cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis

The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.

Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for coronary heart disease (CHD).

Mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (Apo-B). Apo-B plays a role in producing low density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an independent risk factor for the development of coronary heart disease (CHD) or other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events. The purpose of this study is to determine whether mipomersen safely and effectively lowers LDL-C in severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C ≥200 mg/dL (5.1 mmol/L) at screening and the presence of at least 1 of the following criteria:

  * Myocardial infarction (MI)
  * Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  * Coronary artery disease documented by angiography or any other accepted imaging technique
  * Positive exercise test (≥1 mm ST-depression at maximal exercise or test terminated because of angina) or a perfusion defect (e.g., thallium or single photon emission computed tomography)
  * Other clinical atherosclerotic diseases: peripheral artery disease, symptomatic carotid artery disease, abdominal aortic aneurysm
  * Or, if alternative above were not met, fasting LDL-C ≥300 mg/dL (7.8 mmol/L)
* On stable, maximally tolerated statin therapy for 8 weeks
* On stable, medication from an additional class of hypolipidemic agents for 8 weeks.
* On stable, low fat diet for 12 weeks
* Stable weight for 6 weeks

Exclusion Criteria:

* Significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, blood disorders, liver disease, cancer, digestive disorders, Type I diabetes, or uncontrolled Type II diabetes
* Apheresis within 3 months prior to Screening or expected to start apheresis during the treatment phase
Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome

108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided into 3 groups. To groups; exercise, exercise+high-intensity laser therapy (HILT) and exercise+dry needling will be applied. Visual anolog scale (VAS) scores and neck range of motion (ROM) of the patients before-after treatment will be recorded and will be evaluated statistically.

Myofascial pain syndrome (MPS) is a very common disease in the population that seriously affects the quality of life. Although many modalities are used in its treatment, there is still no common protocol. In this study, the investigators aim to compare the effectiveness of high-intensity laser therapy (HILT), which has been popular in recent years, with exercise and dry needling options that have been used for years.

In our study 108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided into 3 groups. To groups; exercise, exercise+high-intensity laser therapy (HILT) and exercise+dry needling will be applied. Visual anolog scale (VAS) scores and neck range of motion (ROM) of the patients before-after treatment will be recorded and will be evaluated statistically.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with neck and / or back pain
* diagnosed with MPS
* had a taut band on the trapezius muscle and at least one active trigger point

Exclusion Criteria:

* Diagnosed with fibromyalgia,
* had systemic disease,
* significant cervical disc lesion / radiculopathy / myelopathy,
* had trigger point injection in the last 6 months,
* had neck or shoulder surgery in the year before being included in the study,
* was pregnant,
* received anticoagulant therapy,
* used aspirin in the last three days, and
* with the cognitive dysfunction patients
Assessment of a Drama Workshop Program for Immigrant and Refugee Adolescents

The purpose of this study is to determine whether a drama workshop program for immigrant and refugee youth is effective in reducing impairment in high school students presenting learning difficulties.


Eligibility Criteria:
Inclusion Criteria:

* All students who are assigned to special classes based on behavioural or learning problems in grades 7-10 in the participating schools will participate in the program and be included in the study if they and their parents consent to in the research.

Exclusion Criteria:

* More severe cases
A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors \[RECIST\] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.

  * Part 1A may have a solid malignancy of any histology.
  * Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
  * Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
* Tumor biopsy must be obtained for all participants (unless medically precluded).

Exclusion Criteria:

* History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], or anti-PD- 1/programmed death-ligand 1 \[PD-L1\] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
* Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.

Other protocol-defined criteria may apply.
The Dose-response "Pilot" Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects

To determine the dose-response relationship for Clobex TM (clobetasol propionate) Lotion, 0.05%. This information will be used to estimate the ED50, D1, D2 parameters for use in a full bioequivalence study.

Study Type: Interventional Study Design: Randomized, open label, one period, dose response, vasoconstrictor assay study.

Official Title: Dose Response of Clobex 0.05% Lotion

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

· Vasoconstrictor Response

Eligibility Criteria:
Inclusion Criteria:

* Non-tobacco-using female subjects, 18 to 50 years of age, inclusive.
* A demonstrated blanching response to Clobex TM (clobetasol propionate) Lotion, 0.05 %.
* A body mass index (BMI) 30 kg/m2 or less as calculated according to Novum Standard Operating Procedures.
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator.
* Signed and dated informed consent form which meets all criteria of current FDA regulations.

