cyrilzakka/clinical-trials huggingface dataset:
Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

Tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. From the previous documented effectiveness and safety of intravenous (IV) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (IV) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. So, it will prolong the postoperative analgesic duration as a primary outcome.

This is a randomized controlled trial that tests the effecacy of the intravenous regional ketorolac in lower limb orthopedic surgeries with spinal anesthesia. The investigators will compare the effect of 30 mg ketorolac without local anesthetic in the injected intravenously in an isolated lower limb (with torniquet) versus intravenous 30 mg ketorolac administered 10 minutes before toniquet pressuerization on the postoperative analgesia.

All patients will receive spinal anesthesia aiming for at least T12-L1 level. Postoperative standard analgesia will be paracetamol and diclofenac, given for both groups.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I or II
* Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia

Exclusion Criteria:

* Pregnant females
* Body mass index ≥ 35 kg/m2
* Allergy to ketorolac
* Had renal, asthmatic, vascular (Raynaud's syndrome) disease, hematological anemias
* Had any history of gastrointestinal tract inflammation, bleeding, ulceration, or perforation besides
* Edema in the operated limb grade ≥ 3
eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate

The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer.

This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* women less tan 38 years
* women Body Mass Index (BMI) between 19-39 kg/m2
* Follicle-Stimulating Hormone (FSH) \<15 mUI/mL on cycle third day
* First IVF/ICSI cycle or second after a positive pregnancy test in the first one

Exclusion Criteria:

* More tan five years of infertility
* Previous uterus surgery
* Uterus malformations
* More tan one miscarriage
SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate

The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs).

This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheumatic drugs (DMARDs). The patient will participate in the study for approximately 183 days. Safety measures will include vital signs (blood pressure, pulse rate, breathing rate), 12-lead electro-cardiogram, adverse events, concomitant medications, and clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests). The patient may be assigned to receive 30 mg capsule orally (by mouth) as one or two capsules three times daily, or receive 100 mg tablet orally once daily, or placebo (no active drug) orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs)
* Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study

Exclusion Criteria:

* Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
* Lab tests revealed elevated liver enzymes within the past 6 months
* Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy
* HIV positive
* Abnormal electrocardiogram
* Chronic or acute infection
The Peer-Delivered "Mind. Body. Voice." Program for High School Women

This study will evaluate the impact of a program (called mind. body. voice. or "mbv") that was collaboratively designed by youth, educators, and researchers, informed by the Body Project (Becker et al., 2013; Stice et al., 2019), Youth Participatory Action Research, and an extended co-design process. The study evaluates the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self-constructs, physical health and mood at five time points over the course of a year. Students will be recruited from two high schools and will be randomized to receive the mbv program or an assessment-only control group.

Eating disorders have the highest mortality rate of any psychiatric condition and are the second leading cause of mental health disability among young women. Given that eating disorders have their peak onset during adolescence (ages 16-19), prevention efforts among adolescent women are critical in order to avert the onset of these chronic and disabling disorders. The mbv program targets body image and appearance related pressures, awareness of body sensations, and agency and community building skills.The program consists of 10 weekly sessions and is delivered by peer facilitators. This study will implement and evaluate the mbv program at the high school level in order to examine the extent to which the program influences young women's mental health and well-being, particularly related to eating disorder risk factors and symptoms.

Utilizing a longitudinal randomized controlled trial, the study seeks to address the following aims:

1. To examine the impact of the mbv program on key aspects of mental health and well-being; specifically, body image and disordered eating symptoms, identity and agency, social and self- constructs, physical health and mood among participating high school women.
2. To explore young women's experiences of participating in the program, including strengths and limitations and perspectives on specific activities.

Eligibility Criteria:
Inclusion Criteria:

* High school women, grades 9-12

Exclusion Criteria:

* Prior participation in the Body Project
Pharmacist Discharge Medication Reconciliation Study

Adverse drug events can occur commonly due to medication errors during the transition of care in a health care facility. Medication reconciliation is the process of comparing medications and providing an accurate medication list as a resource for prescribers, which is currently only being done upon inpatient admission at the CCI. The purpose of this study is to see if pharmacist medication reconciliation at discharge reduces unintentional medication discrepancies for inpatient discharges.


Eligibility Criteria:
Inclusion Criteria:

* Cancer inpatients under the care of Dr. Follett or Dr. Candler
* Cancer inpatients to be discharged from the CCI
* Patients \>18 years of age
* Patients that are taking \>1 medications or herbals total at home.

Exclusion Criteria:

* Cancer inpatients that are considered radioactive or in "hot rooms" (ie. Selectron patients or patients receiving radiation treatment for thyroid)
* Patients that do not remain in hospital \>72 hours
* Patients without a home phone number or equivalent contact number.
* Language barrier (patients unable to speak or understand English).
* Patients that are readmitted and already included into the study.
Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease

A thorough discussion of treatment options to manage inflammatory bowel disease (IBD), including the risks and benefits of each class of medication, can be a complex discussion and time consuming. Having to use a translator adds an additional layer of time and complexity to these discussions as well as potential misunderstanding. Further, in addition to language, cultural differences can also play into treatment acceptance.

This study aims to determine the impact of primary language on the selection of treatment for IBD and on disease outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years of age
* Confirmed diagnosis of IBD (CD, UC or indeterminate colitis)
* Willing to provide consent for participation
* Managed at an outpatient clinic either the Yale New Haven Hospital system or the University of Texas at Austin Hospital system.

Exclusion Criteria:

* Patients \<18
* No confirmed diagnosis of IBD
* Not planning to continue care at either study site (i.e. presenting for a consultation only)
* Unwilling to provide signed consent
Effects of Vitamin D and Omega-3 Fatty Acids on Infectious Diseases and hCAP18 (VITAL Infection)

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids affect risk of infection and plasma hCAP18 levels.


Eligibility Criteria:
Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.
Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.

This is an observational study to determine changes in antibody levels in individuals who have previously donated COVID-19 convalescent plasma (CCP) and have now received at least one dose of a COVID-19 vaccine. At present these donors could no longer donate CCP as their virus-neutralising antibody levels do not reach the level required (Euroimmun of at least 6 IgG signal/control cutoff).

Two blood samples (9 ml total) will be collected at a local NHSBT donor centre to test the levels of the virus-neutralising antibodies in the plasma against different viral strains.

The results of this study will:

1. Determine whether NHSBT will collect CCP or plasma for medicines (PFM) from vaccinated members of the public that could have boosted antibody levels following vaccine administration.
2. Understand if antibody levels rebound to a concentration suitable for CCP and PFM.
3. Provide the evidence to support the use of CCP for the early treatment in COVID (currently under consideration as a collaboration with European partners).
4. Assist in development of recording vaccination status on NHSBT databases of donors.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have had a previous SARS-CoV-2 infection
* Individuals who have previously donated COVID-19 convalescent plasma (CCP)
* Received at least one dose of a SARS-CoV-2 vaccine (any type of vaccine)

Exclusion Criteria:

* Not received a SARS-CoV-2 vaccine
Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.

This study aims to compare the postoperative results after PWB (partial weight bearing) and early FWB (full weight bearing) and to show, that documented early protected weight-bearing after surgical fixation of unstable ankle fractures leads to an improved early clinical outcome and a faster return to work compared to PWB. It also aims to show, that an early FWB is safe in terms of complication rate.

Eligibility Criteria:
Inclusion Criteria:

* patients with surgically stabilized unstable ankle fractures
* signed informed consent
* closed tibial and fibular epiphysis
* age 18 or older

Exclusion Criteria:

* dementia and other known cognitive impairment or incapacity of judgement
* polytrauma
* bilateral injury of the lower extremities
* additional injury of the ipsilateral lower extremity which prevents full weight bearing
* associated injury of one or both upper extremities
* open fractures grade II° and III°
* chronic loss of sensation on plantar aspect of the feet due to known distal neuropathy
* open epiphysis
* pregnancy
Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration

To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.

BACKGROUND:

Neonatal respiratory distress syndrome is one of the leading causes of disability and death in the newborn. In the United States, approximately 10 percent of all infants are premature, and each year about 50,000 cases of neonatal respiratory distress syndrome occur.

Extensive studies in animal models on respiratory distress syndrome have demonstrated that antenatal administration of synthetic (dexamethasone) and natural (cortisol) corticosteroids accelerates lung maturation and significantly diminishes the occurrence of RDS. Although a variety of conditions in newborn infants have been treated with steroids over the past 20 years without adverse effects, investigations have been needed on the short-term effects of corticosteroids administered antenatally on neonate and mother and on the long-term effects on the infant.

The Planning Phase of this trial was completed in March 1977, with formulation of a common protocol and manual of operations. Patient screening and enrollment began in August 1977 and ended on March 1, 1980. Follow-up ended in August 1983 and data analysis was completed October 31, 1983.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Six hundred and ninety-six pregnant women were randomized to four doses of dexamethasone every 12 hours or to placebo. Endpoints were the incidence of respiratory distress syndrome and abnormality of motor-neuro-intellectual development in their infants.

Eligibility Criteria:
Male and female fetuses and infants; pregnant women with anticipated premature delivery and gestational age between 26 and 37 weeks.
Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluid During Renal Transplantation

Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids. Plasmalyte is another fluid which can be used and probably will lead to better metabolic profile in these group of patients.The primary objective of this study will be to compare the effects of using normal saline (NS), Ringer lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal function.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective living donor renal transplant

Exclusion Criteria:

-
Low Dose Pulmonary Irradiation in Patients With COVID-19 Infection of Bad Prognosis

The administration of low-dose lung irradiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.

The present study will evaluate the efficacy of treatment with low-dose pulmonary radiotherapy added to standard support therapy, in hospitalized patients with respiratory symptoms due to COVID-19 pneumonia, who do not experience improvement with conventional medical therapy and are not subsidiaries of ICU

The WHO has officially confirmed that: "Currently, there is no specific pharmacological available treatment for COVID-19".

Beyond vital support, there are not currently treatment options for Coronavirus disease (COVID-19) and related pneumonia, the infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pulmonary irradiation is an option for the treatment of COVID-19 pneumonia and could be available quickly and with a duration of about 15 minutes of treatment.

Thoracic irradiation therapy at very low doses (0.5-1.0 Gy) dates back to the 1920s and was the only effective mean to treat certain infectious and inflammatory diseases prior to the development of antimicrobial therapies in the 1940s.

The goal is to replicate low-dose radiation therapy, just as it was used 80 years ago for viral pneumonia with great success. It will be administered for a new disease, pneumonia caused by COVID-19, for which there is no cure and many people are dying, mainly from severe acute respiratory syndrome leading to very severe hypoxemic acute respiratory failure refractory to treatment.

This therapy is expected to remedy acute respiratory syndrome by reducing inflammation, and it also has a low risk of side effects and toxicities, given the low doses received, more than one hundred times lower, compared to the usual radiotherapy used to tumor treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years old
* Hospitalized with COVID-19 positive not subsidiary of ICU with severe disease defined by the presence of ALL the following characteristics:

  * Presence of unilateral or bilateral pulmonary infiltrates in chest X-ray or computed tomography (CT).
  * Acute respiratory failure expressed by PaO2 / FIO2 \<300.
  * Lymphopenia ≤0.8 × 109 / L (800 lymphocytes / ml).
  * Patients with ≤8 days from the onset of symptoms.

Exclusion Criteria:

* Patient not consent to participate
EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction

This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the standard facemask used in our practice. The satisfaction by the anesthesia provider and its ease of use may change the standard practice in airway management. In addition to these additional effects on patient safety, the facemask is affordable and may reduce the environmental burden of anesthesia waste.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class 1-2
* Undergoing elective surgery
* Aged between 18 and 75 years

Exclusion Criteria:

* Severe acute or chronic lung disease requiring oxygen-therapy;
* Hiatus hernia with gastro-esophageal reflux or other esophageal or gastric abnormalities that require a rapid sequence induction;
* Food intake within the last 6 hours or clear fluid intake within 2 hours prior to surgery;
* Ischemic or congenital heart disease;
* Pregnancy (confirmed by a pregnancy test);
* Patient is scheduled for regional anesthesia and denies conductance of general anesthesia during the surgical procedure;
* Known difficult intubation in the past.
* Difficult Mask Ventilation. Patients having any two of the criteria listed below will be Categorized as "Difficult Mask Ventilation (DMV)" (5,13,14) and will be excluded from enrollment. All others will be classified as "Normal." Age \> 55 BMI \> 26 kg/m2 Lack of teeth Presence of beard History of snoring Limited mandibular protrusion
Efficacy and Safety of Eupasidin-s Tab.(EUPASIDIN-S) in Gastritis Patients

The purpose of this study is evaluate the Efficacy and Safety of EUPASIDIN-S Tab. in Gastritis Patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age is 19 years old and over, men or women
2. Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms
3. Patients with one or more erosions found by gastroscopy
4. Patients who voluntarily signed written informed consent may participate in the study

Exclusion Criteria:

1. Patients with peptic ulcer and gastroesophageal reflux disease
2. Patients with Gastrointestinal malignant tumor or surgery related to stomach resection
3. Patients with thromboembolism and coagulation disorder
4. Patients with significant cardiovascular, pulmonary, heptic, renal primary disease
5. Patients with abnormal laboratory result at screening

   * Aspartate aminotransferase(AST), Alanine aminotransferase(ALT), Creatinine \> upper limit of normal range x 2
   * White blood cell(WBC) \< 4,000/mm3
   * Platelet \< 50,000/mm3
6. Patients administered with H2 receptor antagonists, proton pump inhibitors, muscarine receptor antagonists, other gastiritis treatment drug, protective factor builder, non-steroid anti-inflammatory drugs prior to study in 2 weeks
7. History of allergic reaction to the investigational product
8. Women either pregnant, breast feeding or possible to pregnant without contraceptive method
9. Use of other investigational drugs within 3 months prior to the study
10. Patients that investigators consider ineligible for this study
The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain

Aim of the study To evaluate the effectiveness of sweet orange oil inhalation in reducing dental anxiety and pain in children undergoing local anaesthetic administration.

Research Question:

Can sweet orange oil help to overcome dental anxiety and pain in children undergoing local anaesthetic administration?

PICO approach:

* P: Children 8 to 12 years old need dental treatment under local anesthesia.
* I: Sweet Orange oil inhalation.
* C: Without aromatherapy.
* O:

Primary Outcome Dental Anxiety Modified Child Dental Anxiety Scale - Faces version \[MCDAS(f)-simplified\] Pulse rate

Secondary Outcome

Pain Wong-Baker pain rating scale (WBS)

Eligibility Criteria:
Inclusion Criteria:

* • Children classified with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.

  * Children aged 8-12 years.
  * Patients who need maxillary infiltration anaesthesia in the first dental visit.

Exclusion Criteria:

* Children with any neurological or psychological disorders.

  * Children with previous LA administration.
  * Presence of dental or medical emergency.
  * Presence of systemic disorders.
  * Chidren with common cold.
  * Children with known allergy to topical or local anesthetic agents.
  * Parental refusal for participation.