cyrilzakka/clinical-trials huggingface dataset:
Short to Long Effects of Whole Body Cryostimulation on Insulin Sensitivity Among Overweight

Therapeutic effectiveness of coldness in relieving pain and reducing inflammation has been known for many years now. Over that time, various coldness therapies have gained in popularity, including winter swimming, snow baths or whole body cryostimulation (WBC) . Recent researches have shown positive effects of WBC on metabolic profile, low-to-moderate chronic inflammation and related diseases (e.g., obesity). WBC could be, thus, intended as an adjuvant method in the treatment of dysmetabolic conditions, such as overweight or obesity. WBC is a cheap easily accessible practice, with a few well-defined contraindications and limited non severe possible adverse events, if performed in specialized centres. At the same time, in sport science appears data, which indicated on inhibition of adaptive changes induced by regular training.

The primary aim is to define, through a randomized controlled approach, the relative effectiveness of up to 20 consecutive sessions of either WBC, high-intensity intermittent training (HIIT), or their combination (WBC and HIIT) in improving the metabolic status of overweight and obese subjects. The effects will be assessed, at different time-points, in terms of insulin sensitivity and modification in the profile of hormones regulating the energy metabolism (adipokines, myokines, bone-derived hormones) and the inter-organ cross-talk.

Secondary aims are:

1. To assess the influence of WBC and HIIT on insulin sensitivity and establish the role of myokines (irisin and IL-6) in this regulation. To find the answer for the question if the rise of mentioned myokines cause a decrease of authophagy protein HMGB1.
2. To characterize potential effectiveness of these intervention protocols on bone and energy metabolisms by stimulating in vitro cultured normal human osteoblastic primary cells and β-pancreatic cells with sera obtained from patients at different time points during treatment.
3. To establish, which procedure is most effective at improving insulin sensitivity: training or training supported with WBC treatment, which factors modify this response (body composition or physical capacity of subjects)
4. To establish if training supported with WBC treatment impairs adaptive changes of trained subjects
5. To determine the potential beneficial effects of the intervention protocols on the metabolic homeostasis, and assess how long these changes are maintained over a period of four weeks or three months.

Eligibility Criteria:
Inclusion Criteria:

* obesity (BMI \>30kg/m2),
* age \>18 years,
* diagnosis of impaired glucose tolerance (IGT),
* functional autonomy,
* ability to discernment,
* no WBC treatment within the previous year.

Exclusion Criteria:

* using insulin or other chronic medications,
* inflammatory/immune-mediated pathologies,
* T2D,
* liver or kidney disease,
* cardiovascular diseases,
* neuropathy, retinopathy,
* neoplasia, as well as fragility fractures of bones,
* traumatic fractures in the previous 2 years,
* contraindications for WBC and exercise
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency

This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years.

LAL Deficiency is a rare autosomal-recessive lipid storage disorder that is caused by a marked decrease or almost complete absence of LAL, leading to the accumulation of lipids, predominately cholesteryl esters and triglycerides, in various tissues and cell types. In the liver, accumulation of lipids leads to hepatomegaly, liver dysfunction, and hepatic failure. Although a single disease, LAL Deficiency presents as a clinical continuum with 2 major phenotypes, Cholesteryl Ester Storage Disease (CESD) and Wolman Disease.

Early-onset LAL Deficiency (Wolman Disease) is extremely rare, with an estimated incidence of less than 2 lives per million. It is characterized by profound malabsorption, growth failure, and hepatic failure, and is usually fatal in the first year of life.

Eligibility Criteria:
Inclusion Criteria:

* Participant's parent or legal guardian provided written informed consent/permission prior to any study procedures.
* Male or female child with documented decreased LAL activity relative to the normal range of the laboratory performing the assay or documented result of molecular genetic testing (2 mutations) confirming a diagnosis.
* Growth failure with onset before 6 months of age.

Exclusion Criteria:

* Clinically important concurrent disease or comorbidities.
* Had received an investigational product other than sebelipase alfa within 14 days prior to the first dose.
* Participant was older than 24 months of age.
* Myeloablative preparation, or other systemic pre-transplant conditioning, for hematopoietic stem cell or liver transplant.
* Previous hematopoietic stem cell or liver transplant.
* Known hypersensitivity to eggs.
Effects of Repetitive Transcranial Magnetic Stimulation on Fear of Cancer Recurrence: mPFC-amygdala-hippocampus

Introduction: Previous studies have shown that many breast cancer patients are suffering from fear of cancer recurrence (FCR). However, effective physical intervention for FCR has been scarce. In this study, low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral prefrontal cortex (DLPFC) will be applied on patients with high FCR. We aim to assess the efficacy of low-frequency rTMS in the treatment of FCR in breast cancer patients.

Methods and analysis: This will be a two-arm, randomised controlled trial comparing rTMS, sham stimulation in breast cancer patients with high FCR. A total of 50 breast cancer patients with a high FCR score (\>27) will be recruited. Patients will be randomly assigned to receive 4-week rTMS, sham stimulation. Assessments will be conducted at week 0 (baseline), week 4 (the end of intervention), week 5 (1 week post-treatment), week 8 (1 month post-treatment), and week 16 (3 months post-treatment). The primary outcome of the study will be to ascertain, whether the rTMS program is sufficient in relieving FCR in breast cancer patients (measured by the 7-item FCR scale). Additionally, GAD7, PHQ9, NRS, and ISI7 will be used to measure individual's anxiety, depression, pain, and insomnia symptoms.

This study will be a parallel assignment randomised controlled trial (RCT). Patients will be randomly assigned to rTMS intervention group (rTMS+ TAU), sham stimulation group (sham+ TAU). Treatment will be performed 5 times a week for 4 weeks. Assessments will be conducted at week 0 (baseline), week 4 (the end of intervention), week 5 (1 week post-treatment), week 8 (1 month post-treatment), and week 16 (3 months post-treatment). The screening, assessments, allocation and intervention will all be carried out via a WeChat mini Program (a widely used social communication application, with more than 1.2 billion users in China) specially tailored for the trial. An information sheet will be provided online, and informed consent will be completed online before participation in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Adult;
2. Breast cancer patients undergoing treatment for the first time;
3. Able to understand and sign informed consent;
4. Being able to comply with the intervention.

Exclusion Criteria:

1. Minors;
2. Having a diagnosis for a significant untreated mental or medical illness (e.g., consciousness disturbances, mania, acute phase of schizophrenia, major depressive disorder, etc.);
3. Patients with recurrent cancer;
4. Hospice patients.
Tromsø Birch Rust Allergy Study. Allergy to Birch Rust, a Possible Explanation to Seasonal Airway Allergy During Autumn?

In this project we study if spores from birch rust fungi (Melampsoridium Betulinum = MB) may be the eliciting allergen in patients with seasonal airway allergy during autumn in North Norway. Patients with suspected allergy to MB are compared with non-allergic controls using data about allergic disease and daily allergic symptoms during autumn. Daily spread of MB spores are compared with daily variations in allergic symptoms. Sensitization to MB and MB allergy are tested with skin prick test, specific immunoglobulin E (IgE) in serum, nasal provocation test and basophil activation test (BAT).

It is unknown why patients experience seasonal airway allergy during autumn in Norway, when there is no spread of pollen. Some old studies indicate that rust fungi on other plants may act as allergens to humans (1-6). In Norway, some patients report typical symptoms of allergic rhino-conjunctivitis and asthma from August to October which stops when temperature falls below zero (Celsius). Based on several patient experiences we hypothesize that MB may cause seasonal airway allergy during autumn. In this pilot study we will compare 30 patients with suspected allergy to MB with a control group of 15 non-allergic individuals. All 45 participants will answer the MeDALL (mechanisms of the development of allergy) questionnaire (7) about allergic diseases and daily register allergic symptoms (8) in the period from 1st of August to 15th of October 2020. Daily variations in symptoms will be compared with daily variations in spread of MB spores registered in pollen traps. Sensitization to MB will be tested with skin prick test and specific IgE in serum and allergy to MB with nasal provocation test and basophil activation test (BAT).

Identification of allergens and production of MB extracts for testing will be performed by Luxembourg institute of Health (LiH)(9-12) and BAT by Oslo University hospital (13-14)

Eligibility Criteria:
Inclusion Criteria:

* Self reported seasonal airway allergic symptoms during autumn

Exclusion Criteria:

* Perennial airway allergic symptoms without worsening during autumn
A Study to Evaluate the Relationship of Lenalidomide With Tumor Flare Reaction and High Tumor Burden in Participants With Relapsed or Refractory Mantle Cell Lymphoma

The purpose of this study is to investigate and characterize the association of lenalidomide with tumor flare reaction and high tumor burden in participants with relapsed or refractory mantle cell lymphoma.

This is a European multinational, retrospective, non-interventional study of participants with relapsed or refractory mantle cell lymphoma (R/R MCL). Potential sites will be identified where R/R MCL participants have been treated with lenalidomide. Site inclusion will be limited to countries where lenalidomide is reimbursed for this indication.

Eligibility Criteria:
Inclusion Criteria:

Received at least one dose of lenalidomide commencing after 08 July 2016 for the treatment of relapsed refractory mantle cell lymphoma.

Informed consent of the patient or an authorized third person or authority, if required by law, given prior to data collection.

Patient must be ≥18 years of age at the time of signing the informed consent form.

Exclusion Criteria:

1) Patients will be excluded if they were participating in an interventional clinical trial during the treatment period under observation in this Post Authorization Safety Study.
Respiratory Syncytial Virus Infection in Exacerbations of Chronic Obstructive Pulmonary Diasease: the RECODE Study

The goal of this observational study is to determine the prevalence of respiratory syncytial virus (RSV) infection and evaluate its association with clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations during the RSV season (October-April). The main question it aims to answer is:

* What is the prevalence of RSV infection in patients with COPD during exacerbations in the RSV season?
* Does RSV infection lead to worse clinical outcomes, including hospitalization, longer length of stay, acute cardiovascular events, and/or death in patients with COPD exacerbations?

Researchers will compare patients with RSV infection to those without RSV infection to see if RSV infection results in worse clinical outcomes, such as increased hospitalization, longer stays, cardiovascular events, or death.

Participants will:

* Be adults diagnosed with COPD who present to the emergency department or day hospital due to acute exacerbations of their respiratory symptoms.
* Receive treatment as per standard clinical care for COPD exacerbations, including long-acting bronchodilators and inhaled corticosteroids, and may complete a course of antibiotics and/or oral corticosteroids if prescribed during hospitalization.
* Undergo diagnostic testing for RSV infection as part of the clinical routine to determine the presence or absence of the virus during their exacerbation.
* Have clinical outcomes monitored, including hospitalization rate, length of stay, and any acute cardiovascular events, as well as mortality during the exacerbation period.
* Provide relevant demographic and clinical data, including medical history, COPD severity, comorbidities, and previous exacerbation events.


Eligibility Criteria:
Inclusion Criteria:

* Female or male
* ≥50 years of age
* Seeking urgent medical attention because of ECOPD, as defined by the Rome consensus definition: "in a patient with COPD, an exacerbation is an event characterized by dyspnea and/or cough and sputum that worsen over \<14 d, which may be accompanied by tachypnoea and/or tachycardia and is often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insult to the airways"

Exclusion Criteria:

* Previous RSV vaccination (other vaccines will be allowed and recorded)
* Active cancer (or any other disease) that may alter the immune status of the patient
* Neurologic disorders that incapacitate the participation of the patient
* No signing of the informed consent
Optiflow® to Prevent Post-Extubation Hypoxemia afteR Abdominal Surgery (the OPERA Trial)

To evaluate whether early application of nasal high flow oxygen therapy after extubation can reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio \<300) after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.

Postoperative hypoxemia complicates between 30 to 50% of patients after abdominal surgery. Loss of functioning alveolar units and development of atelectasis after abdominal surgery have been recognized as the underlying mechanisms responsible for postoperative hypoxemia. Supplemental Oxygen administration is therefore widely recommended after extubation in the postoperative period, especially in patients with high risk of postoperative respiratory complications. Although oxygen therapy is effective in preventing the vast majority of severe postoperative hypoxemia after extubation in surgical patients, respiratory failure may occur, thus requiring endotracheal intubation and mechanical ventilation or therapeutic use of non-invasive positive pressure ventilation (NPPV). In patients with postoperative hypoxemia (defined as patients with a PaO2/FiO2 ratio \<300), application of NPPV was found to decrease the incidence of endotracheal intubation after abdominal surgery. Nevertheless, use of NPPV in the postoperative period is responsible for organizational constraints and increases healthcare utilization.

Nasal high flow cannula (NHFC) has been described as an attractive and well-tolerated method of non-invasive oxygen delivery. Previous studies have shown that NHFC generates a low level of positive airway pressure, increases end-expiratory lung volume and reduces airway resistance, thus contributing to a reduction in work of breathing. To date, however, no clinical trials have compared NHFC to standard oxygen therapy in the prevention of postoperative hypoxemia after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.

The primary objective of the study is to compare: 1- Standard oxygen therapy; 2- Nasal high flow oxygen therapy after extubation in patients with intermediate to high risk of postoperative pulmonary complications after abdominal surgery.

Our hypothesis is that, compared with standard oxygen therapy, early application of nasal high flow oxygen therapy can reduce the need for postoperative NPPV for postoperative hypoxemia (defined as PaO2/FiO2 ratio \<300).

Eligibility Criteria:
Inclusion Criteria:

* Planned or unplanned surgical procedures
* Abdominal or abdominal and thoracic surgery
* Expected duration ≥2 hours
* ARISCAT score ≥26 points

Exclusion Criteria:

* Age \<18 years
* Body mass index \>35 kg/m2
* Sleep apnea syndrome
* Patient refusal
* Pregnancy and/or lactation
Randomized Control Trials of Surgery for Pediatric OSA

Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.

Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.

Eligibility Criteria:
Inclusion Criteria:

* OAHI \>= 2
* Tonsillary hypertrophy, Brodsky size 2-4
* Adequate swedish knowledge

Exclusion Criteria:

* Cardiovascular disorders
* Pulmonary disorders
* Neuromuscular disorders
* Cranoifacial malformations
* Genetic disorders
* Earlier performed adenoid-tonsillary-surgery
* Bleeding disorders
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）

This is a multicenter, randomized, open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 9 mg QW versus Semaglutide 2.4 mg QW in overweight or obese (BMI≥27kg/m2) MAFLD subjects. Subjects will be randomly assigned to IBI362 9 mg and Semaglutide 2.4 mg groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week open-label treatment period, and a 12-week drug withdrawal safety follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18 years or older at the time of signing informed consent
2. diagnosed as MAFLD according to the Chinese Guideline for the prevention and treatment of metabolic dysfunction-associated (non-alcoholic) fatty liver disease (Version 2024)
3. liver fat content ≥8% measured by MRI-PDFF
4. BMI≥27 kg/m2
5. Weight change ≤5% within 3 months before screening
6. HbA1c≤10%

Exclusion Criteria:

1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
2. Used drugs or alternative therapies with weight loss effects within 3 months before screening, including but not limited to: GLP-1 receptor agonists, orlistat, phenylpropanolamine, chlorpheniramine, phentermine etc.
3. Received chronic (\>2 weeks) systemic glucocorticoid treatment within 3 months before screening (excluding topical, intraocular, intranasal, and inhaled administration)
4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes)
5. Active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery)
6. Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study
7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
Neoadjuvant Endocrinotherapy of Breast Cancer (Mamma Carcinoma) With Exemestane

The objective of the present clinical investigation is to determine whether hormonal therapy given preoperatively is able to reduce tumor size to an extent that facilitates breast-conserving procedures.

This open, prospective multicenter Phase II pilot trial investigates the efficacy of exemestane, 25 mg once daily over 4 months, in postmenopausal women with primary breast cancer, measured in terms of clinical response

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified breast cancer (punch biopsy), established HER-2/neu status
* Postmenopausal patients (\> 1 year following outset of menopause and/or postmenopausal hormonal profile)
* Clinical staging: T2 (\> 3 cm), T3, T4a-c, N0-1
* Hormone receptor positivity, i.e. estrogen and/or progesterone receptor \> 10 fmol/mg cytosolic protein or ER-ICA-positive and/or PgR-ICA-positive. Positivity of + (low-grade) in one hormone receptor is only eligible in the presence of positivity in the other hormone receptor.
* no internal contraindication
* life expectation \> 6 month
* written informed consent

Exclusion Criteria:

* premenopausal patients and patients with no clearly indicated menopausal status
* manifest second malignant tumor (except basalioma or in situ carcinoma of cervix uteri)
* uncontrolled internal disease i.e. diabetes mellitus, cardiac disease (NYHA III/IV)
* thromboembolic disease
* inflammatory mamma carcinoma
* existence of distant metastases
* former or simultaneously therapy with antioestrogens, aromatase inhibitors, cytostatics or radiotherapy
* corticosteroids before and during the study (except inhalant application)
* lack of compliance
Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer

This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmed as uterine cervical cancer
* Having definite clinical information
* Having received radical hysterectomy or trachelectomy

Exclusion Criteria:

* Not satisfying any of the inclusion criteria