bioihbjkbjnl/mcl2 huggingface dataset:
Neurobiology of Sensory Phenomena in Obsessive-Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The Research Domain Criteria (RDoC) approach seeks to address the neurobiological mechanisms
      of sensory symptoms in patients with obsessive-compulsive disorder (OCD) by investigating
      dimensional components of behavior that more closely align with brain circuitry. This project
      focuses on the dimensional symptom of sensory phenomena (SP), which are uncomfortable or
      aversive sensory experiences that drive repetitive behaviors in OCD, including "not just
      right" sensations, physical urges, and sensations of disgust. SP are very prevalent,
      occurring in 60-80% of OCD patients, and experienced as highly distressing. Unfortunately, SP
      are not well addressed by standard treatment approaches, which may be in part because their
      neurobiological mechanisms are not well understood.

      This project builds on our preliminary data to (1) investigate the neural mechanisms of SP in
      large OCD cohort showing the full range of SP severity and (2) probe for familial risk
      markers in unaffected siblings of patients. For Aim 1, SP will be measured in 100 OCD
      patients using the Sensory Phenomena Scale. Diffusion and fMRI data will be acquired during
      rest and fMRI tasks. In order to identify familial risk markers, Aim 2 will compare sensory
      phenomena and neural circuitry between OCD probands, 50 unaffected biological siblings of OCD
      patients, and 50 unrelated healthy controls without a family history of Axis 1 disorders.
    

Detailed description: 
      This project investigates the neurobiological mechanisms of sensory symptoms in patients with
      obsessive-compulsive disorder (OCD) and their siblings using task-based fMRI, resting-state
      functional connectivity, and diffusion MRI approaches. OCD is a chronic disorder presenting a
      high public health burden. Treatment presents a particular challenge because OCD is extremely
      heterogeneous, with clusters of symptoms likely derived from differing neural etiologies.
    

Intervention name(s): Tasked based functional MRI (fMRI); Eye Tracking Device
Intervention type(s): Other; Other
Intervention description(s): 2-3 brief computer tasks while brain activity is being measured. The tasks performed will involve making button press responses to letters, numbers or shapes on the computer screen.; Camera aimed at eyes to record eye movements during tasks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Nitric Oxide, LPS and the Pathogenesis of Asthma Phase 1
Condition: Healthy; Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of the study is to determine the role of nitric oxide (NO) in asthma. We
      determine the effect of promoter polymorphisms in the gene for the NO producing enzyme,
      nitric oxide synthase (NOS2), on exhaled NO in healthy African Americans and Caucasians. We
      compare exhaled NO levels between African Americans and Caucasians. Information on race or
      ethnicity, serum samples, blood pressure, exhaled breath condensate and health questionnaires
      will be collected.
    

Detailed description: 
      The purpose of the study is to determine the role of nitric oxide (NO) in asthma. We
      determine the effect of promoter polymorphisms in the gene for the NO producing enzyme,
      nitric oxide synthase (NOS2), on exhaled NO in healthy African Americans and Caucasians. We
      compare exhaled NO levels between African Americans and Caucasians. Information on race or
      ethnicity, serum samples, blood pressure, exhaled breath condensate and health questionnaires
      will be collected.

      Three single nucleotide polymorphisms (SNPs) have been identified in Africans that are
      associated with increases in systemic NO production. These studies determine whether the NOS2
      promoter SNPs are associated with differences in basal exhaled NO levels. The study of
      exhaled NO levels in individuals with asthma is confounded by the presence of cell types
      besides bronchial epithelium that produce NO, by differences in the severity of asthma and by
      the use of medications such as corticosteroids which alter exhaled NO levels.

      Therefore, in this study exhaled NO levels in asymptomatic healthy African Americans and
      Caucasians are measured. The initial analysis of exhaled NO levels indicate that a subset of
      African American samples contained lower levels of NO than previous measurements of exhaled
      NO levels in Caucasians. Because differences in exhaled NO levels may influence
      bronchodilation and other airway responses, as part of this study, the exhaled NO levels of
      the African American subjects are compared to the results of sample collections from
      Caucasian samples.

      In addition to measures of exhaled NO levels, information on race or ethnicity and DNA
      samples are collected to characterize samples collected from African American and Caucasian
      subjects. Serum samples, measures of blood pressure and exhaled breath condensate samples are
      collected from African Americans and Caucasians to control for confounding variables.
      Repeated measures of exhaled NO levels are collected to control for fluctuations in exhaled
      NO levels related to upper respiratory infections.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Serum samples, DNA, Exhaled Breah Condensate
    
Keywords: Healthy; Asthma; Nitric Oxide
Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years
Condition: Hernia, Inguinal
MeSH terms: Recurrence; Hernia, Inguinal
Study type: Interventional

Summary: 
      the study is basically aimed at comparing two techniques of herniotomy by comparing there
      recurrence rates
    

Detailed description: 
      in this study, the principal investigator will operate upon patients aged between 2 years and
      12 years by two techniques. in technique called mitchell banks technique, inguinal canal will
      not be opened and in Fergusson gross technique, it will be opened
    

Intervention name(s): Herniotomy
Intervention type(s): Procedure
Intervention description(s): In Mitchell Banks Herniotomy, one of investigators will do herniotomy without opening inguinal canal and in Ferguson Gross Herniotomy , one of investigators will do herniotmy by opening inguinal canal.
Other intervention name(s): Mitchell Banks Herniotomy; Fergusson Gross Herniotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A will get Mitchell Banks herniotomy done and Group B will get Fergusson Gross Herniotomy done.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Influence of n-Acetylcysteine Maintenance on Alcohol Effects
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate the behavioral effects of alcohol during placebo and
      n-acetylcysteine maintenance using sophisticated human laboratory methods.
    


Intervention name(s): Alcohol; Placebos; N-acetyl cysteine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.; Subjects will receive placebo capsules; Subjects will receive n-acetyl cysteine capsules
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
BIO 300 Oral Powder Safety and Pharmacokinetics
Condition: Acute Radiation Syndrome
MeSH terms: Radiation Injuries; Acute Radiation Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, single ascending dose and multiple single dose study in healthy volunteers to
      evaluate the safety and pharmacokinetics of BIO 300 Oral Powder (BIO 300). The single
      ascending dose study consists of 4 ascending dose cohorts and the multiple single dose study
      consists of a single dose given daily for 6 consecutive days.
    


Intervention name(s): BIO 300 Oral Powder
Intervention type(s): Drug
Intervention description(s): Amorphous solid dispersion of genistein milled into a powder
Other intervention name(s): BIO 300; Genistein
Intervention MeSH terms: Genistein
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
Condition: Suture Line Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      A comparison of the rate of surgical site infections after cesarean section depending on the
      type of suture used for subcutaneous closure-continuous versus interrupted.
    

Detailed description: 
      Patients at term that are candidates for elective cesarean section will receive an
      explanation regarding the study and sign informed consent. Patients will then be divided
      randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:

        1. Interrupted sutures.

        2. Continuous sutures. Information regarding medical and obstetric history will be
           collected for each patient.
    

Intervention name(s): Subcutaneous tissue closure
Intervention type(s): Procedure
Intervention description(s): Subcutaneous tissue closure with 2-0 vicryl suture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Intravenous Paracetamol for Postoperative Pain
Condition: Pain, Postoperative; Recovery of Function; Child
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to define if intravenous paracetamol may improve analgesia and
      outcome in pediatric surgical patients treated with non-steroidal anti-inflammatory drugs
      (NSAIDs) postoperatively.

      Hypothesis: intravenous paracetamol in a dose 60 mg/kg/24 h IV, given in addition to IV
      ketoprofen (4,5 mg/kg/24h), improves analgesia and physical recovery in children and
      adolescents following surgery.
    

Detailed description: 
      Patients aged 1-18 years undergoing general, plastic or orthopedic surgery with expected
      moderate to severe pain at least for 24 hours postoperatively, who meet inclusion criteria
      and does not meet exclusion criteria, are enrolled. At the end of surgical procedure, at skin
      closure, all patients are given 1,5 mg/kg intravenous ketoprofen and repeated every 8 hours
      up till 4,5 mg/kg/24 h. Patients in paracetamol group are additionally given the first dose
      of IV paracetamol 20 mg/kg and repeated 6 and 20 hours postoperatively up till 60 mg/kg/24 h.
      Patients in the placebo group are given 0.9% sodium chloride 2 ml/kg IV and repeated 6 and 20
      hours postoperatively.

      After surgery optional rescue analgesia is given on patient request: either tramadol in a
      dose of 2 mg/kg (up till 4 mg/kg/24h), either patient-controlled analgesia (PCA) with
      morphine, as indicated according to the standard of care. Patients are evaluated up till 24
      hours postoperatively. After that patients are followed up as long as indicated per standard
      of care.
    

Intervention name(s): Paracetamol; Placebo (for paracetamol); Ketoprofen; Tramadol; Morphine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients.; administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.
Other intervention name(s): Acetaminophen; 0.9% sodium cloride solution; Normal saline solution; Izotonic saline solution; Ketonal; Tramal
Intervention MeSH terms: Acetaminophen; Ketoprofen; Morphine; Tramadol; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain, Postoperative; Paracetamol; Administration, Intravenous; Anti-Inflammatory Agents, Non-Steroidal; Child; Adolescent
Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy
Condition: Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators aim to investigate the differences between deep continuous muscle
      relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in
      respect to metabolic changes and respiratory mechanics.
    


Intervention name(s): Rocuronium
Intervention type(s): Drug
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility
Condition: Polycystic Ovary Syndrome; Infertility, Female
MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The purpose of the study to evaluate effect of nitroglycerin trans-dermal patches on uterine
      and sub-endometrial blood flow in women with unexplained infertility.
    

Detailed description: 
      90 female patients will be divided into 2 equal groups:

        -  Group I: 30 female patients with unexplained infertility.

        -  Group II: 30 female patients with unexplained infertility will receive nitroglycerin
           trans-dermal patch.

      All subjects will be subjected to the following:

        -  Proper history taking on past medical history, menstrual history and infertility workup.

        -  Proper examination (general, abdominal and local examinations)

        -  Investigations to diagnose unexplained infertility ( male partner's semen analysis as
           well as documented ovulation and a patent uterine cavity and Fallopian tubes in the
           female partner).

        -  Group II (30 patients with unexplained infertility)will receive: (nitrodermal®) 5 mg
           (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the
           follicles ≥ 18 mm just for one cycle

        -  All women included in each group will be subjected to trans-vaginal ultrasound for
           folliculometry till maturation of the follicle ≥18mm.

        -  Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and
           sub-endometrial blood flow.

        -  All women in each group will be subjected to urinary luteinizing hormone (LH) assay. The
           urinary LH assay will be started on cycle day 11, and repeated daily till detection of
           the LH surge.

        -  Six days after detection of the LH surge, 3D power Doppler will be repeated to assess
           the uterine and sub-endometrial blood flow.
    

Intervention name(s): Nitroglycerin; Three dimensional power doppler
Intervention type(s): Drug; Device
Intervention description(s): (nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle.; Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and subendometrial blood flow
Other intervention name(s): nitrodermal patch
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 90 female patients will be divided into 3 equal groups:
Group I: 30 female patients with unexplained infertility.
Group II: 30 female patients with unexplained infertility will receive nitroglycerin trans-dermal patch.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Nitroglycerin Trans-dermal Patch
A Study to Investigate in Healthy Volunteers (Part 1) and in Patients With Type 2 Diabetes Mellitus (Part 2) the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of RO6799477
Condition: Healthy Volunteer, Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of RO6799477 following once daily oral administration for 2 weeks in healthy
      volunteers (Part 1) and in Type 2 diabetes patients (T2D) (Part 2). The anticipated time on
      study treatment is two weeks.
    


Intervention name(s): Placebo; RO6799477
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo daily oral administration; Daily oral administration of RO6799477
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Naproxen Codeine in Arthroscopic Surgery
Condition: Arthroscopic Meniscus Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, the aim is to compare the efficacy of single dose naproxen sodium and
      combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients
      undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more
      advantageous than naproxen alone.
    

Detailed description: 
      Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine
      phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a
      nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic
      datas, possible side effects, pain and sedation levels of patients were recorded. Patient's
      pain and sedation levels were statistically assessed.
    

Intervention name(s): Group N:Naproxen sodium; Group NC :naproxen sodium codeine phosphate
Intervention type(s): Drug; Drug
Intervention description(s): drug will be given 60 minutes before surgery; drug will be given 60 minutes before surgery
Other intervention name(s): Apranax fort tb, Abdi Ibrahim Ilaç,Turkiye; Apranax plus tb, Abdi Ibrahim Ilac, Turkey
Intervention MeSH terms: Naproxen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Naproxen-codeine; preemptive analgesia; day case surgery
A Study Of Three PF-05190457 Formulations In Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the plasma drug concentrations of three formulations
      of PF-05190457 after administration of single doses to healthy volunteers.
    


Intervention name(s): PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457; PF-05190457
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state; 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state; 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state; 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state; 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state; 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state; 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state; 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Single Doses; Biocomparison; Pharmacokinetics; Healthy Volunteers
Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.
Condition: Lyme Borreliosis
MeSH terms: Borrelia Infections; Lyme Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted
      in two study phases: a run-in phase and a main study phase. The study was investigated 3
      doses of a multivalent OspA (Outer Surface Protein A) based Lyme vaccine (VLA15) in healthy
      adults aged 18 to 65 years of age. Study participants received 3 immunizations of the vaccine
      at a monthly interval. The study assessed the immune response as well as the safety profile
      of the vaccine.
    

Detailed description: 
      This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.

      In the Run-in phase, a total of 120 subjects aged 18 to 40 years were randomized 1:1:1:1 to
      receive one of three VLA15 doses (VLA15 low dose (90 µg), VLA15 medium dose (135 µg), VLA15
      high dose (180 µg)) or Placebo as intramuscular vaccinations on Days 1, 29 and 57.

      Dosing was adjusted by injection volume.

      In the Main Study phase, a total of 452 subjects aged 18 to 65 years were randomized 2:2:1 to
      receive VLA15 135 µg or VLA15 180 µg, the two dose groups were selected from the Run-in-Phase
      or placebo, as intramuscular vaccinations on Days 1, 29 and 57. Subjects were enrolled in two
      age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.

      In both study phases, target was to enroll approx. 10 % or more of subjects that were
      baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).
    

Intervention name(s): VLA15; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate; Placebo: PBS (Phosphate Buffered Saline)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: VLA15, Lyme Borreliosis, Vaccine