cyrilzakka/clinical-trials huggingface dataset:
The Impact of the Type and Route of Nutritional Support on Infectious Complications After Upper Gastrointestinal Surgery

The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery

All patients qualified between June 2002 and December 2007 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Malnutrition was defined by the Nutritional Risk Index (NRI), calculated according to the formula used in the Veterans Administration Cooperative Group trial.{, 1991 #70} Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients without features of malnutrition, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications in a population of malnourished patients following elective upper GI surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years,
* Karnofsky performance status score of 80 or more,
* adequate organ function measured by routine blood tests

Exclusion Criteria:

* patients \<18 or \> 80
* Karnofsky performance \< 50
STAAR Visian Toric ICL Post-Approval Study

The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).

This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to high myopia with astigmatism correctable with available TICL powers.
* Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation.
* Able and willing to return for scheduled follow-up examinations after surgery.
* Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Insulin-dependent diabetes or diabetic retinopathy.
* History of previous ocular surgery.
* Cataract of any grade.
* Monocular.
* Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.
* Other protocol-specified exclusion criteria may apply.
The Effect of Soft Tissue Mobilization and Kinesio Taping Applied to Athletics Athletes on Sports Performance

The aim of the research is to evaluate the effects of tool-assisted soft tissue mobilization and kinesiology tape applications applied to the Hamstring muscle on balance, agility and jumping in athletics athletes.

Participants will be divided into 3 groups. Kinesiology taping will be applied to the 1st group, and instrument-assisted soft tissue mobilization will be applied to the 2nd group. The 3rd group will be the control group and no application will be made. All 3 groups will participate in regular training. Before training, applications will be made to the Hamstring muscle on both legs. All 3 groups will be evaluated before, after and 1 month after training, and the 1st and 2nd groups will be evaluated by comparing them with the 3rd group (control group). A 15-minute warm-up period will be given before the measurements. During the post-application measurements, the 1st group will have Kinesiological Taping. There will be 3-minute rest periods between measurements to prevent fatigue. Kinesiology taping; In order to facilitate the muscle, while the subject is standing and his body is flexed to ensure hip flexion, both "I" bands will be applied from the origin to the insertion, with 30% stretching from the medial and lateral, starting from the Ischial Tuberositas to the border of the Popliteal Fossa. Instrument-assisted soft tissue mobilization; The subject is in a prone position on a bed, with the lower extremity in a neutral position, and a hazelnut-sized amount of lubricant will be applied to the working surface, and will be applied to the skin on the back of the upper leg for 5 minutes, targeting the tissue structures. (Hamstring and deep fascia covering this muscle) The pressure and speed will be adjusted according to the tolerance of the subject so as not to cause pain. Participants will be administered the Unipedal Stance Test, Agility T-Test and Standing Long Jump Test.

Eligibility Criteria:
Inclusion criteria

* Have been doing athletics for the last 6 months and participate in training regularly,
* Are between the ages of 10-40,
* Those who train at least 3 days a week,
* Athletes who have consent to participate in the study (athletes between the ages of 10-18 with consent from their parents) will be included.

Exclusion criteria

* Having any history of injury or acute infection,
* Having a systemic and metabolic disease,
* Having a history of chronic pain,
* Having an unhealed or unstable bone fracture,
* Athletes with allergies, infections or open wounds on the skin will not be included.
Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients

These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.

Evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* de novo or secondary LAM (CML excluded) not elligible for intensive chemotherapy.
* Previously untreated

Exclusion Criteria:

* Renal impairment (serum creatinin \>2N)
* Hepatic impairment (TGO ou TGP \> 5N), une cholestase (Phosphatases Alcalines or gamma-GT \> 5N),bilirubin \> 3N

  * Blast crisis CML
  * Acute Promyelocytic Leukemia.
imPulse™ Una Infrasound-to-ultrasound E-stethoscope

This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of asymptomatic and symptomatic COVID-19 digital biosignatures for rapid and accurate adult and child mass screening.

For the next few years or more, the planet probably won't have enough vaccine for everyone. Even as countries with large COVID-19 vaccination programs start pushing to resume travel and trade:

We will not know who is vaccinated and who is not . We will not know who is an (a)symptomatic COVID-19 carrier and who is not.

Because of this, the global community will remain in various stages of masking, social distancing, lock-down, and limited congregation because of cyclical COVID-19 spikes and people will continue to feel unsafe and afraid as novel COVID-19 variants appear and disappear.

