bioihbjkbjnl/mcl2 huggingface dataset:
Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
Condition: Fracture
MeSH terms: Fractures, Bone
Intervention: Vitamin D3; Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Tibial Shaft; Tibia; Femoral Shaft; Femur; Vitamin D; Fracture Healing

Summary:

      The objective is to determine the effect of vitamin D3 supplementation on fracture healing at
      3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult men or women ages 18-50 years

          2. Closed or low grade open (Gustilo type I or II) tibial or femoral shaft fracture

          3. Fracture treated with a reamed, locked, intramedullary nail

          4. Acute fracture (enrolled within 7 days of injury)

          5. Provision of informed consent.

        Exclusion Criteria:

          1. Osteoporosis

          2. Stress fractures

          3. Elevated serum calcium (>10.5 mg/dL)

          4. Atypical femur fractures as defined by American Society for Bone and Mineral Research
             (ASBMR) criteria

          5. Pathological fractures secondary to neoplasm or other bone lesion

          6. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's
             disease, osteomalacia, osteopetrosis, osteogenesis imperfecta etc.

          7. Patients with hyperhomocysteinemia

          8. Patients with an allergy to vitamin D or another contraindication to being prescribed
             vitamin D

          9. Patients currently taking an over the counter multivitamin that contains vitamin D and
             are unable or unwilling to discontinue its use for this study

         10. Patients who will likely have problems, in the judgment of the investigators, with
             maintaining follow-up

         11. Pregnancy

         12. Patients who are incarcerated

         13. Patients who are not expected to survive their injuries

         14. Other lower extremity injuries that prevent bilateral full weight-bearing by 6 weeks
             post-fracture.
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Condition: Adult Idiopathic Generalized Osteoporosis
MeSH terms: Osteoporosis
Intervention: Denosumab
Intervention description: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Intervention MeSH terms: Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: osteoporosis; premenopausal; denosumab; idiopathic; Idiopathic Osteoporosis in Premenopausal Women

Summary:

      The purpose of this research study is to evaluate antiresorptive therapy with denosumab
      (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal
      women with idiopathic osteoporosis.

      Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial,
      "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in
      Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a
      36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6
      months).

      The goals of the study are to estimate the effects of denosumab on central and peripheral, as
      well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data
      to inform the design of a future randomized study. This study presents the first opportunity
      to study the effects of denosumab after TPTD in this unique and severely affected group of
      young women.

      Funding Source: FDA Office of Orphan Products Development (OOPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All women completing NCT01440803 who remain without a disease or medication that
             causes osteoporosis will be offered enrollment into this study.

          -  (Premenopausal status is no longer be required for entry.)

        Exclusion Criteria:

          -  Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine
             transaminase (ALT) above upper limit of normal

          -  Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL

          -  Pregnancy: urine pregnancy test must be negative
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
Condition: Parkinson's Disease; Dysphagia; Dystussia
MeSH terms: Deglutition Disorders; Parkinson Disease
Intervention: EMST; smTAP
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 45 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Rehabilitation; Parkinson's disease; Swallowing; Cough; Dysphagia; Dystussia

Summary:

      Currently, there are no efficacious behavioral treatment approaches to address uncompensated
      aspiration, or aspiration without appropriate cough response, in Parkinson's disease (PD).
      This is of particular public health concern given that aspiration pneumonia is the leading
      cause of death in persons with PD. The overarching aim of the proposed study is to determine
      the efficacy of two distinct intensive rehabilitation paradigms, expiratory muscle strength
      training (EMST) and sensorimotor treatment for airway protection (smTAP), on airway
      protective clinical outcomes in persons with PD and dysphagia. The investigators anticipate
      the results will lead to reductions in the risks associated with airway protective deficits.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with PD (Hoehn and Yahr Stages II-IV)

          2. Difficulty swallowing

          3. Not actively receiving swallowing therapy.

        Exclusion Criteria:

          1. Other neurological disorders (e.g., multiple sclerosis, stroke, etc.)

          2. History of head and neck cancer

          3. History of breathing disorders or diseases (e.g., COPD)

          4. History of smoking in the last five years

          5. Uncontrolled hypertension

          6. Difficulty complying due to neuropsychological dysfunction
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Intervention description: Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, single-arm study to assess the reduction of low-density lipoprotein
      cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia
      (HoFH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ≥18 years of age at the time of the screening visit

          2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)

          3. Willing to consistently maintain usual diet for the duration of the study

        Exclusion Criteria:

          1. Background medical lipid modifying therapy that has not been stable for at least 4
             weeks (6 weeks for fibrates) prior to the screening visit

          2. Having undergone lipid apheresis within 4 weeks prior to the screening visit

          3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives
             (whichever is longer) prior to the screening visit

          4. Previous participation in any clinical trial of REGN1500

        Note: The information listed above is not intended to contain all considerations relevant
        to a patient's potential participation in this clinical trial therefore not all inclusion/
        exclusion criteria are listed.
Effects of Botox in Obstructed Defecation Syndrome
Condition: Obstructed Defecation Syndrome (ODS)
MeSH terms: Syndrome
Intervention: Botulinum Toxin-A; Normal Saline
Intervention description: 100 Units diluted in a 5 cc syringe at a concentration of 20U/mL; Dispensed in a 5 cc syringe
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Botox; Obstructed Defecation Syndrome; ODS; Outlet-Type Constipation; injection

Summary:

      The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve
      symptoms of constipation in obstructed defecation syndrome (ODS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 years or older of all races and backgrounds

          -  Competent to give informed consent

          -  Meet the Rome III diagnostic criteria for functional constipation

          -  Inability to relax the puborectalis muscle at electromyography

          -  Altomare Obstructed Defecation Syndrome score of 15 points or above

          -  Failure of treatment with 2 conservative measures which may be as follows:

               -  1 laxative (osmotic or stimulant) for 2 weeks

               -  1 fiber supplement for one month

               -  And/or trial of biofeedback for at least 4 sessions

        Exclusion Criteria:

          -  Previous treatment with Botox (possible antibodies)

          -  Known hypersensitivity to any of the components of the toxin

          -  Medication regimen includes narcotics

          -  Previous radiation therapy to the anal canal and rectum

          -  Prior proctectomy

          -  Presence of unhealed and symptomatic anal fissure

          -  Presence of anal pain

          -  Presence of fecal incontinence

          -  Presence of full thickness rectal prolapse

          -  Presence of internal sphincter myopathy

          -  Inflammatory bowel disease or proctitis

          -  Pregnancy or breast-feeding

          -  Subject is currently enrolled/ just finished participating in a clinical trial in
             which the intervention/ its carry-over effect may interact with the intervention in
             this trial
A Dose-ranging Study to Evaluate the Safety and Efficacy of UNR844 in Subjects With Presbyopia.
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: UNR844; Placebo
Intervention description: Ophthalmic solution for topical ocular administration; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 234.0
Sex: All
Minimum age: 45 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: loss of elasticity in lens; lens; lens disorder; loss of near vision; Presbyopia; UNR844; farsightedness

Summary:

      Study of safety and efficacy of UNR844 in subjects with presbyopia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Impaired near vision in each eye and when using both eyes, without any near correction

          -  Need a certain level of near correction

        Exclusion Criteria:

          -  Impaired distance vision in either eye, with distance correction (if any)

          -  Severe short- or long-sightedness

          -  Any significant medical or clinical conditions affecting vision, the eyes or general
             health
A Study of TRV130 for the Treatment of Pain After Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: TRV130; Morphine; Placebo
Intervention description: TRV130 1 - 4 mg will be administered every 4 hours; Morphine 4 mg will be administered every 4 hours; Placebo will be administered every 4 hours
Intervention MeSH terms: Morphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 333.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: moderate to severe acute pain; bunionectomy

Summary:

      The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
      placebo in patients with acute postoperative pain after bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and
             internal fixation) with no additional collateral procedures.

          -  Experiences a pain intensity rating of ≥ 4 on an 11 point NRS

          -  Able to provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.
The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
Condition: Cancer-related Cognitive Difficulties
Intervention: Ibuprofen; Home-Based Exercise; Placebo
Intervention description: 200 mg BID and 8 hours apart; A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period; 200mg BID and 8 hours apart
Intervention MeSH terms: Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Cognitive difficulties

Summary:

      This research seeks to determine if a combination of low-dose ibuprofen along with a
      structured home-based walking and progressive resistance exercise program, EXCAP, will be
      effective in reducing cognitive difficulties among cancer patients receiving chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must report cognitive difficulties of 3 or higher on a 0-10 scale

          -  Must provide informed consent

          -  Be able to read English

          -  Have a primary diagnosis of cancer

          -  Be able to swallow medication

          -  Women of child-bearing potential must not be pregnant or become pregnant during the 6
             week study

          -  Agree not to take NSAIDs during the 6 week intervention period

          -  Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over
             the 42-day study period.

          -  Must have the approval of their treating physician to begin the exercise program and
             receive the ibuprofen

          -  Must be over 18 years of age

        Exclusion Criteria:

          -  Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3
             months that is over 400mg daily

          -  Have an allergy to ibuprofen

          -  Be identified as in active or maintenance stage of exercise behavior as assessed by
             the single-item exercise stages of change short form

          -  have physical limitations that contraindicate participation in sub-maximal
             physiological fitness testing or a low to moderate home-based walking and progressive
             resistance program

          -  have a history of peptic ulcer disease within the last 12 months

          -  Diagnosed with a neurodegenerative disease

          -  Had a myocardial infraction within the past 6 months

          -  Patients with a neutropenic episode during the first cycle of chemotherapy or at high
             risk for a neutropenic episode during future chemotherapy cycles at the treating
             physicians discretion

          -  Have confirmed metastatic disease to the central nervous system

          -  Have been hospitalized for a major psychiatric illness within the last 5 years
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Condition: Chemotherapy Induced Anemia
MeSH terms: Anemia
Intervention: Roxadustat
Intervention description: Roxadustat will be administered per schedule specified in the arm description.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Chemotherapy induced anemia; Myelosuppressive chemotherapy; Non-Myeloid malignances

Summary:

      The purpose of this study is to find out if roxadustat (also known as FG-4592) is safe and
      effective for the treatment of anemia in participants receiving chemotherapy treatment for
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of non-myeloid malignancy

          2. Anemia caused by cancer treatment (myelosuppressive chemotherapy) defined as Hb ≤10.0
             grams (g)/deciliter (dL) at screening

          3. Planned concurrent treatment of cancer with chemotherapy for at least 8 additional
             weeks

          4. Estimated life expectancy ≥ 6 months at enrollment (Day 1)

        Exclusion Criteria:

          1. Participants with cancer receiving chemotherapy when the anticipated outcome is cure

          2. Participants who are only receiving hormonal products, biological products, cancer
             immunotherapy or radiation therapy to treat/manage their cancer

          3. History of leukemia

          4. Participants who have received an RBC transfusion or erythropoietic therapy within 4
             weeks of enrollment

          5. Use of any investigational drug within 8-weeks prior to treatment with roxadustat

          6. Clinically significant anemia due to other etiologies

          7. Cardiovascular risks, such as myocardial infarction, stroke, heart failure or
             thromboembolic event (for example, deep vein thrombosis [DVT] or pulmonary embolism)
             within previous 6 months of screening

          8. Clinically significant or uncontrolled ongoing autoimmune disease (for example,
             rheumatoid arthritis, Crohn's disease, celiac disease, etc.)

          9. Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Condition: Patients at Risk for Melanoma
MeSH terms: Melanoma
Intervention: N-acetylcysteine; Placebo arm
Intervention description: N-acetylcysteine (NAC), 1200 mg Oral route 2 doses; Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase II intervention to propose a new melanoma chemoprevention agent. The
      investigators believe oxidative stress/damage in nevi is a probable indication for melanoma
      risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi
      from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate
      whether administration of NAC around the time of UV exposure will reduce melanoma risk in
      high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and
      2) examine key genetic variants that will identify which individuals are most likely to
      benefit from chemoprotection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have at least 2 nevi (each >6 mm diameter) not clinically suspicious for melanoma
             that can be biopsied.

          -  Must be able to receive informed consent and sign an approved consent form that
             conforms to federal and institutional guidelines.

        Exclusion Criteria:

          -  The patient is a minor (< 18 years old).

          -  The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form
             and certified interpreter can be made available if needed)

          -  The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy
             and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing
             potential) will have a urine pregnancy test.)

          -  The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or
             considered vulnerable.

          -  The patient has history of allergic reaction to NAC.

          -  The patient has history of severe asthma.

          -  The patient has been taking NAC or any other oral antioxidant.

          -  The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or
             extensive sunburn.