cyrilzakka/clinical-trials huggingface dataset:
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers

This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.

Subjects will be assigned to one of two cohorts.

1. Cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or matching placebo.
2. Cohort 2 will receive the higher dose of 10 μg vaccine (with or without alum adjuvant) or matching placebo.

Eligible subjects will be randomized to receive the 2 μg dose or 10 µg without or with alum or matching placebo, at a ratio of 3:1, as three single IM injections. There will be an interval of 28(±3) days) between each treatment.

The study will be conducted in a stepwise approach in which a "Pioneer" Group of 2 subjects (one receiving the active vaccine and one receiving the matching placebo) will receive the first injection. These subjects will remain in-house for a 24-hours medical observation after the first injection (not required in the subsequent injections) Once it has been established that there are no safety concerns in the non-adjuvanted "Pioneer" Groups (and after no less than 48 hrs), the next "Pioneer" group (one subject receiving adjuvanted 2 μg vaccine and one receiving the matching alum placebo) will be injected.

If no safety concerns are raised in this group also, after no less than 48 hrs, the rest of the subjects may receive the first injection.

Eligibility Criteria:
Inclusion criteria

* Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
* Negative human leukocyte antigen (HLA) -B27 and no history of reactive arthritis
* Negative HIV, Hepatitis B and Hepatitis C serology tests.
* Blood levels of Shigella flexneri 2a LPS IgG antibodies ≤ percentile 80
* No known history of alcohol abuse

Exclusion criteria

* Subjects with a history of clinically significant gastrointestinal disorders or with any history of frequent diarrhea, nausea or emesis, regardless of etiology.
* Individuals with immunosuppressive diseases or under immunosuppressive therapy
* History of culture-proven S. flexneri.
* Individuals who have household contact with/and /or intimate exposure to an individual with laboratory confirmed S. flexneri.
* Having travelled in countries/areas highly endemic for S. flexneri within 3 months prior to enrolment.
* Previous participation in any study in which a Shigella-vaccine candidate was administered.
* Known contraindication, hypersensitivity and/or allergy to the investigational product or its excipients.
* Known hypersensitivity and/or allergy to any drug or vaccine
* Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study.
Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer

The aim of this study to validate the role of pepsinogens in gastric cancer screening.

Serum pepsinogens (PGs) are the biomarkers for gastric cancer (GC), especially atrophic gastritis which is a precursor of intestinal type GC and severe gastric inflammation which is an indicator for diffuse type GC in young age. So, test for serum PGs can be used to identify high risk patients for GC. The aim of this study is to validate the role of PGs in GC screening.

Sera and the data from esophagogastroduodenoscopy and questionnaires are collected from study subjects, and PGs and anti-H. pylori (HP) antibody are measured. Area under the curve and receiver operating characteristic curve are calculated to identify the optimal cutoff values for PGs.

To validate the usefulness of PGs to predict risk of GC, the subjects are divided into two groups based on each cut-off value for each PG value. Adjusted odds ratios (ORs) and 95% CIs are calculated using multivariate logistic regression. Risk stratification is conducted by combining each PG value and anti-HP antibody in GC subtype.

Eligibility Criteria:
Inclusion Criteria:

* Who undergoes serum pepsinogens and anti-H. pylori antibody tests, and esophagogastroduodenoscopy during a health-screening examination at Seoul National University Hospital Gangnam center (SNUHGC) or Seoul National University Bundang Hospital (SNUBH)

Exclusion Criteria:

* Who do not receive serum pepsinogens or anti-H. pylori antibody studies
* Who do not receive esophagogastroduodenoscopy within 3 months before or after the date of serum pepsinogens and anti-H. pylori antibody tests
* Subjects with recent proton-pump inhibitor therapy 1 month prior to enrollment
* Subjects with prior history of gastrectomy
* Subjects with upper gastrointestinal neoplasms other than gastric adenoma/adenocarcinoma
* Subjects who do not agree to participate in the study or withdraw his/her consent
The Influence of Expectations on Patient Satisfaction in the Pediatric Emergency Department

The purpose of this study is to determine whether physician knowledge of parental pre-visit expectations improves patient satisfaction in the pediatric emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Parent of child less than or equal to 18 years of age

Exclusion Criteria:

* Inability to understand the English language surveys
Open Label Safety Study of a Birch Pollen Allergen Extract

This trial is performed to assess safety of a sublingual birch pollen extract.


Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinoconjunctivitis attributable to birch pollen
* Positive SPT
* Positive EAST

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies
* Partly controlled asthma
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy

The purpose of this study is to compare the efficacy of darbepoetin alfa administered using a front-loading approach with subjects receiving standard weekly dosing in the treatment of anemia in subjects with a non-myeloid malignancy and receiving multicycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Non-myeloid malignancy - At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule - ECOG 0-2 - Cancer and/or chemotherapy-associated anemia Exclusion Criteria: - Known history of seizure disorder - Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy - Unstable or uncontrolled disease/condition, related to or affecting cardiac function - Clinically significant inflammatory disease - Inadequate renal and/or liver function
Use of Sildenafil (Viagra) in Diabetic Men With Erectile Dysfunction: the Impact on Blood Vessels

* To evaluate the impact of nightly sildenafil vs placebo use on diabetic men with and without proven endothelial dysfunction and coexisting erectile concerns.
* To determine if chronic sildenafil use compared to placebo positively impacts endothelial function among a cohort of diabetic mend with erectile dysfunction
* To assess the salvage rate of sildenafil - failures who demonstrate improved response rates over time with chronic use
* To assess if microalbuminuria predicts flow-mediated dilation (FMD) response
* To measure and identify if other patient specific characteristics predict for sildenafil erectile response and flow-mediated dilatation (FMD) response over time (patient specifics; blood pressure, HBA1c, weight, BMI, age IIEF score at baseline)

60 type II diabetic men with erectile dysfunction will be enrolled in this trial, evaluated over a 12 week period. Randomization into one of two arms (placebo, daily sildenafil 50mg) will be a doubly blinded. Subjects will be followed by IIEF, diaries and brachial forearm medial dilatation duplex scans, urinary microalbuminuria and serum chemistry.

Study time-points are at baseline, 6 and 12 weeks.

Study participants will be instructed to use the study medication at the specified frequency but will be allowed flexibility to suit their erectile needs.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Type 2 diabetes \> 6 months in duration. Men using oral hypoglycemic agents and /or insulin will be permitted into the trial.
* Stable hetero- sexual relationship for \> 6 months
* IIEF score at baseline \<21·
* Agrees to sign informed consent

Exclusion Criteria:

* Known hypersensitivity to sildenafil
* Use of nitrates
* Use of anti-coagulants
* History of significant heart disease, +/or myocardial infarction within last 6 months
* Unable to understand or unwilling to sign informed consent
* Concomitant use of erectogenic agent during study
The European Bifurcation Club Left Main Study

The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet ALL of the inclusion criteria:

* Bifurcation distal left main stem stenosis \>50% and

  * Ischaemic symptoms, or
  * Positive non-invasive imaging for ischaemia, or
  * Positive FFR, or
  * LMS IVUS MLA \<6mm2
* Left main diameter ≤5.75mm
* True bifurcation lesion type 1,1,1 or 0,1,1
* LAD and Cx diameter both \>2.75mm
* Unprotected left main
* Patient ≥18 years old

Exclusion Criteria:

* STEMI \<72 hours preceding
* Cardiogenic shock
* Chronic total occlusion of either vessel
* \>2 other coronary lesions planned for treatment
* SYNTAX score for planned lesions to be treated \>32
* LMS trifurcation if all vessels are ≥2.75mm diameter
* Either bifurcation vessel not suitable for stenting
* Platelet count ≤50 x 10\^9/mm3
* Left ventricular ejection fraction ≤20%
* Patient life expectancy less than 12 months
* Participation in another investigational drug or device study
* Patient unable to give informed consent
* Women of child-bearing potential or lactating
Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of functional HoFH
2. If undergoing LDL apheresis, must have initiated LDL apheresis at least 3 months prior to screening and must have been on a stable weekly or every other week schedule and/or stable settings for at least 8 weeks
3. Willing to consistently maintain his/her usual low fat or heart-healthy diet for the duration of the study

Key Exclusion Criteria:

1. LDL-C level \<70 mg/dL (1.81 mmol/L) at the screening visit
2. Background medical Lipid Modifying Therapy (LMT) (if applicable) that has not been stable before the screening visit
3. Lipid-apheresis schedule /apheresis settings (if applicable) that have not been stable for at least 8 weeks before the screening visit
4. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit
5. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
6. Newly diagnosed (within 3 months prior to randomization visit) diabetes mellitus or poorly controlled (HbA1c \>9%) diabetes
7. History of a MI, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, valve replacement surgery, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit
8. Pregnant or breastfeeding women
9. Sexually active women of child bearing potential (WOCBP), who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug
10. Men who are sexually active with women of child bearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period and for 24 weeks after the last dose of study drug regardless of vasectomy status

Note: Other protocol defined inclusion/exclusion criteria may apply.
Long Term Follow Up KET-PD

The purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in Parkinson's disease (PD) and b) the effects of CBT on maintaining the effects of ketamine.

This is a roll-out study from the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394). We will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (TAU) (at 3 and 6 months post-infusions); b) follow-up with 3 months of Cognitive Behavior Therapy (CBT) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. CBT is expected to have a superior sustained antidepressant response to the TAU follow-up group in both ketamine and placebo arms. We hypothesize that ketamine + CBT will show the most superior antidepressant response at follow-up.

Eligibility Criteria:
Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).
Non-Invasive Positive Pressure Ventilation and Adult Respiratory Distress Syndrome (ARDS)

Background and objective: To determine the efficacy of non-invasive positive pressure ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.

Methods: This study was performed in the respiratory intensive care unit (ICU) at a university hospital. 20 patients who achieved the diagnostic criteria for ARDS were included. The patients were prospectively allocated into two groups: a standard therapy group and a NPPV group. Invasive mechanical ventilation indications had been determined before the study. Invasive ventilation was applied to those who in need of intubation, while those given intubation received a standard medical treatment.

Eligibility Criteria:
Inclusion Criteria:The following criteria indicated immediate intubation was needed:

1. Apne or respiratory pauses with loss of consciousness or gasping for breath or imminent respiratory arrest.
2. Inability to increase the patient's PaO2 to more than 40 mmHg and SpO2 to more than 80% with a FiO2\>0.6.
3. Inability to increase the patient's pH levels above 7.35, and development of blurred consciousness and confusion (Glasgow Coma Scale \<9) due to respiratory acidosis despite all the support given.
4. Instability of the patient's hemodynamic parameters (such as systolic blood pressure \<80 mmHg or heart rate \<50 beats/minute lasting \>1 hour despite fluid resuscitation).

Exclusion Criteria:Contraindications for NPPV include:

1. The need for urgent intubation.
2. The need for frequent aspiration due to excessive secretions (more frequent than 15 min.).
3. Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.
Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational dug
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients with HbA1c of ≥7.5% and \<10.5%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria:

* Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)
* Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg
* Patients with serious renal or hepatic disease
* Patients with eGFR of \<45 mL/min/1.73 m2
* Patients who are the excessive alcohol addicts
* Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
Regional Anesthesia for Thyroidectomy

For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine whether it offers real benefits in terms of patient outcome from major surgery, compared with general anesthesia. Although it is clear that regional analgesia in association with general anesthesia substantially reduces postoperative pain, the benefits in terms of overall perioperative outcome are controversial. The aim of this study is to evaluate the effect on short and long-term postoperative outcomes of adding regional analgesia to general anaesthesia in thoridetomic patients.

Patients who are divided into two treatment groups: (a) a bilateral superficial cervical plexus group (group S) and a control group (group C).We performe bilateral superficial cervical plexus block (BSCPB)with 0.25-0.75% ropivacaine10 ml to group S and 10ml NaCl 0.9% to group C. All BSCPB is performed by experienced anesthesia doctor after a standardized induction of general anaesthesia.eneral anaesthesia was induced by using intravenously with midazolam,propofol, fentanyl, cisatracurium is injected IV to facilitate orotracheal intubation. After a standardized induction of general anaesthesia, patients receive Regional Anesthesia at the discretion of the experienced anesthesiologist who was blinded to treatment.

The patient is placed in a supine position with the head turned away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle.

Eligibility Criteria:
Inclusion Criteria:

-Eligible patients fit an ASA I or II classification adult patients who will be scheduled for elective thyroid lobectomy under general anaesthesia.

Exclusion Criteria:

* hypersensitivity to any study drugs
* Long-term use of anticoagulant drugs: warfarin or heparin
* the neck or systemic infection
* communication disorder
* refuse to accept this research subjects.
Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.

Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT. Corticosteroid is the standard first-line therapy for aGVHD. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to control aGVHD.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are fully informed and sign informed consent by themselves or their guardians;
2. Patients receiving first allogeneic hematopoietic stem cell transplantation;
3. Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
4. KPS\>60, Estimated survival \>3 months;
5. No serious organ damage:

   1. ANC in peripheral blood is greater than 0.5×109/l
   2. Creatinine \< 1.5mg/dl
   3. Cardiac ejection index \> 55%

Exclusion Criteria:

1. Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease;
2. Patients with uncontrollable active infection;
3. Patients with recurrence of primary malignant hematopathy;
4. Expected survival is less than 3 months
5. Patients who have histories of severe allergic reactions
6. Pregnant or lactating women
7. The researcher judges that there are other factors that are not suitable for participating
8. Patients who received donor lymphocyte infusion
Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).

Approximately 300 subjects, recruited from approximately 80 study centers in the United States (US), Canada, and Europe will be randomized to DAXI for injection high dose, DAXI for injection low dose, or placebo group, respectively. Subjects will be stratified by treatment center and history of prior treatment with botulinum neurotoxin (BoNT).

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 to 80 years of age
* Meets diagnostic criteria for isolated CD (idiopathic; dystonic symptoms localized to the head, neck, shoulder areas) with at least moderate severity at Baseline (Day 1), defined as a TWSTRS-total score of at least 20, with at least 15 on the TWSTRS-Severity subscale, at least 3 on the TWSTRS-Disability subscale, and at least 1 on the TWSTRS-Pain subscale

Exclusion Criteria:

* Cervical dystonia attributable to an underlying etiology, (e.g., traumatic torticollis or tardive torticollis)
* Predominant retrocollis or anterocollis CD
* Significant dystonia in other body areas, or is currently being treated with BoNT for dystonia in areas other than those associated with isolated CD
* Severe dysphagia (Grade 3 or 4 on the Dysphagia Severity Scale) at Screening or Baseline (prior to study treatment)
* Any neuromuscular neurological conditions that may place the subject at increased risk of morbidity with exposure to BoNT, including peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis)
* Previous treatment with any BoNT product for any condition within the 14 weeks prior to Screening
* Botulinum Neurotoxin Type A (BoNTA), except the investigational daxibotulinumtoxinA, treatment-experienced subjects who had suboptimal or no treatment response to the most recent BoNTA injection for CD, as determined by the investigator, or history of primary or secondary non-response to BoNTA injections, known to have neutralizing antibodies to BoNTA; or have a history of botulinum toxin type B (rimabotulinumtoxinB \[Myobloc/Neurobloc\]) injection for CD due to non-response or suboptimal response to BoNTA