linjc16/ctgov huggingface dataset:
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type 2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome. Specific parameters will be tested before treatment and after 3 months of treatment. Placebo will be compared to 2 different doses of telmisartan per day.

Official Title
-----------------
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients

Conditions
-----------------
Hypertension, Metabolic Syndrome, Hypertriglyceridemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abd. obesity (BMI>25kg/m²) and waist circumference ≥95cm (men),≥80cm (women) Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic) Triglycerides 150-400 mg/dl Normal stress test Normal carotid ultrasound Normal fundoscopy Exclusion Criteria: Diabetes mellitus Secondary cause for insulin resistance LDL-cholesterol >190 mg/dl Atherosclerotic disease Blood pressure >160 mmHg (systolic) and/or >100 mmHg (diastolic) Regular alcohol consumption (>30 g/day) Contraindication against telmisartan Antihypertensive medications Lipid lowering therapy Malignancy Pregnancy or Lactation Women without adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: T1<br>Telmisartan 80 mg/d | Drug: telmisartan<br>* 80 mg per day, orally, weeks 1-14<br>|
| Active Comparator: T2<br>Telmisartan 160 mg/d | Drug: telmisartan<br>* 80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14<br>|
| Placebo Comparator: P<br>placebo | Drug: placebo<br>* placebo; orally weeks 1-14<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in IL-6 |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in fasting lipids; |  | 14 weeks | 
| change in postprandial lipid metabolism |  | 14 weeks | 
| change in inflammatory parameters |  | 14 weeks | 
| change in glucose metabolism |  | 14 weeks |
Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Study Overview
=================
Brief Summary
-----------------
The number of elderly head-and-neck squamous cell carcinoma (HNSCC) patients is increasing; however, the evidence regarding the ideal treatment for this often vulnerable and frail patient cohort is limited. Although the benefit of concomitant chemotherapy has been reported to decrease in elderly HNSCC patients based on the MACH-NC meta-analysis, it remains unknown whether state-of-the art radiotherapy techniques such as intensity-modulated radiotherapy (IMRT), modern supportive treatments and alternative chemotherapy fractionation (e.g., cisplatin weekly) may have altered this observation. The objective of this retrospective multinational multicenter study is to determine the oncological outcomes of elderly patients (≥65 years) with locally advanced HNSCCs undergoing definitive (chemo-)radiation and to investigate the influence of concomitant chemotherapy on overall survival and progression-free survival after adjusting for potential confounder variables such as age, performance status and comorbidity burden.

Official Title
-----------------
Special Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy

Conditions
-----------------
HNSCC, Oral Cavity Cancer, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: definitive (chemo-)radiotherapy of locoregionally advanced (cT3-4 and/or cN+) head-and-neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx primary treatment between 2005 and 2019 age ≥65 years at the time of (chemo-)radiotherapy Exclusion Criteria: adjuvant (chemo-)radiotherapy history of previous head-and-neck cancers or radiotherapy in the head-and-neck region distant metastases at (chemo-)radiotherapy initiation (cM1) HNSCCs of the nasopharynx, salivary glands, skin or with unknown primary

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Overall survival (OS) | Time from radiotherapy start until death from any cause | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Time from radiotherapy start until death from any cause, local progression, locoregional progression or distant progression (whichever occurs first) | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Radiotherapy, Chemotherapy, Chemoradiotherapy, Cisplatin, Cetuximab, Real-world data
A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods.

Detailed Description
-----------------
Analyzing block effects of the lateral sagittal infraclavicular brachial plexus block(posterior and lateral chord), the investigators found it affecting all shoulder relevant nerves , except for the suprascapular and the supraclavicular nerves. Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and block of the posterior and lateral chords infraclavicularly, the investigators believe this novel combination would provide anesthesia for patients scheduled for shoulder surgery.

Official Title
-----------------
A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery

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

Intervention / Treatment
-----------------
* Procedure: Nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for shoulder surgery. American Society of Anesthesiologist grad I-III, 18-70 years, BMI 20-35, Exclusion Criteria: Pregnancy, coagulopathy, allergy to local anesthetics, atrioventricular block, peripheral neuropathy or drug-treated diabetes. Patients using anticoagulation other than acetylsalicylic acid or dipyridamol will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nerve block<br>One novel nerve block combination | Procedure: Nerve block<br>* Nerve block: 31 ml ropivacaine 7.5 mg/ml (Lateral sagittal infraclavicular brachial plexus block) + 4 ml ropivacaine 5 mg/ml (suprascapular nerve block) + 5 ml ropivacaine 5 mg/ml (superficial cervical plexus block)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for general anaesthesia | Investigators will record the number of patients who need to be converted to general anaesthesia | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeons satisfaction with the working conditions | Graded in a) Good and b) Poor | Intraoperatively |
National Wilm's Tumor Study Late Effects

Study Overview
=================
Brief Summary
-----------------
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.

Detailed Description
-----------------
The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Although most people in this study enjoy good health, some may be at risk for certain health conditions. We are collecting information from as many participants as possible in order to determine if they or their offspring are at risk for adverse medical conditions. If there is more than one case of Wilms tumor in a given family, we plan to work with geneticists to try to estimate heritability and recurrence risks.

