cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Standardized Respiratory Physiotherapy in Primary Care

Chronic Obstructive Pulmonary Disease (COPD) is a very important public health problem and one of the most common lung diseases in the world, with repercussions on mortality and high economic costs. The World Health Organization estimates that COPD is the fifth most common disease in the world and the fourth leading cause of death. It is expected to grow in prevalence and mortality over the coming decades; it is estimated that in 2020, it will be the third most common cause of death worldwide.

Primary care is the main ambit in the management of these patients, in fact, it is where most patients with COPD are visited. However, a high proportion of these patients only receive chest physiotherapy treatment in hospitals, and the implementation of this kind of treatment in primary care is still very uncommon.

Hypothesis: There is effectiveness on the quality of life and various predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care (FREAP) in patients with moderate COPD at 6 months after its implementation.

AIMS

To evaluate the effectiveness on the quality of life and various predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index) and the economic impact of a Standardized Respiratory Physiotherapy program conducted in Primary Care (FREAP) in patients with moderate COPD at 6 months after its implementation.

METHOD

Design: Randomized controlled trial

Location: Tarragona-Reus Primary Care Area of the Catalan Health Service. 14 primary care centres were involved in the project (8 from the Reus-Altebrat Primary Care Service and 6 from the Tarragona-Valls Primary Care Service) and 8 units of physiotherapy.

Participants: 129 patients with moderate COPD treated by primary care teams.

Intervention: FREAP program for 6 months. It consisted of an initial health education session conducted in the primary care health centre, three sessions a week for three weeks of breathing exercises and aerobic, physical training in the primary care health centre and a monthly monitoring appointment for the breathing exercises and training for five months in the patient's home. Altogether, 10 sessions in the primary care health center and 5 sessions at the patients' house. Patients randomized in the control group continued with their usual clinical practice.

Main effect measures: Quality of life (St. George Respiratory Questionnaire -SGRQ-). Predictive factors of mortality (BODE index, six-minute walk distance, FEV1, dyspnea, and body mass index). Economic cost of implementing the FREAP program.

Eligibility Criteria:
Inclusion Criteria:

* Mild COPD diagnostic by GOLD criteria.
* Absence of contraindications for walk tests and training.
* Disponibility.
* Age between 40 and 74 years old.

Exclusion Criteria:

* Patients with treatment of oxygen or domiciliary oxygen therapy.
* Communication deficience(dementia, terminal illness, illiteracy).
* Informed consent not available.
Effects of Exogenous Ketones in Healthy Young Adults

Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. The results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.

A total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. Both the participants and investigators were blinded, as the supplements were coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). These measures were performed at both baseline and 6-weeks later.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (no known conditions)

Exclusion Criteria:

* Chronic smoker Pregnant
Morning-Only 4 L PEG vs Split Dose Prep for Afternoon Colonoscopies, Endoscopist-Blinded Prospective Study

Comparison of quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy procedure.

The aim of colorectal cancer screening is to reduce mortality. This can be effectively achieved by colonoscopy with direct visualization of the entire colon to detect preneoplastic lesions such as adenomatous polyps. Bowel preparation quality is critical for the accuracy of colonoscopy, time required to complete the procedure and its success. On the other hand, poor quality of bowel preparation was shown to be associated with a lower adenoma detection rate. Prior studies have shown that time of colonoscopy is one of the major factors influencing bowel preparation quality with the afternoon colonoscopies being notable for a high failure rate. This failure rate is related to poor bowel preparation quality. Given that, the number of afternoon colonoscopies performed is still high due to the increased need for colonoscopies. Therefore, it is suggested that improving the bowel preparation quality can reduce failure rate of afternoon colonoscopies. Several studies on split-dose bowel preparation have shown that it is superior to the conventional day-before regimen, in terms of preparation quality and patient's tolerability. Another study on split-dose bowel preparation also showed that it is associated with a better adenoma detection rate, better polyp detection rate and colonoscopy completion rate. There also have been few studies comparing same day dose vs. day-before for afternoon colonoscopies and showed that same day was superior to day before.There is no data comparing quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split-dose preparation for an afternoon colonoscopy.

Using a 4L PEG-ELS solution, the investigators aim to evaluate the efficacy and patient's tolerability for the same day versus split-dose regimen.

Eligibility Criteria:
Inclusion Criteria:

1. All patients above 18 years of age undergoing elective outpatient colonoscopy at CCF Florida who are scheduled for an afternoon colonoscopy procedure. All patients must have been prescribed a 4 L PEG based bowel preparation.

Exclusion Criteria:

1. Patients who had prior Colectomy or colon resection surgery.
2. Patients with confirmed diagnosis of impaired GI motility.
3. Chronic nausea or vomiting.
4. Severe constipation (=/\<1 bowel movement per week).
5. Pregnancy.
6. Breast feeding.
7. Patients taking drugs which are known to influence GI motility.
8. Hospital inpatients.
Study of Tissue and Blood Samples From Patients With Low-Grade Glioma

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from patients with low-grade glioma.

OBJECTIVES:

* Evaluate the diagnostic and prognostic relevance of alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y, using PCR analysis of microsatellite repeats and FISH.
* Evaluate the diagnostic and prognostic relevance of DNA ploidy by flow cytometric analysis; compare with ploidy determination by FISH.
* Assess the diagnostic and prognostic relevance of various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53.

Eligibility Criteria:
1. Paraffin-embedded tumor tissue blocks of patients enrolled in NCCTG 86-72-51 or 93-72-02 and who had the diagnosis of low-grade glioma.
2. Patients who have the diagnosis of low-grade glioma with an available paraffin- embedded tumor tissue block enrolled in prospective NCCTG and Mayo studies.
The Efficacy of the Kyrobak for Chronic Low Back Pain (LBP-2)

The purpose of this study is to evaluate the efficacy of the Kyrobak continuous passive motion home-use device in relieving low back pain, improving proprioception (balance and fall prevention) and improving the symmetry of muscle function on either side of the spine.

The Kyrobak is an electrically operated, continuous passive motion device including a platform that performs angular oscillations. The Kyrobak is used at home as an aid to relieve mild-to-moderate low back pain.

The study is designed to evaluate the efficacy of daily home use of the Kyrobak for 3 weeks and to assess the sustained efficacy 1 week later.

The evaluation will include the level of pain using the numerical rating scale (NRS), Digital Posturography, Heart Rate Variability (HRV), Static Surface Electromyography (SEMG), a condition-specific low back pain disability status by the Oswestry Disability Index (ODI) and subject satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 or older
* Level of pain - mild to moderate low back pain (≤5 NRS pain)
* Chronic - symptoms must have been present for at least 12 weeks or more.
* Location - lower tip of scapula to back of pelvis
* Etiology - non-specific

Exclusion Criteria:

* Patients who have low back pain due to specific and known causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome (radiating nerve pain from the spine such as sciatica), cauda equinal syndrome (serious neurological disorder where the spinal nerve roots are compressed which can cause).
* Weight in excess of 265 lbs. (120.4 kg)
* Pregnant or breastfeeding
* Recent history of violent trauma
* History of previous back surgery
* Constant progressive, non-mechanical pain (no relief with bed rest)
* Chronic pain other than low back pain
* Past medical history of malignant tumor
* Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
* Mental disorder that would lead to difficulty in questionnaire completion
* Any litigation for low back pain
* Prolonged use of corticosteroids (i.e. used for 3 months or more)
* Present use of prescription pain medication (i.e. Percocet®, Oxycodone, Vicodin®, etc.)
* Physical disability that prevents the subject to lie down/get up
* Drug abuse, immunosuppression, HIV
* Any other condition which in the physician's opinion would make it unsafe for the subject to be treated.
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of insulin.


Eligibility Criteria:
Inclusion Criteria:

* Female with non child-bearing potential
* Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.
* HbA1c below or equal to 11 % at screening (HbA1c value according to international DCCT standard)

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
* Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Neuromodulation With Spinal Stimulation Methods

This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.

Purpose of this project

Spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. Commonly used approaches include low-intensity, direct current (DC) stimulation applied across multiple segments, electrical transcutaneous (ETC) stimulation, and magnetic transcutaneous stimulation (MTC).

Objective: to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. Comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study.

corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.

Eligibility Criteria:
Inclusion Criteria:

* spinal cord injury C4 to L4
* ability to understand and follow directions

Exclusion Criteria:

* history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.
Laser Puncture and Program of Lifestyle Modification in Lupus Females

Serum lipid profile was significantly dysregulated in female systemic lupus erythematosus (SLE) patients

the research will recruit 64 female systemic lupus erythematosus (SLE) obese patients to divide them to two study groups equally. the study groups will receive, for 12 weeks, energy expenditure program (Pilates exercise, managed 5 times per week, combined with low calorie diet for).One group only will receive an additional laser puncture (with 3-time per-week design). The following points will be directly contacted by laser, for two minutes: GB34\&28, ST25\&36\&40, SP6, and CV4\&9\&12.

Eligibility Criteria:
Inclusion Criteria:

* obese female participants
* Lupus females

Exclusion Criteria:

* pregnant lupus female
* lactating lupus females
* neurologic or articular disorders
* another autoimmune conditions
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development

Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse. Several factors may influence infants' microbiota such as mother's diet, mode of delivery, antibiotic exposure and type of feeding. The main goal of this observational study is to evaluate the impact of different types of feeding (breast milk, donor human milk and preterm formulas) on the intestinal microbiota of preterm infants hospitalized in the neonatal intensive care unit (NICU) of Maternidade Alfredo da Costa (MAC). Furthermore, the influence of mode of delivery and the mother's diet, among others factors, on vertical microbiota transmission will be evaluated. After delivery, mothers will be asked to collect their own fecal samples and will be invited to complete a semi-quantitative food frequency questionnaire. Stool samples will be collected from premature infants every 7 days. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

Meconium and the additional 3 fecal samples will be collected from preterm infants by the nursing team of MAC Neonatology Unit. Fecal samples will be collected every 7 days, during 21 days, from diapers into sterile tubes. Mothers will be asked to collect their own fecal samples with an appropriate stool collection kit (EasySampler®) and will be invited to complete a semi-quantitative food frequency questionnaire, previously validated for the Portuguese population.

Infant-feeding profile (breast milk, donor human milk or formula) of preterm infants will be recorded every day to select the most representative (\>50 %) type of infant-feeding received during the 7 days prior to each fecal sample collection.

Additionally, detailed clinical data will be collected during the preterm infant enrollment in the study. Personal clinical data includes sociodemographic information and clinical intrapartum and postpartum outcomes, such as newborn's weight, days of antibiotic exposure, number of total days of hospitalization and others outcomes related to the preterm clinical evolution.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for enrolment, preterm infants must have been admitted to the NICU in less than 24 hours of life, have been born with less than 32 weeks with absence of malformations or metabolic diseases.

Exclusion Criteria:

* non applicable
Effect of Arthrospira Platensis (Spirulina) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant Levels in Chronic Periodontitis Subjects

Introduction- Oxidative stress plays a causative role in pathogenesis of periodontal disease.

It has been reported that Spirulina platensis or its active ingredient C phycocyanin (CPC) exerts anti-inflammatory, anti-oxidative and inhibitory effects on prostaglandin and leukotriene biosynthesis.

Aim- To evaluate the effect of dietary spirulina as an adjunct to SRP on salivary antioxidants level in CP subjects.

Materials And Methods- The study was a randomized double-blind clinical and biochemical trial in which 70 subjects with CP in the age group of 40-55 years, reporting to Department of Periodontology, TKDC and RC, New Pargaon, were equally and randomly divided into Test Group (TG) and Control Group (CG). TG was given 2 gm Spirulina capsules daily, after meals for 1 month and CG was not given any supplementary diet. SRP was done at baseline in TG and CG. Whole saliva sample was collected. Clinical and biochemical parameters will be recorded at baseline, 1 month \& 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with CP (moderate and severe)as per CDC criteria 2007.
2. Patients without any known systemic diseases.

Exclusion Criteria:

1. Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
2. Subjects who have undergone periodontal treatment within six months of inception of study.
3. Tobacco habits in any form and alcoholics.
4. Pregnant and lactating women.
Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery

Hip surgery accounts for a high percentage of both emergency and elective surgical procedures in hospitals. Regardless of surgery being prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated comorbidities. When faced with this patient profile, there is a tendency to undertreat pain for fear of the side effects and pharmacological interactions of conventional analgesic drugs.

Ultrasound-guided regional anesthesia applied in orthopedic and trauma surgery has been shown to reduce the doses of opioids and conventional analgesics, to ease deambulation and early recovery, to improve respiratory dynamics and to reduce vein thrombosis and pneumonias. Our study aims to verify whether L-ESP block is effective in the hip and proximal femur surgeries and allows to lower the dosage of opioids in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes over 18 years of age having undergone hip surgery
* ASA I-III (classification system used by the American Society of Anesthesiologists where I is low anesthetic risk and IV is high risk)
* Capacity to comprehend the principles of pain assessment using the VAS visual analogue scale
* Previously signed an informed consent.

Exclusion Criteria:

* Contraindications for the technique and/or the drugs used in this context
* Technical inability to perform the block
* Severe cognitive impairment or prior mental disabilities described in their medical records
* Patients already included in other clinical trials.
MR-guided Focal Laser Ablation of the Prostate

Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed and biopsy proven prostate cancer
* Intermediate risk patients (PSA \<= 20 ng/mL, Gleason ≤ 7, T2b)
* No previous treatment for prostate cancer
* Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
* Signed informed consent by patient
* Age 18 years or older
* Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)

Exclusion Criteria:

* Impossibility to obtain a valid informed consent
* Patients unable to undergo MR imaging, including those with contra-indications
* Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
* Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
* Patients with evidence for nodal or metastatic disease
* Patients with an estimated Glomerular Filtration Ratio (eGFR) \< 40 mL/min/1.73 m2