cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of a Medicine on Gastric Functions in Healthy Volunteers.

A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect scan. This study requires the participant to make 4 visits to the GCRC in the Charlton building but no overnight stays.

A screening interview and symptoms assessment by the Bowel Disease Questionnaire (BDQ) and consent will be obtained prior to the studies at the testing facility (General Clinical Research Center, 7th floor, Charlton Building, Mayo Clinic). Smoking status will be recorded. Vitals and an electrocardiogram will be obtained. Following an initial screening, subjects will be randomized to itopride or identical placebo.

Day 1: The participant will report in a fasting condition (10 hours) to the study center early in the morning. All participants will undergo the nutrient drink test to assess maximum tolerated volume and postprandial symptoms PRIOR to ingesting any medication.

Day 2-7: The patients will take the study medication as prescribed that is a tablet 30 minutes before meals, three times per day. On days 6, 7 and 8, the morning and midday dose of the medication intake will occur in the clinical research center under supervision of the study staff.

Day 6: The participant will return fasting for 10 hours to the study center early in the morning. Scintigraphic gastric and small bowel transit measurement will be performed, with medication ingested at standard times (30 min prior to meal), and the 99mTc-sulfur colloid labeled egg meal ingested 30 minutes after the morning dose of study medication. Imaging will be taken for 6 hours. Vitals and an electrocardiogram will be obtained Day 7: All participants will undergo a repeat nutrient drink test to assess postprandial symptoms at maximal satiety and 30 minutes after drug ingestion. The satiety study will be completed once a maximum tolerated volume is achieved, and the 30 minute post-meal questionnaire will be completed.

Day 8: The participant will return fasting to the study center early in the morning. Participants will undergo SPECT imaging to evaluate fasting gastric volume starting 30 minutes after ingestion of study medication. The participant will then ingest 300 ml of the nutrient drink Ensure", and postprandial gastric volumes will be calculated as described previously (41-46). Vitals will be obtained.

Eligibility Criteria:
1. Non-pregnant, non-breastfeeding females;
2. 18- 45 years old
3. Body mass index between 20 and 32 kg/m2
4. No alarm indicators on clinical assessment (weight loss of more than 7kg, bleeding, recent recurrent vomiting, progressive dysphagia).
5. No history suggestive of small bowel obstruction
Retrospective Simplex High Viscosity (HV) Bone Cement Study

This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty

This study is a retrospective investigation of subjects who have received primary Triathlon Total Knee Arthroplasty inserted with Simplex High Viscosity (HV) Cement to evaluate the success rate defined as absence of revision for aseptic loosening of components at two years postoperative.

Eligibility Criteria:
Inclusion Criteria:

* The Patient is age 18 or over at time of study device implantation
* Patients who have undergone primary Triathlon Total Knee Arthroplasty in which Simplex HV/Simplex HV Gentamicin was indicated for fixation and used on label
* Patients who have been followed for at least 24 months postoperatively

Exclusion Criteria:

* Patients who have undergone revision surgery
* Patients who have undergone bilateral Knee Arthroplasty
* Patients contraindicated for either the devices implanted, or the cement used, according to medical history review and instructions for use
* Patient has a cementless tibial baseplate.
* Patient has an active or suspected latent infection in or about the affected knee joint
* Patient has muscle loss or neuromuscular impairment in the affected limb that would create an unjustifiable risk
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days)
* Patient has a known hypersensitivity to any of the cements constituents or in patients with severe renal failure
* Patient is a prisoner
The Effects of Respiratory Muscle Strength Training (RMST) on Inspiratory and Expiratory Muscle Strength in Adults and Children With Pompe Disease

The purpose of the study is to determine if respiratory muscle strength training will be beneficial for inspiratory and expiratory muscle strength in adults and children with Pompe disease.

Respiratory muscle weakness results in substantial morbidity and mortality in individuals with almost all forms of neuromuscular disease (NMD), including both the infantile and adult phenotypes of Pompe disease. Although individual patterns of involvement vary, respiratory weakness in Pompe disease typically affects both the inspiratory and expiratory muscle systems. Our pilot data in two individuals with late-onset Pompe disease suggest that RMST may be a treatment for the progressive respiratory weakness encountered in this condition.

Purpose of the Study

* Determine the effect of respiratory muscle strength training on maximum inspiratory pressure, maximum expiratory pressure, upright % predicted forced vital capacity, and aspects of cough function.
* Determine the effect of RMST on functional outcome measures of gross motor function appropriate for individual participants in terms of age and motor skills.

Eligibility Criteria:
Inclusion Criteria:

* include skin fibroblast acid α-glucosidase (GAA) activity ≤1% of the normal mean, a minimum age of 3 years, the ability to participate in an intensive RMST research program, and the ability to maintain a consistent amount of nonresearch related physical activity over the course of the study.

Exclusion Criteria:

* include medical problems which preclude meaningful participation in the study, the inability to perform high effort respiratory tasks using maximum intensity, respiratory weakness so profound that RMST cannot be completed at the minimum pressure thresholds of available respiratory trainers, and the inability to safely perform the protocol. For example, high effort respiratory tasks are occasionally associated with mild, transient dizziness which quickly dissipates following a brief rest. If severe and/or prolonged dizziness were to occur in a particular case, then exclusion from the study would be necessary.
Nutrient Mixtures and Neurodevelopment

Background: Adequate levels of beneficial nutrients are important for neurodevelopment. Although, nutrients are ingested in combination, considering nutrients as a mixture has not been studied with respect to health, such as neurodevelopment.

Objective: To examine the impact of prenatal and childhood nutrition mixtures on neurodevelopment.

Design: Participants included mother-child pairs in the Programming Research in Obesity, Growth Environment and Social Stress (PROGRESS) prospective birth cohort in Mexico City. Prenatal and child nutrition profiles were assessed among 65 and 329 children respectively by analyzing components of a food frequency questionnaire. Child neurodevelopmental outcomes at 4-6 years of age were measured using the McCarthy Scales of Children's Abilities (MSCA).


Eligibility Criteria:
Inclusion Criteria:

Women of children:

* less than 20 weeks gestation at the start of the study
* at least 18 years of age
* and planned to reside in Mexico City for the next three years.

Exclusion Criteria:

Women of children:

* free of heart or kidney disease
* not use steroids or anti-epilepsy drugs
* not consume alcohol.
Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris

The goal of this study is to determine if topical tranexamic acid is capable of decreasing the pigment of the dark spots left from acne bumps. The first line medication used for this often is not tolerated well by patients, and topical tranexamic acid has minimal reported side effects thus far.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Patients with bilateral involvement of facial postinflammatory hyperpigmentation due to acne vulgaris.

Exclusion Criteria:

* Pregnant patients or patients planning to become pregnant during the time of the study.
* Patients with a history of use of hydroquinone, kojic acid, tretinoin, adapalene, tazarotene or azaleic acid in the previous 3 months.
The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma

To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis.
* Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.

Concurrent Treatment:

Allowed:

Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.

Patients must have:

* Documentation of a positive ELISA test for HIV with a confirmatory test.
* Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma.
* Vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness.
* Patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Evidence of pulmonary Kaposi's sarcoma.
* Positive urine screen for recreational drugs.
* Current participation in another antiviral research study.
* Investigator anticipates poor patient compliance with the protocol.
* Patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir.

Concurrent Medication:

Excluded:

* Antiretroviral therapy.
* Protease inhibitor therapy.
* Antiviral agent (e.g., oral ganciclovir or Foscarnet) or prophylactic medication for an AIDS defining illness which the patient cannot be removed from.
* Chemotherapy for Kaposi's sarcoma.
* Treatment with any medications that may interact with ritonavir.

Concurrent Treatment:

Excluded:

Radiotherapy for Kaposi's sarcoma.

Patients with any of the following prior conditions are excluded:

* History of psychiatric illness which is currently medically significant.
* History of pancreatitis.

Prior Medication:

Excluded:

* All antiretroviral therapy within 2 weeks prior to the start of the treatment phase of the study.
* Systemic chemotherapy of interferon within 30 days prior to study entry.
* Previous treatment with a protease inhibitor.

Risk Behavior:

Excluded:

Active substance abuse.
Assessment Of Total Coronary Circulation Time Using TIMI Frame Count Method (TCCT-TIMI)

The aim of this study is to evaluate and describe the total coronary circulation time (TCCT) by using TIMI frame count method in patients performed coronary angiography. TCCT is described as an angiographic index which is the sum of the frame count of coronary artery and venous system. This study also evaluates the relationship between the diseases in arterial system such as coronary artery ectasia, coronary slow flow, coronary artery disease and coronary venous pathologies.


Eligibility Criteria:
Inclusion Criteria:

* Patients whom performed coronary angiography with a suspicion of coronary artery disease

Exclusion Criteria:

* History of cerebrovascular disease, chronic inflamatuar disease, malignity, chronic kidney and hepatic disease
Stereotactic Volumetric Radiotherapy in Prostate Cancer

This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per fraction.


Eligibility Criteria:
Inclusion Criteria:

* Histology of prostate adenocarcinoma
* Age≥ 18 years
* Life expectancy≥ 10 years
* Clinical negative nodes (N0)
* No metastasis presence (M0)
* No previous pelvic radiation therapy
* Total PSA≤10 ng/ml
* Gleason score ≤ 6
* T1-2
* ≤ 3 positive biopsy at prostatic mapping
* Signed informed consent

Exclusion Criteria:

* Positive nodes (N+) or metastatic disease (M+)
* Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders
* Anticoagulant treatment in progress
* Hip or pelvic presence of medical devices that could prevent a correct image acquisition
* Symptomatic haemorrhoidal disease
* Adverse reactions to iodinate or paramagnetic contrast media
* Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years
* Previous pelvic radiotherapy
* Psychiatric disorder that preclude to obtain informed consent
"Compuflo®" in Epidural Space Identification

Recently a computerized injection pump has been programmed with its own mathematical algorithm to measure on a digital display the pressure trend in the form of a continuous curve and it has been connected to an acoustic device that emits a sound at increasing frequencies during the progress of the epidural needle (Compuflo®, Milestone Scientific, Livingston, NJ); it has therefore been made capable of controlling the pressure at the injection point and adjusting the infusion rate according to a predetermined maximum value using the registered Dynamic Pressure Sensing (DPS) technology.

The Compuflo® system guarantees feedback on simultaneous and continuous pressure data, both visual and auditory, identifying and differentiating the different types of tissue. This safe and effective feedback helps medical personnel to identify the epidural space with greater accuracy and alerts them if the needle moves into the identified position.

The aim of the study was to verify the efficacy and usability of the Compuflo® system in a clinical setting.

The setting was the area of gynecology and obstetrics at a tertiary referral level University Hospital.

All the consecutive patients undergoing to an epidural catheter placement with Compuflo® were collected until to a sample size of 140 patients.

Primary endpoint was the number and percentage of successes in the placement of epidural catheters with Compuflo® Epidural. Secondary endpoints were: the number and percentage of accidental dural punctures during epidural catheter placement; the number of attempts aimed at the correct positioning of the epidural catheter; the measurement of procedure time duration; the measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space; the measurement of volume of saline injected by Compuflo® to identify the epidural space.


Eligibility Criteria:
Inclusion Criteria:

signed informed consent to procedure more than 18 years of age

Exclusion Criteria:

NO
A Neurobiological Model of Anhedonia

The purpose of this research study is to better understand anhedonia in Major Depressive Disorder by investigating the reward-related neural and inflammatory correlates.

Background: Despite extensive research on the treatment of Major Depressive Disorder (MDD) relapse rates are as high as 80%. Of those, 30-40% fall into the severe spectrum called treatment resistant depression (TRD) as they fail to respond to at least two lines of antidepressant treatment interventions. TRD has been linked with anhedonia, the inability to experience pleasure or interest in usually enjoyable activities. The neurobiology of anhedonia is poorly understood with recent literature examining an inflammatory association and linking it to deficits in reward-related brain circuitry. The present study examines neurobiological correlates of anhedonia in MDD and TRD, specifically C-Reactive Protein (CRP), IL-6 and ventral striatal (VS) activity. The study also explores whether VS activity mediates the association between inflammation and anhedonia.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of MDD based on the MINI International Neuropsychiatric Interview (MINI)
* For treatment resistant depression participants: unsuccessful treatment with at least 2 types or doses of antidepressant medication treatment
* Right-handed
* Capacity for informed consent
* Score a 9 or higher on the MADRS

Exclusion Criteria:

* Comorbid Bipolar Disorder
* Substance use disorder in the last 12 months
* Schizophrenia, and other psychotic disorders
* Comorbid illness such as endocrinological illness (e.g. Cushing's disease) rheumatologic illness (e.g., systemic Lupus erythematosus, current treatment with glucocorticoids), and autoimmune diseases (e.g. psoriasis)
* Pregnancy
* Daily NSAID or aspirin use and any metallic implant
* Visual/Hearing Impairments that would keep participant from being able to complete tasks
Mind-Body Approaches for Medical Conditions

Chronic diseases are currently the most prevalent and most costly health conditions world-wide, and morbidity is expected to increase over coming years. Factors such that increased life-expectancy and certain life style-related factors, such as smoking, high-fat diet and alcohol-consumption, are commonly associated with the increase in most of the common chronic diseases. However, more complex psychosocial factors such as depression, stress, work-related dynamics and thinking patterns are thought be associated with poor health status and impaired health related quality of life among patients with suffering from chronic physical conditions (i.e. a biopsychosocial approach). Therefore, psychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions.

The aim of this randomized trial is to evaluate the effectiveness of mind-body multidisciplinary rehabilitation on health-related quality of life, and disease specific endpoints in people with rheumatoid arthritis, psoriasis, or heart failure.


Eligibility Criteria:
Inclusion Criteria:

Rheumatoid arthritis:

* RA according to the 1987 revised American College of Rheumatology criteria
* Not selected on the basis of their level of activity.
* The treatment of both the RA and any other medical condition have to be stable and constant for at least three months at the time of enrolment, and no future planned changes of therapy exist at the time of inclusion.
* Oral corticosteroids, if used previously, will be allowed at a maximum prednisone dose with an equivalent of 10mg/day.

Psoriasis:

* Diagnosed plaque psoriasis for 6 months or longer
* Psoriasis medical condition have to be stable and constant for at least three months at the time of enrolment (i.e. no future planned changes of therapy exist at the time of inclusion).
* Exclusion criteria are other immune-mediated conditions requiring current systemic immunosuppressant treatment except psoriatic arthritis.

Heart Failure with reduced ejection fraction:

* Symptomatic patients (NYHA class II or III, or NYHA class IV if CRT planned at enrolment) with systolic heart failure (left ventricular ejection fraction ≤40%) will be considered eligible for enrolment.
* The qualifying left ventricular ejection fraction (measured on stable heart failure medication).

Exclusion Criteria:

* Ability to participate
* Psychopathology: Persons with severe mental illness are excluded.
* Alcohol and/ or drug abuse
* Impaired cognitive functions
PET Imaging of Brain Amyloid Using [11C]MeS-IMPY

Alzheimer's disease is associated with accumulation in the brain of a protein called amyloid. The purpose of this study is to test the ability of a research drug to measure amyloid in brain using positron emission tomography (PET) and a research drug called \[11C\]MeS-IMPY.

Alzheimer's disease (AD) is characterized pathologically by the presence of beta-amyloid plaques in brain. A substantial body of research indicates that the presence of increased beta -amyloid peptide is neurotoxic, and may initiate further pathology observed in AD including neurofibrillary tangles, synaptic loss and dysfunction, and neurodegeneration. There are multiple binding sites available on beta-amyloid plaques. Three clearly identified sites are Congo-red type, Thioflavin-T type, and FDDNP type. Radioligands currently under development using positron emission tomography (PET) for studying beta-amyloid in clinical research or drug development are based on Thioflavin-T site, such as \[11C\]PIB and \[11C\]SB-13. Though variously effective, these radioligands have one or more drawbacks with respect to measuring relative regional beta-amyloid densities. Therefore, we have recently developed \[11C\]MeS-IMPY as an alternative radioligand for imaging beta-amyloid, which will allow a more accurate quantification of amyloid plaques in AD brain. In the current protocol, we wish to evaluate \[11C\]MeS-IMPY in both healthy subjects and AD patients to determine the kinetics of brain imaging beta-amyloid plaques in AD patients.

Eligibility Criteria:
* INCLUSION CRITERIA:

Healthy control subjects aged 18-90 years and AD patients aged 50-90, with history/physical exam, ECG, and laboratory tests.

Informed Consent.

AD Patients: Mini-Mental State Examination (score greater than or equal to 10).

AD Patients: Meet NINCDS-ADRDA criteria for probable AD.

EXCLUSION CRITERIA:

1. Current or prior history of any alcohol or drug abuse.
2. Severe systemic disease based on history and physical exam.
3. Positive result on urine screen for illicit drugs.
4. Laboratory tests with clinically significant abnormalities.
5. Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
6. Pregnancy or breast feeding.
7. Claustrophobia.
8. Presence of ferromagnetic metal in the body or heart pacemaker.
9. History of brain disease other than Alzheimer's disease.
10. Unable to lay on one's back for the PET/MRI scan.
The Social Regulation of Threat-related Vigilance and Arousal

This study will examine the effects of social support on threat vigilance and arousal using eye tracking. We will also test the moderating effects of trauma and discrimination history.

Both interpersonal trauma (IPT) and ethno-racial discrimination amplify risk for hyper-arousal symptoms of posttraumatic stress disorder (PTSD), but the mechanism of this effect is unclear. Prior research suggests that social support plays an important role in regulating emotional responses, a process called social emotion regulation. This study will test whether a history of IPT and/or ethno-racial discrimination influence the social regulation of arousal and vigilance. Social regulation will be tested by contrasting responses under conditions with and without social support.

Eligibility Criteria:
Inclusion Criteria:

* In a stable romantic relationship for 6 months or more
* Normal vision or corrected-to-normal vision
* Fluent in English

Exclusion Criteria:

* If vision is corrected-to-normal, needs to use hard contact lenses, bifocal contact lenses, or glasses
* Experienced a traumatic event within the past 4 weeks