bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat
Condition: Moderate or Severe Submental Fullness
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene
      phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental
      fat.
    

Detailed description: 
      This study is to determine the optimal dose and evaluate safety and efficacy of Polyene
      Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish
      improvement in the appearance of moderate to severe convexity or fullness associated with SMF
      in adults.
    

Intervention name(s): Polyene phosphatidylcholine injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.; Phosphate buffered saline placebo for injection
Other intervention name(s): AYP-101
Intervention MeSH terms: Polyene phosphatidylcholine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Apoptosis; Lipolysis; Fat reduction; Submental fat; Polyene Phosphatidylcholine
Pharmacokinetic Study to Characterize Phenotyping Metrics of the "Basel" Cocktail After CYP Induction or Inhibition
Condition: Metabolic Detoxication, Phase I
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how the pharmacokinetic profiles of each drug of a
      cocktail of six approved drugs (so-called "Basel cocktail") change when the cytochrome P450
      system is inhibited or induced.
    


Intervention name(s): Basel cocktail+(Fluconazole, Ciprofloxacin, Paroxetine); "Basel" Cocktail; Basel cocktail + Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ciprofloxacin; Rifampin; Fluconazole; Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Cytochrome; Phenotyping; Pharmacokinetics
Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function During One-lung Ventilation
Condition: Video-assisted Thoracic Surgery
Study type: Interventional

Summary: 
      The investigators used transesophageal echocardiography (TEE) to assess the change of
      pulmonary blood flow and bi-ventricular function during lung isolation. The investigators
      hypothesized that changes in pulmonary venous flow with lung isolation may be related the
      shunt fraction and oxygenation during one lung ventilation (OLV). The investigators also
      observed the cardiac function during two lung ventilation (TLV) and OLV in supine and lateral
      position by TEE.
    


Intervention name(s): transesophageal echocardiography(TEE)
Intervention type(s): Procedure
Intervention description(s): Transesophageal echocardiography examination will be performed TLV in supine and lateral position, 10, 20 and 30 min during OLV in left lateral decubitus position. By using the transesophageal echocardiography, we will evaluate the changes of pulmonary blood flow and cardiac function.
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects
Condition: Chronic Hepatitis c
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult
      Subjects.
    

Detailed description: 
      A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple
      Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium
      Tablet in Healthy Adult Subjects.
    

Intervention name(s): Kangdaprevir Sodium Tablet; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet，administered orally once daily; Tablet，administered orally once daily
Other intervention name(s): HEC84048Na; HEC84048Na matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in
      nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary
      intervention (PCI) procedure.
    

Detailed description: 
      Coronary artery dissection is a contraindication for the use of rotational atherectomy, since
      rotational atherectomy may propagate coronary dissection. In the presence of coronary
      dissection, conservative management is suggested for approximately 4 weeks to permit the
      dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients
      have frequent angina attacks and some patients develop serious complications including abrupt
      vessel closure during this period. Thus, immediate strategies cope with coronary dissection
      induced by balloon dilation is needed for the early recovery of those patients. The present
      study was performed to compare the safety and efficacy of immediate RA and delayed RA in the
      treatment with nondilatable calcified lesion complicated by coronary dissection.
    

Intervention name(s): Immediate rotational atherectomy (RA); Delayed rotational atherectomy (RA)
Intervention type(s): Procedure; Procedure
Intervention description(s): Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.; Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotational atherectomy; Coronary dissection; Percutaneous coronary intervention; Calcification
The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study
Condition: Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid
      peroxidation and nerve growth factor.
    


Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg daily of oral rosuvastatin for 12 weeks; 100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rosuvastatin; Diabetic polyneuropathy; Nerve conduction; Oxidative stress; Nerve growth factor
A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride
      (HCl) (migalastat) and how migalastat works in participants with Fabry disease.
    

Detailed description: 
      This was a Phase 2, open-label study in male participants with Fabry disease. The study
      consisted of a 4-week screening period during which participants' genotype was assessed for
      α-galactosidase A (α-Gal A) activity in response to migalastat via an in vitro assay.
      Participants were required to have α-Gal A activity responsive to migalastat. The study
      consisted of a 12-week treatment period, followed by an optional 36-week extension period.
      Participants received migalastat 150 milligrams (mg) once every other day (QOD) for 12 weeks
      during the treatment period. Participants could then opt to participate in the extension
      period.
    

Intervention name(s): migalastat HCl
Intervention type(s): Drug
Other intervention name(s): AT1001; Galafold; migalastat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; AT1001; Galafold; Migalastat; Substrate
Budesonide for Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Eosinophilic Esophagitis (EE) is a chronic, T-helper 2 cell (TH2) - type inflammatory
      disorder of the esophagus with a rapidly increasing prevalence. Studies analyzing the natural
      course of EE provide strong evidence, that the chronic inflammation leads to irreversible
      structural changes in the esophagus with a loss of the mucosal elasticity and a fibrosis of
      the sub-epithelial esophageal layers with a concomitant risk of impairment in function.

      Treatment strategies in chronic inflammations have, in general, two main goals: 1) Relief of
      symptoms and 2) Prevention of long-term damage of the affected organ. Until now, the
      treatment of EE is still controversial. Standard recommendations for therapy of this chronic
      eosinophilic inflammation include dilation, systemic or topical corticosteroids and
      leukotriene antagonists. Several of these reports demonstrate, that topical corticosteroids
      may be effective for symptom control as well as for down-regulating the local inflammation.
      Furthermore it has been demonstrated, that treatment with topical corticosteroids is as
      effective as oral prednisone. However, the majority of therapeutic recommendations are based
      on clinical observations, case reports or small case series.

      The purpose of this study is the evaluation of the efficacy and the safety of a monotherapy
      with a topical corticosteroid as short-term induction-treatment and as long-term,
      maintenance-treatment compared with placebo, in the treatment of adult patients with active
      EE.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, single center clinical trial to evaluate the
      efficacy and safety of topically applied Budesonide in the treatment of adult patients with
      Eosinophilic Esophagitis.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Eosinophilic Esophagitis; Budesonide
Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis
Condition: Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      The present study aims to compare the efficacy of assisted rehabilitation treatment, in terms
      of improvement of pain and shoulder articulation, in patients with stage 2 adhesive
      capsulitis compared with unassisted home rehabilitation treatment. This evaluation is
      performed following the glenohumeral capsular hydrodistension procedure performed under
      ultrasound monitoring.
    


Intervention name(s): Hospital-assisted Rehabilitation; Home-based Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Patients are assisted by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition and abduction.; Patients were educated by a physical therapist to perform commuting exercises and active and passive mobilization of the glenohumeral joint in anterior elevation, external rotation, internal rotation, retroposition, and abduction, which they perform at home independently.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Shoulder; Adhesive Capsulitis; Ultrasound
Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects
Condition: Hypertension; Diabetes Mellitus, Type 2; Blood Pressure; Obesity; Cardiac Hypertrophy; Microalbuminuria; Vascular Stiffness
MeSH terms: Cardiomegaly; Obesity; Diabetes Mellitus, Type 2; Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      New strategies trying to achieve blood pressure control and consequently reduce
      cardiovascular risk in resistant hypertensive subjects are promising. In this context, the
      SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a
      potential drug in order to impact on blood pressure levels, as well as target organ damage
      and adiposity in this high-risk population.
    

Detailed description: 
      Objective: The investigators aim to assess whether the intervention with the SGLT2 inhibitor
      -dapaglifozin - reduces PA levels, target organ damage, fat profile and change the adipokines
      levels in patients with resistant hypertension with DM2. Methods and design: This crossover
      randomized, double-blind, interventional study controlled by standard therapy will include 20
      patients with resistant hypertension and type 2 diabetes, followed in Outpatient Clinic
      specialized in Resistant Hypertension at clinical Hospital-UNICAMP. They will be randomly
      assigned into two groups (1) initially treated with dapagliflozin in combination with their
      usual antihypertensive therapy and metformin, at 12 weeks (n = 10) or group (2) Control
      initially treated with glibenclamide at a dose of 5mg daily in combination with
      antihypertensive therapy usual and metformin, at 12 weeks (n = 10). Office ambulatory and
      home BP measurements; anthropometric measurements, determination of vascular stiffness by
      pulse wave velocity, echocardiogram, body bioimpedance, enzyme immunoassays for the
      determination of adipokines, and lab tests to evaluate biochemical parameters will be
      performed pre- and after the use of both treatments. Glycemic parameters, and weight will be
      assessed every 4 weeks. Results and conclusion: The use of SGLT2 inhibitor in these patients
      may provide new strategies for treatment of patients with resistant hypertension.
    

Intervention name(s): Dapagliflozin 10mg; Glibenclamide 5Mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks; Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Other intervention name(s): FARXIGA®; Glibenclamide
Intervention MeSH terms: Dapagliflozin; Glyburide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-way crossover design
Masking: Single (Investigator)
Primary purpose: Treatment
One Year Drug Treatment in First-Episode Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, randomized, double-blind, multi-center study on 1 year course and treatment
      outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in
      first-episode schizophrenia.
    

Detailed description: 
      The objective of this multi-center study is to optimize the long-term treatment of patients
      with first episode schizophrenia. This investigation should contribute to the issue of
      effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic
      treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).
    

Intervention name(s): Haloperidol, Risperidone (drug)
Intervention type(s): Drug
Intervention description(s): targeted dose of 2-4 mg/day over 1 year
Intervention MeSH terms: Haloperidol; Risperidone; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; first episode; long-term treatment; typical vs. atypical neuroleptics
A Comparison of the Neurocognitive and Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels in Adults Ages 20-60 Years Old
Condition: Conditions: None. Focus: Understanding the Obesogenic Potential of Fructose Containing Sugars
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the acute and chronic effects of consumption
      fructose containing sugars and glucose in a real word setting when consumed in a manner and
      amount typical in the American diet.
    

Detailed description: 
      Detailed description (Why and How?) Fructose is known to be metabolized differently than the
      other common monosaccharides. In addition to the well know lipogenic effects, more recent
      evidence has shown that the acute changes in hormones and metabolic parameters that control
      appetite and energy regulation when with fructose consumption may promote caloric
      overconsumption and, in the long-term, weight gain and deteriorations in insulin sensitivity.
      However, fructose is rarely consumed in isolation, but instead is consumed in combination
      with other sugars (with glucose in the case of the two most common sources of fructose: high
      fructose corn syrup (HFCS) and sucrose, or as part of a mixed macronutrient meal. As such,
      the practical significance of these short-term findings of isolated monosaccharide
      consumption is limited.

      AIM 1: investigate the response to ten weeks of daily consumption of typical levels of
      different fructose containing sugars and glucose on measures of glucose and insulin
      metabolism.

      AIM 2: To investigate whether ten weeks of daily consumption changes the fat content of the
      liver, skeletal muscles or abdomen.
    

Intervention name(s): Beverage Consumption
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
The Effect of Bunsimgieum on the Chest Discomfort of Hwa-byung's Major Symptom
Condition: Hwa-byung (Disorder)
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort
      of Hwa-byung's major symptom and develope and establish pattern identification system in
      Hwa-byung.
    


Intervention name(s): mild-ex-gwarip; Placebo
Intervention type(s): Drug; Other
Intervention description(s): three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.; three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
Other intervention name(s): standard code for item: 200005689
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hwa-byung, Bunsimgi-eum(Fenxinqiyin)
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity
      focused ultrasound to target and ablate tumors. It also does not require piercing the tumor
      with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also
      have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus,
      there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback
      could replace RF and Cryo for the treatment of small renal masses where the invasiveness of
      full resection partial nephrectomy is contraindicated due to patient comorbidities.
    

Detailed description: 
      This study uses a treat and resect model where ablation is followed by a partial nephrectomy.
      This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will
      also ensure cancer safety prior validation of the HIFU device. The applied heat of HIFU
      ablation could improve hemostasis and blood loss.
    

Intervention name(s): Sonatherm 600i ablation system
Intervention type(s): Device
Intervention description(s): HIFU ablation of tumor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: carcinoma, renal cell; ablation; laparoscopic surgery; high intensity focused ultrasound