cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth

Complementary food supplements (CFS), fortified products that are mixed with the infant's usual complementary foods, have the potential to improve nutrition among infants. In Africa, maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit their absorption. The impact of CFS products in the context of a maize-based diet has not been well investigated. This study will test two newly developed fat-based CFS products made from soy.

The first product is a fortified fat-based spread that contains essential fatty acids with added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and zinc bioavailability. The second product is a fortified fat-based product containing essential fatty acids. Both products contain soy. The enrichment of the products with essential fatty acids is of particular interest in the South African context, as consumers are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high LA-containing sunflower oil during food preparation. The CFS products could contribute towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.

The results of this study will provide evidence on whether or not two types of fortified CFS have the potential to address malnutrition (linear growth) and improve psychomotor development in infants. If proven effective, this approach of providing multiple nutrients can be made available to infants in the developing world and may lead to sustainable actions.


Eligibility Criteria:
Inclusion Criteria:

* Infants resident in the study area
* Aged 6 months

Exclusion Criteria:

* Severe obvious congenital abnormalities
* Severe anaemia (haemoglobin \< 70 g/L)
* Severe malnutrition (weight-for-length Z-score \<-3.00)
* Other diseases referred for hospitalization by clinic staff
* Plans to move out of the study area in the next 7 months
* Known food allergies/intolerances e.g. to peanuts, milk and fish
* Infants given special nutritional supplements
* Infants known to be HIV+
* Not been borne as a singleton
Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior

Decision Aids (DA) to inform patients about health care options and help them to participate in their care choices are widely advocated. The main argument for offering patients a choice is that patients' preferences vary, and health professionals cannot always know what is "best" for an individual, specially when different outcomes have different benefits and risk profiles. The standard modes of treatment for patients with coronary artery disease (CAD) are coronary artery bypass graft (CABG) surgery, medication, and angioplasty. All three treatments for CAD work better when combined with cardiac risk factor modification behavior (CRFMB). CRFMB is important for the general public, but it is even more important for people with CAD because people with CAD have more at stake. In this RCT study we will evaluate the effectiveness of a CAD-DA with and witout an additional decision counseling program (DCP) on health outcomes and quality of life to improve enhancement of adherence to cardiac risk modification behavior. The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, for CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors. It provides patients with information about what they can you do to prevent the disease from progressing. The DCP is designed to systematically guide patients through the process of deciding what cardiac risk modification behaviors are important for them to carry out. A RCT where 360 CAD patients \> 18 of age scheduled for an angiogram at Rikshospitalet University Hospital in Norway (RH) will be randomly assigned to: (1) CAD-DA group where subjects will receive, for take home, the CAD-DA prior to their scheduled angiogram; (2) DCP group where subjects in addition to the CAD-DA will receive an individual decisional counseling program (DCP) from a trained nurse counselor in their homes prior to their angiogram; and (3) the control group who will receive "usual care". Data will be collected at four points: at the initial visit (T1), 2 months (T2), 4 months (T3) and 6 (T4) months after angiogram

As above

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Scheduled for an angiogram
* Able to read, write, and speak Norwegian
* Live within approximately 100 km of Oslo
* Have a telephone

Exclusion Criteria:

- Cognitive impairment
Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM

In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis


Eligibility Criteria:
Inclusion Criteria:

* age at enrollment is ≥ 18 and ≤ 75 years
* ECOG PS 0-1
* histologically confirmed left-sided colon and rectal carcinoma
* synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery
* patients potential to receive surgery and achieve no evidence of disease (NED)
* able to tolerate surgery
* providing written informed consent

Exclusion Criteria:

* local invasion or distant metastasis other than para-aoritc lymph nodes
* history of other malignant tumor
* coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection)
* emergency surgery
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery

Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. To test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing CPB for CHD surgery.

We conducted a single center prospective trial of infants (≤ 365 days of age) who presented to a single institution for congenital cardiac surgery.

Blood was collected from study participants at 7 time points; 1) post-anesthesia induction, 2) post-CPB/pre-MUF, 3) Intensive care unit (ICU) arrival, 4) post-op hour 4, 5) post-op hour 8, 6) post-op hour 12, and 7) post-op hour 24. At each of the 7 time points blood was analyzed for levels of the following; dexamethasone, cortisol, ACTH, Interleukin (IL) 10, IL 8, and IL 6. In addition, the innate stress response was evaluated with a cosyntropin stimulation test. Each patient received a 1 mcg/1.73 m2 intravenous dose of cosyntropin at; anesthesia induction, prior to dexamethasone (time 1), ICU arrival (time 3), and 24 hours after ICU arrival (time 7). Cortisol levels were measured before (time 1, 3, and 7) and 30 minutes after cosyntropin administration (time 1a, 3a, and 7a).

Eligibility Criteria:
Inclusion Criteria:

* less than 365 days of age
* Congenital cardiac surgery that requires cardiopulmonary bypass

Exclusion Criteria:

* Corticosteroids within 24 hours prior to enrollment
* Less than 36 weeks gestational age at time of surgery
* pre-operative mechanical circulatory support (ECMO)
Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of CTP-543

This is an open-label, single-dose, single-period, parallel group designed study to determine the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of CTP-543 and its major metabolites following administration of a single 12 mg oral dose of CTP-543.


Eligibility Criteria:
Inclusion Criteria:

* Adult males or females aged 18-75
* Body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m2 at the time of screening
* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
* Capable of giving informed consent and complying with study procedures

Additional Inclusion Criteria for Subjects with Hepatic Impairment:

* For moderate hepatic impairment, the subject must have a Child-Pugh score of 7 to 9 at the time of screening. For mild hepatic impairment, the subject must have a Child- Pugh score of 5 to 6 at the time of screening.
* No clinically significant change in disease status within the last 30 days before screening
* The subject must have a condition consistent with hepatic impairment and associated symptoms, but otherwise be determined to be healthy in the opinion of the Investigator
* If diabetic, the subject must have the disease controlled

Exclusion Criteria:

* History of any clinically significant medical condition, psychiatric disease, social condition, or illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* Known history of any GI surgery or any condition possibly affecting drug absorption
* History of prolonged QT syndrome or a QTc interval with Fridericia's correction (QTcF) \> 470 msec for males or QTcF \> 480 msec for females at Screening visit.
* Females who are nursing or pregnant prior to drug administration
* Positive for human immunodeficiency virus (HIV)
* Positive results for coronavirus infection (COVID-19) at screening or check-in
* Positive drugs of abuse or alcohol results at screening or check in (Day -1)

Additional Exclusion Criteria for Subjects with Hepatic Impairment:

* History or current diagnosis of uncontrolled or significant cardiac disease
* Gilbert's syndrome, liver transplant, Wilson's disease, autoimmune liver disease, esophageal variceal bleeding within 3 months prior to screening
* Previous diagnosis of hepatocellular carcinoma
* Acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function
Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity

Type of study: Single-blinded clinical trial to evaluate the effectiveness of Azadirachta indica based Herbal mouthwash to treat the tooth sensitivity in patients.

Participants aged 20 years and above having Gingival Index score 3 will be included in the study. Their tooth sensitivity will be checked initially and then they will be given Herbal based mouthwash for 3 months. Again, their tooth sensitivity shall be checked after 3 months.

In this study Herbal based mouthwash will be evaluated for eliminating the tooth sensitivity in the participants having Gingival Index score 3 with VAS scores for sensitivity ranging between 30-80 . Consecutive non-random sampling technique will be used in this study where Participants included will be assessed for tooth sensitivity through Visual Analogue Scale (VAS) initially for base line readings. These participants will be given Azadirachta indica based Herbal mouthwash for three months and then again their tooth sensitivity will be assessed by Visual Analogue Scale (VAS) for final readings. The mean values of VAS scoring both before and after the usage of herbal mouth wash will be compared to investigate the clinical efficacy of this mouthwash in treating the tooth sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with good general health and no allergy
* Patients who have not used any mouthwash in last 3 month
* Study teeth shall be free of decay and restoration
* Study teeth shalll not be mobile
* Study teeth shall have the Gingival Index score 3
* Participants shall be able to read ,write and willing to give consent.

Exclusion Criteria:

* Patients with poor general health and allergies
* Patients who have used any mouthwash in last 3 months
* Teeth with decay and restorations
* Teeth with mobility
* Teeth with Gingival Index score more than 3
* Participants that wonn't be able to read ,write and willing to give consent.
Hospital Medication Report

Drug Related Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing (included medication error and inappropriate prescription) to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative activity in concert with other health care professionals and offered directly to the patient for improved quality use of medicines. Pharmaceutical care identifies and resolves actual or potential DRPs.

In our clinical practice, during the patient admission in internal medicine unit, a medication reconciliation process was conducted according to a validated protocol. The first step consists of getting the Best Possible Medication History (BPMH), defined as the most comprehensive list of all medications taken by the patient. The second step consists of comparing the BPMH with admission prescription made by the physician in charge. During pharmacist interview, pharmacist discussed about medication adherence and knowledge. The third step consists of characterizing, solving and documenting DRPs.

During the patient's hospitalization, the pharmacist participates at the medication prescription revision. At the discharge of hospitalization, a pharmaceutical standardised interview is carried out during which the pharmacist explains the modifications of treatments to the patient. During this interview, the hospital pharmacist updates the latest treatment changes. For patient with more than 65 years old and long-term affection (or patient with more than 75 years old with or without long-term affection) and 5 medications, the hospital pharmacist write a medication discharge report (MDR) to patient, community pharmacist and general practitioner.

For each medication, the investigators collected its name, dosage, dosage forms and frequency of administration. For each DRP, the investigators collected the type of DRP and the drug classes (according to anatomical therapeutic chemical classification system).

For each MDR, the investigators collected number of medication, number and type of DRP including inappropriate prescription.


Eligibility Criteria:
Inclusion criteria:

- Patients aged above 18 years old, admitted to the medicine unit during the study period and hospitalized for at least 24 hours

Exclusion criteria:

- NA
Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers

The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.

This is a prospective, non-significant risk, open-label, randomized clinical trial of LipiFlow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. All subjects undergo examination to determine study eligibility and to capture the Baseline status. Subjects are randomized to receive LipiFlow® treatment (Treatment Group) or no LipiFlow® treatment (Untreated Control Group). The Treatment group is evaluated one month after receiving LipiFlow® treatment. Study endpoints are evaluated at 3 Months by comparing the Treatment Group to the Untreated Group. To facilitate subject recruitment, the Untreated Control group receives Crossover LipiFlow® treatment (Crossover Treatment Group) at 3 Months. The Crossover Treatment group is evaluated one month after receiving LipiFlow® treatment (4 Months visit).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of meibomian gland dysfunction and dry eye
* At least 18 years of age
* Willing to comply with randomization, attend all study visits and follow patient instructions
* Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
* No change in contact lens type or dimensions for the past 3 months
* Clinician assessment of acceptable contact lens fit and disinfecting solution
* Tear film interferometry of 100 units or less

Exclusion Criteria:

* Systemic disease conditions that cause dry eye
* Use of systemic medications known to cause dryness
* History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
* Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
* Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
* Participation in another ophthalmic drug or device trial in the past month
* Employee, relative of employee or associate of the clinical site
Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease

This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.

This was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously (IV) every 8 weeks. The study population included treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants, as well as 38 UC participants who had tolerated vedolizumab well during Study C13002 (NCT01177228).

In the original study protocol, all participants were randomized to receive vedolizumab at doses of either 6 mg/kg or 10 mg/kg. With the implementation of Amendment 1, the assigned doses of vedolizumab were decreased to 2.0 mg/kg and 6.0 mg/kg. To implement the dose changes, instead of randomizing all participants across both doses, those who rolled over from Study C13002 were reassigned to receive the 2.0 mg/kg dose and all participants who entered C13004 naïve to treatment were to receive the 6.0 mg/kg dose, starting on the next scheduled dosing day. Also, if participants assigned to the 2 mg/kg dose experienced flare, they were to receive the higher 6 mg/kg dose.

In the results analyses for this study, participants are grouped according to the lowest dose received, i.e., 2.0 mg/kg or 6.0 mg/kg vedolizumab.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed and active ulcerative colitis (UC) or Crohn's Disease (CD)

  * Crohn's Disease Activity Index (CDAI) Score of 220 - 450 for participants with CD
  * Partial Mayo score of 2 - 7 for participants with UC
* Patient should be appropriate candidate for biologic therapy per guidelines
* Up-to-date on cancer screening
* No severe systemic disease
* Patients with evidence of abscess
* Agree to comply with study procedures including contraception

Exclusion Criteria:

* Low lymphocyte counts
* History of imaging abnormalities, multiple sclerosis (MS), brain tumor or other neurological illness
* Active or recent serious infections
* Recent treatment with biologic (i.e., Remicade) or investigational drug
* Impending surgery
* Any participants with vedolizumab human anti-human antibody (HAHA) titers ≥1:125 or with a previous immediate hypersensitivity reaction during or shortly after vedolizumab infusion
Statin InTensity to Prevent Coronary Artery Vasculopathy After Heart Transplantation

The investigator's propose to conduct an open-label randomized controlled trial to determine if higher intensity statin (HS) can reduce CAV in comparison to lower intensity statin (LS) after HT. All consecutive patients that meet eligibility criteria will be approached for participation. After heart transplantation, participants (n=70) will be randomized in a 1:1 manner to either HS or LS. Study participation will be for 2 years from the time of randomization. Study outcomes will be compared by research staff blinded to statin group assignment.

Outcomes after heart transplantation (HT) are limited by development of coronary allograft vasculopathy (CAV). CAV comprises of macro- and microvascular coronary disease and is the third leading cause of graft dysfunction and late mortality following HT. The pathophysiology of CAV is multifactorial and major pathways that are implicated include inflammation and dyslipidemia. These pathways are inhibited by statins which serve as the mainstay of CAV prevention.

The International Society of Heart and Lung Transplantation (ISHLT) guidelines recommend administration of low intensity statins (LS) due to a potential drug-drug interaction (DDI) with calcineurin inhibition (CNI) therapy. This DDI is related to concurrent use of an older generation CNI, cyclosporin A (CsA). CsA inhibits intestinal P-glycoprotein to reduce the efflux of statin into the gastrointestinal tract, thereby increasing statin levels in the blood and risk of myopathy. However, the current generation of CNI being utilized in most patients, Tacrolimus, does not inhibit P glycoprotein and may not impact statin levels after HT.

Despite use of LS, the residual risk of CAV development is elevated with nearly half of the patients having angiographic detection 5 years after HT. However, angiography is limited by its inability to detect microvascular disease and invasiveness. Early CAV is also detectable by non-invasive imaging with cardiac positron emission tomography (cPET) through measurement of myocardial flow reserve (MFR). MFR assesses total burden of macro- and microvascular disease and is well correlated with invasive measures of CAV and prognosis.

The protective and inhibitory effects of statins are proportional to their intensity with higher intensity statins (HS) leading to a greater reduction in low density lipoprotein (LDL) and inflammatory markers such as C-reactive protein (CRP) in comparison to LS. Despite these potentially beneficial effects of HS, LS remains the agent of choice for primary prevention of CAV after HT in the absence of a randomized controlled trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* Waitlisted for Heart Transplantation
* Capacity to provide informed consent

Exclusion Criteria:

* History of statin allergy or intolerance
* Hepatic dysfunction
* Redo Heart Transplant
* Awaiting combined heart and liver transplantation