cyrilzakka/clinical-trials huggingface dataset:
The Effects of COX-inhibiting Drugs on Skeletal Muscle Adaptations to Resistance Exercise in Healthy Adults

In this study, healthy human subjects (18-35 yrs) are be randomised to consume 1200 mg ibuprofen or 75 mg acetylsalicylic acid daily during a training period of 8 weeks. During these weeks, subjects perform 2-3 supervised strength training sessions (knee extensions). Before and after training, muscle volume is measured by MRI, and muscle strength is assessed by isokinetic and isoinertial ergometers. Muscle biopsies are obtained from m. vastus lateralis to study gene and protein expression of markers regulating muscle protein turnover and prostaglandin synthesis.


Eligibility Criteria:
Inclusion Criteria:

* Considered healthy
* Moderately trained
* 18-35 yrs

Exclusion Criteria:

* Cardiovascular disease
* Impaired kidney or liver function
* Lower limb injury
* Pregnancy
* Ulcer or gastrointestinal upsets
* Previous reactions to use of NSAID
Obstructive Sleep Apnea and Endothelial Function in Patients With Resistant Hypertension

The purpose of this study is to determine the prevalence of obstructive sleep apnea and associate it with the endothelial function behavior in patients with resistant hypertension. Two groups will be evaluate, one presenting uncontrolled high blood pressure, and other, with controlled blood pressure by drugs.

Introduction: Obstructive sleep apnea (OSA) is considered an independent risk factor for cardiovascular disease. There is evidence that individuals with OSA may have increased inflammatory mediators, changes in the metabolic profile, increased sympathetic activity with consequent elevation of blood pressure (BP) and endothelial dysfunction. Resistant hypertension (RH) is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three hypotensive drugs at full doses, including a diuretic, or the need for \>3 medications to control BP. OSA has been reported as the most common secondary cause of high blood pressure maintenance.

Objective: To determine the prevalence of OSA and associate it with the endothelial function behavior in patients with resistant hypertension comparing to those with BP controlled by medication.

Methods: A cross-sectional study involving 40 hypertensive patients (20 with resistant hypertension and 20 with controlled BP), irrespective of race or gender, with ages between 18 and 75 years. BP was measured by oscillometric method on automatic device. Endothelial function was assessed by peripheral arterial tonometry (PAT) by EndoPAT2000® and the OSA diagnosis also through PAT, using the portable device WatchPAT200®. Anthropometric evaluation was performed through measurements of waist, hip and neck circumference, body mass index, waist to height ratio (WHtR), and body composition assessed by bioelectrical impedance. Statistical analyzes were performed by GraphPad Prism software.

Eligibility Criteria:
Inclusion Criteria:

* ages between 18 and 75 years
* previous hypertension diagnosis

Exclusion Criteria:

-
Cognitive Effects of Bariatric Surgery

There is growing evidence that obesity is associated with adverse neurocognitive outcome. Recent studies demonstrate that elevated body mass index (BMI) is an independent risk factor for Alzheimer's disease, structural brain abnormalities, and cognitive dysfunction in older adults. Preliminary work from our lab extends these findings and shows structural brain differences and cognitive dysfunction also exist in obese young and middle-aged adults.

Bariatric surgery is increasingly viewed as an effective intervention for morbid obesity, though its effects on cognition are unknown. Post-operative nutritional deficiencies are common and can adversely impact cognitive performance. However, substantial weight loss resolves or improves many medical conditions with reversible cognitive effects, suggesting bariatric surgery may provide cognitive benefits.

No study to date has examined the cognitive effects of bariatric surgery. To do so, the proposed study will prospectively assess cognitive performance in 125 bariatric surgery patients enrolled in the Longitudinal Assessment of Bariatric Surgery (LABS) project and 125 matched controls. Bariatric surgery patients will complete a computerized cognitive test battery at four time points: pre-operatively, 12 weeks post-operatively, 12 months post-operatively, and 24 months post-operatively. Matched control participants will complete the test battery at similar intervals. Demographic, medical, and psychosocial information will be collected to elucidate possible mechanisms of change. We hypothesize that the substantial weight loss following bariatric surgery will be associated with improved cognitive performance.


