cyrilzakka/clinical-trials huggingface dataset:
Cough Count Validation

People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.

Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.

The assessment of coughing is currently subjective and based on the symptoms qualitative description as expressed by the patient or parent. Quantitative and objective methods for cough assessment are not available beyond the investigative laboratory and are unique to the specific investigator.

Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways . While the cough reflex is essential in protecting the lung from foreign materials and infection, its excessive or chronic presence is both bothersome and might interfere with the quality of life, sleep pattern and exercise tolerance of the patient. Such a symptom may potentially be indicative of an on-going pathological process , .

People with respiratory infection, asthmatic patients and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.

Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.

The assessment of coughing is currently subjective and based on the symptoms qualitative description as expressed by the patient or parent. Quantitative and objective methods for cough assessment are not available beyond the investigative laboratory and are unique to the specific investigator.

The primary objective of the study is to evaluate the efficacy and validity of novel cough counting device based on the WIM Technology.

The PulmoTrack™ technology includes the PulmoTrack™ 3010/5050 devices that are intended for the analysis, interpretation and recording of lung sounds, and the Automatic Cough Counting Application.

The recording of the lung sounds will be performed by a PulmoTrack™ 3010/5050 device. The lung sounds can subsequently be analyzed for the presence of wheezes and for the presence of cough by the Automatic Cough Counting Application (ACCA).

The technology enables accurate cough count and timing as well as wheeze detection over time.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-80 years.
* Patients with significant chronic cough.
* Patients in hemodynamic stability. Patient is not in respiratory distress.
* Subject or subject's parents/guardians is able to comprehend and give informed consent for participation in the study.

Exclusion Criteria:

* Contraindication to the use of the PulmoTrack™ or performing ARM (Acoustic Respiratory Monitoring).
* Hemodynamic instability and/or SOB.
* Concurrent additional major illness.
* Concurrent participation in any other study.
* Physician objection
Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain

This study is to compare the efficacy of exercises based on the lumbar extension and flexion on the pain relief and the prevention of pain recurrence in chronic low back pain patients.

68 people that meet the inclusion criteria on screening test are assigned to one of two groups by randomization. Each of the group learns one of the exercises based on the lumbar extension or flexion for four weeks. The main outcome variables are measured and compared respectively in baseline, immediately after the education, 3, 6, 12 months after the enrollment. Finally lumbar extension exercise is verified whether it is more effective than the lumbar flexion exercise on the pain relief and the prevention of pain recurrence in chronic low back pain patients.

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain (\>6 months, VAS score of 5 or above)
* presence of discogenic or axial pain
* duration of \>6 months

Exclusion Criteria:

* Spondylolisthesis or retrolisthesis on radiograph
* Hx of spine surgery
* Hx of any spine intervention within 3 months
* other neurological, inflammatory, or poor medical conditions
* who cannot understand or conduct the protocol of the study
Expanding Antimicrobial Stewardship

Gold standard diagnostic criteria for diagnosing acute infection in older adult patients in the Emergency Department do not currently exist. These patients often have atypical presentations which can complicate diagnosis and treatment. The development of an antimicrobial stewardship program for Emergency Department older adult patients can ultimately improve the accuracy of diagnosis and correct antimicrobial prescribing. This research study involves data collection from enrolled subjects and treating physicians. The data will be collected using a patient interview which will be answered directly by the patient or caregiver. Additional surveys will be administered to the Emergency Department treating physician and subsequent physician. Additional data will be abstracted from the Emergency Department chart and from additional charts that often accompanies the patient to the Emergency Department. A physician adjudication process will occur if there is disagreement in diagnosis between the treating Emergency Department physician and succeeding physician.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age

Exclusion Criteria:

* Patient incarcerated
* Chief complaint of suicidal or homicidal ideation
* Patient primarily evaluated by the trauma team
Comparison of 5% Nacl and 10% NaHCO3 As Contrast Agents for Lung Perfusion with EIT

Electrical impedance tomography (EIT) has enabled the bedside monitoring of lung perfusion measurement through the indicator-based contrast method. Currently, hypertonic sodium chloride is the most commonly used contrast agent for lung perfusion evaluation by EIT. However, concerns may be raised regarding the potential risks of hyperchloremia and possible acute kidney injury associated with the use of hypertonic NaCl. Recently, two experimental studies found sodium bicarbonate (NaHCO3) might be an alternative to hypertonic sodium chloride in lung perfusion assessment by EIT. However, whether NaHCO3 results in acceptable bias is unknown in critically ill patients. This clinical study aimed to further investigate the correlation and agreement of lung perfusion and Ventilation/perfusion (V/Q) match by EIT contrast method between two contrast indicators (5%NaHCO3 vs. 10% NaCl) in critically ill patients with respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* In need of lung perfusion assessment due to clinical condition
* With central venous catheter

Exclusion Criteria:

* contraindications to the use of EIT (automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implantable pumps, etc.)
* severe hyperchloremia (\>155 mmol/L)
* unable to tolerate breath-hold maneuver
* pregnant or breastfeeding females
A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants

The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.

A total of approximately 300 infants 2 months of age (over 60 days old and less than 90 days old) will be enrolled and randomized in 1:1 ratio into the study group and control group, with 150 participants in each group.The study group will receive study sIPV developed by Biominhai and control group will receive wIPV developed by SANOFI PASTEUR S.A. The "2+1 sequential" procedure consists of 2 doses of inactivated vaccine (sIPV or wIPV) and 1 dose of bOPV, a total of 3 doses, with 1 month between each vaccination. This study has indicated that the sIPV is not inferior to the wIPV in terms of immunogenicity and safety according to the "2+1 sequential" immunization program in 2-month-old healthy infants.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy permanent residents aged 2 months (over 60 days and less than 90 days);
2. Infant's legal guardians agree to sign the informed consent forms voluntarily;
3. Infant's legal guardians are able to comply with the requirements of the clinical trial protocol;
4. Armpit temperature ≤ 37.0 ℃

Exclusion Criteria:

1. Preterm birth (delivery before the 37th week of pregnancy).
2. Previous vaccination against polio.
3. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
4. History of polio.
5. History or family history of convulsions, seizures, encephalopathy, and neurological disorder.
6. History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the investigational vaccine.
7. Individuals with immunodeficiency or receiving immunosuppression therapy.
8. Disturbance of coagulation diagnosed by doctor (e.g., coagulation factors deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder.
9. Known or suspected concomitant diseases include: respiratory disease, acute infection or active chronic disease, cardiovascular disease, liver and kidney disease, skin disease, mother with HIV infection.
10. Administration of blood or blood-related products or immunoglobulins (hepatitis B immunoglobulins is acceptable).
11. History of administration of live attenuated vaccines within 14 days.
12. History of administration of subunit or inactivated vaccines within 7 days.
13. Individuals with any acute diseases within 7 days, receiving antibiotics or antiviral therapy.
14. Fever within 3 days (Armpit temperature ≥38.0 ℃).
15. Use of any investigational product recently, or have any conditions that the investigator believes may affect the evaluation of the trial.
SARS-CoV-2 Disguise Study

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a pandemic disease with worldwide spreading. Limited data are existed regarding SARS-CoV-2 positive carriers among asymptomatic medical employees in non-profile infectious clinic, e.g. cardiovascular clinic, routinely working in the pandemic region with two million inhabitants. The aim is to test the percentage and increase of the SARS-CoV-2 positive carriers among asymptomatic medical employees in high-volume cardiovascular center in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic medical employees of E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
* Filled questionnaire before SARS-CoV-2 testing
* Nasopharyngeal and oropharyngeal testing for SARS-CoV-2
* Signed informed consent

Exclusion Criteria:

* Unwilling to participate
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan

The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).

Study Design: Multicenter, randomized, double-blind, placebo-controlled

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years.
* Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization.

The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (\>1+); or c) dyspnea.

* NYHA Class III or IV at the time of hospitalization.
* Left Ventricular Ejection Fraction \< = 40% within one year.

Exclusion Criteria

* Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form.
* Positive urine pregnancy test.
* Inability to provide written informed consent.
* Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions.
* Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment.
* Subjects who are on cardiac mechanical support.
* History of bi-ventricular pacer placement within the last 60 days.
* Co-morbid condition with an expected survival less than six months.
* Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization.
* History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
* History of a cerebrovascular accident within the last 30 days.
* Hemodynamically significant uncorrected primary cardiac valvular disease.
* Hypertrophic cardiomyopathy (obstructive or non-obstructive).
* CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
* Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes.
* History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
* History of poorly controlled diabetes mellitus.
* Morbid obesity, defined as \> 159 kg (or 350 lbs) or BMI \> 40.
* Supine systolic arterial blood pressure \< 90 mmHg.
* Serum creatinine \> 3.5 mg/dL or \> 309.4 mmol/L.
* Serum potassium \> 5.5 mEq/L or \> 5.5 mmol/L.
* Hemoglobin \< 9 g/dL or \< 90 g/L.
* History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril).
* History of drug or medication abuse within the past year, or current alcohol abuse.
* Inability to take oral medications.
* Participation in another clinical drug or device trial within the past 30 days.
* Previous participation in this or any other tolvaptan clinical trial.
Gemcitabine/Cisplatin Versus Gemcitabine/Epirubicin for Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy of gemcitabine/cisplatin versus gemcitabine/epirubicin in Stage IIIB/IV NSCLC in terms of response rate and overall survival.

Most patients suffered from nausea, vomiting and prolonged anorexia after cisplatin treatment. Epirubicin is an anthracycline that was used widely in the treatment of cancer. Our previous study of an epirubicin and paclitaxel combination in non-small cell lung cancer patients showed a response rate of 52.6% and good median survival. However, most patients suffered from paclitaxel-related neurotoxicity.

Chemotherapy may increase an average of 1 to 2 months of median survival in inoperable non-small cell lung cancer patients treated with chemotherapy. However, chemotherapy may not provide a cure for these patients. Reduction of side effects and enhancement of life quality of the patients are as important as life prolongation for these patients. We designed a combination chemotherapy using gemcitabine with epirubicin in the treatment of inoperable non-small cell lung cancer. The treatment will be compared to gemcitabine and cisplatin combination.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of stage IIIB/IV NSCLC
* No prior chemotherapy
* Age \> 18 years
* ECOG score \< 0 to 2
* Bi-dimensionally measurable lesions
* WBC \> 4,000/ml, ANC \> 1,500/ml, platelets\>100,000/ml
* Hb\>10g/dl.
* ALT/AST \< 5 times x UNL, bilirubin \< 1.5times x UNL, creatinine \< 1.25 times x UNL, normal calcium level
* Life expectancy \> 12 weeks

Exclusion Criteria:

* CNS metastases, Concomitant myelosuppressive radiotherapy, C/T, hormonal therapy or immunotherapy.
* Active congestive heart failure, angina and/or arrhythmia requiring therapy or previous myocardial infarction
Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.


Eligibility Criteria:
Inclusion Criteria:

* Participant weighs ≥ 40 kg (88 lb)
* Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening.

Exclusion Criteria:

* Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
* Participant has received pharmacologic therapy to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
* Participant uses clean intermittent catheterization (CIC) or indwelling catheter to manage urinary incontinence
* Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of Day 1
* Participant has had previous or current botulinum toxin therapy of any serotype for any urological condition
* Participant has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of Day 1
* Participant has been immunized for any botulinum toxin serotype
* Participant has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
* Participant has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
* Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy
* Participant is male with previous or current diagnosis of prostate cancer
* Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs
* Participant has current or previous uninvestigated hematuria
* Participant has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis
* Participant cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Day 1
* Participant has a known allergy or sensitivity to any botulinum toxin preparation
* Participant has any medical condition that may put him/her at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Participant has current swallowing or breathing difficulties.
Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)

The purpose of this research study is to enhance inclusion and diversity in clinical trial enrollment by training participants to perform and provide feedback through a community-based protocol review process, called DIVERSE.

This research study aims to pilot a protocol review process, called DIVERSE, assessing its feasibility, acceptability, and preliminary efficacy to enhance inclusion and diversity in clinical trial enrollment. Patients and community participants will complete specialized training and provide feedback on clinical trials in development through the DIVERSE process; they will also provide feedback on the process itself. Investigator participants will request review and provide feedback on the DIVERSE process. The study is based on community-based participatory research.

Participation in this research is expected to last about 18 months. It is expected that about 20 patient and community participants and 20 investigators will participate in this research study. The National Cancer Institute and American Society of Clinical Oncology are providing funding for this research study.

Eligibility Criteria:
CAB Participant Inclusion Criteria:

* Age 18 or older
* English speaking
* Ability to understand and willingness to provide oral consent
* DFCI patient who are in remission from a blood cancer \>1 year will be preferred.

CAB Participant Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers \<18 years old)
* Prisoners.
* Unwilling/unable to agree to maintaining the confidentiality of reviews and clinical trial materials, as outlined in Section 9.1
* Note 1: Patients and non-patient community members who are pregnant are eligible. This is a non-interventional study that meets the definition of minimal risk and poses no greater risk to pregnant individuals or fetuses. Pregnancy status will not be assessed.
* Note 2: English fluency is necessary as protocols being reviewed are written in English and cannot be feasibly translated to other languages within the time period necessary to complete timely reviews.

Investigator Participant Inclusion Criteria:

* Age 18 older
* English Speaking
* Site or Principal investigator
* Not a member of the research team
Radiofrequency Ablation Plus Radiotherapy for Small Hepatocellular Carcinoma

Radiofrequency ablation (RFA) and hepatic resection are main treatments for early stage hepatocellular carcinoma. Many randomized controlled trials found these two treatments have similar short term overall survival. However, hepatic resection is associated with higher long-term overall survival. These results reveal that tumor recurrence rate after RFA is higher than that after hepatic resection. And minimal residual tumor may exist after RFA. Radiotherapy after RFA may be effective to prevent early tumor recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnoses of hepatocellular carcinoma based on EASL.
2. Tumors, either single, \>2 and \< 5 cm in size or no more than 3 for size \< 3 cm.
3. Patients must have a performance status of ECOG score \< 2.
4. Patients must have adequate liver reservation and adequate hemogram.

   * Pugh-Child's Score \< 7.
   * The serum total bilirubin level are \< 2 mg/dl.
   * The prothrombin times are \< 3 sec above normal control.
   * The platelet are \> 75 x 109/L.
5. Patient must have serum creatinine \< 1.5 mg/dl
6. Cardiac function with NYHA classification \< Grade II
7. HBsAg (+) .
8. Signed informed consent.

Exclusion Criteria:

1. HCCs with radiological evidence of macrovascular invasion or extrehepatic metastasis are not eligible.
2. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible.
3. Patients with advanced second primary malignancy are not eligible.
4. Patients with pregnancy or breast-feeding are not eligible.
5. Patients with severe cardiopulmonary diseases are not eligible.
6. Patients with clinically significant psychiatric disorder are not eligible.
7. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible.
8. Patients who had prior antitumor therapy for HCC are not eligible.
9. Anti-HCV positive patients are not eligible.