bioihbjkbjnl/mcl2 huggingface dataset:
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
Condition: Chronic Constipation With Overflow; Encopresis With Constipation and Overflow Incontinence; Hirschprung's Disease; Anorectal Malformations
MeSH terms: Anorectal Malformations; Constipation; Encopresis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of additional neuromodulation for
      treatment of chronic constipation in pediatric patients
    

Detailed description: 
      Patients are selected according to the eligibility requirements. After being informed about
      the study and potential risks of neuromodulation, all included patients and next of kin give
      written informed consent to the study.

      At baseline, patients are classified to one of the two predefined subgroups: either medical
      and behavioral therapy is extended and optimized or neuromodulatory treatment is started with
      non-invasive sacral nerve stimulation via single current and two external adhesive
      electrodes. Within 12 weeks, treatment success is evaluated in routine clinical check-ups
      (week 4/8/12) and via specialized questionnaires and bowel movement diaries. Quality of life
      is evaluated at baseline and after 12 weeks of treatment.
    

Intervention name(s): Non-invasive Neuromodulation; Medical and Behavioral Therapy
Intervention type(s): Device; Other
Intervention description(s): Sacral nerve stimulation via two adhesive electrodes (single current).; Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sacral Nerve Stimulation; Neuromodulation
Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
Condition: Type 2 Diabetes Mellitus; Inadequate Glucose Control
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie
    

Detailed description: 
      This study is a double blind, randomized, investigator initiated study on glucose-lowering
      effects and Safety of Adding 0.25 or 0.5 mg Duvie (Lobeglitazone) in Patients With Type 2
      Diabetes With Inadequate Control on Metformin and DPP-4 Inhibitor Therapy. The primary aim of
      the study is to compared changes of HbA1c between 0.25mg robeblitazone add-on group and 0.5mg
      robeglitazone add-on group.
    

Intervention name(s): duvie
Intervention type(s): Drug
Intervention description(s): take the intervention drug once daily according to the randomized groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Eggs on Postprandial Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this randomized, double-blinded, placebo-controlled, 3-way crossover pilot
      study is to determine whether eggs can favorably alter biomarkers of postprandial metabolism
      when included with other cooked breakfast foods typically selected by older Americans.
    


Intervention name(s): Eggs
Intervention type(s): Other
Intervention description(s): Comparison of a high saturated fat/low fiber meal alone, with eggs, and with a protein/cholesterol matched egg-free pudding
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the safety and effect of treatment with experimental antiviral drugs in
      combination with peginterferon alpha-2a and ribavirin in people with hepatitis C virus who
      did not respond to treatment in a previous AbbVie/Abbott combination study.
    


Intervention name(s): ABT-450/r; ABT-267; pegylated interferon alpha-2a (pegIFN); Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ABT-450 (tablets) dosed with ritonavir (capsules or tablets); ABT-267 (tablets); pegIFN alpha-2a (syringe); Ribavirin (tablets)
Other intervention name(s): ABT-450 also known as paritaprevir and r is also know as ritonavir; ABT-267 also known as ombitasvir
Intervention MeSH terms: Interferons; Ritonavir; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus (HCV); Hepatitis C Genotype 1; Chronic Hepatitis C; HCV
Effects of MDMA on Social and Emotional Processing
Condition: Drug Addiction
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine
      (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely
      used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With
      this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory
      animals, the public health implications of ecstasy use may be substantial. Certain subjective
      effects of this drug distinguish it from other stimulants, and may contribute to its
      widespread use: That is, users report that ecstasy produces profound feelings of empathy and
      closeness to others. These so-called 'empathogenic' effects, which may reflect the
      distinctive neurochemical profile of action of the drug, have yet to be characterized in
      controlled laboratory studies. The investigators propose to characterize the effects of MDMA
      on measures of social and emotional processing that may contribute to this 'empathogenic'
      profile, including measures of emotion recognition, emotional responsiveness and sociability.
      The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active
      control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin
      will be used because it appears to produce pro-social behavioral effects resembling those
      attributed to MDMA.
    


Intervention name(s): Within-subjects (MDMA); Within-subjects (oxytocin); Within-subjects (placebo)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received a single dose of MDMA (0.75, 1.5 mg/kg) on two session, oxytocin (20 IU) as an active control on one session (see second Intervention), and placebo one session (see third intervention).; This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session, MDMA on two sessions (see first Intervention), and placebo on one session (see third Intervention).; This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received placebo on one session, MDMA on two sessions (see first Intervention), and oxytocin (20 IU) on one session (see second Intervention).
Intervention MeSH terms: Oxytocin
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A First-In-Human Phase 1b Study of AmnioPul-02 in COVID-19 / Other LRTI
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial
      consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3, with from
      3 up to 6 cohorts i.e. 9-18 subjects.
    

Detailed description: 
      This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial
      consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3. After a
      minimum safety follow-up of 7 days of the last subject in each of the cohorts where a higher
      dosing level may be introduced, a decision on whether to escalate, de-escalate, or stay at
      the current dose will be taken considering safety and efficacy data from all subjects who
      have been treated at the current dose level. The trial design is an adapted version of the
      i3+3 design and will apply 3 dose levels to separate cohorts of 3 subjects. The trial will be
      restricted with respect to a maximum of 9 subjects to be exposed within a dose level, and a
      maximum of 18 subjects to be enrolled in the trial.
    

Intervention name(s): AmnioPul-02
Intervention type(s): Drug
Intervention description(s): Mesenchymal stem / stromal cells, MSC
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential Cohorts
Masking: None (Open Label)
Primary purpose: Treatment
PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy
Condition: Vitrectomy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate
      ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients
      undergoing vitrectomy for macular hole repair or epiretinal membrane peeling
    

Detailed description: 
      This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate
      the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the
      EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing
      vitrectomy for macular hole repair or epiretinal membrane peeling
    

Intervention name(s): Dexamethasone Phosphate Ophthalmic Solution
Intervention type(s): Drug
Intervention description(s): Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System
Intervention MeSH terms: Dexamethasone; Ophthalmic Solutions; Dexamethasone 21-phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of High-Dose Prednisolone (Solu Dacortin®) Treatment on Choroidal and Optic Nerve Head Blood Flow in Humans
Condition: Regional Blood Flow; Optic Disk
Study type: Interventional
Phase: Phase 4

Summary: 
      Because of their antiinflamatory effects, glucocorticoids are often used to reduce edema in
      neurologic tissue and to otherwise mitigate the consequences of neural inflammation. For
      example, high dose prednisolone treatment has been shown to be an effective therapy for
      different eye diseases including severe Graves´ Ophthalmopathy and acute optic neuritis.
      However, contradictory results exists for the influence of high dose prednisolone therapy per
      se on tissue blood flow. Thus, in the current study, we plan to investigate the effect of
      high dose, short time therapy with intravenous prednisolone in patients with optic neuritis
      and severe Graves´ Ophthalmopathy.
    


Intervention name(s): Prednisolone
Intervention type(s): Drug
Intervention MeSH terms: Prednisolone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Optic nerve head blood flow; Choroidal blood flow; Prednisolone; Graves´ Ophthalmopathy; optic neuritis
COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
Condition: COVID-19; Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; COVID-19; Respiratory Tract Infections
Study type: Interventional

Summary: 
      TAFFIX is a nasal powder spray that immediately creates a protective acidic barrier on the
      nasal mucosa against infection by inhaled viruses. The protective barrier lasts 5 hours.

      TAFFIX is approved as a medical device in Israel, intended for use to block inhaled viruses
      within the nasal cavity. In Europe, it is registered as a medical device indicated for use as
      a protective mechanical barrier against allergens and viruses (e.g., SARS-CoV-2) within the
      nasal cavity.

      TAFFIX is used as additional safety mean together with masks, hygiene, and social distancing.

      The study rationale is to evaluate whether daily use of TaffiX™ as prophylaxis will reduce
      the rate of SARS- CoV-2 infection and other upper respiratory infections, compared to the
      placebo control rate.
    

Detailed description: 
      Study Design:

      This is a 2 arms, Randomized, double blind, placebo controlled clinical trial.

      Study population:

      Subjects who, were not diagnosed with COVID-19 previously to their best knowledge and
      according to COVID-19 antibody test.

      Were not vaccinated yet against COVID-19 and will not be vaccinated during their
      participating in the study.

      Up to 1000(500 per study arm) will be enrolled for the purpose of this study.

      Study treatment:

      TaffiX™ will be used daily (up to 3 times a day, every 5 hours) in addition to the protective
      measures instructed by the Ministry of Health The control group will be administrated with
      Placebo- lactose powder for nasal application

      Participation duration:

      Up to 6 weeks

      Concomitant therpay:

      Allowed- no restriction for Concomitant Medications

      Planned interim analyses:

      When no less than 150 subjects have completed the study, an interim analysis for Efficacy and
      safety will be conducted by an independent biostatistician.

      After no less than 500 subjects, additional interim analysis for Efficacy and safety will be
      conducted by an independent biostatistician.

      Serious adverse events will be monitored by an independent safety officer on an ongoing basis
      throughout the study.

      Stop Rule:

      If the proportion of COVID-19 positive rate in the treatment group is statistically
      significantly lower than the proportion of COVID-19 positive rate in the placebo control
      group.
    

Intervention name(s): TaffiX™
Intervention type(s): Device
Intervention description(s): Personal nasal powder spray.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Upper respiratory tract infection; viruses; COVID-19; nasal; powder; prevention; SARS-CoV-2
A Bilateral Interconnected DIEP Flap Based on One Vessel Pedicle for Breast Reconstruction
Condition: Mammaplasty
Study type: Interventional

Summary: 
      Bilateral DIEP flap needs two groups of vessel pedicles. We suppose that the bilateral DIEP
      flap may survive on one vessel pedicle by means of interconnection of bilateral DIEA. This
      study is aimed to build a interconnected vessel system of bilateral DIEP flap based on one
      vessel pedicle and observe its survival in breast reconstruction.
    

Detailed description: 
      The DIEP flap have become the most common and primary choice in autogenous tissue breast
      reconstruction nowadays. In cases with inadequate abdominal soft-tissue volume or abdominal
      midline scar, the bilateral DIEP flap is needed.However, it need two groups of recipient
      vessels. So it is unavailable in cases short of two groups of recipient vessels after
      radiotherapy. This study is aimed to solve the problems by interconnecting one of the
      branches of DIEA each side. The MDCT will be used to predict the branches and perforators of
      DIEA both sides. According to the branches of DIEAs, one branch will be anastomosed with that
      on contralateral side with only one vessel pedicle preserved on one side. We believe that the
      whole flap can be completely nourished with only one vessel pedicle by means of vessel
      interconnection.
    

Intervention name(s): DIEP; Interconnected DIEP
Intervention type(s): Procedure; Procedure
Intervention description(s): flap survival, operation time, flap complications, donor site morbidity.; flap survival, operation time, flap complications, donor site morbidity.
Intervention MeSH terms: Diclofenac hydroxyethylpyrrolidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast reconstruction; DIEP; vessel pedicle
Short Term Results of Tele-Rehabilitation
Condition: COVID-19; Dyspnea
MeSH terms: COVID-19; Dyspnea
Study type: Interventional

Summary: 
      Most people who have coronavirus disease (COVID-19) recover completely without any sequelae.
      However, some patients continue to experience symptoms of COVID-19 even though their tests
      turn negative. This clinical spectrum that occurs after acute infection is called the
      post-COVID syndrome (PCS). Dyspnea, pain, decreased exercise capacity, limitations in
      activities of daily living, poor sleep quality, anxiety and depression are common symptoms in
      PCS. The aim of our study is to examine the effect of tele-rehabilitation-based exercise
      program on dyspnea, pain, functional capacity, sleep quality, anxiety and depression in
      individuals with PCS.
    


Intervention name(s): Tele-rehabillitation; Prescribed Exercise Program
Intervention type(s): Other; Other
Intervention description(s): Tele-rehabilitation program will be performed by physiotherapist two times a week for six consecutive weeks. Program including the following exercises:
Breathing exercises Aerobic exercises Flexibility Strengthening exercises; The prescribed exercise program will be performed two times a week for six consecutive weeks. Program including the following exercises:
Breathing exercises Aerobic exercises Flexibility Strengthening exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tele-rehabilitation; COVID-19
Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)
Condition: Hypercholesterolemia; Atherosclerosis
MeSH terms: Atherosclerosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin
      10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg
      daily in reducing the concentration of LDL-cholesterol (LDL-C) at endpoint after 6 weeks of
      treatment.
    


Intervention name(s): Ezetimibe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets; ezetimibe 10 mg daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily); oral tablet; ezetimibe placebo daily for 6 weeks (added to ongoing therapy with atorvastatin 10 mg daily)
Other intervention name(s): SCH 058235; Zetia
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1b study is to assess the safety and tolerability of JNJ-64565111
      in adult men and women (of non-child bearing potential) with Type 2 Diabetes Mellitus.
    


Intervention name(s): JNJ-64565111; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.; Participants will receive placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Other intervention name(s): Oxyntomodulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of Three Methods for NG Tube Placement
Condition: Unconsciousness
MeSH terms: Unconsciousness
Study type: Interventional

Summary: 
      Background and Aim: Tubular feeding is used, in patients who cannot take food through their
      mouths, but the digestive system has the ability to digest food. This method is safe and
      affordable for the patient and results in maintaining the function of the digestive system
      and reducing the risk of infection and sepsis. The purpose of this study was to compare the
      three methods of the NG tube placement in intubated patients in the emergency department of
      university-affiliated hospitals of Isfahan from2016 to 2018.

      Materials and Methods: This study was a randomized and prospective clinical trial. The
      statistical population of this study was all patients who had been referred to the emergency
      department of Al-Zahra and Ayatollah Kashani hospitals in Isfahan between2016and2018. The
      sample size was 25 in each group, and in total 75 subjects. The first group was NG tube
      insertion by the conventional method, the second group was using brake cable and the third
      group was embeddedby highwayman's hitch or draw hitch, using a silk thread. For all patients,
      demographic characteristics and possible complications were recorded. Finally, the data were
      analyzed using SPSS20 software at two statistical levels of descriptive and inferential.
    


Intervention name(s): NG tube insertion method
Intervention type(s): Procedure
Intervention description(s): a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier
Other intervention name(s): NG tube placement technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of bipolar fractional
      radiofrequency treatment via use of the Profound System to achieve skin tightening and
      contour change in lax submental (beneath the chin) tissue.
    

Detailed description: 
      This is a single-center, unblinded, non-randomized, non-controlled study designed to follow a
      total of up to 15 qualified and consenting subjects to receive one bipolar fractional
      radiofrequency microneedling treatment under an IRB approved protocol. Up to 15 subjects will
      be enrolled and treated at UT Southwestern in the Department of Plastic Surgery. Subjects
      will be identified from the clinical practice of Dr. Jeffrey Kenkel, Department of Plastic
      Surgery.
    

Intervention name(s): Dermal Handpiece
Intervention type(s): Device
Intervention description(s): Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment