cyrilzakka/clinical-trials huggingface dataset:
Effect of Elastic Taping on Stiffness of Lumbar Stabilizer Muscles

Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime.

Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain. Chronic low back pain ranks second among the most common pain complaints under the age of 45 in the industrial age of limited activity. Organic pathology is not encountered in most musculoskeletal system pains. There are usually many underlying causes. The current literature offers a variety of treatment options, depending on the duration and severity of the symptoms of non-specific low back pain. These treatments include behavioral cognitive therapy, medication, electrophysical agents, manual therapy, and general exercises. Looking at the literature, it has been observed that there are not many objective studies investigating the effect of elastic bandage application on muscle elasticity.

'Shear Wave Elastography' is a method that quantitatively reveals the elasticity of tissues by measuring the speed of shear waves formed in the tissues through non-invasive high-frequency ultrasound waves. In recent studies, Shear Wave Elastography has shown promising results in demonstrating the elasticity of peripheral nerves.


Eligibility Criteria:
Inclusion Criteria:

* patients who diagnosed with non-specific low back pain
* between the ages of 18-24
* patients who able to perform at least 40° of trunk flexion

Exclusion Criteria:

* patients who obese, pregnant, had specific low back pain
* indication for surgery in the past 1 year
* the trauma of lumbar region, and systemic inflammatory disease affecting this area
* exercise and conventional physiotherapy in the last 6 months
A Study of Ragweed (Ambrosia Artemisiifolia) Allergy Immunotherapy Tablet in Adults With Ragweed Allergies (P05751)

This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history of physician-diagnosed ragweed-induced allergic rhinoconjunctivitis of 2 years duration or more, with or without asthma
* Must have a positive skin prick test response to Ambrosia artemisiifolia
* Must have a forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value
* Clinical laboratory tests, electrocardiogram (ECG) and vital signs conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor
* Females of child-bearing potential must agree to use medically accepted methods of contraception

Exclusion Criteria:

* Unstable asthma or has experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids in previous 3 months
* Received an immunosuppressive treatment within 3 months
* History of anaphylaxis with cardio-respiratory symptoms.
* History of chronic urticaria or angioedema
* Current severe atopic dermatitis
* Female subject who is breastfeeding, pregnant, or intending to become pregnant
* Has received maintenance doses of immunotherapy with ragweed extract for ≥1 month within the last 5 years
* History of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (IMPs) (except for Ambrosia artemisiifolia), or self-injectable epinephrine
* Unable to or will not comply with the use of self-injectable epinephrine
* Participating in any other clinical trial
Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants with RA for greater than or equal to (\>/=6) months receiving 162 mg tocilizumab PFS-NSD for \>/=8 weeks and who are suitable for continued treatment at their currently prescribed dose
* CGs and professionally qualified HCPs who are able and willing to administer the injection

Exclusion Criteria:

* RA: Functional status Class IV
* RA: Neuropathies or other conditions that might interfere with pain evaluation
* RA: Pregnant or breastfeeding
* RA: Low neutrophil or platelet count at last laboratory assessment
* RA: Elevated liver enzymes at last laboratory assessment
* Current participation in another interventional clinical trial
* Criteria that might give the participant/CG/HCP an advantage in injection tasks such as employment in the pharmaceutical industry, etc.
Computer-Guided Glucose Management Systems in Treating Patients With Hyperglycemia Who Have Undergone Blood and Bone Marrow Transplant

This clinical trial studies computer-guided glucose management systems in treating patients with hyperglycemia who have undergone blood and bone marrow transplant. A computer-guided glucose management system may help manage glucose levels in patients who have undergone blood or bone marrow transplant.

PRIMARY OBJECTIVES:

I. To examine the ability of computer-guided glucose management system (CGGMS) algorithms to control glucose within or close to current University of Washington Medical Center (UWMC) intensive care unit (ICU) targets (100 to 140 mg/dl) in non-critically ill bone marrow transplant (BMT) adult (age \>= 18 years) patients.

OUTLINE:

Patients receive blood glucose management with intravenous (IV) insulin using Glucommander.

Eligibility Criteria:
Inclusion Criteria:

* Post-transplant adult patients (age \>= 18 years) on the BMT Service at UWMC
* Requiring insulin secondary to:

  * Known history of (h/o) type 2 diabetes mellitus
  * Two blood sugar values \> 180 (point of care and/or am lab glycemia)
  * One blood sugar value \> 250 (point of care or AM lab glycemia)

Exclusion Criteria:

* Critically ill patients (intensive care unit \[ICU\] admissions)
* Terminally ill patients
* Eastern Cooperative Oncology Group (ECOG) performance status \> 3
* Previous type 1 diabetes mellitus
* Cognitively impaired patients, unable to consent
The Influence of Beetroot Juice on Racial Disparities in Vascular Health

Black adults are 30% more likely to die from cardiovascular disease (CVD) compared to White adults, and more than half of this racial disparity in cardiovascular mortality may be attributed to the substantially greater prevalence of high blood pressure and vascular dysfunction in Black adults. Nitric oxide (NO) is a potent signaling molecule and key regular of vascular function that is suspected to be reduced in black individuals, but can be enriched by dietary nitrate (e.g., arugula, spinach, beets). The purpose of this study is to test the hypothesis that increasing NO bioavailability via nitrate-rich beetroot juice (BRJ) will lower blood pressure and improve vascular health in Black adults.

The investigators long-term research goal is to investigate mechanisms accounting for the higher prevalence of CVD and high blood pressure in Black individuals, and identify effective preventive strategies. Nitric oxide (NO) is a gaseous molecule that plays an essential role in the regulation of vascular tone and blood pressure regulation. Some, but not all, studies have observed reduced NO bioavailability in Black individuals, which may contribute to racial disparities in vascular health. Dietary nitrate supplementation using beetroot juice (BRJ) is demonstrated to increase circulating NO, lower blood pressure and arterial stiffness, and improve blood pressure regulation in clinical populations and health individuals. The central hypothesis is that increasing NO bioavailability by nitrate-rich BRJ supplementation will lower blood pressure and improve vascular health in Black adults. The investigators acknowledge that racial differences are not entirely driven by ancestry, and thus will assess and account for sociocultural factors and health behaviors (i.e., sleep, physical activity, and nutrition) that may contribute to racial health disparities.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-39 years of age
* Body mass index (BMI) below 30 kg/m\^2
* Free from signs or symptoms of neurologic, cardiovascular (e.g., heart attack, stroke, heart failure, arrhythmia), metabolic, and/or renal disease
* Have a blood pressure no lower than 90/50 mmHg
* Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months

Exclusion Criteria:

* Low blood pressure - less than 90/50 mmHg
* History of cardiovascular disease
* History of cancer
* History of diabetes
* History of kidney disease
* Obesity (BMI \> 30 kg/m\^2)
* Smoking or tobacco use
* Current pregnancy
* Nursing mothers
* Communication barriers
Low-dose Neostigmine at TOF Ratio of 0.7 Improves Neuromuscular Recovery

This study is a prospective observational study. A total of 54 patients were included in this study. We observed the time from neostigmine administration to TOF ratio of 1.0.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective thyroid surgery under general anesthesia
* a body mass index of 18.5-25 kg/m2
* Age ≥ 20

Exclusion Criteria:

* Refused to participate
* history of hypersensitivity to acetylcholinesterase inhibitor
* neuromuscular disease
* hepatic or renal dysfunction
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1019" and Co-administration of "BR1019-3" and "BR1019-2" in Healthy Volunteers

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-3" and "BR1019-2" in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.

  * For men, Those who weigh 50 kg or more
  * For women, Those who weigh 45 kg or more
* Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions during the clinical trial period after listening to and fully understanding detailed explanation of this clinical trial
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(Except for hormone drugs) from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ETC, OTC, Oriental medicine, health functional food concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetic and pharmacodynamic properties such as Interaction of investigational products, half-life)
* Those who have participated in bioequivalence tests or other clinical trials and administered their investigational products within 6 months prior to the first administration date. (However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
* In the case of a female subject, pregnant woman, those suspected pregnancy or lactating woman.
Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke

The Comparative Effectiveness Study of Transthoracic and Transesophageal Echocardiography in Stroke (CONTEST) aims at assessing the diagnostic value of transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE) with regards to treatment consequences in patients with acute ischemic stroke.

For this purpose, the investigators will perform a prospective multicenter diagnostic comparative effectiveness study. Patients with acute stroke will be studied by both TTE and TEE. Patients with already defined stroke etiology and determined secondary prevention will be excluded from the trial. Treatment relevant diagnostic findings will be identified by a central endpoint adjudication committee. In order to demonstrate a hypothesized 2% absolute increase in the number of treatment relevant diagnostic findings by TEE as compared to TTE, 880 stroke patients will be enrolled in six German stroke centers. CONTEST will allow answering the question whether and for which group of stroke patients TEE is indicated in addition to TTE. By this, the study will provide evidence to guide justified recommendations for echocardiography in acute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke or transitory ischemic attack (TIA)
* age ≥18 years
* informed consent

Exclusion Criteria:

* Patients with already defined stroke etiology and determined secondary prevention treatment strategy prior to echocardiography (e.g. atrial fibrillation, carotid artery stenosis, cervical artery dissection)
Adenoma Miss Rate With Water Exchange vs Carbon Dioxide Colonoscopy

This was an observational study comparing consecutive group of WE and CO2 insufflation in terms of right and proximal colon AMR by tandem colonoscopy.

This was a prospective observational study to assess how WE colonoscopy would fit into clinical and research practices. We first observed whether optimal WE colonoscopy decreased the AMR in the right and proximal colon in a tandem approach. If WE did lower the AMR as compared with data in the literature, a randomized RCT deserves to be studied. For the calculation of sample size in the upcoming RCT, the AMR in the CO2 group would be collected. The differences of the AMRs in the right and proximal colon determined by tandem colonoscopy using WE or CO2 insufflation would then be compared.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged 20 years or older undergoing colonoscopy for screening and surveillance indications were considered for enrollment.

Exclusion Criteria:

* familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of inflammatory bowel disease, previous colonic resection, inability to achieve cecal intubation, obstructive lesions of the colon, poor colon preparation, inability to completely remove a polyp, gastrointestinal bleeding, allergy to fentanyl or midazolam, American Society of Anesthesiology classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.
Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)

The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of Depersonalization Disorder (DPD).

This study is a research trial of an outpatient, non-medication, non-invasive investigational treatment called Transcranial Magnetic Stimulation (TMS). TMS applies a magnetic field to the brain for a brief period of time. TMS is a procedure that involves 30 minute-long daily sessions every weekday for a series of weeks. The investigators are testing whether TMS can treat Depersonalization Disorder (DPD).

This is an open-label study. All patients will receive active treatment. DPD symptoms will be monitored through weekly self-report questionnaires as well clinical ratings with a doctor.

Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients, 18 to 70 years of age.
* Primary diagnosis of Depersonalization Disorder.
* Duration of the index episode of at least a year.
* Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and be to continue at the same dose(s) through the duration of the study.
* Capable and willing to provide informed consent

Exclusion Criteria:

* Individuals with a neurological disorder including, but not limited to: brain lesion; history of seizures; history of cerebrovascular accident; history of stroke; cerebral aneurysm, Dementia; Parkinson's Disease; Huntington's chorea; Multiple Sclerosis.
* Increased risk of seizure for any reason, including prior head trauma with loss of consciousness for 5 minutes or more.
* Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
* Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
* If participating in psychotherapy, must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.
* Known or suspected pregnancy.
* Women who are breast-feeding
A Cardiac Surgery Virtual Nutrition Intervention Program Feasibility Study-VIP Study Protocol

This feasibility study will look to identify the impact that a remote/virtual nutritional intervention can have on nutrition literacy and knowledge retention of the cardiac surgery patient.

The proposed VIP study will utilize an interventional feasibility design to implement and evaluate the impact of a virtual nutrition intervention prehab program on cardiac surgery patients. The VIP study looks to measure patient adherence and acceptability, and practicality of the remote platform in hopes it will illicit change to the current standard of nutrition care being provided to cardiac surgery patients.

The current standards of care do not call for dietitian involvement for cardiac surgery patients' pre-surgery and little to no involvement for patients not receiving CABG surgery. This feasibility study looks to address this gap in current patient nutrition care.

The study intervention will provide eligible patients (n=20) with access to four 25-30 minute virtual sessions with a registered dietitian during the two-week period prior to surgery. The dietitian will provide the patient with nutrition counseling prior to the patient's elective cardiac surgery. Zoom (or equivalent) software will be utilized as a remote platform to connect the dietitian virtually with participants during all sessions. The four sessions will follow the same presentation format and will provide all participants with identical nutrition education with curriculum content progressing in each subsequent session. Each session will be comprised of protein education and goal setting, with education content building on previous sessions with a goal of improving patient protein intake perioperatively.

Data will be collected on: (1) participant demographics, (2) physical function, (3) nutritional status and (4) nutrition literacy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* undergoing non-emergent/elective cardiac surgery

Exclusion Criteria:

* not able to communicate in English (read or write)
* in-patients (urgent or emergent care)
* patients who self report protein supplementation on a regular basis
Effectiveness of Low-Dose Theophylline for the Management of Biomass-Associated COPD

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide, and over 90% of COPD-related deaths occurring in low- and middle-income countries (LMICs). Household air pollution (HAP) - from burning solid fuels such as wood, dung, agricultural crop waste, and coal for energy - is the primary risk factor for COPD in these settings. Biomass-related COPD has a distinct histopathology, phenotype and inflammatory profile when compared to tobacco mediated COPD. Despite the high global burden of biomass-related disease, little is known about the effectiveness of pharmacotherapies for biomass-related COPD; to date, no clinical trials have focused specifically on treatment of biomass-related COPD. This study proposes to assess the health impact of biomass-related COPD and test the effectiveness of low dose theophylline compared to standard therapy among adults with biomass-related COPD in Uganda with the aim to assess whether low-dose theophylline improves respiratory symptoms, decreases the inflammatory profile of serum biomarkers and whether administration attenuates the effect of HAP on lung function. The study additionally aims to assess whether low-dose theophylline is a cost-effective intervention based on the incremental cost-effectiveness ratio and a range of willingness to pay thresholds.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years
2. Full-time resident of study area
3. Post-bronchodilator FEV1/FVC \< the lower limit of normal of the Global Lung Initiative Mixed Ethnic reference population
4. Grade B-D COPD
5. Daily biomass exposure

Exclusion Criteria:

1. Plans to move within one year
2. Uncontrolled hypertension
3. Pregnancy (assessed by urine pregnancy test among women of childbearing age/menstrual history)
4. Current use of chronic respiratory medications (Long acting Beta 2 Antagonists (LABA), Long-acting muscarinic antagonist (LAMA), inhaled corticosteroid (ICS))
5. History of post-treatment pulmonary tuberculosis
6. ≥10 pack year tobacco smoking history
7. Known intolerance or contraindication to theophylline.
Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of active psoriatic arthritis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between the ages of 18-75 years.
2. Has a history of psoriatic arthritis (PsA) for at least 6 months, and meets the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening.
3. Active arthritis as shown ≥ 3 swollen joints (66 joints) and ≥ 3 tender joints (68 joints) at both screening and baseline.
4. Active plague psoriatic skin lesion or documented history of plague psoriatic at screening.
5. hs-CRP ≥ 3mg/L at screening.
6. Subjects either (i) do not have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 TNF-inhibitor (TNFi-experienced).

Exclusion Criteria:

1. Non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis), with the exception of nail psoriasis, which is allowed.
2. Other autoimmune or autoinflammatory condition ( ie, rheumatoid arthritis, systemic lupus erythematous, gout), with the exception of inflammatory bowel disease and/or autoimmune uveitis being inactive at least 12 months before the screening, as assessed by the investigator.
3. Active fibromyalgia syndrome
4. Recent history of active infection, chronic infection history or risk of serious infection.