cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease

The primary objective of this trial is as follows:

To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin given daily.

The secondary objective of this trial is as follows:

To determine whether adequate exposure of micafungin is attained. To determine the safety of micafungin in this patient population

Micafungin has been shown to be a reasonable option for treating invasive aspergillosis in hematopoietic stem cell transplantation (HSCT) recipients and has proven as effective as fluconazole for prophylaxis. Whilst micafungin has much to offer, little is known about its pharmacokinetic profile in specific patient populations, specifically concerning alternate dosing strategies with increased dosages over a prolonged dosing interval. Sufficient data are lacking up to now for twice weekly administration of micafungin as antifungal prophylaxis. Decreasing the dosing frequency to twice weekly seems a reasonable approach considering the long terminal elimination life (i.e. 10-17 h) and considering the data available from murine models that support the use of less frequent dosing with higher dosages.

It will enable us to characterize both the pharmacokinetics of micafungin in the hematology cohort and directly compare the exposure to the alternate dosing strategy.

Eligibility Criteria:
Inclusion Criteria:

* Patient receives immunosuppressive therapy for acute GvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
* Subject is at least 18 of age on the day of providing informed consent.
* Has no signs or symptoms of invasive fungal disease
* If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
* Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
* Is managed with a central venous catheter (preferably a quadruple Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International).
* Subject is able and willing to sign the Informed Consent before screening evaluations.

Exclusion Criteria:

* Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature of the trial and the procedures required.
* Has not previously participated in this trial.
Comparison of 2 Different Flow Rates During Oocyte Retrieval

The purpose of this study is to evaluate the effect of different flow rates during oocyte retrieval, on the number of cumulus oocyte complexes (COCs) retrieved.

In the current study, each ovary will be randomly allocated to oocyte retrieval using 0.42 ml/sec or 0.62 ml/sec flow rate.

The primary endpoint will be the number of oocytes retrieved, while secondary outcomes will include oocyte recovery rate (number of oocytes retrieved per follicle aspirated), number of mature oocytes, maturation rate (number of mature oocytes/number of oocytes retrieved), mean oocyte score (by evaluating oocyte shape and size, ooplasm characteristics, structure of perivitelline space (PVS), structure of zona pellucida (ZP) and polar body (PB) morphology), fertilization rate (number of fertilized oocytes/number of mature oocytes), number of blastocysts and blastulation rate (number of blastocysts/number of 2PN).

Patients aged 18-43 years with the presence of at least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval will be eligible for inclusion in the study.

Prior to oocyte retrieval in eligible patients their left and right ovary will be randomly allocated into the 0.42 ml/sec or 0.62 ml/sec flow rate group. Randomisation with minimisation will be employed.

The specific flow rates will be achieved by adjusting the aspiration pressure of the vacuum pump accordingly. A study nurse will be responsible for adjusting the aspiration pressure of the vacuum pump depending on randomization. The doctor performing the oocyte retrieval will not be aware of the flow rate used in each ovary.

All follicles will be aspirated and then flushed if needed up to a maximum of 5 times with an open flushing technique, using a 16G double-lumen needle.

Data will be registered regarding the number of flushes required to retrieve a COC, the morphology of oocytes after denudation, oocyte fertilisation and embryo development up to the blastocyst stage.

Eligibility Criteria:
Inclusion Criteria:

* Presence of both ovaries
* 18-43 years old
* At least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval

Exclusion Criteria:

* One or no ovaries present
* Monofollicular development
* Poor responders
* Previous history of hemorrhage during oocyte retrieval
Health Determinants in Older Adults Living At Home

The observational study will conduct interprofessional assessments by registered nurses, physiotherapists, and occupational therapists of health determinants (i.e., frailty, physical, cognitive, and sensory function, mental and social health, and alcohol use) in older adults (≥75) living at home and applying for a municipal health service. The participants will take part in two assessments, baseline and 5 months. Based on the baseline assessment healthcare professionals will identify factors that can affect older adults' health, provide tailored information, offer measures, and link with proper health services. The aim is that older adults maintain health, function, and self-care and thus can continue aging at home. The main research question is:) How can interprofessional assessments of older adults living at home reduce the risk of impaired function, maintain health and ensure that the elderly receive tailored services?

The population of older adults is rapidly increasing worldwide and in Norway. A present and future challenge is to provide adequate health and care services to older persons. It is imperative to organize the services in a manner that is both adequate for the older persons in need of help and sustainable for health and care services and society. A way to ensure this is to facilitate and promote measures allowing older adults to age well at home. Accordingly, it is of great importance to enable older adults to engage with health determinants that influence their daily life actively. One area of importance is assessing health determinants and acting upon indications of functional decline, cognitive and sensory impairments, and frailty.

The observational study will assess how interprofessional assessments of health determinants in older adults living at home can promote health and reduce the risk of functional decline. The study participants will take part in two assessments of health determinants including frailty, physical, cognitive, and sensory function, mental and social health, and alcohol use. Based on results from the baseline assessment healthcare personnel will identify factors that can affect the older adult's health, provide tailored information to strengthen health literacy, and offer measures available in the health services in the municipality. The second assessment 5 months after baseline will reveal if tailoring measures and services have contributed to maintaining and supporting the older person's health and reduced the risk of functional decline. The aim of the project is that the elderly living at home maintains health, function, and self-care and thus can have more good days at home.

Eligibility Criteria:
Inclusion Criteria:

* Older adults, age ≥75, live at home, being cognitively able to give informed consent, apply for a public health and care service from the municipality, and have a service need for more than two weeks approved by the municipality

Exclusion Criteria:

* \<75 years, cognitive impairment, in need of palliative services
PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

This observational study was designed to evaluate progression free survival after PSMA-PET/CT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.

This is a prospective observational multicenter study including patients treated with upfront radical prostatectomy +/- postoperative prostate bed radiotherapy, with histological result of Prostate adenocarcinoma, affected by biochemical relapse (defined as PSA\>/= 0.2 ng/ml) with a PSA at recurrence \</=1 ng/ml. Patients will be staged with centralized 68 Ga- PSMA PET/CT and treated with a pre-defined approach based on 68 Ga-PSMA PET/CT findings.

The predefined approach will consist in the following flowchart:

1. In negative 68Ga-PSMA PET/CT or positive findings within prostate bed: Prostate bed RT
2. In 68Ga-PSMA PET/CT detecting pelvic nodal recurrence amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT to all positive nodal disease.
3. In abdominal nodal or bone oligometastatic disease amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT on all sites of disease
4. In abdominal nodal or bone metastatic disease (\>3 lesions or non-amenable with SBRT) and/or visceral disease: ADT+/-other systemic therapies available for metastatic hormone sensitive pCa at physician discretion.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age \>18
* Patient suitable for 68Ga-PSMA PET/CT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +/- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA \> 0.2 and \<1

Exclusion Criteria:

* ADT administration within 6 months from study enrollment
* Persistent elevation of PSA after RP measured within 16 weeks from surgery (\> 0.1 ng/ml)
Implantable Cardioverter Defibrillator (ICD) Patients and Inhalation Aromatherapy

The effective management of anxiety and fatigue, which lead to negative physical, social, and psychological impacts and increase treatment costs in individuals with implanted cardioverter-defibrillators (ICD), is of great importance. Complementary and integrative therapy (CIT) methods offer a non-pharmacological, easy-to-apply, and safe intervention alternative for nurses and patients experiencing these symptoms. This study was conducted to investigate the effect of lavender oil aromatherapy, applied by inhalation for two minutes with two drops before bedtime for one month, on anxiety and fatigue levels in individuals with ICD, in a randomized controlled single-blind study design. A total of 86 patients with ICD implantation were included in the study, and 43 patients were randomly assigned to the intervention and control groups. The intervention group received lavender aromatherapy for two minutes with two drops of lavender oil inhaled before bedtime every night for one month, in addition to their routine treatment. The control group received only routine treatment. The study was conducted after obtaining the necessary ethical approval, institutional permission, and informed consent from the patients. The Patient Diagnosis Form, Piper Fatigue Scale (PFS), Spielberger State-Trait Anxiety Inventory Short Form (STAI-SF and STAI-TF), and Visual Analogue Scale (VAS) for Fatigue were used in data collection. The data were analyzed using the Statistical Package for Social Sciences (SPSS) 25.0 and G\*Power program. A value of p\<0.05 was considered statistically significant in comparisons.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who were willing to participate in the study,
* aged between 18 and 65 years,
* with no physical or mental health issues that would hinder communication,
* had an ICD implanted at least 6 months ago,
* had a battery life of at least 3 months,
* had a fatigue level of 3 or higher on the Visual Analog Scale for Fatigue (VAS-F),
* had an EF of 40% or higher,
* and were visiting the cardiology outpatient clinic for ICD control

Exclusion Criteria:

* Individuals receiving anxiolytic or antidepressant treatment,
* those with respiratory system diseases (such as asthma, bronchitis, or chronic obstructive pulmonary disease), 19,231 characters left
* those with a known sensitivity to the essential oils used, and individuals with an olfactory impairment
Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.

This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women at the age of 12 or older at the Screening visit.
* Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).

Exclusion Criteria:

* Those with more than two nodular acne lesions or any cysts.
* Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
* Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
Exercise Effect on Transthyretin Stability

The goal of this study to investigate if exercise predisposes to transthyretin instability. The investigators will evaluate the effect of exercise on transthyretin biochemistry.

This is an investigator initiated observational study, designed to study the effect of exercise on transthyretin stability in three main populations: Group 1: healthy master athletes who are 60 years or older. Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease). Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria: patients should be able to exercise on a treadmill or a bike, willing to consent to the study procedures and willing to return to site during the follow up period of 72 hours for repeated blood and urine collection

Specific inclusion criteria:

* Group 1: Subjects must be at least 60 years of age and meet the master athlete definition of: athletes engaged in cycling ≥8 hours per week or running ≥6 hours per week or triathlon training (combination of swimming, cycling, running) ≥8 hours per week, or equivalent sports activities, for at least 6 months prior to enrollment.
* Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease)
* Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.

Exclusion Criteria:

Taking diflunisal or daily non-steroidal anti-inflammatory drugs (NSAIDs) use within 2 weeks.
Randomised Study to Compare the Efficacy of AZD6244 vs TMZ

The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with late stage malignant melanoma
* Aged 18 or over
* Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal

Exclusion Criteria:

* Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable)
* Participation in any other trial with an investigational product within the previous 30 days
A Continuation Study To Monitor The Long Term Safety Of Patients Completing Protocols ACU-P08-020/020A

This is a 2 year follow up study to monitor the long term safety of the ACI 7000PDT in subjects who are still implanted with the ACI and have successfully completed the ACU-P08-020/020A studies.

This is a two year follow up study designed to monitor and obtain long-term safety data of the ACI 7000PDT in subjects who participated and successfully completed the ACU-P08-020/020A studies. Subjects must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form prior to participating. This continuation study follows subjects still implanted with the ACI and includes two visits, at 12-month intervals, after subjects have been exited (at Month 36) from the ACU-P08-020/020A studies. The first visit is at Month 48 following implantation followed by a final Month 60 visit. The study parameters being measured at these two visits include:

* Specular microscopy
* Slit lamp and fundus examination (ocular health)
* Corrected and uncorrected visual acuity
* Manifest mid-point refraction
* Corneal topography
* Dry eye assessment
* Mesopic and Photopic contrast sensitivity
* Adverse events and complications

All sites participating in the ACU-P08-020/020A studies were invited to participate in the continuation study.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have completed participation in the ACU-P08-020/020A clinical trial.
* Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

* Patients who did not complete ACU-P08-020/020A.
Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.

The study objective is to clinically validate that the presence of recently discovered novel genetic variation adversely affects a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients using biobank samples.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric acute lymphoblastic leukemia (ALL) subjects
* Received 6-mercaptopurine
* Available biobank (bone marrow or blood) sample(s) from which deoxyribonucleic acid (DNA) can be extracted
* White blood cell (WBC) levels

Exclusion Criteria:

* Pediatric ALL subjects who did NOT receive 6-mercaptopurine
* No biobank sample
* No WBC level
Effectiveness of WBV Versus RAS on Spasticity, Balance, and Lower Limb Motor Function on Hemiplegic Stroke Patients

This study investigates the effectiveness of whole-body vibration (WBV) versus rhythmic auditory stimulation (RAS) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. The objective was to compare the two interventions to determine which provides greater benefits in stroke rehabilitation. Hemiplegic stroke patients were randomly assigned to either the WBV group, receiving whole-body vibration therapy, or the RAS group, undergoing rhythmic auditory stimulation sessions.

The study measured spasticity using the Modified Ashworth Scale (MAS), balance with the Berg Balance Scale (BBS), and lower limb motor function through the Fugl-Meyer Assessment (FMA). Results indicated that both WBV and RAS significantly improved spasticity, balance, and lower limb motor function.

Eligibility Criteria:
Inclusion Criteria:

* Participant with Age from 40 to 60 years
* Both males and females
* Diagnosed CVA patients
* Chronic stage (after 6 months of onset
* Individuals with BBS score ≥ 20 ≤ 40
* FMI score up to 3(moderate assistance)
* Able to understand command
* Mini-Mental State Examination (MMSE) score of over 20

Exclusion Criteria:

* Systematic Disorder e.g. Rheumatoid arthritis
* Unstable Angina
* Coexisting physical impairments e.g. limb amputation
* Any previous history of neurological disease other than stroke e.g. Parkinson's
* Any previous history of fractures
* Hearing or perception deficits
* Individuals unable to adhere to the study protocol or attend scheduled follow-up visits.
Shanghai Meiji Health Science and Technology Co., Ltd

Investigators performed a randomized double-blind trial to determine the effects of long-term NnEx ingestion in patients with overweight or obesity. Ninety-five participants (23\<BMI\<30 kg/m2) were randomly allocated to three groups: a control group, a 1 g/day NnEx group, and a 2 g/day NnEx group. The effects of the consumption of 2 g/day or 1 g/day NnEx for 12 weeks on indices of adiposity and fasting blood metabolic parameters were compared with those of no consumption of NnEx.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) of 23-30 kg/m2
* Has no history of using any antidiabetic medication
* Absence of liver, kidney, or heart disease
* Absence of food allergy and daily tea consumption \<2 L
* Meet all of the above criteria and to follow the instructions given during the study.

Exclusion Criteria:

* Testing delayed for \>1 week without justification
* Difficulty attending the hospital on the required days
* Lack of data regarding the times of beverage consumption for over 5% of the study
* Abnormal overeating
* Test results believed to be unreliable because of the lack of provision of diet and exercise reports during the fasting period
* Difficulty drawing blood
* Poor confidence in the test data
The Clostridioides Difficile Trial of REC-3964

This is a multi-center, open-label study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of RE-3964 (doses of either 250 mg or 500 mg PO every 12 hours) for the reduction of Clostridioides Difficile infection (CDI)."

"Approximately 80 individuals will be enrolled in this open-label Phase 2 study, randomized 1:2: 1 to receive oral doses of REC-3964, 250 mg, 500 mg or observation. The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 for the reduction of recurrent Clostridioides difficile infection (rCDI) after initial cure with vancomycin. Participants will receive treatment with REC-3964 for 28 days."

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrhea associated with a positive stool test for C. difficile toxin\[s\] prior to randomization. The Clostridioides difficile infection (CDI) episode, severe or otherwise, must have resolved upon receiving vancomycin with a standard duration of treatment. The participant must be randomized within 2 days of completing vancomycin.
* Have high risk for rCDI (a recurrent CDI episode within the last 6 months for which, in the opinion of the treating physician, standard of care treatment is not an option, age ≥65 years, immunocompromised state, or severe CDI on initial presentation) for whom vancomycin would be acceptable therapy. Exceptions may be approved by the Medical Monitor.

Exclusion Criteria:

* Have an active chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease. Patients with controlled ulcerative colitis or Crohn's disease would be eligible per this Exclusion Criterion.
* Diarrhea cannot be medically controlled by agents that would confound the interpretation of the study results"