cyrilzakka/clinical-trials huggingface dataset:
Genetic Testing and Motivational Counseling for FH

To date, there are highly effective lipid-lowering drugs, the combination of which makes it possible to achieve the target level of LDL-C in most patients with familial hypercholesterolemia (FH). However, the effectiveness of treatment of FH patients strongly depends on adherence to lipid-lowering therapy and to the healthy lifestyle, as well as the detection of the disease and the therapy prescription as early as possible, better in childhood. The aim of the study is to assess the impact of genetic testing and motivational counseling on the effectiveness of treatment and cascade screening in patients with FH.

There are several tasks of the study:

1. To assess the effect of knowledge of patients with FH about the result of their FH genetic testing on the adherence to a healthy lifestyle and hypolipidemic therapy.
2. To assess the impact of knowledge of patients with FH about the result of their FH genetic testing on the effectiveness of cascade screening.
3. To assess the influence of motivational counseling of patients with FH on the adherence to a healthy lifestyle and hypolipidemic therapy.
4. To assess the impact of motivational counseling of patients with FH on the effectiveness of cascade screening.

Eligibility Criteria:
Inclusion Criteria:

* Probable or definite diagnosis of FH according to the Dutch criteria (6 points or more);
* Signed informed consent;

Exclusion Criteria:

* Pregnancy or lactation at the time of enrollment
* Established active severe infectious disease or severe hematologic, metabolic, gastrointestinal or endocrine dysfunctions (for example, uncontrolled thyroid dysfunction or uncontrolled diabetes mellitus) in the opinion of the investigator
* Active liver disease
* Estimated GFR≤ 30 ml / min / 1.73m2
* Any other conditions at Visit 1 that, according to the investigator's opinion, render the patient ineligible for inclusion in the study, may interfere with the patient's participation in the study or patient's completion of the study.
Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients. A Singel Arm Open Label Trial

A Single-Arm Open-Label Trial was performed at the Danish Headache Center (DHC), Department of Neurology, Rigshospitalet - Glostrup as part of the clinic.

Purpose:

To examine the effects of supervised group strength training and posture correction on headache frequency and muscle function around the neck and shoulders in patients with migraine and tension-type headaches.

Hypothesis:

Strength training of the neck and shoulders results in improved muscle function, which leads to a reduction in headache.


Eligibility Criteria:
Inclusion Criteria:

* Migraine patients with stable CGRP or botox.
* Tension type headache with no more than 5 migraine days/month.
* At least four days/months of headache at the moment of recruitment.

Exclusion Criteria:

* Pregnancy
* Post-traumatic headache, or headache that is likely to be associated with trauma.
* Significant psychiatric comorbidities, such as severe depression
* Medication Overuse Headaches.
* Severe arthrosis in the neck, shoulder, or disc herniation in the neck.
Postoperative Consequences of Intraoperative NOL Titration

To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.

Previous work has shown that NOL (Nociception Level) accurately quantifies nociception during general anesthesia.6 Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the PACU (Post-Anesthesia Care Unit). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.

Eligibility Criteria:
Inclusion Criteria:

* Adults having major non-cardiac surgery expected to last ≥2 hours
* American Society of Anesthesiologists physical status 1-3
* Age 21-85 years old
* Planned endotracheal intubation

Exclusion Criteria:

* Planned neuraxial or regional block
* Clinician preference for an opioid other than, or in addition to, fentanyl
* Non-sinus heart
* Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea
* Lack of English language fluency
* Routine user of psychoactive drugs other than opioids
* Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
* Intracranial surgery.
* BMI \> 40
Study About Lymphocytes Change During Menstrual Cycle in Women of Child-bearing Age

The investigators are going to select the normal child-bearing period women as the study subjects and draw their peripheral blood to observe and analyze the change of quantity and percentage of lymphocyte subsets along with the change of menstrual cycle.

Recording their BMI\\menstrual history\\and childbearing history, the investigators would select 300 healthy women in 6 different age groups which are aged 20-24, aged 25-29, aged 30-34, aged35-39, aged 40-44 and aged 45-49, then draw 1-2 ml blood form their peripheral vein (adding EDTA for anti-coagulation). The investigators are going to perform routine examination on the blood samples and detect T\\B\\NK lymphocyte through flow cytometry (FCM), thus calculating the absolute number of every species of lymphocyte. The investigators make assessment for the cellular immune function of the women during child-bearing period via comparing distinction in percentage and absolute number of every lymphocyte subset among reproductive-age women in different ages.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-49;
* Having a regular menstrual cycle of which the menstrual period is between day 3-7, and the period between day 25-35;
* Excluding internal and surgical disease (after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine).

Exclusion Criteria:

* Having experienced severe allergies, trauma history and/or operation history within 3 months;
* With a history of mental illness and/or family history of mental illness;
* Limb disabled;
* Taking medicine within one month;
* Suffering major events or having mood swings.
Relationship of Facial Pattern With Bruxism

The purpose of this study is to determine if the facial pattern is related to the degree of bruxism because the muscles of mastication are the factors of force to the wear of the teeth.


Eligibility Criteria:
Inclusion Criteria:

1. Both genders
2. Age 18 to 60 years
3. Case studies to understand orthodontic intraoral photographs of the upper and lower dental arches, and models of lateral skull radiography for orthodontic
4. Cases with any facial biotype development.

Exclusion Criteria:

1. Totally toothless people
2. Partially toothless the posterior (include both molars and premolars).
3. Dawn Syndrome,alzheimer , partial or bilateral facial palsy, autism, which manifest with bruxism
4. Some other syndrome which alters the pattern of facial development as Pierre Robin,crouzon
Blood Glucose Testing and You

The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18 years of age and above
2. Type 2 diabetes
3. Able to speak, read, and understand English
4. Willing to complete all study procedures

Exclusion Criteria:

1. Type 1 diabetes
2. Currently a user of continuous glucose monitoring system
3. Currently pregnant
4. Hemophilia or any other bleeding disorder
5. Employee of competitive medical device company
6. Cognitive disorder or other condition which, in the opinion of the investigator (or designee), would put the person at risk or seriously compromise the integrity of the study
Growth Hormone's Effect on the Cardiovascular System

To evaluate specific markers of cardiovascular risk before and after growth hormone replacement therapy in a population of growth hormone deficient adults, as compared to an age, gender, and BMI-matched healthy population.

Growth hormone deficiency (GHD) is associated with increased cardiovascular morbidity and mortality. The effects of such a deficiency include decreased exercise capacity and tolerance, impaired cardiac function, a central fat redistribution, increased peripheral arterial resistance, and an unfavorable lipid profile. These effects have been found to be reversed with appropriate replacement therapy with recombinant human growth hormone. We plan to utilize several experimental systems to further investigate the role of growth hormone (GH) in maintaining cardiovascular health. In particular, we would like to further understand the interaction of GH with Plasminogen-activator-inhibitor-1 (a major activator of the fibrinolytic system) as well as the role of GH in the maintenance of vascular function.

Eligibility Criteria:
Inclusion Criteria:

* Adult between the ages of 18 and 65
* Documented Growth Hormone Deficiency as defined by a peak Growth Hormone during a GHRH-Arginine Stimulation test not exceeding 9.5 ng/ml

Exclusion Criteria:

* Personal history of cardiovascular disease (previous myocardial infarction or known coronary artery disease) or diagnosis of heart disease between study visits.
* Personal history of diabetes mellitus or development of diabetes between study visits.
* Initiation of an anti-cholesterol medication or anti-hypertensive between baseline and follow-up study visit.
* Initiation of regular tobacco use between baseline and follow-up study visit.
* Pregnancy or nursing
* Current daily use of any drug known to affect the fibrinolytic system: Aspirin, Aggrenox, Plavix, Persantine, Ticlid, Pletal, Trental, Lovenox, Coumadin, Agrylin, and Hydroxyurea.
Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.

Enrolled patients will undergo collection of salivary and esophageal secretions. Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be re-endoscoped to confirm complete healing of reflux esophagitis. In patients with completely healed reflux esophagitis the second collection of salivary and esophageal secretion will be implemented. In both secretions, adequately coded for the laboratory Research Fellow (blinded in terms of which sample is collected before and which after treatment with rabeprazole) the content of mucin will be measured using commercially available assay and its secretion expressed in units per minute of collection time.

Eligibility Criteria:
Inclusion criteria: 24 patients with endoscopically confirmed reflux esophagitis (Grades A-D according to LA classification) in patients with chronic symptoms of GERD (heartburn with or without regurgitation) between the age of 19 and 79, 12M \& 12F, will be included.

Exclusion criteria: History of GI surgery, primary esophageal motor disorders, any systemic disease, history of drug or alcohol abuse, pregnancy or nursing, allergy to the same drug class as rabeprazole, the need for any concurrent therapy that affects salivary secretion (causing so-called "dry mouth syndrome").
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.


Eligibility Criteria:
Inclusion Criteria:

Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC \>10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).

Exclusion Criteria:

Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
The ACTIVE Intervention to Improve Hospice Care

The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this randomized controlled trial (RCT) will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices.

The ACTIVE Intervention to Improve Hospice Caregiver Pain Management The major goal of this project is to implement and test this promising intervention in three hospice programs. The mixed methods evaluation of this RCT will provide evidence-based data for a tested intervention manual that hospice staff members can use to integrate the intervention into their practices. We will rigorously test the effectiveness of the ACTIVE intervention. We will investigate whether the assessment of the informal caregivers perception of pain management will identify those who will benefit most and whether changes in the perceptions of informal caregivers will result in improvement of patient pain. We will explore barriers and challenges in the implementation of this into every day practice within hospice

Eligibility Criteria:
Inclusion Criteria: Informal Caregiver Inclusion Criteria

1. Informal caregiver of an enrolled hospice patient
2. Age 18 or over and legally able to provide informed consent
3. Involved in decisions related to pain medications
4. Access to at least one of the below:

   1. A standard land line telephone
   2. A high-speed Internet connection with operational computer
5. Without functional hearing loss or with a hearing aid that allows the participant to conduct phone or Internet conversations as assessed by the research staff (by questioning and observation

   -

   Exclusion Criteria:Informal caregivers of hospice patients with a life expectancy less than 14 days as assessed by the hospice nurse with the palliative performance scale (PPS) (99)

   -
PIRA vs Standard Preoperative Education

The purpose of this study is to determine the feasibility and acceptability of enhanced preoperative education using a Pediatric Interactive Relational Agent (PIRA), designed for children ages 4 through10 years and their families, compared to the standard preoperative education currently provided. The study will also look at any differences in anxiety between the two educational groups.


Eligibility Criteria:
Inclusion Criteria:

* Parents (age 18+) and their children, ages 4 through 10 years old, who are undergoing general anesthesia and elective, outpatient ORL surgery at BCH Waltham
* American Society of Anesthesiology (ASA) physical status I or II
* Both parents and their children must be fluent in English

Exclusion Criteria:

* Parents without reliable internet access through a tablet or computer
* Parents of children with diagnosed developmental delays
* Parents who have children who have had previous surgical history under general anesthesia
* Parents of children involved in other anesthesia-related studies at BCH
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants who failed treatment in Study GS-US-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study
* Chronic genotype 1 HCV infection
* HCV treatment-naive
* HCV RNA \> 10,000 IU/mL at screening
* Absence of cirrhosis
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Infection with hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
* For HIV-1/HCV co-infected individuals:

  * Opportunistic infection within 6 months prior to screening
  * Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
  * Treatment with an antiretroviral (ARV) regimen other than one of those listed in the study protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Urodynamics and Clinical Factors That Are Associated With Bladder Over-sensitivity

Urodynamic examination evaluates storage and empting phases of the urinary bladder. It enables the clinician to correlate physiologic findings to patients' complains. The data gathered during the examination divided to storage and empting.

During the storage phase, bladder sensation is measured while the bladder is filled with sterile water. During years of practice, we noticed that early sensation (bladder over-sensitivity) is occasionally associated with bladder outlet obstruction (as demonstrated in the emptying phase of the examination.

The study includes patients who were referred to Urodynamics examination due to lower urinary tract symptoms. There is no actual intervention during the examination. Though, patients are asked to fill an International prostate symptom score (IPSS-questionnaires).

Eligibility Criteria:
Inclusion Criteria:

* All patients refered to Asaf HaRofeh Medical Center for Urodynamic examination

Exclusion Criteria:

* Inability to sign an informed concent
* Administration of analgesics 8 hours prior to the examination
* Known urethral stricture
* Chronic bladder or urethral pain
* Active cystitis
* Permanent urinary catheter
A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis

The purpose of this study is to determine if using Avonex in combination with Zocor is a safe and effective therapy for subjects with relapsing remitting multiple sclerosis.

Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; althoughthe majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manisfested by an increase inGadolinium enhancement on MRI and an increase in inflammatory bioassay markers.

Zocor is in a class of drugs (statins) that are used to lower cholesterol. Statins also have an anti-inflammatory effect on the CNS. Zocor has been shown in a small clinical trial to reduce the number of new MRI-detected brain lesions over a six month treatment period in patients with RRMS. This study is to evaluate the safety of combining Avonex with Zocor for a a period of fourteen months in patients with RRMS and to evaluate the effect of treatment on new or enlarging lesions as measured by MRI.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting MS using the MacDonald criteria.
2. Subjects must be taking some form of interferon therapy (Rebif, Avonex or Betaseron) for a duration of 12 months with documented breakthrough disease as defined:

   * or = 1 documented clinical relapse in past 12 months while on interferon therapy. For eligibility, a pre-study relapse is defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute MS relapse.

   The relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms.

   OR

   \> or = 1 documented Gd-enhancing lesion on cranial or spinal MRI. The presence of a Gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator.
3. The Kurtzke EDSS score must be between 0- 5.0.
4. All subjects must give written consent prior to evaluation and testing.

Exclusion Criteria:

1. Subjects with primary or secondary progressive MS.
2. Female patients may not be pregnant, attempting pregnancy or breastfeeding.
3. Female subjects must use an acceptable form of contraception during the study as defined by the investigators. The rhythm method is not to be used as the sole method of contraception.
4. Subjects unwilling or unable to give informed consent.
5. Subjects that are NAB+ (titers \> or = 20).
6. Abnormal baseline blood test exceeding any of the limits defined below:

   1. ALT or AST \> 2x upper limit of normal (ULN)
   2. CPK \> 2x upper limit of normal (ULN)
   3. Total WBC \< 3,000/mm3
7. No chronic infections (including HIV and Hepatitis B/C) may be present.
Open-label Leucovorin Pharmacokinetic Study in Patients Receiving High Dose Methotrexate With or Without Voraxaze

The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.


Eligibility Criteria:
Inclusion Criteria:

* Receiving High-dose methotrexate (HDMTX) with or without risk of methotrexate (MTX) toxicity, impaired renal function, and delayed MTX elimination
* Require intravenous leucovorin

Exclusion Criteria:

* Arm A only: allergic reactions to lactose
* Arm A only: hereditary fructose or galactose intolerance
* Arm B only: delayed elimination of MTX
Effect of Virtual Reality Training by Novices on Laparoscopic Cholecystectomy in a Porcine Model

This study proposes evaluation of an educational tool, a laparoscopic virtual reality simulator. The purpose of this study is to determine whether training on the LapSim Simulator transfers to improved laparoscopic cholecystectomy operative performance in an animal model.

This is study protocol involves the training and evaluation of general surgery interns on a laparoscopic simulator (LapSim®, Surgical Science Ltd, Göteborg, Sweden, version 3.0.

Eligibility Criteria:
Inclusion Criteria:

* Surgical interns (PGY 1) are eligible
* Twenty-five (25) participants will comprise this group

Exclusion Criteria:

* Prior clinical experience with laparoscopic surgery as the assistant surgeon.
* Prior simulation training (mechanical, PC-based or otherwise).