cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Different Ultrasound Guided Techniques for Saphenous Nerve Block

Saphenous nerve blocks can be technically challenging. Recently described ultrasound techniques have improved the success rate of saphenous nerve blocks, but randomized controlled trials comparing these techniques are lacking. The investigators compared two common ultrasound guided approach for saphenous nerve block: saphenous nerve block at the adductor canal (ACSNB) vs. block by the distal trans-sartorial (DTSNB) approach.

Patients received either ACSNB or DTSNB in this prospective randomized, blinded, non-inferiority clinical trial. The primary objective was to show the non-inferiority of ACSNB to DTSNB in terms of block success. Secondary outcome measures were time required to perform the block, time to onset of successful block, and the visibility of the nerve using ultrasound.

Sample size calculation: To address the primary objective of the study--to show non-inferiority of the ACSNB to DTSNB in terms of success as defined above- the investigators used the test of non-inferiority of two proportions. DTSNB is the primary technique of doing saphenous nerve block at the investigators' institution. From chart review of the electronic records from 2011 to 2012, the investigators found there was a 3% incidence of rescue blocks among saphenous nerve blocks (19 out of 667 blocks) at their institution. This assumed a success rate of approximately 97%. A study by Saranteas et al reported a success rate of 95.6% in healthy volunteers undergoing saphenous nerve block just after it exited from the adductor canal. Based on these two observations, the investigators expected the success rate of DTSNB to be 95%. To establish the non-inferiority of ACSNB to DTSNB, the investigators pre-determined that the success rate of ACSNB should not be lower than 85% (the expected difference in proportions should be less than (95% - 85%) 10%). Under these assumptions, to achieve 80% power, with a one-sided type I error rate of 0.05, the study needed 59 subjects per group; 118 patients total. 120 patients were enrolled for this study., randomized to receive either ACSNB (n=58) or DTSNB (n=62).To show the non-inferiority of the ACSNB to DTSNB, the upper 95% confidence bound of the success rates (πDTSNB - πACSNB) should be less than 10%.

The normality of continuous variables was tested by the Shapiro Wilk's test. Based on the normality assumption, two independent samples t-test or Mann-Whitney U test was performed for continuous variables. Chi-square test or Fisher's exact test was performed for categorical variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective foot and ankle surgery receiving saphenous nerve block for pain management
* American Society of Anesthesiologists Physical Status (ASA PS) scores 1, 2 and 3

Exclusion Criteria:

* Neuropathy
* Allergy to local anesthetics
* ASA PS scores 4 and 5
A Study of Overcoming Social Determinants of Health

This study is being done to determine if assistance in accessing community resources can improve health outcomes. Social determinants of health are the conditions in which individuals are born, work and live that can impact health. These can include access to healthcare, healthy food, education, safe neighborhoods, transportation, political and social environments that are safe and fair.


Eligibility Criteria:
Inclusion Criteria:

- Identified social determinants of health (SDOH). need that impacts healthcare outcomes (identified by the healthcare team)

Exclusion Criteria:

- Non-english speaking patients
A Multi-centre Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects between 18 and 70 years of age.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups.

iv) Subjects who are scheduled to undergo a primary total hip replacement whom the surgeon considers to be suitable for the DePuy PROXIMA™ hip femoral prosthesis.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long term participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects for whom the surgical procedure is a revision of a previous THR or hemi-arthroplasty, or who have previously undergone arthrodesis or osteotomy of the hip.

vii) Subjects undergoing a simultaneous bilateral hip operation.

viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.

ix) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
"Which Type of Exercise is More Effective in Chronic Constipation?

In this study, it will be investigated whether a daily 30-minute walk or abdominal breathing exercise is more effective on chronic constipation.

According to the results of population-based studies conducted in our country, the frequency of constipation varies between 22-40%. In addition to medical treatment, alternative treatments are frequently used in the treatment of constipation. One of these is exercise.

In addition to medical treatment, alternative treatments are frequently used in the treatment of constipation. One of these is exercise. Many traditional breathing techniques developed in Asia are thought to be beneficial to health. In the light of this information, it is aimed to monitor ActiGraph GT3X+ Accelerometer, which is an objective measurement method of physical activity, and to evaluate the effectiveness of breathing exercise, which is one of the abdominal breathing exercises.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and understand Turkish,
* Voluntarily accepted to participate in the research and written consent form was obtained (those who could fill out the forms themselves using their hands, and those who could not use it, from their relatives with verbal consent),
* At least 18 years of age and over,
* Oriented to place, person and time,
* Patients who do not have spinal cord injury, parapilegia, or quadriplegia that may physiologically impede the individual's intestinal excretion Does not have any problems that prevent cognitive, sensory and verbal communication,
* Patients who are conscious and not using any sedating medication
* men and women aged 20-80 at the time of approval

Exclusion Criteria:

* pregnancy or possible pregnancy;
* the habit of doing all kinds of breathing exercises;
Who is Falling? - Fall Risk Prediction Among Community Dwelling Elderly.

The purpose of this study is to investigate if the level of physical activity, selected physical and psychological risk factors can predict risk of falling in older (≥65) community dwellers.


Eligibility Criteria:
Inclusion Criteria:

* Home dwelling
* Manage body transfer independently
* Walking ability for at least 10 meters with or without assistive devices

Exclusion Criteria:

* Progressive neurological or rheumatologically illness
* Diagnosed vestibular problems
* Experienced pain in a substantial degree, limiting or obstructing everyday living
* Known uncorrected visual or hearing problems.
* Serious difficulties in speaking, understanding or reading Danish.
* Cognitive impairment equivalent to Mini Mental State Examination \< 23
Prospective WCD Post CABG Registry (CABG Registry)

The primary objective is to observe the rate of recovery of ventricular function (EF\>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care.

The primary objective of this study is to determine the rate of recovery of ventricular function (EF\>35%) in patients with ischemic heart failure with reduced ejection fraction (EF ≤35%) after undergoing first time, coronary artery bypass grafting (CABG) procedure while being treated with guideline-directed medical therapy (GDMT). It is anticipated that more patients will have EF recovery as compared to a retrospective register where 54% of isolated CABG patients had EF recovery by end of WCD use (Kuehn et al., 2022), mostly driven by the modern improved usage of GDMT drugs.

This study is designed as a multi-center prospective observational study of patients who underwent first time coronary artery bypass grafting procedure with HFrEF at hospital discharge to test the hypothesis that EF recovery will be improved by end of WCD wear due to increased usage of GDMT. The study will target 20% female enrollment and recruitment will be adjusted if the percentage of female subjects enrolled are far from 20%.

Eligibility Criteria:
Inclusion Criteria

* Patient underwent first-time CABG surgery \<10 days before enrollment.
* Patient is prescribed WCD for a primary reason of HF with reduced EF \< 35% measured after surgery but before hospital discharge.
* Patient is ≥18 years old

Exclusion Criteria:

* Patients having combination CABG surgery with heart valve repair.
* Patients with prior CABG.
* Patients who have an active unipolar pacemaker.
* Patients with a physical or mental condition that could impair their ability to properly interact with the WCD.

Patients currently participating in an interventional clinical study. Patients with any skin condition that would prevent wearing the device. Patients with an advanced directive prohibiting resuscitation.
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis

This is a multicenter, open-label study to assess systemic plasma levels of calcitriol, calcium homeostasis and safety in adults with plaque-type psoriasis under conditions of maximized use of CD 2027 3µg/g oily spray twice daily (6 g daily), applied to 20% of BSA for 3 weeks.

There are a total of six visits: Pre-treatment period (Day -15, Day -8 and Day -1) and Treatment period (Day 1/ Baseline, Day 15 and Day 22).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque-type psoriasis involving 10% - 20% of body surface area (BSA), with a Global Severity Score of at least 3 (moderate)

Exclusion Criteria:

* Other type of psoriasis (other than plaque)
* Significant abnormal lab findings
* Secondary hyperparathyroidism
* Vit D deficiency
* Hypercalcemia
A Study to Evaluate the Long Term Safety and Effectiveness of Novantrone Therapy Followed by Copaxone Treatment for Multiple Sclerosis

It is thought that treating Multiple Sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.


Eligibility Criteria:
Inclusion Criteria:

* Participation \& completion of the NC-100 Clinical Trial.
* Able and willing to sign an Informed Consent.

Exclusion Criteria:

none
Profile of Brazilian Climacteric Women: the Brazilian Menopause Study

Cross-sectional study with 1,500 women between 45 and 65 years old. Women participate by answering questionnaires prepared to get information about their perceptions and knowledge about menopause, hormone therapy and other treatments for menopause.

This is a cross-sectional study with 1,500 women between 45 and 65 years old. The subjects participate by answering online questionnaires prepared to get information about their perceptions and knowledge about menopause, hormone therapy and other treatments for menopause. The distribution of subjects respect the distribution of Brazilian population according to country regions and according to socioeconomic class, and taking into account the information of last official Brazilian demographic census.

Eligibility Criteria:
Inclusion Criteria:

* Women between 45 and 65 years of age
* Women able to participate in a questionnaire on a digital platform and who have a device allowing this access

Exclusion Criteria:

* Pregnant or lactating women
Clinical Score Usefulness and EHR Integration

The SOFA score is a severity of illness and prognostic score used in the ICU. It has also recently been adopted as part of the definition of sepsis. This study will prospectively evaluate the usability of automated SOFA scoring for ICU patients within an electronic patient monitoring dashboard. It will also assess for changes in physician ordering (volume and types of orders) after automatic scoring is implemented.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the medical intensive care unit within 2 months of automated SOFA scoring module activation.

Exclusion Criteria:

* Refusal to allow medical records to be used for clinical research.
Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.

The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC).

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SL-T10, GX-I7, and pembrolizumab in combination in patients with metastatic castration-resistant prostate cancer (mCRPC).

Eligibility Criteria:
Inclusion Criteria:

1. Male patients 19 years of age or older at the date of written informed consent.
2. Patients with histopathologically or cytologically confirmed adenocarcinoma of the prostate, documented by bone or soft tissue lesions.
3. Patients with castration-resistant prostate cancer with a blood testosterone level of less than 50 ng/dL at the screening visit.
4. patients with metastatic castration-resistant prostate cancer (mCRPC) who meet the following criteria (based on PCWG3.0 modified RECIST 1.1)

1) Prior taxane therapy for metastatic prostate cancer or confirmed refusal or inadequacy of such therapy 2) Patients who have received prior docetaxel and at least one of the following agents: abiraterone acetate or enzalutamide before or after docetaxel treatment 3) Patients with progression of prostate cancer during/after prior therapy, in the investigator's judgment, with either of the following, in the internal or external castration state

1. PSA progression defined as at least 2 PSA level increases (≥1 week interval between each test) and a PSA level of ≥2 ng/mL at Screening
2. Advanced soft tissue disease as defined by RECIST 1.1
3. Progressive bone disease defined as ≥2 new lesions on bone scan (per PCWG3)

5. Patients who are on androgen deprivation therapy (ADT) of any kind (patients who have not undergone bilateral orchiectomy must begin internal castration therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or anti-androgenic agents, at least 4 weeks prior to Baseline and must continue for the entire duration of the study)

Exclusion Criteria:

1. patient has an active autoimmune disease or is receiving systemic steroid therapy or in immunosuppressive status.
2. Patient has history of chemotherapy, radiation chemotherapy, biological therapy, immunotherapy, or radiation therapy within 4 weeks prior to the screening visit (In case of nitrosoureas or mitomycin, 6 weeks prior to the screening visit)
Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome

The study will be a randomized controlled trial. Twenty-four subjects will be assigned randomly by using the lottery method into two groups. Group A will be given a hot pack in addition to the global hip muscles strengthening exercise while group B is the control group which will receive a hot pack in addition to hip abductor strengthening. The time duration will be 6 weeks. Pain intensity will be assessed by NPRS.3 sessions per week will be given for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week.

Secondary piriformis syndrome is a common condition of extra-spinal sciatica which is related to or around the piriformis muscle and irritates the sciatic nerve. Most cases reported are of secondary piriformis syndrome. Secondary piriformis syndrome is caused due to soft tissue inflammation, and muscular spasms, which result in nerve compression. Inflammation occurs due to trauma on the buttock and piriformis muscle contractures. Strengthening exercise program is another physical technique that has been supported by research in numerous areas, which has effects on the reduction of pain, range of motion, and lower extremity function. This study will aim to compare the effects of global hip muscles and isolated hip abductors muscle strengthening exercise programs on pain, range of motion, and lower extremity function in patients with secondary piriformis syndrome. The study will be a randomized controlled trial. Twenty-four subjects will be assigned randomly by using the lottery method into two groups. Group A will be given a hot pack in addition to the global hip muscles strengthening exercise while group B is the control group which will receive a hot pack in addition to hip abductor strengthening. The time duration will be 6 weeks. Pain intensity will be assessed by NPRS.3 sessions per week will be given for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the 6th week. The collected data will be analyzed in the statistical package for the Social Sciences (SPSS) 25.Parametric/Non-parametric tests will be applied after testing the normality of the data.

Eligibility Criteria:
Inclusion Criteria:

* Both Genders
* age: 20-50 years
* Batty test to diagnose secondary piriformis syndrome

Exclusion Criteria:

* Diagnosed Congenital spinal defects
* Diagnosed Hip arthritis
* Pregnancy
* Diagnosed Disc facet pathology
* History of Spinal trauma
* Musculoskeletal abnormality in the lumbar spine
* Diagnosed Rheumatologic disorders
* Any diagnosed bony or soft tissue systemic disease
A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors.

Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors.

Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.

In Phase 2, study patients will be enrolled into 5 distinct expansion cohorts:

* Cohort 2a: ROS1-positive NSCLC naïve to Tyrosine Kinase Inhibitor (TKI) therapy and up to 1 prior chemotherapy and/or immunotherapy.
* Cohort 2b: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy.
* Cohort 2c: ROS1-positive NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy.
* Cohort 2d: ROS1-positive NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy.
* Cohort 2e: ROS1-positive solid tumor and progressed on any prior therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing\>40 kg).
2. Disease Criteria:

   1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
   2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
   3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
3. Prior anticancer treatment (except cohort 2a).
4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease according to RECIST 1.1.
5. Adequate baseline organ function and bone marrow reserve.

Exclusion Criteria:

1. Patient's cancer has a known oncogenic driver alteration other than ROS1.
2. Known allergy/hypersensitivity to excipients of NVL-520.
3. Major surgery within 4 weeks of first dose of study drug.
4. Ongoing anticancer therapy.
5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.