cyrilzakka/clinical-trials huggingface dataset:
Effects of a Self-regulation Program on Self-care Behaviour of Heart Failure Patients

This RCT study aims to examine the effects of a self-regulation programme on the self-care behaviour and quality of life of patients with heart failure. The following hypothesis was tested: Heart failure patients who receive the self-regulation program will report significant improvements in self-care behaviours after four weeks of the self-regulation programme. In contrast, patients in the control group showed no significant differences.

Eight two patients with heart failure were randomly assigned into the intervention (n = 41) or control group (n = 41). The intervention group participated in a 4-week self-regulation programme, including 20 to 30 minutes of individual self-regulation education and 15 to 20 minutes of telephone follow-up twice per week for four weeks. The control group received only routine outpatient care. Self-care behaviour was measured by the Self-Care of Heart Failure Index at baseline, 4 weeks and 8 weeks after patients were enrolled. Quality of life was measure with the Minnesota Living with Heart Failure questionnaire

Eligibility Criteria:
Inclusion Criteria:

* aged 20 years or older with heart failure diagnosed by a cardiologist (ICD-9:428)
* willing to communicate and participate in this study
* had clear consciousness

Exclusion Criteria:

* a diagnosis of cancer
* a diagnosis of mental illness including anxiety and depression
* had cognitive impairment
* a diagnosis of lung disease, such as asthma or chronic obstructive pulmonary disease
* a diagnosis of renal failure
Does Anesthetic Technique Affect Pneumatic Tourniquet Pressures in Upper Limb Fracture Surgery?

In pneumatic tourniquet applications, the use of an individualized, lowest-effective tourniquet pressure (TP) has been recommended, in order to avoid pressure related complications. The aim of this study is to compare the effects of general anesthesia and axillary block on arterial occlusion pressure (AOP) estimation based TP settings in upper limb fracture surgery.

After, ethical committee approval 80 adult patients undergoing upper limb fracture surgery who gave their signed informed consent will be included. The age below 18 and above 85 years, American Society of Anesthesiology (ASA) physical status \>2, any contraindication to axillary block or GA, adverse reaction history to anesthetic drugs, severe anemia, and refusal to give informed consent will be the exclusion criteria. The patients will be randomized to one of two study groups using a computer-generated randomization list to receive GA (Group 1) and axillary block (Group 2).

Main endpoints are initial and maximal blood pressures, AOP, initial and maximal TPs, and tourniquet time. Additionally, the surgeon will evaluate the quality of bloodless surgical area with respect to the amount of blood using a 4-point scale (1: Excellent= No blood in the surgical field, 2: Good= Some blood in the surgical field but no interference with surgery, 3: Fair= Blood in the surgical field but no significant interference with surgery, 4: Poor= Blood in the surgical field obscures the view) at the beginning, in the middle, and at the end of the surgical procedure. The patients will be observed for signs of tourniquet related complications by a blind investigator. SPSS 20.0 for Windows is used for data analysis. The t test and the χ2 test will be used for continuous and categorical data respectively. A P value below 0.05 will be considered as statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing upper limb fracture surgery

Exclusion Criteria:

* The age below 18 and above 85 years,
* American Society of Anesthesiology (ASA) physical status \>2
* Any contraindication to axillary block or general anesthesia
* Any contraindication to tourniquet use
* Adverse reaction history to anesthetic drugs
* Severe anemia
* Refusal to give informed consent
A Research Study to Compare How Much of the Medicine NNC0519-0130 is in the Blood of People With Overweight or Obesity Who Receive 2 Preparations of the Medicine

This study will look into a new study medicine called NNC0519-0130 to improve the treatment option for people living with excess body weight or type 2 diabetes or both. The purpose of this study is to compare the amount of NNC0519-0130 in the blood of participants who have excess body weight. The study comprises two parts and the participants will receive both preparations NNC0519-0130 B and NNC0519-0130 C, which treatment the participants get is decided by chance. The study will last for about 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential.
* Age 18-64 years (both inclusive) at the time of signing the informed consent.
* Body Mass Index (BMI) between 27.0 kilogram per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole \[mmol/mol\]) at screening.
* Use of prescription medicinal products or nonprescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen, acetylsalicylic acid, or topical medication (including eye drops for pupil dilation) not reaching systemic circulation, within 14 days before screening.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Factors Influencing the Composition of Human Milk

This study aims for characterization of different maternal, infant and environmental factors (e.g. maternal age, pregnancy duration, lactation period, baby gender, circadian rhythm, Holder pasteurisation, etc.) that influence human milk composition.

The study consists of three parts. In the first part the investigators aim to evaluate human milk macronutrient composition depending on the time after delivery and pregnancy duration.

In the second part the investigators aim to evaluate the circadian variation of human milk macronutrient and energy content depending on pregnancy duration.

In the third part the investigators aim to evaluate the influence of Holder pasteurisation on human milk macronutrient, metabolome and bioactive protein (lysozyme and lactoferrin) content.

Eligibility Criteria:
Inclusion Criteria:

having obtained informed consent; after a single-birth pregnancy; women who were not on a special diet; lactating mothers who could not breastfeed their newborns due to the baby's medical condition (either prematurity or disease) but who expressed milk.

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Exclusion Criteria:

breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.

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An Observational Study of Distress, Immune Function, and Pain in HIV.

This case-control study focuses on pain in HIV, which is common despite antiretroviral therapy and compromises quality of life, mental health and daily functioning. Specifically, it will investigate the relationships between psychosocial distress, inflammation and pain in HIV.

We plan to recruit 100 people and follow them for 6 months, taking repeated measures. Participants who report persistent pain at enrolment will be assessed at 0 (baseline), 2, 4, and 6 months. Participants who report no pain at enrolment will be assessed at 0 (baseline) and 6 months. All participants will also be invited to participate in weekly remote assessment of selected self-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive with viral suppression
* report either persistent pain or no pain at enrolment

Exclusion Criteria:

* pregnancy
* acute psychiatric condition requiring urgent care
* cognitive impairment preventing full participation
Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.

RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent including authorization to release health information
* Female or male, 18 to 65 years of age and in good general health
* Willing and able to follow study instructions and likely to complete all study requirements
* Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active disease or irritation at the treatment areas including the eye and the skin
* Pregnant, nursing, or planning a pregnancy during the study; or is a woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control
* Previous participation in a RT001 clinical study
Fish OIL Optimal dosE Determination Study

The primary objective of this trial is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis by examining organ function, blood safety and biochemical parameters, markers of systemic inflammation and innate immunological parameters

Objectives: The overall objective is to determine the effect of IV fish oil on 28-day mortality of critically ill patients with severe sepsis. However, prior to such a large trial, we need to determine the optimal dose of IV fish oils in this population. Therefore, the primary objective of this proposal (FOILED) is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis by examining organ function, blood safety and biochemical parameters, markers of systemic inflammation and innate immunological parameters.

Study Design: This is a multi-centre, open-label, phase I dose ranging clinical trial with prospective controls.

Setting: 2 tertiary care ICUs in Germany (Universitätsklinikum Carl Gustav Carus, Dresden and University Hospital Giessen and Marburg, Giessen).

Patients: Mechanically ventilated adult patients (\>18 years old) admitted to ICU with clinical evidence of sepsis, sepsis associated organ dysfunction, and high expression of inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Adult ICU patients
* Requiring invasive or non-invasive ventilation
* Clinical evidence of sepsis
* Presence of one or more organ failures

Exclusion Criteria:

* \>24 hours from admission to ICU to time of consent
* Low level of inflammatory cytokine (IL-6(qualitative assay \<100 pg/ml)
* lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week)
* Immunocompromised (post-organ transplantation, HIV, neutropenic \[\<1000 PMN\], steroids \>20 mgs/day for 6 months).
* Chronic non-invasive ventilation (except if they become mechanically ventilated)
* Platelet count of \< 30 GPt/L
* Pregnant patients. Urine/blood tests for pregnancy will be done on all women of childbearing age by each site as part of standard of ICU practice.
* Previous enrollment in this study
* Enrollment in other ICU intervention study
* Allergy to fish or fish oil (shellfish allergy not an exclusion criterion)
* Has already received enteral or IV omega-3 fatty acids during this hospitalization and current ICU admission.
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab

This study will test the hypothesis that in patients with previous daratumumab exposure, combination therapy of daratumumab, pomalidomide, and dexamethasone (DPd) will yield higher complete remission (CR) rates in relapsed/refractory amyloidosis than historical pomalidomide/dexamethasone treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary AL amyloidosis of tissue
* Relapsed and/or refractory AL amyloidosis
* Has received daratumumab or Faspro in any prior line of therapy
* Prior pomalidomide exposure allowed if ≥ PR achieved and no disease progression occurred within 60 days of last dose received
* Measurable disease
* Able to give voluntary written consent
* Eastern Cooperative Oncology Group performance status and/or other performance status 0, 1, or 2.
* Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3.
* Total bilirubin ≤ 1.5 × the upper limit of the normal range (ULN) (Total bilirubin ≥ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
* eGFR ≥ 20 mL/min/1.73 m2 (as calculated by Modified Diet in Renal Disease (MDRD) formula)

Exclusion Criteria:

* Non-AL amyloidosis
* Clinically overt myeloma
* Prior exposure to non-daratumumab anti-CD38 monoclonal antibodies.
* Clinically significant cardiac disease
* Severe obstructive airway disease
* Female patients who are lactating or have a positive serum pregnancy test during the screening period
* Planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment.
* Failure to have fully recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior chemotherapy.
* Major surgery within 14 days before enrollment.
* Radiotherapy within 14 days before enrollment.
* Infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before study enrollment. Systemic treatment, within 14 days before the first dose, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, see Appendix 11.7), or use of Ginkgo biloba or St. John's wort.
* Positive for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
* Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374

This is a double blind, randomized, placebo controlled, single and multiple ascending dose study in healthy subjects. Safety evaluation will include (serious) adverse events, vital signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be drawn at specified timepoints.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
3. Weight of at least 50 kg and body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2.
4. Oxygen saturation (O2) at screening must be ≥ 95% on room air.
5. FEV1 ≥ 90% predicted.

Exclusion Criteria:

1. 1. A history of clinically significant ECG abnormalities and/or orthostatic vital signs at screening.
2. History of asthma or reactive airway diseases.
3. Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500 ng/mL.
4. History of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
5. Women of child-bearing potential
Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases

It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will have significantly different receptor occupancy of 5HT2A receptors compared to a healthy age/sex-matched control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-\[18F\]MH.MZ in both populations.

It is hypothesized that improvement in psychosis symptoms in patients taking pimavanserin will be associated with increased baseline receptor density (Hypothesis 1A), and increased receptor occupancy of 5HT2A receptors following pimavanserin administration (Hypothesis 1B). This will be done by measuring 5HT2A receptor density using the PET radioligand (R)-\[18F\]MH.MZ within predefined symptom networks for hallucinations, delusions, and sleep. A PET scan will be obtained in PD patients with psychosis at enrollment to measure baseline 5HT2A receptor density and then again after 6 weeks of pimavanserin. The change in binding between baseline and post-drug treatment window will be used to measure 5HT2A receptor occupancy.

It is hypothesize that improvement in psychosis symptoms in patients taking pimavanserin will be associated with increased functional connectivity and cerebral blood flow within predefined symptom networks for hallucinations, delusions, and sleep. This will be tested by obtaining MRI scans assessing resting state functional connectivity and arterial spin labeling in PD patients with psychosis at enrollment (baseline) and then again after 6 weeks of pimavanserin.

It is hypothesized that functional neuroimaging changes in response to pimavanserin will be associated with baseline 5HT2A receptor density and 5HT2A receptor occupancy after pimavanserin administration. To test this hypothesis, the differences in functional neuroimaging measures and PET 5HT2A receptor will be measured in PD psychosis patients off (at baseline) and on Pimavanserin (post-treatment window).

Eligibility Criteria:
Inclusion Criteria:

* Patient arm - clinical diagnosis of Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, and other variants
* Healthy arm - age and gender matched to patient arm
* Psychosis (presence of hallucinations or delusions) starting after the diagnosis of Parkinson's disease, occurring at least weekly for 4 weeks, severe enough to warrant treatment.
* Study partner available for study visits

Exclusion Criteria:

* Prior stroke or other uncontrolled serious neurological or medical illness
* Contra-indication or inability to tolerate MRI scan
* Use of serotonergic medications in the last 6 weeks
* Incapable of providing independent consent.
* Pregnant or breastfeeding women
* psychosis due to a metabolic, toxic, or primary psychiatric disease
* Deemed unable to complete neurocognitive testing
* For PD Participants: current or prior use of pimavanserin
* Use of antipsychotics in the last 2 weeks
Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury

This study aims to examine the effects of nebulized heparin on the clinical outcomes in adult patients suffering smoke inhalation injury.

Patients will be randomized to receive nebulized heparin or an equal volume of normal saline for 14 days and the incidence of acute lung injury will be compared in either group.

Adult patients who suffered smoke inhalation injury and who are candidates for elective intubation, have evidence of bronchial burn by fiberoptic bronchoscopy, have no evidence of acute lung injury and no more than 24 hours since inhalation injury will be included.

Patients will be randomized into 2 groups:

Group A (Intervention): Patients will receive 5000 IU heparin mixed with 3 ml saline and nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.

Group B (Control): Patients will receive 4 ml of normal saline nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.

The primary end point is the VFDs.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients indicated for elective intubation:

* History of being trapped in a house or industrial fire.
* Production of carbonaceous sputum.
* Perioral facial burns affecting nose, lips, mouth, or throat .
* Altered level of consciousness at any time after the incident and including confusion.
* Symptoms of respiratory distress including a sense of suffocation, choking, breathlessness, and wheezing or discomfort affecting the eyes or throat, including irritation of the mucosal membranes.
* Signs of respiratory distress including stertorous or labored breathing, and tachypnea or auscultatory abnormalities, including crepitations or rhonchi.
* Hoarseness or loss of voice. 2. Evidence of bronchial burn by bronchoscopy to assess severity of inhalational trauma
* NO injury: absence of carbonaceous deposits, erythema, oedema, brochorrhea, or obstruction.
* Mild injury: minor patchy areas of erythema or carbonaceous deposits in proximal or distal bronchi.
* Moderate injury: moderate degree of erythema, carbonaceous deposits, bronchorrhea, or bronchial obstructions.
* Sever injury: sever inflammation with friability, copious carbonaceous deposits, bronchorrhea, or obstruction.
* Massive injury: evidence of mucosal sloughing, necrosis or endoluminal obliteration.

  3. No evidence of acute lung injury at presentation (either by radiology or ABG)
* Radiological findings: Normal lung without increased interstitial markings, ground glass opacification, or consolidation.
* ABG findings : PaO2/ Fio2 \> 300. 4. Time between inhalational injury and intubation not longer than 24 hours.

Exclusion Criteria:

1. Burn injury \> 24 hours.
2. History of pulmonary diseases.
3. Pregnancy or breast feeding.
4. History of allergy to heparin or HIT.
5. History or laboratory evidence of coagulopathy.
6. Burns area \> 50% of total body surface area. -