cyrilzakka/clinical-trials huggingface dataset:
Nutrition Childhood Cancer Survivors

NUTRITION CCS is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission. The study was conducted in the Clinic for childhood cancer survivors. The clinic is attended by patients older than 18 years and was built in 2016 at the St. Anne's Hospital in Brno.

NUTRITION CCS is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission.

Objectives of the study

1. to determine the prevalence (incidence) of nutritional disorders, especially obesity and metabolic syndrome, in cured paediatric cancer patients in adulthood;
2. to investigate the role of adipokines in the development of cardiometabolic complications in this group of patients; 3. to determine whether targeted dietary and lifestyle interventions can lead to improvements in nutritional status and subjectively perceived quality of life of treated paediatric cancer patients in adulthood and objectively assessed cardiometabolic risk

Eligibility Criteria:
Inclusion Criteria:

* Patients after treatment from childhood and adolescent cancers.
* The subject is male or female, aged 18 - 64 years

Exclusion Criteria:

* Patients with acute cancer therapy
* Pregnant women
A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors

A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors

To evaluate VRT106 for injection in patients with locally advanced/metastatic solid tumours for safety and tolerability, exploring the maximum tolerated dose (MTD)/maximum administered dose (MAD)/optimal bioavailable dose (OBD) and/or the recommended phase II clinical dose (RP2D) to provide a recommended dose for subsequent clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.
2. Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female.
3. Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment.
4. Subjects have at least one measurable lesion.
5. ECOG score of 0 to 28 days prior to first dose of IMP.
6. An expected survival time of ≥ 12 weeks.
7. Have sufficient organ function.
8. Female patients of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose of study drug.
9. Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.

Exclusion Criteria:

1. Subject has received any antitumor therapy within 4 weeks prior to the first dose of IMP.
2. Subject has previously received oncolytic virus or other gene drug therapy.
3. Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of IMP.
4. Subject is known to have an allergic reaction to any of the components of IMP.
5. Women who are breastfeeding.
Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC

Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting, and to identify potential neoadjuvant immunochemotherapy beneficiaries.

Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment option to many patients, most evidence is based on interventional clinical trials, in which the participants are highly selected and the therapeutic strategies are restricted, resulting in limited representation. There is still a lack of large-scale multicenter real-world data to further verify the benefits in long term overall survival, identify the potential beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy.

To meet the forementioned need, the investigators will perform a multi-center retrospective cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant immunochemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Cytological or histological diagnosis of non-small cell lung cancer
2. Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery;
3. Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition);
4. No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
5. ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
6. At least one measurable lesion (RECIST v1.1);
7. Age \>= 18 years old and \<= 85 years old;
8. Be able to abide by the visits and related procedures stipulated in the program.

Exclusion Criteria:

1. Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
2. Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI\>30 or if AHI is lower than 30, at least 10 micro arousals identified during diagnosis PSG).
* Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
* Patients receiving social security coverage (excluding MEAs)
* Fluent spoken and written French

Exclusion Criteria:

* Severe heart disease
* Co-existing lung disease
* Co-existing sleep disorder
* Pregnant
* Refused participation
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination

A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.

SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* voluntarily signed the informed consent form.

Exclusion Criteria:

* Pregnant women.
Bilateral Cochlear Implant Benefit in Young Children

The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months.


Eligibility Criteria:
Inclusion Criteria:

* Profound bilateral hearing loss
* Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System
* Age at implant: 12-36 months
* No previous cochlear implant use
* English as the primary language spoken in the home
* Parental willingness to follow study protocol

Exclusion Criteria:

* Deafness secondary to meningitis
* Presence of other conditions that could affect study participation
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
* A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

* Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
* Patients with any clinically significant respiratory conditions other than COPD
* Clinical history that suggests that the patient has asthma as opposed to COPD
* Chronic use of oxygen therapy ≥ 15 hours/day
* Patients with clinically significant cardiovascular conditions
* Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
* Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
* Current diagnosis of cancer other than basal or squamous cell skin cancer
Branched-chain Aminoacids in Sleep Apnea Syndromes (ARSAS)

The initial hypothesis is that branched-chain aminoacids (BCAA) administration could be beneficial to patients suffering from sleep apnea syndrome (SAS), the aim of the present work is to verify this hypothesis.

The literature data demonstrate that a BCAA complementation improves the physical performances, protects lean mass and increases VO2 max during training.

We demonstrated earlier that this complementation can cure at less partly the hypoxemia of chronic obstructive pulmonary patients by a stimulation of respiratory centres.


Eligibility Criteria:
Inclusion Criteria:

* Adult with healthy mind, who has attained his majority, and affiliated to Social Security.
* Patient suffering from SAS confirmed by polysomnography (PSG).
* Written informed consent form signed.

Exclusion Criteria:

* Patients receiving neuroleptics or benzodiazepines and affiliated drugs will not be included in the study.
* Patients suffering for severe SAS : those who have a number of IAH higher than 30 in a validated sleep hour, will be excluded for security reasons.
* Pregnant women, nursing mothers or women susceptible to procreate without efficient contraception.
* Patient presenting hypersensitivity to understudying products and their excipients.
Effects of Increased Tidal Volume on Internal Jugular Vein Cross-sectional Area

As increasing tidal volume, the cross sectional area and circumference of Internal Jugular Vein (IJV) could increase. And In the previous study, Trendelenburg position can increase size of IJV. So investigators would compare the cross sectional area, circumference of IJV and peak airway pressure in neutral and Trendelenburg position


Eligibility Criteria:
Inclusion Criteria:

* patients who are undergoing general anesthesia

Exclusion Criteria:

* history of IJV cannulation
* uncontrolled cardiovascular disease
* severe pulmonary problem
* cervical spinal impairment
Saline Infusion Test in Hyponatremia

Observational study of biochemical volume biomarker levels in response to a standardized intravenous isotonic saline infusion in patients with hyponatremia.

Hyponatremia (low plasma sodium concentration) is a common electrolyte disorder among hospitalized patients that can lead to complications such as gait instability, falls and mental changes. Both hyponatremia itself and overly rapid correction of hyponatremia may lead to brain damage.

There are several underlying causes of hyponatremia that require different treatment strategies. Specifically, hypovolemia is treated with fluid infusion while other common causes such as the syndrome of inappropriate diuresis (SIAD) and hypervolemic conditions need fluid restriction. In clinical practice, it can be challenging to identify the main cause of hyponatremia due to overlapping diagnosis and unreliable diagnostic tools, typically leading to a timely trial and error approach to therapy.

A saline infusion test (SIT) is often used to diagnose hypovolemic hyponatremia. To our knowledge, the test has never been validated, but relies on the rationale that the sodium concentration will increase more with saline infusion in hypovolemia than in other causes of hyponatremia. Typically, one liter of isotonic saline is infused intravenously and an arbitrarily set cut-off for sodium increase is used to indicate hypovolemia. As the response of sodium depends on several factors that affects the renal free water excretion capacity, this measure may not be the most accurate nor the most efficient. Another, more direct, approach could be to measure the change in biochemical markers of circulating volume in response to the volume expansion that comes with saline infusion. We will measure several different biomarkers before, during and after a standardized isotonic saline infusion in patients hospitalized with hyponatremia. Based on the results, we hope to develop a more precise tool for the differential diagnosis of hyponatremia.

Eligibility Criteria:
Inclusion Criteria:

* Plasma sodium 120-130 mmol/L
* Effective osmolality (2 x plasma sodium + plasma glucose) \< 275 milliosmol/L
* Age \> 18 years

Exclusion Criteria:

* Intensive care unit (ICU) admission
* Adequate sodium correction rate: \> 4 mmol/L last 24 hours
* Primary polydipsia: urine osmolality \< 100 mOsm/L
* Hypertonic saline therapy
* Adrenal insufficiency
* Severe heart failure: ejection fraction \< 35 % or clinical suspicion of decompensated heart failure
* Ascites grade 3 (marked abdominal distention and discomfort)
* Chronic renal failure stage 4 or 5: estimated glomerular filtration rate \< 30
* Failure to submit informed consent
High Flow Nasal Cannulae Oxygen Therapy in Respiratory Insufficiency Patients

Chronic respiratory insufficiency in patients with advanced disease to the late treatment depends mainly on mechanical ventilation and other high intensity respiratory support therapy. Strengthen the stability of chronic respiratory insufficiency intervention can reduce the frequency and extent of acute disease, saving medical resources.High-flow nasal cannula (HFNC), as a new non-invasive oxygen therapy system, has gradually become a weapon of respiratory support therapy. There is little research on the role of HFNC in oxygen therapy for chronic respiratory insufficiency.

Our previous studies have found the potential value of HFNC in chronic respiratory insufficiency. The aim of this project is to promote the use of HFNC in the t reatment of chronic respiratory insufficiency in HFRS in Shanghai first, second and third grade hospitals in an effort to confirm that HFNC can improve the prognosis of patients with chronic respiratory insufficiency compared with nasal oxygen therapy.

1. To confirm HFNC used in patients with chronic respiratory insufficiency oxygen therapy than the general nasal catheter oxygen and the difference between what better.
2. We set up a point of research in the tertiary hospitals, secondary hospitals and primary hospitals to explore the different levels of HFNC in the application of the efficacy of the hospital there are differences and what is better. To further clarify the promotion of HFNC to secondary hospitals and primary hospitals have no meaning.
3. Patients with chronic respiratory insufficiency who required long-term oxygen therapy were randomized to a randomized, controlled, multicentre clinical trial of HFNC with nasal oxygen therapy. Analysis and comparison of HFNC and general nasal catheter oxygen in the treatment of chronic respiratory insufficiency there is no difference, HFNC in different grades of hospital use is consistent.
4. Research methods:

4.1 Subjects: Chronic respiratory insufficiency required long-term oxygen therapy to Shanghai Tenth People's Hospital and multi-center hospital patients.

4.2 Study sample size: 100 samples were collected from each of the three test centers. Of which 150 cases of nasal oxygen therapy, HFNC 150 cases.

Eligibility Criteria:
Inclusion Criteria:

- Patients with chronic respiratory insufficiency who require long-term oxygen therapy.

Age 18-85 years old. Agree to participate in this study.

Exclusion Criteria:

- Patients with advanced respiratory support (invasive mechanical ventilation, noninvasive mechanical ventilation) indications Cardiovascular disease caused by respiratory insufficiency Immune dysfunction caused by respiratory insufficiency Tumor-induced respiratory insufficiency People with disturbance of consciousness
Glycemic Response to an Innovative Cookie to Promote Human Health

The aim of this study is to investigate whether using a coarse wheat fraction in wire-cut cookie making induces a lower glycemic response in healthy subjects compared to wheat flour.

This study has a double-blind, randomized, cross-over design. During each of the two study visits, healthy participants will consume a standard portion of cookies. One cookie formulation will present a large amount of coarse wheat fraction, while the other formulation will include only wheat flour and will serve as a control. Blood glucose measurements will be taken postprandially at regular time points. Gastric emptying rate and oral processing behavior will be also object of study.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) range 18.5 - 25.0 kg/m2 at screening visit
* Fasting whole blood glucose values \< 6.3 mmol/L
* Regular diet with 3 meals a day (at least 5 times a week)
* Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigators on the basis of medical history
* Willingness to maintain habitual diet, physical activity pattern, and body weight throughout the trial
* Willingness to abstain from alcohol consumption and to avoid vigorous physical activity for 24 h prior to study visits
* Adequate level of understanding spoken and written English
* Willingness to report lifestyle factors such as level of physical activity and perceived psychological stress
* Willingness to provide informed consent to participate in the study

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria
* Recent participation in any clinical trial (\< 90 days)
* Pregnant or lactating or wishing to become pregnant in the period of the study
* Known history of AIDS, hepatitis, diabetes mellitus (Type I and II), cardiovascular disease, any pathology (or recent surgical event) of the gastrointestinal system or any current metabolic or endocrine disease
* Alcohol consumption of \> 14 standard drinks for women and \> 21 standard drinks for men per week
* Currently smoking (have smoked in the last 28 days) or willingness to smoke during the study period
* Celiac disease or gluten intolerance
* Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids the last 4 weeks before the screening visit
* Use of antibiotics during the last three months
* Reported slimming or medically prescribed diet
* Unwillingness or inability to comply with the experimental procedures and to follow the safety guidelines
Onset and Duration of Forearm Nerve Blockade

This pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. Local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks
* American Society of Anesthesiologists (ASA) physical status I, II or III
* Able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch
* Scheduled to undergo primary hand surgery
* Able to understand the Dutch language, purpose and risks of the study
* Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule, and complete all study assessments

Exclusion Criteria:

* Currently pregnant or nursing
* History of hypersensitivity to local anesthetics
* Contraindication to lidocaine, bupivacaine, paracetamol
* Medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff
* Suspected or known recent history (\< 3 months) of drug or alcohol abuse
* Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Carpal Tunnel Syndrome and which may confound the postsurgical assessments
* Infection at the planned block site(s)
* Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
* Body weight \<40 kg or body mass index \>44 kg/m2
* Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
* Any chronic neuromuscular deficit affecting the Ulnar and Median nerves or muscles of the surgical extremity
* Any chronic condition or disease that would compromise neurological
* Presence of pre-existing coagulation disorders
* Baseline neurological deficits