cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.

The purpose of this study is to demonstrate that the CHF 1535 (fixed combination of Beclometasone Dipropionate (BDP) 100 µg / Formoterol Fumarate (FF) 6 µg) delivered via the NEXT Dry Powder Inhaler (DPI) does not show a greater exposure to BDP, Beclometasone-17-Monopropionate(B17MP, active metabolite of BDP) and FF in comparison to a free combination of BDP DPI plus FF DPI licensed products after a morning dose administration of BDP and FF (total dose of BDP 400 µg / FF 24 µg) in adolescent and adult asthmatic patients.


Eligibility Criteria:
Main Inclusion Criteria:

1. Male and female adolescents (≥ 12 years old) and adults (≥18 and ≤ 65 years old)
2. Written informed consent;
3. Diagnosis of asthma as defined in the GINA guidelines;
4. Patients with stable asthma, according to the Investigator's opinion;
5. Asthmatic patients already treated with ICS or using short-acting inhaled β2-agonists as reliever to control asthma symptoms;
6. Patients with a forced expiratory volume in one second (FEV1) \> 70% of predicted values;
7. Patients with a peak inspiratory flow (PIF) \> 40 L/min
8. Reversibility test;
9. Non- or ex-smokers;
10. A cooperative attitude and ability to be trained about the proper use of DPI and compliant to study procedures;

Main Exclusion Criteria:

1. Pregnant or lactating female;
2. Having received an investigational drug within 2 months before the screening visit
3. Diagnosis of COPD as defined by the current GOLD guidelines;
4. Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality;
5. Known hypersensitivity to the active treatments;
6. History of drug addiction or excessive use of alcohol;
7. Treatment with a xanthine derivative (e.g. theophylline) formulation in the 4 weeks prior to screening;
8. Hospitalization due to asthma exacerbation or asthma exacerbation within 1 month prior to the screening visit;
9. Inability to perform the required breathing technique and blood sampling;
10. Lower respiratory tract infection within 1 month prior to the screening visit;
11. Blood donation (450 mL or more) or significant blood loss in the 12 weeks before the screening visit.
Effectiveness of High-intensity Aerobic Interval Training on Impairments and Activity Limitations in the Acute Phase of Stroke in Benin

This clinical trial aims to examine the effects of combining HIIT on a semi-recumbent cycle ergometer (HIIT-RCE) with conventional physiotherapy on impairments and activity limitations in early subacute stroke. We hypothesized that HIIT combined with conventional physiotherapy would be more effective than conventional physiotherapy in improving workload capacity.


Eligibility Criteria:
Inclusion Criteria:

People with the diagnosis of stroke were screened and recruited within the first-month after the stroke onset according to the following criteria

1. first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
2. muscle strength of the affected leg defined by Motricity Index between 14 and 19, i.e., between 2 and 4 on the Medical Research Council scale;
3. modified Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
4. able to walk at least 5 meters independently with or without assistive devices and understand simple instructions;
5. resident in Parakou or its surroundings
6. wish to participate in the hospital program

Exclusion Criteria:

Patients whose medical records reported

1. uncontrolled cardiac arrhythmias (e.g. atrial fibrillation, ventricular tachycardia), heart failure, or recent myocardial infarction, arteriopathy,
2. primary orthopedic conditions (e.g., fractures, active rheumatoid arthritis),
3. other neurological diseases (such as Parkinson's disease and Alzheimer's disease), (4) patients unable to perform a graded exercise test, i.e., unable to reach the target cadence of 50 rpm or exercise-induced asthma
Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.

The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.


Eligibility Criteria:
Inclusion Criteria:

* Infra-renal abdominal aortic aneurysm

Exclusion Criteria:

* Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial
The Influence of Two Different CO2 Absorbers on Sevoflurane Consumption During Anaesthesia

Traditional sodalime CO2 absorbers are known to not only react with CO2 but also with sevoflurane. Therewith, a potentially harmful compound (compound A) is formed that can be nephrotoxic. In the United States, the sevoflurane manufacturer therefore recommends keeping the FGF (FGF) at \>2.0 L min-1 if a sodalime CO2 absorbent is used. Amsorb Plus® (Datex-Ohmeda Inc., Madison, WI, USA), is a novel type of CO2 absorbent that does not react with sevoflurane. This allows the FGF to be reduced to 0.5 L min-1. This has two important advantages: (i) less fresh sevoflurane is added to the circle system, and (ii) the sevoflurane that is in the system does not react with the CO2 absorber.

Sevoflurane is a potent greenhouse gas with a 100 year CO2-equivalents of 120. Measures that can reduce the consumption of volatile anaesthetics could make a significant contribution to reducing the carbon footprint of the operative process. Additionally, Amsorb Plus® canisters seem to have a longer life span than sodalime canisters and do not need to be disposed of via toxic waste stream, but via domestic waste.

In this study, we were interested if (i) the use of Amsorb Plus leads to a reduction in sevoflurane usage and therefore contribute to a reduction in the CO2 footprint of general anaesthesia with sevoflurane, (ii) Does the use of Amsorb Plus® lead to a reduction in the amount of (toxic) waste produced by operating theatres?

Comparator: a traditional sodalime CO2 absorber (Medisorb™ Multi-Absorber Original, CareFusion, Helsinki, Finland).


Eligibility Criteria:
Inclusion criteria:

* Adult patient
* non-pregnant
* ASA-I to ASA-III
* undergoing Sevoflurane based general anaesthesia (in a therapeutic concentration of 1.0 MAC)
* Elective surgery
* Scheduled operating time \>2 hours.

Exclusion Criteria:

* Unable/ unwilling to participate
* ASA-IV or higher
* Age \< 18 years
* Known pregnancy
* Contra-indications for sevoflurane anaesthesia
* Emergency surgery
* Scheduled operating time \<2 hours.
Mainz Register of Patients With Sleep Disorders

Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.

Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively

Eligibility Criteria:
Inclusion Criteria:

* patients with narcolepsy
* patients with other neurological sleep disorders

Exclusion Criteria:

* patients aged \<18 years
* patients who cannot provide informed consent and don't have a legal guardian
ABILITY - TelerehABILITation: TechnologY-enhanced Multi-domain at Home Continuum of Care Program

The Ability research project, funded in Italy within the Smart Cities and Smart Communities funding program (MInistry of University and Research, Operational Regional Programme, Lombardy, Axis 1, Operational Regional Programme - European Funding for Regional Development 2007-2013), aims at developing and testing the efficacy and the impact of a Personal Smart Health Community able to provide innovative trajectories for people with cognitive impairment, putting them at the core of a continuous and intertwining treatment and support from both formal (e.g. physicians) and informal (e.g. near relatives) caregivers, with special focus on home-based care.

Within this framework of the Ability project the investigators test the efficacy of the home-based motor-cognitive rehabilitation program delivered with two different approaches: the Ability platform versus the usual care program


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as mild AD or MCI due to AD (Albert et al, 2011) according to DSM 5 diagnostic criteria (American Psychiatric Association, 2013);
* MMSE score \>18
* school attendance (≥ 3 years).

Exclusion Criteria:

* dysmetria;
* serious deficits in visual acuity, acoustic perception, and in routine communication skills.
A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer

This trial studies how well a text-based intervention works in improving adherence to hormone therapy in patients with stage I-III hormone receptor positive breast cancer. Women often require long term therapy with adjuvant hormone therapy to prevent the cancer from returning and to improve overall survival. Side effects from hormone therapy may prevent some women from staying adherent to their medication therapy. A text-based intervention may provide educational information to breast cancer patients who are undergoing adjuvant hormone therapy.

PRIMARY OBJECTIVES:

I. Examine the efficacy of messaging for adjuvant hormone therapy compliance promotion (mAHT-CaP) in a randomized control trial (RCT) design.

SECONDARY OBJECTIVES:

I. Conduct mediator analyses of intervention efficacy..

EXPLORATORY OBJECTIVES:

I. Explore whether age (=\< 45 versus \[vs.\] \> 45 at diagnosis) and race/ethnicity (white vs. non-white) moderate intervention effects on medication adherence and symptom distress.

OUTLINE:

PHASE I: Participants attend focus groups on adherence to hormone therapy.

PHASE II: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive text messages twice weekly for 6 months to remind and motivate participants about adjuvant hormonal therapy (AHT) adherence.

GROUP II: Participants receive usual care.

After completion of study, participants are followed up at 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Woman diagnosed with stage I-III breast cancer (BCa).
* Hormone receptor positive tumor.
* Completed local definitive treatment (i.e., surgery chemotherapy, radiation).
* Within 3 month of initiation of a new adjuvant hormonal therapy (AHT) regimen.
* At least 12 months of AHT recommended.
* Able to read and understand English.
* Able to provide informed consent.
* Have a mobile device with text (TXT) capability.
* Know or willing to learn how to use TXT.

