cyrilzakka/clinical-trials huggingface dataset:
An Observational Study to Assess Malnutrition Risk

This is a prospective, observational study for assessing malnutrition risk and its characteristics among children aged 1 to 5 living in under-resourced communities in Colombia. There is also a qualitative component that seeks to gain caregiver, community health worker (CHW), public health professional (PHP), and non-for-profit organization (NGO) insights related to malnutrition risk.


Eligibility Criteria:
Quantitative Inclusion Criteria:

* Children aged 1-5 years
* Children's legal guardian agrees to participate in the study
* Full term pregnancy
* Residence in study area attending Children International (NGO) centers

Quantitative Exclusion Criteria:

* Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes,
* Congenital condition
* Children with disabilities such as cerebral palsy, autism spectrum disorder, neurodegenerative disorders
* Children with chronic or acute infections e.g. HIV, malaria
* Children who are taking medications or other agents that could potentially affect body weight, including diuretics, appetite stimulants, steroids, and growth hormones.
* Children already enrolled in a nutrition program/intervention that includes a supplement

Qualitative Inclusion Criteria:

* NGO staff taking part in nutrition screenings
* Caregivers taking part in nutrition screenings as part of this study
* Community health workers (CHW) working with pediatric malnutrition risk
* Public health professionals (PHP) working with pediatric malnutrition risk
* Agrees to participate in focus group/survey

Qualitative Exclusion Criteria:

* Not involved in the implementation of the study
* Not involved in working with pediatric malnutrition risk
* Declines participation in focus group/survey
Marijuana Approach Bias Retraining and Neural Response in Youth

This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham conditions. Substance use and cognitive assessment will identify changes in MJ use patterns and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance imaging marijuana cue reactivity task, we will determine differences in neural response in reward regions before and after 3 weeks of either AAT or sham treatment.


Eligibility Criteria:
Inclusion Criteria:

* between age 16 and 21
* having \>50 lifetime marijuana use episodes and a pattern of at least weekly marijuana use for the past year (\>1+/week for 52 weeks) at study entry.

Exclusion Criteria:

* not having a parent to consent (for those under age 18)
* prenatal alcohol (\>2 drinks on an occasion or \>4 drinks in a week) or any tobacco or illicit drug exposure
* premature birth (\<34 weeks gestation), birth weight \<5 lbs, or other gestational or perinatal complications
* history of a serious medical or neurological problems that could affect blood oxygen level dependent (BOLD) response, brain development, or study participation, including diabetes and recurrent migraine
* current severe Diagnostic and Statistical Manual of Mental Disorders (DSM-5) major Axis I psychiatric disorder (i.e., exclude participants with bipolar disorder, psychotic disorder)
* use of any illicit substance (e.g., cocaine, methamphetamines) other than alcohol or marijuana \> 100 times
* history of major neurological disorder or head trauma (with loss of consciousness \>10 minutes)
* history of learning disability, pervasive developmental disorder, or other condition requiring special education
* current use of medications that affect cerebral blood flow
* non-correctable visual or hearing problems
* non-fluent in English
* MRI contraindications (e.g., braces, claustrophobia, irremovable metal implants or piercings)
* pregnant on day of scan
* intake of psychoactive medication as tested by urine drug screen.
International CAPS Registry: Pancreas Cancer Cases in Surveillance Programs

Various centers around the world are currently investigating the feasibility and yield of surveillance for pancreatic cancer in high-risk individuals. Evidence is beginning to accumulate that surveillance may lead to the early detection of non-invasive precursor lesions and asymptomatic early stage cancer. Ultimately, the goal of surveillance is to reduce mortality in these high risk individuals, but before this can be confirmed many research questions need to be answered. While the numbers of high-risk individuals screened in each separate screening facility are likely too small to properly address many of these questions, pooling data comprises a sizable sample size providing unique research opportunities. The objective of this study is retrospectively review all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.

The study is a retrospective review of all cases of high-risk individuals participating in our pancreatic surveillance program in whom 1) a suspicious precursor lesions was detected for which a pancreatic resection was performed and 2) in whom an advanced malignant disease was diagnosed. The de-identified information will be entered into an international multicenter database registry.

Eligibility Criteria:
Inclusion Criteria:

* Elevated pancreas cancer risk cohort with pancreas cancer or dysplastic pancreas changes

Exclusion Criteria:
Liver and Biliary Tumor Tissue Registry

Patients having surgery to remove a liver or biliary tissue mass or having a biopsy of a mass or lesion will have a tissue sample collected and stored for future research of liver and biliary diseases. A blood sample may also be collected at the time of enrollment.

The study establishes a tissue and blood registry at Mayo Clinic Florida to support translational investigations into the biology, etiology and prognosis of liver and biliary masses such as through the use of patient-derived xenografts.

Patients having surgery to remove a liver or biliary mass or having a biopsy of a mass or lesion will be asked to donate a portion of the removed mass for research purposes. Only portions of the mass not required for clinical diagnostic evaluation, or surgical waste, will be used in this research study.

The tissues acquired will be stored and used for any specific, hypothesis driven protocols that are IRB approved. Serum and plasma samples may also be obtained at enrollment.

Clinical patient data from medical charts that may be correlative to outcomes will be collected and stored in a password secure data base. Data will be extracted from medical records charts.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo surgical resection of a liver or biliary mass

Exclusion Criteria:

* Under 18 years of age. Prior radiation to mass.
Stalevo in Early Wearing-Off Patients

The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Parkinson's disease
* Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day
* Unchanged antiparkinsonian medication for 6 weeks prior to baseline

Exclusion Criteria:

* Secondary or atypical parkinsonism
* Patients with daily unpredictable OFF periods or painful dyskinesia
Effects of Guided Written Disclosure Protocol on Psychological Distress and Positive Functioning in Persons With Skin Diseases: a Randomized-controlled Trial

We conducted a randomized-controlled trial of Guided Written Disclosure Protocol for dermatological patients with the aim of reducing psychological distress, expressive suppression, and skin-related symptoms, and improving spiritual well-being, cognitive reappraisal, and sense of coherence.

Sample size assessment: A recent meta-analysis reported a study which showed that Guided Written Disclosure Protocol reach on effect size of 0.89 on psychosocial outcomes (Gidron et al., 2002; Mogk et al., 2006). Power analysis showed that with an alpha of 0.05 and a power of 0.80, we needed a sample of 34 participants to detect effect sizes of 0.89 and higher.

Plan for missing data: Occasional missing values were imputed by calculating, for each participant, the average score for each subscale and then replaced.

Statistical analysis plan: We conducted a 2 (group) X 2 (time \[pre-treatment vs. post-treatment\]) repeated measures multivariate analysis of variance (MANOVA) for a set of variables.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Diagnosis of psoriasis or systemic sclerosis by a board-certified dermatologist.

Exclusion Criteria:

* Patients with certified mental disorders (e.g., psychotic illness, major depressive disorder)
* Patients undergoing psychotherapy for at least 6 months in the last 3 years;
* Patients who currently receive psychopharmacological treatment.
A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change).


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria
* Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2
* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

* Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy
* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed
* Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required
* Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study
Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding

The study aims to describe the changes in Levothyroxine dosage requirements in patients with hypothyroidism started on enteral feeding, and assess whether giving levothyroxine on empty stomach affects the mean percentage increase expected in Levothyroxine dosage in these patients.

The study will be a Randomized Controlled trial comparing the mean percentage of Levothyroxine dosage change in hypothyroid patients after the starting of enteral feeding in an inpatient setting in two different groups: a control group where Levothyroxine will be administered with continuous enteral nutrition, and an intervention group where enteral nutrition will be held for two hours before and two hours after the Levothyroxine administration.

The enrollment of eligible patients will be over two to three years and follow up will continue for the duration of the hospital stay or 12 weeks, which ever occurs earlier. Eligible patients will have thyroid function tests at enrollment (within three days of the starting of the tube feeding) and afterwards weekly. Levothyroxine dosage will be adjusted by the endocrinology research team according to the thyroid function results. Initial Levothyroxine dosage and subsequent dosages will be recorded and the mean percentage decrease or increase of Levothyroxine dosage required will be measured in each group. An eventual difference between the two groups mean percentage change will be tested for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Adults admitted to Maimonides Medical Center
* Started on Enteral feeding within 3 days of enrollment: tube feeding, Percutaneous Endoscopic Gastrostomy or PEG tube feeding, or Jejunostomy tube feeding.
* History of Hypothyroidism on a stable dose of Levothyroxine for at least four weeks prior to enteral feeding
* TSH 0.2-10 mIU/ml at enrollment

Exclusion Criteria:

* Concomitant administration of medications that affect thyroid function test including Cholestyramine, Sucralfate, Amiodarone, Lithium, Dopamine, Dobutamine and Dilantin at enrollment.
* Pregnancy
* Known untreated disease or surgery of the small intestine specifically the Jejenum.
The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women

Hypertensive disorders of pregnancy, include pre-existing and gestational hypertension, preeclampsia, and eclampsia, it complicates up to 10% of pregnancies and represents a significant cause of maternal and perinatal morbidity and mortality. Following the "National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy" recommendation is currently a systolic blood pressure (SBP) ⩾ of 140 mmHg and diastolic blood pressure (DBP) ⩾ of 90 mmHg. The diagnosis generally requires two separate measurements. Accepted across international guidelines are the following four categories: Chronic/pre-existing hypertension (Hypertension discovered preconception or prior to 20 weeks gestation), Gestational hypertension (Hypertension that appears de novo after 20 weeks gestation and normalizes after pregnancy), Preeclampsia-eclampsia (De novo hypertension after 20 weeks' gestation accompanied by proteinuria, other features of maternal organ dysfunction or uteroplacental dysfunction), Chronic/pre-existing hypertension with superimposed preeclampsia-eclampsia. Over the past 2 decades, extensive epidemiologic studies have clearly established that obesity is a major risk for gestational hypertension and preeclampsia. The risk of preeclampsia typically doubles with each 5-7 kg/m2 increase in pre-pregnancy. The mechanisms have only been partially explored; increased cytokine-mediated inflammation and oxidative stress, increased shear stress, dyslipidemia, and increased sympathetic activity1 have all been proposed as possible pathways. Few studies have examined the relationship between pre-pregnancy BMI, gestational weight gain (GWG), and the risk of preeclampsia. So, our study aims to evaluate the adverse maternal and fetal outcomes related to hypertension in obese and non-obese pregnant women.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged from 20-35 years.
2. Pregnant women from 28-30 weeks.
3. Pregnant women with a singleton pregnancy.
4. Women with chronic or gestational hypertension.
5. Women with normal baseline investigations (uncomplicated hypertension).
6. Obese women and non-obese women.

Exclusion Criteria:

1. Women with preeclampsia/eclampsia.
2. Women need urgent termination of pregnancy.
3. Women with co-morbidities such as diabetes, renal diseases, cardiac ...etc.
4. Women with confirmed fetal malformation.
5. Women who will refuse to participate.
Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease

EYE-TAR(AD+) is an observational study based on the same design as the princeps EYE-TAR(MA) study, but with a larger number of patients and including an additional evaluation of Facial emotion recognition (based on a more ecological material), in order to reinforce conclusions of the study EYE-TAR(MA) https://doi.org/10.1016/j.npg.2020.08.003.

The main objective is to confirm that facial emotion recognition can be improved in AD using the "Training of Affect Recognition program" (TAR).

The Secondary Objectives are to:

Evaluate the impact of the "Training of Affect Recognition program" (TAR) on oculomotor behavior in a situation of social cognition, on behavioral disorders and on caregiver burden.

Confirm that improvement in facial emotion recognition is related to modification of observation strategies.

Confirm the link between improved recognition of facial emotions, reduced behavioral disorders and caregiver burden.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female.
* AD diagnosed according to l'IWG-2 (Dubois \& al. 2014) criteria,
* Mini-Mental State (MMS-E) ≥15
* Subject accompanied by a family caregiver and whose participation in a cognitive stimulation workshop was recommended in Memory Centre of the RAINIER Centre (Princesses Grace Hospital - Monaco)
* Written informed consent signed by patient and family caregiver.

Exclusion Criteria:

* General anaesthesia within 3 months.
* History of psychiatric and/or neurological disorder (other than the diagnosed neurodegenerative pathology);
* History of alcoholism or drug addiction
* Ophthalmological or neurological problems preventing a video-oculography examination.
* Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
* Cognitive disorders of the neurovisual type (visual agnosia, prosopagnosia, visuo-spatial disorder or visuo-perceptual disorder) or aphasia.
RADA16 for Aquablation Day Case

This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge.

The primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation.

The secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).


Eligibility Criteria:
Inclusion Criteria:

• Any man undergoing Aquablation for LUTS due to BPH

Exclusion Criteria:

• Unwilling to sign consent
CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient with Sepsis in Assiut University Hospitals

the goal of this study is to asses the value of biomarker (CRP, CRP/Alb ratio, N/L ratio) in predictor of the outcome in normotensive patients with sepsis.

The main question it aims to answer is:

Does biomarker (CRP, CRP/Alb ratio, N/L ratio) can predict the outcome in patients with sepsis ?

Sepsis is an unusual systemic reaction to what is sometimes an otherwise ordinary infection, and it probably represents a pattern of response by the immune system to injury. A hyper-inflammatory response is followed by an immunosuppressive phase during which multiple organ dysfunction is present and the patient is susceptible to nosocomial infection.

A biomarker describes a measurable indicator of a patient\&#39;s clinical condition that can be measured accurately and reproducibly. Biomarkers offer utility for diagnosis, prognosis, early disease recognition, risk stratification, appropriate treatment (theranostics), and trial enrichment for patients with sepsis or suspected sepsis C-reactive protein (CRP) is an acute-phase protein that is produced following stimulation by various cytokines in response to infection, ischemia, trauma, and other inflammatory conditions . High CRP levels have been studied in relation to prognosis and mortality in critically ill patients . On the other hand, low serum albumin is known to be associated with poor prognosis and mortality . Based on this knowledge, we speculated that the ratio of CRP to albumin could be used as a predictive marker for mortality.

Recently, the CRP/albumin ratio, a combination of markers for systemic inflammation and nutritional status, has been extensively studied as an independent prognostic marker in patients with infection, malignancy, and other diseases . However, there are relatively few studies conducted focusing on critical care patients in the ICU Among the plethora of biomarkers available to clinicians investigating septic patients in the Emergency Department (ED), white blood cell count (WBC) are always taken into consideration due to their availability and low cost. Serial measurement of RP, is useful for clinicians' decision-making, as its serum levels correlate with the syndrome evo-lution .Neutrophil-to-lymphocyte ratio (NLR) calculated from the complete blood count seems to be a reasonable tool for assessment during the sepsis course (8, 9).

Eligibility Criteria:
Inclusion Criteria:

* Patients with sepsis with normal blood pressure

Exclusion Criteria:

* 1) Patients with history of corticosteroid therapy or antibiotic use before admission.

  2) Patients with hematologic disorders, malignant diseases, chemotherapy or radiotherapy within the previous month .

  3)Patients with shock