bioihbjkbjnl/mcl2 huggingface dataset:
Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement
Condition: Rehabilitation; Analgesia; Anesthesia
Study type: Observational

Summary: 
      Opioid-free anesthesia (ATO) is a multimodal anaesthesia combining different analgesic and
      anesthetic modalities thus excluding opiates as an intraoperative. Recent studies have found
      a benefit from the ATO on postoperative rehabilitation and reduced length of hospitalization.

      Periarticular infiltration with a local anesthetic is one of the measures proposed in OFA
      during the PTH.

      PTH remains a painful procedure and the occurrence of morphinic-related side effects in
      sometimes elderly patients is often observed.

      The main objective of this study is to assess the feasibility of ATO in anterior hip
      replacement under general anesthesia with the primary endpoint of morphine consumption
      measured 24 hours after surgery.
    


Intervention name(s): Cumulative morphine consumption
Intervention type(s): Drug
Intervention description(s): morphine equivalent [mg] 24 hours after the procedure
Intervention MeSH terms: Morphine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ASA (American Society of Anesthesiology) I-III for whom a total Hip
        Prosthesis is programmed anteriorly (Hueler Method).
Pre- and Post-restriction Chocolate Candy Consumption
Condition: Investigate the Maladaptive Eating Behaviors of Normal Healthy Adults
Study type: Interventional

Summary: 
      Craving differs from hunger because it occurs even when a person is in a satiated state and
      in the absence of an energy deficit. Craving is usually triggered by specific foods and may
      be attributable to certain sensory properties of foods. Foods that are craved are often
      regarded as less healthy choices, and are higher in energy content. Chocolate is one of the
      most commonly reported foods craved by people in this country. Together, craving for
      chocolate has been suggested to be a possible cause of weight gain and access to chocolate
      therefore needs to be restricted.

      However, it remains unknown if restriction may induce maladaptive eating behaviors of
      chocolate cravers. The anticipation of going on a diet has been shown to cause restrained and
      disinhibited eaters to react by consuming more chocolate. In this study, we will examine if
      this response is also found in chocolate cravers when they are asked to undergo three weeks
      of chocolate restriction. This study will also examine chocolate cravers' response after the
      chocolate restriction is lifted. We hypothesize that chocolate consumption of cravers will
      increase both before and after chocolate restriction is imposed. We also hypothesize that
      chocolate craving is specific to the food rather than its sweet taste, and that chocolate
      cravers are less willing to substitute chocolate for salty snacks, natural snacks, and sweet
      non-chocolate snacks during the restriction.
    


Intervention name(s): Snack Condition Specification
Intervention type(s): Other
Intervention description(s): Individuals recieve a different snack for every week of the study. This is viewed as 4 phases. Phase 1 measures of habitual chocolate candy consumption (1 week), Phase 2 assesses participants' chocolate consumption while anticipating an oncoming chocolate candy restriction (1 week), Phase 3 is the total chocolate candy restriction period, but participants will be given 3 non-chocolate-candy snack substitutes in a random order (1 week per snack type, 3 weeks total), and Phase 4 examines participants' chocolate candy consumption when the 3-week restriction is lifted (1 week).
Other intervention name(s): Generic Branded Snack Foods (commerically available)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Healthy Environments Partnership
Condition: Cardiovascular Health
Study type: Observational

Summary: 
      The Healthy Environments Partnership was established in October 2000, as a part of the
      National Institute of Environmental Health Sciences "Health Disparities Initiative." The
      Healthy Environments Partnership seeks to expand the knowledge base of how social and
      economic inequalities are linked to disparities in cardiovascular health among residents of
      Detroit. The Healthy Environments Partnership is a project of the Detroit Community-Academic
      Urban Research Center. The partners are: Brightmoor Community Center, Butzel Family Center,
      the Detroit Health Department, Friends of Parkside, Henry Ford Health System, Southwest
      Counseling and Development Services, Southwest Detroit Environmental Vision and University of
      Detroit Mercy and the University of Michigan School of Public Health, School of Nursing, and
      the Institute for Social Research.
    


Time perspective: Other
Keywords: health disparities; social environment; physical environment; racial health disparities
Duloxetine Role in Reducing Opioid Consumption After Thoracotomy
Condition: Post-thoracotomy Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      A total of 60 patients scheduled for thoracotomy with the aim of excision of pleural or lung
      cancer, will be randomized by the use of a computer-generated table of random numbers to
      receive duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after
      the surgical procedure or a placebo pill following the same time schedule.
    


Intervention name(s): Oral Duloxetine 60mg; placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure; placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Thrombocytopenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate
      administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in
      untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.
    

Detailed description: 
      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.
    

Intervention name(s): Fludarabine Phosphate (Fludara)
Intervention type(s): Drug
Intervention description(s): 6 cycles (1 cycle: 5 treatment days every 28 days)
Other intervention name(s): BAY86-4864
Intervention MeSH terms: Fludarabine; Fludarabine phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone
      and In Combination with Vandetanib
    

Detailed description: 
      A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Metformin, an
      OCT2 Substrate, in Healthy Subjects When administered Alone and in Combination with a Single
      Oral Dose of Vandetanib (CAPRELSA) 800 mg
    

Intervention name(s): Metformin 1000 mg; Vandetanib 800 mg
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 500 mg oral tablets; 2 x 300 mg and 2 x 100 mg oral tablets
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; pharmacokinetics; vandetanib; metformin; AUC(0-t); t1/2; tmax; CL/F; Vz/F; Cmax
Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver
Condition: Non-alcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in
      the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat
      distribution in the liver has so far been studied with liver biopsies and single voxel MR
      techniques. With this trial investigators present a new, whole organ MR-quantification of
      liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.
    

Detailed description: 
      Currently, liver biopsy is still regarded as the gold-standard in the diagnosis of
      non-alcoholic fatty liver disease and monitoring of progression. However, accuracy of
      diagnosis is not perfect with a certain risk of sampling error depending on biopsy quality
      and a more or less homogeneous distribution of liver tissue alterations. Complications are
      rare; however, the method is invasive and carries the risk of bleeding. Therefore,
      non-invasive methods (such as serum biomarkers or imaging techniques) are sought for accurate
      diagnosis and safe monitoring of disease progression. Unidimensional transient elastography
      (TE; FibroScan®) is a non-invasive technique, which can be a helpful tool here: however,
      accuracy of diagnosis is depending on the stage of fibrosis and lower grades of fibrosis
      (stage 1 and 2) are difficult to assess. Moreover, in obese patients this method cannot be
      applied.

      In recent years, the development of fat-water magnetic resonance imaging has enabled
      non-invasive assessment of fat and water content in tissues. In addition, modern MRI devices
      allow brief breath holding, which reduces motion artifacts and provides us with excellent
      data and therefore MRI has become an important tool for fat quantification.

      Up to date only a few studies have focused on fat quantification before and after bariatric
      surgery: patients treated with laparoscopic gastric banding (a purely restrictive procedure)
      and patients undergoing metabolic surgery such as sleeve gastrectomy and gastric bypass have
      been examined pre- and postoperatively by means of MRI fat quantification. However, in these
      studies single voxel spectroscopy was used. In contrast, in this current trial investigators
      aim to assess full organ volume, which hopefully will provide more accurate data.
    

Intervention name(s): MR Abdomen
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
HD-tDCS: Effects on the Somatosensory System
Condition: Acute Pain; Neuroplasticity; Brain Modulation; Somatosensory Function
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of high definition tDCS on different
      cortical targets in modulating the nociceptive system in the healthy subjects.
    

Detailed description: 
      The investigators aim to investigate the efficacy of different HD-tDCS electrode
      configurations on modulating the somatosensory/nociceptive system.

      This is done to investigate the hypothesis, that different stimulation protocols can be used
      to modulate the somatosensory and nociceptive system, as shown in the previous studies, but
      that it is necessary to uncover the most efficient way to do so.

      The study uses a double-blinded, sham-controlled, longitudinal design, where quantitative
      sensory testing will be used to assess the somatosensory function of the participants before
      and after a receiving a specific configuration of HD-tDCS on three consecutive days.
    

Intervention name(s): Primary Motor Cortex Stimulation; Dorsolateral Prefrontal Cortex Stimulation; Multimodal Stimulation (DLPFC+M1); Sham stimulation
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of primary motor cortex (M1) using a ring-cathode configuration; Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of dorsolateral prefrontal cortex (DLPFC) using a ring-cathode configuration; Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal multimodal stimulation of dorsolateral prefrontal cortex (DLPFC) and primary motor cortex simultaneously using ring-cathode configurations around the two anodes.; Using the Starstim 32, HD-tDCS equipment we provide sham stimulation with 30 seconds of ramping up to 2 mA intensity, then turning off for 19 minutes and then ramping down from 2 mA intensity to 0 in the last 30 seconds.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Longitudinal, sham-controlled, parallel groups design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: tDCS; HD-tDCS; Somatosensory function; QST; quantitative sensory testing; Non-invasive brain stimulation; NIBS; Transcranial Direct Current Stimulation
Immediate Effect of Light on Reproductive Hormones in Women: a Role of the Spectrum
Condition: Healthy
Study type: Interventional

Summary: 
      The study investigates an acute effect of white-appearing LED light (with a peak in blue
      portion) vs. red LED light of similar irradiance on reproductive hormones in healthy women.
    

Detailed description: 
      Sixteen healthy women came to the laboratory at 7:30 (wearing dark goggles) at two occasions
      (separated by 2-3 days, first time - at the 3rd-8th day of their menstrual cycle) to be
      exposed for 45' to white-appearing or red LED light (sequential allocation). The white light
      has a distinct peak at 460 nm, the narrow-band red light peaked at 651 nm. The LED devices
      were positioned at the distance of 50 cm (white) and 45 cm (red) from the eyes to be matched
      by irradiance (approximately 7.0 microWt/m2); background light in direction of gaze was 5-10
      lux. Blood and saliva samples were collected before, in the middle, and during the last
      minutes of the 45' exposure to be measured later for concentration of luteinizing hormone,
      follicle-stimulating hormone, prolactin, estrogen, progesterone, and also - for cortisol and
      melatonin (the last one - in saliva) as well-studied indicators of the direct effect of
      light.
    

Intervention name(s): Light therapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Light exposure; light spectrum; reproductive hormones; women
The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial
Condition: Neck Pain; Mechanical/Motor Problems With Neck and Trunk
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The study aims to investigate the influence of 5 cupping massage treatments on chronic non
      specific neck pain. 50 patients with neck pain are randomised into cupping treatment and
      waiting list control group. Before and after the intervention the investigators evaluate the
      neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of
      life (SF36) and safety. To investigate neurophysiological effects of cupping the
      investigators also measure mechanical detection threshold (MDT), vibration detection
      threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold
      at pain related and control areas.

      The treatment group receives 5 cupping treatments over a period of 3 weeks.
    

Detailed description: 
      see above
    

Intervention name(s): Cupping massage
Intervention type(s): Procedure
Intervention description(s): Using suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin
Other intervention name(s): Moving cupping treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Nutritional Formula (Protison) on Various Cancer Patients: A Randomized Clinical Trial
Condition: Cancer
Study type: Interventional

Summary: 
      Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in
      omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements)
      are essential for cancer patients to improve health status and tolerability of chemotherapy.
      Hence, the present multi-centered, randomized clinical trial was framed to evaluate the
      efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC,
      BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall
      health status through assessing various anthropometric and biochemical parameters especially
      total proteins, pre-albumin, and transferrin.
    

Detailed description: 
      Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in
      omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements)
      are essential for cancer patients to improve health status and tolerability of chemotherapy.
      Hence, oncologic nutritionist strongly recommends cancer patients (with cachexia) to consume
      a diet rich in protein and dietary fibers along with balanced essential micronutrients like
      vitamins and minerals (Van Norren et al., 2009; Yeh et al., 2013). From the above statement,
      it cleared that nutritional support is a crucial aspect of multi-modal cancer care, by
      improving the overall health status by suppressing various adverse events as well as enhance
      treatment regimen for a speedy recovery. Hence, the present multi-centered, randomized
      clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional
      formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer
      patient by checking calorie intake and overall health status through assessing various
      anthropometric and biochemical parameters especially total proteins, pre-albumin, and
      transferrin.
    

Intervention name(s): Protison cancer nutritional formula (PCNF)
Intervention type(s): Dietary Supplement
Intervention description(s): PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks
Other intervention name(s): Protison
Intervention model: Single Group Assignment
Intervention model description: Supplementation with the commercial nutritional formula (PCNF; 237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Cachexia; Nutritional status; Tube feeding; PCNF
Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      In this pilot study, menthol cigarette smokers will be randomized to one of three
      experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not
      menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol
      cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not
      banned for either product (Condition C - the control condition). All conditions would have
      medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits
      occurring every two weeks over a 6 week period, subjects will receive "credits" that they
      could exchange for any product available in their randomized marketplace condition. Outcomes
      include the amount of each tobacco product used.
    


Intervention name(s): Menthol ban on cigarettes; Menthol ban on cigarettes and e-cigarettes; No menthol ban
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes; Participants will have neither menthol flavored cigarettes or e-cigarettes available; Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia
Condition: Contraception; Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the bleeding pattern during the last 3 months of the
      first MIRENA® and the first year of the second MIRENA® use.
    

Detailed description: 
      This study has previously been posted by Schering AG, Germany. Schering AG has been renamed
      to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the
      trial.
    

Intervention name(s): Levonorgestrel (Mirena, BAY86-5028); Cytotec; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Removal of first MIRENA and insertion of the second MIRENA at entry visit. Removal of MIRENA (in vitro release rate 20 microgram/24h) at year 5 visit.; Cytotec, single, sublingual dose of 400 microgram, 3 hours prior to the MIRENA removal and insertion procedure at entry visit; Placebo, single, sublingual dose, 3 hours prior to the MIRENA removal and insertion procedure at entry visit.
Intervention MeSH terms: Misoprostol; Levonorgestrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intrauterine System; Contraception; Menorrhagia