cyrilzakka/clinical-trials huggingface dataset:
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy

Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected lidocaine prior to regional and general anesthesia.

The J-tip device has not been reported for use prior to regional block anesthesia prior to femoral or sciatic nerve blocks. The use of the J-tip device for lidocaine introduction prior to femoral or sciatic blocks at Arnold Palmer Medical Center has been up to the discretion of the anesthesiologist. It has been anecdotally reported at our institution to have equal or better pain relief for the regional nerve blocks as needle introduction of lidocaine.

This study seeks to evaluate the difference in pain from local anesthetic infiltration with J-tip needleless injection device compared to needle injection by use of Visual Analog Scales.

* To evaluate efficacy of femoral nerve block after J-tip device lidocaine injection post operatively by use of Visual Analog Scales.
* To assess patient and parent satisfaction with J-tip device use by satisfaction questionnaire.
* To assess changes in post operative pain medication amounts with J-tip device use.

Eligibility Criteria:
Inclusion Criteria:

Subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery.

* Able to independently complete the Visual Analog pain scales.
* Subjects who are neurologically intact at area of injection.
* English speaking.

Exclusion Criteria:

* Subjects with known allergies to lidocaine.
* Presence of developmental delay.
* Subjects with blood disorders affecting coagulation.
* Subjects on blood thinners.
* Subjects receiving chemotherapeutic agents.
* Those who use or receive analgesia prior to procedure, except for acetaminophen or Non-steroidal anti-inflammatory medications.
* Any other local sedation at the area of nerve block injection.
* Non-English Speaking
* Subjects with signs of skin infection or pathology at the injection site.
A Study of JNJ-64281802 in Healthy Adult Participants

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history (at screening only), and vital signs performed at screening and Day -1. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study
* Body weight not less than 50 kilogram (kg) and body mass index (BMI) within the range 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, at screening and Day -1
* All women must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) at screening and a negative urine pregnancy test at Day -1
* Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion Criteria:

* Any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
* Has been dosed with JNJ-64281802 in past 3 months
* Current human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
* Current Coronavirus disease 2019 (COVID-19) infection (confirmed by severe acute respiratory syndrome coronavirus 2 \[SARS-CoV2\] polymerase chain reaction \[PCR\]) at the time of admission to the study site (Day -1)
Study Evaluating TTI-237 in Advanced Malignant Solid Tumors.

The purpose of this study is to evaluate the safety, tolerability, and MTD (maximum tolerated dose) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of malignant solid tumor with measurable disease
* Life expectancy of at least 12 weeks
* ECOG (The Eastern Cooperative Oncology Group scale) performance status of 0, 1, or 2

Exclusion Criteria:

* Recent major surgery, radiation therapy or anti-cancer treatment
* History of any other prior malignancy within the last 5 years
Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy

Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery.

hypothesis: There is no difference between the analgesic effect of either Ultrasound guided QL block or laparoscopic Superior hypogastric plexus block on post laparoscopic hysterectomy pain.

Alternative hypothesis:

There is difference between the analgesic effect of either Ultrasound QL block or laparoscopic superior hypogastric plexus block on post laparoscopic hysterectomy pain.

Aim of the work Better achievement of effective analgesia with less opioid consumption and related side effects for post laparoscopic hysterectomy pain.

Objectives To assess effect of both ultrasound quadratus lumborum block and laparoscopic superior hypogastric plexus block on analgesic outcome (Visual Analogue Scale VAS, duration of analgesia) after laparoscopic hysterectomy. To compare between ultrasound quadratus lumborum block and laparoscopic superior hypogastric plexus block regarding to total opioid for postoperative analgesia after laparoscopic hysterectomy and patient satisfaction. To record side effects related to regional block ( e.g., local anesthetic toxicity, vascular and neural injury) and opioids ( neasuea, vomiting, respiratory depression

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent from the patient.
2. BMI of less than or equal 30.0 kg m-2.
3. Age 45-60 years old.
4. American Society of Anesthesiologists (ASA) physical status classes I and II.Exclusion Criteria:

1. Allergy to local anesthetics. 2. Infection at site of injection. 3. Patients with coagulopathy. 4. Patients with chronic pain syndromes. 5. Physical and mental disease which could interfere with pain scores evaluation.

6. Patients with distorted local anatomy.
Study of Imatinib Discontinuation in Chronic Myeloid Leukemia with Deep Molecular Response

The purpose of this study is to evaluate treatment-free remission after imatinib discontinuation in patients with chronic myeloid leukemia with deep molecular response. Before discontinuation, patients will receive pioglitazone associated with imatinib during 3 months.

Treatment of chronic myeloid leucemia (CML) with tyrosine kinase inhibitors (TKIs) changed dramatically the prognosis of CML, with high rates of cytogenetic and molecular remission and increase of overall and progression-free survival. However, the long-term treatment of CML has a high cost to the health system, due to the price of these drugs and the need for continued use. In addition, chronic adverse effects may compromise the quality of life of patients. Discontinuation trials of TKIs have been developed in order to identify groups of patients who may benefit from treatment discontinuation if they have obtained deeper molecular responses.The primary objective of this study is to evaluate treatment free remission (TFR) after imatinib discontinuation in patients treated for more than 3 years with imatinib and with deep molecular response stable for two years (defined in the present study as a molecular response of 4.5 log reduction in breakpoint cluster region (BCR)-Abelson murine leukemia viral oncogene homolog 1(ABL) transcripts levels according to the international scale (MR 4.5; BCR-ABL/ABL ratio \< or = 0.0032%). Patients with these criteria will receive pioglitazone for 3 months concomitant with imatinib, prior to discontinuation. After imatinib discontinuation, patients will be evaluated by molecular assessment of BCR-ABL transcripts levels by quantitative real time polymerase chain reaction (RQ-PCR) monthly during the first year, every 2 months in the second year and then every 3 months. The criteria for restarting treatment will be the loss of major molecular response (MMR), documented by a single RQ-PCR test \> 0.1%, or confirmed loss of 4 log reduction molecular response (MR4.0), by 2 consecutive RQ-PCR tests \> 0.01%.

Eligibility Criteria:
Inclusion Criteria:

* CML in chronic phase
* treatment with imatinib for 3 or more years
* MR4.5 (RQ-PCR\< ou =0.0032%) confirmed by 4 RQ-PCR tests for BCR-ABL in the last 2 years (2 tests within the last 6 months)
* Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 reference level
* Bilirubins ≤ 1.5 reference level
* Contraceptive precautions for women

Exclusion Criteria:

* Patients less than 18 years
* Severe organ disfunction (liver or kidney)
* Severe cardiovascular disease: grade I-IV from New York Heart Association (NYHA) or acute myocardial infarction in the last six months, symptomatic arrhythmias
* Fluid retention grade 3 or 4
* Osteoporosis in treatment
* Patients with previous CML in accelerated or blast phase or blast or Philadelphia positive (Ph+) acute lymphoid leukemia (ALL)
* BCR-ABL mutations related to resistance
* Previous allogeneic bone marrow transplantation
Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

This study is a two-arm trial, comparing the effects of a virtual 12-week group-based exercise intervention vs. control group on physical activity, physical fitness, and quality of life in colorectal cancer survivors, and explore multi-level determinants of physical activity maintenance, 6-months after intervention completion.

Participants will be prospectively assigned or allocated to either a the exercise intervention or a control group for 12-weeks. The control group will be provided with an informational handout from the American Cancer Society describing exercise recommendations and guidelines for cancer survivors. At the end of the study, control group participants will be offered compensation for participation in a community-based cancer specific exercise program (e.g., BfitBwell, Fit Cancer, Livestrong at the YMCA). Supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. Sessions will be delivered synchronously (i.e., in real-time/live) via Zoom. Exercise will be individualized based on the results of baseline fitness assessments and medical history. The intervention will also include virtual, group-based discussion sessions which operationalize behavior change techniques to increase physical activity. Discussion sessions will take place in the same groups, synchronously, via Zoom.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form
2. Fluent in English
3. Have access to a computer or phone with internet and a camera
4. Stated willingness to comply with all study procedures and be available for the duration of the study
5. Be a male or female aged 40 years or older at time of diagnosis
6. Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
7. Completed resection or other surgery 3-24 months prior to enrollment
8. Received chemotherapy and/or radiation therapy within the previous year, with at least 1 cycle of intended chemotherapy completed (does not need to complete all cycles). No plans for additional chemotherapy or radiation therapy.

Exclusion Criteria:

1. Current evidence of metastatic disease
2. Existing participation in ≥150 minutes per week of at least moderate intensity PA
3. Known contraindications for exercise or not able to safely participate in exercise
4. Pregnant women (no testing required)
Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain

Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. If the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. Studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. The purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Unspecific subacute, subacute remitting and chronic LBP
* Both sexes, 20-60 yrs of age
* LBP between 2-8 on a 11-pt numeric rating scale

Exclusion Criteria:

* Previous back surgery
* Sick listed more than one year
* Radiating pain below knee or motor deficits
* Systemic diseases and "red flags"
* Diagnosed psychiatric disease
* Ingoing insurance claim
* Pregnancy
Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events

Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.

We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.

Eligibility Criteria:
Inclusion Criteria:

1. the patients who are according with the II、III stage in CHD western medical diagnosis standard；
2. age between 18 and 75(including 18 and 75)；
3. Signed the informed consent voluntarily.

Exclusion Criteria:

1. The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and so on）；
2. the patients who have myocardial infarction or vascular remodeling in last 3 months；
3. hepatic and kidney function obstacle（ALT、AST\>1.5 times of normal upper limit value）；
4. the patients who cannot control blood glucose properly（fasting blood glucose\>7.0mmol/L and/ or random blood glucose\>11.0mmol/L）；
5. the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）；
6. any other sever diseases such as malignant tumor；
7. the patients who attending other clinical study in late 3 months；
8. pregnant or lactating women；
9. the patients who have allergic constitution or are allergic to many drugs.
Use of Thermography for the Prevention and Diagnosis of Diabetic Foot

Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot.

Objective

To evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.

Significant differences in foot temperatures are expected to be found between subjects with diabetic foot and healthy subjects. It is anticipated that areas of the foot at higher risk of ulceration in subjects with diabetic foot will show higher temperatures due to inflammation and changes in blood perfusion.

The results of the study could validate the use of thermography as an early detection and monitoring tool in patients at risk of developing diabetic foot. This could allow early and personalized interventions to prevent serious complications.

Eligibility Criteria:
Inclusion Criteria:

Subjects of both sexes. Age between 40 and 80 years. Diagnosis of type 1 or type 2 diabetes mellitus (for the case group). Absence of acute inflammatory diseases in the control group. Signed informed consent.

Exclusion Criteria:

Skin diseases that affect the interpretation of thermography. Recent treatment with medications that affect peripheral circulation. History of lower limb amputation.
Equity Using Interventions for Pain and Depression - Pilot Study

This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs).

This 2-arm pilot trial will randomize 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.

Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA along with a 20-minute coaching session to walk them through it (patients may decline the coaching session or schedule for a future time).


Eligibility Criteria:
Inclusion Criteria:

Eligible patients must:

* have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months,
* have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the Pain, Enjoyment of Life and General Activity scale (PEG), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity,
* have at least mild depression, defined as PHQ-8 score ≥5,
* identify as Black or African American,
* have consistent access to a telephone,
* indicate openness to new pain treatments, and
* have a scheduled appointment with their PCP in the next approximate 2-4 months

Exclusion Criteria:

Patients are excluded:

* if previously participated in the PI's past pilot study (IRB #12885) or participation as a Patient Engagement Panel member for this project,
* if medical records indicate severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure), or
* if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.
Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression

In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.


Eligibility Criteria:
Inclusion Criteria:

* Treatment resistant Major depression (grade 3 Sackeim criteria)
* Age above 18 and below 85
* Hamilton (17 item version) score above 12
* Unchanged psychopharmacological treatment for last five weeks.

Exclusion Criteria:

* suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment
* dementia or similar cognitive impairment
* psychotic disorder
* abuse of alcohol or drugs
* pregnant or lactating women
* insufficient birth control measures