cyrilzakka/clinical-trials huggingface dataset:
Musculoskeletal System Ultrasound Examination Data Collection Study for the Development of an Artificial Intelligence Software

The primary objective of this observational study is to acquire ultrasound images (raw data) encompassing various planes within the musculoskeletal system. This data will be instrumental in the development of artificial intelligence-guided software. The study aims to enlist 300 volunteers, comprising individuals with both healthy musculoskeletal systems and those presenting pathologies. These participants will undergo ultrasound scans administered by two experienced professionals, employing FDA-cleared ultrasound devices.

The main question it aims to answer is:

-Are the collected ultrasound images of diagnostic quality?

Ultrasound's cost-effective and user-friendly attributes have positioned it as a cornerstone in diagnosing musculoskeletal system disorders.

In this single-centered and prospective study, the study aims to enlist 300 volunteers, comprising both individuals with healthy musculoskeletal systems and those with pathologies. The collected ultrasound raw data will be used to train models for the identification and highlighting of key anatomical landmarks on ultrasound images. Participants' gender, age, BMI, and medical history will be considered and reported. All scans will be performed on FDA-cleared general-purpose ultrasound devices. Obtained images will be used to develop artificial intelligence-based medical software by Smart Alfa Teknoloji San. Ve Tic. A.Ş., Ankara, Turkey. Smart Alfa has similarly conducted a study in the field of anesthesia using the same method in Nerveblox artificial intelligence software.

The study methodology encompasses the following components:

* Specific body views, guided by established protocols, will be scanned from different body planes. The focus areas encompass musculoskeletal structures.
* A cohort of 300 volunteers, evenly distributed by gender (150 male, 150 female), will have their demographic data (BMI, gender, age) documented.
* To counteract potential biases, the sequence of volunteer participation will be randomized.
* Each scan is expected to take 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers over the age of 18
* Able to accept and sign the Informed Consent Form before participating in the study

Exclusion Criteria:

* Volunteers below the age of 18
* Unwilling to accept or having psychiatric or neurological diseases to sign an Informed Consent Form before participating in the study
* Inability to lie flat
* Anatomical deformity in the area to be scanned
Ethics Education to Support Nurse Leaders in HealthCare

Using an exploratory study design with an educational intervention, a pre/post evaluation of ethical confidence and competence will be completed for nursing leaders working in either acute care or post-acute care with primary purpose to increase ethical competency and confidence in decision making for nursing leaders in a clinical role.

The purpose of this project is to implement an ethics educational program that has been developed in collaboration with subject matter experts to support patient facing nursing leaders. The intervention is an ethics education pathway, which will be used for approximately 60-80 patient-facing nurse leaders who practice in either acute care or post-acute care over a 6-week period. One Pre and two post-assessment questionnaires will be distributed, which include the "Ethical Competence Support Questionnaire" © and the "Ethical Safety Questionnaire" ©. Permission for the instrument use was obtained from the author.

Eligibility Criteria:
Inclusion Criteria:

* employment within an in-patient or outpatient non-profit healthcare setting as a nursing leader.
* settings include acute-care units and post-acute care facilities

Exclusion Criteria:

* nurses working direct care 100% of their time without any formal leadership responsibilities
Dose Reduction of Preoperative Radiotherapy in Myxoid Liposarcomas

To study the feasibility of reducing the dose of preoperative radiotherapy in MLS (Myxoid Liposarcomas) from 50 Gy to 36 Gy while maintaining comparable clinicopathological responses.

* A Bayesian approach is considered for the analysis of this trial. The aim is to provide a stopping rule for inefficacy of the new dose.
* Two aspects are important to elucidate the mechanism of this treatment: dynamic investigations of perfusion and vasculature. Apart from participation to the dose reduction paragraphs of this study, patients will be also asked to undergo, at clinically relevant dose points, dynamic contrast enhanced (DEC) MRI scans and separately tumor biopsies.

Eligibility Criteria:
Inclusion Criteria:

1. Age above or equal to 18 years
2. Biopsy proven MLS (including the reciprocal chromosomal translocation t(12;16)(q13;p11); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen = 18 x 2 GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes (see paragraph 10 for radiobiological considerations).
3. ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) 0-2
4. Patients must be able (physically, mentally and socially) to complete a series of RT, followed by an observation period of 4-6 weeks and undergo surgery.
5. Written informed consent

Exclusion Criteria:

1. Prior radiotherapy to the target area.
2. Anticoagulant medication of any kind; especially Ascal®(and derivates), coumarines (Sintrom® and Marcoumar®), all heparin and heparin-like formulations. (Note: this exclusion criterion only applies for patients consenting to the translational research part of the study; patients on anticoagulant medication as described above may take part in the dose reduction part of the study, but the repeat biopsies may not be taken.)
3. Pregnancy -
Lifeline-NET (Narrative Exposure Therapy): A Short-term Treatment for Traumatized Refugees and Asylum Seekers

Evaluation of a short version of Narrative Exposure Therapy


Eligibility Criteria:
Inclusion Criteria:

* PTSD

Exclusion Criteria:

* Psychotic Disorder,
* Severe Substance Dependence
Osteopathy on IBS Symptoms in Patients With Ulcerative Colitis in Remission

Type : interventional, randomized single blind study Aim : to evaluate 3 sessions of osteopathy on IBS-like symptoms associated with ulcerative colitis in remission Number of patients : 50 (randomization 1:1) Duration of the inclusion period : 2 years Primary end-point : Irritable Bowel Syndrome Severity Scoring System (IBS SSS) at 3 months

Osteopathy has been shown to be effective in IBS patients in few studies and to improve IBS-like symptoms in a short series of Crohn patients. IBS-like symptoms are frequent in patients with ulcerative colitis in remission (about 20 %).

The aim of this interventional, randomized single blind study is to evaluate the impact of 3 sessions of osteopathy on Irritable Bowel Syndrome symptoms in 50 patients (randomisation 1:1) with ulcerative colitis in remission (defined by fecal calprotectin \< 200 µg/g).

The two group of patients will have 4 sessions of osteopathy (M0, M1, M2, M3). The "treated group" will have 3 sessions of osteopathy testing followed by osteopathy treatment (M0, M1, M2) and a final testing session at M3. The "untreated group" will have 4 sessions of only testing osteopathy (M0, M1, M2, M3).

Primary end-points : Irritable Bowel Syndrome Severity Scoring System (IBS SSS) at 3 months (M3) Secondary end-points : Inflammatory Bowel Disease Questionnaire ol, Functional Assessment of Chronic Illness Therapy-Fatigue at M3, evaluation of osteopathic dysfunctions between M0 and M3, questionnaire for use of medication for IBS between M0 and M3

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age between 18 and 90
* Patient with ulcerative colitis (whatever the Montreal grade, E1, E2 or E3) In clinical remission for at least 3 months and with fecal calprotectin \< 200 µg/g
* No modification of Ulcerative Colitis treatment for at least 3 months
* Patient with IBS-liked symptoms defined as in Rome IV classification for Irritable Bowel Syndrome
* Patient with Irritable Bowel Syndrome Severity Scoring System \> 75 at screening
* Patient affiliated to the French Social Security regimen

Exclusion Criteria:

* Patient refusal
* Patient \< 18 yoa
* Patient with colonic or ileal stenosis
* Patient diagnosed as undetermined colitis
* Patient not in remission for Ulcerative Colitis as defined by an endoscopic Mayo score \> 1 within the 3 months preceding the inclusion and/or fecal calprotectin \> 200 µg/g at inclusion
* Osteopathy session(s) within 1 month before inclusion
* Patient with Inflammatory rheumatic disorders (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis)
* Patient with Irritable Bowel Syndrome Severity Scoring System \<75 at screening
* Patient above 18 yoa with law guardianship
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection

The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin.

The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B)
* Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system)
* Plasma HCV RNA of 100,000 IU/ml
* HIV 1 and HIV2 ab seronegative
* Body Mass Index (BMI) ≤ 35 kg/m2 BMI
* Treatment Naive subjects

Exclusion Criteria:

* Contraindications to peginterferon or ribavirin therapy
* Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score \> 5
* Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes
The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (RT) period in participants with familial partial lipodystrophy (FPL). Following the randomized treatment period, participants who did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period and participants who were entered in the OLE period continued to receive volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE period, participants had an option of continued dosing for up to an additional 52 weeks (Week 105 to 156). Participants who did not enter the OLE period went straight to a 13-week post-treatment follow-up period. Following the Week 104 OLE period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing.


Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent to participate in the study (signed and dated) and any authorizations required by law.
* Clinical diagnosis of familial partial lipodystrophy (FPL) plus diagnosis of type 2 diabetes mellitus, hypertriglyceridemia, and fatty liver.
* Diagnosis of FPL is based on deficiency of subcutaneous body fat in a partial fashion assessed by physical examination and low skinfold thickness in anterior thigh by caliper measurement: men (less than or equal to \[≤\] 10 millimeters \[mm\]) and women (≤ 22 mm), and at least 1 of the following:

  1. Genetic diagnosis of FPL OR
  2. Family history of FPL or of similar abnormal fat distribution plus 1 Minor Criteria OR
  3. In the absence of FPL-associated genetic variant or family history, 2 Minor Criteria and body mass index (BMI) less than (\<) 35 kilogram per meter square (kg/m\^2).
* Diabetes not well controlled on antidiabetic therapy with glycated hemoglobin (Hb) HbA1c more than or equal to (≥) 7 percentage (%) to ≤ 12% at Screening.
* Hypertriglyceridemia with fasting triglycerides (TG) levels greater than or equal to (≥) 500 milligrams per deciliter (mg/dL) (≥ 5.7 millimoles per liter \[mmol/L\]) at Screening and Qualification visit, or Fasting TG levels ≥ 200 (≥ 2.26 mmol/L) at both Screening and Qualification Visits for participants who meet the genetic or family history criteria.
* Presence of hepatosteatosis (fatty liver), as evidenced by a screening magnetic resonance imaging (MRI) indicating a hepatic fat fraction (HFF) ≥ 6.4%.

Exclusion Criteria:

* A diagnosis of generalized lipodystrophy.
* A diagnosis of acquired partial lipodystrophy.
* Acute pancreatitis within 4 weeks of Screening.
* History within 6 months of Screening of acute or unstable cardiac condition.
* Low-density lipoprotein cholesterol (LDL-C) more than (\>) 130 mg/dL on maximal tolerated statin therapy.
* Platelet count \< lower limit of normal (LLN).
* Treatment with metreleptin within the last 3 months prior to Screening.
International Liver Surgery Outcomes Study

This study was to designed to measure the true worldwide practice of liver surgery and associated outcomes by recruiting multiple international centres, committing to consecutive patient registration per surgeon and undergo rigorous data validation. It is hoped that these data will provide a more appropriate guide to inform surgeons and patients to assess which level of complexity should be routinely offered for high tumour burden and anatomically difficult scenarios.

Liver surgery was associated with at least 10% mortality in the 1970's. The safety of liver surgery has dramatically improved since with a mortality of now around 1-2%. Individual centres postulate that a perioperative mortality close to 0% should be the standard of major liver resection. Despite these claims, epidemiological studies showed a mortality rate of 6%. Outcomes in liver surgery are likely influenced by indications, complexity, centre and surgeon skills, equipment, centre and surgeon experience. The aim of LiverGroup.org is to develop an international data set on the outcomes of liver resections among a large number of international surgeons. The 'collaborative' model for 'snapshot' clinical audit is now well established and such research is a novel approach for assessing current practice in a short period of time. The primary objective of the study is to provide a verified record of the true perioperative morbidity and mortality of a representative set of liver surgeons worldwide in 2019. Secondary objectives include risk factors for mortality and morbidity using multivariable regression models. Any surgeon performing liver resections is eligible to participate in LiverGroup.org. All consecutive cases will be included and there are no minimum patient numbers per centre. Liver transplantation is excluded. There will be 3 months of prospective patient enrolment and 3 months follow up within the 12-month frame, January to December 2019. All liver resections, all indications, as well as all co-morbidities will be included. Liver transplantation, imaging-guided ablations and liver biopsies are excluded.

Eligibility Criteria:
Inclusion Criteria:

* All indications (including benign and living donor resections)
* All co-morbidities
* Open, laparoscopic or robotic
* Single wedge resections to extended liver resections
* Single or two-stage hepatectomies
* Procedures with liver volume enhancement such as PVE, PVL, ALPPS.
* Resections involving cold perfusion (ex-situ and ante-situ)
* There are no exclusion criteria as related to indication, age or comorbidities.

Exclusion Criteria:

* Liver transplantation
* Imaging-guided liver ablation techniques alone
* Liver biopsies
Collection of Maternal Blood Samples for Development of Non-invasive Prenatal Diagnostic Testing

The purpose of this study is to collect blood samples from pregnant women who achieved pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy screening (with or without single gene gene testing). These samples will be used for test development of non-invasive prenatal diagnostic testing.

Eligible subjects will sign a consent form and have blood drawn at approximately 8-17 weeks gestation. Subjects will received $200 reimbursement for providing this blood sample. The collected samples will be used to help develop non-invasive prenatal diagnostic testing using Natera's Parental Support technology which is already commercialized for genetic diagnosis of in-vitro embryos. In this study, the technology will be tested for it's ability to analyze fetal-specific pieces of DNA isolated from the mother's blood. No results of the maternal blood testing will be reported to the subject or to their physicians.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women willing to donate a blood sample during the first or second trimester of their pregnancy (approximately 8-17 weeks gestation)
* Use of Natera (formerly Gene Security Network)'s commercial preimplantation genetic testing (PGS/PGD)to achieve the current pregnancy

Exclusion Criteria:

* Pregnant women who did not use Natera (formerly Gene Security Network)'s PGS/PGD testing to achieve their current pregnancy
Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)

This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for Acute Respiratory Distress Syndrome (ARDS) with an Extracorporal Membrane Oxygenation (ECMO) immediately after admission to the intensive care unit or conservative treatment. The later can undergo ECMO following failure of conservative therapy as a rescue therapy. Patients will be included within 96h of the onset of symptoms of ARDS and will be randomized according to standard procedure. Follow-up will be performed until hospital discharge.

Patients suffering acute ARDS defined according to the Berlin Definition starting from severe stage with acute onset and (i) ratio partial arterial pressure of oxygen fraction of inspired oxygen inspired oxygen fraction (PaO2/ FiO2) ≤ 200 (ii) Bilateral opacities consistent with pulmonary edema on frontal chest radiograph, and (iii) requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation (iv) no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mm Hg will be treated by ECMO either within 24 hours to referral to an ARDS ECMO center or as rescue therapy after failure of conventional therapy.

Outcome measures have been chosen according to robustness and sensitivity to change. They are of high clinical impact and reflect the treatment effect desired by clinicians. Primary efficacy endpoint: All cause mortality by 28-days. Key secondary endpoints are: 1) 90 day all cause mortality 3) ICU length of stay 4) duration of mechanical ventilation support 5) frequency and duration of renal replacement therapy 6) bleeding requiring transfusions in the ICU 7) SOFA score

Eligibility Criteria:
Inclusion Criteria:

* ARDS as defined according to the Berlin Definition1
* The term "acute onset" is defined as follow: the duration of the hypoxemia criterion and the chest radiograph criterion must be ≤ 7 days at the time of randomization.
* Patients must be enrolled within 96 hours of onset of ARDS and no later than 7 days from the initiation of mechanical ventilation.

Exclusion Criteria:

* Age less than 18 years
* More than 7 days since initiation of mechanical ventilation
* more than 96 hours since meeting inclusion criteria
* patient, surrogate or physician not committed to full intensive care support
* pregnancy
Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris

The goal of this study is to compare how efficient two different types of PDTs are when used in combination with topical 5-ALA. The two types of PDT lights are Blu-U light and Candela V-beam Pulse Dye Laser.


Eligibility Criteria:
Inclusion Criteria:

* 18-79 years of age
* Patients who failed the topical and oral antibiotics after 6 month therapy.
* Patients who failed the topical retinoids after 6 month therapy.
* Patients that are not good candidate to start oral isotretinoin (Accutane) due to contraindications.

Exclusion Criteria:

* Patients who have had Isotretinoin therapy less that 1 year prior to this ALA-PDT procedure.
* Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
* Patients with a history of porphyria.
A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma

This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity (ADCC) in participants with relapsed or refractory (R/R) MM who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 12 weeks
* Measurable disease, as defined by the protocol
* Participants must have received a minimum of 3 prior lines of therapy, including at least one PI, one IMiD, and an anti-CD38 monoclonal antibody
* Best response of stable disease or better with at least one prior anti-CD38 monoclonal antibody containing line of treatment

Exclusion Criteria:

* Any anti-cancer therapy within 3 weeks prior to initiation of study treatment, with exceptions defined by the protocol
* Prior allogeneic stem cell or solid organ transplantation
* Autologous stem cell transplantation within 100 days prior to initiation of study treatment
* Significant cardiovascular disease
* Known clinically significant liver disease
* Active or history of autoimmune disease or immune deficiency
* Known active infection requiring IV anti-microbial therapy within 14 days prior to first study drug administration
* Primary or secondary plasma cell leukemia
* Current CNS involvement by MM
* Other protocol defined inclusion/exclusion criteria may apply