Exclusion Criteria:

• Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex).
Chronotherapy for Depressive Episodes

Evidence-based treatments for depression, such as antidepressive medication, usually have a latency of 4 to 6 weeks before they achieve a therapeutic effect. Chronotherapy is a group of non-pharmacological interventions that presumably act on the circadian system to achieve a rapid-onset clinical effect and better long-term effects and has been shown efficient to improve depressive symptoms. Interventions include sleep deprivation, sleep-phase advancement and stabilization, and light therapy. There are few studies testing the effectiveness of combining these three chronotherapeutic techniques in the initial phase of treatment of depression in a secondary mental health care outpatient clinic. The investigators aim to test the effects and safety of chronotherapy in addition to TAU compared to TAU alone, with the primary outcome being self-reported depressive symptoms at 1 week following randomization. The study is a randomized controlled trial with 76 patients with a depressive episode who initiate outpatient treatment at Nidaros DPS, St. Olavs University Hospital. Participants will be allocated 1:1 to either chronotherapy + treatment as usual (TAU) or to TAU alone.


Eligibility Criteria:
Inclusion criteria. Patients eligible for the trial must comply with all the following at randomization:

* Being 18 years or older
* Willing and able to provide a written informed consent
* Newly diagnosed with an ongoing moderate or severe depressive episode according to the International Classification of Disorders 10th edition (ICD-10) and accepted for outpatient treatment for the depressive episode. The diagnosis is set in consensus of a licensed therapist and a specialist in psychiatry/psychology.
* The patient must score ≥ 9 on the Hamilton Depression Rating Scale-6.
* Must be able to communicate in a Scandinavian language

Exclusion criteria. Patients are considered ineligible for participation if any of the following are present:

* Illnesses where chronotherapy may be contraindicated (for example epilepsy, ongoing attack of multiple sclerosis, blindness, narcolepsy and psychotic depression).
* Known pregnancy.
* Individuals with a known diagnosis of emotionally unstable personality disorder (F60.3).
* Individuals with a known psychotic disorder
* Shiftwork or other related social or work circumstances that inhibit participation
* Participation in an ongoing trial at the outpatient clinic that encompasses digital cognitive behavior therapy for insomnia (recruitment to this trial will end in 2023).
Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.

The monocyte response from patients with T1D CKD will be compared to monocytes from T1D subjects without CKD as a control. Potential subjects will be recruited from existing Cleveland Clinic patients or the community. The study will entail an initial phone screen followed by a formal screening visit to determine eligibility. Eligible subjects will return for a study visit within 4 weeks for a blood draw. There is no intervention. This will complete the study for subjects unless the investigators do not obtain enough monocytes from the initial blood draw to complete the requisite lab studies. If this occurs, the investigators will ask the patient to return for a repeat study visit. All endpoints evaluating monocyte and podocyte injury will be conducted in the lab ex vivo.

Eligibility Criteria:
Inclusion Criteria:

1. T1D CKD subjects:

   1. Adults, males or females diagnosed with T1D
   2. Age 18-65 years
   3. Diagnosed with CKD (eGFR 60-90 ml/min/1.73 m2)
   4. Diagnosed with albuminuria (UACR 30-500 mg/g)
   5. On insulin injections or pump
   6. On CGM

   Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\>70% A1c 5.0-7.0
2. Controls: T1D subjects without CKD

   1. Adults, males or females diagnosed with T1D
   2. Age 18-65 years
   3. No CKD (eGFR \>90 ml/min/1.73 m2)
   4. No albuminuria (UACR \<30 mg/g)
   5. On insulin injections or pump
   6. On CGM

Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\<60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\>70% A1c 5.0-7.0

Exclusion Criteria:

1. Hemoglobin \<9
2. On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days
3. pregnancy or plans to become pregnant
4. On steroids
5. Diagnosed with cancer, immunosuppression/autoimmune conditions
6. Reported heavy alcohol use or recreational drug use
7. Any condition which jeopardizes patient safety or affects monocytes at physician's discretion
LIVESTRONG Survivorship Care Plan: Continued Data Collection and Follow Up Survey

Cancer survivors face unique health challenges as a result of their cancer diagnosis and treatment. OncoLink created an Internet based program for survivors to learn about their risks. A follow up survey will allow us to continue to develop the program in ways that will benefit users. This survey will need to be conducted via email, which will require the collection of the users email address and a secure method of linking the users care plan questionnaire answers to their survey answers.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer
* 18 years of age and older

Exclusion Criteria:

* Persons who have never had cancer. This program is designed for survivors of adult cancers.
* Survivors of childhood cancers are referred to the Children's Oncology Group Long Term Follow up Guidelines.
Proof-of-concept Lymfif

This proof-of-concept study was to explore the implementation feasibility to deliver the Lymfit intervention to participants remotely during the pandemic.


Eligibility Criteria:
Inclusion Criteria:

* 1. previously diagnosed with lymphoma
* 2. have completed chemotherapy
* 3. had access to a smart phone or an electronic device (e.g., tablet) that allowed them to attend virtual meetings and install the Fitbit application

Exclusion Criteria:

-1. have any contra-indications to performing physical activities as determined by the hematologist
OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study

Descriptive prospective non-interventional multicenter study based on newly collected data of Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings (Pulmonology Services)


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 40 years of age
* Patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to last ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management consensus
* Written informed consent prior to participation

Exclusion Criteria:

* Inability for the patient to understand or complete the written Inform Consent or patients questionnaires or to understand Spanish
* Current participation in any clinical trial
* Patients for whom further follow-up is not possible at the enrolling site
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Enzalutamide are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with enzalutamide

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2020 Adverse events reported were including any MedDRA terms Patients treated with enzalutamide reported in the WHO database.

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Trigger-point Blockade in Persistent Pain After Laparoscopical Groin Hernia Repair

Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.

This study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.

The hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following laparoscopical groin hernia repair.

This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after laparoscopically assisted groin hernia repair, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring.

Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent pain (\< 6 mo) after laparoscopical groin hernia repair
* Patients with maximal pain area 3 cm or less from the superficial inguinal ring
* Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of Zealand (Region Sjælland)

Exclusion Criteria:

* Known allergy to bupivacaine or other local anesthetics of amide-type
* Declared incapable of making his/hers own affairs
* Does not comprehend Danish in writing or speech
* Cognitive impairment to a degree influencing the testing reliability
* Known recurrence of the inguinal hernia
* Other surgical procedures performed in the groin or on the external genitals
* Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc
* Abuse of alcohol or drugs
* Unable to cooperate with the sensory examinations
Probability of Target Attainment With Standard Intermittent Bolus Administration of Cefazolin in Patients With Complicated Infections Caused by Staphylococcus Aureus

Given the paucity of pharmacological data on cefazolin treatment of Methicillin-susceptible S. aureus (MSSA) complicated S. aureus infection (CSAI), the primary purpose of this study is to investigate the probability of pharmacological target attainment (in the blood and infected tissue) with standard intermittent bolus administration of cefazolin in patients with CSAI caused by MSSA by determining plasma concentrations of cefazolin and exact Minimum inhibitory concentration (MICs) of the causative MSSA strains in patients with various disease severities (e.g. critically ill vs. noncritically ill patients).

* Sub-study quantitative measurement of Torque Teno virus (TTV): The primary purpose of this sub-study is to describe the viral kinetics of TTV in CSAI patients and to explore the association of TTV viremia with clinical outcomes and molecular markers of activation of the immune system.
* Sub-study investigating antibiotic concentrations in sweat as a non-invasive therapeutic drug monitoring


Eligibility Criteria:
Inclusion Criteria:

* CSAI caused by MSSA. CSAI is defined as MSSA BSI with a positive follow-up blood culture result for MSSA or the presence of a site of infection remote from the primary focus caused by hematogenous seeding (e.g. endocarditis, vertebral osteomyelitis) or extension of the infection beyond the primary focus (e.g. septic thrombophlebitis or abscess); or deep-seated infections caused by MSSA (e.g. osteoarticular infections, deepseated abscesses).
* Current or intended treatment with cefazolin

Exclusion Criteria:

* Previous enrolment into the current study within 30 days
* Hemodialysis (patients on hemofiltration are eligible)
* Patients who are very likely to stop treatment with cefazolin in the next 48 hours as per treating physician (because of treatment failure, switch to oral medication, palliative care, allergy etc.) or who are very likely to be discharged in the next 48 hours as per treating physician.
* Outpatients
* Women who are pregnant (special pharmacokinetic)
* Polymicrobial infection except concomitant isolation of a likely contaminant (e.g. Staphylococcus epidermidis or Propionibacterium acnes) or an anaerobic pathogen. If an additional pathogen is identified after inclusion of the patient into the study, the patient will remain in the study.
* Not-complicated S. aureus infections: non-bacteremic skin- and soft tissue or small Joint infections without deep-seated abscesses (as these patients will be quickly switched to oral antibiotics)
* CSAI caused by methicillin-resistant S. aureus (MRSA)

Additional exclusion criteria for the sub-study investigating cefazolin concentrations in sweat:

* Allergic to pilocarpine
* Continuous oxygen therapy without the possibility to interrupt oxygen administration for 10min
* Pacemaker