cyrilzakka/clinical-trials huggingface dataset:
A Multiple Dose Study To Determine Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Healthy Adult Subjects

The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04455242 administered orally to healthy adult subjects. In addition, the plasma and urine pharmacokinetics of multiple ascending doses of PF 04455242 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple-doses of PF-04455242 on serum prolactin concentration will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects without childbearing potential between the ages of 21 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).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
An Investigational Drug Study in Obese (Considerably Overweight) Patients (0364-006)

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with obesity (considerably overweight).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are obese (considerably overweight) based on body mass index.

Exclusion Criteria:

* Patients with serious or unstable current or past medical conditions
Imiquimod and Influenza Vaccine for Immunocompromised Patients

In this open label, single centre, pilot randomized controlled clinical trial the investigators aim to compare the immunogenicity and safety of a new influenza vaccination strategy consisting in the topical administration of imiquimod at the injection site before vaccination vs. a standard intramuscular vaccine injection in SOT recipients and HIV-infected individuals. The investigators planned to enroll 70 outpatients patients (50% solid-organ transplant recipients and 50% HIV-infected patients) regularly followed at the Transplantation center and the Infectious disease outpatients' clinics of the Lausanne University Hospital. Study participants will be randomized in a 1:1:1 ratio to receive the standard intramuscular vaccine (control group) or a topical application of an imiquimod containing cream followed by intramuscular (imiquimod-IM) or intradermal (imiquimod-ID) vaccine injection. After vaccination participants will be followed for a period of 180 days. Blood samples will be drawn at baseline and at day 21 and 180 for assessment of immunogenicity. Safety outcomes will be assessed immediately after vaccine administration, and at day 7 (phone call), 21 and 180.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written, informed consent
* Age \> 18 years
* HIV infection or at least 3 months after kidney transplantation
* Stable outpatients
* Able and willing to comply with the study protocol

Exclusion Criteria:

* Documented egg and/or imiquimod allergy
* Previous life-threatening reaction to seasonal influenza vaccine (i.e. Guillain-Barré Syndrome)
* Previous severe reaction to imiquimod cream
* Pregnancy or breast-feeding
* Patients with autoimmune diseases
* For HIV-infected patients:

  * Current active opportunistic infection
* For kidney transplant recipients:

  * Ongoing therapy for rejection (including steroid pulse or prednisone \> 2 mg/kg/day over more than 14 days)
  * Ongoing therapy with IVIG and eculizumab or current and past (\<6months) therapy with rituximab
Interleaved TMS-fMRI for Hippocampal Stimulation: Modeling Dose-Response Relationship in Amnestic Mild Cognitive Impairment

Emerging evidence indicates that dysfunction of hippocampal synaptic plasticity, which precedes neuronal degeneration during the progression of Alzheimer's disease (AD), underlies the hallmark cognitive impairment. Although there are currently no effective disease modifying treatments for AD, recent preclinical studies in animal models of AD have suggested that repetitive transcranial magnetic stimulation (rTMS) promotes hippocampal synaptic plasticity and, ultimately, improves learning and memory abilities. Interleaved TBS-MRI is a paradigm, which allows the investigators to study human brain functionality with real-time MRI, to better understand modulations of brain activity in response to the non-invasive brain stimulation, TBS. The interleaved TBSfMRI paradigm can more accurately estimated the immediate brain activity compared to the offline TBS-MRI studies in which TBS is applied outside the MRI. With this interleaved TBS-MRI approach, the investigators will be able to measure immediate changes in targeted brain activity, such as hippocampus activation, following each TBS session. This approach has created the unprecedented potential enabling the investigators to model the dose-dependent effects of TBS more accurately on brain function.

The overarching goal of this proposed project is to maximize TBS effects to non-invasive spaced TBS in MCI. For the comparison, the investigators will include cognitively normal adults. There will be a screening session plus three consecutive days including baseline outcome measures on Day 1, TMS interventions and outcome measures on Day 2, and follow-up measurements on Day 3. In this project, on Day 2, participants will receive three TBS blocks inside the MRI scanner with each TBS block separated by 30-90 minutes to enhance the possibility of maximizing the TBS effect. This will be repeated in two blocks, each with a different TMS protocol. The protocols will be in randomized order.

Eligibility Criteria:
Inclusion Criteria:

* Age 50-80 years
* MCI clinical criteria: (a) self- or informant-reported cognitive complaint; (b) preserved independence in functional abilities; and (c) absence of dementia.
* Objective cognitive impairment supported by the following measures of general cognitive function: (a) Mini-Mental State Exam (MMSE) 24-27 (inclusive); (b) Montreal Cognitive Assessment (MoCA) 18-26 (inclusive); or (c) Clinical Dementia Rating Scale score of 0.5.
* Right handed
* English speaking
* Able to attend daily intervention (Monday-Friday) for 4 days
* Not enrolled in another interventional study within 6 months prior to beginning this study

Exclusion Criteria:

* Contraindications to transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI)
* Other neurological disorders (e.g. stroke, head injuries, or multiple sclerosis)
* Untreated depression
* Current cancer treatment or other medical problems that might independently affect cognitive function
* Clinical Dementia Rating Scale score more than 1.0
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals

To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Agree to participate; understand and sign informed consent;
* Male and female adults, aged 18 to 50 years, inclusive at Screening;
* Generally healthy and medically stable, with no clinically significant abnormalities based on physical examination and laboratory tests as determined by the Investigators;
* Have good venous access;
* Have normal resting blood pressure and normal heart rate (HR) without history of syncope; a subject with out of range blood pressure may be enrolled in the study at the discretion of the Principal Investigator;
* Have a body mass index (BMI) of 18.0 - 30.0 kg/m\^2;
* Female candidates must be \>1 year post-menopausal or practicing a clinically acceptable form of birth control and confirmed by negative urine or serum pregnancy test at Screening;
* Negative HIV-Ab, HBs-Ag and HCV-Ab;
* Negative alcohol test (urine or breathalyzer);
* Negative drug screening results;
* Currently non-smoker; have not used any tobacco products for at least three (3) months prior to Screening; and
* Demonstrate proficiency in the use of MDI and a consistent inhalation time \>2.0 seconds after training, for at least three (3) times, with a maximum of 5 attempts.

Exclusion Criteria:

* Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
* Known intolerance or hypersensitivity to any component of the study drugs (i.e., Epinephrine, Albuterol Sulfate or any sympathomimetic drugs, HFA-134a, thymol, ethanol, ascorbic acid, nitric acid, and hydrochloric acid).
* Upper or lower respiratory tract infection, or other systemic infection within 6 weeks prior to Screening;
* Clinically significant abnormalities in the screening/baseline ECG; prolonged corrected QT interval (QTcF) on ECG: men \>450ms, women: \>470ms; single or multiple premature ventricular contractions (PVC);
* Abnormal thyroid function test (if TSH is out of range, refer to T3/T4 for thyroid function assessment);
* Subject has been on other investigational drug/device studies within 30 days of Screening Visit or planned participation in another investigational drug trial at any time during this trial;
* Women who are pregnant or lactating or planning a pregnancy during the study period;
* Subject has donated or lost \> 500 mL of blood within 3 months of Screening;
* Evidence of alcohol or drug abuse or dependency within 6 months prior to screening; or
* Use of any of the prohibited drugs without appropriate washout.
DIalysis Symptom COntrol-Restless Legs Syndrome Trial

The DISCO-RLS Trial is a randomized controlled trial to determine the safety and efficacy of pharmacologic therapy (ropinirole versus placebo and gabapentin versus placebo) for the treatment of Restless Legs Syndrome in patients with End Stage Renal Disease requiring hemodialysis.

The DISCO-RLS Trial is a randomized controlled trial to determine whether or not a fixed, low-dose therapy with ropinirole and/or gabapentin is safe and effective compared to either alone or placebo for the treatment of Restless Legs Syndrome in patients with End Stage Renal Disease receiving hemodialysis. DISCO-RLS will randomize a total of 80 participants. Participants will be randomized to 1 of 8 treatment sequences. Each sequence is composed of 4 periods and in each period participants will receive 1 of 4 possible combinations of study medications (gabapentin+ropinirole, gabapentin+placebo ropinirole, ropinirole+placebo gabapentin, placebo gabapentin+placebo ropinirole). Eligible participants will complete a 1-week Run-In period followed by 4 periods of 4 weeks each for a total of 16-week follow-up after randomization. A final study visit will be completed at the end of the 16 week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 18 years
* Has received at least 90 days of in-center hemodialysis at a frequency at least 3 times weekly
* RLS defined by 2012 Revised International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria for RLS and of moderate severity defined by an IRLS score greater or equal to 10 with symptoms more than 2 days per week (see IRLS question #7)
* Provides informed consent

Exclusion Criteria:

* Hemoglobin\<80g/L in the previous 4 weeks
* Intolerance to a dopamine agonists (e.g. pramipexole or ropinirole) or alpha 2 delta ligands (e.g. gabapentin, Neurontin, pregabalin, or Lyrica)
* Change in medication to treat RLS in previous 4 weeks
* Current pregnancy
* Planned kidney transplantation, travel or relocation in the next 6 months
* Unable to complete RLS symptom and HRQOL measurements due to language barrier or cognitive impairment
A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of non-childbearing potential or male subjects

  * Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
  * Normal Hepatic function for the healthy subjects
  * Stable Hepatic Impairment for the subjects with moderate hepatic impairment

Exclusion Criteria:

* Treatment with an investigational drug within 30 days of the dose of study medication
* Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
* Use of herbal supplements in the 28 days prior to the dose of study medication
* Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
* A positive urine drug screen for illicit drugs
ASP8825 - Study in Patients With Restless Legs Syndrome

To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome

Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome

Eligibility Criteria:
Inclusion Criteria:

* Patients with RLS, based on the International RSL Study Group Diagnostic Criteria
* History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
* Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period

Exclusion Criteria:

* A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
* A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
* Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias
Chuna Manual Treatment for Patients with Primary Dysmenorrhea Primary Dysmenorrhea

This study is a randomized controlled trial that compares 30 patients with primary dysmenorrhea by assigning them in a 1:1 ratio between patients treated with a Chuna therapy strategy and patients treated with a strategy using physical therapy. The purpose of the study is to confirm the comparative effectiveness of Chuna therapy and physical therapy.

Menstrual pain is known to be caused by increased tension in the uterine muscles and irregular contractions, and is experienced by 50% of women who menstruate. However, most people control pain with NSAIDs or hormones. Among non-pharmacological treatments, manual therapy is known to control menstrual pain by influencing pain perception and pain-related serological factors. Previous research results have shown that manual therapy using sacroiliac joint correction and high-speed, low-amplitude thrust techniques is effective for menstrual pain. However, there is still no randomized controlled study limited to Chuna therapy. Therefore, the investigators would like to conduct a randomized clinical study to determine the effectiveness and safety of Chuna therapy for primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose menstrual pain is NRS 5 or higher during the last 3 months due to primary dysmenorrhea
* Patients who are between 14 and 49 years of age
* Patients whose cycle has been regular between 21 and 40 days for the past 3 months
* Patients who agree to participate in clinical research and provide written test subject consent

Exclusion Criteria:

* Patients whose cause of menstrual pain is determined to be an organic problem (uterine fibroids, adenomyosis, endometriosis, etc.) rather than a primary cause.
* Patients who have taken oral contraceptives or other hormonal therapy within the past 3 months.
* Patients diagnosed with other chronic diseases (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results.
* Patients who are currently taking steroids, immunosuppressants, drugs for mental illness, or other drugs that may affect the results of the study.
* Patients for whom manual therapy is inappropriate or unsafe: history of lumbar fusion or pelvic girdle surgery, spinal fracture, or severe instability.
* Pregnant women, those planning to become pregnant within 6 months, and those planning to take hormones such as oral contraceptives.
* Patients who finished participating in another clinical study less than 1 month ago, or who plan to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection.
* Patients who find it difficult to fill out the consent form for research participation.
* Other cases where participation in clinical research is deemed difficult by the researcher.
Hyoscine Butylbromide Effect on Duration of Labor

To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Low risk gestation between 37 and 41 6/7 weeks.
* Cephalic (vertex) presentation.
* Spontaneous labor in active phase (4 cms)

Exclusion Criteria:

* Premature rupture of membranes upon arrival at the Labor and Delivery Unit \> 4 hours.
* Multiple order pregnancy.
* Stillbirth.
* Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).
Relationships and Differences Analysis in Heart Failure

This study characterizes heart failure patients who attended the University Hospital Würzburg. The primary aim is a better understanding of the relationships and differences between the subgroups HFrEF (EF \< 40%), HFmrEF (EF 40-49%), and HFpEF (EF\>50%), contributing to an improved diagnosis, prognosis and therapy of patients with heart failure.

The varying clinical picture of heart failure (HF) represents a major challenge for patient care in Germany. HF is one of the most common reasons for hospitalization in the Western world. In the chronic course of heart failure, affected patients are committed to morbidity, lifelong therapy and high risk of cardiac decompensation, also associated with high mortality.

Heart failure patients, who visited the Cardiology Department of the University Hospital Wuerzburg, shall be analyzed with regard to all clinical data and outcome. This retrospective work should help to better understand the three groups HFrEF (EF \< 40%), HFmrEF (EF 40-49%) and HFpEF (EF\>50%) and help identifying similarities and differences between the groups.

Hereby we hope for progress in diagnostic, prognostic and therapeutic aspects of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Heart failure
* Minimum of two echocardiographic examinations in a minimum time frame of six months
* Patients must have reached the age of 18
Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life

The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation.

Atrial fibrillation (AF) is associated with a higher risk of stroke, heart failure and deterioration in patients' quality of life and it also has great effect on health care resource utilization due to increasing morbidity and mortality. Catheter ablation has shown to improve patients' quality of life (QOL), even in those who undergo a repeat procedure, equalizing healthy population and lowering subsequent health care resource utilization.

Success rates are usually based on an endpoint of total elimination of AF, typically absence of any AF recurrence \>30 seconds. While this is a high standard for clinical trial reporting, it does not necessarily measure the "clinical" success, since many patients will experience significant reduction in their AF burden with accompanying improvement in their functional status despite having ongoing brief recurrences of AF.

This is a prospective non-randomized, single-arm, cohort study. 200 patients with persistent atrial fibrillation undergoing catheter ablation will be enroled. AF burden post procedure will be evaluated with continuous monitoring with an implantable loop recorder (ILR) to assess recurrences and AF burden. QOL will be measured using the CCS-SAF severity scale, SF-36 and AFEQT scales pre-ablation and at 12 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients undergoing first-time or redo AF ablation.
* Persistent or long-standing persistent AF
* Symptomatic atrial fibrillation
* Willing and able to provide informed consent.
* Willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored
* Atrial fibrillation burden equal or more than 80% prior to the ablation

Exclusion Criteria:

* Paroxysmal AF
* If the patient has had a cardioversion within 2 months of the ablation
* Patients with contraindication to oral or intravenous anticoagulation.
* Contraindication to implantation of an ILR
Using Reinforcement Learning to Personalize Electronic Health Record Tools to Facilitate Deprescribing

The overall goal of the proposed research is to refine and adapt and perform efficacy testing of a novel reinforcement learning-based approach to personalizing EHR-based tools for PCPs on deprescribing of high-risk medications for older adults. The trial will be conducted at Atrius Health, an integrated delivery network in Massachusetts, and will intervene upon primary care providers. The investigators will conduct a cluster randomized trial using reinforcement learning to adapt electronic health record (EHR) tools for deprescribing high-risk medications versus usual care. 60 PCPs will be randomized (i.e., 30 each to the reinforcement learning intervention and usual care \[no EHR tool\] in each arm) to the trial and follow them for approximately 30 weeks. The primary outcome will be discontinuation or ordering a dose taper for the high-risk medications for eligible patients by included primary care providers, using EHR data at Atrius. The primary hypothesis is that the personalized intervention using reinforcement learning will improve deprescribing compared with usual care.


Eligibility Criteria:
Inclusion Criteria:

The trial will intervene upon primary care providers (including physicians and PCP-designated nurse practitioners and physician assistants) at Atrius Health.

Patients of the PCPs will be included in the intervention and analysis if they are \>/=65 years of age and have been prescribed \>/= 90 pills of high-risk medications in the prior 180 days based on EHR data.

Exclusion Criteria:

* Not a primary care provider at Atrius Health
* Prior randomization to intervention arm in the prior NUDGE-EHR trial