cyrilzakka/clinical-trials huggingface dataset:
Transcranial Magnetic Stimulation (TMS) for CRPS

The purpose of this pilot study is to test the durability of response to Transcranial Magnetic Stimulation (TMS) for the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS for varying lengths of time in a pilot study to investigate what the clinical impact.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of CRPS (complex regional pain syndrome)
* Average pain level reported on Numerical Rating Scale meets entry criteria
* Ability to perform the experimental task and procedures.

Exclusion Criteria:

* MRI contraindication (metal implants or devices, claustrophobia)
* TMS Contraindication (eg metal implant or devices near the site of stimulation)
* History of epilepsy
* History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
* Neurologic illness that would interfere with brain integrity
* Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
* Currently pregnant or planning to become pregnant.
* On going legal action or disability claim.
Dual Mobility in "High Risk" Patients

The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.

This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.

We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.

Study Design: Randomized controlled trial with two groups: THA with dual mobility.

44 components vs THA with single-bearing designs

Eligibility Criteria:
Inclusion Criteria:

* Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (\>10 drinks per week), acute displaced femoral neck fracture, age \> 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation \> 115 degrees).

Exclusion Criteria:

* Less than 18 years of age
* Revision THA
* spinopelvic fusion that is more recent than 6 months prior to THA
* isolated cervical or thoracic fusion
* intent to undergo a revision spinopelvic fusion within one year of their index THA
* a history of prior infection in the affected hip
* a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)
* or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches

Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.

To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) greater than or equal to 18.
* Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy
* Willing to refrain from excessive use of alcohol from 48 hours prior to patch application through completion of the study.

Exclusion Criteria:

* Known or suspected pregnancy
* Lactating women
* Status post-partum or post-abortion within a period of 2 months prior to the start of study medication
* A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater
* Smoking
* Hypertension (blood pressure \>140 mm Hg systolic and/or \>90 mm Hg diastolic)
* Valvular heart disease with complications
* ECG (in women with BMI ≥35 kg/m2) with clinically significant findings
* Diabetes Mellitus
* History of headaches with focal neurological symptoms
* Uncontrolled thyroid disorder
* Sickle cell anemia
* Current or history of clinically significant depression in the last year
* Known disturbance of lipid metabolism
* Acute or chronic hepatocellular disease with abnormal liver function
* Hepatic adenoma or carcinoma
* Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
* Plans for major surgery
* History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
* Undiagnosed abnormal genital bleeding
* Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia
* History or presence of dermal hypersensitivity in response to topical applications (bandages, surgical tape, etc.)
* Use of an injectable hormonal contraceptive within the past 10 months prior to the screening visit
* Use of a contraceptive implant or hormone-medicated intrauterine device (IUD) within 1 month prior to the screening visit
* Use of oral contraceptives or other sex steroid hormones within 2 months prior to the screening visit
* Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit
* A recent history (within prior 2 years ) of drug or alcohol abuse
Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors

This study is aimed to demonstrate the long-term effectiveness of 8-week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients.

Background: In recent years, there has been an increase in case number of patients with young colon cancer (YCC). After curative treatment, YCC survivors have more opportunities to meet physical, social and economic burdens. Furthermore, YCC survivors may suffer poor quality of life and depression symptoms related to disease treatments and specific post-treatment care intervention is in unmet need.

Objective: The precision nursing education program will be developed through the eflipped classroom model, including the care of physical symptom based on the patients' needs, Qigong exercise, and mindfulness training. To evaluate the effect of these interventions, the questionnaire of the quality of life of YCC survivors will be employed.

Method: A randomized controlled trial containing 110 patients aged between 20 and 50 years old will be conducted. After completion of curative operation and adjuvant treatments, the subjects will be randomly assigned to a control group, in which routine nursing education care will be provided, and an intervention group, in which 8-week precision nursing education program through the e-flipped classroom model will be applied. The outcome measures include EORTC QLQ-C30, EORTC QLQ-CR29, BDI Depression Scale, Constructed Meaning Scale and FFMQ. The time-points of outcome measures include pre-intervention, post-intervention (at the end of the intervention), and 3, 6 and 9 months after the end of intervention. Univariate analyses will be performed to examine the intervention outcomes among basic characteristics of subjects. Correlation analyses will be performed to investigate the relationships between intervention outcomes and different variables. Comparisons of mean scores in the dependent variables between the experimental group and control group over the five time-points will be used in the generalization of estimating equation models.

Contribution: This study is aimed to demonstrate the long-term effectiveness of 8- week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients.

Eligibility Criteria:
Inclusion Criteria:

* survivor was diagnosed as colon, rectal, colorectal, or/and anal cancer
* aged at least 20 years
* have had completed cancer treatments within the five years prior to enrolling in the study.
* agree and obtain written consent
* could using the online media(ex: Zoom or Google meet..) to attend intervention course

Exclusion Criteria:

* diagnosed with stage IV cancer
* had a recurrence of CRC cancer
* had the other type cancer diagnosis
* now are undering cancer treatment
Patient Navigation for Lung Screening at MGH Community Health Centers

To develop and implement a patient navigator (PN) program for lung screening and smoking cessation in community health center primary care practices. This program will be evaluated in a randomized controlled trial of primary care patients who currently smoke.

The specific aims of this study are:

Specific Aim 1: To develop a patient navigator (PN) program for lung screening for patients who are current smokers, aged 55-77 years, potentially eligible for lung screening and are receiving care at community health centers (CHCs) affiliated with MGH.

Specific Aim 2: To evaluate the effectiveness of the new lung screening PN program in improving screening rates and increasing use of tobacco cessation services in a randomized controlled trial.

Specific Aim 3: To demonstrate that equity is maintained in rates of lung screening and in follow up of abnormal chest CT results, comparing eligible smokers from CHCs with eligible smokers from other practices within the MGH primary care network.

Eligibility Criteria:
Inclusion Criteria:

1. adult patients aged 55-77 years who are current cigarette smokers (according to an algorithm using electronic medical record data), and
2. receive care at one of the five Massachusetts General Hospital community health centers.

Exclusion Criteria:

1. patients who have previously received a diagnosis of lung cancer,
2. have undergone a chest CT within 18 months before enrollment,
3. are subsequently identified as having died prior to the study intervention,
4. deemed by their primary care provider as not eligible for lung screening.
Pulmonary Disease in Patients Referred for Coronary CT

Several studies show an association between chronic obstructive pulmonary disease (COPD) and coronary artery disease (CAD). Besides risk factors such as smoking, both are associated with physical inactivity, advanced age and systemic inflammation The use of coronary computed tomography (CCT) with multiple detectors is a diagnostic method for coronary disease, describing the anatomy and severity of arterial obstruction. One way of estimating the cardiovascular risk is coronary calcium score (CCS). Due to the association between COPD and CAD, it is likely that many patients with IHD diagnosed by CT have reduced lung function.

The aim of this observational study is to establish the correlation between the CCS and lung function. It will also correlate the presence of irreversible airway obstruction with significant coronary lesions.

Patients over 40 years referred to CCT who agree to participate in the study will perform a spirometry with bronchodilator and collect a blood sample to measure serum markers of inflammation and cardiovascular risk (glycemia, lipid profile, C reactive protein (CRP), tumor necrosis factor-alpha (TNF-Alpha) and fibrinogen). The data will be compared in the general population and in subgroups: smokers, former smokers and nonsmokers.

One year after the CCT patients will be contacted by the investigators and accessed for emergency room visits, hospital admissions and fatal or nonfatal coronary or respiratory events.

The investigators hypothesis is that reduced lung function is independently associated with elevated CCS and is, also a risk factor for increased hospital admission and coronary events.

The concomitant assessment of lung function and CCS can contribute knowledge about the epidemiological association between pulmonary disease and CAD. This can also add to evidence for the use of spirometry as a marker of cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for coronary CT.
* Age greater than 40 years

Exclusion Criteria:

* History of myocardial revascularization (surgical or percutaneous)
* Cognitive-functional incapacity to perform spirometry
* Contraindication for administration of 400 mcg of albuterol
* Acute myocardial infarction or unstable angina within 2 weeks
* Angina pectoris class III or IV according to the Canadian Cardiovascular Society
* Heart failure New York Heart Association class III or IV
A Comparison of 000-0551 Lotion Versus Vehicle Lotion in Subjects With Plaque Psoriasis (Study -304)

This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area.
* Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.
* If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.

Exclusion Criteria:

* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
* Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
* Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.
* Subject has used any systemic methotrexate, retinoids, systemic corticosteroids \[including intralesional, intra-articular, and intramuscular corticosteroids\], cyclosporine or analogous products within 90 days prior to study start.
* Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start.
* Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.
* Subject has used topical body (excluding the scalp) psoriasis therapy (including coal tar, anthralin, steroids, retinoids, vitamin D analogs) within 14 days prior to study start.
* Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start.
* Subject is currently using lithium or Plaquenil (hydroxychloroquine).
* Subject is currently using a beta-blocking medication (e.g., propanolol) or angiotensin converting enzyme (ACE) inhibitor at a dose that has not been stabilized.
* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject is currently enrolled in an investigational drug or device study.
* Subject has used an investigational drug or investigational device treatment within 30 days prior to study start.
* Subject has been previously enrolled in this study and treated with a test article.
Comparison of the Postoperative Analgesic Efficacy of SPSIPB and ESPB in Anterior Cervical Discectomy

Anterior cervical discectomy is an operation performed for complaints of pain, numbness or loss of strength due to cervical disc disease. With this operation, pressure due to herniation on the upper neck area, spinal cord or nerve roots is relieved. It is performed by microscopic method from the front of the neck.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare the analgesic effectiveness of serratus posterior superior intercostal plane block and erector spinae plane block, with each other and with the control group in the postoperative period in patients who underwent anterior cervical discectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II-III
* Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* ASA score IV and above
* Patients with a history of bleeding diathesis
* BMI below 18 or above 30 kg/m2
Initial Combination of Gemigliptin and Metformin on Microbiota Change

The purpose of this study is to investigate gut microbiota change and glucose lowering effect of initial combination therapy of gemigliptin and metformin compared to glimepiride and metformin in obese patients with type 2 diabetes.

Obese type 2 diabetes patients who were not treated with anti-diabetic medication within 6 weeks, were randomly assigned to gemigliptin/metformin or sulphonylurea/metformin. After 24 week treatment, gut microbiota composition change, glucose lowering effect, body weight, and gut hormones were compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Drug naive (no anti-diabetic medication within 6 weeks)
* HbA1c \>= 7.5%
* BMI \>= 25.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes
* DKA, HHS
* history of hypersensitivity to sulphonylurea, metformin or DPP-4 inhibitor
* Gestational diabetes mellitus
* Serum Cr \>1.5 mg/dL (male), \>1.4mg/dL (female)
* Abnormal liver function test
* Anti-obesity medication within 3 months
* Gastrointestinal motility drug, laxatives within 3 months
* History of major gastrointestinal surgery
The Singapore Chinese Health Study

The "Singapore Chinese Health Study" is a cohort study established by the Department of Epidemiology and Public Health in National University of Singapore, together with collaborators from several universities in the United States of America. This is a long-term study to help doctors and scientists understand the influence of diet, lifestyle and environment on the development of common diseases among Singaporean men and women. This includes cancer, heart disease, stroke, dementia, osteoporosis, high cholesterol and diabetes. The aim is to help us understand the causes of these diseases and to discover effective and efficient approaches for prevention and treatment.

The cohort consists of more than 60,000 men and women who were enrolled in the Singapore Chinese Health Study during 1993-1998. At the time of enrollment, participants were interviewed in-person regarding their dietary habits and other lifestyle factors. About half of them also donated small amounts of blood and urine for research between 2000 and 2004.

Eligibility Criteria:
Inclusion Criteria:

* Housing estate residents, ages 45-74 years, Chinese

Exclusion Criteria:

* None
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes

The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.

The secondary objectives of this study are to assess other pharmacokinetic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, to assess other pharmacodynamic characteristics of BIOD-105 and BIOD-107 and compare those to Humalog®, and to evaluate the safety and tolerability of BIOD-105 and BIOD-107 compared to Humalog®.

Eligibility Criteria:
Inclusion Criteria:

Subjects must present with the following:

1. Body Mass Index: ≥ 18 - ≤ 28 kg/m2
2. Diagnosed with type 1 diabetes mellitus for at least 1 year
3. Insulin antibody less than or equal to 10 μU/mL at screening

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. Type 2 diabetes mellitus
2. Serum C-peptide \> 1.0 ng/mL
3. HbA1c \> 10.0%
4. History of hypersensitivity to any of the components in the study medication
5. Treatment with any other investigational drug in the last 30 days before screening visit
6. Regular smoking as assessed clinically by the Investigator.
Effect of Covid-19 on Hypertension

In this single center , retrospective study, 5355 covid patient were selected from 2020 to 2022, with recorded blood pressure before covid and recording after covid. Blood pressure before and after covid were compared, by pair T test.

design and participants This single-center retrospective cohort study was conducted at an outpatient cardiology clinic in Shiraz, Iran, between February 15, 2020, and December 28, 2022. We evaluated patients with a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by RNA reverse-transcriptase polymerase-chain-reaction assays from nasopharyngeal or oropharyngeal swab specimens according to World Health Organization guidelines (12). Two physicians (PA, MY) reviewed the patients' electronic medical records, including demographics, comorbidities, vital signs, treatments, and outcomes. Ambiguities were resolved by a third author (MM).

The current study included all COVID-19 patients who had at least one documented blood pressure measurement in the three months preceding infection and one documented measurement one to three months following recovery. The following patients were excluded: those under 18, with hospital admission due to COVID-19, who received corticosteroid therapy, those with a history of systemic inflammatory disease, kidney or liver, immunocompromised patients, and those who switched their antihypertensive regimen during the study. Finally, 5,355 eligible patients were investigated . The primary outcome was to assess BP variation following infection (particularly a prolonged rise in BP) among non-hospitalized COVID-19 patients. The secondary outcome was to identify the predictor factors of BP variation.

The present study was approved by the Ethics Committee of Shiraz University of Medical Sciences under code IR.SUMS.MED.REC.1401.465 , and the need for informed consent was waived due to the study's retrospective nature and the absence of patient identifiers in the presented data.

Eligibility Criteria:
Inclusion Criteria:

* All COVID-19 patients who had at least one documented blood pressure measurement in the three months preceding infection and one documented measurement one to three months following recovery

Exclusion Criteria:

* Age under 18
* Hospital admission due to COVID-19
* Corticosteroid therapy,
* History of systemic inflammatory disease
* kidney disease
* liver disease
* Immunocompromised patients