cyrilzakka/clinical-trials huggingface dataset:
The Effect of Exercise on Pain Sensitivity in a Population With Ongoing Neck Pain Compared to Healthy Controls

This study investigates the effect of exercise on pain sensitivity in ongoing neck pain patients compared to a healthy control group.

Increased pain sensitivity is a common finding in neck pain patients when compared to healthy controls. Although most studies favor exercise as an intervention, the specific effect on pain sensitivity is still debated. This study will investigate the effect of exercise on pain sensitivity in neck pain patients compared to healthy controls

Eligibility Criteria:
Inclusion Criteria: - Healthy participants

* Pain free healthy participants
* Able to speak, read and understand Danish and English

Exclusion Criteria: - Healthy participants

* Pain from the neck or shoulder area during the past 6 months
* Experience of delayed onset muscle soreness (DOMS) during the week leading up to the test session
* Former surgery in neck or shoulder
* Current or previous chronic or recurrent pain condition
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Regular use of analgesics
* Abnormally disrupted sleep in the last 24 hours preceding the experiment
* Lack of ability to cooperate

Inclusion Criteria: - Neck pain population

* Self reported neck pain lasting three months or longer.
* Able to speak, read and understand Danish and English
* Reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion

Exclusion Criteria: - Neck pain population

* Shoulder pain during arm movements
* Experience of DOMS during the week leading up to the test session
* Former surgery in neck or shoulder
* Current or previous chronic or recurrent pain condition other than neck pain
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Abnormally disrupted sleep in the 24 hours preceding the experiment
* Lack of ability to cooperate
A Single Dose Study of Lu AG09222 in a Headache Model With Healthy Subjects

The purpose of this study is to evaluate how well Lu AG09222 can prevent blood vessel dilation in a headache model.

This study will investigate the effect of preventive treatment with Lu AG09222 on vasodilation, heart rate increase, and headache induced by PACAP and VIP.

Subjects will be randomised to three arms, placebo + saline, placebo + VIP and PACAP, and Lu AG09222 + VIP and PACAP. Subjects who complete the study will attend a safety follow-up visit at 10 to 12 weeks after administration of investigational medicinal product.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2, and a body weight ≥ 45 and ≤ 95 kg at the screening visit.
* The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests at screening.

Exclusion Criteria:

* The subject fulfils the diagnostic criteria for a primary headache disorder, or has a first degree relative with a primary headache disorder, according to the International Headache Society (IHS) International Classification of Headache Disorders 3rd edition (ICHD-3), except tension-type headache.
* The subject has or has had tension-type headache more than once per month on average during the 6 months prior to the screening visit.

Other inclusion and exclusion criteria may apply.
Nafamostat Mesilate in the Treatment of Severe Infection-associated Coagulopathy

The objective of this study was to evaluate the therapeutic effect of nafamostat mesilate on patients with severe infection-related coagulation。


Eligibility Criteria:
Inclusion Criteria:

* meets the criteria for sepsis 3.0".
* Targeted population for SIC anticoagulant therapy（http://research-kudo-prediction.s3-website-ap-northeast-1.amazonaws.com/）

Exclusion Criteria:

* Age less than 18, pregnant women, and lactating women
* Patients with a history of hypersensitivity to nafamostat mesilate (previous use of nafamostat mesilate resulted in significant bleeding complications)
* Fibrinogen \< 1.5g/L
* Patients with bleeding or high bleeding risk Patients in the acute phase of trauma or with active bleeding (such as flail chest, significant contusions of the lungs, liver, kidneys, spleen, retroperitoneal bleeding, pelvic fractures, etc.) History of severe traumatic brain injury, intracranial surgery, stroke, cerebral aneurysm, or arteriovenous malformation within the past month prior to enrollment Patients with a history of congenital bleeding disorders (such as hemophilia) Patients with underlying fulminant hepatitis, decompensated cirrhosis, or other severe liver diseases
* Patients receiving the following medications Patients who have received heparin and heparin analogs (including low molecular weight heparin, dalteparin, etc.) within the past 12 hours prior to treatment Patients who have received warfarin within the past 7 days prior to the study and have an INR level above normal Patients who have undergone thrombolytic therapy within the past 3 days prior to the study Patients who have received platelet inhibitors (such as aspirin, clopidogrel, ticlopidine, dipyridamole, etc.) within the past 7 days prior to the study Patients currently receiving other novel anticoagulant medications (such as Xa factor inhibitors like apixaban, rivaroxaban, edoxaban, etc., direct thrombin inhibitors like dabigatran
* ICU treatment time is expected to be no more than 24h
* Patients who have undergone cardiopulmonary resuscitation within the past 7 days prior to the study
* Patients who have participated in other studies within the 30 days prior to enrollment
* Due to irreversible disease states, such as advanced malignant tumors or other end-stage diseases; or patients in a terminal state deemed by the physician to be approaching death
.Patient Blood Management Program in Liver Transplantation

Transfusion management improvement programs, generally known as patient blood management (PBM) programs, are based on a set of perioperative measures aimed at improving clinical outcomes by avoiding unnecessary exposure to blood components.

In a recent series of liver transplants (LT) performed in Spanish centers belonging to the Spanish Liver Transplant Society, despite optimal hemostasis management and preservation of the vena cava, around 20% of patients required massive transfusion (considered as the administration of 6 or more red blood cell concentrates intraoperatively). In addition, 63% of the patients were transfused with at least one packed red cells during the operation.

By correcting the iron deficiency in patients who meet the criteria of the anemia study (transferrin saturation less than 20%), we could improve the hemoglobin level, which would allow a wider margin for the transfusion of red cell concentrates.

This is a prospective observational multicenter study to evaluate the efficacy of iron administration in patients candidates to LT. Inclusion criteria Patients with Hb \< 11.5 g/dL + and transferrin saturation index \< 40%+ferritina \<800mcg/L will receive Fe carboxymaltose iv\* \*Ganzoni formula modified (total iron dose = \[actual body weight × (11.5-actual Hb)\] × 2.4 + 500), and represent the intervention group. Those patients with Hb \< 11.5 g/dL and transferrin saturation index \> 40% will constitute the control group. The Intraoperative managed protocol was standardized within groups and Teams. Demographic and liver function test after iron administration will be registered; perioperative transfusion data will be recorded. Recruitment, treatment and follow-up will be conducted by monitored by an independent audit to assure the quality of data. Specific Data Unit not related to the participated Teams will do statistical analysis. The primary outcome is the feasibility of apply the first pillar of the patient blood management programs (PBM) in LT candidates. Secondary outcomes are the response rate (increase in Hb \> 1 g/dL) to the intervention, and red blood cell requirements in both, intervention and control group

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis on the liver transplant waiting list
* haemoglobin lower than 11.5g/dL
* transferrin saturation index below 40%
* ferritin below 800mcg/L

Exclusion Criteria:

* refusal to participate
* Known hypersensitivity to Ferinject
* current infection
Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology

This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).

This genetic predisposition study does not involve investigational drugs, devices, or treatments. Our broad goal is to identify genomic factors, which contribute to the development or exacerbation of common and critical illnesses that affect preterm and near-term infants. We seek to accomplish this goal in the following ways:

* First: to test candidate gene DNA variations and link already identified single nucleotide polymorphisms (SNPs) producing functional alterations to the risk of clinically important disorders.
* Second: to utilize a whole-genomic approach to identify SNPs not previously linked to the risk of development or progression of neonatal disorders.

Eligibility Criteria:
Inclusion Criteria:

* Less than 34 weeks gestation and less than 1500 g at birth
* Greater than or equal to 36 weeks gestation and either with hypoxic respiratory failure or with mild respiratory distress never requiring assisted ventilation

Exclusion Criteria:

* Life threatening anomalies of any organ system (e.g., cardiac, thoracic, lethal, or non-lethal chromosomal abnormalities)
Efficacy and Feasibility of De-prescribing Rounds in a Singapore Rehabilitative Hospital- a Pilot Randomized Controlled Trial

This open-labelled randomized control trial will be conducted in a Singapore Rehabilitation Hospital to investigate the efficacy, cost-reduction, safety and feasibility of a weekly deprescribing multi-disciplinary inpatient deprescribing round up to 28 days post discharge.

ABSTRACT BACKGROUND: Deprescribing has been effective and safe in reducing polypharmacy and morbidity (e.g. fall), especially amongst elderly. However, little has been studied about the efficacy of a regular multidisciplinary round in deprescribing predefined medications in Singapore rehabilitative hospitals.

AIM: This study aims to evaluating the effects of a weekly multidisciplinary team(MDT) de-prescribing round on the reduction on total daily dose, cost of medications, its safety and feasibility in a Singapore rehabilitative hospital.

Methods: A total of 260 newly admitted patients will be randomised to a de-prescribing intervention (n= 130) or control (usual care) group (n= 130), using GraphPad randomization sequence software ©2017. The 5 steps of deprescribing process will be used and the targets of deprescribing are Beer's list of potentially inappropriate medications (AGS 2015 version), predetermined supplements and symptomatic medications. Predetermined medications were deprescribed following initial MDT assessment, discussion with attending doctors and consideration of patients' preferences regarding discontinuation or dose reduction. Total daily dose reduction, cost and side effects of deprescribing were monitored on admission day 14, 28, discharge day and post-discharge day 28. Time required for such rounds are also measured.

IMPACT: Once proven successful, this effective model of deprescribing could safely help to cut down caregiver's medicine administrative burden, improve compliance and reduce national healthcare cost. This model could also be easily replicated in all Singapore rehabilitative hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Greater or equals to 65 years old
* Newly admitted to rehabilitation or sub-acute disciplines
* Possess 1 or more of the targeted medications

Exclusion Criteria:

* Abbreviated mental test less than 7
* No mental capacity
Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty

This study aimed to determine differences in functional recovery after total hip arthroplasty between a group of patients operated on using a direct lateral approach, an anterolateral minimally invasive approach, and a posterior approach to the hip joint.

Arthroplasty is the most commonly performed surgical procedure in orthopedics and is also considered the gold standard for treating the final stage of osteoarthritis. There are several different approaches, but there are still conflicting studies that talk about the benefits of a particular approach. There is an insufficient number of scientific, prospective studies that monitor the basic functional and rehabilitation parameters, which are also indicators of the success of the performed procedure.


Eligibility Criteria:
Inclusion Criteria:

* hip osteoarthritis

Exclusion Criteria:

* N/A
FINE75+: 5 Year Follow up

In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75 years old or older, were included between September 2009 and June 2010. The purpose of this observational study (FINE75+5) is to describe these patients, especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes. We hypothesize that frailty is independently associated with 5-year mortality.

The term frailty denotes a multi-dimensional syndrome characterized by increased vulnerability and decreased physiologic reserves. Frailty stratification predicts a patient's risk of death and need for institutional care. The construct is well validated, but there is not one single accepted operational definition. The CSHA Clinical Frailty Scale (CFS) is a 7-point scale relying on clinical judgement. It is a global clinical measure of biological age, and it mixes co-morbidity, disability and cognitive impairment.Though frailty instruments so far mainly have been used in a geriatric context, it has been pointed out as relevant for cardiologic patients as well, e.g. regarding risk stratification for elderly patients with NSTEMI.

In the FINE 75+ study, 307 Non ST Elevation Myocardial Infarction (NSTEMI) patients, 75 years old or older, were included between September 2009 and June 2010. We reported importance of frailty for short-term (1 month) and medium-term outcome (1 year) in a NSTEMI population (Ekerstad et al. 2011, Ekerstad et al. 2013). However, there are no published data on the importance of frailty on longer-term outcome. Information on long-term prognosis may substantially improve informed decision making in elderly patients with NSTEMI, with acute potentially harmful treatments aiming at improved long-term prognosis.

The purpose of this study is to describe patients, 75 years old or older, with NSTEMI especially regarding the following variables: cardiovascular risk, co-morbidity and frailty, and to assess the prognostic value of frailty on 5-year outcomes.For the purpose of the current analysis all patients included in the final FINE 75+ study will be followed over 5 years from hospital admission. We hypothesize that frailty is independently associated with 5-year mortality.

Eligibility Criteria:
Inclusion Criteria:

* All patients included in the FINE 75+ study population between October 2009 and June 2010. Patients, 75 years old or older, with diagnosed NSTEMI, and cared for at one of the following hospital care units: cardiology, acute medicine, geriatrics, other internal medicine unit.

Exclusion Criteria:

* Not willing to participate. Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty.
Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC

A retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib plus AI therapy and fulvestrant monotherapy as initial endocrine therapy in the patients with HR+/HER2- advanced breast cancer.

This study is designed to be a retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus AI or fulvestrant monotherapy from August 1, 2018 to December 31, 2020. It is expected to enroll 600 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected retrospectively, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese women ≥18 years old;
2. Diagnosed with locally advanced (stage IIIb/IIIc) or metastatic (stage IV) breast cancer;
3. The molecular classification is pathologically confirmed as HR+/HER2-;
4. Palbociclib plus AI or fulvestrant monotherapy as initial endocrine therapy for advanced breast cancer for at least 1 cycle;
5. The follow-up time should be not less than 3 months after the start of palbociclib plus AI therapy or fulvestrant monotherapy.

Exclusion Criteria:

1. Subjects who have previously received chemotherapy, other CDK4/6 inhibitors or other endocrine monotherapy for advanced breast cancer.
Effect of Cold Atmospheric Plasma on Malassezia Folliculitis

The cold atmospheric plasma may provide a new and effective method for the treatment of Malassezia folliculitis. The investigators conduct this randomized controlled trial to evaluate the effectiveness and safety of cold atmospheric plasma on Malassezia folliculitis. Participants entered this double-blind placebo-controlled trial will randomly assign to treatment with either cold atmospheric plasma or antifungal drugs. The differences of treatment effects of the two groups will be observed and compared.

Malassezia folliculitis is a common disease of young and middle-aged people. It is an inflammatory disease caused by Malassezia infection. Generally, Topical or systemic use of antifungal drugs are the first choice for treatment but sometimes are limited due to adverse drug reactions and drug resistance. Cold atmospheric plasma has an inhibitory or killing effect on pathogenic microorganisms including fungi and has no obvious adverse damage to normal tissues. The investigators conduct this randomized controlled trial to study the effect of cold atmospheric plasma on Malassezia folliculitis, and evaluate its effectiveness and safety for Malassezia folliculitis. All data are recorded and compared after the end of the experiment.

Eligibility Criteria:
Inclusion Criteria:

* Patients are clinical presentation of Malassezia folliculitis in seborrheic areas.
* The diagnoses are mycologically verified by experienced laboratory technicians.
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent.

Exclusion Criteria:

* Combined with other serious systemic diseases.
* History of topical corticosteroids within 2 weeks or history of systemic corticosteroids within 1 month.
* History of immunosuppressive drugs within 1 month.
* History of topical antifungal medication within 2 weeks or systemic antifungal medication within 3 months.
* Pregnant and lactating women.
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study

The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.


Eligibility Criteria:
Inclusion Criteria:

* • Subjects with a colostomy or ileostomy

  * Age 18 years and over
  * Medically stable in the opinion of the investigator
  * Are able and willing to provide informed consent
  * Are able and willing to attend study visits
  * Currently use the same models of pouches as required by the study
  * Have a recent history of frequent pancaking (colostomy patients only)
  * Willing to stop using any lubricants in the pouches whilst participating in the study.
  * Subject has a valid email address for the Investigator to send links to study questionnaires and has access to a web enabled device.

Exclusion Criteria:

* • Subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment

  * Subjects who maybe receiving any concomitant treatment and/or medications which could impact the consistency of effluent during the study period.
  * Allergic to any components of the Novel Lubricant inclusive of Soyabean and/or Vitamin E.
Evaluation of Serum Ages Levels in Patients With Endometriosis

Serum AGES (Advanced Glycation End Products) levels of endometriosis patients are compared with a group of healthy volunteers of the same age.

Serum AGES (Advanced Glycation End Products) levels are compared with 45 endometriosis patients and 45 healthy volunteers of the same age. The energy metabolism of the endometriosis group and its possible relationship with the endometriosis stage will be compared since AGES (Advanced Glycation End Products) gives information about the energy metabolism of the people.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with endometriosis (Surgery or ultrasound)
* Women without endometriosis

Exclusion Criteria:

* Women without endometriosis women who are only suspected endometriosis