellitus type 1, insulin dependent diabetes mellitus type 2, fasting blood glucose ≥ 160 mg/dl; Subjects keeping to a hypocaloric diet (except special diet for diabetics) to reduce body weight; History or presence of angioneurotic oedema; Subjects developing a hypertensive crisis during wash-out or placebo run-in period;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lercanidipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline of systolic blood pressure (BPs) after 4 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, response rate, normalization rate, pulse rate, lipid profile, safety and tolerability. Measures after 4, 8, 12 weeks. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lercanidipine, calcium antagonist, hypertension, obesity
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
iTEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed.

Detailed Description
-----------------
TEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed. At both exam days, a Schirmer test before and after will be performed as well as parameters which indicate immediate effect of treatment and treatment over the 30 days.

Official Title
-----------------
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Device: iTEAR100 treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry eye Exclusion Criteria: unable to read consent investigator discretion

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Interventional Model Description: Open labe therapeutic study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Arm<br>Patient receive iTEAR100 treatment | Device: iTEAR100 treatment<br>* Vibratory energy to the external nasal nerve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer score | Difference between Schirmer score measured before stimulation and after stimulation at each visit | within 5 minutes of stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Scores |  | 30 days |
Elderly Hodgkin Lymphoma Patients Treated With Chemoradiotherapy

Study Overview
=================
Brief Summary
-----------------
Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.

Official Title
-----------------
Outcome of Hodgkin Lymphoma Patients Over Than 60 Years Treated by Chemotherapy and/or Radiotherapy: a Retrospective Study

Conditions
-----------------
Hodgkin Lymphoma, Adult

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over than 60 years Newly diagnosed Hodgkin lymphoma Exclusion Criteria: Data not available

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Time between diagnosis and progression or death - up to 100 weeks |
Role of CCL2 in Alcoholic Liver Diseases

Study Overview
=================
Brief Summary
-----------------
Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic liver disease. Serum levels and liver expression of CCL2 are increased in patients with alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver disease is nevertheless unknown. The aim of the study is to analyze plasma level and liver expression of CCL2 and their relation with liver disease severity and inflammatory infiltrate in our cohort of alcoholic patients. We studied also the association between -2518 CCL2 polymorphism and the severity of alcoholic liver disease.

Conditions
-----------------
Alcoholic Liver Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
ALD patients Inclusion Criteria: Excess alcohol intake Abnormality of liver biopsy compatible with alcoholic aetiology Caucasian ethnicity Exclusion Criteria: Presence of any other chronic liver disease co-infection with HIV Controls Inclusion criteria Caucasian ethnicity presence of a disease

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| alcoholic liver disease<br>alcoholic liver disease patients undergoing a transjugular liver biopsy in our institution | |
| controls<br>Healthy controls patients recruited from the Occupational Medicine Department during a routine physical examination | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.

Study Overview
=================
Brief Summary
-----------------
Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Detailed Description
-----------------
Postoperative pancreatic fistula is a potentially fatal sequela with substantial morbidity and mortality. POPF incidence and risk factors vary. A retrospective observational study was conducted in the surgical unit of Zagazig university hospital . Three hundred forty-seven patients were admitted with a clinical diagnosis of pancreatic fistula following both open and laparoscopic approaches for pancreatic benign and malignant tumors.

Official Title
-----------------
Risk Factors for Postoperative Pancreatic Fistula Following Non-traumatic Pancreatic Surgery. Retrospective Observational Study.

Conditions
-----------------
Pancreas Neoplasm

Intervention / Treatment
-----------------
* Procedure: pancreatic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years, both sexes, respectablee pancreaticoduodenal tumors, or chronic pancreatitis Exclusion Criteria: <18 years, Patients who underwent total pancreatectomies, Patients discovered intraoperatively to be fixed to portal vein or superior mesenteric artery, traumatic pancreatic surgeries, postoperative associated gastric or biliary leak, pancreaticoduodenal cancers infiltrating the colon, stomach or liver.

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 |
| --- |
|Procedure: pancreatic surgery|pancreaticoduodenectomy and distal pancreatectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative pancreatic fistula | an amylase level in the fluid collected from the drain on the third postoperative day (POD) that was > three times the serum amylase level | 3.5 years |
OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA

Study Overview
=================
Brief Summary
-----------------
Acute ischemia of the lower limb (AMI) is a life-threatening emergency that threatens the functional prognosis of the limb. Depending on the clinical presentation and the anatomy of the patient, several therapeutic approaches can be considered: open surgery, endovascular surgery, hybrid surgery or amputation if revascularization is not feasible. The data in the current literature do not allow to clearly establish which therapeutic approach is the most adapted to the patient.

Official Title
-----------------
MULTICENTER OBSERVATIONAL STUDY OF THE OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA

Conditions
-----------------
Acute Ischemia of Lower Limb

Intervention / Treatment
-----------------
* Procedure: operation of ischemia of the lower limbs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years, regardless of gender. Diagnosis of AMI defined according to the Rutherford classification (2). AMI may involve one or both lower limbs. Be able to understand and give free and informed consent (non-opposition) to participate in the study To be affiliated to the social security system Not to object to participating in the study (collection of non-objection) Exclusion Criteria: Voluntary discharge of the patient: opposition to the use of the data (withdrawal of the non-objection) Termination of the study by decision of the sponsor or investigator.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with ischemia of the lower limbs<br> | Procedure: operation of ischemia of the lower limbs<br>* The intervention technique is left to the judgment of the investigator to treat the ischemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 30 days | 
| survival |  | 90 days |
Effect of Celecoxib on Transitional Pain After Outpatient Surgery

Study Overview
=================
Brief Summary
-----------------
Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional pain

Official Title
-----------------
Effect of Celecoxib on Transitional Pain After Outpatient Surgery

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

Intervention / Treatment
-----------------
* Drug: celebrex
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective ambulatory surgery of the shoulder ASA I - III Able to read English Male or female Exclusion Criteria: Allergy to local anesthetic, Cox2, sulpha drug, acetaminophen or oxycodone Women who are pregnant or lactating and women of childbearing age and not following acceptable contraceptive precautions Any major medical or psychiatric problem Those with a known history of narcotic dependence, abuse or chronic narcotic intake Patients with known history of peptic ulcer or GI bleeding in the past, ulcers, congestive heart failure, angina or previous heart attack, coagulation problems, venous thrombosis, kidney or liver disease or strokes

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>celebrex | Drug: celebrex<br>* 400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop<br>|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* placebo given preop and BID postop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue score for pain |  | post-op period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of nausea |  | post-op period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder surgery, analgesia
Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization

Study Overview
=================
Brief Summary
-----------------
Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. The conventional surgical approach includes surgical embolectomy and surgical bypass.From the anesthetic aspect, this emergency condition limits the lengthening cardiovascular assessment of this high-risk patient group which might lead to the uncertainty outcome.With the variety of patients and procedures, we sought to find out the perioperative adverse events, especially major adverse cardiac events, in acute ischemic limb patients undergoing revascularization, in order to increase awareness of the team and properly admit to ICU in a retrospective manner.

Official Title
-----------------
Incidence and Risk Factors of in Hospital Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization Treatment: a Retrospective Cohort Study

Conditions
-----------------
Major Adverse Cardiac Events, Adverse Effect of Unspecified General Anesthetic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age more than 18 years undergoing revascularization surgery or procedure (surgical revascularization, endovascular revascularization, hybrid revascularization, catheter directed thrombolysis) Exclusion Criteria: incomplete data during perioperative period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Incidence of major adverse cardiac events | Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke | during hospital stay, up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the perioperative complication | Incidence of the perioperative other complication, which are major bleeding, repercussion syndrome, compartment syndrome, rhabdomyolysis and unplanned ICU admission from any causes. | during hospital stay, up to 4 weeks | 
| Factors contribute to the adverse outcome | Factors contribute to the adverse outcome, which are the patients' condition and the underlying diseases, the surgical intervention and the anesthetic technique. | during hospital stay, up to 4 weeks |
Cytopenias in Hospitalized Patients of Corona Virus Infection(COVID-19) During First and Other Waves

Study Overview
=================
Brief Summary
-----------------
Demographic, Clinical and laboratory data as well as outcome of total 202 COVID-19 patients who were Polymerase Chain Reaction (PCR) positive and admitted in Fatima memorial Hospital, Lahore, Pakistan, was collected during first and other waves. Data of First wave is from May 2020 to July 2020, second wave from early November to Mid December 2020 and third wave from Mid march to June 2021. Investigator analyzed the data on basis of Systemic immune inflammatory index (SII) as well hematological parameters of First Wave were compared to other waves of COVID-19.

Official Title
-----------------
Cytopenias in Hospitalized Patients of COVID-19 During First and Other Waves

Conditions
-----------------
Corona Virus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 Positive Hospitalized patients All genders Exclusion Criteria: Patients with Known hematological disorders Patients with known chronic Liver Disease

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| Cytopenias in Hospitalized Patients of COVID-19 During First and Other waves | extent of cytopenias is being measured in COVID-19 hospitalized patients. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Cytopenia, Thrombocytopenia, Anemia, Leucopenia
Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
the study compare the hormonal-metabolic and reproductive outcome between combined metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic syndrome

Official Title
-----------------
Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome

Conditions
-----------------
Focus of Study

Intervention / Treatment
-----------------
* Drug: metformin plus letrozole
* Procedure: ovarian drilling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: polycystic ovary syndrome infertility clomiphene citrate resistance Exclusion Criteria: women with other causes of infertility as male factor or tubal factor, those with endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received hormonal treatment or ovulation induction drugs 3 months prior to the study pregnancy during follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin plus letrozole<br>metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle | Drug: metformin plus letrozole<br> <br> * Other names: cidophage plus fumara;|
| Experimental: ovarian drilling<br>bilateral diathermy ovarian drilling, four drills each ovary | Procedure: ovarian drilling<br> <br> * Other names: ovarian dithermy drilling;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hormonal and metabolic changes |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reproductive outcome |  | 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, letrozole, ovarian drilling, clomiphene resistance, polycystic ovary.