cyrilzakka/clinical-trials huggingface dataset:
Aromatherapy Methods in Reducing Anxiety Before Breast Biopsy

A breast biopsy is a cause for anxiety for most women when faced with a diagnosis of breast cancer. Physiological and psychological effects of breast biopsy may continue in the pre-biopsy and post-biopsy period. The aim of this study is to compare the effectiveness of two different aromatherapy methods applied in reducing anxiety before breast biopsy.

Anxiety level was evaluated according to objective criteria by pretesting and posttesting lavender, lavender-mint and odorless (placebo) aromatherapy tablets applied before the biopsy in patients scheduled for breast biopsy.

The study was conducted with 135 patients, 90 of whom were in the experimental group and 45 in the control group. Patients were randomly assigned to the experimental and control groups according to their sequence numbers.

Before the biopsy, lavender aromatherapy and lavender-mint aromatherapy tablets were administered to the experimental group, and an odorless (placebo) aromatherapy tablet to the control group. Aromatherapy tablets 20 minutes after the procedure. First, a small (approximately 1x 0.5 inch), rectangular, absorbent, self-adhesive tablet containing 2 ml of lavender essential oil (10) was adhered to the patient's shoulder level. Research data were collected with the "Spielberger State Anxiety Scale" to determine the level of anxiety before and after breast biopsy.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* Female patients scheduled for breast biopsy (stereotactic biopsy, ultrasound biopsy, magnetic resonance imaging biopsy)
* Individuals who can speak, understand and communicate in Turkish will be included in the study.

Exclusion Criteria:

* Pregnant and lactating women,
* Patients who are allergic to plants (lavender/lavender-mint),
* Patients with a diagnosis of psychiatric illness, migraine, chronic headache or sense of smell
* Patients who have difficulty breathing through their nose
* People who can't smell, who are sensitive to smells or smells
* Patients with a history of asthma, epilepsy or seizures as a precaution.
* Patients with active wheezing
* Patients with cognitive, verbal or hearing problems that may affect communication
Parent Web - Support for Families With Young People

To test an online parent training program. Relative to a randomized wait-list control group, those in the Parent Web (PW) will show benefits on well-being, parenting, stress, youth mental health.

Parent-Web (PW) is internet delivered parent education that is created and developed by researchers at Karolinska Institute's Department of Clinical Neuroscience, namely Kajsa Lönn-Rhodin, Martin Forster, and Pia Enebrink. An effectiveness trial of the universal edition of the Parent Web is made possible through a research collaboration with Pia Enebrink. PW is derived from social learning and coercion theory. PW aims to support parenting practices and parent-child interactions encourage prosocial behaviour and emotion regulation, reduce coercive parenting, improve communication, problem solving, and warmth within families. PW has a universal and selective edition. Universal PW has 5 basic modules (1 module per week, 6-8 weeks) and bonus modules. Basic modules contain information, exercises, and videos of actors showing parenting practices. A family guide supports PW participants through PW modules. This study will test the effects of universal PW with a general population derived sample of parents living in Region Stockholm. All PW trial participants are parents to at least one adolescent child who is aged 11-13 years old.

Eligibility Criteria:
Inclusion Criteria:

1. Participants have to be parents and/or legal guardians of at least one 11 to 13 year old child.
2. Participants must live in Region Stockholm.

Exclusion Criterion:

1. The target child (the 11 to 13-year-old) is presently receiving mental health treatment.
Evaluation Of Cardiac Function In Children 0n Regular Heamodialysis

Cardiovascular disease (CVD) is considered as the predominant cause of mortality and morbidity in chronic kidney disease (CKD) patients .

* Left ventricular diastolic and systolic dysfunction and left ventricular hy pertrophy (LVH) contribute to the increased cardiovascular mortality rate in these patients .Such changes have been observed in young adults and children on prolonged dialysis
* The cardiovascular mortality and morbidity are seen in earlier stages of CKD, and the risk is increased by multiple risk factors such as sodium and fluid retention,hypertension, anemia, inflammation and hyperparathyroidism .
* Left ventricular hypertrophy is a common finding in CKD patients \[8\] and its severity increases with increasing severity of CKD . Initially, LVH is discussed as a physiological response to volume and pressure overload. However, sustained overload in combination with CKD associated risk factors may result in maladaptive LVH characterized by structural changes in the myocardium (calcification, fibrosis and collagen accumulation), resulting in diastolic and systolic dysfunction .
* Causes of LV diastolic dysfunction are impaired active LV relaxation or decreased LV compliance.These changes are reflected in low diastolic volume for a given diastolic pressure, meaning reduced passive LV filling .
* Changes in cardiac structure and function are common among the patients with chronic kidney disease undergoing hemodialysis. As early as 1827, Richard Bright drew attention to the common presence of left ventricular hypertrophy and thickening of the aortic wall in the patients with end-stage renal disease (ESRD).
* Cardiovascular (CV) disease is the leading cause of mortality in the childhood renal replacement therapy population with long-term observational studies reporting 40-45% deaths attributable to CV disease , increasing to 57% when stratified to haemodialysis patients only . In children with CKD, left ventricular hypertrophy (LVH) is common and occurs early in the disease process with reported prevalence up to 65% and increasing to 82% in those on haemodialysis .

  * The present study stresses the importance of echocardiography as the gold standard for the diagnosis of cardiac disease in pediatric patients under maintenance HD as a high-risk population for cardiac diseases.


Eligibility Criteria:
Inclusion Criteria:

* All patients (2-18) years were undergoing regular HD, who were started on dialysis when GFR was ≤15 mL/min/1.73 m 3 three times per week, with each dialysis session lasting for 3-4 h.

Exclusion Criteria:

* Patients of primary cardiac diseases (e.g., congenital or rheumatic heart disease, cardio- myopathy).
Comparison of Curcumin Bioavailability

The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers with blood chemistry values within normal ranges
* Body mass index in a normal range

Exclusion Criteria:

* Pregnancy or lactation
* Alcohol and or drug abuse
* Use of dietary supplements or any medications except contraceptives
* Any known malignant, metabolic and endocrine diseases
* Previous cardiac infarction
* Dementia
* Blood pressure \>140/90 mmHg
* Resting heart rate not within 50 to 90 beats per minute
* Participation in a clinical trial within the past 6 weeks
* Smoking
* Physical activity of more than 5 h per wk
A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.

The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.


Eligibility Criteria:
Inclusion Criteria:

1. The patient scheduled for treatment with isolated hyperthermic perfusion
2. Age over 18 years.
3. Signed informed consent
An Exploratory Clinical Study on Bortezomib for the Treatment of Refractory Rheumatoid Arthritis

The goal of this prospective single-arm open-label trial is to learn about efficacy and safety of Bortezomib in treating patients with difficult-to-treat rheumatoid arthritis. The main questions it aims to answer are:

* Is Bortezomib an effective treatment option for patients with difficult-to-treat rheumatoid arthritis?
* Is Bortezomib safe enough in treating patients with difficult-to-treat rheumatoid arthritis?

Participants will:

* Receive Bortezomib 2 mg per week subcutaneously for twelve weeks in total.
* Follow-up at weeks 4, 12, and 24, while biosamples will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Age \&gt;18 years and \&lt;70 years;
* Absolute neutrophil count ≥1.0×10\^9/L, platelet count ≥100×10\^9/L, aspartate transaminase and total bilirubin within 3 times and 1.5 times the normal upper limit, respectively, and serum creatinine clearance \&gt;60 ml/min;
* Voluntarily sign an informed consent form.

Exclusion Criteria:

* Individuals with concomitant autoimmune diseases;
* Presence of severe, poorly controlled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neuropsychiatric diseases, or laboratory abnormalities that the investigator deems an unacceptable risk for the participant\&#39;s involvement in the study;
* History of malignant tumors (or clinical cure time less than 5 years);
* Subjects who are pregnant or lactating, or planning to become pregnant or start breastfeeding during the study period;
* Vaccination with live virus vaccines within the 4 weeks prior to study entry;
* Allergy to Borussertib or mannitol;
* Participation in any other investigational drug trial in the 12 weeks before the start of this study medication;
* Presence of active hepatitis or a history of severe liver disease at screening: defined as a positive test for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibodies (HCVAb) (Note: If the result of hepatitis B core antibody (HBcAb) is positive and HBsAg is negative, hepatitis B virus (HBV) DNA testing will be performed. If HBV-DNA is negative, the patient is eligible.);
* Active herpes zoster infection, or occurrence of a severe infection in the 12 weeks before the start of the study medication (defined as requiring intravenous antibiotics or hospitalization);
* Other situations that investigators deem unsuitable for inclusion.
Prescription of Triptans in the Grand Est Region, France

The high frequency of migraine contrasts with the disparity of its management. The FRAMIG 3 study, carried out in France on the basis of the definition criteria of migraine of the IHS 2004 classification, identified, on the basis of a questionnaire of a representative sample of the general population of 10532 people, 11.2% of the people meeting the criteria of defined migraine and 10.1% of the criteria of probable migraine. Only 40.2% knew they had migraine. 50% used self-medication. Although available since the late 1990s as an effective and specific treatment for migraine attacks, 7.5% of migraineurs in the FRAMIG 3 study used a triptan. In 2003-4, 1.5% of the 1,793,000 inhabitants of Alsace had received at least one prescription for triptans over a one-year period. 1.9% of them were considered overconsumers (greater than or equal to 144 doses/year). More than 10 years later, another population-based study, using data from the French national health agency, identified 1.8% of insured persons receiving a triptan. Several migraine prophylactic treatments have been shown to be effective in patients with frequent or severe migraine attacks, or who do not respond to crisis treatment, or who claim poor quality of life due to migraine, but only 50% of candidates for such prophylactic treatment were receiving it. Only 1.5% of migraine patients in the FRAMIG 3 study were taking prophylaxis. Quality of life was impaired in 57% of migraineurs in the USA and in 28% of French migraineurs. In Ali's study (Ali 2017), 6.9% of migraineurs had used a neurologist. A Brazilian study shows that the average delay of patients accessing a tertiary center was 17 years. As promising new prophylactic treatments become available, we wanted to study a population of migraineurs identified on the basis of a triptan prescription, in order to try to better identify the characteristics of this population, particularly in terms of analgesic consumption and use of specialized care.

The objective of this study was to describe the quantity of triptans dispensed to residents of the Grand Est region aged 12 years and older, between June 1, 2018, and June 1, 2019, based on health insurance data. The secondary objectives were to compare the characteristics of insured persons who had at least one triptan dispensing with those of other insured persons, and to compare the characteristics of insured persons by quantity of triptans dispensed.


Eligibility Criteria:
Inclusion Criteria:

* beneficiary of the general health insurance scheme between june 2018 and june 2019
* at least 12 years old
* resident in the Grand Est region

Exclusion Criteria:

* none
Effects of Semi-standarized Acupuncture in Chronical Symptomatic Osteoarthritis of the Knee Through: A Randomized Controlled Trial

Introduction:

Knee osteoarthritis is a long-term rheumatic disease with a significant impact on the patient's quality of life and the socio-economic development of societies. The usual treatment consists of non-steroidal anti-inflammatory drugs as a palliative measure. The decrease in the beneficial effect and the appearance of serious long-term adverse effects make it necessary to look for other therapeutic procedures. Acupuncture is a non-pharmacological treatment that could reduce pain and improve functionality in this condition, however current scientific evidence is limited. A previous study has observed a clinical improvement in the combination of sensitized local and peripheral points in the treatment of knee osteoarthritis but studies with a larger sample are needed to confirm these results.

Objective:

Assess the effectiveness of acupuncture using a combination of local and peripheral sensitized points in the treatment of active knee osteoarthritis.

Methods:

A randomized clinical trial will be performed in a hospital centre with 2 groups. The control group will standard treatment plus transcutaneous electrical nerve stimulation, while the intervention group will receive acupuncture in addition to standard care. Study outcomes will be pain, quality of life, function, exercise adherence, drug intake, adverse effects, and body mass index. There will be a 12-month post-intervention follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Usual painful episode of 3 months or more
* Morning stiffness of 15 minutes or more
* Pain equal to or greater than 5 on the VAS
* Grade 2 or greater on the Kellgren-Lawrence scale

Exclusion Criteria:

* Corticosteroid infiltration in the 3 months prior to recruitment
* Rehabilitation treatment one month prior to recruitment
* With a knee prosthesis
* Needle phobia
* Pregnancy
* With pacemakers
* Cardiac arrhythmias
Study of Copanlisib in Hepatic or Renal Impairment

To evaluate the pharmacokinetics and safety of copanlisib in subjects with impaired hepatic or renal function in comparison to healthy subjects


Eligibility Criteria:
Inclusion Criteria:

All subjects - Male and female subjects between 18 and 80 years of age with a body mass index above 18.0 and below 34.0 kg / m² and a body weight of above or equal 50 kg.

Healthy subjects

- Healthy subjects as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations. eGFR ≥ 90 mL/min/1.73 m² (according to Modification of Diet in Renal Disease \[MDRD\] formula).

Subjects with moderate or severe hepatic impairment

* Subjects with confirmed liver cirrhosis by at least one of the following Criteria: histologically by prior liver biopsy showing cirrhosis, liver imaging (computer tomography, and/or ultrasound and/or magnetic resonance imaging scans, and/or fibroscan), or laparoscopy.
* Child-Pugh Clinical Assessment Score 7 to 9 (moderate) or Score 10 to 15 (severe).

Subjects with severe renal impairment

* Subjects with severe renal impairment with an estimated glomerular filtration rate 15-29 mL/min/1.73 m² according to MDRD formula.
* Subjects with stable renal disease: no significant change in renal function as evidenced by serum creatinine value within ±25% from the last determination, obtained within at least 3 months before study entry and the absence of the need to start dialysis in the next 3 months.

Exclusion Criteria:

All subjects

* Active coronary artery disease or myocardial infarction within 6 months of study entry. Immuno-compromised subjects including known history/seropositivity of human immunodeficiency virus (HIV).
* Other concurrent severe and/or uncontrolled medical conditions (e.g. current diagnosis of type 1 or type 2 diabetes mellitus and with HbA1c \>8.5%) that could cause unacceptable safety risks or compromise compliance with protocol.
* Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder cancer as well as localized prostate cancer.
* Uncontrolled hypertension despite optimal medical management (per investigator's assessment).
* Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing and during study conduct. (A list of these medications can be found in Section 16.6 of the protocol. However, this list may not be comprehensive).

Subjects with moderate or severe hepatic impairment

* Symptoms or history of encephalopathy (Grade III or worse)
* Failure of any other major organ other than the liver; severe infection, or any clinically significant illness within 4 weeks prior to study drug administration
* Renal failure with an eGFR \<35 mL/min/1.73 m² Subjects with severe renal impairment
* Acute renal failure at study entry
* Nephrotic syndrome
* Failure of any other major organ other than the kidney
* Acute hepatorenal syndrome
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* RA for \>=6 months;
* receiving outpatient treatment;
* inadequate response to methotrexate, having received and tolerated it for \>=12 weeks, with a stable dose for \>=4 weeks.

Exclusion Criteria:

* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
* inflammatory joint disease other than RA, or other systemic autoimmune disorder;
* diagnosis of juvenile arthritis, or RA before the age of 16;
* previous treatment with \>1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.
Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of psoriasis for at least 6 months.
* Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
* Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
* Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
* Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.

Exclusion Criteria:

* Diagnosis of other active skin diseases or skin infections.
* Participant has known hypersensitivity to adalimumab or it excipients.
* Participant has chronic recurring infections or active tuberculosis.
* Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
* Participant is known to have immune deficiency or is immunocompromised.
Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells

This is a multi-center, open-label, non-randomized controlled trial. Patients with viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be performed postoperatively. All available data will be collected prospectively. Follow-up is 12 months. Informed consent will be obtained from relatives to patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Viral-induced acute respiratory distress syndrome
* Ventilator treatment
* Extracorporeal membrane oxygenation treatment
* Relatives provide written informed consent

Exclusion Criteria:

* None