bioihbjkbjnl/mcl2 huggingface dataset:
Exercise Dose-Response Effects in Prediabetes
Condition: Pre-Diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effects of different amounts and intensities of
      aerobic exercise training programs, with and without weight loss, in people who are at risk
      for diabetes. An additional purpose of the study is to evaluate the factors in the blood and
      in exercising muscles that contribute to the improvement in those risk factors. This
      information will be used to improve exercise training guidelines for improving cardiovascular
      and metabolic health in people with abnormal fasting glucose, also known as prediabetes.
    

Detailed description: 
      729 subjects were consented, 288 participants were randomized.
    

Intervention name(s): Aerobic Exercise; Aerobic Exercise; Aerobic Exercise; Exercise and Diet
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,000 calories per week equaling approximately 10 miles per week OR 2.5-3.5 hours per week; Aerobic exercise at 50% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 4-6 hours per week; Aerobic exercise at 75% peak oxygen use/consumption expending approximately 1,600 calories per week equaling approximately 16 miles per week OR 2-3 hours per week; Exercise - 150 minutes per week (30 minutes / 5 days per week) of aerobic exercise at 50% peak oxygen use/consumption equaling approximately 10 miles per week
Diet - The Clinical Lifestyle Intervention sessions will provide training on needed skills (e.g., calorie counting, portion size estimation) as well as motivation and support in a group counseling setting designed to achieve a weight loss goal of 5 to 7% of baseline body weight.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Abnormal fasting glucose
Optimizing Veteran-Centered Prostate Cancer Survivorship Care
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study will provide much needed information about how to optimize the quality of care and
      quality of life of Veterans who are survivors of prostate cancer.
    

Detailed description: 
      Although there are nearly 150,000 prostate cancer survivors in the VA, there has been little
      research to understand and improve survivorship care for this large population of Veterans. A
      substantial proportion of prostate cancer survivors in the general population have
      significant side effects from treatment (surgery or radiation therapy) that often persist for
      years, including incontinence, erectile dysfunction, and metabolic syndrome, all of which can
      contribute to decreased quality of life. The investigators' pilot data suggests that VA
      prostate cancer survivors experience similar or worse symptom burden to that of the general
      population of survivors. To address the need to improve patient-centered survivorship care
      management for Veterans with prostate cancer, the investigators propose a 4 year study with
      two aims: 1) to conduct a randomized controlled trial to compare a personally tailored
      automated telephone symptom management intervention for improving symptoms and symptom
      self-management to usual care. The investigators expect that those in the intervention group
      will have more confidence in symptom self-management and better symptom self-management and
      prostate cancer quality of life following the intervention, and that these outcomes will
      translate to more efficient use of services for these Veterans, and 2) to compare utilization
      of services among those in the intervention group to those in the control group.
    

Intervention name(s): Interactive Voice Response Symptom Management; Tailored Newsletters
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Interactive Voice Response (IVR) system will provide automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach.; Personally tailored newsletters will incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: prostate cancer; survivorship; intervention; telemedicine
Study of Experience of High-frequency Repetitive Transcranial
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Objective: To understand the personal experience of schizophrenia patients following
      repetitive transcranial magnetic stimulation (rTMS) and its connection with changes in mental
      symptoms, thereby enhancing the overall understanding of TMS.

      Method: The investigators selected eligible schizophrenia patients for fixed-parameter rTMS
      treatment. A self-experience checklist post-TMS treatment and positive and negative symptom
      scales (PANSS) were applied to evaluate the treatment.
    

Detailed description: 
      The investigators recruited male subjects admitted to who met the criteria. They were divided
      into a control and a treatment group. A double-blind approach was adopted. The subjects were
      unaware of whether real/pseudo stimulation was applied, and the evaluators did not know the
      grouping specifics. All of the enrolled cases were tested for stimulation thresholds in the
      bilateral prefrontal cortex. The TMS treatment device was a Magstim RAPID2 neuromagnetic
      stimulator (Magstim) with an "8"-type coil. The study group was administered real
      stimulation. The treatment parameters were as follows: frequency range, 20 Hz; 90% motion
      threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five
      times per week for a total of 20 times. For the control group, a 60% motion threshold was
      set; the remaining parameters were consistent with the study group but with no stimulating
      energy output. The therapeutic instrument model, appearance, operation process, and sounds
      when effecting treatment were the same for both groups. A self-experience checklist post-TMS
      treatment and positive and negative symptom scales (PANSS) were applied to evaluate the
      treatment.
    

Intervention name(s): Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil; Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
Intervention type(s): Device; Device
Intervention description(s): frequency range, 20 Hz; 90% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times; frequency range, 20 Hz，60% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times. But with no stimulating energy output.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CC-90006 in Subjects With Mild to Moderate Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the
      safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of
      CC-90006 following administration of multiple subcutaneous doses in subjects with mild to
      moderate plaque-type psoriasis.
    

Detailed description: 
      The study will be conducted in subjects with mild to moderate plaque-type psoriasis.

      The study will consist of escalating multiple (three) doses in sequential groups.
      Approximately 40 subjects with plaque-type psoriasis will be enrolled into approximately 4
      planned dose cohorts.

      Each cohort will study a different CC-90006 dose level and have ten subjects; eight subjects
      will receive CC-90006 and two subjects will receive placebo. Subjects will be dosed according
      to a computer-generated randomization scheme. Dosing will occur on Days 1, 15 (Week 2), and
      29 (Week 4). During the study, blood samples and punch biopsies will be collected to
      determine the amount of CC-90006 in the body and to evaluate its effect on the subject's
      condition. Subjects will return to the clinic for regular follow up visits for safety, PK,
      and PD. A follow up phone call to each subject to determine general health will occur on Day
      141 (week 20).
    

Intervention name(s): CC-90006; Placebo
Intervention type(s): Drug; Other
Intervention description(s): CC-90006; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; CC-90006; Mild to moderate plaque-type psoriasis; Safety; Pharmacokinetics; Pharmacodynamics
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Condition: Hepatitis B Vaccine
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and
      their immune function and immune response to hepatitis B vaccination were also suboptimal,
      indicating that the current practice of hepatitis B vaccination can't protect HIV-infected
      adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination
      remains a challenge.

      This is a randomized, open-label trial, conducted among HIV-infected adults with drug
      rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of
      three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6
      among HIV-infected adults.
    

Detailed description: 
      Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine
      group or 60µg recombinant hepatitis B vaccine group. The 20 µg group will receive three
      intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group
      will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6,
      respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions
      will be recorded after vaccination.
    

Intervention name(s): 60 µg dose hepatitis B vaccine; 20 µg dose hepatitis B vaccine
Intervention type(s): Biological; Biological
Intervention description(s): three-dose, 60 µg per dose; three-dose, 20 µg per dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatitis B, Vaccine; Randomized Controlled Trial; HIV; Immunogenicity
The Effects of Guided Imagery on Postoperative Pain Management
Condition: Healthy; Nursing Caries
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study was conducted to determine the effects of guided imagery on postoperative pain
      management.
    

Detailed description: 
      The sample of the study consisted of 60 patients (30 in the experiment and 30 in the control
      groups) undergoing lower extremity operations at the orthopedics clinics of the Kahramanmaras
      Necip Fazil City Hospital. The study was conducted between April and September 2018.
    

Intervention name(s): guided imagery
Intervention type(s): Other
Intervention description(s): Guided Imagery CD: A guided imagery CD was prepared by a web designer with the recommendations of the researcher to include relaxing, soft and slow-paced, mixed nature sounds and photographs towards reducing pain in lower extremity surgical operation patients. The directives used for guidance, the audio recordings created as a result of literature review and the video lasted for 13 minutes (
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was conducted with patients undergoing lower extremity operations between April 2018 and May 2019 at the Necip Fazıl City Hospital (Kahramanmaraş, Turkey) as a pretest-posttest study with a quasi-experimental design and a control group.
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Patient; Postoperative; Pain; Visual Analogue Scale; Guided Imagery
Carrimycin in Patients With Locally Advanced, Recurrent, or Metastatic HNSCC (Non NPC): A Phase I Trial
Condition: Oral Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a study conducted to evaluate the safety, tolerability and PK characteristics of
      Carrimycin tablet and measure its anti-tumor efficacy initially in the treatment of patients
      with locally advanced, recurrent, or metastatic head and neck squamous cell carcinoma (non
      NPC).
    

Detailed description: 
      This study is a prospective open phase-I study to investigate the safety, tolerability and PK
      characteristics of Carrimycin tablet in the treatment of patients with locally advanced,
      recurrent, or metastatic head and neck squamous cell carcinoma (non NPC). The 3x3 dose
      escalation design will be adopted, including 200mg, 400mg and 600mg of Carrimycin; and three
      subjects at each dose level initially. If there is no DLT in the dose level of 200mg, the
      dose level of 400mg will be followed; if there is one DLT in the dose level of 200mg, another
      three patients will be added in the dose level of 200mg; if there is no DLT occurs in the
      another three patients, the dose level of 400mg will also be followed; if there is one DLT in
      the another three patients, the trial will be closed. The same condition to the dose level of
      400mg and 600mg. If a patient fails to receive the full prescribed dose for reasons other
      than DLT at the time of the first administration, the patient will be replaced. Carrimycin
      treatment to the patients with DLT will be discontinued immediately and they will enter the
      follow-up period and will not be replaced. The study consists of screening period, treatment
      period and follow-up period. The treatment period continues until the patients develop
      progressive disease, dies, lost to follow-up or withdraw informed consent.
    

Intervention name(s): Carrimycin
Intervention type(s): Drug
Intervention description(s): The study involves three dose groups: 200mg, 400mg and 600mg. Three patients are planned for each dose group. Starting from the low dose group, the treatment to three patients in the 200mg dose group: 200mg of Carrimycin after meals every morning (po) for three weeks, and then discontinue for one week, the tolerance and efficacy evaluation will be performed after the 4 weeks. DLT will be recorded during the 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and
      pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate
      the effect of food on the pharmacokinetics of a single oral dose of AVL-292.
    

Detailed description: 
      Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect
      of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be
      enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other
      without (i.e., fasted), in a randomized sequence.
    

Intervention name(s): 50 mg AVL-292; 100 mg AVL-292; 200 mg AVL-292; 350 mg AVL-292; Placebo capsules
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): AVL-292; AVL-292; AVL-292; AVL-292
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: AVL-292; Safety; Pharmacokinetics; Pharmacodynamics; Pharmacology, Clinical
Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women
Condition: Healthy
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Like in the full immersion, studied in the context of diving, immersion in water causes a
      cascade of events with hemodynamic and hormonal consequences.

      First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60
      minutes later, hypovolemia by stimulating diuresis.

      Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.

      However, when the labor progresses, the dilatation bath is no longer sufficient and epidural
      analgesia remains the only effective method to control pain.

      Used before the realization of an epidural analgesia, dilatation bath could affect blood
      volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked
      to the installation of sensory block of the epidural analgesia in the parturient (severe
      prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal
      distress).

      Before beginning a study in pregnant women, it seems essential to study the hemodynamic
      consequences of the dilatation bath in a comparable population of volunteers healthy young
      women and out of the obstetrical context.
    


Intervention name(s): Lying in a bath during 2 hours; Lying in a bed during 2 hours
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: volunteers
Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
Condition: Hyperglycaemia (Diabetic)
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To investigate whether longer-term improvement of glycemic control in poorly controlled
      diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased
      polyol pathway activity.
    

Detailed description: 
      Polyol pathway activity will decrease in diabetic individuals who undergo intensification of
      their insulin treatment regimens as reflected by lower baseline brain intracellular fructose
      levels and higher intracellular glutathione levels. Furthermore, following longer-term
      improved glycemic control, patients may also have down-regulation of the pathway as reflected
      by decreased production of intracellular fructose in response to hyperglycemic clamp.
    

Intervention name(s): Insulin; exercise; Dietary counseling
Intervention type(s): Drug; Behavioral; Dietary Supplement
Intervention description(s): Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.; Exercise in accordance to the guidelines established by the American Diabetes Association.; Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Capsules
Condition: Anti-Infective Agents
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over
      design was used with a washout of 7 days between the two study periods. Treatment groups
      balanced with the same number of healthy volunteers who were randomly (in two strata: male
      and female) assigned to the study drug administration sequences.
    


Intervention name(s): Cephalexin capsules (Optocef, BAYO5448 ); Cephalexin capsules (Keflex)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 500 mg (One 500 mg capsule); Single dose of 500 mg (Two 250 mg capsules)
Intervention MeSH terms: Cephalexin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of the Bilateral Mandibular Nerve Block (V3) in Mandibular Osteotomy
Condition: Mandibular Fracture Trauma; Orthognathic Surgery; Maxillofacial Osteotomy
MeSH terms: Mandibular Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      The sensory innervation of the face depends on the trigeminal (fifth cranial) which is
      divided into three branches, the mandibular nerve (V3) having motor fibers to the temporal
      and masseter muscle. The regional anesthesia of the face has grown in recent years for
      performing certain actions under light general anesthesia or sedation. The mandibular block
      is a simple and reliable technique but little used. Yet it reduces postoperative pain
      sagittal osteotomy of the mandibular branch by reducing consumption of opioids and in the
      oropharynx cancer surgery. Made with ropivacaine, known for its vasoconstrictive action, it
      also improves the visibility of the operative field during mandibular osteotomies reducing
      bleeding. Despite a real clinical benefit (ease of implementation, latency and duration of
      action of the local anesthetic), the V3 block ropivacaine is not evaluated in the
      maxillofacial surgery.
    


Intervention name(s): Realization of the V3 block in maxillofacial surgeries
Intervention type(s): Procedure
Intervention description(s): bilateral mandibular block in maxillofacial surgeries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mandibular nerve block; mandibular osteotomy