bioihbjkbjnl/mcl2 huggingface dataset:
Taking Open Label Placebo Further: Trial of Imaginary Pills in Test Anxiety
Condition: Test Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Employing imaginary pills could offer a new way of investigating underlying mechanisms of
      open label placebo (OLP) treatment by eliminating the physical treatment constituent (i.e.,
      the pill itself). This can reveal the power of the purely psychological component of a
      placebo and gives insights into underlying mechanisms of placebo effects. The aim of the
      project is to assess possible effects of an imaginary pill in comparison to no treatment, and
      open label placebo treatment in subjects with test anxiety.

      Interventions (seven to three weeks before the exam) will be held online using a video Chat
      application such as zoom (https://zoom.us/) or skype (https://www.skype.com/de/) or will take
      place at the division of Clinical Psychology and Psychotherapy, University of Basel
      (Missionsstrasse 62, 4055 Basel).
    


Intervention name(s): information about "No treatment group"; imaginary pill technique; open label placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will receive no pills and will be told that they are in the no treatment group; Participants will be instructed to take an imagined pill. This instruction consists of a procedure including five steps (i.e., identifying the IP sensitive problem, building trust/belief/reality of the IP, constructing a personally meaningful IP, taking the IP, suggestions for self-administering the IP in real life, and building adherence). Participants in this group receive daily e-mail reminders.; Participants will have the information that they are receiving inert pills (i.e. "P-Dragees", containing "Placebo"), combined with the following scientific rationale: (a) deceptive as well as open label placebos have been found to be effective in relieving symptoms in a variety of clinical conditions namely anxiety, depression, chronic pain (the placebo effect is powerful), (b) classical conditioning are one of the possible mechanism of this effect (the body automatically responds), (c) positive expectations may help but are not necessary, (suspend disbelief), (d) compliance with these instructions are important for outcome (taking the pills faithfully is important).
Participants in this group receive daily e-mail reminders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: imaginary pills; open label placebo (OLP) treatment; placebo
Interest of Evaluating the Movement of the Center of Mass in a Dynamic Avoidance Task as the Endpoint of the Dynamic Equilibrium of Hemiplegic Patients
Condition: Hemiplegic Patients
Study type: Interventional

Summary: 
      For several years, the postural disorders assessment in hemiplegic patients was conducted
      through force plate, using the center of plantar pressure displacement in a static position.

      These are widely used in physical therapy both for assessment and rehabilitation of patients
      with balance disorders.

      For hemiplegic patients, an asymmetric distribution support on each foot and an increased
      surface area of postural sways (more marked on the medio lateral axis) are observed.

      These studies, based on the study of plantar pressure ,are not enough to providea full
      description of the spatio-temporal organization of postural components in hemiplegic
      patients.

      Indeed, postural stabilometric evaluation is based on a simplification of the human skeleton
      by considering it as a simple inverted pendulum swinging on his ankles.

      This simplified model can't be used in dynamic assessment because of the simultaneous
      contributions of several joints during movement. This restricts its clinical interest because
      patients are more exposed to imbalances and falls in dynamic situations. Thus, the hip
      angular movement results in a center plantar pressure displacementwhich is impossible to
      discriminate from the ankle axis movement using stabilometric signal only.

      Thus, it seemed interesting to study another variable valid in dynamic conditions : the
      displacement of center of mass during a dynamic balancing task. This variable is obtained
      through 3D motion capture of the different segments of the human body. The dynamic test is a
      dynamic postural assessment following ball avoidance from three different directions. The
      center of mass displacement will be compared with a functional test known to be
      representative of dynamic balance of the individual capacities: The Timed Up and Go test
      (TUG).

      All of this data aims to improve the hemiplegic postural assessment for physical therapy and
      to help develop new rehabilitative approaches.
    


Intervention name(s): Dynamic Avoidance Task; physical therapy; 3D motion on optoelectronic device
Intervention type(s): Other; Procedure; Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Brief Intervention for Socially Anxious College Drinkers
Condition: Alcohol Consumption; Alcohol Negative Consequences; Social Anxiety
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop and test a new brief intervention to reduce heavy
      drinking and social anxiety in college drinkers.
    

Detailed description: 
      Episodic alcohol abuse is common among college students. Recently, brief interventions
      focusing on motivational strategies and behavior skills to reduce heavy drinking and
      alcohol-related problems have shown beneficial small to medium effects in college drinkers
      who reported heavy drinking and/or alcohol-related problems. Most interventions have not
      taken into account psychiatric comorbidity, in particular social anxiety, a frequent problem
      for college students that has been linked to excessive alcohol use. This project will extend
      knowledge on brief interventions by integrating cognitive-behavioral therapeutic strategies
      for social anxiety with an existing alcohol intervention designed for college students.

      The efficacy of a new integrated treatment, the Brief Intervention for Socially Anxious
      Drinkers (BISAD) was developed and tested. All participants reported heavy alcohol use,
      alcohol-related problems and social anxiety based on standardized measures. Phase I of the
      study focused on the development of the treatment manuals and measures of therapy integrity
      for BISAD and an alcohol-focused intervention, a modified treatment-as-usual at the local
      university. During this phase therapists were trained to administer the manualized
      interventions to study participants (N=12). Phase II included further refinement of the
      therapy integrity measures and data collection for the pilot study (N=41). Participants were
      randomized to either BISAD (n=21) or a modified treatment-as-usual (n=20) condition. The
      pilot study provide preliminary data on the efficacy of the proposed intervention in reducing
      heavy drinking, social anxiety, and their negative consequences at 1-month and 4-month
      follow-ups after treatment termination. These data provide estimated effect sizes for future
      testing of BISAD in a full-scale clinical trial. Furthermore, the study results contribute to
      the conceptualization and methodological development of combined interventions for other
      substance use and psychiatric problems.
    

Intervention name(s): Brief Intervention for Socially Anxious Drinkers (BISAD); Enhanced Alcohol Skills Building and Education Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): integrated alcohol and social anxiety individual intervention; alcohol-focused group intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: alcohol consumption; social anxiety; brief intervention; motivational interviewing; cognitive behavioral
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Condition: Diphtheria; Hepatitis B; Acellular Pertussis; Haemophilus Influenzae Type b; Tetanus; Poliomyelitis; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa
      booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14
      weeks. All infants in this booster study were born to pregnant women who participated in the
      study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as
      per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.
    


Intervention name(s): Infanrix hexa
Intervention type(s): Biological
Intervention description(s): All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pertussis; Immunogenicity; Poliomyelitis; Tetanus; Hepatitis B; Diptheria
Pre and Post Muscular Fatigue - DROP-JUMP TEST
Condition: Motor Control
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Many studies have related the presence of dynamic valgus with several musculoskeletal
      injuries of the hip, knee and ankle. The weakness of the hip abductors is cited as one of the
      factors linked to this poor dynamic alignment of the lower limb, however, motor control can
      also be one of the factors responsible for the poor alignment of the lower limbs.
    


Intervention name(s): drop-jump test
Intervention type(s): Other
Intervention description(s): The participants will be submitted to a kinematic evaluation protocol before and after fatigue protocol and after two weeks they will be submitted again to the same protocol, however, they will be guided and trained on the correct execution of the tested movement.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: rehabilitation; lower limb-muscle; alignment, sequence
Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25mg With Those of Enbrel®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic characteristic of LBEC0101 25mg with active comparator,
      Enbrel® 25mg.
    


Intervention name(s): LBEC0101 (Etanercept 25mg); Enbrel (Etanercept 25mg)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Using an integrated approach, this study examines multiple eating traits concurrently under
      states of hunger and satiety. It examines the impact of short-term appetite and intake
      regulation on longer-term energy intake control and weight development in a cohort of
      ethnically diverse normal-weight and obese boys and girls with different familial
      predispositions to obesity.
    


Intervention name(s): % COMPX (low ED vs. high ED preload); EAH (low ED vs. high ED snacks)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Center of Research Translation (CORT) Project 2
Condition: Pre-hypertension; JNC 7 Stage I Hypertension
MeSH terms: Hypertension; Prehypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We propose a novel intervention for reducing BP that could have a preferential impact in
      patients with hyperuricemia and gout. There is a great need for new anti-hypertensives,
      particularly among those with gout. The proposed study is novel in its plans to investigate
      the physiologic mechanisms through which urate contributes to vascular disease and by which
      ULT may contribute to BP reduction. Also innovative, we will: 1) determine to what extent the
      described benefit of lowering serum urate extends beyond the adolescent population previously
      studied into young adults, 2) test whether a urate-lowering approach will benefit individuals
      that do not yet meet the current definition of hyperuricemia and do not have gout, and 3)
      begin to explore potential mechanisms for the higher prevalence of hypertension among
      African-Americans. If successful, this work could translate to the standard of clinical care
      and to health care recommendations for the population as a whole.
    


Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration.; Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pre-hypertension; JNC 7 stage I hypertension
Effectiveness of Dry Cold Application on Pain and Bruise at the Subcutaneous Injection Site Among Patients Admitted in ICU
Condition: Pain; Bruise
MeSH terms: Ecchymosis; Contusions
Study type: Interventional

Summary: 
      The study evaluate the effectiveness of dry cold application on pain intensity and bruise at
      the subcutaneous injection site among patients admitted in medical I.C.U. Purposive sampling
      technique was used to select 60 hospitalized patients (30 in experimental and 30 in
      comparison group). Dry cold was applied to the subcutaneous injection site using ice bag
      filled with crushed ice with half table spoon of salt for 20 minutes after the administration
      of injection and no intervention was given in comparison group.
    

Detailed description: 
      Setting was randomized by lottery method. Subjects were selected by purposive sampling
      technique. Self-introduction was given to the subjects. Rapport was developed with subjects.
      Nature and purpose of the study was explained to the subjects. Subjects were assured about
      the confidentiality of their responses and informed written consent was taken prior to the
      data collection. Subjects in the experimental and comparison group were administered low
      molecular weight heparin injection subcutaneously by the researcher itself. After
      administration of subcutaneous injection of low molecular weight heparin, dry cold
      application using ice bag (Crushed ice was filled in ice bag with ½ table spoon of salt and
      then covered by clean linen to prevent moisture) was placed over the injection site for about
      20 minutes in experimental group and no intervention was given in comparison group. Pain was
      assessed using numerical pain rating scale after 20 minutes of subcutaneous injection in both
      the groups (experimental and comparison). At 12 hr, 48 hr and 72 hr after the subcutaneous
      injection, bruise was assessed in both the groups using bruise assessment scale.
    

Intervention name(s): Dry cold application; sub cutaneous injection (low molecular weight heparin)
Intervention type(s): Other; Other
Intervention description(s): Dry cold application using ice bag (Crushed ice was filled in ice bag with ½ table spoon of salt and then covered by clean linen to prevent moisture) was placed over the injection site for about 20 minutes.; sub cutaneous injection (low molecular weight heparin) has been administered on injection site
Intervention MeSH terms: Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry cold application; Pain; Bruise; Subcutaneous injection
Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events
Condition: Angina Pectoris; Coronary Artery Disease; Coronary Disease; Heart Disease; Cardiovascular Disease; Chest Pain; Pain; Signs and Symptoms; Arteriosclerosis
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Heart Diseases; Angina Pectoris; Arteriosclerosis; Chest Pain
Study type: Observational

Summary: 
      Compared with standardized western medical drug therapy, this study is mainly about whether
      the combination of standardized western medical drug therapy and Chinese medical continued
      treatment, can further decrease the rate of cardiovascular events for stable angina patients
      and change the condition of angina.
    

Detailed description: 
      We will pick 1100 patients who are according with the II、III stage in CHD western medical
      diagnosis standard, treat them with combination of standardized western medical drug therapy
      and Chinese medical continued treatment, or only with standardized western medical drug
      therapy,the treat course will last 6 months. The patients will be separated in two groups:
      Integrative treatment of Chinese medicine and western medicine group(integrative group) and
      western medical group according to the exposure factors(whether the patients accept
      differentiation of TCM ) during the follow-up period, observe the main indexes: Primary
      Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization.
      Secondary endpoint: the events needed hospitalization which are because of (acute coronary
      syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina
      symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain
      degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        treat with combination of standardized western medical drug therapy and Chinese medical
        continued treatment
      
Keywords: traditional chinese medicine; complementary therapies; traditional chinese medicine syndrome scale
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic
      treatment is safe and effective in reducing the number of acute attacks in patients with
      hereditary angioedema.
    


Intervention name(s): BCX4161; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Oral Prophylaxis
Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma
Condition: Seasonal Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to
      subjects suffering from both ragweed allergy and asthma.
    


Intervention name(s): Ragweed-SPIRE; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ragweed; Allergy; rhinoconjunctivitis; rhinitis; asthma
Stellate Ganglion Block for Major Depressive Disorder.
Condition: Treatment Resistant Depression; Major Depressive Disorder
MeSH terms: Ganglion Cysts; Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a feasibility study, to investigate a new treatment option for major depressive
      disorders by performing a Stellate Ganglion Block (SGB). A SGB is an injection of local
      anesthetic into the sympathetic nervous system (peripheral nervous system) located in the
      lower part of the neck, to relieve pain in the head, neck, upper arm, and upper chest.
    


Intervention name(s): Bupivacaine Hydrochloride; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Injection of Bupivacaine near the stellate ganglion; Injection of Normal Saline near the stellate ganglion
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Feasibility trial; Stellate Ganglion Block; Bupivacaine
A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, parallel group study will evaluate the effects of multiple
      doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male
      volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects
      assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours)
      from Day 1 to Day 17.
    


Intervention name(s): RO4602522; ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Multiple oral doses
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
Condition: HIV Infections; Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with
      hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
    

Detailed description: 
      To determine the effect of rosuvastatin on plasma lipids, lipoproteins, and endothelial
      function in HIV-infected patients on stable lopinavir/ritonavir therapy and to evaluate the
      safety of combined use of rosuvastatin and lopinavir/ritonavir. Also to determine the effect
      of lopinavir/ritonavir on the pharmacokinetics of rosuvastatin compared to historical
      controls an to determine the effect of rosuvastatin on the pk of lopinavir/ritonavir compared
      to historical controls and by intrapatient comparison.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV