linjc16/ctgov huggingface dataset:
The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals

Study Overview
=================
Brief Summary
-----------------
We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.

Official Title
-----------------
The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Dihydralazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men Ages 18 to 40 years. Body mass index less than or equal to 30 kg/m2 Exclusion Criteria: History or clinical signs of heart, lung, kidney, or endocrine organ disease. Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose. Abnormal screening of the urine regarding: albumin and glucose Malignant disease. Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic. Alcohol abuse. Smoking. Drug use or abuse. Known intolerance or allergy to dihydralazine Blood donation within 1 month of the start of the study.

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional sodium excretion |  |  | 
| Heart rate |  |  | 
| Blood pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dihydralazine, Sympathetic activation, Fractional sodium excretion
Eosinophil Markers and Development of Disease in Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
Inflammatory proteins from eosinophil granulocytes in blood from patients with seasonal allergic hayfever have been shown to predict development of asthma at a six-year follow-up. This study is a 15-year follow-up of the same patients to verify earlier results and study disease development.

Detailed Description
-----------------
The study consists of a single visit at which patients fill in a questionnaire on actual hayfever and asthma symptoms as well as current treatment. Blood samples and nasal lavages are drawn and analysed for eosinophils as well as eosinophil cationic protein and tryptase. Spirometry is performed. If patients use drugs which can interfere with results, ie. corticosteroids or beta-agonists, biochemistry and/or spirometry are omitted.

Official Title
-----------------
Eosinophil Markers and Development of Disease in Allergic Rhinitis. A 15-year Follow-up of Patients With Grass Pollen Induced Hayfever.

Conditions
-----------------
Seasonal Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in earlier study (1995) Exclusion Criteria: Treatment with any kind of corticosteroid within two months will exclude from study of inflammatory parameters
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 |
| --- | --- | --- |
| Asthma morbidity | Patients are asked whether they have experienced asthmatic symptoms or have been disgnosed with asthma within the latest 15 years | Single measurement - May 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinitis morbidity | Patients are asked for current hayfever symptoms | Single measurement - May 2010 |
Minimum Effective Volume of Lidocaine-Bupivacaine for Subgluteal Block

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.

Detailed Description
-----------------
The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block. Success rate is defined as a minimal composite score of 6 points (out of 8 points) at 30 minutes.

Official Title
-----------------
Minimum Effective Volume of Lidocaine-Bupivacaine for Ultrasound-Guided Subgluteal Sciatic Nerve Block

Conditions
-----------------
Injuries to the Ankle and Foot

Intervention / Treatment
-----------------
* Other: Subgluteal Nerve Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 75 years American Society of Anesthesiologists classification 1-3 body mass index between 20 and 35 Exclusion Criteria: adults who are unable to give their own consent pre-existing neuropathy (assessed by history and physical examination) coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50) renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) allergy to LA pregnancy prior surgery in the subgluteal region chronic pain syndromes requiring opioid intake at home

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subgluteal sciatic block<br>Subgluteal block with similar volume | Other: Subgluteal Nerve Block<br>* ultrasound-guided subgluteal sciatic nerve block.<br>|
| Experimental: Subgluteal block<br>Subgluteal block with decreasing volume | Other: Subgluteal Nerve Block<br>* ultrasound-guided subgluteal sciatic nerve block.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | minimal composite score of 6 out of 8 points | 0-30 minutes |
Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.

Detailed Description
-----------------
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

Official Title
-----------------
A Multicenter, Open-label Uncontrolled Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T0065 in a 28-day Regimen for 13 Cycles in Healthy Female Subjects

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women between the ages of 18 and 35 years requiring contraception Exclusion Criteria: Pregnancy, lactation, and contraindication of combined oral contraceptive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EV/DNG (Qlaira, BAY86-5027)<br>Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) | Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)<br>* GA: Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral) Tablet, p.o. (oral)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unintended pregnancies after 1 year |  | Throughout 1 year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding pattern and cycle control parameters after 1 year |  | Throughout 1 year of treatment |
Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on postoperative quality of recovery after laparoscopic cholecystectomy

Conditions
-----------------
Gallbladder Polyp, Asymptomatic Gallstones Without Cholecystitis

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II patients aged between 20 and 65 year undergoing laparoscopic cholecystectomy due to gallbladder polyp or asymptomatic gallstones without cholecystitis Exclusion Criteria: Steroid therapy or immunocompromised patients Diabetes mellitus Allergy to lidocaine or dexamethasone Severe renal dysfunction (serum creatinine more than 1.6mg/dl) Severe liver disease ( liver enzymes more than two times normal values) History of atrioventricular block Have a difficulty in understanding QoR-40 (40-item quality-of-recovery scoring system) or Korean language History of physicologic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine group<br> | Drug: Lidocaine<br>* Lidocaine 2mg Kg-1 in normal saline (total volume 25mL) was infused after tracheal intubation, and lidocaine was infused at the rate of lidocaine 2mg Kg-1 h-1 (0.2 ml Kg-1 h-1, equivalent volume as normal saline in dexamethasone group) until the end of surgery (at the time of skin closure).<br>|
| Active Comparator: Dexamethasone group<br> | Drug: Dexamethasone<br>* Dexamethasone 8mg in normal saline (total volume 25mL) was infused after tracheal intubation, and normal saline was continuously infused at the rate of 0.2 ml Kg-1 h-1 until the end of surgery (at the time of skin closure).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR-40 score | 40-item quality-of-recovery scoring system | from baseline to 3 hours on the day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of postoperative nausea and vomiting | 10 cm-visual analogue scale | from baseline to 3 hours on the day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexamethasone, Lidocaine, Quality of Recovery, Laparoscopic cholecystectomy
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.

Official Title
-----------------
A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel

Conditions
-----------------
Nasolabial Folds, Lipoatrophy, Lipodystrophy

Intervention / Treatment
-----------------
* Drug: TAT4 Gel concentration A
* Drug: TAT4 Gel concentration B
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 40-70 years old Healthy volunteers Provision of informed consent Exclusion Criteria: History of skin hypersensitivity Abnormality on screening assessments

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

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

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

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: TAT4 Gel concentration A<br>TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days. | Drug: TAT4 Gel concentration A<br> <br> |
| Experimental: TAT4 Gel concentration B<br>TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days. | Drug: TAT4 Gel concentration B<br> <br> |
| Placebo Comparator: Placebo<br>Placebo product once daily to 50 cm2 for 14 days. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event rates | Adverse event rates by System Organ Class, as graded by current CTCAE | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetics (Cmax) |  | Days 1 and 13 | 
| Plasma pharmacokinetics (Tmax) |  | Days 1 and 13 | 
| Plasma pharmacokinetics (AUC0-24) |  | Day 1 and 13 |
Effect of Stent Size on Dyssynchrony

Study Overview
=================
Brief Summary
-----------------
the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough

Detailed Description
-----------------
Background: the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough Aim: to study short term effect of stent size and number on left ventricular mechanical dyssynchrony after elective PCI to LAD artery. Patients and methods: the study included 150 adult patients with electively stented LAD lesion with DES. Patients were evaluated pre PCI then follow up at 1m and 3m using tissue synchronization image (TSI).

Official Title
-----------------
The Short Term Effect of Stent Size and Number on Left Ventricular Mechanical Dyssynchrony After Elective PCI to Left Anterior Descending Artery

Conditions
-----------------
Left Ventricular Function

Intervention / Treatment
-----------------
* Device: coronary artery stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with electively stented LAD lesion with DES were enrolled in the study. Patients were evaluated pre PCI then follow up at 1m and 3m after PCI using TSI. Exclusion Criteria: patients with Bundle branch block (BBB), Previous percutaneous coronary intervention (PCI), Previous coronary artery bypass graft (CABG), Rhythm other than sinus, Rheumatic heart disease, Prosthetic valve, Complicated or unsuccessful procedure, Patients with significant degenerative changes, Patients with previous STEMI, and dropped patients from follow up were excluded from the study.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: coronary artery stents|Coronary angiography was done for all the patients according to the Judkins technique. All images were evaluated by an experienced operator, significant coronary artery disease was defined as > 70 % luminar diameter stenos. The following data was obtained: Site of stent implantation within LAD. The first Diagonal branch serves as the boundary between the proximal and mid portion of the LAD. Thus, the portion of the artery prior to the origin of the 1st diagonal is known as the proximal LAD, while the segment just below the1st diagonal branch is the mid LAD. The distal segment of the LAD is the terminal third of the artery (Cao et al., 2017). Length, diameter and number of stents. TIMI flow after stent deployment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular systolic function |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stent length, Stent diameter
Haemochromatosis and Periodontitis

