bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical trial to study the efficacy and safety of an investigational drug in acutely
      psychotic people with schizophrenia. Participants in the study will either receive the drug
      being studied or a placebo. This study is accepting male and female participants between 18
      -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60
      locations world wide. The study will last up to nine (9) weeks.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating
      the efficacy and safety of two doses of SEP-363856 (75 and 100 mg/day) versus placebo over a
      6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is
      projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75
      mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. Treatment assignment will be
      stratified by country. Study drug will be taken once a day and may be taken with or without
      food.

      This study is designed to test the hypotheses that treatment with SEP-363856 in adult
      subjects with schizophrenia will result in significantly greater reduction (i.e. improvement)
      in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The
      overall Type I error is controlled for two hierarchical families of hypotheses. The first
      family includes hypotheses about the testing of change from Baseline in PANSS total score at
      Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of
      hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between
      each of the SEP-363856 dose levels vs. placebo.
    

Intervention name(s): SEP-363856 75mg; SEP-363856 100mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP-363856 75mg tablet dosed once daily; SEP-363856 100mg tablet dosed once daily; Placebo tablet dosed once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute psychosis; Schizophrenia
IL-35+Breg/Il-35 Effect on T Cell Immune in Patients With CHB
Condition: Chronic Hepatitis b
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational [Patient Registry]

Summary: 
      The investigators observed the level of IL-35 secreting B regulatory (IL-35+Bregs) cells in
      peripheral blood cells in patients with chronic hepatitis B, and analysed the relationship
      between the IL-35+Bregs level and disease stage, and Th1 and Th2 cells level.
    

Detailed description: 
      Regulatory B cells (Bregs) are involved in the immune tolerance process through multiple
      pathways and Bregs are involved in the process of chronic HBV infection.

      Here the investigators intended to investigate the regulating role and the mechanism of CD19+
      IL-35+ cells on host T cell immune during chronic HBV infection by using in vitro cell
      sorting, B cell differentiation induction, Transwell cell co-culture system and other
      methods.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic hepatitis B infection
      
Keywords: chronic hepatitis B; regulating B cells; T help 17 cells; Interleukin 35
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
Condition: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency
MeSH terms: Agammaglobulinemia; IgG Deficiency; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of
      serious bacterial infections in patients with primary immunodeficiency.

      As secondary endpoints the rate of overall infections, the tolerability and safety of
      IVIG-F10 are studied.
    


Intervention name(s): Immunoglobulins Intravenous (Human)
Intervention type(s): Drug
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunoglobulin intravenous; Agammaglobulinemia; Hypogammaglobulinemia; Common variable immunodeficiency; Immunoglobulin G; Children
The Effect of Inhibitory Kinesio Taping Application on Spasticity, Stretch Reflex and Motor Neuron Activity
Condition: Muscle Physiology
MeSH terms: Muscle Spasticity
Study type: Interventional

Summary: 
      The first aim of this study is whether the inhibitory kinesio taping application can reduce
      spasticity. The second aim of this study is to investigate whether the kinesio taping
      application have neuromodulatory activity on motor neuron and stretch reflex.

      Hypotheses of this study: unlike healthy cases, in patients with spastic hemiplegia

        1. Inhibitory kinesio taping application can reduced spasticity

        2. Inhibitory kinesio taping application can reduced motor neuron activity and stretch
           reflex
    

Detailed description: 
      This study will include 78 spastic hemiplegic patient ( 39 controlled, 39 intervention group)
      Spasticity , Soleus Hmax/Mmax, Soleus T reflex, Soleus H reflex will be evaluated in this
      study.

      Inhibitory kinesio taping method will be used in intervention group for 64-66 hours. Y shaped
      kinesio tape will be applied on spastic gastrocsoleus muscle. Sham kinesio taping method will
      be used in controlled group for 64-66 hours. 2 pieces kinesio tape 2,5 cm width, 5 cm length
      will be applied on gastrocnemius medial and lateral head, 1 piece kinesio tape 5 cm width, 5
      cm length will be applied on achilles tendon.

      Spasticity, Soleus Hmax/Mmax, Soleus T reflex and H reflex will be measured pre-application
      (T0), after-application ( in a few minutes) (T1), after 64-66 hours ( with band applied) (T2)
      and after band removed (T3). Spasticity in both groups will be evaluated with modified
      ashworth scale.
    

Intervention name(s): kinesio taping method; Sham kinesio taping
Intervention type(s): Procedure; Procedure
Intervention description(s): Kinesio tape is an elastic, adhesive, hypo-allergenic, latex-free tape. Kinesio taping method is rehabilitative taping technique. One of the purposes of this technique is to facilitate or inhibit the muscles.; Sham kinesio tape will be used for controlled group. 2,5 cm width, 5 cm length, skin color 2 pieces kinesio tape will be applied on medial and lateral head of gastrocnemius muscle without stretch. 5 cm length, 5 cm width, skin color 1 piece kinesio tape will be a
Other intervention name(s): Antispastic modality; Sham antispastic application
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention group: inhibitory kinesio taping application in spastic hemiplegic patients controlled group: sham kinesio taping application in spastic hemiplegic patients
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Spasticity; kinesio tape; stretch reflex; H-reflex; T-reflex
Unrestricted Diet for Screening Colonoscopy
Condition: Bowel Cleansing; Colonoscopy; Bowel Cancer
Study type: Interventional

Summary: 
      Colonoscopy is the technique of choice for the evaluation of the mucosa of the colon. To be
      able to do the procedure in optimal conditions, it needs to be clean. Therefore, it is
      necessary to carry out a preparation as safe and tolerable as possible. This preparation
      generally consists in a low residue diet the days before the colonoscopy and in the intake of
      a laxative solution. In previous studies, it has been shown that the low residue diet does
      not play a relevant role as it was considered before. Recent studies demonstrated that
      reducing the days of low residue diet does not worsen the cleansing and improves the patient
      experience. The results of this study are required for determining the role of diet
      restrictive diet in colon cleansing.
    


Intervention name(s): Unrestricted diet before colonoscopy; 1-day low residue diet; Bisacodyl 5 MG
Intervention type(s): Other; Other; Drug
Intervention description(s): Free diet, without restrictions; To follow a diet low in residues / fiber. the day before the colonoscopy.; If the participant is at risk of inadequate bowel cleansing, defined by a score of Dik et al ≥ 2 it will be given Bisacodyl 5 milgrams bid for 3 days.
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: bowel cleansing; Diet; Low residue diet
Kansas Intensive Permanency Project
Condition: Serious Emotional Disturbance; In Foster Care
MeSH terms: Affective Symptoms
Study type: Interventional

Summary: 
      The intervention provides services to children with Serious Emotional Disturbance (SED) who
      are in foster care and to their parent(s) to prepare the families for reunification.
    

Detailed description: 
      The intervention provide services to children with Serious Emotional Disturbance (SED) who
      are in foster care and to their birth parents to prepare the families for reunification. The
      evaluation follows a randomized design. The pretest will assess the procedures and
      instruments for collecting data on child, youth, and family functioning. Ultimately, after
      the pretest is complete, the data collected through the evaluation will provide information
      on the extent to which the intervention achieved its goal of improving parenting skills and
      enhancing readiness for reunification among the families who received the services.
    

Intervention name(s): Parent Management Training - Oregon Model (PMTO)
Intervention type(s): Other
Intervention description(s): Evidence-based, behavioral parent management training model, Parent Management Training - Oregon Model (PMTO) tailored to address permanency barriers of parents of children with SED.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Serious emotional disturbance; foster care; child protective services
Pyronaridine Artesunate-Ritonavir Drug-drug Interaction Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine any drug interaction between the
      antimalarial Pyramax (pyronaridine artesunate) and the protease inhibitor ritonavir in
      healthy subjects. The secondary objective of the study is to assess further the safety of
      Pyramax in this setting.
    

Detailed description: 
      This is a phase I, open label, randomized study to determine any drug interaction between
      Pyramax (pyronaridine/artesunate) and the protease inhibitor ritonavir in healthy volunteers.
      A total of 34 healthy volunteers (17 per treatment arm) will be enrolled in the study so that
      at least 30 (15 per treatment arm) will complete it. Subjects will be randomly assigned in a
      1:1 ratio to receive either ritonavir (100 mg) twice daily for 17 days from Day 1-17 plus
      Pyramax (180:60 mg) once daily for 3 days from Day 8-10 in Arm A or pyronaridine/artesunate
      (180:60 mg) alone once daily for 3 days from Day 1-3 in Arm B.

      Subjects will come to the clinic the evening before first dosing of Pyramax / ritonavir. If
      enrolled, and according to the treatment arm, subjects will stay in the clinic and attend
      subsequent visits as follows:

      Arm A:

        -  Inpatient day -1 (evening) to day 17

        -  Ambulatory clinic visit once daily (morning) on day 22, 29, 36, 43 and 50 (end of study
           visit)

      Arm B:

        -  Inpatient day -1 (evening) to day 4 (morning),

        -  Ambulatory clinic visit once daily (morning) on Day 5, 6, 8, 15, 22, 29, 36, and 43.(end
           of study visit) The subjects will be evaluated for pharmacokinetic parameters and
           safety/tolerability.
    

Intervention name(s): Ritonavir and Pyramax; Pyramax
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg ritonavir (one soft gelatin capsule twice per day over 17 days, the evening capsule on day 1 will be omitted) and Pyramax (pyronaridine/artesunate) 180:60 mg (3 to 4 tablets once per day according to weight for 3 days).; Pyramax (pyronaridine/artesunate) 180:60 mg (3 to 4 tablets once per day according to weight for 3 days).
Other intervention name(s): pyronaridine artesunate, PA
Intervention MeSH terms: Ritonavir; Artesunate; Pyronaridine; Pyronaridine tetraphosphate, artesunate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: malaria; artemisinin-based combination therapy (ACT); antimalarial; pyronaridine artesunate (Pyramax)
A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the effect on the exposure of BI 1584862
      in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as
      compared to BI 1584862 when given alone as oral single dose (Reference, R).
    


Intervention name(s): BI 1584862; itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): BI 1584862; itraconazole
Intervention MeSH terms: Itraconazole
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dextromethorphan in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this protocol is to evaluate if Dextromethorphan (DXM) reduces Fibromyalgia
      (FM) pain. DXM is a drug found in several over-the-counter products, including cough
      suppressants. The drug may reduce FM pain by suppressing inflammation in the central nervous
      system. The investigators will be observing the effects of DXM on daily self-reported pain
      measures in people with FM. If DXM reduces FM pain, it will provide important information
      about the nature of FM pathophysiology.
    

Detailed description: 
      Fibromyalgia (FM) is a chronic, widespread pain syndrome. Individuals with FM frequently
      report body pain, fatigue, sleep issues, cognitive impairment, headaches, and other symptoms.
      The disease affects approximately 5% of women in the United States. Many of those patients
      suffer with decreased quality of life and loss of employment.

      The precise pathological mechanism of FM is not yet understood, and there is no targeted
      treatment for the condition. One hypothesis of FM with prior scientific support is that pain
      is caused by abnormal inflammation of the brain. When microglia cells in the brain adopt an
      inflammatory state, they release chemicals that can cause neurons to increase the
      transmission of pain signals.

      DXM has been used in previous research and demonstrated to suppress pain symptoms. When given
      at higher dosages (above 200mg), the medication acts as a dissociative agent. This dosage can
      reduce pain, but produces side-effects that can limit daily functioning. At lower dosages,
      however, DXM may reduce inflammatory aspects of chronic pain while not causing dissociative
      side effects.

      In animal models, central inflammation can be reduced with intraperitoneal dosages of DXM of
      0.1mg/kg. In an average U.S. woman, this dosage would translate to approximately 8mg. Because
      an oral versus intraperitoneal dosing route will be used, the dose will be raised to 10mg,
      administered twice a day (once in the morning and once at night). The investigator will
      examine the impact of 20mg total daily DXM on self-reported FM pain.
    

Intervention name(s): Dextromethorphan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): (1)10 mg, by mouth, twice daily every 12 hours.; 1 capsule, by mouth, twice daily every 12 hours.
Intervention MeSH terms: Dextromethorphan
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Fibromyalgia
Efficacy of Botox in Patients With Idiopathic Clubfoot
Condition: Idiopathic Clubfoot (Talipes Equinovarus)
MeSH terms: Clubfoot; Talipes; Equinus Deformity
Study type: Interventional

Summary: 
      The purpose of this study was to determine the efficacy of adding Botox injection to serial
      manipulations and castings in patients with clubfoot. The study hypothesis was that the use
      of Botox in the setting of serial manipulations and castings is an effective treatment for
      clubfoot.
    

Detailed description: 
      All patients meeting the inclusion criteria will undergo manipulation and casting until
      hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees
      but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at
      10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.
    

Intervention name(s): Botox
Intervention type(s): Drug
Intervention description(s): All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy study; assessment of patient outcomes following treatment
Relation Between Muscle Strength With Exercise Capacity and Dyspnea in LTx
Condition: Lung Transplantation; Pulmonary Rehabilitation
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      Severe exercise intolerance and shortness of breath are present in lung transplant
      candidates. Clinical features that reveal these symptoms in terminal period lung patients
      vary and are unclear. The effect of peripheral muscle strength on exercise capacity and
      dyspnea will be examined in our study.
    

Detailed description: 
      Yedikule Chest Diseases Patients who have been accepted to participate in the pre-operative
      rehabilitation program at the Pulmonary Rehabilitation Unit will be included in the study. A
      6-min walk test, peripheral and respiratory muscle strength measurements, and a dyspnea
      rating scale Mmrc will be applied to the lung transplantation candidates who are trained in
      3-month hospital-based preoperative exercise training in the Pulmonary Rehabilitation unit.
      The tests will be carried out at the beginning and end of rehabilitation. At each testing
      session, the tests will be performed by the same physiotherapist. The correlations of the
      test data with each other will be analyzed.
    

Intervention name(s): Pulmonary rehabilitation
Intervention type(s): Other
Intervention description(s): A 6-min walk test, peripheral and respiratory muscle strength measurements, and a dyspnea rating scale Mmrc will be applied to the lung transplantation candidates who are trained in 3-month hospital-based preoperative exercise training in the Pulmonary Rehabilitation unit. The tests will be carried out at the beginning and end of rehabilitation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; exercise; maximal inspiratory pressure; walk test; muscle strength; dyspnea; lung transplantation
Multicenter Phase II of CD26 Using Sitagliptin for Engraftment After UBC Transplant
Condition: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Hematopoetic Myelodysplasia; Leukemia, Myelogenous, Chronic; Lymphoma, Non-Hodgkin
MeSH terms: Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this trial is to assess the efficacy and safety of sitagliptin in
      enhancing engraftment following umbilical cord blood transplantation (recovery of blood
      counts after transplant).
    

Detailed description: 
      Umbilical cord blood (UCB) is more commonly used for transplantation in children but is being
      used in adults more often. However, because adults are larger than children, the relatively
      smaller stem cell dose in UCB is major limitation for transplantation in adults and
      engraftment can be delayed. This study is trying to find out if the drug sitagliptin can be
      used to increase and speed up engraftment in adults receiving UCB transplantation.
    

Intervention name(s): Sitagliptin
Intervention type(s): Drug
Intervention description(s): Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advanced NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate Pharmacokinetics parameters of a single dose
      [14C] AC0010 in male Patients With Advanced NSCLC.
    

Detailed description: 
      The purpose of this study is to investigate the Absorption, Metabolism, Excretion and
      Pharmacokinetics of a single dose [14C] AC0010 in male Patients With Advanced NSCLC.
    

Intervention name(s): AC0010
Intervention type(s): Drug
Intervention description(s): Oral dose of 14C-labeled AC0010 suspension including 200 mg/83μCi[14C]
Other intervention name(s): 14C-labeled AC0010 oral; AC0010MA
Intervention MeSH terms: Abivertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment