cyrilzakka/clinical-trials huggingface dataset:
Relief of Symptoms of Post-traumatic Stress for Victims of Gun Violence

To test the hypothesis that adult individuals who are victims of gun violence will have decreased symptoms of post-traumatic stress after an individual-level intervention with the Screening and Tool for Awareness and Relief of Trauma (START).

In response to the lack of targeted mental health intervention for gunshot wound survivors, the Screening and Tool for Awareness and Relief of Trauma (START) was developed for patients that come from communities with sustained and persistent trauma. It consists of six screening questions adapted from the validated Primary Care PTSD Screen,\[30\] with input from focus groups, surveys and in-depth interviews with victims of violence and in particular, boys and young men of color. START has been shown to be effective at decreasing symptoms of PTSD in a one-month follow-up, but it has not been piloted on recently injured victims of gun violence specifically nor has it been tested in a randomized control trial design. A better understanding of the utility of this tool and others like it in victims of violent crime for relief of symptoms of post-traumatic stress and prevention of PTSD would contribute to the larger body of literature on PTSD prevention for victims of gun violence while simultaneously addressing a major need in this community.

Eligibility Criteria:
Inclusion Criteria:

* Survivors of gunshot wound presenting to the Emergency room and/or admitted as inpatient that are eligible for the Violence Prevention and Outreach Program (VPOP).

Exclusion Criteria:

* Patients with severe traumatic brain injury
* Children under the age of 18
* Patients otherwise unable to give consent
* Non-English speaking patients
* Victims of sexual assault
* Patients with history of a severe mental illness and/or those already undergoing treatment for a mental illness by a licensed professional.
Pulsed Electromagnetic Field (PEMF) Systems to Promote the Maintenance of Bone and Muscle

This is a pilot study that evaluates the effect of PEMF in maintaining muscle mass postoperatively in individuals experiencing clinical immobilisation due ACL reconstruction surgery. Half of the participants will receive the PEMF therapy in combination with standard rehabilitation programme, while the other half will receive sham therapy in combination with standard rehabilitation programme.

This is a single-site, randomized, double-blinded, prospective pilot study of the effectiveness of once-weekly PEMF therapy in the promotion of muscle maintenance following ACL reconstruction surgery. Eligible subjects will be randomized in a 1:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device, in addition to the standard rehabilitation regimen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone unilateral first-time athroscopic reconstruction with single bundle hamstring graft using both transtibial and transportal techniques for rupture anterior cruciate ligament
* Informed consent signed

Exclusion Criteria:

* Subjects requiring concomitant knee ligament reconstruction
* Subjects having other than hamstring graft for the ACL reconstruction
* Subjects with history of cardiac, neurological, and rheumatological diseases, and previous lower limb surgery/ fracture
* Subjects with Leg circumference \> 63 cm
* Pregnant women
OssiMend BA in Posterolateral Instrumented Lumbar Fusion

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:

  * Instability as defined by \>3mm translation or \>5 degrees angulation
  * Osteophyte formation of facet joints or vertebral endplates
  * Decreased disc height, on average by \>2mm, but dependent upon the spinal level
  * Herniated nucleus pulposus
  * Facet joint degeneration/changes

Exclusion Criteria:

1. Subject is under 18 years of age at the time of consent
2. Subject has had prior lumbar spine fusion surgery at any level
3. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy
4. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
5. Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection
6. Subjects under workers compensation or active litigation
Fish Oil Supplementation to Pregnant Women in China

This randomized controlled trial with fish oil supplementation to pregnant women conducted in areas of China, which are generally low in fish intake and low income, aims at answering the following primary questions:

* Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth
* Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth
* Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of spontaneous delivery in the preterm period

The basic design is that of a randomized controlled trial with three groups randomized in ratios of 1:1:1. Two different doses of long chain n-3 fatty acids are tested against zero grams long chain n-3 fatty acids (lc-n3FA). These are provided in similarly looking gelatine capsules with either fish oil, a mixture (1:3) of fish oil and olive oil, or olive oil. Eligible women are randomized at around gestation weeks 16-24 and are asked to take the capsules until they have completed the preterm period (i.e. at 37 full gestation weeks) or until they deliver. Women are asked to complete questionnaires at randomization about diet and other baseline information, and again in gestation week 30 and after delivery. The trial is undertaken at hospitals in the two provinces of Gan-Su and Shaanxi. The three randomization groups will be compared with respect to proportions of preterm delivery. Cox regression will be used to compare the groups with respect to rates of spontaneous deliveries while accounting for elective delivery by regarding these as censoring events.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy without known complications

Exclusion Criteria:

* Regular user of fish oil
* Regular user of NSAIDs
* Known twin pregnancy
The Impact of Cigarette Smoking on Periodontal Therapy

Periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures in serum), were recruited to this double arm prospective cohort study. Data were collected 3 months following non-surgical and surgical periodontal treatment, and following 12 months with supportive periodontal therapy. Data collected were clinical attachment level, probing depth, bleeding on probing,oral bacteria, serum, blood (PAXgeneBlood), and gingival crevicular fluid.

The overall aim of this work was to study clinical outcomes of active and supportive periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth, and site level. Moreover, to compare the periopathogenic microflora and inflammatory markers in gingival crevicular fluid and in blood in smokers and non-smokers following therapy.

Eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis were included in this prospective cohort study and treated non-surgically and surgically, and then followed-up in a supportive periodontal therapy program for 12 months. Smoking status was validated measuring serum cotinine levels at pre-treatment and 12 months following supportive periodontal therapy.

Clinical measurements included full mouth recordings of clinical attachment level, probing depth, bleeding on probing, and plaque index at pre-treatment and following active and supportive periodontal therapy. At the same timepoints, subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization. Blood samples (PAXgeneBlood), serum, gingval crevicular fluid were also collected at the three timepoints.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* age 35-75 years
* diagnosed with chronic periodontitis
* at least four non-adjacent teeth with proximal sites with a PD ≥6 mm and clinical attachment loss ≥5 mm with BoP and no radiographic signs of apical pathology.
* either smokers (\>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).

Exclusion Criteria:

* subjects who presented with any current medical condition or used medications known to affect periodontal healing
* incorrectly reported smoking status
* use of antibiotics within 6 months of the study
* received subgingival scaling within 6 months of the study
Myeloproliferative Neoplasms and Bone Structure

This is a clinical study to evaluate the effect of CMPN (Chronic myeloproliferative neoplasm) to the bone.

The hypothesis is that patients with CMPN have a higher fracture-rate compared to the background population. We expect to find a lower BMD using conventional DXA scan (dual energy x-ray absorptiometry), and a change in other parameters using HR-pQCT (high-resolution peripheral quantitative computerized tomography).Biochemical bone markers is measured to support the hypothesis.

This is a clinical study to evaluate the effect of CMPN to the bone.

Three individual cohorts are defined; a cohort consisting of 50 patients with Polycythemia Vera (PV), a cohort consisting of 50 patients with Essential Thrombocythemia (ET), and a cohort consisting of 25 patients with Primary Myelofibrosis (PMF).

Patients are recruited from the Department of Hematology, Odense University Hospital.

Interventions consist of:

* Conventional DXA scan to measure Bone Mineral Density (BMD).
* Experimental HR-pQCT to assess geometry, strength and microstructure of the bone in 3 dimension.
* Blood-samples are collected and frozen for later analyses of Biochemical Bone Markers: 1-CTP, Ctx, ALP (alkaline phosphatase)and P1NP.

The outcome is compared to healthy control individuals.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PV (according to WHO 2008 criteria), only JAK2-pos.(Janus kinase 2)
* Diagnosis of ET (according to WHO 2008 criteria), only JAK2-pos.
* Diagnosis of PMF (according to WHO 2008 criteria)independent of JAK2-status.

Exclusion Criteria:

* Pregnancy
* Bone Diseases (Mb. Pagets, Myelomatosis, MGUS (monoclonal gammopathy of undetermined significance), osteogenesis imperfecta, Prim. hyperparathyroidism, osteomalacia.
* Drugs (Prednisone\>3 mth, anti-osteoporotic drugs, anti-estrogen drugs.
* Presence of any psychologic condition or language barrier, which may interfere which a complete understanding, and arise ethnical considerations.
Efficacy and Safety of the Mammalian Target of Rapamycin (mTor Rapamycin) Inhibitor in Vascular Malformations

The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of rapamycin (mTor) pathway plays a role on the development and the lymphatic-vascular organisations.

The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.

The complex vascular malformations induce chronical pains and organic dysfunctions causing significant morbidity and mortality. Therefore, the investigators need to establish guidelines in order to treat these pathologies. Standard treatments such as surgery or interventional radiology are of limited efficacy and related to a high level of recurrences as well as complications. Recent preclinical studies have shown the important role of the PI3Kinase/AKT/mTor pathway on the development and the lymphatic-vascular organisations suggesting an appealing therapeutic target to treat patients with complex vascular malformations.

The aim of this clinical study is to prospectively evaluate the efficacy and the safety of the Rapamycin, an mTOR inhibitor, to treat children and adults with microcystic lymphatic malformations, general lymphatics abnormalities (GLA) or complex vascular malformations for which conventional therapies as surgery or sclerotherapy are ineffective or associated with high risk of important complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complex vascular abnormalities to be threat by a systemic therapy
* Patients must have adequate liver function (LDL-cholesterol, triglycerides,...)
* Patients must have adequate organ function: neutrophils \>1500/mm³, Hb \> 8,0 g et platelets\> 50.000/mm³ (no platelets limits for the Kasabach Merritt syndrome)
* Patients must have adequate renal function(normal creatinin depending on the age), clearance \> 70 ml/min/1.73m² and Urin Protein Creatinine ratio \<0.3 g.
* Karnofsky or Landry \> 50

Exclusion Criteria:

* Dental equipments or prosthesis interfering onto a radiological examen
* Other uncontrolled medical condition (uncontrolled diabetes, hypertension...)
* Concomitant drugs such as inhibitors/inducers of cytochrome P450 3A4 (CYP3A4)
* Immunocompromised patients, including known seropositivity for HIV
* Digestive problems modifying the absorption of Rapamycin (gastric tube feeding accepted)
* Pregnant or nursing (lactating) women
* Prior treatment with phosphatidylinositol 3-kinase (PI3K) and/or mTOR inhibitors
Train the Trainer Curriculum to Scale up AI Supported Echo for RHD Screening in a Public Health System

The first primary objective of this study is to determine the diagnostic performance (sensitivity and specificity) of primary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by expert trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease. The second primary objective is to determine the diagnostic performance (sensitivity and specificity) of secondary MOH nurses who have completed certification in focused echocardiography acquisition and interpretation by MOH nurse trainers to accurately identify patients who are screen positive and screen negative for rheumatic heart disease.

Objective 1:

4 ultrasound naïve nurses (Primary) employed at the HCIII/IVs participating in ADD-RHD Part 1 (SOMREC REF 2021-61) in Lira, will be trained and certified by experts in echocardiography for RHD on focused RHD echocardiographic screening examination and interpretation using a novel AI guided software.

Focused RHD screening echocardiograms by the 4 nurses will be integrated into routine clinical practice at their assigned HCIII/IVs for 1 month.

Screen positive patients will be referred to LRRH for confirmatory echocardiogram using a Standard echocardiographic machine under the National RHD registry (SOMREC REF 2014-137).

All echocardiograms will be uploaded to a secure cloud-based server and over-read by a cardiologist with in one - two (1 - 2) weeks to ensure patient safety and to determine trainee performance.

Diagnostic accuracy, sensitivity, specificity, positive and negative predictive values will be calculated.

4 MOH trainees will use pre-recorded PowerPoint presentations to conduct hands-on training for phase 2 (secondary) nurses.

Objective 2:

Similar to Phase 1 with just a few exceptions. 12 MOH nurses will be trained and certified by MOH nurse trainers from phase 1 to acquire and interpret RHD focused screening echocardiograms using a novel AI guided software.

Screening will be integrated into routine care for 2 months and diagnostic performance assessed.

Eligibility Criteria:
Inclusion Criteria:

* Attend same HCIII/IV sites that the MOH nurses work at
* Agree to participate via the study's informed consent

Exclusion Criteria:

* Very sick participants requiring transfer to higher level facility or inpatient care
A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101

A first in human phase 1 study in healthy volunteers to assess AL101 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK, PD and Bioavailability of intravenously and sub-cutaneously administered AL101 in Healthy Volunteers.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.0-35.0 kg/m2
* 45-120 kg, inclusive
* At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.
* Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit.
* In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.
* Willingness and able to comply with the study protocol, in the investigator's judgement.

Exclusion Criteria:

* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Positive drug or alcohol at screening and prior to first dose
* History of alcohol abuse or substance abuse
Multi-marker Approach for Risk Assessment in PAH

Prospective registry including incident patients and prevalent patients which pretends to identify clinical characteristics, treatment trends in-hospital and ten years follow-up outcome through major adverse cardiovascular events (MACE) in a China population with well characterized PAH.

baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart.

Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases.

Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests

MACE include:

death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of \>15% from baseline in 6MWD (or \>30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）

Eligibility Criteria:
Inclusion Criteria:

diagnosis of PAH (by RHC)

Exclusion Criteria:

Refusal to participate.
Effects of Dietary Intervention and Surgery on NAFLD (Non-Alcoholic Fatty Liver Disease)

Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition where fat accumulates in the liver and can lead to inflammation and scarring. It mostly causes no symptoms, however, in the most advanced cases there is an increased risk of liver cancer or liver failure.

NAFLD is currently managed by weight loss and treating associated diseases such as diabetes. No medicines have been licensed to directly treat it but bariatric surgery has been shown to be usually beneficial, although it is unknown whether some operations are better than others. It is also unclear whether this is due to general weight loss or other factors.

This study will be conducted in a hospital setting and aims to determine what changes in liver fat and fat processing occur after pre-operative low calorie diet and the two most common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.

Participants will have ten study visits, four of which may be combined with NHS appointments. Participants will undergo investigations including MRI scans to measure changes in NAFLD and DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be added to allow changes in fat processing to be detected. In addition to samples taken as part of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal)) will be used for research. Visits will take place before and after low calorie diet and bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery is already planned for the participant
* Participant is willing and able to give informed consent for participation in the study.
* Aged ≥18 or ≤75 years.
* Body Mass Index ≥35 ≤55 kg/m2

Exclusion Criteria:

* Contraindication to MRI
* Prior or current participation in a CTIMP that could affect study results
* History of alcoholism or a greater than recommended weekly alcohol intake (14 units per week)
* History of albumin allergy
* Anticoagulant treatment
* Pregnant or nursing mothers
* Type 2 Diabetes
* A liver disease other than NAFLD
* Histological confirmation of lack of NAFLD on liver biopsy
* Large hiatus hernia (that would prohibit Sleeve Gastrectomy)
* Active gastrooesophageal reflux disease (that would prohibit Sleeve Gastrectomy)
* Active malabsorptive intestinal disease (that would prohibit Roux-en-Y Gastric Bypass surgery)
Emotional Experience and Burnout in Physician

Recent studies have highlighted a high incidence of burnout among surgeons. The aim of this study is in particular to investigate if this is the consequence of performing surgery (i.e. invasive procedures) or whether it is related to the cultural background of surgeons.

A mixed method approach (qualitative approach and quantitative approach) will be used to investigate surgeons, as well as gastroenterologists and radiologists who perform invasive procedures and gastroenterologists and radiologists who do not perform invasive procedures. The qualitative approach will rely on face-to face interviews with purposively sampled physicians of the 5 groups and will be continued until saturation. The quantitative approach will rely on a questionnaire that will be sent to physicians of the 5 groups.

Eligibility Criteria:
Inclusion Criteria:

* Digestive surgeon, Gastroenterologist, Radiologist

Exclusion Criteria:

* None