cyrilzakka/clinical-trials huggingface dataset:
The Effect of Sprouting of Wheat on Postprandial Glycemic and Satiety Responses of Wheat Bread Products

The objective of this study is to investigate the effect of inclusion of 50% sprouted wheat wholemeal in a bread recipe on the postprandial glycemic and satiety responses, as well as on appetite-related sensations and acceptability of the developed products relative to a product made with a similar unsprouted wheat recipe.

This study is a randomized crossover trial involving three different bread products. At each study visit, capillary blood glucose will be measured at fasting, and then 15, 30, 45, 60, 90, and 120 minutes following the start of ingestion of the study food. Visual analogue scales will be used to assess appetite and fullness sensations at fasting, and then 30, 60, 90 and 120 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Age 18-40 years
* Normal non-fasting plasma glucose (\<7.9 mmol/L but not below 3.3 mmol/L)
* BMI ranging from 18.5 to 27.9 kg/m2
* Regular consumer of wheat-based bread products (\>1x per week).

Exclusion Criteria:

* Smoking or regular use of recreational drugs (marijuana, ecstasy, LSD, magic mushrooms etc.)
* Heavy alcohol use (defined as typically \>14 drinks per week or \>4 drinks on one occasion)
* Restrained eater (\>16) as defined by the questionnaire at screening (Appendix E: Three Factor Eating Questionnaire, Stunkard et al.,1985)
* Unusual sleep patterns (Shift-worker, or sleeps 4 hours or less regularly) or irregular breakfast consumption.
* Recent (i.e. \>4 kg in previous 3 months) or intended weight loss or gain
* Food allergies or any life-threatening allergy (food or otherwise)
* Gluten intolerance or sensitivity
* Medications known to affect glucose tolerance (excluding oral contraceptives)
* Presence of disease or drug(s) which influence digestion and absorption of nutrients; including steroids, protease inhibitors or antipsychotics.
* Inability to adhere to Study Protocols
Label-free Raman Spectroscopy for Discrimination Between Breast Cancer Tumor and Adjacent Tissues After Neoadjuvant Treatment

After neoadjuvant therapy, the primary lesion in breast cancer patients may experience tumor regression, which increases the difficulty of distinguishing between breast cancer and adjacent tissues. Raman spectroscopy is a form of scattering spectroscopy, which offers rapid and sensitive analysis, delivering detailed biochemical information and molecular signatures of internal molecular components within the sample. This study aims to discern between cancer and adjacent tissues after neoadjuvant therapy in breast cancer patients using label-free Raman spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* (1) aged ≥ 18 years; (2) histologically confirmed invasive breast cancer (clinical tumor stage T1 to T4, nodal stage N1-3, and metastasis stage M0); (3) previous treatment with neoadjuvant chemotherapy with or without target therapy (such as trastuzumab, pertuzumab), or endocrine therapy; (4) enough frozen samples of breast cancer tumor and adjacent tissue.

Exclusion Criteria:

* (1) undergoing sentinel lymph node biopsy with indocyanine green dye or methylene blue injection after neoadjuvant therapy; (2) Breast cancer during pregnancy and lactation, inflammatory breast cancer.
Safety Study of NBP608 in Healthy Adult Volunteers

* Indication: Protection against varicella and herpes zoster
* Study Objectives

  * Primary: Safety and tolerability assessment after single dose administration of NBP608
  * Secondary: immunogenicity assessment after single dose administration of NBP608

This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1\~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 20 and over
* Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
* Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit
* Subjects of seropositive for Varicella-Zoster virus at screening visit

Exclusion Criteria:

* Patients with herpes zoster
* Subjects with a history of vaccination for herpes zoster
* Pregnant or lactating women
* Participants in another clinical study within 4 weeks before vaccination in this study, etc.
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women

Obesity is one of the biggest public health problems of the 21st century as it increases the risk of many co-morbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and puerperium. Obesity is a risk factor for cesarean delivery, failed induction of labor and labor dystocia, and prolonged labor curves especially among women with class III obesity.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous onset of labor.
* Body mass index ≥ 30 kg/m2.
* Gestational age ≥ 37 weeks.
* Singleton pregnancy.
* Cephalic presentation.
* Reassuring fetal heart rate monitoring.
* Inefficient uterine contractions during active labor
* Women who will accept to participate in the study.

Exclusion Criteria:

* Non-reassuring fetal assessment at the time of recruitment.
* Women received cervical ripening agents.
* Any patients contraindicated for vaginal delivery.
* Multiple gestations.
* Malpresentation.
* Previous cesarean delivery.
* Patients with cardiac diseases, pre-eclampsia or any other medical disorders.
* Fetal demise.
* Intrauterine growth restriction.
* Estimated fetal weight ≥ 5000 grams.
* Pre-labor rupture of membranes \> 24 hours.
Cancer Venous Thromboembolism (VTE)

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
* Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
* Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
* Able to provide written informed consent.

Exclusion Criteria:

* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
* Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
* Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
* Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function

Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit powder on cutaneous microcirculation and endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
* Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology
* Healthy normal skin condition at the forearm
* BMI: 19-30 kg/m2
* Female
* Age ≥ 40 and ≤ 70 years
* Nonsmoker
* Able and willing to follow the study protocol procedures

Exclusion Criteria:

* Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, L-Arginine, Niacin, medication of haemodilution, blood flow stimulating products like Aspirin) potentially interfering with this study at screening
* For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
* Atopic dermatitis or affected skin at the forearm
* Regular consumption of caffeine \> 275 mg (equivalent to 3-4 cups of coffee or 9 cups of black tea)
* Change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day))
* Diet high in vegetables and fruits ≥ 5 portions per day
* Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results
* Subjects not willing to avoid polyphenol rich foods and abstain from beverages containing caffeine the day prior to visit 1 and 2
* Subjects not willing to abstain from intake of analgesic medication (e.g. Aspirin) 24 hours prior to and during visit 1 and 2
* Sunbathing or the use of sun-beds 2 weeks prior to study days
* Injury on the finger, influencing the EndoPAT™ measurement
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study
* Known hypersensitivity to the study product or to single ingredients
* Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
* Known HIV-infection
* Known acute or chronic hepatitis B and C infection
* Blood donation within 4 weeks prior to visit 1 or during the study
* Subject involved in any clinical or food study within the preceding month
The Influence of the Results of Surgical Treatment in Patients With Gunshot and Mine-explosive Wounds on the Formation of Chronic Pain

In 82.1% of patients with gunshot and mine-explosive injuries, the pain becomes chronic. The impact of the results of surgical treatment on the processes of chronic pain in this category of patients remains insufficiently studied. Therefore, the study of such a factor will be important to improve the results of pain treatment.

The influence of the results of surgical treatment in patients with gunshot and mine-explosive wounds on the formation of chronic pain needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics. Considering that in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in the treatment of such patients.

Eligibility Criteria:
Inclusion Criteria:

* the presence of gunshot and mine-explosive injuries

Exclusion Criteria:

* absence of gunshot and mine-explosive injuries
Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease

Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m).
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day)
* Known renal failure or allergy to acetazolamide and other sulfonamides
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts

This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy（ALA-PDT) to a conventional regimen for treatment of small genital warts. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosed with Genital Warts;
2. Aged \> 18 years;
3. All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents agreed to take a picture of the skin lesions.
4. The maximum diameter of a single carcass does not exceed 0.5cm; the skin lesions are at least 6 or more or substantially symmetric

Exclusion Criteria:

1. Those who did not complete the informed consent;
2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound; the individual corpus callosum is more than 0.5cm in diameter; the corpus callosum is located in the vagina, the anal canal, the cervix;
3. Patients with skin photoallergic diseases, porphyria;
4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;
5. Patients with other obvious diseases that may affect the evaluation of efficacy; (6)Scars or patients with a tendency to form scars;

(7)Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants; (8)Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy; (9)Those with severe neurological, psychiatric or endocrine diseases; (10)Women who are pregnant, breast-feeding or using inappropriate contraceptives; those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment.
German Epicardial Collateral CTO Registry

The EPIC registry is an observational multicentre registry evaluating the technical feasibility of retrograde CTO-PCI using epicardial collateral connections. It will evaluate the frequency, effectiveness, safety and outcomes of patients who underwent CTO-PCI using this approach. The EPIC registry retrieves data from CTO centres across Germany.

The EPIC registry is the first German-wide observational multicentre registry evaluating the technical feasibility, clinical success and safety of retrograde CTO-PCI using epicardial collateral connections. The EPIC registry retrieves data from CTO centres across Germany. All patients will be followed-up to 30 days after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice.

Exclusion Criteria:

* None.
Telerehabilitation-based Yoga and Mindfulness Home Program in Postmenopausal Women Having Social Isolation

In the postmenopausal period when the woman spent 1/3 of her life; Due to the lack of estrogen, some physical and psychological changes occur. These changes may cause some problems. For women who perceive menopause as the first step of old age, loss of physical strength, energy, attraction and fertility, menopause can also lead to anxiety. In addition to these, they are among the emotional changes in the menopausal period in symptoms such as hypersensitivity to events, fatigue, and insomnia. Sometimes it can even be seen in psychological disorders such as melancholy and depression. The new coronavirus pneumonia (COVID-19), which appeared in Wuhan in December 2019, started to appear in different countries soon after. All countries have taken measures to prevent the spread of this virus. To this end, Turkey remains at home on March 21, 2020, and has commissioned social isolation measures. Studies investigating the effects of social isolation show that psychological and physical problems occur in individuals. Studies have shown that yoga and mindfulness programs have an impact on people's anxiety, depression, and the ability to control themselves. The purpose of this study; To investigate the effectiveness of telerehabilitation based yoga and mindfulness programs on psychological resilience, physical awareness and physical activity in postmenopausal women in social isolation due to the COVID-19 outbreak. Using telerehabilitation-based home programs aims to use an innovative model.


Eligibility Criteria:
Inclusion Criteria:

* Being physically or perceptually competent to exercise,
* No spinal pathology or deformity,
* Volunteering to participate in the study,
* Not having menstruation for at least 12 months
* Hormonally, surgically induced or natural menopause-confirmed women

Exclusion Criteria:

* Those with serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker)
* Those with inflammatory or systemic disease malignancy
* Psychological dysfunction
* Those who use corticosteroids
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors

This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and diagnose brain tumors.

PRIMARY OBJECTIVES:

I. To determine if 68Ga-DOTATOC (gallium Ga 68-edotreotide) PET when combined with magnetic resonance imaging (MRI) will differentiate embryonal tumors such as medulloblastoma and supratentorial primitive neuroectodermal tumor (PNET) from the low and high grade gliomas.

II. To determine if 68Ga-DOTATOC PET will aid in the identification of residual tumor post operatively in those patients who were 68Ga-DOTATOC PET positive prior to surgery.

OUTLINE:

Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with brain tumors will be eligible for this study
* Eligible subjects must be able and willing to undergo the procedures of the study
* Electronic version of pre-surgery MRI must be available for co-registration purposes
* Fresh frozen tumor, and/or paraffin block of biopsy or resected tumor is recommended, but not required to determine expression of somatostatin receptors in tumor by immunohistochemistry and/or quantitative polymerase chain reaction (qPCR)

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin of body that would preclude obtaining an MRI as part of the initial study evaluation
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons
* Presence of any additional medical condition such as inter-current illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump

The purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy.

A prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or femoral osteotomy metal work removal.

Subjects will be randomized into two groups: the first group will have an anesthetic pain pump device supplemented with oral analgesia and the second group will only receive oral analgesia. The anesthetic continuous device will be used continuously for 48 hours and with a flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. Subjects in both groups will receive oral analgesia according to their pain requirements. The amount of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4 day period. Subjects will have their pain score assessed daily with the use of the Non-Communicating Children's Pain Checklist-Postoperative Version. Their overall satisfaction with post-operative pain management will be assessed at the end of the study with the use of the Parent Total Quality Pain Management questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy between 3 and 17 years old.
* American Society of Anesthesiologists (ASA) intubation grade I, II or III.
* Ability of subject or primary caregivers to give informed consent, to understand what the study entails and to be able to complete the patient Pain Diary during the post-operative period. Subjects should be available for daily telephone follow-up until the data is completed and they should be able to return the completed Pain Diary to the Primary Investigator.
* Willingness and understanding of parent or guardian to have their child randomized to receive either the continuous infusion pain pump device or oral analgesics for their child's pain management.
* English or Spanish-speaking care parent or guardians who are able to complete the Pain Diary.

Exclusion Criteria:

* ASA IV or V,
* Known allergy or sensitivity to bupivacaine,
* Subjects who will have more than the above mentioned procedure performed during their surgical visit,
* Subjects with significant kidney or liver disease,
* Parents/guardians who are assessed by the PI or co-investigators to be unable or unwilling to complete the study's Pain Diary or behavioral tools, and
* Parents/guardians who are unwilling to allow their child to be randomly assigned to receive either the pain pump with oral analgesics or oral medications alone.