cyrilzakka/clinical-trials huggingface dataset:
Diphenhydramine for Acute Migraine

Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite the fact that data supporting this practice do not exist. The investigators propose a randomized double blind study to test the hypothesis that 50mg of intravenous diphenhydramine, when added to standard migraine therapy, will result in a greater rate of sustained headache relief than standard migraine therapy alone. For this study, standard migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patients who present to the Montefiore emergency room (Bronx, NY) with an acute migraine will be approached for participation. They will be screened for medication contra-indications and non-migraine etiologies of headache. The study will be randomized. Assignment will be concealed. Participants and researchers will be blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours in the Emergency Department and by telephone 48 hours after medication administration. A sample size calculation, based on pilot data, revealed the need for 374 participants. An interim analysis will be performed after 200 participants have been enrolled with the goal of assessing for lack of conditional power.


Eligibility Criteria:
Inclusion Criteria:

* Acute migraine headache
* Present to our emergency room in the Bronx, NY for treatment of migraine headache

Exclusion Criteria:

* Temperature \> 100.3 F
* Pheochromocytoma
* Seizure disorder
* Parkinson's disease
* Use of monoamine oxidase (MAO) inhibitors
* Use of anti-rejection transplant medications
* Use of potassium supplements
* Use of pramlintide
Pre Procedural Biomarkers Might Predict Recurrent Atrial Fibrillation After Catheter Ablation

Evaluation of the predictive value of serum levels of adipocytokines and primary phase reactant for recurrent atrial fibrillation (RAF) after catheter ablation in 26 patients had persistent and 91 patients had paroxysmal AF. During 12-m follow-up, 41 patients had RAF (35%). Patients had RAF were significantly older, had significantly higher BMI, lower ejection fraction and wider maximal left atrial diameter (LAD). Serum hs-CRP, IL-6, TNF-α, visfatin, and adiponectin levels were significantly higher in patients developed. Elevated serum levels of TNF-α, visfatin and adiponectin are a significant positive predictors for RAF.

Objectives: Estimation of serum levels of visfatin, adiponectin, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) in patients had atrial fibrillation (AF) resistant to medical treatment and assigned to catheter ablation (CA) to evaluate these biomarkers as predictors for recurrent AF (RAF).

Patients \& Methods: 117 patients; 26 patients had persistent and 91 patients had paroxysmal AF underwent had clinical and echographic evaluations and gave blood samples for ELISA estimation of serum levels of studied cytokines. CA was performed through isolation of all pulmonary veins according to the stepwise procedure of ablation. Patients were re-evaluated every three months till 12-m follow-up for post-procedural RAF.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic paroxysmal or persistent AF that was resistant to medical acceptable daily dose therapy in patients who were free of exclusion criteria and accepted to sign the written fully informed consent to undergo CA and to give pre-procedural blood samples.

Exclusion Criteria:

* History of the presence of longstanding persistent or permanent AF,
* myocardial infarction, acute coronary syndrome (ACS),
* significant heart failure (NYHA3),
* dilated or hypertrophic cardiomyopathy,
* left ventricular ejection fraction (LVEF)\< 35%, congenital pathologies,
* significant valvular heart disease,
* pulmonary embolism,
* venous thrombosis,
* intracardiac thrombus or inability to take warfarin or other oral anticoagulants,
* hepatic or renal insufficiency,
* acute inflammatory states (sepsis, chronic obstructive pulmonary disease in acute phase),
* cancer,
* autoimmune pathologies.
Laser and Therapeutic Ultrasound in the Management of the Chronic Non-specific Low Back Pain

The objective of this study is evaluate the laser and ultrasound effect on pain and disability in women with non-specific chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* non-specific chronic low back pain
* moderate pain
* eutrophics women

Exclusion Criteria:

* disk herniation
* cardiac diseases
* psychiatrics diseases
* endocrinous diseases
* fractures of the spine
* fractures of lower members
* diabetics
* dental emergency
* local infections
* local non sensibility
* analgesics and anti-inflammatories in use
* neurologic diseases
* pregnancy
Vitamin D Intervention in Infants - 6 Years Follow-up (VIDI2)

Exposure to vitamin D intervention in early life may have permanent effects on physiology and metabolism. Bone growth and mineralization, development of immunity, body composition and brain structure and functioning may be affected. The importance of a long-term surveillance includes follow-up of both beneficial but also harmful effects of vitamin D.

Vitamin D intervention in infants (VIDI) study was conducted in 2013-2016. VIDI study was a large randomized trial that aimed to evaluate effects of two vitamin D supplemental doses of daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections, immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic regulation of mineral homeostasis. Current study is a 6 Years Follow-up (VIDI2) study of the original VIDI trial.

Our focuses of interest in the follow-up are: bone strength, growth pattern, body composition, and morbidity due to infections and allergic diseases, and the development of immunity. Further, in addition to more classical associates of vitamin D, our aim is to continue to follow-up children's neurocognitive development and mental health. We will also focus on the effect of vitamin D supplementation on occurrence of molar-incisor hypomineralization, dental caries, and oral immunity.


Eligibility Criteria:
Inclusion Criteria:

All who participated in the original VIDI study until last study visit at the age of 2 years.

Exclusion criteria:

None
GSI Cardiac on Revolution Apex - US

The goal of this clinical data collection study is to collect raw CT scan data using a new GSI Cardiac mode on GE HealthCare's Revolution Apex CT system.

Two groups of participants will be enrolled:

A) Participants scheduled to undergo a Coronary CT Angiography (CCTA) as part of their standard of care

B) Participants scheduled to undergo a cardiac catheterization or have a history of heart attack

Participants in Group A will:

-Have a standard of care CCTA immediately followed by a research GSI Cardiac scan

Participants in Group B will:

-Have a research CCTA immediately followed by a research GSI Cardiac scan

Both groups will be in the study for approximately 1 day. There are no follow-up visits after the day of scan.


Eligibility Criteria:
Inclusion Criteria:

Subjects may be included in this study if they meet the following criteria:

1. Who are ≥18 years of age;
2. Able to sign and date the informed consent form; AND,
3. Cohort A: Undergoing a scheduled clinically indicated CCTA; OR,
4. Cohort B: Known history of myocardial infarction or undergoing a clinically indicated cardiac catheterization due to known pathology.

Exclusion Criteria:

Subjects may be excluded from participating in study if they meet any of the following criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. Anyone with known or suspected allergy to iodinated contrast agents;
4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are in need of urgent or emergent care;
6. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject;
7. Who are unwilling to have GEHC personnel present for the CT exam; AND,
8. Cohort A: Undergoing a scheduled clinically indicated CCTA for anatomy assessment (aberrant origin, etc.)
Cell-free DNA in Hereditary And High-Risk Malignancies

The goal of this study is to develop an effective, sensitive blood test that can detect early tumours in patients with known or suspected hereditary cancer syndromes (HCS). If this new blood test is accurate, it could be used to screen patients for cancer and allow for earlier cancer detection. The study will also use questionnaires and interviews to understand how patients feel about incorporating these tests into routine medical care, and the perceptions of the medical value of test results.

The objective of this protocol is to develop a method to detect early signs of cancer in 'previvors' (people with HCS that do not yet have a cancer diagnosis). This will enable prediction of cancer onset so that patients and their doctors can make decisions to treat or prevent the cancers. HCS patients will be recruited from across Canada to provide blood samples before and after cancer diagnosis. In parallel, there will be development of a circulating tumour DNA (ctDNA) -based test to detect early stage cancer and evaluation on the cost-effectiveness and feasibility of integrating such screening protocols into routine clinical care. In concert, consultation with patients and health care providers will occur to create recommendations for use within clinical care.

Eligibility Criteria:
Inclusion Criteria:

1. Individual with any known or suspected hereditary cancer predisposition (i.e. individuals with an identified pathogenic or likely pathogenic variant in a cancer predisposition gene and/or a family history of cancer without an identified gene mutation) at any stage in their cancer journey (ie: cancer survivor, unaffected with cancer, current cancer patient).
2. Individual must be greater than 18 years of age
3. Individual must speak English or French to participate in the qualitative interview and/or survey

Exclusion Criteria:

1. Individuals that do not meet the outlined inclusion criteria.
Life Cycle Assessment of Different Types of Anesthetic

Following Ethics approval, all adult patients undergoing surgery to fix the wrist fracture will be approached and consent to undergo this study. The amount of waste generated from general anesthetic, regional anesthetic and regional+general anesthetic will be collected and weighed.

Patients undergoing this type of wrist surgery have only regional anesthetic, or general anesthetic, or both ie. regional anesthetic and general anesthetic.

The aim of the study is to compare the amount of waste generated from each type of anesthetic and this will give us a better idea of which anesthetic is more environmentally sustainable.

Following Ethics approval, all adult patients undergoing surgery to fix the wrist fracture will be approached and consent to undergo this study. The amount of waste generated from general anesthetic, regional anesthetic and regional+general anesthetic will be collected and weighed. Waste will include disposable and reusable wastes. Examples of disposable waste are all plastic packaging, syringes, needles, breathing tube, breathing circuits, gloves as well as drugs. Examples of reusable waste will be anesthetic face mask, laryngeal mask (which is a form of airway device that can be reprocessed), sterile gowns. The amount of anesthetic gas used will be obtained from the anesthetic machine.

Patients undergoing this type of wrist surgery have only regional anesthetic (freezing performed higher up in the arm to numb the whole arm for several hours), or general anesthetic (patient completely goes to deep anesthetic sleep), or both ie. regional anesthetic (freezing just for pain control afterwards) and general anesthetic (patient goes to deep anesthetic sleep after the freezing is done and they may need less pain killer during the surgery as well as afterwards).

The amount of waste generated will be compared amongst these 3 groups by life cycle analysis.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing open reduction and internal fixation of wrist
* ASA 1-3

Exclusion Criteria:

* no contraindications for general anesthetic in the group for general anesthetic and vice versa
Clinical and Molecular Study of Endometriosis and Adenomyosis

The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.

Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10% of women, that typically cause pain and / or infertility, thereby exerting a negative impact on the patients' quality of life.

Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely accepted pathophysiological hypothesis for endometriosis is that of the implantation of ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into the myometrium, presenting different forms: diffuse, focal or cystic.

Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult and affected patients are subject to a long delay for appropriate management.

We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore, highlighting specific clinical and molecular markers would shorten the diagnostic time.

Eligibility Criteria:
Inclusion Criteria:

* Women of age between - 18 and 42 years old.
* In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.
* Having a radiological diagnosis made by a referral practitioner and/or operated in the department

Exclusion Criteria:

* HIV-positive women, HBV and HCV
* During pregnancy
* Having a cancer diagnosis
* Refusing to sign a consent.
To Explore the Factors Affecting the Effectiveness of Smoking Cessation

Objectives:

Promoting quitting smoking and training smoking cessation educators in hospital, school, community, and workplace was being vigorously pushed by Health Promotion Administration. Since the implementation of the second-generation smoking cessation program by Health Promotion Administration, both the general public and medical institutions have worked with greater vitality to practice and promote quitting smoking. However, studies on smoking cessation in the inpatient remain inadequate. Increasing cessation motivation for inpatient smokers and evaluating their nicotine dependence are essential. In this study, we aimed to explore the factors that might influence the smoking cessation in the inpatients.

Method: A cross-sectional questionnaire survey was conducted on inpatients participants at the smoking cessation.

Questionnaire comprising（1）Demographic characteristics: age, sex, marital status, education, （2）physiological factors（concentration of carbon monoxide, nicotine dependence, disease severity）,（3）psychological factors（psychological dependence on smoking , smoking cessation stages of behavior change, smoking cessation self-efficacy）, （4）Social Factor: social support,（5）smoking Behavior indicators: smoked, daily cigarette consumption, smoking experience. After giving health education cessation of treatment one month, three months and six months, interviewed by telephone quitting behavior index contains daily cigarette consumption, quit rates point.


Eligibility Criteria:
Inclusion Criteria:

* being a current smoker (who had smoked more than 100 cigarettes in their lifetime),
* aged \> 20 years,
* with clear consciousness,
* being able to communicate using Mandarin or Taiwanese

Exclusion Criteria:

* with acute psychiatric disorders,
* inability to complete the questionnaire
Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Special Drug Use Surveillance of Vaccinees After the First Vaccination

The purpose of this survey is to assess the safety freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.

This survey was designed to assess the safety of live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.

Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection \[Japanese Pharmacopoeia\]), wherein a 0.5-mL portion is typically administered subcutaneously as a single dose.

In addition, freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) should be used in accordance with the "Regulations for Vaccination" and the "Guidelines for Routine Vaccination."

Eligibility Criteria:
Inclusion Criteria:

-Vaccinees who meet both of the following conditions \[1\] and \[2\]:

1. Vaccinees who have no prior history of either measles or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) as the initial vaccination.
2. Vaccinees whose guardians are able to participate in a questionnaire survey on the health status of vaccinees after vaccination with freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain).

Exclusion Criteria:

-
Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Patients With AMD

The purpose of his study is to evaluate the long term safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry Age-Related Macular Degeneration (AMD) from one to five years following the surgical procedure to implant the MA09-hRPE cells.

This study is a long term, follow up to the ACT MA09-hRPE 001 phase I/II trial. The phase I/II trial (referred to as the core protocol) was an open-label, non randomized, dose escalation, multi-center trial. Thirteen AMD patients were treated in this trial. Ten patients with profound vision loss (visual acuity \<= 20/400) received a single subretinal injection of MA09-hRPE cells, starting at a dose of 50,000 MA09-hRPE cells transplanted (three patients), 100,000 MA09-hRPE cells transplanted (three patients), 150,000 MA09-hRPE cells (three patients) and increasing to a maximum dose of 200,000 MA09-hRPE cells transplanted (one patient). Three patients with severe to moderate loss (visual acuity \<= 20/100) received a dose of 100,000 MA09-hRPE cells. All patients who participated in the core protocol are eligible for participation in this follow-up protocol. The first visit of this long term follow-up protocol will correspond to the last visit of the core protocol, and will take place at 12 months post cell implantation. Informed consent will be obtained at this visit. Patients will be evaluated at 18, 24, 36, 48 and 60 months post-transplant (or more frequently as clinically indicated). Follow-up will include obtaining information about ophthalmological findings and events of special interest as defined in the Primary Outcome. At the last visit of this follow-up study, whether at 60 months post-transplant or at early discontinuation, patients will be invited to participate in a safety surveillance study for an additional 10 years under a separate protocol which will continue to monitor the long term risks of MA09-hRPE cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Must have been treated with hESC-RPE cell transplant in the core protocol.
* Able to understand and willing to sign the informed consent to participate in the follow up study.

Exclusion Criteria:

- There are no exclusion criteria.
The 36-month Extension to Follow up Sub Study

The purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic Syndrome (PTS) during the 2 years of follow up in the SOX Trial.

The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) for two years following DVT could be helpful in preventing or delaying onset of PTS at three years, however data supporting this is limited.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
* Who have no contraindications to standard treatment with heparin and/or warfarin, and
* Who provide informed consent to participate

Exclusion Criteria:

* Contraindication to compression stockings
* Limited lifespan (estimated \< 6 months)
* Geographic inaccessibility preventing return for follow-up visits
* Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
* Treatment of acute DVT with thrombolytic agents
Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle

Occlusive or ischemic training is a type of strength training which is becoming more and more popular every day. The safety, efficacy and detailed description about the use of occlusive training is well documented in the literature. However, the effects on hypertrophy and the stiffness of the muscle tissue are not studied. We aimed to measure these changes by ultrasound technology in a randomized controlled design.

Patients were randomized into classical hypertrophy and occlusive hypertrophy groups. The participants are free from any systemic disease, infection or recent injury. Both groups perform hypertrophy training with different intensities. The outcome measures are; thickness determined by B-mode ultrasound and stiffness by shear-wave elastography. Comparison of both groups will be made.

Eligibility Criteria:
Inclusion Criteria:

* Healthy recreational athletes

Exclusion Criteria:

* Any kind of systemic disorder
* Active or chronic infection
* Recent (last 6 months) musculoskeletal injury
* Performed strength training at last 72 hours