cyrilzakka/clinical-trials huggingface dataset:
A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis

This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 65 years of age inclusive
* Patients with chronic kidney disease Stage III-IV not on dialysis
* Hb \< 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)
* Adequate iron status as judged by the treating physician

Exclusion Criteria:

* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
* Significant acute or chronic bleeding
* Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
* Active malignant disease during the last five years (except non-melanoma skin cancer)
* Uncontrolled or symptomatic secondary hyperparathyroidism
* Epileptic seizure during the last 6 months
* Poorly controlled hypertension (sitting blood pressure \> 170/100 mmHG)
* Myocardial infarction or stroke, or severe or unstable CAD
* Severe liver disease during the previous 6 months
* Congestive heart failure NYHA Class III-IV
* Diagnosis or suspicion of pure red cell aplasia (PRCA)
* Planned elective surgery during the study period (except cataract surgery and vascular access surgery)
* Transfusion of red blood cells during the previous 2 months
* Pregnant women
* Any contra-indications to Mircera
Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients

Aim: This study was conducted to investigate the effectiveness of two types of mattresses with different support surfaces used in bedridden patients.

Method: The sample of this quasi-experimental study consisted of 60 patients according to the inclusion criteria. A group I and group II of 30 patients each were formed from the sampled patients. For the patients in group I, a bed with a cube/block system and vibration (massage) feature was used. For the patients in group II, a viscoelastic mattress was used. The data of the study were collected with the ''Patient Identification Form'', ''Braden Scale'', ''Pressure Wound Observation Form'' and ''Wound Measurement Chart''. Number-percentage distributions, Chi-square, Fisher's Exact Probability Test and Mann-Whitney-U tests were used to evaluate the data.

Implications for Clinical Practice: It was determined that the support surface used affected the pressure sore size and the mattress with cube/block system and vibration (massage) feature created smaller sized wounds in the sacrum, trochanter, malleolus and heel regions. In the sacrum, scapula, and heel regions, although not statistically significant in terms of wound stage and the number of patients who developed pressure sores, it was seen that the mattress with cube/block system and vibration (massage) feature was more effective.


Eligibility Criteria:
Inclusion Criteria:

* A "low risk" rating on the Braden Scale.
* Voluntary informed consent from conscious patients and consent from the legal guardian for unconscious or confused patients.
* Absence of pressure sores upon admission to the clinics.
* A BMI (Body Mass Index) not exceeding 30.00 (as classified by the World Health Organization).

Exclusion Criteria:

* The patient's bed was changed in less than ten days after inclusion in the study,
* Patient referral,
* Discharge
* Exhitus was the exclusion criteria.
The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level

The study aim is to examine the relationship between providing information to women prior to elective cesarean delivery and anxiety levels around surgery.

the patients will be assigned into two groups - intervention and control. In the intervention group - the day before surgery the women will watch a pre-prepared video showing in detail the course of events around the operation.

the level of anxiety, pain level and Intake of Analgesics will be compared between the two groups

Women will be recruited for research at the time of admission preoperatively. According to randomization women will be divided into two groups - intervention and control In the intervention group - the day before surgery the women will watch a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation - from the woman's perspective - from the time they were admitted to the department, preparation for surgery, entrance to the operating room, anesthesia procedure, surgery Itself, post-operative recovery and recovery course in maternity ward.

The movie will be shown to the patient by one of the study investigators. In the control group - women will receive general information about the surgery as part of the routine informed consent process, without watching a pre- prepared film.

the level of anxiety, pain level and Intake of Analgesics will be compared between the two groups

Eligibility Criteria:
Inclusion Criteria:

* First cesarean surgery

Exclusion Criteria:

* Women who have had surgery beyond age 2 years
* Women with anxiety disorders
* Women with comorbidity that might alter cortisol and catecholamine excretion,
* Women with comorbidity associated with severe pain that might distort pain ratings
* Women with psychiatric comorbidity that might reduce the ability to understand the videotape and questionnaires
* Women who consume any medication that might affect urinary excretion of cortisol
* Women undergoing cesarean surgery due to obstetric complication (gestational hypertension, pre-eclampsia, gestational diabetes mellitus)
Molecular Mechanism Study of Uterine Sarcoma

The purpose of this project was to use multi-omics technology to screen the key factors for the occurrence and development of uterine sarcoma.

Uterine sarcomas are rare mesenchymal neoplasms in the female genital system, accounting for about 1% of female reproductive tract malignancies and 3%\~7% of uterine malignancies. Subtypes of uterine sarcoma are leiomyosarcoma, endometrial stromal sarcoma, and adenosarcoma. Uterine leiomyosarcoma is the most common uterine sarcoma, accounting for about 1% to 2% of all uterine malignancies.

Uterine sarcomas differ in histologic appearance and clinical behavior. The incidence of uterine sarcoma is low and the prognosis is poor. Its manifestations mainly include abnormal vaginal bleeding, abdominal pain and abdominal mass, but none of these symptoms are specific.

For uterine sarcoma, there are no diagnostic serum markers and imaging features and the diagnosis of uterine sarcoma still mainly depends on postoperative pathological results. However, with the development of omics technology, immunophenotypes and molecular characterization of uterine sarcomas have increasingly been utilized to improve diagnostic classification and prognostication in uterine sarcomas. Uterine leiomyosarcoma, the most common subtype of uterine sarcoma, does not have a single defining molecular abnormality.

This project intends to use multi-omics technology to screen the key factors for the occurrence, development, and malignant transformation of uterine sarcoma, especially uterine leiomyosarcoma, and to map the interaction network of cell signaling pathways. It provides key molecular markers for the early assessment of recurrence and malignant transformation of uterine myoma after conservative treatment, and provides a molecular mechanism basis for finding solutions to prevent the progression and malignant transformation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older;
2. Newly treated or recurenced uterine sarcoma.

Exclusion Criteria:

1. Diagnosis of other malignancies within the past 5 years;
2. history of pelvic or vaginal radiation therapy;
3. Known high-grade lesions of the cervix and endometrium.
Three-Year Clinical Evaluation of Bonded Posterior Restorations: Amalgam vs Resin Composite

Background: This 3-year clinical trial compared the performance and post-operative sensitivity of a posterior resin composite with that of bonded-amalgam in large sized cavities. Additionally, it was evaluated whether resin composite could be an alternative for bonded amalgam.

Methods: This was a randomized clinical trial. Patients in need of at least two posterior restorations were recruited. Authors randomly assigned one half of the restorations to receive bonded-amalgam and the other half to composite restorations. Forty bonded-amalgams and composites were evaluated for their performance on modified Ryge criteria and post-operative sensitivity using VAS for 36-months.


Eligibility Criteria:
Inclusion Criteria:

To be included, the teeth to be restored had to:

1. be asymptomatic
2. have occlusal and adjacent teeth in contact
3. have cavity sizes exceeding the one-third of the bucco-lingual distance between cusp tips -

Exclusion Criteria:

* Patients with periodontitis, poor oral hygiene, bruxism or a history of allergic reactions to any of the materials
DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.


Eligibility Criteria:
Inclusion Criteria:

Presence of complex coronary lesions defined as follows:

* long lesions (\>28 mm);
* CTO, a total occlusion of duration more than 3-months;
* Lesions involving a bifurcation, defined as a division with a side branch large enough to be stented (i.e. \>2.25 mm);
* Patients requiring 4 or more stents
* Reference vessel diameter: \>2.25 mm to \<4.0 mm

Exclusion Criteria:

* Age under 18 years old;
* Significant co-morbidity precluding clinical follow-up;
* A positive pregnancy test in women with child-bearing potential;
* Contra-indication to dual anti-platelet therapy;
* Thrombocytopenia \<100,000/uL;
* Major surgery planned which will lead to discontinuation of antiplatelet therapy;
* In-stent restenosis;
* Treatment of saphenous vein graft;
* CTO with long sub-intimal tracking (\> 20 mm).
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
* For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
* Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts.
* ECOG performance status between 0 and 2
* At least 1 lesion with measurable disease at baseline
* Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)

Exclusion Criteria:

* Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
* Autoimmune disease
* Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
* Uncontrolled CNS metastases

Other protocol defined inclusion/exclusion criteria could apply
Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis

A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction began in August 2016 and was completed in April 2017. The clinical setting: University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal study for chronic plantar fasciitis.

Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Pain (\>90 days) from previously diagnosed Plantar Fasciitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
* No History of surgery to the affected anatomy.
* No alternative treatment procedures within the last 90 days.
* Age: 18 - 85, depending on the study.
* Unilateral Pain
* Willingness to complete treatment and post treatment regimen as described.
* Patients who have provided written and verbal informed consent.

Exclusion Criteria:

* Patients currently enrolled in any other non-conservative, device, or Investigational New Drug clinical trial, or who have participated in a clinical study involving the Plantar Fascia, thirty days prior to study initiation;
* Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
* Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
* At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
Examining EAL for PTSD

This RCT will evaluate the efficacy of Equine Assisted Learning for reducing PTSD symptoms in public safety personnel (e.g., fire fighters, police, nurses, etc.).

The purpose of the proposed project is to investigate the effectiveness of Equine Assisted Learning (EAL) for reducing symptoms related to PTSD among public safety personnel. EAL is an intervention in which mental health clinicians and equine specialists work together with clients to address a learning goal via unmounted interaction with a horse. Recent literature indicates that EAL shows promise in addressing a range of mental health diagnoses among a variety of populations, including military and Royal Canadian Mounted Police veterans with PTSD. The EAL intervention will be delivered at Cartier Farms in Spruce Home, Saskatchewan. Research components of this study will be conducted virtually via Zoom.

The investigators will employ a randomized controlled trial design with pre-post and follow-up testing. Participants will be randomized into one of two groups: the intervention group will receive the EAL intervention for 8 weeks while waitlist control condition will not receive this treatment for the same amount of time. Data on PTSD symptom severity will be collected from all participants prior to the start of the EAL intervention (baseline), again within two weeks after the EAL intervention is complete (post), and then a final time three months after the EAL intervention ends (follow-up). The two groups will then be compared to determine whether there are differences in PTSD symptom severity between groups. To obtain a sufficient sample size while also running appropriately sized EAL groups of 10 per session, the investigators will conduct four rounds of randomization, Thus, the final sample size will be 80 (40 in the intervention condition and 40 in the waitlist control condition). All individuals in the waitlist control condition will be offered EAL following their completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for PTSD;
* Employed as a police officer, fire fighter, paramedic, nurse, or emergency dispatcher; and
* Fully vaccinated against COVID-19.

Exclusion Criteria:

* Substance use that limits one's capacity to participate in the intervention;
* Suicidality; or
* Enrollment in another study investigating PTSD intervention efficacy.
Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed

This is a prospective, multi-center, longitudinal, mother-infant pair, therapeutic drug monitoring study. The aim of this study is to determine concentrations of antiretroviral drugs in plasma and breastmilk in people living with HIV who chose to breastfeed while using antiretrovirals. At a planned hospital visit an extra maternal blood sample (1 to 2 per visit) and extra infant blood sample (1 per visit) will be collected, as well as a breastmilk sample (1 to 2 per visit). Ideally, sample collection will take place at least during the 1, 3 and 6 month post partum follow up visit. Measured concentrations will be used to calculate milk to plasma ratios, relative and absolute infant dosages.


Eligibility Criteria:
Inclusion criteria

* Patients of at least 18 years of age at the moment of screening
* Patients with HIV-1 as documented with positive HIV antibody test, HIV RNA of antigen test
* Patients breastfeeding their infant
* Patients using antiretrovirals for the treatment of HIV-1 with a marketing authorisation in Europe (table 1 in Appendix)
* Patients using current antiretrovirals for a minimum of 2 weeks to assure drug concentrations are in steady state
* Patients who are able and willing to sign an informed consent

Exclusion Criteria:

No exclusion criteria will be used at the screening for the trial.
The Turbine-based Insufflator Safety and Feasibility Study

The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. Turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device.

The turbine-based insufflator for minimal access surgery provides a new technological basis for insufflation. Until now, insufflation uses a static pressurized gas volume that is strongly affected by external pressure and vice versa pressures onto the surrounding structures. Turbine technology permits highly accurate pressure control, and an intra-abdominal volume that is dynamically adapted to ventilation. In this safety and feasibility trial, the pressure stability of a turbine-based insufflator is investigated in patients undergoing laparoscopic surgery. In addition, small amplitude oscillation are superimposed to the intra-abdominal pressure at the start of insufflation. Those oscillometric measurements will be used to estimate the abdominal compliance through the forced oscillation technique.

Study population: Adults who are scheduled for an elective intraperitoneal laparoscopic surgical procedure at Erasmus MC.

Main study parameters: safety and feasibility of turbine-based insufflation in terms of (Serious) Adverse Device Effects.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Elective laparoscopic surgery
* Intraperitoneal procedure
* Planned use of a main 11 mm trocar
* Informed consent

Exclusion Criteria:

* Pregnancy
* Inability to contain the insufflation gas to the intraperitoneal cavity
Health After Birth Intervention Trial

This trial is to assess the feasibility of a larger, definitive RCT and determine the clinical effectiveness of an NHS 1:1 programme versus a modified programme with a low carbohydrate dietary intervention (as per Feinman and colleagues classification) with telehealth, physical activity and enhanced behaviour change on specified health outcomes amongst post-partum women living with obesity

For individuals living with obesity, the post-partum period is currently the initial, optimal timeframe for weight management. Many women reconceive during the post-partum phase, increasing the risk of between-pregnancy bodyweight retention and even gain. Consequentially, many re-enter subsequent pregnancies with a higher BMI often associated with unfavourable obstetric outcome and further cyclical perpetuation.

Health behaviour change is an important facet within weight management interventions and delivery may be enhanced by digital technologies, for example, telehealth. Short messaging service (SMS) may be used to enhance communication between patients and practitioner and is relatively inexpensive to use.

Low carbohydrate diets continue to gain traction however research is arguably confounded by the lack of a universally agreed definition and classification. Feinman and colleagues (2015) propose intermediary categories. The experimental arm of this trial will be encouraged to adopt a non-ketogenic LCD as per Feinman.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18 or above
* Ready and motivated to make lifestyle changes
* Have a Body Mass Index of ≥30 kg/m2 (at initial booking appointment)

Additional study specific criteria

* English speaking and ability to read English language
* Capacity to consent to participating in the study
* Are non-diabetic or those with Type 2 diabetes which is diet controlled
* Deemed medically fit by GP/medical professional to participate via email
* Have recently given birth (within 1 year)
* Are not receiving weight management support elsewhere e.g. NHS, Scottish slimmers, weight watchers
* Have access to a mobile phone and weighing scales

Exclusion Criteria:

* Have uncontrolled hypothyroidism
* Have unstable psychosis or severe and unstable personality disorder
* Are pregnant
* Have dementia
* Have moderate to severe learning disability or learning difficulty which impairs the ability to adhere to the programme (identified by medical history and confirmed with GP)
* Current alcohol or substance misuse (6 month period of abstinence)
* Active purging
* Bulimia Nervosa
* Binge Eating Disorder

Additional study specific criteria

* Known cancers
* Type 1 Diabetes or Type 2 Diabetes on any Diabetic medication (including Insulin)
* Have a pacemaker
* Renal impairment
* Taking Orlistat or any other weight loss medication or had previous bariatric surgery