cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy in Japan

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.

Secondary Objectives:

* To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo
* To evaluate the safety and tolerability of alirocumab
* To evaluate the development of anti-alirocumab antibodies
* To evaluate the pharmacokinetics of alirocumab

The duration of study participation depended on the status of the participant at screening: 21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment period of 12 weeks, followed by an 8-week follow-up period.

Eligibility Criteria:
Inclusion criteria :

- Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 5-20 mg for at least 6 weeks prior to screening and likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit.

OR

- Participants with primary hypercholesterolemia who were receiving a lipid-lowering treatment other than atorvastatin, or who were not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening if they were likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) after a 6-week run-in treatment period on atorvastatin therapy.

Exclusion criteria:

1. LDL-C \<100 mg/dL (\<2.59 mmol/L)

   * at screening visit for participants who were being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening OR
   * at the end of the 6-week run-in period on atorvastatin for participants receiving a lipid lowering treatment other than atorvastatin, or not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening
2. Participants with type 1 diabetes
3. Participants with type 2 diabetes treated with insulin, or without, and considered poorly controlled at screening.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?

Previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. Here, the investigators will determine if 3 brief sessions of high-intensity interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in sedentary, overweight males.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week)
* Overweight (BMI 25-29.9 kg/m2)

Exclusion Criteria:

* Personal history of any major illness (i.e. cardiovascular disease, diabetes, hypertension, cancer, renal/liver impairments, major psychiatric disorders, eating disorders etc.)
* History of chest pain (either at rest or during exercise.)
* Abnormal resting ECG at screening visit
* Chronic use of any prescribed or non-prescribed medications (i.e. anti-hypertensive, statins, metformin, anti-inflammatories, antidepressants etc.)
* Blood pressure or blood lipids outside of reference ranges
* Serum ferritin \<30ng/mL
* Uncontrolled asthma, current fever, or upper respiratory infection
* Current intake of \> 140g alcohol/week
* Current smokers of cigarettes/cigars/marijuana
* Current intake of any illicit substance
* Experience claustrophobia in confined spaces
* Donated blood in the past 3 months
* Migraines
* Unable to comprehend study protocol
* Unable to perform exercise on a cycle ergometer at second screening visit
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting

The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.

Eligible patients will be randomized to receive different antiemetic regimens . In the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .In the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .During the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of CINV,nausea patients will be measured by a visual analogue scale (VAS) ,other adverse events should be recorded as well.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Histologically or cytologically confirmed malignant disease
3. Accept chemotherapy for the first time
4. Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin\>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide\>=1500mg/m2,adriamycin\>60mg/m2,epirubicin\>90mg/m2,dacarbazine，ifosfamide\>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin\>=300mg/m2,cyclophosphamide\>=600-1000mg/m2,adriamycin\>50mg/m2)
5. Written informed consent

Exclusion Criteria:

1. Pregnant or breast-feeding
2. Uncontrolled psychosis history
3. Inability or unwillingness to understand or cooperate with study procedures
4. Central nervous system tumors primary or secondary
5. Concurrent abdominal radiotherapy
6. History of uncontrolled diabetes mellitus
7. Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
8. Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
9. Pre-existing nausea or vomiting
10. Inadequate hematological function and abnormal liver and renal function.
11. History of sensitivity to olanzapine
12. Concurrent application of quinolone antibiotic therapy
13. Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
15. Concurrent application of systemic corticosteroids
16. Active infection or gastrointestinal dysfunction
The Effect of Postoperative "Peanut Ball" Rehabilitation After Total Knee Replacement.

The purpose of this randomized controlled study is to evaluate the effect of postoperative exercise with a "peanut ball" after total knee replacement, on pain, intake of pain killers, knee function, and health-related quality of life.

After being informed about the study and potential risks, all patients giving written informed consent will be included in the study.

At baseline, before surgery, all patients will meet a nurse, a physical therapist, and an orthopedic doctor and answer questions about their health condition and do functional tests.

Each week is randomized to be either "peanut ball" or standard exercise week, with all patients during that week receiving the same treatment. Thus, depending on what week the patients are operated they will be mobilized with postoperative exercise with a "peanut ball" or to a standard exercise program (no peanut ball) 3-5 times/day for 6 weeks. All patients randomized to exercise with a "peanut ball" will receive a ball for free to bring home.

At the ward, the nurses will ask about the patient's pain level two times a day and register all medicines. The physical therapist will introduce the exercise and inform the patients to do the exercise 3-5 times/day a´ 15 minutes and fill in all exercises in an exercise diary.

2 weeks after surgery all patients have a standard visit to a nurse and a physical therapist at the orthopedic department. At this visit, the nurse will register the pain level and all intake of medicine and the physical therapist will measure the range of movement and the sit to stand test.

3 months after surgery all patients have a standard visit to a physical therapist at the orthopedic department. At this visit, all outcomes will be filled in or measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis planned for surgery with total knee replacement at Skåne University Hospital.

Exclusion Criteria:

* Patients who do not understand and talk the Swedish language
* Patients with dementia
* Revision surgery of the knee
* Unicompartmentmental knee replacement
Nonmyeloablative Allogeneic Transplant

Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.

same

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 55 years or
2. Age \< 55 and LVEF \< 45% or creatinine clearance \< 60 ml/min
3. Ability to cover the cost of the transplant, necessary medications, and transportation/housing.
4. Caregiver must be available while outpatient

Guidelines for Cladribine-Melphalan-based conditioning:

* Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis)
* AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt)
* ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt)
* MDS (RAEB, RAEBiT, CMMoL)
* CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy
* Hodgkin's lymphoma (first or greater relapse)
* Non-Hodgkin's Lymphoma
* Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse
* Indolent Histology Second or greater relapse
* Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy)
* Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant)
* Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias)

Guidelines for total lymphoid irradiation-based conditioning

* MDS (RA, RARS)
* CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past)
* Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy)
* Renal Cell Cancer (metastatic disease at multiple sites)
* Malignant Melanoma (metastatic disease at multiple sites)
* Sarcoma (all subtypes presently, unresectable metastatic disease)
* Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy)
* Thymoma (unresectable disease)

Exclusion Criteria:

1. Prior allogeneic stem cell or bone marrow transplant
2. Current or past history of invasive mycotic infection
3. Breast Feeding
Effect of a Mixed Macronutritional Meal With Medium Chain Triglycerides on the Oxidation of Postprandial Macronutrients

The main aim of this study is to determine the effect of the addition of medium chain triglycerides to a mixed macro nutritional meal on postprandial macronutrients oxidation (i.e. fat oxidation, carbohydrate oxidation, change in respiratory quotient, peak respiratory quotient, etc.).

A mixed meal characterized by a high quantity of carbohydrates could develop an increment in the postprandial carbohydrate oxidation. Medium chain triglycerides could be absorbed and metabolized immediately. It is plausible that its addition to a mixed meal unchains the decrement in the carbohydrate oxidation and increment in fat oxidation. If this hypothesis it is correct, its lower postprandial carbohydrate oxidation could develop a higher postprandial exposure to hyperglycemia, being of clinical interest.

20 young adults will be randomized into two conditions (experimental and control conditions) with 7 days of separation between conditions. Each evaluation day will conform to the following tests:

1. Basal metabolic rate assessment through indirect calorimetry.
2. Intake of the corresponding mixed meal (experimental or control)
3. Postprandial nutrient oxidation and energy expenditure through indirect calorimetry
4. Blood samples assessment in 9 time points during the evaluation day.
5. Post-prandial sensations related to appetite in 11 time points during the evaluation day

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Ages 18-30 years
* BMI: 18-27.5 kg/m2
* Stable weight over the last 3 months (body weight changes\<35kg)
* Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols.

Exclusion Criteria:

* History of cardiovascular disease
* Diabetes or hypertension
* Pregnant, planning to become pregnant, or breastfeeding
* Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results.
* Hematological pathology
* Have had a blood transfusion or severe blood loss within the last 3 months
* Allergy/intolerance to milk proteins, fish, soy, and/or any ingredient of the mixed meal
* Any non-controlled medical condition which could influence results or could be worsened by the participation in the study
* Claustrophobia
* Needle phobia
* Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
Meal Schedule Effects on Circadian Energy Balance in Adults

This study will test will how eating on a particular daily schedule may effect energy, weight gain or loss, and body temperature.

Although there have been a large number of studies in humans on the effects of food intake at night, very few studies directly address the hypothesis that inappropriately phased eating or snacking (i.e., at night) in humans disrupts metabolism and respiratory quotient (RQ) patterns and there are no studies that we are aware of that directly measure circadian clock phase relative to timing of food intake while evaluating metabolism. This may be critical, because it is well established that the timing of food intake can also modulate circadian clock phase.

Hypothesis: Food consumption in the subjective night (e.g., 20:00 - 02:00) will result in a different circadian metabolic profile measured by RQ) than food consumed in the subjective day.

Aim 1: To determine if there are daily rhythms of switching between lipid and carbohydrate metabolism in humans that are altered by the timing of food intake. Aim 2: To determine if timing of food intake results in "internal desynchronization" between the metabolic rhythms (RQ) and the rhythm in core body temperature (a marker of central circadian phase).

Aim 3: To determine if body composition has measurable impact on the circadian regulation of metabolism.

In this study we will test human subjects in a specially designed whole-room indirect calorimeter where energy expenditure and RQ will be monitored by indirect calorimetry continuously over 56 hours. Circadian phase and amplitude will be assessed by continuously recording the core body temperature rhythm using the Vital Sense Integrated Physiological Monitoring System in which subjects swallow a telemetry capsule that transmits core body temperature to a data acquisition module. In consultation with a nutritionist at Vanderbilt, we will use a cross-over design in which daily diets have the same caloric and nutritional value but in which the subjects consume the calories that would normally be breakfast as snacks consumed in the late-evening.

Eligibility Criteria:
Inclusion Criteria:

* Be able to understand the study, provide written informed consent (in English), and be able to fill out the questionnaire
* Be male or female older than 18 years of age;
* Have a normal BMI (20-25) or be obese (BMI more than 30);
* Have a normal basal glucose level (70-100 mg/dL)
* If female of childbearing potential, have a negative pregnancy test on study day;

Exclusion Criteria:

* Be pregnant or lactating;
* Have known sleep, metabolic (e.g., diabetes), or gastro-intestinal disorders except obesity;
* Had alcohol less than 24 hours before admission;
* Require assistance with activities of daily living;
* Have difficulty swallowing
* Be unable to complete a food and sleep diary
* Be smokers
Propofol Versus Esketamine for Rapid Sequence Intubation in Critically Ill Patients

Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old
* Physician indicated intubation

Exclusion Criteria:

* Pregnancy
* Intubation during cardiac arrest
* Known of suspected intracranial hypertension
* Known allergy to propofol or esketamine
* Bradycardia (heart rate below 50 beats per minute) or atrioventricular block
CopenHeartRFA - Integrated Rehabilitation of Patients Treated for Atrial Fibrillation With Radio Frequency Ablation

Atrial fibrillation is the most common arrhythmia and affect 1-2 % of the population in the western world. Atrial fibrillation can be treated with a relatively new procedure, called radiofrequency ablation.

The aim of this study is to explore if patients treated with ablation for atrial fibrillation, benefit from an integrated rehabilitation programme, that consist of physical training and psycho-educative consultations with a specialised nurse.

The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity and other factors.

1-2 % of the population in the western world live with atrial fibrillation. One way to treat atrial fibrillation is with radiofrequency ablation. Ablation is a relatively new treatment and therefore only few studies has been exploring how the patients are doing after discharge. In Denmark the patients are not offered rehabilitation, only brief follow-up with a doctor. Therefore the aim of this study is to explore if the patients will benefit from a integrated rehabilitation programme consisting of physical training and psycho-educational intervention.

A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients treated for atrial fibrillation with radiofrequency ablation. The trial is a parallel arm design.

A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of four psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative post-intervention study will explore rehabilitation participation experiences.

The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity, self-rated health, quality of life, sleep-quality and reduce anxiety, depression, health care utilisation, work cessation and mortality in patients treated for atrial fibrillation with radiofrequency ablation and that it is cost effective.

210 patients will be included.

Questionnaires, cardiopulmonary testing, 6 minute walking test and qualitative interviews will be used to evaluate the effect and meaning of the programme.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* treated for atrial fibrillation with radiofrequency ablation on Rigshospitalet, Denmark
* 18 years or older
* speaking and understanding Danish
* providing written informed consent

Exclusion Criteria:

* unable to understand study instructions
* who are pregnant or breastfeeding
* with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training
* who does strenuous physical training several times a week on competition level
* who does not wish to participate
Preventive EXACYL® on Perioperative Bleeding During Orthognathism of Maxillary Surgery

Prospective, randomized, double-blind, placebo-controlled, mono center, Phase III trial to compare EXACYL in preventive with placebo on perioperatory bleeding in orthognathism surgery.

The aim of our study was to evaluate the clinical value of preventive treatment EXACYL® on bleeding during surgery to orthognathism. Our hypothesis is that this preventive treatment is not enough reduces bleeding to cause a change in patient management (count additional blood count, extra padding, transfusion).

Prospective equivalence trial type controlled by two parallel group, randomized, triple-blind (patient, surgical team, anesthesia team).

* EXACYL® Group: 1 syringe 1g EXACYL® on one hour + 1 syringe 1g EXACYL® on 8 hours
* Control group: 1 syringe 30 mL of saline on one hour + 1 syringe 30 mL saline on 8 hours Main criteria is amount of blood during the entire hospitalization: bleeding during surgery completed in the amount of blood present in the suction drains and nasogastric tube until ablation thereof.

Eligibility Criteria:
Inclusion Criteria:

* Patients to be operated on an osteotomy of the maxilla through a orthognathism surgery in the department of surgical specialties Salengro hospital
* Senior surgeon
* Hb ≥ 12 g / dL in the preoperative
* Patient ASA 1 or 2

Exclusion Criteria:

* Patient with coagulation disorders
* Patients treated with anticoagulant or antiplatelet
* Patients who require anticoagulation postoperatively
* Patient with against-indication to EXACYL® ( severe renal failure , convulsions history, history of thromboembolism venous or arterial )
* Surgery recognized preoperatively as particularly complicated by surgeons
Study of Gemcitabine and Abraxane for Pancreas Cancer

A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting

This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic adenocarcinoma of the pancreas
* Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
* Radiographically measurable or evaluable disease
* Age \>/= 18 years
* ECOG performance status 0-2
* Adequate hepatic, bone marrow and renal function

Exclusion Criteria:

* Prior gemcitabine-based chemotherapy in the first line setting
* No active severe infection, or known chronic infection with HIV or hepatitis B virus
* No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
* No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
* Patients with known CNS metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
* Anticipated patient survival under 2 months