cyrilzakka/clinical-trials huggingface dataset:
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis

Vancomycin is the most commonly used empiric treatment for infectious peritonitis in patients on peritoneal dialysis. Current dosing and monitoring for safety and efficacy is empiric, especially for those on rapid-cycling modalities. The goal of this study is to understand the pharmacokinetics of vancomycin in patients on rapid-cycling peritoneal dialysis modalities in order to derive an optimal dosing regimen.

Peritoneal dialysis (PD) is a form of renal replacement therapy indicated for those with acute kidney injury or end stage renal disease. Currently, two modalities of PD exist and is individualized based on patient and life-style specific factors. Continuous ambulatory peritoneal dialysis (CAPD) allows 4 - 5 exchanges performed manually whereas automated peritoneal dialysis (APD) involves continuous, automated, cyclical exchanges performed by a device at home during the night. Peritonitis is a common complication in PD and accounts for a large portion of hospital readmission and mortality. Vancomycin is the most common antibiotic recommended and has notable gram-positive coverage used empirically during suspected peritonitis.

Despite widespread use, vancomycin lacks good pharmacokinetic characterization in PD. Early pharmacokinetic studies using vancomycin were conducted predominantly in patients on CAPD on glucose-based prescriptions. Data is non-existent in PD patients administered the novel dialysate solution icodextrin, or those treated with overnight APD. The impact of residual kidney function (RKF) on vancomycin in PD is also lacking. Enhanced vancomycin clearance in RKF may result in under-dosing, while overdosing may result in nephrotoxicity and loss of clinically important RKF.

The investigators will characterize the pharmacokinetic profile of vancomycin following a single intraperitoneal dose of vancomycin in icodextrin dialysate to non-infected PD patients and examine the relationship between RKF and vancomycin clearance using serum, dialysate and urine. The goal is to use this data in non-infected subjects to generate information to guide vancomycin dosing in patients on rapid-cycling PD modalities.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or females between 18 - 85 years old
* Stabilized on a PD regimen for \> 3 months prior to study initiation

Exclusion Criteria:

* Clinically significant disease unrelated to renal impairment or deemed unfit by the investigator
* Allergy or hypersensitivity to vancomycin or icodextrin-containing dialysis solution
* Active peritonitis infection
* Previous intraperitoneal antibiotic treatment within 2 months
* Previous intravenous vancomycin treatment within 2 months
* Hemoglobin \< 9 g/dL
* Pregnant or breast-feeding women
Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen

This surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) as well as to evaluate the status of treatment compliance in osteoporosis patients in daily medical practice.

The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. For at least 30 minutes after administration, patients should avoid lying in a supine position and should avoid taking food, drink (except for water) or other oral drugs. For more details, see the "Precautions related to dosage and administration" section of the package insert.

Eligibility Criteria:
Inclusion Criteria:

* Osteoporosis patients

Exclusion Criteria:

* None
Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia

Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologically confirmed bladder cancer
* M0
* ECOG-performance status ≤ 2
* Informed consent

Exclusion Criteria:

* Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
* Cardiac Pacemaker
* Myocardial infarction within the past 12 months
* Congestive heart failure
* Complete bundle branch block
* New York Heart Association (NYHA) class III or IV heart disease
* Disease that would preclude TUR, chemoradiation or deep regional hyperthermia
* Metal implants (lenght \> 2cm or dense clusters of marker clips in the pelvis)
* Active or therapy-resistent bladder infections
* Pre-existing or concommitant immunodeficiency Syndrom
* Pregnant or lactating women
* Patients not willing to use effective contraception during and up to 6 months after therapy
Sutent Rechallenge In mRCC Patients

Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

A sample size of n = 40 patients will allow to estimate of the median PFS with a precision around 1.8 months (based on data from Rini et al.) This retrospective and prospective study is designed to estimate the effect of Sutent rechallenge.

The PFS (estimated from Kaplan-Meier estimate) will be the primary endpoints. In addition, the effects of sunitinib at the 2 periods of treatment (i.e. first line sunitinib vs. rechallenge) will be compared by Wilcoxon signed-rank test for PFS values and by McNemar test for overall response rate (ORR).

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented metastatic RCC containing predominantly clear cell component.
* Previously received sunitinib in first line, 2 or more antitumor therapies subsequently and then received sunitinib for a second time.
* At least 1 cycle of sunitinib rechallenge (1 cycle= 4 weeks on/2 weeks off).
* At least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter (LD) ³ 10 mm when measured by spiral computerized tomography (CT) (5-mm slice thickness contiguous) or ³ 20 mm when measured by conventional CT (10-mm slice thickness contiguous). The lesion must be ³ 2 times the size of the slice thickness per RECIST criteria.
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Patient who didn't receive Sunitinib in first line.
* Patient who received less than one line of treatment .
Efficacy of Diode Laser in Maturogenesis of Immature Teeth With Necrotic Pulps

Recruited patients with immature permanent maxillary anterior teeth with non-vital pulp, and periapical radiolucency, age ranging from 8 to16 years old were randomly allocated into three groups (n=13): Group I, disinfected using the triple antibiotic paste, Group II, disinfection was done using diode laser, and Group III, were disinfected using the triple antibiotic paste, diode laser was used for biostimulation. All groups were evaluated for the increase in root length and thickness and decrease in apical diameter at baseline, 3, 6, 9, and 12 months after treatment

* The investigator recruited patients who are found eligible to the criteria then randomly allocated into three groups (n=13)
* Group I: thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the blood clot method.
* Group II: thirteen teeth were Laser disinfected; revascularization was done using the the blood clot method.
* Group III: thirteen teeth were disinfected by triple antibiotic paste then revascularization was done using the the blood clot method followed by diode laser bio-stimulation.
* periapical x rays was taken at baseline, 3, 6, 9, and 12 months after treatment for the increase in root length and thickness, decrease in apical diameter evaluation

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients.
* Immature permanent maxillary anterior teeth.
* Non vital pulp.
* patents age between 8-16 years.
* Both sexes.
* Restorable teeth.
* No internal or external root resorption.
* No horizontal or vertical root fracture
* Radiographic periapical radiolucency
* No history of previous endodontic treatment of the tooth.

Exclusion Criteria:

* Medically compromised patients
* Previous endodontic therapy of the affected tooth.
* Teeth diagnosed with vital pulp.
* Teeth with periodontal pocket more than 3mm deep.
* Teeth with caries below the bony level (non-restorable tooth).
* Mature teeth with complete apices.
A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer

This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin 100 milligrams per square meter (mg/m\^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m\^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year plus a 1-year follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result
* Participants with stages between Stage IB (T1N1M0) and Stage IIIC
* ECOG performance status score equal to or less than (\<=) 2 during screening
* Left ventricular ejection fraction equal to or higher than (\>=) 55% with acceptable levels of liver and renal functions
* No known contraindication to capecitabine, oxaliplatin, and trastuzumab
* No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason

Exclusion Criteria:

* Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin
* Previous neoadjuvant chemotherapy and/or radiotherapy
* Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma)
* Known (previously diagnosed and ongoing) malabsorption syndrome
* Active gastrointestinal bleeding
* Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma
* Clinically significant cardiac or cardiovascular disease
* Uncontrolled hypertension
* Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study
* Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin
* Known or suspected hypersensitivity against trastuzumab or proteins of rodents
* Pregnancy or lactation
Study of Bulevirtide in Participants With Chronic Hepatitis D Infection

The main goal of this study is to collect post marketing data from patients with chronic hepatitis D virus (HDV) infection who are treated with bulevirtide to describe the long-term effects of bulevirtide treatment and evaluate the safety of participants treated with bulevirtide.

The study design time perspective is retrospective and prospective for participants who previously participated in MYR-Reg-02 and are currently receiving BLV and prospective for participants who are scheduled to receive BLV.

Eligibility Criteria:
Key Inclusion Criteria:

* Individuals who have been diagnosed with chronic hepatitis D virus (HDV) infection for at least 6 months before study enrollment, confirmed by respective documentation in the individuals' medical records.
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
* Must be willing and able to comply with the visit schedule and study requirements.
* Cohort 1 only: Must have participated in study MYR-Reg-02.
* Cohort 2 only: Individuals scheduled to receive bulevirtide (BLV) according to the approved label or for whom the decision to start treatment with BLV according to the approved label has been made and treatment initiation is planned.

Key Exclusion Criteria:

* Individuals currently enrolled in BLV clinical treatment studies and/or other interventional clinical studies with an investigational agent.
* History or current presence of clinically significant illness or any other major medical disorder that may interfere with individual follow-up, assessments, or compliance with the protocol.
* Coinfection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) (Individuals with HCV antibodies can be enrolled if HCV RNA is negative).
* Solid organ transplantation.
* Any history, or current evidence of clinical hepatic decompensation (ie, ascites, encephalopathy, jaundice, or gastrointestinal bleeding (GIB)).
* Presence of hepatocellular carcinoma (HCC) as evidenced by imaging (eg, ultrasound or computed tomography scan) performed within 4 months prior to Day 1 for individuals with cirrhosis and within 6 months prior to Day 1 for individuals without cirrhosis.
* Pregnant or breastfeeding females.
* Individuals with a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by a positive polymerase chain reaction test result.
* Known hypersensitivity or contraindication to BLV or formulation excipients.
* Individuals who are committed to an institution by virtue of a court or official order.
* Individuals deemed by the study investigator to be inappropriate for study participation for any reason not otherwise listed. This includes persons dependent on the sponsor, investigator, or trial site.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ryme Medical TLD Pilot Study

Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study

The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)

Eligibility Criteria:
Key Inclusion Criteria:

* Symptomatic chronic obstructive pulmonary disease
* ≥40 years of age
* Smoking history of at least 10 pack years
* Candidate for bronchoscopy in the opinion of the Investigator

Key Exclusion Criteria:

* Recent COPD exacerbation or respiratory infection
* Prior lung intervention with device in place
* Pulmonary nodule or malignancy requiring treatment
* Current chemotherapy or radiation therapy and/or has received treatment within 6 months
* Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not prescribed by a physician
* Clinically significant serious or unstable medical conditions (e.g., heart disease requiring treatment, uncontrolled diabetes)
* Pregnant, nursing, or intent to become pregnant during study duration
Prevalence of Pancreatic Cysts During Routine Endoscopic Ultra Sound

The investigators are interested in performing a detailed examination of the pancreas via EUS (Endoscopic Ultra Sound)for patients referred for a non-pancreatic condition. The hypothesis is to make a statistical determination of how many pancreatic cysts the investigators discover incidentally.

The prevalence of incidental pancreatic cysts discovered during EUS. (see data tables)

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included: patients \>18 years old with decision making capacity referred for EUS for any other indication other than the evaluation of a known pancreatic cyst, solid mass, or suspected mass.

Exclusion Criteria:

* Any known history or evidence of the following from any previous imaging study: pancreatic cyst, solid mass, suspected pancreatic mass, dilated main pancreatic duct
* Previous surgical resection of any portion of the upper GI tract such as Billroth II that would not permit complete EUS exam of the pancreas
* Laboratory and/or clinical evidence of ongoing acute pancreatitis
* Previous pancreatic surgical resection
* Pregnancy
* Incarceration
* High risk for sedation
* Coagulopathy and/or thrombocytopenia
* The patients underwent a complete EUS examination of the pancreas.
Effects of a Blueberry Enriched Diet on the Skeletal Muscle Regenerative Process

One of the greatest challenges faced by older adults is maintaining physical function and strength with aging. Deterioration of skeletal muscle with aging leads to loss of mobility, decreased quality of life, and ultimately loss of independence. Skeletal muscle deterioration with aging is multifactorial, with a key factor being impaired skeletal muscle regeneration following damage. Muscle regeneration is a multistep process that requires a viable population of skeletal muscle specific progenitor cells (MPCs). MPCs reside in the skeletal muscle in a dormant state until activated by stress or injury cues. Upon activation, MPCs divide, commit to the muscle cell lineage, and fuse to form new multinucleated cells or repair damaged muscle cells. In older adults this regenerative process is impaired, which amplifies skeletal muscle deterioration. The investigators demonstrated that the ability of MPCs to divide (proliferate) is reduced, while MPC death is elevated in MPCs from healthy older adults. Further, the investigators have demonstrated that impaired nutrient metabolism, cellular inflammation, and oxidative stress are key mechanisms in this age-related disruption of MPC proliferation and overall skeletal muscle health. Therapies that improve the regenerative process and nutrient metabolism as well as attenuate oxidative stress and inflammation are necessary to improve overall skeletal muscle health of older adults. Blueberries have properties that the investigators hypothesize will improve the proliferative capacity (increase cell division and reduce cell death) of MPCs. Additionally, the investigators hypothesize that consumption of blueberries will improve skeletal muscle regeneration in the aging population via improved nutrient metabolism, attenuated cellular inflammation, and reduction of oxidative stress. The hypotheses will be tested using a dietary blueberry intervention. Serum from our human subjects \[blueberry enriched diet (BED)-serum\] will be collected and used to treat primary human MPCs. Ultimately, the investigators hypothesize that a blueberry enriched diet provides an ideal, natural therapy to improve MPC proliferative capacity, which is necessary to attenuate skeletal muscle deterioration.


Eligibility Criteria:
Inclusion Criteria:

* Young 21-40 y women
* old 65-79 y women

Exclusion Criteria:

* known musculoskeletal disease (e.g., rheumatoid arthritis)
* movement disorder (e.g., Parkinson's disease) or other disorder that might affect skeletal muscle mass, function, or metabolism (e.g. diabetes, cancer)
* obese (BMI ≥ 30.0 kg/m2)
* long-term treatment with exogenous hormones or other pharmacological interventions -known to or that have the potential to influence muscle mass or function (e.g. glucocorticoids)
* antibiotic use within 6 months of intervention
Impact of Personalized Rehabilitation Guidance

To investigate the impact of personalized rehabilitation guidance based on the WeChat Official Accounts Platform on the functional recovery and quality of life of patients with knee osteoarthritis (KOA).Ninety patients diagnosed with KOA undergoing joint replacement were included via convenient sampling.The patients were randomly divided into an observation group and a control group,with 45 patients in each group.The control group received traditional rehabilitation guidance,while the observation group received personalized rehabilitation guidance through the WeChat Official Accounts Platform in addition to the traditional guidance.Different care plans had varying effects on patients' scores on the 36-item Short Form Health Survey (SF-36),Visual Analog Scale (VAS),and Lysholm Knee Scoring Scale.


Eligibility Criteria:
Inclusion Criteria:

* aged 50 to 80 years;
* conscious, without cognitive impairments, and able to complete reading independently or with assistance;
* able to operate a smartphone and use WeChat;
* willing to participate in this study and provide signed informed consent.

Exclusion Criteria:

* acute cerebrovascular disease with sequelae in the past 6 months;
* coexisting primary psychiatric disorders;
* unable to perform physical exercise due to physical disability in the lower limbs;
* postoperative complications, such as deep vein thrombosis or infection;
* participation in other interventional studies.
Accelerated rTMS for Treatment-Resistant Major Depression

High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode;
* Baseline score ≥ 13 on the QIDS-C
* Stable medication regimen (\>= 4 weeks) prior to study enrolment

Exclusion Criteria:

* Psychotic features in the current episode
* Lifetime history of psychotic disorders and/or bipolar I or II disorders
* Substance or alcohol abuse/dependence in the past 6 months
* Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
* Uncontrolled medical disease (e.g., cardiovascular, renal)
* Pregnancy and/or lactation
* Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy, metallic head implant)
* Hearing loss
Vitamin A for BPD Prevention

Chronic bronchopulmonary dysplasia (BPD) is a very common complication in preterm infants born at a young gestational age, and is a serious disease that impairs respiratory long-term outcome and is associated with higher-frequency neurodevelopmental injury. Lowering the incidence of BPD may improve the health of the preterm babies and neurodevelopmental delay of preterm infants.Vitamin A deficiency may be one of the factors associated with the development of BPD in preterm infants. According to the literature, oral vitamin A administration can lower the incidence of BPD. In our study we plan to give 5000 units of retinol / dose / day, every day for 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Premature babies under 29 weeks, at any birth weight
* A preterm baby is less than 4 days to life

Exclusion Criteria:

* Major congenital malformations
* Known chromosomal disorders