cyrilzakka/clinical-trials huggingface dataset:
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids

The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.


Eligibility Criteria:
Inclusion Criteria include:

* Male and female patients aged 6 to 16 years, inclusive, who are expected to require ongoing around-the-clock opioid treatment equivalent to at least 20-mg daily dose of oxycodone for at least 2 weeks for management of moderate to severe (based on the investigator's judgment) malignant or nonmalignant pain.
* Patients must be opioid tolerant, ie, have been treated with opioids for at least the 5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the equivalent during at least the last 48 hours prior to the start of study drug dosing and have tolerated the therapy, as demonstrated at the start of study drug dosing.
* Patients who are currently using transdermal fentanyl should have been on the patch for at least 3 days before removing the patch and oxycodone hydrochloride (HCl) controlled-release (CR) treatment can only be initiated at least 18 hours following the removal of the transdermal fentanyl patch.
* Patients must not require more than a 240-mg total daily dose of oxycodone HCl CR tablets.
* Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.
* Patients must not be currently on an investigational medication/therapy at the start of screening or during the study.

Exclusion Criteria include:

* Female patients who are pregnant or lactating.
* Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects \[eg, nausea, constipation\]).
* Patients who have received epidural opioids \< 2 hours prior to the first dose of study drug or who have received epidural morphine \< 12 hours prior to the first dose of study drug.
* Patients who are contraindicated for the use of opioids.
* Patients who are contraindicated for blood sampling.
* Patients who are currently being maintained on methadone for pain.
* Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices.
* Patients who have had surgery within 5 days prior to Day 1 (day of first dose of study drug).
* Patients who, in the investigator's opinion, have an underlying gastrointestinal condition or other disorder that may predispose them to obstruction.

Other protocol-specific inclusion/exclusion criteria may apply.
Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture

In this project, volunteers will be recruited to cool the superficial skin of the axillary brachial plexus away from the puncture point, resulting in local peripheral nerve cooling, and observe its impact on the pain of arterial puncture.To explore the local peripheral nerve cooling treatment can produce controllable and reversible analgesic effect even if away from the wound, and provide a new nonpharmaceutical analgesic mode for clinical.

Arterial puncture is a common cause of iatrogenic pain and anxiety, which can lead to stress and arterial spasm, leading to puncture failure.Clinicians usually use pharmacology to treat acute pain, but it is often accompanied by circulatory and respiratory depression, abnormal coagulation function, edema, pruritus, nausea, vomiting, constipation, addiction, etc., which can lead to death, and doctors strictly restrict the use of indications.In addition to drugs, electrical, light, mechanical or thermal stimulation can produce local reversible blocking effect of the peripheral nerve.Temperature is a simple, controllable and reversible physical factor.Current studies have shown that cooling the peripheral nerve to 10-15°C for 10 minutes can relieve pain, and numbness can occur after 15 minutes.These results suggest that cooling the peripheral nerve of sensory innervation in the remote trauma area can reduce nerve conduction velocity and signal amplitude, and provide a new method for non-pharmaceutical analgesia.Local peripheral nerve cooling therapy is an attractive approach to blocking nociceptive information because it is non-addictive, reversible, and allows simultaneous electrophysiological monitoring of the blocked nerve.In this project, volunteers will be recruited to cool the superficial skin of the axillary brachial plexus away from the puncture point, resulting in local peripheral nerve cooling, and observe its impact on the pain of arterial puncture.To explore the local peripheral nerve cooling treatment can produce controllable and reversible analgesic effect even if away from pain stimulation, and provide a new nonpharmaceutical analgesic mode for clinical.

Eligibility Criteria:
Inclusion Criteria:

1. 18 \~ 65 years old;
2. ASA I-II level;
3. Patients with perioperative invasive arterial blood pressure monitoring;
4. Right-handed;
5. Allen test was normal (palm color quickly turned red or returned to normal within 10 seconds after release of ulnar artery pressure);
6. Participate voluntarily and be able to understand and sign informed consent.

Exclusion Criteria:

1. Patients with a history of musculoskeletal, vascular, neurological or psychiatric disorders;
2. Patients with a history of diabetes or other systemic diseases
3. Patients who used any analgesic medication within the month before and during the study;
4. Patients with a history of smoking, alcohol or drug addiction;
5. Paraesthesia, scar, redness, damage, rash, etc. exist in the skin of the patient in the test area;
6. Patients whose surgical area overlaps with the cooling treatment or puncture area;
7. Female subjects are menstruating.
Cataract Surgery: Femto LDV Z8 Versus Conventional

The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract surgery.

Cataract Surgery according to conventional procedure, with the exception of two steps (Capsulotomy and Lens Fragmentation) which are performed with a Femtosecond Laser in the study group. Used equipment for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment (group A) Cataract surgery will be performed conventionally, this means the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification. (group B)

Eligibility Criteria:
Inclusion Criteria:

* Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens Implantation
* Able to co-operate with the docking system for the femtosecond laser
* Clear corneal media
* 50 years of age or older
* Willing and able to return for scheduled follow-up examinations

Exclusion Criteria:

* Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
* Maximum K-value that exceeds 58D
* Minimal K-value of less than 37D
* Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
* Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
* Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
* Known sensitivity to planned concomitant medications
* History of lens or zonular instability
* Keratoconus or keratectasia
* Immune compromised or diagnosis of connective tissue disease, clinically sign. atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study PI.
* Anterior chamber depth (ACD) \< 1.5 mm or ACD \> 4.8 mm as measured from the corneal endothelium.
* Extensive corneal scarring
* Developmental disability or cognitive impairment (would preclude adequate comprehension of the Informed Consent (IC) form and/or the ability to record the study measurements)
* Concurrent participation in another ophthalmological clinical study
Extension Study in a Cohort of Adult Patients With COVID-19 Infection

The main objective of this study is to evaluate the incidence of post-COVID morbidity and characterize the complications profile in patients who participated in the APLICOV-PC study. APLICOV-PC study was a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin (1,5 mg, 2,0 mg and 2,5 mg) administered three consecutive days, in adult patients with confirmed diagnosis of COVID-19 who require hospital admission.

The APLICOV-PC proof of concept study demonstrated the antiviral activity of plitidepsin in terms of reducing viral load, inducing recovery, and impact on lymphocyte reconstitution and other inflammatory parameters.

A percentage of patients, which varies between 10 and 25%, continue to show symptoms at 3 months after contracting the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection: For some of them this significantly restricts their life, requiring them to take long-term sickness leave from work, and leaving them with sequelae that may continue for more than one year.

With this study, Pharmamar intends to evaluate whether the treatment with plitidepsin, by attaining a reduction in the viral load and a faster recovery of the patient, could have a relevant impact on the emergence of sequelae resulting from the SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patient who participated in the APLICOV-PC study receiving treatment with plitidepsin and who gives consent.

Exclusion Criteria:

* There are no exclusion criteria for this study.
Intra-venous Zoledronic Acid Once Yearly

The study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patient is an ambulatory female 45 years of age or older
* Postmenopausal women with diagnosis of osteoporosis
* Prescription of zoledronic acid or any OBP as per the current Canadian monograph
* Must provide informed consent

Exclusion Criteria:

* Any prior use of iv bisphosphonates within the last 2 years
* Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease)
* Metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia..
* Non-corrected hypocalcaemia at the time of zoledronic acid infusion
* Creatinine clearance \< or = 30 ml/min
* Unwillingness or inability to comply with the study requirements
* Concurrent participation in a clinical trial of an investigational drug, or within the last 30 days

Other protocol-defined inclusion/exclusion criteria may apply.
DECIDE-HF: Heart Rate Variability in Heart Failure Patients

The purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed and dated the study-specific informed consent form
* Subject is 18 years of age or older
* Subject is expected to remain available for follow-ups
* Subject is able and willing to comply with the protocol requirements
* Subject has predominant Normal Sinus Rhythm
* Subject has systolic Heart Failure and is at the moment of enrollment in NYHA class II or III and has an ejection fraction of less then 40%
* Subject has had a HF-related hospitalization in the past 12 months

Exclusion Criteria:

* Subject needs permanent atrial pacing (\> 10%)
* Subject has intermittent 2nd or intermittent 3rd degree block
* Subject has persistent or permanent AF
* Subject has Long QT syndrome, Brugada syndrome, Jervell and Lange- Nielsen syndrome, Romano-Ward syndrome, Andersen-Tawil syndrome or Timothy's syndrome
* Subject has had recent (\<2 months) acute coronary syndrome
* Subject has had recent (\<2 months) revascularization
* Subject has a pending cardiac transplant or revascularization
* Subject has severe stenotic valvular heart disease
* Subject has severe pulmonary (forced expiratory volume in 1 s \< 1 L) hepatic or renal (plasma creatinine \> 0.2 mmol/L) disease
* Subject is participating in another study that may affect the results of this study
CORAL XT - Open-label Extension Trial of the CORAL Trial

The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.

The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed indicating that the participant understands the purpose of and procedures required for the trial and is willing to participate in the trial.
* Participants must be at least 18 years of age at the Enrollment Visit.
* Women of childbearing potential must have a negative pregnancy test at enrollment and must not be lactating at the Enrollment Visit.
* Participants must be willing to use medically acceptable and highly effective methods of birth control.
* Participants who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.

Exclusion Criteria:

* The participant has a clinically significant disease or condition other than cancer which in the investigator's opinion may affect efficacy or safety assessments.
* Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
* Participants taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment.
* History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia).
* Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial.
* Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.
DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer.

OBJECTIVES: I. Determine the objective tumor response rate, duration of response, and time to disease progression in patients with metastatic colorectal cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at end of study treatment. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cancer of the colon or rectum Clinical evidence of metastatic disease Failed 1 prior chemotherapy regimen for metastatic disease Measurable disease No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No unstable or serious concurrent medical condition No concurrent serious infection requiring parenteral therapy No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Other cancer curatively treated with surgery alone that has not recurred for more than 5 years No psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen for metastatic disease No prior taxanes At least 28 days since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At least 28 days since prior large-field radiotherapy and recovered No concurrent radiotherapy Surgery: At least 14 days since prior major surgery and recovered
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.


Eligibility Criteria:
Inclusion Criteria:

* Participant is currently taking a statin medication for the treatment of high cholesterol
* Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl

Exclusion Criteria:

* Women who are pregnant or nursing, or women who intend to become pregnant
* Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study
A Research Study, Looking at How NovoMix® Works in People With Type 2 Diabetes in Local Clinical Practice in Algeria

The purpose of the study is to collect information about how NovoMix® 30 works in real world adult population with type 2 diabetes. Participants will get NovoMix® 30 as prescribed by the study doctor. The study will last for about 6-8 months. Participants will be asked questions about their health and their diabetes treatment as part of their study doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available NovoMix® 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
* Male or female, greater than or equal to 19 years at the time of signing informed consent
* Diagnosed with type 2 diabetes and treated with basal insulin plus 1-3 bolus insulin injections per day for at least 24 weeks prior to informed consent
* Available and documented HbA1c value less than or equal to 12 weeks prior to initiation of NovoMix® 30 treatment

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Participation in any clinical trial of an approved or non- approved investigational medicinal product within 24 weeks prior to initiation of NovoMix® 30 treatment. Clinical trials do not include non-interventional studies
* Hypersensitivity to NovoMix® 30 or to any of the excipients
* Pregnancy or intention of becoming pregnant
Early Oral Immunotherapy in Infants With Cow's Milk Protein Allergy

Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%.

The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions.

Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited.

The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.


Eligibility Criteria:
Inclusion Criteria:

• children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels)

Exclusion Criteria:

* children with not IgE-mediated clinical manifestations
* children with a known immunodeficiency
High Risk Multiple Gestation Study

The objectives of the clinical study are to demonstrate the accuracy of our proprietary algorithm method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than other currently available screening tests.

This will result in fewer unnecessary amniocenteses and Chorionic Villus Sample (CVS) procedures, which are associated with a risk of miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older at enrollment
* Clinically confirmed multiple gestation pregnancy
* Pregnancy at high risk for genetic aneuploidy as defined below:

  * Confirmed positive aneuploidy by invasive testing
  * Non invasive prenatal testing "high risk" result
  * Serum screening risk of greater than 1:100
  * Ultrasound abnormalities indicative of aneuploidy

    * Structural abnormality of the posterior fossa
    * Holoprosencephaly
    * Structural cardiac anomaly
    * Omphalocele
    * Nuchal translucency greater than or equal to 3.5 mm or a nuchal fold greater Hydrops of unknown etiology
  * Age ≥ 38 years at delivery (if serum screening risk is not less than 1:100)
* Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate
* Able to provide informed consent

Exclusion Criteria:

* Women carrying singleton pregnancy
* Surrogate or egg donor used