cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India.

Investigators plan to study the prevalence of comorbidities in patients undergoing oncosurgeries

Plan to study the prevalence of Coronary Artery Disease, Hypertension, Diabetes Mellitus, Hypothyroidism, History of Corona Virus infection in patients undergoing oncosurgeries.

In the Pre anesthesia checkup patients age , sex , Weight in kilograms, Height in centimeters , pulse rate, Blood Pressure will be noted and value\>140/90 mmHg will be taken as hypertensive. History will be obtained about diagnosed Coronary Artery Disease , Diabetes Mellitus, Hypertension , Hypothyroidism , History of previous Corona Virus Infection (RT-PCR Test Positive) .Relevant investigations Electrocardiography and Echocardiography for assessment of Coronary Artery Disease. Fasting or Random Blood Sugar , Thyroid Function Test will be done .

Fasting Blood Sugar \>126 milligram/ Decilitre and Random Blood sugar \>200mg/dL will be taken as diabetic. TSH more than 5 micro IU/mL will be hypothyroid .

Eligibility Criteria:
Inclusion Criteria: Patients undergoing Oncosurgeries Age above 40 years .

-

Exclusion Criteria:

Age below 40 years Emergency Surgery Patient Refusal
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074

The primary objective of this study is to evaluate the effect of multiple doses of the UGT inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary objectives of this study are to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with the UGT inhibitor valproic acid and to evaluate the effect of the UGT inhibitor valproic acid on the PK of the M13, M14, and M16 metabolites of BIIB074.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a body mass index between 18 and 32 kg/m\^2, inclusive.
* Must be male, postmenopausal female, or surgically sterile female
* Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
* History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
* Treatment with any prescription or over-the-counter oral medication (excluding acetaminophen) within 14 days prior to Day -1 and an unwillingness or inability to refrain from this treatment during study participation, unless specifically permitted elsewhere within this protocol.
* Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Effect of Ultrasound-guided Transversus Abdominis Plane Block After Laparoscopic Bariatric Surgery

Purpose:

To explore and compare Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative nausea and vomiting and Early Outcome After Laparoscopic Bariatric Surgery To evaluate and examine TAPB can reduce the application of intraoperative and postoperative opioids and the duration of analgesia

Poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with ropivacaine in Laparoscopic Bariatric Surgery

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo Laparoscopic Bariatric Surgery
2. Subject's American Society of Anesthesiologists physical status is I-III.
3. BMI\>35kg/m2
4. The subject's parent/legally authorized guardian has given written informed consent to participate

Exclusion Criteria:

1. Subject has a diagnosis of renal or liver failure.
2. Subject has a diagnosis of mental illness
3. Subject is allergy and contraindication to Ropivacaine.
4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle

The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
* Subjects who are willing to discontinue contact lens wear for the duration of the study.
* Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria:

* Subjects who have any uncontrolled systemic disease or debilitating disease.
* Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
* Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
* Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
* Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
* Subjects with suspected iritis.
* Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
* Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
* Subjects who are immune compromised.
The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults

In this double blind, crossover study participants will take a placebo for 3 weeks each. Gut permeability will be assessed weekly using food-grade sugar molecules. On the second week, participants will take aspirin, which will make their intestine permeable to the sugars. Participants will be asked to provide urine and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the probiotic.


Eligibility Criteria:
Inclusion Criteria

1. Healthy individuals, aged 21 to 50 years who have ≥6 stools/week.
2. Willing to discontinue the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, naproxen, or indomethacin, for the full length of the study.
3. Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests. The sugar probe tests are visits 2, 3, 4, 6, 7, and 8.
4. Willing to avoid the use of antidiarrheal or laxative medication on a regular or an "as-needed basis" during the full length of the study.
5. Willing to provide urine and stool samples during the study collection periods.
6. Have used aspirin in the past and did not experience adverse effects.
7. Willing to consume three tablets (325 mg each or 975 mg total) twice within a 9 to 12-hour period. This challenge will be repeated twice during the 14-week study.
8. Willing to complete online questionnaires, records, and diaries associated with the study and to complete all clinic visits.
9. Willing to discontinue consumption of fermented foods or probiotics.
10. Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact immune function or inflammation during the pre-baseline period and throughout the study protocol.
11. Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on six occasions.
12. Willing and able to consume the probiotic and placebo daily for 3 weeks each.
13. Willing and able to complete the informed consent form in English.
14. Willing to provide a social security number to receive study payment.

Exclusion Criteria

1. History or current impaired cardiovascular circulation or uncontrolled hypertension, diabetes, bleeding tendencies, kidney, liver or chronic respiratory diseases including asthma, gastrointestinal disorders including heartburn, or any other disease, that by the investigators discretion could interfere with the intestinal barrier function of the subject.
2. Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
3. Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin/mineral supplements.
4. Allergy to aspirin, milk, yeast, or soy.
5. Known sensitivity to gluten.
6. Current smokers.
7. Women who are lactating, know that they are pregnant, or are attempting to get pregnant.
8. Use of another investigational product within 3 months of the screening visit.
Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block

In this study, investigators aimed to compare the Quadratus Lumborum Block and the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy

After ethical committee approval, informed written consent will be obtained from all patients.

A Sample size of 60 patients (30 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective laparoscopic cholecystectomy under general anesthesia will be randomized to receive bilateral QLB or TAP before the surgery. The dose of local anesthetic in both groups will be 20 ml 0.25% Bupivacaine. Allocation to either group will be done using permuted block randomization method.

Patients will be taken to the block room 1 hour before surgery. ECG, NIBP and SpO2 monitor will be done. The IV access route will be provided. The patient will be given 0.03 mg / kg IV midazolam for routine premedication. Block will be applied by a blind anesthetist to the other data of the study. Under ultrasound guidance a 22 Gauge Sonoplex needle will be used for both techniques. The calculated dose of local anesthetic will be injected bilaterally with intermittent aspiration. The spread of injectate will be seed on ultrasound.

The procedure time for both blocks will be recorded and 30 minutes after the procedure is completed, and the patient will be taken to the operation room. General anesthesia will be applied to the patient in the operation procedure in the standard procedure. Intraoperative heart rate and / or mean arterial pressure is increased to 20% of the basal value and 0.5 mcg / kg IV fentanyl will be added. 30 minutes before the end of operation, 1 mg IV paracetamol and NSAID (dexketoprofen) 50 mg IV will be administered to the patient before extubation. The patient will be infected with IV PCA in the morphine. PC 1 mg IV bolus dose will be adjusted to 10 minutes of locked-out period. In the postoperative period, 4 \* 1 gr / 24 h IV paracetamol will be given to each patient.

All patients will be assessed postoperatively by a blinded investigator: in the post-anesthesia care unit and at 0, 2, 4, 6, 12 and 24 h postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3
* elective Laparoscopic cholecystectomy
* 19-65 years
* Written informed consent

Exclusion Criteria:

* Patient refusal Local infection at the site of injection
* Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy - Inability to comprehend or participate in pain scoring system
* Inability to use intravenous patient controlled analgesia
Comparison of Simultaneous Laparoscopic and Open Operations for Synchronous Liver Metastases With Colorectal Cancer

retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from January 2011 to November 2020 at the Russian Scientific Center for Roentgenoradiology. 2 groups of 21 patients each were formed: group 1 included a patient with simultaneous laparoscopic operations, group 2 included a patient with simultaneous open operations.


Eligibility Criteria:
Inclusion Criteria:

* patients with synchronous metastatic liver lesions with colorectal cancer

Exclusion Criteria:

-
Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care

The Center for Mind -Body Medicine has developed a mind-body skills group program that incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement. These mind-body skills are designed to increase self-awareness and self-regulation. This program has been shown to significantly improve depression symptoms in children and adolescents with posttraumatic stress disorder in Gaza, but it has not yet been tested in a US adolescent population. The purpose of this study is to determine the feasibility of using mind-body skills groups to reduce depression in adolescents and to investigate the effects of the program on factors such as self-efficacy, mindfulness and rumination which are likely to mediate improvement.


Eligibility Criteria:
Inclusion Criteria:

* Eskenazi Primary Care patients at time of screening
* 13-17 years old
* Diagnosis of depression confirmed by Mini International Neuropsychiatric Interview (MINI) Kid Screen (with adolescent)
* English speaking
* Willingness to attend mind body skills group for duration of the intervention (10 sessions over approximately 10 weeks)

Exclusion Criteria:

* History of bipolar disorder or psychosis
* Acute and immediate risk of suicide, determined by clinical assessment
* Lack of capacity to assent (adolescent) or lack of capacity to consent (parent/guardian)
* Previous participation by the adolescent in the Eskenazi Mind Body Group intervention
Effects of Curcumin on Postprandial Blood Glucose, and Insulin in Healthy Subjects

Previous animal studies have shown that extracts of Curcumin lowers blood glucose.

To study the effect of curcumin on postprandial blood glucose and plasma concentrations of insulin in fifteen healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Fifteen healthy subjects without symptoms or a history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were included in this crossover study.

Exclusion Criteria:

* Connective tissue disease or cerebrovascular or endocrine disease.
Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty

As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose regardless of their pre-operative risk of transfusion. Therefore the aim of the study is to determine whether or not repeated dosing of oral TXA reduces the post-operative reduction in hemoglobin, hematocrit, number of transfusions, and post-operative blood loss following primary TKA and THA surgeries in patients with low pre-operative hematocrit and high risk for transfusion. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regime.

Total joint arthroplasty is associated with the risk of moderate to significant blood loss. Because TXA has been shown to significantly reduce the need for blood products during total joint replacement, it is now the standard of care at many institutions. Oral and intravenous TXA are equivalent, but oral TXA is cheaper and allows for ease of repeat dosing. Although low preoperative hemoglobin is a risk factor for transfusion, no studies that have compared standard TXA dosing to risk stratified dosing of TXA. The investigators hypothesize that a multi-dose TXA regimen will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen.

At the pre-operative clinic appointment and before the day of surgery, the study staff will assess the potential subject's eligibility. Once eligibility is established, the potential subject will be approached regarding their participation in this clinical trial. The investigators will provide 48 hours before the date of surgery to allot for questions and consideration of the Informed Consent document. Once all patient questions have been answered, patients willing to be in the study will sign the Informed Consent. Patients will be randomized, via standard randomization tables that provide a 1:1 distribution of subjects between the two groups through blocked randomization, no later than the morning of surgery to either of the two treatment groups: Conventional Oral TXA Group or Multi-Dose Oral TXA Group.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* scheduled for a primary cemented TKA or cementless THA
* preoperative hematocrit less than 36%

Exclusion Criteria:

* Known allergy to TXA
* acquired disturbances of color vision
* refusal of blood products
* pre-operative use of anticoagulant therapy within five days before surgery
* a history of arterial or venous thrombotic disease (including a history of Deep Vein Thrombosis, Pulmonary Embolus, Cerebrovascular accident or Transient ischemic attack)
* pregnancy, breastfeeding
* major co-morbidities (myocardial infarction or stent placement within one year, severe pulmonary disease, renal impairment, or hepatic failure)
* undergoing a revision TKA, revision THA, hip resurfacing, or Unicompartmental Knee Arthroplasty
* younger than 18 years old
* decline to participate
Rapid Injection Technique Without Aspiration

This experimental, single-blind, randomized controlled trial study was conducted to compare the effect of the rapid injection technique without aspiration on pain level in the vaccination for the young adult students. The population of the study consisted of the nursing students who had to be tetanus vaccinated as a protective measure. The students were divided into two groups, as the rapid injection technique without aspiration and control group. The Numerical Rating Scale was used to determine the perceived pain level

Study Design; This was an experimental, single-blind, randomized controlled trial.

Study Population and Study Sample; The study was conducted in Turkey, in a family health center (FHC) in Central Anatolia Region. The population of the study consisted of the nursing students (n:125) of the faculty of health sciences who had to be tetanus-vaccinated as a protective measure before the clinical practice. Sample selection was not performed in the study and the whole population was tried to be reached. However, as 53 students were vaccinated before and 2 students used a painkiller before the vaccination, the sample of the study consisted of a total of 70 students.

The distributions of the students, who came to the family health center for the vaccination and were in accordance with the inclusion criteria, to the intervention group in which the rapid injection technique without aspiration was applied and the control group in which no intervention were applied by the simple randomized method. The papers with the same color and folding shape that represented the two study groups were put into a cloth bag. In order to provide the randomized distribution and reduce all the negative effects, the required explanation was made to the individuals to be vaccinated and they were requested to pull a paper randomly from the bag. In this way, the groups were balanced and totally 35 students were included in each group.

The personal information form was filled for each individual, who came to the FHC for the vaccination and agreed to participate in the study, before the procedure. The tetanus vaccine was applied into the deltoid muscle of the left arm in the sitting position in both the intervention and the control groups in the vaccination room. All the vaccines were made by a single researcher in order to eliminate the vaccination differences.

Outcome Measures Pain Level; As the study was a single-blind trial, the pain assessment was performed by another nurse, in the second minute after the injection, using the numerical pain rating scale, in order to provide neutrality. The nurse was informed by the researcher about the use of the scale. The nurses had no conflict of interest.

Eligibility Criteria:
Inclusion Criteria:

* healthy students,
* who did not take any painkiller before the vaccination,
* agreed to participate in the study and gave verbal consent were included in the study.

Exclusion Criteria:

* the individuals with pain and/or acute pyretic disease,
* who underwent topical anesthesia and/or used any painkillers were excluded from the study.
Comparing Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery

Open gastrectomy causes severe postoperative pain due to wide surgical incisions, retraction of the abdominal wall and direct manipulation of the visceral organs. It leads to delayed postoperative recovery, increased medical expenses and poor surgical outcomes. Epidural analgesia, intrathecal morphine and patient-controlled analgesia are frequently used in the postoperative pain management of abdominal surgeries. Intrathecal morphine is applied as a standard protocol in many centers due to its ease of application and effective pain control. However; it has undesirable effects such as postoperative nausea-vomiting, itching and most importantly respiratory depression. Regional interfascial plane blocks, such as erector spina plane block, have recently been popular in clinical practice to provide postoperative pain control. Erector spina plane block, when placed preoperatively, is expected to reduce opioid consumption and improve outcomes. The primary implication of this study is to compare postoperative pain scores and opioid consumption. It is also aimed to compare the effectiveness of Numeric Rating Scale and Clinically Aligned Pain Assessment Tool used in postoperative pain assesment.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients undergoing open gastrectomy surgery

Exclusion Criteria:

* Patients with solid organ dysfunction
* Patients who receive opioid or corticosteroid medication prior to surgery
* Patients with bleeding diathesis
* Patients with psychiatric disorders
* Patients who can not be contacted after surgery