cyrilzakka/clinical-trials huggingface dataset:
Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy

This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.

This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old.
* The diagnosis of ACM was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
* Patients or their families agreed to participate in the study and authorized informed consent.

Exclusion Criteria:

* Incomplete clinical data.
* Do not agree to the inclusion or refuse to authorize the informed consent.
Effects of Kegel Exercises and Myokinetic Release of Trigger Points in Primary Dysmenorrhea

The rationale of this study is despite the widespread belief that exercise can reduce dysmenorrhea, evidence-based studies are limited. Studies are therefore required to evaluate the association between quality of life and the primary dysmenorrheal females, the functional impact on the quality of life and primary dysmenorrhea females also it's a crucial time for females to focus on their studies and dysmenorrhea can add to the fatigue levels and cause distress in this age group thus the purpose of this study is to determine whether myokinetic active release of trigger points in the rectus abdominis, gluteus medius and quadratus lumborum is a more effective way to reduce dysmenorrhea than kegel exercises

Existing research may concentrate on specific interventions or populations, leaving a void in our knowledge of the possible synergistic effects of various exercises when done both alone and in combination, Studies have provided that dysmenorrhea is treated with pelvic floor strengthening however, there is little evidence that myokinetic involvement can lead to progressive outcomes. Given the interdependence of physiology, anatomy and dysfunction. Myokinetic trigger point release may be helpful in promoting the recovery of primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Age 17-25 years
* Diagnosed cases of dysmenorrhea
* Subject having trigger point in rectus abdominins, quadratus lumborum and gluteus medius
* With regular cycles 21-35 days lasting 3-7 days

Exclusion Criteria:

* Oral contraceptives used for menstrual irregularity
* Other gynecological disease like fibroids, endometriosis
* Who take analgesia
* Endometrial polyp, having pelvic infection using IUD, having venous congestion in internal genital organs.
The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis

Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Immune-related hepatitis (IRH) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for ICIs monotherapy, including 1%-2% with grade 3 or higher. Therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for IRH.


Eligibility Criteria:
Inclusion Criteria:

* The lung cancers were diagnosed by pathological evaluation.
* The PD-1/PD-L1 inhibitors were administered in all patients.
* Grade 3-5 immune-related hepatitis had occurred.
* The pre-treatment tissues or peripheral blood were available.

Exclusion Criteria:

* The pathological type was not lung cancers.
* Grade 1-2 immune-related hepatitis would be excluded.
* The any-grade hepatitis were induced by chemotherapy or virus.
Dysphagia Rehabilitation for Nasopharyngeal Carcinoma Patients Post Radiotherapy

In Hong Kong, every 30 and 12.9 in 100,000 males and females respectively has nasopharyngeal carcinoma (NPC). With early detection and advances in medical care, the number of NPC survivors post radiotherapy is rapidly growing in Hong Kong. One of the most distressing consequences post radiotherapy for NPC patients is swallowing disorder, or dysphagia. Dysphagia in NPC patients almost certainly cause frequent chest infection, dehydration, malnutrition and limitations to concurrent treatment such as oral medication. Given the existing large costs NPC patients incur to the healthcare system, dysphagia only serves to further inflate the soaring costs.

In an attempt to reduce dysphagia related costs to the healthcare system, swallowing rehabilitation is offered to NPC patients. Currently, two major swallowing rehabilitation approaches are commonly adopted. The first is traditional rehabilitation, which involves patients performing various oropharyngeal exercises aimed at improving swallowing physiology. The other swallowing rehabilitation approach is transcutaneous electrical stimulation, which entails using small amount of electric current to increase muscle strength while patients are engaged in swallowing activities. These two methods are proven as effective in patients with stroke and head and neck carcinoma patients. Neither of these methods, nevertheless, yields any efficacy studies in treating NPC patients. Yet, clinicians continue to use either one or both rehabilitation methods as swallowing rehabilitation.

This study aims to address the gap in efficacy studies on swallowing rehabilitation for NPC patients post radiotherapy. The research results should provide justification for rehabilitation time, clinicians' efforts, costs involved and resources used in rehabilitating the swallowing difficulties of the NPC patients.


Eligibility Criteria:
Inclusion Criteria:

* able 18 years of age
* undergone primary radiotherapy or chemoradiotherapy as the treatment
* are expected to complete the 12 month follow-up

Exclusion Criteria:

* prior history of head and neck surgery except biopsies of the NP or the neck nodes
* previous history or having a concurrent neoplasm other than NPC
* other severe medical problems that might contribute to dysphagia, e.g. cerebral vascular accident, neuromuscular diseases, respiratory diseases that may cause dysphagia
* present contraindications for the use of electrical stimulation which include pregnancy, pacemaker, other implanted electrodes or significant reflux
* non-oral feeding is contemplated in prior to treatment
* inability to complete the assessment including cognitive impairment
* of a low life expectancy related to NPC or other illnesses
* history of dysphagia prior to radiotherapy or chemoradiotherapy
Activity, Balance and COPD (ABCOPD)

This research project incorporates a series of studies to investigate the relationship between physical performance (e.g. tests of strength, balance and walking distance) and physical activity (activity measured in day to day life) in people with COPD and other chronic lung diseases.

The research project incorporates the following components:

Study 1) A prospective, observational study, to assess the relationship between a comprehensive set of measures of walking ability, strength and balance, and daily physical activity in people with chronic lung disease. Patients will attend a single assessment session to evaluate physical capacity. They will also wear a physical activity monitor for a week following completing these tests to assess physical activity and aspects of physical performance. Participants will also be invited to return two months later to provide evidence about the repeatability of measurements.

Study 2) A parallel study comparing assessment of performance during six-minute walk tests by an observer to a semi-automated assessment using an activity monitor worn by the patient. This will involve a single visit and be carried out during walking tests carried out as part of routine clinical care.

Study 3) A qualitative study to investigate experiences and perceptions of participants of dance groups for people with chronic lung disease, as a novel form of physical activity. This will be used to inform the design of subsequent trials of dance interventions for chronic lung disease.

Eligibility Criteria:
Inclusion Criteria:

* Adults with stable chronic lung disease
* Able to understand instructions.
* Age and sex matched healthy controls.

Exclusion Criteria:

* For the main study, the presence of other comorbidities causing a significant reduction in mobility (for example stroke with neurological deficits, severe arthritis, significant peripheral neuropathy, significant visual impairment, dementia etc.).
* exacerbation of lung disease within the last 2 months.
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza Vaccine Administered to Elderly Subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Males and females volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry.
* Individuals able to comply with all the study requirements.
* Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
* Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

Key Exclusion Criteria:

* Individuals with any serious chronic or acute disease.
* Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination.
* Individuals with known or suspected impairment/alteration of immune function.
* Individuals with known or suspected history of drug or alcohol abuse.
* Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
* Individuals within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.
* Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
* Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
* Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
* Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines.
* Individuals who are part of study personnel or close family members conducting this study.
* BMI \> 35 kg/m2.
A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction

The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.

This is a non randomized (the study medication is not assigned by chance), open-label (all participants and study staff know the identity of the treatment), multi-center, prospective (looking forward using observations collected following participant enrollment), and non-comparative study in which participants with erectile dysfunction will be observed to evaluate the safety and effectiveness of mirodenafil for 12 weeks. Safety evaluations will include assessment of adverse events, and record of concomitant medications. The study will be conducted in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with erectile dysfunction
* Participants prescribed mirodenafil on demand

Exclusion Criteria:

- Participants who have administered mirodenafil for other than an approved indication
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection

This is a multi-centre, randomised, double blind, placebo controlled clinical study which is designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to severe hemoptysis.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years;
* Hemoptysis \>=100 mL within 24 hours;
* Bronchiectasis diagnosed by chest high resolution CT;
* Patient, family or guardian is willing to sign the informed consent form.

Exclusion Criteria:

* With severe hepatic or renal insufficiency, ALT\>3 ULN, creatinine clearance \<30 mL/min or serum creatinine ≥200 µmol/L or ≥2.5 mg/dL;
* Uncontrollable hypertension (SBP\>180mmHg or DBP\>110mmHg) or hypotension shock (SBP\<90 mmHg) at randomization;
* History of thrombosis, patients who have undergone thrombosis, or who have severe hematologic diseases;
* Patient with bleeding caused by DIC or vascular disease;
* Patient with coagulation dysfunction

  1. INR\>2
  2. Patient with abnormal coagulation function or other bleeding disease (including clinical congenital bleeding disorders, such as von Willebrand disease or acquired hemophilia; hemorrhagic disease; and significant unexplained hemorrhagic disease)
  3. Platelet count \<100×109 /L;
* known allergic to aspirin, clopidogrel, heparin, snake venom blood clotting enzyme, or any component in the study drug allergy or allergic constitution;
* Women who are pregnant or lactating and women of child-bearing agewho do not take reliable contraceptive measures;
* Patients who are or are planning to participate in other clinical trials during the study period;
* Within 72 hours before using the following products including Hemocoagulase For Injection (邦亭®), injection spearhead haemocoagulase (巴曲亭®), Haemocoagulase Agkistrodon for Injection (苏灵®), Hemocoagulase Atrox for Injection (立止血®), leaf pigment or other hemostatic agents;
* Life expectancy of less than 3 months;
* Any other patients who have been judged unfit to participate in this clinical study, including those who are unable or unwilling to comply with the protocol requirements;
* Patients who had participated in other clinical studies within three months prior to the study.
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.

The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and older
* Patients undergoing leadless pacemaker implant at UMass Chan Medical Center
* Subjects able to understand and provide written informed consent.

Exclusion Criteria:

* Patients who are pregnant
* Patents who are not able to ambulate prior to the procedure
* Other conditions that, in the opinion of the investigator constitute a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
* Prisoners or wards of the state.
Trial to Evaluate the Efficacy of the HLPFC Coil Deep Transcranial Magnetic Stimulation System in Treating Attention Deficit and Hyperactivity Disorder (ADHD) in Adults

The aim of the study is to investigate the efficacy of trans-cranial magnetic stimulation in treating attention deficit disorder in adults.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* ADD/ADHD

Exclusion Criteria:

* any DSM-IV psychiatric disorder except ADD/ADHD
* use of psychoactive medications
* Epilepsy
* brain injury
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution

A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use.

A pilot monocentric, open phase I study to investigate the efficacy and safety of a new oral gut cleansing solution NRL994 in patients submitted to colonoscopy.

The study was carried out as an open, uncontrolled investigation in a group of 36 in-patients scheduled for colonoscopy. Patients were enrolled one or two days prior to the endoscopic procedure. Gut cleansing started in the evening prior to the intervention when the first dose of LDBP was taken; bowel preparation was continued in the morning of the day of colonoscopy when the second dose was taken. A patient's participation in the study ended after completion of the endoscopic procedure.

A dose of NRL994 was diluted in 1000 mL of water and consisted of 100 g PEG 3350, 7.5 g sodium sulphate, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, 46 mmol sodium chloride, and 12.46 mmol potassium chloride. The product was flavoured with lemon flavour (2.015 g), anhydrous citric acid (1.565 g), and potassium acesulfame (0.35 g).

Each dose of one litre had to be swallowed within one hour, followed by 500 mL of additional clear fluid.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained prior to inclusion
* Male or female
* Inpatients 18 to 60 years old with indication for complete colonoscopy
* Willing and able to complete the entire procedure and to comply with study instructions
* Females of childbearing potential must employ an adequate method of contraception.

Exclusion Criteria:

* Ileus
* Intestinal obstruction or perforation.
* Toxic megacolon.
* History of any colonic surgery.
* Cardiac Insufficiency (NYHA grad III and IV).
* Ischemic cardio vascular disease.
* Renal insufficiency (creatinine above 1.4 mg/100 ml).
* Cirrhosis of liver (child B or C).
* Known hypersensitivity to polyethylene glycols and/or Vitamin C.
* Concurrent participation in an investigational drug study or participation within 30 days of study entry.
* Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
* Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
* Abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit
* Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmgH).
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis

The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Signed Consent of the patient;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* Decongestants dependent patients or patients receiving allergen specific immunotherapy;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs).
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer

To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2


Eligibility Criteria:
Inclusion Criteria:

* ECOG score 0-1
* ER\>10%, PR\>10%, HER2(0)/HER2(1+)/HER2(2+) and no amplification of FISH
* BRCA1/2 gene mutation
* No other site metastases were detected by imaging evaluation after surgical treatment
* Non-PCR breast cancer after neoadjuvant therapy, or breast cancer with postoperative pathology indicating ≥pN2
* The patient had no major organ dysfunction

Exclusion Criteria:

* Allergic to the investigational drug, inability to take the drug orally, or refusal of the medication regimen
* Has been enrolled in another study or has been discontinued for less than or equal to 4 weeks
* There is serious dysfunction of vital organs (heart, liver, kidney)
* Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years
* In other acute infectious disease or chronic infectious disease activity period
* A history of uncontrolled seizures, central nervous system disorders, or mental disorders
* There is a known history of human immunodeficiency virus