cyrilzakka/clinical-trials huggingface dataset:
PANDA: PKU Amino Acid Evaluation

Phenylketonuria (PKU) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (PAH), which leaves them unable to convert Phenylalanine (Phe) into Tyrosine (Tyr). PKU patients have specific dietary needs and must follow a restrictive diet in the aim of preventing toxic levels of the amino acid phenylalanine (Phe) accumulation.

The exploratory study's main objective is to measure blood amino acid levels and to gain quantitative insights in children with PKU on a protein substitute with respect to evaluation of nutritional intake.

Eligibility Criteria:
Inclusion Criteria:

Both PKU and Non-PKU comparison subjects:

1. Age ≥ 2 and ≤ 12 years
2. Willing and able to provide informed consent by parents or legal representatives (and assent if required by local law/regulations)
3. One subject per family

   PKU subjects specific inclusion criteria:
4. PKU subjects identified by newborn screening and started low Phe diet before 1 month age
5. Usage of at least two Phe-free protein substitutes on a daily basis for at least 26 consecutive weeks up to Visit 1
6. Average Phe-level ≤360 µmol/L based on at least two blood Phe values from the past 12 months up to Visit 1

   Non-PKU comparison subjects specific inclusion criteria:
7. Same age (±3 years) and sex as an included PKU subject

Exclusion Criteria:

Both PKU and Non-PKU comparison subjects:

1. Current psychiatric disorders
2. Severe hepatic, thyroid or renal dysfunction
3. Acute illnesses like fever, flu, diarrhea, or vomiting (subjects should be symptom free for a week prior to V1)
4. Serious conditions (e.g. cancer, hydrocephalus, fatal heart disease)
5. Participation in any other clinical intervention studies involving test products concomitantly or within six weeks prior to entry into the study

   PKU specific exclusion criteria:
6. Use of BH4, or drugs that may interfere with main outcomes

   Non-PKU comparison subjects specific exclusion criteria:
7. PKU diagnosis or any other diagnosed disorder of amino or organic acid metabolism
Effects of Mat and Reformer Pilates in Multiple Sclerosis

Our study aims to investigate the effects of core stability-based Mat Pilates and Equipment-Based Pilates training on anticipatory postural adjustments (APA), balance, and gait in individuals with Multiple Sclerosis (MS). Participants diagnosed with MS will be randomly assigned to Mat Pilates, Equipment-Based Pilates, or a control group. Both Pilates programs will be conducted twice a week for eight weeks.

Assessments will be conducted before and after the training period. Anticipatory postural adjustments (APA) will be evaluated using electromyography (EMG) electrodes placed on the Erector Spinae and Tibialis Anterior muscles while participants take a step. Biomechanical responses related to APAs, specifically center of pressure displacement, will be measured using a force platform (Biodex® BioSway).

Core endurance will be assessed using the lateral bridge test, Modified Biering-Sorensen test, trunk flexion test, and prone bridge test, while core strength will be evaluated through sit-ups and push-ups. Balance will be measured using posturography. The Activities-Specific Balance Confidence (ABC) Scale will assess confidence in performing daily activities requiring balance. Functional mobility will be evaluated using the Timed Up and Go (TUG) test. Spatiotemporal gait parameters and variability will be analyzed with the BTS® G-WALK system. The Multiple Sclerosis Quality of Life Questionnaire (MSQOL-54) will assess quality of life.

This study is unique in that, unlike previous Pilates studies, it will be the first to examine the effects of different Pilates methods on APAs, which are crucial for both locomotor activities and postural stability in individuals with MS. Additionally, it will be the first study to evaluate two commonly used Pilates techniques in terms of their impact on balance and gait.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis by a specialist physician
* Having a disability level between 0-4.5 according to the Expanded Disability Status Scale (EDSS)
* Being between the ages of 18-65
* Not having had an attack in the last 3 months
* Mini-Mental Test score \> 25

Exclusion Criteria:

* Having another neurological disorder
* Having orthopedic, cardiovascular, and pulmonary problems that may affect the research results
* Having vision, hearing, and perception problems
* Having a disease that may affect the immune system, such as infection, cancer
Management of Persistent Epistaxis Using Floseal Hemostatic Matrix

Nosebleeds that persist even after adequate traditional nasal packing may require aggressive treatment strategies to stop bleeding. Currently these strategies include a surgical approach to cut off blood supply to the vessel that is bleeding. FloSeal Hemostatic matrix is a gel like medical therapy that is inserted into the nose and is engineered to stop bleeding in severe cases, possibly avoiding the need for surgery. In this study the investigators will randomize patients to either receive FloSeal Hemostatix matrix or traditional nasal packing as a treatment for severe nosebleeds. The main outcome will be whether the investigators are able to stop bleeding with FloSeal or traditional packing alone and whether additional measures are necessary to stop the bleeding. The investigators will also perform a patient comfort survey and cost analysis. Even if FloSeal has equal effectiveness in treating nosebleeds as traditional packing, if it is much more comfortable for patients then it may be the favourable treatment.

Background: Epistaxis is the most common emergent consultation to otolaryngology-head \& neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy¬ and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis.

Methods: A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 hours post-treatment, and 2) self-reported patient comfort at 48 hours post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed.

Eligibility Criteria:
Inclusion Criteria:

* All patients age 18+ presenting with epistaxis that requires an ENT consult that had a first attempt at treatment by an emergency physician.

Exclusion Criteria:

* Patients will be excluded based on the presence of a hypo-coagulable state. Including patients actively taking anti-coagulant medications or other patients with either acquired or hereditary bleeding disorders.
Opioid Maintenance Medications Comparison Study

A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.


Eligibility Criteria:
Inclusion

* age 21 to 55 years
* diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
* evidence of recent opioid use on toxicologic screening

Exclusion

* serious medical or psychiatric illness requiring long-term medication
* positive pregnancy test
Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital

Chronic obstructive pulmonary disease (COPD) is a worldwide public health challenge because of high prevalence and related disability and mortality (1).

Acute exacerbation of COPD (AECOPD), defned as the worsening of respiratory symptoms and requirement of additional clinical treatment, it reduces lung function and quality of life, and is accompanied by an increased disease-related burden, high hospital mortality and poor outcome (2).

Chronic obstructive pulmonary disease frequently coexists with other chronic diseases, namely comorbidities. They negatively impact prognosis, exacerbations and quality of life in COPD patients. Local and systemic inflammation have been proposed as having a potential role in explaining the association between COPD and these comorbidities (3).


Eligibility Criteria:
Inclusion Criteria:

patients with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation

Exclusion Criteria:

* Stable COPD
* Any other chronic chest diseases; Bronchial asthma or bronchiectasis
Zinc Supplementation in Pediatric Sepsis

a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.

a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.

The study included 72 cases that were randomly divided into 2 groups

A- Group A (Zinc treated group):

Included 36 cases who received oral zinc sulfate supplementation at doses ranging from 10 mg (infants) to 20 mg (under-five children) of elemental zinc per day, a dosage that is safe in these children.

B- Group B:

Included 36 cases who didn't receive zinc sulfate supplementation.

Method of randomization:

The cases were randomly divided into two groups using the closed envelope technique. The numbers from 1 to 72 were written in flat pieces of papers and put in closed envelopes that were randomly distributed to the participants.

The cases with the odds number were allocated to the zinc treated group while the cases with the even numbers were allocated to the other group.

Eligibility Criteria:
Inclusion Criteria:

* 2- Pediatric patients who fulfill Pediatric Consensus criteria for definition of severe sepsis as 1) greater than or equal to 2 age-based systemic inflammatory response syndrome criteria, 2) confirmed or suspected invasive infection, and 3) cardiovascular dysfunction, acute respiratory distress syndrome, or greater than or equal to 2 organ system dysfunctions

Exclusion Criteria:

* Infants and children with history of prematurity (\< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, surgical conditions and any other chronic medical condition.
* Those who are regularly taking vitamin or mineral supplementations
Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.

We are investigating the effects of a mind-body based mobile application on the experience of chronic pain.

Participants meeting our criteria for chronic pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will be enrolled in the study and randomized into control (usual care, waitlisted) or intervention group (6-week mind-body based mobile application intervention). Randomization will be stratified by pain intensity and gender using computer-generated block randomization to create varying block sizes of 4 and 8. We will run the trial in multiple cohorts in series to obtain desired sample size.

All participants will complete online questionnaires at baseline and post-intervention at 6 weeks that measure pain intensity, interference with daily living, pain perceptions, mental health outcomes, and medication use. Participants will also complete weekly questionnaires on weeks 2 to 6 to gauge frequency of application usage (intervention) or other pain treatments (control). Participants in the intervention group will be asked to repeat the follow-up questionnaire at 12-weeks.

See protocol for more details. (submitted at time of registration)

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 19 to 75 years with chronic pain.
* chronic pain is defined as having non-malignant chronic or persistent pain for at least 6 months.
* Participants must experience pain at least half the days in the last 6 months.
* Pain can include bodily pain or head (migraine) pain.

Exclusion Criteria:

* Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application.
* Individuals reporting any of the following psychiatric illness: schizophrenia, dissociative or personality disorders, bipolar disorder.
* Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis.
* Individuals reporting substance use disorder (within the last 6 months).
* Individuals that have previously used mind-body apps for the treatment of chronic pain.
Effect of Anti-HIV Therapy (HAART) on HIV Levels in the Lungs and on Lung Cell Inflammation in HIV-Infected Patients

The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces lung inflammation in HIV-infected patients.

Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates a high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is able to decrease viral load in the lungs, it should also be able to decrease lung-cell inflammation in these patients.

Lymphocytic alveolitis in HIV-infected patients probably represents a local immune response to HIV-infected cells in the lung. The intensity of lymphocytic alveolitis may therefore reflect the viral load in the lung. If so, treatment that reduces viral load in the lung (e.g., HAART) should also decrease the number of cytotoxic T lymphocytes (CTLs) in the alveolar space and should return pulmonary immune responses toward normal.

Patients are stratified by CD4 count: less than 200 cells/mm3 or 200 - 500 cells/mm3. BAL is performed and blood samples are collected prior to initiation of HAART and after 1 and 6 months of HAART. If a patient has detectable HIV in the lung after 6 months of HAART, the patient is asked to submit to an optional fourth BAL after 12 months of HAART. BAL fluid and cells are analyzed for HIV viral load, percent lymphocytes, and lymphocyte subsets. Responses in the lung are compared to simultaneous changes in these variables found in the peripheral blood. Each patient serves as his/her own control.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are at least 18 years old.
* Have a CD4 count less than or equal to 500 cells/mm3 and an HIV RNA level greater than or equal to 5000 copies/ml.
* Are about to start a regimen of at least 3 anti-HIV drugs (HAART).

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have ever received protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
* Have had signs or symptoms of lung disease in the past 30 days (pneumonia, bronchitis, emphysema, asthma, severe cough, or severe shortness of breath).
* Have received certain medications, including HIV vaccines.
* Have received chemotherapy within 30 days prior to study entry, or have cancer that will require chemotherapy.
* Are pregnant and will be beyond the first 3 months of pregnancy by Week 24 (Month 6) of the study.
Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension

300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.

