cyrilzakka/clinical-trials huggingface dataset:
Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children

This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation of pulmonary inflammation in asthmatic children.

The hypertonic saline is a traditional technique to collect induced sputum, it´s safe and viable in asthmatic children, as well as the technique of sputum induction and processing has been standardized for schoolchildren.

Sometimes researchers have difficulties to obtain induced sputum in stable patients and it´s possible to use physiotherapy maneuvers to induced sputum. The manouvers are safe for adult and children asthmatics stable.

This study aimed to evaluate the effectiveness to collect induced sputum by physiotherapy maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Asthmathic children used inhaled corticosteroids not associated with long-acting beta2-agonist.

Exclusion Criteria:

* Asthmathic children to diagnose with other chronic pulmonary pathologies (cystic fibrosis, ciliary dyskinesia, bronchiolitis obliterans, and bronchopulmonary dysplasia) before study, no significant pulmonary pathologies, incapacity to realize pulmonary function and insufficient sample.
Efficacy of an Anorectal Fistula Plug With Sealing of the Internal Opening as a Treatment for Perianal Fistula

The investigators aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and radiologically with MR imaging.

Perianal fistula is a challenging condition for colorectal surgeons. Achieving a favourable balance between healing and incontinence is the key to success. Surgeons have adopted many methods to close off this abnormal tract, which include laying opening, use of setons, advancement flaps and permanent stoma. A more recent approach has been the use of devices or substances to block the tract in the hope that it will seal off. Most of the devices that have been used to close the tract have not proved to be as effective in healing as a lay open with high rates of fistula persistence. A major failure of the devices has been their early expulsion and their inability to seal off the internal opening.

The new Curaseal plug may be able to overcome these shortcomings. This plug has a disc to seal the internal opening, with a suture to be placed at the external opening, which may prevent it falling out and ensure internal opening closure.

The investigators aim to assess the efficacy of the Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts. Healing of the fistula tract will be assessed both clinically and radiologically with MR imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are psychologically stable and suitable for intervention and able to provide informed consent

  * Patients who are willing and competent to fill in questionnaires and undergo investigations at various time points during the study
  * Patients with an idiopathic extra and trans-sphincteric perianal fistula.

Exclusion Criteria:

* Patients aged less than 18 or \>80 years.
* Patients unfit to undergo general or spinal anaesthesia.
* Patients with a supra-levator fistula.
* Patients with a rectovaginal fistula.
* Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis).
* Patients with a fistula secondary to trauma, foreign body, developmental cyst or pelvic irradiation.
* Patients who are immunosuppressed.
Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance

Loss of slow wave sleep (SWS) is common in mild cognitive impairment (MCI) and Alzheimer's disease, and is thought to worsen thinking, memory and brain degeneration. Initial studies suggest that correction of sleep deterioration may slow the progression of brain damage in mild cognitive impairment, and might be able to stop the development of Alzheimer's disease. Transcranial alternating current stimulation (tACS) uses electrodes to deliver very small amounts of electricity through the brain, with direct effects on brain cell function. Transcranial electric stimulation has been demonstrated to enhance slow wave sleep and to improve memory when applied during sleep in healthy adults. The purpose of this research is to investigate tACS to modulate sleep, thinking/memory, mood, and quality of life among normal healthy adults, older adults, as well as individuals with MCI.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-85
* Native English speakers
* Neurological diagnosis of amnestic mild cognitive impairment (aMCI)

Exclusion Criteria:

* brain tumors
* skull defects
* epilepsy
* metal implants/devices above the neck
* eczema or sensitive skin
* insomnia
* sleep apnea that requires use of a CPAP machine
* rapid eye movement (REM)-sleep behavior disorder
* currently pregnant or trying to become pregnant during the study period
* diagnosis of cognitive impairment \*cognitive impairment required for MCI arms
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients

The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.


Eligibility Criteria:
Inclusion Criteria:

* Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation
* Male or female subject at least 18 years of age and younger than 65 years
* Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)

Exclusion Criteria:

* Subject has a panel reactivity antibody grade \> 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons
* Subject received a kidney transplant from a non-heart beating donor
* Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine \> 1.5 mg/dL (united network for organ sharing \[UNOS\] expanded criteria donor)
* Cold ischemia time of the donor kidney is ≥ 30 hours
Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients

The purpose of this study is to compare two different therapies for actinic keratoses in organ transplant recipients with regard to efficacy and tolerability. The investiagtors are planning to examine treatment with Imiquimod 5% cream versus treatment with Methyl-aminolaevulinate 16% cream and subsequent irradiation with red light, so-called photodynamic therapy, in this patients' group. A secondary objective of our study is to investigate the reduction in the field cancerisation after both treatments using fluorescence diagnostic method and digital imaging.

Organ transplant patients (OTP) require lifelong immunosuppressive therapy and consequently are prone to develop skin tumors, i.e skin cancer is the most frequent malignancy in organ transplant recipients. OTP frequently develop extensive areas of actinic damage, epidermal dysplasia, wich accounts for increased risk of aggressive skin cancer development in susceptible patients, and are referred to as "field cancerisation". Therefore the whole area of field cancerisation has to be treated. In our study we will treat this areas with two different methods and not only the single visible lesions of actinic keratoses.In this open prospective randomized intraindividual study one half of the patients' scalp or face will be treated with Imiquimod 5% cream for 4 weeks, 3 times a week, and the other half with Methyl-aminolaevulinate 16% cream photodynamic therapy, two applications in two weeks interval. The pre- and post treatment extension of field cancerisation will be assessed by means of a highly sensitive digital fluorescence imaging system.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients who had received a kidney, liver, lung or heart transplant more than 3 years prior to inclusion into the study
* Patients who had been treated at least 6 months prior to study entry with a stable twofold or threefold immunosuppressive treatment
* Patients who had clinically confirmed epithelial dysplasia (actinic keratoses) in at least two anatomically separated contralateral areas on the face and/or scalp with comparable size and extension and minimum distance of 5 cm

Exclusion Criteria:

* Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area
* Known allergy to imiquimod and/or methyl-aminolaevulinate and/or one of the other components of the investigational products and/or peanut oil
* Patients who have received retinoids, interferons or investigational drugs within 4 weeks of study initiation
* Patients who are participating in othe dermatological study
* Persistent Hepatitis B or C infections
* Any evidence of systemic cancer
* Patients who have received any systemic cancer chemotherapy or radiation therapy
* Pregnant or lactating women
* Patients
Take 2 Pills and Go Volunteer in the Morning

In this study, doctors will "prescribe" volunteer work for their patients. The investigators are determining whether it is feasible for providers to recommend volunteering to their patients, and whether patients who are recommended this "treatment" actually do volunteer work (i.e., find it "acceptable"). The study is focused on uninsured patients at Loyola Medicine's Access to Care (ATC) Clinic. The study's secondary aim is to determine whether or not engaging in volunteer work yields health benefits.

In this feasibility study, doctors will "prescribe" volunteer work for their patients. The setting is Loyola Medicine's Access to Care Clinic, which serves patients who are low-income and uninsured (and often members of racial/ethnic minority groups). The investigators are determining whether it is feasible for providers in a low-resourced primary care setting to recommend volunteering to their patients, and whether patients who are recommended this "treatment" actually do volunteer work (and how much). The investigators are also interested in measuring whether volunteering is associated with any potential health benefits, specifically well-being and self-esteem.

Promoting volunteerism is the intervention because research evidence suggests that volunteer work may be good for one's health. For example, research shows that volunteering is associated with numerous potential health benefits: improved mental health, increased physical activity, higher preventive health care utilization, lower cardiovascular risk and lower mortality. Besides better health, volunteering also can teach valuable skills, help individuals meet others, and foster new relationships.

Despite all these potential benefits, rates of volunteering are low. Overall, just one in four people volunteers. Additionally, people who have lower incomes are less likely to volunteer (14% of people with incomes below $20,000 vs. 35% of people with incomes above $100,000. And minority groups are less likely to volunteer than whites (just 19% of African Americans and 15% of Latinos compared with 26% of Whites).

Thus, the intervention is aimed to increase volunteer participation rates among groups unlikely to volunteer: low-income uninsured persons who are members of racial/ethnic minority groups.

Eligibility Criteria:
Inclusion Criteria \* Access to Care patient

Exclusion Criteria

\* None
Prebiotic vs Probiotic in Multiple Sclerosis

This is a randomized crossover-designed study to explore the immunologic effects of Prebiotics, as opposed to direct supplementation with beneficial bacteria (Probiotics) in the immune system of patients with MS and Clinically Isolated Syndrome (CIS). Eligible patients will take 6 weeks of two different supplements - Prebiotics and Probiotics. Participants will be randomly assigned to take either of two agents for 6 weeks as their first supplement. Then, participants enter a 6-week washout period. After the washout period, participants will take the second supplement for 6 weeks. After taking the second supplement, participants will have a 6-week washout period.

Soluble fibers (prebiotics) are fermented by beneficial bacteria (probiotics) in the colon to produce short-chain fatty acids (SCFAs) which are the main source of nutrition for the cells in the gut. It has been reported that the fermentable fiber inulin and SCFAs may exert some beneficial effects including anti-inflammatory effect on the immune system. To date, the effect of supplementation with fermentable dietary fiber, such as prebiotics in patients with Multiple Sclerosis (MS) has not been investigated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 or older) diagnosed with MS (Relapsing-remitting type) or CIS and recruited within 10 years of symptom onset, and
* Adult patients receiving anti-CD20 therapy (rituximab or ocrelizumab) who have received at least one cycle at the time of recruitment

Exclusion Criteria:

* Active relapse within 3 months of enrollment
* Steroid use within 4 weeks of enrollment
* Antibiotics use within 3 months of enrollment
* Daily pre or prebiotic use within 3 months of enrollment
* Diagnosed with any of the autoimmune disorders: Rheumatoid Arthritis, Lupus, Celiac disease, Vitiligo, Psoriasis, Psoriatic Arthritis, Hashimoto's Thyroiditis, Graves' Disease, Sjogren's syndrome, Type 1 Diabetes, Scleroderma, Crohn's Disease, Ulcerative Colitis, Alopecia Areata.
* Had surgery of the GI tract in the last 5 years (with the exception of cholecystectomy and appendectomy)
* Had a major bowel resection
* Prior use of any of the following drugs: Mycophenolate/Cellcept, Cyclophosphamide/Cytoxan, Methotrexate/Novantrone, Azathioprine/Imuran, Cladribine/Leustatin/Mavenclad, Daclizumab/Zenepax, Alemtuzumab/Campath/Lemtrada
* Have any of the following active uncontrolled gastrointestinal (GI) illnesses:

  1. Crohn's disease, ulcerative colitis, indeterminate colitis
  2. Irritable bowel syndrome: moderate-severe
  3. Persistent or chronic diarrhea of unknown etiology
  4. Severe Chronic constipation or difficulties with defecation
  5. Persistent, infectious gastroenteritis, colitis or gastritis
  6. Clostridium difficile infection (recurrent)
  7. Gastric or intestinal ulcerations/GI bleeding
  8. Gastrointestinal or colonic malignancy: polyps, masses, dysplasia or cancer
* Active use of bismuth subsalicylate-containing products
* Currently pregnant
Effect of OFA in Laparoscopic Gastrectomy

The investigator will examine the effects of opioid free anesthesia in patients undergoing laparoscopic gastrectomy. The investigator expect that opioid free anesthesia will reduce postoperative pain and opioid consumption.

And investigator will analyze the association between postoperative pain and patient's underlying psychological characteristics and pain sensitivity. The investigator anticipate that psychological characteristics and pain sensitivity may be realted to postoperative pain and opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer

Exclusion Criteria:

* Patients with a history of allergic reactions to drugs
* Patients with a history of drug addiction
* Patients with chronic pain who require analgesics
* Patients with cancer other than the stomach
* History of hospitalization for psychiatric disorders
* Patients with sleep apnea
* Preoperative pulse oximetry (SpO2) \< 95 %
* Moderate or severe hepatic impairment
* bradycardia (HR\<50bpm), hypotension, atrioventricular block, intraventricular or sinus block
* Body mass index over 35 kg/m2
* Blood clotting disorders
* Pregnant/lactating women
* Cognitive impairment
* Unable to read consent form (eg illiterate, foreigner, etc.)
Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer

This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer.

PRIMARY OBJECTIVES:

I. Characterize sex differences in patient-reported symptomatic immune-related adverse events.

II. Determine the level of discordance between clinician-assessed and patient-reported symptomatic immune-related adverse events according to patient gender.

OUTLINE: This is an observational study.

Patients complete surveys and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older on date of enrollment (Confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
2. Histologically confirmed diagnosis of cancer and plan to begin SOC immunotherapy for the treatment of cancer per FDA approval and/or National Comprehensive Cancer Network (NCCN) guidelines (Confirmed by review of cancer diagnosis and treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
3. Treating oncologist anticipates at least 6 consecutive months of SOC immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)

Exclusion Criteria:

1. Diagnosed with breast, prostate, testicular, penile, or gynecologic cancer (Confirmed by review of the cancer diagnosis as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
2. Previously received immunotherapy (Confirmed by review of cancer treatment history as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
3. Life expectancy of \<6 months at time of enrollment per the treating oncologist (Confirmed by the professional opinion of the treating oncologist and subsequently recorded in a CRF.)
4. Concurrently receiving a non-immunotherapy treatment, including chemotherapy, biological, or targeted therapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
5. Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g. pain) (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
6. Participation in a clinical trial of experimental immunotherapy (Confirmed by review of the treatment plan as documented in the Electronic Medical Record (EMR) and subsequently recorded in a CRF.)
7. Needs to rely on a proxy to complete patient-reported outcome instruments (Confirmed by self-report on Health History Questionnaire.)
8. Unwilling or unable to complete consent form and surveys electronically (Confirmed by successful completion of electronic consent form and baseline survey in REDCap.)

Assessment of participant eligibility is at the discretion of the Principal Investigator, Dr. Deanne Tibbitts.
Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)

The purpose of this trial is to evaluate the effects of a remote and intensive physical activity promotion program for people with Type 2 Diabetes (T2D), in comparison to a usual model of PA counseling, in glycemic levels, level of physical activity and quality of life in adults in elderly with T2D.

The PRACTICE Trial aims to assess the effectiveness of a remote and intensive physical activity promotion program in contrast to the usual advice for physical activity on the management of HbA1c in people with T2DM.

The duration of the trial will be 24 weeks. Participants will be allocated to the intervention group or control group. The data collection will include variables related to (a) physical activity levels; (b) quality of life; (c) self-care in T2D; (d) functional capacity levels; and (e) adverse events related or not to the study.

Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older;
* Glycated hemoglobin ≥ 8.0%;
* Being a resident in Porto Alegre or metropolitan areas (Viamão, Alvorada, Cachoeirinha, or Canoas);
* Eligibility to perform physical activity after cardiovascular risk assessment;
* Have some means of access to the internet (direct access or via a family member who can receive the research material and share the information/material sent with the participant).

Exclusion Criteria:

* Physically active, that is, performing at least 150 minutes of moderate to vigorous PA per week;
* Not having their own cell phone capable of receiving calls and text messages;
* Progressive neurological disorder (e.g., Parkinsonism, Alzheimer's Disease);
* Psychiatric disorder that makes the intervention unfeasible;
* Physical, language, hearing, vision or cognition disorder that makes it impossible to attend the evaluations and carry out the intervention;
* Severe cardiovascular disease (class III and IV heart failure, unstable angina), history of macrovascular event in the last 12 months (acute myocardial infarction, revascularization procedures, deep vein thrombosis, stroke or pulmonary embolism);
* Joint, muscle or bone injury that makes the intervention unfeasible;
* Planning to move to cities outside the geographic area where the study is carried out;
* Inadequate control of comorbidities. Resting systolic blood pressure \>180 mmHg and/or resting diastolic blood pressure \>100 mmHg;
* Physical limitation that makes it impossible or brings risk to the participant's practice (e.g. lower limb amputation that makes locomotion difficult, use of crutches, cane).
Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer

Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.

Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

Secondary objectives:

To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.

To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.


Eligibility Criteria:
Inclusion Criteria:

* Man with Prostate Cancer
* Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
* Osteopenia/osteoporosis proven by bone density test.

Exclusion Criteria:

* Creatinine clearance \< 30ml/min
* Hypercalcemia
* Actual treatment by Bisphosphonate or steroids
* Hypersensibility to Bisphosphonate or any contraindication to its use.
* Metastatic prostate Cancer
* Patients not suitable for compliance.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.