cyrilzakka/clinical-trials huggingface dataset:
Chronic Cold Acclimation Stimulates the Browning of Subcutaneous White Adipose in Patients With Type 2 Diabetes Mellitus

Adipose tissues, which include white adipose tissue (WAT) and brown adipose tissue (BAT), play an essential role in regulating whole-body energy homeostasis. Recent studies also reveal the presence of a subset of cells in WAT that could be induced by environmental or hormonal factors to become "brown-like" cells, and this "beigeing" process has been suggested to have strong antiobesity an antidiabetic benefits. More recently, one study showed that Short-term cold acclimation (10 days) improved insulin sensitivity, but did not activate the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus. Here, investigators hypothesize that a chronic cold acclimation can activate the the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus.

All subjects must receive metformin therapy, Patients have chronic cold acclimation intervention for 33 days. During the subsequent cold acclimation period, subjects are exposed to an environmental temperature of 14-15 °C for 33 consecutive days, with cold exposure for 2 h on the first day, 4 h on the second day and 6 h on the third through the 33th day.Biopsy for subcutaneous white adipose and skeletal muscle was performed before and after the intervention program under local anesthesia. The brown fat characteristics and insulin signaling of biopsy samples will be measured. The expression levels of uncoupling protein-1 (UCP-1), peroxisome proliferator-activated receptor r coactivator 1 a (PGC1a), growth factor receptor binding protein-10 (Grb10), PR domain containing 16 (PRDM16) will be determined before and after the intervention programme from the biopsy samples. In addition, a combination of positron emission tomography (PET) and computed tomography (CT) - with the glucose analogue 18F-fluorodeoxyglucose (18F-FDG) as a tracer will be performed for brown adipose tissue before and after the intervention programme.Insulin sensitivity will be checked before and after the intervention programme by insulin clamp assay, and endothelial function will be measured by ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* 18-60 years old
* Body mass index 18.5-28 kg/m2
* HbA1c \< 6.5%
* Well controlled diabetes

Exclusion Criteria:

* Type 1 diabetes
* Body mass index \< 18.5 kg/m2
* Body mass index \> 28 kg/m2
* Female
* Taking any drugs other than metformin
* haemoglobinA1c \>=6.50%
Effects of Fermented Rye Bran Products on Helicobacter Pylori (HP) Infection and Metabolic Risk Factors

The investigators hypothesize that long-term fermented high-fibre rye intake may reduce the Helicobacter pylori infection through dampening inflammation and thereby leading to lower adherence of the bacteria to surfaces.The investigators further hypothesize that that inflammation could be a potential causal link between HP infection and insulin resistance, a risk factor for type 2 diabetes and cardiovascular disease.

A randomized, double-blind, 12 week parallel dietary intervention study is conducted to evaluate the effects of the two novel food products containing fermented rye bran in normal weight and overweight men and women with prevalent HP infection. A follow-up is planned at week 24. The primary endpoint is severity of HP infection indicated by a breath test. Secondary endpoints include effects on chronic inflammation, insulin resistance, blood lipids, blood cholesterol,body weight, intestinal microbial clusters et al. The food products given to the treatment group will be a novel breakfast cereal product and a crispbread product containing fermented rye bran. The control product will be corresponding products based on refined wheat.

Eligibility Criteria:
Inclusion Criteria:

1. Both men and women are eligible.
2. Age: 20-70 years old.
3. HP: 13C-urea breath test value（DOB）above 4.
4. 50% of the participants should have BMI below or equal to 24 and 50% should have BMI above 24.
5. Willing to consume test products for 12 weeks.

Exclusion Criteria:

1. Smokers.
2. In medication (except medication for mild hypertension).
3. Having allergies or food intolerance.
4. Having chronic disease, such as type 2 diabetes, cardiovascular disease and cancer.
5. Diagnosis of peptic ulcer.
6. Pregnancy or to be pregnant.
7. Having travel plans in 4 months.
The ELUTES Clinical Trial

ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce restenosis in the coronary artery.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
* Patient must be an acceptable candidate for coronary artery bypass surgery.
* Patient or legal guardian must have signed informed consent.
* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion Criteria:

* Patient must be less than 18 years old.
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
* Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
* Women of child bearing potential.
* Patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
* Patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.
VR-MARS Virtual Reality, Medical Assistance and Rescue for Space

VRMARS is a medical simulation study in microgravity. Healthy volunteers (n=18) test in microgravity the functionnality of an augmented reality headset in which a medical assistance is displayed.


Eligibility Criteria:
Inclusion Criteria:

Healthy male or female volunteers.

* Aged between 18 and 66.
* Not currently pregnant.
* Affiliated to a social security system or, for non-Europeans, holders of a European Health Insurance Card (EHIC).
* Have signed written consent for the study.
* Have passed a standard JAR FCL3 Class 2 (Private Pilot Aptitude) medical examination less than 1 year old.

Exclusion Criteria:

On the day of the flight, before the volunteer boards the plane:

* Flu, digestive symptoms (nausea, vomiting), fever.
* Pregnancy: a urine pregnancy test will be performed on the morning of the flight before boarding.
* Altered mental state (flight anxiety, phobia).
* Failure to attend the safety briefing.

During the flight :

* Non-compliance with basic safety instructions.
* Flight-related side effects: fatigue, motion sickness.
A Single-blind, Dose-tapering Study of KWA-0711 in Patients With Chronic Constipation

The purpose of this study is to evaluate the efficacy and safety of tapered KWA-0711 dose in chronic constipation patients.


Eligibility Criteria:
Inclusion Criteria:

* The patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment.
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder.
* Patients who have organic constipation.
* Patients who received intestinal resection.
Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.

Methodology:

* Basic orthodontic record will be taken.
* impression with bands on upper first molars will be taken.
* Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).
* CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.
* Delivery, check the retention and fitness of the appliance.
* Cementation of the appliance using band cement(compomer).
* Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.
* Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.
* Closure of the device, and leave the appliance in-situ for five months as a retention.
* Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome: skeletal and dento-alveolar expansion will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral Dental posterior cross-bite
* Skeletal Maxillary constriction
* Male and female patients.
* Chronological age (18-30 years).
* Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
* Good oral hygiene.
* No craniofacial anomalies or syndromes

Exclusion Criteria:

* Scissor-bite
* Orthodontically-treated
* functional cross bite due to premature occlusal contact
* patients with a syndrome
* cleft patients
The Effect of Cataract Extraction on the Contractility of Ciliary Muscle

The purpose of this study is to investigate the changes in the pilocarpine-induced ciliary body movement before and after cataract extraction in order to determine the effect of lens sclerosis on the ciliary muscle contractility.

The functional changes in the ciliary body in presbyopia are not only important in a study of the mechanism for presbyopia but are also a key to various procedures or devices used to restore accommodation. Therefore, it is becoming increasingly important to quantify the in vivo accommodative changes in the aging ciliary muscle with and without a lens. We are going to evaluate the changes in the pilocarpine-induced contractility of the ciliary muscle in eyes with presbyopia before and after cataract extraction using ultrasound biomicroscopy (UBM).UBM will be performed with and without instilling 2 % pilocarpine, as well as before and 2 months after cataract extraction. Images of the ciliary body will be compared visually using Adobe Photoshop 7.0.

Eligibility Criteria:
Inclusion Criteria:

* Age : same or more than 55 years
* Patients with senile cataract who are going to get cataract surgery

Exclusion Criteria:

* Age : less than 55 years
* Previous ocular disease other than cataract.
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer between 6 - 35 months old; Term birth; Birth weight \>2500g;
* Proven legal identity;
* Written consent of the guardian(s) of the volunteer;

Exclusion Criteria:

* Received seasonal influenza vaccine in the current year;
* Suffering from seasonal influenza in the past 6 moths;
* Axillaty temperature \> 37.0 °C;
* History of allergy to any vaccine or vaccine ingredient;
* History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* Autoimmune disease or immunodeficiency;
* Congenital malformation, developmental disorders;
* Severe malnutrition;
* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
* History of epilepsy (except febrile seizures occurred \< 2 years of age or pure epilepsy occurred within the past 3 years that does not need treatment)
* Chronic diseases (e.g., viral hepatitis, tuberculosis, diabetes, blood diseases, or neurological disorders)
* Acute disease or acute stage of chronic disease;
* Receipt of any of the following products:

  1. Any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry;
  2. Any live attenuated vaccine within 30 days prior to study entry;
  3. Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
  4. Blood product within 3 months prior to study entry;
  5. Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry;
* Participate or will participate in other clinical trial(s) during this study;
* Based on the judgment of investigator(s) or the Ethic Committee, there was any condition indicating that the subject should be excluded;
Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer

Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment.

The patients with locally advanced rectal cancer were collected retrospectively, and the relevant information such as clinical baseline characteristics, imaging data and preoperative/postoperative pathological data were collected and integrated, applying the method of deep learning to construct the model, in order to predict and evaluate the risk factors (invasion of mesorectal fascia, status of cancer nodule, long-term prognosis, tumor recurrence, etc.) which are important in clinical diagnosis and treatment. After the model was established, prospective studies were carried out to validate the model, continue training and enrich the effectiveness of the model.

Eligibility Criteria:
Inclusion Criteria:

1. Primary rectal adenocarcinoma was diagnosed before operation
2. Preoperative MRI staging was diagnosed as stage cT4 rectal cancer
3. Receiving neoadjuvant therapy before operation (including but not limited to chemotherapy, radiotherapy, immunotherapy or targeted therapy, etc.)
4. Middle and low rectal cancer (the distance between the lower margin of the tumor and the anal margin ≤ 12cm measured by MRI)
5. Receive radical resection of rectal cancer

Exclusion Criteria:

1. lack of clinical TNM staging information or other key clinical information about MRI
2. the imaging quality is poor or the MRI image has artifacts
Kangaroo Care Education Programme (KCEP)

A quasi-experimental and longitudinal study was conducted to evaluate the effectiveness of the kangaroo care education program (KCEP) on Mothers, Nurses, and Infants Outcomes in a Neonatal Intensive Care Unit. Forty-eight mother-infant dyads were enrolled per arm in the control and experimental groups. The control group received standard routine care, while the experimental group received a maternal kangaroo care education program.

Introduction:

Kangaroo care (KC) is a simple, low cost and highly effective evidence-based nursing intervention that can benefit from mother-infant bonding attachment. Most mothers of premature infants will experience stress being separated from their premature infants. Bonding with premature infants will develop their brain and also make them feel loved, safe, and secure. Therefore, KC will help in bonding attachment, increase weight gain, decrease hospitalization, and increase breastfeeding rates.

Aim:

This study aims to investigate the effectiveness of two programs; a nursing education program and a mother education program regarding KC techniques on mothers, nurses, and infant outcomes.

Method:

A combination of two designs: Quasi-experimental and longitudinal designs with self-administered questionnaires were carried out to evaluate mothers, nurses, and infant outcomes using the Kangaroo Care Questionnaires Survey (KCQs) and Parental Stressor Scale: Neonatal Intensive Care Unit, Parental and Relationship (PSS: NICU: P\&R) at a neonatal intensive care unit (NICU) of a Malaysian teaching hospital in Klang Valley. The kangaroo care education program (KC-EP) included theoretical and practical sessions on the KC benefits and hands-on KC techniques. The study consisted of three phases: Phase I (n=48 mother-infants dyads) in the control group, Phase II (n=47 nurses - KC-EP), and Phase III (n=48 mother-infants dyads-KC-EP) in the experimental group. Data collection for mothers and infants occurred at various time points during the study; pre-intervention (T0) post - 1-month intervention (T1) and post - 3-month intervention (T2). For the nursing outcomes occurred before and after the 7th day of the intervention program. The results were analyzed using the Statistical Package of Social Sciences(SPSS) version 23. Descriptive statistics were used to analyze the demographic data and items of the questionnaire. GLM univariate and repeated measure analysis of variance (RM-ANOVA) followed by Bonferroni test for mean comparison between control and experimental groups at (T0, T1, and T2).

Eligibility Criteria:
Inclusion Criteria:

* Premature infant at corrected age between 28 weeks to 36+6 weeks gestation.
* Both mothers and premature infants were medically and surgically stable.
* Mothers were willing to perform KC and admitted to the NICU.

Exclusion Criteria:

* Surgical infant i.e cleft lip, cleft palate, spina bifida, exomphalos, and omphalocele.
* Infant required medical treatment eg. prolonged phototherapy treatment.
* Trisomy 21.
A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)

The aim of this study is to evaluate efficacy and tolerability, and number of positive response to treatment with CAELYX (50 mg/m\^2), administered as monotherapy once per 4 weeks to patients with metastatic epithelial ovarian cancer, resistant to previous platinum therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
* Women must be greater than or equal to 18 years of age, of any race.
* Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
* Morphology (cytology or histology) confirmed diagnosis of epithelial ovarian cancer.
* Patients with 1 or more measurable and/or evaluable tumors, according to the results of CT, MRT scans or X-ray, etc.
* Patients, including those after primary surgical treatment, who had previously received platinum chemotherapy and in whom second-line therapy is indicated.
* Karnofsky performance status above 60%.
* Left ventricular ejection fraction above 50% (according to the results of echocardiography).
* Adequate bone marrow function as indicated by:

  * Platelets \>100x10\^9/L
  * Haemoglobin \> 9 g/dL
  * Absolute neutrophil count \>1.5x10\^9/L
* Adequate renal function as indicated by:

  * Serum creatinine \< 1.5 х ULN
* Adequate liver function as indicated by:

  * Bilirubin level and AST or ALT activity \< 2 х ULN (with the exception of cases related to primary disease).

Exclusion Criteria:

* Women who are pregnant or nursing.
* Subjects who have not observed the designated washout periods for any of the prohibited medications.
* Subjects who have used any investigational product within 30 days prior to enrollment.
* Medical history indicating serious concomitant diseases, such as congestive heart failure of II NYHA class or higher, insulin-dependent diabetes mellitus, clinically significant liver disease, mental disorders.
* Non-controlled bacterial, viral or fungal infections.
* Conditions and reasons (medical, social and psychological) that might prevent adequate follow-up of patients.
* Any other active primary tumor under treatment (except basal or squamous cell carcinoma or in situ cervix carcinoma).
* Patient has symptomatic metastasis to brain.