cyrilzakka/clinical-trials huggingface dataset:
VisR Ultrasound for Noninvasively Monitoring Renal Allograft Health

Ten percent of American adults, more than 20 million people, have chronic kidney disease, which in the advanced state of end stage renal disease is most desirably and cost-effectively treated by kidney transplantation. However, 20-30% of transplanted kidneys fail in living recipients by 10 years, owing largely to insufficient monitoring methods. The goal of the proposed research is to improve noninvasive kidney transplant monitoring using a new ultrasound-based imaging method called Viscoelastic Response (VisR) ultrasound.

Renal transplantation is the most desirable and cost effective treatment for end stage renal disease, but 20-30% of allografts fail in living recipients by 10 years, and prolonging graft health is one of the major unmet needs for transplant patients. Although graft health is extended by preemptive treatments that prevent irreversible damage, intervention is inadequately motivated by current transplant monitoring methods. Noninvasive methods, including changes in serial serum creatinine levels, lack sensitivity and specificity. In the absence of reliable noninvasive biomarkers, invasive biopsy remains the standard for assessing transplant health, but surveillance or "protocol" biopsies are associated with morbidity and cost and are therefore controversial in stable, unsensitized patients. The lack of a demonstrated, noninvasive biomarker for allograft health - one that identifies early graft degeneration with sufficient sensitivity and specificity to motivate appropriate biopsy and enable timely intervention - represents a major gap in renal transplant management.

To fill this gap, the proposed re-search aims to demonstrate Viscoelastic Response (VisR) ultrasound, a novel acoustic radiation force (ARF)-based technology that noninvasively interrogates the viscoelastic properties of tissue, for monitoring renal allograft health. The investigators hypothesize that in vivo VisR ultrasound delineates renal allograft dysfunction earlier and with greater sensitivity and specificity than serum creatinine concentration in renal allograft recipients.

To test this hypothesis, the investigators will determine which VisR outcome metrics detect renal allograft dysfunction clinically by performing serial VisR imaging in living donor (LD) and deceased donor (DD) transplant recipients. Imaging results will be compared to biopsy findings to determine VisR's ability to detect dysfunction. The investigators will also compare serial VisR and serum creatinine outcomes in terms of ability to detect renal allograft dysfunction and the timeliness of detection.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Selected by treating physician to be in need of renal transplant surgery
3. Ability to provide informed consent
4. Ability to communicate with pertinent staff
5. Ability to understand and comply with study requirements

Exclusion Criteria:

1. Inability to provide valid consent
2. Inability to communicate with pertinent staff
3. Inability to remain motionless for at least 20 minutes
4. Renal transplant deeper than 4 cm

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Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-linking in Eyes With Corneal Thinning Conditions

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function.

Eligibility Criteria:
Inclusion Criteria

Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:

1. 8 years of age or older
2. Signed written informed consent
3. Willingness and ability to comply with schedule for follow-up visits
4. Contact Lens Wearers Only:

   1. Removal of contact lenses for the required period of time prior to the screening refraction:

      Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks
   2. Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
5. Presence of central or inferior steepening.
6. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
7. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:

   1. Fleischer ring
   2. Vogt's striae
   3. Decentered corneal apex
   4. Munson's sign
   5. Rizzutti's sign
   6. Apical Corneal scarring consistent with Bowman's breaks
   7. Scissoring of the retinoscopic reflex
   8. Crab-claw appearance on topography
8. Steepest keratometry (Kmax) value ≥ 47.20 D
9. I-S keratometry difference \> 1.5 D on the Pentacam/Orbscan map or topography map
10. Posterior corneal elevation \>16 microns
11. Thinnest corneal point \>300 microns
Dyslipidemia-related Risk Factors in Dialysis

In this study, we studied lipoprotein abnormalities-related variables as risk factors for the development of cardiovascular disease in patients on renal replacement therapies.We studied 96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24 healthy controls.We concluded that metabolic acidosis activating the inflammation and lipoprotein oxidation influences the dyslipidemia and cardiovascular morbidity of patients on renal replacement therapies.Dialysis adequacy was positively associated to cardioprotective HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized lipids than hemodialysis modalities.

Blood samples were obtained by venipuncture in the peritoneal dialyzed patients and control group in a twelve hours fasting state.In hemodialyzed patients blood was drawn just before the start of the mean weekly dialysis session also in a twelve hours fasting state from the vascular access.

All samples were received once at baseline time ( in the start of the study ). Peripheral systolic and diastolic blood pressures were calculated as an average of 10 measurements during a renal replacement treatment month in the starting time of the study.

Also, electrocardiographic examination, echocardiography and the calculation of ankle-brachial blood pressure index became once in the start of the study.

Eligibility Criteria:
Inclusion Criteria:

* permanent renal replacement therapy more than 6 months and
* accurate dry body weight

Exclusion Criteria:

* acute illness,
* significant infection,
* malignancy,
* Kt/V for urea \<1.2.
Hyaluronic Acid Filler IMD1 Basic for Correction of Nasolabial Folds

Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* main inclusion criteria: severity rating scale grade 3 or 4

Exclusion Criteria:

* main exclusion criterion: other nasolabial fold corrections within 6 months prior to study entry
Optimising Screening for Early Disease Detection in Familial Pulmonary Fibrosis

In this study the prognostic value of the current screening parameters for familial pulmonary fibrosis (FPF) will be investigated by looking at the screenings of 200 first-degree relatives of patients with FPF.

Also insight in the natural history of early FPF, and the necessary interval between screenings visits will be investigated.

Familial pulmonary fibrosis (FPF) is a fatal lung disease that is often not diagnosed until a significant portion of the lung function is lost. Median survival after diagnosis is 3 to 5 years. As treatment can only slow down lung function decline, early disease detection is essential to provide timely therapeutic support. As first-degree relatives of patients with FPF are at high risk of developing pulmonary fibrosis as well, a screening protocol has been put in place. However, the value of current screening parameters to detect early asymptomatic disease as well as the optimal interval between screening appointments are unknown. A prospective study into the prognostic value of these screening markers in the target population and the appropriate clinical setting is needed to develop an evidence-based screening protocol. There will be an emphasis on easily operable parameters that may allow for redirection of (part of the) screening activities to the general practice in the future.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic first-degree relative of patients with familial pulmonary fibrosis (FPF)

Exclusion Criteria:

* A previous diagnosis of interstitial lung disease (ILD)
* Minors (aged \<18 years)
* Pregnant

Note: woman who are pregnant at the start of the study or at the time of the HRCT are not allowed to participate. If a participant gets pregnant at a later stage during the study, she will not be excluded from the study. To be able to account for a potential effect of pregnancy during data analysis, female participants can be asked if they are pregnant at every visit.
Non-surgical Interventions for Infertility in Endometriosis

A parallel design randomized clinical trial was carried out on 18 women with clinically diagnosed endometriosis who wish pregnancy in the Department of Reproductive Endocrinology and Infertility, Bangabandhu Sheikh Mujib Medical University, (BSMMU), Shahbag, Dhaka. Those who voluntarily provide consent to participate in this study will be randomly allocated to one of the two treatment arms. Allocation concealment will be done by sequentially numbered sealed envelopes. The arms and interventions are cabergoline (0.5 mg twice weekly for 6 months, plus timed intercourse) and dydrogesteron (20 mg daily from day 5 to day 25 of menstrual cycle for 6 months, plus timed intercourse).The women will be assessed by telephone interview at monthly intervals, TVS and serum Ca 125 at 3 months and 6 months.

Infertile women with endometriosis will be recruited from those attending Dept of Reproductive Endocrinology and Infertility after clinical diagnosis on the basis of sonographic findings of chocolate cyst with or without dysmenorrhea. After evaluating for eligibility criteria and taking informed consent she will be randomized to either cabergoline group or to dydrogesterone group. Women assigned to cabergoline group will receive 0.5 mg cabergoline twice weekly (fridays and tuesdays), after meal at night for 6 months. The dydrogesterone group will receive 10 mg of dydrogesterone twice daily from day 5 to day 25 of menstrual cycle for six months. She will be followed up every month to check for compliance or any side effects. The couple will have intercourse timed with LH kit or intercourse on alternate days from day 10 to day 15 of the cycle if the LH kit is not available. She will visit 3 months and 6 months after the beginning of treatment. At each follow up visit, she will be assessed for pregnancy, visual analog scale for pain and transvaginal sonogram to measure the chocolate cyst. Estimation of serum CA125 and any side effects will be noted.

Eligibility Criteria:
Inclusion Criteria:

1. Women of reproductive age 18-35 yrs
2. Women who are infertile or wish pregnancy
3. Sonographic diagnosis of chocolate cyst with or without dysmenorrhea
4. Women staying with her husband

Exclusion Criteria:

1. Recurrent endometrioma after previous surgery
2. BMI at or more than 30 kg/m2
3. Significant abnormalities in renal and liver function.
4. Known male factor
5. Use of investigational drugs or hormones, concomitant or in last 30 days.
Efficacy of Local Direct Median Nerve Block

Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is indicated when failed conservative treatment. Although it can be done either with local anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The study is conducted to compare the efficacy of two methods and we hypothesized that the local direct median nerve block has effectiveness in intraoperative pain control not inferior to brachial plexus block in endoscopic carpal tunnel release.

The study is randomized-control trial conducted in single center (Orthopaedic department, Faculty of medicine, Thammasat university) The patients with failed conservative treatment of carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized block-of-4 method.The local direct median nerve block is done by the surgeon and brachial plexus block in done by single anesthesiologist after that the patient will be operated with 1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative pain in case record form.The patient will return the case record form at 2-week and also stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional outcome (Thai version Bonton questionaire)

Eligibility Criteria:
Inclusion Criteria:

1. Patient with carpal tunnel syndrome, confirmed by EMG
2. Failed conservative treatment 3 months
3. Age ≥18 years old

Exclusion Criteria:

1. Allergic history of xylocaine
2. Any other condition that can cause carpal tunnel syndrome or peripheral neuropathy e.g. DM, hypothyroidism, pregnancy, tumor
3. Any patient that has been coverted to open carpal tunnel release
Inhaled Beclomethasone to Prevent Chronic Lung Disease

To test if inhaled glucocorticoids, early in the course of respiratory failure in premature infants, permit normal lung growth and differentiation, thus preventing development of bronchopulmonary dysplasia.

BACKGROUND:

Bronchopulmonary dysplasia (BPD), a fibrotic/emphysematous lung disorder is a common sequela among extremely premature infants. The severity of BPD, but not incidence, has been reduced by surfactant therapy. BPD remains one of the most significant contributors to excessively prolonged hospital stays and, therefore, potentially avoidable costs. Research leading to a reduction in BPD morbidity should prove cost effective in the estimated 10,400 affected infants annually (40 percent of a projected 26,000 survivors of birthweights less than 1,250 grams).

Inflammation is a significant component of both clinical and experimental model BPD and is the subject of numerous basic science investigations begun since the empiric observation that BPD responds favorably to systemic steroids. The known side effects of systemic steroids have led to their cautious sequential controlled clinical investigation, initially for late treatment (at more than 30 days of age), then early treatment (two weeks), then very early treatment (seven days), and even prophylaxis (day one). The prophylactic clinical trial of inhaled steroids, starting at day three for 21 days, is a logical next step in this sequence of determining the least dangerous, yet effective means to prevent or treat the inflammatory components of BPD.

DESIGN NARRATIVE:

Multicenter, randomized, double-blind, placebo-controlled. The premature infants were randomized to beclomethasone or placebo on day three of life. Beclomethasone was delivered in a decreasing dosage, from 40 to 5 micrograms per kilogram of body weight per day, for four days. The primary outcome measure was bronchopulmonary dysplasia at 28 days of age. Secondary outcomes included bronchopulmonary dysplasia at 36 weeks of postmenstrual age, the need for systemic glucocorticoid therapy, the need for bronchodilator therapy, the duration of respiratory support, and death.

Clinical sites included the Boston Perinatal Center at the New England Medical Center Hospitals, the Baystate Medical Center in Springfield, Massachusetts, and the Pennsylvania Hospital in Philadelphia. The Data Coordinating Center was at Boston University School of Medicine. Support for the trial ended in April, 1999.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Premature boy and girl infants with birth weight less than 1,251 grams, gestational age less than 33 weeks, and postnatal age three to fourteen days, who continue to require mechanical ventilation with an emphasis on enrollment at three days.
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children with SCN1A-Positive Dravet Syndrome

ENDEAVOR is a Phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged ≥6 to \<36 months (Part 1) and aged ≥6 to \<48 months (Part 2). Part 1 follows an open-label, dose-escalation design, and Part 2 is a randomized, double-blind, sham delayed-treatment control, dose-selection study.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be aged between ≥6 months and \<36 months in Part 1 and \<48 months in Part 2.
* Participant must have a predicted loss of function pathogenic or likely pathogenic SCN1A variant.
* Participant must have experienced their first seizure between the ages of 3 and 15 months.
* Participant must have a clinical diagnosis of Dravet syndrome or the treating clinician must have a high clinical suspicion of a diagnosis of Dravet syndrome.
* Participant is receiving at least one prophylactic antiseizure medication.

Exclusion Criteria:

* Participant has another genetic mutation or clinical comorbidity which could potentially confound the typical Dravet phenotype.
* Participant has a known central nervous system structural and/or vascular abnormality (indicated by an MRI or CT scan of the brain).
* Participant has an abnormality that may interfere with CSF distribution and/or has an existing ventriculoperitoneal shunt.
* Participant is currently taking or has taken antiseizure medications (ASMs) at a therapeutic dose that are contraindicated in Dravet syndrome, including sodium channel blockers.
* Participant has experienced seizure freedom for a period of 4 consecutive weeks within the 90-day period prior to informed consent.
* Participant has previously received gene or cell therapy.
* Participant is currently enrolled in a clinical trial or receiving an investigational therapy, including under an expanded access and/or compassionate use program.
* Participant has clinically significant underlying liver disease.
A Study of TSN1611 Treating Patients with Advanced Solid Tumors Harboring KRAS G12D Mutation

The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part.

Phase 1 Part:

The phase 1 part will evaluate the prespecified dose levels of TSN1611. Dose escalation will continue until up to the highest planned dose or the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is determined. Dose optimization could be performed as indicated by the emerging data.

Phase 2 Part:

Phase 2 part will evaluate the efficacy and safety of TSN1611 as monotherapy at the recommended dose in separate groups of patients with pancreatic cancer, colorectal cancer, non-small cell lung cancer, or other solid tumors, harboring KRAS G12D mutations.

Eligibility Criteria:
Subjects must meet all the following inclusion criteria to be eligible for participation in this study:

* The subject fully understands the requirements of the study and voluntarily signs the ICF.
* At least 18 years of age at the time of informed consent.
* Life expectancy of 3 months or more.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumor harboring KRAS G12D mutation; subjects must be refractory or intolerable to standard treatment, or have no standard treatment available, etc.
* Patients with adequate cardiac, liver, renal function, etc.

Exclusion Criteria

Subjects will be excluded if they meet any of the following criteria:

* Leptomeningeal disease or Active central nervous system (CNS) metastases.
* Prior systemic anti-cancer treatment within 21 days or 5 half-lives (whichever is shorter will be used as the criteria) prior to the first dose of study drug.
* Radical radiation within 4 weeks prior to the first dose of study drug; palliative radiotherapy within 1 week prior to the first dose of study drug.
* Any unresolved Grade 2 or higher toxicity from previous anticancer therapy except alopecia.
* Has participated in a study of investigational agent and received the investigational agent within 21 days or 5 half-lives, if known (whichever is shorter) prior to the first dose of study drug.
* History of interstitial lung disease (ILD), drug induced IDL, or current active pneumonitis, radiation pneumonitis requiring therapeutic intervention, or uncontrolled other lung disease.
* Any of the following in the past 6 months: myocardial infarction, unstable angina, symptomatic congestive heart failure, stroke or transient ischemic attack, pulmonary embolism.
* Prior treatment with KRAS G12D targeted therapy.
* Has a history or current evidence of any severe condition, concurrent therapy, or laboratory abnormality that might confound the interpretation of the study results, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.
Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia

The purpose of our study is to determine whether one injection with plasma into the origin of the plantar fascia is an effective treatment of plantar fasciitis.

90 patients will be randomized into three groups. 30 patients will be treated with one plasma injection, 30 patients will be treated with one injection with saline and 30 patients will do physiotherapy and use heel cups. The two groups who receive injections will do the same physiotherapy and use heel cups, as the conservatively treated group.

Both groups randomized to receive an injection will have a 10 ml blood sample taken from their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The injection into to the origin of the plantar fascia i done 10 minutes after the sample of blood is obtained. The content of the syringe i blinded to both the investigator and the patient.

The injection i performed from the medial aspect of the heel under guidance of ultrasound. No local/systemic analgetic is used. The content of the syringe is spread using peppering technique into the origin of the plantar fascia.

Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The questionaires will be Foot Function Index and SF-36 as well as questions about their use of analgetics, use of heel cups and intensity of their physiotherapy


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 70 of age
* Sore at the insertion of the plantar fascia on calcaneus
* A VAS score of at least 4 at the insertion of the plantar fascia on calcaneus taking the first step in the morning
* Symptoms for 6 to 12 months
* Ability to understand danish and give informed consent

Exclusion Criteria:

* Previously operated in the same ankle or foot
* Pain anywhere else in the foot on palpation otherwise than at the insertion of the plantar fascia on calcaneus
* Inflammatory disease
* Diabetes
* Formerly rupture of the Achilles tendon
* Formerly treated with plasma injections
* Ongoing infection treated with antibiotics
* Treated with steroid during the trial
* Treatment of the plantar fasciitis exceeding conservative treatment
* Use of crutches, walker or similar
* Pregnancy