bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study
Condition: Healthy; Substance-related Disorder; Mood Disorder
MeSH terms: Substance-Related Disorders; Mood Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to investigate effects of methylphenidate, modafinil, and
      3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") on emotion-processing and cognitive
      performance using functional magnetic resonance imaging (fMRI) techniques. The primary
      hypothesis is that these psychostimulants differentially affect processing of emotional
      stimuli and potentially leading to alterations in social cognition and behavior.
    

Detailed description: 
      Methylphenidate and modafinil are increasingly used as performance enhancers or "smart drugs"
      by students. 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") is widely used as
      recreational drug to enhance emotions. We plan to investigate effects of these
      psychostimulants on emotion-processing and cognitive performance using functional magnetic
      resonance imaging (fMRI) techniques. Single doses of methylphenidate (60mg), modafinil
      (600mg), MDMA (125mg), or placebo will be administered before an fMRI scan in a
      placebo-controlled, randomized cross-over study design in 24 healthy subjects. Subjective
      emotional effects, sociability, neurohormonal, cardiovascular responses, and plasma drug
      concentrations will also be assessed and analyzed for potential brain-induced changes in
      brain activity in networks processing emotions. The primary hypothesis is that these
      psychostimulants differentially affect processing of emotional stimuli and potentially
      leading to alterations in social cognition and behavior. The work should clarify the
      neuropharmacological basis of the potentially differential effects of these drugs. This
      information will improve our understanding of the neurofunctional effects of methylphenidate,
      modafinil, and MDMA, and inform the ongoing debate surrounding brain doping with cognitive
      and mood enhancers.
    

Intervention name(s): Methylphenidate; Modafinil; MDMA; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 60mg per os, single dose; 600mg per os, single dose; 125mg per os, single dose; per os
Other intervention name(s): Ritalin; Concerta; Medikinet; Focalin; Modasomil; 3,4-Methylenedioxymethamphethamine; Ecstasy; capsules containing manitol looking identical to methylphenidate, modafinil, and MDMA
Intervention MeSH terms: Methylphenidate; Modafinil
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Methylphenidate; Modafinil; MDMA; fMRI; emotion-processing; social cognition
Augmenting Clozapine With Sertindole - SERCLOZ
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether addition of sertindole to clozapine
      treatment can improve psychosis or the metabolic side-effects of clozapine in patients with
      treatment-resistant schizophrenia.
    

Detailed description: 
      Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the
      drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the
      study clozapine treatment is augmented with sertindole. Patients are randomized to either
      clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for
      12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be
      reduced due to the addition of sertindole.
    

Intervention name(s): Serdolect; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 16 mg, 12 weeks; placebo
Other intervention name(s): sertindole
Intervention MeSH terms: Sertindole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Treatment-resistant; sertindole; clozapine
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
Condition: Cardiovascular Risk Factor; Heart Diseases; Inflammation
MeSH terms: Heart Diseases; Inflammation
Study type: Interventional

Summary: 
      This research study will test the effects of Q CAN PLUS powder on serum lipids, selected
      inflammatory and oxidative parameters and genome-wide methylation
    

Detailed description: 
      The purpose of this research study is to investigate the effects of a dietary supplement from
      soybeans that might help in managing heart disease. The rationale for this study is to reduce
      the risk factors of heart disease in high risk individuals by using soy supplements. The
      dietary supplement intervention trial is a randomized, 2x2 cross over design with 24 subjects
      in free-living conditions. There will be a two week run-in (acclimation period) after which
      subjects will be randomized to receive either QCAN powder or placebo powder for 12 weeks.
      Following a two week wash out period, subjects will be switched over(cross over) to alternate
      treatment. Thus, the interventions of the study will last for a total of 28 weeks.
    

Intervention name(s): Q CAN PLUS; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy; Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This dietary intervention trial is a randomized, 2x2 crossover design with 24 subjects in free-living conditions.There will be a two week run-in (acclimation period), after which subjects will be randomized to receive either Q CAN powder or placebo powder for 12 weeks. Following a two week wash out period, subjects will be switched over to the alternate treatment.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Fermented Soy; Cardiovascular Disease; Inflammation; DNA Methylation
Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and
      Safety of midazolam, caffeine and rosuvastatin.
    


Intervention name(s): EDP-235; Midazolam; Rosuvastatin; Caffeine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive EDP-235 once daily on Days 5-15; Subjects will receive midazolam once daily on Days 1 and 12; Subjects will receive rosuvastatin once daily on Days 2 and 13; Subjects will receive caffeine once daily on Days 1 and 12
Intervention MeSH terms: Midazolam; Caffeine; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug-drug interaction
Evaluating the Dietary Supplement Anatabloc in Thyroid Health-ASAP (Antabloc Supplementation Autoimmune Prevention)
Condition: Thyroiditis, Autoimmune
MeSH terms: Thyroiditis; Thyroiditis, Autoimmune
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety, tolerability, and potential effects of Anatabloc
      dietary supplementation on antithyroid autoantibodies, thyroid structure, and thyroid
      function in subjects with autoimmune thyroiditis.
    

Detailed description: 
      This is a 5-visit, 12-week, double-blind, randomized, placebo-controlled, parallel-group
      study.
    

Intervention name(s): Anatabloc Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day; Placebo, as mint flavored lozenges, to be taken 3 times each day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hashimoto Disease; Thyroiditis
Using Diode Laser in 2nd Stage of Implant.
Condition: Dental Implant Exposure Using Diode Laser
Study type: Interventional

Summary: 
      Dental Implants that are teeth replacements usually place with two stages. In the second
      stage the implant fixture, (which is the body that inserted in the bone is exposed to place
      the artificial tooth), is exposed using surgical blade, however; an alternative method using
      diode laser may be used. This study aimed to compare the two methods in relation to pain
      anticipated by the patients and the need for local anesthesia usage.
    

Detailed description: 
      Second-stage implant exposure involves removing soft tissue above the dental implant, as a
      part of the implant procedures to replace the missing teeth which can be done either by using
      diode laser or traditional method This study included fifteen patients, aged between 18 and
      70 years old. Implant exposure was performed on 15 patients has at least two implants in two
      groups: group 1 with a diode laser at 940nm and group 2 with the traditional method performed
      either using a puncture, flap, or incision in 5 private clinics and one governmental run
      hospital in city of Baghdad/ Iraq.
    

Intervention name(s): diode laser 940nm
Intervention type(s): Device
Intervention description(s): Exposure for the two implants was done at the same visit, with one implant being exposed using diode laser and the other implant using traditional method
Intervention model: Single Group Assignment
Intervention model description: 15 patients that have at least two dental implants in jaws.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diode laser; dental implant; local anasthesia
Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder
Condition: Panic Disorders
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this pilot study is to evaluate the improvement in social function following
      therapy with venlafaxine extended release (XR) in the treatment of panic disorder (PD) in
      comparison to paroxetine. An additional purpose of this pilot study is to obtain the
      tolerability of using venlafaxine extended release (XR) in the treatment of panic disorder
      (PD) in comparison to paroxetine.
    


Intervention name(s): VENLAFAXINE; Paroxetine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paroxetine; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Panic Disorders
The Detection of Circulating Tumor Cells (CTCs) in Patients With Colorectal Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
Condition: Neoplastic Cells, Circulating
MeSH terms: Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time
      biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in
      colorectal cancer could play an important role in diagnosis, predicting the risk for tumor
      recurrence, and providing novel target therapy biomarkers. In view of these facts, the
      investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting
      human tumor cells of colorectal cancer in normal peripheral blood after cryosurgery with or
      without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators
      also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)
      method.
    

Detailed description: 
      1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately
      17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients
      with colorectal cancer and healthy volunteers. The blood of the healthy volunteers will be
      used to evaluate the sensitivity and specificity and as negative control cells. To avoid
      contamination with skin cells, 2 mL blood will be discarded before the study samples will be
      taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for
      20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood
      cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear
      cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis
      of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in
      phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR.
      Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to
      choose an adequate therapy.
    

Intervention name(s): Flow cytometry (FCM); RT-PCR
Intervention type(s): Other; Other
Intervention description(s): Use FCM to test PBMCs/CTCs from volunteers/patients.; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ⅱ,Ⅲ,Ⅳ stage colorectal cancer come to Fuda Hospital for treatment.
      
Keywords: Colorectal Neoplasms; Circulating Tumor Cells
A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the bioequivalence of alendronate in combination with vitamin D
      compared to alendronate alone and the bioequivalence of vitamin D in combination with
      alendronate compared to vitamin D alone.

      This was an open-label, randomized, 2-part, crossover study. Each participant participated in
      one part of the study only (i.e., each participant participated only in Part I or only in
      Part II). Participants entered the study sequentially within each part of the study. A
      washout of at least 12 days separated each treatment period within each part of the study.
    


Intervention name(s): alendronate sodium+vitamin D combination; Comparator: alendronate; Comparator: Vitamin D
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.; A single dose tablet of 70mg alendronate in one treatment period of each sequence.; Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Alendronate; Vitamins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
Condition: Erectile Dysfunction; Metabolic Syndrome
MeSH terms: Erectile Dysfunction; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a controlled, randomized, multi-center prospective study of vardenafil to determine
      efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic
      Syndrome. This study will explore the rate of patients who do need to switch to the highest
      dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re
      nata)
    


Intervention name(s): Vardenafil (Levitra, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks; Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Vardenafil; Erectile Dysfunction; Double-blind study
The Different Response of Endocrine Hormones to Hypoglycemia in Patients With Type 1 or Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Endocrine hormones, not only blood glucose responsive hormones, but also sexual hormones,
      thyroid hormones, growth hormones and so on, may have response and activites in hypoglycemia.
      However, the different responses of endocrine hormones to hypoglycemia in patients With
      diabetes remain unclear.
    

Detailed description: 
      This study will observe the changes of insulin, C-peptide, glucagon, growth hormone, IGF-1,
      ACTH, cortisol, thyroid function, sexual hormone in newly diagnosed men with type 2 and type
      1 diabetes mellitus using hyperinsulinaemic hypoglycaemic clamp technique
    

Intervention name(s): The hyperinsulinaemic hypoglycaemic clamp
Intervention type(s): Diagnostic Test
Intervention description(s): Glucose will be clamped at 5.0 mmol/L for approximately 30 minutes, and then be lowered to 3.0 mmol/L for 30 minutes
Intervention MeSH terms: Hypoglycemic Agents
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Normal subjects and newly diagnosed male patients with type 1 or type 2 diabetes
School Nurse Intervention and After School Exercise Program for Overweight Teens
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      Adolescent overweight and obesity have increased dramatically in the past several decades.
      High schools are well-positioned to deliver weight loss treatment to overweight and obese
      adolescents, as they have the facilities and staff to deliver a physical activity program,
      school nurses with the skills to provide counseling, and are easily accessible by
      adolescents. This exploratory study will test the feasibility and ability of a school-based
      intervention, consisting of school nurse counseling and a school-based exercise program, to
      reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in
      overweight and obese adolescents. If effective, this could prove to be a cost-effective and
      relatively easy intervention to disseminate widely for significant public health impact.
    


Intervention name(s): Lookin' Good Feelin' Good; Information attention-control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six 30-minute individual student-centered counseling sessions delivered by school nurses during the first two months followed by weekly weigh-ins and monthly visits over the subsequent 6 months, plus an exercise program in the school 3 times a week for the full eight months of the intervention.; Six individual sessions with school nurse over the first two months followed by monthly visits over the remaining 6 months to check weight and behavior changes and provide a series of pamphlets on weight and weight management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: School Nurse; Overweight; Obesity; Counseling; Intervention; Exercise
Duloxetine for Chronic Depression: a Double-blind Study
Condition: Dysthymic Disorder; Depressive Disorder NOS
MeSH terms: Depression; Depressive Disorder; Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are studying a new antidepressant medicine, duloxetine, for the treatment
      of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by
      the FDA for the treatment of major depression. The investigators are testing whether this
      medicine is also effective for adults with chronic depression (dysthymic disorder or
      dysthymia).

      Chronic depression, lasting two or more years, often causes significant suffering and
      impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during
      which half of the participants will take the new medication and half will take a placebo (an
      inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin,
      during which all subjects can be treated with an FDA-approved antidepressant medication.

      Eligible subjects may also receive MRI scans, to help the investigators understand how
      antidepressants work in treating depression.
    

Detailed description: 
      This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in
      chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or
      Depression, Not Otherwise Specified (Depression NOS).

      The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12
      weeks (Continuation Phase) is open-label and all subjects will receive active medication.

      Tests of cytokine functioning will be performed and analyzed for treatment and placebo
      effects.

      In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI)
      sub-study, in which a variety of brain imaging techniques (including anatomical MRI,
      functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at
      baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.
    

Intervention name(s): Duloxetine (Cymbalta)
Intervention type(s): Drug
Intervention description(s): duloxetine medication up to dose of 120 mg/day
Other intervention name(s): duloxetine; Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dysthymia; dysthymic disorder; chronic depression; chronic low-grade depression; atypical depression; minor depression; depression NOS; depression; depressive disorder; mood disorder; unipolar depression; low-grade depression