cyrilzakka/clinical-trials huggingface dataset:
Evaluation of STARgraft AV for Hemodialysis Access

This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis.

Performance of the STARgraft AV will be compared against control implants of commercially available standard ePTFE grafts approved for the same use.

The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to:

1. Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year.
2. Verify safety of the STARgraft AV multilayer construction in extended vascular access use.

It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, \> 18 years or age.
2. Patient has given informed consent to participate in the trial.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Able to effectively communicate with study personnel.
5. Candidate for a new arterio-venous graft placed in the upper arm.
6. Life expectancy judged to be at least 2 years.
7. Axillary vein of greater than or equal to 7 mm in diameter.
8. Brachial artery of greater than or equal to 4 mm in diameter.
9. Systolic blood pressure equal to or greater than 120 mmHg.
10. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or angiogram.

Exclusion Criteria:

1. Unable or unlikely to comply with trial protocol and/or follow-up.
2. Pregnancy.
3. Clinical morbid obesity.
4. Anatomical limitations.
5. Immunodeficiency syndrome.
6. History of bacterial infection within 8 weeks prior to graft implantation.
7. History of hypercoagulation or bleeding disorders.
8. Elevated platelet count \> 1 million per microliter of blood.
9. History of heparin-induced thrombocytopenia syndrome (HIT).
10. Medically confirmed stenosis of the veins downstream of the implant site.
11. Inadequate arterial flow or pressure proximal to the implant site.
12. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial.
13. Fever greater than 38° C.
14. Prior allergic reaction to silicone.
Sphenoorbital Meningioma Management.

Investigators will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours.


Eligibility Criteria:
Inclusion Criteria:

* all patients who have spheno_orbital meningioma with proptosis and candidate for surgery.

Exclusion Criteria:

* all patients have proptosis caused by other lesions than spheno_orbital meningioma.
GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic solid tumors for which established therapy is ineffective, not tolerable, or does not exist
* Patients with histologically or cytologically documented locally advanced or metastatic breast cancer who have received at least one prior chemotherapy-based regimen for incurable disease (Arm A)
* Patients with histologically or cytologically documented locally advanced or metastatic CRC who have not received prior oxaliplatin-based therapy within 1 year of initiation of study treatment. (Arm B)

Exclusion Criteria:

* Prior anti-cancer therapy that fulfills the following criteria: a total of more than six courses of an alkylating agent, a total of more than four courses of carboplatin-containing chemotherapy regimens, and a total of more than two courses of nitrosoureas or mitomycin C, high-dose chemotherapy requiring stem-cell support, and irradiation to \>= 25% of bone marrow-bearing areas
* Current dyspnea at rest because of complications of advanced malignancy or other disease requiring continuous oxygen therapy
* Known deficiency of dihydropyrimidine dehydrogenase (DPD)
* Bisphosphonate therapy for symptomatic hypercalcemia
* Known untreated or active central nervous system (CNS) metastases
* Pregnancy, lactation, or breastfeeding

For Arm B:

* Inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* History of myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment
* History of stroke or transient ischemic attacks within 6 months prior to the first dose of study treatment
* Significant vascular disease within 6 months prior to the first dose of study treatment
* History of hemoptysis within 1 month prior to the first dose of study treatment
* Patients with one or more pulmonary tumor masses with evidence of cavitation
* Evidence of bleeding diathesis or significant coagulopathy
* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of study treatment
* History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment
* Clinical signs or symptoms of GI obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding
* Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* The presence of an ulcerating breast cancer tumor will not render a patient ineligible
* Proteinuria
Efficacy and Safety Study of Squalamine Ophthalmic Solution in Subjects With Neovascular AMD

A Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration. Patients will receive injections of ranibizumab. In addition, patients will receive either Squalamine lactate 0.2% eye drops or Placebo eye drops. The study duration is approximately 9 months to primary endpoint

Phase 3 Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration Methodology: Phase III, multicenter, randomized, double-masked, placebo-controlled study conducted over 9 months

(Screening/Baseline to Week 36): Patients will be randomly assigned to one of 2 treatment groups in a 1:1 ratio:

* Squalamine lactate ophthalmic solution, 0.2% BID + ranibizumab every 4 weeks
* Placebo ophthalmic solution BID + monthly ranibizumab every 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years
* A diagnosis of choroid neovascularization (CNV) secondary to AMD with CNV comprising at least 50% of the total lesion area on fluorescein angiography (FA)
* Central subfield thickness (spectral domain (SD)-OCT central 1 mm) of ≥ 300 μm
* Best-corrected visual acuity (BCVA) 20/40 to 20/320 (73- to 24-letter score on the Early Treatment of Diabetic Retinopathy Study \[ETDRS\] chart)

Exclusion Criteria:

* Neovascularization secondary to any other condition than AMD in the study eye; Blood occupying greater than 50% of the AMD lesion, or blood \> 1.0 sq. mm underlying the fovea
* Pigment epithelial detachment (PED) without associated subretinal fluid and/or cystic retinal changes
* Clinical evidence of diabetic retinopathy or diabetic macular edema in the study eye
* Confounding ocular conditions in the study eye which will affect interpretation of OCT, VA or assessment of macular appearance (e.g., cataract, epiretinal membrane, retinal vascular occlusive disease)
* Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye or any condition preventing VA improvement
* Uncontrolled glaucoma in the study eye, or currently receiving topical glaucoma medication in the study eye
A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females

This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy postmenopausal females.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female, age at least 45 years at the time of signing informed consent. With at least 12 consecutive months since the last spontaneous menstrual bleeding (if there was any uncertainty of the time of the last spontaneous bleeding, the postmenopausal status is to be confirmed with follicle stimulating hormone (FSH) 40 mIU/mL)
* Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day). A subject smoking less than one cigarette or the equivalent per day must be able or willing to refrain from smoking and use of nicotine substitute products during the trial
* Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
* Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic. If white-coat hypertension is suspected a single repeat measurement is allowed, last measurement being conclusive
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis

The purpose of this study is to determine whether MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.

Osteoarthritis (OA) is the commonest form of joint disease, characterized by articular cartilage degradation with an accompanying periarticular bone response and a synovial membrane inflammation. Clinical manifestations of OA in the knee include pain in and around the joint, stiffness of the joint after rest, crepitus on motion and limited joint. MM-II medical device was designed to reduce wear and lower friction in knees of osteoarthritis patients by creating a lubricating layer onto cartilage surfaces upon injection. The purpose of this study is to determine whether a medical device MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic unilateral knee tibiofemoral OA
* Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees on a recent 3 months time X-Ray
* Knee pain within the last 24 hours before assessment more than 40mm on VAS
* Pain on most days in the last month

Exclusion Criteria:

* Knee pain equal or more than 80mm on a 100mm VAS.
* Pain in the contra lateral knee; more than 30mm on a 100 VAS.
* Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
* Any condition that may interfere with the measure of pain in the targeted knee
* Concomitant meaningful synovial fluid effusion
* Post trauma OA
* Gross ligamentous instability of the knee
Effect of Acid Suppression Medication on Pediatric Microbiome

The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.

Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.

Eligibility Criteria:
Inclusion Criteria:

* Zero to 4 years old
* Being considered for PPI or H2RA treatment for refractory GERD
* Parent is able to give informed consent

Exclusion Criteria:

* Prevalent C. difficile infection (excluded via stool PCR at week 0)
* Use of systemic antibiotics within the past 90 days
* Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)
* Increased risk for fracture due to vitamin D deficiency or other causes
* Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)
* Congenital deficiency in immunity (e.g., such as IgA deficiency)
* Cystic fibrosis
* Significant dynamic or uncontrolled comorbidity such as HIV or malignancy
* Use of medications with potential interaction with PPIs
Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound

This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.

This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. There will be an inclussion visit in which personal information will be recorded and the consent will be signed. Randomization will be done after inclusion, following a balanced blocks model. Information of the surgery technic won't be available for the investigator. The patients will have a journal in which they'll write their postoperative symptoms. Follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. Data will be based in clinical examination, patient's diary and medical records. Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test, or in case needed, a multivariate Cox regression analysis. The secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.

Eligibility Criteria:
Inclusion Criteria:

* Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
* Ability to understand the study, to sign the consent and to complete the follow-up.

Exclusion Criteria:

* Under 18 years of age.
* Complex/recurrent fistula.
* Patients in which by clinical criteria is decided not to perform a fistulotomy.
* Anorectal malignancy.
* Crohn's desease.
* ASA IV or other contraindication for surgery.
* Inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.
Effects of a Virtual Reality Intervention on Mental Health Outcomes and Academic Success in Physical Therapy Students

Exploring the impact of a virtual reality program, First Resort on graduate physical therapy student wellness and academic success.

This study is exploring the impact of an 8-week virtual reality intervention among graduate physical therapy students. Self-report measures of anxiety, depression and stress will be collected pre/post to assess the impact of the virtual reality intervention.

Purpose:

1. Determine if there is an impact of a virtual reality intervention on symptoms of anxiety, depression and stress levels in first year physical therapy doctoral students
2. Explore correlations between performance, anxiety, depression, stress and First Resort use in first year physical therapy doctoral students
3. Explore the feasibility of use of First Resort app in first year physical therapy doctoral students

Eligibility Criteria:
Inclusion Criteria:

Physical Therapy students enrolled at a single university in the southern United States during the fall 2024 semester

-

Exclusion Criteria:

Patient Health Questionnaire-8 score of 15 or more General Anxiety Disorder-7 score of 15 or more History of seizures History of motion sickness History of epilepsy History of balance impairment History of significant visual History of auditory impairment

-
SPI-guided vs PRD-guided Analgesia During FESS for Intraoperative Blood Loss

The aim of this randomized trial is to assess the efficacy of analgesia , compare the utility of Pupillary Dilatation Reflex (PRD), Surgical Pleth Index (SPI) for monitoring pain perception intraoperatively and their influence on intraoperative blood loss, quality of surgical field using Boezaart Bleeding Scale (BBS) in patients undergoing functional sinus surgery (FESS)

Intraoperative blood loss during FESS constitutes a major problem for a surgeon because it influences quality of surgical field. Each incident of haemorrhage makes the operator stop the procedure in order to bring back the optimal visualization of the intranasal anatomy. In the end it prolongs the time of procedure.

Currently, intraoperative blood loss is estimated based on Boezaart Bleeding Scale (BBS) (0 - no bleeding (cadaveric conditions), 1 - Slight bleeding, no suctioning required, 2 - Slight bleeding, occasional suctioning required, 3 - Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed, 4 - Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed, 5 - Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible).

Recently, the Surgical Pleth Index (SPI) and Pupillary Dilatation Reflex (PRD) were added as a surrogate variable showing the nociception-antinociception balance into above mentioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. PRD value \>5% reflects increased sensitivity to painful stimulus as well as delta SPI\>10 or any SPI\>50, and they constitute the indication for administration of rescue analgesia intraoperatively.

This study aims at evaluating utility of SPI-directed analgesia or PRD-directed analgesia or Boezaart scale-directed analgesia using remifentanil on the intraoperative blood loss, haemodynamic stability and time duration of surgery.

Currently, FESS is most often performed using total intravenous anaesthesia (TIVA) which is by majority of anaesthesiologists believed to reduce the intraoperative blood loss compared to general anaesthesia using volatile anaesthetics, but literature provides conflicting findings in this area.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate in the study
* written consent to undergo functional endoscopic sinus surgery under total intravenous anaesthesia
* ASA (American Society of Anesthesiologists) I-III

Exclusion Criteria:

* age under 18 years old
* allergy to propofol
* pregnancy
* any anatomical malformation making PRD or SE measurement impossible
The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain

This study aims to investigate if a low back pain screening tool is helpful for the caregivers to direct the rehabilitation in a more efficient way, at an earlier stage. Primary Health care centers in the municipality of Halmstad, Sweden will be enrolled to participate in the study as either "Control" or "intervention". The primary Health care centers who are enrolled taking part in the intervention, will use the provided screening tool when taking care of patients seeking care for low back pain. Scorings from the screening tool will "label" the patients as one of Three pre-defined risk levels. The caregiver will then use the provided risk level when deciding how to proceed the rehabilitation. Based on the risk level identified, the patient is directed to one of three levels of treatments - including simple advice; physiotherapy; or multimodal rehabilitation. The screening tool is used as a complement to the examination, allowing the physiotherapist /GP to decide how to proceed with rehabilitation using the back screening tool, together with Clinical examinations. The Control Group consists of patients recruited when seeking care for back pain at a Primary Health Care service who has been randomly selected as "Control". The care givers at the Control primary Health care will conduct as usual, not using the back pain screening tool in their Clinical examinations.


Eligibility Criteria:
Inclusion Criteria:

* Seeking care for low back pain at any of the included primary Health care.

Exclusion Criteria:

* Red flags