bioihbjkbjnl/mcl2 huggingface dataset:
Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase 4, multi-center, open-label, one-arm, pilot study in patients with active
      ankylosing spondylitis refractory to conventional treatment. Remicade will be given at Weeks
      0, 2, and 6 and then every 8 weeks up to Week 54. The number of patients showing ASAS-20
      clinical response at Week 14 will be evaluated.
    


Intervention name(s): Remicade
Intervention type(s): Biological
Intervention description(s): Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
Other intervention name(s): Infliximab; SCH 215596
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effect of Injection Lypolysis (Lipodissolve) Treatments to Reduce Body Fat
Condition: Abdominal Subcutaneous Fat
Study type: Interventional

Summary: 
      The combination of phosphatidylcholine (PPC) and deoxycholate (DC) injected into subcutaneous
      fat is often popularly referred to as "Lipodissolve" therapy. Despite its attractiveness as
      an easy and noninvasive cosmetic treatment, the safety, effectiveness, and how the injections
      might work remain unclear. This study will investigate the hypothesis that injections of
      PPC/DC will reduce the amount body fat in the treated area. If so, the mechanisms responsible
      for the fat loss will be explored to find out whether fat cells die from toxic effects or are
      broken apart by the PPC/DC. Patients will receive at least 2 (no more than 4) treatments with
      PPC/DC injections every 2 months. Several methods of measuring fat loss will be used in the
      study, including photography and measurement of patients, tissue biopsy, blood tests, and
      MRI. The study will also record side effects of the treatments as well as patient
      satisfaction.
    


Intervention name(s): phosphatidylcholine and deoxycholate
Intervention type(s): Drug
Intervention description(s): 50 mg phosphatidylcholine, 42 mg deoxycholate subcutaneous injection Every 8 weeks x 2 with additional 2 treatments optional
Other intervention name(s): PPC; DC; Lipodissolve
Intervention MeSH terms: Deoxycholic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Dietary Components on Gastrointestinal Side Effects Induced by Orlistat, a Lipase Inhibitor
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The objective of the Orlifat trial is to investigate if dietary fibres from linseeds and
      dairy calcium (Capolac ®) may reduce gastrointestinal side effects related to increased fecal
      fat content, induced by treatment with Alli® (orlistat). Secondly, effect on food intake,
      anthropometry, Quality of Life and cardiovascular risk markers will be evaluated. The trial
      is designed as a randomised 2 x 2 factorial 13-weeks parallel intervention, in which 72 obese
      participants will be randomised to supplementation with flaxseed fibres and/or dairy calcium
      concentrate (Capolac) in addition to treatment with Alli ®:

        1. Alli® (60 mg t.i.d) plus placebo (rice flour)

        2. Alli® plus 5 g flaxseed fibers

        3. Alli® plus 1200 mg Ca from Capolac

        4. Alli® plus 5 g flaxseed fibers and 1200 mg Ca from Capolac
    


Intervention name(s): Control; Capolac; Flax fiber; Capolac+Flax fiber
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Alli treatment plus placebo (rice flour); Alli treatment plus Capolac supplement (1200 Ca/d from Capolac); Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed); Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Obesity; orlistat; fat excretion; fiber; dairy calcium
Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors
Condition: Refractory or Recurrent Solid Tumors; Rhabdomyosarcoma; Non-Rhabdomyosarcoma Soft Tissue Sarcoma; Ewing Sarcoma
MeSH terms: Sarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The Phase 1 part of the study is conducted to determine the maximum tolerated dose (MTD) and
      Recommended Phase 2 Dose (RP2D) of eribulin mesilate in combination with irinotecan
      hydrochloride in pediatric participants with relapsed/refractory solid tumors (excluding
      central nervous system [CNS] tumors).

      The Phase 2 part of the study is conducted to assess the objective response rate (ORR) and
      duration of response (DOR) of eribulin mesilate in combination with irinotecan hydrochloride
      in pediatric participants with relapsed/refractory rhabdomyosarcoma (RMS),
      non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and ewing sarcoma (EWS).
    


Intervention name(s): Eribulin mesilate; Irinotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; IV infusion
Other intervention name(s): E7389; (S)-4,11-diethyl-39 3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]-indolizino[1,2-b]quinolin-9-4-yl-[1,4'-bipiperidine]-1'-carboxylate, monohydrochloride, trihydrate
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eribulin mesilate; irinotecan; combination therapy; children
Pre-biotics and Probiotics for Constipation in Parkinson's Disease
Condition: Constipation
MeSH terms: Parkinson Disease; Constipation
Study type: Interventional

Summary: 
      Constipation is the most frequent (prevalence, about 60%) dysautonomic non motor symptom
      affecting Parkinson's disease (PD) patients. Unfortunately, limited treatment options have
      been investigated and are now available for the management of constipation in PD. Preliminary
      data have suggested that probiotics could be help improving bowel habits but high-quality
      randomized trials are required in this area. Therefore, the investigators designed a
      randomized trial to evaluate whether the use of a fermented milk containing multiple
      probiotics strains and prebiotic fiber have a beneficial effect on constipation in PD
      compared to placebo.
    


Intervention name(s): Probiotics and prebiotic; Placebo
Intervention type(s): Other; Other
Intervention description(s): Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber; Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses
Condition: Nurses; Work-Related Stress Disorder; Pain; Fatigue
MeSH terms: Fatigue; Occupational Stress
Study type: Interventional

Summary: 
      Pain, fatigue, and stress lead to decrease on their work performance with biopsychosocial
      functioning disorders on nurses. This study was conducted to examine the effects of the
      "Workplace Health Promotion Program" (WHPP) on pain, fatigue, stress, professional quality of
      life (Pro-QoL) and coping skills for nurses.
    

Detailed description: 
      The investigators conducted a randomized control trail in 30 nurses admitted to their
      Hospital. Progressive relaxation training, posture and breath exercises and ergonomic
      suggestion as a WHPP was applied to the intervention group (n=15) during the five weeks.
      Visual Analogue Scale (VAS) was used to determine the pain, fatigue and stress levels of the
      nurses. Brief COPE and the Professional Quality of Life Scale, Version 4 (Pro-QoL) were used
      to evaluate the coping skills and quality of life. The evaluations were performed three times
      on all the participants as; before and after training and the one-year follow-up.

      Inclusion criteria of this study were working actively and at least 40 hours working in a
      week. Participants who have psychiatric illnesses with or without medication, prior training
      or current use of relaxation therapy and participants without consent were excluded.

      Eighty nurses aged between 18 and 65, working in a hospital have been informed about the
      study. Forty-three nurses who met the criteria and signed consent forms were included in this
      study. WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.
    

Intervention name(s): WORKPLACE HEALTH PROMOTION PROGRAM
Intervention type(s): Other
Intervention description(s): WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The WHPP was applied to the intervention group in the workplace for two times a week for five weeks. During the first 5 minutes of the session, breathing exercises, 20 minutes, PMR and 10 minutes, posture exercises were performed. PMR has progressed gradually to every session. The program is under control with a follow-up chart of what the participants do every day, and the participants were supported with various reminders (i.e., graphical leaflets on PMR techniques which also can be used as a guide while practicing at home). Participants of the control group rested in a room for 40 minutes and were told that they could read every session.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coping skill; quality of life; pain; fatigue; Workplace Health Promotion Program
The Impact of Preoperative Supplementation of Zinc
Condition: Surgery; Nutrition Disorders
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      1. Pre operative anthropometric assessment including : weight in kg, height/length and BMI

        2. Pre operative Zinc supplementation (dose according to the age) for 7 days preoperatively
           for cases

        3. Postoperative data collection
    

Detailed description: 
      Postoperative data collection :

        -  Length of hospital stay

        -  Complication and sorting of them

        -  Lab withdrawal of inflammatory markers on 2-3 day postoperatively
    

Intervention name(s): Zinc
Intervention type(s): Dietary Supplement
Intervention description(s): Zinc Supplementation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Diphtheria; Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers,
      children, adolescents, and adults

      Objective:

        -  To describe the safety profile after each and any dose (when applicable) of Menactra
           vaccine in participants aged 9 months to 55 years for registration.
    

Detailed description: 
      Infants and toddlers will receive 2 doses of vaccine 3 months apart. Children ≥ 2 years
      through adults aged 55 years will receive 1 dose of vaccine. All participants will be
      evaluated for safety up to 28 days post-vaccination.
    

Intervention name(s): Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular. 2 doses 3 months apart; 0.5 mL, Intramuscular.
Other intervention name(s): Menactra®; Menactra®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Meningococcal Vaccine
The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
Condition: Sleep Apnea Syndromes
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This study is a prospective, multi-center, randomized crossover of the NightBalance SPT
      compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
    

Detailed description: 
      This study is a prospective, multi-center, randomized crossover of the NightBalance SPT
      compared to APAP for the treatment of POSA.

      The Primary Objective of the study is to demonstrate non-inferiority of treatment with the
      SPT as compared to APAP.
    

Intervention name(s): NightBalance Sleep Position Trainer (SPT); Automated Adjusting Positive Airway Pressure (APAP)
Intervention type(s): Device; Device
Intervention description(s): Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.; Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 6 week crossover study, randomized to order of treatment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Positional Sleep Apnea; Positional Obstructive Sleep Apnea; POSA; OSA; Obstructive Sleep Apnea; Sleep Apnea
A 6-month Study to Evaluate Sulforaphane Effects in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the study is to investigate whether adding sulforaphane will benefit the negative
      symptoms and cognitive function in individuals who have schizophrenia.

      This study will compare the sulforaphane with placebo. There is a thirty percent change (less
      than half) of receiving the placebo. The purpose of including placebo is to judge if the
      outcome is related to the study medication rather than other reasons.
    

Detailed description: 
      This study will be carried out in The Third Jiangyin Hospital in China and total of 120
      schizophrenia patients with one negative symptom item score of PANSS≥3 will be enrolled into
      the study. Individuals who participate in the study will be followed for 24 weeks. The
      changes in clinical symptoms and neurocognitive function will be assessed from baseline
      (week-0) to week-12, and week-24.
    

Intervention name(s): Sulforaphane; placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.; Placebo is made of starch
Other intervention name(s): Nutramax
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; sulforaphane
Jerusalem Handwashing Study
Condition: Illness Absenteeism; Handwashing Behavior
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this preschool intervention trial was to determine whether a hygiene
      program can promote handwashing and thereby reduce illness absenteeism.
    

Detailed description: 
      Please see citations of published reports.
    

Intervention name(s): Preschool handwashing intervention program; Home component intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This preschool-based intervention program used a multi-pronged approach that included elements aimed at preschool staff, children, and school nurses, as well as hygienic changes to the classroom environment.; The home component was intended to reinforce handwashing practices through education in the home. It consisted of a video, a magnet, and a card.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Handwashing; Randomized controlled trial; Cluster randomization; Community intervention trial; Disease prevention; Pediatric communicable disease; Preschool; Illness absenteeism
A Study of Blood Levels of Nicotine Following an Electronic Cigarette
Condition: Nicotine Replacement Therapy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the amount of nicotine that is absorbed into the blood
      stream following the use of a new Electronic Cigarette device called the CN electronic
      cigarette. The amount of nicotine delivered via the CN electronic cigarette will be compared
      to the amount of nicotine delivered from smoking a regular cigarette and from using the
      Nicorette® Inhalator.

      Electronic cigarettes aim to mimic the experience of cigarette smoking, by delivering
      nicotine rapidly. Unlike cigarettes however, they do not contain all of the many harmful
      combustion products contained in tobacco smoke.

      Electronic cigarettes are readily available in many markets, and may contain significant
      quantities of nicotine. However, they are not regulated as medicines, and their manufacturers
      can make no medicinal claims about them.

      Such products are unregulated, having not been subjected to regulatory review by either the
      Medicines and Healthcare Products Regulatory Agency (MHRA) or any Notified Body.

      It is the intention of CN Creative (makers of the CN electronic cigarette) to submit an
      application to the MHRA for the CN Electronic Cigarette, in order to make a high quality,
      regulated product available. Males aged 18-65, who smoke and who have no intention of
      stopping smoking during the trial are eligible to take part in this study. The study consist
      of a screening visit, a treatment period with 5 overnight stays with nicotine treatment on
      days 1, 2, 3 and 4 with a post study visit on day 5.
    


Intervention name(s): CN electronic cigarette 10 mg; CN electronic cigarette 15 mg; Nicorette Inhalator 15 mg; Cigarette
Intervention type(s): Device; Device; Device; Other
Intervention description(s): Inhalation; Inhalation; Inhalation; Inhalation
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: E-cigarette; healthy volunteer study; Pharmacokinetics; Nicorette
A Study Investigating the Effects of Neprinol Study Product on Vascular Function
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label study investigated the effectiveness of Neprinol on maintaining healthy
      cardiovascular health in overweight and obese adults. Subjects took 3 capsules, 3 times per
      day over a period of 12 weeks.
    


Intervention name(s): Neoprinol
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Coagulation; Circulatory Function; Blood Pressure; Inflammatory response; Blood Glucose; Healthy vascular function
Effects of Core Stabilization Exercises vs. Schroth's Program on Posture and Quality of Life in Females With Scoliosis.
Condition: Scoliosis Idiopathic
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The objective of this study is to compare the effects of core stabilization exercises versus
      schroth's program on posture and quality of life in females with idiopathic scoliosis
    

Detailed description: 
      Scoliosis is a 3 dimension condition that effects most of our population specifically
      females. It is not only a bend in your spine but according to new research, its also twisting
      it. The curvature effects the effected individual physical and the social anxiety due to
      appearance and a continues state of lethargy effects their quality of life immensely. The
      posture is poorly effected along with a visual appearance. Often someone with scoliosis might
      find good posture difficult. Often someone with scoliosis will lean forwards and to the side
      either slightly or a lot. They will often try to avoid doing this, which can lead to slightly
      bent knees and the pelvis tilting backwards. Scoliosis is often defined as spinal curvature
      in the "coronal" (frontal) plane. While the degree of curvature is measured on the coronal
      plane, scoliosis is actually a more complex, three-dimensional problem which involves all 3
      planes. It is defined by the Cobb's angle of spine curvature in the coronal plane and is
      often accompanied by vertebral rotation in the transverse plane and hypokyphosis in the
      sagittal plane. These abnormalities in the spine, costal-vertebral joints, and the rib cage
      produce a 'convex' and 'concave' hemithorax.

      Only females having idiopathic scoliosis with cob's angle 10°-26° with age ranging between
      19-30 are included and any subjects with surgical interventions are excluded.

      Population will be divided in to two groups. One group will perform scroth exercises for 4
      weeks and the other group will perform core straightening exercises for 4 weeks each. Once
      the time period is complete, the posture will be measured using pelvic and shoulder
      goniometers to check the level of tilt and for quality of lifestyle, we will be using quality
      of life (Scoliosis Research Society-22 questionnaire)
    

Intervention name(s): Core stability exercise; Scroth's Program
Intervention type(s): Other; Other
Intervention description(s): The core stability training consist of three phases; The Schroth program include exercises for rotational breathing, spinal elongation, deflexion, stretching, de-rotation, and strengthening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment