bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Flexibility in Major Depression in the Course of Pharmacological and Psychotherapeutic Treatment
Condition: Cognitive Performance in Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Cognitive deficits in major depression seem explicable by the well-recognized concept of
      impaired neuroplasticity in mood disorders. This concept initially emerged from preclinical
      evidence that antidepressants phosphorylate and therefore activate the cyclic AMP response
      element binding protein (CREB) that is essential for synaptic plasticity. Nevertheless, the
      question remains whether the activation of CREB by antidepressants is relevant for the
      remission of cognitive deficits in patients. We addressed this issue by investigating the
      cognitive improvement during treatment with either citalopram or reboxetine because these
      antidepressants are different in their capacity to increase phosphorylated CREB (pCREB).
      Besides the pharmacological treatment groups, another group of patients was treated
      exclusively with psychotherapy.
    

Detailed description: 
      We randomly assigned forty-five depressive patients to one of three treatment groups
      (Citalopram, Reboxetin or interpersonal psychotherapy (IPT)). At baseline, day 7 and day 28
      we assessed the severity of depression and the cognitive performance with respect to
      cognitive flexibility, memory and attention. We measured pCREB with an enzyme linked immuno
      sorbent assay (ELISA).
    

Intervention name(s): citalopram; reboxetine; interpersonal psychotherapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 20 to 30 mg per day for 4 weeks; 4 to 8 mg per day for 4 weeks
Intervention MeSH terms: Citalopram; Reboxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Depression; CREB; cognitive performance; psychotherapy; SSRI; SNRI
Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity
Condition: Overweight and Obesity; Insulin Resistance
MeSH terms: Sarcopenia; Obesity; Overweight; Insulin Resistance
Study type: Observational

Summary: 
      The goal of this research study is to learn more about the hormones that muscles make during
      exercise, and if those hormones are associated with type 2 diabetes risk in adults who are
      overweight or obese. Participants will undergo exercise testing on an upright bicycle, with
      blood samples taken for muscle hormones before and after exercise. The hypothesis is that
      adults with overweight/obesity and insulin resistance will have an impaired muscle hormone
      profile in response to exercise compared to adults with overweight/obesity who are not
      insulin resistant.
    


Intervention name(s): Cardiopulmonary exercise test (CPET)
Intervention type(s): Procedure
Intervention description(s): CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults with overweight or obesity
Risk Assessment and Treat Compliance in Hypertension Education Trial
Condition: Hypertension; Dyslipidemia
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional

Summary: 
      The RATCHET study assesses if patient knowledge of estimated cardiovascular risk at current
      and recommended target blood pressure levels improves compliance in the management of
      hypertension.
    


Intervention name(s): Knowledge of Cardiovascular Risk Assessment
Intervention type(s): Behavioral
Intervention description(s): Knowledge of Cardiovascular Risk Assessment and risk reduction at target BP, reviewed every 3-6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypertension; compliance
Effect of Tyrosine Supplementation on Cognitive Performance and Mood During Military Stress
Condition: Reaction to Severe Stress, Unspecified
MeSH terms: Stress Disorders, Traumatic, Acute
Study type: Interventional

Summary: 
      The objective of this research is to determine if tyrosine, an amino acid found in
      protein-containing foods, will mitigate the cognitive deficits and adverse effects on
      behavior and mood produced by exposure to military stress. This study was conducted at the US
      Navy Survive, Evade, Resist, Escape (SERE) school at Brunswick, Maine (ME).

      Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain
      neurotransmitter that is critical for the central nervous system (CNS) response to various
      types of acute stress. Psychological stress increases catecholamine turnover in the brain,
      increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and
      human studies have shown that tyrosine supplementation can produce beneficial effects on
      cognitive and physiological functions during exposure to a variety of acute stressors.

      This project will determine if volunteers treated with supplemental tyrosine during stressful
      phases of SERE training experience less degradation in cognitive performance and mood than
      volunteers treated with placebo. Tyrosine or placebo will be administered in a specially
      developed food bar provided to volunteers. The bar is part of a prototype of ration-component
      designed for use during assault operations. A between-subjects, double blind experimental
      design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has
      been tested in hundreds of volunteers without adverse effects.

      Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 80
      volunteers complete the study. They will be tested during several portions of SERE. A
      comprehensive but brief battery of cognitive tests, as well as saliva samples, and heart rate
      data will be collected in a manner that does not interfere with ongoing training.

      Hypotheses:

        1. Exposure to the stressors of SERE school will adversely impact cognitive performance and
           mood of volunteers.

        2. The adverse effects of psychological stress on cognitive performance and mood during
           SERE school will be reduced when volunteers are given supplemental tyrosine compared to
           placebo treatment.
    


Intervention name(s): Tyrosine-Containing Food Bar; Placebo Bar
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of
      GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days
      to Participants With Probable Alzheimer's Disease
    

Detailed description: 
      A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of
      GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days
      to Participants With Probable Alzheimer's Disease
    

Intervention name(s): DMXB-A
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer; Probable Alzheimer disease
Evaluation of the 755nm Alexandrite for Unwanted Tattoos
Condition: Unwanted, Non Cosmetic, Tattoos
Study type: Interventional

Summary: 
      The purpose of this study is to collect further data on the safety and efficacy of removing
      unwanted non cosmetic tattoos (including recalcitrant) using a 755nm Alexandrite laser.
    


Intervention name(s): 755 nm alexandrite laser
Intervention type(s): Device
Intervention description(s): 755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer.
Condition: Prostate Adenocarcinoma; Metastasis
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Study type: Interventional

Summary: 
      This study will assess and compare the diagnostic performances and image quality of two WB 3D
      T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :
      the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its
      acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,
      reducing the exam's acquisition time, patient discomfort and increasing machine availability.
    

Detailed description: 
      Whole-body (WB) magnetic resonance (MR) imaging has increasingly been used for the screening
      of bone and soft-tissue metastases in patients with prostate cancer (1). A limitation for its
      implementation is the 45-60 minutes duration of current WB MRI examinations. Conventional WB
      MR imaging studies consisted of anatomical two-dimensional (2D) T1-weighted and
      fat-suppressed fluid-sensitive (proton-density fat-saturated (PDFS) or short-tau
      inversion-recovery (STIR)) and of a functional diffusion-weighted imaging sequence. Recent
      research has confirmed the feasibility of replacing the 2D anatomical sequences by a single
      three-dimensional (3D) T1-weighted fast spin echo (FSE) sequence (2).

      This study will assess and compare the diagnostic performances and image quality of two WB 3D
      T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer :
      the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its
      acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence,
      reducing the exam's acquisition time, patient discomfort and increasing machine availability.

      The aim of this study is to evaluate the feasibility of the replacement of the WB 3D
      T1-weighted FSE MR imaging sequence by the WB 3D T1-weighted GE MR imaging sequence.
    

Intervention name(s): Diagnostic performance 3D T1
Intervention type(s): Diagnostic Test
Intervention description(s): Although non-invasive, the prospective addition of a new MRI sequence to a routine MRI protocol is considered by our ethical committee as an "interventional" study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MRI; MRI sequences; prostate cancer; cancer; staging; bone metastasis; node metastasis
Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome (PCOS); Overweight and Obesity
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Study type: Interventional

Summary: 
      The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe
      and effective regimen to improve insulin resistance and decrease body weight in
      overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced
      energy restriction.
    

Detailed description: 
      Intermittent fasting regimens involve periods fasting followed by periods of eating freely.
      Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening
      the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in
      adults with obesity. Accumulating evidence suggests that TRF is an effective means of
      decreasing body weight and improving insulin resistance but did not have any negative impact
      on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary
      syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70
      % of women with PCOS are obese or overweight, and obesity is associated with insulin
      resistance. Since many women with PCOS seem to have insulin resistance, compensatory
      hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of
      ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important
      to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine
      whether TRF is a safe and effective regimen to improve insulin resistance and decrease body
      weight in overweight/obese PCOS patients.
    

Intervention name(s): Time Restricted Feeding; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).; Participants receive a general lifestyle counseling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Overweight and Obesity; Time-Restricted Feeding; Intermittent fasting regimens
Fat Quality on Blood Lipids and Immune Response
Condition: Dietary Prevention
Study type: Interventional

Summary: 
      The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory
      markers after intake of food items with different fatty acid composition.
    


Intervention name(s): Food items
Intervention type(s): Other
Intervention description(s): Food items with different fatty acid composition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: LDL-cholesterol
Effects of Low Frequency Magnet Therapy on Spasticity in Patients With Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Background: Spasticity is a major challenge in patients with cerebral palsy (CP). It may
      cause unwanted complications and may affect the patient's quality of life. Currently there is
      no satisfactory long lasting control of spasticity. Many lines of evidence indicate that
      magnet therapy may be a useful intervention in the management of spasticity. Several studies
      showed that magnet may inhibit neuronal firing in the human nervous system; however, its
      effects weren't studied on spasticity. Objectives: The goal of the present study was to
      determine the short-and long-term effects of pulsed low frequency magnetic field therapy on
      spasticity in patient with CP. Methods: 48 patients with CP, who have measureable level of
      spasticity, were selected. The sample was divided randomly into active magnet group (received
      magnet therapy, 32 subjects) and placebo group (16 subjects). At the end of the 4th week the
      magnet group was divided into two sub-groups: 1st sub-group received magnet therapy for
      another 4 weeks while the other received the placebo. Measurements was taken at baseline,
      4th, 8th and 12th weeks. Modified Ashworth Scale was used to measure spasticity, foot
      pressure platform system was used to measure the contact area and the maximum force of the
      feet, gross motor function measure (GMFM) was used to measure the functional level of the
      patients. The cerebral palsy quality of life (CP-QoL) questionnaire was used to measure the
      patients' various dimensions of quality of life.
    


Intervention name(s): Low frequency magnetic therapy
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Comparison Between Reciproc and Protaper Next
Condition: Dental Pulp Necrosis
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional

Summary: 
      Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc
      reciprocating files versus that resulting after using ProTaper Next rotary files in
      asymptomatic necrotic molars.
    

Detailed description: 
      Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria
      and patients are then randomized to receive treatment either using Reciproc Files or ProTaper
      Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24
      and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation
      is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24
      hours following obturation. The time required to complete instrumentation is also measured
      and compared using the two files.
    

Intervention name(s): Reciproc files in reciprocating motion; ProTaper Next files in continuous rotary motion
Intervention type(s): Procedure; Procedure
Intervention description(s): An endodontic file that works through a reciprocating motion; An endodontic file that works through a continuous rotary motion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety of and Immune Response to Vaccination With 2 Experimental HIV Vaccines in Healthy Adults
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The HIV Vaccine Trials Network (HVTN) is doing a study to test 2 experimental HIV vaccines in
      combination with 2 licensed vaccines for tetanus and hepatitis B. HIV is the virus that
      causes AIDS. Tetanus is an infection that causes muscular spasms. Hepatitis B is a virus that
      can cause liver failure.

      About 100 people will take part in this study at multiple sites. The US National Institutes
      of Health (NIH) is paying for the study.

      We are doing this study to answer several questions.

        -  Are the HIV study vaccines safe to give to people?

        -  Are people able to take the HIV study vaccines without becoming too uncomfortable?

        -  How do people's immune systems respond to the HIV study vaccines? (Your immune system
           protects you from disease.)

        -  Can people's immune responses to a tetanus or hepatitis B vaccines help us understand
           how their immune systems might respond to the HIV study vaccines?

        -  Is there a common immune response to licensed vaccines like the tetanus and hepatitis B
           vaccines?
    


Intervention name(s): ALVAC-HIV; AIDSVAX B/E; Placebo for ALVAC-HIV; Placebo for AIDSVAX B/E; Hepatitis B vaccine; Tetanus toxoid vaccine; Placebo for hepatitis B vaccine; Placebo for tetanus vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Formulated as a lyophilized vaccine for injection and is reconstituted with 1.05 mL of sterile Sodium Chloride solution (0.4% NaCl) for a single 1 mL dose of >1.0 x 106 CCID50/mL, to administer intramuscularly (IM).; 300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant. Each vial contains 1.2 mL of sterile suspension, to administer 1 mL IM.; A sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1.05 mL of sterile Sodium Chloride (0.4% NaCl) for a single 1 mL dose, to administer IM.; Sodium Chloride for Injection, 0.9% administered IM.; Each 1 mL dose contains 20 mcg of hepatitis B surface antigen (HBsAg) adsorbed onto 500 mcg aluminum as aluminum hydroxide, to administer IM.; The active ingredient is tetanus toxoid (≥ 40 I.U. / 0.5 mL) adsorbed on aluminium hydroxide dihydrate (600 mcg of aluminium), to administer IM.; Sodium Chloride for Injection, 0.9% administered IM.; Sodium Chloride for Injection, 0.9% administered IM.
Other intervention name(s): vCP1521; gp120; HBV vaccine; ENGERIX-B; Tetanus vaccine; Tetavax
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV infection; Vaccine
Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section
Condition: Hypotension Symptomatic; Vasoconstriction; Cesarean Section Complications; Obstetric Anesthesia Problems
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      This will be a double-blind randomized study, aiming at investigating a fixed rate
      phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in
      combination with co-hydration with colloids for the prevention of maternal hypotension in
      elective cesarean section
    

Detailed description: 
      Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric
      anesthesia practice, with a definitive superiority as compared to general anesthesia, since,
      by their use, serious complications involving the airway can be avoided.Spinal anesthesia has
      become the favorable technique for both elective and emergency cesarean section due to a
      quick and predictable onset of action, however, it can be frequently complicated by
      hypotension, with incidence exceeding 80% occasionally.

      The aim of the current randomized controlled double-blinded trial was to compare the effect
      of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus
      placebo in parturients subjected to elective cesarean section under combined spinal-epidural
      anesthesia. All parturients will also receive colloid co-hydration.
    

Intervention name(s): phenylephrine infusion; norepinephrine infusion; placebo infusion
Intervention type(s): Other; Other; Other
Intervention description(s): in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated; in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated; in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated
Other intervention name(s): medication used for blood pressure maintenance; medication used for blood pressure maintenance; medication used for blood pressure maintenance
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention