cyrilzakka/clinical-trials huggingface dataset:
Rivaroxaban Hypericum Trial

Single-center, open-label, sequential treatment study to investigate the influence of the combined P-glycoprotein and CYP3A4 inducer hypericum perforatum on the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy volunteers.

Each session (one with and one without preceding CYP induction) will start with phenotyping using 25 mg fexofenadine orally for P-gp phenotyping and 2 mg midazolam orally for cytochrome P450 (CYP) 3A4 phenotyping. After a washout period of 5 days, subjects will receive a single oral dose of 20 mg rivaroxaban, a dose currently approved for human use in clinical routine. The same procedure will be repeated after pretreatment with St. John's wort extract (Jarsin®) twice daily 450 mg po (dose usually used in clinical routine) for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men or women, age between 18 and 45 years (inclusive) at screening
* BMI between 18 and 28 kg/m2 (inclusive) at screening
* No clinically significant findings on the physical examination at screening
* Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening
* Ability to communicate well with the investigator and to understand and comply with the requirements of the study
* Women of child-bearing age: willingness of using a double barrier contraception method during the study, i.e. a hormonal method (oral contraceptive, intrauterine device) in combination with a mechanical barrier (e.g. condom, diaphragm)
* Signed informed consent

Exclusion Criteria:

* Known allergic reaction to any excipient of the drug formulations
* Known photosensitivity
* Smoking
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
* Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation
* Treatment with an investigational drug within 30 days prior to screening
* Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St. John's wort) within 2 weeks prior to screening
* Pregnant (positive results from urine drug screen at screening) or lactating women
* History or clinical evidence of any disease (e.g. gastrointestinal tract disease) and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity
* Legal incapacity or limited legal capacity at screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment

This pilot randomized clinical trial studies palliative care intervention in improving quality of life, psychological distress, and communication in patients with solid tumors receiving treatment on phase I trials. Cancer patients experience many symptoms related to treatment and the cancer itself that can be distressing and impact quality of life. Palliative care focuses on managing these symptoms and may help patients with solid tumors live more comfortably.

PRIMARY OBJECTIVES:

I. Test the effects of a palliative care intervention (PCI) on patients' quality of life (QOL), psychological distress and satisfaction with communication, comparing the experimental versus control groups.

II. Test the effects of a PCI on patients' symptom intensity and symptom interference with daily activities, comparing the experimental versus control groups.

III. Test the effects of a PCI on patients' hospital and palliative care resource utilization and clinical trial retention rates, comparing the experimental versus control groups.

IV. Test the effects of the timing of PCI initiation (early versus delayed) on patient outcomes, comparing the experimental versus control groups.

V. Describe patients' satisfaction with the PCI.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive part I of the PCI comprising quantitative surveys, comprehensive palliative care assessment by the Research Nurses, and goals of care discussions beginning prior to administration of the first dose of phase I treatment. Patients then receive part II of the PCI comprising recommendations from the interdisciplinary team, patient educational sessions, and supportive care referrals following the first dose of phase I treatment and is completed within one month of the first treatment.

ARM II: Patients receive usual care until 12 weeks post-treatment initiation. Patients then receive both part I and II of the PCI.

After completion of study, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with solid tumors who are eligible for participation in Phase I clinical trials of investigational cancer therapies
* Patients who have signed an informed consent for participation in Phase I clinical trials
* Able to read or understand English-this is included because the intervention and study materials (including outcome measures) are only in English
* Ability to read and/or understand the study protocol requirements, and provide written informed consent

Exclusion Criteria:

* Patients diagnosed with hematologic (as a population distinct from solid tumors and different trials) cancers.
Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.


Eligibility Criteria:
Arm 1 Inclusion Criteria:

* At least 18 years of age;
* AIS A to D;
* Neurogenic bladder and bowel dysfunction;
* Stable medical condition

Arm 2 Inclusion Criteria:

* At least 18 years of age;
* AIS A to D;
* Neurogenic bladder and bowel dysfunction;
* Use of intermittent catheterization for bladder emptying;
* Prior implantation of a Medtronic scES array

Arms 1 and 2 Exclusion Criteria:

* Prior Botox injections of the bladder and/or bladder augmentation surgery;
* Colostomy bag,
* Ventilator dependent;
* Any implanted pump (i.e. Baclofen pump, pain pump, etc.);
* Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Patient and Operator Centered Outcomes Concerning Connective Tissue Graft Should Be Considered to Choose Adequately Which Protocol to Use

The goal of this clinical trial is to evaluate patient and operator centered outcomes after connective tissue graft harvesting with a fully digital workflow and compare this approach with a conventional one. The main questions it aims to answer are:

* Does it differ in patient- and operator-centered outcomes between the conventional and digital workflow?
* What is the difference in time efficiency between conventional and digital protocols? Researchers will compare digital guided versus conventional technique to choose adequately which protocol to use.

Participants will:

* Receive periodontal surgery to treat gingival recession site
* Visit the clinic after 2 weeks for suture removal \&amp; filling the survey
* The time will be recorded during the surgery

50 sites will be included. All investigations will be carried out in accordance with the 1975 Helsinki Declaration, as revised in 2013 for ethical approval. All participants will provide written informed consent after receiving explanations on study objectives and procedures. Primary outcomes will be patient- and operator-centered outcomes. Patient- and operator-centered outcomes will be assessed through visual analogue scale (VAS), questionnaires containing self-developed questions about each phase of the treatment which will be administered at the end of each phase. The questionnaires will be administered as part of a survey which aimed to obtain information about the dental practices. Secondary outcomes will be time-efficiency by assessing workflow duration and number of appointments needed to complete the procedure. The treatment phases will include digital analysis of landmarks and design, of the guide and surgical phase (free gingival graft harvesting ). Time will be recorded in minutes. All the parameters will be recorded in the clinical chart by the same two operators not involved in the treatment after each phase was completed. The planned duration for the research will be 6 months.

Eligibility Criteria:
Inclusion Criteria:

* area need soft tissue augmentation around teeth either coronal or apical to recession
* must have a general health showing no contraindications for oral surgery must be at least 20 years old.
* patients also had to have good oral hygiene before the treatment

Exclusion Criteria:

* signs or symptoms of bruxism or clenching
* if they were suffering from uncontrolled systemic conditions
Comparison of Karyotyping, CMA and NIPT for Prenatal Diagnosing Chromosomal Anomalies

This diagnostic test is aimed to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies. Pregnant women who needed prenatal genetic diagnosis meted the study criterion; fetal amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was collected for NIPT detecting. And the CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

Aim: to compare the Karyotyping, CMA and NIPT for prenatal diagnosing chromosomal anomalies.

Design: diagnostic test Set: Prenatal diagnosis center of Taizhou City Study population: The Pregnant women who needed amniocenteses for prenatal genetic diagnosis were recruited.

Methods: amniotic fluid was regular examined by Karyotyping and CMA, and maternal peripheral blood was used for collected for NIPT detecting.

Statistic: CMA result as a golden standard, the main outcome is compared the diagnostic efficacy of NIPT for diagnosing chromosomal anomalies.

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women who needed amniocenteses were recruited during the study period, include high risk for serum screening, aged over 35 years and ultrasound abnormal.
2. only singleton were included

Exclusion Criteria:

1. women who met the contraindication for invasive procedure as : threaten abortion, acute infectious disease.
2. Women who unfitted for NIPT analysis include multiple, history of allogeneic blood cell transfusion.
Drug Eluting Balloon Angioplasty for Recurrent Cephalic Arch Stenosis in Dialysis Fistulas

This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (DEB) versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in hemodialysis patients.

The cephalic vein constitutes the major outflow conduit for radial- cephalic autogenous accesses and is the sole outflow conduit for brachial- cephalic autogenous accesses. The portion of the cephalic vein that becomes perpendicular in the region of the deltopectoral groove before its confluence with the axillary or subclavian vein,the cephalic arch, is prone to the development of hemodynamically significant stenosis which is usually treated with balloon angioplasty. Unfortunately restenosis due to angioplasty induced intimal hyperplasia is common and periodic repeated angioplasty is necessary to maintain patency.

Paclitaxel is a mitotic inhibitor used in cancer chemotherapy which is used as an antiproliferative agent for the prevention of restenosis (recurrent narrowing) of blood vessels after balloon angioplasty caused by excessive intimal proliferation. It is locally delivered to the wall of the blood vessel during the dilatation using a paclitaxel eluting balloon.

Initial trials with these balloons have shown promising results in peripheral arteries and early encouraging results in dialysis access.

Eligibility Criteria:
Inclusion Criteria:

* Upper limb dialysis access fistula
* Angiographically demonstrated cephalic arch stenosis \>50% within 6 months of last angioplasty using a non drug eluting balloon
* Clinical evidence of hemodynamically significant stenosis: strong pulse and weak thrill on physical exam, prolonged bleeding from puncture sites, raised Kt/V, raised dialysis venous pressure

Exclusion Criteria:

* Contrast allergy
* Unable to give informed consent
* Cephalic arch stent or stent graft
* Life expectancy less then 6 months
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE). LY3361237 will be administered by injections just under the skin. The study will last up to 26 weeks and may include up to 17 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have received a diagnosis of SLE at least 24 weeks before screening (at least 4 of 11 criteria in 1997 revised American College of Rheumatology \[ACR\] classification)
* If a participant is taking oral prednisone (or prednisone equivalent) for SLE, the dose must be ≤20 milligrams per day (mg/day) for at least 8 weeks prior to screening, and must have been stable for at least the last 2 weeks
* If a participant is taking any of the following medications for SLE, the medication must have been used for at least 12 weeks and stable for at least the last 8 weeks:

  * Azathioprine ≤200 mg/day
  * Antimalarial (e.g., chloroquine, hydroxychloroquine, quinacrine)
  * Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 grams per day (g/day)
  * Oral, SC, or intramuscular methotrexate ≤15 milligrams per week (mg/week)

Exclusion Criteria:

* Participants must not have a history of, or current, inflammatory joint or skin disease other than SLE
* Participants must not have a current active bacterial, viral, or fungal infection
* Participants must not have evidence of significant liver or kidney dysfunction
* Participants must not have received cytotoxic medications (e.g., cyclophosphamide) within the last 3 months.
* Participants must not have received any intra-articular, intramuscular, or intravenous glucocorticoids within the last 3 months
* Participants must not have received blood products (e.g., blood transfusion, platelets, etc.) within the last 12 months
Comparison of Mesh Fixation and Non-Fixation in eTEP

Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate.

One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation.

In the eTEP technique, dissection is performed in a larger area than in TEP. For this reason, it can be thought that the possibility of mesh displacement is higher in the eTEP procedure. The purpose of this study is to confirm this idea with a prospective study. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. However, there is no study on mesh detection in the eTEP technique. The aim of the study is to compare patients who underwent withmesh fixation and without mesh fixation laparoscopic eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral inguinal hernias,
* Patients aged 18-65.

Exclusion Criteria:

* Younger than 18 years, and older than 65 years,
* Incarcerated or strangulated inguinal hernias,
* Patients with bilateral inguinal hernias,
* Patients who are contraindicated to receive general anesthesia,
* Pregnancy
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Histologically confirmed Hodgkins lymphoma
* Relapsed or refractory disease after the first line of treatment
* Age 18-70 years old
* Ejection fraction greater than 50%
* ECOG 0-2 status
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign an informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.
ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood

Conducting the ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood is to validate performance claims for precision of the ABL90 FLEX PLUS ctBil and FHbF parameters in neonatal whole blood while being influenced by testing environment that is representative of intended use environment, site variability, intended use testing environment and operator variability in a Point-of-Care (POC) setting.

The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS.

The study is being conducted in Denmark and in total, a minimum of 54 subjects are to be enrolled to provide successful measurement values from 3 different sites.

The conduct of the clinical study is to determine the repeatability of ctBil and FHbF parameters in neonatal whole blood using contrived fetal cord blood from umbilical cord/placenta measured by the intended users in syringe, short probe, and capillary modes available for ABL90 FLEX PLUS, in a POC setting.

The primary endpoint is the Repeatability (SD) for each parameter, parameter level and measuring mode, pooled across sites.

Participating sites are maternity wards or similar site conducting planned cesarean sections. Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section after week 38 of gestation will be enrolled in the clinical study. When the subject has signed ICF, the site will collect cord blood from umbilical cord/placenta and when relevant prepare contrived samples by having access to adult type 0 Rh neg whole blood for diluting HbF in cord blood.

Three POC users, such as a nurse, a physician, or a therapist that care for the woman in the maternity ward will perform all measurements and they shall contribute evenly to the total number of samples measured. Replicate measurements shall be performed by the same user.

6-10 mL of cord blood is collected in a blood collection syringe from each umbilical cord/placenta, contrived, and the sample is aliquoted into 5 safePICO aspirators (max volume 1.5 mL) or into 25 capillary tubes.

At each site, samples will be collected for the 2 parameters, 3 modes and 3 levels, completing measurements from minimum of 18 samples from 18 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section.
* Informed consent collected from subject able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
* Subject evaluated by the principal investigator or designee as suitable for the study according to the protocol.

Exclusion Criteria:

* Subjects with known infectious disease such as Hepatitis C or HIV (to ensure the operator safety).
Efficacy of High Power Laser Versus Low Level Laser in Ultrasonographic and Functional Outcomes in Patients With Knee Osteoarthritis

this study will be conducted to compare between high power laser and low-intensity laser on ultrasonographic and functional outcomes in patients with knee osteoarthritis

Osteoarthritis (OA) is a major source of pain, disability, and socioeconomic cost worldwide. The epidemiology of the disorder is complex and multifactorial, with genetic, biological, and biomechanical components. It is estimated that 63 to 85 percent of Americans over age 65 have radiographic signs of OA and that 35 to 50 percent have symptoms of pain, stiffness or limitation of motion. Between 9 and 12 percent of elderly Americans (approximately 3 million people) have enough impairment from OA that they cannot perform their major activities, and half of these individuals are totally disabled (confined to bed or a wheelchair). High power laser therapy (HPL) that involves higher-intensity laser radiation is a new, painless, and powerful modality that showed significant results in pain reduction. One of the modalities commonly used by clinicians was Low Level Laser Therapy introduced as an alternative, safe and non-invasive treatment for OA about 30 years ago.A more recent systemic review investigated the effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis and concluded that Both LLLT and HPL are beneficial as adjuncts to rehabilitation exercise in the management of knee OA. Based on an indirect comparison, the HPL and exercise seems to have higher efficacy in reducing knee pain and stiffness, and in increasing function. To confirm this finding, a direct comparative investigation of the two types of laser therapy may be necessary. ninety patients with knee osteoarthritis will be assigned randomly to three groups; the first experimental will receive high power laser plus conventional physical therapy, second one will receive low-intensity laser and traditional physical therapy, finally, the third group will receive traditionally therapy only

Eligibility Criteria:
Inclusion Criteria:

* X-ray stages II and III osteoarthritis
* Age between 45 and 75 years.
* BMI equal to or less than 35.

Exclusion Criteria:

* Unwillingness to participate in the study.
* Uncompleted evaluation/treatment programs.
* Any damage to the knee joint during the study.
* Using any treatment other than prescribed therapeutic protocols.