cyrilzakka/clinical-trials huggingface dataset:
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

An investigation of non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

The test products are non-CE marked stoma tape products. This investigation is a randomised, open-label, comparative, cross-over study, with three test periods. In total, 12 subjects will be included and randomised.

Eligibility Criteria:
Inclusion Criteria:

* Has given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had a stoma for more than ½ year
* Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
* Willing to change baseplate every second day or less frequent
* Willing to avoid using Concave baseplate during the study.
* Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.

Exclusion Criteria:

* Currently receiving or have within the past 2 months received radio-and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
* Is pregnant or breastfeeding
* Having dermatological problems in the peristomal area (assessed by investigator)
Therapeutic Drug Monitoring of Tildrakizumab in Psoriasis Patients

Biologics such as tildrakizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study, the investigators aim to investigate the predictive value of early serum trough levels of tildrakizumab and determine the therapeutic window of tildrakizumab in psoriasis patients.

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of tildrakizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (100mg)). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards tildrakizumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
* Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* Participants who have currently a predominant nonplaque form of psoriasis
* Participants who are pregnant, nursing or planning a pregnancy
* Participants who are unable or unwilling to undergo multiple venapunctures
* Participants who are treated according to a different dosing schedule than standard dosing of tildrakizumab
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.

The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria:

* Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated
Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women

The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.

Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.

Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.
* Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

Exclusion Criteria:

* One (1) or more osteoporotic vertebral fractures (T4-L4).
* Diseases that may affect bone metabolism.
* Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.
Radiofrequency Therapy of the Neck Muscles for Treating the Post-dural Puncture Headache After Cesarean Delivery.

Postdural puncture headache (PDPH) is a frequent complication after neuraxial anaesthesia due to accidental puncture of the dura mater. After spinal anaesthesia, the rate of PDPH may reach up to 28,7% of cases. PDPH is more common in females, especially obstetric patients, young age and more after epidural than spinal anaesthesia because of needle type. PDPH interferes with the patient's ability to resume activities, prolongs the hospital stay, and causes chronic headaches in up to 28% of cases.

Several treatment modalities were described for PDPH. Conservative treatment, an epidural blood patch, peripheral nerve blocks, such as sphenopalatine ganglion block (SPGB) and more excellent occipital nerve block (GONB) using local anaesthetic block or through percutaneous radiofrequency ablation or direct injection of local anaesthetic and steroid directly into the neck muscles; were all proven effective in treating PDPH. Radiofrequency (RF) is a commonly used technique to treat different types of pain, headaches, and musculoskeletal abnormalities. The second-generation non-invasive RF modality was recently developed as Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer). Tecar therapy provided promising results in treating chronic pelvic and postpartum perineal pain. To our knowledge, Tecar therapy efficacy in treating PDPH has not been evaluated before. This study aims to assess the effectiveness of Tecar therapy as a non-invasive technique for treating PDPH. This study hypothesizes that Tecar therapy could be an effective non-invasive technique for treating or reducing PDPH.


Eligibility Criteria:
Inclusion Criteria:

* female patients aged over 18 years
* ASA physical status I or II.
* scheduled for elective cesarean delivery under spinal anaesthesia
* who developed PDPH with failed conservative treatment

Exclusion Criteria:

* Patients with a history of long-standing diabetes.
* peripheral vascular diseases
* cervical spine disorders
* receiving analgesics and anticonvulsant medication .
Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy

The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD).

The main questions we aim to answer are:

* How does the use of stand-on PMDs affect static balance in children with cerebral palsy?
* How does the use of stand-on PMDs affect dynamic balance and mobility function in children with cerebral palsy?

Children ages 4-6 years old with cerebral palsy (GMFCS levels II and III) will:

* Use individually-adapted stand-on PMDs for three months.
* Undergo tests to measure static balance, dynamic balance, and mobility function before and after the intervention.
* Receive a full biomechanical assessment (kinematics, kinetics, muscle activity, gait spatiotemporal characteristics).

Researchers will compare pre-intervention and post-intervention measurements to quantify improvements in balance, muscle activation, and mobility.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of spastic diplegia CP, GMFCS level III;
2. Between 4 and 6 years old (age band selected based on the benefits of early intervention and the age-limitation imposed from the size constraints of the PMDs (toy cars) selected for the intervention);
3. Able to stand and to walk short distances (at least 10 meters) with or without external assistance;
4. Physician medical clearance to participate; and
5. Exhibit sufficient cooperation and attention so that simple verbal instructions can be followed.

Exclusion Criteria:

1. Have notable orthopedic conditions (e.g., lower extremity amputation; recent hip surgeries or soft tissue lengthening);
2. Inadequate vision to complete study's procedures safely;
3. Serious/unstable cardiac conditions that prevent engagement in the Evaluation Sessions; and
4. Any other factor that might hinder full participation in the study or confound interpretation of the results.
Does Pupil Size Matters in Refractive Surgery?

To determine the influence of pupil size in refractive surgery. If any influence exist.


Eligibility Criteria:
Inclusion Criteria:

- above 18 years suffers from myopia

Exclusion Criteria:

- suffer from keratoconus younger than 18 years old had previous eye surgery.
Pre-emptive Effect of Duloxetine in the Second Knee in Staged Total Knee Arthroplasty

In Korea, the interval between knee arthroplasties is usually 1 week. According to previous studies, when total knee arthroplasty was performed at 1-week intervals, total bleeding was reduced and the period of hospital stay was shortened.

However, if stepwise total knee arthroplasty is performed at intervals of one week, the pain is greater after the second operation, and the reason for this phenomenon is known to be due to central sensitization and opioid resistance.

Therefore, the investigators aim to confirm whether Duloxetine reduces the central sensitization as previously known and affects the pain control after the second operation.

Degenerative arthritis of the knee is one of the most common arthritis. Currently, total knee arthroplasty is the most commonly used surgical procedure. The degenerative changes of the knee are often seen on both sides, and bilateral total knee arthroplasty is usually performed. In the past, bilateral total knee arthroplasty was performed at the same time. When bilateral total knee arthroplasty was performed simultaneously, the complications such as increased mortality occurred. So, it is common to perform bilateral total knee arthroplasty in a stepwise manner.

In Korea, the interval between knee arthroplasties is usually 1 week. According to previous studies, when total knee arthroplasty was performed at 1-week intervals, total blood loss was reduced and the period of hospital stay was shortened. However, if stepwise total knee arthroplasty is performed at intervals of one week, the pain is greater after the second operation, and the reason for this phenomenon is known to be due to central sensitization and opioid resistance.

Therefore, the investigators aim to 1) whether the pain is greater than the first operation at the second operation in the control group. 2) whether the pre-operative and post-operative duloxetine use causes the pre-analgesic effect on the second operation. 3) whether the central sensitization, clinical score, and painkiller usage are different by comparing duloxetine-treated group and control group.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for staged bilateral total knee replacement arthroplasty due to osteoarthritis of the knee.

Exclusion Criteria:

* Known allergic reaction to duloxetine
* Secondary arthritis (ex. Rheumatic arthritis, traumatic arthritis, septic arthritis)
* History of major operation(ex. Arthroscopic knee arthroplasty, osteotomy, open reduction, and internal fixation)
* History of manic or bipolar disorder, epilepsy, increased intraocular pressure or risk of acute angle-closure glaucoma, liver disease, moderate renal disease (CLcr \< 30ml/min), severe heart disease, uncontrolled hypertension, unregulated narrow-angle glaucoma
* Known congenital or acquired coagulopathy
* Known genetic disorders such as fulminant intolerance / glucose-galactose uptake disorder/sucrose isoleucetase deficiency
* Taken MAO inhibitor, anti-depressants, diuretics, duloxetine
* Refuse to participate in the study
Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001)

Researchers want to learn if MK-4002 (also known as HPN217) can treat relapsed or refractory multiple myeloma (RRMM). The goals of this study are to learn about the safety of different doses of MK-4002 and how well people tolerate them. Researchers also want to learn what happens to different doses of MK-4002 in a person's body over time.


Eligibility Criteria:
Major Inclusion Criteria:

1. Patients ≥18 years of age at the time of signing informed consent
2. Documented RRMM for which no standard therapy options are anticipated to result in a durable remission. Relapse defined as progressive disease after initial response (minimal response \[MR\] or better) to previous treatment, more than 60 days after cessation of last treatment. Refractory disease defined as \<25% reduction in M protein or progression of disease during treatment or within 60 days after cessation of treatment.
3. Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
4. Measurable disease defined as at least one of the following:

   1. Serum M-protein ≥0.5 g/dL
   2. Urine M-protein ≥200 mg/24 hours
   3. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65)
5. Resolved acute effects of any prior therapy to baseline severity or Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤1.

Major Exclusion Criteria:

1. Plasma cell leukemia; non-secretory myeloma (e.g., solitary plasmacytoma)
2. Patients with only extramedullary relapse of multiple myeloma who do not meet requirement for measurable disease.
3. Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the start of study
4. Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of Screening. However, any patient receiving immunosuppressive medication will be excluded.
5. History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received any treatment for their autoimmune disorder in the past 3 years
6. Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3-year remission: non-melanoma skin cancer, resected melanoma in situ, in situ cervical cancer, adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for ≥2 years, low-risk prostate cancer with Gleason score \<7 and prostate-specific antigen \<10 ng/mL
COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

Primary objective:

1. Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.

Secondary objectives:

1. Monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
2. Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
3. Evaluate the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;
4. Evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus;
5. To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.

Methodology:

1. Administration at baseline of a questionnaire for the collection of clinical data.
2. Perform a blood sample to measure antibody response in vaccinated subjects
3. Administer a questionnaire to evaluate adverse events after vaccination
4. Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination
5. An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.
6. In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.
7. In the event that a subject participating in the study presents during the course of the observation the positivity for the molecular research of SARS-CoV-2 RNA to the oro-nasopharyngeal swab, a new sample will be performed and sent to the Istituto Superiore di Sanità for the search for viral variants.


Eligibility Criteria:
Inclusion Criteria:

All subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study.

Exclusion Criteria:

All subjects who refuse to give consent or who have contraindications to vaccination.
Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer

RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

OBJECTIVES:

* Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification.
* Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs.
* Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid.
* Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection.

Patients are followed for disease evolution.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed invasive breast cancer

  * T0, T1, or T2 no greater than 3 cm, N0
  * Amenable to surgery
* No inflammatory breast cancer
* No ductal cancer in situ or multicentric invasive ductal cancer
* No nipple/areola or central breast cancer (at least 2 cm from areola)
* No metastatic disease
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* Over 18

Sex

* Not specified

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant
* Negative pregnancy test
* No known allergy or intolerance to patent blue V dye

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No prior surgery for cancer

Other

* No prior neoadjuvant treatment for cancer
Study of ONO-1078 in Patients With Chronic Sinusitis

To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study


Eligibility Criteria:
Inclusion Criteria:

* chronic sinusitis

Exclusion Criteria:

* acute sinusitis
* chronic sinusitis with acute exacerbation
Nitroglycerine Versus Dexmedetomidine Infusion in Intraoperative Management of Uncontrolled Hypertension

This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.

Nitroglycerine is a direct vessel wall vasodilator with more venodilator effect than arterial dilator effect. It is used as an anti-anginal and antihypertensive drug. On the other hand, dexmedetomidine is a highly selective alpha 2 adrenergic agonist with sympatholytic effect. This study aim to compare the efficacy of intraoperative dexmedetomidine infusion versus Nitroglycerin infusion in cancer patients with accidental uncontrolled intraoperative elevation of blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients with controlled hypertension and undergoing surgical procedures under general anesthesia
* ≥ Age 18 years.

Exclusion Criteria:

* patient refusal
* patients on Beta blockers
* kidney or liver function impairment
* bradycardia, any degree of heart block and severe cardiorespiratory disease