cyrilzakka/clinical-trials huggingface dataset:
Effect of Feeding Jejunostomy on Sarcopenia in Patients with Esophageal Cancer

Participants were diagnosed with esophageal cancer needing chemo- or radiochemotherapy before the potentially curing surgery consisting of esophagectomy. At the time of diagnosis, in all participants, a laparoscopy to complete staging was performed. In some patients, a feeding jejunostomy tube (FJT) was placed at the time of staging laparoscopy; in others, the FJT was placed at the time of esophagectomy. A common risk factor for higher morbidity and mortality is sarcopenia, a condition associated with low skeletal muscle. This study aims to determine whether the timing of the FJT placement affects the progress of sarcopenia.

At the City Hospital Zurich Triemli, an FJT tube is inserted in approximately two-thirds of patients before commencing neoadjuvant therapy. Another third receive an FJT at the time of esophagectomy to ensure postoperative enteral feeding. To this day, no prospective, randomized study exists as to whether placing an FJT at diagnosis or esophagectomy impacts sarcopenia. Retrospectively collected data is limited due to small sample sizes and observational character.

This is a retrospective, single-center cohort study using disease-related data already collected. The study design includes statistical balancing techniques to achieve comparability between the two groups and estimate an unbiased treatment effect of the timing of FJT placement.

All data is extracted from the clinical information systems and radiological systems and is credible, protected data. It is taken exclusively from the medical records; patients are not contacted for data collection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and above at the time of diagnosis.
* Advanced-stage esophageal cancer or cancer of the esophageal junction and treated with curative intent, including neoadjuvant treatment.
* Patients who received an FJT either before neoadjuvant treatment or during definitive surgery.

Exclusion Criteria:

* Insufficient data for analysis
* Written rejection of general consent
Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

The goal of this prospective randomized controlled trial is to explore the efficacy and safety of Oscillation and Lung Expansion-a airway clearance technology-in bronchiectasis. Participants will receive Oscillation and Lung Expansion or postural drainage randomly in this study. and the symptom, quality of life scores and amount of expectoration will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute exacerbation of bronchiectasis

Exclusion Criteria:

* Haemoptysis greater than 50ml
* state of endangerment
* pneumothorax
* Lung surgery history within 6 months
* Severe heart, brain and nervous system diseases
Comparison of Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy

The goal of this clinical trial is to compare the Ciprofol and Propofol Under IoC1 and IoC2 Monitoring for Adenotonsillectomy Participants will be randomly allocated to two groups: Ciprofol group (Group C) and Propofol group (Group P). For those in Group C: they will be given ciprofol during anesthesia induction and maintenance .For those in Group P: they will be pgiven ciprofol during anesthesia induction and maintenanc This study evaluates ciprofol versus propofol under IoC1/IoC2 guidance in pediatric T\&A, providing evidence for ciprofol's efficacy and safety in pediatric anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I/II, age 3-11 years, weight 13-50 kg.

Endoscopic T\&A or adenoidectomy.

Exclusion Criteria:

* Recent upper respiratory infection.

Difficult airway, organ dysfunction, developmental/psychiatric disorders.

Drug allergies.
Effects of Specific Lipid Fractions-enriched Infant Formulae

This is a multicenter, randomized, double-blind, parallel-group, reference-controlled 4-month pilot safety study to evaluate the effects of specific lipid fractions-enriched infant formulae on growth of infants aged 0-4 months. The study will test the hypothesis that growth of infants fed the specific lipid fractions-enriched infant formulae will be noninferior to growth of infants fed standard infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Infant is ≤14 days old on day of enrollment
* Gestational age ≥37 weeks (full term infants)
* Birth weight ≥2500 g and ≤4500 g
* Singleton birth
* Having obtained his/her parents'/legal representative's informed consent

Exclusion Criteria:

* Having any significant pre-natal and/or post-natal disease and/or congenital illness or malformation that may affect normal growth.
* Infant undergoing antibiotic therapy.
* Re-hospitalization for more than 2 days in the first 14 days of life.
* Parents not expected to comply with the protocol during the period of study participation.
* Infants currently participating in another trial
Novel Technique of Analgesia Following Open Liver Resection

Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. The study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. Patients will be randomly assigned to AW catheter group treated with drug or control treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years age
* Undergoing liver resection using a subcostal incision

Exclusion Criteria:

* Patients unable to comprehend instructions, consent, or co-operate with pain assessment (including psychiatric disorders, pre-operative sedation, coma)
* Allergy to any study medications
* Patient not able to be extubated postoperatively for any clinical reason
* Laparoscopic surgery
* Co-existing epidural or intrathecal analgesia
* Chronic pain disorders or on long-term opioid use
* History of substance or alcohol abuse
* Transplant donor liver resections
* Patients with liver cirrhosis
Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD

The aim of this study was to investigate the airway inflammatory profile and the clinical presentation of chronic obstructive pulmonary disease (COPD) in never smokers compared to smokers with COPD.

40 COPD patients (21 smokers and 19 never smokers) and 28 healthy never smokers were included in the present study. Information about respiratory symptoms and comorbidities were collected. Subjects underwent pulmonary function tests and COPD was defined according to Global Initiative for Chronic Obstructive lung Disease spirometric criteria. Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α)). The Mann-Whitney U and the χ2 tests were used for results comparisons. Correlations between symptoms, spirometric parameters, cytokines levels, inflammatory cells and risk factors of COPD were examined with Spearman's rank correlation test.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with COPD, according to GOLD criteria (smokers and never smokers). Moreover, inhaled short-acting β2-agonists were stopped at least 8h before the test and inhaled long-acting β2-agonist were stopped at least 48h before the test.
* Healthy control subjects : never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms.

Exclusion Criteria:

* COPD patients were excluded from the study if they had an exacerbation, a respiratory tract infection or if they used a systemic form of corticosteroid preparation (oral or intravenous injection therapy) or antibiotics within the two months prior to the study entry. Patients with other respiratory disorder like pneumonia, pulmonary emboli, congestive heart failure, lung cancer or tuberculosis were also excluded.
Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus

Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous involvement at some point during course of their disease. In spite of the esthetic consequence during the acute phase, the main problem is still related to its disfiguring and incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the conventional therapy. Unfortunately, approximately 30% will be refractory to these measures. For those patients, immunosuppressive therapy can be an alternative with controversial results. Several series have shown a 90% of clinical efficacy in patients treated with Thalidomide. Unfortunately, the main drawback has been the serious described side effects such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide analogue, more potent, efficient and with better safety profile has been discovered. The main objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve patients with refractory cutaneous lupus will be included. Lenalidomide will be started at 5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the end of follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Histologically proven cutaneous lupus erythematosus with or without associated systemic disease
* Presence of at least a grade II erythema as assessed by the validated modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
* Cutaneous lesions involving more than 18% of the body surface calculated according to the rule of the nines, or history of severe side effects or lack of efficacy following thalidomide therapy, in cutaneous lupus disease refractory to conventional treatment with antimalarials and topical steroids.
* No pregnancy or wish to become pregnant during the study period.

Exclusion Criteria:

* Pregnancy, breastfeeding or the use of not adequate contraception.
* Severe thrombocytopenia (\<30x10E9 cells/L) or leucopoenia (\<1500x10E9), known at least 30 days prior to the onset of the study,
* Previous history of arterial/venous thrombosis,
* Presence of antiphospholipid antibodies
* Presence of moderate-severe renal impairment (FG \<30 ml/min)
* Progressive renal disease.
* Lack of written informed consent prior to participation in the study.
* Presence of a concomitant systemic flare that may require other systemic treatments for its control
* Any psychiatric o social disease that may interfere with the study and follow-up
* HIV, B or C hepatitis
Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate

The aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX_IMF) vs infant milk formula with similar macronutrient, mineral and fatty acid composition but lower amounts of beta-palmitate (ST_IMF). Own mother milk (OMM) fed infants will serve as reference group.

A large number of low birth weight infants during their hospital stay experience poor growth and this has been linked to reduced neurodevelopment scores.

Several enriched infant milk formulas are available for preterm infants who cannot be fed human milk. The use of infant milk formulas (IMF) enriched with triglycerides similar to human milk lipids have shown to be associated with better fatty acid and mineral intestinal absorption.

In this multicenter, randomized, controlled clinical trial, preterm infants (gestational age lower than 32 weeks), who can not be fed human milk, will be randomized to receive IMF with high or low amounts of beta-palmitate (about 60% vs 10%, respectively). A non-randomized own human milk-fed group will be included as a reference. Patients will be on the study diet as soon as possible after birth and till 36 weeks of gestation. Neurodevelopment follow-up will be performed at 24 months corrected age.

Eligibility Criteria:
Inclusion Criteria:

* gestational age between 24 and 32 weeks of gestation at enrollment,
* birth weight greater than 750 grams,
* singleton or twin birth (no triplet or higher),
* fraction of inspired oxygen lower than 0.60 at enrollment,
* feasible enteral feeding,
* cardiovascular stable condition,
* informed consent form signed by at least one parent or legal guardian.

Exclusion Criteria:

* congenital malformations, genetic, metabolic and endocrine disorders,
* suspicious infection at enrollment,
* intrauterine growth restriction (\<10th centile) at enrollment,
* maternal diabetes requiring insulin therapy,
* neonatal asphyxia.
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)

The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients with NASH (Parts B and C).


Eligibility Criteria:
Inclusion Criteria:

* Part A Only

  * Has body mass index (BMI) ≥18 kg/m\^2 and ≤28 kg/m\^2
  * Has normal 12-lead electrocardiogram (ECG)
* Parts B and C Only:

  * Has BMI ≥18 kg/m\^2 and ≤40 kg/m\^2
  * Has a diagnosis of NASH documented in the patient's medical history or a clinical suspicion of NASH based on defined study criteria
  * Has screening liver biopsy with NASH activity score (NAS) score of ≥3 per NASH Clinical Research Network (CRN) criteria

Exclusion Criteria:

* Parts A, B and C:

  * Has any clinical safety laboratory result considered clinically significant and unacceptable by the Investigator
  * Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
  * Has known history or evidence of drug abuse, within 12 months prior to screening
  * Has evidence of other forms of known chronic liver disease
  * Has recently received an investigational agent
  * Has any uncontrolled or serious disease, medical or surgical condition that my interfere with participation or data interpretation
  * Has excessive alcohol intake for ≥ 3 months during past year
  * Has history of intolerance to SC injection(s)
  * Has international normalized ratio (INR) \>1.2
  * Has platelet count \<140x10\^9/L
* Part A Only

  * Has systolic blood pressure (BP) \>140 mmHg and diastolic \>90 mmHg;
  * Has used certain prescription drugs within last 14 days prior to screening
  * Has used certain over the counter (OTC) medication within 7 days prior to screening
  * Has estimated glomerular filtration rate (GFR) \<90 mL/min/1.73m\^2 at screening
* Parts B and C Only

  * Has abnormal ECG
  * Has changes in certain prescription medications defined in the protocol within the specified timeframe prior to screening
  * Has GFR\<45ml/min/1.73m\^2
the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris

a comparison of efficacy and adverse side effects occurrence of Doxycycline and Azithromycin in the management of moderate acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Between 18 to 30 year old
* Moderate facial Acne(At least 10 inflammatory lesions with maximum 3 nodules and pseudocysts

Exclusion Criteria:

* Pregnancy
* Breast Feeding
* Acne Fulminant
* Acne conglobate
* Isotretinoin therapy within past 6 months
* topical treatment in last 2 weeks
* use of systemic antibiotic in the last month
* Hyperandrogenism symptoms
* Menstrual irregularity
Management of Acute Appendicitis at District General Hospital

The Investigators aim to assess;

1. whether the changes in managing patients during COVID has reduced the negative appendicectomy rate?
2. compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis?
3. Whether there uniformity in prescribing postoperative antibiotics with resultant outcomes?
4. Whether the incidence of complicated appendicitis has increased?

As acute appendicitis is the most commonly managed emergency presentation for surgeons, the investigators aim to assess whether the changes in managing patients during COVID has reduced the negative appendicectomy rate, to compare the difference in outcomes of conservatively and surgically managed Acute Appendicitis? to assess whether there uniformity in prescribing postoperative antibiotics with resultant outcomes? to assess whether the incidence of complicated appendicitis has increased? This will be a single centre retrospective observational study. All the patients presenting in A\&E department with a diagnosis of acute appendicitis to be included. the only exclusion criteria are the age of participants for less than 5 years. The data will be analysed and calculated using SPSS version 23.

Eligibility Criteria:
Inclusion Criteria:

* All participants reporting in accident and emergency with a diagnosis of acute appendicitis irrespective of age above 5 years, gender and morbidities (this group for conservative management)

Exclusion Criteria:

* None
6 Minute Push & 30 Second Sprint Tests Reliability & Relationship to Fitness, Participation, & Environmental Assessments

The purpose of this study is to assess the relationship between physical fitness and wheelchair mobility capacity and 1) participation; 2) self-reported environments barriers; and 3) self-reported avoidance of environmental features.


Eligibility Criteria:
Inclusion Criteria:

* at least 1 year post-injury
* able to self-propel a manual wheelchair
* spinal cord injury between C5 and T5

Exclusion Criteria:

* spinal cord injury above C5 or below T5
* spinal cord injury severity of AIS D
* unstable angina or myocardial infarction within the past month
* resting heart rate \>120
* systolic blood pressure \>180 mm Hg, or diastolic blood pressure \>100 mm HG
Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)

A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any use of a CAPP device will be monitored to identify complications.

Providers will be surveyed twice at 4 and 8 months using open ended methods.

Eligibility Criteria:
Inclusion Criteria:

* Any patient receiving CAPP during study period.

Exclusion Criteria:

* None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.
Rehab in Mild Stable DCM: Feasibility RCT Comparing Structured Rehabilitation to Clinical Surveillance

The goal of this feasibility RCT is to establish the feasibility of undertaking a RCT investigating the effectiveness of a multi component structured rehabilitation intervention aiming at reducing physical disability in people with mild stable Degenerative Cervical Myelopathy. The main question it will answer are what is the incidence of mild stable DCM in the neurosurgical OPD clinics, what is the eligibility rate and participate rate of those eligible. It will also investigate the acceptability of the intervention to both participants and clinicians and participant retention.

Researchers will compare a structured rehabilitation intervention to clinical surveillance. The structured rehabilitation intervention will include education, a physical activity behavioural change intervention, cervical range of motion exercises, neck, upper limb and scapular strengthening exercises and task specific hand function training.


Eligibility Criteria:
Inclusion Criteria:

* • Diagnosis of DCM (Clinical symptom of DCM +/- Upper motor neuron sign + imaging evidence of cervical cord compression). Diagnosis will be confirmed by a consultant neurosurgeon (19).

  * Modified Japanese Orthopaedic assessment (mJOA) score of 15-17, indicating mild DCM. The mJOA is a clinician administered validated measure of DCM severity (20)
  * Adequate comprehension of English to understand the purpose of the study and give written informed consent

Exclusion Criteria:

* Patient or surgeon preference for urgent surgical decompression for progressive DCM, motor radiculopathy or severe unrelenting radicular arm pain or significant risk factors for progression including co-existing cervical radiculopathy and circumferential cord compression.

  * Diagnosis of other neurological condition that could confound assessment.
  * Involvement in another clinical study or trial
  * Pregnancy
  * If the participant is unable to commit to a 12-week programme of up to 10 sessions of supervised rehabilitation and participating in a regular home exercise programme for the duration of the study.
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS

To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy

The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of MTP-I on hepatic fat accumulation.

Eligibility Criteria:
Inclusion Criteria:

1. LDL-C between 100 and 190 mg/dL
2. Hepatic fat under 6.2% per MRS

Exclusion Criteria:

1. Pregnant or lactating females
2. Uncontrolled hypertension \>180/95 mmHg
3. Chronic renal insufficiency - serum creatinine \>2.5 mg/dL at screen
4. Liver disease; i.e., hepatitis, cirrhosis
5. Major surgery within 3 months of screen
6. Cardiac insufficiency
7. Hx of malignancy other than basal or squamous cell within past 5 yrs
8. Participation in any investigational drug study within 6 wks of screen
9. Prior exposure to AEGR-733 in past 12 months
10. Serious or unstable medical or psychological conditions
11. More than one alcoholic drink per day
12. Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4
13. Currently taking corticosteroids
14. Other lipid-lowering meds (washout permitted)
15. Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted)
16. Acute CVD or event within previous 6 months
17. Diabetes Mellitus
18. Hepatitis B or C
19. Medicated COPD
20. Idiopathic pulmonary fibrosis
21. G.I. disorders that cause chronic diarrhea
22. Fasting triglycerides =/\> 400 mg/dL
23. Body Mass Index \> 35kg/m2