cyrilzakka/clinical-trials huggingface dataset:
Remdesivir for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

This study looks at the safety and effectiveness of Remdesivir in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Remdesivir plus current standard of care (SOC), or with placebo plus current SOC.

This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to evaluate the safety and efficacy of Remdesivir at improving outcomes for patients with acute respiratory failure related to COVID-19.

This protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol.

This protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

The protocol is for a Phase 3 study.

Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.

This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for Remdesivir versus placebo with use of the ordinal outcome. The planned sample size is 320 participants. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio.

Randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) at enrollment. Other agent-specific stratification factors may be considered.

An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.

Eligibility Criteria:
Inclusion Criteria:

Refer to the master protocol (NCT04843761)

Exclusion Criteria:

Refer to the master protocol (NCT04843761)

Additional Exclusion Criteria:

* Prior receipt of any dose of remdesivir during the present illness
* GFR (glomerular filtration rate) \< 30 ml/min and not receiving dialysis
* ALT (alanine aminotransferase) or AST (aspartate aminotransferase) \> 10 times upper limit of normal
* Unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days after completion of remdesivir vs. placebo
Handling Oxygenation Targets in the Intensive Care Unit

Handling oxygenation targets (HOT) is standard of care in the intensive care unit (ICU), however the quality and quantity of evidence is low and potential harm has been reported. The aim of the HOT-ICU trial is to assess the overall benefits and harms of two levels of oxygenation targets in adult critically ill patients with acute hypoxaemic respiratory failure in the ICU.

Acutely ill adults with hypoxaemic respiratory failure admitted to the intensive care unit (ICU) are at risk of life-threatening hypoxia, and thus oxygen is administered. However, the evidence on the optimal level of oxygenation is of low quantity and quality with no firm evidence for benefit or harm. Importantly, liberal use of supplementary oxygen may increase the number of serious adverse events including death. The aim of the HOT-ICU trial is to assess the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen administration in acutely ill adults with hypoxaemic respiratory failure at ICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Acutely admitted to the ICU AND
* Aged ≥ 18 years AND
* Receives supplemental oxygen with a flow of at least 10 L per minutes in an open system including high-flow systems OR at least a FiO2 of 0.50 in a closed system including invasive or non-invasive ventilation or CPAP systems AND
* Expected to receive supplemental oxygen for at least 24 hours in the ICU AND
* Having an arterial line for PaO2 monitoring

Exclusion Criteria:

* Cannot be randomised within twelve hours after present ICU admission
* Chronic mechanical ventilation for any reason
* Use of home oxygen
* Previous treatment with bleomycin
* Organ transplant during current hospital admission
* Withdrawal from active therapy or brain death deemed imminent
* Fertile woman (\< 50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
* Carbon monoxide poisoning
* Cyanide poisoning
* Methaemoglobinaemia
* Paraquat poisoning
* Any condition expected to involve the use of hyperbaric oxygen (HBO)
* Sickle cell disease
* Consent not obtainable according to national regulations
* Previously randomised into the HOT-ICU trial
Vitality Trial - Sampling Examination Data

This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination will be done and the data will be compared to the other examinations.


Eligibility Criteria:
Inclusion Criteria:

* MRI exmination outcome: positive Late Enhancement, proof of infarction scars by contrast agent.

Exclusion Criteria:

* no exclusion criteria as patients are asked to participate after evaluating the MRI examination outcome
Intensified Dosing of Cellcept (Mycophenolate Mofetil) in Kidney Transplantation

The primary objective of this study is to determine whether 4 grams daily of mycophenolate mofetil (MMF) results in a greater proportion of individuals adequately exposed as measured by drug levels (area under the curve of \> 40 mg\*hr/L).

Several studies have shown that early exposure to adequate levels of immunosuppression are required to reduce acute rejection rates in kidney transplantation.(1, 2) Our center has shown that early exposure of mycophenolate mofetil (MMF or Cellcept) is associated with acute rejection rates and that many patients are underexposed in the early transplant period.(2) In a recently completed multicenter Canadian (CLEAR) study we found that higher doses of mycophenolate mofetil (MMF 3 grams daily versus 2 grams daily) were associated with better early exposure by day 5 and that this was associated with less rejection but no increase in toxicity.(3) The best cut point that discriminated between low and high rejection rates was a mycophenolic acid (MPA) 12 hour area under the curve (AUC) of 40 mg\*hr/L. Patients below this level experienced rejection rates of 50% compared to \<16% for those above this level. Even with the higher dose 26% of subjects were inadequately exposed. Since medication adjustments based on drug levels is hampered by steady state conditions and the turn around time of MPA testing we are interested in exploring even higher initial doses of MMF with the aim to maximize the numbers of patients achieving adequate early exposure to MPA.

Objectives:

The primary objective of this study is to determine whether 4 gms daily of MMF results in a greater proportion of individuals adequately exposed as measured by a day 5 MPA AUC of \>40 mg\*hr/L.

The secondary objectives of this study are to assess the ability of this strategy to achieve target MPA AUC exposure of 40-60 mg\*hr/L by day 14 and to determine the distribution of MMF doses that are necessary to achieve this level of exposure. Safety data (hemoglobin and WBC counts, need for further dose changes based on gastrointestinal intolerance, acute rejection, renal function, and wound infection) will be also collected over the first 3 months post transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing single organ kidney transplantation.
* Age \> 18 years old.
* Patients who would normally receive our standard therapy of basiliximab, tacrolimus, MMF and steroids.
* All patients will be required to sign informed consent.

Exclusion Criteria:

* Patients will be excluded if they require anti-thymocyte induction therapy, have documented gastroparesis, have known intolerance to MMF, or are prescribed cyclosporine.
* As a standard policy all women of childbearing age will be informed about the risks of all immunosuppressive drugs on fetal outcomes and will be required to use 2 forms of birth control.
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.


Eligibility Criteria:
Inclusion Criteria:

* FOR THE MAIN TRIAL, NN5401-3594:
* Type 1 diabetes mellitus for at least 12 months
* Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
* HbA1c 7.0-10.0% (both inclusive)
* BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
* FOR THE EXTENSION TRIAL, NN5401-3645:
* The subject must have completed the six-month treatment period in trial NN5401-3594

Exclusion Criteria:

* FOR THE MAIN TRIAL, NN5401-3594:
* Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
* Cardiovascular disease within the last 6 months
* Uncontrolled treated/untreated severe hypertension
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
* Cancer and medical history of cancer
* FOR THE EXTENSION TRIAL, NN5401-3645:
* Anticipated significant lifestyle changes during the trial
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.

The purpose of this study was to investigate whether dexmedetomidine used in the perioperative period of elective cesarean section can improve maternal mood, improve analgesic effect, improve maternal recovery quality, and then make the breastfeeding better.At the same time, this experiment attempts to explore the optimal dose of dexmedetomidine to produce the above effect.

After obtaining the informed consent, parturients were randomly divided into two groups according to the computer-generated random number table, namely, dexmedetomidine group and the control group.Spinal anesthesia is administered to all maternal women undergoing elective cesarean delivery. Immediately after the umbilicus is cut, the infusion of the experimental drug was started until the end of the operation, and the PCIA pump with the study medication is used during 2 days postoperatively.Continuous follow-up for three days after surgery.Follow-up personnel recorded LATCH score, VAS score, quality-of-recovery score and other indicators.In the 6th week after caesarean section, the outcome indicators were collected by electronic questionnaire and telephone follow-up.This randomized controlled trial is aims to prove that dexmedetomidine, used in parturient with elective cesarean section, can improve maternal mood and prolong the duration of breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

1. ASA class I or II
2. BMI≦35kg/m2
3. Greater than 37 weeks gestation
4. Expressed a desire to breastfeed for a least 3 months postpartum
5. Elective cesarean section

Exclusion Criteria:

1. Intraspinal anesthesia contraindication
2. Twin or fetal Intrauterine distress
3. Preoperative history of application of analgesia or sedative drug
4. Severe cardiac and pulmonary dysfunction
5. History of neurological and psychiatric diseases
Therapeutic Drug Use for CKD Patients

Chronic kidney disease (CKD), characterized as renal dysfunction, is recognized as a major public health problem with high morbidity and mortality worldwide. This study aimed to analyze the common drug use and combinations of different stages and types of CKD patients. The study is a multicenter retrospective study involving three hospitals. Investigators reviewed and analyzed all patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022. Chronic kidney disease was defined as eGFR less than 60 mL/min per 1·73 m(2) or the presence of albuminuria. The study selected seven types of drugs based on hospital electronic medical record data, including β Receptor blockers, angiotensin converting enzyme inhibitor blockers, angiotensin II receptors, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, and calcium channel blockers. Chi-square test, Mann-Whitney Wilcoxon test, and Kruskal Wallis test will be used for statistical analysis. The main purpose of this study is to provide evidence for promoting rational drug use in CKD patients by describing the drug use. The secondary purpose of the study is to explore the efficacy, safety and economy of SGLT-2 inhibitors in diabetes nephropathy (DN).


Eligibility Criteria:
Inclusion Criteria:

1. Visit time (based on admission time for inpatients) is from July 1, 2020 to June 30, 2022
2. Any diagnostic type of the patient's visit includes CKD related diagnostics
3. Age ≥ 18 years old

Exclusion Criteria:

1. Diagnosis includes malignant tumors
2. Diagnosis includes uremia, hemodialysis, or peritoneal dialysis
3. Diagnosis includes jaundice
4. Incomplete clinical data
Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS

To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).


Eligibility Criteria:
Inclusion Criteria:

* Patients who are between 18-90 years old
* Patients undergoing RIRS for treatment of 1-2 cm diameter kidney stones

Exclusion Criteria:

* Patients who have congenital urogenital abnormalities
* Patients who have previous stone surgery history
A Study of LY900014 Formulation in Healthy Participants

This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
* Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
* Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 450 milliliters (mL) within the last month
Effects of Functional Incidental Training in VA NHCU Residents

This research on Functional Incidental Training ( FIT) primarily involves women residing in community nursing homes. It is an individualized rehabilitative protocol intended to improve mobility, endurance, strength and continence in frail, older, functionally impaired and disabled veterans.

Objectives of the project are as follows:

1) Test the effects of FIT on transfer ability, continence, ambulation/mobility, balance and fall risk, strength, and endurance; 2) Determine the characteristics of NHCU residents who respond to FIT; 3)Identify the most sensitive outcome measures related to FIT; and 4) Determine the labor costs of FIT relative to usual care.

This research on Functional Incidental Training ( FIT) primarily involves women in community nursing homes.

Objectives:

1. test the effects of FIT on functions such as transfer ability, continence, ambulation/mobility,balance and fall risk, strength, and endurance; 2. determine the characteristics of NHCU residents who respond to FIT; 3. identify the most sensitive outcome measures related to FIT; and 4. determine the labor costs of FIT relative to usual care.

. The intervention is an individualized rehabilitative protocol intended to improve mobility, endurance, strength and continence in frail, older, functionally impaired and disabled veterans in VA nursing home care units(NHCUs).The design is a multi-site cross-over design, to be carried out in five NHCUs (Atlanta, Durham, Salisbury, Augusta, Tuscaloosa) over about eight months in each site. About 24 residents will be recruited in each NHCU: 12 each will be randomized to initial intervention and control for 8 wks and evaluated; the controls will then receive the intervention and vice versa for another 8 wks with another evaluation. Patients are seen 4x a day for FIT activities, including walking/using wheel chair, prompted toileting, strengthening exercises. Outcome measures will be made in a blinded manner by Project Manager.

Eligibility Criteria:
Functionally impaired elderly
Study Of AG-013736 In Patients With 131I-Refractory Thyroid Cancer

The primary purpose is to determine how effective AG-013736 is in shrinking thyroid cancer that is resistant to radioactive iodine

Additional study details: assess safety and efficacy

Eligibility Criteria:
Inclusion Criteria:

* Radioiodine-refractory metastatic or unresectable locally-advanced thyroid cancer
* At least 1 measurable target lesion, as defined by RECIST

Exclusion Criteria:

* Thyroid lymphoma
* Previous treatment with anti-angiogenesis agents
* No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism within 12 months prior.
Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.

This study was addressed to patients having an immediate or differed pregnancy desire and presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.

* The primary end point was the assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look performed 10 to 20 weeks post-surgery.
* The secondary end points were the assessment, throughout a 3 years follow-up period, of:

  * pregnancy rate,
  * adverse events related to adhesions,
  * adnexal adhesions according to American Fertility Society score,
  * abdomino-pelvic adhesions according to the modified American Fertility Society score.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with the fertility by the patient who having an immediate or differed desire of pregnancy.
* Size: diameter ≥ 6 cm at echographia (for the highest diameter)
* Location interstitial and / or subserosa
* planned laparotomic surgery
* negative pregnancy test within 48 hours of surgery
* signed inform consent

Exclusion Criteria:

* History of abdomino-pelvic surgery (except appendicectomy - cesarotomy)
* Pre-operative embolization
* Endometriosis stage \>1 (American Fertility Society classification ≥ 5)
* Pregnant patient
* Diabetes
* Chronic corticotherapy / immuno-supressor or immuno-modulator drugs
* Previous analog LH-RH drug therapy for the uterine myoma
Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease

This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.

This study will evaluate the safety and tolerability of treatment with CTP-499 starting with 600 milligrams (mg) once a day (QD) for 2 weeks followed by 600 mg twice a day (BID) for 2 weeks in non-dialysis patients associated with moderate chronic kidney disease defined as an estimated Glomerular Filtration Rate or eGFR that is 30-59 mL/min/1.73m2

Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of chronic kidney disease
* If taking antihypertensive and antidiabetes medications, regimen must be stable for a minimum of 4 weeks
* Patient has systolic blood pressure less than or equal to 160 mm Hg and diastolic blood pressure less than or equal to 95 mm Hg

Exclusion Criteria:

* Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or clinically unstable autoimmune, endocrine, neurological, psychiatric, retinal, cardiovascular, bronchopulmonary, hepatic, gastrointestinal or musculoskeletal disorder
* Patient has acute, active and/or current unstable renal impairment disease
* Patient has been hospitalized for acute renal failure in the past year
* Patient has active malignancy or a history of neoplastic disease
* Patient has QTc interval \> 450 milliseconds
* Patient is currently on cytotoxic or other immunosuppressive therapy