cyrilzakka/clinical-trials huggingface dataset:
A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer

This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer.
* Rising PSA while on hormonal therapy or following surgical castration.
* Documented evidence of metastatic disease.

Exclusion Criteria:

* Have received cytotoxic chemotherapy.
* Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.
PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas

This trial is an open-label, single-arm, phase 0/1 study of high-grade glioma that aims to evaluate the feasibility, preliminary efficacy and safety of the precision treatment strategy.

The investigators have established a precision treatment strategy, that select chemotherapeutic drugs or targeted drugs based on information from PTCs drug-screening or/and bioinformatic prediction. In this study, the investigators are going to exploit this strategy for the precision treatment of recurrent high-grade gliomas. The investigators will evaluate the feasibility, safety and preliminary efficacy via collecting the indexes comprising clinical presentation, results of imaging examination, clinical assays, KPS, neurological score, etc.

Eligibility Criteria:
Inclusion Criteria:

* 1 At the age of 18\~75, regardless the gender
* 2 The lesion of primary surgery was diagnosed as WHO II\~IV Glioma by histologic pathology
* 3 Received radiotherapy and Temozolomide-based chemotherapy within 5 years
* 4 Recurrent and respectable gliomas, and have been neurosurgically resected
* 5 The resected recurrent gliomas was identified as WHO III\~IV Glioma by histologic pathology
* 6 None postoperative standard therapeutic regimens can be followed when participating the recruitment
* 7 Can understand the trial's content and sign informed consent

Exclusion Criteria:

* 1 Having other untreated malignant tumors
* 2 The amount of resected tumors is not enough for genomic sequencing or PTCs drug screening
* 3 Received Carmustine implants within 6 months prior to enrollment
* 4 Subjects with active HBC, HCV or HIV infection
* 5 Subjects with uncontrolled cardio- or cerebro- vascular diseases
* 6 Subjects with uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes
* 7 Subjects with other conditions in their active phase that would interfere trial participation
* 8 Subjects receiving immunosuppressants after organ transplantation
* 9 Subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment, or receiving anticoagulant therapy
* 10 Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment
* 11 Subjects with other conditions that would interfere participating in the trial at the investigator's discretion
* 12 Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures
Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen

Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.

Recurrent HCV in the liver allograft is becoming the leading indicator for retransplantation. Studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic HCV liver disease. Treatment of acute allograft rejection with steroid boluses is also associated with rapid HCV recurrence. The relative contribution of various calcineurin inhibitors to recurrent HCV liver disease has not been established. Previous retrospective studies, as well as prospective studies have not demonstrated a difference in recurrent HCV liver disease rates between patients receiving CsA or tacrolimus immunosuppression regimens respectively.

Eligibility Criteria:
Inclusion Criteria:

* adult patients who have received liver transplant

Exclusion Criteria:

* pregnant women
* nursing women
Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study

The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.

It describes the long-term quality of life (QoL) after ultrasound guided foam sclerotherapy (UGFS) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis.

Recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s.

The initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (GSV) ) as measured by colour flow duplex ultrasound (DUS). DUS findings of the treated proximal GSV were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. Patients in categories 2 and 4 are considered to have reflux.

Eligibility Criteria:
Inclusion Criteria:

* all patients included in previous FOAM study

Exclusion Criteria:

* no received informed consent
The Effects of n-3 LCPUFAs in Patients With Colorectal Cancer

The aim of this study is to determine the effects of n-3 PUFAs on weight, physical funktion and quality of life in patients with colorectal cancer.

Primary outcomes:

* Weight
* Physical function
* Hand-grip strength

Secondary outcomes:

* Quality of life
* Mid-upperarm circumference
* Incorporation of n-3 PUFAs into cell membranes

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Patients with diagnosed colorectal cancer with metastases treated with chemotherapy on Rigshospitalet, Copenhagen

Exclusion Criteria:

* \< 18 years
* Patients in palliative care
* patients with haemophilia
* Patiens in treatment of anti-coagulation
* Patients with genetic hyperkolesterolemia
* Pre-dialytic patients (GFR\<15ml/min/1,73m2 eller kreatinin ≥500 mmol/L)
Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan

This study will assess the safety, reactogenicity, and immunogenicity of Gam-COVID-Vac (Sputnik V) vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19). The vaccine contains two recombinant adenoviral vectors harbouring SARS-CoV-2 Spike gene. The vaccine will be administered intramuscularly on a 2-dose prime-boost schedule. Participants will be healthy adults aged greater than or equal to 18 years, voluntarily undergoing vaccination according to the guidelines of the Ministry of Healthcare of Kazakhstan.

Sputnik V (Gam-COVID-Vac) is an adenoviral vector vaccine developed by The Gamaleya Research Institute of Epidemiology and Microbiology (Moscow, Russia), registered and approved by the Ministry of Healthcare of Kazakhstan. The vaccine incorporates two recombinant adenoviral (rAd) vectors, rAd5 and rAd26, harbouring SARS-CoV-2 Spike (S) gene.

Earlier Phase I/II clinical trials established that Sputnik V is safe and efficacious when given intramuscularly in two sequential doses, as a rAd26-S prime at day 0 followed by rAd5-S boost at day 21, at 1x10\^11 particles per dose. The aim of the current study is to provide data on the safety, reactogenicity, and immunogenicity of Sputnik V in adults vaccinated in Kazakhstan using the established vaccination regimen. In addition, the effects of prior COVID-19 exposure on the vaccine safety, reactogenicity, and immunogenicity will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be healthy (in the physician's clinical judgment and as confirmed by medical records, and physical examination at screening).
* Willing to give informed consent, and answer short questionnaires on past exposure to COVID-19 and post-vaccination reactogenicity.
* Willing to comply with the requirements of the protocol.

Exclusion Criteria:

* Participant shows signs of an acute illness (excluding minor illnesses such as diarrhea or mild upper respiratory tract infection).
* Participant has a positive laboratory-confirmed test result for SARS-CoV-2 infection at screening.
* Deemed by investigators to be unlikely to complete study protocol.
Trial of Adjunctive Vitamin D in Tuberculosis Treatment

The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.


Eligibility Criteria:
Inclusion Criteria:

* Suspected smear positive pulmonary tuberculosis.
* Age 18 years or older.
* Written informed consent to participate.

Exclusion Criteria:

* Known intolerance of vitamin D or first-line anti-tuberculous therapy.
* Taking antituberculous therapy for more than six days in the six months preceding enrolment.
* Taking the following medication in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy.
* Taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol.
* Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, HIV infection, liver failure, renal failure or malignancy
* Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing)
* Biochemical disturbance at enrolment: serum corrected calcium \>2.66 mmol/l, serum AST \>120 IU/l, total serum bilirubin \> 40 micromol/l or serum creatinine \> 250 micromol/l
* Breastfeeding or pregnancy
De-escalating Vital Sign Checks

The overall goals for this study are: 1) to develop a predictive model to identify patients who are stable enough to forego vital sign checks overnight, 2) incorporate this predictive model into the hospital electronic health record so physicians can view its output and use it to guide their decision-making around ordering reduced vital sign checks for select patients.

Patients in the hospital often report poor sleep. A lack of sleep not only affects a patient's recovery from illness and their overall feeling of wellness, but it is a leading factor in the development of delirium in the hospital. One method for improving sleep in the hospital is to reduce the number of patient care related interruptions that a patient experiences. Vital sign checks at night are one example. In hospitalized patients who are clinically stable, vital sign checks that interrupt sleep are often unnecessary. However, identifying which patients can forego these checks is not a simple task. Currently, the hospital's quality improvement team asks physicians to think about this issue every day and order reduced, or "sleep promotion", vital sign checks on patients they believe could safely tolerate it. The investigators goal is to use a predictive analytics tool to reduce the cognitive burden of this task for busy physicians.

The investigators plan to develop a logistic regression model, trained on data from the electronic health record (EHR), to predict, for a given patient on a given night, whether they could safely tolerate the reduction of overnight vital sign checks. The model will use variables, such as the patient's age, the number of days they have been in the hospital, the vital signs from that day, the lab values from that day, and other clinical variables to make its prediction. The outcome is a binary variable, whether the patient will or will not have abnormal vital signs that night. The training data is retrospective therefore it contains the nighttime vitals that were observed, which the investigators will code as a binary variable and use as the outcome variable for the model to train against.

The investigators will incorporate this algorithm into an EHR alert so physicians can observe its output during their work, and use this information, complemented by their own clinical judgment, to decide about ordering reduced vital sign checks for a given patient.

The investigators will study the effect of this EHR alert on several outcomes: in-hospital delirium (measured by nurse assessment), sleep opportunity (a measurement, based on observational EHR data, of patient care related sleep interruptions), and patient satisfaction (measured by nationally-administered post-hospitalization HCAHPS surveys). Balancing measures, to ensure that reduced vital sign checks do not cause patient harm, will be rapid response calls and code blue calls.

Physician teams will be randomized to either see the EHR alert (intervention arm) or not see the EHR alert.

Eligibility Criteria:
Inclusion Criteria:

* All physician teams that operate under the UCSF Division of Hospital Medicine

Exclusion Criteria:

* N/A
Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma

The purpose of this study is to assess the safety of soluble beta-glucan (SBG) in combination with antibody and chemotherapy treatment in patients with non-Hodgkin-s lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. CD20 positive B-cell non-Hodgkin's lymphoma
2. Treatment with rituximab and CHOP or COP
3. Performance status 0 or 1 according to the WHO scale (Appendix)
4. Expected lifetime of more than 12 weeks
5. Age ≥ 18 years
6. The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained

Exclusion Criteria:

1. Women who are pregnant or breast-feeding. For fertile women, a negative pregnancy test must be provided during the screening test. Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation
2. Lymphoma involvement of central nervous system
3. Reduced bone marrow function defined by leukocyte counts \< 3.0 x 109/l, neutrophil counts \< 1.5 x 109/l, thrombocyte counts \< 100 x 109/l or hemoglobin \< 10 g/dl
4. Reduced liver function defined by bilirubin \> 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN
5. Reduced renal function defined by serum creatinine ≥ 2 x ULN
A Multi-Center Study of Detection of Low Ventricular Ejection Fraction

This is a multi-site, retrospective study to evaluate the performance of a locked AI-based algorithm for detection of left ventricular systolic dysfunction. A prerequisite for inclusion of subjects from each institution will be the availability of at least one digital 12-lead ECG paired with an echocardiogram with LVEF information within 30 days of the date of the ECG. The AI-ECG LVSD algorithm will be applied on all ECGs and diagnostic performance features for the detection of LVSD will be estimated using the provided paired LVEF value (Low LVEF as the reference label). Performance will also be assessed in subgroups of subjects determined by demographic and clinical factors.

Following institutional review board approval, 12,000 12-lead ECG's paired with an echocardiogram with LVEF information within 30 days of the date of the ECG will be collected across three enrolled sites. Each site will provide data from up to 4000 enrolled subjects that meet the inclusion criteria. No other demographic characteristics or enrichment will be considered in the selection of subjects in order to best represent the general population for that site. Sites will securely transfer the data to a centralized repository for processing.

Once data is collected, the device will be used to analyze the ECG data for all enrolled subjects without reference or access to the echocardiogram data. The device will display a binary 36 prediction of the likelihood of LVEF less than or equal to 40%. Results will be compared to the echocardiogram reference standard in accordance with the statistical analysis plan.

Eligibility Criteria:
Inclusion Criteria:

- Adult subjects with or without known cardiac disease who are either inpatients or outpatients with ECGs and an echocardiogram within 30-days of the ECG date.

Exclusion Criteria:

* No research authorization provided
* An ECG signal shorter than 10 seconds or that is not interpretable
* An echocardiogram is considered technically challenging
* Only qualitative interpretation of left ventricular systolic function available (i.e., "decreased EF") without a numerical value.
* A paced rhythm
Effects of LH and FSH on Metabolic Regulation in Cumulus Cells

The combined use of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) has improved IVF pregnancy rates in infertile women aged 35-40, but its mechanisms remain unclear. This prospective study will examine how FSH and LH combined treatment affects cumulus cell energy metabolism. Sixty participants will be divided into two groups receiving either combined therapy or FSH alone. The study will analyze patient characteristics, infertility history, and compare mitochondrial function in cumulus cells to evaluate treatment effectiveness.

The impact of combined follicle-stimulating hormone (FSH) and luteinizing hormone (LH) treatment on ovulation stimulation in older infertile women has garnered significant attention in reproductive medicine. While research indicates improved in vitro fertilization (IVF) pregnancy rates in women aged 35-40 receiving combined FSH and LH therapy compared to FSH alone, the underlying mechanisms and effectiveness remain unclear. This prospective study aims to investigate the effects of combined FSH and LH treatment on cumulus cell energy metabolism in infertile women aged 35-40 undergoing IVF treatment. The research will involve 60 participants divided into two equal groups: one receiving combined FSH and LH therapy and the other receiving FSH alone. The study will collect comprehensive data including baseline characteristics, infertility history, ovarian function parameters, and ovulation stimulation cycle outcomes. Additionally, cumulus cells will be collected from both groups to compare their mitochondrial metabolic function. Through this investigation, we seek to understand whether the combined hormone approach can enhance cumulus cell energy metabolism and improve overall ovulation stimulation outcomes in this specific age group. CopyRetryClaude can make mistakes. Please double-check responses.

Eligibility Criteria:
Inclusion Criteria:

* Age 35-40 years
* BMI 18-30 kg/m2
* planning to undergo IVF cycles

Exclusion Criteria:

* Primary ovarian insufficiency
* history of oophorectomy
* receiving oocyte donation
* Chromosome anomaly
* Congenital uterine anomaly
* Severe intrauterine adhesion
* Malignancy
* Using hormone therapy or supplements in recent 3 months
Evaluating the Effects of Electroacupuncture and Rosiglitazone Combined Therapy

Aims: To evaluate the efficacy of rosiglitazone (TZD) and electroacupuncture (EA) combined therapy on patients with type 2 diabetes mellitus (T2DM). A randomized single-blind placebo controlled clinical trial was used.

Methods: A total of 31 newly diagnostic type 2 diabetic patients, who fulfilled the eligibility criteria were recruited and received various allocated interventions. They were randomly assigned into two groups, the control group (TZD, N=15) and the experimental group (TZD + EA, N=16). Changes in their plasma free fatty acid (FFA), glucose and insulin levels together with their homeostasis model assessment (HOMA) indices were statistically assessed between before and after treatment. Hypoglycemic activity (%) was also compared between these two groups.

Expecting Results: This study will compare the hypoglycemic activity and the ability of improving insulin resistance between the TZD and TZD+EA group. Also, the lowering effect of the plasma FFA concentration will be investigated.

This study is compared the effect between combined therapy (EA+TZD) and drug (TZD) on the patient of type 2 DM.

Eligibility Criteria:
Inclusion Criteria:

* all included native Taiwanese patients, age from 20 to 65 years who diagnosed with type 2 diabetes mellitus within 5 years and keep the same anti-hyperglycemic agents for control diabetes before and during the period in this study
* compatible with the diagnostic criteria of diabetes mellitus according to American Diabetes Association

Exclusion Criteria:

* individuals with nephrotic syndrome (urine protein over 3.5 g/day) and edema or renal failure (serum creatinine over 115 μmol/L)
* individuals who were diagnosed of heart failure (NYHA Fc III\~IV) or pacemaker implantation
* individuals with abnormal liver function (GOT and GPT level above 2 folds of normal range) or diagnosis of liver cirrhosis
* individuals with higher HbA1C level (HbA1C above 9%)
* pregnant women
* individuals who were receiving the classes of drugs thiazolidinediones already
* individuals who were receiving insulin therapy already
* individuals who were receiving other therapy during the period of study
* individuals suffering a homeostasis disorder or other systemic disease
* individuals who did not comply with the treatment during the study period
Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes

Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.


Eligibility Criteria:
Inclusion Criteria:

* Age: 5 to 12 years old
* Myopia (spherical equivalent with cycloplegic) ≤ -0.50D
* Astigmatism \< 1.50D
* Anisometropia \< 1.50D
* Best-corrected visual acuity ≥ 20/20

Exclusion Criteria:

* Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.
* Participants with ocular pathology such as retinal detachment.
* Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.
* Participants with systemic diseases that may affect vision.
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.

Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Major Inclusion Criteria:

  * Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule.
  * According to the Investigator's opinion will benefit from continuing treatment with relacorilant

Exclusion Criteria:

* Major Exclusion Criteria:

  * Premature discontinuation from a relacorilant parent study.
  * Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
  * Has poorly controlled hypertension
  * Has Stage ≥ 4 renal failure