cyrilzakka/clinical-trials huggingface dataset:
Virtual Visits at Brigham and Women's Hospital

Clinicians slated for virtual visit rollout will be randomized (stratified by department) to either receive immediate virtual visit on-boarding (intervention arm) or delayed (3-months later) virtual visit on-boarding (control arm). The investigators plan to enroll no more than 200 clinicians.

Any clinician in a department selected by the Brigham Health Virtual Care team for access to virtual visits is eligible, unless s/he saw less than 20 patients monthly over the last 6 months.

The Brigham Health Virtual Care team will onboard all clinicians and provide virtual visit support as per their usual protocol. The primary study endpoint is third-available appointment, a well-adopted measure of access. Other secondary endpoints revolve around continuity, efficiency, utilization, safety, cost, and patient experience.

If enrolled in the intervention arm, the following steps will occur:

* The clinician will receive the intervention arm follow-up email ("Follow-up Email - Intervention" in the Appendix).
* The Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process.
* The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform (attached).

If enrolled in the control arm, the following steps will occur:

* The clinician will receive the control arm follow-up email ("Follow-up Email - Control" in the Appendix).
* Three months from the time of the follow-up email, the Brigham Health Virtual Care team will work with the clinician toward immediate on-boarding (software training, hardware setup, technical support) as per their usual process.
* The clinician will schedule virtual visits as s/he and/or her/his department see fit. Virtual visits occur on an already-in-use Partners- and Brigham-approved video platform (attached).

The investigators plan to follow patients of both clinician cohorts for a total of 6-months. The investigators will perform retrospective review of patient electronic health records and patients will receive a redcap survey (attached), an evaluation mechanism already employed by the Virtual Care team.

Again, aside from the initial randomization and retrospective data collection and analysis, all of the above would have occurred irrespective of this research protocol.

Eligibility Criteria:
Inclusion Criteria:

* Clinician whose department is chosen for virtual visit rollout

Exclusion Criteria:

* Clinician who saw on average fewer than 20 patients monthly over the past 6 months
* Clinician who opts out of virtual visits
Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels in Familial Hypercholesterolemia

Familial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation.

The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of HeFH subjects.

The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C concentration variability and are associated with Lp(a) levels.


Eligibility Criteria:
Inclusion Criteria:

Subjects with familial hypercholesterolemia:

* Aged between 18-65 years
* Carrier of a mutation in the LDL receptor gene

Controls:

* Aged between 18-60 years
* HDL-cholesterol \> 1.1 mmol/L
* Triglycerides \< 1.7 mmol/L
* Fasting blood glucose \<6.1 mmol/L
* Normal blood pressure (\<130/85)

Exclusion Criteria:

* Subjects with a previous history of cardiovascular disease
* Subjects with Type 2 diabetes
* Were pregnant or nursing;
* Subjects with a history of cancer
* Subjects with acute liver disease, hepatic dysfunction, or persistent elevations of serum transaminases
* Subjects with a secondary hyperlipidemia due to any cause
* History of alcohol or drug abuse within the past 2 years
* hormonal treatment
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Rib Fracture Cryoanalgesia

Rib fractures lead to poor patient outcomes and even death 3. Data suggests effective pain management is crucial to obtain favorable outcomes 4, 5Current outpatient treatment modalities are limited to oral or topical medications with low efficacy and high risk for opioid dependence. In-patient management with a thoracic epidural TEA is largely considered the gold standard, but the risks of TEA may outweigh the benefits 6 to 8.

Methodist Dallas Medical Center MDMC is an urban Level I Trauma Center that manages over 200 rib fracture cases annually. MDMC has a history of developing and using innovative analgesia techniques aimed at improving outcomes. In 2010 we first described the need for advancements in the treatment of rib fracture patients 1. Later, we validated the technique that is now used at hundreds of trauma centers around the world 2. Our surgical and research teams have a history of advocating for optimal management of rib fracture pain in order to prevent serious complications.

This study will seek to describe the effective use of cryoanalgesia as a feasible method of pain management in the rib fracture patient. With a small cohort and case series, we will describe and refine the procedure and preliminary efficacy of the FDA-approved iovera system in adult rib fracture patients. In order to ethically assess the clinical relevance of the iovera system, our objective will be accomplished by completing a case series

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age Acute pain attributed to rib fracture(s) Able to obtain consent

Exclusion Criteria:

* \<18 years of age Pregnant Incarcerated Confounding injuries or significant pain attributed to secondary injury Patients with any of the following: cryoglobulinemia; paroxysmal cold hemoglobinuria; cold urticarial; Raynaud's disease; open and/or infected wounds at or near the treatment site
Pemoline in the Treatment of Stimulant Dependence - 5

The purpose of this study is to assess the efficacy of pemoline in treating cocaine and/or methamphetamine dependent adults with comorbid Adult Attention Deficit Hyperactivity Disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome

Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (ASRM-ESHRE Rotterdam criteria)
* BMI of 30 kg/m2 or higher

Exclusion Criteria:

* significant cardiovascular disease
* significant kidney or hepatic disease
* personal or family history of medullary thyroid carcinoma
* known history of gallbladder disease
* known history of pancreatitis
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM

This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
* BMI = 18.5-35 kg/m2 (inclusive) at screening.
* Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
* 7.0% ≤ HbA1c ≤ 11.0% at screening.

Exclusion Criteria:

* Women in pregnancy or lactation.
* Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
* Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
* Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
* Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
* Known or suspected hypersensitivity to trial product(s).
* Participation in a clinical study of another study drug within 1 month prior to randomization.
Evaluation of Stigma and Related Factors in Fibromyalgia

Stigmatization is especially studied in mental disorders such as schizophrenia. In recent years, different chronic diseases such as AIDS, tuberculosis, and diabetes have also been shown to decrease in quality of life due to the "stigma" of these patients.

Stigmatization is especially studied in mental disorders such as schizophrenia. In recent years, different chronic diseases such as AIDS, tuberculosis, and diabetes have also been shown to decrease in quality of life due to the "stigma" of these patients. Fibromyalgia patients with chronic widespread body pain and accompanying subjective fatigue, depression, and anxiety; Although there is no objective pathology from the outside, it can be stigmatized in family life, work-life and health institutions they apply for the diagnosis of pain due to the intensive complaints. The fact that the subjective complaints seen without an objective pathology are so severe makes the management of these patients difficult. To reveal the presence of stigma in patients diagnosed with fibromyalgia compared with the healthy control group is the main aim of this study. It is the secondary purpose of this study to determine related factors such as gender, age, educational status, marital status, employment status, income level, pain duration, pain intensity, medications used, and social support received from patients' family and the environment. We hypothesize that this group of patients suffers more stigma and the quality of life decreases due to this stigma.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* To be diagnosed with fibromyalgia according to American College of Rheumatology 2016 revised criteria

Exclusion Criteria:

* Have been diagnosed and treated with fibromyalgia before
* Presence of any diagnosis that can cause secondary fibromyalgia (rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis)
* The presence of anemia
* Vitamin D deficiency
* Presence of known endocrine, neurological and cardiac diseases
* Antidepressant use
Pilot Study of Ultrasound in Rheumatoid Arthritis

Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made.

This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis with symptom onset at least 12 months previously
* Current disease-modifying anti-rheumatic drug (DMARD) therapy or biologic therapy
* Currently stable arthritis defined as no change in DMARD treatment over previous 6 months, and no use of steroids (enteral, parenteral or intra-articular) over previous 6 months

Exclusion Criteria:

* Inability to provide informed consent
* Current or recent (within 4 months) participation within another clinical trial
Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction

Effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial


Eligibility Criteria:
This study will include a non-probability purposive sample of 136 infertile women undergoing IVF recruiting from the outpatient clinics according to the following inclusion criteria:

* age 20 to 45 years
* having a general health score below 28,
* can read and write,

Exclusion criteria include:

* psychiatric problems,
* previous assisted reproductive technology failure,
* leave the intervention for any reason and
* women suddenly experience severe traumatic or psychological events.
Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.

Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Diagnosis of adenocarcinoma of the lung
* Patient has had at least one core biopsy of her tumor
* Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
* Stage four (IV) or three (III) B non-small cell lung cancer
* Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
* Three or more weeks since last radiation therapy
* Three or more weeks since last major surgery
* Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
* Life expectancy of 8 weeks or more
* Blood tests that show kidneys, liver and bone marrow to be working adequately
* Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study

Exclusion Criteria:

* Prior exposure to Tarceva (OSI-774, erlotinib)
* Uncontrolled central nervous system problems
* Prior chemotherapy regimen
* Difficulty swallowing
* A disease or disorder that interferes with ability to digest and absorb food
* Incomplete healing of previous oncologic or other major surgery
* Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
* Pregnant or breast feeding
* A medical condition that could make it unsafe for patient to participate in this study
Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.

Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.

This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.

Eligibility Criteria:
Inclusion Criteria:

* Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:

  * aCL IgG/M (\>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or
  * aβ2GPI IgG/M(\>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or
  * Positive LA test based on the International Society of Thrombosis \& Haematosis Recommendations

Selected Exclusion Criteria:

* History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis
* History of Transient Ischemic Attack Confirmed by a Neurologist
* SLE Diagnosis based on the ACR Classification Criteria \> 4/11
* Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria
* Current Hydroxychloroquine or another antimalarial treatment (-3 months)
* Current warfarin treatment (-3 months)
* Current heparin therapy( -3 months)
* Current pregnancy
* History of Hydroxychloroquine eye toxicity
* History of Hydroxychloroquine allergy
* Known glucose-6-phosphate dehydrogenase deficiency
A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain

The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain from interstitial cystitis and/or painful bladder syndrome.

This study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared with placebo in patients with moderate to severe, chronic bladder pain from Interstitial cystitis (IC) and/or painful bladder syndrome (PBS). Interstitial cystitis (IC) and PBS are urological disorders characterized by symptoms of bladder pain, urinary urgency, urinary frequency, and the need to get up during the night in order to urinate. The study has 3 phases: a screening phase (up to 3 weeks), a double-blind treatment phase (12 weeks), and a post-treatment phase that ends 26 weeks after the last dose of study medication. The study duration will be approximately 36 to 46 weeks.

A single dose of JNJ-42160443 (9 mg/ml) or matching placebo given as an injection under the skin once every 4 weeks for up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pelvic pain (\>6 months) perceived to be related to the urinary bladder and accompanied by urinary symptoms such as frequent urination during the day and/or night, and/or urgency to void
* Total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
* The mean of the average pain intensity scores at screening phase \>=5 (on a scale of 0 to 10)
* Medically stable

Exclusion Criteria:

* Urinary culture is positive for a urinary tract infection; Recent invasive therapy to the bladder
* History or current conditions indicating that the bladder pain can be caused by diagnoses other than IC/PBS (eg, pain caused by a confirmed or suspected neoplasm)
* History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated
* Women who are pregnant or breast-feeding
* A body mass index (BMI) of \>39 kg/m2
Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy

The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of intravenous ARB-001467

Approximately 24 subjects will be enrolled in three cohorts: two cohorts of HBeAg-negative subjects and one cohort of HBeAg-positive subjects and 12 HbeAg-negative subjects will be enrolled in cohort 4. All subjects will be non-cirrhotic, with chronic hepatitis B virus (HBV) infection, and will have been receiving nucleos(t)ide-analogue (NA) therapy with entecavir or tenofovir for at least 12 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Documented chronic HBV infection for ≥12 months prior to Screening Visit.
* Quantitative HBsAg ≥1000 IU/mL at the Screening Visit.
* Subjects currently receiving entecavir and/or tenofovir for ≥12 months and HBV DNA undetectable.

Key Exclusion Criteria:

* Known co-infection with HIV, hepatitis C virus, and hepatitis D virus.
* Receiving or planning to receive systemic immunosuppressive medications during the study or ≤2 months prior to the first dose of study treatment.
* Receiving or planning to receive interferon during the study or ≤12 months prior to the first dose of study treatment.
* Significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia.
* Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine ≤12 months prior to the Screening Visit.
* Any known pre-existing medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings.
Wheelchair Positioning and Neuromuscular Diseases

This database will describe sitting postural control in wheelchair, as well as PW pain, and pressure ulcers associated with sitting, in patients with neuromuscular disease (NMD).

Neuromuscular diseases are genetic diseases of the muscle or its innervation (nerve connection) causing respiratory, cardiac and especially motor difficulties which may require use of wheelchair. However there is no standardized positioning protocol, so it seems interesting to us to study wheelchair positioning in neuromuscular diseases).

The purpose of this study is to describe sitting posture in the wheelchair in patients with neuromuscular disease, pain associated with using the wheelchair, but also to assess the effectiveness of the recommended equipment making the same evaluations in follow-up consultation (a few months after receipt of the prescribed TAP).

Posture is assessed by the tool: Measurement of Postural Control in Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0), which is a validated tool.

Pain is assessed by a Simple Verbal Scale or by a Visual Analog Scale. This database could allow providing guidelines of good practice, for wheelchair positioning for patients with neuromuscular disease.

Eligibility Criteria:
Inclusion Criteria :

* Patient with neuromuscular disease
* Written informed consent (IC) obtained
* Adult patients (\> 18 years) Or
* Adults under guardianship who has given theirs oral consent and guardian's consent obtained Or
* Childs who has given theirs oral consent and parents' consent obtained
* Wheelchair user

Exclusion Criteria :

• Patient not seen in positioning consultation by N. Pellegrini and / or E. Dupitierr
Symbicort Onset of Action 2

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of asthma and baseline lung function test results as determined by the protocol
* Required and received inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma or asthma that is markedly effected by seasonal factors
* Has required and received non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers