bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Carbonated Soft Drinks on Appetite-Regulation
Condition: Obesity; Diet
Study type: Interventional

Summary: 
      Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation
      leading to obesity development. Although drinks sweetened with aspartame are available the
      anticipated positive effect of these drinks on obesity development has not been convincing.
      However, the mechanisms linking drinks intake to obesity are yet to be clarified.

      The investigators aim is to investigate the short-term effects of soft drinks
      (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration
      of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety
      (measured by visual analogue scales) and energy intake. The study is a crossover,
      intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on
      four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink,
      aspartame-sweetened soft drink, semi-skimmed milk or water) is served.

      The investigators expect to clarify the mechanisms linking drinking habits to obesity
      development and provide scientifically based nutritional guidelines.
    


Intervention name(s): Sugar-sweetened soft drink; Aspartame-sweetened soft drink; Semi-skimmed milk; Water
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 500mL as a preload drink; 500mL as a preload drink; 500mL as a preload drink; 500mL as a preload drink
Intervention model: Crossover Assignment
Masking: None (Open Label)
HPV Self-test to Increase Cervical Cancer Screening in Asian Women
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The study was to pilot test the feability of using HPV self-sampling testing to increase
      cervical cancer screening among under-served Asian women through engaging community-based
      organizations in the greater Philadelphia and New York City area, addressing a significant
      global cancer burden, the preventable infection-related cervical cancer.
    


Intervention name(s): Education on cervical cancer prevetnion; Dynamic group interaction; Physician engagement; Patient Navigation; General Health Education
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Motivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention; Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;; Engaging community bilingual physicians in cervical cancer screening and referral;; Patient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment.; general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the long-term safety and tolerability of
      JNJ-54861911 during 6 months of treatment in participants with early (predementia)
      alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious
      onset of dementia, impairment of memory, judgment, attention span, and problem solving skills
      are followed by severe apraxias and a global loss of cognitive abilities]).
    

Detailed description: 
      This is a double-blind (neither the researchers nor the participants know what treatment the
      participant is receiving), placebo-controlled (an inactive substance; a pretend treatment
      [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has
      a real effect), randomized (study drug assigned by chance), multi-center (when more than one
      hospital or medical school team work on a medical research study), parallel-group study. The
      study consists of 3 Parts; Screening Phase of 90 days, double-blind Treatment Phase of 6
      months and Follow-up Phase of 7 to 28 days following the last dose in Month 6. Eligible
      participants in the early (predementia) AD spectrum will be randomized to either Treatment
      group 1, 2 or placebo and participants who previously participated in study 54861911ALZ1005
      will be enrolled in this study and will receive the same treatment as in study
      54861911ALZ1005. The study duration for each participant will be approximately 10 months.
      Blood and cerebrospinal fluid (CSF) samples will be collected to evaluate the plasma
      pharmacokinetics of JNJ-54861911, as well as amyloid beta fragments. Participants' safety
      will be monitored throughout the study, including magnetic resonance imaging (MRI) and
      cognitive measures.
    

Intervention name(s): JNJ-54861911, 10 milligram (mg); JNJ-54861911, 50 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will self-administer JNJ-54861911, two tablets of 5 mg each for a total of 10 mg, orally, once daily, from Day 1 until Month 6 in treatment group 1.; Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6 in treatment group 2.; Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; JNJ-54861911; Placebo
Effect Of Pressure Biofeedback on Deep Cervical Muscle Training Among University Teachers.
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of pressure biofeedback on deep cervical
      muscle in university teachers suffering from neck pain, Functional Disability and muscle
      endurance.
    

Detailed description: 
      The purpose of this study will be to determine whether training of deep cervical flexor
      muscles with pressure biofeedback has any significant advantage over conventional training
      for pain and disability experienced by university teachers with neck pain. This study will be
      a randomized control trial with double blinded protocol. Patient will be randomly allocated
      in two groups. the experimental group received deep cervical flexor muscles training with
      pressure biofeedback and conventional exercises. The control group received deep cervical
      flexor muscles training with only conventional exercises.
    

Intervention name(s): Pressure biofeedback; Conventional exercises for deep cervical muscle training
Intervention type(s): Device; Other
Intervention description(s): Deep cervical flexor training by using preesure biofeedback will be given 5 days a week for 6 week Conventional exercise for deep cervical muscle training will be given 5 days a week for 6 weeks; Conventional exercise for deep cervical muscle training will be given 4 days a week for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck pain; Disabilty; Muscle endurance; Pressure biofeedback; Teachers
BIPAP in the Management of Acute Respiratory Distress Syndrome
Condition: Mechanical Ventilation Complication
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      Evaluation of biphasic positive airway pressure as a new mode of ventilation in management of
      acute respiratory failure constituted in ARDS as a category of hypoxaemic respiratory failure
      in comparison to conventional ventilation.
    

Detailed description: 
      Biphasic positive airway pressure (BIPAP) is a mode of mechanical ventilation that allow
      unrestricted spontaneous breathing independent of ventilator cycling, using an active
      expiratory valve. BIPAP mode is pressure-limited and time-cycled, Ventilation occurs via the
      time-cycled switching between two set pressure levels. In the absence of spontaneous
      breathing, this mode resemble conventional pressure controlled ventilation.

      A proposed advantage of BIPAP compared to conventional pressure-controlled ventilation is the
      improved distribution of gas to dependent lung regions as the result of spontaneous breathing
      enabled during the inspiratory and expiratory time cycles, so prevents atelectasis and
      promotes alveolar recruitment resulting in an improved ventilation-perfusion matching.

      ARDS is an acute diffuse, inflammatory lung injury, leading to increased pulmonary vascular
      permeability, increased lung weight, and loss of aerated lung tissue with hypoxemia and
      bilateral radiographic opacities, associated with increased venous admixture, increased
      physiological dead space and decreased lung compliance.

      In patients with ARDS, BIPAP with spontaneous breathing contributes to improved pulmonary gas
      exchange, systemic blood flow and oxygen supply to the tissue. This is reflected by clinical
      improvement in the patient's condition, which is associated with significantly fewer days on
      ventilatory support, earlier extubation and a shorter stay in the intensive care unit.
    

Intervention name(s): BIPAP mode/SIMV PC mode
Intervention type(s): Other
Intervention description(s): BIPAP is a mode of ventilation recently used in ARDS
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group
Masking: Single (Participant)
Primary purpose: Other
Keywords: BIPAP , ARDS
Self-Management in African Americans With Diabetes and Hypertension
Condition: Diabetes
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary aim of the study is to design a group-based, culturally appropriate
      self-management skills training intervention for disadvantaged African-Americans with both
      diabetes and hypertension and to compile an intervention Manual of Operations (MOO). The
      investigators are developing an intervention to assist individuals in reducing weight and
      hemoglobin A1c.
    


Intervention name(s): Intensive diabetes self-management education; Enhanced standard diabetes education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 18 group classes led by a dietitian and peer supporters, and weekly telephone calls by peer supporters. Intervention focus was on diet and physical activity.; 2 3-hour diabetes education classes taught by a health educator at a local clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients
Condition: Cataract Diabetic
MeSH terms: Cataract; Diabetic Retinopathy
Study type: Interventional

Summary: 
      This study examines the use of Trypan Blue staining of the corneal endothelium in patients
      undergoing phacoemulsification. It is a single-center prospective, randomized individual
      cohort study. One eye in each patient with diabetic retinopathy will undergo
      phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye
      will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes
      will undergo intraocular lens implantation. Preoperative and four-week postoperative
      quantitative and qualitative morphometric endothelial cell analyses of the cornea will be
      performed using noncontact specular microscopy.
    


Intervention name(s): Phacoemulsification with and without Trypan Blue capsule staining
Intervention type(s): Procedure
Intervention description(s): Phacoemulsification for patients with diabetic retinopathy having cataract in both eyes. One eye underwent phacoemulsification with trypan blue capsule staining and the other eye underwent phacoemulsification without trypan blue.
Intervention MeSH terms: Diminazene aceturate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Chronic Obstructive Pulmonary Diseases and Proprioceptive Neuromuscular Facilitation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      To investigate the effects of resistant proprioceptive neuromuscular facilitation exercises
      on physical fitness, respiratory muscle strength, walking distance and quality of life in
      chronic obstructive pulmonary patients.
    

Detailed description: 
      The study was carried out between January 2017 and January 2019, with patients followed up
      with the diagnosis of COPD in Çanakkale Mehmet Akif Ersoy State Hospital and Çanakkale
      Onsekiz Mart University Medical Faculty Hospital, Department of Chest Diseases. It was
      approved by Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee
      (Date: 30.12.2016, Decision No. 573) and was done in accordance with the Declaration of
      Helsinki. All participants were informed about the purpose of the study, the total duration
      of treatment and the applications to be made, and a consent form was signed. The study was
      conducted as a prospective and randomized controlled study, and inclusion and exclusion
      criteria were determined.

      Thirty-five patients diagnosed with COPD were referred to the study, four patients were
      excluded because they did not meet the inclusion criteria, and the study was conducted with a
      total of 31 participants.

      The 31 patients included in the study were randomized after their initial evaluation and
      divided into two groups as experimental and control groups. Patients meeting the inclusion
      criteria were divided into 2 groups. Randomized by ordering by date of application.
    

Intervention name(s): MIP/MEP
Intervention type(s): Diagnostic Test
Intervention description(s): MIP/MEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COPD
Inflammation and Postoperative Tramadol Analgesia
Condition: General Surgery
MeSH terms: Inflammation
Study type: Observational

Summary: 
      Patients will be admitted in the intensive care unit after major abdominal surgery. All
      patients will receive 100 mg of tramadol intravenously every 6 hours. Pain will be assessed
      before and half an hour after tramadol administration by verbal Numeric Rating Scale.
    

Detailed description: 
      To all patients included in the study from the blood sample taken prior to the operation the
      leukocytes counts, c-reactive protein (CRP), procalcitonin (PCT) and lactate level will be
      performed, as well as arterial blood gas analysis.

      After admission to the intensive care unit, all patients will receive 100 mg of tramadol
      intravenously every 6 hours. Pain will be assessed before and half an hour after tramadol
      administration by verbal Numeric Rating Scale (NRS). Pain score will be compared between
      patients with and without systemic inflammation. Systemic inflammation is defined as
      fulfilling at least two of the following major criteria: fever > 38 oC or hypothermia < 36
      oC, tachycardia > 90 beats/minute, pCO2 in arterial blood < 4.3 kPa and leukocytes >
      12.000/mm3 or < 4.000/mm3. Also, preoperative values of CRP > 50 mg/L and PCT > 0.5 ng/ml was
      also considered systemic inflammation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study included patients admitted in the intensive care unit after major abdominal
        surgery performed with open laparotomy.
      
Biospecimen description: 
      CRP, PCT. leukocyte count, lactate, arterial blood gas
    
Keywords: Postoperative analgesia; tramadol; intensive care unit
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The proposed protocol is an open-label pilot study of the treatment of cocaine dependence
      using lisdexamfetamine (LDX), a prodrug of d-amphetamine. The investigators plan to enroll 12
      patients in an eight-week open-label trial to obtain preliminary data regarding the safety,
      tolerability, and potential utility of lisdexamfetamine for treatment of cocaine dependence
      and to determine an effective dosage range.
    

Detailed description: 
      In an eight-week open label outpatient pilot trial, we will evaluate the safety,
      tolerability, and potential utility of LDX in the treatment of cocaine dependence. Patients
      will receive a flexible-fixed dosing schedule under open-label conditions. Patients will be
      titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and
      then maintained on the highest tolerated dose for four weeks, followed by a two week run-down
      period. All participants will receive medication management counseling and individual therapy
      using a structured compliance enhancement manual designed for pharmacotherapy trials in
      subjects with substance use disorders.

      The primary outcome measures will be 1) the maximum total lisdexamfetamine dose achieved
      during the study period defined as the highest amount of medication per day maintained for a
      seven day period 2) lisdexamfetamine tolerability as measured by adverse effects reported on
      the Systematic Assessment for Treatment and Emergent Events (SAFTEE). Secondary outcome
      measures will be 1) cocaine use as recorded by the number of days of use on the Timeline
      Follow-Back method (Sobell & Sobell, 1992) and confirmed by urine toxicology, 2) cocaine
      craving as measured by the Cocaine Craving Scale (CCS) and Cocaine Craving Questionnaire
      (CCQ) and 3) alternate measures of cocaine use, such as the dollar value of cocaine used per
      day, as measured by the Timeline Follow-Back method, and the proportion of urine toxicology
      samples negative for cocaine.
    

Intervention name(s): Lisdexamfetamine; medication management
Intervention type(s): Drug; Behavioral
Intervention description(s): Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks; All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
Other intervention name(s): Vyvance
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cocaine; lisdexamfetamine
Influence of Losartan and Diphenhydramine on Emotional and Cognitive Functions in Healthy Human Subjects
Condition: Memory, Long-Term; Memory, Short-Term
Study type: Interventional

Summary: 
      This project aims at identifying novel pharmacological targets for the treatment of memory
      disorders.
    

Detailed description: 
      To investigate the effects of the histamine H1 receptor antagonist diphenhydramine and the
      angiotensin II receptor antagonist losartan on emotional and cognitive functions in healthy
      human subjects.
    

Intervention name(s): Losartan, Diphenhydramine, Placebo
Intervention type(s): Drug
Intervention description(s): placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg
Intervention MeSH terms: Diphenhydramine; Promethazine; Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Virtual Peer-to-Peer (VP2P) Support Mentoring for Chronic Pain: A Pilot RCT
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes
      and quality of life in adolescents with chronic pain.
    

Detailed description: 
      The aim of this project is to develop and examine the impact of a virtual peer support
      program on health outcomes and quality of life of adolescents with chronic pain using a
      waitlist randomized controlled trial. In addition to standard medical care, adolescents in
      the experimental group will receive a manualized peer mentorship program that will provide
      modeling and reinforcement by trained young adults aged 16-25 years who have learned to
      function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45
      minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to
      quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support,
      and self-management skills.
    

Intervention name(s): Virtual Peer-to-Peer Support Mentoring
Intervention type(s): Behavioral
Intervention description(s): The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 30-60 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 2.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: adolescent; Skype; peer mentorship; internet self-management
Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The purpose of this study is to compare the frequency of long-term post operative pain after
      an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an
      totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The
      investigators will also be assessing the cost for the procedures and hospital care as well as
      the cost for sick-leave depending on procedure performed. The study hypothesis is that the
      laparoscopic approach will be associated with less long term post operative pain.
    


Intervention name(s): Mesh repair for primary inguinal hernia
Intervention type(s): Procedure
Intervention description(s): Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh
Other intervention name(s): Lichtenstein (LLA); TEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment