bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Craniosacral Therapy on Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial is to determinate the efficacy and safety of
      Craniosacral Therapy in the treatment of chronic unspecific neck pain.
    

Detailed description: 
      Craniosacral Therapy (CST) is a variation of osteopathic manipulation with an integrative
      approach. By soft manual palpation of the craniosacral and fascia system sensory, motor,
      cognitive, and emotional processes can be influenced. In the prevention and treatment of
      chronic pain syndromes Craniosacral Therapy is demonstrated to be effective in clinical
      practice and quite a few scientific trials. But yet there are no randomized controlled
      studies concerning to chronic neck pain. So the aim of this study is to investigate whether a
      total of 8 CST units of 45 minutes will be effective in patients suffering from chronic
      nonspecific neck pain in contrast to sham therapy of the same extent. The prospective study
      design includes measurement points at baseline, post treatment, and 3 months follow-up.
    

Intervention name(s): Craniosacral Therapy; Sham Craniosacral Therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Standardized therapy protocol (according to Upledger): Still point technique, diaphragm release, compression-decompression and lift techniques of the cranial bones, facial balancing in the region of shoulder and pelvis and somato-emotional unwinding; Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck Pain; Craniosacral Manipulation; Complementary Therapies; Randomized Controlled Trial; Sensory Thresholds; Quality of Life
Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)
Condition: Fatigue; Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fatigue; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the use of modafinil in the treatment of fatigue in
      patients with Primary Biliary Cirrhosis.

      The general aim of the study is to identify a safe and effective therapy for fatigue in
      patients with primary biliary cirrhosis.
    

Detailed description: 
      The general aim of the study is to identify a safe and effective therapy for fatigue in
      patients with primary biliary cirrhosis. Specific aims include: 1) to determine the safety
      profile of modafinil in patients with primary biliary cirrhosis; 2) to evaluate the
      beneficial effects of modafinil on patients with primary biliary cirrhosis and fatigue as
      documented by a well-validated questionnaire (Fisk Fatigue Severity Score) to be applied at
      the beginning and end of the study period; and 3) to compare the performance of three
      questionnaires (Fisk Fatigue Severity Score, Fatigue Severity Scale and the fatigue domain of
      the PBC-40) as instruments to determine the benefits of a therapeutic intervention on fatigue
      by establishing the minimally important clinical difference of these measures of fatigue.
    

Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention description(s): 100 mg tablets of modafinil or matched placebo will be given for a total of 12 weeks. Patients will be instructed to start one capsule once daily (modafinil or placebo), and dose will be titrated according to tolerability and response.
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fatigue
South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention
Condition: Mild Cognitive Impairment; Aged
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study evaluates acceptability and efficacy of multidomain intervention program to
      prevent cognitive impairment and protect brain health in Korean at-risk elderly. A third of
      participants will receive facility-based intervention for 6 months, a third will receive
      home-based intervention for 6 months, and a third is waiting list controls.
    

Detailed description: 
      Despite extensive research in the field of Alzheimer's disease (AD), no treatment has yet
      been developed to modify the progression of AD. Therefore, it is important to manage vascular
      and metabolic risk factors, to eat healthy foods, to exercise, and to participate in social
      activities to prevent dementia. The FINGER study showed that the multi-domain intervention
      program is effective to prevent cognitive impairment and disability in elderly.

      In South Korea, exercise and leisure programs, and brain activity for the elderly also have
      been conducted in welfare centers and public health centers. However, there are not enough
      programs that have proven effective in the studies.

      So the investigators would like to develop a multi-domain intervention program and
      investigate applicability and efficacy before a large-scale randomized controlled trial.
    

Intervention name(s): Multidomain intervention program
Intervention type(s): Other
Intervention description(s): Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: They will be randomly allocated to facility-based multidomain intervention group, home-based intervention group, and a regular health advice group (referred to as control group) at a ratio of 1:1:1.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; dementia; intervention; mild cognitive impairment
Erythropoietin in Hemolytic Uremic Syndrome
Condition: Hemolytic-Uremic Syndrome; Anemia
MeSH terms: Azotemia; Hemolytic-Uremic Syndrome; Syndrome; Hemolysis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the impact of early administration of erythropoietin in the number
      of red blood cell transfusions in children with Shiga toxin-producing Escherichia coli
      hemolytic uremic syndrome (STEC-HUS).
    

Detailed description: 
      Introduction:

      Anemia in STEC-HUS is treated with red blood cell (RBC) transfusions. It can causes
      hypervolemia, hyperkalemia, exacerbate the thrombotic state of the disease, transmit
      infectious agents and trigger antigenic sensitization. Anemia is mainly due to hemolysis, but
      deficit of erythropoietin synthesis (EPO) may aggravate it. Although recombinant human EPO is
      frequently used in children with STEC-HUS there is no adequate evidence of its benefit. If it
      is confirmed that EPO reduce the number of RBC transfusions, its administration could
      diminish the aforementioned risks and also reduce costs.

      Objective:

      To determine if EPO administration decreases the number of RBC transfusions and; secondarily,
      to assess if its levels influence on transfusion requirement.

      Methodology:

      Randomized, open controlled clinical trial. We will include 28 patients (14 per arm) <18
      years with STEC-HUS admitted to our hospital. They will be grouped after randomization:(1)
      One to standard of care (RBC transfusions with hemoglobin ≤7 mg / dl and/or hemodynamic
      instability) and (2) the other to standard of care plus EPO (50 u / kg subcutaneous three
      times weekly) and RBC transfusions with hemoglobin ≤7 mg / dl). Serum EPO will be measured by
      ELISA and together with the clinical and laboratory variables, association with RBC
      transfusions number will be sought. Written informed consent and assent when appropriate,
      will be requested prior to enter into the study.
    

Intervention name(s): erythropoietin
Intervention type(s): Drug
Intervention description(s): erythropoietin 50 International Units (IU) per kilogram three times weekly by subcutaneous route
Other intervention name(s): EPO
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hemolytic-Uremic Syndrome; erythropoietin; RBC transfusion
A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, ability of GSK Biologicals'
      investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree
      to which the vaccine can cause side effects, when administered alone and in combination with
      Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of
      RSVPreF3 and 2 Boostrix [Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine]
      formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in
      an extension of the study to assess the durability of the immune response after the first
      dose vaccination, and to assess the safety and immunogenicity following a second dose
      vaccination of the RSVPreF3 maternal vaccine.
    


Intervention name(s): RSVPreF3 formulation 3; RSVPreF3 formulation 2; Boostrix-ex-US; Boostrix-US; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.; One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.; One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.; One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.; One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002012)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth
      in male and female subjects with hair loss
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Effect of Hypertonic Sodium Chloride on Urinary Biomarkers in Healthy Subjects and Patients With Chronic Kidney Disease
Condition: Nephropathy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Patients with chronic kidney disease (CKD) have a defect in the tubular reabsorption of
      sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy
      subjects.

      Urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be
      measured after an infusion with hypertonic saline in CKD patients and healthy subjects.
    

Detailed description: 
      The fractional sodium excretion is elevated as high as 10-20% In patients with chronic kidney
      disease (CKD) Changes in the sodium intake results in a slower expansion and/or reduction in
      extracellular fluid in CKD patients.

      Urinary biomarkers reflects the kidneys transport of sodium and water in the nephron.

      Changes in the sodium-and water channel activity is induced by intervention with hypertonic
      Saline (3.0%) The change in sodium-and water channel activity is followed by change in
      extracellular and intracellular fluid compartments and the plasma concentration of vasoactive
      hormones.

      The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2,
      u-ENaC-gamma and u-AQP2), the activity of the sodium-and water channels, the extra- and
      intracellular fluid compartments and the plasma concentration of Vasoactive hormones in
      patients with CKD and in healthy subjects.

      Subjects and patients are examined during one examination day. Four days prior to the
      examination day the subjects consume a standardized diet based on the amount of sodium and
      calories. On the examination day the subjects receive an infusion with hypertonic saline.

      Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2,
      u-ENaC-gamma and u-AQP2) are measured to evaluate the activity of sodium channels in the
      nephron and changes in fluid compartments are measured by body composition monitor.
    

Intervention name(s): hypertonic saline
Intervention type(s): Other
Intervention description(s): hypertonic saline 3.0 % (7 ml/kg)
Other intervention name(s): hypertonic NaCl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Nephrology; chronic kidney disease; sodium-channels; water-channels; BCM
Pilot Study to Assess the Safety and Efficacy of BioProtect Balloon in Prostate Cancer Subjects
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Primary Goal

      The study's primary goal is to assess the safety of the BioProtect biodegradable balloon
      implant and implantation procedure, in prostate cancer subjects undergoing routine radiation
      therapy (XRT) treatment. Safety of the BioProtect device will be assessed by reporting
      adverse events.

      Secondary Goal

      The study's secondary goal is to evaluate the effectiveness of the BioProtect biodegradable
      balloon implant in prostate cancer subjects undergoing routine XRT treatment. Effectiveness
      will be assessed in terms of increased distance between anterior rectal wall and prostate and
      noticeable reduction of isodose to the rectum.
    

Detailed description: 
      Primary Endpoint Parameters

      The incidence of unexpected serious adverse events related to BioProtect's SpaceGuard balloon
      implant and/or implantation procedure:

        1. Serious Adverse Events related to the BioProtect balloon and/or implantation procedure
           were defined by the Clinical Trials.gov definition of a serious adverse event. Serious
           Adverse Events will be documented in Serious Adverse Event Form.

        2. Adverse Events related to the BioProtect balloon and/or implantation procedure. Adverse
           Events were documented in Adverse Event Form.

        3. Subjective discomfort related to the balloon and implantation procedure were assessed by
           a pain analogue scale.

      Secondary Endpoint Parameters A 10% decrease or greater of the average rectal doses at V50 in
      at least 75% of the subjects after balloon implantation as compared to the doses at V50
      before the balloon implantation. This was measured by routine Dose Volume Histogram (DVH) per
      local hospital practice and according to the instructions regarding anatomical landmarks
      delineated in this protocol.
    

Intervention name(s): balloon implant; Balloon implantation
Intervention type(s): Device; Procedure
Intervention description(s): Absorbable perirectal spacer implantation; Implantation of the balloon between the prostate and the anterior rectal wall
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prostate; cancer; radiation; biodegradable implantable balloon; intrarectal balloon
Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
Condition: Bronchopulmonary Dysplasia; Premature; Neonatal Death
MeSH terms: Bronchopulmonary Dysplasia; Perinatal Death; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial
      effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary
      dysplasia (BPD).

      This single-center, non-randomized, controlled, blinded trial assessed the effect of a single
      intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very
      preterm neonates, a high-risk population.
    


Intervention name(s): Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Intervention type(s): Other
Intervention description(s): Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; Bronchopulmonary Dysplasia; preterm; cord blood mononuclear cells
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used
      medication in patients with type 2 diabetes
    


Intervention name(s): sitagliptin phosphate; Comparator: metformin hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): (1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period; (4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.
Other intervention name(s): MK0431
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
Condition: HIV Infections; HIV Seronegativity
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can
      prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.
    

Detailed description: 
      This study consists of 2 parts:

      Part A: Dose-escalation protocol using oligomeric gp160MN/LAI-2. Part B: Placebo-controlled,
      randomized, double-blind (within arm) study of vCP205 priming with gp160MN/LAI-2 boosting.

      Volunteers are followed for at least 1 year.
    

Intervention name(s): gp160 MN/LAI-2; ALVAC-HIV MN120TMG (vCP205)
Intervention type(s): Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Viral Vaccines; HIV-1; Dose-Response Relationship, Drug; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; Avipoxvirus; Immunization; HIV Envelope Protein gp120; Recombination, Genetic
Adenoma Detection by Polypectomy During Both Insertion and Withdrawal
Condition: Adenoma of Large Intestine
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with
      careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g.
      <1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon
      is in different conformation during insertion and withdrawal phases. We think careful
      inspection and polypectomy during both insertion and withdrawal can improve adenoma detection
      rate.
    


Intervention name(s): Both insertion and withdrawal; Only withdrawal
Intervention type(s): Procedure; Procedure
Intervention description(s): inspection and polypectomy during both insertion and withdrawal of colonoscopy; inspection and polypectomy during only withdrawal of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Tolerability Study of N6022 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy
      subjects.
    

Detailed description: 
      This is a single dose escalation, first-time-in-human study with three ascending cohorts.
      Eligible subjects will receive a single dose of investigational medicinal product or placebo
      on Day 1 and will be followed for safety, PK, and PD for 72 hours post dose. Follow-up visits
      on Day 4 and Day 7 for the end-of-study safety. Participation of an individual subject may
      last up to 36 days from the time of screening until the end-of-study follow-up visit. Each
      cohort will enroll a sentinel pair (1:1 randomized to active: placebo). These subjects will
      be followed for 48 hours postdose and safety data reviewed before the remaining subjects in
      the cohort receive IMP. A Safety Monitoring Committee will review the seven-day safety data
      in each cohort before proceeding to the next ascending dose cohort, according to the stopping
      rules outlined in the protocol.
    

Intervention name(s): N6022; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is an injectible formulation which will be given at 5, 15 & 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses.; This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.
Other intervention name(s): N6022
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment