bioihbjkbjnl/mcl2 huggingface dataset:
Cytokine Changes After Colorectal Cancer Resection
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Based on our previous research, this study aims to determine reliable surgical stress
      response markers in patients undergoing radical resection of colorectal cancer.
    

Detailed description: 
      Every surgical intervention represents a stress for patient's organism. During the operation,
      numerous changes in the patient's metabolism take place, that are termed surgical stress
      response. Leading cause of surgical stress response is tissue destruction that always
      accompanies operations. Surgical stress response is effected through activation of
      hypothalamus-pituitary-adrenal axis and through sympathetic activation.

      The consequences of surgical stress response are numerous. Surgical stress response is
      essential to uneventful postoperative recovery. On the other hand, excessive surgical stress
      response may lead to serious postoperative complications, such as heart and kidney failure,
      venous thrombosis, disruption of operative wound and wound infection.

      In prior studies the investigators have shown the kinetics of postoperative serum interleukin
      changes after radical resection of gastric cancer.

      This study aims at determining reliable markers of surgical stress response severity in
      patients undergoing radical resection of colorectal cancer.
    

Intervention name(s): colorectal cancer resection
Intervention type(s): Procedure
Intervention description(s): Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site
Other intervention name(s): Hemicolectomy; Rectosigmoid resection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with colorectal cancer treated in the University Hospital Dubrava
      
Biospecimen description: 
      For each patient, serum samples will be stored at -80°C for later determining of serum
      cytokine levels
    
Keywords: Colorectal cancer; Surgical stress response; interleukins
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
Condition: Obesity
MeSH terms: Blindness
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine whether the extract of the green tea is effective on
      obese women.
    

Detailed description: 
      We conducted the pilot study in 2005. The initial findings showed the extract of green tea is
      benefit on obese women. The potential benefit include appetite lowing, lipid markers
      decreasing and regulating balance of obese related hormone peptides. So we designed this
      trial.
    

Intervention name(s): the extract of green tea
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: obesity; green tea
Interactive Intention-Driven Upper-Limb Training Robotic System
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of this study is to determine robotic hand system is more effective than
      conventional physical and occupational therapy at promoting functional recovery of the
      affected arm in subjects after stroke.
    

Detailed description: 
      This study will investigate the recovery in hand and upper limb functions when the physical
      training is assisted by an exoskeleton robotic hand system.

      Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All
      subjects should have sufficient cognition to follow simple instructions as well as understand
      the content and purpose of the experiment, and also should be able to sit up for 1 hour.

      During the training, you will be asked to do the hand open and hand grasp by
      Electromyography-driven robotic control strategy.

      There will be evaluations on the upper limb motor functions before and after the 20-session
      of training and follow up session by clinical assessments on functional recovery.
    

Intervention name(s): Hand Robotic Training; Hand and Arm Robotic Training; Conventional therapy
Intervention type(s): Device; Device; Other
Intervention description(s): Training for 20 sessions for one hour, 3-5 times per week.; Training for 20 sessions for one hour, 3-5 times per week.; Training for 20 sessions for one hour, 3-5 times per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Hand; Upper Extremity; Robotics
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety of AMG 623 in subjects with systemic lupus
      erythematosus. The study consists of a 21 day screening period followed by administration of
      the investigational product and up to 70 day follow up period.
    


Intervention name(s): AMG 623; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of AMG 623 administered as subcutaneous and intravenous doses; Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Telmisartan, Amlodipine and Combination in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose
      combination after single dose in healthy Chinese subjects.

      To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine,
      following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A5) tablet alone and
      in combination, in healthy Chinese subjects.

      To evaluate the safety and tolerability of T80 and A5 alone and in combination in healthy
      Chinese subjects.
    


Intervention name(s): amlodipine/telmisartan/combination
Intervention type(s): Drug
Intervention description(s): patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the change in glycemic control from baseline to endpoint (last available
      posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes
      receiving either glimepiride or metformin as monotherapy.
    


Intervention name(s): glimepiride; metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
A Study to Investigate the Effects of Gastric Acid Suppression by Rabeprazole and BMS-986165 on How Fast and Complete The Drug is Absorbed Into the Body of Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of stomach acid suppression by
      rabeprazole and BMS-986165 on how fast and complete the drug is absorbed into the body of
      healthy participants.
    


Intervention name(s): BMS-986165; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days.; Specified dose on specified days.
Intervention MeSH terms: Deucravacitinib; Rabeprazole
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants
Condition: Anemia, Iron-Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      This study aims to determine whether umbilical cord milking can improve iron related health
      outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord
      milking, while the other half will receive routine clinical treatment and care.
    

Detailed description: 
      In recent years, several professional organizations have recommended delayed cord clamping to
      improve placental transfusion for newborns born vaginally based on a series of randomized
      controlled studies. However, no similar recommendations are available for cesarean-delivered
      infants. Investigators found that cesarean-delivered infants were more vulnerable to iron
      deficiency and anemia compared with those born vaginally, suggesting that it is urgently
      needed to find a similar anemia prevention strategy for infants born by cesarean sections.

      In this study, investigators aim to test whether umbilical cord milking (UCM), a potentially
      promising strategy for cesarean delivery, can improve iron related health outcomes for
      cesarean-delivered infants. A total of 450 term pregnant women who are planning to give
      births by cesarean sections will be enrolled from two hospitals in Hunan province and
      randomly assigned to either UCM group or control group. Infants will be followed up at 1, 6,
      12, 18 months for the evaluation of the impact of UCM on iron deficiency, anemia, as well as
      growth and the developmental status of language and mental/behavioral outcomes.
    

Intervention name(s): Umbilical cord milking
Intervention type(s): Procedure
Intervention description(s): As same as that in arm descriptions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anemia, Iron-Deficiency; Cesarean Section; Umbilical Cord Milking; Randomized Controlled Trial
A Bioequivalence Study Between Two Brands of Medications to Treat Cough & Cold Symptoms
Condition: Bioequivalence; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, randomized, two-period cross-over study with 72 healthy male and
      female volunteers. The investigational products will be given (after fasting overnight) at
      separate visits separated by 7 ± 3 days. Blood for pharmacokinetic analyses will be drawn
      pre-dose and at 5, 10, 15, 20, 25, 30, 40, 60, 75, 90, 105 minutes, as well as 2, 2.25, 3, 4,
      5, 6, 8, and 12 hours after drug administration. Subjects will also be monitored to capture
      any adverse events that may occur. Bioequivalence will be assessed based on the single-dose
      pharmacokinetics of paracetamol, guaifenesin and phenylephrine, respectively
    


Intervention name(s): Tablet paracetamol, guaifenesin and phenylephrine HCL; Vicks Active SymptoMax Plus powder for oral solution
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive two tablets, each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride; Each subject will receive one sachet, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride
Other intervention name(s): Benylin Cough & Cold All in One Relief Tablets
Intervention MeSH terms: Acetaminophen; Phenylpropanolamine; Phenylephrine; Oxymetazoline; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Molecular and Functional Neurobiology of Physical Exercise
Condition: Physical Exercise Behavior (Liking/Aversion)
Study type: Interventional

Summary: 
      In this study, we use positron emission tomography (PET) and functional magnetic resonance
      imaging (fMRI) to study brain mechanisms that contribute to physical exercise-induced reward.
      We examine whether acute physical exercise releases endogenous opioids in the brain, and
      whether it modulates brain responses to viewing appetizing foods. Unraveling these mechanism
      are instrumental from a public health perspective, given the undisputed positive health
      effects of physical exercise.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with
      anthracycline and taxane regimen for patients with metastatic breast cancer
    


Intervention name(s): gemcitabine; gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days; 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
Other intervention name(s): LY188011; Gemzar; LY188011; Gemzar
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: after; anthracycline; taxane; regimen
Prophylactic Selective Lateral Neck Dissection in Patients With Papillary Thyroid Carcinoma
Condition: Thyroid Neoplasm; Lymphatic Metastasis
MeSH terms: Carcinoma; Neoplasm Metastasis; Thyroid Neoplasms; Thyroid Cancer, Papillary; Lymphatic Metastasis; Thyroid Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to prospectively analyze the incidence of occult lateral neck
      metastasis (LNM) and to elucidate the factors that predict LNM in papillary thyroid carcinoma
      (PTC) with central neck metastasis (CNM) by performing prophylactic selective lateral neck
      dissection (SND).
    

Detailed description: 
      The lymphatic drainage pattern of the thyroid is uniform and consistent, and therefore,
      metastatic patterns are relatively predictable. Initial nodal metastasis in PTC usually
      occurs in the paratracheal and pretracheal nodes in level VI of the central compartment of
      the ipsilateral neck and spreads to the lateral cervical lymph nodes. Macroscopic skip
      metastases to the lateral compartment of the neck in the absence of central disease are
      uncommon.
    

Intervention name(s): prophylactic selective lateral neck dissection
Intervention type(s): Procedure
Intervention description(s): Level II, III, IV lymph node dissection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Papillary thyroid carcinoma with neck metastasis; neck dissection
Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2269557 to Japanese Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase (PI3K) delta
      inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment
      of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD). The
      purpose of the study is to assess the safety, tolerability and pharmacokinetics (PK) of
      single and repeat doses of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI)
      to healthy Japanese subjects. This is the first time for Japanese subjects that GSK2269557
      will be administered via the ELLIPTA DPI with the addition of magnesium stearate.

      In each group of this study, subjects will receive a single dose of either GSK2269557 or
      placebo in Session 1 and receive daily dose of GSK2269557 or placebo for 10 days in Session
      2. Session 1 of the next dose strength may be run in parallel with the Session 2 of the
      previous dose. The doses planned for the study are 200 micrograms (mcg), 500 mcg and 700 mcg.
      There will be at least 10 days washout between the two dosing sessions. Follow up period will
      start 10 days (+-1 day) after the last dose of Session 2. A total number of 36 subjects will
      be enrolled for the study with 27 subjects receiving a dose strength of GSK2269557 and 9
      subjects will receive each dose strength of GSK2269557. ELLIPTA is a trademark of the GSK
      group of companies.
    


Intervention name(s): GSK2269557 ELLIPTA DPI; Placebo ELLIPTA DPI
Intervention type(s): Drug; Drug
Intervention description(s): GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate. This will be supplied in two strength of 100 mcg per blister and 500 mcg per blister.; Placebo ELLIPTA DPI contains lactose
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; GSK2269557; Dry powder Inhaler (DPI); tolerability; safety; ELLIPTA
A Study of Effects of Selpercatinib (LY3527723) on Repaglinide in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of selpercatinib on how fast
      repaglinide gets into the blood stream and how long it takes the body to remove it when
      administered in healthy participants. Information about safety and tolerability will be
      collected. The study will last up to 12 days.
    


Intervention name(s): Repaglinide; Selpercatinib
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Intervention MeSH terms: Repaglinide
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Condition: Ovulation Induction; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This prospective, randomized clinical trial double blinded study, has been carried on 160
      infertile patients seeking pregnancy in Gynecology and Obstetrics Department, Zagazig
      University Hospitals during the period from January 2019 to November 2019, the participants'
      randomizations were done and patients divided into two groups; group I: included 80 women
      receiving Clomiphene citrate (CC) plus Isoflavonoids. Group 2: included 80 women receiving
      Clomiphene citrate only
    

Detailed description: 
      Phytoestrogens continue to be of increasing interest because of their possible influence on
      the physiology of the reproductive tract.

      The aim of Prospective randomized clinical trial study is to evaluate effect of adding
      isoflavonoids to clomiphene citrate during ovulation induction in women with PCOS on the
      endometrial thickness which has an impact on pregnancy rate.

      This study included 160 infertile women seeking pregnancy and they were divided into two
      groups. Clomiphene is given orally at dose, one tablet twice per day (tablet 50 mg), from day
      3 to day 7 for all patients (group I and group II),while phytoestrogens are given at dose,
      two tablets two times per day (tablet 800mg), from day 3 to day 12 only for group I, followed
      by HCG injection on attaining mature follicle(s) by trans-vaginal US scan with diameter ≥ 18
      mm.
    

Intervention name(s): Rosafem (FEMININE FORMULA)
Intervention type(s): Drug
Intervention description(s): Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human chorionic gonadotropin; clomiphene Citrate; Isoflavonoids; polycystic ovary syndrome
Intravenous vs Oral Analgesia in Cancer Patients With Severe Pain After Successful Titration
Condition: Cancer Pain
MeSH terms: Cancer Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Pain is one of the most common and fear symptoms for cancer patients, which seriously affects
      the quality of life in cancer patients. At present, oral opioid is the most common route to
      administrate cancer pain. However, the patients do not satisfy the pain administration with
      oral opioid after successful titration in many cases, especially the cases with severe cancer
      pain. Patient controlled analgesia (PCA) with hydromorphone can take analgesic effect
      rapidly. The aim of this trial is to compare the maintenance with hydromorphone PCA
      intravenously or switch to Sustained-Release Morphine orally after successful titraton with
      hydromorphone PCA intravenously in severe cancer pain.
    


Intervention name(s): PCA IV Hydromorphone (continuous dose = 0); PCA IV Hydromorphone (continuous dose ≠ 0); Oral morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4) evaluate once every 24 hours; Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4) evaluate once every 24 hours; Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours
Intervention MeSH terms: Morphine; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orally; PCA intravenously; Analgesia; Severe cancer pain