bioihbjkbjnl/mcl2 huggingface dataset:
Patient Response to Spinal Manipulation
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a biomechanical study which is Project 1 in the Developmental Center for Clinical and
      Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01; principal
      investigator Christine Goertz, DC, PhD). This study is designed to monitor both physiological
      and patient self-report outcome variables. In addition, as there is little quantitative
      information on Spinal Manipulation Technique procedures reported in clinical trials, the
      study is designed to collect preliminary kinetic measures of the spinal manipulation
      technique delivery (i.e. force-time profiles).
    

Detailed description: 
      Participants with narrowly defined chronic low back pain will be included in this study. Each
      participant will be treated 12 times over the course of 6 weeks. The following data will be
      collected: participant characteristics that may predict outcome or be modifiers of force used
      by provider (gender, age, height, weight, and Body Mass Index); spinal segment load during
      the pre-load and thrusting phases (force and moment in the pre-load phase, peak load, and
      loading rate); physiological measures (posterior-anterior global stiffness and
      flexion-relaxation); patient-centered outcomes of back pain and function; and adverse events.

      Study participants (n= 80) will be recruited from the Quad Cities metro area. A team of
      experienced chiropractic clinicians working at the Palmer Center for Chiropractic Research
      will treat study participants. Each of the study participants will receive 2 High Velocity
      Low Amplitude Spinal Manipulation treatment visits per week over a 6 week period. The
      physiological assessments will be performed immediately before and after Spinal Manipulation
      delivery during treatment visits 1, 5 & 12 (6 sets of assessments in total). During these
      same treatment visits, we will also capture the kinetic measures during Spinal Manipulation
      delivery for spinal segment load analysis. Participant patient-centered outcomes will be
      measured at baseline 1, and treatment visits 6 and 13. For simplicity, data collection time
      points will be named as baseline, after 2 weeks, and after 6 weeks.
    

Intervention name(s): HVLA-SM
Intervention type(s): Other
Intervention description(s): High Velocity Low Amplitude Spinal Manipulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Back Pain
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C
      (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under
      the concentration-time curve during the defined dosing interval ([AUC0-τ] either every 3
      weeks [AUC0-21 days] or every 4 weeks [AUC0-28 days]) and maximum concentration in a dosing
      interval (Cmax) in participants diagnosed with primary humoral immunodeficiency (PI)
      currently receiving chronic IVIG replacement treatment.
    


Intervention name(s): Gamunex-C; IVIG-PEG
Intervention type(s): Biological; Biological
Intervention description(s): Intravenous infusion.; Intravenous infusion.
Other intervention name(s): IVIG-C
Intervention MeSH terms: Immunoglobulins, Intravenous
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study model for this is Single-Sequence crossover.
Masking: None (Open Label)
Primary purpose: Treatment
A Trial Investigating NN1218 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the absorption and
      effect in the body of NN1218 in subjects with type 1 diabetes.
    


Intervention name(s): NN1218; insulin aspart; NN1218; NN1218; NN1218; NN1218
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.2 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin); 0.4 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin); 0.2 U/kg body weight injected subcutaneously (under the skin)
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Sinquanon for Prevention of Antibiotic-associated Diarrhea in Adults
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a probiotic, SINQUANON, on the
      reduction of the occurrence of diarrhea associated with antibiotic use in adults.
    

Detailed description: 
      The study aims to evaluate the efficacy of a specialized multi-strain probiotic, SINQUANON,
      on the reduction of the incidence of antibiotic-associated diarrhea in adults and to
      demonstrate the benefit of administering the specialized multi-strain probiotic as a routine
      add-on to antibiotic therapy on prevention of antibiotic-associated diarrhea in adults who
      take antibiotics in the outpatient setting.
    

Intervention name(s): Sinquanon; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This probiotic food supplement includes fourteen probiotic bacterial strains of Lactobacillus Spp, Bifidobacterium Spp., Bacillus coagulans, Saccharomyces boulardii, three prebiotics and Vitamin-B complex - B1, B2, B3, B6, B7, B9 in an enterosolvent cellulose capsule. The product includes supplementary substances: maltodextrin and magnesium stearate.
2 capsules once a day during the antibiotic dosing. 1 capsule a day for 14 days following completion of antibiotic dosing.; The placebo product will have the same appearance as the active product and the same composition but without the live bacteria, prebiotics, and vitamin-B complex. 2 capsules once a day during the antibiotic dosing. 1 capsule a day for 14 days following completion of antibiotic dosing.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, multicenter, double-blind, placebo-controlled, randomized, parallel-arm clinical study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Probiotics; Antibiotics; Antibiotic-associated diarrhea; High-dose; Multistrain
Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
Condition: Adenoid Cystic Carcinomas; Cisplatin
MeSH terms: Carcinoma; Carcinoma, Adenoid Cystic
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators conducted this study to evaluate the efficacy of Chidamide combined with
      cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
    

Detailed description: 
      Adenoid cystic carcinomas (ACCs) constitute of 1% of head and neck cancers. This type of
      tumor grows slowly with a high potential of local recurrence. Approximately 50% of patients
      develop distant metastases, and 33% patients die within 2 years. The initial therapy of these
      malignancies consists of surgical resection followed by radiotherapy. Systemic therapy is
      crucial in the management of recurrent and metastatic disease. However, nowadays, there were
      no standard chemoimmunotherapy regimes. Previous report showed that overall response rate was
      only less than 10% using single-agent chemotherapies, and the best results were achieved by
      cisplatin. Chidamide is a new benzamide class of histone deacetylase inhibitor with marked
      antitumor activity. And a phase I study has showed that one of three patients with
      submandibular adenoid cystic carcinoma achieved a partial response treated with Chidamide.
      The investigators conducted this study to evaluate the efficacy of Chidamide combined with
      cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma, in order to find
      a potential promising way to treat this kind of disease.
    

Intervention name(s): Chidamide combined with cisplatin
Intervention type(s): Drug
Intervention description(s): Chidamide combined with cisplatin
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Can Quercetin Increase Claudin-4 and Improve Esophageal Barrier Function in GERD?
Condition: Gastroesophageal Reflux Disease; GERD; Acid Reflux; Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose:

        1. Determine if oral quercetin increases the expression of claudin-4 in the lining of the
           esophagus of patients with a diagnosis of gastroesophageal reflux disease (GERD); and

        2. Determine whether the increase in claudin-4 by oral quercetin is accompanied by
           improvement in the barrier function and acid resistance of the lining of the esophagus
           of patients with a diagnosis of gastroesophageal reflux disease (GERD)

      If interested, participants will be consented and provided a questionnaire to complete as
      part of the study. Participants will undergo endoscopy for routine care and will have up to 8
      esophageal biopsies (small tissue samples) taken for the research study. After endoscopy,
      participants will be contacted to begin a 6 week treatment period with study drug (Quercetin,
      taken twice daily).

      At the end of the 6 week period, participants will be scheduled to have blood drawn and to
      have a follow-up endoscopy with biopsies performed for the research study.
    

Detailed description: 
      Patients must be symptomatic (heartburn) and agree to allow endoscopic biopsies from the
      lower 5 cm of esophagus for research purposes. If the endoscopy demonstrates non-erosive
      reflux disease, biopsies of Esophageal Squamous Epithelium (ESE) are obtained and placed in
      mRNA-Later to assess claudin-4 mRNA by qRT-PCR and protein expression by Western blot (53,
      64) while other biopsies of ESE are obtained and handled as in SpAim#2 to assess barrier
      function of ESE. After consent, subjects complete a questionnaire assessing demographics,
      disease-specific parameters such as duration of symptoms and past treatment, and the
      gastroesophageal reflux disease (GERD) Symptom Assessment Scale (GSAS), a validated measure
      of GERD severity. Following this, patients in open label fashion are given orally 500 mg
      Quercetin (Q) twice daily (bid) [Pure, House of Nutrition, Yonkers, NY] for 6-weeks. Symptoms
      are monitored 1 week before and for the 6 week treatment period. At 6 weeks, a blood sample
      is obtained for determination of Q and its metabolites by HPLC and endoscopy and biopsies of
      ESE are repeated and processed as initially done for claudin-4 levels in ESE.
    

Intervention name(s): Quercetin
Intervention type(s): Drug
Intervention description(s): Two 250 mg capsules of quercetin twice-a-day one hour before meals with a glass of water.
Intervention MeSH terms: Quercetin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gastroesophageal reflux disease; GERD; Acid reflux; Reflux; Quercetin
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of
      afatinib depending on the timepoint of ritonavir administration
    


Intervention name(s): afatinib; ritonavir + afatinib; ritonavir + afatinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): standard therapeutic dose; simultaneous intake of ritonavir and afatinib on second treatment day; on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet
Intervention MeSH terms: Ritonavir; Afatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Condition: Hemophilia A; Bleeding Disorder
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhagic Disorders; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      Characterizing the impact and treatment of reproductive tract bleeding on women and
      post-menarchal girls with bleeding disorders.

      Objectives: This is a cross-sectional observational study of women and girls (WG) with
      bleeding disorders enrolled in the American Thrombosis and Hemostasis Network (ATHN) dataset.
      Based on the investigators' study of currently available data of WG with bleeding disorders
      in the ATHNdataset, the investigators hypothesize that the information currently captured in
      the core data elements of the ATHNdatasest does not adequately capture data specific to WG
      with bleeding disorders. Further, the investigators hypothesize that it is feasible for
      Hemophilia Treatment Centers (HTCs) to include data points specific to WG with bleeding
      disorder when enrolling participants in the ATHNdataset. This hypothesis will be evaluated
      through the following specific aims:

      Specific Aim 1: Characterize reproductive tract bleeding in a cohort of WG with bleeding
      disorders cared for at US HTCs.

      Specific Aim 2: Characterize the treatment strategies for and the impact of heavy menstrual
      bleeding in a cohort of females with bleeding disorders cared for at HTCs.

      Specific Aim 3: Evaluate the feasibility of adding female specific core data points to the
      ATHNdataset.
    

Detailed description: 
      This is a multi-center, cross-sectional study of women and girls with bleeding disorders
      receiving care at Hemophilia Treatment Centers (HTCs). To further characterize this
      population, WG who receive care at federally funded US HTCs will be approached regarding
      participation. Following assent and/or consent, participants will be asked to complete a
      series of forms. In order to assess their bleeding symptoms, they will complete the self-BAT
      (Bleeding Assessment Tool) as well as the Menstrual Bleeding Questionnaire (MBQ). In order to
      assess their quality of life, they will complete the PROMIS-29 quality of life inventories.
      Patients may be contacted if they miss a question on any of these forms. Phone call should
      take no more than 15 minutes. Study staff will complete an intake form which includes data
      regarding bleeding disorder diagnosis as well as treatment, using information obtained from
      the patient, chart review, and the ATHNdataset.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women and girls receiving care at federally funded US Hemophilia Treatment Centers will be
        approached regarding participation.
Safety of Larazotide Acetate in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the safety, tolerance and pharmacokinetics of multiple, oral doses of
      larazotide acetate.
    

Detailed description: 
      CLIN1001-003 was a Phase 1, randomized, double-blind, placebo controlled multi-dose study to
      determine the safety, tolerance, and pharmacokinetics (including food effect) of 3 dose
      levels of larazotide acetate in healthy volunteers. Three (3) cohorts of 8 subjects, in which
      six (6) subjects in each cohort received larazotide acetate in escalating doses of 0.25 mg, 1
      mg, or 4 mg TID for 10 days and two (2) subjects received placebo TID for 10 days, were
      studied. Subjects maintained a standard gluten-free diet. Subjects were dosed three times a
      day 30 minutes prior to meals except for the morning dosing on Days 1, 5, and 10. For the
      morning dosing on Days 1, 5, and 10 subjects, fasted overnight prior to dosing and for 2
      hours post dose. Subjects were evaluated for safety (medical history, physical examination,
      vital signs, clinical laboratory testing, and 12-lead electrocardiograms) throughout the
      study. Serial blood samples were collected or pharmacokinetic determinations at baseline and
      2 hours post morning dose on Days 1, 2, 5, 6 and 10.
    

Intervention name(s): larazotide acetate
Intervention type(s): Drug
Intervention description(s): capsule for oral administration
Other intervention name(s): AT-1001; INN-202
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Phase 1, randomized, double-blind, placebo controlled multi-dose study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: celiac disease; larazotide acetate
YKL-40 and IL-6 Levels in Periodontal Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Observational

Summary: 
      The primer aim of the study was to investigate saliva and gingival crevicular fluid (GCF)
      YKL-40 and also interleukin-6 (IL-6) levels in chronic periodontitis pathogenesis.
    

Detailed description: 
      This study consisted of two groups: 26 periodontally healthy individuals and 26 generalized
      chronic periodontitis patients. Chronic periodontitis patients were received nonsurgical
      periodontal treatment. Clinical measurements were recorded, saliva and GCF samples were
      obtained before and at first and third months after periodontal therapy. Levels of YKL-40 and
      IL-6 in saliva and GCF were analyzed by enzyme-linked immunosorbent assay.
    

Intervention name(s): Nonsurgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): Nonsurgical periodontal therapy includes oral hygiene education and scaling and root planning approaches to eliminate microbial dental plaque that is the primary etiology of periodontal diseases.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 52 participants
      
Biospecimen description: 
      Saliva and gingival crevicular fluid
A Study to Evaluate the Use of Placenta Protein 13 (PP13) in the First Trimester of Pregnancy as a Diagnostic Aiding Tool in the Assessment of the Risk for Developing Preeclampsia in Women With Low and Unknown Risk
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether it is possible to detect changes in the
      concentration of PP13 in the blood of pregnant women who may go on to develop the
      complication of preeclampsia later on in the pregnancy, and if these changes can be detected
      early enough to allow early diagnosis and treatment for prevention of these complications and
      reduce their damage. This study will test if the PP13 biomarker during the first trimester of
      pregnancy has the ability to provide assessment of risk for the development of preeclampsia
      that necessitates delivery before 37 weeks gestation or can predict preeclampsia before 34
      weeks gestation.
    

Detailed description: 
      After obtaining informed consent maternal demographics, vital signs, height, weight, medical
      history, pregnancy dating, dipstick for urine protein, previous lab results, nuchal
      translucency results and uterine artery Doppler results (if done) will be obtained. Blood for
      PP13 will be obtained at 7-13 weeks and optionally at 21-23 weeks. Hospitalization and
      delivery information will be obtained via a chart review for evidence of preeclampsia.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant patients seen or referred to the obstetrical clinic
      
Biospecimen description: 
      Maternal serum - placental protein 13 level
ACE527 Safety and Immunogenicity Study
Condition: Enterotoxigenic E. Coli (ETEC) Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immune response to ACE527.
    

Detailed description: 
      The study is a phase I, single center, double-blind, placebo-controlled dose finding clinical
      study to evaluate the safety, tolerability and immunogenicity of the live attenuated, oral
      vaccine ACE527. The study is designed to evaluate 2 doses of the ACE527 in 2 cohorts. Each
      cohort will consist of approximately 18 subjects (healthy subjects), approximately 12 of them
      receiving ACE527 and approximately 6 receiving placebo.

      Within a cohort, the second dose will only be given if safety and tolerability of the first
      dose is acceptable. This assessment will be based on evaluation of data up until Day 7 by the
      Independent Safety Committee (ISC) as per written guidance. The first dose of each cohort
      will be administered during an inpatient stay. Escalation to the next dose level will be
      dependent on an acceptable safety profile of the first dose at the previous dose level, based
      on evaluation of safety data by an Independent Safety Committee (ISC). The decision to
      administer the second dose at the higher level will also require review of the safety and
      tolerability of the second dose at the lower level.

      The second dose will be administered at the outpatient clinic and the subjects will be
      observed for at least 60 minutes after vaccination prior to discharge from unit.
    

Intervention name(s): ACE527 vaccine; Placebo vaccine
Intervention type(s): Biological; Biological
Intervention description(s): First cohort: Two doses, each of 3x10^9 cfu of each strain (9x10^9 cfu total per dose) administered on Days 0 and Day 21 (out-patient).
Second cohort: Two doses, each of 3x10^10 cfu of each strain (9x10^10 cfu total per dose) administered on Days 0 and Day 21; First and second cohort: The placebo vaccine will be administered at Days 0 and Days 21.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccination; Diarrhea; Traveler's Diarrhea; ETEC; Enterotoxigenic E. coli