cyrilzakka/clinical-trials huggingface dataset:
Trial of Essential Amino Acid Supplementation in Protein Deficient Patients Following Total Knee Arthroplasty

The goal of this trial is to assess the efficacy of essential amino acids (EAA) on muscle atrophy and malnutrition compared to a placebo in patients following a total knee arthroplasty. The investigators specific objectives included analysis of (1) muscle strength, (2) change in malnutrition, (3) perioperative complications (4) physical activity.

Three orthopedic surgeons will participate in the study (MBC, DJM, SAJ). The surgical procedure will be performed as per each surgeon's routine practice. Patients will be asked to ingest 20g of EAA or placebo two times a day between meals 1 week prior and 2 weeks postoperatively. Patients will be given a pill organizer that has two doses per day with either EAA or placebo. Thigh circumference will be measured at baseline, 2 weeks and 6 weeks post-operatively. The mid-thigh measurement will be taken while the patient stands erect with their feet slightly apart and their weight equally distributed. The girth measurement is taken perpendicular to the long axis of the thigh. The tape measure will be placed at the level midway between the trochanterion and tibiale laterale sites each time to ensure that the same location is measured each time. The investigators will measure strength using a handheld dynamometer and performing a straight leg raise and knee extension at 90 degrees on the operative and the non-operative leg preoperatively, 2 weeks and 6 weeks post-operatively. The medial and lateral epicondyles of the femur will be used to position the subject's knee joint through the axis of rotation on the dynamometer. Strength will be tested at 30, 45 and 60 degrees of flexion. Physical activity will be collected using the Knee Society Score at baseline and at 6 weeks postoperatively. After the trial is commenced, there will be no additional enrollment once study numbers have been met.

Eligibility Criteria:
Inclusion Criteria:

* All patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis

Exclusion Criteria:

* All patients who were wheelchair bound preoperatively
* All patients who cannot participate in an outpatient physical therapy program for 3 days per week after surgery
Drug Eluting Pantera Lux Catheter Registry

All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.

All patients are treated with the Pantera Lux Paclitaxel releasing balloon.

Clinical follow ups at 1, 6 and 12 months after coronary intervention.

Eligibility Criteria:
Inclusion criteria:

* Signed Patient Informed Consent / Data Release Form
* Patient eligible for percutaneous coronary intervention (PCI)
* Patient is older than 18 years of age

Exclusion Criteria

* Patient has a known allergy against appropriate anticoagulation / antiplatelet therapy
* Patients with known allergy against paclitaxel or BTHC
* Patients with a target lesion that was previously treated by brachytherapy
* Pregnant woman or lactating woman
Calcium Mass Balance and Dialytic Efficiency of a New cITRate-containing and Acetate-free Dialysis flUidS: CITRUS Study

This study aimed to evaluate the effect on the calcium balance of a concentrate with 1 mM citrate and locate the equivalent concentration of calcium (Ca_eq) at a concentration of 3 mM acetate and traditional with 1.5 mM calcium in HD. The secondary objective is to evaluate the performance in the medium term of purifying the concentrate with 1 mM citrate and Ca_eq, compared to traditional concentrated with 3 mM acetate and 1.5 mM calcium in HD.

Primary Objective The primary objective of this study is to find the formulation of calcium (1.50, 1.65 and 1.75 mM) in the bath with 1 mM citrate which allows the equivalence of calcium balance (Ca_eq) in a sitting HD compared to traditional concentrated with 3 mM of calcium acetate and 1.5.

Secondary objectives

* Evaluate the purifying performance of small and medium-sized molecules in HD with concentrated with 1 mM citrate and Ca_eq compared to traditional concentrated with 3 mM calcium acetate and 1.5.
* Observe the effects on hemodynamic of the concentrate through the variation of the pre and post-dialysis blood pressure and intradialytic symptoms (cramps, hypotension, headache).
* Evaluate the variations of the parameters of mineral metabolism: Predialytic values of PTH, alkaline phosphatase treatments with concentrated Cit (1 mM citrate and Ca_eq) and concentrated with traditional Ac (3 mM calcium acetate and 1.5).

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically stable.

  * age\> 18 years.
  * HD therapy for more than 3 months.
  * good vascular access native functionality that enables real blood flow of at least 250 ml / min.

Exclusion Criteria:

* Patients with the features listed below may not be enrolled in this survey:

  * Life expectancy \<6 months.
  * residual diuresis\> 500 ml / day.
Enhancing Community Capacity to Improve Cancer Care Delivery

Undertreated patient symptoms and resulting acute care use require approaches that improve symptom-burden. Previously a a lay health worker (LHW)-led symptom screening intervention was developed for patients with advanced cancer. This intervention will be expanded to all patients with cancer and the LHW will be trained to refer patients to palliative care and behavioral health. This intervention will evaluate the effect on symptom-burden, survival, healthcare use, and total costs.

From 11/1/2016 - 9/30/2018, all newly diagnosed Medicare Advantage enrollees with solid or hematologic malignancies were enrolled in the intervention. Outcomes were compared outcomes to patients in the year prior (control arm). The primary outcome was change in symptoms using the Edmonton Symptom Assessment Scale (ESAS) and Personal Health Questionnaire-9 (PHQ-9) at baseline, 6- and 12-months post-enrollment. Secondary outcomes were between-group comparison of survival, 12-month healthcare use and costs.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with cancer
* Diagnosis of relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician.
* Must be 18 years or older.
* Must have capacity to verbally consent

Exclusion Criteria:

-Inability to consent to the study due to lack of capacity as documented by the referring physician.
Stereotactic Body Radiation Therapy for Breast Cancer

This is a prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.


Eligibility Criteria:
Inclusion Criteria:

Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.

Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment.

Primary breast and axillary surgery not recommended/performed due to any of the following:

* distant metastatic disease
* unresectable T4 disease and/or
* medically inoperable and/or
* patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent.

Exclusion Criteria:

Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease \>= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy \> 50% of the ipsilateral whole breast volume.

Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g.

scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).

Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
Akershus University Hospital Retrospective Cohort Study of Family Based Treatment

The goal of this observational study is to compare short and long-term effects of manualised Family Based Treatment for adolescent anorexia nervosa to those of non-manualised family therapy. The study will approach former patients who were treated before and after Family Based Therapy was adopted in an outpatient clinic, and extract data from electronic health records and public registries.

A two-group retrospective exploratory cohort study with longitudinal follow-up comparing adolescents with anorexia nervosa treated with generic family therapy to those treated with the manualised Family Based Treatment (FBT). The primary aim is to investigate whether adoption of FBT has led to faster normalisation of weight and lower rates of eating disorder in early adulthood. Secondary aims are to investigate whether implementation of FBT has changed the time to discharge, heterogeneity of patient weight change across treatment, rates of adverse events, rates of readmission, patient experiences of the treatment, long term functional outcomes and mortality. Data are extracted from patient health records, reported by participants and extracted from public registries.

Eligibility Criteria:
Inclusion Criteria:

• Clinical diagnosis of F50.0 Anorexia nervosa or F50.1 Atypical anorexia nervosa according to the International Classification of Diseases-10.

Exclusion Criteria:

• Patient was treated during the years 2018-2020 and FBT was never initiated according to patient health records.
A Feasibility Study to Evaluate Skin Cleansing With a Sodium Hypochlorite Wash

Feasibility study in approximately 20 subjects to investigate the rate of infection with subjects undergoing elective lower extremity arterial bypass graft surgery or femoral endarterectomy. The subjects are instructed to shower with the sodium hypochlorite body wash daily, or as modified by the physician, for 5 of the 7 days leading to their surgery.

This is a feasibility study in approximately 20 subjects over a 5-week period per subject. The study will investigate the rate of infection with subjects undergoing elective lower extremity arterial bypass graft surgery or femoral endarterectomy. The subjects are instructed to shower with the sodium hypochlorite body wash daily, or as modified by the physician, for 5 of the 7 days leading to their surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female greater than the age of 18 years.
2. Subject is willing and able to give written informed consent and to comply with the requirements of the study.
3. Subject has 5 or more days of time prior to elective surgery scheduled to sign consent and begin washing parameters.
4. Subject is capable of taking a shower and lathering their entire body, or is able to be helped by a caregiver to shower each day with lather on their entire body for 5 out of 7 days immediately prior to elective surgery. (Modifications for bath usage can be made by the physician if the result of the product being left on the skin of the entire body for the time commitment is maintained, and if the body can be rinsed with poured water. Bed bath is not considered an allowable modification.)

Exclusion Criteria:

* 1) Subject is on antibiotics prior to surgery.

  2) Subject is unable to maintain washing regimen for the full study term.

  3) Subject is unable to follow pre-surgery cleansing instructions for 5 of the 7 days immediately prior to surgery. (Bed bath is not considered a cleansing day.)
Evaluating the Impact of a Digital Psychosocial Tool (Wysa) on Life Skills and Well-being of College Students in India

The goal of this study is to learn the feasibility of a digital psychosocial tool (Wysa) in improving life skills and overall wellbeing of English-speaking college students in IIT-Gandhinagar, a university in India. This will be conducted using pre-post assessments examining resilience, self-efficacy, problem solving, and wellbeing as well as examining app usage during the intervention period. The main questions it aims to answer are:

1. The feasibility and acceptability of Wysa amongst college students enrolled at the university
2. The effectiveness of Wysa in improving the life skills and well-being of college students enrolled at the university

This study will employ a mixed methods pre-post design to examine whether a digital psychosocial tool can help college students in India learn ways to manage their problems and improve their wellbeing. Students enrolled at the Indian Institute of Technology, Gandhinagar (IIT-Gn) and are interested in learning skills to manage stressors are invited to participate in the study. The intervention being studied is the Wysa app which includes an AI-based chatbot, a library of toolpacks , and SOS resources. Participants will complete baseline research procedures (T0) and be able to download the app. Participants can use the Wysa app for a period of 2 months. At the end of 2 months, participants will be invited to complete their endline assessments (T1). Another follow-up assessment (T2) will be carried out 1 month after the intervention period completion. A sub-sample of participants will be invited to participate in qualitative interviews to provide feedback about their experiences using the Wysa app and to understand the barriers and facilitators to acceptability and effectiveness of the app.

