bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Pharmacokinetics Study for KT07 Capsule
Condition: Healthy Adult Subjects; Pharmacokinetics; Safety and Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and
      tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part
      1 and Part 2.

      The primary objectives of Part 1 include selection of suitable PK markers for bioanalysis,
      development and validation of GLP bioanalytical methods for follow-up PK studies, assessment
      of PK of potential markers following an oral administration of KT07, and provision of PK
      sampling strategy for Part 2.

      The primary objective of Part 2 is to evaluate the PK profile following a single dose and
      multiple doses in healthy adult subjects.
    

Detailed description: 
      This is a 2-part PK study. Each Part consists of 3 phases: a 2-week screening phase, drug
      administration and PK sampling phase, then a safety follow-up visit at Day 7 after the last
      dose. Subjects enter screening at Visit 1.

      Part 1: Pilot single-dose PK Study Part 1 is an open-label study. Six (6) eligible male adult
      healthy volunteers aged between 18 to 65 years will receive a single oral dose of KT07
      capsules on Day 1.

      Part 2: Single and multiple-dose PK Study A total of 20 healthy subjects will participate in
      this part of the study, which consists of 2 cohorts with 10 subjects each. Subjects will
      receive either active treatment or placebo treatment in each cohort in a double-blind manner
      to evaluate PK and safety of KT07.
    

Intervention name(s): Low dose KT07; High dose KT07; Low dose Placebo; High dose Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 4 capsules, followed by multiple doses on Days 8-12; A single dose of 6 capsules, followed by multiple doses on Days 8-12; A single dose of 4 capsules, followed by multiple doses on Days 8-12; A single dose of 6 capsules, followed by multiple doses on Days 8-12
Other intervention name(s): Lianhua Qinwen; Lianhua Qingwen; placebo; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Phase I; Pharmacokinetics (PK); KT07
Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury
Condition: Spinal Cord Injury; Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Spasticity is the most problematic self-reported secondary medical problem in patients with
      spinal cord injury. It has the potential to negatively influence quality of life through
      restricting activities of daily living. Problematic spasticity can cause pain and fatigue,
      disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a
      negative effect on patients morbidity. For this reason there is enormous interest in
      therapeutic interventions addressing to decrease spasticity in persons with spinal cord
      injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on
      spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no
      studies are published, assessing the effect of extracorporeal shock wave therapy on focal
      spasticity in patients with spinal cord injury.

      The purpose of this study is to investigate the effect of a one-time ESWT on lower limb
      spasticity in patients with an incomplete spinal cord injury.
    


Intervention name(s): Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
Intervention type(s): Device
Intervention description(s): 2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extracorporal shock wave therapy (ESWT); spasticity; spinal cord injury
Memory Rehabilitation Strategies in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The clinical characteristics of MS are extremely variable from one patient to another. In
      about 60% of cases, motor disabilities are associated with cognitive deficits. The present
      study aims to compare three forms of cognitive / motor rehabilitation in three groups of
      patients with MS: rehabilitation of verbal memory with the Rehacom program; combined
      rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor
      rehabilitation course. Aims of the study will be: to verify whether the combined cognitive /
      motor rehabilitation can induce a significantly greater improvement in the memory performance
      of patients with MS compared to rehabilitation alone; check whether any improvement is
      objectively verifiable by patients and the impact it may have on patients' quality of life;
      monitor these effects after 6 months.

      For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed
      with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be
      divided into an initial clinical, cognitive, emotional, quality of life and functional
      self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions
      will be provided with the pre-established rehabilitation treatments for a total duration of
      12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a
      further overall reassessment will be carried out after 6 months, aimed at follow-up
      monitoring (T2).

      Statistical analyzes will be of two types:

      Within Group (aimed at assessing any improvement in the cognitive performance of each group
      of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed
      at comparing the results obtained by each group with those of the other 2 groups at T0, T1,
      and T2).
    


Intervention name(s): Cognitive Rehabilitation; Combined Rehabilitation; Motor Rehabilitation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Each patient performed two weekly sessions of 45 minutes each, for 12 weeks; Each patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks.; Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Rehabilitation; Motor Rehabilitation; Cognitive Impairment
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant in the Treatment of Major Depressive Disorders
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an
      antidepressant versus an antidepressant alone in patients with MDD with inadequate response
      to an antidepressant treatment.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine fumarate
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: MDD; Depression
Pashto Translation of Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      There is a need for a culturally adapted screening tool to aid health care professionals or
      clinicians screen for the presence of neuropathic pain associated with spinal cord injuries
      in Pashtoon population. . Since Paraplegic center Hayatabad Peshawar is a reputable institute
      for spinal cord injury patients' rehabilitation in Khyber pakhtun khwa where most of Pashto
      speaking SCI patients are rehabilitated. While working there as a physical therapist I, my
      other colleagues and patients felt a need for a screening tool for pain in Pashto language
      .So I decided to a conduct a tool validation study. This study will help the clinicians to
      assess their patient's pain type easily through the Pashto version of LANSS pain scale in
      Pashtoon population and hence will help in timely management of the pain.
    

Detailed description: 
      The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, a screening
      questionnaire for identifying patients with neuropathic pain, was developed to identify
      patients with neuropathic mechanisms dominating their pain experience. The original English
      version of the LANSS pain scale has been translated and validated in Turkish, Spanish,
      Swedish, Brazilian, Portuguese, and Chinese Mandarin languages. However, no neuropathic pain
      questionnaire including the LANSS has yet been established in Pasto language in Pakistan.

      Although these screening tools are based on descriptors, their linguistic adaptation and
      validation into different languages are feasible and this ensures their reliability and
      validity in languages other than those in which they were initially developed.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        spinal cord injury patients
      
Keywords: Pain
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
Condition: Lymphoma, Mantle-Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is
      also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients
      with mantle cell lymphoma.
    


Intervention name(s): PD-0332991
Intervention type(s): Drug
Intervention description(s): 125 mg, oral, Days 1-21 of a 28-day cycle
Intervention MeSH terms: Palbociclib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Telemonitoring in CPAP Treatment
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Wireless telemonitoring was used during the habituation phase of continuous positive airway
      pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated
      either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time,
      patient satisfaction and treatment efficiency and efficacy were compared between the groups
      at baseline and after one year treatment the CPAP adherence and treatment efficacy were
      recorded.
    

Detailed description: 
      Wireless telemonitoring was used during the habituation phase of continuous positive airway
      pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated
      either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time,
      patient satisfaction and treatment efficiency and efficacy were compared between the groups
      at baseline and after one year treatment the CPAP adherence and treatment efficacy were
      recorded.

      This study was part of our regular testing and quality assurance procedure when developing
      and revising clinical treatment protocol of sleep apnoea patients. When planning remarkable
      changes in treatment protocol we have to test whether it is feasible and cost-effective to
      change the protocol. The data was retrospectively collected from hospital records and nurses'
      notes (nursing time). According to instructions of our hospital, the Ethics Committee
      approval is not required. The approval of the hospital (Head of the Division of Medicine) for
      testing the wireless telemonitoring system of CPAP treatment was applied and received
      (Protocol Record T200/2013, diary number TO5/049/13). Written informed consent was obtained
      from those patients allocated to the telemonitoring group.
    

Intervention name(s): Telemonitoring
Intervention type(s): Device
Intervention description(s): Wireless telemonitoring
Other intervention name(s): Restraxx System (ResMed, Sydney, Australia)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep apnea; CPAP; telemonitoring; telecare
Anidulafungin in Treating Immunocompromised Children With Neutropenia
Condition: Infection; Neutropenia; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Anidulafungin may be effective in preventing fungal infections in
      immunocompromised children who have neutropenia.

      PURPOSE: This phase I/II trial is studying the side effects of anidulafungin and to see how
      well it works in preventing fungal infections in immunocompromised children with neutropenia
      caused by chemotherapy or aplastic anemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety, tolerability, and pharmacokinetics of anidulafungin in
           immunocompromised children with neutropenia.

        -  Determine the frequency of deeply invasive fungal infections in children receiving this
           drug for early empirical therapy.

      OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1
      of 2 groups according to age (2 to 11 years vs 12 to 17 years).

      Patients receive anidulafungin IV once daily over 45-120 minutes. In both groups, cohorts of
      6 patients receive escalating doses of anidulafungin. Treatment continues for up to 28 days
      or until patients recover from neutropenia or become eligible for standard empirical
      antifungal therapy in the absence of unacceptable toxicity or breakthrough fungal infection.

      Patients are followed at 7-9 days.

      PROJECTED ACCRUAL: A total of 25 patients (approximately 12 per group) were accrued for this
      study.
    

Intervention name(s): anidulafungin
Intervention type(s): Drug
Intervention MeSH terms: Anidulafungin
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: infection; neutropenia; unspecified childhood solid tumor, protocol specific
Safety, Tolerability and Activity of SRX246 in Adults With Intermittent Explosive Disorder
Condition: Intermittent Explosive Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to explore the safety and tolerability, and to compare the activity of
      SRX246 against placebo, in adults with Intermittent Explosive Disorder (IED).

      Adult Male and Female subjects with a current diagnosis of IED will be enrolled. After a
      two-week baseline lead-in phase, study subjects who continue to meet enrollment criteria will
      be randomized to either SRX246 or Placebo treatment groups.

      Study subjects will be examined and asked to answer questionnaires at weekly scheduled visits
      throughout the trial. The study results will be determined based on any changes observed over
      the study period.
    

Detailed description: 
      This exploratory Phase II study has been designed to examine the safety and tolerability
      profile, and to compare the activity of the novel V1a vasopressin antagonist (SRX246) against
      placebo, in adults with DSM-5 Intermittent Explosive Disorder (IED).

      Adult Male and Female subjects with a current DSM-5 diagnosis of IED will be enrolled. All
      subjects will undergo systematic diagnostic assessment for DSM-5 Axis I and II disorders.
      Subjects with DSM-5 IED (without current, co-morbid, DSM-5 Major Depression) whose: (a) Life
      History of Aggression (LHA) score is > 12, (b) Overt Aggression Scale Modified (OAS-M)
      "Irritability" score is > 6 and, (c) screening OAS-M "Aggression" score is > 15, will be
      entered into a two-week baseline lead-in phase.

      After the lead-in phase, study subjects who continue to meet OAS-M criteria will be
      randomized to one of the two (2) treatment conditions and stratified by gender so that equal
      numbers of males and females are assigned to SRX246 and Placebo Groups. Those who do not meet
      the criteria will exit the protocol at that time. Treatment Conditions: (a) 8-week course of
      SRX246 (4 weeks at 120 mg bid, and 4 weeks at 160 mg bid) or (b) 8-week course of Placebo,
      followed by a one-week "taper" to withdraw subjects from study medication.

      IED subjects in all conditions will have structured diagnostic interview sessions and
      questionnaires administered throughout the trial. Blinding to treatment condition will be
      maintained by using different personnel for these activities. Analysis of a change from
      baseline in the diagnostic measures will be performed.
    

Intervention name(s): SRX246; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsules
Intervention MeSH terms: SRX246
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intermittent Explosive Disorder; IED; Aggression; SRX246; Vasopressin 1a Receptor Antagonist; V1a
Modification of ESIN-osteosynthesis in a Femoral Fracture Model and Its Transmission to Clinical Practice
Condition: Femoral Fracture; Children
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional

Summary: 
      Elastic stable intramedullary nailing (ESIN) is the standard treatment for displaced
      diaphyseal femoral fractures in children. However, some literature report high complication
      rates (10-50%) in complex fractures. Data of our own patients with special emphasis on
      complications showed also mediocre results. Thus, a biomechanical study was conducted to
      search for modifications. In this study the stiffness with a 3rd nail implanted was compared
      to the classical 2 C-shaped configuration. For each of the 3 configurations of retrograde
      ESIN (titanium nails) eight composite femoral grafts (Sawbones®) with an identical spiral
      fracture were used: 2C configuration (2 C-shaped nails, 2x3.5 mm), 3CM configuration (3rd
      from antero-medial, + 1x2.5 mm) and 3CL configuration (3rd from antero-lateral, + 1x2.5 mm).
      Each group underwent biomechanical testing in 4-point bending, IRO/ERO and axial compression
      (0°/9°). Due to a significantly higher stiffness of 3CL in the anterior-posterior, internal
      rotation and 9° compression directions implantation of 3 nails became standard treatment for
      all dislocated femoral fractures at our department.

      All patients were followed prospectively. The following data was collected: Type of
      osteosynthesis, any kind of complication (additional procedures like cast or external
      fixateur, Re-Do operations, misalignment, pseudarthrosis, skin irritation, infection), time
      until full weight bearing and time until implant removal. At follow-up the legs were
      controlled for a possible length discrepancy and a possible deviation of axis. Patients'
      satisfaction was controlled by CSQ (clients satisfaction score, Larsen et al 2002). Further
      on the Harris Hip Score was used. X-ray controls were done as standard care protocol after 1
      and 3-4 months (dependend on age).

      Level of Evidence IV Keywords: Elastic stable intramedullary nailing, biomechanical testing,
      fracture, femur, treatment, children, adolescents.
    

Detailed description: 
      see above
    

Intervention name(s): 3-Nail-ESIN in femoral shaft fractures
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Elastic stable intramedullary nailing; biomechanical testing; fracture; femur; treatment; children; adolescents
Oocyte Vitrification for In Vitro Fertilization (IVF) Patients and Women With Fertility Threatening Conditions
Condition: Fertility Preservation
Study type: Observational

Summary: 
      Vitrification is a method of cryopreserving tissue for future use. It is widely used to
      preserve extra, good quality embryos generated from infertility treatments. It is becoming
      popular for the preservation of oocytes (eggs) as well, but is still considered
      investigational in this respect. The purpose of this study is to provide egg freezing for
      patients desiring fertility preservation. Although commonly used in clinics around the world,
      it should be offered as an IRB approved study procedure until it is no longer considered
      investigational by the American Society of Reproductive Medicine.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IVF patients who desire to have extra eggs, in excess of what is needed for their IVF
        cycle, or subjects requesting fertility preservation due to fertility threatening
        conditions such as cancer, advanced age or other.
      
Biospecimen description: 
      oocytes