cyrilzakka/clinical-trials huggingface dataset:
Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area (BSA) \<1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (NSCLC) after failure of first line platinum- based chemotherapy


Eligibility Criteria:
Inclusion criteria:

1. Patients aged 20 years or older at the date of informed consent
2. Patients with body surface area (BSA)\<1.5 m2 at screening
3. Patients with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy (patients with non-target lesion only are eligible) First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy is accepted.
4. Patients who have life expectancy of at least 3 months
5. Patients who are Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening
6. Patients obtained written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP)and Japanese GCP

Exclusion criteria:

1. Patients who have received more than one prior line of chemotherapy (i.e., second or third line chemotherapy) for advanced or metastatic NSCLC (Prior monotherapies with an epidermal growth factor receptor tyrosine kinase inhibitors \[EGFR-TKI\]) or anaplastic lymphoma kinase (ALK) inhibitor can be allowed)
2. Patients who have received previous therapy with other vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) inhibitors (other than bevacizumab) for the treatment of NSCLC at any time
3. Patients who have received following treatments within 4 weeks prior to start of study therapy 1) Other investigational drugs 2) Chemo-, hormone-, immunotherapy, or monoclonal antibody.
4. Patients who have received molecular target therapy including EGFR TKIs and ALK inhibitors within 2 weeks prior to start of study therapy
5. Patents who have received radiotherapy within the past 3 months (in the case of limited -field \[e.g. brain or bone metastasis\] radiotherapy with palliative intent), within 2 weeks) prior to start of study therapy
6. Patients who not recovered clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy (=CTCAE grade 2 Adverse Event from previous treatment) at screening

further exclusion criteria may be applied
Effects of a Single Session of Physiotherapy on Patients Operated for Lumbar Spondylolisthesis

The goal of this clinical trial is to investigate whether a meeting with physiotherapist before hospital discharge can improve the post-operative outcomes in patients who have undergone lumbar fusion surgery for spondylolisthesis.

The main question it aims to answer is:

* The primary endpoint investigated is the degree of disability measured using the ODI-I one month after the surgical intervention.
* The secondary endpoints are the level of pain measured using the NRS scale at 1 and 3 months post-surgery; disability at 3 months measured using the ODI-I questionnaire; physical function assessed using the UWT at 1 and 3 months post-surgery; psychological factors such as self-efficacy and fear of movement measured using the TSK and PSEQ-I at 1 and 3 months after lumbar fusion surgery; health status and quality of life measured at 3 months with the HADS-I and SF-36-I questionnaires; and the patient's satisfaction regarding their hospital stay, assessed using a PREMs questionnaire administered at the time of discharge.

The "usual care" group will instead be discharged by the spinal surgeon following the standard procedures.

The physiotherapist will provide the patient with advice regarding their return home and will suggest simple exercise to be performed at home until the next visit, one month after surgery. Additionally, the patient will have the opportunity to communicate, either by email or phone, with the physiotherapist until the follow-up visit with the spinal surgeon.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients who have undergone lumbar fusion surgery due to monosegmental lumbar spondylolisthesis.

Exclusion Criteria:

* Patients who have undergone previous lumbar surgeries
* Patients operated on for other lumbar pathologies
* Patients with pre-existing neurological deficits not related to the condition being treated
* Patients with systemic conditions (inflammatory, infectious, neoplastic, etc.) or neuromuscular disorders
* Patients with cognitive deficits or psychiatric disorders
* Patients who do not speak Italian fluently
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients

A multicenter, randomized, double-blind, triple-dummy, group-comparison study using placebo and nitrazepam as a comparative drug.


Eligibility Criteria:
Inclusion Criteria:

* Nonorganic insomnia associated with schizophrenia and manic-depressive psychosis.

Exclusion Criteria:

* Patients with allergic reactions to zolpidem or nitrazepam; Patients with serious cardiac disorders; serious hepatic impairment; serious renal diseases.
Development and Evaluation of the Healthy Beat Accupunch (HBA) Exercise Program for the Community Older Adults

The goals of this research project were: 1) to develop a senior-tailored Healthy Beat Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility, compliance, and long-term effects of a six-month, DVD-guide HBA exercise program.

A three-year, longitudinal, triangulation research method was applied. First Year (Phase I): A preliminary HBA exercise program, including hard copy descriptions and DVD demonstrations of each exercise, was mailed to the 16 experts in the Delphi advisory panel for their critique and evaluation. First Year (Phase II): A quasi-experimental, one-group, pretest-posttest design was used to pilot-test the feasibility of the HBA exercise program on a group of 31 community-dwelling older adults in a community care station. Second Year: A cluster randomized controlled trial was used to test the effects of a six-month, instructor-led HBA exercise program on the functional fitness (cardiovascular-respiratory function, body flexibility, muscle strength, and muscle endurance) of the community-dwelling older adults. Through the use of convenience sampling strategy, eight community care stations with 232 older adults in Kaohsiung were recruited and randomly assigned based on their community care stations to a HBA experimental group or a wait-list control group. Participants in the experimental group received the HBA exercise program led by trained and certified instructors, three times per week, 40 minutes per practice for six months; participants in the wait-list control group continued with their regular daily activities. One pre-test and two post-tests, three months apart, were conducted. Third Year: Using the same method as in the second year, participants from the second year continued practicing the HBA exercise program, but guided by a DVD, for another six months. The feasibility, compliance, and effectiveness of the DVD-led HBA exercise program on the community-dwelling older adults were tested, and another two post-tests, three months apart, were conducted on the same outcome measurements as in the second year.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling older adults aged 65 and over
* Mandarin or Taiwanese speakers
* able to stand and walk without assistive devices
* cognitive alert and able to verbally state their name, address, and answer questions.

Exclusion Criteria:

* participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses.
320-slice Coronary Computed Tomography (CT) Angiography

The primary aim of this study is to determine the potential utility of 320-slice volume-CT for obtaining adequate diagnostic accuracy while at the same time improving image quality compared with previous generations of CT scanners and simultaneously enabling a reduction in both radiation exposure and contrast agent amount required.


Eligibility Criteria:
Inclusion Criteria:

* 40 years of age
* sinus rhythm

Exclusion Criteria:

* prior conventional coronary angiography
* unstable presentation
* coronary artery bypass graft or stent
* pregnancy or breast-feeding
* creatinine \> 2.0 mg per deciliter
New MRI Sequences in Spine and Joint

Low back pain and osteoarticular degeneration or injury is the leading worldwide cause of years lost to disability, accounting for 17 % of all patients with disabilities and its burden is growing alongside the increasing and aging population. The anatomical regions of the intervertebral disc include the central nucleus pulposus, the peripheral fibrocartilaginous annulus fibrosus, and the superior and inferior cartilaginous endplates (CEP). The CEP is a thin layer of hyaline cartilage located between the avascular intervertebral disc and the bony vertebral endplate. The endplate cartilage consists of chondrocytes interspersed throughout an extracellular matrix of proteoglycans, collagen (types I and II), and water. It plays an important role in the function and homeostasis. The CEP has been considered the pathway between the largely avascular disk tissues and the blood supply of the vertebral body and thus provides nutrition for disk cells. Many musculoskeletal tissues, including the CEP, cartilage-bone interface of articular joints, entheses, tendons, and ligaments, have components with very short T2 values (much less than 1 msec), which are orders of magnitude shorter than that of the nucleus of the disk (\~100 msec). In a conventional pulse sequence, such as proton density-weighted spin-echo (SE) or fast SE, with standard clinical section profile, the minimum echo time (TE) is typically 10 msec, which is much longer than that needed to capture the short-lived signal from these tissues. Recently, ultrashort echo sequence UTE technology has been introduced, and the TE time can be as low as 0.008ms. This range of TE is sufficient to capture signals from the cartilage endplate before it decays. With using new MRI technology, such as IR-UTE, UTE-MT, UTE-T2\*mapping, Maigc, DTI, and IVIM, which can quantitative tissues that have previously been "invisible" at conventional MR imaging, and provide imaging basis for early diagnosis of injury at molecular level. The purpose of this study was to investigate the clinical application value of different MRI sequences in spine and joint.


Eligibility Criteria:
Inclusion Criteria:

* 1.The patient had history and clinical symptoms of low back pain and joint sports injury 2.The patient had a history of osteoporosis; 3.There was no contraindication of MRI; 4.The patient who has clear lumbar intervertebral disc degeneration or herniation or osteoporosis or joint sports injury found by routine CT or MRI examination, and the clinical symptoms were consistent with the image.

Exclusion Criteria:

* 1. Patients with previous history of lumbar or joint surgery; 2. Patients with congenital bone deformity; 3. Patients with history of lumbar tumor and infection; 4. Cognitive function is limited or mental illness can not cooperate with imaging.
STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion

Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions.

Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention.

Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* CTO referred for PCI
* Diameter of the Target vessel for PCI between 2.5 and 4.5mm
* Agreement to participate and signed informed consent after information
* Affiliation to Social Security System
* French comprehension

Exclusion Criteria:

* Pregnant women, breast-feeding,
* History of an allergic reaction or significant sensitivity to any stent component or to contrast dye
* Intrastent CTO
* Major calcifications in the CTO
* Inclusion in another interventional study
* Person under guardianship or curatorship
A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate (as the predominant histology)
* High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:

  * Greater than or equal to (≥)4 bone metastases by bone scan and/or
  * ≥1 visceral metastases by computed tomography or magnetic resonance imaging
* Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 \& 6) inhibitor
* Development of metastatic prostate cancer in the context of castrate levels of testosterone
* Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
* Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
* History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
* Uncontrolled hypertension
* Clinically active or chronic liver disease, moderate/severe hepatic impairment
* Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization
A SYNdemic BASed INtervention for MSM With High Risk Behavior: Design of a Randomized Controlled Trial

The purpose of this randomized controlled intervention study at the STI outpatient clinic of Amsterdam is to answer the following questions : Does a personalised behaviour intervention comprising of targeted in-depth screening on mental health problems and drug use and, in case identified, subsequent linkage to care increase help seeking behaviour, and decrease risk behaviour in MSM who are at high risk for STIs and HIV?


Eligibility Criteria:
Inclusion Criteria:

* MSM
* Sufficient understanding of Dutch or English and
* 2 STIs in the last 24 months or a PEP treatment for HIV negative MSM

Exclusion Criteria:

* Men will be excluded if they are not able to complete follow-up or otherwise deemed by clinic staff to be unsuited for participation.
NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG

The purpose of this study is to determine if NIR fluorescent imaging is an effective approach to detect the margins of head and neck tumours or lymph nodes draining the tumour

Primary objective:

definition of the distribution of intravenously injected ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients or in nodes recurrences in head and neck cancer

Secondary objectives:

* Evaluation of the ability of NIR fluorescence imaging to determine the tumoral volume, specifically the margins of the tumoral tissues (in the operating room and in the pathology department)
* Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring neck dissection with or without resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation).
* Informed consent form signed.

Exclusion Criteria:

* Age less than18 years old.
* Inability to give informed consent.
* History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
* Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
* Documented coronary disease.
* Advanced renal impairment (creatinine \> 1,5mg/dl).
* During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
* Pregnancy, breastfeeding
Performance Evaluation of the Biological Diagnosis of HIT

Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.


Eligibility Criteria:
Inclusion criteria :

* Adult patient (≥ 18 years of age)
* Hospitalized at HUS between 01/01/2009 and 31/12/2019
* Specimen sent to the HUS Hematology Laboratory for biological diagnosis of HIT between 01/01/2009 and 31/12/2019
* Data collected by the CRPV and analyzed by the HIT multidisciplinary group in order to reach a consensus decision on the presence or absence of HIT
* Patient does not object to the reuse of his medical data for scientific research purposes.

Exclusion criteria:

* Patient for whom no test has been performed at the HUS Hematology Laboratory
* Patient for whom no data has been collected by the CRPV
* Patient for whom the HIT group could not confirm or deny the presence of HIT
Perinatal Care and Medication Assisted Treatment: Carbon/Emery Counties

The purpose of this study is to enhance perinatal opioid use disorder (OUD) treatment in a rural setting by developing an evaluated curriculum of perinatal OUD provider education.

The research team will establish and evaluate a perinatal model of care for OUD serving two counties, Carbon and Emery, which have high rates of OUD and overdose. This model of care will entail University of Utah medical clinicians providing education and webinars to healthcare providers in Carbon/Emery counties who care for pregnant women with OUD and their babies. This model of care will also help other social and behavioral health care providers in the area to understand how to treat and better coordinate care. No clinical services are being provided by University of Utah investigators or staff.

Eligibility Criteria:
Provider Inclusion Criteria:

* Must be employed as staff at one of our sub-contracted agencies or community partners
* Must directly provide care to pregnant women with OUD in Carbon and/or Emery Counties, UT

Provider Exclusion Criteria:

* Unwilling or unable to adopt treatment approaches presented from University of Utah clinicians to patient care
* Not directly working with pregnant patients with OUD
Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps

Endoscopic mucosal resection (EMR) is an effective and has been widely used technique for the treatment of superficial colorectal neoplasms. Although, conventional EMR (CEMR) showed high efficacy for the management of colorectal superficial neoplasms, there is problematic limitation in this technique - incomplete resection. In literature, the anchoring-tip EMR (AEMR), named as "Tip-in EMR" was first introduced in 2016 from Japan. Recently, several retrospective studies have been suggested about the effectiveness of AEMR. However, there has been no prospective randomized controlled study to identify its advantage over CEMR. Therefore, the investigators performed a multicenter randomized controlled trial to estimate the effectiveness of AEMR compared with CEMR for the endoscopic treatment of intermediate-size (10 to 20 mm) colorectal polyps.

After injection of normal saline solution mix, snaring was tried for CEMR. In AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate-size (10 to 20 mm) colorectal polyps
* Morphologically sessile (Is), slightly elevated (IIa), flat (IIb), and slightly depressed (IIc) as Paris classification of superficial neoplastic lesions
* Laterally spreading tumor (granular and nongranular type) as Kudo classification.

Exclusion Criteria:

* Pedunculated or excavated/ulcerated polyps
* Polyps with features strongly suggestive of submucosal invasive carcinoma
* Polyps in patients with inflammatory bowel disease, familial polyposis, electrolyte abnormality, and coagulopathy
* Residual lesions after endoscopic resection or presence of severe submucosal fibrosis.