Official Title
-----------------
National Wilm's Tumor Study Late Effects

Conditions
-----------------
Wilm's Tumor

Intervention / Treatment
-----------------
* Other: none, screening only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously enrolled in NWTS 5.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: screening<br>this is a screening study and no intervention. | Other: none, screening only<br>* Screening protocol with no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if survivors from Wilms tumors or their offspring are at risk for adverse medical conditions. |  | 1 year after closure of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
late effects
Causes of Low Back Pain in Nurses in Israeli Hospitals

Study Overview
=================
Brief Summary
-----------------
An examination of the various factors that cause lower back pain in nurses in four hospitals in Israel such as; socio-demographic, professional, posture while ambulating patients and job environment.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurses working in orthopedics, surgical, intensive care and internal medicine units Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain in nurses
The Study of LTBP1 of Postmenopausal Women Osteoporosis Molecular Mechanism of Kidney Yang Deficiency Syndrome

Study Overview
=================
Brief Summary
-----------------
Postmenopausal Osteoporosis is characterized by a decrease in bone mass as well as a deterioration of the bone architecture resulting in an increased risk of fracture,which is directly related to the lack of estrogen and also associated with a variety of genetic and acquired factors. Previous studies have found that POP molecular regulation mechanism of kidney Yang deficiency syndrome may be associated with LTBP1 gene expression. This topic using RT-PCR and Western Blot detection POP of kidney Yang deficiency group and healthy group LTBP1 mRNA and proteion's expression level,validate LTBP1 relevance to POP the kidney Yang deficiency syndrome.To provide a scientific basis for clinical treatment.

Official Title
-----------------
The Study of LTBP1 of Postmenopausal Women Osteoporosis Molecular Mechanism of Kidney Yang Deficiency Syndrome

Conditions
-----------------
Kidney Yang Deficiency Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent. Female ages 45 to 75 had gone through natural menopause before two years In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate; In accordance with the western medicine diagnostic criteria; In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study Exclusion Criteria: Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods Age: <44 and > 76 years old; With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor; With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases; Psychosis or alzheimer's patients; Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.; This medicine allergic constitution or composition of known to have allergies; In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Postmenopausal Osteoporosis of kidney Yang deficiency syndrome |  | To observe the changes in gene expression(Day 1) |
A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

Study Overview
=================
Brief Summary
-----------------
This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).

Official Title
-----------------
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache

Conditions
-----------------
Episodic Cluster Headache

Intervention / Treatment
-----------------
* Drug: Civamide (Zucapsaicin)


Participation Criteria
=================
Eligibility Criteria
-----------------
At least 2 year history of episodic cluster headache (meeting IHS criteria) At least 2 previous episodes Expected duration of cluster period is at least 6 weeks but not longer than 16 weeks At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Civamide (Zucapsaicin)|nan|

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
-----------------
Headache, Cluster, EC, Episodic Cluster
Fractional CO2 Laser in the Treatment for Cesarian Scar

Study Overview
=================
Brief Summary
-----------------
Fractional CO2 laser can improve the Cesarian scar

Conditions
-----------------
Cesarian Scar

Intervention / Treatment
-----------------
* Device: Fractional CO2 laser and pulsed dye laser
* Device: Pulsed dye laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female receiving Cesarean surgery for more than 1 month Exclusion Criteria: Pregnancy Keloid Photosensitivity Wound Pacemaker Recent retinoid intake
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Pulsed dye laser (V-beam) | Device: Pulsed dye laser<br>* Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass<br>|
| Experimental: Experimental group<br>Fractional CO2 laser(eCO2)and pulsed dye laser (V-beam) | Device: Fractional CO2 laser and pulsed dye laser<br>* Fractional CO2 laser: 50 mJ, 100 spots/cm2, a scan area of 4_4mm, static mode, and two passes Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Vancouver Scar Scale (VSS) | We measured quartile grading scale at 1st, 5th and 7th months of study and evaluated the change of the scale | 1st, 5th, 7th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quartile grading scale | We measured quartile grading scale at 5th and 7th months of study. | 5th, 7th month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarian scar, Fractional CO2 laser
The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes

Study Overview
=================
Brief Summary
-----------------
An orthosis in the ballet shoe to see if pain reduction during dancing on pointes will decrease. One group of pre-preprofessional ballet dancers will receive an orthosis and will train during four weeks with it. The other group without a orthosis will be the control group.

Official Title
-----------------
The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes

Conditions
-----------------
Ballet Dancers

Intervention / Treatment
-----------------
* Device: orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: girls on preprofessional ballet schools with a minimum of 30 minutes professional training a week; 12 to 18 years old pain during dancing on pointes Exclusion Criteria: experience with wearing a orthosis in their ballet shoe

Ages Eligible for Study
-----------------
Minimum Age: 12 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orthosis<br> | Device: orthosis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-score |  | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower extremities muscle ratio |  | four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ballet shoe, orthosis, pain