cyrilzakka/clinical-trials huggingface dataset:
Weaning Preterm Infants at 1500 Grams From Incubators

Background: The weight at which infants are weaned from incubators varies among neonatal units.

Objective: To determine the effect on weight gain, temperature stability and resting energy expenditure (REE) of weaning infants at body weight of 1500 g versus 1600 g.

Design/Methods: infants will be randomized to incubator weaning at the weight of 1500 g or 1600 g. Preterm infants 1500 g birth weight, fully enterally fed, and without supplemental oxygen, at the postnatal age of 2 weeks will be included. Infants will be weaned to a warming bassinet (Babytherm 8000, Dräger) set to keep a mattress temperature of 37°C while decreasing it gradually to room temperature. Failure to wean is defined as core body temperature of \< 36.1°C. Data collection included skin and rectal temperature obtained before weaning, and at 1/2, 1, 2, 6, 24, and 48 hours after weaning, weekly weight gain (g/kg/d). REE (kcal/kg/24h) will be measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after weaning.

Eligible infants will be randomized by computer generated random numbers, to either the study group weaned at 1500 g or the control group weaned at 1600 g. Both groups will be weaned to a warming bassinet (Babytherm 8000, Drager). The Babytherm 8000 WB is an open care infant warming system with a warmed gel mattress with temperature control . The system is set to keep the mattress temperature of 37 degrees Celsius while decreasing it gradually to 32 0C and shutting the system off. On transfer to the Babytherm infants are dressed with a hat and two vests. Only after the infant maintained a normal body temperature under these conditions he could be transferred to an open bassinet. Failure to wean was defined as core body temperature of \<36.10C.

Data collection included skin and rectal temperature obtained before weaning, and at 1/2, 1, 2, 6, 24, and 48 hours after weaning, daily and weekly weight gain (g/kg/d). Resting Energy Expenditure- REE (kcal/kg/24h) is measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after weaning to the warming bassinet.

Data Collection included: PR temperature after 30 min, 60 min, 2 hours, 6 hours, 24 hours, after which temperatures were taken 4-hourly until 48 hours (degrees C), skin (axillary) temperature (degrees C), after 30 min, 60 min, 2 hours, 6 hours, and than again every 4 hours until 48 hours. REE (kcal/kg/24h)rate of hypothermia requiring return to the incubator, weight gain after 24 hours of weaning and over 1 week.( g/kg/d),time to discharge ( days).

Eligibility Criteria:
Inclusion Criteria:

* stable preterm infants weighing ≤1500 g
* fully enterally fed, and without supplemental oxygen
* steroid or antibiotics treatment
* at the postnatal age of ≥ 2 weeks were included
* infants \< than 2 weeks of age

Exclusion Criteria:

* ventilated infants or those requiring oxygen supplementation
* parenteral nutrition
* antibiotic treatment or steroids treatment were excluded
BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population.

This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no intervention in study drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \>/= 2 months of age through 16 years of age
* A parent/caregiver must sign an informed consent
* Patient must provide assent, as appropriate based on local institutional review board guidelines

Exclusion Criteria:

* Patients presenting with the following conditions:

  * exacerbations of cystic fibrosis (CF)
  * meningitis
  * Brain abscess
  * bacterial endocarditis,
  * Bone and joint infections
* having any of the following conditions but lacking a personal history may be admitted to the trial:

  * Arthritis
  * Juvenile rheumatoid arthritis (JRA)
  * Rheumatoid arthritis (RA)
  * Systemic lupus erythematosis (SLE)
  * History of rheumatic fever
  * Psoriasis
  * Inflammatory bowel disease
  * Osteoarthritis (OA)
* Known underlying rheumatological disease, joint problems known to be associated with arthropathy.
* Patients with any pre-treatment baseline musculoskeletal exam abnormalities
* Known risk of experiencing seizures, a history of any convulsive disorders
* Requiring any concomitant therapeutic course of systemic antibacterial agent
* Participation in any industry-sponsored clinical drug development study within one month prior to this study
* Known significant liver impairment (ALAT/ASAT and/or baseline bilirubin \> 3 times upper limit of normal)
* Known significant renal insufficiency (calculated creatinine clearance of \< 30 ml/min/1.73 m²)
* Are pregnant or lactating, or are sexually active and using unreliable contraception.
Laryngeal Mask Airway in Laparoscopic Hernia Repair

This prospective randomized study will evaluate the effectiveness of laryngeal mask airway (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal hernia at CMH.

This study aims to evaluate the effectiveness during general anesthesia of laryngeal mask airway versus endotracheal tube for laparoscopic inguinal hernia repair. There are limited pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures compared with traditional endotracheal intubation. This study aims to add to this literature in providing information comparing the two techniques. The rationale for this study is to show that general anesthesia with laryngeal mask airway is an effective and non-inferior technique compared with general anesthesia with endotracheal intubation in pediatric patients undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency of care and respiratory complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic inguinal hernia repair.
* Ages 12 months to 8 years of age
* American Society of Anesthesiologists Physical Status Classification ASA 1 or 2
* ASA 1- A normal, healthy patient
* ASA 2- A patient with mild systemic disease
* Elective with appropriate NPO status
* English speakers
* Spanish speakers

Exclusion Criteria:

* Patients with current gastroesophageal reflux
* Obesity (CDC \>= 95th %ile)
* Contraindications to study protocol medications
Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV)

The purpose of this study is to assess the optimal dose of EBP921 by comparing the efficacy and safety of 2 dose regimens in patients with chronic HDV.

This is an open-label, phase 1b, proof-of-concept study to assess the safety and efficacy of EBP921, a prenylation inhibitor, in subjects chronically infected with delta hepatitis. Subjects will be randomized to receive one of two different doses of EBP921. Dosing will occur over 28-days and during that time, evidence of antiviral response will be assessed by frequent measurements of HDV-RNA via PCR assay. In addition, safety lab data will also be collected along with surveillance monitoring of HBV activity.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 18 or older with the capacity to give written informed consent
2. Patients with compensated chronic HDV infection as indicated by presence of anti-HDV in serum.
3. Liver biopsy should be performed within one-year of study screening and graded using the Knodell scoring system.
4. Presence of HDV antigen in liver tissue or HDV-RNA in serum.
5. Active HBV replication will not exclude patients.
6. Previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
7. Patients who are HBV therapy-naïve or who previously received HBV antiviral therapy will be eligible. Patients currently taking HBV antiviral therapy will e considered on a case basis.
8. Female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of EBP921 dosing.

Exclusion Criteria:

1. Severe neuropsychiatric disorders
2. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
3. Pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
4. Underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, HIV antibody positive, AIDS)
5. Chronic (\> 4 weeks duration) diarrhea
6. Body weight \> 128 kg and \< 40 kg
7. Uncompensated cirrhosis
8. Absolute neutrophil count less than 1500 per cubic millimeter
9. Platelet count less than 90,000 per cubic millimeter
10. Evidence of concurrent HCV infection with positive serum HCVRNA
11. Evidence of hepatocellular carcinoma
12. Active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
13. Diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
14. Any experimental therapy in the previous 6 months prior to enrollment.

16. Patients with a history of multiple drug resistant HBV 17. Patients receiving interferon therapy for any reason.
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.


Eligibility Criteria:
Inclusion Criteria:

* From 18 to 85 years of age
* Present with symptoms consistent with an acute ischemic stroke for revascularization within 8 hours from symptom onset
* Refractory to or not eligible for IV rtPA therapy., e.g., presenting between 0 and 3 hours from symptom onset AND contraindicated for IV rtPA, or presenting between 3 and 8 hours of symptom onset, or evidence of persistent occlusion from vascular imaging after IV rtPA
* Evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation
* NIH Stroke Scale (NIHSS) score 8 or more points
* Signed informed consent

Exclusion Criteria:

* History of stroke in the past 3 months.
* Females who are pregnant
* Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or higher
* Known severe allergy to contrast media
* Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
* CT evidence of the following conditions at randomization:

  * Significant mass effect with midline shift
  * Large infarct region \>1/3 of the middle cerebral artery territory
  * Evidence of intracranial hemorrhage
* Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
* Angiographic evidence of preexisting arterial injury
* Rapidly improving neurological status prior to enrollment
* Bilateral stroke
* Intracranial tumors
* Known history of cerebral aneurysm or arteriovenous malformation
* Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>1.7
* Baseline platelets \<50,000
* Use of IV heparin in the past 48 hours with PTT \>1.5 times the normalized ratio
* Baseline glucose \<50mg/dL or \>300mg/dL
* Life expectancy less than 90 days prior to stroke onset
* Participation in another clinical investigation that could confound the evaluation of the study device
The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD

To determine if the NMDA antagonist, CP-101,606, is effective for depression


Eligibility Criteria:
Inclusion Criteria:

* Primary DSM-IV diagnosis of MDD

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over 2 years.

Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate
* Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before. In case of incompatibility with methotrexate, Humira can be used as monotherapy

Exclusion Criteria:

* Hypersensitivity against the drug or one of the other ingredients
* Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
* Moderate to severe cardiac insufficiency
Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Laparoscopic Bariatric Surgery.

This randomized study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation and pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery.

Dexmedetomidine is an α -2 adrenergic agonist that has been proven to attenuate the hemodynamic response to intubation and pneumoperitoneum along with dose sparing effect on opioids and propofol .It has been used in multiple routes such as intravenous, intramuscular, oral, nasal, or intrathecal routes .Inhalation of nebulized drug is noninvasive and associated with high bioavailability .Nebulized Dexmedetomidine may offer an attractive alternative to both intravenous as well as intranasal routes of administration because drug deposition following nebulization takes place over nasal, buccal, as well as respiratory mucosa.

Eligibility Criteria:
Inclusion Criteria:

* This study will include 90 adult morbidly obese patients of both sex with BMI (40-50), (ASA) III physical status, aged between 18 -50 years scheduled for elective laparoscopic bariatric surgery under general anesthesia.

Exclusion Criteria:

1. Patient's refusal.
2. Decompensated hepatic or renal or cardiac disease.
3. Expected difficult airway management.
4. Uncontrolled hypertension.
5. Psychiatric disease.
6. Sever pulmonary disorders.
7. Patients on opioid, alcohol, beta-blockers or allergy to any of the study drugs.
Venetoclax Combined With Azactidine in the Treatment of ALAL

The prognosis of acute leukaemias of ambiguous lineage is poor. The effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. Therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. Venetoclax can significantly improve the remission rate and prolong PFS and OS. At present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly AML patients. It also shows a high response rate in relapsed/refractory AML or MDS patients. There are few clinical studies on the treatment of ALAL. The purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed ALAL patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 15 and ≤ 65 years.
2. Patients diagnosed with ALAL according to 5th edition of WHO Acute Leukaemias of Ambiguous Lineage diagnosis standard.
3. New diagnosed patients.
4. ECOG performance status score less than 3.
5. Expected survival time #3 months.
6. Patients without serious heart, lung, liver, or kidney disease.
7. Ability to understand and voluntarily provide informed consent.

Exclusion Criteria:

1. Patients who are allergic to the study drug or drugs with similar chemical structures.
2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
3. Active infection.
4. Active bleeding.
5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
6. Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
7. Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
8. Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
9. Surgery on the main organs within the past six weeks.
10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
11. Patients who have received organ transplants (excepting bone marrow transplantation).
12. Patients not suitable for the study according to the investigator's assessment.
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System

Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.

Obstructive Sleep Apnoea (OSA) is a condition characterised by partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit.

Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up.

The purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.

Aim

* To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
* To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use

Eligibility Criteria:
Inclusion Criteria

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients being treated for OSA for \>6 months
* Patients using a ResMed nasal mask system
* Patients who can trial the trial mask for 7 nights

Exclusion Criteria

* Patients not willing to give written informed consent
* Patients who can not read and comprehend English
* Patients being treated for OSA for \<6 months
* Patients using an inappropriate mask system
* Patients using Bilevel flow generators
* Patients who are not using CPAP between 7 and 13 cmH2O
* Patients who are pregnant
* Patients who cannot trial the trial mask for 7 nights
* Patients with a hearing impairment
Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in Patients With Sore Throat Due to a Common Cold.

This study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sore throat due to an upper respiratory tract infection, with recent onset (within 48 hours)
* Sore throat of at least moderate pain intensity

Exclusion Criteria:

* - History of hypersensitivity to any of the study drugs and listed excipients or to drugs of similar chemical classes
* Evidence of mouth breathing or severe coughing
* Evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower respirator tract infection
* Severe renal, liver or cardiac impairment
* Severe lung disease