cyrilzakka/clinical-trials huggingface dataset:
Maternal Postop Temperature After Cesarean Delivery

It is unclear whether routine addition of intra-operative forced-air warming in addition to warmed intravenous fluids during cesarean delivery under spinal anesthesia is beneficial. In this single-center randomized trial, we aim to test the primary null hypothesis that our current protocol of warmed intravenous fluids is similar to a combination of warmed intravenous fluids with intra-operative lower-body forced-air warming to maintain maternal temperature after cesarean delivery under spinal anesthesia.

We also aim to assess the rate of maternal shivering during and after the procedure between the two groups, the maternal thermal comfort score, neonatal Apgar scores and umbilical pH levels. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to continue our current protocol of warmed intravenous fluids only during cesarean delivery.

Primary aim Investigate whether a combination of intra-operative lower-body forced-air warming and warmed IV fluids is superior to our current standard of warmed IV fluids alone in influencing maternal core temperature following spinal anesthesia for cesarean delivery.

Secondary aim

1. To compare mean core temperature on arrival to post-anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
2. To compare incidence of hypothermia among women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
3. To compare incidence of shivering following recovery in post anesthesia care unit (PACU) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
4. To compare thermal comfort levels for women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
5. To compare use of meperidine in post anesthesia care unit (PACU) to treat postoperative shivering, in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone
6. To compare newborn outcomes (rectal temperature at birth, umbilical vein pH \& Apgar scores post-delivery) in women who received combination of intra-operative lower-body forced-air warming and warmed IV fluids versus IV fluids alone

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age between 18-50 years old
3. American Society of Anesthesiologists (ASA) physical status 2-3
4. Gestational age greater than 37 completed weeks
5. Singleton pregnancy
6. Elective cesarean delivery.

Exclusion Criteria:

1. Known allergy to local anesthetics
2. Contraindication for spinal anesthesia

   1. Patient refusal
   2. Bleeding diathesis
   3. Neuropathy
Cardio-Renal Registry

Cardiovascular disease is the leading cause of morbidity and mortality among patients with chronic kidney disease (CKD). Even after adjustment for known cardiovascular risk factors, including diabetes and hypertension, mortality risk progressively increases with worsening CKD. As glomerular filtration rate (GFR) declines the probability of developing coronary artery disease (CAD) increases linearly, and patients with GFR \<60 mL/min/1.73 m2 have 2-3-fold increased CV mortality risk, relative to patients without CKD. Management of CAD is complicated in CKD patients due to the likelihood of comorbid conditions and potential for side effects. Despite their high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularisation. This observation, referred to as the "treatment risk paradox," has been well described and may be explained by physicians' concerns regarding possible nonrenal side effects as well as renal toxicities. Furthermore, patients with severe CKD have traditionally been under-represented in most large cardiovascular clinical trials. Therefore, recommendations for both medical and revascularisation of CAD have relied heavily on extrapolation of results from the non-CKD population.

This data will add to that literature by assessing the characteristics and outcomes of patients with CAD and CKD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.


Eligibility Criteria:
Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Nephrology team.

Inclusion Criteria:

1. Both male and female patients ≥16 years of age will be included
2. All patients will be reviewed by the Nephrology team a the RLH with renal disease.

Exclusion Criteria:

1. Patients \<16 years will not be included in this study.
Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population

Sleep apnea syndrome (OSA) frequently occurs in obese population undergoing bariatric surgery. There is a need for alternative screening tools for sleep apnea detection in the pre-operative period. The investigators would like to compare ApneaLink and complete polysomnography in this population.

OSA can occur in up to 78% of patients undergoing bariatric surgery(1). Moderate to severe case will benefit from CPAP therapy, that can help avoiding post-operative complications(2).

In this population, the investigators propose complete attended in-hospital polysomnography (PSG)in patients with a clinical high probability of OSA.

According to obesity epidemics (3), waiting list for PSG in sleep labs is every day longer.

The investigators want to assess sensitivity and specificity of a new portable screening tool, ApneaLink, to detect OSA in a bariatric population.

Design:

monocentric and prospective study

Methods:

Patients:

- OSA suspicion based on :

* symptoms and signs (snoring, apneas , neck circumference \>38 (women) or 43cm (men))
* BMI \> 50
* BMI \> 40, \> 40 y
* BMI \> 35, men, hypertension
* increased serum Bicarbonate
* Polyglobulia

Measurements

* Polysomnography in sleep lab with concommitant recording performed with Apnea LinkTM (nasal flow and oxymétry recording).
* between 2 weeks : recording performed with Apnea LinkTM (nasal flow and oxymétry recording)at home.

Eligibility Criteria:
Inclusion Criteria:

* obese patients
* \> 18 years old
* in whom a bariatric surgery is planified and who have to undergo a polysomnography for OSA screening

Exclusion Criteria:

* pulmonary, neurologic, neuromuscular disease
* \< 18 years old
"Nuance Hearing" for Attention Deficit Hyperactivity Disorder

The aim of the current study is to examine whether the ability to avoid irrelevant auditory stimuli and focus hearing, enabled by the device developed by "Nuance Hearing", may help students with ADHD in classroom listening situations by significantly reducing background distractions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of attention deficit hyperactivity disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM IV)
* Have fulfilled the "Test of variables of attention"
* with normal hearing

Exclusion Criteria:

* Moderate to severe co-morbid psychiatric disorders
* Neurological chronic disease
Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne

We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not been evaluated yet for both the Cilotax and DESyne and we first sought to decide the reference intervals using 40 samples (total 44 patients for each group considering 10% drop-out rate) as the pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 20 years old
* Patients in the treatment of subjects with all-comer who are to undergo PCI

Exclusion Criteria:

* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year
HD16 for Early Stage Hodgkin Lymphoma

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin Lymphoma
* CS I, II without risk factors

  * large mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
  * extranodal involvement
  * elevated ESR
  * 3 or more involved nodal areas
* Written informed consent

Exclusion Criteria:

* Leucocytes \< 3000/µl
* Platelets \< 100000/µl
* Hodgkin Lymphoma as composite lymphoma
* Activity index (WHO) \> 2
CG Future® Annuloplasty Ring/Band Clinical Trial

The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated the Patient Informed Consent (PIC);
* Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation;
* Willing to return to the implanting hospital for a 9 month follow-up visit

Exclusion Criteria:

* Unwilling or inability to sign the PIC;
* Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints;
* Life expectancy of less than one year;
* Pregnant or desire to be pregnant within 12 months of the study treatment;
* Less than 18 years and more than 85 years of age.
Improving Work Outcome for People With Severe Mental Illness

The purpose of this study is to investigate the efficacy of IPS in Denmark and compare effects of 1. Individual Placement and Support (IPS) vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. standard intervention, among individuals with severe mental illness.

Individual Placement and Support (IPS) is established as the most effective vocational intervention available for persons with severe mental illness,and the intervention is widely recognized as an evidence-based practice. Despite evidence, long-term job retention and economic self-sufficiency have not been clearly demonstrated. Research has suggested that integrating methods such as cognitive remediation and social skills training could reduce such limitations. Further, there has not been conducted any randomized controled trials with IPS in Scandinavian countries with highly developed and generous social security and welfare systems, and with high thresholds to the open labour market.

The aim of this study is to investigate the effectiveness of IPS in Denmark and compare effects of 1. IPS vs. 2. IPS + cognitive remediation and work-related social skills training vs. 3. Standard intervention.

The intervention is based on the 7 principles of IPS Supported Employment, and IPS enhanced with cognitive remediation and work-related social skills training, consists of 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.

Eligibility Criteria:
Inclusion Criteria:

Psychosis within the schizophrenic spectrum (F 2, International Classification of Diseases (ICD 10)).

Severe depression (F33, ICD-10) or Bipolar disorder (F31, ICD-10) and minimum 3 years psychiatric treatment.

Motivated for employment or education. 18 to 65 years old. Participants must speak and understand Danish.

Exclusion Criteria:

Lack of informed consent Above 64 years and receiving state pension Match group 1 (No problems besides unemployment)
China STEMI Care Project Phase 2

The program is to improve STEMI medical care quality in China. With the documents issued by National Health and Family Planning Commission of the People's Republic of China, the program was initialed in at least 200 primary PCI capable hospitals together with hundreds of adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30 patients will be enrolled consecutively from each PCI-capable center initially and from non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI capable hospitals will be enrolled and all of them will be followed up for 1 year. Key performance indicators (KPIs) in STEMI care will be collected using both national PCI online registry and a program STEMI online registry database for the purpose of improvement of medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each hospital after data analysis in each period. Comparison of every two cross-sectional data (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the improvement of medical quality.


Eligibility Criteria:
Inclusion Criteria:

* STEMI patients with symptom onset within 30 days

Exclusion Criteria:

* None
Effects of Family Work Shop for Children With Developmental Delays: a Randomized Trial

To identify the therapeutic effects of short-term family-centered work shop for children with developmental delays

1. The family work shop has a total of 6 weeks, with 6 families in one course. 2. Two hours per session, one time per week. Aims;

1. Assess the effects of family work shop for children with developmental delays, including functional performance and health-related quality of life.
2. Assess the family strain by work shop for parents of children with developmental delays.

Eligibility Criteria:
Inclusion Criteria:

* 18 M/O to 36 M/O children with developmental delays, under regular rehabilitation programs

Exclusion Criteria:

* less than 18 M/O and older than 36 M/O failed to obtain written informed consent
Back2LiveWell: Community Based Prevention of Back Pain Flare-ups

The primary objective of this study is to compare the effectiveness and cost-effectiveness of an individualized group based exercise and education program supported in the community to a control group of usual care in preventing back pain flare-ups and to mitigate the negative consequences of subsequent episodes if they occur.

Secondary objectives are to:

• To compare the effectiveness of the two interventions in preventing an activity-limiting LBP flare up at 12 and 24 months.

Secondary objectives are to:

* To compare the effectiveness of the interventions in mitigating the negative consequences of LBP.
* To evaluate the cost-effectiveness of the interventions in preventing activity-limiting LBP flare-up.
* To identify subgroups of individuals that may best respond to each one of the two interventions.

Exploratory objectives include:

* evaluate the fluctuating nature of back pain using a smart phone application to collect pain measures once a week for 1 year (trajectories will also be evaluated to compare between group effects)
* assess adherence to physical activity using activity monitors.
* evaluate the relationship between activity levels and flare-ups as a method for understanding pain triggers and impact of activity pacing.

Eligibility Criteria:
Inclusion criteria:

Participants will be included if they meet the following criteria

* Have been discharged \<3 months from physiotherapy, chiropractic or osteopathic care following a course of treatment for LBP (pain in the area between the 12th rib and buttock crease)
* Have non-specific LBP which is pain not attributed to a specific diagnosis such as sciatica, ankylosing spondylitis, vertebral fracture, etc.
* Non-specific LBP sometimes called mechanical LBP accounts for \~85% of LBP diagnosis.
* Between 18 and 80 years of age

Exclusion criteria:

Participants will be excluded if they meet the following criteria:

* Ongoing high pain intensity, defined as pain intensity of 6 or more on a 0-10 point scale. The cut off of 6/10 is used in the literature to dichotomise low/moderate to high pain intensity.
* Co-morbidity preventing participation in physical activity evaluated using the Physical Activity Readiness Questionnaire (PAR-Q) from the American College of Sports Medicine guidelines
* Inadequate English to complete outcome measures
* Currently participating in an exercise program similar to the one we will evaluate.
* History of spine surgery
Improving Social Functioning in People with Substance Use and Mental Health Disorders Using VR

ROPVR, a multi-centre, pragmatic randomized controlled trial (RCT) aims to evaluate a VR-technology which has been developed within an exploratory study and a development study, which facilitates social functioning among persons with a substance use and mental health disorder. Investigators will test a VR-program versus treatment as usual among patients enrolled into a long-term addiction-treatment facility. The RCT aims to evaluate the effectiveness of VR training compared to treatment as usual in improving resilience, quality of life, practical and social functioning and social participation (from baseline to 6 months), and to evaluate the cost-effectiveness of VR training versus treatment as usual.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 years or older receiving in-patient SUD treatment in specialized addiction treatment units in South-East Norway. This may include persons serving prison sentences during in-patient treatment according to the Execution of Sentences Act in Norway
* having the capability to read, understand and sign the Norwegian informed consent form
* willing and able to attend VR training two times a week for 5 weeks

Exclusion Criteria:

* significant visual, auditory, or balance impairment or other diseases affecting safety during VR sessions (e.g., epilepsy)
* current clinically significant severe mental health disorder (e.g., acute episode of psychosis or current active suicidal plans). Persons with psychotic disorders or other severe mental illness are not excluded if their condition is stable.
* severe travel sickness as a proxy for simulation sickness
Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer

Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 75 years;
* Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer;
* Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment;
* Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria;
* ECOG performance status of 0-2;
* Expected survival ≥ 3 months;
* Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L;
* Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤ 5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN in patients with Gilbert's syndrome;
* Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.

Exclusion Criteria:

* Ovarian low-grade malignant tumor patients;
* Patients who have received abdominal or pelvic radiotherapy;
* Patients with central nervous system disease or brain metastases;
* Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured;
* Prior Grade ≥ 2 sensory or motor neuropathy;
* Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
* Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
* Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy;
* Patients not suitable for participation in this study judged by investigator.
To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)

To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient, \>18 years of age
* Patients with hypercholesterolemia who meet the following lipid criteria:

  1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl
  2. secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl
* The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study

Exclusion Criteria:

* Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris
* Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1
* Uncontrolled hypertension with systolic blood pressure \> 160 mmhg or diastolic \> 100 mmhg at visit 1.
* Unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening
Retrospective Evaluation of Delirium Data From Previous Study Patients for Studies at the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF

Evaluation of several studies of the Clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF to create a register with the delirium data from anesthesiology study patients between 18 - 100 years. The primary purpose of the register is to assess factors influencing the development of delirium.

In a subproject, risk factors that may lead to the development of postoperative delirium in the elderly will be evaluated with regard to gender differences using patients from the age of 60 with different surgical procedures. The risk factors examined are based on the evidence-based and consensus-based recommendations of the ESA guideline and literature review. In addition, the delirium incidence rate and the delirium severity is examined regarding gender differences.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age ≥ 18 years of studies of the clinic for Anesthesiology and Intensive Care Medicine CCM/CVK/CBF

Exclusion Criteria:

* None