cyrilzakka/clinical-trials huggingface dataset:
Implementation of GLA:D Program in West Virginians With Osteoarthritis of the Knee

This study will examine feasibility of implementing Good Life with Osteoarthritis in Denmark (GLA:D) program in West Virginians with osteoarthritis of the knee

Using West Virginia (WV) as an implementation site, this study will examine the feasibility of process implementation and effectiveness of the Good Life with Osteoarthritis in Denmark (GLA:D) program in individuals with osteoarthritis of the knee (KOA). Specifically, the study will examine the feasibility and acceptability of the GLA:D program in individuals with KOA. This study will also assess the magnitude of changes in self-reported knee pain and functional impairments as well as physical performance in individuals who receive GLA:D compared to those who receive control interventions consisting of disease-specific education and exercises for KOA.

Eligibility Criteria:
Inclusion Criteria:

1. Between 45 to 90 years of age,
2. Osteoarthritis of the knee (KOA) (Kellgren and Lawrence grade 2, 3, or 4) confirmed by an orthopedic surgeon based on plain film radiographs and symptoms, and
3. Recommendation by an orthopedic surgeon to pursue conservative management of KOA.

Exclusion Criteria:

1. Prior joint replacement surgery in the ipsilateral knee,
2. Known history of cognitive impairments or any neurodegenerative disease,
3. Any other neurological or musculoskeletal pathologies that have resulted in permanent mobility deficits or functional impairments,
4. Medical conditions that would preclude them from participating in exercise programs, and
5. Inability to read and comprehend English.
Cross-cultural Adaptation and Validation in Moroccan Arabic Dialect "Darija" of the QoR-15 Postoperative Recovery Quality Score"

The QoR-15 Is a post operative recovery score developed in 2013 from the QoR-40 with an advantage of simplification. The investigators Aim to translate and to validate a such useful score in Arabic adapted for Morocco by a full psychometric evaluation of the Arabic version, by testing its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, gynecological surgery, or digestive endoscopy in the National Institute of Oncology of Rabat, affiliated to Mohammed V University in Rabat, Morocco.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Agreement in writing for the use of the data

Exclusion Criteria:

* Patients who expressed their refusal to participate in the study
* Patients unable to express their non-opposition to participating in the study
* Patients operated on for surgery for which it was highly probable that it would not be possible for them to answer the questionnaire postoperatively (first 24 hours)
* Patients who do not master the Arabic language, neither read nor spoken
Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII)

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Presentation in the Emergency Department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.

Exclusion Criteria:

* Voluntary removal of the patient;
* Sending home with instructions to return for further services
Diagnostic Performance of C Reactive Protein and Delta CRP in Acute Appendicitis

The diagnosis of acute appendicitis is difficult and despite important advances in medical sciences, detailed patient questioning and precise medical examination are the main keystones of the diagnosis of acute appendicitis and up to now, results still unsatisfactory.

Acute appendicitis is the most common surgical emergency and the most common source of community-acquired intra-abdominal infections. The lack of accuracy in the diagnosis of acute appendicitis yields often to two types of outcomes: a delay in diagnosis leads to perforation and peritonitis in up to 15% of the cases and unnecessary appendectomy is associated with post-operative complications such as wound infection and adhesions. CRP is an acute phase protein that is often used by many surgeons as a diagnostic marker of acute appendicitis. During the evaluation of patients with possible appendicitis in the emergency department (ED), repeated physical examination of the abdomen may provide further information about the decision making. However, the role of repeated laboratory examinations is not proven.

The purpose of this study was to investigate whether repeated serum CRP measures could be useful to predict acute appendicitis, after 3 hours of observation, in comparison with the histopathological findings.

Eligibility Criteria:
Inclusion Criteria:

* age \> 8 year old
* clinical suspicion of acute appendicitis including the presence of direct tenderness in the right lower quadrant, percussion and rebound tenderness, pyrexia, anorexia, nausea and vomiting.

Exclusion Criteria:

* patients receiving anti coagulants
* pregnant women
* patients using antibiotics during the study period.
Lactobacillus-containing Cultured Milk Drink Alleviates Depression Score Among Adults With Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is frequently associated with any form of psychiatric comorbidities including subthreshold or subclinical depression. Modification of gut ecology with probiotics has implicitly improved IBS and depressive symptoms. However, the efficacy of probiotics on IBS with existing subthreshold depression remain elusive. Therefore, the aim of this study is to evaluate the effects of lactobacillus-containing cultured milk drink on depression scores in adults diagnosed with IBS.

A total of 140 subjects who fulfilled Rome IV criteria for IBS will be recruited from a tertiary medical centre and among public volunteers. The depression status and categories will be assessed using the Centre Epidemiologic Studies Depression Scale Revised questionnaire (CESD-R): normal mood (score\<16), or subthreshold depression (score\>16). The subjects are randomised and blinded into four groups: Group A (Normal mood with placebo, n=35), Group B (Normal mood with probiotics, n=35), Group C (Subthreshold depression with placebo, n=35) and Group D (Subthreshold depression with probiotics, n=35). The subjects will be instructed to consume two bottles of cultured milk drink daily for 12 weeks. The probiotic cultured milk drinks contained 10\^9 cfu L. CASEI-01 and LA-5. The severity of depression will be measured using Patient Health Questionnaire (PHQ-9) at pre- and post-12-week intervention. Secondary outcome on IBS symptoms severity will be assessed with IBS Symptoms Severity Score (IBS-SSS) and IBS Quality of Life (IBS-QOL).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years old,
* Meet ROME IV criteria for irritable bowel syndrome,
* Consented to participate in the study.

Exclusion Criteria:

* Lactose intolerance,
* Gastrointestinal disorders such as inflammatory bowel diseases, liver diseases, pancreatic diseases or malignancies,
* Any neurological diseases or malignancies,
* Pregnant and lactating mothers,
* Any metabolic diseases such as hypertension, hypercholesterolaemia, diabetes mellitus, hyper- and hypothyroidism.
* Known psychiatric diagnoses or/and consume psychotropic drugs,
* Ongoing electroconvulsive therapy (ECT),
* Consumption of antibiotics, probiotics, prebiotics, symbiotics products, laxatives, antispasmodics, and/or anticholinergics who refuse to consent for participation.
Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells.

PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.

OBJECTIVES: I. Determine whether patients with metastatic ovarian and non-small cell lung cancer receiving carboplatin and paclitaxel have significantly fewer neuropathic events when treated with amifostine.

OUTLINE: This is a randomized, parallel group, double blind, controlled study. Patients are randomized to either the amifostine or control group. All patients receive intravenous paclitaxel over 3 hours, followed by carboplatin once every 3 weeks for 6 cycles. Patients who are randomized to the amifostine group receive intravenous amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel therapy. Patients randomized to the control group receive an intravenous placebo solution. Patients are discontinued from the study if they have disease progression or unacceptable toxic effects after 2 cycles of treatment. Patients are followed monthly for 8 months post treatment.

PROJECTED ACCRUAL: A total of 80 patients will be accrued (40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer) within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage III/IV ovarian or non-small cell lung cancer

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing No history of platinum, paclitaxel or amifostine hypersensitivity Prior myelosuppressive events allowed No clinically significant ascites

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 1 month of study Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy within 1 month of study Surgery: Not specified
Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects

PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and cortisol responses to naloxone by blocking the effect of the CRH increases induced by naloxone at the postsynaptic receptors. Demonstration of a statistically significant attenuation of naloxone induced increases in cortisol and/or ACTH concentrations by PF-00572778 compared to placebo would thus constitute proof of mechanism for the compound. Therefore, this study is to evaluate pharmacodynamic effects of PF-00572778 following naloxone challenge in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 45 years; Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Family (1st degree relatives) and personal history of meeting Diagnostic and Statistical Manual -IV (DSM-IV) criteria for alcohol abuse or dependence.
Thalidomide in Treating Patients With Chronic Graft-Versus-Host Disease Following Bone Marrow Transplant

RATIONALE: Thalidomide may interfere with the body's ability to recognize transplanted bone marrow cells as foreign and may help treat patients with graft-versus-host disease.

PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating patients who have chronic graft-versus-host disease following bone marrow transplantation.

OBJECTIVES: I. Determine the efficacy of thalidomide in patients with steroid dependent or refractory chronic graft vs host disease following an allogeneic bone marrow transplant. II. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to the type of bone marrow transplant received (allogeneic vs matched unrelated donor) and type of chronic graft vs host disease (steroid dependent vs steroid refractory). Patients receive either oral thalidomide or placebo 2-4 times a day for 6 months. The drug is then tapered until stopped. If disease recurs, the drug may be restarted for a second 6 month course. The maximum duration of treatment is 18 months. Patients continue on steroid therapy, which is tapered during study therapy. If no response is seen after 8 weeks, patients may cross over to the other alternate drug. Patients are followed weekly for 1 month, then every month for 1 year.

PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed chronic graft vs host disease following an allogeneic bone marrow transplant (BMT) Greater than 100 days since BMT Must be receiving at least 1 mg/kg of prednisone or equivalent immunosuppression

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Not specified
Achieving Blood Pressure Control Through Enhanced Discharge

The primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. Enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period.

A targeted sample of patients with uncontrolled blood pressure at the time of their emergency department visit discharge will be randomized into either standard or enhanced discharge. To control for medication effects in achieving blood pressure control, both groups will receive similar blood pressure medication while actively participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* Present with uncontrolled blood pressure to the emergency department (\>140/90 for non-diabetics and \>130/80 for diabetics)
* Self-reported history of hypertension

Exclusion Criteria:

* End-stage renal disease
* No history of hypertension
* Do not present with uncontrolled blood pressure
DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis

The aim of the study is to evaluate whether patients with early equivocal appendicitis can be observed instead of immediate diagnostic imaging. Half of the patients are randomly assigned to observation group, while the other half will undergo diagnostic imaging. The hypothesis is that resolving appendicitis is common in these patients. Thus, in observation group there will be fewer patients with appendicitis diagnosis and observation reduces the use of diagnostic imaging and surgery.

For the study equivocal appendicitis is defined as clinical suspicion of appendicitis with Adult Appendicitis Score between 11 and 15. The estimated prevalence of appendicitis in such patients is around 50%.

Diagnostic imaging is done using conditional computed tomography i.e. abdominal ultrasound first and computed tomography only after negative or inconclusive appendicitis after ultrasound.

In observation group repeated clinical examination is done after 6-8 hours interval with repeated blood test for calculation of Adult Appendicitis Score. Patients with decreasing score value continue observation without imaging, whereas patients with the same score value or higher (but below 16) undergo diagnostic imaging as in other group. Laparoscopy is done without imaging in patients with high score (16 or higher). Antibiotics are not allowed, but prophylactic antibiotics during induction of anesthesia are allowed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of acute appendicitis
* Equivocal appendicitis defined by Adult Appendicitis Score: Score ≥11 and ≤15.

Exclusion Criteria:

* C-reactive protein \>99 mg/l
* Time from symptom onset over 24 hours
* Pregnancy
* Antibiotics given within last 24 hours
* Suspicion of other disease than appendicitis, that would require immediate interventions such as surgery, diagnostic imaging or gynecologic consultation
* Missing written informed consent
* Patient randomized earlier to the study
Effect of tDCS on Upper Extremity After Strokes

The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.

This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.

The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.

This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.

Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni. Hospital IRB, KOREA.

Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of neurorehabilitation in republic of Korea.

Patients will be randomly divided to four groups; group1 is anodal stimulation on the lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.

The stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks.

Fugl-Meyer upper motor score will be measured as a primary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-85
2. Unilateral Stroke patients
3. Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke
4. Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand
5. The patient has subscribed the informed consent

Exclusion Criteria:

1. Insert a metal object on the head
2. Convulsive disorders
3. History of brain diseases other than stroke
Changes in Radicular Pain and Pain Modulation

The objectives of this study are: 1)To investigate the difference in pain modulatory mechanisms using quantitative sensory testing (QST) between healthy controls and patients with radicular leg pain due to nerve root compression. 2) To investigate the association between changes in radiating leg pain and pain modulation among the patient group.

Few studies have investigated pain modulatory mechanisms using QST in patients with lumbar radiculopathy due to nerve root compression. Knowledge about the association between changes in the experience of pain and changes measures of pain modulation is to our knowledge limited. The results could potentially contribute to knowledge about mechanisms involved in lumbar radiculopathy and facilitate future studies. The hypotheses of the study are: 1) Measures of pain modulation will be less efficient among patients with lumbar radiculopathy showing reduced pain inhibition and facilitated temporal summation compared to healthy controls. 2) Improvements in pain modulation will be associated with improvements in clinical pain outcomes

Eligibility Criteria:
Inclusion Criteria:

Patient group

* Radiating leg pain due to nerve root compression verified by MRI
* Clinical findings in accordance with MRI findings
* Average leg pain ≥ 3/10 on a numeric pain rating scale Controls
* No current or previous history of ongoing musculoskeletal pain

Exclusion Criteria:

Applies for both groups.

* Other specific medical conditions e.g. rheumatologic disease, diabetes or vascular diseases.
* Pregnancy
Tissue Culture Versus Swab Culture in Prosthetic Joint Infections

The main purpose of this study is to compare the effectiveness and accuracy of tissue cultures and swab cultures to diagnose prosthetic joint infection.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are scheduled for revision TJA surgery.
2. Subjects are willing to sign the informed consent document.

Exclusion Criteria:

1. Subject not willing to sign the informed consent document.
A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult

This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

For this study, the investigators will recruit 100 frail men and women aged 75 and over from the greater Montreal area. Enrolled participants will have 4 visits at their residence. The first visit, is a screening visit, the second is a pre-intervention assessment of cognition and functional abilities and explanation of the exercise program. The third visit will be a virtual visit, by phone call, and the final visit will be a post-intervention assessment of cognition and functional abilities.

Participants in the experimental group will engage in the SAFE exercises three times a week for 12 weeks at home while continuing their activities of daily living (ADLs) without any changes. Participants in the control group will not engage in the SAFE exercises but will be asked to maintain their ADLs without any changes. Before and after the 12-week intervention, all participants will complete a comprehensive battery of assessments to evaluate changes in their muscular strength, functional capacities, cognitive abilities and quality of life. At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

Eligibility Criteria:
Inclusion Criteria:

* Considered Frail or Pre frail according to Fried's criteria

Exclusion Criteria:

* Smoked within 6 months prior to study enrollment,
* dementia diagnosos,
* Abused drugs, medication or alcohol within up to 30 days prior to the start of the study.
* drug or alcohol-addiction,
* Heart disease, history of heart attacks or electrocardiogram abnormalities
* Any family history of thrombosis, thrombosis risk,
* hypocalcaemia,
* uric acidemia,
* orthostatic intolerance,
* vestibular disorders,
* considerable musculoskeletal issues,
* chronic back pain,
* head trauma,
* seizures,
* ulcers,
* renal stones,
* gastro-esophageal reflux disease,
* renal function disorder,
* hiatus hernia,
* migraines,
* mental illness diagnosis
* prescribed medication that may interfere with the interpretation of the results