cyrilzakka/clinical-trials huggingface dataset:
Elemental Formula Hypoallergenicity

The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.


Eligibility Criteria:
Inclusion Criteria:

* Born at term (\>36 weeks gestation)
* 2 months to ≤12 years of age at enrollment
* Documented CMA within 6 months prior to enrollment
* Otherwise healthy
* Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
* Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
* Having obtained his/her legal representative's informed consent

Exclusion:

* Children consuming mother's milk at the time of inclusion and during the trial
* Any chromosomal or major congenital anomalies
* Any major gastrointestinal disease or abnormalities other than CMA
* Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)
* Immunodeficiency
* Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
* Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
* Unstable asthma
* Severe uncontrolled eczema
* Severe anaphylactic reaction to milk within the last 2 years
* Severe anaphylactic reaction to breastmilk within the last 2 years
* Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
* Currently participating in another clinical trial.
Comparison of Two Methods to Estimate the Lung Recruitment

In this study the investigators aim to compare two common methods to estimate the lung recruitment in ALI/ARDS patients.


Eligibility Criteria:
Inclusion Criteria:

* ALI/ARDS

Exclusion Criteria:

* Barotrauma
Glucose, Whey Protein and Time to the Next Meal on Mealtime Food Intake in Children

The investigators hypothesize that glucose and whey protein given 30 and 60 min before a pizza meal will exert different effects on food intake in adolescent children, and will depend on pubertal stage. Food intake will be measured at 30 and 60 min following a glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or sweetened noncaloric beverage. Subjective appetite will be measured as well.


Eligibility Criteria:
Inclusion Criteria:

* children with no emotional, behavioral or learning problems

Exclusion Criteria:

* underweight children
* children with emotional, behavioral or learning problems
* children who dislike foods in study
Acute Kidney Injury in Patients on Dapagliflozin and Other Antidiabetic Medications

To compare, by insulin use at the index date, the incidence of hospitalization for acute kidney injury (AKI) among patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy

The overall goal of this research study is to estimate the risk of hospitalization for acute kidney injury in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. Dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations.

The study will be implemented in three administrative health care data sources in two countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD); and in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the HealthCore Integrated Research Database (HIRDSM). Individuals in the databases will be included in the study if they meet the following age criteria; 18 years and older (CPRD and HIRD), or 65 years or older (Medicare); and if they did not have type 1 diabetes, are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. The study period starts July 1, 2013 in CPRD, January 1, 2014 in PHARMO and January 9, 2014 in the United States data sources, and will end at the latest available data at each database at the time of analysis.

Eligibility Criteria:
Inclusion Criteria:

1. receive newly prescribed dapagliflozin (with or without other ADs) or receive a newly prescribed AD (with or without other ADs) in a class other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy;
2. do not have any diagnostic code indicating type1 diabetes;
3. are aged 18 years or older at the index date for CPRD patients, 18-64 years for HIRDSM patients, or 65 years or older for Medicarepatients; and
4. have been enrolled in the data source for at least 180 days before the first prescription or dispensing dapagliflozin or eligible index comparator AD

Exclusion Criteria:

-previous diagnosis of chronic kidney failure
The Transtheoretical Model For Polycystic Ovary Syndrome

The main objective of this study was to investigate the impact of individual counseling programs which has been designed from the Transtheoretical Model (TM) suggesting a healthy diet and physical activity for the students diagnosed with PCOS in the management of their syndrome. The data for the analysis was drawn from a sample of 854 students at first and a totally of 67 students were administered the scales. The control (N=33) and experimental groups (N=34) were formed based on a simple randomization technique.


Eligibility Criteria:
Inclusion Criteria:

* voluntary participation
* absence of sexual activity
* belonging to the age group of 19-24
* absence of chronic diseases
* absence of any physical disability and a lack of mental disorders.

Exclusion Criteria:

* being on medicine
* scores of above 18.5 and below 30 on the Body Mass Index (BMI)
Mathematical Modeling of the HIV Transmission Risk After Initiation of Antiretroviral Therapy in naïve HIV-infected

The objective of this study is to explore the impact of initiation of ART with different regimens in naïve MSM (in the setting of acute and chronic HIV-infection) on the probability of transmission of HIV by mathematical modeling.

The HIV epidemic among men who have sex with men (MSM) continues to expand in low, middle, and high-income countries. The disproportionate HIV disease burden in MSM is explained largely by the high per act and per-partner transmission probability of HIV transmission in receptive anal sex . Current strategies are inadequate to control HIV spread among MSM; much more vigorous prevention efforts are required, including the early initiation of antiretroviral therapy (ART) that has been shown to reduce the rates of sexual transmission of HIV-1 and the adaptation and expanded use of pre-exposure prophylaxis (PrEP) to prevent the acquisition of HIV-1 infection .

Initiation of ART with regimens based on integrase strand transfer inhibitors (INSTI) is associated with a faster decline in HIV-RNA load than what is observed with regimens based on non-nucleoside transcriptase inhibitors (nnRTI), and protease inhibitors (PI). The clinical impact of this finding is unknown although clinical anecdotes suggest that it may it may cause a rapid decline in HIV RNA in women presenting with HIV in late pregnancy.

The objective of this study is to explore the impact of initiation of ART with different regimens in naïve MSM (in the setting of acute and chronic HIV-infection) on the probability of transmission of HIV by mathematical modeling.

Eligibility Criteria:
Inclusion Criteria:

* naïve HIV-infected MSM

Exclusion Criteria:

* none
EEG Cap for Identification of Non-Convulsive Status Epilepticus

Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.

At the completion of neurology evaluation, if NCSE is in the differential diagnosis according to institution best practice, then consented participants will undergo placement of a large size, 20-channel EEG cap from Electro-Cap International with a Natus E-2-2520-26 electrode board adapter with initiation of recording. The placement of the EEG cap will be restricted to residents formally trained in its placement by an EEG tech. This study will only be performed during times when EEG techs are not available onsite for rapid placement of standard 21-channel EEG electrodes, such as during night-call shifts.

Prior to placement of EEG cap, evaluating staff member will request immediate standard-electrode EEG. The investigators will record time from neurology consultation request to placement of EEG cap as well as time from consultation request to obtaining a standard EEG. The investigators will also record time to confirmation or exclusion of NCSE. Initial diagnosis or exclusion of NCSE will be performed by on call resident, if the resident received prior training regarding EEG cap placement, and attending. Secondary quality assessment will be performed by two independent EEG interpreters blinded to clinical history. Secondary assessment will be qualified as acceptable or inacceptable interpretation based on whether greater or less than 50% of the recording is judged interpretable. Secondary assessment will also include interpretation of NCSE by a third independent reader if there is disagreement between first two. The number of patients excluded from the study will also be recorded, including the reason for exclusion.

Eligibility Criteria:
Inclusion criteria:

1. Patients with suspected NCSE in the Mayo Clinic Florida hospital, emergency room or intensive care unit.
2. Age: Patients of 18 years or older will be included in this study
3. Education: All education levels will be included

Exclusion criteria:

1. Patients younger than 18 years of age.
2. Patients with open head trauma.
3. Patients with anatomy that would preclude EEG cap placement.
4. Patients excluded for anatomical or age-related reasons will be tracked to determine applicability of the EEG cap to the patient population at Mayo Clinic.
5. Pregnant females
6. Large head size not amenable to cap placement
7. Scalp infection
8. Inability to obtain informed consent
A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of fremanezumab in adult participants aged 18 to 70 years, inclusive, for the prevention of PTH. The study will include a double-blind (DB) treatment period (12 weeks) and an open-label (OL) treatment period (12 weeks).


Eligibility Criteria:
Inclusion Criteria:

* The participant has a body weight greater than or equal to (≥) 45 kilograms (kg).
* Traumatic injury to the head has occurred, defined as a structural or functional injury resulting from the action of external forces.
* The participant has a diagnosis of PTH.
* The participant is not using preventive medications for headache.
* Women of childbearing potential whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study and for 30 weeks after the last study drug administration. Men must be sterile or, if they are potentially fertile or reproductively competent (that is, not surgically or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study and for 30 weeks after the last study drug administration.

NOTE- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

* The participant has a previous history of brain imaging showing evidence of intracerebral hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a consequence of the traumatic head injury. Brain images with structurally insignificant changes, as discussed and approved by the sponsor, will be reviewed by the sponsor on a case-by-case basis.
* The participant has PTH attributed to craniotomy.
* The participant has whiplash and subsequent headache but no history of head injury or concussion.
* The participant is using analgesic medications containing opioids (including codeine) or a barbiturate on average more than 15 days per month.
* The participant has had exposure to a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway (erenumab, eptinezumab, galcanezumab, and fremanezumab) during the 6 months prior to the day of the screening visit.
* The participant is currently being treated with onabotulinumtoxinA (for example, Botox, Dysport, Xeomin) application in the head or neck or received any such injection during the 3 months prior to the screening visit.
* The participant has been implanted with any electronic devices for headache prevention during the 3 months prior to the screening visit or is currently using any implanted or externally applied stimulator or device.
* The participant has been treated with a nerve block for head and/or neck during the 3 months prior to the screening visit.
* The participant is a pregnant or lactating woman or plans to become pregnant during the study.

NOTE- Additional criteria apply, please contact the investigator for more information.
A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women

The purpose of this study is to help women lose the weight they gained during their pregnancy using a SmartPhone app the investigators have developed called E-Moms. The investigators hypothesize that the moms given the app to use during the study will lose more weight than the moms who do not use the app.

The E-Moms Study will last about 4 months. The weight management program is 4 months long and will end about 6 months after the participant's baby is born. All participants will receive Women, Infants and Children (WIC) services.

For the weight management program, participants will be put into one of these groups:

1. WIC Moms: receive advice and services for nutrition and weight management after pregnancy from their WIC clinic.
2. WIC E-Moms: receive a personalized diet and exercise plan to help them lose the weight they gained during their pregnancy. All information will be given to them using a SmartPhone, such as an iPhone. They will also get advice and services from your WIC clinic.

Eligibility Criteria:
Inclusion Criteria:

* Are a female who has delivered a baby within the last 2 months
* Are 18 years of age or older
* Have a body mass index ≥25 kg/m2 or \<40 kg/m2
* Are accepted for post-pregnancy WIC services
* Are English-speaking

Exclusion Criteria:

* Are participating in the Nurse Family Partnership program
* Had multiples in your most recent pregnancy
* Are unwilling to be assigned at random to either of the 2 study groups
* Are planning to move out of the study area within the next 6 months
* Have a history of psychiatric conditions or chronic disease than can impact body weight, appetite, or energy intake such as HIV/AIDS, cancer, bipolar disorder or schizophrenia
* Currently use antipsychotic medications or have used such medications in the previous 12 months
* Have been diagnosis with type I diabetes
* Report having a heart attack, stroke, or being hospitalized or treated for chest pain
* Currently taking medications or supplements to aid in weight loss
* Have had weight loss surgery in the past year or plan to have it prior to study completion.
* Currently participating in another interventional study that influences weight control
* Currently abusing drugs or alcohol (up to 14 drinks per week allowed)
Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers

Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events and adverse drug reactions observed from the date of administration to 7 days after administration.


Eligibility Criteria:
Inclusion Criteria:

1. Japanese healthy male volunteers (20 to 64 years old)
2. BMI（Body Mass Index）should be within a range of 17.6 and 26.4.
3. Subjects who agreed not to smoke or drink during hospital stay.
4. Subjects who do not excessively consume alcohol and those who do not excessively smoke
5. Subjects who are not judged as abnormal during the screening period in the physical examinations including 12-lead ECG, clinical symptoms, clinical examination, immunological examination (hepatitis B examination, hepatitis C examination, AIDS examination, syphilis examination).
6. Subjects who are not judged as abnormal during the before administration in blood electrolyte.
7. Subjects who have no clinical abnormalities and are judged to be eligible to the study by the investigator.

Exclusion Criteria:

1. Subjects who had previous significant gastrointestinal surgeries.
2. Subjects with a history of 12-lead ECG abnormality.
3. Subjects who have constipation（less than 2 bowel movement per week）
4. Subjects who have addictive of diarrhea
5. Subjects who have history of shock or hypersensitivity to sulfates (sodium sulfate, potassium sulfate, magnesium sulfate, etc.).
6. Subjects who have history of drug allergy.
7. Subjects who donated 200 mL or 400 mL of whole blood 4 weeks or 12 weeks respectively prior to the administration of investigational drug, or who donated blood component last 2 weeks.
8. Subjects who have participated in an investigational study within 4 months before signing the consent.
9. Subjects who is participating in the other investigational study
10. Subjects who received NPF-08 in the past
11. Subjects who are judged by the investigator as not adequate to participate the study.
The Effect of Split-belt Treadmill Training on Gait in Parkinson's Disease

People with Parkinson's disease (PD) often show gait impairments such as, shuffling gait, short steps and gait asymmetry and irregularity. These gait problems are already apparent in the early disease stages, having an immense effect on daily life functioning. Especially Freezing of Gait (FOG), where the patients are not able to initiate or continue their movement despite their intention to do so, is a debilitating problem. It is thought that lack of gait adaptability could be an underlying cause of FOG. With a split-belt treadmill the speed of both legs can be controlled independently, which forces participants to actively adapt their gait to the new situation. In a previous study performed at our lab, it was shown that only one session of split-belt training (SBT), in which the speed of one leg was reduced, improved gait adaptability and other gait features compared to tied-belt training (TBT). Furthermore, overground turning speed improved after only one single training session and this was even retained 24 hours later, indicating training induced long-term potentiation. Since the short-term effects of SBT are promising, the objective of this study is to investigate if 4 weeks of SBT, 3 times a week, has an effect on gait deficits found in individuals with PD, compared to 4-weeks, 3 times a week, of TBT.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of PD according to the recent criteria of the Movement Disorders Society made by a neurologist
2. Participants should be able to walk 5 minutes at a stretch without a walking aid
3. Hoehn \& Yahr stage II or III in the ON state of medication
4. Mini Mental State Examination score of 24 or above
5. Participants should have a steady medication schedule at the start of the study (no change in the past month).
6. To be included as a freezer participant a score of at least 1 or higher should be recorded with the New Freezing of Gait Questionnaire.

Exclusion Criteria:

1. Current enrollment in another clinical study which may interfere with the conduction of this study.
2. Orthopedic injuries or other musculoskeletal problems, which could possibly effect balance and/or gait.
3. Unable or unwilling to commit to 4 weeks of training, 3 times a week
4. Participation in walking training in the month prior to the start of the study
5. Other neurological impairments (except PD)
6. Cardiovascular exercise risk factors diagnosed by a doctor
Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound

The purpose of this study is to test therapeutic benefits of silver dressing compared with non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may antibacterial effect on infected diabetes mellitus foot.

Investigator will recruit sixty patients. Participant will be randomly assigned to one of two groups. One is using silver dressing group in NPWT, another is using non-silver dressing group in NPWT. Participant will visit in screening day, NPWT apply day and F/u day for 4 months. Investigators will conduct to check the wound base, Lab, wound culture.

Eligibility Criteria:
Inclusion Criteria:

* The patient above 20 years and has type I, II of diabetes mellitus foot ulcer
* Infected ulcer has one of below.

  1. clinically infection symptom in ulcer area : warmth, erythema, tenderness/swelling

     * induration, purulent discharge etc.
  2. Confirmed case of bacteria in wound culture.
  3. Conformed case of abnormal range of erythrocyte sedimentation rate (ESR)/C-reactive protein(CRP) level in lab.
* Has to be applied NPWT because suture is impossible in ulcer area.
* The patient voluntary agreed to this protocol.
* In the opinion of investigator, It is suitable to participate in this study.

Exclusion Criteria:

* Infection in bone so patient need amputation
* Female with childbearing, lactating or not agree to prevent pregnancy.
* Has Sepsis, Osteomyelitis
* Has Connective tissue disease of disturbance of healing of wound Ex) Rheumarthritis,systemic lupus erythematosus(SEL), myalgia.
* The patient to diagnosis of Sickle sell disease or Charcot's joint.
* The patient stability treated chronic wasting disease.
* Malignant tumor or history of malignant disease. (Not diagnosis of complete recovery.)
* The patient treated chemotherapy, radiation therapy, immune-suppressants therapy,adrenocortical hormones therapy.
* Although necrosis tissue is removed, the target ulcer did not heal because of gangrenous, necrosis tissue or purulent pyorrhea.
* Has ulcer with cardiac arrhythmia thrombus, venous insufficiency, diabetic necrobiosis lipoidic.
* In case of using prohibited concomitant medications during study.

  a. Oral system steroid b. Immune-suppressive drug c. Unfractionated heparin infusion d. improper drugs in the opinion of investigator.
* Hypersensitivity with applicators. (NPWT, Silver)
* The patient participated in other clinical trials within 30 days
* In the opinion of investigator, the patient is not suitable to participate in this study.