cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome

To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have medical history with clear documentation of diagnosis of nephrotic syndrome
* Patient who received renal biopsy within 1 year prior to screening and confirmed the pathologic classification: Minimal Change Disease (MCD), IgA nephropathy, Mesangioproliferative Glomerulonephritis (MsPGN), Membranous Nephropathy (MN), Focal Segmental Glomerulosclerosis (FSGS)
* Patient with the above different pathologic classification who received adequate hormone therapy more than 8 weeks (including FSGS more than 12 weeks)prior to screening and have 24hr-urine protein≥2.0g/day at screening Adequate hormone dose is defined as prednisone (prednisolone) equivalent dose of 0.8 to 1.0 mg/kg/day (inclusive)
* Male or female patient between 18 and 70 years (inclusive) at informed consent obtained date
* Patient with body weight between 40kg and 80kg (inclusive) at screening
* Patients who sign the informed consent form

Exclusion Criteria:

* Other primary nephrotic syndrome, e.g. membrano-proliferative glomerulonephritis (MPGN)
* Secondary nephrotic syndrome (e.g. diabetic nephropathy, anaphylactic purpura nephritis, lupus nephritis, type B hepatitis-related nephritis, renal amyloidosis)
* Patient who had history of allergy to any investigational product (MZR, CTX) or hormone
* Patient who had received accumulated dosage of CTX \>3g within one year prior to screening
* Patient who had received immunosuppressant or Chinese traditional medicine with immunosuppressive effect within 30 days prior to screening
* Patient who received other investigational drugs within 30 days prior to screening
* Patient who have received plasma exchange therapy or immunoadsorption therapy within 30 days prior to screening
* Patient who require pentostatin or live vaccine (not including flu vaccine)
* Patient who is undergoing renal replacement therapy
* Patient who received kidney transplantation
* Patient with malignancy
* Patient with severe hypertension (SBP \> 160mmHg or DBP \> 100mmHg) which has not been effectively controlled
* Patient with white blood cell count \<3×109/L /L(=3.0 GI/L)
* Patient with SCr \> 176.8μmol/L
* Patient who has a value that is \> 3 times of the upper limit of normal range for AST or ALT
* Patient with hepatitis B, hepatitis C or HIV infection
* Patient with other serious infections
* Patient who is unsuitable for participating in this study in the opinion of investigators ( e.g. uncontrolled diabetes, central nervous system lupus , lupus encephalopathy, active psychosis,osteonecrosis of the femoral head, fulminant hepatitis, peptic ulcer, etc.)
* Female patient who is pregnant, currently breast feeding or willing to become pregnant
* Patient with any other diseases that would affect the evaluation of efficacy or safety
Temozolomide in Treating Patients With Newly Diagnosed Anaplastic Oligodendroglioma or Mixed Oligoastrocytoma

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.

OBJECTIVES:

* Determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (AO) or mixed oligoastrocytoma (MOA) treated with temozolomide.
* Determine the response rate in these patients.
* Assess the quality of life of patients with AO or MOA treated with this regimen.

OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma).

Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria:

  * Bidimensionally measurable disease
  * Evaluable disease
  * Nonevaluable disease as demonstrated by gross total surgical resection
* No immediate need for cranial irradiation

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Life expectancy ≥ 12 weeks
* Absolute granulocyte count ≥ 1,500/mm³
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.0 times ULN
* AST ≤ 3.0 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No infection requiring systemic antibiotics within the past 14 days
* No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
* No unrelated medical problems that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for this malignancy
* No prior radiotherapy to the brain
* No surgery requiring general anesthesia \> 2 hours in duration within the past 10 days
* No prior temozolomide
* Concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry
Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.
Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.

The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile when administered with ketoconazole. Subjects will be treated first with AZD5069 only followed by a washout period before starting with the combined treatment (both ketoconazole and AZD5069).

An open-label, fixed-sequence, single-centre phase I study to assess the effect of ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose AZD5069 to healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 50 years (inclusive).
* Veins suitable for cannulation or repeated venipuncture.
* Healthy volunteers with neutrophil counts within the laboratory normal reference range at Screening
* Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum weight 50 kg and maximum weight 100 kg.
* Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening.

Exclusion Criteria:

* Healthy volunteers with latent tuberculosis as suggested by their history and judged by the Investigator
* Healthy volunteers who belong to a high-risk group for HIV infection.
* Known or suspected history of significant drug abuse as judged by the Investigator.
* History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.
* Plasma donation within 1 month of screening or any blood donation/blood loss \>500 mL during the 3 months and/or 1350 mL within the 12 months prior to screening.
Patient Perspective Midline Catheter in the Emergency Department

This study examines the patient satisfaction and perspective on the use of ultrasound guided midline intravenous catheters compared to standard ultrasound guided peripheral catheters.


Eligibility Criteria:
Inclusion Criteria:

* Patient in the emergency department
* Failed 2 or more conventional attempts at vascular access \*or\*
* history of requiring US guided vascular access
* US Fellowship trained physician available

Exclusion Criteria:

* basilic vein access is contraindicated
* patient undergoing advanced resuscitation
Pro-2-Cool Device Clinical Study

This study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mTBI) among adolescents participating in sporting activities.

This is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. The pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. In addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study.

Subjects will be assigned to study arm based on a block randomization schedule generated a priori.

The study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (NSR) to the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 12 - 21 years
* Initial provider visit is within 8 days of mTBI injury
* Confirmed mTBI diagnosis from sporting activities
* In generally good health as confirmed by medical history and as determined by site investigator
* Has a symptom score of at least 7 (analogous of the SCAT5 symptoms score)
* Has informed consent obtained per protocol and as required per Institutional Review Board (IRB)

Exclusion Criteria:

* Cleared to return to play during initial visit
* Suffers a serious TBI as evidenced by worsening symptoms, specifically:
* Seizure
* Hospitalization
* Existing positive diagnostic testing, which include radiology scans that indicate brain bleed
* Slurred speech, which has not resolved within 72 hours of mTBI injury
* Sustains another head or neck injury at the time of mTBI injury which requires medical treatment
* Known or disclosed pregnancy or breast-feeding
* History of a serious medical or psychiatric disorder that include:

  * Suicide attempt in the last 6 months
  * Unmanaged depression or anxiety
  * Hospitalization in the last 6 months for psychiatric treatment
* History of Reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
* Previously diagnosed with a cerebrovascular disorder
* Is unable to understand the study requirements or the informed consent
* Currently enrolled in another investigational research study that may confound the results of this study
* Non-English speaking subjects and parents/legal guardians
Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury

Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes.

A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury.

This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* less than or equal to 8 years of age
* scheduled for cardiac surgery

Exclusion Criteria:

* severe pre-existing renal insufficiency
Mechanical Alternans Study

The purpose of this study is to determine whether mechanical alternans (alternating strong and weak heart beats with a constant beat-to-beat interval), can be used to predict malignant ventricular arrhythmias, requiring defibrillation or appropriate ICD therapies, and to predict progression of heart failure and death.


Eligibility Criteria:
Inclusion Criteria:

* structural heart disease
* ischemic or non-ischemic cardiomyopathy

Exclusion Criteria:

* pregnancy
* age \< 18 years old
Comparison of Rehabilitation Intervention, Supported by Telemedicine, With Standard Rehabilitation After Distal Radius Fracture.

This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring

Distal radius fracture is a common pathology. The surgical indication is given by the difficulty in obtaining fracture reduction or by the instability of the fracture. The long-term functional prognosis of the wrist depends largely on patients' adherence to the prescribed indications/exercises in the immediate postoperative phase.

This is a randomized clinical trial of two parallel arms, aiming to compare two rehabilitation interventions: an experimental intervention including telemedicine support and remote monitoring of compliance of usual indicated exercises, versus the usual protocol of indicated exercises supported by printed material (triptych) and without remote monitoring.

Eligibility Criteria:
Inclusion Criteria:

* distal radial fracture (A2 to C3 type according to the Orthopaedic Trauma Association classification system)
* indication for standard rehabilitation post-surgery

Exclusion Criteria:

* immediate post-surgery complication
* multiple fractures or severe injuries
* history of bone metabolism condition
* illiterate
* non-Spanish speaking
* mental disorder
* not familiar with electronic devices
68Ga-labeled NY108 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY108 (68Ga-NY108) PET Imaging in patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male;
3. Patients diagnosed with prostatic cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. Patients with biopsy-proven PSMA positive;
6. ECOG score 0\~3; Life expectancy of at least 3 months;

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot perform PET/CT imaging scan;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis; Inadequate control of arrhythmias, including atrial fibrillation;
7. Uncontrolled hypertension;
8. Syphilis, HBV, HCV, or HIV positive subjects;
9. Male subjects of reproductive age cannot take effective contraceptive measures;
10. Patients with a history of mental illness or related conditions;
11. Other subjects considered unsuitable by researchers.
TWK10 Improves Muscle Mass and Functional Performance in Frail Older Adults

To explore the effect of "Lactobacillus plantarum TWK10 (hereinafter referred to as TWK10)" produced by synbiotech Biotechnology Co., Ltd. on alleviating and improving the aging and debilitating diseases of the elderly. Methods: It is expected to recruit 55-85-year-old senior citizens, who are assessed by the Clinical Frailty Scale (CFS) as debilitating disease grades 1 to 4 as the experimental subjects of this study. All subjects were divided into three groups according to the principle of balance order of frailty grades, namely (1) placebo group (Placebo group, average 77.4 years old), (2) supplement TWK10 probiotic 2x1010 CFU/day dose group (TWK10-L) Group, average 77.1 years old), (3) supplemented with TWK10 probiotic 6x1010 CFU/day dose group (TWK10-H group, average 79.0 years old). The experiment was supplemented for 24 consecutive weeks, and before supplementation, 6 weeks, 12 weeks, 18 weeks, the whole body composition and bone density test, as well as the functional fitness test were carried out in sequence. The items include: 3 meters walking ( Balance and gait assessment), 10-meter walking, 30-second sit-ups, and changes in the maximum grip strength of the left and right hands. Results: The experimental data showed that in the functional test, supplementing the TWK10-H group significantly improved the 3m gait balance, 10m walking, and lower limb muscle strength (30-second sit-ups) in the functional test. In terms of body composition and bone density, TWK10-H can significantly increase relative muscle mass after 18 weeks of supplementation. Conclusion: This study confirmed that supplementation of Lactobacillus plantarum TWK10 for 18 consecutive weeks can significantly promote the improvement of functional tests for the elderly, such as: 3m gait balance, 10m walking, lower limb muscle strength and grip strength, and can maintain and improve muscle mass. It has the effect of improving the frailty and muscle loss of the elderly.


Eligibility Criteria:
Inclusion Criteria:

* The clinical frailty scale (Clinical Frailty Scale, CFS) assessed as frailty grade 1\~4.

Exclusion Criteria:

* Diagnosed by the attending physician and confirmed that there is no stroke, hypertension patients and no exercise contraindications
* Can't sit to stand independently
* long-term antibiotics.
Prospective Data Collection to Compare RAL for Hysterectomies and Other Indications in to Conventional Laparoscopy

This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.

This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.

100 patients affected by uterine diseases with indication for hysterectomy undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System (See Synopsis - Indication A) and are compared to a cohort of 200 patients treated with conventional laparoscopic surgery from a similar ongoing study (Ethics vote: 621 /2018BO1).

100 patients affected by other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery (see Synopsis - Indication B) undergo treatment with robotically assisted laparoscopic procedures using the Senhance Surgical System and are compared to a cohort of 200 patients with indication for other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery (see Synopsis - Indication B) who underwent conventional laparoscopic surgery at the Department of Women's Health in the past.

At the end of patient recruitment, surgical procedure times, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the robotic assisted treatment/conventional laparoscopic surgery to multiple access and/or to a laparotomic (open) approach will be documented.

Patients will answer questionnaires (German version of the Short Form-36health survey questionnaire (Medical Outcomes Trust), German version of the female sexual function index (FSFI)) at baseline and at 3 and 6 months of follow-up. A questionnaire for patient satisfaction will be answered one day post procedural, at discharge and at 3 and 6 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* BMI ≤40 kg/m2
* indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer
* indication for radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for cervical cancer
* indication for modified radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for endometrial cancer
* indication for other uterine conditions / adnexal conditions that require uterine/adnexal/tubal surgery: Fibroids, Endometriomas, Cystic masses, Ectopic pregnancies, Sactosalpinx, Inflammatory adnexal disease, Opportunistic salpingectomy as part of hysterectomy or exclusively, Cervico-/Sacrokolpopexy
* size of uterus and vagina allows for retrieval by the vaginal route in cancer patients
* written informed consent

Exclusion Criteria:

* known extensive intra-abdominal adhesions
* anaesthesiological contraindications to laparoscopy
* women with pacemaker or other implants where electrosurgery is to be avoided
* women with known defects of the hemostasis
* pregnancy
* other internal or anatomical criteria that preclude a minimal invasive approach
* inability to understand patient information
Treatment of Diacapitular Condylar Fractures

A new surgical approach, denoted as the supratemporalis approach, was designed to treat diacapitular condylar fractures of the mandibular condyle.This approach prevented facial nerve injury and did not increase the frequency of other complications. Therefore, the investigators suggest this surgical procedure as a routine and safe approach to diacapitular condylar fractures, which can also be applied to temporomandibular joint（TMJ）and to the zygomatic arch.

Eighty-four patients (112 sides) with diacapitular condylar fractures were treated surgically. Forty-four patients (64 sides) were treated with the supratemporalis approach, and forty patients (48 sides) were treated with traditional preauricular approach. Data on the surgical procedures and complications were recorded. The follow-up periods were 12 -24months. The evaluated parameters include facial nerve injury，the maximum mouth opening, mandibular movements, occlusion, scar formation，hemorrhage and infection.Seven patients sustained facial nerve paresis in the group treated with the traditional preauricular approach. No case of facial nerve injury was observed in the supratemporalis approach group. No other significant differences were detected between the two groups in the functional and esthetic aspects.

Eligibility Criteria:
Inclusion Criteria:

* clinical and radiographical diagnosis of DFs;

Exclusion Criteria:

1. condylar fractures with undisplaced fractures;
2. Fractures without the reduction of the condylar height;
3. A obvious scar at the temporal region, affecting the placement of the original incision.