cyrilzakka/clinical-trials huggingface dataset:
This is a Phase 1 Study in Which Healthy Volunteers and Participants with Chronic HBV Infection Will Receive HT-101 or Placebo and Will Be Assessed for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity

Phase 1 Study of HT-101 in Healthy Subjects and Patients With Chronic Hepatitis B The trial consisted of two components. Part A involved a single ascending dose study where healthy participants were administered one dose of HT-101 or placebo subcutaneously (SC). Part B involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered two dose of HT-101 or placebo every 4 weeks subcutaneously (SC).


Eligibility Criteria:
Inclusion Criteria: Subjects were eligible for inclusion into the study if they met each of the following criteria:

Part A SAD: Healthy Participant

* Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg;
* Participants who promise having used effective contraception for at least 1 month before screening, and have no plans for pregnancy or donating sperm or eggs, and will voluntarily use effective physical means of contraception (including the partner) during the study and for 3 months after the end of the study;

Part B MAD: Patient with CHB

* Male subjects weighed ≥ 50.0 kg, female subjects weighed ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m\^2 (inclusive);
* Chronic HBV infection for \>/= 6 months;
* The quantitation level of HBsAg was \> 200 IU/mL and \< 5000 IU/mL; The quantitation level of HBV DNA \< 2×10\^4 IU/mL;
* Subjects promised to use effective contraception for at least 1 month before screening, and have no fertility, donate sperm or eggs and voluntarily take highly effective physical contraception (including partners) during the trial and within 3 months after the end of the trial;

Exclusion Criteria:Subjects were excluded from the study if one or more of the following criteria were applicable

* Participants with history of drug allergy or specific allergy;
* Participants who had psychiatric conditions or diseases in cardiovascular, respiratory, endocrine, kidney, liver, digestive tract, skin, immune, blood, nerve and other systems;
* Participants with history of active pathological bleeding, or bleeding tendency;
* Participants with abnormal results of physical examination, vital sign examination, ECG examination, laboratory test in the screening period which were judged as clinically significant by clinicians;
* Participants with significant liver fibrosis or cirrhosis;
* Participants with symptoms or a history of hepatic decompensation;
* Participants with a history or suspected risk of liver cancerr;
Magnesium Sulfate vs Placebo for Placental Abruption

To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.

We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.

Eligibility Criteria:
Inclusion Criteria:

- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.

Exclusion Criteria:

- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress
Effects of Ocular Electroacupuncture on Oculomotor Nerve Palsy

The purpose of the study is to testify the efficacy of treating oculomotor nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.

The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for oculomotor nerve palsy (ONP), through treating ONP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by oculomotor nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Eligibility Criteria:
Inclusion criteria;

1. patient with confirmed diagnosis of complete oculomotor nerve palsy (with or without mydriasis) made by neurologist or ophthalmologist;
2. patient in stable condition after treatment for primary disease;
3. age between 18 to 80 years old without gender limitation;
4. haven't received acupuncture intervention for ONP before;
5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.

Exclusion criteria:

1. those with other diagnosed medical conditions known to contribute to ONP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
3. those with serious medical conditions that might limit their participation;
4. those with eye or other location with serious infections;
5. women who had a positive pregnancy test or who were planning to become pregnant during the study period;
6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
7. who had participate in other clinical trials, which may affect the results.
The Effects of an Exercise Programme for Older Patients With Heart Failure

Patients with heart failure have decreased exercise tolerance, balance problems, and fall risks. The purpose of this research was to investigate the effect of an exercise program based on the Empowerment Model for participants with heart failure. This randomized, controlled study including pre-test/post-test and the measurements were performed between January-November 2014 at a university hospital in Izmir, Turkey. Intervention group (n = 11) and control group (n = 10) participated in the research. The intervention group received 45-60 minute individual training and 12 weeks of individual follow-up. The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated. Patients in the control group did not receive any intervention except for their routine treatment. Data were collected before the education of exercise and after 12 weeks; sociodemographic data questionnaire, pedometer, accelerometer, Berg Balance Scale, HF Empowerment Scale, estimated weekly exercise monitoring form and exercise booklet had been utilised. The SPSS statistical package program was used to analyze the data.

Patients with heart failure have decreased exercise tolerance, balance problems, and fall risks. The purpose of this research was to investigate the effect of an exercise program based on the Empowerment Model for participants with heart failure.

This randomized, controlled study including pre-test/post-test and the measurements were performed between January-November 2014 at a university hospital in Izmir, Turkey. Intervention group (n = 11) and control group (n = 10) participated in the research. The intervention group received 45-60 minute individual training and 12 weeks of individual follow-up. The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated. Patients in the control group did not receive any intervention except for their routine treatment. Data were collected before the education of exercise and after 12 weeks; sociodemographic data questionnaire, pedometer, accelerometer, Berg Balance Scale, HF Empowerment Scale, estimated weekly exercise monitoring form and exercise booklet had been utilised. The SPSS statistical package program was used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* were aged 60 years or older
* independent
* literate
* able to communicate verbally
* participating voluntarly in the study

Exclusion Criteria:

* were having a diagnosis of psychiatric illness
* a visual or auditory impairment
* previously participated in another exercise program
* any contraindication to exercise (uncontrolled arrhythmia, hypertension and metabolic illness, ejection fraction)
Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses

The aim of this study is to investigate the effects of a nature-centred integrative oncology day care unit programme ("outdoor concept") compared with an already established integrative oncology day care unit programme ("indoor concept").


Eligibility Criteria:
Inclusion Criteria:

- cancer diagnosis

Exclusion Criteria:

* cognitive impairment that would interfere with questionnaire replies or the intervention
* pregnancy or lactation
* known serious mental illness
* participation in another study
Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR

This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.

Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.

Eligibility Criteria:
Inclusion Criteria:

* Men, women at least 18 years old.
* Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.
* Patients:

  * with acute tracheitis,
  * acute tracheobronchitis,
  * acute bronchitis,
  * mild community-acquired pneumonia or
  * acute exacerbation of chronic bronchitis

Exclusion Criteria:

* Patients without previous administration of Klacid®SR and patients who used Klacid®SR less than 6 weeks ago or more than 24 months ago. The information about previous administration of Klacid®SR will be based on physician records or patients anamnesis.
* Patients with known hypersensitivity to macrolide antibiotics
* Patients with documented renal impairment (creatinine clearance under 30 ml/min).
* Patients with documented liver parenchyma impairment (AST, ALT and GMT \> 3x higher level in comparison with the norm)
* Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine
* Pregnancy
* Breast feeding
Enhancing Cancer Care Of Rural Dwellers

Through a multi-level remote intervention, the Vanderbilt-Ingram Cancer Center (VICC) seeks to improve comprehensive cancer care delivery to patients residing in rural communities with persistent poverty. We plan to do this by using telehealth to broaden the reach of our NCI-designated comprehensive cancer center in these communities

Objectives:

* Evaluate the clinical effectiveness of a multi-level telehealth-based intervention for rural hospitals consisting of provider access to tumor board expertise that incorporates disease, patient and molecular tumor characteristics, together with patient access to a supportive care intervention to improve cancer care delivery.
* Evaluate the facilitators and barriers to future larger-scale dissemination and implementation of the multi-level intervention, designed to enhance quality rural cancer care delivery.

Eligibility Criteria:
Inclusion Criteria:

Provider and Patient:

- At least 21 years of age or older and English speaking with the ability to provide informed consent

* Oncology providers within designated VHAN oncology practices
* Newly diagnosed or relapsed cancer patients of aforementioned oncology providers
We Compared the Covid-19 Acute Respiratory Distress Syndrome (ARDS) Patients Who Applied Prone Positioning for16-24 Hours vs 24-48 Hours

The goal of this study is to understand if there is any improvement on oxygenation of patients diagnosed with Covid-19 ARDS patients when we extend the duration of prone positioning.

Second outcome of the study is to investigate mortality of patients when we extend the duration of prone positioning.


Eligibility Criteria:
Inclusion Criteria:

COVİD 19 ARDS patients patients who have been intubated for 48 hours and more

Exclusion Criteria:

Pediatric patients Patients who extubated in less than 48 hours Patients with Lung and pleural malignancies
Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)

The purpose of this study is to determine if certain findings (blood tests, symptom improvement, etc.) after acute heart failure treatment can identify a group of patients who are safe for early hospital discharge.

A fundamental question faced by physicians treating acute decompensated heart failure (ADHF) is "When has treatment worked sufficiently for safe discharge, and who requires further treatment?" Patients with ADHF have a high incidence of morbidity and mortality. Current guidelines for emergency department (ED) and hospital disposition of patients with ADHF are based on limited empirical evidence. This creates clinical uncertainty regarding disposition leads to prolonged hospitalizations, higher costs and increased resource consumption. The specific aim of the study is to develop a prediction rule from readily available clinical data to help physicians identify ADHF patients eligible for safe and early discharge from the ED and hospital after treatment is initiated.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the modified Framingham criteria
* Have baseline data available within 1 hour of initial ED therapy
* Have previously documented systolic dysfunction (ejection fraction less than 50%) by echocardiogram
* Willing and able to give informed consent

The exclusion criteria are:

* Patients less than 18 years of age.
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.


Eligibility Criteria:
Inclusion Criteria:

* Be male aged 45 or older.
* Sign an informed consent form.
* Be in good health.
* Received NX-1207 in a previous completed study or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.
* Have Prostate Gland Volume ≥ 25 mL (25 g).

Exclusion Criteria:

* Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection
* Post-void residual urine volume \> 200 mL
* Presence of a symptomatic median lobe of the prostate
* History of use of self-catheterization for urinary retention.
* Urinary retention in the previous 12 months.
* Prostatitis
* Urinary tract infection more than once in the past 12 months
* Prostate or bladder cancer.
* PSA ≥10 ng/mL
* Poorly controlled diabetes
* History or evidence of illness or condition that may interfere with study or endanger subject
* Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days
* Use of specific prescribed medications that may interfere with study or endanger subject
Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers

The rationale for this study is to investigate the absorption, metabolism and excretion of \[14C\]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any metabolites, if possible, of \[14C\]PF 02341066 in humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter

The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA \[pVGI.1(VEGF2)\] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.


Eligibility Criteria:
Inclusion Criteria:

* Are willing and able to give informed consent
* Have CCS class III or IV angina refractory to optimized medical therapy
* Experience signs or symptoms of angina during the exercise tolerance test (ETT)
* Have identified area(s) of reversible ischemic myocardium
* Have procedurally acceptable targeted treatment zones

Exclusion Criteria:

* Have exercise-limited non-cardiac chest discomfort
* Unwilling or unable to undergo exercise testing
* Able to exercise greater than 6 minutes on the treadmill
* Are candidates for conventional revascularization procedures
* Are or have been enrolled within 30 days, in another experimental study
* Have had the most recent angiogram more than 6 Months prior to screening
* Previously received an investigational angiogenic agent
* Have another disease severe enough to limit exercise test or place patient at risk
* Have uncontrolled: atrial fibrillation, atrial flutter, and/or significant arrhythmias
* Have evidence of left ventricular aneurysm or ventricular thrombus
* Are unwilling or unable to undergo cardiac catheterization or nuclear testing procedures
* Have had a Q-wave MI, within 60 days
* Have severe aortic valve stenosis or have a mechanical aortic or mitral valve
* Have unstable angina or an acute non-Q-wave myocardial infarction within 14 days
* Have had a documented stroke or transient ischemic attack within 60 days
* Are pacemaker dependent
* Have a recent history of active diabetic retinopathy or age-related wet macular degeneration
* Have a history of cancer within the last 5 yrs. or have current evidence of a malignant neoplasm
* Have a history of alcohol or drug abuse within 90 days
* Are pregnant or lactating
* Have reproductive potential and are unwilling to use condoms for contraception for 1 year after treatment - both male and female
* Are unable to return to the clinic for the scheduled follow-up appointments
* Are taking medications which may produce an undue risk
* Have areas of LV wall less than 6mm thick
Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery

Animal studies have shown that preconditioning with hyperbaric oxygen can induce central nervous system and heart ischemic tolerance. This study was designed to determine the protective effect of hyperbaric oxygen preconditioning on brain and myocardium ischemia-reperfusion injury during coronary artery bypass graft surgery.

60 patients scheduled to undergo coronary revascularization were recruited for this trial. Exclusion criteria included Emergency operation, age older than 80 years, learning difficulty, previous cerebrovascular disease, visual or hearing impairment, history of pneumothorax, Claustrophobia, middle ear disease, EF \< 35%. Patients were randomized either to the control group or hyperbaric oxygen group. The laboratory analysis of markers included S100B, NSE and troponin I. The assessment of cognitive dysfunction was performed 5 days before surgery and 7 days after surgery and haemodynamic measurements, length of stay in ICU, length of stay in hospital post-operation were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo coronary revascularization surgery.

Exclusion Criteria:

* Emergency operation
* Age older than 80 years
* Learning difficulty
* Previous cerebrovascular disease
* Visual or hearing impairment
* History of pneumothorax, claustrophobia, middle ear disease, EF \< 35%
Guatemala Internal Medicine Physicians' Knowledge of Non-communicable Disease Clinical Preventive Services

A national cross-sectional survey was conducted to evaluate recommendations on clinical preventive services and additional information on non-communicable disease prevention. Trained surveyors interviewed interns, residents and attendings of the Internal Medicine departments of all teaching hospitals in Guatemala. Analysis compared recommendation practices within and between hospitals.

A voluntary, anonymous, self-completed, cross-sectional survey was administered to all available internal medicine staff in Guatemalan teaching hospitals.

The questionnaire included: physician's demographics, work time dedicated to outpatients, knowledge of leading causes of death in Guatemala, guidelines used for non-communicable disease prevention, simulated cases asking for recommendation(s) on different preventive services for asymptomatic adults (i.e. whether they recommended them or not, appropriate frequency and starting age, preferred screening method, and availability of the service(s) at their hospital). The survey also assessed barriers faced in providing adequate services, and opinions on who should implement changes in national health care and in medical education.

The answers given by the internal medicine staff were compared with the United States Preventive Services Task Forces (USPSTF) Recommendations and Guatemalan Ministry of Health Guidelines.

Analysis compared recommendation practices within and between hospitals.

Eligibility Criteria:
Inclusion Criteria:

* All interns, internal medicine residents and attendings (including department director, unit directors and regular attendings) that are currently training or working in an Internal Medicine department in any of the ten teaching hospitals in Guatemala.

Exclusion Criteria:

* Staff that is on vacations, on sick leave or suspended by any reason.