bioihbjkbjnl/mcl2 huggingface dataset:
Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Duloxetine has recently been shown to be effective in reducing the pain in chronic pain
      patients. Duloxetine is known to exert a central mechanism, however the precise human brain
      structures responsible for mediating its pain-relieving properties are not known. We will use
      functional magnetic resonance imaging (FMRI) to investigate the neural and functional
      correlates of pain.
    


Intervention name(s): duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30-60mg of duloxetine daily; Placebo pill once daily
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression
Condition: Perinatal Depression; Ketamine; Cesarean Delivery; Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Postpartum depression is common in mothers early after childbirth and produces harmful
      effects not only on mothers, but also on infants and young children. Parturients with
      prenatal depression are at increased of postpartum depression. Low-dose ketamine can be used
      for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on
      parturients with prenatal depression. This study is designed to investigate whether low-dose
      ketamine administered during cesarean delivery can decrease the incidence of postpartum
      depression in parturients with prenatal depression.
    

Detailed description: 
      Postpartum depression refers to maternal depression developed early after childbirth, with
      reported incidences varied from 15% to 20%. The development of postpartum depression produces
      harmful effects not only on mothers, but also on infants and young children. Prenatal
      depression or high depression score is an independent risk factor for the development of
      postpartum depression.

      Ketamine is commonly used as an general anesthetic. In addition, low-dose ketamine is
      recommended for antidepressant therapy. We hypothesize that low-dose ketamine has a
      therapeutic effect on parturients with prenatal depression. However, evidences in this aspect
      are insufficient. The purpose of this study is to investigate whether low-dose ketamine
      administered during cesarean delivery can decrease the incidence of postpartum depression in
      parturients with prenatal depression.
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.; Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
Other intervention name(s): Ketamine hydrochloride; Normal saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prenatal depression; Ketamine; Cesarean delivery; Postpartum depression
The Effect of Glitazone Treatment on Bone Marrow and Bone Marrow Cells
Condition: Change in Bone Mineral Density; Change in Bone Marrow Fat Content
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoporosis is a generalised bone disease leading to an increased risk of fractures. The
      disease is caused partly by environmental and partly by genetic factors. It is well known
      that the fat content of the bone marrow is increased in osteoporotic patients. Animal studies
      suggest that stimulation of bone marrow stem cells through the molecule PPARgamma with the
      drug rosiglitazone converts the stem cells to fat cells instead of bone cells thereby
      decreasing bone strength. In a single study healthy volunteers were treated with
      rosiglitazone for 14 weeks and had a decrease in bone mineral density.

      In the present study we wish to investigate the effect of this treatment on bone and fat
      tissue. 25 women above the age of 60 will be treated with rosiglitazone 8 mg/day for 14 weeks
      and compared with 25 women receiving placebo.

      The effect will be evaluated as follows:

        1. The effect on bone marrow density will be examined by a bone scan prior to and after
           treatment and again after 6 and 9 months.

        2. The effect on bone turnover will be measured in blood- and urine samples at the same
           times.

        3. The effect on fat distribution will be evaluated by an MRI scan after treatment.

        4. The effect on bone marrow cells will be investigated bone marrow sampling immediately
           after treatment

        5. The direct effect on fat will be examined by a biopsy immediately after treatment The
           study hypothesis is that rosiglitazone treatment decreases bone mineral density and
           increases bone marrow fat content. The causal molecular mechanisms will be investigated
           from the bone marrow and fat samples
    


Intervention name(s): Rosiglitazone; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): one tablet of rosiglitazone 8 milligrams per day for 14 weeks; One encapsulated placebo pill a day for 14 weeks
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: BMD; Rosiglitazone; Bone marrow fat
A Comparative Study for Efficacy and Safety Between 4% Hydroquinone Cream With or Without Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
Condition: Picoseconds Laser; Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Comparative study for Efficacy and Safety Between 4% hydroquinone cream with or without
      Fractional Picosecond 1,064 nm Laser for the Treatment of Dermal or Mixed Type Melasma
    

Detailed description: 
      Primary Objective:

        -  To compare clinical efficacy by Modified MASI score between Fractional Picosecond 1,064
           nm laser and daily application of 4% hydroquinone with 4% hydroquinone alone Secondary
           objectives

        -  To compare the clinical endpoints of Mexameter Melanin Index, brownish spot and
           Ultraviolet spots by VISIATM complexion analysis, The Antera 3D® imaging technology for
           pigmentation, quality of life by Dermatology Life Quality Index and patient's
           satisfaction between Fractional Picosecond 1,064 nm laser and 4% hydroquinone with 4%
           hydroquinone alone
    

Intervention name(s): Fractional Picosecond 1,064 nm laser; 4% hydroquinone cream
Intervention type(s): Device; Drug
Intervention description(s): Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream
Intervention MeSH terms: Hydroquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized split face
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of paliperidone
      extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder
      with symptoms of emotional instability, detachment from reality, often with delusions and
      hallucinations, and withdrawal into the self) who were receiving treatment with any oral
      (having to do with the mouth) antipsychotic medication and who needed to be switched to
      paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or
      due to side effects.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-centric
      (conducted in more than one center) and non-comparative study of paliperidone ER in
      participants with schizophrenia who have a previous history of bad adherence to the
      antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible
      participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally
      (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily
      be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom
      Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone
Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes
Condition: Type 2 Diabetes; Overweight; Obese
MeSH terms: Diabetes Mellitus, Type 2; Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the effect of replacing diet beverages with
      water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic
      risk factors of diabetic obese and overweight female adults when they are in a
      multidisciplinary weight loss plan.
    


Intervention name(s): DBs at the end of the main meal + Diet; Water at the end of the main meal+ Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.; Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: diet beverages; water; diabetes; weight loss; insulin sensitivity
TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of the phase 1 translational pilot study proposed here is to gather preliminary
      data investigating the efficacy of transcranial direct current stimulation (TDCS) and
      cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The
      recent use of TDCS over task relevant regions to alter behavior holds incredible promise for
      use in cognitive retraining intervention protocols. Previous studies of cognitive retraining
      have focused on implicit training techniques. This proposed study will attempt to enhance
      these implicit training techniques through the use of TDCS during implicit retraining in
      order to increase learning of avoidance-related action tendencies towards tobacco. The
      objective of this pilot study is to establish the feasibility and obtain preliminary data on
      the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette
      smoking in individuals with nicotine addiction.
    


Intervention name(s): Active Retraining; Sham Retraining; Active transcranial direct current stimulation (TDCS); Sham transcranial direct current stimulation (TDCS); Nicotine Replacement Therapy (Habitrol)
Intervention type(s): Behavioral; Behavioral; Device; Device; Drug
Intervention description(s): Administration of Nicotine Replacement Therapy Patches
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
OPC-61815 in Healthy Chinese Male Subjects
Condition: Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of OPC-61815
      in healthy Chinese Male subjects
    

Detailed description: 
      To evaluate the pharmacokinetic (PK) characteristics of single and multiple intravenous
      administration of OPC-61815 in healthy Chinese subjects.

      To evaluate the safety of single and multiple intravenous administration of OPC-61815 in
      healthy Chinese subjects.

      To evaluate the pharmacological effect of single and multiple intravenous administration of
      OPC-61815 in healthy Chinese subjects.
    

Intervention name(s): OPC-61815 injection
Intervention type(s): Drug
Intervention description(s): Intravenous administration of OPC-61815 at 8 mg or 16 mg. 8mg group will be intravenously administered only on D1, once a day. 16mg group will be intravenously administered on D1，D3-D9, once a day.
Intervention model: Sequential Assignment
Intervention model description: 8 mg and 16 mg.
Masking: None (Open Label)
Primary purpose: Treatment
CoolSculpting of the Flank With Alternate Treatment Parameters
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous
      fat layer reduction with an alternative treatment parameter.
    

Detailed description: 
      The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in
      the flank.
    

Intervention name(s): The Zeltiq CoolSculpting System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
Liking of Snack Foods - Sub-Study 1
Condition: Eating Behavior; Obesity; Satiation
Study type: Interventional

Summary: 
      Specific Aims: Environmental factors contributing to overconsumption, such as larger food
      portion sizes, may be contributing to the obesity epidemic. The objective of the proposed
      study is to examine the independent and combined effects of portion size and quantity of food
      on intake in normal weight males and females. Participants will be randomly assigned to one
      of four conditions varying in the portion size and quantity of junk food provided: small
      quantity of food packaged in small portions (SSP), small quantity of food packaged in large
      portions (SLP), large quantity of food packaged in small portions (LSP), and large quantity
      of food packaged in large portions (LLP). A box containing four different junk foods,
      packaged according to one of the four conditions, will be given to participants to take home
      for three days. The total amount of food consumed from the box over the three days will be
      measured. It is anticipated that portion size and quantity of food, both independently and
      combined, will influence intake, such that larger portion sizes and quantity of food provided
      to participants will produce greater intake.Subject Population: We propose to recruit 60
      healthy men and women, aged 18-50 years, with a body mass index (BMI) of less than or equal
      to 28. Participants will be non-smokers, unrestrained eaters, and have no known food
      allergies to the foods used in the investigation.Methods/Design: Participants will be
      randomly assigned to one of four conditions, varying in portion size (small versus large) and
      quantity of food provided (small versus large). A box containing four junk foods, packaged
      according to one of the conditions, will be provided to participants. They will be encouraged
      to eat as much or as little of the food as they want, but to at least taste each of the four
      foods over the three-day period. During this time, they will be instructed to not eat any
      other junk foods. At the end of the three-day period, participants will return the box with
      any remaining uneaten junk food.Data Analyses: The dependent variables, the amount of grams
      and kcals consumed from the provided junk foods, will be examined between the four different
      conditions.Significance: If portion size and quantity are related to intake, subsequent
      studies will develop clinical interventions related to reducing portion size and/or quantity
      of food available in the household.
    


Intervention name(s): portion or unportioned food
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Cocaine Use and Outcomes of General Anesthesia
Condition: Anesthesia
Study type: Observational

Summary: 
      In this prospective study, investigators plan to evaluate the outcome of general anesthesia
      in the context of patients with a positive cocaine urine test. Patients with a positive urine
      cocaine test who do not appear acutely toxic and have normal vital signs may not have an
      increased rate of perioperative complications during elective surgery compared to similar
      patients with negative urine cocaine screening tests. Patients who are chronic cocaine users
      may have a higher anesthetic requirement.
    

Detailed description: 
      Patients with a history of cocaine abuse who are scheduled to undergo surgery at Parkland
      Hospital will be asked to provide a urine sample for a screening toxicology test on the day
      of surgery. Patients will also be asked to fill out a questionnaire with questions pertaining
      to their drug use history. The remaining aspects of perioperative care, including the general
      anesthetic technique, will be standardized for all patients and will not differ from the
      standard of care. The anesthesia faculty, resident, or CRNA will identify patients and obtain
      consent and ask the patient to fill out the questionnaire. This prospective study is intended
      to enroll about 300 cocaine positive and negative patients over a 2 year period.

      Blood samples will be collected for analysis of cardiac troponin T (cTnT) pre- and
      postoperatively.
    

Intervention name(s): Urine cocaine negative; Urine cocaine positive
Intervention type(s): Other; Other
Intervention description(s): Preoperative urine cocaine negative; Preoperative urine cocaine positive
Intervention MeSH terms: Cocaine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA physical status 1-3 subjects with cocaine use disorder who are scheduled to undergo
        surgery.
      
Keywords: Anesthesia; Cocaine Use
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage)
      immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet
      and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed
      state.
    


Intervention name(s): Saxagliptin; Metformin IR (glucophage); Saxagliptin + Metformin IR (FDC)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, Oral, 2.5 mg, Once Daily, 1 week; Tablets, Oral, 1000 mg, Once Daily, 1 week; Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week
Other intervention name(s): Onglyza; Glucophage; Onglyza; Glucophage
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid
Condition: Osteonecrosis of the Jaw; Infection Leading to Hospitalization
MeSH terms: Infections; Communicable Diseases; Osteonecrosis
Study type: Observational

Summary: 
      A non-interventional study to assess incident rates of Osteonecrosis of the Jaw and
      Infections leading to hospitalization in Cancer patients treated with XGEVA™ in Sweden,
      Denmark and Norway.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cancer patients treated with antiresorptive therapies for SRE prevention
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open label, randomized, two-treatment, two-period, two-sequence,
      single dose crossover food effect study in 18 subjects. The subjects will receive the study
      medication under either fed or fast during each treatment period.
    

Detailed description: 
      The present study will be conducted in healthy male volunteers. A single oral dose will be
      administered to the subject in each treatment period (under either fasting or fed state).
      Each treatment period will be separated by at least 7 calendar days. Post dose PK blood
      samples will be collected in each treatment period to evaluate the food effect on
      bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.
    

Intervention name(s): RP6530
Intervention type(s): Drug
Intervention description(s): Single oral dose
Other intervention name(s): A dual PI3K delta/gamma inhibitor
Intervention MeSH terms: Tenalisib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fasting; Fed condition; Pharmacokinetics