bioihbjkbjnl/mcl2 huggingface dataset:
Kinetic Method to Detect Dehydration
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional
Phase: Phase 1

Summary: 
      1. The distribution and elimination of infusion fluids can be studied by volume kinetics, a
           mathematical method based on serial analysis of the blood hemoglobin concentration.

        2. The hypothesis of the present study is that the elimination of infused fluid is retarded
           in the presence of dehydration, and that volume kinetics would therefore be capable of
           detecting dehydration in human subjects.

        3. We induce dehydration by injection graded doses of furosemide (a diuretic drug) in
           healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to
           when the same volunteer receives the same fluid without being in a dehydrated state.
    

Detailed description: 
      1. Fifteen healthy male volunteers are subjected to 4 experiments. They drink 800 ml of
           water at 6:00 AM to make sure they are not dehydrated when the experiments begin.

        2. On two occasions the volunteer receives, at 9:00 AM, an intravenous infusion of acetated
           Ringer´s solution being either 5 ml/kg or 10 ml/kg, over 15 min. The blood hemoglobin
           concentration is measured during 16 occasions during 120 min by invasive blood sampling
           and also non-invasively by a pulse oximeter (Masimo´s Radical 7).

        3. On two other occasions, the infusions are preceded for 2 hours of deliberate
           dehydration. Doses of furosemide 5 mg are repeated 3-4 times with the goal of creating
           dehydration amounting to approximately 2 liters of fluid. Excreted urine is collected
           and the volume measured.

        4. The kinetics of each infusion is calculated by volume kinetics, and the data compared
           pairwise from the experiments with and those without dehydration.

        5. The accuracy and precision of the non-invasive monitoring of Hgb can be determined.

        6. The study is ended with that the Hgb response between the lying and sitting position is
           compared and with that the fluid balance is restored by ingestion of water.

        7. Experiments are performed in the Department of Intensive Care at Linköping University
           Hospital, Sweden.
    

Intervention name(s): Dehydration; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Furosemide 5 mg is given intravenously over 2 hours until approximately 2 liters of body fluid is lost.; No dehydration is induced
Other intervention name(s): Furosemide för intravenous administration; Acetated Ringer´s solution; Acetated Ringer´s solution
Intervention MeSH terms: Furosemide; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: dehydration; fluid therapy; pharmacokinetics; hemoglobin
Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was done to determine if the use of a combination of preoperative rectal
      misoprostol 400µg used with intraoperative perivascular vasopressin is better than
      perivascular vasopressin used alone to decrease bleeding at myomectomy.
    

Detailed description: 
      A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus.
      This procedure can be associated with significant blood loss which can result in significant
      morbidity and mortality. The drug misoprostol which has been been use in the treatment of
      postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective
      myomectomy at the University hospital of the West Indies and from the private practice of the
      participating doctors who were invited to participate in the study. Patients were randomized
      to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before
      surgery. Twenty five patients received misoprostol and twenty patients did not.
    

Intervention name(s): Misoprostol + vasopressin; Vasopressin
Intervention type(s): Drug; Drug
Intervention description(s): 400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.; Vasopressin was used in all patients during surgery.
Other intervention name(s): Cytotec; Anti-diuretic hormone
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Misoprostol; Diuretics
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Myomectomy
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate
      pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product
      and SC single dose of current dupilumab product in male and female healthy participants aged
      18 to 65 years.

      The estimated duration is up to 21 days of screening period, followed by the treatment day
      with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total
      duration from screening to EOS will be 64 days maximum.
    

Detailed description: 
      Duration per participant is up to 64 days
    

Intervention name(s): Dupilumab (SAR231893)
Intervention type(s): Drug
Intervention description(s): Injection solution Subcutaneous
Other intervention name(s): REGN668
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Raltegravir Insulin Sensitivity Study
Condition: HIV Infections
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to look at the effects of two different HIV medications on the
      body's response to insulin (a hormone that regulates blood sugar levels). This will be done
      using a method called the 'euglycaemic clamp'

      The study will also investigate the effects of these drugs on blood fats and on circulating
      markers in the blood stream related to blood vessels (vascular inflammation markers).
    

Detailed description: 
      Subjects will undergo four euglycaemic clamp procedures in order to determine the extent of
      glucose disposal. The first clamp will be performed prior to the commencement of the first
      study drug administration, the second one following two weeks of study drug, the third after
      a two week washout period, prior to commencement of second study drug administration and the
      fourth after two weeks of the second study drug
    

Intervention name(s): Raltegravir then lopinavir/ritonavir; Lopinavir/ritonavir then raltegravir
Intervention type(s): Drug; Drug
Intervention description(s): raltegravir 400mg twice daily for first 14 days of study lopinavir/ritonavir 400/100mg twice daily for last 14 days of study; lopinavir/ritonavir 400 mg twice daily for the first 14 days of the study raltegravir 400mg twice daily for the last 14 days of the study
Intervention MeSH terms: Ritonavir; Lopinavir; Raltegravir Potassium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Raltegravir; Euglycaemic clamp; healthy volunteer
A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Women With IBS-C
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a commercially available fermented
      dairy product containing probiotics (4 weeks, twice a day) on abdominal distension in IBS
      patients with constipation (IBS-C).
    


Intervention name(s): 1-fermented dairy product; 2- milk-based non-fermented dairy product (control product)
Intervention type(s): Other; Other
Intervention description(s): Arm 1 - Intervention 1 (probiotics); Arm 2 - Intervention 2 (control)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Influence of Escitalopram on Fear Conditioning
Condition: Fear Conditioning
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to learn how differences in learning under mildly-stressful
      circumstances may be changed by taking an antidepressant medication. This medication is
      called Lexapro (Escitalopram). The investigators will also examine the impact of any anxiety,
      depression, and stress related symptoms on learning processes. The investigators will also
      look at the response of these symptoms to Lexapro.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Escitalopram 10mg/day or matched pill placebo
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Discovering the Effect of Venous Insufficiency on Nocturia (DEVINe)
Condition: Edema Leg; Venous Insufficiency of Leg; Nocturia; Bio-Impedance Measurements
MeSH terms: Venous Insufficiency; Nocturia
Study type: Interventional

Summary: 
      Nocturia, or waking during the night to pass urine, is a multifactorial disease. An important
      cause of nocturia are peripheral edema due to accumulation of fluid in the lower limbs.
      Venous insufficiency is an important cause of peripheral edema. The investigators hypothesize
      that, as a result of the lying position during the night, the accumulated fluid in the lower
      limbs returns to the systemical circulation leading and is excreted during nighttime. This
      will lead to a higher voiding frequency during the night.

      With this trail the investigators wanst to prove the difference in leg edema between healthy
      volunteers and volunteers with venous insufficiency (Type 1 or 2).
    


Intervention name(s): Tilt Test; Inbody S10; Tape measurements; SOMNOtouchTMNIBP, Vivisol, Belgium
Intervention type(s): Behavioral; Device; Device; Device
Intervention description(s): Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes; Bio-electrical impedance measurement every 5 minutes; Every 5 minutes, circumference of every leg is measured using a tape measure; Continous measurement of blood pressure, heart rate and saturation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder
Condition: Aggressive Behavior; Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      Street children and children of vulnerable families in conflict or former conflict regions
      are often exposed to multiple traumatic events and situations in which they are forced to
      engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims
      to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful
      experiences and positive emotions linked to violent behaviour in the past. Additionally,
      visions for the future are developed in order to foster successful reintegration into
      society.
    


Intervention name(s): Narrative Exposure Therapy for violent offenders (NETvo)
Intervention type(s): Behavioral
Intervention description(s): During NETvo the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress and also on perpetrated violent acts. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. Positive emotions and cognitions reported for violent acts are linked to the respective past. During four sessions the most important traumatic experiences and perpetrated violent acts are processed. In the fifth session plans and ideas for the future are developed to assist the children to reintegrate themselves into society.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aggressive Behavior; Appetitive Aggression; Post-Traumatic Stress Disorder
Real-time Interactive Digital Healthcare System in Patients With Breast Cancer; Randomized Controlled Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This study aims to examine the effect of hospital-home linkage short-term rehabilitation
      therapy using real-time interactive digital healthcare system (Uincare Homeplus) in
      post-operative patients with breast cancer. This is prospective study. 100 breast cancer
      patients who underwent axillary lymph node diessection or breast reconstruction following
      mastectomy will be examined, and those with limited range of motion (ROM) of affected
      shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS,
      quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week,
      8-week, and 12-weeks after enrollment.
    

Detailed description: 
      The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer
      surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and
      etc. Due to this limited ROM, the patients may have difficulty with activities of daily life
      and quality of life may be reduced.

      Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and
      motion capture technology to track 3D motion of the patients' articulation. Using this
      technology, the patients can receive feedback of their motion immediately.

      The objective of the study is to examine the effect of hospital-home linkage short-term
      rehabilitation therapy using real-time interactive digital healthcare system (Uincare
      Homeplus) in post-operative patients with breast cancer.
    

Intervention name(s): Uincare Homeplus; Brochure
Intervention type(s): Device; Other
Intervention description(s): Interactive digital healthcare system; Brochure
Other intervention name(s): digital healthcare
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Multisystem Cell Therapy for Improvement of Urinary Continence
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      The rising success of cell therapies places an increasing burden on health care costs.
      Consequently, the need to reduce production costs while maintaining quality has been widely
      acknowledged. In addition, the demand for high-quality products with an optimal safety
      profile is increasing. The proposed cell treatment is the first therapeutical option with the
      possibility to revert the underlying condition. The investigators expect that this healing
      response will be achieved with minimal side effects justifying the addional costs and
      complexity.
    

Detailed description: 
      muscle precursor cells (MPCs) will be isolated from biopsies of the lower leg of patients,
      seeded, expanded and cultivated in vitro in a GMP facility to generate vital muscle cells
      dedicated for implantation.

      These muscle cells exhibit myogenic phenotype (IHC and flow cytometry) and therefore
      morphological and histological prerequisites approximating the properties of native skeletal
      muscle tissue. The muscle progenitor cells shall be applied in external sphincter muscle for
      the treatment of patients with stress urinary incontinence.
    

Intervention name(s): Muscle Precursor Cells (MPCs), ATMP
Intervention type(s): Other
Intervention description(s): The advanced therapeutic investigational product, the MPCs, is a living, autologous cell-product isolated from a biopsy of the patient's own musculus soleus.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label, monocentric, first-in-man trial to assess safety and tolerability of a new therapeutic strategy for stress urinary incontinence based on the implantation of muscle precursor cells (MPCs) 40 female patients suffering from urinary incontinence since at least 6 months (predominant clinical diagnosis of SUI) and who are candidate for a surgical treatment will be included .
All patients are treated by the same product: Autologous MPCs. After treatment, the patients will be randomized 1:1 in the MPC-group or NMES+MPC-group to investigate the benefits of an additional physiotherapy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Muscle Precursor Cells
Training Balance Control in Children With Cerebral Palsy Using Virtual Reality Games
Condition: Cerebral Palsy, Spastic
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      In this study the clinical relevance of the use of commercially available virtual reality
      games in the rehabilitation of balance will be assessed in children with cerebral palsy. It
      will be investigated how different commercially available platforms (i.e. Xbox One + Kinect
      and Nintendo Wii + balance board) will affect the compensations of children with cerebral
      palsy to preserve their balance. The effect of 1 training session will be assessed as well as
      the effect of a long-term training of 8 weeks.
    


Intervention name(s): Balance rehabilitation using X-box One & Kinect
Intervention type(s): Other
Intervention description(s): the virtual reality games (Kinect sports rivals) can be controlled with movements of the body that are registered through the kinect camera.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: balance; rehabilitation; exergaming; virtual reality
Efficacy and Safety of Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Condition: Age-Related Macular Degeneration; Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Aflibercept (produced by
      CinnaGen Co, Iran) compared with Eylea® (Regeneron, USA) in subjects with Neovascular
      Age-related Macular Degeneration (nAMD).

      All the participants will receive one of the following regimens:

      Aflibercept (CinnaGen Co, Iran) or Eylea® (Regeneron, USA), 2 mg (vial 0.05 ml) by
      intravitreal injection every 4 weeks for the first 3 injections, followed by 2 mg every 8
      weeks until week 48 of study.

      The primary objective of this study is to verify the non-inferiority of Aflibercept (CinnaGen
      Co, Iran) versus Eylea® (Regeneron, USA) in achieving maintaining vision (losing<15 letter on
      ETDRS chart) at week 52 in comparison to week 0 in participants with Neovascular AMD.
    


Intervention name(s): Aflibercept (CinnaGen Co, Iran); Aflibercept (Regeneron, USA)
Intervention type(s): Biological; Biological
Intervention description(s): Aflibercept (CinnaGen Co, Iran) by intravitreal injection; Aflibercept (Regeneron, USA) by intravitreal injection
Other intervention name(s): Eylea®
Intervention MeSH terms: Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AMD; nAMD; Recombinant Fusion Protein; anti-VEGF; Aflibercept
Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I study is conducted to determine the maximum tolerated dose (MTD), dose limiting
      toxicity (DLT), safety and pharmacokinetics (PK) profile of a single agent CKD-516 injection
      on a weekly schedule in patients with advanced solid cancers failed to standard therapy. The
      usefulness of the this regimen is evaluated by response rate, progression free survival and
      vascular disruption effect by Dynamic Contrast-Enhanced MRI (DCE-MRI).
    

Detailed description: 
      OBJECTIVES:

        -  I. Determine the maximum tolerated dose of CKD-516 administered at single doses every 21
           days in patients with advanced solid tumors.

        -  II. Determine both the toxicity and dose limiting toxicity of this regimen in these
           patients.

        -  III. Determine the plasma and urine pharmacokinetics of CKD-516.

        -  IV. Gather preliminary data regarding possible antitumor effects in those patients with
           measurable diseae. Assess the effects of CKD-516 on tumor blood flow using DCE-MRI
           scanning techniques, and establish the dose at which these effects occur.

      OUTLINE: This is an open label, dose escalation study. Patients receive CKD-516 IV over 30
      minutes on day 1, 8 every 3 weeks in the absence of unacceptable toxicity or disease
      progression. Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum
      tolerated dose(MTD) is determined. The MTD is defined as the dose preceding that at which 2
      of 3 or 2 of 6 patients experience dose limiting toxicity.
    

Intervention name(s): CKD-516 inj
Intervention type(s): Drug
Intervention description(s): 5.0 mg/2ml; 1.0, 2.0, 3.3, 5, 7, 9 ~ mg/m2; Day 1, Day 8 every 3 weeks
Other intervention name(s): CKD-516
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tubulin polymerization inhibitor; CKD-516; Phase I; Vascular disrupting agent; DCE MRI