cyrilzakka/clinical-trials huggingface dataset:
Treatment for Achilles Tendinopathy

The purpose of this study is to determine whether sclerotherapy using a 25% dextrose and 1% lidocaine solution is an efficacious treatment for patients with chronic Achilles tendinopathy who have failed a home based, heavy load eccentric training program.

The purpose of this research project is to optimize the clinical outcome of patients with Achilles tendinopathy. Patients who fail a standardized physical therapy regiment (eccentric training protocol) will be randomly allocated into two groups with one group receiving an injection of hypertonic glucose and Lidocaine (sclerosing solution) and the other receiving an injection of Lidocaine (control). Neovascularisation (growth of new blood vessels and nerves into a damaged area of the tendon) appears to be associated with pain and subsequently a decrease in function and use of the affected tendon. Results of an observational study in Sweden revealed that in all patients for which eccentric training was unsuccessful neovascularisation was present. Sclerosis of neovessels appears to be successful in removing the pain associated with Achilles tendinopathy in both mid-portion and enthesitis patients. However, there are no studies that have administered this technique to a homogenous patient population in a prospective, controlled and randomized manner. In addition, there are no studies that have compared the effects of eccentric training in healthy individuals versus patients with painful Achilles tendinopathy in a controlled longitudinal study. It is expected that patients for whom eccentric training is unsuccessful and who subsequently receive sclerosing therapy will show a statistically significant improvement in pain and function.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older with a minimum of 3 months of clinically determinant history and symptoms (pain) consistent with unilateral Achilles tendinopathy (enthesitis or mid-portion) as diagnosed by a sport medicine physician.
* Participants are not required to have tried other treatments, however, those who have tried other treatments (except injection treatments) including, but not restricted to, oral NSAIDs, topical NSAIDs, shoe modifications, and physical/athletic therapy will not be restricted from the study
* Provide informed consent for the controlled longitudinal study and RCT

Exclusion Criteria:

* Individuals with physical ailments precluding them from performing the eccentric training program
* Worker's Compensation Board (WCB) and elite athletes (varsity, national and professional level).
* Individuals younger than 18 years of age will be excluded from this trial due to the complicating factors of musculoskeletal immaturity and the lack of relevant research of Achilles tendinopathy and neovascular bundles in this population.
* Previous Achilles tendon rupture of the tendon in question
* Individuals that have received any type of injection in or around the Achilles tendon
* Known allergy to dextrose based sclerosing agent or other contraindications
* Known allergy to Lidocaine
A Study of the Effect of High Altitudes on Physiological and Metabolic Markers in Adults Living at Qinghai-Tibet Plateau for Work Purpose

This ambispective cohort study aims to evaluate the effect of high altitudes environment on human's physiological and metabolic markers, specific markers of main human systems, and incidence rate and severity of chronic mountain sickness (CMS).

Qinghai-Tibet plateau is a high altitudes area with average 3,000-5,000 meters height in China. As the partial pressure of oxygen in inspired air falls with increasing terrestrial elevation above sea level, many physiological variables in human body could be affected by this hypobaric hypoxic environment. Up to date, there are no large scale clinical trials assessing these changes in chinese population. The study here would like to provide the newest medical information on the changes of physiological variables and correlation between specific risk factors in chinese adults living at high altitudes for work purpose.

Eligibility Criteria:
Inclusion Criteria:

* Be provided verbal or written informed consent;
* Men and women ≥ 30 and ≤ 65 years of age;
* Adults living at Qinghai-Tibet Plateau for Work Purpose, and the altitude of residence is more than 2,500 meters;
* Providing electronical or paper medical examination reports which conducted in 2016.

Exclusion Criteria:

* Pregnant or breast-feeding women;
* Be excluded by Principal investigator for subject's compliance or safety reasons.
Estimating Usual Iodine Intake From Spot Urinary Iodine Concentrations

The overall objective of this study is to develop a reliable method to obtain habitual iodine intakes from spot urinary iodine concentration (UIC) and to assess the prevalence of inadequate iodine intake in school-age children and women of reproductive age. We will evaluate different methods to estimate iodine intake from UIC and estimate the prevalence of inadequate and excess iodine intake in UIC studies conducted in populations with low, adequate and high iodine intakes using the the established estimated average requirement (EAR)/Tolerable Upper Intake Level (UL) cut-point method.


