cyrilzakka/clinical-trials huggingface dataset:
Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill patients, possibly in part through an attenuation of the proinflammatory cytokine response and a Immune function. In this trial intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 28 days.

A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 28 days and control patients will be received maltodextrin along with enteral formula for 28 days. Patients will be evaluated for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old) admitted to ICU
* Start of study intervention within 48 hours after ICU admission
* Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
* Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

* Enrollment in a related ICU interventional study
* Requiring other specific enteral nutrition for medical reason
* Death or Discharge before 5th day
* Having any contra-indication to receive enteral nutrition
* Pregnant patients or lactating with the intent to breastfeed
* Requiring other specific enteral nutrition for medical reason
* BMI \<18 or \> 40.0 kg/m2
* Have life expectancy of \<6 mo
* Patients who are moribond
* Liver cirrhosis- Child's class C liver disease
* Have seizure disorder requiring anticonvulsant
* History of allergy or intolerance to the study product components
* Receiving glutamine during two weeks before start study product
* Have other reasons
Latent Iron Deficiency at Birth Influences Auditory Neural Maturation in Late Preterm and Term Infants

This study evaluates auditory neural maturation by auditory brainstem evoked response in late preterm and term infants with in utero iron deficiency compared with neonates with normal in utero iron status.

Iron is an essential nutrient for brain development. During early human development, iron is required for multiple neurodevelopmental processes. To meet the iron requirements of a developing brain, active transfer of iron occurs across the placenta during the last trimester of pregnancy and therefore most term infants have iron replete status at birth. However, maternal iron deficiency during pregnancy, a global health problem, can negatively affect the fetal iron status. In addition, prematurity, maternal diabetes mellitus, preeclampsia, maternal smoking, and intrauterine growth restriction during pregnancy have also been associated with decreased iron transfer to the fetus often leading to in utero iron deficiency.

Cord serum ferritin (SF) level at birth provides a good measurement of fetal tissue iron storage concentration and is therefore often used to evaluate in utero iron status. The absolute and interpeak latencies on auditory brainstem evoked response (ABR) are often used as surrogate outcome measures for neural maturation in the neonates. The absolute latencies for each of these ABR waves and the interpeak latencies (IPL, I-III, III-V, and I-V) are influenced by the degree of myelination, neuronal development, synaptic function, and axonal growth in the auditory nervous system. The absolute latencies and IPL decrease as the auditory neural system matures with age in neonates.

Although iron is essential for auditory neural maturation during the perinatal period, there is a paucity of data regarding the concomitant effect of in utero iron deficiency on auditory neural maturation in late preterm and term infants. The present prospective study is planned with an objective to determine the association of in utero iron deficiency as evaluated by cord ferritin with auditory neural maturation at birth in ≥ 34 weeks GA infants.

Eligibility Criteria:
Inclusion Criteria:

* Neonates born between 34 - 42 weeks of gestation at Sir Ganga Ram Hospital, New Delhi

Exclusion Criteria: Infants with

* craniofacial anomalies
* chromosomal disorders,
* hemolytic disease (coomb's positive),
* multiple gestation,
* history of third trimester maternal infections,
* clinical chorioamnionitis,
* Apgar score \< 5 at 5 minutes,
* TORCH infections (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex),
* clinical or culture proven sepsis,
* admission to the Neonatal Intensive Care Unit,
* infants on whom cord blood not collected and on whom ABR could not be performed
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the ALS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic criteria El Escorial and revised Airlie House.
* Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
* Patients of less than 2 years after the onset of ALS.
* Patients whose progress of the condition during 12 weeks before administration meet other requirements.

Exclusion Criteria:

* Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
* Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
* In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
Just in TIME - Intervention With Dance and Yoga for Girls With Recurrent Abdominal Pain

Recurrent abdominal pain affects up to 37% of school-age children, mostly girls. These problems results in decreased quality-of-life, absence from school, lower sleep quality and increased health-care consumption. Long-term effects are lasting pain-symptoms and increased risk for psychiatric illness.

The scientific evidence for interventions towards long-term pain in children is limited and pharmacological treatment is not effective. Cognitive behavioral therapy has shown some effect but is time- and resource consuming. Dance and yoga can enhance positive protective factors through better body awareness and increased self-regulation. Relaxation in yoga also has positive effect on abdominal pain.

The aim of this study is to evaluate the effects of an intervention with dance and yoga for girls, 9 to 13 years old, with recurrent abdominal pain. The participants will be identified through pediatric clinics in Örebro County, primary health care and school health care. They will be randomized to intervention with weekly dance- and yoga class for 8 months or control group with standard treatment. Primary outcome is the fraction of girls in each group who, direct after intervention, has decreased their maximum pain measured by Faces Pain Scale. Secondary outcomes are stress, psychical health, well-being, school and sleep functions, physical activity and health-economy. The study group will be followed up for two years.

Just-in-TIME is an interdisciplinary research group with expertise in interventions for psychosomatic problems in children and adolescents. TIME, which stands for Try, Identify, Move and Enjoy, also characterizes this project, aiming at decreasing recurrent abdominal pain through an intervention with dance and yoga for 9-13 year old girls.


Eligibility Criteria:
Inclusion Criteria:

Girls 9-13 years old as of pediatricians receive or have received the diagnosis functional abdominal pain or IBS according to the ROME III criteria and stating that they have persist symptoms for at least 2 months after completed investigation from pediatricians. Persistent symptoms are measured by pain diary at baseline and means that the girl at least once in the pain diary estimates 4 or higher as measured by the Faces Pain Scale (FPS-R).

Exclusion Criteria:

* Simultaneous celiac disease or inflammatory bowel disease (IBD).
* Difficulties in following verbal instructions such as hearing impaired or mentally retarded.
* Girls who are deemed to have such serious psychological symptoms that other treatment is required. All participants in the study, which estimates over 13 at the Children's Depression Screener (Child-S), will meet a psychologist / psychiatrist to assess whether they can participate in the study or have direct access to the Children and Youth psychiatry.
* Children treated with CBT.
Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia

This is a multi-centre, open, randomized, haloperidol-referenced, 47 days two treatment sessions, parallel-group study.

After screening period, eligible subjects will be entered 5 days treatment session I to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation, then will be followed by 6 additional weeks treatment session II for exploring the effect of medicine switching from IM injection to oral.

Acute psychotic agitation is a common problem in many patients with schizophrenia that includes agitation, aggression, excitement and violence. An investigation showed that about 26% psychotic patients were brought to the psychiatric emergency room because of the psychotic agitation symptoms. The primary objective is to compare the efficacy between risperidone oral solution combination clonazepam oral and haloperidol IM injection on controlling psychotic agitation in patients of acute schizophrenia and schizophrenic-affective disorder.

The secondary objectives are: (1) to explore the possibility of decreasing efficacy of acute 6 weeks treatment from IM injection to oral; (2) to compare the safety between risperidone oral solution combination clonazepam oral and haloperidol IM injection.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 45 years
* DSM-IV diagnosis of acute exacerbation of schizophrenia or schizoaffective disorders
* A score of ≥ 14 on a 5-item acute-agitation cluster (including excitement, hostility, uncooperativeness and poor impulse control) derived from the PNASS
* The total scores ≥60 on the PANSS

Exclusion Criteria:

* Women who are pregnant or breast feeding, or who plan to become pregnant during the study
* The psychotic agitation is caused by delirium, epilepsy, mental retardation and affective disorder; intoxication or symptoms of withdrawal from alcohol or other psychoactive substances
* Clinical laboratory values indicating serious medical illness
* Known hypersensitivity to any of the study medications
* Treatment with a depot antipsychotic with 1 cycle of screening
* Using of disallowed medication
ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)

This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks.

The study is designed to evaluate the safety and treatment effects of ATH-1017 in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized, double-blind, placebo-controlled, parallel-arm treatment duration of 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with confirmed diagnosis of Parkinson's disease or Dementia with Lewy Bodies
* MoCA score 11 to 23, inclusive, at screening
* Probable Parkinson's Disease Dementia or Lewy Body Dementia
* BMI between ≥ 16and ≤ 35 kg/m2 for females and between≥ 18 and ≤ 35 kg/m2 for males at Screening
* Reliable and capable support person/caregiver, who is willing to accept responsibility for supervising the treatment or, if required, administering study drug, and assessing the condition of the subject throughout the study in accordance with all protocol requirements

Exclusion Criteria:

* Hoehn-Yahr stage 5
* History of significant neurological disease other than PDD or DLB that may affect cognition at onset of dementia
* Subjects on deep brain stimulation
* History of brain MRI scan indicative of any other significant abnormality
* History of unexplained loss of consciousness, and epileptic fits
* Hearing test result considered unacceptable for auditory ERP P300 assessment
* Diagnosis of severe major depressive disorder even without psychotic features (GDS score \[15-item scale\] \>7 at Screening)
* Significant suicide risk based on C-SSRS
* Significant psychosis (according to Diagnostic and Statistical Manual of Mental Disorders)
* Moderate or severe substance abuse disorder (according to DSM-5)
* Myocardial infarction or unstable angina within the last 6 months
* Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
* Clinically significant ECG abnormality at Screening
* Chronic kidney disease (eGFR \< 45 mL/min using Cockcroft-Gault formula)
* Hepatic impairment with alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal, or Child-Pugh class B and C
* Malignant tumor within 3 years before Screening
* Memantine at any dose or combination
* Donepezil at 23 mg
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

This is prospective and randomized study to compare the pharmacodynamics (t\>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection.

Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T\>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> or = 20 years
* Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
* Patients who are likely to survive 3 days

Exclusion Criteria:

* Patients who have documented hypersensitivity to imipenem or other carbapenems
* Patients who have an estimated creatinine clearance of \< 50 ml/min
* Patients who are in circulatory shock or hypotension (systolic \< 90 mmHg)
* Patients who are pregnant
Barley Beta-glucan, Glycemic Control, and Appetite

Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food intake.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Body Mass Index (BMI) values of 18.5-40.0 kg/m2
* Normal fasting blood glucose (\<100 mg/dL)

Exclusion Criteria:

* Use of medications known to be associated with weight change (e.g., beta-blockers)
* Use of steroid pills or shots such as prednisone or cortisone
* Use of nicotine
* Weight change of ten or more pounds in the last three months
* Major daily variation in physical activity (e.g., athletes in training)
* History of extensive small bowel surgery or surgery to treat obesity
* History of heart attack, stroke, or bypass
* History of cancer within the last five years (exception: non-melanoma skin cancer)
* Recent or current medical diagnosis or medical treatment that would alter appetite, energy needs, satiety, and/or could impact the results of the trial
* Medical diagnoses of diabetes, cardiovascular disease, high levels of blood lipids, asthma, cold, and flu (exception: hypertension, if treated with medication prescribed more than three months prior to the screening activity)
* Fear of blood or needles
* Dietary restrictions that would interfere with consuming test foods (e.g., gluten intolerance, vegan, corn syrup allergy)
* Following a weight modification diet
* Sensitive to food textures present in the test foods
* Following personal schedules that would not permit attendance at all scheduled testing sessions
* Unable to comprehend the nature of the trial or instructions
* Unable to understand English sufficiently to complete the trial
Bournemouth University Resilience Training for Surgeons

The challenges that characterise surgical practice may result in a myriad of stressors that impact upon the personal and professional lives of surgeons. This includes a high likelihood that surgeons will have to deal with adverse patient outcomes due to surgical complications and errors, sometime during their careers. Such stressors can have undesirable effects on the surgeon in terms of quality of life and psychological well-being (e.g. anxiety, feelings of regret), as well as lowered professional confidence and impaired perceptions of professional competence. Furthermore, there is evidence that these kinds of negative impacts can also lead to burnout and depression. As well as the detrimental effects on surgeons and those around them, this in turn may lead to more errors and poorer outcomes for patients. This study will examine the efficacy of an ACT based training intervention to enhance resilience and psychological flexibility.

Research in a range of occupational settings has indicated that resilience plays an important role in ameliorating the impact of adverse events in high pressure environments. This project will use a randomised controlled trial research design to assess the efficacy of brief one-to-one Acceptance and Commitment Training (ACTr), designed to enhance surgeons' psychological resilience. According to the model ACTr is based on, psychopathology is primarily the consequence of psychological inflexibility i.e. inability to persist or change behaviour according to long-term values due to language and cognition skills, which has particular significance when an individual is confronted with stress or adversity.

The main aim of this research is to assess the efficacy of a brief one-to-one Acceptance and Commitment Training course. Researchers wish to ascertain whether such a course can increase surgeons' resilience by increasing psychological flexibility, valuing and self-compassion (all of which are expected to be positively impacted by this training). This research will fill a gap in the relevant research literature; namely that no research project as far as we are aware has evaluated ACTr as a means to enhance resilience in surgeons. In fact any research conducted on resilience training with a surgical population is rare.

Eligibility Criteria:
Inclusion Criteria:

Trainee surgeons and consultant surgeons

Exclusion Criteria:

None
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies

This is a single group, Phase 4, single-arm post-marketing study for treatment.

The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants (aged from 12 to less than 18) with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies.

Participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 12 to less than 18 years of age at the time of signing the informed consent.
* Participant has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT).
* Has active moderate to severe cGVHD.
* Has received at least one line of prior systemic therapy for cGVHD.
* Participant must receive a corticosteroid therapy for cGVHD with a stable dose for at least 2 weeks prior to the first dose of the IMP.
* Has a Lansky-Play performance score of ≥60.
* Participants should have an expected survival of longer than 6 months.
* Body weight of 30 kg and above.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* The participant or their legally authorized representative (LAR) must be capable of giving signed informed consent.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Recurrence of hematologic neoplasms (according to the corresponding criteria for recurrence of primary hematologic neoplasms) or post-transplant lymphoproliferative disease at screening.
* Received investigational systemic therapy for cGVHD within 28 days prior to enrollment, unless the prior treatment had been washed out for at least 28 days or 5 half-lives prior to enrollment, whichever is shorter.
* Absolute neutrophil count (ANC) \<1.0 × 10\^9/L.
* Platelet count \<50 × 10\^9/L.
* Alanine aminotransferase (ALT) \>3× the upper limit of normal (ULN), aspartate aminotransferase (AST) \>3 × ULN.
* Total bilirubin (TBIL) \>1.5 × ULN (\>3 ULN if Gilbert's syndrome).
* Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73 m\^2 using the revised Bedside Schwartz formula . Revised Schwartz equation: CrCl (mL/min/1.73 m\^2) = 0.413 × (height \[in cm\])/Creatinine (in mg/dL) at screening visit.
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
Treatment for Calcium Phosphate Kidney Stone Disease

The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.

We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers.

The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.

The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.

Eligibility Criteria:
Inclusion Criteria:

Aim 1

* Hypocitraturic CaP stone formers
* urine citrate \<320mg/d
* elevated pH as 24-hr urine pH above 6.40
* \>21 years

Aim 2

* Hypercalciuric CaP stone formers
* 24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use
* high pH as \>6.40 in the absence of urinary tract infection
* \>21 years