cyrilzakka/clinical-trials huggingface dataset:
SAFE Study - Septal Pacing for Atrial Fibrillation Suppression Evaluation

This is a randomized, parallel, single-blinded multi-center study. The objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of the atrial fibrillation (AF) Suppression algorithm.


Eligibility Criteria:
Inclusion Criteria:

1. Have a history of paroxysmal AF with documented AF episode within the last 6 months; documentation of AF is required. It can be documented by one of the following:

   * Holter documentation and the strip must be at least 30 seconds; OR
   * one page of 12-lead electrocardiogram (ECG); OR
   * transtelephonic recording for more than 15 seconds.
2. Have a conventional indication for a pacemaker due to either sinus or atrioventricular (AV) node diseases.
3. Provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Be at least 18 years old.

Exclusion Criteria:

1. Already implanted with a pacemaker or implantable cardioverter defibrillator (ICD).
2. Are expected to have heart surgery within the next 6 months.
3. Have angina pectoris, New York Heart Association (NYHA) Class III or Class IV.
4. Are expected not to be able to tolerate high rate pacing.
5. Have less than 12 months' life expectancy.
6. Are on the cardiac transplantation list.
7. Are in chronic AF.
8. Have a reversible aetiology of AF (e.g., hyperthyroidism, acute post-cardiac surgery AF, etc.).
Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis

Autologous stem cell therapy has been shown to be effective in patients with systemic sclerosis. Nevertheless treatment is associated with treatment related mortality and patients die during follow up despite successful transplantation.

Intention of this trial is to improve overall survival by modifying the existing protocol used for the ASTIS trial.

To reduce treatment toxicity we reduce the dose of Cyclophosphamide (CYC) for mobilisation to 2x1g.

Especially in patients with cardiac manifestations we also modify the conditioning regimen by adding thiotepa and reducing CYC; as CYC has known cardiotoxic side effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of progressive systemic sclerosis \<7 years
* Progressive course despite cyclophosphamide pretreatment
* Cyclophosphamide i.v.: at least 3 x with 500-1000 mg/m² every 3-4 weeks or
* Cyclophosphamide p.o. with at least 100mg/day for at least 2 months or
* Contraindication to treatment with cyclophosphamide
* Progress defined as at least one of the following criteria:

  * Increase in the mRSS
  * Worsening of the lung function
  * Increase in fibrosis/alveolitis in thorax CT
  * Worsening kidney function through manifestation of systemic sclerosis
* Limited or diffuse cutaneous progressive form of Ssc with organ manifestation in the lungs/heart or kidneys

Exclusion Criteria:

* Age \<18 years
* Pregnancy or inadequate contraception
* Severe heart failure with ejection fraction (EF) \< 30% in echo
* Pulmonary arterial hypertension with systolic pulmonary arterial pressure (PAPsys) \>50mm Hg
* Kidney insufficiency: creatinine clearance \<30 ml/min
* Reduced lung function
* Inspiratory vital capacity (IVC) \< 50% of normal
* Carbon monoxide (CO)-Diffusion capacity SB \< 40%
* Previously damaged bone marrow
* Leukopenia \< 2,000/µl
* Thrombopenia \< 100,000/µl
* Previous myelotoxic treatment:
* Cyclophosphamide \> 50g cumulative (relative)
* Infection (Hepatitis B/C, HIV, Salmonella carrier, syphilis, relative: history of tuberculosis)
* Severe concomitant psychiatric illness (depression, psychosis)
* Substance dependence
* Continued nicotine abuse
* Continued alcohol abuse
* Continued drug abuse
* Consent not given
* Poor compliance
Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block

Patients having lumbar spinal fusion often complain about severe postoperative pain and postoperative rehabilitation process can be affected negatively. Postoperative pain that cannot be well controlled may lead to delayed mobilization, pulmonary and thromboembolic complications, prolonged hospital stays, and chronic pain syndromes. Pain after spinal surgery can arise from several different tissues, such as the vertebrae, disks, ligaments, dura, facet joint, muscle, fascia, and subcutaneous and cutaneous tissues.

Ultrasound-guided lumbar erector spinae plane block (ESPB) has been shown to reduce postoperative pain in patients undergoing posterior lumbar interbody fusion (PLIF). However, the duration of analgesia after single-shot ESPB with commonly used local anesthetics is reported to be no more than 12 h, which often not long enough to provide satisfactory postoperative pain relief, as the pain typically lasts for several days. Compared with perineural route, intravenous additives to local anesthetics are commonly accepted as its safety and efficiency have been reported. Moreover, co-administration of intravenous dexamethasone and dexmedetomidine significantly prolonged the time to ﬁrst rescue analgesic request after single-shot interscalene brachial plexus block. However, more data are needed especially for lumbar ESPB.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 yrs
2. American Society of Anesthesiologists physical statusⅠ-Ⅲ
3. Involvement of ≤3 spinal levels
4. Undergo elective posterior lumbar interbody fusion
5. Informed consent

Exclusion Criteria:

1. A known allergy to the drugs being used
2. Pre-existing neuropsychiatric disorders or language barrier
3. Analgesics intake, history of substance abuse
4. Contraindications to peripheral nerve block
5. Acute cerebrovascular disease
6. Severe liver failure
7. Uncontrolled low blood pressure
8. Sinus bradycardia or atrioventricular block
A Study of HM11260C in Healthy Male Subject

Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.

Primary Objective: To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single subcutaneous dose of HM11260C in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers, age range 20 to 45 years
2. Weight\>50 and \< 90kg, Body mass index of \>18 and \<27 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study

Exclusion Criteria

1. Acute disease within 1 month prior to start of study drug administration
2. Has previously disease which affect drug absorption, distribution, metabolism, excretion (e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic disease, renal disease)
3. History or presence of clinically significant and active cardiovascular, pulmonary, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor
4. Has unsuitable clinical test results through the medical checkup, within 35 days prior to start of administration of study drug (medical history, physical examination, ECG, laboratory test)
5. Laboratory test results

   1. AST (sGOT) or ALT (sGPT) \> 1.25Xupper normal limit
   2. Total bilirubin \> 1.5Xupper normal limit
   3. Absolute Neutrophil Count \< 1500 mm2
6. History or presence of clinically significant allergic disease (including mild allergic rhinitis and allergic dermatitis which is not necessary to medication)
7. Prior exposure to products related to Exenatide
8. Use of any prescription medication within 14 days prior to Day 1
9. Use of any medication within 7 days prior to Day 1 (over-the-counter medication, herbal products, nutrient, vitamins)
10. Subject who can't eat standard meal received by Korea University Anam Hospital
11. Donor of whole blood for transfusion within 60 days prior to start of study drug administration or donor of apheresis within 20 days or Receiver of blood transfusion within 1 month
12. Participation in another clinical study within 60 days prior to start of study drug administration
13. Taking Caffein(\> 5cups/ day) or alcohol abuse (\> 30g/ day) or excessive smoker(\> 10 Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study
Examination of the Effectiveness of Nasal Irrigation Techniques in Infants With Nasal Congestion

The research investigates the effects of high-volume and low-volume nasal irrigation techniques applied to relieve nasal congestion in infants with nasal congestion due to upper respiratory tract infections. The study examines the physiological parameters of infants who undergo nasal irrigation, crying duration, frequency of the procedure, and the baby's feeding patterns.

This study aims to investigate the effects of two different nasal irrigation techniques applied to relieve nasal congestion on infants' physiological parameters, crying duration, feeding habits, and the frequency of the procedure repetitions.

A randomized controlled experimental study was conducted with 80 infants aged 1-12 months who presented at the pediatric emergency clinic with nasal congestion due to upper respiratory tract infection. In the study, the 1st group of infants received low-volume saline solution, while the 2nd group received high-volume saline solution for nasal irrigation. Physiological parameters were measured before the procedure, immediately after the procedure, and 5 minutes after the procedure. Procedure duration and baby's crying duration were recorded. Subsequently, breastfeeding was initiated for the infants, and their physiological parameters were measured again during breastfeeding. Parental satisfaction levels with the procedure were also assessed. Finally, the frequency of the procedure repetitions was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Infants diagnosed with Upper Respiratory Tract Infection and recommended nasal cleaning with saline solution by a physician,
* Infants whose parents provided consent for their participation in the research,
* Term-born infants aged 1 month to 12 months,
* Breastfed infants,
* Infants without chronic illnesses,
* Conscious infants,

Exclusion Criteria:

* Infants with congenital anomalies affecting the respiratory system (such as choanal atresia, etc.),
* Infants with allergic rhinitis,
* Infants who used antibiotics or corticosteroids before hospital admission,
* Infants with growth retardation, were excluded from the study.
Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma Patients

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both IMP321/LAG-3 and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety and tolerability of this vaccination. Tumor responses following this vaccination will also be documented.

The primary objective of this study is:

* to evaluate melanoma antigen specific immune response induced by this vaccination with tumor antigenic peptides derived from MAGE-A3 (Melanoma Antigen family A3) (MHCI: MAGE-A3.A2 and MHCII: MAGE-A3.DP4), NY-ESO-1 (New York Esophageal squamous cell carcinoma antigen-1), Melan A (analog ELA and native EAA) and NA-17A with IMP321 (ImmuFact)/ LAG-3Ig (Lymphocyte activation gene-3 immunoglobulin-like domains) as adjuvant/immunostimulant, formulated with Montanide ISA-51.
* to assess the safety and tolerability of this vaccination

The secondary objective is to document tumor responses in patients following this vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage II, III or IV melanoma patients.
* Tumor expression of Melan-A.
* Human leukocyte antigen-A2 (HLA-A2) positive.
* Expected survival of at list 3 months.
* Karnofsky scale performance status of 70 % or more.
* Age ≥ 18 years.
* Able to give a written informed consent.
* The following laboratory results:

Hemoglobin ≥ 100g/L, Neutrophil count ≥ 1.5 x 109/L, Lymphocyte count ≥ 0.5 x 109/L, Platelet count ≥ 100 x 109/L, Serum creatinine ≤ 2 mg/dL (0.18mmol/L), Serum bilirubin ≤ 2mg/dL (0.034mmol/L), Granulocyte count \> 2.5x109/L, Aspartate Amino Transférase (ASAT), Alanine Amino Transferase (ALAT) \< 2.5 x upper limit of normal, Activated Partial Thromboplastin Time (aPTT) within the normal ranges ±25%, Thromplastin (TP) ≥ 80%

Exclusion Criteria:

* Clinically significant heart disease.
* Serious illness, eg. serious infections requiring antibiotics, uncontrolled peptic ulcer, or central nervous system disorders.
* History of immunodeficiency disease or autoimmune disease.
* Metastatic disease to the central nervous system, unless treated and stable.
* Known HIV positivity.
* Known seropositivity for hepatitis B surface antigen.
* Concomitant treatment with steroids, antihistamine drugs. Topical or inhalation steroids are permitted.
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
* Pregnancy or lactation.
* Women of childbearing potential not using a medically acceptable means of contraception.
* Psychiatric or addictive disorders that may compromise the ability to give informed consent.
* Lack of availability of the patient for immunological and clinical follow-up assessment.
* Coagulation or bleeding disorders.
* Kidney dysfunction with creatinine \> 2 X the upper limit of the normal value.
* Reported strong (allergic) reactions to previous vaccination.
Immune Checkpoint Inhibitors and Atherosclerotic Plaque Volume

In this study, investigators plan to test whether Immune Checkpoint Inhibitor (ICI) treatment leads to an accelerated progression of atherosclerosis in patients with lung cancer. Atherosclerosis is an immune-mediated inflammatory disease and these same checkpoints being targeted for cancer are critical negative regulators of atherosclerosis in animal and cellular models. Aortic plaque progression will be compared between cases (on ICI) and controls from pre-ICI to post-ICI among patients with non-small cell lung cancer. Groups will be matched for age, cancer type and stage and cardiovascular risk factors. Traditional markers of cardiovascular (CVD) risk and cancer-specific factors (ICI mono- and combination therapy, number of cycles, occurrence of immune-related adverse events, chest radiation, steroid use) will be associated with the change in aortic plaque volume.


Eligibility Criteria:
Inclusion Criteria:

Cases:

* Subjects with non-small cell lung cancer treated with Immune Checkpoint Inhibitors.
* Available contrast enhanced CT scans of the chest both immediately pre-ICI (\< 1 month) and latest follow-up.

Controls:

* Subjects with non-small cell lung cancer, age, cancer stage and cardiovascular risk factor matched to cases.
* Available contrast enhanced CT scan of the chest at two time-points at a similar interval between scans as the cases.

Exclusion Criteria:

none
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over
* Patients able and willing to provide informed consent
* Patients with wounds with a duration of no less than 2 months and no more than 12 months
* Patients must be willing to complete the QoL (quality of life) questionnaires via a valid email address
* Patients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound:

  * Chronic ulcers (Venous, arterial, mixed aetiology or diabetic foot ulcers)
  * Pressure Injury Stage II or greater
* Patients must be willing to attend visits as per schedule in protocol

Exclusion Criteria:

* Patients with known allergies to any of the materials used in the dressing
* Patients with known malignant wounds
* Patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
* Patients, who in the opinion of the Investigator, are considered as unsuitable for any other reason
* Patients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
Continuous Treatment Study of Topiramate in Migraine Participants

The purpose of this study is to evaluate the safety and efficacy of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting and constipation or diarrhea) who completed the JNS019-JPN-02 study.

This is an open-label (all people know the identity of the intervention), multicenter (conducted in more than one center), dose-titration (dose escalation/reduction) study of topiramate in participants with migraine. This study is a continuous study for the participants who were enrolled in the JNS019-JPN-02 study. Participants who completed the JNS019-JPN-02 study will receive treatment for 52 weeks starting at Visit 4 of the JNS019-JPN-02 study. The present study will consist of 3 weeks of Transfer period (during this period the dose titration will take place and along with dose titration the new treatment will be initiated at 25 milligram per day \[25mg/day\]), Continuous treatment period (32 weeks), Exit period (up to 3 weeks) and Follow-up period (4 weeks). Participants in the Continuous treatment period will receive topiramate tablets orally in the dose range of 50 mg/day to 100 mg/day. Dose can be increased or decreased as per Investigator's discretion. The maximum daily dose will be 200 mg/day. Efficacy will be primarily evaluated by change from Baseline in the number of monthly migraine attacks in Continuous treatment period. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

- Participants who completed the JNS019-JPN-02 study or discontinued the study at Week 4 or after in fixed-dose period because of insufficient efficacy

Exclusion Criteria:

* Participants who discontinued the JNS019-JPN-02 study for an adverse event unrelated to the underlying disease
* Participants judged unfavorable to be transferred to this study because of the safety assessments in the JNS019-JPN-02 study
* Pregnant (carrying an unborn baby) female participants
* Other participants who were considered ineligible as per Investigator's discretion
Perennial Allergic Rhinitis Study In Pediatric Subjects

The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to \<12 Years with Perennial Allergic Rhinitis (PAR)

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of perennial allergic rhinitis.

Exclusion criteria:

* Have significant concomitant medical conditions.
* Use of corticosteroids or other allergy medications during the study.
* Have abnormal ECG.
* Have laboratory abnormality.
* Have abnormal eye exam.
Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis.

Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.

Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.

Four visits are included in the study period.

Eligibility Criteria:
Inclusion Criteria:

* Couples with ages between 20 and 40
* Couples under an assisted reproduction treatment: Artificial Insemination or In vitro Fertilization.
* Signature of informed consent

Exclusion Criteria:

* Anovulation
* Hyperprolactinemia
* Hypogonadotropic hypergonadism
* Hypergonadotropic Hypergonadism
* Hyperandrogenisms
* Polycystic ovary syndrome
* Endometriosis
* Pelvic adhesions
* Myomas, polyps and / or uterine synechia
* Diagnosis of tubal factor (hydrosalpinx, tubal obstructions)
* Low ovarian reserve
* Azoospermia
* Sperm motility (A + B) \<25%
* Sperm morphology ≤2%
* With chronic diseases that cause intestinal malabsorption
* With known congenital or acquired immunodeficiency.
* Obesity (IMC ≥ 30)
* Current history or diagnosis of alcohol, tobacco and drug abuse
* Uncertainty about the willingness or ability of the participants to comply with the requirements of the protocol.
Mi-iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?

Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to maintain normal iron levels. It is unclear, however, whether treatment is necessary when individuals have moderate elevation of iron in the body. This research project will study the effects of treatment in this group by assessing a number of scans, questionnaires and blood tests in treated and untreated individuals.

There is mounting evidence that treatment of moderate iron overload in HFE related hereditary haemochromatosis (HH) is not necessary. This project aims to undertake a randomised patient-blinded trial of erythrocytapheresis compared to sham erythrocytapheresis (using plasmapheresis) in individuals who have serum ferritin (SF) above the upper limit of the normal range but \< 1000ug/L (defined here as moderate iron overload) due to HFE mutations and to compare the prevalence of symptoms and objective markers of disease in the two treatment arms.

Eligibility Criteria:
Inclusion Criteria:

1. HFE C282Y homozygous.
2. Aged 18 - 70 years .
3. SF above the upper limit of the normal range of 300µg/L but less than 1000µg/L with a currently or previously raised TS (\>greater than the upper limit of normal for the testing laboratory).

Exclusion Criteria:

1. HH due to genotypes other than HFE C282Y homozygosity.
2. Normal SF, SF \> 1000µg/L.
3. Other major risk factor(s) for liver toxicity or other significant co-morbidities including positivity for hepatitis B or C, excess alcohol consumption (\> 60g/day in males and 40g/day in females) or body mass index \> 35.
4. Has had venesection therapy for HH in the last two years.