This large-scale, multi-site, multi-national study is informed by a completed pilot study at Johns Hopkins- NCT04556149. This study is designed to validate the ability of the imPulse™ Una infrasound-to-ultrasound e-stethoscope to rapidly and accurately screen outpatients with and without confirmed COVID-19 with sensitivity, specificity, positive and negative predictive value matching (PPA \>95%) for early, accurate, and rapid, self-directed and point-of-care diagnosis of COVID-19 in areas still lagging in access to vaccines.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willingness to comply with study procedures
* Inpatient Cases - hospitalized patients with positive COVID-19 PCR test, collected from a respiratory sample within the last 7 days, AND pulmonary symptoms within 72 hours of enrollment
* Outpatient Cases - participant being screened for COVID-19 with positive COVID-19 PCR test respiratory sample Controls - Outpatients with negative COVID-19 PCR test respiratory sample and no pulmonary diagnosis or symptoms Cases or Control not able to sit or stand will be allowed to participate in just the parts of the staircase exam they're capable of doing.

Exclusion Criteria:

* Assisted ventilation, including high flow nasal cannula, or ventilator support
* Unable to comply with study procedures, defined at investigator's discretion
* Participants with any visible skin infections or open wounds in areas where the imPulse™ Una device would be applied
Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy

This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

After NAC, the sentinel lymph node (SLN) identification rate is lower, and it has a higher false-negative rate than that in early-stage breast cancer. As appropriate SLN surgery directly affects the treatment and prognosis of patients undergoing NAC, evaluation to identify SLN using various methods is necessary.

This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

Eligibility Criteria:
Inclusion Criteria:

* The patient with locally advanced breast cancer who achieved neoadjuvant chemotherapy
* Confirmed operability with imaging study after neoadjuvant chemotherapy
* Age over 20 years old
* ECOG Performance status : 0-2
* The patient with written informed consent form

Exclusion Criteria:

* The patient with previous ipsilateral breast cancer history
* The patinet with previous ipsilateral axillary surgical procedure (e.g. excisional or incisional biopsy, axillary dissection)
* The patient without neoadjuvant chemotherapy
* Inoperable imaging study after neoadjuvant chemotherapy
* Inflammatory breast cancer
* Pregnant patient
The Effect of Television Watching on Liking of Food

The purpose of the study is to investigate the effect of television viewing on liking of food.

The objective of this investigation is to determine whether participants will have a change of liking of food based on television viewing. The specific aims of the study are:

1. Determine the effect of television on liking of food.
2. Determine the effect of no television on liking of food.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 35 years
* Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2
* Unrestrained eater (≤ 12 on the Three Factor Eating Questionnaire \[TFEQ-R\])
* Report a favorable preference for foods served in the meal including: macaroni and cheese and salad (dressing will be chosen by the participant via initial phone screen), participants must rate each food item ≥ 3 during phone screen and ≥ 50 on a visual analogue scale (VAS) during the initial screening session
* Regularly eat a meal before 10:00 am
* Are able to complete all sessions within eight weeks of the screening session
* Report being a non-smoker
* Are not taking medications that affect appetite or food intake
* Are not pregnant or breastfeeding
* Are not on a dietary plan or have dietary restrictions that prevent consumption of certain types and/or amounts of food

Exclusion Criteria:

* Binge eating; and/or
* Athletes in training
A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder

The purpose of this research study is to determine the effectiveness of 2 target doses of R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder.

Approximately 488 subjects will be involved in the study.


Eligibility Criteria:
* Generally healthy adults on the basis of a physical examination, medical history, ECG and laboratory work-up.
* Subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol.
* The subject also needs to be an outpatient to participate in this study.
Aerobic Exercise in Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is the most common neuromuscular disease in childhood with an estimate incidence of 1 in 3500 to 5000 male births. The effect of aerobic training on muscle architectural properties and motor functions such as muscle activation is not clear in DMD. The aim of this study is to investigate the effects of aerobic training on these parameters in children with DMD. Twenty children with DMD included in the study will be divided into two groups as home program and home program+aerobic training with block randomization method. Home program including stretching, respiratory, range of motion and mild resistance exercise with body weight will be asked to apply 3-5 days a week for 12 weeks, aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period. Muscle architectural properties, muscle strength, muscle activation and motor function will be assessed with ultrasonographic, hand-held myometry, surface EMG and Motor Function Measure, consecutively. Assessments will be applied at pre-training and after 12 weeks of training.


Eligibility Criteria:
Inclusion criteria:

* Children had diagnosis of DMD confirmed by genetic analysis,
* Children had functional level of Grade 1 and 2 according to Vignos Scale.

Exclusion criteria:

* Children had undergone any surgery or suffered injury of the lower limbs,
* Children had comorbid disease
* Children were applied regular aerobic training in last 6 months.
AIH-induced Walking Recovery After Subacute SCI

The purpose of this study is to determine how mild breathing bouts of low oxygen may restore walking and leg strength in persons who have sustained a spinal cord injury.

The goal of the study is to determine whether repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) improves recovery of walking and strength after spinal cord injury. This idea stems from animal studies on respiration, in which investigators showed that mild AIH improves breathing in rats with spinal injuries. These studies showed that AIH induces plasticity, strengthening neural connections by increasing the production of key proteins and improving the sensitivity of spinal cord circuitry. The ultimate goal of this research is to assess the potential of mild AIH as a therapeutic approach not only in persons with chronic spinal cord injury but also in persons with subacute injury. By applying AIH during early stages of recovery, the investigators hope to expand the potential benefits of AIH to a broader range of persons with spinal injury, thereby improving functional independence and quality of life for servicemen and civilians.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old
* medically stable with medical clearance from physician to participate
* spinal cord injury (SCI) at or below C3 (phrenic sparing) and above L5 with at least motor function preserved below the neurologic level
* non-progressive etiology of spinal injury
* American Spinal Injury Association Impairment Scale (AIS) grade A-D
* 2-12 months post-injury (subacute)

Exclusion Criteria:

* severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection (e.g. bladder), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis (history of fractures), active heterotopic ossification in the lower extremities, or history of peripheral nerve injury in the legs
* score less than 24 on Mini-Mental Exam
* severe autonomic dysreflexia
* history of cardiovascular/pulmonary complications
* pregnancy
* severe obstructive sleep apnea (OSA), characterized by uncontrolled hypoxia and sleep fractionation

Specific inclusion/exclusion criteria for recruiting non-ambulatory subjects:

Participation in this group requires all of the above inclusion/exclusion criteria, as well as being unable to complete any of the below measures:

* timed up-and-go (TUG) test
* 10-meter walk test (10MWT)
* 6-minute walk test (6MWT)

Specific inclusion/exclusion criteria for recruiting ambulatory subjects:

Participation in this group requires all of the above criteria, as well as successful completion of at least one below measure:

* timed up-and-go (TUG) test
* 10-meter walk test (10MWT)
* 6-minute walk test (6MWT)
Efficacy Study of Liraglutide vs.Sitagliptin vs. Glargine on Liver Fat in T2DM Subjects

The aim of this study is to explore the effectiveness of liraglutide combined with metformin in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared to sitagliptin and insulin glargine in combination with metformin.

This is a 26-week, randomized, open-label, active controlled, parallel group, multi-centre trial.To compare the change of intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy(MRS) or MRI estimated proton density fat fraction (MRI-PDFF) as measured by MRI IDEAL IQ (Iterative Decomposition of water andfat with Echo Asymmetryand Least-squares estimation) in type 2 diabetic patients with non-alcoholic fatty-liver disease after a 26-week treatment of liraglutide, sitagliptin or insulin glargine per day combined with metformin.The primary endpoint will be defined by intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy (MRS) or MRI-PDFF as measured by MRI IDEAL IQ.

Eligibility Criteria:
Inclusion Criteria:

* Recorded Type 2 diabetes diagnosed at least 3 months before the study; At least 3 months treatment on a stable dose（≧1500mg/d）of metformin before the study
* 6.5%\<HbA1c ≤10%
* Clinically diagnosed simple liver steatosis
* 30-75 years old
* Female subjects should be postmenopausal, surgically sterile, or using contraceptives for 3 months before screening and continuing throughout the study;
* BMI 20\~35 kg/m2 and with a history of stable body weight (≤10%variation for ≥3 months)
* intrahepatic lipids (IHL) \>10%

Exclusion Criteria:

* Type 1 diabetes
* Treatment within the last 3 months with Thiazolidinediones(TZDs), orlistat, insulin, any history of incretin based therapy or any other drugs associated with hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone or methotrexate)
* History or current episode of pancreatitis or other disease of the pancrea; Impaired liver function, defined as plasma alanine transaminase(ALT) \>2.5 times of upper normal limit
* Moderate and severe renal insufficiency defined as MDRD formula glomerular filtration rate\<60ml/min/1.73m2
* Weekly alcohol intake\>14 units for women or \>21 units for men
* Any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis
* History or family history of medullary thyroid cancer(MTC), or multiple endocrine neoplasia type 2(MEN-2)
* Congestive heart failure(NYHA III\~IV)
* Severe gastric-intestinal diseases
* Pregnancy and/or intention of becoming pregnant
* Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator; Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may, at the Investigator's discretion, be continued throughout the trial at an unchanged dose
GlowTest COVID-19 Antigen Home Test Kit QRI Use Study

The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.

The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use. The Arion Bio GlowTest COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals aged 2 to 13. The objective of the study is to determine the usability of the GlowTest COVID-19 Antigen Home Test in a simulated home use environment. This is an open label study to evaluate the usability of the GlowTest COVID-19 Antigen Home Test using information from the Quick Reference Instructions and website.

30 subjects (including both English speaking and Spanish speaking) will be split evenly into two sections: 15 participants testing themselves and 15 participants testing another person (child). There will be one testing site in the United States (US).

Eligibility Criteria:
Inclusion Criteria:

* An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
* Males and females ages 2 and older.
* Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)
* Subject agrees to complete all aspects of the study

Exclusion Criteria:

* Subject has a visual impairment that cannot be restored with glasses or contact lenses.
* Subject has prior medical or laboratory training.
* Subject uses home diagnostics, e.g., glucose meters, HIV tests.
* Subject has prior experience with home COVID test kits.