bioihbjkbjnl/mcl2 huggingface dataset:
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
Condition: TBI Depression
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Traumatic brain injury (TBI) is frequently complicated by depression and other problems such
      as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and
      behavioral problems. Untreated depression can lead to reduced productivity and poor global
      outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of
      TBI-related depression. The overarching goal of this small study is to determine the
      effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and
      co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a
      brain stimulation technique. It involves generating a brief magnetic field in a coil that is
      placed on the scalp. The magnetic field passes through the skull and induces a weak
      electrical current in the brain that briefly activates neural circuits at the stimulation
      site. Adults aged 18 and older, with a history of head injury of mild or moderate severity ,
      who are currently experiencing symptoms of clinical depression may join the study.
    


Intervention name(s): Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS); Sham Comparator: Sham Treatment
Intervention type(s): Combination Product; Device
Intervention description(s): LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.; Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Other intervention name(s): low frequency right rTMS; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TBI Depression; co-morbid psychiatric symptoms
H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy
Condition: H. Pylori Infection
Study type: Observational

Summary: 
      The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has
      increased worldwide. Eradication failure using triple therapy is strongly associated with
      CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication
      which emphasizes on predicting individual drug responses before treatment.

      Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was
      developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has
      increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not
      available, a 14-day modified bismuth-containing quadruple regimen is recommended as a
      first-line H. pylori eradication. However, there is no comparison study between modified
      quadruple therapy and tailored eradication based on the presence of CAM resistance using
      DPO-PCR.
    

Detailed description: 
      The investigators aim to evaluate the success rate, adverse drug events, and
      cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on
      the presence of CAM resistance.
    

Intervention name(s): H. pylori eradication
Intervention type(s): Drug
Intervention description(s): Antimicrobial agents for H. pylori eradication
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        H. pylori-infected patients
      
Biospecimen description: 
      Biospecimen would be obtained for urease test (commercial name: CLOtest) or molecular test
      (DPO-PCR).
Effect of Varying Proportions of Low and High Energy Dense Foods Over 5 Days in Preschool Children
Condition: Feeding Behavior
Study type: Interventional

Summary: 
      In this study, the investigators will vary the proportions of high- and low-energy-dense
      foods served to preschool children at all meals and snacks during three 5-day periods. In the
      three experimental conditions, the same foods will be served; only the amounts and
      proportions of foods will be varied. In the Baseline condition, typical proportions of
      age-appropriate foods will be served. In the Addition condition, the portion sizes of
      low-energy-dense foods will be increased, and in the Substitution condition, the portions of
      low-energy-dense foods will be increased by replacing an equivalent amount of foods higher in
      energy density. The primary aim is to determine the effect on children's energy intake of
      varying the proportion of low- and high-energy-dense foods served, either by addition or
      substitution, over 5 days. It is hypothesized that children will consume less energy when
      they are served meals in which low-energy-dense foods are substituted for foods higher in
      energy density over 5 days and that children will consume more energy when served meals to
      which low-energy-dense foods are added. Additionally, we will test the hypothesis that daily
      energy intake in the three conditions will begin to converge across the 5-day period.
    


Intervention name(s): Food proportionality
Intervention type(s): Other
Intervention description(s): Proportions of high and low energy dense foods manipulated
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Condition: Benign Prostate Tissue
Study type: Observational

Summary: 
      The overall goal of this project is to quantify the long-term effects of dutasteride on the
      architectural and nuclear features of benign prostate tissue, using state-of-the art digital
      image analysis techniques. The ultimate result will be a multivariable morphological
      "signature" that could provide a useful indicator of an individual's degree of drug response.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Cross-sectional comparison of biomarkers in prostate biopsy tissue (Year 2 and Year 4)
        already collected in REDUCE trial
      
Biospecimen description: 
      Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
    
Keywords: Benign prostate; serum DHT; Dutasteride; PSA; Avodart
A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Monotherapy phase: To evaluate and compare the safety, tolerance, pharmacokinetics, and
      preliminary activity of nevirapine administered alone in mildly to moderately symptomatic
      HIV-infected children ages 2 months to less than 18 years; to evaluate and compare the
      safety, tolerance, and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to
      less than 2 months. Combination therapy phase: To evaluate and compare the safety, tolerance,
      pharmacokinetics, and preliminary activity of nevirapine administered in combination with
      zidovudine (AZT) in mildly to moderately symptomatic HIV-infected children ages 2 months to
      less than 18 years.

      Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic
      than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro
      inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition
      of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction assay.
    

Detailed description: 
      Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic
      than the nucleoside analogues are needed. Nevirapine (BI-RG-587) has shown in vitro
      inhibitory activity against HIV-1 reverse transcriptase and has shown a synergistic
      inhibition of HIV-1 replication when combined with zidovudine (AZT) in a plaque reduction
      assay.

      Sixty mildly to moderately symptomatic HIV-infected children (five patients in each of four
      age groups) will receive oral nevirapine at 1 of 3 doses for 168 days. If preliminary
      activity is demonstrated and toxicity is acceptable after 84 days of treatment in the three
      oldest age groups (ages 2 months - less than 2 years, ages 2 years - less than 13 years, and
      ages 13 years - less than 18 years), children ages 1 day - less than 2 months will receive
      one of the three doses of nevirapine. Additionally, 15 additional patients (five in each of
      three age groups) will receive zidovudine in combination with nevirapine. At the end of 24
      weeks of combination therapy, patients discontinue zidovudine for 2 weeks while remaining on
      nevirapine, in order for pharmacokinetic sampling to be done. Children will be enrolled
      sequentially by decreasing age and increasing nevirapine dose.
    

Intervention name(s): Nevirapine; Zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Nevirapine
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents; Zidovudine; Nevirapine
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly
      dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin
      (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone
      deficiency.
    


Intervention name(s): somapacitan; somatropin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.; Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.; Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.
Other intervention name(s): NNC0195-0092
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Measurement of Empathy and Its Efficacy in Psychotherapy
Condition: Psychotherapeutic Processes; Transference (Psychology)
Study type: Interventional

Summary: 
      The purpose of the research is to: 1) to test whether psychotherapy including immediate
      feedback of empathy data is more efficacious than therapy without such an exchange of data,
      2) to measure the degree of accuracy of therapist's empathy and its relationship to the
      patient's estimate of the therapist's empathy.
    

Detailed description: 
      Objective: To develop and evaluate a feedback method for measuring and increasing therapists'
      empathic accuracy and reducing empathic errors in psychotherapy. Method: Sixteen (16)
      patient-therapist pairs were randomly assigned to intervention and control groups. All
      patients rated their own functioning using the GAF (Global Assessment of Functioning) and
      predicted the accuracy with which their therapists would estimate their ratings. Therapists
      rated the patient's GAF, predicted the patients' ratings of their own GAFs, and rated their
      confidence in their own predictions. In the intervention condition, therapist and patients
      discussed the previous session's ratings for a few minutes of the therapy session. Results:
      Intervention therapists showed greater empathic accuracy relative to controls on our empathy
      measure (t(14) = 2.69, p < .01) and increased empathy over time on the Barrett-Lenard Empathy
      subscale (t(32) = 3.21, p < .01). We also found significant effects on errors related to
      perceived accuracy of therapist empathy. Patients in the control group were found to perceive
      their therapists to be either more or less accurate than was actually the case
      (over/under-idealization), but such biases were not as strong in the intervention group.
      Similarly, therapists in the control group were likely to over-estimate their own accuracy
      (over-confidence) to a greater extent than intervention therapists. Affective responses to
      the instrument were positive overall and did not differ by condition. Conclusion: Empathy
      feedback and feedback concerning degrees of patient idealization and therapist confidence may
      be effective in improving functioning as well as in increasing empathic accuracy in
      psychotherapy.
    

Intervention name(s): Empathy Feedback
Intervention type(s): Behavioral
Intervention description(s): Discussion of empathy ratings between patients and therapists during psychotherapy sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Empathy; Feedback; Psychotherapy
The Influence of Stability Boots on Gait Pattern in Healthy Adults
Condition: Rehabilitation After Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      After an ankle injury like distorsions, fractures or arthrodeses, or congenital defects ankle
      support limit the range of motion in the joint, help pain relief, control loading of the
      injured tissues and promote recovery of a normal gait pattern. Gait analysis is applied in
      orthopedics, sport science and rehabilitation. Numerous measure systems and methods enable
      accurate analysis of human movement.

      The study is set to describe and compare the gait analysis of two modifiable stability boots
      (Ortho® Tri-Phase and the VACOped®) on the standard walking parameters during two conditions
      (level and ramp walking) in healthy adults and draw comparisons with a control indoor shoe.
    

Detailed description: 
      The participants are joining one session in the gait lab. Here the are measured during
      walking with normal shoes and two modifiable stability boots. The duration of a session is
      typically 3 hours.
    

Intervention name(s): VACOped; Ortho Tri
Intervention type(s): Device; Device
Intervention description(s): restriction of ankle joint motion; restriction of ankle joint motion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Individually Tailored Training Prescriptions in Cancer Patients: The TOP Study
Condition: Cancer
Study type: Interventional

Summary: 
      The TOP Study is a two-stage study on individually tailored endurance and resistance training
      prescriptions for breast and prostate cancer patients after the end of primary therapy in
      order to optimize training effects.
    

Detailed description: 
      The TOP Study is a two-stage study on individually tailored endurance and resistance training
      prescriptions for breast and prostate cancer patients after the end of primary therapy in
      order to optimize training effects.

      The TOP Study Part I aims at identifying the most appropriate way of individual intensity
      prescription. In a descriptive cross sectional study, 20 breast and 20 prostate cancer
      patients perform singe endurance and resistance training sessions prescribed by means of
      different methods of intensity prescription. The most appropriate method of intensity
      prescription is identified through considering predictability/homogeneity of physiological
      responses as well as perceived exertion and enjoyment.

      The TOP Study Part II aims at investigating the most effective training method in terms of
      enhancing physical fitness for both endurance and strength training. The design is an
      exploratory four-arm 12-week randomized controlled training intervention trial in 60 breast
      and 60 prostate cancer patients. In two endurance arms, vigorous continuous training is
      compared to a polarized program consisting of moderate training and aerobic high intensity
      interval training (HIIT). Similarly, in two resistance training arms, standard machine based
      hypertrophy training is compared to training following a daily undulating periodization
      design.
    

Intervention name(s): Standard endurance training; Polarized endurance training; Standard resistance training; Daily undulating periodization resistance training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Continuous vigorous training 2 x per week on a cycle ergometer; Continuous moderate training 1 x per week and aerobic high intensity interval training (HIIT) 1 x per week on the cycle ergometer; Machine based hypertrophy training 2 x per week; Machine based daily undulating periodization resistance training 1 x per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast cancer; Prostate cancer; Exercise prescription; High intensity interval training; Daily undulating periodization training; Aerobic training; Resistance training; Physical fitness; Exercise
Protein Recommendation to Increase Muscle
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a feasibility study to test the potential efficacy of diets of different amounts of
      protein and calories for patients with cancer. We hypothesize that nutritional deficits play
      a significant role in muscle loss and that nutritional therapy is an important first step in
      reversing or preventing muscle loss and maintaining/improving physical function.
    

Detailed description: 
      Severe muscle depletion (sarcopenia) is a common issue among cancer patients and adequate
      nutrient intake is pivotal to maintain muscle mass. Yet, optimal amounts of protein are
      undefined for preventing or treating sarcopenia in people with cancer as most methodological
      approaches to assess protein requirements are expensive, burdensome and unfeasible for this
      population. This study's overarching goal is to investigate the potential efficacy of diets
      of different protein content on: 1) muscle mass maintenance (primary endpoint); and 2)
      improvements on physical function in cancer patients capable of oral nutrition support.
      Additional study measurements include: energy metabolism (including total body), body
      composition using multi-compartment models, blood biomarkers, and quality of life.

      In a randomized controlled trial approach, we will employ high protein feeding (2 g/kg/d,
      n=16) versus a standard recommendation (1 g/kg/d, n=16) in patients with newly diagnosed
      colorectal cancer for 12 weeks. Prescribed energy intakes will be framed by the amount of
      calories to meet energy needs and to support protein synthesis, but prevent fat mass gain.
      Carbohydrate, fat and protein intake will be adjusted throughout the intervention to achieve
      the desired rate and amount of energy and protein intake. An oral protein powder supplement
      made from high-quality whey protein will be provided to the participants to help increase
      their protein intake as needed. A multivitamin will be given to all participants throughout
      the study. Participants will receive weekly calls from the study coordinator to ensure
      adherence to the dietary intervention.
    

Intervention name(s): Dietary counselling; Dietary Protein
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Protein; Diet intervention; Muscle; Colorectal cancer
Use of Virtual Reality Game in Rehabilitation of Stroke Patients in Tan Tock Seng Hospital
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee
      strength
    

Detailed description: 
      Either 1 of 3 physiotherapists will recruit the patient from NICU if the GCS is 14 - 15.
      Silverfit 3D will then be used for 20 minutes each day to train the knee and arm strength
      until the patient's discharge from ICU. Baseline muscle strength will be measured and graded
      by the physiotherapist using Medical Research Council grading then followed up by the same
      physiotherapist on discharge from ICU and on discharge from hospital.
    

Intervention name(s): Silverfit 3D
Intervention type(s): Device
Intervention description(s): Virtual reality game used for rehabilitation of stroke patients
Intervention model: Single Group Assignment
Intervention model description: Single Arm study
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: virtual reality; Silverfit 3D; rehabilitation