bioihbjkbjnl/mcl2 huggingface dataset:
Study of Fibromyalgia Treated With Milnacipran
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the characteristics of the nerves and the small veins
      in the skin of people with fibromyalgia. This information will then be used to identify
      possible processes in the skin that may help explain why some people feel pain relief with
      the study drug (milnacipran) and others do not. The investigators expect to learn more about
      the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients.
      The investigators hypotheses are:

        1. The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical
           and/or morphological pathology among the sensory innervation.

        2. Fibromyalgia patients may have different sites of innervation.

        3. Milnacipran may have a therapeutic effect on some fibromyalgia patients.

        4. Abnormalities in fibromyalgia patients may predict the likelihood of a good response to
           milnacipran.
    


Intervention name(s): Milnacipran; Skin biopsy; Skin Biopsy
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Subject with Fibromyalgia will then be titrated onto milnacipran over 8 days to subject reported optimal pain control or a maximal dose of 100mg/day per package insert. Subjects will be permitted to increase or decrease their dosing at any time during the study per MD discretion in order to maintain optimal pain control.; Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.; Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female; age 18 to 70
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared
      to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately
      controlled with metformin and sulphonylurea combination therapy. Patients will be randomized
      to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg
      once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to
      continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years,
      and the target sample size if 500+ individuals.
    


Intervention name(s): insulin glargine; metformin; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): starting dose 10 IU daily; As prescribed; 10 mg once weekly; 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly)
Intervention MeSH terms: Metformin; Insulin Glargine; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
Condition: Liver Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will
      receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight
      subjects from each classification of hepatic impairment will be enrolled. Plasma samples will
      be collected before and at specified intervals after dosing and the concentration of MNTX
      will be analyzed.
    


Intervention name(s): SC Methylnaltrexone (MNTX)
Intervention type(s): Drug
Intervention MeSH terms: Methylnaltrexone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Single Intravesical Doses of TTI-1612 in Women With Interstitial Cystitis/Bladder Pain Syndrome
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and pharmacokinetics of TTI-1612 in
      women with interstitial cystitis/bladder pain syndrome.
    

Detailed description: 
      Single doses of TTI-1612, at seven escalating dose levels, will be administered
      intravesically to women with IC/BPS. Drug will be retained in the bladder for 30 minutes.

      TTI-1612 pharmacokinetics will be studied through the collection of blood samples at various
      time points, from 5 minutes to 8 hours post administration on dosing day, then at 24 and 48
      hours post dosing. Serum will be isolated for subsequent analysis and determination of the
      following parameters: maximum serum concentration (Cmax), time of maximum observed
      concentration (Tmax), area under the curve to the final time with a concentration above the
      limit of quantification (AUC 0-t) and to infinity (AUC 0-∞), elimination half-life (t½),
      clearance (CL) and volume of distribution (Vz).

      TTI-1612 safety will be determined through monitoring of the subjects' vital signs, ECGs,
      clinical laboratory evaluations, adverse events (if any) and physical examinations.
    

Intervention name(s): TTI-1612
Intervention type(s): Drug
Intervention description(s): Single intravesical 30-minute treatments with escalating doses of TTI-1612.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bladder; cystitis; frequency; nocturia; pain; urgency
Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes
Condition: Prediabetes; Type-2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examined whether dietary-induced reductions in lipoprotein-associated
      phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma
      affected metabolic profiles in PBMCs and plasma.
    

Detailed description: 
      Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2
      diabetes were randomly assigned to a control group (normal diet with refined rice) or a
      whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary
      intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4%
      of protein-derived energy and approximately 3% of fat-derived energy.
    

Intervention name(s): Dietary intervention-refined rice; Dietary intervention-whole grains and legumes
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects in the control group maintained the usual refined-rice diet.; Subjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
CARE Mentalizing-Focused Parenting Group Outcomes Study
Condition: Parent-Child Relationship; Parenting
Study type: Interventional

Summary: 
      The primary objective of this clinical trial is to evaluate the 12-week mentalizing-focused
      group parenting intervention, Connecting and Reflecting Experience (CARE), relative to a
      treatment as usual (TAU) group in an outpatient child mental health clinic.
    


Intervention name(s): CARE Parenting Group Treatment; Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.; Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attachment; Parenting; Parent-Child Relationship; Caregivers; Parents; Child Mental Health; Child Development
A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      MDK-703-101 is a single ascending dose study, to determine the safety, tolerability, and
      PK/PD of MDK-703 in healthy adult subjects.
    


Intervention name(s): MDK-703 or Placebo
Intervention type(s): Biological
Intervention description(s): Injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single center, open label, fixed-order, crossover, food-effect,
      pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
    


Intervention name(s): tricaprilin; standard meal; high-fat meal; overnight fast
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Tricaprilin formulated as AC-SD-01; standard meal; high-fat meal; fasting for at least 9 hours
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of POC Pulse-dose Demand Oxygen Delivery for Nocturnal Hypoxemia
Condition: Nocturnal Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      The aim of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen
      Concentrator on peripheral oxygen saturation in adults receiving supplemental oxygen at night
      and examine whether the device can adequately maintain oxygen saturation during sleep.
    

Detailed description: 
      The study design is a prospective, single site, single arm, open label, pilot study. The aim
      of this study is to describe the effect of the Inogen Rove 6 Portable Oxygen Concentrator on
      peripheral oxygen saturation in adults receiving supplemental oxygen at night and examine
      whether the device can adequately maintain oxygen saturation during sleep, i.e., achieve
      target with initial titration setting and/or with any needed adjustments of setting.
    

Intervention name(s): InogenOne Rove 6 Portable Oxygen Concentrator
Intervention type(s): Device
Intervention description(s): overnight use of Portable Oxygen Concentrator, 6 hours minimum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypoxemia, oxygen
Different Type Ultrasound Guided Epidural Block Methods
Condition: Epidural Anesthesia; Ultrasound
Study type: Interventional

Summary: 
      The nerve blocks applied with ultrasonography are used for pain and operation after many
      operations today.

      Applications with ultrasonography shorten the processing time, reduce the amount of local
      anesthetic used and lead to fewer complications.

      However, the use of ultrasonography is not so common in neuraxial regional anesthesia
      applications. In the literature, epidural applications accompanied by ultrasonography were
      applied with different approaches.
    

Detailed description: 
      In this study the investigators will used the two different ultrasound -guided epidural block
      approach .

      Paramedian sagittal oblique and Transverse interlaminar. The investigators will used this two
      technique in epidural catheter placement using the real-time ultrasound.
    

Intervention name(s): Epidural block
Intervention type(s): Other
Intervention description(s): Epidural catheter insertions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
C Reactive Protein in Home Quarantined Coronavirus Disease 2019 (COVID -19) Patients.
Condition: COVID -19
Study type: Interventional

Summary: 
      During the peak of the second COVID -19 wave, the hospitals were over-crowded. Many COVID -19
      positive patients had to stay at home and reach out to their family physicians for guidance.
      Medical follow-up for these patients was a daunting challenge. As in - patient hospital
      facilities were not readily accessible due to over crowding, early objective tests to
      identify home quarantined patients prone to deterioration and timely medical intervention to
      avoid hospitalization were required.

      Based on early assessment of inflammatory markers like CRP and clinical signs like persistent
      high-grade fever, need-based early medical intervention was initiated in home quarantined
      COVID -19 patients prior to the onset of hypoxia, in order to avoid complications and
      hospitalization
    

Detailed description: 
      25 home quarantined COVID -19 patients who contacted online for medical guidance underwent
      clinical and biochemical evaluation. Radiological evaluation was done only if indicated.

      Based on early objective biochemical tests like elevated CRP and clinical signs like
      persistent high-grade fever on the third or fourth day after onset of symptoms, early medical
      treatment was initiated prior to onset of hypoxia.

      All the 25 patients recovered without any complications and did not require hospitalization.
    

Intervention name(s): Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins; Oral low dose steroid; Intravenous Antibiotics with Low dose steroid.; Oral anti-coagulant
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D; Low dose oral methyl prednisolone was added.; Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given; Rivaroxaban was given for minimum 4 weeks depending on D dimer levels
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular; Anti-Inflammatory Agents; Anticoagulants; Coagulants; Histamine Antagonists; Histamine H1 Antagonists
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COVID -19;; Home quarantine;; C-Reactive Protein (CRP);; D-Dimer,; Early Intervention prior to onset of hypoxia
The Effects of a Novel Probiotic Supplement on Menopausal Symptoms and Bone Health
Condition: Menopause
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study is designed to evaluate the potential effects of a novel probiotic
      supplement on the severity of global menopause symptoms (e.g., psychological, somatic,
      urogenital symptoms) and on bone health in postmenopausal women.
    

Detailed description: 
      Menopause is a natural phase in which a woman's menstrual cycle permanently cease. During
      this time, women undergo many biological changes, including a decline of estrogen level or
      alterations in the vaginal microflora. This can result in the onset of various physiological
      and psychological menopause-related symptoms which may continue into postmenopausal years.

      The present study aims to evaluate the potential effects of a probiotic supplement on global
      menopause symptoms including psychological, somatic and urogenital symptoms. It is
      hypothesized that this probiotic, consumed over a 12-week period, will help reduce the
      symptoms of menopause by modulating the mucosal microflora of the vaginal linings.
      Additionally, it is hypothesized that the continued consumption of this probiotic combination
      over a total of 48 weeks will aid in the overall maintenance of bone health and may
      ameliorate bone density loss.

      144 healthy postmenopausal women (≥ 40 to < 60 years old) in the U.S. who are experiencing
      menopause-related symptoms will be randomized to the study (12-week period), and a subset (72
      postmenopausal women) will continue the study for an additional 36 weeks (Bone Health Study).
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dosing regimen of one capsule daily for a maximum of 48 weeks.; Dosing regimen of one capsule daily for a maximum of 48 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Probiotics; Menopausal symptoms; Bone health; Vulvar and vaginal atrophy; Vaginal microflora; Anxiety; Depression; Urinary incontinence; Metabolic syndrome biomarkers; Sleep quality; Gut microflora; Bone resorption markers; Bone formation markers; Bone Mineral Density (BMD); Fracture risk assessment
Characterization of Chitin-glucan Fiber Fermentation in Human After a Single Administration
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this research study is to characterize the fermentation of chitin-glucan fiber by
      assessing the volatile compounds released in the breath. For this purpose, an interventional
      study with control will be performed. After a single administration of 4.5 g of chitin-glucan
      fiber, the kinetic of production of exhaled volatile compounds (such as H2, methane, SCFAs,…)
      will be measured during twelve hours. These results will be compared to the exhaled volatile
      compounds measured during twelve hours after supplementation with 4.5g of maltodextrin
      (placebo).
    


Intervention name(s): Chitin-glucan; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Second test day (D2), subjects will received 4.5g of chitine-glucan; First test day (D0), subjects will received 4.5g of maltodextrin.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes
Condition: Hypertrichosis
MeSH terms: Hypertrichosis
Study type: Interventional

Summary: 
      Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in
      gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the
      Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled.
      Each participant received two vials of gel suspension, which contained bimatoprost and normal
      saline, respectively, each mixed 1:1 with GonakTM gel and labeled "right eye" and "left eye"
      according to randomization. The suspension was applied to the eyelashes every evening on the
      designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly
      intervals during the study and at 1 and 3 months after study completion. Visual acuity,
      ocular symptoms, intraocular pressure and photographs were documented at these same
      intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control
      average of 1.13mm) which was a statistically significant difference (p=0.009). The average
      intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity
      or iris discoloration was noted in any of the subjects. Discussion: Our data showed an
      increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have
      eyelash lengthening properties.
    

Detailed description: 
      Study completed
    

Intervention name(s): Bimatoprost Suspension
Intervention type(s): Drug
Intervention description(s): see prior
Other intervention name(s): Lumigan
Intervention MeSH terms: Bimatoprost
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bimatoprost; Eyelash lengthening; Prostaglandin Analogs; Cosmetics
An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      This long-term extension study is designed to monitor the long-term safety, tolerability, and
      efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of
      subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored
      SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be
      administered in this study.
    


Intervention name(s): Not applicable (no therapy is administered as part of this study)
Intervention type(s): Other
Intervention description(s): No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior "parent" study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects can only participate in this study upon completion of a Samumed SM04690-OA phase 2
        or phase 3 study.
      
Keywords: knee; osteoarthritis; intra-articular injection; SM04690
Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid
      homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.
    


Intervention name(s): NGM282; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment