cyrilzakka/clinical-trials huggingface dataset:
Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding

This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.

The purpose of this study is to evaluate the outcome of transcrestal sinus elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Data to be collected includes demographics, past medical history including autoimmune diseases and connective tissue diseases, smoking history and known allergies. Implant data will be collected and change in crestal bone height will be measured radiographically and cone beam computed tomography at follow up. The protocol will include both single-staged and two-staged procedures. Adverse events will be collected and reported.

Eligibility Criteria:
Inclusion Criteria:

1. Transcrestal sinus lift planned
2. Implant therapy planned
3. Crestal bone height \< or equal to 6mm
4. Missing tooth or teeth for function
5. Nonsmoker -

Exclusion Criteria:

1. Patients with known collagen hypersensitivity
2. Patients with sensitivity to porcine-derived materials
3. Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.
4. Pregnant or planning to become pregnant (verbal confirmation)
The Effect of AC-134 in Chronic Kidney Diseases

The objective is to explore the effects of adding AC-134 on renal function, proteinuria, uremic toxins, and metabolism-related markers in chronic kidney disease.

Chronic kidney disease (CKD) management primarily focuses on addressing associated complications such as hypertension, diabetes mellitus, cardiovascular disease, and proteinuria. In addition to standard therapies, reducing the accumulation of toxins, particularly gut-derived uremic toxins like indoxyl sulfate (IS) and p-cresol sulfate (PCS), may help alleviate uremia symptoms. This study assesses the impact of oral AC-134 capsules containing activated charcoal adsorbent on CKD patients. The assessment will include evaluating changes in renal function, proteinuria, uremic toxins, and metabolism-related markers.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-90 years.
* Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients.
* Signed informed consent is required before enrollment.

Exclusion Criteria:

* Use of other brand-activated charcoal supplements during the study period.
* Pregnant or lactating women.
* Patients who have undergone kidney transplantation.
* Obstructive nephropathy within the past month.
* Acute kidney injury within the past three months.
* Gastrointestinal bleeding or severe constipation within the past three months.
* Patients with active malignancy within the past two years.
* Severe cardiovascular diseases such as congestive heart failure New York class III-IV or cerebrovascular disease
* Severe liver disease, such as liver cirrhosis with ascites.
* Active infectious disease
Vinorelbine in Treating Children With Recurrent or Refractory Cancers

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.

OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children.

OUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory solid malignant tumors of childhood including: Soft tissue sarcoma Rhabdomyosarcoma Nonrhabdomyosarcoma Extraosseous Ewing's sarcoma CNS tumors Astrocytoma Primitive neuroectodermal tumor Atypical teratoid/rhabdoid tumors Ependymoma Recurrent neuroblastoma Measurable disease No more than 2 prior treatment regimens

PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: For patients with solid tumors (unless marrow involvement): Absolute neutrophil count (ANC) at least 1000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) For patients post bone marrow transplantation: ANC at least 1,000/mm3 Platelet count at least 50,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) Hepatic: Total bilirubin no greater than 1.5 times normal SGOT/SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: Seizure disorder allowed if well controlled CNS toxicity no greater than grade 2

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior bone marrow transplantation No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for increased intracranial pressure due to CNS tumors Radiotherapy: At least 6 months since prior radiotherapy to craniospinal axis, spine, and/or more than 50% of the bony pelvis Concurrent radiotherapy to localized painful lesions allowed if at least one measurable lesion is not in radiation field Surgery: Not specified Other: No concurrent participation in another CCG, POG, or COG therapeutic study
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT

CART therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 and BCMA T cells in treating high risk multiple myeloma followed with auto-HSCT.

Adults ages 18-75 with high risk Multiple Myelomas (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment).

Design:

Participants may be screened with:

Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in a laboratory. Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the T cells through the IV within 3 days. Maintenance therapy with IMiDs was received after combined CAR T infusion.

After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.

Participants will visit the clinic 1, 2, 3, 6, 9 and 12 months after the infusion, then every 3 months until disease progression. A bone marrow sample will be taken at the 3-month visit.

Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma patients eligible for auto-HSCT.
* High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment).
* Expected survival ≥ 3 months.
* Creatinine \< 2.0 mg/dl.
* Blood coagulation function: PT and APTT \<2x normal.
* Arterial blood oxygen saturation\>92%.
* ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal
* Karnofsky scores ≥ 60 and ECOG score≤2.
* Adequate venous access for apheresis, and no other contraindications for leukapheresis.
* Patients should not take immunotherapy in three months prior to CART cells infusion.
* Voluntary informed consent is given.

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene therapy products.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* HIV infection.
* History of myocardial infarction and severe arrhythmia in half a year.
* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
* Patients with fever of unknown origin (T\>38℃).
Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.

The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient.

Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.

Eligibility Criteria:
Inclusion Criteria:

At start of the run-in period:

* Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the Rome III criteria:
* Recurrent abdominal pain/discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics:

  1. improvement with defecation;
  2. onset associated with a change in the frequency of stool;
  3. onset associated with a change in form (appearance) of stool.
* Symptom-onset at least 6 months prior to diagnosis.
* Loose/watery stools at least 25% of the time in the last 3 months AND hard/lumpy stools less than 25% of the time in the last 3 months.
* More than 3 bowel movements per day at least 25% of the time in the last 3 months.
* For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy.
* Mentally competent, able to give written informed consent.
* For women of childbearing potential: Use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment.
* Normal physical examination or without clinically relevant abnormalities.

At randomisation:

-Confirmation of IBS-D severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period.

Exclusion criteria:

* Organic abnormalities of the gastrointestinal tract, including history of colonic or major abdominal surgery.
* History of gluten enteropathy.
* Lactose intolerance as assessed by response to diet.
* History of positive tests for ova or parasites, or occult blood in the stool.
* Previous diagnosis of diabetes mellitus (either type 1 or 2).
* Unstable medical condition.
* Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease.
* Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months.
* Use of concurrent medication with drugs known to interfere with gastro-intestinal motility or sensitivity.
* Pregnancy or breastfeeding.
Sodiumhexametaphosphate Versus MTA as Pulp Capping Material for Immature Permanent Teeth

Sodiumhexametaphosphate will be used as capping material for dental pulp of immature permanent teeth


Eligibility Criteria:
Inclusion Criteria:

* healthy children
* cooperative children
* deep carious lesion
* traumatic pulp exposure
* immature permanent teeth

Exclusion Criteria:

* uncooperative children
* children with systemic disorders
* non vital immature permanent teeth
Proton Pump Inhibitors and Dysbiosis in Cirrhosis

The purpose of this study is to find out whether the use of medications that suppress acid in your stomach can change the composition of your bowel bacteria.


Eligibility Criteria:
Inclusion Criteria for PPI initiation study:

* Cirrhosis not on current PPI or acid suppressive therapy
* No systemic antibiotics or probiotics

Exclusion Criteria for PPI initiation study:

* On systemic antibiotics
* On PPI or acid suppression therapy already
* unable to give informed consent
* Allergy to proton pump inhibitors

Inclusion Criteria for PPI withdrawal study:

* Cirrhosis on current PPI for an FDA-unapproved indication
* No systemic antibiotics or probiotics

Exclusion Criteria for PPI withdrawal study:

* On systemic absorbable antibiotics
* On PPI or acid suppression therapy for an FDA-approved indication
* unable to give informed consent
* unwilling to withdraw PPI
Postprandial Response to Almond Consumption in Overweight Hispanic Pregnant Women

Currently, about one third of all women entering pregnancy are obese. The prevalence of metabolic disorders during pregnancy has increased concurrently with the rise in maternal obesity. Although dietary interventions are used routinely to reduce metabolic disease in non-pregnant obese individuals, no specific dietary advice is provided to obese, pregnant women unless they develop gestational diabetes mellitus. In this study, the investigators will specifically assess the effect of replacing dairy fats with almonds in a breakfast meal on the postprandial metabolic response. This cross-over, randomized control trial will examine the postprandial metabolic response to 0 or 2 oz of almonds in standardized test meals in pregnant Hispanic women with prepregnancy BMI between 25 and 40. Hispanics are at higher risk for gestational diabetes and the metabolic syndrome. The investigators hypothesize that consuming almonds in place of dairy fat reduces the glycemic response and improves the postprandial lipid profile in these high-risk women.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Hispanic women
* Between 30 and 36 weeks gestation
* Prepregnancy BMI between 25 and 40

Exclusion Criteria:

* Diagnosis of gestational diabetes mellitus
* Preexisting diabetes mellitus
* Renal disease
* Thyroid disease
* Cardiovascular disease
* History of drug abuse
* Nut allergies
Trigger Point Injections Versus Lidocaine Patch for Myofascial Pain in the Emergency Department

The aim of this trial is to investigate the efficacy of trigger point injections with 1% lidocaine in reducing myofascial back and neck pain in the Emergency Department compared to lidocaine patches 5%.

After being informed about the study and the potential risks and benefits, all patients will be randomized into either the trigger point injection group with 1% lidocaine, or the 5% lidocaine patch group. Pain scores will be recorded while in the emergency department, and we will have a 5 day follow-up phone call to assess efficacy. Patients who present to UCI Department of Emergency medicine will be screened and recruited prospectively, and information regarding this study will be available on clinicaltrials.gov as a method of recruitment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosed with myofascial pain of the posterior neck or back. \*The diagnosis of myofascial pain was based on established criteria of having a palpable taut band (trigger point) that when depressed reproduced the patient's pain.

Exclusion Criteria:

* midline spinal tenderness
* evidence of radiculopathy
* pregnant
* have an allergy to lidocaine
* altered or deemed incapable of making informed consent
* had signs of infection or skin breakdown over the trigger point.
Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.

60 patients with abdominal obese, man with WC \> 90 cm and woman with WC \> 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.

Background: This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.

Methods: 60 patients with abdominal obese, man with WC \> 90 cm and woman with WC \> 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subject has abdominal obese seventy subjects between the age 18 and 65 years
* Abdominal obesity was defined as having a waist circumference (WC) \>90 cm for men or WC \>80 cm for women was defined based on the Asia-Pacific criteria of the International Diabetes Federation.

Exclusion Criteria:

* pregnant or breastfeeding, had taken any treatment for weight loss or any medication known to affect weight
* had a weight loss of 3% or more in the preceding 3 months, had undergone any major surgery during the 1 year prior to study commencement
* had any inserted metallic materials including a pacemaker.
* aspartate aminotransferase or alanine aminotransferase of 100 mg/dL or more
* serum creatinine of 1.5 mg/dL or more
* a history of coronary arterial disease or cerebrovascular disease, impairment of a major organ system, cancer, severe lung diseases, severe cerebral trauma, uncontrolled hypertension and psychiatric diseases including eating disorder, etc.
Clinical Evaluation of Biofinity Multifocal Compared With Air Optix Aqua Multifocal and With PureVision Multifocal

This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.

This is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the BIOFINITY® MULTIFOCAL lens and respectively the AIR OPTIX® AQUA MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5) and the PUREVISION® MULTIFOCAL lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.

Each subject will have 5 visits with the investigator:

* (V1) An inclusion visit during which the first pair of lenses are fitted;
* (V2) An optimization visit after 7 to 9 days of wearing the first lens;
* (V3) An evaluation visit after an additional 10 to 15 days of wearing the first lens (17 to 24 days) and at which time the second pair of lenses are fitted;
* (V4, V5) Visits are conducted as in V 2 and V3 with the second pair of lenses.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged 18 years or older
* Patients with proven presbyopia
* Patients who do not wear contact lenses or who wore spherical lenses before being included in the study
* Myopic patients whose spherical equivalent is less than or equal to 9.00 D (or a "lens" power less than or equal to -8,00 D) or hypermetropic patients whose spherical equivalent is less than or equal to +5.50 D (or a "lens" power less than or equal to +6,00 D) or emmetropic patients for distance vision (plan)
* Patient able to fill in a diary without help
* Patients who gave their informed consent to take part in the study

Exclusion Criteria:

* Patients with a contra-indication for wearing contact lenses
* Patients suffering from any ocular pathology that might interfere with the evaluation of the lenses
* Patients wearing multifocal lenses or spherical lenses for monovision before being included in the study
* Astigmatic patients whose cylinder is more than 0.75 D
Knee Swelling Under Use of Compression Stockings After Outpatient Surgery

Outpatients who undergo knee surgery are designated two different clinical study groups. Group A receives common wrapping after surgery to the first postsurgical day and will be provided with compression stockings for the following 10 days, while group B only receives common wrapping and will not be provided with compression stockings.

The investigators are going to investigate the effect of compression stockings on postsurgical swelling and formation of edema on outpatients.

The investigators are planing on investigate the effect of compression stockings on postsurgical swelling and formation of edema. For this purpose the investigators devide outpatients who have undergone knee surgery to two different clinical study groups. Group A receives a common compression bandage after surgery to the first postsurgical day and receives compression stockings afterwards for the following 10 days, while Group B only receives a common compression bandage to the first postsurgical day. Group A will be instructed to wear compression stockings for 24 hours on the first two postsurgical day, afterwards at least for 8 hours a day.

Preoperatively the investigators are going to determine the volume and circumference of both legs using the Bodytronic 600 by Bauerfeind. Subsequently the measurement will be repeated on the first, forth and tenth postsurgical day. The investigators are going to measure the range of motion, also the patients of both groups will be asked to mark pain and tension on a visual analog scale and write down the amount of time they have been lying, sitting and standing each day. Group A will document the amount of time for how long they were wearing compression stockings each day.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* signed release form

Exclusion Criteria:

* deep vein thrombosis
* swelling caused by cardiac, venous or endocrine genesis
* dysfunction of the lymphatic system
* dysfunction of kidney or liver
* Use of water withholding medication
* massive adiposity
* cachexia
* epilepsy
Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance. The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle. The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18 years or older
* Willing to provide written consent
* Pathologically confirmed prostate cancer on previous biopsy
* Suitable for and consenting to high-dose-rate brachytherapy for treatment as standard of care.

Exclusion Criteria:

* • Previous radiotherapy to the prostate
Nutritional Deficiencies in the Bariatric Patients

Although morbidly obese subjects have larger than regular caloric intake, there is evidence that they suffer from nutritional deficiencies at a higher rate than the general population, probably because they eat mostly "unhealthy food."


Eligibility Criteria:
Inclusion Criteria:

* All morbidly obese subjects who are surgery candidates

Exclusion Criteria:

* Previous bariatric operations