cyrilzakka/clinical-trials huggingface dataset:
The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks

Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair. Many factors influence the onset and duration of peripheral nerve blocks. In the advent of ultrasound-guided nerve blocks, the accuracy in administering LA has significantly improved, potentially reducing the required dosage, which is also associated with less risk for toxicity. However, the effect of the concentration of LA on the onset time and duration of ultrasound-guided ankle blocks for forefoot surgery has not yet been studied. This poses a clinically relevant dilemma regarding the necessity of administering lower or higher concentrations of ropivacaine to achieve a clinically relevant faster onset time and longer duration of an ankle block.

This study aims to evaluate the differential effects of 0.25%, 0.5%, and 1% ropivacaine on the onset time and duration of ultrasound-guided ankle blocks in patients having forefoot surgery for anesthesia and postoperative analgesia. We hypothesize that the use of 1% ropivacaine for ultrasound guided ankle blocks will result in a significantly faster onset time and a longer sensory block duration, and thus analgesia, compared to the use of 0.25% and 0.5% ropivacaine in patients having forefoot surgery. The primary outcome is the difference in the duration of the sensory blocks. The secondary outcomes are the difference in onset time of the sensory block, motor function, the postoperative pain scores, opioid consumption, and proportion of failed blocks.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent
* Age 18 to 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk
* ASA physical I-II-III
* Able to ambulate (ability to walk independently, with or without assistive devices)
* Able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick/cold/ light touch sensation test) as the patient will have to perform these sensory and motor assessments by him/herself at home at postoperative day 0 to 2

Exclusion Criteria:

* Language barrier
* Preexisting lower extremity neuropathy
* Contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement)
* Contraindications for use of NSAIDs
* Allergy to local anesthetics
* Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment
* Weight below 50 kg based on a maximum dose of 3 mg/kg ropivacaine and a maximum dose of 150 mg ropivacaine.
* Preoperative use of opioids or gabapentin less than 3 days before surgery
* Contraindications for use of paracetamol
* Contraindications for use of tramadol
Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis

In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.

In this study, we will collect the peripheral blood of 1,3,5,7,10,14 day after diagnose of sepsis.All the patients rolled in this study will be divided into three groups which is sepsis, severe sepsis and septic shock group according their severity. Then,the flow cytometry will be used to detect the express of Tim-3 on monocyte and ELISA will be used to exam the plasm soluble Tim-3.IL-6,IL-10,IL-12 and TNF-αin the peripheral blood will also be detected. We would like to find a new marker to predict the severity and prognosis of sepsis patients.

Eligibility Criteria:
Inclusion Criteria:

* More than one of the following:

clinical manifestations: (1) a body temperature greater than 38℃ or less than 36℃; (2) a heart rate greater than 90 beats/minute; (3)tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mmHg; and (4)an alteration in the white blood cell count, such as a count greater than 12×10\^9/L, a count less than 4×10\^9/L, or the presence of more than 10 percent immature neutrophils

Exclusion Criteria:

* (1)patients younger than 18 years of age; (2)agranulocytosis (granulocyte counts,0.5×10\^9/L); (3) those discharged within 24 h; (4) those diagnosed with HIV infection or cancer; and (5) patients who refused to participate.
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis

This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Male or female
* Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)
* Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
* Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.

Exclusion Criteria:

* Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
* Unwillingness or inability to comply with study procedures
* Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
* Clinically active malignant disease
* Previous thrombotic disorder
* History of known pulmonary embolism or known secondary anti-phospholipid syndrome
* Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)
* Major trauma or surgery within 14 days of study treatment start
* Mental condition rendering the subject (or the subject's legally acceptable representative\[s\]) unable to understand the nature, scope and possible consequences of the study
* Alcohol, drug, or medication abuse within one year prior to study treatment start
* Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
* Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
* Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
* History of long-term use of immunosuppressive agents
* Organ transplants in the previous 6 months
* Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study
Directly Observed Therapy in HIV Infected Adolescent Focus Groups

The purpose of this study is to help researchers use information from HIV infected adolescents to design a directly observed therapy (DOT) program that will help adolescents take their anti-HIV medications correctly.

The rate of HIV infection among adolescents is increasing at an alarming rate. Adherence to antiretroviral therapy has been a major challenge in achieving and maintaining adequate control of the disease in this population. DOT has been shown effective in individuals with tuberculosis (TB), but DOT in HIV infected populations has not been thoroughly examined. This study will collect information from HIV infected adolescents in order to establish a DOT program that will increase successful adherence to HIV treatment and will benefit the public by preventing development of viral resistance and reducing the risk of transmission.

Adolescent participants in this study will be assigned to one of three 2-hour focus group sessions, each at a different site. The participants will complete a questionnaire and will give input about designing a DOT intervention model that will be accepted by adolescents. The model will then be used in a pilot study to determine the feasibility of implementing DOT programs in the community to help HIV infected adolescents.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected due to high-risk behavior
* Regular attendee of local adolescent HIV support group
* Current use of antiretrovirals or history of antiretroviral therapy
* Permission of parent or legal guardian if participant is less than the legal age of consent. Assent of the minor participant should be obtained where required.

Exclusion Criteria:

* Perinatal HIV infection
* Visibly distraught or emotionally unstable
* Pregnancy or breast-feeding
Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test

The purpose of this study is to evaluate the performance of the Sentosa SA HSV1/2 Qualitative PCR Test. Precision of results and concordance of results with a reference assay will be evaluated.

This study will utilize residual samples from male and female patients with signs and symptoms of oral or genital HSV infections. Genital samples will include internal and external genital lesions such as those collected from lesions of the anus, buttocks, vagina, labia, or penis. Oral samples will include those collected from lip, gum, and mouth lesions. For concordance testing, the sample size is based on historical study design and estimates of the expected prevalence of HSV1 and/or HSV2 in the population enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Sample was taken from a lesion from an internal or external oral or genital site.
* Sample was submitted to a clinical laboratory for the purpose of testing for the presence of HSV1 or HSV2.
* The following information about the patient from which the sample was taken is available: presumptive diagnosis or signs and symptoms causing assay requisition; site of lesion; age at time of sample collection or date of birth, and sex.
* Sample was collected in universal viral transport media, using a plastic shaft swab made of either polyester, cotton, rayon or Dacron.
* There is sufficient residual sample to perform both test and reference assays.

Exclusion Criteria:

* Sample leaked during shipment or storage prior to assay.
* Sample has undergone more than 1 freeze-thaw cycle before testing;
* Sample eluent is not clear after centrifugation (refer to section 6.3.1).
* Sample ID is missing or ambiguous.
* Sample is collected using alginate calcium swab.
* Sample handling and storage requirement in section 5.4 not followed
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects

This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale (COWS), subject-rated assessments, and a urine drug screen.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained prior to any study procedure being performed
* Subject is a male or non-lactating female with a negative urine pregnancy test
* Subject is aged 18 to 65 years, inclusive
* Current diagnosis of opioid dependence or addiction per the Diagnostic and Statistical Manual of Mental Disorders - 4th edition (text revision) (DSM-IV-TR) criteria including physical dependence on opioids
* Daily short-acting opiate use of at least 60 mg morphine equivalent no opioid use for at least 12 hours prior to Screening with positive opiate result on urine drug screen
* Clinical opioid withdrawal scale (COWS) score ≥9
* Subject is in good general health in the judgment of the Investigator as determined from the physical and oral examination findings.

Exclusion Criteria:

* Use of a long-acting opioid within the last 72 hours
* Use of an investigational drug or device within the last 30 days
* History of hypersensitivity, allergy, or intolerance to buprenorphine, naloxone, or related drugs
* Immediate suicidal risk, as determined by meeting any of the following:

  1. History of suicidal ideation ≤ 3 months prior to Baseline with a score of 4 (intent to act) or 5 (specific plan and intent) on the eC-SSRS
  2. History of suicidal behavior ≤1 year prior to Baseline (actual attempt, interrupted attempt, aborted attempt and/or preparatory acts/behavior) on the eC-SSRS
* A history or current evidence of any clinically significant disorder or any other condition which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
A Pilot Unrestricted Payment Program for Early-stage Cancer Patients: the PAYMENT Trial

This clinical trial studies whether an unrestricted cash payment program can be used to improve financial and clinical outcomes in early-stage cancer patients with financial concerns. A cancer diagnosis can have poor financial outcomes, and the cost of cancer treatment can lead to high medical debt and financial hardships for the patient and family. Financial hardship during cancer treatment is associated with adverse outcomes including poorer quality of life, lower treatment compliance, more aggressive use of hospital-based care, and worse survival. Newly diagnosed cancer patients with financial concerns may avoid treatment entirely so that they can continue to work and maintain income, provide for their families, or pay rent. An unrestricted cash payment program provides patients with a preloaded cash card once monthly. The patients can choose what to use the card to pay for and may include items like food, rent, or utilities. This provides a period of guaranteed income for the patients and may prevent them from falling into poverty and improve financial and clinical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive a $1000 preloaded cash card once monthly for 3 months.

ARM B: Patients receive a $100 preloaded cash card once monthly for 3 months.

After completion of study intervention, patients are followed up 3 months and 6 months post randomization.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18
* Ability to understand English
* Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
* Within 90 days of a non-metastatic or early-stage solid tumor receiving or rescheduled to receive treatment in the neoadjuvant, adjuvant or definitive setting for curative intent. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Current cancer patient at PeaceHealth (Southwest Medical Center or St. Joes)
* Not current Medicaid enrollee
* Not enrolled in hospice
* Screens positive for financial fragility
Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis

The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or more), female or male
* Histologically confirmed diagnosis of extra-CNS primary solid cancer
* Diagnosis of leptomeningeal metastases confirmed or probable per EANO ESMO criteria
* Performance status compatible with enrolment into clinical trials
* Ability to consent
* Signed informed consent form from patient
* Participation in a parallel clinical trial is allowed in this non-interventional study

Exclusion Criteria:

* Inability to give informed consent
* Inability to adhere to recommended follow-up according to the treating physician

Vulnerable participants will not be included.
A Community-based, Behavioral Intervention to Improve Screening for Hepatitis C Among High-risk Young Adults in Wisconsin

The goal of this study is to evaluate the effectiveness of a brief, computerized behavioral intervention for promoting screening for hepatitis C and reducing risky behavior for people who inject drugs (PWID).

People who inject drugs (PWID) are at high risk for hepatitis C virus (HCV) infection if they share contaminated injection equipment with others. Many are infected but are unaware of it, making it likely they will transmit the virus to others if they share contaminated injecting equipment. Problems related to hepatitis C can be avoided if people know their status by getting tested and referred to treatment.

In this study, the investigators will recruit eligible PWID in several cities in Wisconsin using a social networks strategy, in which clients who receive services at a syringe exchange program are asked to refer peers who also inject drugs to participate in the study. All participants will undergo a baseline computerized risk assessment that elicits information about hepatitis C status, previous testing, transmission risk behaviors, and overdose risk. Participants will then be randomly-assigned to receive either standard risk reduction counseling from a prevention specialist, or computerized tailored risk reduction messages that are specific to their reported risk behaviors, attitudes and beliefs. A follow-up assessment will be completed after 3 months to evaluate changes in behavioral risk and intention to undergo HCV screening. A database will be searched to determine which participants returned for HCV screening within 12 months of enrollment, and of those, which ones tested positive for HCV.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* English-speaking
* Reports injection of illicit drugs in the past month

Exclusion Criteria:

* Unable to provide informed consent due to cognitive impairment
* Unwilling to provide personal locator information and consent to be contacted for follow-up after 3 months.
* Currently known to be pregnant
Effect of Stress on Heroin-Related Memory Retrieval

The purpose of this study is to determine whether cortisol and propranolol are effective in the modulation of stress induced heroin-related retrieval enhancement.


Eligibility Criteria:
Inclusion Criteria:

* Participants had to have met DSM-IV criteria for heroin dependence prior to abstinence.

Exclusion Criteria:

* current use of any medications; current DSM-IV diagnosis of any affective, anxiety, or psychotic disorder; current dependence on any substance besides heroin and nicotine (based on DSM-IV criteria); or risk factors for untoward side effects from propranolol and cortisol (i.e., irregular heartbeats, history of cardiogenic shock, history of severe heart failure, asthma, fungal Infections, hyperlipidemia, history of hypertension, or abnormal ECG or other laboratory findings).
Brain Network Stimulation for Chronic Low Back Pain.

This study looks at the non-invasive brain stimulation technique in people with chronic low back pain to see:

* How effective non-invasive brain stimulation is at improving pain intensity in people with chronic low back pain?
* How safe non-invasive brain stimulation is and what side effects there may be?
* What study participants think of the study procedures and of the non-invasive brain stimulation as a treatment technique for chronic low back pain.

Participants will be assigned to receive either active brain stimulation group or sham stimulation group randomly.

Participants will be required to attend a total of twelve treatment sessions (approximately 1-hour each, three sessions per week, for four consecutive weeks).

Assessments will be done at baseline (in the week 0), immediately post-completion of the intervention (in the week 5), and at the follow-up of one-month (in the week 8), three-months (in the week 16) and six-months (in the week 28) post-completion of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 75 years on the day of screening
* Pain in the lower back (region between 12th rib and gluteal fold) with or without accompanying leg pain that occurs for at least half the days in the last six months
* An average pain intensity of ≥4 on the 11-point NPRS (0=No pain to 10=Pain as bad as you can imagine) in the week prior to enrolment
* A disability score of ≥5 on Roland-Morris Disability Questionnaire (RMDQ).

Exclusion Criteria:

* Known or suspected serious spinal pathology (fracture; lumbar canal stenosis, malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder)
* Suspected or confirmed pregnancy or less than six months post-partum
* Inflammatory disorders
* Auto-immune conditions
* Recent soft tissue injuries of the back in the last 3 months
* Recent steroid injections to the back in the past 3 months
* Recent spinal surgery in the past 12 months or scheduled/waiting for any major surgical procedures during the treatment or follow-up period or underwent rhizotomy or any neurosurgical procedures
* History of neurological conditions, or psychiatric disorders (except depression and anxiety disorders)
* History of cancer, or currently receiving/scheduled for receiving therapy for cancer
* Cognitive impairments (dementia, Alzheimer's disease; indicated by a total score of 24 or below on Mini-Mental State Examination)
* Alcohol or substance abuse
* History of epilepsy or seizures
* Presence of any electronic implants (e.g., pacemaker), metal implant in the body (particularly head and neck), or spinal cord stimulator.
Big Data Analysis of OSA Patients on Positive Airway Pressure (PAP) Treatment: Real-life Monitoring

The present study aims to determine to what extent remote monitoring of PAP related to patients' clinical parameters is able to provide relevant data on predictors of compliance, subgroups of patients who may benefit from this technological tool, variations in AHI over time, occurrence of central events at the start of therapy and, in short, to shed new light on this disease and its treatment, all within the application of continuous positive pressure therapy in the real world.

Among the intended objectives is the identification of phenotypes involved in the use and efficacy of PAP therapy: development of a predictive model, as well as the evaluation of the impact of long-term telemonitoring of patients with Obstructive Sleep Apnea (OSA).

The study initially arose from the need to diagnose, treat and follow up patients with suspected OSA in compliance with the social distancing rules imposed by the COVID-19 pandemic.

It is an ambispective cohort study, with retrospective data collection from the start date of the pandemic (March 2020) to December 2021, and prospective data collection from the approval of the protocol to December 2022.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with OSA since March 2020 with indication for treatment with PAP have been telemonitored on an ongoing basis since initiation of therapy continuing to be telemonitored at the current time.

Exclusion Criteria:

* Undiagnosed OSA patients