cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia

The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with Candida, Aspergillus, and other opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an important step in the amelioration of fungal disease.

Patients are first split into groups to receive either voriconazole or AmBisome. Both drugs are given through a vein (IV) for at least 3 days. At the conclusion of 3 days, the voriconazole patients are then switched to oral voriconazole. The AmBisome patients continue with IV AmBisome. Both groups continue treatment until blood counts increase and fever subsides.

Eligibility Criteria:
Inclusion Criteria:

You may be eligible for this study if you:

* Are at least 12 years of age.
* Are hospitalized with low white blood cell counts.
* Have received at least 96 hours of IV antibiotics.
* Have an oral temperature (or equivalent) of 38.0 C (100.4 F) or greater within the 24 hours before the study starts.
* Are not pregnant or breast-feeding.
* Agree to use a barrier method of contraception (e.g., a condom) during the study

Exclusion Criteria:

You will not be eligible for this study if you:

* Have a serious fungal infection.
* Have a history of an allergic reaction to antifungal agents.
* Are taking certain medications which may interfere with the study drug.
* Are participating in a clinical trial of any investigational drug.
* Have previously participated in this trial.
* Have any conditions which could affect your safety, make evaluation of response difficult, or make it unlikely that you can complete the course of therapy.
Determination of Adipocytokine in Synovial Fluid of Osteoarthritis Patients

The purpose of this study is to determine the concentration of different adipocytokine (adiponectin, leptin, resistin, visfatin, osteopontin) and an inflammation classic markers as Interleukine 1 beta, tumor necrosis alfa, interleukine 6 and high sensibility reactive c protein in the synovial fluid of knee osteoarthritis patients, and compare with the inflammation detected with ultrasonography evaluation of the joint. In last years, some studies appeared focusing on the role of adipocytokines in osteoarthritis and they correlated adipocytokines with cartilage degradation and x-ray degree; in our study we will focused in the importance of adipocytokines in the inflammatory changes more than in joint destruction.


Eligibility Criteria:
Inclusion Criteria:

* aged 50 to 81
* primary osteoarthritis of the knee
* synovial effusion in examination
* patient who have the results in our database

Exclusion Criteria:

* any other rheumatic conditions as rheumatoid arthritis or another inflammatory disease
* secondary knee osteoarthritis
* history of knee surgery
* any conditions that at investigator criteria exclude the patient from study procedures
Non-inferiority Study of a Cardiac Tele-rehabilitation in Hybrid Form Compared to a Cardiac Rehabilitation

Cardiac tele-rehabilitation in a hybrid form can be a choise for the management of cardiovascular diseases. The aim is to increase the participation rate of patients in cardiac rehabilitation.

This new form of care can be as effective as traditional care.

The Covid-19 pandemic has had indirect effects on the health system, particularly in the management of cardiovascular diseases. Rehabilitation centres had to adapt their operation to the recommendations of health authorities. The choice appeared to be unavoidable: tele-rehabilitation care in a hybrid form. Moreover, Many patients do not participate at this kind of care. Many identified factors can explain this low rate of participation : a lack of proximity facilities does not promote patient participation.

The objective of this study is to demonstrate a comparable effectiveness between a cardiac telerehabilitation programme in hybrid form and a cardiac classic rehabilitation programme.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 ans
* Patients with heart disease
* Inclusion in the rehabilitation program

Exclusion Criteria:

* Cardiac decompensation
* No stabilised acute coronary syndrome
* Decompensated heart failure
* Severe ventricular rhythm disorders
* Severe functional limitation
Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled Trial

This study will investigate whether the combination of moxibustion and characteristic lifestyle intervention of TCM can alleviate the clinical symptoms and improve quality of life and mental health in patients with abdominal obesity. The results are expected to provide clinical evidence for the application of the combination of moxibustion and characteristic lifestyle intervention of TCM in patients with abdominal obesity.

This study will be a randomized controlled trial conducted from January, 2020 to January, 2022 that includes 150 participants who have abdominal obesity and meet the eligibility criteria. The participants will be randomly divided into 3 groups in a 2:2:1 allocation ratio.The intervention group will receive moxibustion combined with characteristic lifestyle intervention of TCM;the other group will receive moxibustion combined with lifestyle intervention;the control group will receive lifestyle intervention only.Each treatment will last 12 weeks including 8 weeks of intervention period and 4 weeks of follow-up period. The primary outcome is the waist circumference(WC),the secondary outcomes include obesity-related indicators,serum biochemical indexs,blood pressure, conversion score of constitution characteristics, and measurement of the scale.Adverse events will be recorded during the intervention and follow-up period.

Eligibility Criteria:
Inclusion Criteria:

Patients recruited for this study should meet the following inclusion criteria:

1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.

Exclusion Criteria:

Patients with any of the following criteria will be excluded from the study:

1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
3. Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
4. History of bulimia, anorexia, or any other eating disorders.
5. Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
6. History of surgical weight loss, postoperative adhesions.
7. History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
8. Presence of local skin rupture, allergy and scar constitution.
9. Unable to cooperate with the research caused by other diseases or reasons.
MCR Syndrome in Quebec : Results From NuAge Study

The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the Quebec elderly population.

Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with physiological and pathological aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Both declines in cognition and locomotion are associated, furthermore the temporal nature of their association has been unclear for a long time. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that MCR syndrome is a pre-dementia syndrome, suggesting that low gait performance is the first symptom of dementia. The uniqueness of MCR syndrome is that it does not rely on a complex evaluation or laboratory investigations. Indeed, this syndrome combined subjective cognitive complaint and objective slow gait speed, and is easy to apply in population-based settings.

Prevalence and incidence of MCR syndrome, as well as its association with incidence of cognitive decline and impairment, have never been reported in Canada. Nutrition as a determinant of successful aging: The Quebec longitudinal Study (the NuAge study) is a Quebec population-based observational cohort study performed in healthy older community-dwellers adults which provides a unique opportunity to: 1) obtain reliable estimates of MCR syndrome prevalence and incidence, 2) determine the distribution of clinical and biological (blood biomarkers and genetic) characteristics associated with MCR syndrome, 3) examine the association of MCR syndrome and its biological characteristics with cognitive decline and incidence of cognitive impairment in the Quebec elderly population.


Eligibility Criteria:
Inclusion Criteria:

* All included participants of NuAge Study

Exclusion Criteria:

* no information about cognitive complaint in NuAge database
* no measure of walking speed in NuAge database
* no follow-up completed in NuAge database
Normobaric Oxygen Therapy for Individuals With First-Episode Psychosis

Single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: Effects on symptomatology and cognition.

Functional deficits in prefrontal, limbic, and temporal regions of the brain are well-documented among individuals with psychotic disorders. Mitochondrial dysfunction may contribute to such pathology, and effective functioning of mitochondrial activity in the brain in dependent on a sufficient supply of oxygen. These data suggest that oxygen therapy may improve symptoms in individuals with psychosis. This small pilot study will test this hypothesis.

Individuals with first-episode psychosis will be randomized to receive either (i) 4 weeks of nightly normobaric oxygen therapy (40% FiO2) or (ii) 4 weeks of a placebo condition utilizing room air oxygen levels (21% FiO2). Participants will be blinded to what condition they receive. Both conditions will be delivered via nasal cannula connected to oxygen concentrators at five liters per minute (lpm), and participants will be instructed to complete the intervention overnight while sleeping. At the end of the 4 week period, all individuals will receive an additional 4 weeks of unblinded (i.e., "open label") nightly normobaric oxygen therapy (40% FiO2). Study assessments will be completed at (i) enrollment; (ii) 4 weeks after enrollment, and (iii) 8 weeks after enrollment.

Eligibility Criteria:
* Diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the Structured Clinical Interview for the DSM-5.
* Less than 5 years since the onset of frank psychotic symptoms as determined using the Symptom Onset in Schizophrenia Inventory .
* No evidence of a pre-existing intellectual disability defined as a premorbid IQ \>70 as estimated using the Reading subtest of the Wide Range Achievement Test-4.
* Ages 15-35
* Non-smoker for past six months
* Absence of suicidal ideation or behavior over the past month as assessed by the Columbia Suicide Severity Rating Scale
* The American Association for Respiratory Care notes that "no absolute contraindications to oxygen therapy exist when indications \[for oxygen therapy\] are present."
A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection

The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
* Age of 18 to 55 years (inclusive).
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Participants of reproductive potential (childbearing potential1) must be willing and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year from at least 30 days before administration of the trial medication until 30 days after trial completion.

Exclusion Criteria:

* Previous exposure to adalimumab or proposed adalimumab biosimilar drugs.
* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) that deviates from normal and judged as clinically relevant by the investigator.
* Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
* History of relevant orthostatic hypotension, fainting spells, or blackouts.
* Chronic or relevant acute infections.
* Positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C (Hep C) at screening.
* History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex).
* Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial.

Further exclusion criteria apply.
Synthetic vs Natural Estrogen in Combined Oral Contraception

The main objective of the study is to compare the metabolic effects of natural estradiol and synthetic ethinylestradiol used in combined oral contraception in healthy women. A progestin-only preparation will be used in comparison. The main goal is to study the effects on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP). Our hypothesis is that the natural estradiol preparation will influence blood glucose levels, markers of coagulation and chronic inflammation less than the ethinylestradiol preparation. The progestin-only preparation will not effect these parameters.


Eligibility Criteria:
Inclusion Criteria:

* BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any hormonal contraceptives, no contraindications for use of hormonal contraception

Exclusion Criteria:

* Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation, abnormal result in pre-screening 2h oral glucose tolerance test, regular medications
S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)

This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy . With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.

Eligibility Criteria:
Inclusion Criteria:

* 18 ≤ age ≤ 70 years old
* Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer therapy, etc.
* The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
* Having given written informed consent prior to any procedure related to the study
* Expected survival time ≥3 months

Exclusion Criteria:

* Known to have abdominal viscera metastasis of gastric cancer patients
* Inadequate hematopoietic function which is defined as below:

  * white blood cell (WBC) less than 3,500/mm\^3
  * absolute neutrophil count (ANC) less than 1,500/mm\^3
  * platelets less than 80,000/mm\^3
* Inadequate hepatic or renal function which is defined as below:

  * serum bilirubin greater than 2 times the upper limit of normal range
  * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
  * blood creatinine level greater than 1.5 times ULN,Creatinine clearance \< 60ml/min
* Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
* Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
* Psychiatric disorder or symptom that makes participation of the patient difficult
* Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
* Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
* Known DPD deficiency
* Have the history of allograft transplantation
* Conducted the autologous bone marrow transplantation in 4 weeks
* Participate in other clinical trial before the start of this trial in 4 weeks
* Patient compliance is bad or researchers believe that patients are not suitable for this treatment
* Known to have active hepatitis patients
* HER-2-positive patients (ICH3+or FISH+)
* History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
Telerehabilitation on Physical and Mental Health of the Elderly in the Covid-19 Pandemic Context

Introduction: Due to the COVID-19 pandemic scenario, social distancing has become the main strategy to contain this pandemic, causing negative impacts on the physical and mental health of the elderly population. To promote the continuity of offering health services during isolation telerehabilitation was used. Thus, it is important to investigate the effect of a physical exercise program and health education through telerehabilitation on physical and mental aspects in order to establish it as an alternative care for the elderly. Objectives: To evaluate the effect of a program of physical exercises and health education by telerehabilitation on signs of sarcopenia, physical performance, hand grip strength and levels of anxiety, depression and sleep quality in elderly women. Method: In this non-randomized clinical trial, considered a pilot study, eight elderly women (73,00±4,69 years old) will be submitted to 16 weeks of intervention through a program of physical exercise and health education using the Google Meet platform (synchronous online), frequency of 3 weekly sessions and duration of 50' (Initial rest: 5'; Warm-up: 15': Resistance exercises: 20'; Stretching exercises: 5'; Relaxation and final rest: 5'). Before and after the intervention period, the following tests will be applied: SARC-F, Short Physical Performance Battery, hand-grip dynamometry, Geriatric Anxiety Inventory, Geriatric Depression Scale and Pittsburgh Sleep Quality Index. To compare the two moments, the paired Student's T-test or Wilcoxon test (normality assessed by the Shapiro-Wilk test) will be used with p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 60 years or older;
* Able to perform all the proposed assessments;
* Not present cognitive impairment according to the assessment of mental status through the Mini Mental State Examination;
* Participate in the supervised physical exercise program in person, prior to the beginning of the COVID-19 pandemic.

Exclusion Criteria:

* had a frequency of participation in the program below 75%.
The FLASH Study: A Study of Roflumilast Versus Placebo in Patients With Asthma (BY217/M2-023)

The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.


Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of persistent chronic bronchial asthma
* Baseline lung function within specified parameters
* No change in asthma treatment during the last 4 weeks prior to start of baseline period
* Stable clinical state
* Except for asthma, in good health
* Non-smokers or ex-smokers

Main Exclusion Criteria:

* Poorly controlled asthma
* Diagnosis of chronic pulmonary disease and/or other relevant lung diseases
* Patients using continuously (more than 3 days per week) \> 8 puffs/day rescue medication