cyrilzakka/clinical-trials huggingface dataset:
Hydrocortisone 50 mg Every 6 Hours Compared to Hydrocortisone 300 mg Per Day in Treatment of Septic Shock.

We performed a multicenter, prospective, randomized, double-blind, pilot study in four adult medical intensive care units. Patients presenting septic shock were rapidly administered one of two regimens of hydrocortisone, either a 50-mg intravenous bolus every six hours during seven days (200-mg group) or a 100-mg initial bolus followed by a continuous infusion of 300 mg daily for five days (300-mg group). Hydrocortisone was stopped abruptly at the end of treatment.

Hydrocortisone hemisuccinate (Hydrocortisone Upjohn) was supplied as a powder in 100 mg vials to be reconstituted with 2 ml of sterile water diluent. The placebo was saline serum supplied as 10 ml ampoules. The study drugs were administered according to two protocols. In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days. In the two groups, hydrocortisone was stopped abruptly at the end of treatment. The investigators had the choice or resuming hydrocortisone at the end of the fifth day if deemed necessary.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* septic shock in accordance with the American College of Chest Physicians/Society of Critical Care Medicine Consensus Committee criteria. Septic shock was managed in accordance with the 2004 edition of the Surviving Sepsis Campaign guidelines.
* no minimal vasopressor dose was needed to enter the trial.

Exclusion Criteria:

* medical history of adrenal insufficiency
* ongoing corticosteroid treatment
* pregnancy
Impact of Telehealth Education in Diabetes Patients

The goal of this clinical trial is to to evaluate the effectiveness of continuity of in-hospital care with the application of a structured telemonitoring protocol in self-care activities in patients with type 1 or type 2 Diabetes Mellitus or those who have an HbA1C level greater than or equal to 6.5% during hospitalization, regardless of the reason for hospitalization. The main question\[s\] it aims to answer are:

• Is telehealth education effective for improving self-care for type 1 or type 2 Diabetes Mellitus or those with an HbA1C level greater than or equal to 6.5% during hospitalization will be included, regardless of the reason for hospitalization? Participants will answer the Diabetes Self-Care Activity Questionnaire Researchers will compare patients in the intervention group, in addition to the hospital's standard hospital guidance, will receive an educational approach through structured telemonitoring, reinforcing and validating the points addressed in the face-to-face guidance, which are considered the foundations of self-care.

This study have two groups of patients. Group 1 will be carried out at discharge, discharge orientation of the patient with diabetes and application of the Diabetes Self-Care Activity Questionnaire (QAD). For this group, a new contact will be made within 30 days after discharge, where the QAD will be applied again.

Group 2 will be performed at the time of discharge, guidance for discharge of patients with diabetes. This group will receive 3 contacts, the first will be carried out within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge, where diabetes education guidelines will be given to the patient in all contacts. At the time of discharge, and in the third contact, 30 days, the QAD will also be applied.

Eligibility Criteria:
Inclusion Criteria:

* patients who were hospitalized at Hospital Israelita Albert Einstein and included in the subcutaneous insulin protocol to control hyperglycemia
* patients monitored by the Diabetes Program, an institutional program that manages glycemic changes that occur within the institution.
* patients with type 1 or type 2 Diabetes Mellitus or those with an HbA1C level greater than or equal to 6.5% during hospitalization.

Exclusion Criteria:

* Patients not submitted to the first face-to-face educational approach required by protocol
* Patients discharged on the weekend or holidays
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption

Opioids analgesic are the gold standard for intraoperative pain management. Their short- and long-term adverse effect motivate anesthesiologists to explore opioid sparing strategies. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. This new randomized controlled trial (RCT) will answer the question whether an intraoperative dexmedetomidine infusion compared to placebo has a clinically significant impact on intraoperative remifentanil consumption during a laparoscopic abdominal elective surgery.

Opioids analgesic have been used for intraoperative pain management for decades. They are the gold standard for pain relief due to their high efficacy. However, the short- and long-term adverse effects of opioids motivate anesthesia teams to explore opioid sparing strategies employing a combination of analgesics and adjuvants via continuous infusions. Opioid tolerance and opioid-induced hyperalgesia can lead to dose escalation of prescribed opioids and poor pain control.

Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that could help minimize opioid consumption both intraoperative and postoperative due to its sedative, analgesic and sympatholytic properties. Other post-procedure applications such as reduction of cough, agitation and shivering have been described.

Many trials have studied the impact of intraoperative dexmedetomidine on post-operative pain scores, post-operative opioids consumption and common side effects compared with a remifentanil intraoperative infusion. One randomized controlled trial studied the impact of a 30 min dexmedetomidine infusion on intraoperative remifentanil consumption in ASA 1-2 patients undergoing maxillofacial or cervicofacial surgeries. They found a clinically meaningful reduction of 33% of remifentanil consumption at 120 minutes in the dexmedetomidine group. This trial aims to demonstrate a similar reduction when extending to ASA 3 patients undergoing laparoscopic surgery. Furthermore, the investigators aim to evaluate patients' recovery and pain status 24h after the surgery which hasn't been done before in the context of joint dexmedetomidine and remifentanil infusion. The investigators hypothesize that patients of the dexmedetomidine infusion group will require less intraoperative remifentanil to keep the NOL-index into the prespecified range. In the PACU, lower pain score et less opioids requirements are anticipated.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* Laparascopic surgery (including general surgery, gynecology, urology) a small abdominal incision (less than 5 cm) will be tolerated.

Exclusion Criteria:

* Patient refusal
* Chronic use of opioids
* Allergy to medication used in the trial
* Pregnant or breastfeeding women
* Contraindications to dexmedetomidine (Bradycardia, arrythmia or pace- maker, severe ventricular dysfunction)
Microinvasive Glaucoma Surgery -The Lowering Effect of Intraocular Pressure on Glaucoma Patients With High Frequency Deep Sclerotomy

Highlights the high-frequency deep sclerotomy (HFDS) as a promising ab-interno surgery in primary open-angle glaucoma (POAG) patients and evaluates the eﬃcacy and safety of the procedure.

\[Materials and Methods \] This is a single-centre, prospective, non-blinded, interventional trials designed to evaluate the therapeutic effect and safety of HFDS in POAG patients. A total of 30 subjects were recruited, all of whom were outpatients of the ophthalmology department of attending physician MeiLan Ko in the National Taiwan University Hospital Hsin-Chu Branch. The 20 subjects were all diagnosed with POAG. The surgery was performed in the surgery room of the National Taiwan University Hospital Hsin-Chu Branch. The surgery was performed using the abee® glaucoma tip of Oertli phacoemulsiﬁcation machine (Cata-rhex3, Switzerland) and goniolens. During the procedure, nasal six pockets penetrating 1mm deep into the trabecular meshwork and Schlemm's canal were formed to promote aqueous humor outflow.

\[Postoperative follow-up and evaluation\] The postoperative IOP and visual acuity (VA) were measured in every follow-up visit for 6 months. Postoperatively, Cravit/Lotemax drops were given to prevent inflammation and infections; besides, Pilocarpine 2% eye drops were provided to reduce IOP for postoperative medication.

\[Data Statistics and Analysis\] Statistical analysis was done by IBMSPSS v21.0 statistical software (IBM Corporation, New York, USA). Data analysis was done by chi square (χ2) test, paired samples T-test and repeated ANOVA measurements with Bonferroni post hoc analysis. The results are considered statistically signiﬁcant with a P value \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic open angle glaucoma and were indicated for surgery due to either progression of field defect and raised intraocular pressure above 21 mmHg in spite of maximum medical treatment or for patients who were not compliant patient to their medical treatment.

Exclusion Criteria:

* Patients with close-angle, congenital, traumatic, neovascular, and uveitic glaucoma, patients with prior penetrating and nonpenetrating glaucoma surgeries or laser therapy, and eyes with corneal opacity precluding visualization of the angle.
Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. The main questions it aims to answer are:

* The recommended doses (RDs)
* The safety and tolerability
* The PK and the preliminary efficacy


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants with unresectable advanced or metastatic disease or 1L or 2L+ clear cell Renal cell carcinoma.
2. Have not received HIF-2α targeted therapy previously.
3. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1; Eisenhauer et al, 2009) as determined by the Investigator.
4. For all participants, archival tumor tissue material should be obtained; if archival tissue is not available or is older than 2 years, then a fresh biopsy should be obtained, if medically feasible. Specific requirements for tumor tissue samples will be described in the Laboratory Manual.
5. Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
6. Karnofsky Performance Status (KPS) ≥70%.
7. Screening ambulatory oxygen saturation (SpO2) ≥92%.
8. Screening left ventricular ejection fraction (LVEF) above the institutional lower limit of normal.

Key Exclusion Criteria:

1. Participants who have been previously treated with a HIF-2α targeted therapy and/or zanzalintinib.
2. Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Participants with clinically-relevant ongoing complications from prior radiation therapy are not eligible.
3. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
4. Concomitant anticoagulation with oral anticoagulants except for 1) prophylactic use of low-dose aspirin for cardioprotection or low dose low molecular weight heparins (LMWH) or 2) therapeutic doses of LMWH or specified direct factor Xa inhibitors.
5. Administration of a live, attenuated vaccine within 30 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Fu's Subcutaneous Needling Treatment for Knee Osteoarthritis

The population affected by degenerative knee arthritis is very large. The investigator performed Fu's subcutaneous needling (FSN). This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of Fu's subcutaneous needling (FSN) therapy on patellar pain in patients with degenerative arthritis.

The population affected by degenerative knee arthritis is very large. According to a survey conducted by the Ministry of Health and Welfare, the prevalence of osteoarthritis of the knee in Taiwan is about 3.5 million people, accounting for about 15% of the total population. Its effects are a heavy burden on socio-economic costs, and in addition to being included in medical expenses, serious cases can lead to incapacity to work; therefore, the disease is an important factor in causing disability and disability First, it is worth our attention.

Floating needle is a kind of dry needle therapy, which has been used in the treatment of degenerative arthritis for more than 20 years. It has been clearly annotated in the treatment strategy that it uses disposable floating needle needles at the superficial subcutaneous fascia, Parallel to the muscle to sweep away, and with reperfusion activities, muscle pain caused by muscle fascia and soft tissue pain with immediate and good pain relief effect, but still lack of treatment and rigorous evaluation of the establishment.

For the reasons of the degenerative arthritis pain, the clinical observation is not entirely due to the cause of joint deformity or cartilage damage, soft tissue lesions around the knee is also a common source of pain, the use of floating needle for the diagnosis of soft tissue injury , And observed its efficacy, which is also the core of this study.

This experiment used a randomized single-blind experiment to assess the immediate, short-term and long-term effects of floating needle therapy on patellar pain in patients with degenerative arthritis. The assessment tools included the VAS, WOMAC , Lesquesne index, the Muscle Tension Changes in the Lower Extremities, and Gyko .

Eligibility Criteria:
Inclusion Criteria:

- 1.Volunteers who are older than 50 years old and can cooperate with the experiment.

2.Established diagnosis of unilateral or bilateral degenerative knee arthritis. 3.There is a local trigger point around the unilateral or bilateral knee joint which on the muscle of Vastus lateralis, Vastus medialis, Gastrocnemius, or Tibialis anterior.

Exclusion Criteria:

* 1.There are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women.

  2.There has been a history of drug abuse (including excess alcohol) that affects pain assessors.

  3.Have received knee surgery. 4.People with central or peripheral nerve disease. 5.Cognitive impairment, unable to cooperate with the experimenter. 6.Patients currently receiving other treatments for knee osteoarthritis
Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography

The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City).

The importance of sleep upon physiological and psychological health has been extensively documented. It has been proposed that adequate sleep, as well as good sleep quality, is vital for wellbeing. (1). Some have suggested that sleep curtailment has paralleled the increased prevalence of cardiometabolic disease including obesity (2), type 2 diabetes mellitus (3, 4), hypertension (5, 6) and more. Sleep researchers face a major challenge since there are multiple methods for sleep assessment, all of which have advantages and disadvantages.Whilst polysomnography (PSG) is considered to be the gold standard for sleep assessment, there are some limitations including laboratory attendance for the participant and sleep scoring variance. Sleep questionnaires are widely utilized, particularly in large epidemiological studies, but are susceptible to inaccuracies and some have not been validated against PSG. Wrist actigraphy has provided researchers with an attractive equivalent and there are now multiple commercial manufacturers available. Actigraphic devices are usually worn on the non-dominant wrist and the instrument is used to monitor wrist movements through the use of an accelerometer and a memory chip. Wrist actigraphy is useful in the detection of sleep, wake, and activity.

Eligibility Criteria:
Inclusion Criteria:

* Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old

Exclusion Criteria:

* Not attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Under 18 or over 80 years old. Pregnancy. Unable to provide informed consent.
Ramosetron on Late PONV (Postoperative Nausea and Vomiting)

The purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (PONV) after breast surgery in high risk PONV patients. The investigators compared PONV amomng 3 groups- group C: no additional ramosteron, group B: two additional ramosteron doses at 12 hour interval, group M: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.

The investigators included high risk patients of PONV with a score of 3 or more as measured by the Apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. All patients was received ramosetron 0.3 mg at the end of surgery. The patients were evaluated for number of PONV (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. Nausea was defined as an unpleasant feeling of vomiting. Retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. PONV were further detailed quantified using the RINVR score (Rhodes Index of Nausea, Vomiting, and Retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods.

Intravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. The patients were evaluated 2 hours after ondansetron administration. If the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* American Society of Anesthesiologists (ASA) physical status I or II
* requesting IV PCA (patient control of analgesia) for pain control
* the high-risk group of PONV with a score of 3 or more as measured by the Apfel's score.

Exclusion Criteria:

* emergency operation
* re-operation
* drug abuse, allergy
* major organ disease (gastrointestinal, cardiovascular, respiratory, cerebral, renal or hepatic disease)
* smoker
* pregnancy
* lactation
* previously use of antiemetics or systemic steroids within 48 before surgery
Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study

There is a growing body of evidence in the literature regarding the adverse effects of hyperglycemia in critically ill patients. To target and maintain better blood glucose regulation we implemented an insulin protocol with target blood glucose levels between 81-110 mg/dL.


Eligibility Criteria:
Inclusion Criteria:

* Surgical or medical critically ill patients
* An expected ICU-stay of more than 72 hours
* Age \> 16 years
* Need for insulin therapy
* Patients must have an arterial line

Exclusion Criteria:

* Patients who did not respond to the inclusion criteria
* Patients with diabetic ketoacidosis
* Cardiac surgical patients
* Patients transferred from other hospitals
* Other study enrollment
Advance Care Planning With Formerly Homeless Older Adults Residing in Permanent Supportive Housing

The homeless population is aging, with an increasing proportion of individuals over age 50 who experience accelerated aging, high rates of mortality, and a high risk of not having their wishes honored at the end of life. The goal of this randomized control trial (RCT) is to test the effectiveness of adapted evidence-based advance care planning (ACP) interventions for formerly chronically homeless older adults living in permanent supportive housing (PSH).

Advance care planning (ACP) aims to elicit patients' medical preferences; yet older adults experiencing chronic homeless have low rates of ACP. Significant policy attention has focused on rehousing chronically homeless people into Permanent Supportive Housing (PSH), subsidized permanent housing with voluntary supportive services. Our team will use PREPARE for Your Care (PREPARE) - an easy-to-use, evidence-based, online ACP program with video stories. This program includes easy-to-read advance directives, an ACP group visit guide, and an ACP one-on-one facilitation guide. Our team developed a Community Advisory Board (CAB) and together identified preliminary adaptations to the PREPARE materials for the PSH setting.

The objective of this proposal is to co-develop PREPARE-PSH and compare the effectiveness of facilitated group versus one-on-one visits among formerly chronically homeless older adults in PSH. In Aim 1 the investigators will engage in a rigorous co-development process through in-depth interviews and focus groups with 20 PSH residents and the CAB. The investigators will use a theory-informed framework and qualitative content analysis to co-create a PREPARE-PSH program. For Aim 2, the investigators will conduct a Hybrid (NIH Stage III efficacy/effectiveness), Type 1 cluster randomized trial to compare the delivery of PREPARE-PSH through facilitated groups vs. one-on-one visits using mixed effects models. Randomization will be at the site level, balanced by site size. In Aim 3, the investigators will purposively sample Aim 2 participants for in-depth interviews (n=30-40), conduct focus groups with PSH staff (n=30-40), and obtain input from CAB members (total n=10-15). The investigators will explore implementation-relevant factors associated with: (a) high and low ACP engagement and sustainability of PREPARE-PSH using the Behavior Change Wheel (BCW and the Consolidated Framework for Implementation Research (CFIR) model. Relevance to NIH and public health: PREPARE-PSH may reduce health disparities in ACP among formerly chronically homeless older adults.

Eligibility Criteria:
Inclusion Criteria:

* Formerly chronically homeless adults living in permanent supportive housing
* English speaking

Exclusion Criteria:

* Non-English Speaking
* Screen positive for moderate-to-severe cognitive impairment
* Self-report being deaf or blind
* Cannot provide informed consent based on the teach back method