Eligibility Criteria:
Inclusion Criteria:

* lived in study area \>= 12 months
* no reported intake of Amiodarone
* no history of thyroid dysfunction / goiter (past \& present)
* no exposure to iodine containing contrast agents within the last 12 months

Second arm: Women aged 18 - 49, exclusion / inclusion criteria apply, plus non-pregnant, non-lactating.
The Short-term Efficacy of Gastrodia and Uncaria Drink in Treating Hypertension

The purpose of this study is

1. To determine whether the Gastrodia and Uncaria Drink is effective in the treatment of masked hypertensive patients below 70 years.
2. To find out the suitable groups for the Gastrodia and Uncaria Drink treatment.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 to 70 years
* didn't use any anti-hypertension drugs within 2 weeks
* stage 1 masked hypertensive patients, which means clinic blood pressure\<140/90 mmHg,however the daytime(8:00-18:00) 24h ambulatory blood pressure between 135/85 and 150/95mmHg
* be willing to participate in the trials and able to finish clinic visit

Exclusion Criteria:

* secondary hypertension
* be allergic to the clinical trial medicine
* occurrence of stroke, CKD, myocardial infarction within 2 years
* dysfunction of liver or kidney and fundus hemorrhage
* arrhythmia
* ALT, AST, TBL upper the twice of normal range, Scr≥2.0mg/dl, K+≥5.5mmol/L, Urine protein≥2+
* psychiatric disorders
* pregnant, breastfeeding
* other serious conditions in which is not fit for the study
Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.


Eligibility Criteria:
Inclusion Criteria:

1. singleton pregnancy
2. reassuring fetal status at time of presentation
3. Bishop Score \<6

Exclusion Criteria:

1. Closed cervix
2. Breech presentation
3. Multiple gestations
4. Recent vaginal bleeding
5. Placenta previa
6. non reassuring fetal status
7. Active genital herpes infection
Predictors of Poor Prognosis in HFpEF

Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.

Heart failure with preserved ejection fraction (HFpEF) is a serious condition with an unfavorable prognosis.

The investigators aimed to evaluate in patients with HFpEF:

* the prognostic significance of standard resting hemodynamic parameters compared to key cardiac reserves;
* the prognostic significance of clinical parameters (sex, age, NYHA class, extra-cardiac diseases, therapy);
* the prognostic significance of biological markers of hemodynamic stress and biomarkers of inflammation and fibrosis;
* to identify independent predictors of adverse prognosis of HFpEF.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and data informed consent;
2. New York Heart Association (NYHA) class II-III heart failure;
3. Left ventricular ejection fraction \> 50%;
4. Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.

Exclusion Criteria:

1. Evidence of myocardial ischemia during stress echocardiography;
2. Significant lesions of the main coronary arteries;
3. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);
4. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;
5. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);
6. Primary pulmonary artery hypertension;
7. Significant left-sided structural valve disease;
8. Anemia (Hb \< 100 g/L);
9. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (CKD-EPI);
10. Non-cardiac conditions that complicate/exclude participation in the study;
11. Exacerbation of heart failure less than 3 months prior to study entry.
A Study of S-268019 for the Prevention of COVID-19

The main purpose of this study is to assess the efficacy of S-268019-b for the prevention of COVID-19 in the initial vaccination period prior to crossover in participants without evidence of infection before vaccination as compared to placebo.

Eligible participants will be randomized to receive either S-268019-b or placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods, an initial vaccination period (Day 1 to Day 224), and a crossover vaccination period (Day 225 to Day 435).

Eligibility Criteria:
Inclusion Criteria:

* Agree not to participate in any other SARS-CoV-2 prevention trial during the study follow-up.
* Capable of using Diary without difficulties (if applicable, with assistance by caregiver).

Exclusion Criteria:

* Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
* Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.
* Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome \[AIDS\], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy).
* Previous vaccination against SARS-CoV-2.
* Any inactivated vaccine received within 14 days prior to the first dose of study intervention.
* Any live vaccine received within 28 days prior to the first dose of study intervention.
* Immunoglobulin preparations, blood products, or a blood transfusion within 3 months prior to the first dose of study intervention.

Other inclusion and exclusion criteria may apply.
Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions

A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-


Eligibility Criteria:
Inclusion Criteria:

* The decision to treat with Otezla® has been made independently before inclusion in this study
* Patient age ≥ 18 years
* Existing diagnosis of active psoriatic arthritis
* At least moderately severe psoriatic arthritis (Physician's Global Assessment (PGA) scale ≥ 2)
* Insufficient response or intolerance to previous Disease-Modifying Anti-Rheumatic Drug (DMARD) treatment (disease modifying anti-rheumatic drugs)
* A written informed consent statement by the patient permitting data collection, evaluation, storage and transfer

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to apremilast or one of the other ingredients in the film tablets
* Other criteria according to the summary of product characteristics Breast-feeding
Home-based Early Intensive Hemiparesis Therapy: Engaging Nurture

The purpose of the study is to assess implementation and effectiveness of a caregiver-delivered rehabilitation intervention for infants and toddlers with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* aged three to 24 months (corrected, if premature)
* clinician-identified hand asymmetry
* suspected/confirmed cerebral palsy (hemiplegia or triplegia)
* willing to withhold other formal upper-limb focussed treatment during the study intervention - willing to commit to completing 18 weeks of daily home-practice and attending weekly therapy sessions.

Exclusion Criteria:

* participation in formal constraint induced movement therapy (CIMT) within last six months
* upper limb botulinum toxin A injections within previous six months
* brachial plexus injury
* lower motor neuron dysfunction
* upper limb congenital limb difference.
Exercise Intervention in Adolescent and Young Adult Cancer Survivors

Adolescent and young adult (AYA) survivors of cancer face a future of persistent medical issues across a wide spectrum of diseases One study examining health data from this cohort (ages 15-29) reported significantly higher rates of smoking, obesity, cardiovascular disease, hypertension, asthma, and poorer mental health among the cancer survivors when compared to healthy controls. Prescribed exercise has broad and far-reaching beneficial physiological effects that cut across multiple body systems and consistently improves emotional well-being, decreases fatigue and depression, and enhances quality of life. Although a growing body of evidence consistently demonstrates the physiological and psychological benefits of exercise interventions in adults with cancer, there are no studies examining the effects of individualized, prescribed, supervised exercise in pediatric, adolescent and young adult cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 15 and ≤ 39 years,
2. History of cancer
3. At least three months off of cytotoxic chemotherapy (note: hormone therapy is permitted)

Exclusion Criteria:

1. Evidence of significant liver dysfunction, congestive heart failure, cardiovascular disease
2. History of CNS tumor
3. Down's Syndrome
4. Unable to perform aerobic and/or strength exercises with full range of motion (limb immobilization, limb amputation, or surgical complications.
5. Neurological disorder
6. Baseline exercise of 30 minutes per day three times a week already being performed.
The Development Of A Novel Biomarker For Early Identification Of The Individual's State Of Tolerance To Heat

Today, the level of tolerance to heat is based on physiological strain indices, with no correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to heat. The aim of the present project is to develop a simple assay, based on specific designed sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly correlate each individual's state of tolerance to heat to the level of OS. These biomarkers specially designed and synthesized to form a novel probe (not present as such in biological organs). The method will be based on the incubation of the suggested biomarkers with the patient's blood sample and the measurement of the level and type of oxidative alteration of the markers. For this goal, post heat stroke patients, with different levels of tolerance to heat and subjects during a process of acclimation to heat will be studied. Such a method will add to our ability to better determine the level of tolerance to heat and not rely only on the measurements of temperature and heart rate during an exercise-heat stress.


Eligibility Criteria:
Inclusion Criteria:

for study group: post heat stroke subjects. for control group: healthy subjects matched by age to study group

Exclusion Criteria:

for control group: any prior heat illness, Diabetes, heart failure, high blood pressure (SBP \>140mmHg), any febrile illness within the last two weeks prior to testing.

for study group: Diabetes, heart failure, high blood pressure (SBP \>140mmHg), any febrile illness within the last two weeks prior to testing
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity

This study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney disease. This treatment is compared to sodium chloride treatment, which serves as control for increased sodium-intake and no treatment, which serves as time-control.

