cyrilzakka/clinical-trials huggingface dataset:
Metabolic Response to Beverages With Various Sweetening Systems Consumed During Meal in Overweight and Obese Subjects

The purpose of this clinical study is to investigate the effect of drinking a sugar-sweetened beverage along with a meal on insulin concentrations and, glucose and lipid metabolism, in overweight and obese subjects, during a 10-hour visit.


Eligibility Criteria:
Inclusion Criteria:

* Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study
* Subject who is able to communicate well with the investigator and to comply with the requirements of the entire study
* If of child bearing potential, female subject must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively: oral birth control pills (at least 1 full monthly cycle prior to study product administration); intra-uterine device (IUD); double barrier methods (such as condoms and spermicide)
* Subject with a body mass index (BMI) between 25 and 35 kg/m² inclusive

Exclusion Criteria:

* Pregnant woman, based on positive urine pregnancy test, or planning to become pregnant during the study or breast-feeding woman
* Surgical operation on digestive tract, except appendectomy
* Subject who had any surgery or intervention requiring a general anaesthesia in the preceding 4 weeks, or who plans to have one during the course of the study
* Subject with diagnosed or suspected allergy or hypersensitivity to any food ingredient, including components of the study products (ingredients of sugar-sweetened beverages)
* Blood donation within the last 3 months or planning to give blood during the course of the study
* Subject involved in any other clinical study within the preceding month or in the exclusion period after another clinical study
* Subject in a situation, which in the Investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
* Evidence of clinically relevant cardiovascular, metabolic, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrine or psychiatric history of disease as determined by medical history, physical examination, and vital signs
* Clinically significant abnormal results for urine or blood analyses
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis.

Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.


Eligibility Criteria:
Inclusion Criteria:

* McDonald Diagnosis of Multiple Sclerosis or 2006 Diagnosis of neuromyelitis optica.
* Aged 16-65 years.
* Disease duration≥2years
* Poor response to steroid therapy.
* Written informed consent and follow the clinic trail procedure

Exclusion Criteria:

* Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value.
* Combined Pneumonia or other Severe systemic bacteria infection.
* Severe drug allergic history or anaphylaxis to 2 or more food or medicine.
* Intracranial hypertension dues to Other brain lesions (eg. Brain cancer)/
* HIV+, TPPA +， patients diagnosed as HBV or HCV.
* Tumor Markers +
* Severe psychotic patients, cognitive dysfunction,Or can not understand or sign the Consent Form.
* Coagulation disorders.
* Uncontrolled hypertension after treatment，blood pressure≥180mmHg/110 mmHg.
* Pregnancy.
* Enrollment in other trials in the last 3 months.
* Other criteria the investigator consider improper for inclusion.
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants

The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50 to 100 kilogram (kg)
* Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m\^2)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
* History of splenectomy
* History of epilepsy, other neurological disorders, or neuropsychiatric conditions
* Other protocol defined exclusion criteria could apply
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema.

The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.

Breast cancer is a serious health issue that affects 1 in 8 women. Although numerous treatments have arisen in recent years to aggressively combat this disease and increase survivorship, many survivors develop a crippling condition that can result in devastating physical and psychological impairments. Breast reconstruction by any method may help recovery psychologically. However, some individuals still report experiencing pain following their recovery from surgery. Additionally, secondary lymphedema is a common yet poorly understood complication of breast cancer patients. For those individuals who undergo axillary lymph node dissection the rates of incidence of lymphedema approach 47%. These rates tend to increase further for patients who receive irradiation treatment or mastectomies. Currently there is no known cure for lymphedema. Current treatments include non-invasive measures as well as surgical interventions. Vascularized lymph node transfer (VLNTx) is a fairly recent surgical procedure that has shown promising results.

The goal of this research study is to analyze the clinical outcome of subjects who undergo breast reconstruction with perforator flaps and/or VLNTx using information collected as part of standard care.

Clinical data will be collected prospectively. All subjects who undergo a surgical procedure will complete the online persistent postsurgical pain assessment questionnaire.

The BreastQ questionnaire will be completed by patients prior to and after undergoing breast reconstruction and/or lymphedema treatment.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema

Exclusion Criteria:

* Pregnant
* unable to read
Comparative Effects of Aerobic Exercises, Resistance Training and Combined Training on Heart Failure Patients

To compare the effectiveness of aerobic training and resistance training and combined training on heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with ejection fraction greater than 35%

Exclusion Criteria:

* Patients with unstable angina
* Patients who had severe pain in the lower limbs
* Patients with Blood pressure greater than 190/120mmHg were excluded
* Patients who had positive contraindication for cardiac rehabilitation were not admitted in this study
Carbon Dye Tattooing of Biopsied Axillary Node in Breast Cancer

The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).

Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. The need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is anticipated so that these nodes may be identified at the time of surgery. Measures that improve both the accuracy of nodal evaluation after NACT and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension (Spot dye). The concept is based on the experience in the gastrointestinal tract wherein tattooing is widely used for marking lesions or tumours biopsied during endoscopy. India ink tattoos of colonic lesions remain identifiable over a long period of time. Spot is routinely used in the UK for tattooing gastrointestinal tract lesions and is used to mark the axillary lymph nodes in breast cancer by some centres in the US and Europe. The intraoperative success of identifying tattooed axillary lymph nodes and their concordance to sentinel nodes will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Male or female
* Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node
* Invasive breast cancer
* Written informed consent for the study

Exclusion Criteria:

* Not undergoing surgery or unfit for surgery
Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia

This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.

As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Eligibility Criteria:
Inclusion Criteria:

In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.

Exclusion Criteria:

In accordance with Summaries of Product Characteristics (SPC).
Effectiveness of Topical Olive Oil in Prevention and Management of Radiation Induced Oral Mucositis

This research aims to investigate the effectiveness of topical olive oil application both clinically and biochemically as a suitable affordable treatment modality for prevention and management of radiation oral mucositis and its associated pain for head and neck cancer patients receiving radiotherapy.

Twenty adult patients seeking radiotherapy treatment for head and neck cancer are to be selected. Patients meeting the eligibility criteria are to be equally and randomly allocated in 2 different groups. Group 1 will include10 patients receiving topical olive oil application, twice daily (Experimental arm). Group 2 will include 10 patients receiving Sodium bicarbonate 5% solution, twice daily (Control arm). Both intervention and control groups will start the application of the agents two days before the induction of radiotherapy. Evaluation will be done using World Health Organization (WHO) scale for oral mucositis to record the extent and severity of oral mucositis. Pain and discomfort will be evaluated using Numeric Rating Scale (NRS). Clinical evaluation using both scales will be performed after starting radiotherapy every other week ( after 2 weeks, after 4 weeks and after 6 weeks at the end of the treatment). Patients scores will be recorded at similar intervals. Total Antioxidant Capacity "TAC" will be used to study the biochemical effect of topical olive oil application by evaluating the oxidative stress in the saliva. Saliva samples will be collected from all patients of both groups prior to the beginning of radiotherapy, and a second sample will be collected after six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are aged above 25 years up to 65 years.
* Both genders are eligible.
* Patients with head and neck cancer who are planned to receive radiotherapy either as postoperative (adjuvant after surgery) or definitive therapy.
* Patients planned to receive radiotherapy treatment with a dose of 60-70 Gy.

Exclusion Criteria:

* Patients with known sensitivity to olive oil and/or any of its products
* Patients with gingival or oral ulceration or mucositis
* Smokers
* Vulnerable patients (pregnant women, neonates, children, prisoners, persons with physical handicaps or mental disabilities)
* Pregnant and lactating women.
* Patients with any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
* Patients suffering from any physical or mental disabilities that would interfere with or be affected by the study procedure.
Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies

Clinical study BCD-201-1 is a double-blind randomized study of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of BCD-201 versus Keytruda following intravenous administration to subjects with advanced unresectable, metastatic, or recurrent melanoma and NSCLC.

The study aimed to establish the equivalence of PK and similarity of the safety, immunogenicity, and PD profiles of BCD-201 and Keytruda.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Body weight 60 to 90 kg;
* Histologically confirmed melanoma or NSCLC (patients with NSCLC are eligible to participate if high tumor PD-L1 expression \[≥50%\] is confirmed by local or central laboratory results);
* ECOG score 0-1;
* Laboratory test results consistent with adequate functioning of systems and organs;
* Willingness of males and females of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and within 6 months after the administration of the last product dose

Exclusion Criteria:

* Indications for radical therapy (surgery, radiation therapy);
* Previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic melanoma or NSCLC (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment was completed at least 6 weeks prior to randomization);
* Active metastases in the central nervous system and/or carcinomatous meningitis;
* Patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period;
* For patients with NSCLC: presence of activating EGFR mutations/ALK translocations;
* Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study;
* Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders \[vitiligo, alopecia, or psoriasis\] not requiring systemic therapy are eligible to participate);
* The need for therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization;
* History of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening;
* Hypersensitivity or allergy to any of the pembrolizumab product components;
* Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.
Tensegrity Principle in Massage Therapy on Selected Anatomical Examples

The study design is a randomised, controlled, parallel, two-arm trial. The subjects are randomly assigned to one of the study groups: the intervention group or the control group. The study will analyze the applicability of the tensegrity principle in the massage therapy. The main aim of this study is to examine if the tensegrity principle can be used in massage therapy to increase the effectiveness of the intervention. Contractile and passive mechanical properties are assessed before and after the intervention.

The phenomenon of tensegrity, despite the ever-growing interest and its many supporters, still remains a theoretical model. Its assumptions refer to the possibility of spreading stresses between individual elements of the musculoskeletal system in order to achieve structural homeostasis. An important role here is played by muscles that remain in structural contact with each other, e.g. through a common bone attachment or fascia. Theoretically, this means that a change in the tone of one muscle can lead to changes in the tone of other muscles that are structurally connected to it. It is worth noting that this mechanism works both when one of the muscles increases its tension and when this tension is decreased.

The difficulty associated with assessing the significance of tensegration for the motion system consists in the proper design of research that accurately quantifies this phenomenon. Experiments conducted to date have mostly been performed in vitro. Despite their scientific value, analyses of this type only take part of this phenomenon into account, because they do not consider the presence of body fluids as well as the tension produced by nerves and blood vessels.

In this project the following connection between muscles are tested:

* deltoid muscle and brachioradialis muscle
* latissimus dorsi muscle and the anterior compartment muscles of the forearm,
* tensor fasciae latae and pectoralis major muscle

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 24 years;
* healthy individuals, with no lower and upper extremities pathology;
* PA≥600 MET-min/week assessed by IPAQ questionnaire;
* no medical contraindication of massage therapy;
* body mass index 18,5 \< BMI ≤ 25kg/m2
* signing the informed consent.

Exclusion Criteria:

* individuals suffering from neurologic or orthopaedic problems;
* lower ot upper extremities surgical interventions;
* cancers;
* musculoskeletal disorders
* body mass index 18,5 \> BMI ≥ 25kg/m2
* the lack of informed consent.
Blood Biomarkers in Major Depression

Depression is a leading cause of disability worldwide, affecting nearly 16% of the general population. Its physiopathology remains unclear. Based on gene-environment studies and epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE) results from the convergence of multiple factors including biological factors such as multi-genic vulnerability, hormonal and immunological variations as well as environmental factors. As a consequence, mRNA could define a biological signature of the MDE.


Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder at inclusion according to the DSM IV at the time of the inclusion,

  * Having a score on the scale of depression of Hamilton ( HDRS-17) \> 19 at the time of the inclusion,
  * Taken care by a grown-up psychiatric department, that the coverage(care) is realized in ambulatory or during a hospitalization

Exclusion Criteria:

* Schizophrenia
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination

PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between, and including, the ages of 40 and 80 years.
* Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease.
* Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up \> 6 months ago.
* Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.

Exclusion Criteria:

* A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
* History or presence of significant cardiovascular disease.
* ECG abnormalities.
* Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
* Evidence of organ or blood disorders.
A Comparative Study of Six Methods to Measure Human Contrast Vision

This study evaluates the relative performance of different methods to measure the human spectral contrast sensitivity function (CSF).

The human spectral contrast sensitivity function (CSF) is a better way to estimate human vision than letter charts commonly used by ophthalmologists, optometrists and opticians.

The current methods used to measure the CSF are often unreliable, due to high variability between measurements. This study will compare four (4) new tests with two (2) currently used standard tests. The contrast sensitivity function will be measured using all of the six (6) methods three times (3) in each of the two (2) eyes at two (2) occasions. Each subjects CSF will be measured 6x3x2x2 = 72 times.

In addition, for each of the CSF measurements, the time used to measure the CSF and number of background variables for the subjects will be recorded.

After informed consent is obtained, the subjects will undergo a visual examination. If they match the inclusion criteria they will be included. At that time or at their earliest possible convenience, their CSF will be measured using the six methods and some background information will be recorded.

The follow-up measurement occasion will occur between 4 to 6 weeks (28 to 42 days) after the first.

To facilitate comparison with previous studies, the CSF-measurements (in rel. contrast/cycles/degree) will be converted to a log (Base 10 logarithm) scale. The unit will thus be log CSF (LCSF) \[log\[relative contrast\]/log\[cycles/per degree\]\].

Eligibility Criteria:
Inclusion Criteria:

* Normal best corrected visual acuity: LogMAR = 0
* No current or previous eye disease in either eye.
* Student at Uppsala University

Exclusion Criteria:

* Previous surgery in any eye
* Inability to follow the test procedure.