cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients

This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* age: ≥ 70 years inclusive at Visit 1.
* patients with a confirmed diagnosis of T2DM
* HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
* body mass index (BMI) in the range of 19-45kg/m2

Exclusion Criteria:

* FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
* previous or current participation in any vildagliptin clinical study.
* history of hypersensitivity to DPP-4 inhibitors.
* concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
* donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply
Feasibility Study of Tumor Blood Flow Measurement by Detection of Positron Activation Post Proton Therapy (DS01)

The purpose of this study is the development of noninvasive (having no direct contact) detector and electronic system that will directly measure tumor blood flow rate.


Eligibility Criteria:
Inclusion Criteria:

Solid tumors in the intracranial, thoracic, or pelvic regions.

Exclusion Criteria: N/A

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EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)

The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.

In patients with impaired kidney function, dietary phosphorus can not be completely excreted, which leads to elevated levels of serum phosphorus. Elevated serum phosphorus leads to increased levels of parathyroid hormone (PTH), and is associated with bone disease and other adverse consequences such as soft-tissue and vascular calcification, and increased morbidity and mortality. It is therefore important to prevent hyperphosphatemia and maintain serum phosphorus levels within the range recommended by K/DOQI. In patients on dialysis, phosphate binders are routinely used to control serum phosphorus by absorbing dietary phosphate during the transit through the intestine. However, the use of phosphate binders for non-dialyzed patients with chronic kidney disease (CKD) is not an FDA approved indication, although some physicians treat patients prior to dialysis based on clinical judgment. The goal of this study is to demonstrate the efficacy of calcium acetate (PhosLo) in controlling serum phosphorus in patients with moderate to severe decrease in kidney function.

Eligibility Criteria:
Inclusion Criteria:

* Non-dialyzed male or female patients with CKD, with a GFR of less than 30mL/min/1.73m² who have elevated serum phosphorus or who develop elevated serum phosphorus following washout from phosphorus-binding therapy.
* Patients must have written informed consent
* Negative serum pregnancy test if appropriate
* Expected to be able to comply with protocol procedures and schedule

Exclusion Criteria:

* Unstable angina pectoris
* Severe congestive heart failure
* Severe liver dysfunction
* Severe malnutrition
* Severe hyperparathyroidism
* AIDS (HIV positive subjects without AIDS are not excluded)
* Active malignancy for which the subject is receiving chemotherapy or radiation
* Subject unlikely to complete the study
* History of obstructed bowels or hypersensitivity to any of the study medications or their components
* History of swallowing disorders such as dysphagia (that would prevent the subject from taking the study drug) severe gastrointestinal motility disorders, or major GI tract surgery
* Participation in an investigational drug or device trial within 30 days of randomization
* Subjects on Vitamin D therapy
* Subjects with acute symptoms, in the last month, or current radiographic evidence of kidney stones
* Subjects who have undergone renal transplant or receiving dialysis
* Or any condition with makes patient participation not in the patients best interest
Functional Ability, Symptoms and Quality of Life in Patients With Post Covid-19 Condition

Up to 20% of patients with Covid-19 develop symptoms that last more than 3 months, which is known as long Covid or Post-Covid-19 condition. The mechanism of the long term symptoms is not totally understood although inflammation, autoimmune reactions and thromboembolism are among suspected contributors. At Helsinki University hospital, a long Covid clinic was opened in June 2021. The aim of this cohort study is to monitor the patients that attend the clinic, follow up their functional abilities, quality of life and prognosis.

The patients are asked to give their informed consent for the participation in the cohort study. They fill in a questionnaire before entering the clinic that assesses their symptoms, previous medical history, medications, lifestyle, symptoms, sleep, psychosocial measures including depression, anxiety, resilience and quality of life.

The patients are asked to give blood samples that rule out other diseases that may cause the symptoms. At the clinic, they attend a physician's consultation with physical exam. Later, in another apppointment, a physicotherapist assesses their physicial functioning including 6 minutes walking test and grip strength. They also attend a psychologist who conducts short, 30 min neuro-cognitive testing.

Patients receive psychoeducation of the Post Covid-19 condition and individual, tailored support and rehabilitation. They are given the opportunity to take part in group counselling once a week during 6 weeks.

The patients are followed up by nurse telephone calls at 3, 6 and 12 months as well as by questionnaires via a secured website.

The main outcome measure in this study is functional ability as measured by WHODAS2.0.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosed Covid-19 infection at least 3 mo before entry (either PCR positive or antigen test positive or hospitalisation because of Covid-19)

Exclusion Criteria:

* patients for whom participation would be too exhausting, for example bed patients
* patients who cannot fill in the questionnaires in Finnish
Effects of Mifepristone on Biomarkers of Metabolic Function and Neuropsychological Performance Among Middle-Aged and Older Individuals

The purpose of this study is to study the effect of cortisol,a stress hormone in the body, on memory and attention in people with a history of depression, but who are not in the midst of a current depressive episode.

Cortisol may affect parts of the brain associated with memory and attention directly. It may also indirectly affect the brain by controlling how much insulin the body makes. Insulin is thought to impact cognition by changing the amount of sugar available in certain parts of the brain.

The investigators are studying this question by giving patients a medication, called Mifepristone, which reduces cortisol's effect on the brain. The investigators will compare results from several groups of people, including differences between men and women, and between those with and without insulin resistance.

The specific aims of this study are threefold:

1. To evaluate the association between glucose utilization and neuropsychological performance on tests of verbal memory and attention among patients with a history of depression, but who are euthymic, at baseline;
2. To evaluate changes in neuropsychological test performance among patients with a history of depression and who have insulin resistance who are treated with open-label mifepristone and,
3. To explore interactions between changes in patients' glucose tolerance profiles and changes in verbal memory and attention. An exploratory aim is to explore the interaction of changes in cortisol awakening response and changes in verbal memory and attention within subjects with and without IGT, as well as the potential mediating effects of gender.

Eligibility Criteria:
Inclusion Criteria:

* Ages 50-70
* History of depression, not currently depressed.

Exclusion Criteria:

* History of type 1 or type 2 diabetes.
* Use of a medication that interacts with Mifepristone.
Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency

The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
* Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

* Subjects who are pregnant or lactating
* Subjects who have sensitivity to drugs that provide local anesthesia
* Subjects suffering from active infection of the external eye
* Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)
Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions

Despite preventive treatments and the promotion of oral health, dental caries is one of the most prevalent chronic diseases in the population and treatment of caries lesions in deciduous teeth is a fundamental procedure aimed at increasing the resistance of the remaining tooth structure to preserve the permanent dentition. The present study aims to make a clinical evaluation of the Hall Technique compared to direct restorations with universal adhesives and bulk fill resins in large destruction of deciduous teeth. 90 children between 5 and 10 years old, healthy, of both sexes, without distinction of race, enrolled in the clinics of Universidade Metropolitana de Santos-UNIMES will be selected. The in-office treatments will be carried out by a trained researcher, according to the manufacturer's instructions for each material and scientific evidence on the respective topic. Participants will be divided into 03 groups according to the proposed treatments. Group 1 - Universal adhesive restorative procedure + condensable bulk fill resin; Group 2 - Hall Technique with Shofu steel crowns and Group 3 - Steel crown with conventional technique. The evaluated outcomes will be: effectiveness of the technique and longevity of the restorations.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy child, without systemic changes;
2. Good behavior;
3. Clinically, present at least two deciduous molars with caries in dentin involving more than three surfaces, with vision and direct access, without signs and symptoms of pulp involvement.

Exclusion Criteria:

1. Children with any serious systemic disorder;
2. Lack of cooperation.
3. Clinically present at least one deciduous molar with carious lesion in the dentin involving signs and symptoms of pulpal involvement.
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)

To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.

The study will consist of 12 months of double-blind treatment. Patients will continue to take the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).

Eligibility Criteria:
Inclusion Criteria:

1. The patient completed 24 weeks of treatment in Study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) as part of the Retrieved Dropout (RDO) population.
2. The patient was compliant with taking study medication in Study 015.
3. The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion Criteria:

1. The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
2. The patient has shown clinically significant deterioration during participation in Study 015.
3. The patient discontinued Study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) in Study 015.
PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.


Eligibility Criteria:
Inclusion Criteria:

* Advanced Non-Small Cell Lung Cancer (NSCLC)
* Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
* Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
* Measurable disease .
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Tissue available for KRAS/ EGFR testing
* Creatinine clearance \> 40 cc/min or serum creat \< 1.5 x ULN

Exclusion Criteria:

* Chemotherapy
* Radiotherapy
* Biological or investigational agents within 4 weeks of baseline disease assessment.
* Patients who lack of tolerance of erlotinib therapy.
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis

The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Eligibility Criteria:
Inclusion Criteria:

* Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
* Subject completes the informed consent process
* Subject agrees to take study medication when scheduled
* Subject complies with all clinical trial instructions. Commits to all follow-up visits
* Subject agrees to abstain from sexual intercourse from the time of randomization through the first seven days immediately following treatment

Exclusion Criteria:

* had any other sexually transmitted disease or gynaecological abnormality requiring treatment
* had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
* had used antifungal medication in the week before entry; or
* were expected to menstruate within seven days of the start of treatment
* infected more than one candida species
A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition

This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.

The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at day of consent;
* Is a male, or is a non-pregnant non-lactating female who is either of non-child-bearing potential, or is using adequate means of birth control;
* Has a h/o of urinary incontinence from neurogenic bladder of spinal cord injury etiology;
* Has impairment based on the American Spinal Injury Association (ASIA);
* Use clean intermittent catheterization;
* Has urinary incontinence between scheduled catheterization;
* Capable of understanding and complying with the protocol.

Exclusion Criteria:

* Have one or more treatable conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency;
* Have any medical condition that precludes their participation in the study, or may confound the outcome of the study;
* History of major lower urinary tract surgery, procedures;
* Has an active skin disorder, affecting TDS application site areas;
* Hypersensitivity to the investigational drug;
* Has participated in any study involving administration of an investigational compound within 30 days before this study.
Caregiver Burden and Distress in Hematopoeitic Stem Cell Transplant

The purpose of this study is to examine the impact that serving as a caregiver for a patient undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and overall distress. It will also look at whether caregiver burden leads to an increase in hospitalization and overall outcome.


Eligibility Criteria:
Inclusion Criteria:

Patient:

* Any patient undergoing autologous or allogeneic HSCT at The Blood and Marrow Transplant Program at Northside Hospital
* Patients must have a single primary caregiver
* Patients must be willing to comply with all assessments as outlined in the protocol
* Patients must be willing to sign informed consent

Caregiver:

* Must be the primary caregiver for an autologous or allogenic HSCT patient at the Blood and Marrow Transplant Program at Northside Hospital
* Caregiver must be willing to comply will all assessments as outlined in the protocol
* Caregiver must be willing to sign consent
A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma

The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.

Multiple myeloma (MM) is a malignant disease with abnormal proliferation of clonal plasma cell, which is often accompanied by multiple osteolytic damage, hypercalcemia, anemia, and kidney damage. QLS4131 is a novel tri-specific humanized antibody. The study consists 3 periods: screening phase, treatment phase and a post-treatment follow-up phase. The study will evaluate safety, tolerability, pharmacokinetics and preliminary antitumor activity of QLS4131 administered to participants with relapsed or refractory multiple myeloma. Total duration of study is up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, regardless of gender.
2. Subjects should be willing and able to comply with the study schedule and protocols.
3. Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.
4. Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.

Exclusion Criteria:

1. Known hypersensitivity to any of the ingredients of this product.
2. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
3. Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
Comparison Between Invasive Pressure Flow Study and Non-invasive Penile Cuff Test

To provide evidence of promising tests to noninvasively diagnose bladder outlet obstruction (BOO) in men with benign prostatic hyperplasia.

1. Penile cuff test provides a means of obtaining a urodynamic diagnosis with a high level of accuracy without the morbidity and expense of invasive Pressure flow study.
2. Penile cuff test may be particularly useful in the counseling of patients prior to benign prostatic hyperplasia operation. Patients diagnosed as obstructed following a penile cuff test can be reassured that surgery has a high chance of resulting in symptomatic benefit


Eligibility Criteria:
Inclusion Criteria:

1. Male patients with Low Urinary Tract Symptoms over 6 months. (International prostatic symptom score \>= 12)
2. Patients scheduled to have pressure flow study.
3. Able to give fully informed consent

Exclusion Criteria:

1. Patients with urologic malignancies such as prostate cancer and bladder cancer
2. Patients underwent urethral, prostate surgery
3. Patients with urethral stricture or bladder diverticulum or bladder neck contracture
4. seems not to be appropriate to this study by the decision of investigators because of any other reasons