cyrilzakka/clinical-trials huggingface dataset:
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee

This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and CENATONE tablet in the treatment of osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥40 and ≤80 years of age
* Radiographic evidence of grade 1,2 or 3 osteoarthritis based on the Kellgren \& Lawrence radiographic entry criteria
* Stable osteoarthritis during 3 months
* Score of 100mm Pain VAS ≤ 80mm at screening
* Score of 100mm Pain VAS ≥ 40mm at baseline
* Written consent form voluntarily

Exclusion Criteria:

* Disease of spine or other Lower limb joints that could affect fo evaluate the efficacy
* History of surgery or arthroscopy of the study joint within 6 months
* Trauma of study joint within 12 months
* Medication of constantly(more than 1 week) corticosteroid by oral within 3 months
* Diagnosed with psychical disorder, and taking medication
* Medication of intra-articular injection within 3 months
* Uncontrollable Hypertension patients at screening test
* History of upper gastrointestinal ulceration within 6 months, History of upper gastrointestinal bleeding within 12 months
* History of lower gastrointestinal bleeding within 12 months
* History of coronary artery bypass, systemic lupus erythematosus or mixed connective tissue disease
* Serum creatinine, ALT, AST, total bilirubin over ULN X 2.0 at screening test
* History of hypersensitivity of LAYLA, CENATONE or NSAIDs
* Participation in another clinical trials within 4 weeks
* Medication of constantly (more than 1 week) narcotic analgesics within 3 months
* Not consent about using effectual contraception method during trial
* Pregnant or lactating woman
* History of malignant tumor within 5 years
* Investigator's judgment
A Comparative Study of Knee Systems

The custom cutting guides personalized for each patient via pre-operative MRI will result in significantly faster intraoperative time with comparable knee alignment accuracy, cost, knee function, and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* must be scheduled to undergo TKA with no bilateral TKA planned within 6 weeks of the initial surgery date
* must be 18 years of age or older
* must be capable and willing to provide informed consent
* must have flexion contracture less than 15 degrees.
* must have ligament stability no more than 2 degrees instability in varus/valgus extension stress

Exclusion Criteria:

* medical condition or personal circumstances that will prevent participation and completion of the follow-up visits at 3 weeks, 6 weeks and 3 months post-op
* currently participating in or has participated in (within 30 days prior to inclusion in this study) another clinical trial of an investigational drug, biologic, device, or procedure
* known pre-operative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process
* Knee alignment deformities greater than 7 degrees varus or valgus
* known prior knee revisions or previous surgeries deemed to compromise the TKA incision exposure
* known medical conditions prohibiting the use of MRI or nickel allergy, sensitivity, or hardware in the region of the knee
A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)
* 6 Month cognitive decline
* Stable marketed AD therapy x2 months or additional marketed AD therapy during study
* Score of \<=4 on the Modified Hachinski Ischemia Scale
* CT results consistent with Alzheimer's disease
* Medically stable
* 6 years education
* Reliable study partner (caregiver)
* Must be able to swallow capsules

Exclusion Criteria:

* Premenopausal women
* Dementia due to other causes than Alzheimer's disease
* History of stroke
* Immunocompromised
* Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
* Unstable Vitamin B-12 deficiency
* Hematologic or solid malignancy within 5 years
* Geriatric Depression Scale \>= 6
* Unstable medical condition
* Alcohol or drug abuse history with 12-months of study entry
* Significant drug allergy
* Alzheimer's disease modification experimental therapy with 12 months of study entry
* Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
* Any other experimental therapy with 30-days of study entry
Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia

Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in the blood are at risk of developing pulmonary hypertension and strain on the right side of the heart, both of which are known to increase symptoms and worsen prognosis It is not fully established whether interval exercise training in patients with severe COPD and concomitant low oxygen levels is beneficial.

This study aims to evaluate the effects of aerobic interval exercise training in patients with severe COPD and low oxygen levels in the blood, with a particular emphasis on such effects on the cardiovascular system and pulmonary circulation.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease (COPD)
* Forced Expiratory Volume 1 second (FEV1) \<60% of predicted
* FEV1%FVC \<70 % of predicted (FVC = Forced Vital Capacity)
* Qualify for Long term oxygen therapy (LTOT), or presence of significant desaturation on exercise.

Exclusion Criteria:

* Unstable ischaemic heart disease or valvular heart disease.
* Active malignant disease.
* Substance abuse.
* Physical or mental disability that prevents participation in the exercise programme or testing.
* Pregnancy.
* Exacerbation of COPD or respiratory tract infection last 6 weeks before.
* Completed pulmonary rehabilitation programme or other organised exercise programme last 3 month
* Use of high doses of systemic steroids.
DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support with Technology for Latinx Patients

The specific aims of this project are to culturally adapt the DM-BOOST intervention for Latinx patients, usability test 'DM-BOOST para Latinx' to optimize cultural appropriateness and patient engagement and conduct a feasibility evaluation of DM-BOOST para Latinx. These aims will be accomplished via a community-based participatory research approach in collaboration with clinical, community and patient partners. This project will inform subsequent proposals to evaluate implementation of DM-BOOST in the UMass Memorial Health Care system.


Eligibility Criteria:
Aims 1 and 2 Patient Inclusion Criteria:

* Age \> 18 years
* Diagnosis of type 2 diabetes
* Identifies as Hispanic/Latinx
* Spanish language preference

Aims 1 and 2 Patient Exclusion Criteria:

* Cognitive impairment
* Current prisoner
* Pregnant women

Aim 3 Patient Inclusion Criteria:

* Age \> 18 years
* Diagnosis of type 2 diabetes
* Identifies as Hispanic/Latinx
* Spanish language preference

Aim 3 Patient Exclusion Criteria:

* Cognitive impairment
* Current prisoner
* Pregnant women
* Completed DSMT in previous year
Attachment Style of Type 2 Diabetics, and Cognitive, Social and Emotional Variables as Explanatory Factors of Adherence to Self-care Behavior and Diabetes Control

This study will expand the understanding of factors associated with adherence to self care and the diabetes control among diabetes type 2 patients. The theoretical framework of the study incorporates central variables from two theoretical models: a cognitive model of health behavior - "Health Belief Model", and the Stress and Coping model. The study is innovative in its focus on the association between the patient's attachment style and adherence to self care and diabetes control, a topic less studied among diabetes patients, in addition to cognitive, social and emotional variables. Further emphasis is upon a comparison of the study model between males and females.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* 40-70 years of age
* Hebrew speaking
* members of maccabi healthcare services
APA on Sleep Quality in Women With PCOS

Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep problems. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS.

Polycystic ovary syndrome (PCOS) is a prevalent disorder affecting 5-18% of reproductive-age women. In recent years, women with PCOS appear to have an increased frequency of sleep problems, and the prevalence of poor sleep in PCOS is high at 31%. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS. We verified the effect of APA pressure on sleep quality, quality of life, anxiety level, sex hormone indexes, and biochemical indexes in two groups after the intervention. So as to provide a sleep management strategy in PCOS women for future clinical practice guidelines.

Eligibility Criteria:
Subjects were included if they

1. were aged between 18-40 years old;
2. met the clinical diagnostic criteria of Western and Chinese medicine for PCOS with sleep disorders;
3. were evaluated by the Pittsburgh Sleep Quality Index Scale (PSQI) and had a score ≥ 7 points;
4. did not participate in other clinical trials.

Subjects were excluded if they

1. had a serious organic condition such as cardiovascular, cerebrovascular, liver, or kidney disease;
2. had acute gynecological inflammation, gynecological tumors, or reproductive system malformations;
3. had severe anxiety, depression, or other mental illnesses;
4. were pregnant;
5. had used sleeping and sedative drugs in the past month;
6. were allergic to ear point tape;
7. had local rupture of the skin at the selected ear point;
8. refused to fill out questionnaires and sign informed consent forms.
Effect of KMC on Neurobehavior of Preterm Neonates

This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Stable preterm neonates with gestational age between 31 and 35 weeks.

Exclusion Criteria:

* Neonates with major congenital birth defects or chromosomal anomalies.
* Perinatal asphyxia and intra-ventricular hemorrhage.
* Hemodynamically significant cardiac abnormalities.
* Neonates received postnatal steroids.
* Neonates whose mothers had a history of drug abuse during pregnancy.
ACC - Atrial Contribution to CRT

This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the resynchronised ventricles in the event of right atrial pacing.

All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of heart failure
* Left ventricular dysfunction
* Ventricular dyssynchrony
* 18 years or of legal age in order to give informed consent according to national laws
* Able to understand the nature of the procedure
* Available for follow-up on a regular basis at an approved investigational center

Exclusion Criteria:

* Atrial Fibrillation
* Life expectancy of less than six months due to other medical conditions
* For women: pregnancy or absence of medically accepted birth control
* Inability or refusal to sign the Patient Informed Consent
* Inability or refusal to comply with the follow up schedule or protocol requirements
* Inability to undergo device implant, including general anaesthesia if required
* Mechanical tricuspid prosthesis
* Currently enrolled in another investigational study, including drug investigations
* Hypertrophic Obstructive Cardiomyopathy (HOCM)
* Not meeting the inclusion criteria
Short-term Effects of Humidification Devices on Respiratory Pattern and Work of Breathing During Invasive Ventilation

This study compares the short-term effects of a new humidification system (Hygrovent Gold) and two other humidification devices (heated and moisture exchanger and heated humidifier) on respiratory pattern and work of breathing, during invasive ventilation.

Three humidifying devices are commonly and indifferently used during mechanical ventilation, but their impact on respiratory mechanics and, eventually, mechanical ventilation efficacy, particularly in patients highly dependent from mechanical ventilation, are not superimposable.

It has already been described that heated and moisture exchangers (HME), increasing dead space, can negatively affect ventilatory function and gas exchange, in comparison to heated humidifiers (HH).

The Hygrovent Gold, mainly because of its position between the tracheostomy and the Y-piece of the ventilatory circuit and its structure, may lead to analogous or even worse effects, determining and increase in inspiratory resistances and dead space and consequently an increase in the work of breathing.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hypercapnic respiratory failure (PaCO2 of 45 mmHg or more)
* Long-term mechanical ventilation via tracheostomy
* Clinical stability

Exclusion Criteria:

* Non collaborative subjects
* Acute respiratory failure
* Haemodynamic instability
* Encephalopathy
Study to Determine Appropriate Nurse: Patient Ratios in Peritoneal Dialysis Programs

As the resolution of the Brazilian Federal Council of Nursing (COFEN) sizing the framework of nursing professionals is essential to ensure the safety and quality of patient care. To achieve such goals actions are needed to evaluate the variety of tasks and performance specific to each area in nursing profession. The National Agency for Health Surveillance (ANVISA), through Board Resolution (RDC-154) determines that the nurse to patient ratio is 1 to 30 in hemodialysis and 1 to 50 on peritoneal dialysis, however these targets are not based on any evidence, and same apply to other Latin-American countries. Objective: To determine the appropriate nurse: patient ratio for peritoneal dialysis unit. Method: This research will be developed in two phases. The first with an observational design with descriptive and qualitative approach. There will be a focus group with experts in the field, to defined the activities and responsibilities of the peritoneal dialysis nurse, and produce a tool with a list of activities. A time-orientated score will be created. In the second stage a cross-sectional quantitative approach will be used. To apply the instrument from by direct observation of activities performed by nurses during their workday. With the instrument activities will be timed and the overall time of each nursing activity will be determined by multiplying the time spent by the total number of patients. It is expected tat this strategy will increase time on treatment and/or decrease dropout rates, by developing an easy test/ formula application to determine the correct ratio according to the peritoneal dialysis program. This tool will provide better outcomes for patients as well as allow for growth of peritoneal dialysis programs with qualified assistance and patient safety.

Research question:

Can a time-oriented score system and expert consensus be applied to PD to develop an easy and repeatable system to evaluate work load for peritoneal dialysis nurses to achieve the best outcomes and allow for planned growth of the unit?

Eligibility Criteria:
Inclusion Criteria:

* To have at least one year of experience with peritoneal dialysis

Exclusion Criteria:

* Not applicable
* Consent withdraw
Effect of Transportation Method on Preoperative Anxiety in Children

To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status I
* scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* history of anesthesia or surgery
* developmental delay
* weighing over than 38kg
* severe pain
* administrated psychotomimetic drug
Point of Care Ketone Measurement in the Newborn

Low blood sugar levels are common in babies after birth. This may be normal as babies can use other sources of energy. However if a baby does not produce these fuels the brain can be starved of energy and be damaged. Measurement of these fuels is not done as part of clinical practice in the newborn. The investigators aim to see whether at the same time as taking the blood sugar level from a heel prick these fuels can be measured in a small drop of blood. At the same time as blood needs to be taken for clinical reasons the study team will to take a drop of blood from 50 babies to see how good the point of care (POC) meters are compared to the laboratory at measuring these fuels. If accurate these POC meters could identifying those at risk from brain damage as well as prevent separation of mothers and babies who are establishing breast feeding.


Eligibility Criteria:
Inclusion Criteria:

* Infants having blood samples taken for clinical management of glucose control

Exclusion Criteria:

-
Home Pulmonary Rehabilitation for COPD

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD, confirmed by spirometry
* Age ≥40 years (to avoid recruiting participants with asthma rather than COPD)
* Current or previous smoker (≥10 packs per year)
* Confidence in using the proposed pulmonary rehabilitation (PR) system
* English language fluency

Exclusion Criteria:

* Study candidate experiencing an acute COPD exacerbation (can be included after the acute event)
* Inability to walk (orthopedic-neurologic problems or confined to a bed)
* Currently in PR or finished PR in the last three months (unlikely to improve)
* Pregnant women
* Live in an area where cell phones do not work/
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

The purpose of this study is to examine if Nivolumab by itself, or Nivolumab in combination with other anti-cancer drugs, will result in meaningful tumor size reduction, in participants with colon cancer that has come back or has spread, and who have a specific biomarker in their tumors.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Histologically confirmed recurrent or metastatic colorectal cancer
* Measurable disease per RECIST v1.1
* Microsatellite instability expression detected by an accredited laboratory
* Participants enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases are not allowed
* Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Prior malignancy active within the previous 3 years except for locally curable cancers
* Participants with active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Other protocol-defined inclusion/exclusion criteria apply
Liquid Biopsy Collection Study

The purpose of this study is to develop a liquid biopsy approach for detection of circulating tumor cells (CTC) that could be used in place of the more invasive and potentially risky methods of tissue biopsy. The aims of the project are: (a) determine whether the Chaperonin-Containing TCP-1 (CCT) chaperonin can used to identify rare cancer cells in blood, and (b) establish whether the cancer cells detected using the CCT chaperonin for identification have invasive or metastatic potential.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age greater than or equal to 18 and less than or equal to 80 years.

Exclusion Criteria:

* Adults unable to give informed consent
* Individuals who are not yet adults (infants, children, teenagers; under the age of 18)
* Individuals who weigh less than 110 lbs (as standard clinically advised to not give blood)
* Pregnant women (due to hormonal changes in blood)
* Prisoners
* Persons reporting a current microbial (bacterial, viral, or fungal) infections
* Persons reporting that they are current taking antibiotic medications
* Persons with body temperatures above 99oF (indicating a fever)
Effectiveness of Rebound Therapy in Parkinson's Patients

Today, physiotherapy approaches in Parkinson's Disease (PD) form the basis of optimal treatment together with medical and surgical treatment. It is stated that various rehabilitation interventions may be effective in the field of physiotherapy. The frequently preferred among these rehabilitation interventions is the conventional treatment approach. In the conventional treatment, various exercises are preferred to improve balance and walking, as well as stretching and strengthening. On the other hand, rebound therapy require strong integration of the neuromuscular system and provide more active use of lower extremity muscle strength. Rebound therapy have been shown to be effective in improving balance in many neurological disease groups, but there is very little study on rebound therapy in PD. It was shown that rebound therapy improve proprioceptive sense, joint range of motion and quality of life. On the other hand, no study has been found showing its effect on balance and walking. Therefore, there is a need to investigate the effectiveness of rebound therapy on balance and walking.

This study is a randomized controlled study. The patients will be randomly divided into two groups as rebound and control. The rebound group will perform exercises on a trampoline, consisting of 15 minutes of trunk and extremity stretching, 10 minutes of walking, and approximately 30 minutes of task-oriented exercises, twice a week for six weeks. While the control group will follow the same program as the rebound group, they will only perform task-oriented exercises on a stable surface, unlike the rebound group. As the outcome measures, disease severity and disability, balance, and gait performance will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 40-80 years of age
* Having diagnosed with "Parkinson's Disease" by a specialist physician
* Having between 1-3 stages according to the Hoehn and Yahr Scale
* Mini-Mental Test score more than or equal 24

Exclusion Criteria:

- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results