cyrilzakka/clinical-trials huggingface dataset:
The Patient Expectation in Dry Needling and Analgesia

This study will evaluate placebo mechanisms related to dry needling(DN) trying to determinate whether an additive effect occurs when DN is provided with an instructional set known to enhance placebo analgesia. External manipulation of patient expectation for receiving DN will be performed, in a similar way as has been already done in studies investigating the influence of expectation on spinal manipulative therapy interventions. The main purpose of this study will be therefore to determine, for the first time, how subjects' expectation about the effect of DN influences the resultant hypoalgesia. Analgesic effects of DN will be assessed using the conditioned pain modulation (CPM) paradigm, which has not been previously evaluated in relation to DN.

Just before DN intervention, participants will receive a positive or a neutral expectation instructional set regarding effects of a DN technique on pain perception. This instructional set will be randomly allocated to each patient.

Participants in the positive expectation group will be told that DN procedure: "is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain". Participants in the neutral expectation group will be told that DN procedure: "is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain".

DN intervention An experienced and trained physical therapist will provide DN to all the subjects. This researcher will be blinded to the specific expectation instructional set the participant receives. Participants will receive one session of DN treatment for the active Myofascial Trigger Points(MTrP) located at the upper trapezius muscle. They will be placed in a prone position on the examination table. Solid filament needles of 0.30 mm diameter and 40 mm length will be used. The needle will be inserted into the skin over the palpated MTrP using pincer palpation, and slowly advanced perpendicularly until it reaches the MTrP and a twitch response is elicited.

Eligibility Criteria:
Inclusion Criteria:

* neck pain (≥3 months of duration)
* VAS of 4-5 of pain.
* Presence of at least one active MTrP located at the upper trapezius.

Exclusion Criteria:

* Patients with previous cervical spine or shoulder surgery.
* Cervical spine radiculopathy or myelopathy.
* Systemic disease.
* Fibromyalgia.
* Pregnancy.
* Using sedative drugs.
* Needle phobia.
* Bleeding disorder.
* anticoagulant medication.
* Previous experience with DN for myofascial pain.
* Skin lesion and infection or inflammatory oedema at the MTrPs site
Evaluation of Anti-COVID 19 Pfizer Vaccination Effect on COVID 19 Detection Using Breath Analysis

The objective of this study will be to evaluate the effect of vaccination on breath VOC content.

By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.

The objective of this study will be to evaluate the effect of vaccination on breath VOC content.

By capturing and analyzing the breath of anti-COVID-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the COVID-19 antigen.

Rapidly growing serological evidence shows that IgM, IgG, and IgA antibodies against the S or N proteins evolve rapidly in the serum of asymptomatic as well as symptomatic COVID-19 patients within a week of infection or symptom onset and stay elevated with progressing disease.

Since the standard serology testing at Shamir Medical center tracks the presence of IgG only, those serologic tests will be conducted before and 48 hours following the second vaccination dose.

Nevertheless, since IgM antibodies are known to be produced by four to seven days following the first dose of vaccination, although IgM serology testing cannot be performed, the investigators are interested in sampling breath at this time range, in order for them to correlate it with the changes in the subjects' physiologic condition.

Since this is an unknown metabolic volatile compound mixture, the goal will be to identify compounds and quantify them with a high level of precision and subsequently correlate them with the disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years at the time of consent
* Capable of understanding written and/or spoken language
* Able to provide informed consent
* Assigned to undergo anti-COVID-19 vaccination

Exclusion Criteria:

* Age under 18 years old
* Under guardianship or deprived of liberty
* Pregnant or lactating woman
* Not eligible for anti-COVID-19 vaccination
tDCS to Enhance Cognitive Training in Multiple Sclerosis

Expected results: an improvement in cognitive performance in both groups, boosted in the experimental arm and not confined to general frontal-cognitive abilities; potential changes would be reflected also by neurophysiological measures and in QoL.

Discussion: Investigators hope to provide additional treatment tools for RRMS subjects, with a medium-long term efficacy and an extensive effect. This exploratory pilot study will help to set the rationale for future studies, providing preliminary data useful for selecting the best primary outcome and for calculating a better sample size.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinically definite diagnosis of relapsing remitting MS (RRMS);
* Male or female subjects, 18 to 65 years old;
* Expanded Disability Status Scale (EDSS) score ranging from 0 to 5.5 (included);
* Predominant deficits in either attention/information processing;
* Fluent Italian speakers;
* Normal or corrected-to-normal vision;
* Ability to understand the purpose and risk of the study and provide signed informed consent.

Exclusion Criteria:

* MS patients in different phase of the disease (as primary/secondary progressive MS; benign MS) or Clinical Isolated Syndrome (CIS) patients;
* Exclusive cognitive impairment in different domains (e.g., memory);
* CT/neuromodulation program ongoing or in the preceding 6 months;
* Clinical exacerbations, neuroradiological activity of the disease, modification of EDSS score and disease modifying treatments/steroids during the last 3 months preceding study enrolment;
* Significant medical disorders or other major systemic, psychiatric, neurological disorders or alcohol/substance abuse that could interfere with cognitive functioning;
* Antidepressant/psychoactive drugs in the past 3 months;
* Contraindications to tDCS (intracranial metallic plates, implanted devices, skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, pregnancy, etc).
Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA

The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is older than 18 years of age
2. Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
3. Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
4. Evidence of reversible ischemia that is attributable to the left coronary arterial system by Dobutamine Echo
5. Left ventricular ejection fraction greater than 25%
6. Male or non-pregnant female (NB: Females of child bearing potential must have a negative pregnancy test)
7. Patient understands the nature of the procedure and provides written informed consent prior to enrollment
8. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone

Exclusion Criteria:

1. Recent (within three months) acute coronary syndrome
2. Recent (within six months) successful PCI or CABG
3. Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
4. De-compensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to screening
5. Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
6. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
7. Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina
8. Severe valvular heart disease
9. Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
10. Patient having undergone tricuspid valve replacement or repair
11. Chronic renal failure (serum creatinine \>2 mg/dL), including patients on chronic hemodialysis
12. Moribund patients, or patients with comorbidities limiting life expectancy to less than one year
13. Contraindication to required study medications that cannot be adequately controlled with pre-medication
14. Known allergy to stainless steel or nickel
15. Contraindication to having an MRI performed (NB: Cardiac MRI subset patients only)
16. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
17. Mean right atrial pressure higher than or equal to 15 mmHg
18. Patient with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as:

Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left SVC) and/or; CS diameter at the site of planned reducer implantation less than 9.5 mm or greater than 13 mm
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-65 years old
* Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
* The patient's current depressive episode must be at least 8 weeks in duration

Exclusion Criteria:

* Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control
* Patients with a history of meeting DSM-IV-TR criteria for:

  * any manic or hypomanic episode
  * schizophrenia or any other psychotic disorder
  * obsessive-compulsive disorder
* Patients who are considered a suicide risk
Shared Decision-Making: AFib 2gether Mobile App

Shared Decision-Making: AFib 2gether™ is a research study that focuses on a mobile application developed by Pfizer, Inc with consultation from Dr McManus' called AFib 2gether™. Through this app, patients can determine their risk of stroke due to atrial fibrillation and prioritize questions and concerns for discussion with their cardiology provider.


Eligibility Criteria:
Inclusion Criteria:

Providers:

* Caring for at least 3 patients aged 18 years and older
* Have at least 3 patients with International Classification of Diseases tenth revision (ICD-10) diagnostic code consistent with atrial fibrillation (AF) or atrial flutter
* Have at least 3 patients with a CHA2DS2-VASc stroke risk score of 2 or more
* Have at least 3 patients who are not on anticoagulation
* Have at least 3 patients with upcoming appointments within the next 4 months

Patients:

* Age 18+
* Preferred language is English
* Atrial fibrillation diagnosis
* Chads vasc score 2 or higher
* Not on anticoagulants
* No watchman or atrial appendage closure
* Had an ambulatory care center (ACC) cardiology appointment in the past 12 months
* Future appointment in the next 4 months with the same provider

Exclusion Criteria:

Providers:

* Providers who do not care for at least 3 patients aged 18 years and older
* Have patients that do not have an ICD-10 diagnostic code consistent with AF or atrial flutter
* Does not have patients with a CHA2DS2-VASc stroke risk score of 2 or more
* Their patients are on anticoagulation
* Their 3 patients do not have an upcoming visit within the next 4 months

Patients:

* Under the age of 18; patients
* No ICD-10 diagnostic code consistent with AF or atrial flutter
* Did not have a visit with a cardiovascular medicine specialist in the previous one year
* Patients with a CHA2DS2-VASc score less than 2
* Currently prescribed an anticoagulant
* No upcoming cardiology visit in the next 3 months
* Has a WATCHMAN device or left atrial appendage closure surgery
* On hospice or for whom life expectancy is less than six months and patients
* Bleeding episode or fall with injury in the last four weeks
* Does not speak English
* Prisoner
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation

Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant.

PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for PGD is often expensive, and it is the leading cause of death following lung transplantation. Many potential lung donors and recipients are considered unsuitable for lung transplantation because of concern for the development of PGD. Increased levels of chemicals that are involved in bleeding and clotting, including protein C, and certain markers of oxidant stress, which can cause damage to the body's cells and tissues, may increase a person's risk of developing complications following a lung transplant. The purpose of this study is to analyze blood samples to determine if elevated levels of certain chemicals may be associated with an increased risk of developing PGD after lung transplantation.

This study will enroll individuals who are undergoing lung or heart and lung transplantation. Blood samples will be collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will also review participants' medical records. There will be no additional study visits.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing lung or combined heart and lung transplantation

Exclusion Criteria:

* Undergoing combined organ transplantation other than heart and lung transplantation
Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Both males and females will be included
* Negative pregnancy test and effective contraception.

Exclusion Criteria:

* Breastfeeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

* To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
* To evaluate the effects of alirocumab on other lipid parameters.

The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-week randomized treatment period and 8-week follow-up period.

Eligibility Criteria:
Inclusion criteria:

Either A or B below and who were not adequately controlled with their lipid-modifying therapy:

A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents

OR

B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.

Exclusion criteria:

* Age \< 18 years
* LDL-C \<70 mg/dL (\< 1.81 mmol/L)
* Fasting serum triglycerides \> 400 mg/dL (\>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Early Detection of Cardiac Toxicity in Childhood Cancer Survivors

To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).

Cardiac toxicity is a significant potential complication for patients receiving anthracycline chemotherapy. Cells in the cardiovascular system have limited regenerative capability, making them susceptible to long term adverse effects from these chemotherapeutic agents. The ability to detect subclinical changes in cardiac function will allow clinicians to use proven treatments to prevent further progression in this vulnerable population. The current standard testing uses echocardiography, which is not as sensitive as cardiac MRI or serum biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that have received anthracycline based chemotherapy
* Age: 8 years old - 25 years old
* Subjects that do not require sedation for cardiac MRI.
* Subjects must have completed treatment in the last 10 years

Exclusion Criteria:

* Patients with significant congenital heart defects
* Patients with renal injury or renal failure, defined as an estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73 m2 body surface area), as previously calculated)
* Patients that require sedation for a cardiac MRI
* Subjects that are pregnant or lactating
* Patients with contraindications to a cardiac MRI:
* Cardiac pacemaker or implantable defibrillator
* Cerebral aneurysm clip
* Neural stimulator
* Metallic ocular foreign body
* Any implanted device (i.e. insulin pump, drug infusion device)
* Claustrophobia
* Metal shrapnel or bullet
* Investigator assessment of inability to comply with protocol
* Unable/unwilling to lie still throughout the research procedure
* Persons with cognitive impairment
Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients

The purpose of this study is to determine whether eradication of Helicobacter pylori infection is effective in the improvement of platelet counts in children and adolescents with chronic ITP.

Helicobacter pylori infection has been associated with Immune Thrombocytopenic Purpura (ITP), and there is scientific evidence for the investigation and treatment of this bacterium for adult patients with ITP. However, in children this causal association is not clear, with few published studies.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic immune thrombocytopenic purpura
* children and adolescents up to 20 years

Exclusion Criteria:

* known hypersensitivity to any of the drugs
* recent treatment for H. pylori eradication
Empagliflozin-based Quadruple Combination vs Insulin Glarine-based Combination Therapy in Patients With Type 2 Diabetes

This study evaluates the efficacy and safety of the empagliflozin as add-on thearpy compared to insulin glargine-based antidiabetic agents (OADs) combination thearpy in patients with type 2 diabetes inadequately controlled on triple OADs in a real clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Are inadequately controlled with triple OADs (metformin, sulfonylurea, dipeptidyl peptidase inhibitor) as evidenced by HbA1c \>7.5% and \<12.0%

Exclusion Criteria:

* Type 1 diabetes
* Gestional diabetes
* Diabetes due to secondary causes
* Receiving anticancer treatment
* Receiving glucocorticoids or immune-suppressants
* Have been treated with sodium glucose co-transporter 2 inhibitors for more than 7 consecutive days within 3 months before entering the study
* Have been treated with any type of insulin for more than 7 consecutive days within 3 months before entering the study
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology \[SUO\] Guideline (2020)
* Has undergone complete transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:

  * Recurrence within 1 year, low-grade Ta
  * Solitary low-grade Ta \>3 cm
  * Low-grade Ta, multifocal
  * Solitary high-grade Ta, ≤3 cm
  * Low-grade T1

    * Restage TURBT may be done at the discretion of the investigator

Exclusion Criteria:

* Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit

High risk NMIBC defined as:

* High-grade T1
* Any recurrent, high-grade Ta
* High-grade Ta \>3 cm (or multifocal)
* Any carcinoma in situ (CIS)
* Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
* Any variant histology
* Any prostatic urethral involvement

Low risk NMIBC defined as:

* First occurrence of low-grade solitary Ta ≤3 cm
* Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence
* Papillary urothelial neoplasm of low malignant potential
Behavioral Modulation of Intrusive Memories

The purpose of the study is to examine whether sleep affects the development of intrusive memories.


Eligibility Criteria:
Inclusion Criteria:

* healthy participants
* German on a native level

Exclusion Criteria:

* former or present psychiatric disorders
* physical illnesses
* history of trauma
* pregnancy or lactation period