This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhotic patients of any aetiology with Infection - suspected or documented and Mean arterial pressure less than 65 mm of Hg

Exclusion Criteria:

1. Cirrhosis patients in septic shock who are already on vasopressors and/or inotropes
2. Cirrhosis patients in septic shock with structural heart disease
3. Cirrhosis patients in septic shock with chronic renal failure/dialysis dependent/volume overloaded state
4. Cirrhosis patients in shock, caused by other reasons, other than septic shock
5. Cirrhosis patients in septic shock in whom contraindication to internal jugular or subclavian line insertion is present
6. Age less than 18 years
7. Previous episode of septic shock during the same hospital stay
8. Pregnant or lactating women
9. Patients in need for emergent surgical interventions
10. Cirrhosis patients in septic shock with chronic obstructive lung disease and right heart failure
11. Cirrhosis patients in septic shock with associated upper gastrointestinal bleed or coagulopathy related bleed with a haemoglobin of less than 8g/dL or requiring urgent transfusions of blood and blood products
12. A previous adverse reaction to human albumin solution
Evaluation of the Potentiating Effect of tDCS on Opioid Analgesia of Pain Threshold in Humans

The purpose of this study is to evaluate the potential additive effect of tDCS compared to placebo-sham in opioid analgesia on pain thresholds in nociceptive experimental model in healthy volunteers .

Pain is a prevalent symptom in medicine and the role of various opioids is valuable in the treatment of moderate to severe pain. Several technologies of brain stimulation , including transcranial direct current stimulation ( tDCS) are emerging as therapeutic options for many pain conditions. The effect of tDCS was demonstrated in sensory perception , decreasing the threshold for acute pain in healthy volunteers and in various chronic pain conditions . There is evidence about the use of tDCS with the participation through many mechanisms in cortical modulation , including the regulation of neurotransmitters, including opioids. In the context of neurostimulation, opioidergic system and cortical pain modulation, emerge the hypothesis of a possible potentiating effect of tDCS on clinical application of opioid analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy
* Without medication
* Sign the informed consent

Exclusion Criteria:

* Patients who did not understand the Portuguese
* Acute or chronic pain conditions
* Medical or psychiatric disorders
* History of sleep disorders (apnea, hypersomnia, somnambulism...)
* History of alcohol or substance abuse
* Neurological disorder
* Use of anti-inflammatory drugs, steroids and non-steroids, opioid and non-opioid analgesics, psychiatric medications, anticonvulsants, alpha and beta blockers
* Traumatic brain injury
* Neurosurgery
* Metallic implant in the brain
Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations

The study explores the potential benefits of a sugar water solution for decreasing pain in infants during routine immunizations.

Acute pain during early life may alter infant pain responses, cognitive development, and behavioral outcomes. Immunization injections represent a relatively brief exposure to acute pain, yet assessment studies demonstrate that infants respond with significant distress during the injections. This study will examine the analgesic potential of oral sucrose in diminishing the pain associated with immunization injections in 6 week to 4-month-old infants. The proposed mechanism of action is via the activation of endogenous opioids that attenuate nociceptive information at the level of the dorsal horn.

Comparison: Administration of oral sucrose 2 minutes prior to immunizations compared to administration of sterile water 2 minutes prior to immunizations

Eligibility Criteria:
Inclusion Criteria:

* Currently between 2 and 4 months of age
* Birth between 37 and 42 weeks' completed gestation;
* Birth weight greater than 2.5 kg
* No evidence of acute or chronic disease processes.

Exclusion Criteria:

* They are experiencing concurrent illness
* They received an analgesic/sedative 6 hours prior to the office visit
* The infant has breast fed 30 minutes prior to the visit or wishes to breast feed during or immediately after the immunization
* The infant has been introduced to solid food
* The infant may not receive a pacifier
* The infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered
* Language barriers preclude the process of obtaining parental consent.
Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls Risk Factors

Action Seniors!: A 12-Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls Risk Factors


Eligibility Criteria:
Inclusion Criteria:

Aged 70 years and older, present to a health care provider with a fall, mini mental state exam of at least 24

Exclusion Criteria:

Progressive neurological condition, medical condition precluding participation in physical activity, residing in a nursing home/extended care facility