bioihbjkbjnl/mcl2 huggingface dataset:
Internet-based Self-help Program for Vestibular Rehabilitation in Chronic Dizziness
Condition: Vertigo
MeSH terms: Vertigo; Dizziness
Study type: Interventional

Summary: 
      Chronic dizziness,or persistent positional perceptual dizziness (PPPS) is a common condition
      that results in impaired quality of life and work ability of those affected. Vestibular
      Rehabilitation (VR) is an evidence-based and recommended treatment for chronic dizziness. The
      treatment involves training in specific exercises that challenge the balance system and
      eventually improve dizziness. The main challenge with this treatment is that it is usually
      best provided with individual follow-up of therapists trained in the method. Limited
      resources and the lack of dissemination of this knowledge mean that only a minority of
      patients receive adequate treatment. An internet-based self-help program in vestibular
      rehabilitation has been developed in Norwegian with demonstration and instructions of
      exercises. The program has six lessons, together lasting for six weeks. Patients are given
      the opportunity to exercise at home, without the use of treatment resources and without
      spending time traveling to the treatment site. Patients will have access through their
      general practitioner or health institution at no extra cost. If it turns out that the program
      works according to the intention, the investigators will be able to offer VR to a large
      number of PPPS patients who previously would not receive treatment for their condition.

      The aim of the pilot study is to find out if the internet program for PPPS works as intended
      and evaluate incoming data and make changes to the program. In addition, the investigators
      will gain experience in using the program before designing a randomized clinical trial (RCT).
      The aim of such an RCT would be to compare this internet based treatment to traditional
      treatment.
    


Intervention name(s): Internet-based self-help program
Intervention type(s): Behavioral
Intervention description(s): The program is divided into six short weekly lessons providing information about chronic dizziness and vestibular rehabilitation, and demonstrating the exercises by video. The program is freely available in the Norwegian electronic handbook for physicians (NEL). The participants in the study will receive the internet address after inclusion in the study.
Intervention model: Single Group Assignment
Intervention model description: Consecutively recruited at Department of Neurology at Molde County hospital, outpatient clinic.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Telerehabilitation; Internet; Norway
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency, Pediatric; Endocrine System Diseases; Hormone Deficiency; Pituitary Diseases
MeSH terms: Dwarfism, Pituitary; Pituitary Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered
      once-a-week. Approximately 150 children (males and females) with growth hormone deficiency
      (GHD) will be included. All study participants will receive TransCon hGH. This is a global
      trial that will be conducted in, but not limited to, the United States, Canada, Australia,
      and New Zealand.
    


Intervention name(s): TransCon hGH
Intervention type(s): Drug
Intervention description(s): Once weekly subcutaneous injection at a starting dose of 0.24 mg/kg/week
Intervention model: Single Group Assignment
Intervention model description: All study participants will receive TransCon hGH
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Growth Hormone; hGH; GHD; rhGH; Pediatric Growth Hormone Deficiency; Long Acting Growth Hormone; Somatropin; Prodrug; Growth Failure; Growth Hormone Replacement Therapy; Sustained Release Growth Hormone; Growth Hormone Deficiency; TransCon GH
Transplantation for Patients With Chronic Lymphocytic Leukemia
Condition: Leukemia, Lymphocytic, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional

Summary: 
      To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell
      transplantation for the treatment of chronic lymphocytic leukemia.
    

Detailed description: 
      To determine effectiveness of allogeneic transplantation in eradicating chronic lymphocytic
      leukemia.
    

Intervention name(s): high dose chemotherapy then autologous hematopoietic cell transplant; ablative allogeneic hematopoietic cell transplant
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Celecoxib in Preventing Breast Cancer in At-Risk Premenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or
      recurrence of cancer. Celecoxib may be effective in preventing breast cancer in at-risk
      women.

      PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing breast cancer
      in premenopausal women who are at risk of developing cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the change in proliferation in benign breast epithelial cells as measured by
           Ki-67/MIB-1 in premenopausal women at high risk for estrogen receptor-negative breast
           cancer treated with celecoxib.

        -  Determine the feasibility of this regimen by dropout rate of these patients during 12
           months of treatment and compliance.

        -  Determine the proportion of these women likely to express cyclooxygenase-2 protein
           (COX-2) in at least 10% of benign ductal epithelial cells.

        -  Compare the success rate of obtaining adequate ductal epithelial cells by random
           periareolar fine needle aspiration (FNA) and ductal lavage in these patients before vs
           after 12 months of a prevention intervention.

        -  Assess pain associated with FNA and ductal lavage in these women.

        -  Correlate, if possible, serum proteomics pattern with cytologic assessment and
           mammographic density at baseline and at 12 months in these patients.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive oral celecoxib twice daily. Treatment continues for 12 months in the absence
      of clinical evidence of cancer confirmed by biopsy or unacceptable toxicity.

      Patients are assessed at baseline and at 12 months for mammographic breast density, serum
      hormone levels, and serum IGF-1/IGFBP-3. Patients undergo ductal lavage or fine needle
      aspiration for assessment of supernatant proteomics and breast biomarkers.

      Patients are followed at 2 weeks and then annually for 5 years.

      PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 10-14
      months.
    

Intervention name(s): celecoxib
Intervention type(s): Drug
Intervention description(s): Celecoxib daily for 12 months
Other intervention name(s): Celebrex
Intervention MeSH terms: Celecoxib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer
High-activity Natural Killer Immunotherapy for Small Metastases of Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of high-activity natural killer
      immunotherapy to small metastases of colorectal cancer.
    

Detailed description: 
      By enrolling patients with small metastases of colorectal cancer adapted to enrolled
      criteria, this study will document for the first time the safety and the short and long term
      efficacy of high-activity natural killer cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): High-activity natural killer
Intervention type(s): Biological
Intervention description(s): Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): HANK cell
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer; High-activity natural killer
Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Nitroprusside is used commonly in the Intensive Care Unit for long periods of time in order
      to reduce blood pressure. It is not known if the body compensates over time to the blood
      pressure lowering, and if when the nitroprusside is stopped the blood pressure goes up at a
      faster rate and is higher than it was at the start of the treatment. This study will answer
      these questions.
    

Detailed description: 
      This is a phase 2, multicenter, randomized, double-blind placebo-controlled, parallel group
      study to determine the persistence of the effect of SNP on blood pressure and to assess the
      potential for rebound hypertension associated with prolonged infusion in pediatric subjects.

      The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase
      in the absence of other stimuli.
    

Intervention name(s): nitroprusside; placebo infusion
Intervention type(s): Drug; Drug
Intervention description(s): nitroprusside continuous infusion, dose to be titrated to clinical effect; blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion
Other intervention name(s): Nipride
Intervention MeSH terms: Nitroprusside
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: nitroprusside; intensive care unit; hypertension; blood pressure reduction
Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic
      stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by
      intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is
      determined that each dose is safe and tolerable, the next higher dose will be given to the
      next group.
    


Intervention name(s): DS1040b; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DS-1040b in solution for intravenous infusion; Saline solution for intravenous infusion
Other intervention name(s): Investigational product; Saline solution
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fibrinolysis enhancer; TAFIa inhibitor; Developmental Phase I
Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery
Condition: Acute Pain; Post Operative Pain; Anorectal Disorder; Analgesia
MeSH terms: Rectal Diseases; Pain, Postoperative; Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Anorectal problems, such as hemorrhoids, fistula, fissures, Etc., often require surgical
      treatment. Patients often have postoperative pain after these surgeries, which increases
      discomfort and hospital length of stay. The efficacy of oral non-opioids in the treatment of
      such pain is poor. Hydromorphone is an opioid analgesic commonly used orally or intravenously
      for postoperative pain management. We designed this trial to investigate the efficacy and
      safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single
      dose hydromorphone versus intrathecal placebo in treating postoperative pain among human
      subjects after anorectal surgery, but also the recovery of postoperative motor capacity in
      these human subjects.
    


Intervention name(s): Intrathecal Hydromorphone Mono Injection; Intrathecal Placebo Mono Injection
Intervention type(s): Drug; Drug
Intervention description(s): Experimental Drug: Hydromorphone Hydrochloride Injection. Administration: subarachnoid space mono bolus inject, + 5% glucose injection diluted to 75 μg:1.5ml, Speed ≤ 0.5 ml/s; Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s
Other intervention name(s): ITHM; ITPO
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hydromorphone; intrathecal opioid; post operative pain; anorectal surgery; placebo
Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers
Condition: Postoperative Pain; Chronic Pain
MeSH terms: Chronic Pain; Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose
      Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor
      agonist HSK21542 in Healthy Volunteers.

      The study will enroll approximately 50 adults. The anticipated study duration will be up to 6
      months.
    


Intervention name(s): HSK21542; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, injection, starting dose of 0.2ug escalating up to 20ug; Single dose, injection matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Postoperative Pain
Saliva Modification Related to Fat Perception in Human
Condition: Fat Sensitivity
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      The perception of fat represents major scientific and nutritional issues. This research aims
      to identify salivary markers that could predict and possibly explain this perception in
      healthy human being. This would help to develop nutritional strategies for a more rational
      consumption of fat.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male, healthy
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
Condition: Cerebral Palsy; Parent-Child Relations
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      1. To find out the relation between the severity of ADL limitation in diplegic CP children
           and the level of parents' stress.

        2. To detect the correlation between the PS level to the different domains of ADL
           limitation.

        3. To determine the substantial factors that underlying the parents' stress of those
           diplegic CP children.
    

Detailed description: 
      The health and well-being of children are intimately related to their parents' physical,
      emotional and social health in addition to child-rearing practices. The way parents of CP
      children deal with their stress may adversely affect their parenting ability, which in turn
      leads to difficulties for the child, which may lead to more parenting stress. The extent to
      which parents of CP children adjust and the resources to meet the needs of their children is
      of primary concern to professionals working in children's healthcare.

      To support parents, it is important to determine the level of independence of diplegic CP
      children in their daily lives. This is necessary to identify predictors of their stress,
      which may be a mentally debilitating factor in their lives. In return, it may support us as
      physiotherapists to make more informed decisions about treatment planning, as well as
      facilitate conversations with parents around identifying sources of stress and developing
      healthy coping strategies that lead to a better quality of life for their children. Finally,
      this will have a direct positive impact on the children's abilities
    

Intervention name(s): Assessing the correlation between Functional Impairment and Parenting Stress
Intervention type(s): Other
Intervention description(s): Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Sample size estimation was carried out to determine the recruited number of the diplegic CP
        children from the outpatient clinic at the Faculty of Physical Therapy, Cairo University,
        Physical Therapy Department at the National Institute of Neuromotor Disorder, Abu El-Reesh
        Hospital, and private physiotherapy clinics. The age of patients will range from 18 months
        to 5 years old. Both sexes will participate in this study.
Improving Person-Centered Care for Family Planning in India
Condition: Family Planning
Study type: Interventional

Summary: 
      To evaluate the impact of a training to ASHAs on person-centered care (PCC) for family
      planning (FP).
    

Detailed description: 
      ASHAs will be provided with a training on family planning (FP) counseling and method options.
      Half of the group will receive additional trainings on person-centered care (PCC) principles
      and respectful care while the other half of the group will not receive this additional
      training. Women working with both the control ASHAs (FP trained) and Interventions ASHAs
      (FP+PCC trained) will be surveyed following their interactions with the ASHA to understand
      the quality of their experience with the ASHA and whether the woman has taken up a FP method
      of her choice following interaction with the ASHA.
    

Intervention name(s): Training of AHSAs on PCC for FP; Enhanced FP training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ASHAs provided with training on FP methods and counseling plus PCC for FP; Participation in an enhanced FP training including PCC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Person-Centered Care
Effect of Saccharomyces Cerevisiae on the Improvement of Gastro-intestinal Disorders Associated to IBS With C Phenotype
Condition: Constipation-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Syndrome; Constipation
Study type: Interventional

Summary: 
      The main objective is to assess the effect of an 8-week daily supplementation with IbSium®
      (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal
      disorders associated to the type C IBS (constipation predominant).
    


Intervention name(s): Saccharomyces cerevisiae CNCM I-3856; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.; 2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prospective Evaluation of Anorganic Bovine Bone Mineral Versus Calcium Phosphosilicate Alloplastic Bone Putty in Direct Sinus Augmentation: a Spilt-mouth Study
Condition: Sinus Floor Augmentation; Maxillary Sinus
Study type: Interventional

Summary: 
      The purpose of this split-mouth clinical study is to evaluate the clinical, radiographic and
      histological outcomes of lateral window sinus augmentation with a bovine xenograft or a CPS
      putty bone substitute in posterior maxillary sites and the survival of implants placed in
      these sites following healing.
    


Intervention name(s): Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation; Anorganic bovine bone mineral in direct sinus augmentation
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sinus Floor Augmentation; Maxillary Sinus; Bone Substitutes; Bone Regeneration
A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813
      in early symptomatic Alzheimer's disease.
    


Intervention name(s): Donanemab; Placebo; LY3202626
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered IV; Administered IV; Administered orally
Other intervention name(s): LY3002813
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TRAILBLAZER-ALZ