cyrilzakka/clinical-trials huggingface dataset:
Dynamic SAX vs Conventional LAX in Radial Artery Cannulation.

When performing vascular cannulation such as radial artery cannulation, ultrasonography (US) helps proper positioning of the tip of needle in the vascular lumen, which facilitating cannulation of the catheter and successful pressure monitoring. Conventionally, short-axis out-of-plane (SAX) and long-axis in-plane (LAX) views are commonly used method to image the target vessel during cannulation under US guidance. Dynamic needle tip positioning (DNTP) method is newly introduced by one group of investigators who conducted a related study using vascular phantom model.

In DNTP, SAX is used, and additionally, when the needle tip is imaged in the screen as an echogenic point, the practitioner (a) proximally moves the US probe a bit, and then (b) the needle is advanced until the needle tip reappears in the screen. In this manner, the practitioner repeats (a) and (b) until the needle is inserted 1 cm into the lumen of vessel, and then the catheter is inserted to finish the procedure.

DNTP has not been compared to conventional imaging methods. The aim of this trial is to see the effect of DNTP on success rate of the radial artery cannulation at the first attempt, compared to the conventional LAX.


Eligibility Criteria:
Inclusion Criteria:

* Elective cardiovascular surgery where RA catheterization is newly required.

Exclusion Criteria:

* skin infection or trauma
* Bilateral arteriovenous fistula for dialysis
* Severe peripheral vascular disease
* Severe arteriosclerosis or arterial atheroma
* Raynaud disease
* Shock
* Patients on ECMO or IABP support
* Morbid obesity
* Profound coagulopathy
* Negative results of modified Allen's test
Molecular Analysis of 150 Lung Adenocarcinoma

LUNG-EST is a retrospective study including 152 patients who benefit from lung surgery during the years 2012 to 2013 at Hospices civils de Lyon and with a diagnosis of lung adenocarcinomas. For all patients, clinical data and histopathological data are available. The objective of this study is to characterize these lung adenocarcinomas by the LungCarta Panel using the mass spectrometry array Sequenom. This panel could identify 214 DNA mutations and/or frameshift insert/deletion among 26 oncogenes. Once included in the study, the adenocarcinomas are also included in a Tissue MicroArray (TMA) in order to perform immunohistochemical analysis. Immunohistochemical staining with innovative antibodies are correlated with clinical, histopathological and molecular data.

Our hypothesis is that this TMA could constitute a good tool to screen interesting protein's expression.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* lung adenocarcinoma
* Surgical specimen

Exclusion Criteria:

* not adenocarcinoma subtype of lung cancer
* Tumour biopsy
* insufficient material for DNA extraction
Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention

The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.


Eligibility Criteria:
Inclusion Criteria:

1. Subject was \> 19 years of age.
2. Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion.
3. Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.

   3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).

   3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (≥ 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length ≥30 mm or stent length ≥32 mm), or vein bypass graft stented
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Cardiogenic shock at the index admission
2. Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
3. Pregnant and/or lactating women.
4. Concurrent medical condition with a life expectancy of less than 1 years
5. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

6 Subject was unable to provide written informed consent or participate in long-term follow-up.
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198

This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 to 49 years of age inclusive;
* Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive);
* Male or female;

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
* A history of significant hypersensitivity, intolerance, or allergy to any drug compound;
* History of alcohol or other substance abuse;
Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.

This study aims to determine and compare acupuncture therapy and chiropractor group therapy to reduce anxiety and depression among HIV/AIDS patients at Being Alive, Los Angeles. In this controlled clinical trial, a total of 30 patients will be divided into two groups, 15 in the acupuncture therapy group, 15 in the chiropractor group therapy. The Hospital Anxiety and Depression Scale (HADS), The Patient Health Questionnaire 9-item (PHQ-9) and Generalized Anxiety Disorder 7- item scales (GAD-7) will be used as screening tools for depressive and anxiety symptoms respectively.

In this study, the objectives are to determine and compare the prevalence of symptoms of depression and anxiety and find the most effective treatment method to assist patients in improving their quality of life utilizing holistic health treatments such as acupuncture and chiropractic to support their physical and mental health. Depression and anxiety are currently a major public health challenge worldwide especially during the Covid-19 pandemic. Approximately 280 million people within the world have depression, and over 700,000 people die due to suicide per annum (WHO, 2021). This depression and anxiety in PLWHAs can result in poor quality of life, and quality of work, school, and family life. Also, risky sexual behavior, the spreading of the virus, and at its worst, depression can result in suicide.

This controlled clinical trial will explore the treatment of acupuncture versus chiropractor care to seek out which treatment can help people living with HIV/AIDS (PLWH/A) to reduce depression and anxiety among PLWH/A patients in Being Alive, Los Angeles.

Eligibility Criteria:
Inclusion Criteria:

* single intervention only

Exclusion Criteria:

* chiropractic and acupuncture together
Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery

Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

Eligibility Criteria:
Inclusion Criteria:

* visually significant cataracts

Exclusion Criteria:

* allergy to fluoroquinolones, cobalamin (B12)
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.

This is a randomized, double-blind, placebo- and active-controlled study to evaluate the effectiveness of two dose levels of topiramate (200 and 400 milligrams/day) compared with lithium and placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder. The trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. Efficacy assessments include the change from baseline to Day 21 for the total Young Mania Rating Scale (YMRS) score. Also included as efficacy assessments during the 12 week study are the Global Assessment Scale (GAS), Montgomery-Åsberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions (CGI), and health-related quality of life measures at specified time intervals. Safety assessments include evaluation of adverse events throughout the study, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) througout the study, as well as changes in clinical laboratory tests (hematology, chemistry, urinalysis), electrocardiograms (ECGs), and physical examinations at specified times. The study hypothesis is that the change from baseline in Young Mania Rating Scale (YMSR) total score at Day 21 will be significantly better for the topiramate groups than for the placebo group and that the study drug will be well tolerated by the patients. Topiramate: oral tablets (50 milligrams\[mg\]); increasing from once daily (50mg) to 3-times daily; target total daily dose 200mg or 400mg, maintained through Week 12. Lithium: oral capsules (300mg); increasing from once daily (300mg) to three-times daily; target total daily dose 1500-1800 mg.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
* )
* At least one previous manic or mixed episode
* Meeting minimum severity criteria (a Young Mania Rating Scale \[YMRS\] score of \>=20 at screening and baseline visits) for the current acute manic or mixed episode
* Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test

Exclusion Criteria:

* DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)
* DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
* Experienced a manic episode while taking an antidepressant or psychostimulant drug
* Known hypersensitivity to topiramate or previously participated in a topiramate study
A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia

The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).

This is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic participants. This study consists of a screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early withdrawal visit. Safety evaluations will include adverse events, clinical laboratory tests, concomitant medications, physical examination, and vital signs, which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
* Must be admitted to a hospital within 4 weeks prior to Screening experiencing an acute exacerbation of schizophrenia
* Have a positive and negative syndrome scale (PANSS) total score of more than or equal to 60 or clinical global impressions - severity (CGI-S) score of more than or equal to 4 (moderately ill) at Screening
* Agree to protocol-defined method of contraception
* Must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at Screening

Exclusion Criteria:

* Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
* Have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination
* Have a history of neuroleptic malignant syndrome
* Participants at risk of suicide
* Have received clozapine within 1 month prior to Screening
Therapeutic Education Using an Internet Application in Hereditary Ichthyosis

The main purpose is to evaluate the feasibility (global use) of a therapeutic patient education program using a specific web application in patients with hereditary ichthyosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with hereditary ichthyosis, according to the classification established during the 2009 consensus conference
* Who has given his informed consent form
* Who is affiliated to a social security system

Exclusion Criteria:

* Patient who has already participated in a therapeutic patient education program for the hereditary ichthyosis
* Unable to connect or use a computer tool
* Impossibility to be present at the only face-to-face session
* Patient who is not available for the collective educational session
* Patient with little or no motivation to follow a therapeutic patient education program (motivation evaluated by the educational team by phone call before inclusion)
* Patient not mastering the French language
* Person under legal protection (guardianship, curators or safeguard of justice)
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.


Eligibility Criteria:
Inclusion Criteria (abbreviated):

Skeletally mature adults between 22 and 80 years old (inclusive);

Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam;

Oswestry Low Back Pain Disability Questionnaire score of ≥ 35;

Involved disc(s) between L2 and S1;

Exclusion Criteria (abbreviated):

Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia;

Active malignancy;

Nondiscogenic source of symptoms (e.g. tumor, etc.);

Multiple level symptomatic degenerative disc disease where more than one level requires fusion;

Previous spinal instrumentation or a previous interbody fusion procedure at the involved level;

More than one level to be fused
Anatomical Resection of Liver MetAstases iN patIents With RAS-mutated Colorectal Cancer

the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated colorectal liver metastasis (CRLM).

Despite increasing application and success of personalized treatment in medical oncology, little progress has been made in personalized surgical cancer therapy. The ARMANI trial presents the first prospective, randomized trial to evaluate effectiveness and safety of molecular-guided resection in patients with colorectal liver metastasis (CRLM). While CRLM might be removed independently of the liver's segmental borders, retrospective data favor anatomic resections in the subgroup of patients with a mutation in the RAS oncogene. Therefore, the ARMANI trial will test the hypothesis, if an anatomic resection (AR) improves long-term outcome vs. a non-anatomical resection (NAR) in patients undergoing surgery for RAS-mutated CRLM. The trial will be carried out among 11 high-volume centers of hepato-biliary surgery in Germany. A total of 220 patients will be enrolled and randomized in a 1:1 ratio to undergo an AR vs. NAR. The primary endpoint is intrahepatic disease-free survival (iDFS). In addition, the study will provide important data on perioperative outcomes and quality of life for both surgical techniques. Given the trend among liver surgeons to aim for parenchymal-sparing operations to preserve liver parenchyma, a positive trial will be practice changing and present the first piece of high-level evidence on benefits of personalized surgical therapy guided by the tumor's mutational profile in patients with CRLM.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer with RAS mutation (KRAS or NRAS)
* Colorectal liver metastases (single or multiple)
* Planned R0 resection of liver metastases (and primary tumor, if present)
* Anatomical and non-anatomical liver resection technically feasible
* Male and female patients, age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Extrahepatic metastases
* Planned staged liver resection (e.g. two-stage hepatectomy)
* Diagnosis of another cancer \< 5 years prior to randomization Exceptions: curatively treated in situ cervical cancer, curatively resected non-melanoma skin cancer
* Expected lack of compliance
* Addiction or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
Efficacy of Different Stretching Techniques on Hamstring Muscle Tightness in IT Professionals

Brief Summary

This clinical trial aims to learn if static stretching and myofascial release work to improve hamstring muscle tightness and lower limb functional ability among IT professionals. It will also learn about the superiority of one maneuver over another. The main questions it aims to answer are:

* Does static stretching and myofascial release work to improve hamstring muscle tightness and lower limb functional ability among IT professionals?
* Which stretching maneuver is more effective in reducing hamstring muscle tightness and improving the lower limb functional ability among IT professionals? Researchers will compare static stretching to myofascial release to see if both work equally or are superior to each other in reducing hamstring muscle tightness and improving lower limb functional ability among IT professionals.

Participants will:

* Both groups received an application of hot packs for 20-25mins at the posterior aspect of the thigh.
* In addition, group 1 performed static stretching of the hamstring muscles for thirty seconds, with a thirty-second gap, repeating the same maneuver three times/day for five days/week for three weeks.
* Group 2 received a myofascial release. This maneuver involves the proper positioning of the practitioner\&#39;s hands on both sides of the hamstrings, pulling them in opposite directions with firm pressure, and holding the stretch for three to five minutes each stretch, completing five to seven stretches per session with a gap of two minutes between each stretch, and continued five sessions per week for three weeks.

Tightness in the hamstring muscles presents a considerable issue for many people, especially those in professions requiring long sitting periods, such as IT workers. This group often experiences a high rate of hamstring tightness because their jobs involve extended sitting and minimal physical movement. As a result, IT professionals may suffer from limited knee extension and reduced functionality, leading to discomfort and lower productivity at work and in daily activities.

The impact of hamstring tightness on knee extension and overall function has been extensively studied across various populations. Limited knee extension, commonly associated with hamstring tightness, can disrupt standard walking patterns and affect joint stability, raising the risk of musculoskeletal injuries, particularly around the knee. Additionally, the reduced functional ability caused by hamstring tightness can negatively influence daily tasks, job performance, and overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

* IT professionals
* males and females)
* aged between 30 and 45 years
* working in passive roles for at least 6 hours a day, and
* reported symptoms of hamstring muscle tightness such as decreased flexibility and discomfort during prolonged sitting, and found positive active knee extension test.

Exclusion Criteria:

* History of musculoskeletal injuries or neurological disorders affecting lower limb function, and
* showed non-cooperation.