In chronic kidney disease (CKD), as glomerular filtration rate decreases, excretion of hydrogen ions fails, leading to progressive metabolic acidosis (arterial pH \< 7.35 and a serum bicarbonate concentration \< 22 meq/L). Metabolic acidosis enhances further progression of CKD. It is known that the intrarenal renin-angiotensin system (RAS) is stimulated during metabolic acidosis, but it's specific role in the renal response on changes in the acid-base balance is unknown. Correction of metabolic acidosis by administration of bicarbonate is a common intervention in patients with metabolic acidosis due to chronic kidney disease. It is proven to slow down progression of CKD. There is no knowledge on the effect this therapy has on the intrarenal RAS. Since acidosis does not change serum renin levels, and bicarbonate therapy has no effect on blood pressure, it seems to have no effect on the systemic RAS. The investigators hypothesize that bicarbonate therapy diminishes intrarenal RAS activity without affecting the systemic RAS.

Eligibility Criteria:
Inclusion Criteria:

* male or female adult (≥18 years)
* chronic kidney disease stage 4, i.e. estimated glomerular filtration rate (MDRD) 15-30 ml/min
* plasma bicarbonate concentration of 15-24 meq/L

Exclusion Criteria:

* bicarbonate level \>24 meq/L or \<15 meq/L, the latter because in that case it seems highly recommended to start sodium bicarbonate suppletion and not to postpone this
* sodium bicarbonate use in the 1 month preceding the study
* heart failure
* liver cirrhosis
* blood pressure \>140/90 mmHg despite the use of 3 different antihypertensives
* a kidney transplant in situ
* a history of nonadherence to medication
* use of calcineurin inhibitors (these immunosuppressive drugs are known to induce metabolic acidosis and influence electrolytes and acid-base balance)
Pain Prevalence and Risk Factors Among Sarcoma/Melanoma Oncology Patients in an Outpatients Setting

The primary objective of this research project is to estimate the number of patients with sarcoma or melanoma attending an outpatients clinic that are in pain or have unmet pain needs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoma or melanoma cancer
* Able to respond to an assessment in written English.
* Able to provide informed consent to participate in the study.

Exclusion Criteria:

* Patients whose health would be compromised by participation in the study
Role of Pioglitazone in Preventing Diabetes

A three year prospective, double blinded, placebo controlled, randomized clinical trial in impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing the conversion to Diabetes.

A randomized controlled study was designed to find out whether pioglitazone will prevent the conversion to diabetes in subjects who are non obese and with impaired glucose tolerance.

It is a double blind prospective study for 3 years. The study was started in October 2003 and randomization was completed in May 2005. A total of 6643 subjects were screened and 406 were randomized either to pioglitazone or placebo(investigator blinded-groups assigned A and B). At randomisation subjects were given standard advice on diet,exercise and benefits of life style modifications.

Subjects both male and female, aged between 35 and 55 years, with no known history of diabetes, willing and available for a 3 year study alone were screened. Pregnant women, subjects with major illness such as cancer, hepatic or cardiac diseases and on transferable jobs were excluded from the study. The initial dose of tablet was 15mg o.d. which was titrated after a month to 30 mg o.d. in subjects who did not show any adverse events.

The subjects will be undergoing annual reviews with a repeat OGTT, for 3 years. An interim review at every six months is also being done. Proforma containing details of anthropometry, occupation, physical activity, dietary habits, details of medications, regularity of treatment will be done at each interview.

The main expected outcomes of the study will be a reduction in conversion of IGT to diabetes and benefits of the drug on anthropometric variables and biochemical parameters.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age 35 - 55 years
* No known history of diabetes
* Willing and available for a 3 years study

Exclusion Criteria:

* Pregnant women
* Subjects with major illness such as cancer, hepatic or cardiac diseases
* Transferable jobs
MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
* Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
* Glaucoma not adequately controlled

Exclusion Criteria:

* Diagnosis of glaucoma other than open angle glaucoma
* Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
* Neovascular glaucoma in the study eye
* Prior glaucoma surgery in the study eye
* Clinically significant corneal disease
* Patients with poor vision