bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
Condition: Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to
      investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes
    


Intervention name(s): saxagliptin; saxagliptin; saxagliptin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): orally administration at 1 mg once a day for 12 weeks; orally administration at 2.5 mg once a day for 12 weeks; orally administration at 5 mg once a day for 12 weeks; orally administration once a day for 12 weeks
Intervention MeSH terms: Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Effect of Renal Function on the Single-Dose Pharmacokinetics of BAY 43-9006
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 400 mg (2 x 200 mg tablets) sorafenib single dose, open-label study being conducted
      to compare the pharmacokinetics of plasma and urine and safety of sorafenib in subjects with
      severe, moderate, and mild renal impairment with those exhibiting normal renal function.
    


Intervention name(s): Sorafenib (BAY43-9006, Nexavar)
Intervention type(s): Drug
Intervention description(s): All subjects were given a open-label, single dose of 400mg sorafenib
Intervention MeSH terms: Sorafenib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
Condition: Heart Failure With Preserved Ejection Fraction (HFpEF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and
      tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who have been
      stabilized and initiated at the time of or within 30 days post-decompensation.
    

Detailed description: 
      The purpose of this study is to assess the effect of sacubitril/valsartan vs. valsartan on
      changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF
      decompensation) who have been stabilized and initiated at the time of or within 30 days
      post-decompensation
    

Intervention name(s): sacubitril/valsartan; valsartan
Intervention type(s): Drug; Drug
Intervention description(s): Sacubitril/valsartan (LCZ696) is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period.
Valsartan matching placebo is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period.; Valsartan is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period.
Sacubitril/valsartan (LCZ696) matching placebo is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period.
Other intervention name(s): LCZ696
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart failure with preserved ejection fraction (HFpEF); Heart failure hospitalization; NYHA; NT-proBNP; Acute decompensated heart failure; Sacubitril/valsartan; Global evaluation of treatment effectiveness (GETE); Worsening Heart Failure
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an single dose,two-way, crossover, oral bioequivalence study.
    

Detailed description: 
      The study was an single dose, two-way crossover, oral bioequivalence study of Lamotrigine
      tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL®
      tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fasting
      condition. 26 subjects (19 men and 7 womens) are enrolled and completed the study. The
      washout period is 14 days between the two periods of the study.
    

Intervention name(s): Lamotrigine; Lamictal®
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine Tablets 200 mg; Lamictal® 200 mg Tablets
Other intervention name(s): Lamictal® 200 mg
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Lamotrigine; crossover
Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures
Condition: Bone Fracture; Tibia Fractures
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Africa, Europe and Middle East. This trial investigates the
      efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to
      placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the
      first part, the patients will be evaluated with regard to efficacy (fracture healing) and
      safety at short time intervals until week 24 post-surgery. In the second part, long-term
      safety and fracture healing up to 12 months post-surgery will be evaluated.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients
Condition: HIV Infection
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people
      are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more
      likely to be diagnosed with opportunistic infections, their risk of death is higher and their
      rate of immunological improvement is slower (Mussini C et al., 2008). These patients often
      present a real challenge due to their advanced clinical status (Borghi V et al., 2008).
      Unfortunately, little is known about the clinical presentation of these patients, their
      responses to antiretroviral treatment and especially about the changes in the adaptive and
      innate immunity of the GALT.
    

Detailed description: 
      The investigator proposes to evaluate the virological, immunological and clinical outcomes of
      ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the
      longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and
      peripheral blood of HIV infected patients under ART. In particular the investigators want to
      longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels
      of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by
      real-time PCR and correlate these data with laboratory and clinical parameters.

      The investigators expect that this longitudinal study and experiments outlined in the
      protocol will provide valuable information about several important issues of the clinical
      outcome of patients under ART as well as understanding immunopathology during HIV-infection.
    

Intervention name(s): colonoscopy with endoscopic biopsies
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        prospective longitudinal non- controlled phase IV study, 30 patients
      
Biospecimen description: 
      Endoscopic biopsies, PBMC
    
Keywords: HIV; GALT
Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Condition: Pediatric Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, open label, active-controlled, randomized safety and dose finding study
      of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth
      hormone deficient children.
    


Intervention name(s): MOD-4023; Somatropin
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly subcutaneous injection; Once daily subcutaneous injection of Genotropin
Other intervention name(s): Genotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GHD; r-hGH; Long-acting
Do Self-Rated Performance Status Scores Correlate With Health-Care-Provider-Scores?
Condition: Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to determine if patients are able to self-rate their physical
      abilities and how these ratings compare to the ratings of their health-care provider.
    

Detailed description: 
      The Karnofsky Performance Scale (KPS) is a highly validated and essential measuring tool
      across the cancer population. The scale relates to purely physical ability and covers 11
      stages, ranging from normal health to death, with each stage scored as a percentage. The
      score is determined by the health-care provider and is based on observation and narrative
      patient descriptions. The purpose of this study is to compare the scores rated by the
      health-care provider to the scores that patients assign to themselves.
    

Intervention name(s): Karnofsky Performance Status Score
Intervention type(s): Other
Intervention description(s): Karnofsky Performance Status scores will be independently completed by both the patient and their health-care provider at each routine clinic visit.
Other intervention name(s): Performance Status Scale
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: QOL; Quality of Life; KPS; Karnofsky Performance Status; Cancer
Continuous Subcutaneous Infusion of Pramlintide and Insulin
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if giving the study drug in a slow and steady dose will
      lower blood sugars during the meal and after-meal time.
    

Detailed description: 
      The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control
      for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term health
      problems. Insulin management is aimed to control blood sugar as near to normal as safely
      possible. However, the possibility of low blood sugars still remains. Low blood sugars the
      major limiting factor in gaining "tight" control of blood sugar. Insulin (the hormone that
      lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping
      this careful balance. There is a lack of insulin and failure of glucagon to work correctly in
      diabetes. This leads to high blood sugars right after a meal.

      It is very difficult to have normal blood sugars when someone has diabetes. This may be due
      to another hormone called amylin. This hormone may be too low in people with Type 1 diabetes.
      Amylin is made in the pancreas (the part of the body that makes insulin). Amylin works by
      lowering blood sugars after a meal. Pramlintide is the name of the study drug. It is the
      man-made form of amylin. It is given as a shot (under the skin) like insulin. Pramlintide has
      been FDA approved.

      Studies in adults have shown that amylin lowers the high levels of glucagon made after a
      meal. This results in improved "after meal" high blood sugars and overall blood sugar
      control. Currently, the drug is given as a separate shot from insulin. When given as a shot
      (one dose shot given all at once) to children and young adults, it seems to cause low blood
      sugars right after a meal. The "slowing down" of food digestion may be the cause of the low
      blood sugars with pramlintide use. Another possible cause of the low blood sugars may be the
      way drug is being given (instant shot versus a slow infusion through a pump).
    

Intervention name(s): Pramlintide
Intervention type(s): Drug
Intervention description(s): Basal and bolus pramlintide subcutaneous infusion
Other intervention name(s): Symlin
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; hypoglycemia; hyperglycemia
Randomized Controlled Trial Comparing Transanal Doppler-guided Arterial Ligation With Mucopexy and Stapled Haemorrhoidopexy
Condition: Symptomatic Haemorrhoidal Disease Requiring Surgical Management
Study type: Interventional
Phase: Phase 3

Summary: 
      This multicentre RCT aims to compare two surgical treatments of haemorrhoidal disease:
      doppler-guided arterial ligation with mucopexy (DGALM) and stapled haemorrhoidopexy according
      to Longo (SH). The hypothesis of the trial is that the DGALM is at a lesser risk and is more
      cost-effective than SH. With a large number of patients managed in more than 20 centres, we
      aim to demonstrate that DGALM has a lower morbidity than SH when treating haemorrhoidal
      disease. At a lower postoperative risk and a lower risk of sequelae, the DGALM would
      demonstrate to be cost-effective for health care system and attractive for patients.
    


Intervention name(s): doppler-guided arterial ligation with mucopexy; stapled haemorrhoidopexy according to Longo
Intervention type(s): Device; Device
Intervention description(s): doppler-guided arterial ligation with mucopexy; stapled haemorrhoidopexy according to Longo
Other intervention name(s): THD; AMI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Haemorrhoids, Surgery, Cost-effectiveness, Morbidity, Risk assessment,RCT, Stapled haemorrhoidopexy, Doppler-guided, Haemorrhoidal artery ligation, Outcome
Performance Developement of Patients With Paraplegia During First Rehabilitation
Condition: Physical Activity
MeSH terms: Paraplegia
Study type: Observational

Summary: 
      A high physical fitness is crucial for a good quality of life in persons suffering from a
      spinal cord injury. The aim of the present observational study is to investigate the
      influence of an individually tailored 8-week endurance training program on endurance
      performance of patients with a paraplegia during their first rehabilitation.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): As this is an observational study, we will only supervise testing and training sessions which were performed anyway during first rehabilitation as daily therapeutic routine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a paraplegia during the first rehabilitation
French Study to Highlight the Unmet Treatment Needs of 3L+ CP-CML and With T315I-mutated CML Patients
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Observational

Summary: 
      A retrospective multi-center cohort study design was used to address the study objectives,
      using medical records obtained from three clinical centers in France.
    

Detailed description: 
      The index date for patients in the 3L cohort was defined as the date of initiation of 3L
      therapy. The index date for the T315I cohort was defined as the date of treatment initiation
      with TKI or allogeneic stem cell transplantation (allo-SCT) after identification of T315I
      mutation status. The baseline (i.e., pre-index) period was defined as the 6 months prior to
      the index date, and the post-index period was defined as the time from the index date to the
      date of last patient contact or patient death. Patients who were alive at the end of the
      follow-up period were censored at the date of last contact.
    

Intervention name(s): 3L Therapy; T315I
Intervention type(s): Other; Other
Intervention description(s): Treatments received in 3L were dasatinib, nilotinib, imatinib, ponatinib, bosutinib, and allo-SCT; Patients with chronic myeloid leukemia with T315I mutation
Other intervention name(s): third-line treatment
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study included CML-CP patients (i.e., 3L patients and patients with T315I mutation) who
        met the eligibility criteria
      
Keywords: BCR::ABL,; Chronic myeloid leukemia,; Tyrosine kinase inhibitor,; T315I mutation
Pain Classification in Caregivers for Children With Cerebral Palsy
Condition: Chronic Pain; Cerebral Palsy; Musculoskeletal Pain; Caregivers
MeSH terms: Musculoskeletal Pain; Cerebral Palsy; Chronic Pain
Study type: Observational

Summary: 
      The care of children with Cerebral Palsy is a process that continues for many years.
      Individuals who take care of them experience musculoskeletal pain due to the difficulties
      they experience and face pain that becomes chronic over time. For individuals who take care
      of children with CP, determining the types of chronic pain is important in order to clarify
      the classification criteria and for individuals to reach better living standards by tailoring
      the treatments they will receive. Therefore, the aim of the study is to determine the types
      of chronic pain in caregivers for children with cerebral palsy.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The convenience sampling will implement for this cross-sectional study. Caregivers for
        children with Cerebral palsy chronic pain who presented at the different Educational and
        Rehabilitation Center in Kutahya will screen for eligibility by a clinician and will
        subsequently request to participate in this study.
      
Keywords: chronic pain
The Effect of Perineural Dextrose Injection in Patients With Ulnar Neuropathy at the Elbow
Condition: Ulnar Neuropathies
MeSH terms: Ulnar Neuropathies
Study type: Interventional

Summary: 
      Ulnar neuropathy at the elbow (UNE) is the second most common neuropathy and occurs after
      recurrent or elongated elbow flexion. Diagnosis of UNE depends on clinical symptoms, physical
      examination, and electrophysiological findings. Imaging methods such as ultrasonography (USG)
      and magnetic resonance imaging show cross-sectional area and echogenicity of ulnar nerve and
      give information about to surrounding structures around the ulnar nerve. In mild and moderate
      cases, conservative treatments are administered up to 6 months, who do not benefit from
      conservative treatment are referred to surgery. There are not many options for conservative
      treatment. Activity modification, nerve gliding exercises and night splints are conservative
      treatment methods. Steroid injection is no longer recommended. Perineural dextrose injection
      is applied in tendinopathies and entrapment neuropathies (especially carpal tunnel syndrome).
      In the literature, there is no study showing effect of perineural dextrose injection in
      patients with UNE. The investigators design a randomized, double-blind, controlled trail to
      evaluate the effect after ultrasound-guided perineural injection with 5% dextrose in patients
      with UNE.
    

Detailed description: 
      After obtaining written informed consent, patients of clinically diagnosed with UNE were
      randomized into intervention and control group. Participants in intervention group received
      one-session ultrasound-guided perineural injection with 5% dextrose and control group
      received one-session ultrasound-guided perineural injection with normal saline. No additional
      treatment after injection through the study period. The primary outcome is visual analog
      scale (VAS) and secondary outcomes include Quick-DASH (Disabilities of Arm, Shoulder and
      Hand), cross-sectional area (CSA) of the ulnar nerve, motor nerve conduction velocity and
      distal latency of the ulnar nerve. The evaluation was performed pretreatment as well as on
      the 2nd week, 1st and 3rd month after the treatment.
    

Intervention name(s): 5 cc 5% Dextrose solution; 5 cc salin
Intervention type(s): Other; Other
Intervention description(s): Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).; Ultrasound-guided perineural injection with salin (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment