cyrilzakka/clinical-trials huggingface dataset:
Pectointercostal Block for Postoperative Pain Management After Sternotomy

This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound-guided bilateral pectointercostal facial block in children undergoing cardiac surgery via midline sternotomy.

Following approval from the research and ethics committee ,preoprrative preparation, and induction of anesthesia The patient will be assigned to two equal groups. Conventional control group(C) (n=30) where --- children will not receive any intervention.

Pectointercostal facial group (PI) (n=30) where --children will have bilateral Pectointercostal Block.

Patient positioning and preparation for Ultrasound-guided PIFB After skin disinfection, the PIFB will be performed in a supine position using a high-frequency (6-13 MHz) linear ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA). The probe will be placed at 2 cm lateral from the sternum and parallel to the sternum and will be scanned laterally to identify 4th and 5th costal cartilage The pecto-intercostal fascial plane will be located between the pectoralis major muscle and the external intercostal muscle or the costal cartilage. A 22G, 50 mm peripheral block needle, Stimuplex® Ultra 360 (B. Braun, Melsungen, Germany) will be placed under the pectoralis major and above the external intercostal muscle with an in-plane approach with the ultrasound probe, in a caudal-to-cranial direction until the tip is positioned in the interfascial plane between the PMM and IIM .

A test bolus of saline (1 mL) will be injected to determine that the tip has been placed in the correct fascial layers. Finally, 1.5 mg/kg of 0.2% bupivacaine will be injected into this plane in two locations, over the 2nd and 4th rib. The method on the other side of the PIFB will be the same Care will be taken not to cross the toxic dose of bupivacaine (3 mg/kg). (6) .

Heart rate, mean arterial pressure, and oxygen saturation will be monitored continuously.

After completion of the surgery, inhalational anesthetics will be stopped as well as the muscle relaxant.

The patient will be then transferred to the ICU.Postoperative assessment and analgesic regimen: An IV Paracetamol 15 mg / kg will be given and will be repeated every 8 hours .The Face, Legs, Activity, Cry, Consolability scale (FLACC) (table 1) will be assessed in the PICU and every 4 hours for 24 hours. The time to the first request of rescue postoperative analgesic will be: "the time interval between the onset of block and the first request to postoperative analgesia". When patients first complain of pain (FLACC score ≥4) rescue analgesia will be given in the form of incremental intravenous morphine

Eligibility Criteria:
Inclusion Criteria:

* age 6 to 36 months
* sex both
* Weight \> 5kg
* Pathology A-V canal , ASD closure, VSD closure surgery through a midline sternotomy.

Exclusion Criteria:

* Redo patient.
* History of allergic reactions to local anesthetics.
* Bleeding disorders with INR \> 1.5 and/or platelets \< 50 000.
* Rash or signs of infection at the injection site.
* Emergency procedures.
Taekwondo for Children With Autism Spectrum Disorder

This study uses a mixed methods design to understand the effectiveness of using taekwondo as an intervention for children with ASD and its effect on social interaction skills and everyday life. Qualitative research emphasizes that meaning can be explained and interpreted only by those who experience it. A pretest-posttest design will be used to describe what occurs after the introduction of the taekwondo intervention and understand the changes that occur after exposure. Collecting information through the lived experiences and observations from the parents will be collated with the pre and post results of the children participants' social interaction skills.

Qualitative data will be collected through pre and post semi-structured interviews with the parents to understand their observations of their child before and after completing the taekwondo program. Interviews will also be conducted with the child to understand their perspectives on physical activity participation. Interview questions will also explore how the effectiveness of the program has impacted the children's engagement in daily activities.

Quantitative research will be collected through pre and post results from the Autism Social Skills Profile-2 (\[ASSP\] assessment that will be completed by the parents. The ASSP-2 provides a comprehensive measure of social functioning for children and adolescents with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Formal diagnosis of autism spectrum disorder (ASD)
* Able to follow and understand English verbal instructions during the screening process.
* No experience or prior experience with martial arts.
* Able to walk and move without using adaptive equipment

Exclusion Criteria:

* Physical disabilities that would prevent participation in taekwondo (e.g. wheelchair bound)
Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)

The purpose of this randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. This study will provide preliminary evidence of the link between patient outcomes and treatment mechanisms.

The investigators hypothesize that:

* both treatment groups will demonstrate significant improvements in pain and function;
* only subjects in the core stabilization group will demonstrate significant improvements in trunk movement and muscle control.


Eligibility Criteria:
Inclusion Criteria:

1. duration of the current episode less than 3 months,
2. average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale,
3. self-report global function less than 80% (0-100 %, 100% = normal pain free function)
4. Oswestry Index \> 19%
5. no physical therapy or chiropractic treatment for the current episode of low back pain.
6. clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding

Exclusion Criteria:

1. permanent structural spinal deformity (e.g., scoliosis),
2. spinal fracture or history of spinal fracture,
3. osteoporosis,
4. inflammatory joint disease,
5. signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
6. previous spinal surgery,
7. frank neurological loss, i.e., weakness and sensory loss in a NR distribution,
8. pain or paresthesia below the knee,
9. leg length discrepancy of greater than 2.5 cm,
10. history of neurologic disease that required hospitalization,
11. active treatment of another medical illness that would preclude participation in any aspect of the study,
12. pregnancy,
13. vestibular dysfunction,
14. extreme psychosocial involvement
15. allergies to medical tape or adhesives
16. Body mass index greater than 30 kg/m2
Study to Determine if Monitoring of Labor Shortens the Time to Delivery

The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be ≥ 18 years old
* Nulliparous
* Singleton fetus in vertex presentation
* Gestational age 36-0/7 or more
* Reassuring fetal heart tracing

Exclusion Criteria:

* Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
* Low lying placenta (edge 3cm or less from cervix)
* Known or suspected fetal or maternal infection
* Maternal thrombocytopenia (platelet count \<100,000)
* Maternal bleeding disorder
* Women with previous uterine surgery
* Known major fetal malformation
* Suspected fetal growth restriction (EFW\<10th percentile)
* Subjects with significant psychiatric history
* Major maternal morbidity (e.g. major cardiac disease)
* Subjects with indication for immediate delivery
* Limit on cervical dilation (e.g., up to 7 cm.)
* Prolonged rupture of membranes (i.e., \> 24 hours)
Black Walnuts and Health

Walnuts are a nutrient dense food, but most health research is on English walnuts (EW). Black walnuts (BW) contain a different antioxidant and fatty acid profile, and more protein, compared to EW. The purpose of the study was to compare postprandial responses following the consumption of 3 breakfast meals containing either butter (control), BW, or EW.

This study was a randomized, double-blind control trial consisting of 3 study visits for 3 different treatments. The treatments were high-fat breakfast muffins containing either butter (control), black walnuts, or English walnuts. The investigators recruited healthy, normal-weight adults between the ages of 15 and 45y. Study visits were completed in a random order with at least 72 hours between each visit. Anthropometrics, questionnaires, and fasting and postprandial blood samples were collected at each visit.

Hypothesis: The walnut-containing meals would mitigate post-meal increases in glucose, insulin, triglycerides (TG), and lipid peroxidation while improving all measures of subjective appetite and TAC compared to the traditional meal without nuts.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women
* Normal-weight (body mass index = 18-24.9kg/m2)

Exclusion Criteria:

* Allergies to test meal ingredients (gluten, eggs, or nuts)
* Medication/supplement usage
* Chronic disease
* Pregnancy or plans to become pregnant
* Special diets
* Tobacco use
A Comparative Study of Ventilation Strategies in Different Surgical Positions on Intracranial Pressure and Cerebral Blood Flow During Laparoscopic Surgery

The purpose of this clinical trial is to investigate the effects of laparoscopic surgery in the Trendelenburg and Reverse Trendelenburg positions, and variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) on esophageal pressure, airway pressure, tidal volume, intracranial pressure, and cerebral blood flow.

The study aims to address the following primary questions:Does laparoscopic surgery in the Trendelenburg or Reverse Trendelenburg position increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? Do variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV) increase esophageal pressure, airway pressure, and intracranial pressure, and decrease tidal volume and cerebral blood flow? The investigators will compare variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), and pressure-controlled ventilation (PCV) to determine which ventilation mode results in the least physiological disturbance for patients.

Participant Procedures:

Participants will: Be positioned according to the surgical requirements.Be randomly assigned to mechanical ventilation with either variable tidal volume ventilation (V-VCV), pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).

Undergo assessments at the following time points: immediately after endotracheal intubation, immediately after pneumoperitoneum, immediately after position change (Trendelenburg or Reverse Trendelenburg), 30 minutes after position change, and 1 hour after position change.

Have their esophageal pressure, airway pressure, intracranial pressure, tidal volume, and internal jugular vein blood flow recorded at each assessment time point.


Eligibility Criteria:
Inclusion Criteria:

* Age: Unrestricted
* American Society of Anesthesiologists (ASA) Physical Status: Class I-III
* Surgical Position: Requires the use of either the Trendelenburg position or the Reverse Trendelenburg position during the procedure.
* Ventilation: Planned mechanical ventilation is required during the procedure, with suitability for one of the following modes: pressure-regulated volume-controlled ventilation (PRVC), conventional volume-controlled ventilation (C-VCV), or pressure-controlled ventilation (PCV).

Exclusion Criteria:

* Significant Cardiopulmonary Disease:
* Intracranial Disease
* Severe Coagulopathy or Current Anticoagulant Therapy
* Presence of Psychiatric Illness, Cognitive Impairment, or other condition that precludes the ability to understand or comply with the study.
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB1, IB2, IIA1).

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:

1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
3. To assess postoperative complications and quality of survival.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).
2. Age ≥ 21 years and ≤ 70 years.
3. Surgery type B and C (refer to Q-M surgical staging)
4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin \> 60g/L Platelets \> 70\*109/L Leukocytes \> 3\*109/L Creatinine \< 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.
5. No history of other malignancies.
6. Non-pregnancy.
7. Physical strength classification: Karnofsky score ≥ 60;
8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)

Exclusion Criteria:

1. Those who are contraindicated for various surgeries and cannot undergo surgery.
2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
3. Patients with recurrent cervical cancer
4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.
Influence of Manual Physical Therapy on Habitual Activity in Knee Osteoarthritis

The investigators assessed overall physical activity and sleep quality in subjects with knee osteoarthritis(OA) at baseline, and at four and 12 weeks following initiation of physical therapy. Subjects received a course of manual physical therapy with interventions targeted to relevant impairments in the lower quarter. No progressive activity intervention or guidance on sleep hygiene was included. The purpose of this study was to assess a relationship between manual physical therapy and habitual physical activity and sleep behavior in individuals with knee OA.


Eligibility Criteria:
Inclusion Criteria:

1. Knee pain and crepitus with active motion and morning stiffness \< 30 minutes and age \> 38 years old.
2. Knee pain and crepitus with active motion and morning stiffness \< 30 minutes and bony enlargement.
3. Knee pain and no crepitus and bony enlargement.

Participants will have to meet all of the following additional inclusion criteria:

1. Age \> 38 years old.
2. Tricare beneficiary
3. Ability to read and speak English well enough to provide informed consent and follow study instructions
4. Knee OA is the participant's most physically limiting condition as determined by patient's self report.
5. Able to ambulate 20 meters (65.6 feet) feet without an assistive device.
6. Radiographic findings of knee OA

Exclusion Criteria:

* 1.) Presence of any medical "Red Flags" affecting the knee:

  1. Tumor, neoplasm etc. affecting the knee
  2. Current or past history of rheumatoid arthritis or similar rheumatic condition
  3. Current or past history of gout or pseudogout affecting the knee
  4. Active Infection in the knee within the past 12 months

     2.) Inability to participate in the therapy plan prescribed by the treating therapist 3.) Any prior Physical Therapy for the knee in the past 12 months 4.) Injection to the knee joint within the previous 30 days 5.) Surgical procedure on either lower extremity within the past 6 months 6.) Any prior lower extremity joint replacement surgery 7.) A physical impairment unrelated to the knee that prevents the subject from safely participating in any aspect of the study 8.) History of cardiac, respiratory, or musculoskeletal disorders (e.g. amputation) that restrict lower extremity function. 9.) Any physical, psychological, or emotional condition that is more symptom producing, or activity limiting than their knee OA.

     10.) Any condition that disrupts sleep more than knee OA, such as a sleep disorder or Obstructive Sleep Apnea 11.) Inability to speak/read English adequately to understand and provide informed consent 12.) Pregnant or intending to become pregnant in the next year 13.) Military service members in a WTU (Warriors in Transition Unit) or service equivalent or pending a medical evaluation board/discharge process. For non-military personnel, anyone that is pending or undergoing any litigation. 14.) WOMAC Score \< 30 15.) Unable to provide informed consent to participate in the study
A Survey of Attitudes of Experienced Blood Donors

This study examines the effects of a web-based motivational interview on 1) internal motivation to donate blood; 2) donor autonomy, competence and relatedness; and 3) donation intention and behavior. The study also evaluates whether group differences in donation intention and behavior are mediated by autonomy, competence, and relatedness, and in turn, internal motivation.

Voluntary blood donation is both important and necessary for the provision of a steady and safe blood supply. With an aging population and increased restrictions on who can donate blood, maintenance of a stable blood supply is essential. Although 38% of the United States population is eligible to donate, only 5% actually does so. Retention of donors is essential to assuring the continuity of a safe blood supply; repeat donors are safer, more cost effective, and less likely to experience adverse reactions. Current recruitment and retention methods may not be sufficient to encourage repeat donations. According to Self-Determination Theory, people are more likely to persist with behaviors that are internally versus externally motivated. Internal motivation is enhanced by supporting an individual's needs for autonomy, competence, and relatedness. One intervention that has shown early promise as a novel method to enhance internal motivation to donate blood is motivational interviewing. However, implementation of a motivational interviewing intervention is costly and time consuming. Given the time and money required for training and delivery of a motivational interviewing intervention, the current study is designed to test the efficacy of a newly-developed web-based version of a motivational interview. Participants will be randomly assigned to complete either an on-line motivational interview about their blood donation experience or an on-line knowledge interview about blood donation.

Eligibility Criteria:
Inclusion Criteria:

* Subject donated blood within the last week with New York Blood Center.
* Subject has made 2 or more blood donations.
* Subject is eligible to donate blood again.

Exclusion Criteria:

-
Geriatric and Oncologic Assessment Before Treatment

In a randomized controlled trial, the investigators wish to investigate, if oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in older frail patients with gynaecologic and urologic cancer is superior to standard assessment (PS and clinical assessment) in oncologic treatment decision.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified gynaecologic cancer (ovarian, uterine, or cervical cancer) or urologic cancer (prostate, bladder, or kidney cancer).
* Suited for first line medical oncologic treatment with chemotherapy and/or targeted therapy.
* Age ≥ 70 years.
* Understands, speaks, and writes Danish.
* Signed informed consent.

Exclusion Criteria:

* Previous cancer diagnosis except for carcinoma in situ of the cervix or skin cancer other than malignant melanoma.
* Previous chemotherapy and/or targeted therapy for current cancer diagnosis.
* Previous radiation therapy or concomitant radiotherapy for current cancer diagnosis.
* Surgery within the last 4 weeks.
Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients

Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation

1. Enrich CTCs from advanced Non-Small Cell Lung Cancer (NSCLC) patients with Driver gene mutation, and detect the Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) fusion, ROS proto-oncogene receptor tyrosine kinase 1 (ROS1) fusion, RET proto-oncogene (RET) fusion and Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping by Lung cancer Polymerase Chain Reaction (PCR) panel kit, and verify the mutation coincidence rate between CTCs and tumor tissue.
2. Enrich ctDNA from advanced NSCLC patients with Driver gene mutation, detect the EGFR mutation by PCR, and detect the ALK fusion, ROS1 fusion, RET fusion and MET 14 exon skipping by next generation sequencing (NGS), and compare the mutation coincidence rate between CTCs and ctDNA.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male, 18 years of age or older
2. Histologically or cytologically proven diagnosis of advanced NSCLC patients without any target therapy or chemotherapy
3. Able to get tumor tissue gene (EGFR/ALK/ROS1/RET/MET skipping) testing results by Lung cancer Polymerase Chain Reaction (PCR) panel kit carried out in hospital
4. Signed and dated informed consent

Exclusion Criteria:

1. Combine with other tumor type
2. The investigator judges the situation that may affect the clinical search process and results
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers

The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it:

1. Safe
2. Well tolerated
3. Does the body absorb and eliminate HIB210 as expected

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Eligibility Criteria:
Key Eligibility Criteria:

* Healthy male and females between 19 to 65 years of age
* Normal or not significantly abnormal laboratory tests and EKG findings during Screening
* No significant medical conditions that might affect ability to participate in the study or present a safety risk
* No evidence of significant or recurrent infection or recent infection
* No history of cancer other than certain skin cancers and limited cancer of the cervix of the womb
* Willingness to comply with birth control requirements of the study (for both men and women)
* No recent major surgery or trauma or planned surgery during the study or within 1 month after the study
* Body mass index (BMI) between 18 and 32 kg/m2