cyrilzakka/clinical-trials huggingface dataset:
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.

Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Female/male of at least 40 years of age
* Patient diagnosed with COPD
* Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).
* Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).
* Signed declaration of consent

Exclusion Criteria:

* The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.
* Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.
* Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.
* Patient is participating in a clinical trial.
COMT on Aspirin Platelets Effects (CAPE)

Specific Aim I: Examine the role of genetic variation in COMT on platelet function in a blinded, randomized, placebo controlled clinical trial of daily placebo or Aspirin (81mg) for 10 ± 3 days. Platelet function will be assessed with platelet aggregometry and by fluorescence-activated cell sorting (FACS) of platelet adhesion molecules P-selectin and GPIIb/IIIa in platelets activated with arachidonic acid, thrombin, collagen, epinephrine and ADP.

Specific Aim II: Examine the effects of platelet releasates harvested at the end of each treatment arm on angiogenesis.

This is a randomized double-blinded, placebo controlled study. This study is designed to detect the variation in platelet function based on COMT variation and how these platelets respond to cancerous cells.

We expect to recruit 60 healthy participants with the intention of studying 45 participants to complete the protocol.

Individuals aged 18 to 40 years will be eligible to participate in this study if they do not have history of fainting/problems related to blood draws, major chronic medical illnesses, regular or current treatment of Aspirin™.

Examine the role of genetic variation in in catechol-O-methyltransferase (COMT) on platelet function in a randomized double-blinded placebo controlled clinical trial of daily Aspirin™ (81 mg) versus placebo over 10-14 days. Platelet function will be assessed with a platelet aggregometry and by fluorescence-activated cell sorting assessment of platelet adhesion molecule GPIIIb/IIIa and p-selectin.

Eligibility Criteria:
Inclusion Criteria:

* healthy, 18-40 years

Exclusion Criteria:

* taking aspirin. Smoking, pregnancy, history of cancer of cardiovascular disease. Mental illness.
A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate

The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive detection, complications, pain level, operation time and costs et al.


Eligibility Criteria:
Inclusion Criteria:

* prostate-specific antigen \> 4ng/ml
* Palpation is positive

Exclusion Criteria:

* older than 80y
* prostate-specific antigen \> 100 ng/ml
LFMT vs Placebo in New Biologic Start for Ulcerative Colitis

To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.

This is dual-center, randomized, double-blind, placebo-controlled pilot trial for UC patients with active disease who are being initiated on treatment with vedolizumab or ustekinumab.

The study will recruit 40 outpatients at 2 Canadian healthcare centres at the University of Alberta Hospital (University of Alberta), and the Hamilton Health Sciences (McMaster University).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older but less than 75 years of age
2. Able to provide informed consent
3. Established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria
4. Active UC defined as total Mayo score between 6-12 AND Mayo endoscopic sub-score \>1 with disease that extends 15 cm or more from the anal verge
5. Selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. Patients must be:

   * Biologic naive; OR
   * Have failed anti-TNF, anti-integrin, anti IL12/23 or oral small molecules
6. Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
7. Willing and able to comply with all required study procedures

Exclusion Criteria:

1. Severe UC requiring hospitalization
2. Indeterminate colitis
3. Evidence of or treatment for C difficile infection or other intestinal pathogen, including CMV, within 4 weeks prior to enrollment
4. Evidence of toxic megacolon or gastrointestinal perforation on imaging
5. Abdominal surgery within the past 60 days

   * Neutropenia with absolute neutrophil count \<0.5 x 109/L
   * Peripheral white blood cell count \> 35.0 x 109/L and fever (\>38 degrees Celsius)
   * Planned or actively taking another investigational product
   * Uncontrolled medical conditions such as psychiatric disorders or substance abuse
   * Severe underlying disease such that the patient is not expected to survive for at least 30 days
6. Pregnant or lactating
7. Unwilling to discontinue non-dietary probiotic
8. Antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study
9. FMT within 3 months prior to enrollment
10. Use of the following medications:

    1. rectal/topical therapy within 2 weeks of screening
    2. cyclosporine, tacrolimus or thalidomide within 4 weeks of screening
    3. tofacitinib within 4 weeks of screening
    4. adalimumab or infliximab within 8 weeks of screening
    5. vedolizumab within 8 weeks of screening
    6. ustekinumab within 12 weeks of screening
    7. prednisone \> 30 mg/d
11. Investigator deems enrolment in the study is not in the best interest of the patient
Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan

To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
* Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
* Female subjects required to be adequately protected against pregnancy.

Exclusion Criteria:

* pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias, heart failure, significant ECG abnormalities, and uncontrolled hypertension.
* Any significant systemic, organ, neurological, endocrine, metabolic, and psychological disorders reported by the patient or discovered during the physical examination
* Subjects considered to have atypical migraine such as frequent attacks, prolonged aura or any migraine that was considered atypical.
* Subjects who, during the course of the trial, required treatment with sumatriptan or any other 5-HT1B/1D agonist in addition to study medication.
Iron Absorption From Encapsulated Iron Sulphate in Microspheres

Food fortification has shown to be efficacious to alleviate the burden of micronutrient deficiencies. Ensuring the bioavailability of iron and maintaining the sensory quality and stability of the fortified food and other added micronutrients remains a challenge. Soluble iron compounds cause minor organoleptic changes in foods but their bioavailability in man is rather low. Water-soluble iron compounds, such as ferrous sulphate (FeSO4), are the compounds in which the iron is most bioavailable; however, they often cause unfavorable sensory changes.

Encapsulation of iron has excellent potential for overcoming unwanted sensory changes and iodine losses in salt, while maintaining acceptable bioavailability. In the present project, we would like to investigate the iron bioavailability from a new formulation of encapsulated iron sulphate based on hyaluronic acid (HA) and a polymer from the eudragit family.


Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 40 years old
* Marginal iron status (PF \<25 ng/ml)
* Body weight \< 65 kg
* Normal body Mass Index (18.5 - 25 kg/m2)
* Signed informed consent

Exclusion Criteria:

* Pregnancy (assessed by a pregnancy test) / intention to become pregnant
* Lactating up to 6 weeks before study initiation
* Moderate or severe anaemia (Hb \< 9.0 g/dL)
* Elevated C reactive Protein (CRP) (\> 5.0 mg/L)
* Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
* Continuous/long-term use of medication during the whole study (except for contraceptives)
* Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
* Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
* Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
* Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate

Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate


Eligibility Criteria:
Inclusion Criteria:

1. Child diagnosed with CPP who has a peak-stimulated Lutenizing Hormone(LH) concentration over 5 IU/liter before initiation of therapy
2. Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys.
3. Tanner stage ≥2
4. Advanced bone age (Bone Age/Chronological Age \>1.1)
5. Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures

Exclusion Criteria:

1. Patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion
2. Patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition
3. Currently on or planning growth hormone treatment
4. Previous Gonadotropin-Releasing Hormone agonist treatment
5. Any patient who in opinion of the investigator should not participate in the study
NeisVac-C Single Prime Study in Infants

The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an infant aged 8 to 11 weeks at the time of first vaccination
* Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination
* Subject was born at full term of pregnancy (\>= 37 weeks) with a birth weight \>= 2 kg
* The parent(s) or legally authorized representative of the subject provides written consent for participation
* The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol
* The parent(s) or legally authorized representative and the subject will be available for the duration of the study
* The parent(s) or legally authorized representative of the subject agrees to keep a subject diary

Exclusion Criteria:

* Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines
* Subject has had an acute or chronic infection requiring systemic therapy (antibiotic or antiviral) or other prescribed treatment within the 2 weeks prior to the first vaccination in this study
* Subject has a rash or dermatologic condition which may interfere with injection site reaction rating
* Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder
* Subject has a disease, or is currently undergoing a form of treatment, or was undergoing a form of treatment within 30 days prior to study entry, that could be expected to influence immune response
* Subject has received any blood products or immunoglobulins within 60 days of study entry
* Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination
* Subject has previously been vaccinated against meningococcal C disease
* Subject has a known or suspected immune dysfunction
* Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.)
* Subject was administered an investigational drug within six weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
* Subject or his/her parent(s) / legally authorized representative are in a dependent relationship with the study investigator or with a study team member; dependent relationships include close relatives (i.e. children, partner/spouse, siblings) as well as employees of the investigator or site conducting the study
Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18-40 years of age
* Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
* Moderate or severe pain within 6 hours of completion of surgery

Exclusion Criteria:

* Other oral surgical procedures during the same session except the removal of supernumerary third molars
* Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
* Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
* Allergy to shellfish

Additional Inclusion/Exclusion Criteria May Apply
Virtual Reality and Fatigue Education

It was planned to evaluate the effect of distraction intervention with virtual reality and fatigue education on the level of fatigue and anxiety in children with cancer.

H1: The fatigue scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.

H2: The anxiety scores of the patients who received distraction intervention with virtual reality and were given fatigue training were lower than the group that was given only fatigue training.

Data collection After the child and his family are informed about the study, their written informed consent will be obtained. All children included in the study on the day (day 0) prior to the start of chemotherapy treatment will be given training on fatigue. In order to determine how he felt and his level of fatigue on the day of the training, it was planned to apply the Child Anxiety Scale-State (CAS-D), Child Fatigue Scale-24 Hours and Visual Fatigue Scale at 16.00 (pretest).

After randomization is achieved, a distraction intervention will be applied once a day for 10-15 minutes with virtual glasses on the 1st, 2nd and 3rd days of the chemotherapy treatment of the children in the study group. This intervention is planned to take place between 14.00-15.00 in the afternoon.

Eligibility Criteria:
Inclusion Criteria:

* Be between 7-18 years old
* Inpatient chemotherapy treatment for more than three days
* 4 weeks over the time of diagnosis (not in the induction phase)
* Having a hemoglobin level above the criteria for transfusion of blood products (8 mg/dl for hematological malignancies, below 7 mg/dl for oncological malignancies).
* The child voluntarily agrees to participate in the study and consent is obtained from the child and parent

Exclusion Criteria:

* Being in terminal period
* undergoing a surgical operation
* Unwillingness to participate in the study
Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.


Eligibility Criteria:
Inclusion Criteria:

* Has given written informed consent before any trial-related activity is performed.
* Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
* Is a male patient aged 18 years or older
* Has a screening serum testosterone level \>1.5 ng/mL
* Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
* Has a screening PSA value of ≥2 ng/mL
* Has a life expectancy of at least 12 months

Exclusion Criteria:

* Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
* Is currently treated with a 5-α-reductase inhibitor
* Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
* Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
* Has hypersensitivity towards any component of the investigational medicinal product
* A marked baseline prolongation of QT/QTcF interval
* A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
* Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
* Has a known or suspect hepatic, symptomatic biliary disease
* Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
* Has other clinically significant laboratory abnormalities
* Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
* Has a mental incapacity or language barriers precluding adequate understanding or co- operation
* Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
* Has previously participated in any degarelix trial
Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery

This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict normothermia).

Control Group:

The congenital heart surgery will be performed according to usual practice with the degree of intra-operative hypothermia determined by the cardiothoracic surgeon based on the anticipated complexity of the case. Following completion of the surgical procedure, the infant will be rapidly rewarmed on CPB at a rate of 0.2 to 0.3°C per minute to a normothermic temperature of 36.5°C. Infants in this group will be given a single weight-based 15 mg/kg dose of intravenous Tylenol in the operating room (OR) by the anesthesiologist as the chest is being closed. The infant will be transported to the Pediatric Intensive Care Unit (PICU) for routine post-operative monitoring. If the infant develops a fever, ice packs will be applied to the axilla and groin per usual routine and removed once the fever has abated.

Experimental group:

Partial rewarming will occur on CPB to 35°C. During the last hour of surgery, the infant's temperature will be maintained at 35°C while the chest is closed by using a BairHugger and lowering the room temperature. Transfusions of packed red blood cells, fresh frozen plasma and cryoprecipitate will not be automatically warmed. Infants will be given a single 15 mg/kg dose of IV Tylenol in the OR. The infant will be transported to the PICU at 35°C and placed on the temperature-regulating blanket. The infant will be incrementally rewarmed with increases in temperature of 0.3°C every 2 hours for 6 hours, then 0.2°C every 2 hours for 6 hours to the goal temperature of 36.5°C. Once the infant is stable, EEG will be performed for 48 hours to screen for seizures. The PI will interpret the EEG every 6-8 hours. The infant will remain on the blanket at 36.5°C for another 12 hours. The blanket and esophageal temperature probe will then be removed a total of 24 hours after surgery was completed.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of congenital heart disease requiring congenital heart surgery on bypass
2. Age less than 6 months at the time of surgery
3. Intra-operative hypothermia less than or equal to 35°C

Exclusion Criteria:

1. Concern for underlying coagulation disorder such as hemophilia
2. Death in the operating room
3. Inability to wean of cardiopulmonary bypass at conclusion of surgery
Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
* Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
* Non-fertile females

Exclusion Criteria:

* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.