cyrilzakka/clinical-trials huggingface dataset:
Treatment for Patients With Osteoarthritis (OA)

The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index \[WOMAC\] pain score) of AMG 108 (300 mg subcutaneously \[SC\] every 4 weeks) in subjects with OA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria
* Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
* If currently taking any over the counter nutritional supplements, must be on stable doses for greater than 2 months prior to screening
* If utilizing physical therapy, biomechanical devices or orthotic support, must have been using treatment or device for greater than or equal to 2 months prior to screening
* If currently or previously taking any non-prescribed supplement (e.g., glucosamine or chondroitin sulphate, shark cartilage, diacerein, soya extract, etc.) must be on stable doses for at least 2 months prior to screening
* If currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), must be on stable doses for at least 2 months prior to screening
* Able to discontinue NSAIDs at least 5 half-lives (approximately 3 days) prior to Day 1
* Radiographic evidence of tibio-femoral compartment knee OA within 12 months of screening
* Signed written informed consent

Exclusion Criteria:

* Malignancy within the previous 5 years, except for basal cell or in situ cancer
* Significant hematologic disease - Active infection or history of recurrent or chronic infections
* Known diagnosis of HIV, hepatitis B, or hepatitis C infection
* Uncontrolled diabetes or cardiovascular disease and hypertension
* Inflammatory arthropathy including secondary OA
* Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement are not exclusions)
* End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4)
* OA of the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 10\^9/L and/or platelet count less than 100 x 10\^9/L observed within 1 month preceding screening
* Prior intra-articular (IA) injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with SC anakinra
* Concurrent or recent (less than or equal to 1 month) use of experimental therapy
* Prior IA corticosteroid injection within 1 month of study
* Prior viscosupplement therapy within 3 months of study
* Contraindication(s) to IA injections
* Subjects who are pregnant or breast-feeding, or plan to become pregnant during the study
* Subject is not using adequate contraception
* Known allergy to E coli-derived products
* Unable to understand informed consent
* Concerns regarding subject's compliance with the protocol procedures
* Subject will not be available for follow-up assessment
* Active substance abuse
Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

The objective of this single center prospective clinical trial is to evaluate the safety and efficacy of carotid Baroreflex Activation Therapy (BAT) in advanced heart failure (HFrEF). Beyond that, the primary aim of this study is to identify patients of the whole HFrEF population that are most likely to benefit from this new promising therapy.

Baroreflex activation therapy (BAT) is a new treatment option for patients (pts) suffering from heart failure with reduced left ventricular ejection fraction (HFrEF) to improve functional status and quality of life. Yet it is unknown which pts of the whole HFrEF population are most likely to benefit from this new promising therapy. As this invasive technique should definitely not be proposed for all HFrEF pts with left ventricular ejection fraction of 35 % or less the aim of this single center prospective clinical trial is to evaluate to which extent possible factors (e.g. cardiac resynchronization therapy (CRT), atrial fibrillation) may influence the response to BAT. To analyze any possible differences concerning the modulation of the autonomic nervous system caused by BAT in the presence of atrial fibrillation or cardiac resynchronization therapy, heart rate variability (HRV) analyses will be performed additionally. As autonomic nervous activity plays a pivotal role in the genesis and termination of atrial fibrillation any possible impact of baroreflex activation therapy on atrial fibrillation will be examined.

Eligibility Criteria:
Inclusion Criteria:

* chronic heart failure (NYHA functional class III)
* LVEF of 35% or less
* chronic stable Guideline-directed medical therapy (diuretic agent, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and a beta blocker, if tolerated)
* resting heart rate between 60 and 100 beats/min
* systolic blood pressure of at least 100 mmHg

Exclusion Criteria:

* estimated glomerular filtration rate \< 30 ml/min/1.73 m²
* Plaque and atherosclerosis reducing the linear diameter of the internal or distal common carotid arteries by 50% or more
* acute pulmonary edema within the last six weeks
* implantation of Pacemakers, ICDs or CRTs within the last 3 months or planned for the next three months
* life expectancy \< 1 year
* body mass index \> 40 kg/m²
* symptomatic uncontrolled bradyarrhythmias
* severe asthma, chronic obstructive pulmonary disease or restrictive lung disease
* active malignancy
* pregnancy
Permanent Pacing for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.

The present trial is undertaken as a pilot study on selected patients, to evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of Obstructive Hypertrophic Cardiomyopathy (OHCM) to pacing, in terms of reduction of Left Ventricular Outflow Tract (LVOT) pressure gradient and functional capacity improvement.

The Primary Objective is to demonstrate a long-term reduction in LVOT obstruction at rest and/or after Valsalva/Exercise \> 30% in patients responding to acute stimulation test


Eligibility Criteria:
Inclusion Criteria:

* unequivocal diagnosis of HCM, on the basis of 2-dimensional echocardiographic demonstration of a hypertrophied (wall thickness \>15 mm or \> 13 mm in familial HOCM) and non dilated LV in the absence of another cardiac or systemic disease capable of producing the same magnitude of hypertrophy;
* patients in whom coronary disease has been excluded;
* presence of severe refractory symptoms (NYHA class II-IV), as evidenced by moderate-to-severe functional disability resulting from exertional dyspnea or chest pain sufficient to support a desire for alternative treatment modalities, following administration (in standard dosages) of beta-blocker and either disopyramide or verapamil, independently or in association;
* peak instantaneous LV outflow tract gradient \> 50 mm Hg (resting or provoked), estimated by continuous wave Doppler;

Exclusion Criteria:

* end-stage phase of HCM (unless CRT therapy is considered);
* ejection fraction \<50% (unless CRT therapy is considered);
* severe mitral valve disease (+++) not related to systolic anterior movement and/or papillary muscle abnormalities;
* age below 18 years.
Validation of the Quality of Recovery Questionnaire for the Postanesthesia Care Unit (QoR-PACU)

Quality of recovery after surgery and anesthesia is an important endpoint in perioperative medicine. Several questionnaires have been developed that assess the patient's perception on postoperative recovery at 24 h after surgery. This study aims to adapt validate the Quality of Recovery 15-questionnaire for application in the postanesthesia care unit.


Eligibility Criteria:
Inclusion Criteria:

* elective non-cardiac surgery
* general anesthesia
* fluency in German

Exclusion Criteria:

* postoperative intensive care unit stay
Exercise and Systemic Lupus Erythematosus

The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 7 and 40 years
* SLEDAI ≤ 4

Exclusion Criteria:

* Cardiovascular dysfunction
* Rhythm and conduction disorders
* Musculoskeletal disturbances
* Kidney and pulmonary involvements
* Peripheral neuropathy
* Use of tobacco
* Treatment with lipid-lowering or hypoglycemic drugs
* Fibromyalgia
* Use of chronotropic or antihypertensive drugs
* Physically active subjects
Non-Invasive CVP Method to Standard CVP Method

This is a prospective, comparative, internally controlled device study that will enroll a total of 100 adult patients that require the placement of central venous catheter and CVP monitoring to assess volume status and cardiac preload.

Standard CVP Method

The CVP line is inserted into the internal jugular vein central venous catheter or subclavian vein catheter and threaded to the point where the superior vena cava meets the inferior vena cava prior to entry into the right atrium of the heart. The catheter is hooked to a pressure bag which is pressurized to 200 cm water. This pressure allows the infusion of about 3ml of fluid each hour but keeps the line patent. The distal tip of the CVP line is connected to a transducer and taped to the arm at a level which is in line with the heart.

Research Procedure (non-invasive CVP Method)

A physiologic data acquisition system (Zoe Medical, Topsfield MA)) will be used to monitor CVP, upper arm impedance changes, and upper arm cuff pressures.

The subject's CVP pressure transducer will be zeroed at the level of the right atrium (midaxillary line) with the use of a carpenter's level.

A tetra-polar impedance configuration will be used to measure upper arm impedance. A pair of current-injecting electrodes will be placed in positions 1 \& 4 and two sensing electrodes will be placed in positions 2 \& 3 (where a traditional blood pressure cuff would be positioned, overlying the brachial-axillary vein system). These leads extend from the Zoe Medical device. (Figure 1 taken from Ward et al., in press).

Electrobioimpedance will be measured in the upper portion of an upper extremity using an electrobioimpedance amplifier contained within the Zoe Medical device. A constant current source (1mA, 100kHz) will be sent through the current electrode and the voltage drop between the two sensing electrodes will be amplified.

A blood pressure cuff attached to the Zoe Medical Device will be positioned over the two sensing electrodes.

The cuff pressure will be quickly inflated to a value higher than CVP but lower than the diastolic arterial pressure (40 mm Hg) and kept at that pressure for 45-60 seconds.

At the end of the inflation hold period, release the cuff pressure valve and open to atmosphere to allow rapid self-deflation

Repeat measures 3 times in each subject for a period of 10 minutes

If the subject requires volume resuscitation, diuresis, or are administered inotropic drugs, we will reevaluate CVP with the non-invasive method during these circumstances. CVP will be measured every 1 minute to capture rapid changes in CVP. The length of time that the investigators monitor CVP will depend on the length of time required to detect changes in CVP.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Require CVP monitoring in the supine position as part of routine care
* Central venous access obtained by either internal or external jugular, or subclavian vein

Exclusion Criteria:

* Patients aged \< 18 years
* Patients who are pregnant
* Patients that will be in the prone position
* Central venous access obtained by the femoral vein
App-Based Optimization of Long-Term CPAP Adherence and Quality of Life

The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence.


Eligibility Criteria:
Inclusion Criteria:

* In both trials of Aim 2, twenty adults (≥18 years) per trial will be recruited who are newly diagnosed with OSA and speak English.
* In both trials, we will purposely recruit samples balanced by biological sex and OSA severity (apnea hypopnea index: 5-14 vs. ≥ 15).
* Inclusion Criteria are the same for both Aim 2 trials; Adult patients from MCCSM sites who:

  * Are diagnosed with OSA based on clinical diagnostic testing via laboratory or home-based sleep study;
  * Own and have the functional and cognitive ability to use an Apple (iOS9 or higher) or Android (4.2 or higher) smartphone with minimal to no assistance;
  * Are prescribed continuous or auto-titrated CPAP;
  * Agree to using a smartphone application and wearable wrist sensor; and
  * Speak and read English.

Exclusion Criteria:

* Unwilling to complete study measures and engage with SleepWell24;
* Refuse to not use the Fitbit application during the study trial;
* Have any conditions that would impede full participation (e.g., communication or cognitive impairments that limit ability to read and/or follow directions, other acute or severe health, cognitive, or psychological conditions);
* Currently participating in other lifestyle programs (e.g. active, formal weight loss program or research study; smoking cessation program, etc.);
* Decide to use a different PAP device than ResMed Airsense 10;
* Prescribed high-dose benzodiazepines (equivalent to \> 1 mg lorazapam/night);
* Daily opioid medication use at night;'
* Unwilling to discontinue use of any current wearable sensor for the duration of the trial;
* Previous documented history of treatment/referral for claustrophobia;
* Previous CPAP use;
* Currently engaging in shiftwork defined as night shift or rotating day and night shifts; and
* Currently pregnant, trying to conceive, or breastfeeding.
Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy

A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Male subjects and female subjects aged ≥18 years
* Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy
* A body mass index ranging from 18 to 45 kg/m2

Exclusion Criteria:

* Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
* Unstable or uncontrolled diabetes
* Clinically significant 12-lead ECG abnormalities
rTMS for the Treatment of Primary Progressive Aphasia: A Randomized Controlled Trial

The primary progressive aphasia (PPA) is a neurodegenerative condition characterized by a gradual, irreversible decline of language function (Mesulam, 2001). There are no known treatments for PPA so far. The relentless progression of PPA symptoms eventually leads to a profound impairment in communication ability and, ultimately, to more generalized deficits of cognition. Some cases and small studies reported that Transcranial Magnetic Stimulation (TMS), one of the non-invasive neuromodulation tech, can be employed to facilitate language production and improve the language ability in patients with PPA. Herein we will explore the tolerance and efficacy of TMS for the treatment of PPA by the randomized controlled trial .Meanwhile the functional MRI tech will be used to investigate the neural network changing in the procedure


Eligibility Criteria:
Inclusion Criteria:

All participants had also been evaluated previously by a behavioral neurologist at the Peking Union Medical College Hospital and had been clinically diagnosed with a variant of PPA.

Exclusion Criteria:

1. Scored below 15 on the mini-mental state exam (MMSE) due to concerns that global cognitive impairment might preclude their ability to follow the directions and interfere with task performance.
2. Had a history of seizures or unexplained loss of consciousness, pregnancy, surgical breach of the skull, or any other medical or surgical contraindication to receiving noninvasive brain stimulation.
3. Is unable to complete the treatment and evaluations
Emergency Ultrasound of the Gallbladder

The purpose of this study is to determine whether fasting for 8 hours prior to ultrasonography for cholelithiasis (gallbladder pain) is needed.

Ultrasonography of the gallbladder is currently the diagnostic modality of choice in determining cholelithiasis and cholecystitis. Historically this test has been performed in the Radiology suites where the patient was expected to fast for times of six to ten hours. Patients presenting to emergency departments (ED) have also been required to wait to have their study performed in order to have better visualization of the gallbladder. However, few studies have examined whether a fasting time matters in determining gallbladder pathology. Furthermore, with the emphasis on through-times in the ED, most EDs cannot afford holding their patients in the ED to wait for a test. Finally, with the advent of emergency bedside ultrasonography and the greater level of comfort emergency physicians (EP) have in diagnosing gallbladder pathology, it is possible to now determine an answer within minutes. We will test to see if EPs trained in the use of emergency bedside ultrasound can effectively and efficiently determine gallbladder pathology and if fasting has an impact on their ability to perform a quality ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 75
* Ability to consent for study

Exclusion Criteria:

* Inability to give informed consent
* Known pregnancy
* Prior cholecystectomy
* Inability to consume a fast food breakfast
* Known history of cholelithiasis
Safety, Attenuation and Immunogenicity of GAP3KO Administered Via A Stephensi Mosquitoes

Study designed to evaluate safety and tolerability of a genetically attenuated P. falciparum (GAP3KO) that arrests early in the liver stage of the parasite life cycle. Study will also confirm the attenuation of the GAP3KO parasites using peripheral blood smears. Secondary objectives are to evaluate the humoral immune responses to GAP3KO.

This single arm, open-label, phase 1 safety study is designed to evaluate the safety and tolerability of a genetically attenuated P. falciparum (GAP3KO) that arrests early in the liver stage of the parasite life cycle. The study will also confirm the attenuation of the GAP3KO parasites using peripheral blood smears. The secondary objectives of the study are to evaluate the humoral immune responses to GAP3KO.

A total of 10 healthy, malaria-naïve adult subjects will be enrolled to receive GAP3KO via the bite of 150-200 GAP3K0-infected A. stephensi mosquitoes under controlled conditions. Subjects will be evaluated for safety, reactogenicity, and signs and symptoms of malaria to confirm attenuation for 28 days, including monitoring in a hotel setting 8-18 days post GAP 3KO administration.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* No hematologic, hepatic, or renal disease
* Weight greater than 50 kg
* Assessment of Understanding completed and passed prior to enrollment
* Availability and reliable access to trial center
* Females must use two forms of pregnancy prevention

Exclusion Criteria:

* Recent (within 6 months) or planned travel to malaria endemic area
* History of confirmed malaria diagnosis
* Anticipated use of the following:

  * Investigational malaria vaccine at any time
  * Malaria chemoprophylaxis within 6 months
  * Chronic systemic immunosuppressive medications within 6 months
  * Blood products or immunoglobulin within 120 days
  * Systemic antibiotics with antimalarial effects within 30 days
  * Investigational product or vaccine within 30 days
  * Live vaccine within 28 days; killed vaccine within 14 days of GAP3KO
  * Medications known to significantly interact with chloroquine or Malarone
* History of:

  * Sickle cell trait or other hemoglobinopathies
  * Splenectomy or functional asplenia
  * Systemic anaphylaxis
  * Severe allergic reaction to mosquito bites or malaria treatment drugs
  * History of chronic or active neurologic disease
  * Cardiac disease or stroke
* Clinically significant medical condition, abnormal lab results
* Clinically significant abnormal ECG
* Moderate or high risk for coronary heart disease
* Acute illness
* Pregnant or nursing female
* HIV, Hepatitis B, or Hepatitis C
* Psychiatric condition that precludes compliance with the protocol
* Suspected or known alcohol or drug abuse
* Staff with direct involvement in conduct of the study or GAP activities
Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients

Organ transplant patients and staff members at the Transplant Institute have received pandemic H1N1 influenza vaccine (Pandemrix) and specific antibody production was measured by haemagglutination inhibition according to the clinical guidelines and policy, respectively. This study retrospectively assessed the immune response after vaccination.

A total of 100 organ transplant patients and 36 healthy controls were included in the study. All individuals were vaccinated between October and November 2009 and received 2 doses of Pandemrix. Serum samples were collected at baseline before vaccination and 1 month after the first and second vaccination. Individual hemagglutination-inhibiting serum antibody titers were measured.Frequency of \> 4 -fold increase in antibody titers and seroconversion from non-protective prevaccination titers to protective postvaccination titers were recorded. Adverse events were reported.

Eligibility Criteria:
Inclusion Criteria:

Cohort number 1:Organ transplant patients who were vaccinated and serum sample drawn at baseline.

Cohort number 2: Staff members who were vaccinated and serum sample drawn at baseline.

Exclusion Criteria:

Cohort number 1: Organ transplant patients who were vaccinated and no serum sample drawn at baseline.

Cohort number 2: Staff members who were vaccinated and no serum sample drawn at baseline.
Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.

To evaluate the effect of mosapride on DPG by 13 C - octylic acid breath test.

IF C13- octylic acid be absorbed by mucous membrane of small intestine, octylic acid will be oxidated to CO2.Patients eating food containing C13, and then collect their expired gas at 15, 30,45,60,75,90,105,120,150,180,210,240min, analyse the mass of C13 by mass spectrometer, then can calculate the gastric emptying rate.

Eligibility Criteria:
Inclusion Criteria:

1. 18≤ age ≤ 75
2. Patients coincided to, the WHO diagnostic criteria for diabetes in 1999 (namely have diabetes symptoms, plasma glucose tendency for 11.1 / L, at any time or fasting plasma glucose tendency for 7.0 / L, or oral glucose tolerance test 2 h plasma glucose levels tendency for 11.1 / L）
3. fasting blood-glucose≤7.0mmol/L and 2h postprandial plasma glucose≤10.0mmol/L
4. Be diagnosed diabetes more than 5 years, blood sugar steady in one month.
5. have the following symptoms for over 4weeks: early satiety ,postprandial fullness ,nausea, vomting,abdominal distension,belching, inappetence, epigastric pain, constipation.
6. Be diagnosed as Delayed Gastric Emptying by C13 breath test.
7. Signed informed consent.

Exclusion Criteria:

1. take gastrointestinal drugs within 2 weeks prior to screening. Or patients with other digestive disease.
2. All patients will be administrated gastroscope in order to exclude stomach or duodenum disease, pyloric obstruction. It's normal in Liver, gallbladder, pancreas,spleen, nephridium by Ultrasound examination .
3. Serious ketoacidosis.
4. History of abdominal operation.
5. Thyroid hypofunction or hyperthyroidism.
6. nervous system disease or autoimmune diseases.