cyrilzakka/clinical-trials huggingface dataset:
Multicenter Study of Denture Adhesive

To establish evidence based guidelines for denture adhesives (powder and cream), multicenter cross over randomized clinical trial will be carried out.

The null hypotheses are that there are no difference on improvement from baseline to post application of two adhesives powder and cream, in terms of general satisfaction, oral related quality of life, masticatory function and oral conditions.

This is multicenter study of 10 academic affiliated institutions. The clinical trial will be carried out in randomized allocation at each site, and data will be gathered. The intervention will be 3-arms and center institution (Nihon University) will generate each site random numbers for allocation and each site will follow this randomization. Research protocol had been published at Nihon University and distributed to each site.To survey its protocol compliance, the study meeting will be held periodically (twice an year).

Eligibility Criteria:
Inclusion Criteria:

* edentulous

Exclusion Criteria:

* Cannot answer the questionnaire
* Deteriorating general conditions
* Maxillofacial defect
* Metal denture user
* Already denture adhesive users
* Severe xerostomia
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease

To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).

Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.

Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years

Eligibility Criteria:
Inclusion Criteria for Study Part 1:

1. The subject is male or female, 30 to 80 years of age on the date of informed consent.
2. The subject has an established diagnosis of Type 2 Diabetes Mellitus.
3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
4. The subject has an established diagnosis of Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (eGFR) between 20 and 50 mL/min/1.73m².
5. The subject has blood pressure less than 150/90 at the Screening Visit.
6. The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
7. A minimum of 2 measurements of Estimated Glomerular Filtration Rate (eGFR) or serum creatine ratio (sCr) should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of Chronic Kidney Disease (CKD).

Exclusion Criteria for Study Part 1:

1. The subject has a history of type 1 diabetes mellitus.
2. The subject has a history of renal transplantation.
3. The subject has a serum Hemoglobin A1c (HbA1c) level greater than 10% at the Screening Visit.
4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
5. The subject has hemoglobin levels less than 9 g/dL prior to each Renal Autologous Cell Therapy (REACT) injection.

Inclusion Criteria for Study Part 2:

1. The subject is willing and able to provide signed informed consent.
2. The subject was enrolled into Part 1 of the study and received at least one Renal Autologous Cell Therapy (REACT) injection.

Exclusion Criteria for Study Part 2:

1. The subject is currently receiving renal dialysis.
US NAB With ROSE Versus US FNAB With no ROSE

This is an investigator-initiated, single center, controlled, randomized clinical trial with two parallel arms in a 1:1 ratio. The objective of the study is to systematically assess the influence of rapid on-site evaluation (ROSE) on the diagnostic yield for diagnosis and molecular profiling, as well as on the safety, of pulmonologist-performed ultrasound-assisted needle aspiration biopsy (US-NAB) of superficial lesions across different metastatic sites in a series of consecutive patients with suspect locally advanced or advanced lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Known/suspected lung cancer
* Presence of a suspected "superficial" metastasis at imaging studies (CT and/or PET)
* Indication to tissue sampling for diagnosis, staging and/or molecular profiling
* 18 years or older
* Provision of a written informed consent

Exclusion Criteria:

* Inability or unwillingness to consent
* Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
* Use of antiplatelet (excluded aspirin) or anticoagulant drugs that cannot be discontinued
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx \& larynx) that is not amenable to curative therapy.
* No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
* Measurable disease detected by imaging exam (CT or MRI).
* Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.

Exclusion Criteria:

* Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
* No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
* Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
* Inadequate hematologic, renal or hepatic function.

Other protocol defined inclusion/exclusion criteria could apply
Tissue Penetration of Antibiotics in Obesity

The purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* BMI \<25 and \>40
* Scheduled for elective abdominal or pelvic surgery
* Surgical plan for intraoperative cefoxitin prophylaxis
* Able to provide informed consent

Exclusion Criteria:

* Allergy to Cefoxitin
* Renal or Hepatic insufficiency
Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether sunitinib is effective in treating non-small cell lung cancer.

PURPOSE: This phase II trial is studying sunitinib to see how well it works when given as maintenance therapy in treating patients with stage III or stage IV non-small cell lung cancer which is previously treated with combination chemotherapy.

OBJECTIVES:

Primary

* To investigate the effect of sunitinib malate on the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer Secondary
* To evaluate the toxicity of sunitinib when administered in the maintenance setting.
* To evaluate the additional response rate to sunitinib malate when administered in the maintenance setting.
* To evaluate the overall survival of patients treated with sunitinib. After completion of study treatment, patients are followed every 2 months for 1 year, every 6 months for 1 year, and periodically for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* No evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
* Histologically or cytologically confirmed primary non-small cell lung cancer who have stable or responding disease after prior treatment with 3-6 courses of platinum -based therapy
* Not a candidate for combined modality therapy
* No cavitary lesions

Exclusion Criteria:

* Evidence of symptomatic or untreated brain metastases, spinal cord compression, or carcinomatous meningitis
Augmenting Exposure Therapy With Self-Distancing

Anxiety is prevalent, impairing, and costly in childhood. Evidence-based treatments for pediatric anxiety exist; however, as many as 40-60% of youth do not demonstrate optimal response. By identifying psychological factors that potentiate symptom severity and treatment response, it may be possible to strengthen these factors to treat, or even prevent the development of youth emotional disorders.

This study aims to examine whether the combination of Exposure and Self-Distancing is a feasible, acceptable, and efficient intervention for increasing perseverance in the face of exposures. This will be measured by child and parent report of treatment acceptability, examination of attendance and dropout rates, as well as participant and therapist report of participant engagement during exposures.


Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian willing to give informed consent to participate
* Children who give written or oral assent
* Ages 7 and older to under 18 years old
* Has a historical anxiety diagnosis (diagnosed within the last year either within a clinical or clinical research setting) and have moderate or greater levels of current anxiety symptoms
* Current or past history of elevated symptoms of depression, obsessive-compulsive disorder and posttraumatic stress are allowable, but anxiety must be the chief complaint
* No evidence of acute risk due to suicidal intentions or behaviors in the past 6 months.

Exclusion Criteria:

* Currently receiving cognitive behavioral therapy or any other form of psychotherapy
* Have elevated symptoms of bipolar I/II disorder, schizophrenia/schizoaffective disorder, schizophreniform disorder, psychosis Not otherwise specified (NOS), mental retardation, severe behavioral concerns, or autism
* History of current substance/alcohol abuse/dependence (Past history abuse is allowable if in remission for greater than 1 year)
To Identify HLA-A1101-restricted Peptide Epitopes Derived From Novel Oncoantigens (URLC10, KIF20A, and CDCA1) Applicable for Cancer Vaccine in Singapore

Aim: To identify HLA-A1101-restricted peptide epitopes derived from novel Oncoantigens (URLC10, KIF20A, and CDCA1) applicable for Cancer Vaccine in Singapore.

Methods: The panel of candidate peptides are synthesized and tested for their ability to induce peptide-specific CTL responses, in order to screen the peptide epitopes applicable for the cancer vaccination. Briefly, peripheral blood lymphocytes (PBLs) derived from HLA-A1101(+) healthy donors are taken and cultured in the presence of the each candidate peptide with recombinant IL-2 for 2 weeks, and then, re-stimulated with dendritic cell pulsed with the peptide following another 2 week culture. Thereafter, CD8(+) T lymphocytes were negatively selected with CD4-magnetic beads from cultured lymphocytes and tested for their peptide specificity employing enzyme-linked immunospot (ELISPOT) assay. These conditions are completely performed in in-vitro system. Importance in medicine: If one could identify the peptide epitopes from novel Oncoantigens, it is applicable for clinical trials of cancer vaccination.

Benefits \& Risks : There is no risk except for the matter of venipuncture in each individuals.

The ideal target molecules for cancer vaccination are thought to be selectively expressed in tumor cells, but not in the normal cells, with high frequent and homogenous expression within tumor. We have proved that novel Oncoantigens, URLC10, KIF20A and CDCA1, have these characters as ideal target molecules for the cancer vaccination and are highly expressed in a variety of tumor type such as gastric, lung, and pancreas cancer. Since HLA-A1101 haplotype is most frequent in Singaporean, it is essential to indentify the HLA-A1101-restriced peptides derived from these Oncoantigens to develop cancer vaccination.


Eligibility Criteria:
Inclusion Criteria:

* The participants should be healthy,
* non-pregnant adults who weigh at least 50kgs

Exclusion Criteria:

* Age of \< 22 and \> 80 years old.
* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
* Decision of unsuitableness by Principal Investigator or physician-in-charge.
Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis

This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.

The efficacy and safety of hypertonic saline (HS) in CF patients over 6 years of age has been demonstrated in clinical trials of 2 to 48 weeks' duration. Based on these results, a large randomized, placebo-controlled trial of the efficacy and safety of 7% HS administered twice daily for 48 weeks to infants with CF, 4 to 15 months of age at enrollment, is planned (the Infant Study of Inhaled Saline (ISIS) trial). It is anticipated that 150 infants at up to 16 sites will be enrolled in the ISIS trial.

To date, the only evaluations of the safety of HS in infants with CF have been small single-dose studies. There has been no evaluation of the tolerability of chronic HS administration. The goal of this study is to assess the safety and tolerability of exposure to 14 days of 7% HS administered twice daily in infants with CF, prior to enrolling subjects in the planned large, randomized, controlled trial. Conduct of this study will provide evidence for the tolerability of chronic HS administration in infants with CF and estimates of the proportion of infants who do not tolerate chronic HS treatment. The results will be used to establish the appropriate measures of tolerability at enrollment in the ISIS trial, and to refine sample size estimates to account for withdrawal due to intolerance of HS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF as defined by one or more clinical features of CF and a documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
* Informed consent by parent or legal guardian
* 12-30 months of age at enrollment

Exclusion Criteria:

* Wheezing at the baseline evaluation at the enrollment visit
* Oxygen saturation \< 95 % at the baseline evaluation at the enrollment visit
* Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate, or new rhinorrhea, nasal congestion or rhinorrhea, with onset in the week preceding the enrollment visit
* Investigational drug use within 30 days prior to the enrollment visit
* Known intolerance of albuterol
* Current enrollment in a therapeutic clinical trial
* Condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures
Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy

Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.

Purpose: This study compares administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.

Patients and methods: Patients will be randomly assigned to one of two groups: midazolam given via traditional intravenous route or midazolam via a nasal atomizer. Outcomes are patient perception of anxiety with the drug delivery method, discomfort with administration, pain during the procedure, and length of sedation effects. Medical personnel rated ease of use, efficacy, time to sedation and time to transport after procedure.

Eligibility Criteria:
Inclusion Criteria:

* all men who request no-scalpel vasectomy procedure

Exclusion Criteria:

* anyone not eligible for no-scalpel vasectomy procedure
Prone Positioning vs. Prone Positioning and NO Inhalation in COVID-19 ARDS.

The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS.

The investigators aim to investigate the effects of prone positioning and prone positioning with NO inhalation for COVID-19 patients with ARDS. Patients with COVID-19-associated ARDS were ventilated in prone position with or without NO inhalation, the arterial blood gas (ABG) tests were performed at 16 hours after prone positioning.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with COVID-19 associated ARDS

Exclusion Criteria:

* patients who have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure
Safety and Efficacy Study Of The Thoracic Aortic Stent Graft System Treating Aortic Dissection

This is a prospective, multicenter and single-arm trail to study the safety and efficacy of the thoracic aortic stent graft system that specially designed for treating aortic dissection.

This trail is conducted in several centers all around China. In about 18 months, 120 subjects with aortic dissection will be recruited, all of which receive endovascular treatment using the thoracic aortic stent graft system (Zylox-Tonbridge Medical Technology Co., Ltd. ). The subjects will be followed up in 30 days/ 6 months/ 12 months/ 2-5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years;
* Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent；
* Subjects who are diagnosed with Stanford type B aortic dissection requiring reconstruction of the left common carotid artery and left subclavian artery or requiring reconstruction of the left subclavian artery;
* Appropriate access to the femoral artery, iliac artery, brachial artery, etc. that can be used for endoluminal aortic therapy.

Exclusion Criteria:

* The same surgery requires intervention for other vascular lesions；
* History of surgery in the aortic arch or endovascular repair surgery;
* Severe stenosis or calcification or distortion in the anchoring area of the proximal end of the stent;
* Subjects with severe liver, kidney failure；
* Subjects with severe coagulation disorders；
* Female subjects who are pregnant, lactating within the study period or unable to contraception during the trail.
* History of allergies to anesthetics, contrast agents or the material of stent/ deliver system；
* Inability to tolerate anesthesia；
* History of acute myocardial infarction, cerebral infarction or cerebral hemorrhage within 3 months before surgery;
* Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint.
* Subjects with acute systemic infection
* Other circumstances judged by researchers that are not suitable for enrollment .
Hypertension In Postpartum Preeclampsia Study

This study aims to evaluate whether NSAIDs (Non-steroidal antiinflammatory drugs) administered during the postpartum period influence blood pressure in women with hypertensive disorders of pregnancy. The study design is a prospective double blinded randomized control trial with participants randomized to receive postpartum analgesic regimens with and without NSAIDs.

Non-steroidal antiinflammatory drugs (NSAIDs) are effective agents for the management of pain in the postpartum period. The addition of NSAIDs to post-cesarean analgesic regimen has been shown to improve post-cesarean pain and reduce opioid requirements. However, concern has been raised over use of NSAIDs in hypertensive pregnant patients, as recent evidence suggests the potential for increased blood pressure in patients with chronic hypertensive disorders receiving these agents. Notably, these studies were conducted on patients with longstanding chronic hypertension, which included males and non-pregnant females, and it is therefore unclear whether this recommendation is appropriate for patients with transient hypertensive disorders of pregnancy.

This protocol describes a randomized trial to evaluate whether NSAIDs influence blood pressure parameters in patients with hypertensive disorders of pregnancy. Patients with severe hypertensive disorders of pregnancy (Severe HDP) will be studied separately from women with mild hypertensive disorders of pregnancy (Mild HDP).

Eligibility Criteria:
Inclusion Criteria:

* Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
* Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
* Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
* Gestational hypertension
* Preeclampsia without severe features
* Preeclampsia with severe features
* Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
* Eclampsia

Exclusion Criteria:

* Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
* Severe hypertension: Patients with at least one severe blood pressure measurement (systolic \>160mmHg or diastolic \>105mmHg) prior to randomization
* Renal dysfunction (Serum creatinine measurement \>1.3mg/dL during the current pregnancy)
* Low platelet count (recorded measurement \<50,000 during hospital admission)
* Significant liver dysfunction (AST or ALT \>500)
* Known sensitivities to ibuprofen or acetaminophen
* Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
* Postpartum hemorrhage requiring transfusion