cyrilzakka/clinical-trials huggingface dataset:
Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers

The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.

Specific aims include exploration of possible mechanisms of adverse events that have been observed in iron supplementation trials in infants in malaria endemic regions by:

1. Characterizing the impact of enteral iron administration on the evolution of the intestinal microbiome in infants from 6 to 9 months of age.
2. Characterizing iron administration-associated inflammatory responses and correlate these with changes in the intestinal microbiome in infants from 6 to 9 months of age. Specifically, changes in the microbiome will be correlated with biomarkers reflecting:

   1. Intestinal inflammation;
   2. Systemic inflammation, bacterial translocation, and oxidant stress;
   3. Iron status and homeostasis
3. Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).

Eligibility Criteria:
Inclusion Criteria:

* Term infant
* Birthweight \> 2500 g
* Healthy with no apparent congenital anomalies
* Up-to-date with vaccinations
* Hb \>10 g/dL
* Breastfeeding with intent to continue for duration of study
* Negative blood slide for malaria
* Written informed consent

Exclusion Criteria:

* Acute malnutrition
* Current or anticipated used of infant formula or other fortified products
* Current or planned use of iron (or zinc) supplements
* Previous hospitalization for malaria within the last four weeks
* Persistent diarrhea
Lazertinib 160mg in EGFR T790M NSCLC

The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer
* Patients in a palliative setting who is not applicable for the curative treatment
* EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI
* Confirmed EGFR T790M mutation after the previous EGFR TKI
* Available to receive lazertinib either as po or vis levine tube
* Willing to participate clinical trial
* Age over or equal to 19
* ECOG PS 0 to 2

Exclusion Criteria:

* Previously received 3rd generation EGFR TKI
* No clinical benefit is expected based on the investigator's decision
* Uncontrolled symptomatic CNS metastases
* Uncontrolled systemic disease
ACT-CSP for Family Caregivers of Palliative Care Patients

The goal of the study is to test the feasibility, acceptability and preliminary efficacy of an acceptance and commitment therapy for supporting caregiver programme (ACT-CSP) on reduction of caregiver burden, anxiety and depressive symptoms and enhancement of caregiving self-efficacy, resilience and quality of life by ACT when compared to usual care, for caregivers of palliative care patients.

This study will employ a pilot randomized controlled trial recruiting caregivers of palliative care patients to receive either a 3-week acceptance and commitment therapy for supporting caregiver programme (ACT-CSP) plus usual care (n = 15) or usual care only (n = 15). The components of acceptance and commitment therapy process will be emphasized in the intervention programme, which include perspective taking, self-as-context and defusion (i.e. recognizing worry thoughts as thoughts only), identifying values and acceptance of present-moment experience with respect to the values, and committed action. The ACT-CSP will be delivered by a trained ACT facilitator. Participants will be followed up at Week 6 and Week 8 after recruitment to collect data for assessing the study objectives.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18;
* Self- or patient-identified as a family caregiver of an adult patient receiving palliative care at the study site
* Have been taking care of the patient in the past 3 months;
* Able to communicate in Cantonese at the time of recruitment;
* Have access to internet and videoconferencing device such as mobile phone;
* Have caregiver burden as measured by Caregiver Strain Index (CSI) ≥ 7.

Exclusion Criteria:

* Mentally incompetent (Mini-Mental State Examination (MMSE) \< 23),
* Participating in regular psychosocial interventions.
Zinc and Biobehavioral Development in Early Childhood

Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.


Eligibility Criteria:
Inclusion Criteria:

* Born at term of non-low birth weight
* Free of major malformations, genetic abnormalities or health problems associated with developmental delays
* Planning to remain in study area for one year
* In good general health

Exclusion Criteria:

* Low birth weight
* Non-term delivery
* Vision or hearing problems
* Anemia
The Feasibility of Chatbot-based Stress Management Intervention STARS for Youth in Lithuania

The study aims to assess the feasibility of a chatbot-based stress management intervention among youth in Lithuania.

The intervention is a chatbot-based stress management intervention developed by the World Health Organization (WHO). It consists of 10 sessions which include: Introduction (1), Psychoeducation (2), Emotion Regulation (3, 4), Behavior Activation (5, 6), Managing Problems (7), Thought Challenging (8, 9), and Relapse Prevention (10). Each session consists of psychoeducation and exercise parts. Trained e-helpers contact participants to support them individually on a weekly basis.

The effect of the intervention will be compared against a control group which gets basic psychoeducation. The intervention is provided in Lithuanian.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18-25 years
* Understanding the Lithuanian language
* Having access to a device for intervention delivery
* Experiencing moderate levels of psychological distress

Exclusion Criteria:

* People at imminent risk of suicide
* People currently experiencing a psychotic episode
* People currently experiencing interpersonal violence
* Current dependency on alcohol/drugs
Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia

The purpose of this randomized, open label clinical trial is to determine if oral miltefosine is a safe and effective alternative, compared with parenteral meglumine antimoniate for the treatment of pediatric Cutaneous caused by L. Viannia species in Colombia.


Eligibility Criteria:
Inclusion Criteria:

* 2 to 12 years of age (inclusive)
* Parasitologically confirmed CL
* Availability to receive supervised treatment for 28 days (i.e., directly observed therapy, to ensure the therapy is appropriately administered and received - e.g., the miltefosine is "swallowed")
* Availability to return for follow-up visits for at least 6 months after treatment is initiated

Exclusion Criteria:

* Weight under 10kg
* Previous use of SbV, miltefosine or other antileishmanial therapy
* Simultaneous mucosal lesions suggestive of or proven to be mucosal leishmaniasis
* If a girl, ability to reproduce (history of menarche)
* Relative or absolute contraindications for the use of SbV drugs or miltefosine, including history of cardiac, renal or hepatic disease
* Patients with pretreatment haemoglobin \<10g/dl or blood urea nitrogen (BUN), serum creatinine, ALT, AST or amylase values that exceed the upper limit of normal
* If living in Malaria endemic areas (eg. Tumaco) only: A positive malaria thick smear
The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children

To examine the impact of a structured physical activity program focused on bone strength in elementary school children in the framework of their physical education classes on:

1. Bone strength of children participating in the activity.
2. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal jumping strength, static balance, dynamic balance and coordination.


Eligibility Criteria:
Inclusion Criteria:

* First and second grade pupils
* Healthy

Exclusion Criteria:

* Medical condition does not permit participation in physical education class
Awake Endotracheal Intubation in Cervical Injury

The researcher will compare awake endotracheal intubation with glidescope video assisted laryngoscope vs fiberoptic bronchoscope in patients with traumatic cervical injury;

One hundred patients undergoing post traumatic cervical spine fixation under general anesthesia will be randomly allocated to two groups in a prospective study. Between December 2022 and May 2023.

All patients will be premedicated before the procedure and after giving 500 ml of lactated ringer solution with glycopyrrolate 0.2 mg iv and dexmedetomidine 1 mic/kg IV over 10 minutes then 0.4 mic/kg/h continuous IV infusion. All patients will receive standard clinical care monitoring including three lead ECG, noninvasive arterial blood pressure measurement and pulse oximeter. Patient will be administered oxygen 6 L/min through nasal prong.

Patients will be allocated into two equal groups (50 patients per group) for awake intubation with either FOB (F group) or GVL (G group) according to computer generated randomization technique. Each patient will receive nebulization with 5 ml of lidocaine 1% for 5 min followed by topicalization of soft palate and fauces with 5 puffs of lidocaine spray (10 mg/spray) immediately before the technique of endotracheal intubation (ID 6.5 mm for female and 7 mm in male, armored tube. Before airway manipulation each patient will receive a bolus dose of fentanil 1 mic/kg.

During the procedure Philadelphia cervical collar will be removed and MILS of cervical spine will be carried out by trained assistant (senior registrar anesthetist, 5 years' experience). After successful intubation (by consultant anesthesia who had more than 100 times successful intubation with either FOB or GVL) and neurological assessment (by spinal surgeon), general anesthesia will be induced with propofol 1.5 mg/kg, cisatracurium 0.1 mg/kg and remifentanil 0.5 lg/kg. Hypotension (decreased in MAPP 20% of base line) will be treated with ephedrine bolus 5-10 mg and 250 ml of lactated ringer solution. Only three attempts will be permitted per each patient and if failed plan B was to carry out endotracheal intubation under inhalational induction with FOB without neuromuscular blockade and to exclude patients from the study. Attempt will be held if O2 saturation decreased below 90%.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients
* ages 26-44
* undergoing a selective cervical spine fixation.

Exclusion Criteria:

* body mass index (BMI) more than 35 kg/m2.
* Obstructive airway disease
* cardiovascular disease
* apparent airway difficulty
* patient refusal .
Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH)

The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active.


Eligibility Criteria:
Inclusion Criteria:

* Older than 65 years
* A score equal to or higher than 15 out of 35 in the MEC-35 (Miniexamen Cognoscitivo) cognitive test
* A score equal to or higher than 50 out of 100 in the Barthel Index
* Able to stand-up and walk for 10 meters

Exclusion Criteria:

* Unstable Clinical Situation
* When the potential harms outweigh the benefits, according to the judgment of the healthcare personnel at the NHs
Immediate Loading and Fully Guided Surgery: Single Implants

To evaluate the overall treatment outcome of single implants installed with the assistance of fully guided-surgery, submitted to immediate loading with restorations fabricated with the help of intraoral scanning, during a 1-year follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age who had signed an informed consent
* in need of a single-tooth replacement of an incisor, canine or pre-molar in the maxilla.

Exclusion Criteria:

* general contraindications for oral surgery
* patients with inadequate oral hygiene
* need for bone grafting or ridge augmentation.
Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements

The purpose of this study is to compare the severity of NAFLD in diabetic patients to that in non-diabetic patients.

1. Patient recruitment: eligible patients in the department of endocrinology and department of gastroenterology are encouraged to participate in this study.
2. Non-diabetic patients admitted to the department of gastroenterology for other gastroenterological diseases. If available, these patients' data will be collected as control groups. Each diabetic patient is matched with a non-diabetic patient by factors of age, gender and BMI.
3. Hepatic steatosis and fibrosis are diagnosed via controlled attenuation parameter (CAP) and liver stiffness measurement by FibroScan ®, respectively. According to the meta-analysis of individual patient data published recently, the CAP in dB/m will be adjusted by deducting 10dB/m from the CAP value for NAFLD/NASH patients, 10dB/m for diabetes patients and deducting/adding 4.4dB/m for each unit of BMI above/below 25kg/m2 over the range of 20-30kg/m2.
4. Regular laboratory tests are performed, including complete blood counts, liver function, renal function, coagulation function, glycosylated hemoglobin, lipid metabolism, urine albumin/creatinine ratio, 24-hour urine albumin.
5. Anthropometric data consists of height, weight, body mass index (the weight in kilograms divided by the square of the height in meters) and waist circumference.
6. The diabetic duration, diabetic complications, the grading of hypertension, and the history of anti-diabetic drugs are gathered from medical records.
7. The data are collected via EpiData software. They are input into computer twice by a single researcher to avoid typing errors.
8. Site monitoring and auditing: As a project for postgraduate thesis, this study is monitored and audited by the school of postgraduate. The research records will be checked in December, 2016, as a mid-term inspection
9. Statistical analysis plan: data are summarized and presented using appropriate descriptive statistics. The normality of continuous variables is assessed by skewness statistic and graphically by normal probability plot. Patients characteristics between those with and without diabetes, and in diabetes group, between those with and without elevated CAP are compared using independent t test, Chi-square, or Fisher's exact tests as appropriate.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* type 2 diabetics

Exclusion Criteria:

* malignancy;
* severe cardiovascular complications;
* any history of chronic hepatitis (hepatitis B or C virus infection, autoimmune hepatitis, Wilson's disease, hemachromatosis);
* secondary causes of fatty liver ( glucocorticoids, amiodarone, tamoxifen);
* alcohol consuming (20grams per day for male, and 10 grams per day for female);
* any hints of type 1 diabetes ( ketoacidosis, ketonuria, using insulin within 1 year after diagnosis)
Serologic Testing of Household Contacts of Confirmed Cases of COVID-19

SARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed.

Transverse, observational and descriptive study involving household contacts of documented patients with COVID-19 infection: contacts will be invited to participate and a blood sample will be drowned: IgM and IgG qualitative and quantitative measurements will be performed. Demographic data regarding age, comorbidities, calculated time spent before and after the patients diagnosis, isolation practices etc.

Eligibility Criteria:
Inclusion Criteria:

1. Persons over 1 years of age.
2. .Meet COVID-19 confirmed case intradomestic contact definition:

   1. Living in the same home as the patient with SARS-CoV-2 PCR test detected (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit.
   2. Living in the same home as the patient with a PCR test for SARS-CoV-2 Indeterminate (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit and that the initial patient has positive IgM/IgG serology for SARS-CoV-2.
3. .Informed Consent.

Exclusion Criteria:

1. .Have fever, cough, pharyngeal pain or clinically have symptoms compatible with COVID-19 at the time of recruitment.
2. .Autoimmune disease, cancer, neutropenia.
3. .Under 1 years of age.
4. .Patients who, in the investigator's opinion, should be excluded from the research protocol.
Left Elective Colectomy in Renal Transplanted Patients

Aim of the study :

To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted population.

Methods :

From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a referral center were prospectively collected.

Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted patients (C-group) Short and longterm outcomes were compared between the two groups.

Primary outcome :

90 days postoperative anastomotic leak rate

From January 2010 to December 2015, data from patients requiring an elective left colectomy for benign or malignant indication were collected prospectively in our colorectal surgery database.

According to our exclusion criterial patients were retrospectively divided into two groups: kidney transplant recipients (KTR-group) and control group (C-group).

The surgical indication for an oncologic left colectomy was retained by the expert surgeon, after a multidisciplinary conversation meeting comprising at least one surgeon, one gastroenterologist, one nephrologist, one radiologist and one oncologist. The surgical indication for diverticular disease was based on French guidelines.

Demographic, clinical, intraoperative and postoperative, histological, length of hospital stay and mortality data were collected over a 90-day period following the intervention.

Eligibility Criteria:
Inclusion criteria:

* Open or laparoscopic left elective colectomy with colo-rectal anastomosis
* age \> 18 y.o.

Exclusion criteria:

* emergency surgery
* past history of rectal surgery
* ASA I
Neural and Physiological Responses to Real-World Experiences

UCLA researchers looking for healthy individuals (aged 35-50) who have a home computer with internet access, are not pregnant, planning to become pregnant, or currently breastfeeding (if female), to participate in a study investigating whether real-world experiences alter the brain and body. This study takes place over an eight week period and involves providing the names of 8 close friends or family members, completing a neuroimaging session, providing blood and saliva (for genetic analysis), and a 6-week period in which participants login twice a week to complete online questionnaires. Compensation is up to $210 for those who complete all aspects of the study. Please email realworld.ucla@gmail.com for more information.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 35-50

Exclusion Criteria:

Following a structured telephone interview, prospective participants with the following conditions will not be able to participate:

1. claustrophobia, left-handedness, or presence of metal in their body (for the neuroimaging procedures),
2. possible presence of a depressive disorder, which may interfere with the gratitude intervention (assessed by the Patient Health Questionnaire; Spitzer et al., 1999),
3. regular use of medications that may impact inflammatory processes (anti-inflammatory drugs, steroids, opioids),
4. current smokers or excessive caffeine users (\> 600 mg/day) because of known effects on inflammation, and
5. pregnancy (which would affect oxytocin gene expression).