bioihbjkbjnl/mcl2 huggingface dataset:
Determination of Protein Requirements in Pregnancy
Condition: Pregnancy
Study type: Interventional

Summary: 
      Protein is an essential part of our diet. It is used to build muscle and body tissue, send
      signals throughout our body and to support the immune system. Dietary protein is even more
      crucial during pregnancy as it is needed for healthy growth and development of the baby.
      There is very minimal data available on how much additional protein is required during
      pregnancy. Current recommendations are based on older techniques such as nitrogen balance
      studies of non-pregnant adults and minimally based on pregnancy specific data. There is no
      scientific information regarding the amount of protein needed during different stages of
      pregnancy.

      The investigators hypothesize that the current recommendations of protein intake during
      pregnancy are underestimated.

      The goal of this study is to measure protein requirement in healthy pregnant women
      (19-35y)using a more quick and modern technique called the indicator amino acid oxidation
      technique (IAAO).
    


Intervention name(s): Protein Intake
Intervention type(s): Dietary Supplement
Intervention description(s): Oral consumption of Eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: pregnancy; protein requirements; Indicator Amino acid oxidation; Stable isotopes
Effect of Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects
      with stable heart failure (HF) with reduced ejection fraction (HFrEF).
    

Detailed description: 
      This was a randomized, double-blinded, placebo-controlled, multiple-dose study in subjects
      with stable heart failure (HF) with reduced ejection fraction (HFrEF). After completing the
      Screening period, a total of 71 subjects were randomized, in a 1:1:1 ratio, to receive either
      placebo, 4 mg elamipretide, or 40 mg elamipretide once daily for 28 consecutive days.

      Each treatment group went through 3 distinct periods: Screening, Treatment, and Follow up.
    

Intervention name(s): 4 mg elamipretide; 40 mg elamipretide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days; Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days; Subcutaneous injection of placebo administered once daily for 28 consecutive days
Other intervention name(s): MTP-131; Bendavia; MTP-131; Bendavia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Absorption & Elimination of Radiolabelled GSK2269557
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2269557 is being developed as an anti-inflammatory agent for the treatment of chronic
      obstructive pulmonary disease (COPD) and other inflammatory lung diseases such as asthma.
      This study is designed to investigate the recovery, excretion, and pharmacokinetics (PK) of
      (14 Carbon [C])-GSK2269557 administered as a single intravenous (IV) dose (concomitant with
      an inhaled non-radiolabelled dose) and as a single oral dose in 6 healthy male subjects.
      Subjects will receive [14C] radiolabelled GSK2269557 administered as IV infusion, with a
      nonradiolabelled dose of GSK2269557 via dry powder inhaler (DPI) in treatment period 1 and a
      single dose of [14C]-GSK2269557, administered as an oral solution in treatment period 2.
      There will be a washout period of at least 14 days after inhaled and IV dosing before
      subjects takes part in treatment period 2. The IV microtracer dose of GSK2269557 will be
      administered concomitant to an inhaled non-radiolabelled dose to ensure that the
      pharmacokinetics represent a clinically relevant dose. The total study duration will be up to
      11 weeks, including a screening visit, 2 treatment periods and a follow-up visit.
    


Intervention name(s): [14C]-GSK2269557 IV infusion; GSK2269557 via DPI; [14C]-GSK2269557 oral solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The [14C]-GSK2269557 solution will be available in dosing strength of 10 µg, administered as single dose IV infusion over 15 minutes. It will be prepared by dissolving a hemisuccinate salt (GSK2269557T) in normal saline.; GSK2269557 DPI will be available with dosing strength of 1000 µg, administered as oral inhalation intended to inhale twice. It will be prepared by blending GSK2269557 hemisuccinate salt (GSK2269557H) with lactose and magnesium stearate.; The [14C]-GSK2269557 solution will be available with dosing strength of 800 µg, administered as single dose orally. It will be prepared by dissolving [14C]-GSK2269557 hemisuccinate salt (GSK2269557T) in water.
Intervention MeSH terms: Nemiralisib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a 2-period, single-sequence crossover study. Subjects will receive IV and inhaled doses of GSK2269557 in treatment period 1 and oral dose of GSK2269557 in treatment period 2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK2269557; Pharmacokinetics; Radiolabel; Healthy; Excretion; Bioavailability
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to characterize rosacea patients', being treated with Oracea,
      perception through visual analog scale reporting.
    


Intervention name(s): Oracea
Intervention type(s): Drug
Other intervention name(s): doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads)
Intervention MeSH terms: Doxycycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Papulopustular Rosacea; Oracea; anti inflammatory doxycycline
The Effects Of Intravenous Ibuprofen on Pain, Oxidative Stress and Inflammation in Laparoscopic Hysterectomy Operations
Condition: Analgesia; Ibuprofen; Acetaminophen; Oxidative Stress
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Objective: The aim of this study is to evaluate whether the exposure of oxidative stres in
      the peroperative period and the postoperative 24th hour can be decreased with the
      thiol-disulfide homeostasis (TDH) method and C-Reactive Protein (CRP) with intravenous
      ibuprofen used for postoperative analgesia in patients undergoing total laparoscopic
      hysterectomy Material and Method: Sixty-nine patients with American Society of
      Anesthesiologists (ASA) scores I and II who scheduled for laparoscopic hysterectomy were
      included in the study. The patients were randomly divided into two groups as ibuprofen and
      paracetamol (Group IP) and paracetamol (Group P) with the sealed envelope method. When the
      vascular access was established from all patients (T0), after blood was drawn for TDH and CRP
      measurements, while 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9%
      isotonic and iv infusion of 1 g paracetamol was started simultaneously, only 1g of
      paracetamol infusion was administered in Group P. In the IP group 800 mg ibuprofen and 1 g
      paracetamol, in the P group only paracetamol, the medicines specified for each group
      administered intravenously every 6 hours. The postoperative pain level in the patients was
      evaluated at the 1st, 2nd, 6th, 12th and 24th hours with the Visual Analogue Scale (VAS).
      Rescue analgesia with 1mg/kg tramadol as an iv bolus was applied to patients whose VAS score
      was 4 and above. Other blood samples for CRP and TDH were taken before insufflation (T1),
      after desufflation (T2) and at the postoperative 24th hour (T3). Demographic and hemodynamic
      data of the patients, duration of anesthesia and Trendelenburg position, need for additional
      analgesia, presence of nausea and vomiting, VAS scores, pathology results, CRP and TDH levels
      were recorded.
    


Intervention name(s): Ibuprofen 800 mg
Intervention type(s): Drug
Intervention description(s): 30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Diabetes Mellitus
Study type: Observational

Summary: 
      Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral
      development in non-diabetic patients with stable coronary artery disease. Our aim in this
      study is to find out any possible relationship between the levels of circulating monocyte
      subsets and coronary collateral development in type 2 diabetic patients.
    

Detailed description: 
      83 diabetic patients with severe coronary artery disease were enrolled in the study. These
      patients were investigated according to their collateral development. Monocytes and their
      subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population consisted of 83 consecutive type 2 diabetic patients who have
        undergone coronary angiography because of stable symptoms and signs of coronary artery
        disease. The main inclusion criterion was the presence of >95% stenosis of at least one
        major coronary artery in their first coronary angiogram.
      
Keywords: Coronary collaterals; diabetes mellitus; monocyte subsets
Synchronous Telerehabilitation vs Face to Face Method for Upper Extremity Functions in Children With Hemiparetic CP
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of synchronous telerehabilitation
      on improving upper extremity function in children with hemiparetic cerebral palsy.
    

Detailed description: 
      46 children with hemiparetic cerebral palsy who meet the inclusion criteria and agree to
      participate in the study will be included. The participants will be randomly divided into two
      groups. The groups are: a) the synchronous telerehabilitation group; b) face to face
      rehabilitation group. Both groups will receive physiotherapy 2 days a week (1 session of 45
      minutes) for 12 weels, for a total of 24 sessions. Evaluations will be made at baseline and
      the end of the treatment.
    

Intervention name(s): Telerehabilitation; Face to face rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Telerehabilitation program: Intervention will be applied by video interview for 12 weeks, 2 days a week, 45 minutes a day through the Zoom application. The application is free and can be installed on desktop or laptop computers, tablets and smartphones. The content of the activities to be done for that session by phone call to the parent before the interventions; Information will be given about the preparations such as keeping the materials on the table, suitable environment for that week's session and camera angle. Instructions and tips for parent support during the intervention will be given before and during the session. Intervention will be focused on upper extremity skills and activities of daily life of the individuals.; Face to face program: Intervention will be applied by physiotherapist for 12 weeks, 2 days a week, 45 minutes a day in clinic. Intervention will be focused on upper extremity skills and activities of daily life of the individuals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of Dabigatran Etexilate Capsule in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters
      prior to administration of a high dose of dabigatran etexilate in a QT study
    


Intervention name(s): Dabigatran etexilate low dose; Dabigatran etexilate medium dose; Dabigatran etexilate high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Caring Hand Massage - an Intervention in Cancer Patients Undergoing Chemotherapy in an Outpatient Setting - a Pilot Study
Condition: Cancer
Study type: Interventional

Summary: 
      Since there is a limited amount of evidence on the feasibility and outcomes on the use of
      hand massage in patients undergoing cancer treatment, the purpose of this study is to
      evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing
      chemotherapy, and to measure its influence on their symptoms.
    


Intervention name(s): Caring Hand Massage
Intervention type(s): Behavioral
Intervention description(s): Caring Hand Massage is a hand massage therapy program with several steps and techniques.
Other intervention name(s): Hand Massage Therapy Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Determination of Sun Protection in Sunscreen Formulas (Study SR09-15)(P08236)(COMPLETED)
Condition: Sun Protection
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor
      (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with
      and without ensulizole.
    


Intervention name(s): Sunscreen Test Code: V53-028; Sunscreen Test Code: V53-030; Standard SPF 4 Sunscreen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole; Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone; 8% Homosalate Standard SPF 4 Sunscreen
Intervention MeSH terms: Sunscreening Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sunscreens
Efficacy and Safety of Potenfill for Temporary Penile Enhancement
Condition: Penile Enhancement
Study type: Interventional

Summary: 
      The purpose of this study is to evlauate the efficacy and safety of poteinfill, compared to
      the powerfill.
    


Intervention name(s): Potenfill; Powerfill
Intervention type(s): Device; Device
Intervention description(s): Maximum: 22ml; Maximum: 22ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery
Condition: Pain, Postoperative; Anesthesia
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The Transversus Abdominal Plane (TAP) block has been used with good success to decrease
      postoperative pain following laparatomy. If the TAP block provides any improvement in the
      quality of recovery following laparoscopic hysterectomy, it could decrease the need for
      postoperative narcotics and allow for more outpatient hysterectomy procedures.
    


Intervention name(s): TAP Block
Intervention type(s): Drug
Intervention description(s): Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
Other intervention name(s): Ropivacaine with Epinephrine
Intervention MeSH terms: Epinephrine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: recovery; postoperative; pain; laparoscopy; hysterectomy; ropivacaine; TAP block; local anesthesia
Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control
Condition: Intraoperative Complications
MeSH terms: Intraoperative Complications
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Pre-operative blood glucose (BG) concentrations in type 2 diabetic patients undergoing
      elective non-cardiac surgery; have an increased incidence of in-hospital morbidity for
      cardiopulmonary and infectious complications. Also, hyperglycemia is associated with
      increased production and impaired scavenging of oxygen reactive species, polymorph nuclear
      neutrophil dysfunction and decreased intracellular killing, resulting in poor wound healing
      and increased risk of infection. Thus, perioperative optimal glucose management contributes
      to reduced morbidity and mortality. Recommendations favor moderate levels of capillary blood
      glucose (CBG); maintaining it in the range of 140-180 mg/dl.

      Peri-operative doses of rapidly acting insulin for glycemic control could be done by the
      sliding scale or the bolus-infusion approaches. The sliding scale of insulin is commonly used
      to manage peri-operative hyper-glycaemia. It involves administering prescribed doses of
      insulin when the CBG is within determined ranges and withholding insulin when the CBG is
      within normal range. When used as a sole therapy; it results in under-insulinisation and thus
      hyper-glycaemia. The use of a dynamic insulin regimen like the intravenous bolus-infusion
      approach; allows adjusting the blood glucose level according to the insulin sensitivity of
      each patient, thus, better glucose control and less variations than the intermittent
      intravenous bolus of short-acting insulin in the sliding scale despite the same blood glucose
      target.
    

Detailed description: 
      compare the rapidly acting insulin injection via the bolus-infusion approach (Study group) to
      the sliding scale approach (Control group) as regards the intra-operative glycemic control
    

Intervention name(s): Rapid-Acting Insulin
Intervention type(s): Drug
Intervention description(s): 50 IU of rapid acting insulin taken by a 100 units (1ml) insulin syringe will be added to a 50 ml syringe containing normal saline (NS) to have a total volume of 50 ml with a concentration of 1 IU of insulin per 1 ml of NS
Other intervention name(s): Crystalline insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insulin; Intra operative; Sliding scale; Bolus- infusion
A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib
      therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass
      surgery
    


Intervention name(s): Parecoxib Sodium/Valdecoxib; Placebo/Valdecoxib; Placebo/Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Parecoxib sodium 40 mg intravenous (IV) on the day after surgery (Day 1) following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received parecoxib 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV parecoxib sodium, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.; Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.; Patients received placebo matched to parecoxib sodium 40 mg IV on Day 1 following recovery from anesthesia, contingent on an acceptable postoperative status, verification of baseline eligibility, and lack of perioperative complications. A second dose of placebo matched to parecoxib sodium 20 mg IV was administered on Day 1. On the day following surgery, patients received placebo matched to parecoxib sodium 20 mg IV at 8 am and each subsequent dose was administered at 12-hour intervals. After receiving at least 6 doses of IV placebo, patients were transitioned to oral placebo matched to valdecoxib 20 mg taken at 12-hour intervals until the total treatment duration of 10 days had been completed.
Intervention MeSH terms: Parecoxib; Valdecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment