cyrilzakka/clinical-trials huggingface dataset:
Daily Tadalafil and Gastric Emptying Time in Diabetic Gastroparesis

The investigators hypothesize that in adult patients with diabetic gastroparesis with Type 1 diabetes (HbA1c ≤ 10.5%), daily tadalafil use will significantly improve gastric emptying compared to baseline as measured by gastric emptying time.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosis
* Age 18 - 65 years (inclusive)
* Hemoglobin A1c ≤ 10.5% within the last 4 months
* Diagnosis of gastroparesis, or symptoms consistent with gastroparesis (early satiety, chronic intermittent nausea or vomiting with food intake)
* Patient has gastroparesis confirmed on screening study
* A female patient is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea, or child-bearing potential with negative serum hCG prior to each gastric emptying study.

Exclusion Criteria:

* Active nitrate use (e.g. Cialis, Viagra, Levitra, nitroglycerin, Isordil, Imdur, amyl nitrate/poppers)
* Fasting fingerstick glucose \> 250 mg/dL
* History of abdominal surgery including gastric banding procedure
* Patient is on chronic parenteral feeding
* Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
* Regular opiate use
* Recent (last 6 weeks) history of poor control of diabetes e.g. hypoglycemia requiring medical intervention, diabetic ketoacidosis, admission for control diabetes or complications of diabetes
* Acute severe gastroenteritis
* The patient has participated in another clinical trial in the last 30 days.
* Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study \[e.g., prokinetic drugs, macrolide antibiotics (erythromycin), GLP-1 mimetics/analog, amylin analog\]
* History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition that would in the opinion of the investigator make the subject unsuitable for inclusion in this clinical study.
* Chronic angina or NYHA class III or IV CHF
* Concurrent use of ketoconazole or itraconazole
* History of severe vision loss, retinitis pigmentosa, or non-arteritic anterior ischemic optic neuropathy (NAION)
* History of CVA
* Pregnant females as determined by positive serum hCG test
* Lactating females
* Uncontrolled hypertension (SBP \> 160 or DBP \> 100)
* Hypotension (SBP \< 90 or DBP \< 60)
* Other major medical conditions: priapism, sickle cell anemia, multiple myeloma, leukemia, active cancer diagnosis, HIV/AIDS, alcoholism, or bleeding diathesis.
* Intolerance to active or inactive ingredients of Cialis, or intolerance to other PDE-5 inhibitors.
A Phase 2/3 Study in Adult and Pediatric Participants With SCD

The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.

This is a three-part, multicenter, Phase 2/3 study of orally administered osivelotor in participants with sickle cell disease (SCD).

Part A will evaluate the safety, tolerability, and efficacy of osivelotor in adult participants with SCD to determine an optimal dose.

Part B will evaluate the efficacy of osivelotor versus placebo in adult and adolescent participants with SCD for 48 weeks.

Part C will evaluate the pharmacokinetics (PK) and safety of single and multiple doses (MD) of open-label single arm osivelotor administered to pediatric participants.

Eligibility Criteria:
Inclusion Criteria:

Part A, Part B, and Part C:

* Male or female with SCD
* Participants with stable Hb value as judged by the Investigator
* For participants taking hydroxyurea and/or L-glutamine, the dose must be stable for at least 90 days prior to signing the ICF or assent and with no anticipated need for dose adjustments during the study in the opinion of the Investigator.

Part B:

* Participants with SCD ages 12 to 65 years, inclusive
* Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening.

Exclusion Criteria:

Part A, Part B, and Part C:

* Participants who had more than 10 VOC within 12 months of screening
* Female participant who is breastfeeding or pregnant
* Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1
* Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF
Monitoring and Evaluation of Micronutrients (Sprinkles) Project

The purpose of this study is 1) to evaluate the effectiveness in reducing anemia among children 6-24 months of age by providing daily micronutrient Sprinkles through the Government of Pakistan's Lady Health Worker program; 2) to assist in the monitoring the National Sprinkles Pilot Project.

According to the recent National Nutrition Survey in Pakistan (2001-2002), approximately 66.5% of children under five have anaemia.

Looking at the magnitude of the problem, National Program for Family Planning (FP) and Primary Health Care (PHC) (also known as the Lady Health Workers (LHW) Program) has developed National Sprinkles Pilot Project Proposal with technical assistance of Micronutrient Initiative and Aga Khan University (AKU). As the projects technical partner, AKU is responsible to conduct the monitoring and evaluation of the project.

The study will use a cluster randomized pre-post intervention design that compares before and after hemoglobin (Hb) measurements, serum ferritin, serum retinol and urinary iodine among children who received Sprinkles and age-appropriate feeding advice (Sprinkles-Advice group) and children who only receive age-appropriate feeding advice (Advice-only group). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. However, intervention LHWs, will give additional advice regarding the benefits of Sprinkles and its appropriate use.

The target population selected for the study consisted of children between the ages of six and eighteen months of age in the catchment area of the Lady Health Workers.

Eligibility Criteria:
Inclusion Criteria:

* Child's mother gives written consent after hearing an explanation of the study
* Random selection of child in household with more than one eligible child

Exclusion Criteria:

* Any household in which consent is not given
* Children with any congenital or physical disability (such as cleft palate, Down's Syndrome, etc.)
* Child from a family which intends to migrate during the study period
Nocturnal Insulin-Glucose in Hospital: Tight Control

The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes
* Diabetes duration \> 3 years
* Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
* A1c 6-9%
* No ketoacidosis during the previous 12 months
* Glomerular Filtration Rate (GFR) \> 60 ml/kg/min m2
* Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice

Exclusion Criteria:

* Gastroparesis
* Hypoglycemia unawareness
* Uncorrected visual impairment
* Deafness
* BMI\> 35 kg/m2
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern

The occurrence of persistent vaginal bleeding following laparoscopic supracervical hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists have claimed that removal of any remaining endometrium in a reverse cone pattern at the time of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The effect of this particular technique has not been reported.

Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1\&K2, Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved.

Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient satisfaction 12 months after the procedure (10-point analogue scale).

Design: Prospective randomised trial. Methods; The study participants are randomised to laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone pattern followed by electrocoagulation of the upper cervical canal (n =70).


Eligibility Criteria:
Inclusion Criteria:

* All premenopausal women who are referred to the departement due to a benign condition requiring hysterectomy and who have given informed consent are eligible for study recruitment

Exclusion Criteria:

* Women who are unable to communicate in written Norwegian or oral English language.
* Woman with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative smear or wtih atypical hyperplasia og malignancy in preoperative endometrial biopsy
* Women who after a thorough clinical evaluation are found to be more suited for vaginal, abdominal or total hysterectomy
* Women with a coexisting condition requiring no remaining ovaries after the procedure
* Postmenopausal women
* Women using hormone therapy (HT)
The Head Impulse Test in the Screening of Vestibular Function

The alternate binaural bithermal caloric test (ABBT) is a well established examination in the evaluation of the dizzy patient. ABBT is useful in detecting the side of peripheral vestibulopathy by stimulating each ear separately, it contributes to the diagnosis of bilateral vestibular involvement when all responses to cold and warm stimuli are reduced, and adds to the differentiation of peripheral from central vestibular involvement by measuring the fixation-induced inhibition of the caloric response. In spite of these benefits, ABBT is the most time-consuming part of the electronystagmography/Videonystagmography (ENG/VNG) test battery, and frequently causes significant inconvenience to the patient due to the repeated extreme vestibular stimuli.

The head impulse test (HIT) assesses vestibular function by brisk, passive rotations of the head in the plane of the examined semicircular canals. Whenever the vestibulo-ocular reflex (VOR) is deficient, this maneuver would produce catch-up saccades aiming to the re-fixation of the eyes on the target. Hence, both residual VOR and catch-up saccades act synergistically to stabilize gaze. The HIT requires only several minutes and might cause minimal discomfort only.

The study hypothesis is that the HIT recorded by standard VNG equipment of the VNG system would provide diagnostic information on the side of vestibular involvement matching that of the ABBT.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Videonystagmography(VNG) test battery is indicated for the diagnosis of dizziness or vertigo

Exclusion Criteria:

* Signs of retrocochlear lesion or central vestibular pathology in bed-side otoneurological examination or audiometry or ENG/VNG
* Age \< 18 years
* Otitis externa
* Otitis media
* Tympanic membrane perforation
* Status Post Mastoidectomy
* Limitations of neck movements in the horizontal plain
Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI

The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).

A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.

Eligibility Criteria:
Inclusion Criteria:

1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
3. Written informed consent
4. Age of at least 18 years

Exclusion Criteria:

1. Permanent pacemaker implantation before TAVI procedure
2. The occurrence of conduction disturbances more than 30 days after TAVI procedure
3. No written informed consent
4. Inability to obtain informed consent from participant
5. Predicted inability to obtain cooperation from patient during observation period
A Comparison of Capnography Sampling Lines

This study evaluates the performance of eight (8) cleared capnography carbon dioxide (CO2) sampling filterlines during patient simulated scripted activities when connected to a Medtronic (MDT) dual parameter monitor.

The eight (8) Capnography CO2 Sampling Filterlines (CCSF) have different designs for obtaining a gas sample for CO2 measurement and also for delivering supplemental oxygen (O2).

In this study awake, healthy volunteers will evaluate the 8 CCSF (Capnography CO2 Sampling Filterline) to determine their performance variability in providing a representative exhaled CO2 sample for measurement on the Capnostream 35 dual parameter monitor during scripted activities of closed mouth/open mouth breathing during both high and low respiration rate with supplemental oxygen delivery at 5lpm.

Eligibility Criteria:
Inclusion Criteria:

1. Non-hospitalized adults ≥ 18 years old.
2. Willing and able to give informed consent.

Exclusion Criteria:

1. Lack of an informed consent.
2. Subjects not able to accommodate the proper application of the cannula.
3. Subject not willing or able to comply fully with the study procedures.
4. Subjects with sensitivity to nasal cannula in both nares.
5. Subject with skin allergies to medical adhesives.
6. Subjects with runny nose the day of the study participation.
7. Subject, who in the opinion of the Principal Investigator, should not be enrolled.
Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-metastatic cancer of the prostate gland
* Patient to be 18 years and above

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.
Clinical and Economic Validation of the ISGPS Definition of PPAP

This prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment.

The study will be conducted at approximately 37 investigative sites in Europe, Asia, Oceania, and the United States. Only high volume centers for Pancreatic Surgery will be included in the study. All patients scheduled to receive elective pancreaticoduodenectomy (PD Kausch-Whipple or Longmire-Traverso) for all type of pancreatic disease (benign, malignant, or premalignant) will be enrolled. The study duration per subject will be up to 30 days after surgery or all the in-hospital lengths of stay. Preoperative care will follow institutional standards, according to each center involved. Surgical resection and reconstruction will be carried out according to the techniques adopted by each participating center. Both patients undergoing open and minimally invasive surgery can be considered eligible. Postoperative management will follow the institutional standards of each center. Serum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days (POD) 1 and 2.Serum C-reactive protein (CRP) will be measured according to each institutional policy and reported once assessed from POD 1 to 3. Drain fluid amylase, or lipase activity will be checked according to the Institutional standards of each involved, and the values will be retrieved whether assessed from POD 1 to five. Radiological imaging will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious for abdominal complications.The severity of complications will be assessed according to the Clavien-Dindo (CD) classification system 32 . Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery. Length of hospital stay is calculated from the day of surgery to discharge. Preoperative, intra-operative, and postoperative data will be recorded prospectively.

The estimated study duration will be 15 months. Time for data analysis must be considered negligible. Patients' follow-up will last 30 days after surgery to catch any additional morbidity even after discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective PD;
* Male and females ≥ 18 years;
* Upfront or after neoadjuvant therapy surgery is allowed;
* The ability of the subject to understand the character and individual consequences of the clinical trial;
* Written informed consent.

Exclusion Criteria:

* Patients undergoing emergency surgery;
* Informed consent withdrawal;
* Inability to perform the resection for any reason;
* Total or distal pancreatectomy.
Thyroid Cancer in Surgical Treated Multinodular Goiter

This study aims to investigate, based on existing knowledge, the incidence of occult thyroid carcinoma in a cohort of patients with MNG, providing new insights into the prevalence and characteristics of thyroid malignancies in MNG. It seeks to contribute to optimizing diagnostic evaluations for patients with multinodular goiter.

This retrospective study included patients with a preoperative diagnosis of multinodular goiter who underwent total or partial thyroidectomy from January 2018 to May 2024 at the Department of Medical and Surgical Sciences at the University Hospital "Ospedali Riuniti" in Foggia. The study's objective was to investigate the incidence of thyroid carcinoma in patients undergoing thyroidectomy for MNG, also analyzing associated demographic and clinical variables.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with multinodular goiter via thyroid ultrasound, with or without FNA cytology.
* patients who underwent surgery.
* availability of complete clinical data

Exclusion Criteria:

* history of thyroid carcinoma or other thyroid neoplasms.
* not completed postoperative follow up.
* patients with preoperative FNA results indicating malignancy (TIR 4-5), suspicion of malignancy (TIR 3), or indeterminate significance (TIR 1)
Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization

The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Participant must successfully complete the MRI screening form if receiving an MRI
* Participant must be scheduled to undergo radioembolization for any indication
* Participant must be ≥ 18 years of age
* Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria:

* Participant must not have any contraindications to MRI scanning
* Patient must not be pregnant or breastfeeding
* If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR \< 30 mL/min/1.73 m2) measured within the past 60 days
* If agreeing to MRI contrast, participant must not be on dialysis
* If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
* PET/MRI or PET/CT is not able to be scheduled within 72 hours of radioembolization
Effectiveness of Aurix Therapy in Pressure Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard care and compared 1:1 to patients receiving undefined Usual and Customary Care.

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. Aurix is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of Aurix to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which pressure ulcers will be treated using Aurix and standard of care to determine time to heal at 16 weeks. Comparison will be made to patients receiving undefined Usual and Customary Care in a 1:1 manner.

Eligibility Criteria:
Inclusion Criteria:

1. Medicare eligible
2. ≥18 years of age
3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
5. For subjects with potentially multiple eligible PUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
6. Debrided ulcer size between 3 cm2 and 200 cm2
7. Subject has received UCC care for ≥ 2 weeks at treating wound clinic
8. Demonstrated adequate pressure relief regimen
9. Duration ≥ 1 month at first visit
10. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria:

1. Subjects known to be sensitive to Aurix components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
2. Stage I pressure ulcers
3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
4. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by Aurix
5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
6. Patients on chemotherapeutic agents or any malignancy in the wound area
7. Subjects who are cognitively impaired
8. Serum albumin of less than 2.5 g/dL
9. Plasma Platelet count of less than 100 x 109/L
10. Hemoglobin of less than 10.5 g/dL
11. Subject has inadequate venous access for repeated blood draw required for Aurix Administration.
12. Life expectancy of \< 6 months.