cyrilzakka/clinical-trials huggingface dataset:
Assessing Early Behavioral Indicators of Formula Tolerance

The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.


Eligibility Criteria:
Inclusion Criteria:

* Singleton at birth
* Term infant with birth weight of 2500 g or more
* Crying or fussing for 3 or more hours per day
* Consuming mostly infant formula
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

* Current use of extensively hydrolyzed or amino acid infant formula
* Planned use of probiotics during the study
* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Enrollment in another interventional clinical research study
Effects of the Insole on Balance Capacity in Chronic Stroke

Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift body weight or to with stand external pertubations. Postural movement patterns include three discrete control strategies: hip, knee, and ankle strategy. The ankle rocker is an important factor to maintain balance during standing and the ankle strategy restores the center of mass (CoM) to a position of stability through body movement. As a result, effective control of foot motion and ankle stability may decrease postural sway and the risk of fall in chronic stroke.The purpose of this study is to investigate the effects of the insole on balance capacity in chronic stroke.

An important determinant of activities of daily living performance is standing balance. Therefore, poor balance, or postural stability, is significant predictors the risk of fall. After a fall, the patient can experience psychological, physical, social, economic, and sometimes fatal effects. The injuries can reduce the patient's mobility as well as independence and influence quality of life.Patients with chronic stroke wearing functional insoles and sham insoles to challenge balance tests.

Eligibility Criteria:
Inclusion Criteria:

* A history of unilateral chronic stroke occurrence over 6 months prior to the study
* Ability to understand verbal instructions.
* Ability to walk 5 meters independently without the need of ankle-foot orthosis.

Exclusion Criteria:

- A diagnosis of other neurological or musculoskeletal disorders that could affect postural balance.
Pharmacokinetics of Drugs Administered to Children

This is a prospective study of children \<21 years of age with the goal of characterizing the PK of drugs administered per standard of care as prescribed by the treating caregiver.


Eligibility Criteria:
Inclusion Criteria:

* Children (\< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

Exclusion Criteria:

* Failure to obtain consent/assent (as indicated)
Artificial Intelligence-assisted Diagnosis

This study aims to investigate whether an AI-assisted decision support can improve the diagnosis of congenital heart diseases on Chest X-ray.

Congenital heart disease (CHD) is a structural abnormality of the heart and/or great vessels and the frequency of CHD is nearly 1% in general population. In clinical practice, Chest X-ray is an important routine method for detection of CHD. However, its learning curve is high. Based on Chest X-ray, Artificial intelligence (AI) has the potential to improve the efficiency and accuracy of CHD. This study aims to investigate whether an AI-assisted decision support can improve the diagnosis of congenital heart diseases on Chest X-ray.

This study will enroll subjects with CHD, and the enrollment will be divided into two phases.

Phase 1: Previous data of chest X-ray in patients with CHD. A minimum of 3000 patients is reached.

Phase 2: Prospective inclusion of general patients with chest X-ray. A minimum of 5000 patients is reached.

Eligibility Criteria:
Inclusion Criteria:

1. Chest X-ray of patients with ASD;
2. Chest X-ray of patients with VSD;
3. Chest X-ray of patients with PDA;
4. Chest X-ray of patients with PFO;
5. Chest X-ray of patients with PS;
6. Chest X-ray of patients with TOF/PAA;
7. Chest X-ray of patients with MS;
8. Chest X-ray of patients with other heart diseases;

Exclusion Criteria:

1. CHD Patients without surgical, interventional validation;
2. Serious Scoliosis;
3. Pulmonary inflammation or consolidation
Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device

Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy and Left Ventricular Assist Device program is to improve heart function with stem cell therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.

Currently Left Ventricular Assist Device-only patients are being implanted and followed. Feasibility of autologous mesenchymal stem cell grafting in patients receiving heart mate will be assessed in a 4 patient pilot trial. Mesenchymal stem cell are delivered during Left Ventricular Assist Device surgery by intramyocardial infusions. Recovery of contractile function of the heart is assessed during attempts to wean patients from Left Ventricular Assist Device

Eligibility Criteria:
INCLUSION CRITERIA:

* Postmenopausal female or female who may become pregnant but is using adequate contraceptive precautions with negative pregnancy test,
* Severe Left Ventricular dysfunction with Ejection Fraction \< 30% with ischemic cardiomyopathy,
* New York Heart Association Class III or IV,
* No revascularization options available,
* Listed or not for cardiac transplantation,
* Clinical indication and accepted candidate for Left Ventricular Assistance Device implantation as a destination therapy or as a bridge to transplantation,
* Optimal medical therapy.

EXCLUSION CRITERIA:

* Cardiothoracic surgery within 30 days prior to study entry,
* Myocardial infarction within 3 months prior to study entry,
* Prior cardiac transplantation,
* Left Ventricular reduction surgery or cardiomyoplasty,
* Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism),
* Left ventricular aneurysm or wall thickness preventing cell injections,
* Anticipated requirement for biventricular mechanical support,
* Stroke within 30 days prior to study entry,
* Received investigational intervention within 30 days of study entry,
* Pregnant or breastfeeding at time of study entry,
* Human Imune deficiency Virus, Human T-cell Lymphotrophic Virus, Hepatitis B Virus and Hepatitis C Virus positive within 30 days prior to study entry,
* Active systemic infection within 48 hours prior to study entry,
* History of cancer in the last 5 years,
* Patient participant to other research,
* Patient under treatment that may exert an inhibitory or stimulatory effect on the growth and multiplication of cells, or with immunosuppressive properties.
Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank

The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in healthy subjects.

Arm 1 Assignment: Individuals will be assigned to group 1 or group 2 based on their genetic features.

Arm 2 Assignment: Each study subject will serve as their own control.

Delivery of Interventions:

* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
* During the study, the subjects will complete the following

  * Arm 1: Undergo frequent blood sampling for up to 12 hours
  * Arm 2:

    * Period 1: Blood sampling q10 min for up to 12 hours with concurrent administration of naloxone bolus followed by a naloxone infusion
    * Period 2: Blood sampling q10 min for up to 12 hours with concurrent administration of naloxone bolus followed by a naloxone infusion

Eligibility Criteria:
Inclusion

* Age 18-45 years (women) OR 18-60 years (men)
* Genetic sequencing data available via Mass General Brigham Biobank
* All medical conditions stable and well controlled
* If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
* Negative urine drug screening panel
* Hemoglobin within sex-specific reference range
* For women, negative serum hCG pregnancy test

Exclusion

* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
* Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
* Current or recent use of a medication that affects the opioid pathway
* Active illicit drug use
* Excessive alcohol consumption (\> 10 drinks/week)
* For women, pregnant or breastfeeding
Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis

The purpose of this prospective randomized trial is to study the role of Indocyanine green (ICG) to visualize the Critical View of Safety during emergency Laparoscopic Cholecystectomy for patients with Acute Cholecystitis.

After informing about the study and obtaining consent to participate, patients who are diagnosed with Acute Cholecystitis and posted for emergency Laparoscopic Cholecystectomy will be randomly assigned to receive either ICG or not as a method to identify the Critical View of Safety during the operation.

The primary outcome is whether there was a precise and satisfactory visualization of the junction between the cystic duct, the common hepatic duct, and the common bile duct by indocyanine green compared to the control group. The time taken to achieve this will be measured in minutes from video recordings of the laparoscopic surgery. The process will be further assessed by a surgeons' satisfaction score.

The expected duration of the study will be 12 months involving a total of 80 patients randomized into two groups- 40 patients in the intervention group and 40 patients in the control group.

The expected outcome of the study is that ICG is more effective than the control group in providing precise and satisfactory visualization of Critical View of Safety and takes less time. We predict the surgeons to be equally or more satisfied with ICG compared to control.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for emergency Laparoscopic Cholecystectomy for Acute Cholecystitis
* Patient age ≥ 18 years.
* Patients who consent to take part in the study

Exclusion Criteria:

* Preoperative planned for Open Cholecystectomy
* Allergy towards iodine, iohexol or ICG
* Pregnancy or lactation
* Renal insufficiency
* Legally incompetent for any reason
* Withdrawal of inclusion consent at any time
* Prisoners
Fractional Laser in Combination With UVB Therapy in Vitiligo Patients

Rationale: Vitiligo is a common skin disorder that can impair a patient's quality of life. Many depigmented lesions in vitiligo patients remain therapy resistant for medical treatment. Therefore new therapeutic options in these patients are necessary. Currently, dermabrasion by conventional or fractional laser therapy in combination with NB-UVB therapy and steroids appears to be effective in therapy resistant areas. However, little literature on this combination is available.

Objectives: To assess the efficacy and patient safety of (1)fractional CO2-laser treatment in combination with NB- UVB,(2) fractional CO2-laser treatment in combination with NB- UVB and topical corticosteroids versus NB-UVB treatment alone(3) Study design: Prospective observer blinded randomised intra-patient controlled study.

Study population: 23 patients ≥ 18 years with non segmental vitiligo who receive NB-UVB treatment at the Netherlands Institute for Pigment Disorders (SNIP) at the Academic Medical Centre University of Amsterdam. We will include patients with 3 depigmented lesions that are resistant to NB- UVB treatment after 3 to 6 months.

Methods: Three NB-UVB resistant depigmented regions on the trunk or extremities will be randomly allocated to;(1) NB-UVB treatment in combination with fractional CO2 laser abrasion, or (2) NB-UVB treatment in combination with fractional CO2 laser abrasion and topical steroids, or (3) NB-UVB treatment alone. NB-UVB treatment and topical steroids will be given according to the standard treatment protocol of the SNIP and continued for at least 6 months. Two and 6 months after the laser treatment, the percentage of repigmentation of the lesions will be assessed.


Eligibility Criteria:
Inclusion criteria

* Patients with non segmental (generalised) vitiligo visiting the Netherlands Institute for Pigment Disorders
* receiving NB- UVB treatment for 3 to 6 months
* Age \>18 years
* At least 3 therapy resistant vitiligo lesions on the extremities or trunk larger than 5x5 cm or one vitiligo lesion on the extremities or trunk of at least 5x15 cm.
* Patient is willing and able to give written informed consent

Exclusion criteria

* Skin type I
* Recurrent HSV skin infections
* Hypertrophic scars
* Keloid
* Cardial insufficiency
* Patients who are pregnant or breast-feeding
* Patients not competent to understand what the procedures involved
* Patients with a personal history of melanoma or non-melanoma skin cancer
* Patients with atypical nevi.
Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

The purpose of this study was to compare the fit and comfort of two types of contact lenses.

The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age of consent and sign Informed Consent document.
* Normal binocularity.
* Be able to wear soft contact lenses.
* Willing to comply with the wear and study visit schedule.
* Spherical contact lens prescription within 0.50 diopter of the available lens powers.
* Spectacle cylinder less than or equal to 1.50 diopter.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
* Other protocol-defined exclusion criteria may apply.
Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring

The purpose of this study was to compare the Continuous Non-invasive Arterial Pressure (CNAP) monitor with the gold standard of invasive arterial pressure monitoring during:

1. induction and maintenance of general anaesthesia
2. intensive care unit treatment of postoperative patients with an ASA 3 or 4 status

The CNAP monitor continuously measures blood pressure using a finger cuff. It showed a good agreement to invasive blood pressure measurements during anaesthesia induction and maintenance during surgery. In critical ill patients cardiac arrhythmia is probably a confounding factor affecting accuracy and interchangeability of CNAP. As systolic arterial CNAP pressure in comparison to mean pressure shows no statistical interchangeability with invasive measurements, mean pressure should be considered when making therapy decisions.

A problem is the missing standard criterion for comparison of continuously devices with invasive pressure.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* BMI \< 35 kg.m²
* Patients capable of giving informed consent
* patients undergoing elective surgical procedures in supine position under general anesthesia
* perfusion of the examined arm evidenced by a positive Allen's test

Exclusion Criteria:

* Patients not competent or unwilling to provide informed consent
* Patients with history of neurological, neuromuscular seizure
* Patients where IBP cannula, CNAP™ finger-cuff and CNAP™ upper arm cuff cannot be placed on the same arm
Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions

Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT

To Compare the single-dose bioavailability of Kali's Ondansetron 24 mg ODT with that of GlaxoSmithKine's Zofran 24 mg ODT under fasting conditions

Eligibility Criteria:
Inclusion Criteria:

* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form(ICF) duly signed by the volunteer
* Males and females aged between 18 and 55 years with a body mass index (BMI) greater or equal to 19 and below 30 kg/ m2
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance(laboratory tests are presented in section 6.1.1.3)
* Healthy according to the laboratory results and physical examination.
* Non- or ex- smokers

Exclusion Criteria:

* Significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
* Females who are pregnant, lactating or are likely to become pregnant during the study phases.
* Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body.
* Positive pregnancy test before and during the study.
* Maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease.
* Any clinically significant illness in the previous 28 days before day 1 of this study.
* Use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.).
* Participation in another clinical trial in the previous 28 days before day 1 of this study.
* Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
* Positive urine screening of drugs of abuse (drug names are presented in section 7.1.4).
* Positive results to HIV, HBsAg or anti-HCV tests.
Fecal Continence Outcomes and Quality of Life After Excision of Sacrococcygeal Teratoma (Retrospective Study)

Sacrococcygeal teratoma is one of the most common tumors that occur in the neonatal period. It presents either as a mass protruding from the sacrococcygeal region or as a pelviabdominal mass according to the type. Surgical excision is the main treatment, most masses are benign, however some are malignant and require radiotherapy or chemotherapy. Complications may occur due to pressure resulting from the tumor growth in the fetal period, or due to damage to important near tissues during surgical excision. Postoperative complications may be urinary as neurogenic bladder, Lower gastrointestinal as constipation, soiling or incontinence. In this work we study the outcomes of fecal continence through a questionnaire and its effect on the quality of life of the affected children.


Eligibility Criteria:
Inclusion Criteria:

* all patients with sacrococcygeal teratoma operated after july 2010 and older than 3 years old.

Exclusion Criteria:

* Patients lost to follow up before 6 months after surgery.
* Patients with Currarino triad.
A Study of the Effect of RO4607381 on Atherosclerotic Plaque in Patients With Coronary Heart Disease

This study will assess the effect of RO4607381, compared to placebo, on atherosclerotic plaque in patients with coronary heart disease (CHD) including patients with other CHD risk factors. After a pre-randomisation period during which positron emission tomography computed tomography (PET/CT) and MRI will be conducted, patients will be randomized to receive either RO4607381 600mg po daily, or placebo po daily. PET/CT and MRI scans will be taken at intervals during the study. The anticipated time on study treatment is 2 years, and the target sample size is 100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* CHD, including patients with other CHD risk factors;
* treated appropriately for dyslipidemia;
* clinically stable.

Exclusion Criteria:

* previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
* recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
* severe anemia;
* uncontrolled hypertension;
* poorly controlled diabetes.
An Evaluation of Divalproex vs. Olanzapine for Alcohol Abuse Relapse Prevention in Patients With Bipolar Disorder

This study will evaluate how effective mood stabilizers are in the treatment of bipolar disorder with comorbid alcoholism

Bipolar affective disorder is a medical illness with substantial morbidity and mortality. Further fueling the severity of this illness is the substantial co-occurrence with substance abuse that together poses an enormous public health problem.

This study will evaluate the efficacy of divaproex sodium (DVPX) vs. olanzapine (ZYP) vs. for alcohol relapse prevention and secondary mood stabilization. Bipolar patients who are actively drinking will be randomized to either Depakote ER ® (flexible dose schedule up to 2500 mg) or Zyprexa® (flexible dose schedule up to 20 mg). Adjunctive benzodiazepine will be utilized for the treatment of alcohol withdrawal and as an adjunct anxiolytic during the early titration of DVPX and ZYP. Patients who, after 2 weeks, have stabilized will continue in the prophylaxis study which will last up to 46 weeks. Flexible dose scheduling and adjunctive antidepressant treatment as clinically indicated will be done to maximize tolerability, treatment compliance, and mood stability.

The primary outcome measure will be alcohol abuse relapse which will be defined, a priori, as 5 drinks in a 24 hour period. Patients who have a relapse as such defined will be terminated from the study. Secondary alcohol outcome measures (i.e. number of drinking days, % drinking days per month, standard drinks per drinking occasion, craving) will be assessed through the time-line follow-back method. Secondary outcome measures of mood stabilization (major mood relapse and adjunctive medication) will be assessed by prospective life charting.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* DSM-IV criteria for manic episode based on the SCID (Spitzer 1996)
* DSM-IV criteria for alcohol dependence or abuse based on the SCID. Meeting criteria for polysubstance dependence or abuse will not be exclusionary.
* Alcohol dependence/abuse confirmed by corroboration.
* Negative urine pregnancy test l

Exclusion Criteria:

* Inability to give informed consent
* Liver function tests greater than 3X the upper limit of normal
* History of adverse reaction to divalproex sodium or olanzapine
* History of seizure other than directly associated with prior alcohol withdrawal
* History of major head trauma with LOC \> 5 minutes or skull fracture
* History of hypertension, neurologic illness
* Active hepatitis, hepatic encephalopathy, or history of pancreatitis
* Not practicing a reliable form of birth control