cyrilzakka/clinical-trials huggingface dataset:
To Test the Effectiveness of a Trained Nurse Led, M-health Enabled Intervention to Control Blood Pressure in India

This study evaluates the effect of a mobile health technology enabled trained nurse led intervention on control of blood pressure among patients with hypertension seeking care in the community health centres in the southern state of Andhra Pradesh, India. half the community health centres will receive the intervention and the other half will receive the routine care.

The burden of hypertension is very high in India but the control rates of hypertension are very low. One of the important reasons for this is the lack of awareness and the inability of the doctors working in busy out patient settings of public health facilities to care adequately for the patients. Hence there is a need for task shifting.

In this trial a trained nurse care coordinator will be placed in the Community Health Centres (CHCs) and she will be provided with an Electronic Decision Support System (EDSS), in the form of an android application installed on a tablet, to treat hypertension. The trial will be carried out in twelve CHCs of Visakhapatnam district in southern Indian state of Andhra Pradesh.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged ≥30 years.
2. Willing to provide written informed consent for the study.
3. Identified as suffering from hypertension (≥160/100 mmHg) with or without co-morbidities such as left ventricular hypertrophy, heart failure, coronary artery disease, peripheral vascular disease, or diabetes mellitus

Exclusion Criteria:

1. Participants aged \<30years
2. Unwilling/unable to provide written informed consent for the study
3. Having malignancies or life threatening conditions
4. Currently participating in other clinical trials
5. Those with plans to move residence in the year ahead.
Pure Red Cell Aplasia in Patients With Chronic Kidney Disease and in Use of Epoetin Alfa

The purpose of this study is to determine occurrence of pure red cell aplasia in a group of participants with chronic renal insufficiency and with resistance criteria to epoetin alfa treatment.The investigational product is producted by Bio-Manguinhos / Fiocruz (BIO-EPO) and it is provided by the Unified Health System.


Eligibility Criteria:
Inclusion Criteria:

* Use of alfa epoetin manufactured by Bio-Manguinhos for at least 8 weeks before the moment of hyporesponsiveness diagnosis;
* Nonuse of alfa epoetin from another manufacturer for at least 24 weeks before hyporesponsiveness diagnosis;
* Presence of the criteria for pure red cell aplasia disease, which is absence of a significant reduction in serum levels of leukocytes and platelets.

Exclusion Criteria:

The screened patients who have at least one of the following criteria will be excluded from the study, and it may be replaced by another participant for the research.

* if there is no legal representative, an intellectual disability that restrain the compliance and signature of informed consent,
* no agreement assigning the informed consent;
* It will be excluded from the study if from the moment of hyporesponsiveness diagnosis the participant have: lactation pregnancy, hypersensitivity or intolerance previously known for alfa epoetin or one of its components, intolerance or allergy to parenteral iron, acute hemorrhage, kidney transplantation, hemolysis defined as the presence of anemia associated with high levels of indirect bilirubin and lactate dehydrogenase , percentage of reticulocytes\> 1.5% absolute reticulocyte\> 75,000 / microliter.
* deficiency of folate and / or vitamin B12.
* pancytopenia.
* in use with medications known to cause anemia and / or pure red cell aplasia as: Valproic Acid; Azathioprine; Chloramphenicol; Phenytoin; Isoniazid; Mycophenolate mofetil.
* presence of the following comorbidities: Diabetes mellitus; epilepsy; chronic viral hepatitis; secondary hyperparathyroidism uncontrolled; hypertension systolic; inflammation (acute or chronic); myelofibrosis; myelodysplasia; neoplasm and thalassemias;
* severe disease in the 24 weeks before the hyporesponsiveness diagnosis; including: stroke, septic shock, thromboembolic events; acute myocardial infarction
* lack of information or damage to quality data that avoid disease classification as a case of hyporesponsiveness.
* Immunoglobulin M and Immunoglobulin M serology for Parvovirus B19, Epstein-Barr and Cytomegalovirus.
* serology for HIV in the last 12 months.
* established immunological disease.
* dosage of protein C-reactive titrated .
* presence of antinuclear antibody and rheumatoid factor.
2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy

In transoral thyroidectomy via vestibular approach (TOETVA), prophylactic antibiotic for 5\~7 days is recommended for the clean-contaminated wound. In this study, the investigators design a 2-day versus 7-day antibiotic prophylaxis to compare the surgical result and infection rate.

Remote-access thyroid surgery has gained popularity and has advanced significantly over the past two decades, given the patient desire to avoid cosmetically displeasing scarring. The mostly recently introduced remote thyroid surgery is the transoral endoscopic thyroid surgery via vestibular approach (TOETVA). Because of the several advantages comparing with other removeaccess thyroid surgery, making it nowadays growing in popularity since 2016. However, TOETVA carry some inherent risks, including mental nerve injury, tumor seeding and local recurrence, fibrosis-induced long-lasting pulling sensation below the lower jaws, and surgical site infection coming from the clean-contaminated environment of oral incision.

Comparing with clean wound via the traditional open surgery, TOETVA carry the potential risk of infection. Based on the author's recommendation, prophylactic antibiotic (augmentin) will be administered 30 minutes before incision at operative room, followed by 2-day course of intravenous antibiotic, then shift to 5-day course of oral antibiotic finally. Up to date, only few case complicating postoperative infection were reported with extremely low infection rate (\<1%). Therefore, the investigators want to study the short-course (2 days) of antibiotic coverage is also effective to prevent surgical site infection. It was proved in the preliminary study, comprising 5 patients in each group (2-day course in the study group and 7-day course in the control group). Later, the investigators will recruit more patients (n=100) to confirm this study.

Eligibility Criteria:
Inclusion Criteria:

1. Suspicious or proved thyroid cancer with size smaller than 4cm
2. Symptomatic benign thyroid nodules less than 6cm in size
3. Thyroid cyst
4. Follicular neoplasm
5. Graves' disease

Exclusion Criteria:

1. Previous thyroid or parathyroid surgery
2. History of radiation at neck
3. Could not tolerate the general anesthesia.
Food Reinforcement, Weight Status, and Energy Density

The investigators previous studies have shown that obese and non-obese individuals respond differently to daily intake of snack food. The purpose of this study was to determine whether these differences are specific to high energy density snack foods. The investigators hypothesized that obese individuals would show an increase in motivation to obtain high energy density snack foods after two weeks of daily consumption, but that non-obese women and obese women consuming low energy density foods would have reduced motivation to consume snack foods after two weeks of daily consumption.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 50 years old, female, like study foods.

Exclusion Criteria:

* current smoker, currently on a diet, medical conditions or medication affecting appetite (ex. methylphenidate).
Combined Effects of Isometric Wall Squats and High Intensity Interval Training on Rate Pressure Product in Normotensive and Pre-hypertensive Sedentary Adults

Hypertension is leading yet preventable risk factor for cardiovascular disease and all-cause mortality worldwide. Prehypertension identifies those at high risk of developing HTN, prompting intervention to prevent or delay the onset of the disease. High intensity interval training (HIIT) is a time efficient mode of training with established benefits, while Isometric wall squats (IWS) also provide a range of proven benefits and advantages, but their combined effect on BP measures is yet to be determined.Hence the objective of this study is to compare the effects of isometric wall squats along with high intensity interval training versus high intensity interval training alone on rate pressure product, SBP and DBP, heart rate and anthropometric measures in normotensive and pre-hypertensive sedentary adults

Pre-Hypertension is not a disease itself rather it categorizes those who are at the risk of developing hypertension in future. By targeting pre-hypertensive and normotensive individuals we are focusing on preventive measures, potentially reducing incidence of HTN and cardiovascular conditions in future. If found effective, this study can help in providing training protocols while also decreasing the risk of hypertension in future.A total of 15 sessions of high intensity interval training alone in one group and combination of high intensity interval and isometric wall squat in other group, for thrice a week on alternative days for 5 consecutive weeks will be given.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female adults aged 18-45 years.
* Participants lying in Low PA (inactive) category on basis of IPAQ.
* Pre-hypertensive adults:
* SBP- 120 mmHg or more and \<140 mmHg
* DBP of 80 mmHg or more and \< 90 mmHg.
* Normotensive adults: SBP \< 120 mmHg and DBP \< 80 mmHg. Exclusion Criteria
* Diagnosed with any current infections.
* Subjects with any diagnosed cardiovascular or respiratory conditions.
* Subjects with diagnosed musculoskeletal or neurological conditions which hinder participation in physical activity program.
* Active Smokers
* Those with any contraindication to exercise testing or training.
* Pregnant females
Sonic Window Study Evaluation Plan

The goals of this study are as follows; evaluation of the products' readiness to market, ascertain initial reactions by target users, evaluate actual use in potential clinical settings and any difficulties encountered with product use and actual venous cannulation.

This study was cancelled

Eligibility Criteria:
Inclusion Criteria:

* Patient Requires needle placement

Exclusion Criteria:

* Under 18 years of age
* Needle placement not required.
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults with Ocular Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and the local legal age of consent for clinical studies
* Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy"
* Is MGFA Class I (any ocular muscle weakness)
* Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2

Exclusion Criteria:

* Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia
* Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years;
* Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement;
* Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.

Exclusion Criteria:

* Participation in another randomized drug or device study before reaching primary endpoint;
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
* Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined;
* Known pregnancy;
* Life expectancy of less than 1 year.
PREMIUM Migraine Trial

The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence of migraine headaches.

The objective of this study is to evaluate whether percutaneous PFO closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed as having migraine headaches both with and without aura
* Have a Patent Foramen Ovale (PFO)
* A migraine history and show a refractoriness to medical treatment
* Willing to participate in follow-up visits

Exclusion Criteria:

* Subjects whose primary headaches are other than migraine headaches
* Who overuse migraine treatments
* With a clinical history of stroke or Transient Ischemic Attack (TIA)
* With contraindication to aspirin therapy and Clopidogrel
* Pregnant or desire to become pregnant within the next year
IVUS Guided PCI for CKD to Reduce CI-AKI

Patients with Chronic kidney disease are most vulnerable to contrast induced nephropathy after Percutaneous coronary intervention, intravascular ultrasound guidance can be used to safely guide the procedure to reduce the contrast usage, this randomized trial is design to test the hypothesis that IVUS based ultra-low contrast PCI is feasible and can reduce the contrast induced nephropathy.

Prospective, open-label, randomized(1:1), multi-center trial of 320 patients allocated to one of the treatment arms(IVUS-guided ultra-low contrast PCI or angiography-guided PCI).

The study population will be composed of patients with renal dysfunction referring for PCI on one to more coronary artery. target lesion must be assessable with IVUS.

eGFR will be re-evaluated 48 hours after the procedure. and at 1 month, 3 month, 6 month, 12 month. as well as follow-up for other clinical outcomes unless contra-indicated all patients will receive intravenous hydration 12 hours before and after the procedure. saline infusion at a dose of 1ml/kg/hour. if with reduced ejection fraction or overt heart failure reduce the saline infusion to 0.5ml/kg/hour. the use of sodium bicarbonate and diuretic will be left at the discretion of the operator All procedure will be performed using non-ionic, low osmolar or iso-osmolar, iodine-based contrast media the study groups will be compared according to the intention-to-treat principle. Categorial variables will be compared by Fisher's exact test and continuous variables by students T test. Time-dependent events will be estimated by the Kaplan-Meier method and compared by hazards cox model or log-rank test.

Eligibility Criteria:
Inclusion Criteria:

- age over 18 years coronary artery disease referred for percutaneous intervention, with stent, Drug coated bloon, or bioresorbable stent, of one or more epicardial vessel.

target lesion must be assessable by IVUS at baseline and during the procedure. 60ml/min/1.73m2\<=Baseline Calculated creatinine clearance \>=15ml/min/1.73m2 consent can be obtained and comply with all study procedures.

Exclusion Criteria:

- Use of \>50ml of iodinated agent\<72 hours Planned used of iodinated contrast within 72 hours after the index procedure use of other nephrotoxic agents\<7 days known allergy to contrast agents unstable or unknown renal function prior to PCI life expectancy less than 1 year
Detection and Application of Organic Disease With Phonocardiac Spectrometry

Western medicine, as to disease detection, is based on histological pathology and organ anatomy, therefore biochemistry and medical imageology were developed to determine the location and mechanism of the sickness. Chinese medicine, in the other way around, follow the harmony between man and nature, creating four ways of diagnosis, namely looking, listening, questioning and pulse feeling, which evaluate the physiological homeostasis by the yin-yang of qi and blood, further judging the energy exchange between individual and the universe.

Western medicine, as to disease detection, is based on histological pathology and organ anatomy, therefore biochemistry and medical imageology were developed to determine the location and mechanism of the sickness. Chinese medicine, in the other way around, follow the harmony between man and nature, creating four ways of diagnosis, namely looking, listening, questioning and pulse feeling, which evaluate the physiological homeostasis by the yin-yang of qi and blood, further judging the energy exchange between individual and the universe.

Pulse sound provides perfect detection of disease in Chinese medicine. Hence we plan to digitalize the pulse sound for a better interpretation of the sickness. According to past studies of pulse sound from radial artery, the lower frequency is below 25Hz, which falls into the detection range of Messener's corpuscles (2-80Hz), which are located intensively in index and middle fingers. However, radial artery is relative thinner and the pulse sound is not easy to target by the microphone, not to mention the interference from artery sclerosis. To this end our research group developed Phonocardiac spectrometry (PCS) to replace the traditional pulse instrument.

Since heart beats continuously, we hypothesize that each organ is regularly sending the signal back to heart, which modulate the contraction and beating of heart, reflecting different state of each organ. Heart is just like the commander of an orchestra band, who can direct the rhythm and style of the band by the music score and instruments. Once the instrument is damaged, the commander (heart) also adjusts himself. PCS can easily locate the pulse sound, and directly detect and analyze the cardiac spectrum. The real-time state in heart-organ axis can be readily monitored, recorded and investigated by PCS.

Our preliminary analysis focuses on patients with liver and pancreatic cancers. The results demonstrate the different pattern of cardiac spectrum between patients and normal people, which can be further sorted by disease types. By applying PCS measurement and the novel algorithm calculation to various diseases, we aim to build up a novel platform for disease screening or even diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer, out- and in-patients in gastroenterology division of Wanfang hospital.

Exclusion Criteria:

* 1.The decline and fall of informed consent.
* 2.Pregnancy.
* 3.Heart murmur grading greater or equal to level 3.
* 4.Cardiac Arrhythmia.
* 5.Patient with critical conditions such as renal or heart failure.
Herniorrhaphy for Postoperative Pain

Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.


Eligibility Criteria:
Inclusion Criteria:

* Able to sign Informed Consent
* Scheduled to have inguinal hernia repair
* Be a reasonably healthy adult 18 - 75 years of age
* Body mass index ≤ 39 kg/m2
* If biologically female, not pregnant or planning to become pregnant
* If biologically male, using acceptable birth control
* Be willing and able to complete study procedures

Exclusion Criteria:

* Previously inguinal herniorrhaphy
* Concurrent painful condition that may require analgesic treatment
* History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation
* Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months
* History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
* Impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis.
* Impaired renal function (e.g., creatinine \> 1.5 × ULN).
* Malignancy in the past year
* Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures

This is a Phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (aPDT) for nasal disinfection in all patients (universal) presenting for surgery at an acute care hospital for a wide range of surgical procedures.

The purpose of the proposed study is to gather data regarding the safety and efficacy of nasal photodisinfection treatment in eliminating colonization of the anterior nares with S. aureus. The anterior nares are often considered the primary reservoir of S. aureus and other pathogens on the body, therefore, this product could play an important role in helping to eliminate this pathogen reservoir in patients. Since photodisinfection is a non-antibiotic approach that does not generate antibiotic resistance, this could be a beneficial approach to achieving nasal disinfection. Additionally, photodisinfection has an extremely broad spectrum of activity and is effective against bacterial, viral, and fungal pathogens including emerging pathogens such as C. auris.

This is a Phase 2 study. Nasal cultures will be performed on all patients admitted for surgery at Memorial Health University Medical Center over a 1-month period. This will determine the prevalence rate of S. aureus and other pathogens in community patients who are being admitted for surgery. The results of this culture will not be known to the research staff until several days later. Clinical trial subjects will universally receive a nasal disinfection treatment followed by a post-treatment culture. This will demonstrate the efficacy of nasal disinfection against Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form within 30 days of surgery.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female ≥ 18 years of age.
4. Patient being admitted for a surgical procedure.
5. Ability to tolerate a 4-minute non-painful nasal light illumination.

Exclusion Criteria:

1. Male or female \<18 years of age.
2. Inability to tolerate insertion of the nasal light illuminator due to nares size, shape, or anatomical variants.
3. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
4. Nasal obstructions precluding placement of light illuminator.