cyrilzakka/clinical-trials huggingface dataset:
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum

This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.

Patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) PA-21 followed by high-dose (2000mg/d) PA-21 (sequence A-B) or to receive high-dose PA21 followed by low-dose PA21 (sequence B-A) with washout-phases in between. An open label design with a sub-therapeutic dose of PA21 as control treatment was chosen because creating a convincing placebo for PA21 is not feasible.

The study will start with two study visits on the 2nd and 3rd dialysis session of the week , where dialysis patients are still treated with standard of care to establish baseline values (duration: 0.5 weeks). Next will be an initial run-in wash-out phase, where all phosphate binders taken by the patient as standard of care treatment will be discontinued and no phosphate binders will be introduced. Consequently, there will be a PA21 treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another PA21 treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 days of duration. Patients will be followed up to 10.5 weeks after randomization until the last study visit of the final wash-out phase.

Eligibility Criteria:
Inclusion Criteria:

* Prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF)
* Hyperphosphatemia (serum phosphate \> upper limit of normal within the last 3 months) or current phosphate binder use
* No use or constant dose of vitamin D and/or calcimimetics for ≥2 weeks

Exclusion Criteria:

* Allergy to sucroferric oxyhydroxide (PA21), to other ingredients of Velphoro or to any iron-medication
* Current or history of calciphylaxis (calcific uremic arteriolopathy - CUA)
* parathormone \>800 pg/ml
* Parathyreoidektomie planned or expected
* Significant GI or hepatic disorders
* Hypercalcemia (total serum calcium \>2.6 mmol/l) at screening
* Antacids containing aluminum, calcium, magnesium or bicarbonate
* Oral iron treatments/supplements
* Pregnant and nursing (lactating) women
Comparison of Short- and Long-time Action Observation Training on Upper Limb Function in Children With Cerebral Palsy

To compared short- and long-time action observation training (AOT) in terms of grip strength, the Jebsen Taylor Hand Function Test (JTHF), the Quality of Upper Extremities Skills Test (QUEST), and the ABILHAND-Kids test.


Eligibility Criteria:
Inclusion Criteria:

* ages between 6 and 15 years
* confirmed diagnosis of spastic CP
* below grade 2 on the modified Ashworth scale
* between grade 4 and 8 on the house functional classification system
* ability to understand the assessor's instructions.

Exclusion Criteria:

* severe spasticity in UL (MAS\>2)
* orthopedic surgery in the UL within 6 months
* absence of sensory
Survey to Identify Substance Use in Teenagers and Adolescents

This is a prospective survey study of patients 12-21 years undergoing anesthetic care. The primary objective is to determine the incidence of illicit substance use and abuse prior to anesthetic care. The secondary objective is to determine the illicit substances used and their frequency in patients presenting for anesthetic care.

The participants will be asked to complete a survey in REDCap using an iPad during the visit. The study will record any positive answers from the drug and tobacco use questions routinely asked of the parents during the on-line pre-admission testing process. These include yes/no answers regarding drug, alcohol, and tobacco use.

The information collected will include only demographic data including age, weight, gender, ethnicity/race, and zip code. Survey data will be coded and will not include patient information. Completion of the survey will take approximately 15-20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients 12-21 years of age
* Presenting for surgery or procedure requiring anesthesia

Exclusion Criteria:

* Patients who are not able to complete the computerized survey due to physical or intellectual impairment
* Patients who are non-English speaking
iTBS to Enhance Social Cognition in People With Psychosis

The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are:

* Compare changes in social cognitive performance between the active vs. sham treatment groups
* Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups

Each participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-39 years.
2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5).
3. Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first- or second-generation antipsychotics permitted).
4. Able to participate in the informed consent process and provide voluntary informed consent.

Exclusion Criteria:

1. A history of a DSM-5 substance use disorder (other than cannabis, caffeine, or tobacco) within the past six months; or a positive baseline urine drug screen. Only participants meeting for moderate to severe cannabis use disorder will be excluded.
2. Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset \< 35 years of age and/or diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)
3. Acute or unstable medical illness (e.g., delirium, cancer, uncontrolled diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardial infarction), whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
4. Neurological disease associated with extrapyramidal signs and symptoms (e.g., Parkinson's disease); epilepsy, if the person has had one or more grand mal seizures in the past 18 months; history or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder
5. Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher due to the potential of these medications to limit the efficacy of iTBS
6. Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
7. Prior Psychosurgery
8. Presence of MRI contraindications (e.g., pacemakers)
9. Pregnancy
10. TMS treatment in the past three months
Evaluation of Safety, PK, and Preliminary Effects on Scar Formation of Multiple Intradermal Administrations of RXI-109

The purpose of this trial is to evaluate the safety and tolerability of multiple (3) intradermal doses of RXI-109 at small surgical incisions in the abdominal skin of healthy volunteers. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually, histologically, and by biomarker analysis.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 21-50 years of age
* General good health; if female not pregnant or lactating
* Phototype 3 and above based on the Fitzpatrick scale.

Exclusion Criteria:

* Pregnant or lactating
* Use of tobacco or nicotine-containing products within 1 month prior to enrollment and while on study
* Type 1 or 2 diabetes mellitus
* A history or presence of any medical condition or therapy that would make the subject an unsafe candidate in the opinion of the investigator
Validation of Pulsewave Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women

The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff in pregnant and postpartum women who have either normal blood pressure or high blood pressure.

The study will include a series of nine blood pressure measurements. The measurements will alternate between a gold standard auscultatory blood pressure measurement and the Pulsewave monitor.

A trained clinician will be used for gold standard measurements using an appropriately sized cuff around the upper arm, a sphygmomanometer, and a stethoscope. Systolic blood pressure is defined by the first Korotkoff sound; diastolic blood pressure is defined by the fifth Korotkoff sound.

Measurements by the Pulsewave monitor will be performed using a proprietary oscillometric wrist cuff automated by a computer tablet and software made by CloudDx Inc.

Women will be seated for 5 to 10 minutes before the first blood pressure measurement. During this time, 4 circumference measurements will be taken of the arm and wrist.

1. The armpit will be measured as proximally as possible.
2. The mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process.
3. The distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease.
4. The wrist will be measured approximately 2 cm proximal to the wrist flexion crease.

The first two blood pressure measurements will be used as a way to orient the subject to each device and the methods so that they are comfortable with the cuff and the process. The seven subsequent measurements will be used for analysis. There will be a 30 second to 60 second period between blood pressure measurements.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant or admitted to the postpartum unit
* Normotensive women - No diagnosis of hypertension
* Hypertensive women - Diagnosis of hypertensive disorder of pregnancy

Exclusion Criteria:

* Women in active labor
* Women \< 18 years of age
* Non-english speakers
The Usefulness of Staining Lymph Nodes During Operations for Cancer Thyroid in Detecting the Nodes That Have Cancer

Detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland during operation is useful. It saves the patient from having a second operation to remove these nodes later on when they become obvious. The problem is that there are many lymph nodes around the gland. The theory is that only one node will get the first spill of the tumour cells.

In this study the investigators are trying to use an inert colored material to inject into the tumour. This should run in the same path as the tumour cells and should therefore stain the one lymph node that will be affected first should the tumour spread.

The stained lymph node is excised and examined instantaneously for tumour affection. If it is found to be affected by the tumour, then the operation is extended to include removal of all its fellow lymph nodes. If it is found to be free from the tumour, then this patient does not have tumour spread.

The study includes 45 consecutive patients diagnosed as differentiated thyroid cancer by clinical examination and/or fine needle aspiration cytology (FNAC).

Exclusion criteria are: previous neck surgery, pregnancy and known hypersensitivity to the dye used.

An informed consent was obtained from all the patients. Peroperative workup includes history taking, clinical examination, relevant laboratory investigations including thyroid hormone assay, ultrasonography of the neck with special emphasis on the thyroid focal lesion and cervical lymph nodes. FNAC was attempted in all patients.

All patients were then subjected to operation:

A systematized surgical approach was adopted for the purpose of the study: this started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. This was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (SLN); performing total thyroidectomy and bilateral central neck dissection.

The resected specimen was fixed by formaldehyde, stained with hematoxylin and eosin and examined with light microscopy.

If the SLN was found to be free of malignant deposits, it was further examined by immunohistochemical staining.

Statistical analysis: Descriptive statistics were used to analyze demographic data. Sensitivity, specificity and predictive value of the SLN were calculated.

The histopathological report of the excised specimen was considered the criterion standard.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed to have differentiated thyroid carcinoma and has no detectable cervical lymphadenopathy.

Exclusion Criteria:

* Previous neck surgery, pregnancy and known hypersensitivity to the dye used.
The Study of an Investigational Drug, Revusiran (ALN-TTRSC), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Whose Disease Has Continued to Worsen Following Liver Transplant

The purpose of this study was to evaluate the safety and effectiveness of revusiran (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has continued to worsen after liver transplantation. Dosing has been discontinued; patients are being followed-up for safety.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FAP (familial amyloidotic polyneuropathy) with documented TTR mutation
* Received an orthotopic liver transplant ≥12 months before the date of informed consent
* An increase in polyneuropathy disability (PND) score post-transplant
* Polyneuropathy Disability score of ≤3b

Exclusion Criteria:

* New York Heart Association (NYHA) classification of \>2
* Other known causes of sensorimotor or autonomic neuropathy (eg, autoimmune disease)
A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies

The aim of the trial is to determine the recommended phase II dose of weekly intravenous topotecan in combination with a fixed dose (25 mg or 15 mg) of weekly intravenous temsirolimus in patients with and without prior pelvic radiation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent or metastatic ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma, cervical carcinoma, endometrial carcinoma, vulvar carcinoma, vaginal carcinoma, or carcinosarcoma of the ovary, endometrium or cervix.
* Prior Therapy: at least one and may have up to three prior cytotoxic chemotherapeutic regimens for the management of primary disease.
* Must be at least 18 years of age.
* GOG performance status must be 0 or 1.
* Patients must have adequate organ and marrow function as defined below:

  * hemoglobin ≥10g/dL
  * absolute neutrophil count ≥1,500/uL
  * platelets ≥100,000/uL
  * total bilirubin below the institutional upper limit of normal
  * AST(SGOT)/ALT(SGPT) below the institutional upper limit of normal
  * creatinine below the institutional upper limit of normal
  * cholesterol ≤ 350 mg/dL (fasting)
  * triglycerides ≤ 400 mg/dL (fasting)
  * albumin ≥ 3.0 mg/dL
* negative pregnancy test for women able to have children
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior therapy with topotecan
* More than 3 prior cytotoxic chemotherapeutic regimens or treatment with temsirolimus or any other mTOR inhibitor
* Concomitant hormonal therapy or radiation therapy
* Clinically significant infections or other medical problems of significant severity
* History of unstable angina or myocardial infarction within the past six months
* Known brain metastases unless the metastases have been controlled by prior surgery or radiotherapy, and the patient has been neurologically stable and off of steroids for at least 4 weeks.
* Any requirement for oxygen
* Cannot be receiving potent enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital) nor any other potent CYP3A4 inducer such as rifampin or St. John's wort, as these may decrease temsirolimus levels. Use of agents that potently inhibit CYP3A4 (and hence may raise temsirolimus levels), such as ketoconazole, is discouraged, but not specifically prohibited.
An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia

This study investigates correlation between dreaming in propofol anesthesia and an Observer-rating-scale of facial expression after gastrointestinal endoscopy in adults. It also compares dreamers and non-dreamers in age, BMI, propofol dose, duration of procedure, mean arterial pressure, pulse values and Bispectral index values.

After Ethical committee approval and written informed consent was obtained, a total of 124 patients undergoing gastrointestinal endoscopy were recruited in the prospective observational study. Anesthesia was maintained using incremental propofol doses until the patient was calm and unresponsive to painful stimuli. Bispectral Index (BIS), blood pressure (BP) and pulse were monitored in typical intervals: before induction, during induction, at the beginning of the procedure, at 2nd, 5th and 10th minute of the procedure, and on emergence. On the emergence of anesthesia, the patient's facial expression was rated numerically (-3 pain, +3 smile). Thereafter patients were asked to rate their dream.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing gastrointestinal endoscopy at Osijek University HOspital form September 2016 to October 2017.

Exclusion Criteria:

* . Patients who were younger than 18 years, unscheduled patients who were not hemodynamically stable, those who were not able to understand study protocol, and who did not sign written informed consent were not included in the study. Patients whose procedure was longer than 60 minutes and patients with incomplete records were excluded from the study.
Effectiveness of SMS Nudging to Increase Coverage of Influenza Vaccination Among the Elderly

The trial will investigate to what extent SMS reminders for influenza vaccination increases coverage of influenza vaccination among elderly from the majority population, and among elderly from immigrant groups with low vaccination coverage

Background: The coverage of influenza vaccination among elderly in Norway is insufficient, especially in some immigrant groups. To improve public health, there is a need for an intervention that can increase influenza vaccination coverage. Further, interventions tailored to reduce potential barriers among immigrants can reduce health inequities.

Objective: InfluSMS aims to determine if SMS nudging increases vaccination coverage among those aged 65 or older (i) in Norway's general population; (ii) among immigrants born in Poland; (iii) among immigrants born in Ukraine; and to evaluate the impact of SMS nudging in Norwegian versus in the official language of the native country of immigrants born in Poland or Ukraine.

Methods: InfluSMS is a pragmatic randomized controlled trial conducted among people aged 65 or older residing in Norway. Influenza vaccination coverage is the main outcome, measured in control and intervention arms for each of the three populations listed above. In all three populations, the control arm is standard care, i.e., no individual reminder for influenza vaccination. All populations have an intervention arm that will receive an SMS nudge in the Norwegian language. In addition, the Polish and Ukrainian immigrant populations include a second intervention arm that will receive an SMS nudge in Polish or Ukrainian, respectively. Allocation to study arm is randomized, and the intervention will take place at the start of the 2025/2026 influenza season. All eligible individuals will be passively followed up through the National Immunisation Registry SYSVAK, from which individual influenza vaccination status three months after the SMS nudge will be extracted.

Results: Inclusion of participants will start in the third quarter of 2025, and the registry data will be available in the first quarter of 2026. Coverage rates of each strategy, and coverage differences between strategies will be presented.

Implications: SMS nudging could be integrated into the national influenza vaccination program if the trial shows it effectively increases influenza vaccination coverage among the elderly. Further, the trial will establish whether language is a barrier for influenza vaccination uptake among recent immigrant groups that have low influenza vaccination coverage, and to what extent this potential barrier can be diminished by SMS nudging in the official language of their native country.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65+ (age at the end of 2025, i.e., born 1960 or earlier)
* Resident in Norway and have a valid ID number on 1 September 2025
* Have a registered mobile phone number

Exclusion Criteria:

* Have received the 2025 influenza vaccine prior to the SMS nudge dispatch date
* Have emigrated or died before SMS nudge dispatch date
Management of Prelabor Rupture of the Membranes at Term

Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).

Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.

PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.

In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.

Eligibility Criteria:
Inclusion Criteria:

1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
2. Women at gestational age 370/7 or more.
3. Vertex presentation.

Exclusion Criteria:

1. Age 18 and under.
2. High order gestation.
3. Women with contraindication for a vaginal delivery.
4. Active labor.
5. Documented fetal anomalies.
6. Known or suspected intrauterine infection (temperature \> 38 degrees, leucocytosis).
7. Non reassuring fetal heart rate tracing.
8. Positive group B streptococcus status.