cyrilzakka/clinical-trials huggingface dataset:
Lactocare Baby Drops in Infants Colic

The objective of this study is to determine an efficacy of the combination of L. rhamnosus 19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in infants aged 4 through 12 weeks with IC. The active group of infants will receive lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at the end of intervention to define a difference between the groups

There is accumulating interest in role of lactobacilli in decreasing cry and fuss in infant colic, the condition that affects around 1 of 4-5 infants. The interest for dietary supplementation has been evoked by a line of earlier studies, indicating that infants with colic had an increased number of gas-forming E.coli in the intestines and potential interference between lactobacilli and E.coli. Systematic review of evidence, based on the 6 randomized controlled dietary studies, conducted in Italy, Poland, Australia, Canada, and Finland, has concluded of the decrease of the mean time cry of infant by -55 minutes a day after the 3 weeks dietary course with lactobacilli . In the mentioned studies most commonly used lactobacilli were L. reuteri, however, the effect of combination of L. reuteri with other lactobacilli remains unknown.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form signed by both parents.
2. Gender: males and females;
3. Age: 4 -12 weeks;
4. Infant colic, defined as cry/fussing lasting \> 3 h, occurring \> 3 d for 7 days;
5. Gestational age 37-42 weeks;
6. Birth weight 2,500-4,200 g;
7. Stated availability throughout the study period;
8. Sated availability of mobile phone or phone with answering machine.

Exclusion Criteria:

1. Any formula feeding in any amount;
2. Failure to thrive (weight gain less than 100 grams per week as averaged from the birth weight to the weight at entry);
3. Current maternal smoking;
4. Known moderate or severe disease of any systems (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune);
5. Present intake of antibiotics by infant or mother;
6. Present intake of prebiotics or probiotics by infant or mother;
7. Difficulty of parents to comprehend study requirements as judged by the physician;
8. Suspected parental alcohol or drug addiction as judged by the physician.
Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral protamine Hagedorn \[NPH\] insulin) once daily (OD), for at least 3 months
* Ongoing treatment with: metformin with or without other oral antidiabetic drugs (OADs) for at least 3 months prior to randomisation
* HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
* BMI maximum 40.0 kg/m\^2

Exclusion Criteria:

* Treatment with insulin regimens other than a basal insulin regimen (insulin detemir or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
* Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months prior to visit 1
* Current rosiglitazone users
* Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
* Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
* Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer hereof (except basal cell skin cancer or squamous cell skin cancer)
Retrieval of Patient Information After Discontinuation

A Phase 3b, Study of Subjects With Alzheimer's Disease Who Discontinued Treatment in Bapineuzumab Phase 3 Clinical Studies (ELN115727-301/302/351) or Who Completed Studies ELN115727-301 and 302 but did not Enroll in Study ELN115727-351.


Eligibility Criteria:
1. Signed, dated, and written informed consent obtained from the subject and/or the subject's legally acceptable representative (LAR, if applicable) in accordance with local regulations.
2. Signed, dated, and written informed consent, obtained from the subject's caregiver in accordance with local regulations.
3. Subject must have participated in the Study 301, 302, or 351 and have received at least 1 dose of study treatment (bapineuzumab or placebo).
4. Subject must have been off treatment for at least 12 months prior to Visit 1.
5. Subjects must have a primary caregiver for the duration of the study.
6. Subject's caregiver must have the ability to assess the subject and answer questions over the phone.
Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children

Comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone, clonidine, or saline (salt water) are added to ropivacaine.

The local anesthetic, which is currently used for caudal analgesia, is called ropivacaine. It works well and is safe in infants and children. Doctors commonly add small amounts of other medication to ropivacaine to prolong the duration of pain relief provided by a single injection of caudal analgesia.

In this study, the length of duration of pain relief the child receives from caudal analgesia will be examined when different medications are added to ropivacaine. Specifically, dexamethasone, clonidine, or saline (salt water) will be added to ropivicaine and the length of time it takes before the child needs more pain medication will be determined.

Clonidine has been added to caudal analgesia for infants and children for many years. It increases the duration of pain relieving effect of ropivicaine by itself, however, it may lead to prolonged sedation following the surgical procedure (an undesired effect) and it is expensive.

Dexamethasone has been used for adult epidurals and nerve blocks and in spine surgeries. It prolongs the duration of pain relief and causes less sedation. It is commonly administered to children during surgery to help decrease nausea and vomiting after surgery. It is also much cheaper than clonidine.

Eligibility Criteria:
Inclusion Criteria:

* The subject will receive presurgical caudal block
* American Society of Anesthesiologists (ASA) 1 or 2
* Day surgery unit
* weight 30 kg or less

Exclusion Criteria:

* Neuromuscular disease
* Back problem
* Caudal area skin infection
* Mental retardation
* Developmental delay
* Bleeding disorder
The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

Adult Patients with Severe Sepsis

Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score \<25 or single organ dysfunction).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.

Exclusion Criteria:

* Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
* Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
* Platelet count less than 30,000/mm3.
Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment

This study will be done to investigate the feasibility and effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, and motivational enhancement on the cognitive function via none-face-to-face platform in mild cognitive impairment.

The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the Mediterranean-DASH Intervention for Neurodegenerative Delay diet (MIND) diet. They will be educated about vascular risk factor management every 2 weeks. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities. All intervention will be administered via tablet personal computer (PC) application at home.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed end-of-study evaluation and participated in the preceding randomized controlled trial (RCT) "Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment".
* Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
* Having a reliable informant who could provide investigators with the requested information
* Provide written informed consent

Exclusion Criteria:

* Major psychiatric illness such as major depressive disorders
* Dementia
* Other neurodegenerative disease (e.g., Parkinson's disease)
* Malignancy within 5 years
* Cardiac stent or revascularization within 1 year
* Serious or unstable symptomatic cardiovascular disease
* Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
* Severe loss of vision, hearing, or communicative disability
* Any conditions preventing cooperation as judged by the study physician
* Significant laboratory abnormality that may result in cognitive impairment
* Illiteracy
* Unable to participate in exercise program safely
* Coincident participation in any other intervention trial
SQUEEZE Trial: A Trial to Determine Whether Septic Shock Reversal is Quicker in Pediatric Patients Randomized to an Early Goal Directed Fluid Sparing Strategy vs. Usual Care

The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.

Please see published pilot trial protocol for more information about the SQUEEZE Trial and rationale for this study.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for 1 and 3 must be answered YES to be eligible for study.

* Age 29 days to less than 18 years of age
* Patient has Persistent Signs of Shock including one or more of the following:

  * Vasoactive Medication Dependence
  * Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age)
  * Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output)
* Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause)
* Patient has received initial fluid resuscitation of: Minimum of 40 mL/kg of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing less than 50 kg, OR Minimum of 2 litres (2000 mL) of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing 50 kg or more.
* Patient has Fluid Refractory Septic Shock as defined by the Presence of all of 2a, 2b, and 2c.

Exclusion Criteria:

* Patient admitted to the Neonatal Intensive Care Unit (NICU)
* Patient requiring resuscitation in the Operating Room (OR) or Post-Anesthetic Care Unit (PACU)
* Full active resuscitative treatment not within the goals of care
* Shock Secondary to Cause other than Sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock)
* Previous enrolment in this trial, where known by the research team
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease

The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) or in combination with a fixed oral dose of 5-ASA and enteral nutrition in patients with active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active Crohn's disease
* Patients who have a primary lesion in either the small intestine or the large intestine
* Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
* Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
* Either inpatient or outpatient

Exclusion Criteria:

* Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)
* Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)
* Patients with an artificial anus
* Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)
* Patients who have a complication of malignant tumor
* Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period
Satiety Response of Short Chain Fructooligosaccharide

Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced satiety may play a key role in this relationship. The colonic fermentation of fibers is theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are rapidly fermentable fibers that can easily be added to foods to impact these parameters.

The objective of this study was to evaluate the satiety response of scFOS and its ability to decrease food intake.

Intervention study with fiber added to beverages and acute effects on satiety measured.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Age 18-64 years
* Non-smoking
* Not taking medication
* Non-dieting (weight stable in prior 3 months)
* BMI 18-27
* English literacy

Exclusion Criteria:

* Do not regularly consume breakfast
* Food allergies to ingredients found in study products
* BMI \<18 or \>27
* Diagnosed cardiovascular, renal, or hepatic disease diabetes mellitus
* Cancer in previous 5 years (except basal cell carcinoma of the skin)
* Any gastrointestinal disease or condition
* Recent bacterial infection (\< 3 months)
* Recent or concurrent participation in an intervention research study
* History of drug or alcohol abuse in prior 6 months
* Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
* Eating disorder
* Vegetarians
* People who eat more than approximately 15 grams of fiber per day
* Women who are pregnant or lactating
* Women with irregular menstrual cycles
The Effect of Umbilical Vein Catheterization on Splanchnic Oxygenation in Preterm Infants

Objectives: This study aimed to assess the impact of umbilical vein catheter (UVC) placement on splanchnic oxygenation in preterm infants.

Methods: In our single-center, prospective, observational cohort study, near-infrared spectroscopy probes were placed to monitor regional splanchnic oxygen saturation (rSO2S) and calculate fractional tissue oxygen extraction (FOE) in preterm infants (GA \< 34 weeks, BW 1000-2000 g) for one week post-stabilization. Gestational age-matched UVC (+) and (-) Groups were clinically and physiologically compared, before and after UVC placement/removal.

The purpose of this study was to evaluate how the insertion of an umbilical vein catheter (UVC) affected the splanchnic oxygenation of preterm newborns..

Eligibility Criteria:
Inclusion Criteria:

* Parents agreed to participate in the study
* Infants born in our hospital, who were followed up in the NICU, with a gestational age of \<34 weeks and a birth weight of 1000-2000 grams
* Infants who indicated UVC placement, and for whom NIRS measurements were taken both before and after UVC placement were included in the UVC (+) Study Group
* Infants who did not have a UVC but matched the Study Group regarding gestational age and birth weight constituted the UVC (-) Control Group

Exclusion Criteria:

* Infants who died during the first week of life
* Transferred to another hospital
* Chromosomal anomalies
* Major congenital anomalies affecting splanchnic bed monitoring (such as congenital heart disease, abdominal wall defects, or congenital diaphragmatic hernia)
* Inherited metabolic disorders
* Hydrops fetalis
* TORCH infections
* Multiple organ failure
* Spontaneous intestinal perforation
* Lesions in the area where the NIRS sensor was placed
* If UVC was removed for any reason before 24 hours
* Severe anemia or polycythemia (Infants with a birth hemoglobin (Hb) level of 10 g/dl or below were considered severe anemic, and those with a Hb level of 22 g/dl or above were considered polycythemic)
Ketoconazole Foam 2% for the Treatment of Versicolor

Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.

Objectives

1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.
3. To assess treatment satisfaction as rated by patients

Study Design:

This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/potassium hydroxide (KOH) assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, aged 19 years and over.
2. Clinical presentation of tinea versicolor.
3. Positive KOH using calcofluor.
4. The ability to provide informed consent (including photography release)

Exclusion Criteria:

1. Use of topical antifungal to the affected area in the past 30 days
2. Use of topical steroid to the affected area in the past 14 days
3. If female, positive urine pregnancy test at screening (female patients of childbearing potential must be practicing a reliable method of birth control, not be planning a pregnancy, not be breast-feeding during the study)
4. Patients with a dermatologic condition in the region of the treatment site that in the investigator's opinion may interfere with the study results
5. Current diagnosis of immunocompromising conditions
6. Any medical or psychiatric condition that may interfere with treatment or compliance
A Study With NLY01 in Subjects With Type 2 Diabetes

This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject with type 2 diabetes for at least one year
* Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic
* Body Mass Index (BMI) 22.0 to 35.0 kg/m\^2,

Exclusion Criteria:

* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
* Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator
* Any prior exposure to an exenatide-based product (BYETTA and BYDUREON)
* History of gastroparesis
* History of severe hypoglycemia in the past 6 months
* If female, pregnant or breastfeeding