Study Overview
=================
Brief Summary
-----------------
Periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth. It is strongly associated with the major pathogenic red complex, including Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola1 and thus is considered an infection. Recent advances in the pathogenesis of periodontal disease have suggested that polymicrobial synergy and microbiota dysbiosis together with a dysregulated immune response can induce inflammation-mediated damage in periodontal tissues2-4. Interestingly, currently periodontitis is associated with a growing number of systemic diseases, including cardiovascular diseases, adverse pregnancy outcomes, diabetes5-7 and hereditary haemochromatosis8.

Official Title
-----------------
Haemochromatosis and Periodontitis

Conditions
-----------------
to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic

Intervention / Treatment
-----------------
* Diagnostic Test: dental probes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 35 to 64 years with homozygosity hemochromatosis C282Y Patients regularly enrolled in a health insurance plan Patients with at least 10 natural teeth Patients who have given informed written, dated and signed consent Exclusion Criteria: Diabetic patients Simultaneous participation in another study Pregnant or lactating women The incapacitated persons and persons deprived of their liberty Patients who do not speak French, both written and spoken Patients previously included in this trial Patients with heart valves or endovascular equipment (risk of infective endocarditis ...) Patients with a history of maxillofacial surgery Patients whose oral status is considered incompatible with entry into the study, at the discretion of the investigator Patients on drugs that can cause gingival hypertrophy, such as Hydantoins (phenytoin), Dihydropyridines, Diltiazem or Ciclosporin Patients on medication that can cause gingival bleeding (anticoagulants, antiplatelet agents and aspirin).

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: diagnostic test<br> | Diagnostic Test: dental probes<br>* Measurement of the depth of the periodontal pockets and clinical loss<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of periodontal diseases | To evaluate the prevalence of periodontal diseases in patients with hemochromatosis at the time of diagnosis and / or their usual therapeutic | 2 years |
Registry for Hypoparathyroidism Wuerzburg

Study Overview
=================
Brief Summary
-----------------
Long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. To further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a standardized interview as well as blood sampling and examinations such as echocardiography and renal ultrasound are performed.

Detailed Description
-----------------
Design: In a longitudinal prospective trial the comorbidities, mortality, hypocalcemic and hypercalcemic events and quality of life in patients with chronic hypoparathyroidism will be evaluated by a standardized interview, blood sampling and further examinations such as echocardiography and renal ultrasound. Patients: Patients will be recruited out of the patient population of the University Hospital Wuerzburg. Statistical Analysis: Documentation and analysis will be performed at the Department of Medicine I, Endocrine and Diabetes Unit, University of Würzburg, Germany. Data will be documented after pseudonymisation in a data base. For further analysis data will be compared to sex- and age-matched controls.

Official Title
-----------------
Registry and Biobank for Patients With Hypoparathyroidism Wuerzburg

Conditions
-----------------
Comorbidities and Coexisting Conditions, Morality, Hypocalcemia, Hypercalcemia, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of 18 chronic hypoparathyroidism (>12 months) under established therapy or chronic pseudohypoparathyroidism (>12 months) under established therapy written informed consent Exclusion Criteria: age <18 years no detailed documentation of hypo- or pseudohypoparathyroidism

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidites | Comorbidities such as renal diseases, cardiovascular disease, psychiatric diseases under treatment | 15 years | 
| Subjective health status | Assessment of the subjective health status by standardized quality of life (QoL) questionnaires (e.g. short form-36, Patient Health Questionnaire 28) | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypocalcemic and hypercalcemic events | documentation of frequency of hypocalcemia under standard treatment | 15 years | 
| Mortality |  | 15 years |