cyrilzakka/clinical-trials huggingface dataset:
An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race

The purpose of this study is to compare the effectiveness of acetaminophen extended release caplets to placebo in treating the muscle aching and pain (soreness) that occurs after a marathon.

This is a randomized, double-blind, placebo-controlled study to compare the effectiveness and safety of acetaminophen and placebo in treating muscle aching and pain (soreness) that occurs in subjects who complete a marathon. Subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650 mg caplets taken three times a day, for four days) or placebo (two placebo caplets taken three times a day, for four days). The primary measurement of efficacy is the average change from baseline in muscle soreness, on Day 1, the day of the marathon. Safety assessments consist of monitoring adverse events, and a physical examination at the screening visit, including vital signs, weight, a medical history review, and a urine pregnancy test for females of childbearing potential. The hypothesis of the study is that acetaminophen is more effective than placebo in the relief of post-race muscle aching and pain (soreness) score on the evening of the race. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day over a four day period or two placebo caplets, taken by mouth, three times a day over a four day period.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to comply with the study schedule
* be able to swallow the study medication
* complete the marathon
* not take any analgesics after completing the marathon and before their eligibility to participate in the study has been determined
* rate their muscle soreness at least a 4, on a 0 - 10 point scale

Exclusion Criteria:

* Previous diagnosis of osteoarthritis
* currently have or have had a medical condition that may be relevant in one's eligibility to participate in the study
* known hypersensitivity to acetaminophen
* unable to understand or follow the instructions for the study
* taken any investigational medication within 30 days of the marathon
RED-FLAGS Index Validation in Crohn's Disease Patients

Observational prospective study to validate a new index for early diagnosis of Crohn's disease (CD)

The study will be conducted in Italian referral centers for Crohn's disease and will involve general practitioners (GPs) for RED-Flags Index validation.

The project is divided into two phases.

1. retrospective phase (4 weeks). All the general practitioners participating to the study will extrapolate from their patient's database, the total number of patients with a Crohn's disease diagnosis performed in the past. The date of diagnosis will be indicated. No other information will be provided. These data will be then analyzed to obtain, for each GP, the total number of CD diagnosed in each semester.
2. retrospective phase (6 months). GPs will administer the RED-Flags questionnaire to all patients that meet inclusion and exclusion criteria, after informed consent signature. All these patients will be then referred to the nearest referral center, to be evaluated by a gastroenterologist specialized in CD, to confirm or exclude a CD.

Eligibility Criteria:
Inclusion Criteria:

1. at least one of the following symptoms, for at least 4 weeks (either continuous or intermittent)

   1. diarrhea (\>3 bowel movements per day)
   2. nocturnal diarrhea
   3. weight loss (≥5% of usual body weight)
   4. abdominal pain (chronic or intermittent)
   5. perianal lesions or fistulae or perianal abscess (hemorrhoidal diseases excluded)
2. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. known diagnosis of Crohn's disease, ulcerative colitis, chronic diverticulosis or any other gastrointestinal disease
2. any clinical condition that, in the opinion of the investigator, can alter stud results
3. inability to understanding and complying with protocol requirements
4. informed consent not signed and dated by the subject
Medicine Adherence and Effects on Transplants With Pilloxa's Electronic Pillbox

Poor adherence to medication among patients with chronic diseases is a major problem. A patient group where the adherence to prescribed medications is extremely important are organ transplanted patients. It is well established that lack of adherence to immunosuppressive medication drastically increases the risk of rejection reactions, graft loss and deaths.

Pilloxa is a device meant to help users manage medication and support adherence to medication. This study evaluates if Pilloxa improves adherence to treatment for transplanted patient compared with conventional management. Patients who have received a transplanted kidney or liver will be studied.

Pilloxa is a system comprising of: a box with 14 separate containers to temporarily store tablets/capsules in and that can be open by 14 independent lids, a smartphone application and cloud based servers. The pillbox will at given times detect if pills are present in the different compartments and can connect, send and receive information to/from mobile application and the cloud.


Eligibility Criteria:
Inclusion Criteria:

* Patient had an organ (liver or kidney) transplanted.
* Patient who wishes to participate in the study and who is able to understand, read, write and give written informed consent in the Swedish or English language. For persons under the age of 18, the guardians must understand, read, write and give written informed consent in the Swedish or English language.
* Ongoing daily immunosuppressive medication that is expected to continue during the study period.
* Handles medication by herself or, in the case of children, that medication is handled by the guardian.
* The patients doses of immunosuppressants fits into the chambers of the product.
* The patient's medicine ordination is not expected to change more often than once weekly.
* Owns and uses a compatible smartphone, option for underage children that guardians hold a compatible smartphone.

Exclusion Criteria:

* Suffers from dementia, neurological disease or other cognitive impairment which causes problems in understanding instructions or managing medication independently.
* Physical inability to use the product as intended.
Effect of Mulligan Versus Maitland Mobilization on Lumbar Proprioception in Patients With Chronic Nonspecific Low Back Pain

this study will be conducted to compare between the effect of mulligan mobilization versus Maitland mobilization on pain ,function and lumbar proprioception in patients with chronic nonspecific low pain

Low back pain (LBP) is considered as one of the most widespread musculoskeletal disorders, impacting over 80% of the world's population, resulting in work absence, medical consultation, a decline in quality of life, and financial burden. Lumbar repositioning error was high around 30° of trunk flexion in individuals with CLB. When lumbar proprioceptive deficiencies arise, the activation pattern of back muscles is disturbed, the mechanics of the spinal unit differs from that of a healthy spine, and the recurrence rate of LBP increases . CLBP is managed using various intervention modalities, including drug therapy and physical therapy approaches . Physical therapy modalities, such as manual therapy, therapeutic exercises, and biopsychosocial techniques, are used for treating LBP. Manual therapy is a common and suggested modality for treating CLBP that has strong evidence. It is employed in physical therapy practice, including Maitland mobilization and Mulligan mobilization. Mulligan mobilization as well as Maitland mobilization has significant effect on pain ,function disability and lumbar repositioning error. But there is gap about which is more beneficial. So we conduct this study to determine which technique is more beneficial for patients

Eligibility Criteria:
Inclusion Criteria:

* They had interrupted or continuous LBP symptoms for more than 3 months
* both gender

Exclusion Criteria:

* specific LBP
* those who were pregnant
* those with neurological problems
Risk Evaluation and Stratification of Low Risk for Cardiovascular Disease in Women

This study will evaluate the ability of Coronary Computed Tomography Angiography (CCTA), used as a first-line diagnostic tool in women with stable chest pain and low risk for Coronary Artery Disease (CAD), to reduce the number of women requiring more than one diagnostic test to rule in or rule out CAD. Half of the participants will undergo CCTA as the first test to investigate stable chest pain, while the other half will undergo any test ordered by their family physician.

Coronary artery disease (CAD) is the leading cause of death in women globally. Women are more likely to present with atypical chest pain that may be difficult to diagnose using traditional testing methods, resulting in over-investigation.

Coronary computed tomography angiography (CCTA) has high negative predictive value for exclusion of CAD in low to intermediate risk populations. We plan to investigate CCTA as a first line test to exclude coronary artery disease as a cause of stable chest pain and whether it is a cost effective strategy that reduces time to diagnosis, wait times to see cardiologists, emergency department visits, downstream and repeat testing and radiation exposure as compared to usual care with comparable patient safety and satisfaction level.

Another intervention being tested in this trial is the Cardiac Link pathway. This is a new clinical program at Women's College Hospital that aims to expedite cardiology referral for patients exhibiting clinically significant findings while undergoing CCTAs.

We hope that with use of CCTA as the first test, the number of women who require only one test (i.e. CCTA) to sort out whether or not CAD is responsible for their chest pain will increase, thereby decreasing over-investigation of low risk women.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥ 40 years of age
* Stable chest pain or equivalent symptoms
* Planned non-urgent, non-invasive testing for diagnosis of chest pain or equivalent symptoms

Exclusion Criteria:

* Acute coronary syndrome, including acute myocardial infarction or unstable angina, known non-ischemic cardiomyopathy or other cardiac disease (e.g. mitral valve prolapse, etc.) which would require urgent cardiac evaluation
* Known CAD
* Prior cardiac evaluation for current episode of symptoms
* Previously investigated for CAD in the last 12 months
* Severe allergic reaction to iodinated contrast (mild reactions such as urticaria that can be controlled by premedication with Benadryl \& Prednisone may be included in the study)
* Renal failure or dysfunction (estimated Glomerular Filtration Rate\<30ml/min/m2 within the past 3 months)
* Pregnancy (status will be confirmed verbally. For premenopausal patients who are unsure, status will be confirmed by completing a pregnancy strip test).
Effect of Vitamin d and Omega 3 on Osteocalcin

Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels

The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the OCN levels.

This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on PLASMA OCN levels in females and males with vitamin D deficiency (VDD).

This randomized, controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks,separately and with each other, on the plasma levels of OCN and 25-hydroxy vitamin D (25OHD).

This study was conducted during winter in 86 healthy Jordanian females and males with VDD with a mean age of (40± 10) years.

Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of vitamin D deficiency (VD \< 30 ng / ml).

Exclusion Criteria:

* People who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation.
* People with bone disorders also excluded.
Antimicrobial Photodynamic Therapy Mediated by Papain Gel on Peri-Implantitis Lesions

The elimination of pathogenic microorganisms from the muco-gingival tissue and implant pockets system is one of the main aspects for success in the treatment of peri-implantitis. The purpose of this study is to conduct a blinded and randomized clinical trial to evaluate the effectiveness of photodynamic therapy in the treatment of peri-implantitis. Twenty implants with peri-implantitis will be selected. Implants will be randomly divided into two groups (n = 10), Group 1: control - conventional treatment and Group 2: conventional treatment and antimicrobial photodynamic therapy (aPDT). aPDT will be performed after the purse removal service in sites with pockets greater than or equal to 5 mm. The photosensitizer will be PapaMblue®, which will be deposited in the peri-implant pockets, with pre-irradiation time of 1 min. Next, the laser emitting a wavelength of 660 nm, with power of 100 mW, for 2 min, radiant exposure of 30 J/cm2 and power density of 250 mW/cm2 in the buccal and mesial regions will be applied. The distribution of the data within each group will be evaluated and the variances will be checked to choose a more appropriate statistical analysis. The sample calculation is based on the literature and the significance level of 5% will be adopted.


Eligibility Criteria:
Inclusion Criteria:

* Have peri-implantitis;
* Have at least one implant with a clinical depth of probing equal to or greater than 5 mm;
* Age range of 18 to 65 years.

Exclusion Criteria:

* Smokers or ex-smokers who stopped the habit less than 12 months before the screening;
* Have decompensated diabetes;
* Anemia;
* Cancer;
* Pregnant;
* Use antibiotics in the last 3 months12;
* Make use of anti-inflammatories or have coagulation disorders (use of anticoagulants, presence of liver diseases, thrombocytopenia, immunosuppression);
* In orthodontic treatment;
* Patients who maintained a biofilm index higher than 25%.
T-Cell Response in Patients Receiving Trastuzumab and/or Chemotherapy for HER2-Positive Solid Tumors

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is looking at blood samples from patients receiving trastuzumab and/or chemotherapy for HER2-positive solid tumors to assess T-cell response.

OBJECTIVES:

* Assess T-cell activation in blood samples of patients receiving trastuzumab (Herceptin®) and/or chemotherapy for HER2-positive solid tumors.

OUTLINE: Blood samples are collected from patients at baseline and on days 21, 42, and 84 of trastuzumab (Herceptin®)/chemotherapy. Patients may be contacted 3-6 months after completion of trastuzumab/chemotherapy to donate another blood specimen.

Blood samples are examined for T-cell proliferation and intracellular cytokine production. CD8 T-cell response, HER2/neu-specific antibody titers, and skin hypersensitivity test responses are also measured.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of solid epithelial tumor, including, but not limited to, the following:

  * Breast cancer
  * Ovarian cancer
  * Lung cancer
  * Uterine cancer
  * Prostate cancer
* HER2/neu-positive disease by immunohistochemistry or fluorescent in situ hybridization
* Must be receiving trastuzumab (Herceptin®) and/or chemotherapy (e.g., paclitaxel, docetaxel, fluorouracil, or estramustine)

PATIENT CHARACTERISTICS:

* Absolute neutrophil count \> 1,000/mm\^3
* Absolute lymphocyte count \> 400/mm\^3
* Platelet count \> 90,000/mm\^3
* Hemoglobin \> 8 g/dL

PRIOR CONCURRENT THERAPY:

* No other chemotherapy within the past 4 weeks
Earplugs and Eye Masks for Reducing Delirium

There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been conducted with intensive care unit (ICU) patients. Therefore, we propose to conduct a single-arm pilot study for an eventual single-blinded randomized controlled trial designed to assess the efficacy of earplugs and eye masks worn at night for prevention of delirium in a population of general medicine inpatients over the age of 65. The primary outcome will be incidence of delirium as measured by Confusion Assessment Method (CAM). In this pilot study, we will assess feasibility and will not perform any statistical comparisons. In the subsequent randomized controlled trial, we will be comparing the hazard rates on an intention-to-treat basis. Secondary outcomes will be exploratory and include length of stay, cost data, and use of pharmacologic interventions for sleep, delirium, or agitation. There are no physical risks and no cost to the subjects in this study.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department
* Age \>= 65

Exclusion Criteria:

* Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred from another department
* Admitted as "observation" (i.e., expected length of stay \< 2 nights)
* Admitted \> 24 hours prior to time of enrollment
* Non-English-speaking patients will be excluded because a language barrier would introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g., availability of translator services)
* Blind or deaf patients will be excluded because they are unlikely to benefit from the intervention, but sensory-impaired patients will be included
* Patients lacking decision-making capacity for whom no Legally Authorized Representative (LAR) is available
* Primary reason for admission "altered mental status", drug withdrawal, stroke, or seizure
* Patients for whom a withdrawal pathway has been preemptively initiated based on their substance use history (e.g., the alcohol withdrawal pathway order set or other as needed ("PRN") orders for the indication of withdrawal)
* Delirium present at time of enrollment
* Glasgow Coma Scale (GCS) \< 10 at time of enrollment
* Enrolled in this trial during a previous admission (i.e., we will not resample)
* Enrolled in a separate trial this admission
* Contraindication to using earplugs or an eye mask (e.g., facial trauma or other safety concern)
* Significant fall risk per nursing assessment
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers

The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.

Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females
* Between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Illicit drug use
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Surgical Plate Osteosynthesis of Distal Radius Fractures

Primary objective of the study is to demonstrate specific indications for the

surgical treatment of distal radius fractures using the locking compression

plate.

In addition the differences between the surgical treatment compared to

conservative treatment with respect to fracture healing, functional outcome

and subject satisfaction will be analysed after 6w./6m./1y./2y.

Eligibility Criteria:
Inclusion Criteria:

* skeletally mature female and male
* Distal radius and ulnar fractures AO 23
* 10 days after injury

Exclusion Criteria:

* general or local conditions adversely affecting the bone physiology
* ISS \>16
* osteosynthesis close to the wrist joint where a different implant has been used
* history of drug and alcohol abuse
Targeted Training for Trunk Control_case Series Cerebral Palsy

If a child with cerebral palsy does not develop independent sitting balance by 4 years of age, their prognosis for walking is very poor. Surprisingly little is known about how to facilitate head control or upright sitting balance and functional mobility in the child who is not developing these skills. This is one of the first studies that will examine intermediate stages in the development of the postural control system in children with neurologic deficits. Clinical researchers at The Movement Centre in Oswestry, England have developed a method called Targeted Training in which trunk control is trained in children segment by segment using a specific training device. This study aims to examine kinematic and electromyographic changes in a case series of children who undergo a 6-month Targeted Training intervention.


Eligibility Criteria:
Inclusion Criteria:

* neurologic diagnosis that results in a deficit in trunk control (i.e. cerebral palsy, traumatic brain injury)
* age 4-17 years
* Gross Motor Function Classification System (GMFCS) level III, IV or V for children with cerebral palsy

Exclusion Criteria:

* spinal fixation
* fixed scoliosis
* uncontrolled seizures
Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty

Patient outcomes following total knee replacement and standard physical therapy will be compared between subjects who use the Breg Flex study device vs those who do not. Subjects will be evaluated for knee range of motion, strength and patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon (Burnikel)
2. Individuals who are at least 55 years of age
3. Individuals with a body mass index (BMI) \<45
4. Must be able and willing to complete all study assessments and to be followed for the full course of the study.
5. Must be able to read, write and follow instructions in English.
6. Must be able and willing to provide informed consent.
7. Must be willing and able to attend the pre-op assessment

Exclusion Criteria:

1. Individuals with a history of any underlying neurological conditions
2. Individuals with a history of stroke
3. Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
4. Individuals with physical conditions which would make them unable to perform study procedures
5. Pregnant women or inadequate precautions to prevent pregnancy
6. Diagnosis of a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site.
7. Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis)?
8. Individuals with muscle diseases (i.e. muscular dystrophy)
9. Visible skin injury or disease on their legs
10. Principal investigator for this study, or member of study staff