cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain

The purpose of this study is to examines the effectiveness of Core stabilization exercise on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain.

This study is to compare the effectiveness of Core stabilization exercise and physical therapy on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain. There are 2 groups receiving 2 different kinds of intervention: treatment group receiving core stabilization exercise (CSE) and control group receiving physical therapy including therapeutic ultrasound and hydrocollator pack. Each intervention will perform for 7 weeks. The patients will assess for all outcome measures at baseline, 7 weeks of intervention, and 1- month follow-up

Eligibility Criteria:
Inclusion Criteria:

* Onset of back pain within 6 -12 weeks participants had no history of back pain for a period of 6 months prior to the current episode.
* Pain intensity measure by a numerical rating scale (0-10 NRS) and a score of pain at least 3 out of 10.
* Never receive the treatment by core stabilization exercise (CSE) during 3 months before participate in this study.

Exclusion Criteria:

* Pregnancy
* Onset of serious spinal pathology: spinal fracture, spinal tumor or spinal infection.
* Cauda equina syndrome.
* Presented at least 2 out of 3 signs of neurological deficit
Effects of Subcutaneously Infiltrated Nicardipine on the Success Rate of Radial Artety Cannulation

The goal of this study is to compare the success rate of subcutaneously infiltrated nicardipine to normal saline in radial artery cannulation


Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* the patient who need to arterial line

Exclusion Criteria:

* allergy to nicardipine
* history of peripheral artery disease
* BMI \> 40 kg/m2
* unwilling to participate or denial of informed consent
AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery

The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Subjects age greater than or equal to 60 and less than or equal to 95 years at the time of signing the Informed Consent Form.
* Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a frailty score of 4 to 7 using the Clinical Frailty Scale
* Female subjects with an Follicle-stimulating hormone (FSH) equal to or \> 25.8 milli-international units (mIU) /mL (milliliter), if not currently on hormone replacement therapy.

Exclusion Criteria:

* Score of less than or equal to 24 on the Mini Mental State Examination (MMSE)
* Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform pulmonary function tests, undergo blood draws, read and respond to questionnaires.
* Active listing (or expected future listing) for transplant of any organ.
* Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin \<8 g/dl, white blood cell count \<3000/mm3, platelets\<80,000/mm3, international normalized ratio (INR) \> 1.5 not due to a reversible cause (i.e. Coumadin), aspartate transaminase, alanine transaminase, or alkaline phosphatase \> 3 times upper limit of normal, total bilirubin \> 1.5 mg/dl.
* Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to: HIV, advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilatory defect.
* Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
* Be an organ transplant recipient.
* Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma if recurrence occurs.
* Have a non-pulmonary condition that limits lifespan to \< 1 year.
* Have a history of drug or alcohol abuse within the past 24 months.
* Be serum positive for HIV, hepatitis B Surface Antigen (BsAg) or Viremic hepatitis C.
* Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
* Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
* Have hypersensitivity to dimethyl sulfoxide (DMSO)
School-based Intervention to Support Active Travel

"PULSE - School-based intervention" is a feasibility study designed to support active travel among adolescents. The curricular intervention is designed to increase the students' health literacy as well as their autonomous motivation for active travel. The intervention will last for 6 weeks during fall 2023. The first session will be delivered by a science and education center, and the consecutive sessions will be delivered by teachers. PULSE sessions will contribute to the attainment of specific competence aims related to two interdisciplinary topics, "Health and life skills" and "Sustainability", as defined in PE, social science, and science. The research question is the following: Can increased attention to the barriers and benefits of active travel increase physical activity for youths?

Previous reviews and meta-analyses of school-based active travel interventions have found educational strategies to be the most effective. However, previous intervention studies are heterogeneous, and the majority demonstrate poor intervention quality and a lack of description of the interventions. The present study has developed a theory-based educational intervention designed to increase knowledge and empower behavioral change. To ensure local relevance, quality, effectiveness, and sustainability, the intervention has been developed by means of a co-creation process during five collaborative workshops. Participants were a combination of researchers, educators from the science center, representative of the municipality initiative Global Active City in addition to representatives of the teachers from the schools which are to implement the intervention. The intervention is designed to support learning, self-regulation, and autonomous motivation for sustained behavioral change. The theoretical framework is guided by the Self-determination theory developed by Deci and Ryan. The learning activities are predominantly student active and often group-based, introduced by short videos and teacher instructions. The intervention is designed to support three basic psychological needs that, according to the Self-determination theory, are pivotal for motivation and behavioral change: (1) students' need for autonomy and agency related to active travel, (2) their need for relatedness and social support in their efforts to make lifestyle changes when faced with personal, social, and structural barriers, and (3) their need for mastery and competence.

The following data will be collected:

* Questionnaire to students, pre and post
* Document of implementation and adoption completed by teachers
* Group interviews with students who participate in the intervention
* Interviews with teachers who deliver the interviews

Eligibility Criteria:
Inclusion Criteria:

* Student in 9. grade at the 4 intervention schools

Exclusion Criteria:

-
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)

This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with active ankylosing spondylitis
* BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4

Exclusion Criteria:

* have total ankylosing of spine
* have allergies to infliximab
* serious infection
Breast Cancer Detection in Breast Surgical Specimens With the Histolog Scanner, Slide-free Confocal Microscope

Study to assess the capability of physicians (breast surgeons and pathologists) to recognize breast cancer in images of fresh lumpectomies generated with the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device.

Breast cancer is the commonest cancer in female worldwide and breast-conserving surgery (BCS) became the most frequently performed surgical treatment for women with early-stage breast cancer. The ability to identify subclinical and deep-seated tumor during BCS is still difficult, and the surgeon must rely on nonspecific visual changes and manual palpation of subtle irregularities to guide cancer excision. Although there is no consensus on negative surgical margins, at least 20 % of patients undergo more than one procedure to achieve acceptable margins as part of breast-conserving strategy. The development of reliable intraoperative assessment tools which can provide a timely indication of whether re-excision in tumor bed after BCS is indicated at the time of primary surgery would be an asset. The Histolog Scanner is a recent confocal microscope designed for fresh tissue ex-vivo medical imaging with high resolution and speed to guide intraoperative assessment and offer support in clinical decision making. Allowing the quickest and most effective intraoperative assessment of breast surgical specimen regardless of center clinical workflow and intraoperative availability of pathologist, is the aim of this international study. The main objective is to demonstrate that both pathologists and surgeons are able to detect breast cancer tissues in Histolog Scanner images of breast surgical specimens.

Fresh Breast surgical specimens with breast cancer (invasive or in-situ) will be imaged with the Histolog Scanner prior Standard-of-Care final assessment in pathology. Content of the images will be reviewed by a board of expert pathologists using the gold standard (H\&E-stained images) as reference. Blind assessment of the breast cancer content of these Histolog Scanner images will be realized by breast surgeons and pathologist.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patient ≥18 years old
* Women with diagnosed, operable invasive or in situ ductal carcinoma, invasive lobular carcinoma who are deemed breast surgery candidates (i.e. lumpectomy or mastectomy).
* Patient able to read, understand and give informed consent

Exclusion Criteria:

* Patient not informed
* Patient previously treated for breast carcinoma
* Patient has undergone presurgical neo-adjuvant treatment
* Patient is pregnant/lactating
* Patient is male
* Participation in any other clinical study that would affect data acquisition
Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

Prospectively Investigate the effectiveness and safety of neoadjuvant cetuximab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS wild-type locally advanced rectal cancer


Eligibility Criteria:
Inclusion Criteria:

1. A biopsy proven histological diagnosis of rectal adenocarcinoma；
2. An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type;
3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
5. Age between 18-75 years;
6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
7. Has sufficient organ function:

   * Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L, neutrophils ≥ 1.5 × 109/L
   * Liver function: ALT and AST \< 2.5 × ULN;
   * Renal function: serum creatinine \< 1.5 ULN;
8. Willing to participate and informed consent signed；

Exclusion Criteria:

1. Patients with mutations in any of KRAS, NRAS, or BRAF, microsatellite instablility-High;
2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
4. Female patients who are pregnant or breastfeeding;
5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
6. Patients with active infection;
7. Poor overall health status, ECOG ≥ 2;
8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
9. Known hypersensitivity reactions to any investigational drugs;
Regional Anesthesia for Breast Surgery

Patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only.

Postoperative, all patients will receive a morphine PCA. They will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Patients scheduled for mastecotmy with or without axillary dissection, will be randomized to receive preoperative either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only.

All the patients also received a general anesthesia induced by propofol and esmeron for endotracheal intubation and desflurane for maintaining.

Sensory block by ice and pinprick test application and maximum spread after 40' from LA injection will be registered.

Postoperative, all patients will receive a morphine PCA, ketorolac 30 mg/12h and paracetamol 1g each 8h.

Morphine consumption will be registered. Patients will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for radical mastectomy for cancer.
* age \> 18 y-o
* Written informed consent

Exclusion Criteria:

* Bilateral surgery
* Opioids user
* BMI \> 35
* Postoperative Intensive care
A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.

The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary endpoint at the end of the treatment, measured by polysomnography.

The secondary objectives and endpoints of this study are as follows:

* To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints:
* Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely:
* Latency time to the beginning of the sleep;
* Frequency of night wake-ups;
* Time awake during bedtime;
* Early morning awakening;
* Total time in bed;
* Sleep efficiency;
* Sleep variables measured by actigraph;
* Insomnia Severity Index (see Appendix B);45
* Pittsburgh Sleep Quality Index (see Appendix C);46
* To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form for the study;
* Be ≥ 20 to ≥ 64 years old;
* Have diagnosis of symptomatic primary insomnia for at least 3 months;
* Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes;
* Be able not to take any insomnia medication for 14 days before randomization to the study (washout period).

Exclusion Criteria:

* Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study;
* Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study;
* Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study;
* Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes;
* History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day);
* History of substance abuse or dependence;
* Patients with severe co-morbidities (at the investigator's opinion);
* Presence of liver disorders, cirrhosis or liver failure;
* Presence of psychiatric disorders diagnosed at the adult life or currently under treatment;
* Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.
Drug-drug Interaction Study With GLPG3667 and Midazolam in Healthy Subjects

A study in healthy volunteers to look at the effect of the test medicine, GLPG3667, on how midazolam (MDZ) is taken up and eliminated by the body.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form. Female subjects should be of non-childbearing potential, defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy, i.e. surgical removal of the fallopian tubes, or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone level in the postmenopausal range. These female subjects must also have a negative pregnancy test. For surgical sterilization, documented confirmation will be requested.
* A body mass index between 18.0 and 30.0 kg/m², inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests available at screening and prior to enrolment. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be within normal ranges. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to investigational product (IP) and/or MDZ ingredients or history of a significant allergic reaction to IP and/or MDZ ingredients as determined by the investigator.
* Treatment with any medication (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal subjects) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.

This list only contains the key exclusion criteria.
Nutrition-Focused Approach During CGM Initiation: A Qualitative Study

The purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with type 2 diabetes (T2D) who received a nutrition-focused approach (NFA) when initiating continuous glucose monitor (CGM).

The purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with T2D who received the NFA when initiating CGM.

A single 30-minute semi-structured interview will be conducted in approximately 15 people who have completed participation in the A21-292 study (also called the My Diabetes Study).

The My Diabetes Study, is a randomized clinical trial to assess the impact of using a NFA or a self-directed approach during CGM initiation. The NFA was developed specifically for the randomized clinical trial study.

Eligibility Criteria:
Inclusion Criteria:

* Participant was randomized to the nutrition-focused approach arm of the My Diabetes study
* Participant completed all required study visits in the My Diabetes study; this includes the baseline visit, the two intervention visits, and the study completion visit
* Participant had at least 70% "Time CGM Active" on a 10-day Dexcom Clarity Report at study completion visit
* Participant is willing to be recorded during the interview

Exclusion Criteria:

* Participant was randomized to the self-directed approach study arm of the My Diabetes study
* Participant is deemed unsuitable for participation due to any cause as determined by the Investigator
Simulation of Adenosine Push Methods for Treatment of SVT Using Agitated Saline Visualized by Ultrasound

Supraventricular tachycardia (SVT) is an abnormally fast heart rhythm arising from improper electrical activity in the upper part of the heart. SVT is commonly treated with adenosine using three different IV administration techniques. However, it is not well known which of these three techniques is the quickest or most likely to reach the heart in order to stop SVT. This study will simulate each of those techniques in an investigator-blinded procedure. Intravenous agitated saline, used as a surrogate for a dose of adenosine, will be administered to healthy volunteers using all three techniques and monitored using bedside ultrasound to observe their efficacy and speed in reaching the right side of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 18 years and older
* Able to understand and provide signed consent for the study
* Must be healthy; not being actively treated for any condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being, as evaluated by study investigator

Exclusion Criteria:

* Non-English speaker
* Those with contraindications to peripheral IV placement, such as infection or other contraindication noted from evaluation by study investigator
* Pregnancy