Exclusion Criteria:

* History of allergy to any systemic or topical corticosteroid (including clobetasol) or to any cream, lotion, ointment, gel, cotton, soap, cosmetic, rubber, or tape, which in the opinion of the Investigator would compromise the safety of the subject or the study.
* Presence of any skin condition or coloration that would interfere with placement of test sites or the response or assessment of skin blanching.
* Significant history or current evidence of chronic infectious disease, system disorder (especially hypertension or circulatory disease), or organ dysfunction.
* Presence of a medical condition requiring regular treatment with prescription drugs.
* Drug or alcohol addiction requiring treatment (in-patient or out-patient) in the 12 months prior to dosing.
* Use of any topical dermatological drug therapy (including topical corticosteroids) on the flexor surface of the ventral forearms in the 30 days prior to dosing.
* Use of any tobacco products in the 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to initial study dosing.
* Pregnant or lactating.
Apixaban for the Acute Treatment of Venous Thromboembolism in Children

To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.


Eligibility Criteria:
Inclusion Criteria:

1. Birth to \<18 years of age with a minimum weight of 2.6 kg at the time of randomization.
2. Presence of an index VTE which is confirmed by imaging.
3. Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks.
4. Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator's judgement.

Exclusion Criteria:

1. Anticoagulant treatment for the index VTE for greater than 14 days prior to randomization. Neonates that are enrolled into the PK cohort must be on a minimum of 5 days and a maximum of 14 days SOC anticoagulation prior to randomization. Neonates that are enrolled into the post PK cohort may receive SOC anticoagulation for up to 14 days prior to randomization.
2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE.
3. A mechanical heart valve.
4. Active bleeding or high risk of bleeding at the time of randomization.
5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.
6. Abnormal baseline liver function at randomization.
7. Inadequate renal function at the time of randomization.
8. Platelet count \<50×109 per L at randomization.
9. Uncontrolled severe hypertension at the time of randomization.
10. Use of prohibited concomitant medication at the time of randomization.
11. Female subjects who are either pregnant or breastfeeding a child.
12. Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment.
13. Unable to take oral or enteric medication via the NG or G tube.
14. Known inherited or acquired antiphospholipid syndrome (APS).
15. Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)
Complications in Central American Diabetic Patients: Historic Cohort

Retrospective, observational study to determine the prevalence of complications in Central American diabetic patients.

This is retrospective observational study aimed to determine the prevalence of complications in Central American diabetic patients. Patients included are treated in the usual outpatient practice setting and we will try to determine the prevalence of diabetic complications in these patients.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus diagnosed between 2004 and 2009
* seen by the attending physician for the first time between January and December 2009.
* male or female patients between 18 and 80 years

Exclusion Criteria:

* none
Quantitative Assessment of Diffusion Spectrum Imaging in Breast Cancer

This project intends to prospectively collect patients with suspected breast malignant tumors by ultrasound or mammography. After routine MRI scanning, all patients underwent diffusion spectrum imaging (DSI) sequence scanning. The inclusion criteria were as follows: (1) breast cancer was confirmed by surgery or biopsy. (2) pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer. (3) routine MRI and DSI scans were performed within one week before the pathologic examination. The exclusion criteria were as follows: (1) patients who had received treatment before DSI scanning; (2) patients who underwent breast tumor biopsy within two weeks before DSI image acquisition; (3) pathology results of breast masses were other diseases besides breast cancer. (4) post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.

Breast MRI data were collected on a 3T MR scanner (Magnetom skyra, Siemens Healthcare, Erlangen, Germany). All participants used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion-weighted imaging (DWI), DSI, and contrast dynamic enhancement (DCE). A total of 22 GSI quantitative parameters were derived from NeudiLab software that is based on the open-source platform DIPY (diffusion imaging in Python, http://nipy.org/dipy). The correlation between DSI quantitative parameters and pathological indexes (i.e., ER, PR, HER-2, Ki-67, and LVI) was evaluated by Spearman correlation analysis. The independent predictors of GSI quantitative parameters for different pathologic characteristics discrimination in breast cancer were determined by the logistic regression analysis. The predictive performance of DSI quantitative parameters for difference pathologic classifications was assessed by the receiver operating characteristic (ROC) curves and their respective area under the curves (AUCs).


Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer was confirmed by surgery or biopsy.
2. Pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer.
3. Routine MRI and DSI scans were performed within one week before the pathologic examination.

Exclusion Criteria:

1. Patients who had received treatment before DSI scanning.
2. Patients who underwent breast tumor biopsy within two weeks before DSI image acquisition.
3. Pathology results of breast masses were other diseases besides breast cancer.
4. Post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute

The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute
* Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days
* Patients aged 3 years of age to adulthood
* Written informed consent obtained from parental caregiver

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Patients less than 3 years of age.
Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)

Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)

The purpose of the present study is to examine the effects of transcranial magnetic stimulation (TMS) on cognitive control among individuals with posttraumatic stress disorder (PTSD).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Endorse lifetime exposure to at least one Criterion A traumatic event
* Report clinically significant posttraumatic stress disorder (PTSD) symptoms (score of ≥ 33 on the PTSD Checklist for DSM-5 \[PCL-5\]).

Exclusion Criteria:

* Endorse medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
* Report an unstable medical condition or any current medical condition that precludes safe participation in the trial (e.g., unstable metabolic abnormality, unstable angina, etc.)
* Report any history or diagnosis of dementia or other cognitive disorder, which may interfere with engagement
* Report any history or diagnosis of Severe Traumatic Brain Injury
* Report any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness, which precludes safe participation in the trial
* Report a primary obsessive-compulsive disorder (OCD) diagnosis
* Report an active substance use disorder (within last 3 months) or any current substance use that precludes safe participation in the trial
* Report suicide risk that precludes safe participation in the trial, defined as clinical impression that the participant is at significant risk for suicide (i.e., greater than moderate level of suicide risk, in accordance with the Joiner et al. (1999) suicide risk framework)
* Report an inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
* Report a current, planned, or suspected pregnancy
Validity and Reliability of SCIM-SR

To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR.

To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR. scım-sr Turkish form has been created. Patients with spinal cord injuries who applied to our physical therapy clinic filled out the form twice.

Eligibility Criteria:
Inclusion Criteria:

* SCI \>1 month
* 18-70 years
* agree to participate
* give written consent

Exclusion Criteria:

* not read Turkish,
* not write Turkish,
* cognitive problems
A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo within each cohort where the observational period is 18 weeks for Part 1 and 28 weeks for Part 2. All subjects will be dosed for 13 weeks in Part 1 and for 28 weeks in Part 2 with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.

ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The overall purpose of this trial is to evaluate the safety and tolerability when applying dose titration of ascending doses of ZP7570 and at steady state.

The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with corresponding volume of placebo. After informed consent has been obtained, eligibility of the subjects will be assessed during a screening Visit (V1). Additional tests to assess safety and PK and PD will take place during in-house visits and ambulatory visits.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 64 years, both inclusive.
* Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2, both inclusive.
* In overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening.

Exclusion Criteria:

* History of gastrointestinal (GI) diseases including functional complaints that could interfere with the pharmacokinetics of the IMP or auxiliary medicinal product (acetaminophen) of the trial.
* Any relevant abnormal renal parameters in the following ranges:

Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.
Social and Behavioral Influence (SBI)

The purpose of the study is to improve patient-physician communication and clinical decisions in the context of serious illness that may affect important clinical outcomes. The investigators will examine how variations in communication patterns and clinical decisions are affected by patient demographics (e.g age, sex), patient interactional style (e.g. communication behaviors) and physician characteristics (e.g. attitudes, background, training).

This will be a randomized field experiment. Physicians will receive two unannounced covert standardized patient (SP) visits during the 12-24 months after enrollment. SPs are trained actors who will pose as patients to assess physician behavior and communication. Each SP will present just like a real patient, and will have a standardized fabricated scenario and identity. The SP visit will be unannounced; the physician will not be informed at the time of the visit that they are seeing an SP. The visits will be covertly audio-recorded. This is being conducted at 3 sites: University of Rochester, Rochester, NY; Purdue, IN; and University of Michigan.

Eligibility Criteria:
Inclusion Criteria:

* Currently in clinical practice
* Do not plan on moving during the next year

Exclusion Criteria:

* Non-physicians
Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus

The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with RSV


Eligibility Criteria:
Inclusion Criteria:

* Availability for the required study period (including the inpatient phase, ability to comply with study requirements and attend follow-up study visits
* Able to provide written consent for participation after reading the Consent Form and after having adequate opportunity to discuss the study with an investigator or qualified deputy.
* Good general health status as determined by a screening evaluation no greater than 120 days but not less than 14 days prior to enrollment and admission to the research unit
* Low titers of RSV neutralizing antibody measured during screening.

Exclusion Criteria:

* Significant acute or chronic, uncontrolled medical illness
* Presence of household member or close contact to someone who:

  * Is less than three(3) years of age
  * Has a known immunodeficiency
  * Is receiving immunosuppressant drugs
  * Is undergoing or soon to undergo cancer chemotherapy within 28 days of enrollment
  * Has diagnosed emphysema, chronic obstructive pulmonary disease(COPD), or severe lung disease
  * Is elderly and residing in a nursing home, or
  * Has received an organ transplant
* Females are not eligible for this study
* Evidence of or history of drug or alcohol abuse (within the past 6 months) or positive urine drug or alcohol screen

Other protocol-defined inclusion/exclusion criteria may apply.