Eligibility Criteria:
Specific criteria for bariatric surgery patients include:

Inclusion Criteria

* 25-65 years of age
* Enrolled in LABS project
* English-speaking

Exclusion Criteria

* History of neurological disorder or injury (e.g. dementia, stroke, seizures)
* Moderate or severe head injury (defined as \>10 minutes loss of consciousness; Alexander, 1995)
* Past or current history of severe psychiatric illness (e.g. schizophrenia, bipolar disorder)
* Past or current history of alcohol or drug abuse (defined by DSM-IV criteria)
* History of learning disorder or developmental disability (defined by DSM-IV criteria)
* Impaired sensory function

Inclusion/exclusion criteria for matched control participants include:

* All of the inclusion/exclusion criteria for the surgical patients, except for enrollment in the LABS project
* No history of bariatric surgery procedures
* No interest in bariatric surgery procedures in the next two years
The Efficacy and Safety of Lumbar MSAT on Acute Low Back Pain

This study is a single blind, randomized controlled trail. condition/disease: acute low back pain treatment/intervention: motion style acupuncture treatment

"Motion Style Acupuncture Treatment(MSAT)" is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation. This treatment is known to relieve the pain and increase the range of motion(ROM). However, there has been no specific value for the effect of this treatment.

So, the investigators will conduct a randomized controlled trials to verify the efficacy and safety of Lumbar MSAT. From March 2021 to December 2021, the investigators will collect 96 inpatients who are suffered from Low back pain with the numeric rating scale(NRS) over 5 after injury by acute traffic accident(TA). For experimental group(n=48), the investigators will conduct MSAT three times(on 2nd, 3rd and 4th day of hospitalization) and other Korean medical treatment. For control group(n=48), just Korean medical treatment except MSAT will be conducted. For these two groups, the investigators will compare NRS, Visual Analogue Scale(VAS), Range Of Motion(ROM), Oswestry Disability Index (ODI) and EuroQol 5-Dimension (EQ-5D), Patient Global Impression of Change (PGIC)."

Eligibility Criteria:
Criteria: Inclusion Criteria:

* Patients who needs hospitalization due to acute low back pain that occurred within 7 days after traffic accident
* Patients with NRS ≥ 5 for low back pain
* Patients aged 19-70 years on the date they sign the consent form
* Patients who provide consent to participate in the trial and return the informed consent form

Exclusion Criteria:

* Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc.
* Patients with progressive neurological deficits or with severe neurological symptoms- Patients who have had surgery or procedures within the last three weeks
* The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
* Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
* Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study
* If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease
* Patients who are pregnant or planning to become pregnant
* Patients with a serious mental illness
* Patients who are participated in clinical trials other than observational studies without therapeutic intervention.
* Patients who are difficult to complete the research participation agreement
* Other patients whose participation in the trial is judged by a researcher to be problematic
Chemoembolization in Treating Patients With Primary Liver Cancer or Metastases to the Liver

RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.

PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.

OBJECTIVES:

* Evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization.
* Evaluate tumor response achievable with chemoembolization in this patient population.
* Evaluate the toxicities of this treatment in these patients.
* Evaluate survival of these patients following this treatment.
* Evaluate extrahepatic patterns of failure following chemoembolization, to determine whether intrahepatic progression may be forestalled and survival affected in these patients.
* Validate a consistent method of performing chemoembolization in a multicenter setting.

OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases).

Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. Immediately following delivery of the chemoemulsion, particulate embolization is performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe.

In the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. After completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor.
* Unresectable.
* Bidimensionally measurable disease by Computed Tomography (CT), Magnetic resonance imaging (MRI), or UltraSound Scanning (US) within 6 weeks of registration.
* Evidence of patent portal vasculature by Doppler US, MRI, or angiography.
* Serum total bilirubin \< 2.0 mg/dl and serum creatinine \< 2.0 mg/dl within 4 weeks of registration.
* Absolute neutrophil count (ANC) \> 2000/µl and platelets \> 50,000/µl within 4 weeks of registration.
* Expected survival of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Age \>= 18 years.

Exclusion Criteria:

* Evidence of extrahepatic disease that is likely to be life-threatening within 3 months, such as brain or symptomatic lung metastases.
* Previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy within 4 weeks.
* Concurrent malignancy.
* Pregnant or breast-feeding women.
* History of life-threatening contrast allergy.
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)

This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.

Photorefractive Keratectomy (PRK) is a common elective surgery used to correct refractive errors. We propose that amniotic fluid drops may be beneficial in promoting ocular surface healing following PRK. Purified amniotic fluid (pAF) contains anti-inflammatory, anti-microbial and regenerative factors similar to solid amniotic membrane. Individual patients will be randomized to one of two post-operative drop regimens, control eyes that will receive placebo saline solution (NaCl 0.9%, Baxter Medical), and study eyes that will receive pAF four times daily for seven days.

This is a randomized, double-masked, placebo-controlled study to determine

* the safety of pAF in patients who undergo PRK
* if pAF hastens re-epithelialization following PRK compared to placebo
* if pAF reduces post-operative pain following PRK compared to placebo
* if pAF affects visual outcome following PRK compared to placebo
* if pAF affects ocular surface staining and corneal regularity following PRK compared to placebo

Eligibility Criteria:
Inclusion:

1. Patients aged 21 years and older.
2. Patients undergoing PRK for visual correction in both eyes.
3. Willing and able to give consent for study participation and comply with study procedures, including follow-up visits.

Exclusion:

1. Patients with any active eye disease, including keratoconus or any other ectactic disorders.
2. Patients with documented uncontrolled diabetes.
3. Patients with severe dry eye as measured by corneal staining.
4. Patients with calculated PRK treatment resulting in residual stromal bed \<300 um.
5. Patients who have had previous eye surgery or refractive laser procedures.
6. Patients with any active collagen vascular disease.
7. Patients who do not have potential of 20/20 or better best corrected vision in each eye.
Ankylosing Spondylitis and Spondyloarthritis Evaluation Tool Study

This study aims to test whether a new instrument (questionnaire) is useful for identifying patients with ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent

Exclusion Criteria:

* Inability to provide informed consent
The Development of a Metabolomic Test to Diagnose and Quantify Pancreatic Exocrine Insufficiency (The DETECTION Study)

DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.

Pancreatic exocrine insufficiency (PEI) is prevalent and progressive among patients with pancreatic cancer, treatment with pancreatic enzyme replacement therapy (PERT) has been proven to reduce gastrointestinal symptoms, improve quality of life and survival and is therefore recommended in NICE guidelines. Despite this, most patients with PEI do not receive PERT.

One cause for under treatment is lack of a well-tolerated and accurate diagnostic test that can provide quick results. The current, most widely used test, the faecal elastase stool test, has low accuracy, particularly after surgery, and results take several days. Furthermore, the test cannot help with dosing of PERT.

Metabolomics can be used to quantify metabolites in blood. These metabolites are directly influenced by normal digestion and absorption of food, for example blood lipid levels are very different in the fed and fasted states. This program of work will give a standard meal to healthy controls and patients with PEI and screen their blood before and after a test meal. Differences in the metabolic profile will be used to develop a 'fingerprint' of PEI based upon one metabolite or a combination of metabolites.

The ultimate goal is to develop a simple blood test that can be used outside of specialist centres that is acceptable to patients, can accurately diagnose PEI and can guide treatment with PERT.

This body of work aims to investigate the metabolome of patients with PEI (of different causes), PEI will be defined in the different cohorts by a multimodel approach with the 13C MTGT as primary reference test and FE-1 and PEI-Q used as supporting tests.

A test meal will be given to fasted participants alongside baseline blood samples and breath samples. Patients will then have blood and breath taken hourly for 6 hours. Blood samples will be spun and frozen for batch metabolomic analysis.

Eligibility Criteria:
Inclusion Criteria: (for main pancreatic cancer cohort)

* PDAC
* PEI (as defined by breath test)
* Tolerating oral diet Inclusion Criteria: (for CF cohort)
* CF
* PEI (as defined by breath test)
* Tolerating oral diet Inclusion Criteria: (for CP cohort)
* CP
* PEI (as defined by breath test)
* Tolerating oral diet

Exclusion Criteria (all arms):

* No other GI conditions
* For each arm no evidence of the other arm conditions
* For health controls, no history of CP, CF or pancreatic cancer
* No GI surgery (except pancreatic resection in the pancreatic cancer cohort)
* Unable to consent
* Unable to travel to UHB for testing
* Prognosis \< 2months
* Performance status 2+
Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Patients

Investigators will evaluate the implementation of an evidence-based, Spanish-language, digital, cognitive-behavioral therapy intervention (SilverCloud) in primary care settings for Latino patients with depression and/or anxiety. 426 participants will be enrolled in a two-armed trial comparing self-guided vs. supported dCBT (SilverCloud). At the provider level, investigators will compare the efficacy of provider referrals with the use of a clinic patient registry to identify candidates who could benefit from a digital mental health intervention.

The investigators will evaluate the implementation of an evidence-based, Spanish language, digital cognitive-behavioral therapy (dCBT) intervention (SilverCloud) in safety-net primary care clinics for Limited English Proficiency (LEP) Latinx patients with depression and/or anxiety. An effectiveness-implementation hybrid trial (Type 2) design with both provider and patient-level randomization will be conducted. At the provider-level the investigators will compare outreach (using the clinic patient registry) with inreach (traditional provider referral), at the patient-level two modes of delivery of the dCBT platform - supported and unsupported will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. PHQ-9 ≥ 10 or GAD-7 ≥ 8
2. Has access to the Internet via smartphone and/or broadband at home, and basic level of technological literacy or willingness to undergo a brief technology use training
3. ≥18 years of age
4. Preference for receiving medical care in Spanish
5. Not in concurrent psychotherapy
6. If currently taking an antidepressant medication, patient must have been on a stable dose for at least 6 weeks, and have no plans to change the dose. We will permit patients on antidepressants to enter the study, as this will increase generalizability. Antidepressant status will be monitored at each assessment to control for those effects, if necessary.

Exclusion Criteria:

1. Currently receiving psychotherapy, as this treatment will be offered as a frontline treatment for depression and anxiety, however, patients are allowed to be referred to treatment while participating in this study and initiation of treatment will be monitored and considered in analyses
2. Visual, hearing, voice, or motor impairment or illiteracy that would prevent completion of study procedures
3. Diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, or substance use disorder
4. Severe suicidality (as assessed by expressing suicidal ideation, plan, and intent). Although procedures with back-up plans are in place for patients who develop suicidality (see Human Subjects Section), patients assessed with severe suicidality will be referred to more-intensive treatment resources.
Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia

The objective of this trial is to assess acupuncture of different treatment frequency on improving quality of life in patients with functional dyspepsia.

The effect of treatment frequency of acupuncture on the functional dyspepsia is unclear. In this study, 60 participants with FD will be recruited and randomly allocated (using a 1:1:1 allocation ratio) into three times a week group, once a week group and waiting for treatment group. Participants will receive acupuncture treatment at bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3) of different treatment frequency for 4 weeks. This trial is designed to analyze the acupuncture of different treatment frequency on improving quality of life in patients with FD and to provide evidence for the establishment of acupuncture treatment quantization standard of FD.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of FD as defined by the Roman IV Functional Dyspepsia Diagnostic criteria

   One or more of the following:
   1. Bothersome postprandial fullness
   2. Bothersome early satiation
   3. Bothersome epigastric pain
   4. Bothersome epigastric burning AND No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms Epigastric Pain Syndrome (EPS) criteria: fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.

   Postprandial Distress Syndrome Diagnostic (PDS) criteria: must include one or both of the following at least 3 days per week:
2. Age 18-75 years.
3. Signed informed consent and volunteered to participate in the trial.

Exclusion Criteria:

Candidate participants with any of the following items will be excluded from this trial.

1. Gastrointestinal motility drugs taken within the past 15 days; Acupuncture treatments within the past 30 days; participating in other ongoing clinical trials
2. Severe heart, lung, liver, brain or kidney damage.
3. Would-be mothers, pregnant or lactation;
4. Progressive malignant tumor or other severe consumptive diseases, easy to be complicated with bleeding and infection;
5. Cognitive impairment such as unable to express subjective symptoms of discomfort or give informed consent.
Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty

To verify that CT scan and X-ray can predict the collapse of the necrotic femoral head before hip arthroplasty and effectively guide the surgical management.

Osteonecrosis of the femoral head (ONFH) is a common and frequently occurring disease. The main clinical manifestations are hip pain and dysfunction. The etiology and pathogenesis of ONFH caused by various reasons are the problems that have not been solved yet in the field of orthopedics. If want to achieve satisfactory therapeutic effect, surgical choice is essential. It is very important for prognosis to master the indications of operation and take appropriate treatment measures, especially the great difference between palliative surgery and hip arthroplasty.

To determine whether the femoral head collapses and the degree of collapse of the articular cartilage of the femoral head can help physicians to select an optimal surgical plan. Chinese scholars commonly believe that if the femoral head collapse is less than 2 mm, investigators can choose autologous bone graft, allogeneic bone graft and other palliative surgery. If the femoral head collapse is more than 2 mm, investigators can choose total hip arthroplasty. However, above standard has not been extensively accepted worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral ONFH confirmed preoperatively (FICAT stages III and IV; Appendix 1)14
* Unilateral total hip arthroplasty
* Age range: 32-68 years
* Irrespective of sex
* Sign the informed consent

Exclusion Criteria:

* Infection
* Tuberculosis
* Tumor
* Severe osteoporosis