bioihbjkbjnl/mcl2 huggingface dataset:
Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors
Condition: Breast Cancer; Cognitive Impairment; Cognition
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to examine the relationship between nutrition, physical activity
      and brain function in breast cancer survivors.
    

Detailed description: 
      The current study will examine the potential relationships between physical activity, dietary
      intake, body composition and cognition in breast cancer cancer survivors and age-matched
      women without a previous cancer diagnosis. Additionally, we will measure blood inflammatory
      markers to explore the relationship between lifestyle factors and inflammation.

      The study involves two, 1hr appointments at Texas State University. The first visit will
      include cognitive testing and body composition assessment. Participants will be given an
      activity monitor to wear for one week and a packet of questionnaires to complete at home. At
      the second visit, a fasted blood sample will be collected, and participants will complete a
      food frequency questionnaire.
    

Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female breast cancer survivors and women who have never had a previous cancer diagnosis
      
Biospecimen description: 
      Serum and plasma
    
Keywords: nutrition; physical activity; breast cancer survivor; cognition
Neuropeptide Treatment for Hot Flushes During the Menopause
Condition: Menopausal Flushing
MeSH terms: Flushing; Hot Flashes
Study type: Interventional
Phase: Phase 2

Summary: 
      Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational
      product
    

Detailed description: 
      Double-blinded, placebo-controlled, 2-way crossover study in 30 menopausal women with
      untreated hot flushes treated with a neurokinin 3 receptor (NK3R) antagonist

      Aims:

      To investigate whether an NK3R antagonist can reduce menopausal flushing

      Treatment:

      4 weeks administration of active drug and placebo in random order
    

Intervention name(s): NK3R antagonist - AZD4901; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Neurokinin 3 receptor antagonist; Placebo
Other intervention name(s): nil others; nil others
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Menopausal flushing
Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral
      follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in
      non-infertile women.
    


Intervention name(s): Anti Mullerian Hormone Measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Anti Mullerian Hormone was measured in all patients within two months before the first insemination cycle
Intervention MeSH terms: Hormones
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Non Infertile women who undergo a donor sperm insemination due to absence of male partner
        or complete azoospermia or the presence of a genetic condition in the partner that made the
        couple opt for donor sperm.
      
Keywords: Donor sperm insemination; Anti Mullerian Hormone; Ovarian reserve; Antral follicle count
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the absorption and systemic pharmacokinetics of
      AN2690 following daily application to all ten (10) toenails for 28 days.
    

Detailed description: 
      A single center, open-label, multiple-dose study design will be used. Planned enrollment is
      20 subjects to complete 15. Subjects must have a clinical diagnosis of onychomycosis of each
      great toenail and a clinical diagnosis of onychomycosis of six of the remaining toenails.
    

Intervention name(s): AN2690
Intervention type(s): Drug
Intervention description(s): AN2690 7.5% Solution, once daily for 28 days
Intervention MeSH terms: Tavaborole
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onychomycosis; Fungal Nail
Nuchal Cord Detection in Sonographic Evaluation by a First Year Resident.
Condition: Fetal Cord Entanglement
MeSH terms: Nuchal Cord
Study type: Interventional

Summary: 
      The investigators aim to prove that minimal sonographic training for nuchal cord detection in
      an unexperienced first year medical resident is more than enough to detect the phenomenon.
      Patients undergoing elective cesarean section will undergo a routine ultrasound (that is
      performed to detect the fetal heart rate and the fetal presentation) during which the
      resident will attempt to detect nuchal cord. The resident will then attend the patient's
      surgery to verify the findings.
    

Detailed description: 
      Patients undergoing elective cesarean section will undergo a routine ultrasound examination
      during which fetal heart rate, fetal presentation and nuchal cord presence will be
      documented. During surgery, after the fetus is delivered, presence or lack of nuchal cord
      will be documented.

      The aim of the study is to show that minimal sonographic training may assist even an
      unexperienced sonographist in detection of such a subtle yet important phenomenon.

      The study will be performed utilizing the newest resident in the OBGYN department.
    

Intervention name(s): Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Pre-operational ultrasound for the detection of fetal heart rate, fetal presentation and presence of nuchal cord.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of the Effects of PEITC on Oral Cells With Mutant p53
Condition: Oral Cancer
MeSH terms: Mouth Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this clinical trial is to examine the effects of phenethyl isothiocyanate (PEITC),
      a compound derived from cruciferous vegetables, on oral cells with mutant p53. The p53
      protein's normal (wild-type) function within cells is to act as a tumor suppressor, or
      anti-cancer protein. When mutated, the p53 protein not only no longer executes the functions
      of a tumor suppressor, and it can gain functions as a pro-cancer protein.22 The proposed
      clinical trial will utilize oral cells collected from subjects who are heavy smokers. Since
      the subjects are regularly exposed to mutagenic chemicals it is the thought that their oral
      cells will contain measurable levels of mutant p53. The participants will consume watercress
      juice, which is rich in PEITC (See Figure 1). Previous studies in the laboratory showed PEITC
      selectively depletes mutant p53, and not wild type p53, in cell culture. Our hypothesis is
      that the ITC in the watercress juice will lead to the depletion of mutant p53 within the oral
      cells. This depletion could lead to a possible clinical application of this compound, such as
      chemopreventives or oncologic treatments of individuals with oral cancers.
    


Intervention name(s): Watercress Juice
Intervention type(s): Dietary Supplement
Intervention description(s): The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mutant p53; watercress; Phenethyl isothyocyanate; oral cells of smokers
L-PZQ ODT in Schistosoma Infected Children
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT)
      tablets in Schistosoma infected children aged 3 months to 6 years.
    


Intervention name(s): L-PZQ ODT; Biltricide®; L-PZQ ODT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.; Participants will receive single oral dose of Biltricide® 40 mg/kg crushed tablet on Day 1.; Participant will receive single oral dose of L-PZQ ODT 60 mg/kg as decided by the IDMC.
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosomiasis; Children; L-praziquantel; Biltricide®
Pharmacokinetics and Safety Study of Omecamtiv Mecarbil in Healthy Japanese Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of omecamtiv mecarbil in healthy volunteers in Japan.
    

Detailed description: 
      This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,
      Cytokinetics is now listed as the sponsor.
    

Intervention name(s): Omecamtiv mecarbil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omecamtiv mecarbil tablets for oral administration; Matching placebo tablets
Other intervention name(s): AMG 423
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart failure
Nitric Oxide (NO) Donors and Inhibitors Study: Study to Evaluate L-Arginine and Aminoguanidine in Asthmatic Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the effects of oral and inhaled
      administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled
      NO and NO metabolites in exhaled breath condensate, saliva and nasal lavage fluid in normal
      and asthmatic subjects.
    

Detailed description: 
      Nitric oxide (NO) is produced by a variety of cells within the respiratory tract,
      particularly airway epithelial cells, and its increased concentration in asthma is likely to
      derive from inducible NO synthase (iNOS) expressed in inflamed airways. To evaluate whether
      an increased bronchial flux of NO (ie, airway wall NO flux [Jno] in picoliters per second)
      produced in the large airways is due to an enzyme overexpression, we administered a
      relatively selective iNOS inhibitor, aminoguanidine, by nebulization in a double-blind,
      placebo-controlled manner in asthmatic and healthy subjects and also investigated whether the
      same concentration of inhibitor has any effect on NO produced in the peripheral lungs (ie,
      alveolar NO concentration [Calv] in parts per billion [ppb]) or on the diffusing capacity of
      NO (Dno) [in picoliters per second-1 per ppb-1) in the airways. Aminoguanidine administration
      resulted in a significant reduction in Jno compared with administration of the saline
      solution control in eight healthy subjects and in eight patients with asthma but caused no
      significant changes in Calv or in Dno in either group.
    

Intervention name(s): Aminoguanidine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 500mg; 2ml
Other intervention name(s): Inhalation of aminoguanidine; Nebulase saline solution
Intervention MeSH terms: Pimagedine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma
Study of Safety and Immune Response of the Sm14 Vaccine in Adults of Endemic Regions
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical trial phase 2a is designed to assess the safety of the active ingredient
      (protein + adjuvant) and secondarily its immunogenicity in healthy male adults from 18 to 49
      years of age with a history of infection with intestinal and urinary schistosomiasis, living
      in the Valley of the Senegal River, a highly endemic area for schistosomiasis. Two arms in
      the study will test different doses of GLA-SE adjuvant (2.5 and 5 μg). This phase IIA in
      adults is considered to be a preliminary step in safety before starting trials in children in
      endemic areas to S. mansoni or S. haematobium, target population of the vaccine.
    

Detailed description: 
      A phase 2a trial, self-contained, open-label, randomized, dose-escalation study in two
      parallel arms receiving three (3) injections at D0, D28, D56; both groups receiving 50 μg
      Sm14 vaccine candidate solution, either combined with 2.5µg GLA-SE for the first group and
      5µg for the second one in adults living in a S. mansoni and S. haematobium endemic area.

      Sm14: recombinant protein produced in yeast following Good Manufacturing Practices (GMP)
      conditions, presented in vials containing 0.55 ml solution Sm14, 0.4 ml solution is diluted
      with 0.4 ml of GLA (Synthetic Glucopyranosyl lipid A) for intramuscular administration.

      Medical examinations are performed at D0 (before injection, 1 hr and 4 hr after), and a
      safety evaluation at 24 hrs and 48 hrs, after each injection.

      Blood analysis: Liver function tests - renal function tests - blood counts, at W-1 before
      inclusion, and then 7 days after each injections and at W13 and W21 during the follow-up.

      Blood samples for immune response analysis at time of each injection, and then W12 and W20.
    

Intervention name(s): Sm14; GLA-SE solution
Intervention type(s): Biological; Drug
Intervention description(s): Three 0.5 mL intra-muscular injections of the vaccine solution (50µg Sm14) will be administered on D0, W4, W8 (D = day, W = week).; Two (2) adjuvant concentrations will be made and packaged at 0.4 mL/vial, per GMP standards. One lot at the concentration of 10µg/mL for injection in the first cohort at 2.5µg GLA-SE/injection and one lot at the concentration of 20µg/mL for the second cohort intended to receive 5.0µg of GLA-SE/injection
Other intervention name(s): rSm14; Glucopyranosyl Lipid A in Stable Emulsion; Glucopyranosyl Lipid Adjuvant-Stable Emulsion; Toll-like Receptor 4 Agonist GLA-SE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Schistosomiasis; Recombinant vaccine; rSm14; GLA-SE; Fatty acid-binding protein (FABP); Phase II Clinical Trial; Senegal
Study Assessing the Position of Cricothyroid Membrane in Relation to Movement of Neck From Neutral to Extended Position
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      Ability to provide oxygen to patients undergoing general anaesthesia is crucial. This is
      traditionally provided using face mask, supraglottic airway (breathing tube above voice box)
      or endotracheal tube (breathing tube in wind pipe). However in some patients it may be
      impossible to provide oxygen through any of these above means which can be life threatening
      and lead to permanent brain damage/death. One of the ideal ways of managing this emergency
      situation is to pass a breathing tube through a membrane in the front of the neck called
      cricothyroid membrane with the neck in extension position where permitted. Many studies have
      recommended identifying the cricothyroid membrane before general anaesthesia in high risk
      patients but with their head in neutral position. This study will be a pilot study to check
      if the cricothyroid membrane remains in the same place in neutral and extended positions.
    

Detailed description: 
      This is a non-randomised observational pilot study. The results of the study will be used to
      determine the size of the sample required for a planned randomised controlled trial in the
      future. All the volunteers will be asked to lie on a trolley with the head in neutral
      position- Defined as alignment of external auditory meatus (outer ear canal) to the sternal
      angle (prominent portion of breast bone) is horizontal. A radiologist trained in ultrasound
      of the neck will identify the position of upper and lower border of the cricothyroid membrane
      using ultrasound and then mark these borders and the centre point with a black surgical
      marker pen. Then the volunteer will be asked to extend the neck and the same steps will be
      repeated using a red surgical marker pen. The distance between the two centre points will
      then be measured using a calliper/ measuring scale.
    

Intervention name(s): ultrasound
Intervention type(s): Procedure
Intervention description(s): ultrasound of the neck to identify the position of upper and lower border of the cricothyroid membrane.
Intervention model: Single Group Assignment
Intervention model description: Healthy volunteers
Masking: None (Open Label)
Primary purpose: Basic Science
Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study aims to investigate the postprandial effects of cocoa supplementation in glucose
      and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The
      investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal
      breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in
      patients with diabetes. Randomized cross-over controlled trial, in which participants will be
      assigned to the placebo or cocoa group with breakfast meal. Patients with type 2
      diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups
      cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive
      high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI)
      measurements will be conducted at fasting, 30 min, 1,2, 4 & 6 hours postprandial each day for
      2 days.
    


Intervention name(s): Cocoa polyphenols
Intervention type(s): Dietary Supplement
Intervention description(s): Cocoa polyphenols (960mg) reconstituted in water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: diabetes; cocoa polyphenols; postprandial glycemia; postprandial lipemia
Glucose, Activity, Diet, & Sleep Assessment Study
Condition: Metabolism Disorder, Glucose
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Observational

Summary: 
      GLADS is a cross-sectional, observational study assessing free-living diet, physical
      activity, sleep, and glucose profile over a 2-week period in healthy adult men and women.
    

Detailed description: 
      Monitoring free-living lifestyle behaviors can provide important information on behavioral
      determinants of health. New technologies have improved accessibility of ambulatory assessment
      of diet, biomarkers, physical activity, and sleep. The study will assess the effects of
      free-living diet assessed by questionnaire and sleep and physical activity measured by
      actigraphy on interstitial glucose measured by continuous glucose monitoring in healthy adult
      men and women over a 2-week period.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Observation of diet, physical activity, sleep and interstitial glucose
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult men and women willing to record food intake with their smartphone, complete online
        questionnaires, and wear body sensors to measure physical activity, sleep, and glucose.
Effects of Gaze Stabilization Exercises on Dizziness, Balance and Quality of Life in Cervical Spondylosis Patients
Condition: Dizziness; Balance; Distorted; Cervical Spondylosis
MeSH terms: Spondylosis; Vertigo; Dizziness
Study type: Interventional

Summary: 
      To determine the effects of gaze stabilization exercises on dizziness, balance and quality of
      life in patients with cervical spondylosis.
    

Detailed description: 
      A randomized controlled trial will be performed in which total 32 patients with cervical
      spondylosis will be included. The data will be collected from Riphah rehabilitation centre
      Lahore and Ittefaq hospital Lahore. The duration of study will be ten months. Dizziness
      handicap inventory, Romberg test and Vestibular Disorders Activities of Daily Living Scale
      will be used as data collection tools.

      Data collection will be started after taking informed consent from all patients.

      Patients will be allocated to intervention groups by randomization. The patients in group A
      will be given gaze stabilization exercises and habituation exercises along with neck
      isometrics for 4 weeks. The patients in group B will be given neck isometrics for treatment
      of cervical spondylosis for 4 weeks. After data collection, analysis of pre and post values
      will be done by using SPSS 25.
    

Intervention name(s): gaze stabilization exercises; neck isometrics
Intervention type(s): Other; Other
Intervention description(s): patients will perform gaze stabilization exercise, Static neck exercise, and Habituation exercise. Neck isometric exercises like isometric flexion, extension, lateral bending will be performed.; Patients in Conventional group will get neck isometric exercises like isometric flexion, extension, lateral bending.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be allocated to intervention groups by randomization. The patients in group A will be given gaze stabilization exercises and habituation exercises along with neck isometrics for 4 weeks. The patients in group B will be given neck isometrics for treatment of cervical spondylosis for 4 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dizziness; Balance; Distorted; Cervical Spondylosis