bioihbjkbjnl/mcl2 huggingface dataset:
An Expanded Access Trial in Japan 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 trial in Japan 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.

      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 to 6
      times. The doctors regularly check participants' health and take note of any unwanted
      effects.
    


Intervention name(s): spesolimab
Intervention type(s): Drug
Intervention description(s): solution for infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of
      metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic
      renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine
      in metastatic renal cell carcinoma patients.
    


Intervention name(s): Capecitabine
Intervention type(s): Drug
Intervention description(s): 1,250 mg/m2 orally twice a day, days 1-14
Intervention MeSH terms: Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Nusinersen on Adults With Spinal Muscular Atrophy
Condition: Adult Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Observational

Summary: 
      Observational study of adult patients with spinal muscular atrophy types 2 and 3 receiving
      nusinersen
    

Detailed description: 
      Observational study to assess effects of nusinersen on motor function in adult patients with
      spinal muscular atrophy who are both ambulatory and non-ambulatory. Subjects will receive
      standard of care with nusinersen intrathecal injection and undergo baseline and every 6 month
      motor assessments and pulmonary function testing during the first two years of treatment with
      nusinersen.
    

Intervention name(s): nusinersen
Intervention type(s): Drug
Intervention description(s): Subjects will receive nusinersen and be observed with motor assessments for 24 months
Other intervention name(s): Spinraza
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The population to be studied are a homogenous group of adult subjects with 5q SMA seeking
        treatment with nusinersen. The subjects will have a broad phenotype spectrum of motor
        weakness including ability to ambulate, non-ambulatory and varying degrees of upper limb
        motor function and respiratory and swallow abilities, with some more affected and requiring
        invasive ventilation or NIV, and/or PEG tubes for nutrition.
Music Therapy/Physical Therapy Intervention to Enhance Well-being and Functional Recovery Post-stroke
Condition: Stroke With Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to see if group Music Therapy and Physical Therapy will help in
      the recovery from stroke. It is hoped that music and physical therapy in a group setting will
      help physical, mental, and social well-being.
    

Detailed description: 
      The purpose of the study is to investigate the feasibility and efficacy of an "enriched,"
      combined music therapy/physical therapy (MT/PT) rehabilitation intervention that addresses
      physical, psychological, and social well-being simultaneously in a group setting to enhance
      post-stroke recovery. The intervention will be implemented through collaboration between the
      Nordoff-Robbins Center for Music Therapy at NYU Steinhardt and the Motor Recovery Laboratory
      at the Rusk Institute of Rehabilitation Medicine, NYU Medical Center.
    

Intervention name(s): Music & Physical Therapy
Intervention type(s): Other
Intervention description(s): Participants will receive combined Music Therapy and Physical Therapy for 6 Weeks. Two times per week for 1 hour.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rehabilitation; Fingers; Grasp; Strength; Brain Function; Physiopathology; Functional Laterality; Psychomotor Performance; Biomechanis; Touch; Music Therapy; Weight-Bearing
Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate the effect of intraoperative methadone on postoperative
      analgesic requirements, pain scores and patient satisfaction in comparison to standard
      intraoperative pain control with fentanyl.
    

Detailed description: 
      Patients of both genders and up to age 75 and ASA classification III were enrolled, when
      undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general
      anaesthesia. Patients were randomized to receive either a single shot of methadone (0.2mg/kg)
      or fentanyl (0.003mg/kg) for induction of anesthesia. In cases of insufficient intraoperative
      analgesia repeated fentanyl administration was possible. Postoperative analgesia was provided
      with patient controlled morphine in both groups (PCA = Patient Controlled Analgesia). Pain
      was assessed using the numerical rating scale (NRS) at rest and after coughing, at 15 minutes
      post extubation, and repeated every 6 hours up to 72 hours postoperatively. The levels of
      sedation and nausea/vomiting were also evaluated in parallel.
    

Intervention name(s): Methadone
Intervention type(s): Drug
Intervention description(s): methadone for control postoperative pain
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: methadone; postoperative pain; acute pain therapy; postoperative pain therapy
Effects of Garlic Supplements on Drug Metabolism
Condition: Healthy
Study type: Observational

Summary: 
      This study will determine whether garlic supplements affect the way certain drugs are
      processed in the body.
    

Detailed description: 
      Garlic supplements, which are often used to lower cholesterol and prevent cancer, are one of
      the most commonly used herbal products in the United States.

      However, little is known about the way garlic supplements may interact with prescription
      medications when used simultaneously. This study will investigate four commonly used garlic
      supplements: garlic powder with a low content of allicin (a compound with antibacterial
      properties), garlic powder with a high allicin content, garlic oil, and aged garlic. The
      effects of these 4 garlic products on the drug-metabolizing enzyme cytochrome P450 (CYP) and
      a drug transporter, P-glycoprotein (Pgp) will be examined.

      Participants will be randomly assigned to receive one of the four garlic supplements for 4
      weeks. Drug probes of CYP and Pgp will be used to assess the in vivo activities of the
      substances. On the first day of garlic ingestion, blood collection will occur immediately
      after participants ingest their garlic supplement and 3, 4, and 6 hours after ingestion.
      Urine collection will occur immediately after participants' first garlic ingestion and 12,
      15, and 72 hours after ingestion. Blood and urine collection will determine the concentration
      of the drug probes in the body, which will indicate changes in CYP and Pgp. Blood and urine
      tests will be repeated at the end of the study.
    

Intervention name(s): Garlic powder with high allicin content; Garlic powder with low allicin content; Garlic oil; Aged garlic
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Allicin; Allyl sulfide
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Whole blood, urine
    
Keywords: Drug Interactions; Pharmacokinetics; Garlic; Complementary Therapies; Complementary and Alternative Medicine
Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy of an infusion of Ronopterin (VAS203) on clinical outcome
      in patients with moderate and severe traumatic brain injury. Half of the participants will
      receive Ronopterin (VAS203), while the other half will receive placebo.
    

Detailed description: 
      Severe and moderate traumatic brain injury (TBI) constitutes a major health problem. TBI is
      the leading cause of death and disability among young adults in developed countries, and the
      incidence in the elderly population is increasing.

      Neurological damage after TBI is caused not only by the accident itself, but evolves
      afterwards. The posttraumatic secondary injury includes - among others - inflammation and
      oedema formation with subsequent increase of intracranial pressure. A key molecule in these
      processes is the gas nitric oxide, which is produced in excess during neuroinflammation.

      Ronopterin (VAS203) is an inhibitor of nitric oxide synthase. Ronopterin reduces excess
      nitric oxide production and subsequent secondary injury.
    

Intervention name(s): VAS203; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Treatment; Placebo
Other intervention name(s): Ronopterin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery
Condition: Colorectal Resection
MeSH terms: Infections; Surgical Wound Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors,
      surgical site infections (SSI) remain the most frequent complication of colorectal resection
      (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of
      local antimicrobial agents seems successful.

      The primary aim of the present trial was to evaluate the efficacy of a surgical suture,
      coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after
      colorectal operations.
    

Detailed description: 
      This was a non-sponsored, multicenter, prospective, randomized, controlled, single-blind
      study. Two hundred and seventy-three patients candidate to colorectal resection were
      enrolled. Exclusion criteria were: age < 18 or > 85 years, pregnancy, peritonitis, peritoneal
      contamination during operation, ongoing infections, ASA score > 3, denied consent.

      135 were randomized to the treatment arm and 136 to the control arm. Treatment consisted of
      abdominal wound closure by suturing peritoneum, fascia, subcutaneous tissue, and skin with
      Polyglactin 910 Triclosan-coated suture (treatment arm) or with Polyglactin without Triclosan
      (control arm). SSI were defined according to the Atlanta CDC. Patients were followed up by
      office visits for 30 days after discharge.
    

Intervention name(s): Triclosan coated suture; regular suture
Intervention type(s): Device; Device
Intervention description(s): The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture; The control arm will have the abdominal wound sutured with a regular non-coated suture
Intervention MeSH terms: Triclosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: triclosan; colorectal; surgery; surgical site infection
To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart
Condition: Chronic Obstructive Pulmonary Disease; Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to evaluate the effect of AZD3199 on the electrical
      activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic
      (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known.
      Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will
      also be assessed.
    


Intervention name(s): AZD3199; Moxifloxacin; Placebo comparator
Intervention type(s): Drug; Drug; Other
Intervention description(s): Single dose, oral inhalation; Single dose, oral encapsulated tablet; Single dose, oral inhalation
Other intervention name(s): Avelox®
Intervention MeSH terms: Moxifloxacin; AZD-3199
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Respiratory disease; Bronchiolitis; Emphysema; Lung disease causing persistent narrowing of the airways
Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
Condition: Hyperemesis Gravidarum; Temperament; Morning Sickness
MeSH terms: Hyperemesis Gravidarum; Morning Sickness; Vomiting
Study type: Interventional

Summary: 
      In this study, the investigators aimed to research the relationship between affective
      temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The
      investigators aimed to assess temperament differences between healthy pregnant women and
      pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.
    


Intervention name(s): TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Intervention type(s): Other
Intervention description(s): Participants filled out the TEMPS-A survey at their first visit.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of Xisimin (loratadine) compared
      with Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under
      fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.
    


Intervention name(s): Loratadine (Xisimin [Test Treatment]); Loratadine (Clarityne [Reference Treatment])
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.; Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.
Other intervention name(s): JNJ-1754415-AAA
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
An Adaptive Design Trial Of GW274150 In The Treatment Of Acute Migraine
Condition: Migraine Disorders; Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Nitric oxide (NO) is likely to be involved in the development of migraine headache. Nitric
      oxide synthase (NOS) is an important chemical involved in the production of NO. Reduction of
      NOS, and therefore NO, may be an effective technique for the treatment of migraine headache.
      GW274150 is a highly selective inhibitor of NOS and offers the potential of anti-inflammatory
      activity in migraine through a novel mechanism of action. The intent of this study is to
      investigate the safety and efficacy of GW274150 for the acute treatment of migraine headache.
    


Intervention name(s): GW274150
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: GW274150; Nitric Oxide; acute migraine
Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pancreatic islets are the part of the pancreas that produce insulin and help control the
      blood sugar. This study aims to improve islet transplantation as a treatment for Type 1
      Diabetes by using a new combination of immunosuppressive drugs that have been successful in
      treating other autoimmune diseases and in preventing kidney transplant rejection.
    

Detailed description: 
      The primary objective of these studies is to assess the efficacy and safety of allogeneic
      pancreatic islet transplantation in the treatment of type I diabetes mellitus. A secondary
      study objective is to evaluate the efficacy of various immunosuppressive protocols and agents
      in preventing autoimmune destruction and rejection of allogeneic islet transplants. A
      tertiary objective is to determine the safety and efficacy of allogeneic pancreatic islet
      transplantation in patients who have received another organ transplant such as a kidney or
      liver.
    

Intervention name(s): Belatacept and Raptiva
Intervention type(s): Drug
Intervention description(s): immunosuppressant agent to prevent rejection in transplant recipients
Other intervention name(s): immunosuppressant
Intervention MeSH terms: Abatacept; Immunosuppressive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was intended to assess the safety, efficacy, and response to treatment using the
      American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to
      investigate a potential biomarker profile in adult patients with established rheumatoid
      arthritis
    


Intervention name(s): ACZ885 (investigational); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The ACZ885 was supplied in 6 mL colorless glass vials each containing nominally 150 mg ACZ885 (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.; Matching placebo of ACZ885 was supplied in the form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.
Other intervention name(s): Canakinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
A Study Looking Into the Effect of NNC 55-0414 in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. A seven day dose escalation study in subjects with type 2
      diabetes.
    


Intervention name(s): NNC 55-0414
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exercise for Subacromial Pain Syndrome
Condition: Subacromial Pain Syndrome
MeSH terms: Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      This study evaluates the effect of Heavy Slow Resistance exercise (HSR) exercise in
      comparison with traditional supervised exercise as treatment for patients with subacromial
      shoulder pain. The purpose is to evaluate if HSR is feasible fir these patients, and compare
      its effect to traditional exercise at pain and function of the shoulder. One half will
      complete the heavy slow resistance exercise, the other will complete the conventional
      exercise.
    


Intervention name(s): Different exercise
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Condition: Advanced or Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor
      receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The
      investigators' phase I study has shown that the drug's toxicity is manageable and the maximum
      tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib
      can improve progression free survival or overall survival compared with placebo in patients
      with metastatic gastric carcinoma who failed two lines of chemotherapy.
    


Intervention name(s): apatinib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent; placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment