bioihbjkbjnl/mcl2 huggingface dataset:
EP4-receptor Antagonism and Prostaglandin E2 (PGE2) in a Human Headache Model
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether EP-4 receptor antagonist can prevent the
      headache expected during a Prostaglandin E2 infusion.
    


Intervention name(s): BGC20-1531
Intervention type(s): Drug
Intervention description(s): oral administration followed by Prostaglandin E2 infusion
Other intervention name(s): EP-4 receptor antagonist
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pain, Discomfort, and Functional Impairments During Rapid and Slow Maxillary Expansion
Condition: Maxillary Constriction
MeSH terms: Constriction, Pathologic
Study type: Interventional

Summary: 
      This study will assess and compare the levels of pain, discomfort, and functional impairments
      between rapid and slow maxillary expansion in treating skeletal maxillary constriction in the
      early adolescence period (i.e. between 12 and 16 years).

      The study sample will consist of 32 patients who suffer from a skeletal posterior crossbite.
      The sample will be allocated randomly into two groups: RME group and SME group.

      The patients will be asked to fill out the attached questionnaires at three assessment times.
    

Detailed description: 
      Skeletal maxillary constriction is a popular orthodontic malocclusion that can be seen at any
      age. The maxillary expansion is the most important treatment choice of this skeletal problem
      in the upper jaw. There are many types of maxillary expansion regarding the force amount and
      the number of expansion times: slow maxillary expansion (SME) rapid maxillary expansion
      (RME), and semi-rapid maxillary expansion (SRME).

      Practitioners are conscious that complaints submitted by children and adolescents during the
      active phase of expansion, such as pain, discomfort and oral ulcers are common symptoms. This
      trial of two parallel groups will compare the pain, discomfort and functional impairments
      accompanying the rapid and slow maxillary expansion in early adolescent patients.

      RME group: A bonded modified Hyrax palatal expander will be applied. SME group: A removable
      palatal expansion appliance with a midline screw will be applied.

      To assess the pain, discomfort and functional impairments, patients will be asked to fill out
      questionnaires of six questions: 1) What is the degree of pain/discomfort you have
      experienced?; 2) Do you have difficulty in mastication?; 3) Do you have difficulty in
      swallowing?; 4) Do you have a sense of tension or pressure in soft tissue?; 5) Do you have
      swelling in soft tissue?; and 6) How easy is the treatment procedure?.
    

Intervention name(s): Modified Hyrax Palatal Expander; Removable Palatal Expander
Intervention type(s): Device; Device
Intervention description(s): The rapid maxillary expansion will be performed. The expansion should be accomplished between 10 to 15 days at most. The screw is going to be turned in a rapid manner.; The slow maxillary expansion will be performed. The expansion will be performed in a slow manner. Patients may need between 6 to 8 months to achieve the required expansion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: posterior crossbite; rapid maxillary expansion; slow maxillary expansion; pain; discomfort
Bronchopulmonary PK of AT-527 (R07496998)
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of
      AT-527 (R07496998)
    


Intervention name(s): AT-527
Intervention type(s): Drug
Intervention description(s): administered twice daily (BID) for 2.5 days (5 doses in total)
Other intervention name(s): RO7496998
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The LATCHING Pilot Project
Condition: Breastfeeding
Study type: Interventional

Summary: 
      The purpose of this study is to learn if group-based phone counseling is effective for
      increasing breastfeeding rates, reducing the early introduction of solids and increasing
      maternal weight loss after pregnancy.
    


Intervention name(s): Behavior Lifestyle Intervention; Usual prenatal care
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will be involved in group-based counseling. Sessions will be about 1 hour each and comprise up to 10 people. The sessions will be led by a trained health educator. The calls will be a chance for participants to discuss challenges with breastfeeding, problem solving skills, educational information, and discuss balanced diet topics.; Participants will receive the standard education given by their OBGYN or other healthcare provider. No additional breastfeeding, nutrition or postpartum weight loss education will be provided to participants by the investigators during pregnancy. After delivery, participants will follow normal pediatric visit schedule.
Other intervention name(s): Group-based phone counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: group-based counseling; phone counseling; conference calls
The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism
Condition: Deep Venous Thrombosis
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Observational

Summary: 
      The purpose of this study is to determine the effectiveness of infrared thermal imaging in
      adjunctive diagnostic screening for lower limb deep venous thrombosis (DVT).
    


Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        DVT patients included in this study had been definitively diagnosed as having DVT with CPUS
        and/or angiography. Included non-DVT volunteers were confirmed to be without DVT with CPUS.
        The healthy volunteer group matched the DVT group in number, age, and gender.
      
Keywords: infrared thermal imaging; deep venous thrombosis
Lower Limb Compression Prevents Hypotension After Epidural in Labor
Condition: Labor Pain; Maternal Hypotension
MeSH terms: Hypotension; Labor Pain
Study type: Interventional

Summary: 
      The goal of this study is to determine whether the use of sequential compression devices
      (lower limb compression) can reduce the rate of maternal hypotension after epidural, and
      therefore reduce the incidence of fetal heart tracing complications during labor.
    

Detailed description: 
      Maternal hypotension during epidural anesthesia in laboring patients can cause a number of
      problems for both mother and fetus. Despite standard anesthesia protocols designed to
      minimize the occurrence of hypotension during epidural placement, approximately 30% of
      laboring patients will still experience clinically significant hypotension. Maternal
      hypotension can affect placental blood flow causing fetal bradycardia and academia, as well
      as maternal symptoms such as dizziness, nausea, and vomiting. Therefore, there is a need for
      improved management of women in labor at time of epidural placement to avoid negative
      consequences for mother and fetus. We plan to investigate whether the use of lower limb
      compression devices at the time of epidural would decrease maternal hypotension.

      Pregnant women who request epidural anesthesia during labor will be recruited and enrolled in
      this single site, randomized controlled trial. Patients will be randomized into either
      control or sequential compression device (SCD) groups. Following epidural, blood pressures
      will be measured at 1, 5, 15, 30, 45, and 60 minutes and rates of hypotension with subsequent
      fetal heart tracing abnormalities will be recorded.
    

Intervention name(s): Sequential compression devices
Intervention type(s): Device
Intervention description(s): Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.
Other intervention name(s): Lower extremity intermittent compression devices
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization of patients to either control or study groups.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Epidural anesthesia; Lower extremity compression
A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia
Condition: Benign Prostate Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with
      benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.
    

Detailed description: 
      This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced,
      double-blind study. After obtaining the written consent, patients meeting the eligibility
      criteria at the preliminary enrollment will receive oral administration of placebo in a
      single-blinded manner (single-blind placebo run-in period). Then, patients meeting the
      eligibility criteria at the main enrollment will receive drug or placebo (double-blind
      treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to
      confirm the safety of the study drugs after the treatment period (safety follow-up period).
    

Intervention name(s): ASP4901; Tamsulosin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): YM617; Harnal
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASP4901; BPH
iPeer2Peer Program for Adolescents With Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older
      mentor who has learned to manage their IBD well and can support them emotionally and
      socially. This study will compare two groups of teens: those who are in the iPeer2Peer
      program and those in the control group (no mentor).
    

Detailed description: 
      The iPeer2Peer program matches teens with Inflammatory Bowel Disease (IBD) with an older
      mentor who has learned to manage their IBD well and can support them emotionally and
      socially. This study will compare two groups of teens: those who are in the iPeer2Peer
      program and those in the control group (no mentor).

      The proposed trial aims to examine the impact of the iPeer2Peer program on self-management
      skills of youth with IBD (mentees) as well as health outcomes of peer mentors in the program.
      This innovative program leverages the Internet, commonly used by youth, to improve access and
      acceptability of self-management interventions while fostering social engagement in youth
      with IBD, thereby potentially improving HRQL.
    

Intervention name(s): iPeer2Peer program; Waitlist control
Intervention type(s): Behavioral; Other
Intervention description(s): In addition to standard care, youth in the experimental group will receive the iPeer2Peer Program. The iPeer2Peer program is a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with IBD aged 18-25 years) who have learned to function successfully with their disease. Mentors will encourage youth to develop and engage in disease self-management skills and provide social support.; The control group will receive standard care but without the iPeer2Peer Program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Condition: Cervicobrachial Neuralgia; Myofascial Pain Syndromes
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Neuralgia; Brachial Plexus Neuritis; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Several studies have previously examined the use of botulinum toxin serotype A for myofascial
      pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:

        1. inclusion of confounding conditions in the proband group, and

        2. inability to identify predictors of response.

      This study attempts to define the characteristics of responders to botulinum serotype A for
      myofascial pain of the neck and shoulders (cervicobrachial syndrome).
    

Detailed description: 
      Design: Single-center, double-blind, placebo-controlled, enriched trial.

      Subjects will wash-out of their existing pain medications at least 2 weeks prior to baseline
      visit. At baseline, patients with a Numerical Pain Rating of 4 or greater will be injected
      with Botulinum Toxin Serotype A. At 14 weeks postinjection, those who at the 6 weeks
      post-injection visit had at least a 50% decrease in their pain outcome measures will be
      randomized into one of two treatment groups. Group 1 will receive a second BTX injection
      while group 2 will receive an injection of saline and both groups will be followed for an
      additional 6 weeks.
    

Intervention name(s): Botulinum toxin serotype A
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Botulinum toxin serotype A; Cervicobrachial syndrome; Myofascial pain; Cervicothoracic myofascial pain; Propulsion; Postural abnormality
Transverse Abdominis Plane Block in Laparoscopic Ventral Hernia Repair
Condition: Ventral Hernia
MeSH terms: Hernia; Hernia, Ventral
Study type: Interventional

Summary: 
      The current study aims to determine if transverse abdominis plane block using local
      anesthetic agents (bupivacaine 0.25% + Ropivacaine 0.20%) decreases the post operative pain
      and helps in early mobilization or discharge from hospital in patients undergoing
      laparoscopic ventral hernia repair.
    

Detailed description: 
      Patients meeting inclusion criteria would be randomised after admission. Those patients in
      experimental arm shall receive the TAP block under USG guidance while those in control arm do
      not receive any block. Surgery shall be proceeded in the usual manner in all the patients and
      assessment for pain starts in the immediate post operative or recovery room after the patient
      is completely conscious. The total amount of analgesic required by the patient is measured.
      Pain assessment is done using the visual analog scale (VAS) at regular intervals until follow
      up review.
    

Intervention name(s): Laparoscopic ventral hernia repair with TAP block; Laparoscopic ventral hernia repair without TAP block
Intervention type(s): Procedure; Procedure
Intervention description(s): Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery; No block administered during Laparoscopic ventral hernia surgery
Other intervention name(s): Bupivacaine 0.25% and Ropivacaine 0.2% subcutaneous injection
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective double blinded balanced allocation, randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TAP block; laparoscopic IPOM; post operative pain
A Study of the Bioequivalence of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish bioequivalence of paliperidone ER tablets
      manufactured at Gurabo as compared to paliperidone ER tablets manufactured at Vacaville,
      administered as a single dose of 12 mg under fasted conditions to healthy male volunteers,
      and to assess the safety and tolerability of both formulations.
    

Detailed description: 
      This is a randomized, open-label, 2-way crossover study in healthy male adults.The study
      consists of a screening phase and an open label treatment phase during which each patient
      will receive the 2 treatments of the study drug separated by a washout period of 7 to 14
      days. Treatment A will consist of a single oral dose of 12-mg paliperidone ER, tablets
      manufactured at Gurabo, administered under fasted condition. Treatment B will consist of a
      single oral dose of 12-mg paliperidone ER, tablets manufactured at Vacaville, administered
      under fasted condition. Blood samples for pharmacokinetic analysis will be collected at
      pre-dose and for 96 hours post-dose for each period. As a change in manufacturing site will
      take place, bioequivalence between 12 mg tablets (highest dose strength) from the 2
      production sites (Gurabo [Puerto Rico, USA] and Vacaville [California, USA]) needs to be
      demonstrated. This pivotal bioequivalence study is designed to examine the pharmacokinetics,
      safety, and tolerability of paliperidone ER manufactured at Gurabo in comparison with
      paliperidone ER manufactured at Vacaville

      Two single oral doses of paliperidone ER 12 mg
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paliperidone ER; Schizophrenia, Mood disorders, Antipsychotic drugs
A Study to Investigate Efficacy, Tolerability and Safety of ABY-035 in Patients With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, prospective, multicenter, randomized, double-blind, placebo-controlled,
      dose finding trial in parallel-groups with primary endpoint at Week 16 (visit V9) to
      investigate the efficacy, tolerability, safety, pharmacokinetics and immunogenicity of
      ABY-035 in adult patients with PsA.
    

Detailed description: 
      The study evaluates two dose levels of ABY-035, in comparison to placebo, in subjects with
      psoriatic arthritis. The clinical trial duration is 72 weeks (Screening - last FU visit)
      comprised of up to 4 weeks of screening, 44 weeks of double-blind-treatment, and 24 weeks of
      follow-up.

      Treatment Periods are:

        -  Treatment Period I: from V1 (Week 0) to V9 (Week 16)

        -  Treatment Period II: from V9 (Week 16) to V16 (Week 44: last dosing)

      At visit V1 (Week 0), patients who meet the entry criteria will be randomly assigned in equal
      rates (1:1:1) to one of three parallel groups (A, B, C).

      The treatment will be administered once every 2 weeks (Q2W).

      Patients assigned to groups A and B will receive active treatment from V1 to V16 (group A =
      40 mg ABY-035; group B = 80 mg ABY-035). Patients initially assigned to placebo will switch
      to active treatment at visit V9 in a blinded fashion (group C = Placebo from V1 to V8 and 80
      mg ABY-035 from V9 to V16).
    

Intervention name(s): ABY-035; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): ABY-035 solution for injection; Placebo to ABY-035 solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of the Involvement of 15q11 - q13 Chromosome Region and CYFIP1 Gene in Autism. Attempt a Genotype-phenotype Correlation
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      Autism, ranked among the '' pervasive developmental disorders' (ASD), is characterized by
      disturbances in the areas of reciprocal social interaction, communication and behavior,
      interests and activities restricted, repetitive. Various studies indicate that autistic
      disorder is subjected to a genetic predisposition, most likely polygenic and heterogeneous.
      However, no major gene responsible for this disorder has yet been identified. Given the link
      between the Fragile X syndrome (the most common form of mental retardation (MR) hereditary)
      and autistic behavior, it seems interesting to look, also, a possible link to the molecular
      level. Among the proteins interacting with FMRP (absent protein in fragile X patients), the
      investigators were interested to CYFIP1, protein encoded by the gene CYFIP1 appears to be a
      good candidate gene involved in the RM and autism by its chromosomal position and function.
      As FMR1, CYFIP1 is expressed in the brain cortex, hippocampus and Purkinje cells of the
      cerebellum. This protein co-localizes and interacts with Rac and FMRP, which are both
      involved in neurogenesis and cognitive development. In humans, the gene encoding CYFIP1 is
      located in the 15q11-q13. Now, the only autosomal abnormalities most frequently observed in
      autism are those involving the proximal 15q region, including duplications or 15q11-q13
      triplications interstitial, of maternal origin.

      These data suggest that an / or more autism genes responsible are probably present in the
      15q11-q13 chromosomal region, although no gene has yet been identified. Thus, the study of
      the role of CYFIP1 gene in patients with autism spectrum disorders would most likely
      contributory.

      The investigators wish to study the involvement of the 15q11-q13 chromosomal region and
      CYFIP1 gene in autistic disorder in a hundred patients from the Autism Resource Centre (ARC)
      Nice PACA antenna, over a two year period.

      The diagnosis and assessment report of children likely to be included in this study will be
      conducted at ARC Nice. Balance sheets are made according to the recommendations of the High
      Authority of Health for diagnosis of infantile autism and PDD. These children are then sent
      to the Genetic Consultation Nice Hospital where an analysis of the background and a specific
      morphological examination will be realized..
    


Intervention name(s): Genetic test
Intervention type(s): Genetic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic