bioihbjkbjnl/mcl2 huggingface dataset:
Weight Management in Mothers and Adult Daughters
Condition: Overweight or Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to develop, implement, and evaluate a behavioral weight
      management intervention with a communication training component for Mexican-American women.
      The study has three specific aims.

      Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral
      weight loss treatment using results from formative data collected from Mexican-American
      mother-daughter dyads. The adapted intervention will focus on improving dyadic communication
      and collaboration for providing reciprocal support for healthy eating and physical activity
      behaviors.

      Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter
      dyads. Dyads will be randomly assigned to partner-based treatment with or without
      communication skills training.

      Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and
      psychosocial variables with changes in measures assessing interpersonal communication.
    


Intervention name(s): Communication; Standard
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral weight management program adapted for mother-daughter dyads with communication skills training; Behavioral weight management program adapted for mother-daughter dyads without communication skills training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple
      administrations of the rotigotine transdermal system. The study was conducted in adolescent
      subjects (13 to <18 years of age) with idiopathic Restless Legs Syndrome (RLS).
    


Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention description(s): Rotigotine transdermal patch:
Dose (size): 0.5 mg/24 h (2.5 cm^2)- 1 mg/24 h (5 cm^2)- 2 mg/24 h (10 cm^2)- 3 mg/24 h (15 cm^2) The patch has to be applied continuously for 24h. After 24h, the patch has to be removed and a new one applied.
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Rotigotine; Restless Legs Syndrome; RLS; Children; Adolescents
Phase IIa Study of Multiple Doses of AbGn-168H by iv Infusion in Moderate to Severe Chronic Plaque Psoriasis Patients
Condition: Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa, randomised, double-blind, placebo-controlled, multiple dose,
      multi-center study of AbGn-168H in subjects with moderate to severe chronic plaque
      psoriasis.The objectives of this study is to investigate efficacy, safety, tolerability, and
      pharmacokinetics (PK) of multiple doses of AbGn-168H administered intravenously to patients
      with moderate to severe chronic plaque psoriasis.
    


Intervention name(s): AbGn-168H; placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis; dermatology; monoclonal antibody
Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer
Condition: Stage-Ⅱ Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin),
      fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ
      colorectal cancer.

      Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia)
      in the end of study.

      Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea,
      diarrhea vomiting over the 12 weeks.

      Safety will be evaluated including vital signs are recorded at all visits.
    

Detailed description: 
      There were 18 out of 20 patients who completed the trial and eligible for statistical
      analysis, 2 patients withdraw because the wound infection. There were 11 (61%) male patients
      and 7 (39%) female patients. The patients aged from 30 to 73 years and their mean age was
      50.4 years.

      The grade of each adverse event evaluation mainly allocated in Grade 0 and Grade 1. The
      incidence of Grade 3 or 4 was only found for the following symptoms: leucopenia, neutropenia,
      and anemia. One (6%) adverse event of leucopenia occurred at visit 1 and visit 2,
      respectively. One (6%) adverse event of neutropenia occurs at visit 1, visit 2, and visit 3,
      respectively; while 2 (13%) events occurred at visit 5. One patients suffered adverse event
      of anemia at visit 5 and visit 6.
    

Intervention name(s): Orectalip
Intervention type(s): Drug
Intervention description(s): Oxaliplatin 85mg/m2 in D5W 250 ml IV drip 2hrs on D1, Leucovorin 100mg/m2 in N/S 100ml IV drip 2hrs on D1, follow by 5-FU 2400mg/m2 IV infusion 24hrs on D1
Other intervention name(s): Fluorouracil; Leucovorin
Intervention MeSH terms: Leucovorin; Fluorouracil
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: high-risk stage-Ⅱ Colorectal Cancer,Orectalip,oxaliplatin
A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
Condition: Partial Epilepsy; Catamenial Epilepsy
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone -
      on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic
      medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females
      with catamenial epilepsy.

      Catamenial epilepsy refers to a relationship between seizure frequency and a woman's
      menstrual cycle, where the number of seizures increases around the time of a woman's
      menstrual cycle.
    


Intervention name(s): Ganaxolone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral suspension 200-500 mg 3x/day; non-active placebo
Intervention MeSH terms: Ganaxolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Partial onset seizures; Complex-partial seizures; Anticonvulsant; Partial seizures; Catamenial epilepsy
A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular Disorders
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Neuromuscular Diseases; Atrophy
Study type: Interventional

Summary: 
      The primary objective of the study is to explore the convergent validity of smartphone-based
      Konectom DOAs against in-clinic standard assessments.

      The secondary objectives of this study are to evaluate the test-retest reliability of
      smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship
      between Konectom upper limb DOAs and conventional upper limb assessments in clinical
      environments; to determine the relationship between Konectom lower limb DOAs and status of
      ambulation in clinical environments; to evaluate group differences in smartphone-based
      Konectom DOAs [self-administered at home and in-clinic] between person with spinal muscular
      atrophy (PwSMA) and healthy subjects (HS); to evaluate the variability of Konectom DOAs
      self-administered in everyday environment in HS and PwSMA; to compare Konectom DOAs between
      in-clinic supervised administration versus self-assessments in everyday environment in HS,
      PwSMA groups; to evaluate the relationship of Konectom DOAs against patient-reported outcomes
      (PROs) in PwSMA and to evaluate the clinical safety of Konectom in PwSMA.
    


Intervention name(s): Konectom NMD Application
Intervention type(s): Device
Intervention description(s): Administered as specified in the treatment arm.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Neuromuscular Diseases; Spinal Muscular Atrophy; Digital technology; Digital outcome assessments; Smartphone; Digital Biomarkers
Physical Therapy Rehabilitation Program Combined With Music on Pediatric With Lower Limb Burn
Condition: Lower Limb Burn
MeSH terms: Burns
Study type: Interventional

Summary: 
      The purpose of the current study was to evaluate the effect of physical therapy
      rehabilitation program combined with music therapy on pediatric with lower limb burn.
      Methods. A twelve-week randomized controlled study including thirty lower limb pediatric
      burned patients who randomly divided into two groups, Group(A) received physical therapy
      rehabilitation program combined with music therapy in addition to routine medical care while
      Group (B) received physical therapy rehabilitation program without music therapy. Pain was
      assessed by visual analogue scale (VAS) and range of motion (ROM) was assessed by goniometer,
      and gait assessed by GAIT Rite. Assessment was carried before and after treatment
    


Intervention name(s): Exercise with music
Intervention type(s): Other
Intervention description(s): physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Contribution of Ultrasonography in the Evaluation of Cervical Induction-delivery Time
Condition: Delivery Uterine; Birth; Induced
Study type: Interventional

Summary: 
      Study of the contribution of ultrasound measurements of the uterine cervix related to the
      calculation of Bishop score. Evaluation of the period between cervical induction and
      delivery. Study of ultrasound data to improve the care of these patients requiring induction.
    


Intervention name(s): Ultrasonography of the cervix
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Drug-drug Interaction Study With ASP1941 and Glimepiride
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of
      glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics,
      safety and pharmacodynamics of ASP1941 (Part B).
    

Detailed description: 
      Study includes two parts. Part A is to investigate the effect of multiple oral doses of
      ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of
      multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.
    

Intervention name(s): ASP1941; Glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Glimepiride; Ipragliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug interaction; ASP1941; Glimepiride; Healthy subjects
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the
      emptying of the colon and increases total colonic transit time.
    


Intervention name(s): Placebo; Solabegron (GW427353)
Intervention type(s): Drug; Drug
Other intervention name(s): Placebo
Intervention MeSH terms: Solabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: GW427353; b3-Adrenergic Receptor Agonist; Irritable Bowel Syndrome (IBS); pharmacokinetics; tolerability; gastrointestinal transit
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of the present study are to determine pharmacokinetics of ambroxol in
      healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for
      four days
    


Intervention name(s): Ambroxol - in single rising doses; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ambroxol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Astringency and Bitterness Perception
Condition: Taste Bitter-Salty
Study type: Observational

Summary: 
      The investigators are conducting a study to better understand how the average consumer
      differentiates between bitter and astringent sensations, both of which are typically
      unpleasant sensations characteristic of some healthy foods. Astringency is the dry/rough
      sensation elicited by foods such as green bananas and some wines. Although trained scientists
      can differentiate between these stimuli, untrained participants rate them similarly, despite
      their differences. This confusion has created additional barriers in understanding the
      mechanism of astringent perception, which is currently debated. Understanding how to design
      experiments where untrained participants can clearly evaluate both sensations will lay the
      foundation to better understand astringency.

      One mechanism that is believed to contribute to astringency is the interaction of astringent
      stimuli with salivary proteins. Interestingly, the salivary protein profile may be influenced
      by consumption of fruits and vegetables. Therefore, the investigators will evaluate how
      bitter and astringent perceptions differ among high and low consumers of fruits and
      vegetables by collecting saliva following exposure to the stimuli. This knowledge will inform
      approaches to increase the appeal of healthy food.
    


Intervention name(s): Astringency and bitterness perception
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will be involved in 1-4 experiments that test how they rate and differentiate between bitter and astringent flavored beverage samples
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  Not underweight (BMI > 18 kg/m^2)

          -  Not be trying to gain or lose weight

          -  Males and females 18-45

          -  No known issues with taste, smell, swallowing, choking, or salivation
      
Biospecimen description: 
      Saliva
Improvement the Anti-migraine Treatment Efficacy by Tailoring the Drug to Individual's Pain Modulation Profile
Condition: Pain
Study type: Interventional

Summary: 
      -  To delineate brain mechanisms that subserve endogenous analgesic (EA) in the healthy
           state.

        -  To identify alterations in mechanisms supporting EA in chronic pain (migraine) and their
           therapeutic relevance.
    

Detailed description: 
      The proposed research will use psychophysics and multiparametric MRI to (i) delineate the
      brain mechanisms that subserve and regulate endogenous analgesia (EA)in the healthy state and
      (ii) to identify alterations in mechanisms supporting EA in chronic pain and their
      therapeutic relevance. In both healthy subjects and chronic pain patients, EA will be probed
      using the DNIC (diffuse noxious inhibitory controls) and offset analgesia paradigms.
      Functional MRI will examine activation of brainstem mechanisms important in EA, while both
      functional and structural connectivity analyses will assess the regulation of these brainstem
      mechanisms by cerebral cortical regions involved in attention and affect. One pathological
      painful condition, migraine, will be examined since it allows changes in EA associated with
      chronic pain to be investigated between episodes of pain. Finally, EA and EA associated
      structural and functional parameters will be used to predict the efficacy of one compound,
      amitriptyline, to treat migraine in individual patients. Taken together, the proposed
      research will provide substantial insights into basic mechanisms supporting and regulating EA
      and can provide a foundation for mechanism-based individualized choice of therapy that may
      benefit all chronic pain patients.
    

Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention description(s): duloxetine 60mg once a day for 5 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Keywords: endogenous pain modulation; migraine; fMRI; duloxetine; preventive migraine treatment
Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Condition: Recurrent Calcic Urolithiasis
MeSH terms: Urolithiasis; Urinary Calculi; Kidney Calculi; Nephrolithiasis; Recurrence; Calculi; Lithiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Renalof administration promotes partial or
      total dissolution of urinary calculi and improves physicochemical parameters and metabolic
      activity in patients with recurrent calcic urolithiasis. The duration of this double-blind
      placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients
      to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters
      will be assessed every 4 weeks.
    


Intervention name(s): Renalof; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One Renalof tablet (Orally administered) three times a day (just before each meal: breakfast, lunch and dinner), for 12 weeks; One Placebo tablet (Orally administered) three time a day (just before each meal: breakfast, lunch and dinner), for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dietary supplement; Renalof; Recurrent calcic urolithiasis; Renal calculi
Add-on to Micamlo BP Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, randomised, double-blind, active-controlled, parallel-group
      comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg
      +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+
      amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the
      double-blind period in essential hypertensive patients who fail to respond adequately to
      telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a
      6-week open-label run-in period taking T80/A5 mg.
    


Intervention name(s): Telmisartan + amlodipine; hydrochlorothiazide; Telmisartan + amlodipine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): FDC tablet; tablet; FDC tablet; placebo matching hydrochlorothiazide tablet
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Regulation of Inflammatory Parameters by Telmisartan in Hypertensive Patients
Condition: Hypertension; Metabolic Syndrome; Hypertriglyceridemia
MeSH terms: Metabolic Syndrome; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A number of studies have shown that certain blood-pressure medications such as ACE-inhibitors
      and angiotensin-II-receptor blockers (ARB) can reduce the incidence of diabetes mellitus type
      2. This protocol will evaluate whether inflammatory mechanisms mediate this effect. The
      investigators therefore will investigate the effect of telmisartan, a potent ARB, on lipid
      metabolism, glucose metabolism and inflammation in patients with the metabolic syndrome.
      Specific parameters will be tested before treatment and after 3 months of treatment. Placebo
      will be compared to 2 different doses of telmisartan per day.
    


Intervention name(s): telmisartan; telmisartan; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 80 mg per day, orally, weeks 1-14; 80 mg per day; orally, weeks 1 and 2; 160 mg per day; orally, weeks 3-14; placebo; orally weeks 1-14
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether transcranial cathodal direct current
      stimulation (tDCS) delivered over the cerebellum can improve essential tremor.
    


Intervention name(s): Cathodal cerebellar transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: essential tremor; cerebellum; transcranial direct current stimulation; electrophysiology
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Condition: Pediatric Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity
      index (CAI) score and other evaluation indicators in pediatric patients with moderate to
      severe ulcerative colitis after TA-650 administration of at a dose of 5 mg/kg at weeks 0, 2,
      and 6, and then every 8 weeks at weeks 14 and 22. The safety and pharmacokinetics are also
      evaluated.
    


Intervention name(s): TA-650
Intervention type(s): Drug
Intervention description(s): TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infliximab; REMICADE; TA-650