Eligibility Criteria:
Inclusion Criteria:

* Are between 18-25 years of age
* Are a student of Idian Institute of Technology, Gandhinagar (IIT Gandhinagar)
* Are able to read and understand English
* Have access to an internet enabled smartphone

Exclusion Criteria:

* Have previously used Wysa app (the intervention)
* Presence of self-harm/suicidal risk
Formula Tolerance of Term Infants

To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants


Eligibility Criteria:
Inclusion Criteria:

* Participant is judged to be in good health as determined from participant's medical history by parent report
* Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
* Participant's birth weight was \>= 2490 g (\~5 lbs. 8 oz.)
* Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
* Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
* Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local privacy regulation authorization prior to any participation in the study

Exclusion Criteria:

* An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse.
* Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
* Participant participates in another study that has not been approved as a concomitant study
* Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
* Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
* Participant has been treated with antibiotics within 7 days prior to enrollment
Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes

This study was conducted to investigate the effects of daily supplementation of fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.

This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance test were assessed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years with fasting glucose 100\~140 mg/dL at least two of the following

Exclusion Criteria:

* Lipid metabolic disorder
* Acute or chronic inflammatory disease
* Taking medication of corticosteroid within 4 weeks of the study
* Cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker)
* Allergic or hypersensitive to any of the ingredients in the test products
* Participation in other clinical trials within 2 months
* Abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome)
* Taking medication of lipid phosphates within 3 months of the study etc,
Electromagnetic Stimulation (FREMS) in Patients With Painful Diabetic Neuropathy

We postulate that frequency-modulated electromagnetic stimulation (FREMS) may decrease pain in patients with painful diabetic neuropathy.

The stuy was designed as a randomized, double-blind, placebo-controlled cross-over trial. Each patient received two series of ten treatments of either FREMS or placebo in random sequence, with each series lasting no more than three weeks. Primary outcomes (daytime and night-time pain scores) an secondary outcomes (Motor and sensory nerve conduction velocity, sensory tactile perception, foot vibration perception threshold, quality of life, cutaneous microvascular flow, partial tissue tension of oxygen and carbon dioxide) were measured at baseline, after FREMS/placebo series and after 4 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* type 1 or type 2 diabetes (American Diabetes Association criteria)
* painful diabetic neuropathy with reduced sensory/motor nerve conduction velocity (i.e., \<40 m/sec in at least one nerve trunk of the lower limbs)
* vibration perception at the big toe \>25 V

Exclusion Criteria:

* presence of any concomitant severe disease
* pregnancy
* renal disease (serum creatinine \>2.0 mg/dL)
* history or current foot ulcer
* lower limb arterial disease (ankle-brachial index \<0.9) or transcutaneous partial pressure of oxygen \<50 mmHg)
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea

The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested:

Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance.

Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.

Pre-specified primary analysis for Aim 1 is the change in AHI with combination treatment versus oral appliance alone (%reduction versus placebo; including hypopnea events without desaturation/arousals).

Aim 2 seeks to identify subgroups of patients that have the greatest reduction in AHI (responders) with each treatment (post-hoc). We will use baseline physiological measures of the four traits causing OSA (collapsibility, responsiveness, loop gain, arousal threshold) to determine which characteristics predict responses to each intervention (leave-one-out support vector machine modeling). Clinical measures of the same traits will be estimated from the placebo night to confirm that responses can be predicted with clinically-available data. We will also test whether responders to oral appliances have a greater response to oxygen than oral appliance non-responders (and vice-versa), to address whether responders to both treatments are similar or different.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed OSA or suspected OSA based on snoring

Exclusion Criteria:

* Severe co-morbidities (cardiovascular, renal, lung disease, neurological), including:

Congestive heart failure, Neurological conditions that may affect sleep or breathing (e.g. neuromuscular diseases e.g. myasthenia gravis; neurodegenerative diseases e.g. Alzheimer's/Parkinson's)

* Medications that will substantially affect respiration, including opioids, barbiturates, theophylline, doxapram, acetazolamide, pseudoephedrine
* Claustrophobia
* Insomnia and other non-respiratory sleep disorders
* Inability to sleep supine
* Contraindications to oral appliances, including insufficient teeth to support the device, periodontal problems inducing tooth mobility, active temporomandibular joint disorder
* Allergy to lidocaine or oxymetazoline HCl