cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting

The investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

Obese patients having bariatric surgery have frequently postoperative nausea and vomiting (PONV). We want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

Two groups to be studied: one will receive 4 mg dexamethasone at the end of the anesthetic induction and 4 mg ondansetron at the end of the surgical procedure, one will receive normal saline.

One hundred twenty consecutive patients meeting the inclusion and exclusion criteria and who give written informed consent to participate in the study will be randomly assigned to one of two experimental groups using a 1:1 ratio.

Patients will be continuously monitored in the post anesthesia care unit (PACU) and the medical floor for a total of 24 hours post operatively. Episodes of nausea, vomiting and administration of rescue therapy for either nausea or vomiting will be recorded and time stamped. In addition, severity of nausea will be evaluated by the patient using a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Rescue therapy for PONV episodes will consist of 4 mg ondansetron followed by 0.625 mg droperidol if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-75 years
* Scheduled for bariatric surgery under total intra-venous closed-loop anesthesia
* Apfel score equal or greater than 2
* Consenting to participate in the study

Exclusion Criteria:

* Pregnant, breast feeding women
* Allergy
* Contraindication to dexamethasone
* Contraindication to ondansetron
* Contraindication to propofol, remifentanil, morphine, ketoprofen
* Limit to the use of bispectral index
Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients

The goal of this clinical trial study is to compare dexmedetomidine versus the combination of dexmedetomidine with ketamine in hemodynamic changes and sedative effects in ARDS patients who are in need of mechanical ventilation. The main question\[s\] it aims to answer are:

* \[question 1\]: Which dose that get the target in sedation, single and combined drugs?
* \[question 2\]: In which drug group that hemodynamic did not affect Participants will be patients with ARDS that will be divided into two group the first ont will receive dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and the second one will receive dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.

This study will include 60 patients with ARDS who will be admitted to the intensive care unit (ICU) and chest ICU of Banha university hospitals during the period between June 2023 and June 2024.

ARDS will be diagnosed based on the presence of new or worsening symptoms within one week of a known clinical insult; bilateral opacities on anteroposterior chest X-ray that are not due to effusions, nodules or lobar or lung collapse; and hypoxemia, defined as arterial oxygen tension/fraction of inspired oxygen (Pao2/FiO2) \< 300 mm Hg and a minimum positive end-expiratory pressure ≥ 5 cm H2O, that is not explained by heart failure or fluid overload.

Patients were divided randomly into two groups. Group A (n = 30); received with starting dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and Group B (n = 30); received dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.

All patients will be subjected to the following:

1. Thorough history taking and clinical examination
2. Calculation of acute physiology and chronic health evaluation (APACHE) score at time of ICU admission
3. Sedation score calculation using the Richmond Agitation-Sedation Scale (RASS)
4. ECG, blood pressure monitoring
5. Measurement of plasma C-reactive protein (CRP) level before and after initiation of sedation.
6. Measurement of oxygenation status (Pao2/Fio2) before and at 24, 48, 72, and 120 h after the administration of the sedatives
7. Any adverse effects related to sedation or intubation will be recoded

All data will be tabulated and statistically analyzed

Eligibility Criteria:
Inclusion Criteria:

* patients with ARDS with the following:

  * Those whose duration of endotracheal intubation was \> 120 h
  * those whose ages were 18- 70 years old
  * those with acute physiology and chronic health evaluation (APACHE) II scores \> 12 points.

Exclusion Criteria:

* patients with a history of allergy to ketamine or dexmedetomidine
* Pregnant women,
* patients in the early stage of recovery,
* patients with unstable hemodynamics, bradycardia, sinus arrest, or other cardiac arrhythmias
Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.

This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied in Taiwanese subjects at the clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Subjects without headache pain over 30 days and at least 18 years old who will visit the clinic, inclusive of male and female.
* Subjects who are able to complete the ID Pain-T Questionnaire.

Exclusion Criteria:

* Subjects who are illiterate or unable to complete questionnaire.
* Subjects who are currently participating in another study or have participated in another pain study within one month of study entry.
* Subjects with low back pain are unable to participate in this study; as the sciatica caused by the piriformis (exclusive of the other types of sciatic pain), lumbago, unclear identification in nerve injury (e.g. complex regional pain syndrome type I) or mixed origin (e.g. cancer pain).
Efficacy and Safety Study: Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Movement Disorders in Patients With Intracranial Hemorrhage (ICH).

This pilot study aims to assess the effectiveness and safety of rTMS in the treatment of movement disorders in patients with ICH.

While the fatality rate of intracerebral hemorrhage (ICH) has decreased, many patients continue to experience persistent limb movement dysfunction. Motor dysfunction in ICH is commonly attributed to basal ganglia hemorrhage, as the basal ganglia play a central role in the extrapyramidal motor system. Therefore, promoting the remodeling of the extrapyramidal motor system holds great significance for effectively treating ICH patients with movement disorders.

Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive neuromodulation technique that can modulate neuronal activity, influence neuronal synaptic plasticity, and enhance brain function. Currently, rTMS has shown promise in improving motor function among patients with stroke and those who have undergone brain tumor surgery, which provides valuable insights for its potential application in patients with motor dysfunction following ICH surgery.

This pilot study aims to evaluate the efficacy and safety of rTMS in the treatment of ICH patients with movement disorders. The participants will be randomly assigned to either a real rTMS treatment group or a sham group. The study will assess and compare various clinical outcomes, including the FMA (Fugl-Meyer Assessment), NIHSS (National Institutes of Health Stroke Scale), and BI (Barthel Index) scores, over a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Participants between the ages of 45 and 65 years old.
2. More than 1 month and less than 3 months after ICH
3. With severe and moderately severe motor functional impairment, indicated by a Functional Motor Assessment (FMA) score ranging from 0 to 55.
4. Unilateral basal ganglia hemorrhage with a hematoma volume of 30-60ml, measured using the ABC2 method based on preoperative CT scans.
5. Participants should have a stable level of consciousness, with a score of 0 to 1 on the level of consciousness, level of consciousness questions, and level of consciousness instructions of the National Institutes of Health Stroke Scale (NIHSS), along with stable vital signs.
6. Underwent surgical treatment for ICH within 2 weeks after the event, utilizing either craniotomy or endoscopic hematoma evacuation, with an evacuation rate of at least 80%.
7. Signed the informed consent.

Exclusion Criteria:

1. With a history of epilepsy.
2. With movement disorders resulting from causes other than basal ganglia hemorrhage.
3. With severe general impairment or coexisting medical conditions.
4. With emotional issues or cognitive impairments, as indicated by a Mini-Mental State Examination (MMSE) score below 21.
5. With any contraindications to transcranial magnetic stimulation (TMS), such as having metal implants in the brain or using a pacemaker.
A Multidisciplinary Intervention for Weight Loss

This is an open label study in which obese participants were treated with a restrictive hypo-caloric diet under hospitalization for a maximum period of 3 months in a metabolic rehabilitation unit. A multidisciplinary approach was used (combination of diet, physical exercise and psychotherapy)


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* BMI \>= 30
* one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others)

Exclusion Criteria:

* active cancer
* severe cognitive or functional impairments
* severe behavioral disorders
* known kidney failure (previous glomerular filtration rate \<30 ml/min)
* known liver failure (Child B or C)
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma

This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.


Eligibility Criteria:
Inclusion Criteria:

1. \> or = 18 years of age
2. Patient at the University of Colorado Anschutz Medical Campus Cutaneous Oncology Clinic or Dermatology Clinic OR attend the fundraising event of the Colorado Melanoma Foundation

Exclusion Criteria:

1. No exclusion criteria listed
Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans

Two-thirds of the US population, particularly African Americans (AA), is at risk for inadequate or deficient 25-hydroxy-vitamin D (25(OH)VD). Epidemiological studies demonstrate an association between better health outcomes and higher blood levels of 25(OH)VD . Randomized controlled clinical trials have shown that, while supraphysiological high doses of VD are needed to achieve adequate blood levels of 25(OH)VD, not all subjects respond to them. Recent studies have also questioned the therapeutic effects of high-dose VD supplementation. Severe VD deficiency has been associated independently with the future risk of mild cognitive impairment (MCI) and dementia. A reduction in GSH and an increase in the oxidative stress levels of serum, erythrocytes, and circulating lymphocytes has been observed in MCI and Alzheimer disease, findings similar to those in VD deficient persons. Scholarly reviews conclude that excess oxidative stress is one of the major risk factors for AD and support a potential therapeutic role for L-cysteine (LC, a GSH precursor) and vitamin D (VD) supplementation in the treatment of Alzheimer disease symptoms. This application presents the investigators' design for a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that supplementation with VD in combination with L-cysteine (LC) is more successful at optimizing the statuses of 25(OH)VD \[biological signatures\] and simultaneously decreasing TNF-α, IR \[functional or clinical outcomes\], and oxidative stress, suggesting a better therapeutic approach compared with supplementation with VD alone in AA subjects.


Eligibility Criteria:
Inclusion Criteria:

* African American volunteers only
* Participants between the ages of 18 and 65
* Must be In good general health
* Women with negative pregnancy tests

Exclusion Criteria:

* Subjects with Diabetes, Heart disease, Sickle Cell disease, or Epilepsy
* Subjects with serum positive pregnancy test or breastfeeding
The Effects of Using an Interactive Game With Virtual Reality for Children During Intravenous Placement

To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 6-12.
* Children who where clearly conscious.
* Children who agreed and were required to receive intravenous injections after physicians' diagnoses.
* Children and their primary caregivers who could communicate in Mandarin or Taiwanese
* Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

Exclusion Criteria:

* Children with developmental delay, epilepsy, or heart diseases
* Children undergoing chemotherapy; children who were visually or hearing impaired
* Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters.
* Children who had sustained head trauma in the past month
* Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents
* Children who required blood transfusions and blood preparation to be performed according to physician diagnoses
* Children who received two or more intravenous injections and had their blood drawn only one time
Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile bearings in the revision TKA setting include reduction in polyethylene wear, decreasing fixation stresses, and protection of the constraining mechanisms. Several studies have reported satisfactory clinical results after revision total knee arthroplasty but no study with a large number has specifically addressed the clinical outcomes after revision total knee arthroplasty using the mobile bearing design

Failure modes of revision total knee arthroplasty (TKA) that include prosthetic loosening and damage to constraining mechanisms often require revision TKA. Mobile bearing revision TKA components have been developed in hopes of lessening these failure mechanisms. Our purpose is to evaluate the use of mobile bearings in revision TKA.

Retrospective clinical and radiographic evaluation of 340 revision mobile bearing TKAs using the PFC Sigma and LCS posterior stabilized rotating platform implants (Depuy, Warsaw, IN) will be performed. Indications for revision include instability, loosening, arthrofibrosis, chronic hemarthrosis, failed patellofemoral replacement, failed unicompartmental knee replacement, infection reimplantation, and supracondylar fracture nonunion.

Eligibility Criteria:
Inclusion Criteria:

Requiring a revision of a primary knee replacement. Indications for revision include instability, aseptic loosening, failed unicompartmental knee replacement, infection reimplantation, arthrofibroisis, chronic hemarthrosis, failed patellofemoral replacments, and non union of a supracondylar femur fracture.

Exclusion Criteria: None since they have all required a revision.
Effect of Pectointercostal+ESP Block on Postoperatif Analgesia in Open Heart Surgery

American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks and 1 ml epinephrin will add to the each local anesthetic solutions. 10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain assessment will perform with visual analog scale (VAS)

American Society of Anaesthesiologist physical status II-III, aged between 18-65, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block and block will not perform to the control group. Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain assessment will perform with visual analog scale (VAS). VAS, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the VAS score is higher than 4, the rescue analgesic diclofenac Na 75 mg will administer intravenously.

Eligibility Criteria:
Inclusion Criteria:

* ASA II-III patients
* The patients who will operate for open heart surgery

Exclusion Criteria:

* The patients with Coagulopaty
* Allergy with local anesthetics
* infection at the injection sites
* Obesity (BMI \>35kg/m2)
* Liver and/or kidney failure
Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy

The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women.

The primary outcome of the study is major structural defects, and the secondary outcomes of the study are spontaneous abortion/miscarriage, stillbirth, elective termination/abortion, premature delivery, small for gestational age, pattern of 3 or more minor structural defects, postnatal growth of live born children to 1 year of age, postnatal serious or opportunistic infections in live born children to 1 year of age, and hospitalizations in live children up to 1 year of age.


Eligibility Criteria:
Key Inclusion Criteria:

Cohort 1: Dupilumab-Exposed Cohort

* Pregnant women
* Exposure to dupilumab for the treatment of the approved indications of atopic dermatitis (AD) or asthma, for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy.

Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)

* Pregnant women
* Diagnosed with a dupilumab-approved indications of moderate-to-severe AD without asthma or moderate-to-severe asthma; frequency matched to the exposed group by disease indication, with the indication and severity validated by medical records when possible.
* No exposure to dupilumab any time in the current pregnancy or within 10 weeks of the first day of the LMP and may or may not have taken another medication for their disease in the current pregnancy.

Cohort 3: Healthy Comparison Cohort (Comparison Group 2):

* Pregnant women

Key Exclusion Criteria:

Cohort 1: Dupilumab-Exposed Cohort

* Women who have first contact with the project after prenatal diagnosis of any major structural defect
* Women who have used dupilumab for an indication other than asthma or AD

Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1):

* Women who have first contact with the project after prenatal diagnosis of any major structural defect
* Exposure to dupilumab within 10 weeks of LMP or anytime during the current pregnancy

Cohort 3: Non-Diseased Comparison Cohort (Comparison Group 2):

* Exposure to dupilumab within 10 weeks prior to the first day of the LMP
* Women who have a diagnosis of any dupilumab approved indication
* Women who have first contact with the project after prenatal diagnosis of any major structural defect

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Prevalence and Intervention of Hypomagnesemia in Users of Proton-pump Inhibitors

Hypomagnesemia is a severe side effect of longterm use of all available proton-pump inhibitors (PPIH). It develops due to intestinal malabsorption of Mg2+.

This study investigates the application of dietary inulin fibers in users of proton-pump inhibitors with such a hypomagnesemia. To this end, repetitive short-term trials of 14 days of orally administered inulin, separated by a wash-out period of 14 days each were performed in cases of PPIH and controls. This study was not blinded or randomized.

Hypomagnesemia due to PPI use (PPIH) has a low frequency, but is a difficult to control side effect in clinical practice. It develops over years and results in severe symptoms related to the hypomagnesemia. Due to the widespread use of PPIs, the real number of PPIH may be high. Currently, there is a lack of intervention strategies and no general treatment protocols for patients exist. It is generally anticipated that PPI-withdrawal and antacid replacement therapy is the only working method to recover patients from the hypomagnesemia. However, this frequently resulted in rebound of gastric acid related complaints.

The molecular mechanism of PPIH involves a reduction of Mg2+ absorption by the large intestine. Inulin fibers have been shown to have prebiotic properties. The intestinal microbiome ferments inulin and releases butyrate into the luminal compartment of the intestine. This results in acidification which enhances the uptake of Mg2+ and Ca2+ mediated by pH-sensitive ionchannels.Thus inulin may counteract PPI induced reduction of luminal protons and therefore reestablish normal Mg2+ absorption.

To this end cases with PPIH and controls underwent two 14 day trials of orally administered inulin under separated by wash-out periods of 14 days. During the experimental phase blood measures of electrolytes were monitored.

Eligibility Criteria:
Inclusion Criteria:

* Chronic PPI use
* Hypomagnesemia

Exclusion Criteria:

* Uncontrolled diabetes
* Irregular use of the inulin fibers