bioihbjkbjnl/mcl2 huggingface dataset:
An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This Expanded Access Program in China is open to people with a serious skin disease called
      Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to
      people with a GPP flare-up who have no alternative treatment options. This means that no
      therapy exists and participation in a clinical study is not possible.

      Participants get a single infusion of spesolimab into a vein. They can get another spesolimab
      infusion one week after the first infusion if the doctors think it is helpful.

      Participants are in the program for about 4 months and visit the study site about 5 times.
      Participants who benefit from the treatment during that time may repeat the treatment in case
      they experience a new GPP flare-up. The doctors regularly check participants' health and take
      note of any unwanted effects.
    


Intervention name(s): spesolimab
Intervention type(s): Drug
Intervention description(s): spesolimab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome
Condition: Attention-Deficit/Hyperactivity Disorder; Tourette Syndrome
MeSH terms: Hyperkinesis; Tourette Syndrome; Syndrome; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The investigators will conduct a randomized placebo-controlled trial of a computerized
      intervention targeting working memory in 30 children with comorbid
      Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).
    

Detailed description: 
      Because impairments in executive functions (EFs), such as working memory, are associated with
      functional impairments in youth with neurodevelopmental and neuropsychiatric disorders,
      strategies that target EFs are critical. Neuroplasticity-based cognitive training has been
      found to improve cognition in youth with ADHD and in adults with schizophrenia. In this
      trial, the investigators seek to extend the relevance of computerized cognitive training to
      youth with comorbid ADHD and Tourette Syndrome. Given the literature, the investigators
      hypothesize that computerized working memory training will produce gains in untrained
      cognitive tasks and behavioral ratings of executive functions in youth with ADHD+TS. The
      investigators will assess aspects of attention and executive functions in 30 affected youth
      and randomize them 1:1 to either neuroplasticity-based cognitive training or enjoyable
      age-appropriate computer games not intended to improve cognition. Cognition will be assessed
      again after 30 training sessions over 6 weeks and then again at a one-month follow-up.
    

Intervention name(s): Targeted Cognitive Training (TCT); Youth Appropriate Online Games
Intervention type(s): Behavioral; Other
Intervention description(s): The instructors have selected a set of computer exercises designed to specifically target working memory, which is a cognitive construct relevant to ADHD and Tourette Syndrome. The tasks were designed to benefit subjects through principles of learning-dependent plasticity.; Engaging games not designed to improve cognition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attention-Deficit/Hyperactivity Disorder; Tourette Syndrome; Working Memory Training
A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
      blinded phase only will be described in this record. Participants were randomized in a 4:1
      ratio to receive GWP42003-P or matching placebo.
    


Intervention name(s): GWP42003-P 20 mg/kg/Day Dose; Placebo; Clobazam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GWP42003-P was an oral solution containing 25 mg/mL cannabidiol (CBD) or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).; Placebo oral solution contained the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).; Participants were already on a stable dose of CLB at Baseline and continued to take a stable dose of CLB for the duration of the blinded phase of the study. CLB was administered either once or twice daily in line with the physician's preferred dosing regimen for the CLB for each participant.
Other intervention name(s): CBD; Cannabidiol; Epidiolex; CLB
Intervention MeSH terms: Cannabidiol; Clobazam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabidiol; GWP42003-P; Clobazam; Epidiolex; CBD
PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of Xevinapant (Debio 1143)
      and its metabolite D-1143-MET1 as well as safety and tolerability of Xevinapant (Debio 1143)
      in healthy East Asian participants.
    


Intervention name(s): Xevinapant (Debio 1143)
Intervention type(s): Drug
Intervention description(s): All participants (Japanese and non-Japanese East Asian) will receive single oral dose of xevinapant (Debio 1143) on Day 1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: East Asian; Japanese; Pharmacokinetic; Ethnic sensitivity
Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber
Condition: Tolerance
Study type: Interventional

Summary: 
      The objective of this study is to determine the tolerance and utilization of polydextrose and
      soluble corn fiber through analyses of fecal samples of fermentative end-products
      (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.
    

Detailed description: 
      Soluble fibers have been shown to have many positive effects in humans, including laxation
      and maintaining gastrointestinal health. It is expected that feeding soluble fibers will
      decrease protein fermentative end=products while increasing carbohydrate fermenative
      end-products, and lead to a more beneficial microbial profile. Determination of the effects
      of nutriose and polydextrose when included as supplemental fiber in a human diet will give
      insights to its potential to maintain or improve gut health and highlight its use in the food
      industry.

      The object of this study are first to determine the tolerance of soluble fibers polydextrose,
      inulin and nutriose when provided as supplemental fiber to an existing diet. The second
      objective is to determine the utilization of polydextrose and nutriose through analyses of
      fecal samples of fermentative end-products and shifts in microbial populations.
    

Intervention name(s): polydextrose; soluble corn fiber
Intervention type(s): Other; Other
Intervention description(s): polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods; nutirose- 7, 14, or 21 grams/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
EEG Studies of Sevoflurane-Induced General Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are performing this research study to find out how and where the anesthetic
      drugs sevoflurane and ketamine act in the brain. Sevoflurane and ketamine are anesthetics (a
      drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness).
      The investigators will study the brain using a machine that records the brain's electrical
      activity, called an electroencephalogram (EEG).
    

Detailed description: 
      During this research study, participants will receive sevoflurane, and sevoflurane and
      ketamine together, at a high enough dose to induce general anesthesia (make study
      participants "fall asleep"). During one visit participants will receive only sevoflurane;
      during another visit participants will be given both sevoflurane and ketamine together. The
      investigators will record EEG the entire time. The investigators will also ask some questions
      related to pain and cognitive function.
    

Intervention name(s): Sevoflurane; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will received sevoflurane for approximately 60 minutes.; Subjects will received sevoflurane and ketamine for approximately 60 minutes.
Intervention MeSH terms: Ketamine; Sevoflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics and safety of single dose and multiple doses of
      desvenlafaxine in Korean healthy subjects and compare to westerners.
    


Intervention name(s): desvenlafaxine; desvenlafaxine; desvenlafaxine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days; two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: pharmacokinetics; safety; desvenlafaxine; Korean healthy subjects
Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration
Condition: End Stage Kidney Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The proposed study seeks to determine the appropriate balance between the removal of
      undesirable small molecular substances (urea, creatinine, phosphate) and large molecular
      substances (ß2-m) and the retention of important substances (e.g.albumin) for the Baxter
      Xenium XPH dialyzer type under defined therapeutic conditions of olHDF primarily concerning
      filtration flow rates in relation to blood flow/plasma water flow rates. Furthermore the
      possibility of the removal of certain protein-bound substances shall be investigated together
      with the impact of increasing ultrafiltration on the parameters of the micro-inflammation.
    

Detailed description: 
      The new high flux dialyser membrane Xenium XPH 210 from Baxter will show an considerably
      increased removal of ß2-Microglobulin with olHDF in post dilution mode together with a
      markedly increased removal of small molecules (urea, creatinine, phosphate). The loss of
      albumin will depend on the treatment modalities. However, the albumin permeability is
      tolerable over the whole range of total filtration rate selected and applied to the patients.

      Together with the albumin loss into the filtrate/dialysate a small amount of albuminbound
      substances is detectable.

      Parameters of micro-inflammation can be influenced by an increasing convective part of the
      treatment.
    

Intervention name(s): Dialyzer Baxter Xenium XPH 210
Intervention type(s): Device
Intervention description(s): High-Flux dialyzer
Other intervention name(s): Baxter Xenium XPH 210
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis; on line; postdilution; high-flux dialyzer; hemodiafiltration
Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40
Condition: Thyroid Operation Under General Anesthesia
Study type: Interventional

Summary: 
      Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely
      used, and there are many clinical trials comparing these on various aspects of anesthesia.
      However, there have not been studies comparing the quality of recovery from the different
      methods of general anesthesia. In this study, the investigators compare the functional
      recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40
      questionnaire.
    


Intervention name(s): desflurane group; TIVA group
Intervention type(s): Drug; Drug
Intervention description(s): anesthesia is maintained with desflurane and remifentanil (Desflurane group); anesthesia is maintained with fresofol and remifentanil (TIVA group).
Intervention MeSH terms: Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: desflurane, total intravenous anesthesia, QoR-40
Pharmacokinetics in End Stage Renal Disease Patients
Condition: Healthy Volunteers; Renal Failure
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of
      firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers
      and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis.
    

Detailed description: 
      It is planned to enroll a total of 28 subjects to receive a single oral dose of
      investigational medicinal product (IMP): 14 ESRD patients will be enrolled in three Hungarian
      centres (1st arm) and 14 Healthy volunteers will be enrolled by Eurofins Optimed in Gières,
      France (2nd arm).

      Subjects will be screened for eligibility to participate in the study up to 21 days prior to
      the first administration. For both arm, subjects will be admitted into the Clinical Research
      Unit (CRU) on Day -3. On the morning of Day 1, subjects will receive a single 500 mg oral
      dose of firibastat following an overnight fast (i.e., at least 10 hours). Subjects will be
      confined to the CRU until discharge on Day 3 with PK blood sample draws for measurement of
      firibastat and its main metabolites being taken throughout the confinement.

      A follow-up post study visit will occur on Day 10 post-dose to ensure the ongoing wellbeing
      of the subjects.
    

Intervention name(s): firibastat
Intervention type(s): Drug
Intervention description(s): Single oral dose of 500 mg administration on Day 1
Other intervention name(s): QGC001
Intervention MeSH terms: Firibastat
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      "Closed loop artificial pancreas" systems have been under development for the control of
      blood sugars in those living with diabetes. These systems consist of a continuous glucose
      sensor, which sends a signal to a computer program that automatically determines how much
      insulin to give. The computer program then tells an insulin pump to deliver the insulin.
      While such systems have been tested under a number of conditions, post-meal blood sugars are
      difficult to control. This study is designed to see if liraglutide, a glucagon like peptide
      receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1
      diabetes while they are on a closed loop system.
    

Detailed description: 
      Open-label, crossover study comparing the peak post-prandial glucose levels and the
      incremental post-prandial glucose area under the curve (AUC) during closed loop (CL) control
      alone and during CL control with liraglutide in an inpatient research setting. Data generated
      during outpatient baseline evaluation and liraglutide dose titration phases of the study will
      be compared to assess the short-term efficacy of this agent during open-loop continuous
      subcutaneous insulin infusion (CSII) pump treatment.
    

Intervention name(s): ePID closed loop system; liraglutide
Intervention type(s): Device; Drug
Intervention description(s): Insulin pump controlled by closed loop unit and algorithm; Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)
Condition: Chronic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast)
      compared to placebo on improved lung function in patients with chronic asthma.
    


Intervention name(s): Comparator: montelukast; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.; 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Other intervention name(s): SINGULAIR®, PROAIR® HFA
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic asthma
Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer
Condition: Unresectable Esophageal Cancer
MeSH terms: Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable
      esophageal cancer (EC). However, as high as more than 40% of EC patients experienced
      locoregional recurrence after concurrent CRT. Immunotherapy targeting the PD-1/PD-L1
      checkpoints has demonstrated promising activity in advanced EC. The aim of this study was to
      evaluate the efficacy and safety of the combination of toripalimab (an anti-PD-1 antibody)
      combined with definitive CRT in locally advanced esophageal squamous cell carcinoma (ESCC).
    


Intervention name(s): Toripalimab; Paclitaxel/Cisplatin; Intensity-modulated radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Patients received toripalimab 240 mg on days 1 and 22 during radiotherapy followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year.; Patients received 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 during radiotherapy.; All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.
Other intervention name(s): JS-001; TP; IMRT
Intervention MeSH terms: Paclitaxel; Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal squamous cell carcinoma; Definitive chemoradiotherapy; Toripalimab; Clinical complete response
Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets
Condition: Orbital Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      After people lose an eye, for whatever reason, they often experience fat atrophy of the
      tissues in the orbit. This leads to a sunken appearance that is often not correctable by a
      cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/
      invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own
      disadvantages. This study seeks to demonstrate an improvement in the retention of injected
      autologous fat by mixing in autologous PRP (platelet rich plasma).
    


Intervention name(s): autologous fat grafting with PRP to anophthalmic orbits
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anophthalmic orbits; autologous fat; platelet rich plasma; orbital atrophy; anophthalmos; cannula
Urethrocutaneous Fistula Rate After Double Dartos and Single Dartos Tubularized Incised Plate Urethroplasty
Condition: Hypospadias
MeSH terms: Hypospadias; Fistula
Study type: Interventional

Summary: 
      The subjects were divided into two groups. Each group comprised 30 children. Children were
      randomly allocated in two groups via computer generated tables. Children in group-A underwent
      single dartos tubularized incised plate urethroplasty while those in group-B underwent double
      dartos tubularized incised plate urethroplasty.
    

Detailed description: 
      In group A dartos flap is raised from foreskin of the patient and applied as a single layer
      after tubularization in between neourethra and skin . In group B dartos flap is raised from
      the foreskin of patient and divided in two equal halves.Both flaps are placed as two layers
      in between skin and neourethra.After surgery patient is kept in ward for 10 days with
      stent.Patient is followed up in OPD on after 7th day after discharge for outcome.
    

Intervention name(s): Group B; Group A
Intervention type(s): Procedure; Procedure
Intervention description(s): To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty; To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty
Other intervention name(s): Double dartos TIP; Single dartos TIP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment