bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Behavioural Therapy of Early Dementia
Condition: Dementia
MeSH terms: Dementia
Study type: Observational

Summary: 
      A randomized, controlled, parallel-group trial to evaluate the efficacy of a cognitive
      behavioral therapy for patients with early dementia.
    

Detailed description: 
      The KORDIAL study is a randomized, controlled, parallel-group trial evaluating the efficacy
      of a cognitive behavioral therapy for patients at the early stage of Alzheimer's disease. The
      3-month experimental intervention consists of 12 individual sessions with regular involvement
      of carers or other patient proxies. Strategies for improving the patient's coping ability and
      for enhancing their psychological well-being are combined. The primary outcome criterion is
      functioning in the everyday context after completion of the intervention and after another 6
      months. The control condition will be treatment as usual. The study will be conducted in 5
      university outpatient units and in 5 specialist offices.
    

Intervention name(s): Cognitive behavioral therapy for early Alzheimer's disease; Control
Intervention type(s): Behavioral; Other
Intervention description(s): 12 weekly individual sessions, total duration 3 months, regular involvement of patient's proxy ever second session. Intervention is manualized but is flexible with regard to individual resources and needs.; Patients and proxies who are assigned to treatment as usual
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to memory clinics and specialist (psychiatrist, neurologist) offices
      
Biospecimen description: 
      not required
    
Keywords: Early dementia in Alzheimer's disease (MMSE ≥ 21)
Reducing Sedentary Time in Obese Adults
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      Greater time spent in sedentary behaviors, independent of physical activity level, can
      increase risk of morbidity and mortality. Objective assessments indicate that bariatric
      surgery patients spend large amounts of time in sedentary behaviors. The present study is the
      first to test whether a mobile health (mHealth) approach that employs widely adopted
      smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible
      and acceptable method of reducing sedentary time in these patients and other obese
      populations.
    


Intervention name(s): Behavioral intervention to reduce sedentary time delivered via mobile smartphone
Intervention type(s): Behavioral
Intervention description(s): The overall goals of the intervention are to decrease overall sedentary time and to increase the number of breaks in sedentary time. The intervention approach combines an advanced smartphone device with an on-board accelerometer and a sophisticated smartphone application to: 1) monitor participants sedentary behavior in real time in their natural environment; and 2) use monitored data to deliver immediate, individually-tailored, goal-driven prompts and feedback to encourage substitute of sedentary behaviors with physical activity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sedentary behavior; Physical activity; Obesity; Mobile health; Smartphone
Clinical Trial With MSC for Graft Versus Host Disease Treatment
Condition: Acute Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Sequential administration of MSCs obtained from adipose tissue is an effective and safe
      treatment for acute graft versus host disease refractory to first-line treatment. Furthermore
      the infusion of these cells produces a biological pattern in patients that relates to the
      clinical response.
    

Detailed description: 
      Multicenter, open, non -controlled clinical trial. It is a phase I-II trial to assess the
      safety and efficacy of sequential infusion of allogeneic MSCs from adipose tissue, expanded
      "in vitro" platelet lysate in the treatment of patients undergoing hematopoietic stem cell
      trasplantation, who have developed a refractory graft versus host disease to first line of
      treatment.

      This is a prospective, multicenter, open to patients undergoing allogeneic transplantation in
      Spanish hospitals, with one cohort of patients who receive four sequential doses of MSC.
    

Intervention name(s): Adult Allogeneic Mesenchymal cells from adipose tissue.
Intervention type(s): Drug
Intervention description(s): Study treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products.
Subjects will receive four sequential IV dose of Mesenchymal stem cells.
Sequential doses:
Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg
Other intervention name(s): MSC for the treatment of graft -versus -host disease
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Leptin A-200, Caffeine/Ephedrine and Their Combination Upon Weight Loss and Body Composition in Man
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare three treatments to see which causes the most weight
      loss, fat loss, loss of stomach fat and improvement in blood tests like cholesterol.
    

Detailed description: 
      Three treatments are compared to see which causes the most weight loss, fat loss, loss of
      stomach fat and improvement in blood tests like cholesterol.

      1) Leptin A-200 injections daily with 2 inactive pills taken three times a day, 2) Caffeine
      with ephedrine pills taken 3 times a day with an inactive injection daily and 3) Both Leptin
      A-200 injections daily and caffeine with ephedrine pills taken three times a day.
    

Intervention name(s): caffeine and ephedrine; Leptin A; caffeine, ephedrine, and leptin A
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.; Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.; Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
Intervention MeSH terms: Ephedrine; Pseudoephedrine; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacogenetics of Doxazosin for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Doxazosin, an alpha 1-adrenergic receptor antagonist, may play an important role in cocaine
      addiction in humans. This study will evaluate to what extent the prospective screening for
      catecholamine related polymorphisms for alpha 1 NE receptor/transporter, COMT and DBH as main
      targets predict the treatment efficacy of doxazosin for cocaine-using behavior.
    

Detailed description: 
      The NE system, especially the alpha 1-adrenergic receptor, may play an important role in
      cocaine addiction in humans. The results of this study will provide medical safety data on
      the duration of the induction schedule that will be optimal for attaining our target dose of
      8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related
      alpha 1 receptor antagonists for cocaine addiction.

      This 16-week double-blind, placebo controlled clinical trial will provide treatment for 100
      cocaine-dependent patients and includes a 13 week medication trial (weeks 1-13) and up to 2
      week washout period(weeks 14-15). Qualifying subjects will be randomized to receive Doxazosin
      8 mg/day, or placebo during the study participation.

      Subjects will be receiving 1 mg study medication/placebo capsules at week 1, with 4mg/week
      induction rate for weeks, according to their randomized assignments, and are maintained on
      these agents through week 13. At the end of the study (weeks 14-15), participants will
      undergo discontinuation from active/placebo medication over a 2-week period. Subjects who
      wish to be transferred to an appropriate treatment program or treatment-research program will
      be helped with referral during the 2 week period (weeks 14-15).
    

Intervention name(s): Doxazosin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doxazosin is initiated at 4 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 2 weeks. Participants will be maintained on 6mg-8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15.; Matched placebo daily dosing
Other intervention name(s): Cardura (Doxazosin Mesylate); sugarpills ( Capsules)
Intervention MeSH terms: Doxazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Cocaine Dependence; Substance Related Disorders; genotype
Study of Effects of Low Level Laser Therapy in the Physical Training and the Muscle Responses in Humans.
Condition: Healthy Young Male Volunteers; Non Athletes; Free of Metabolic Disease; Joint, Bone and Muscles of Lower Limbs Free of Any Disease
MeSH terms: Metabolic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this study is that a chronic program of physical strength

      training, associates to effects of low level laser therapy (LLLT) can,

      possibly, provide changes in genic expression of muscle and to promote an

      enhancement of anaerobic muscle performance in humans.
    


Intervention name(s): Photon stimulation by low level laser therapy
Intervention type(s): Device
Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, double-blind, randomized, parallel-group study to compare the
      efficacy,pharmacodynamics (PD), pharmacokinetics (PK), safety, and immunogenicity of BAT2506
      versus Simponi® in participants with active PsA.

      The study will consist of up to 4-week Screening Period, a 52-week Treatment Period, and a
      8-week Safety Follow-up Period.
    


Intervention name(s): BAT2506; EU Simponi
Intervention type(s): Drug; Drug
Intervention description(s): 50mg/0.5mL; 50mg/0.5mL
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Schizophrenia Study In Adults
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A Placebo Controlled Study For Patients With Schizophrenia
    


Intervention name(s): talnetant; risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Talnetant; schizophrenia; NK3 receptor antagonist; psychosis
Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain
Condition: Uterine Pain
Study type: Interventional

Summary: 
      To evaluate that perioperative regular usage of propacetamol to reduce post cesarean section
      uterine contraction pain and opioid consumption
    

Detailed description: 
      The most common method of pain control after cesarean section is intravenous patient-control
      analgesia (IVPCA) with morphine. Multimodal analgesia could improve the quality of
      perioperative pain control and reduceside effects of opioids. Previous researches marked that
      perioperative pain after cesarean section includes somatic wound pain and visceral uterine
      contraction pain.

      According to Academy of Breastfeeding Medicine, propacetamol is a safe pain-killer for an
      expectant mother and almost free from breast milk after intravenous injection. This study is
      a prospective double-blind randomized-controlled trial to evaluate that propacetamol could
      reduce visceral uterine contraction pain after cesarean section. Post cesarean section women
      will divide into three groups:

        1. pain control with IVPCA for 2 days

        2. pain control with IVPCA and propacetamol 1g every 6 hours for 2 days

        3. pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
    

Intervention name(s): Propacetamol 1g; Propacetamol 2g; IVPCA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): pain control with IVPCA and propacetamol 1g every 6 hours for 2 days; pain control with IVPCA and propacetamol 2g every 6 hours for 2 days; pain control with IVPCA
Other intervention name(s): Propacetamol 1g + IVPCA; Propacetamol 2g + IVPCA; IVPCA alone
Intervention MeSH terms: Acetaminophen; Propacetamol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cesarean section; uterine contraction pain; propacetamol
Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety
      and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with
      epilepsy according to an initiation or a conversion scheme, during repeated dosing (100
      mg/administration twice daily for 4.5 days).
    

Detailed description: 
      Eligible subjects will be randomized in a 1:1:1:1 ratio to the 4 treatment arms
    

Intervention name(s): Brivaracetam tablets; Brivaracetam bolus; Brivaracetam infusion; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 100 mg, intake twice daily (BID) for 7 days during Run-In Period; 10 mL (= 100 mg) of Brivaracetam administered intravenously over 2 minutes twice daily (BID) during Evaluation Period; 10 mL (= 100 mg) of Brivaracetam diluted in 90 mL 0.9 % isotonic saline sterile solution for intravenous administration infused over 15 minutes twice daily (BID) during Evaluation Period; 100 mg twice daily (BID) for 7 days during Run-In Period
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: N01258; Brivaracetam; Epilepsy; IV; intravenous
Evaluation of Cicaplast in Subjects With Skin Irritation
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Observational

Summary: 
      The aim of this open, before/after, multicentric study is to assess the effect and tolerance
      of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked
      dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients
      are asked to apply the product at least twice a day until complete recovery (maximum 21
      days).
    

Detailed description: 
      Dermscan has implemented a quality management system which has been certified by the
      International Standards Organization (ISO 9001: 2015). This quality assurance system includes
      appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not
      involved in the audited study. A certificate of quality inspection signed by the person who
      checked the report is enclosed in each study.

      Statistical method

      Regarding the descriptive analysis, the quantitative data is summarized using the following
      statistics by time point:

        -  Number of values

        -  Mean

        -  Median

        -  Standard deviation (SD)

        -  Minimum value

        -  Maximum value.

      Are summarized in frequency (N) and percentage (%) by time point:

        -  the Investigator's Global Assessment (IGA) score assessed by the investigator using a
           6-point scale

        -  the soothing effect assessed by the subject using a 4-point scale for the parameters
           pain and pruritus

        -  each global tolerance score assessed by the investigator and by the subject using a
           4-point scale.

      The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is
      summarized using statistics for quantitative variables at each time point.

      The local signs of irritated area assessed using a 4-point scale (erythema, desquamation,
      pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time
      point and by parameter.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adults, teens and children meeting the inclusion and exclusion criteria and willing to
        adhere to the protocol and study procedures
      
Keywords: skin irritation; irritative dermatitis; superficial burn
Study to Test the Efficacy and Safety of Vafidemstat in Adult Borderline Personality Disorder Population
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      PORTICO is a Phase IIb study to evaluate the efficacy and safety of vafidemstat in an adult
      borderline personality disorder (BPD) population.
    

Detailed description: 
      PORTICO is a double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial
      to evaluate the efficacy and safety of vafidemstat in an adult borderline personality
      disorder (BPD) population.
    

Intervention name(s): vafidemstat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.2mg capsule; placebo capsule
Other intervention name(s): ORY-2001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Borderline personality disorder; vafidemstat
A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This non-randomized, single group, open-label study will investigate the mass balance, routes
      of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the
      pharmacokinetics of a 14C-labeled tracer in healthy volunteers
    


Intervention name(s): RO5424802
Intervention type(s): Drug
Intervention description(s): Single oral doses followed by IV or oral administration of a 14C-labeled tracer
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation
Condition: Tricuspid Regurgitation
MeSH terms: Tricuspid Valve Insufficiency
Study type: Observational

Summary: 
      Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without
      significant left-sided valvular or myocardial diseases.

      Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.
    

Detailed description: 
      Inclusion criteria Severe isolated TR for more than 6 months

      Exclusion criteria

        1. Severe mitral and aortic valvular heart disease

        2. Age equals to or more than 75 years

        3. Malignancy or serious comorbidity with life expectancy < 5years

        4. Acute or subacute infective endocarditis requiring antibiotics therapy

        5. Untreated hyperthyroidism

        6. Constrictive pericarditis

        7. Unclosed significant atrial septal defect

        8. Previous tricuspid valve surgery

        9. Significant coronary artery disease

       10. Cardiomyopathy

       11. Pregnancy

       12. Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without
        significant left-sided valvular or myocardial diseases.

        Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR
      
Keywords: Clinical course and prognostic factors in patients with severe isolated TR
Effects of Combining Eccentric and Aquatic Based Exercise on Muscle Function
Condition: Hydrotherapy
Study type: Interventional

Summary: 
      The study will compare the effects of eccentric resistance training versus eccentric training
      combined with aquatic plyometric training on muscle function outcomes.
    

Detailed description: 
      This study will use a parallel, randomized group design. Two groups will be randomly formed
      with one group comprising an eccentric only resistance training condition (experimental
      control) and the other comprising an eccentric combined with aquatic-based plyometrics
      condition (experimental). All subjects, regardless of group, will train on a multiple-joint
      eccentric machine one time per week for 7 weeks. The combined group will also perform an
      aquatic-based exercise session one time (on a separate day from the eccentric training) per
      week. Muscle function will be assessed via a battery of tests including jumps, sprints, and
      isometric and eccentric maximal strength.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Both arms/conditions use varying forms of exercise as the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized parallel two group design.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: plyometrics; vertical jump; depth jump; muscle strength; muscle power; eccentric training
Phytosterol Supplementation and Cardiovascular Risk
Condition: Hypercholesteremia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol
      metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12
      weeks of supplementation.
    

Detailed description: 
      This study examined the effects of 2.6 g/d of phytosterol ingestion on LDL cholesterol
      metabolism. It is expected that this dose will significantly reduce LDL cholesterol after 12
      weeks of supplementation.

      The study recruited 72 men and women 20-70 years of age with mild hypercholesteremia (>130
      mg/dl LDL-C). They were assigned to 1 of 2 groups. Participants ingested the supplement or a
      placebo for 12 weeks, with an interim assessment at 6 weeks. Participants agreed to maintain
      current diet, medication, and exercise habits and to not donate blood during the trial.
    

Intervention name(s): phytosterol
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Prevention
Keywords: LDL-C, phytosterol