bioihbjkbjnl/mcl2 huggingface dataset:
Role of the Serotonin 5-HT2A Receptor in LSD-induced Altered States of Consciousness (LDR-Study)
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Serotonin receptors, especially the 5HT2A receptor, are thought to be involved in the effects
      of various recreationally used psychedelic substances such as LSD. LSD potently stimulates
      the 5-HT2A receptor but also 5-HT2B/C, 5-HT1 and dopaminergic receptors. LSD induces acute
      transient alterations in waking consciousness including visual perceptual alterations,
      audio-visual synesthesia, derealization and depersonalization. LSD has therefore been used as
      experimental tool ("psychotomimetic") in modern psychiatric research to study psychotic-like
      states and model psychosis in healthy subjects [1-5]. However, the dose-effects of 5-HT2A
      receptor stimulation by LSD has not yet been studied. Additionally, there is still very
      limited data to what extent the 5HT2A receptor contributes to LSD's effects and its role in
      the mediation of the full response to LSD at a high dose is unclear. A recent experimental
      human study showed the 5-HT2A receptor antagonist ketanserin fully blocked the subjective
      effects of a moderate dose of 100 µg of LSD [6]. But, whether the effects of a high 200 µg
      oral dose of LSD can be blocked by the selective pharmacological 5-HT2A antagonist ketanserin
      remains to be tested to confirm the critical role of the 5-HT2A receptor in more pronounced
      alterations of consciousness and perception. The present study therefore explores the role
      the 5-HT2A receptor in LSD-induced altered states of consciousness using escalating doses of
      LSD and the 5-HT2A receptor blocker ketanserin administered before a high dose of LSD.
    


Intervention name(s): LSD; LSD; LSD; LSD; LSD; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.025 mg LSD per os, single dose; 0.05 mg LSD per os, single dose; 0.1 mg LSD per os, single dose; 0.2 mg LSD per os, single dose; 0.2 mg LSD plus 40 mg ketanserin per os, single doses each; Capsules containing mannitol looking identical to the other drugs.
Other intervention name(s): Lysergic Acid Diethylamide; Lysergic Acid Diethylamide; Lysergic Acid Diethylamide; Lysergic Acid Diethylamide; Lysergic Acid Diethylamide
Intervention MeSH terms: Lysergic Acid Diethylamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Proposal for a New Classification of Secondary Cleft Lip and Nose Deformities in Repaired Unilateral Cleft Lip
Condition: Patients With Unilateral Cleft Lip With or Without Cleft Palate
MeSH terms: Cleft Palate; Cleft Lip
Study type: Observational

Summary: 
      Congenital cleft lip with or without cleft palate is one of the most common congenital
      malformations with an estimated incidence of about 1 every 500 to 700 live births. Cleft lip
      and palate are caused by a complex combination of many environmental and genetic factors
      sharing into the etiology. Patients with cleft lip and palate undergo multiple surgeries to
      reconstruct the anatomy and function to achieve symmetric, aesthetic, and functional
      nasolabial region. The most important goals of correction of the cleft are to achieve an
      acceptable facial appearance and psychological and social well-being for the patient and his
      or her family. Therefore, assessment of nasolabial appearance following cleft surgery remains
      an important parameter for evaluating the outcome of the procedure. Unfortunately, some
      residual deformities in the nasolabial region such as the abnormal shape of the nose, scar of
      the upper lip, uneven white roll, notched or excess vermilion border will remain noticeable.
      So, the assessment of secondary cleft nasolabial deformities needs a reliable rating scale.
      Although many scoring systems have been described in the literature, there is no globally
      accepted reliable one. A frequently used scoring system is the one proposed by Asher-McDade
      that uses frontal and lateral view masked prints of the nasolabial area. The use of
      three-dimensional (3D) imaging seems to be the most reliable in assessing cleft-related
      facial deformities. However, scoring based on two-dimensional (2D) photographs is easier to
      perform and more applicable in daily practice because all cleft patients are photographed
      during their treatment journey at predetermined intervals. Assessment of secondary nasolabial
      deformities in cleft patients in large numbers of patients helps compare the aesthetic
      results of the different treatment protocols and techniques.
    


Intervention name(s): Patients with Unilateral Cleft Lip with or without Cleft Palate
Intervention type(s): Other
Intervention description(s): 2 dimensional Photographs of patients with unilateral cleft lip with or without cleft palate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with repaired unilateral cleft lip with or without cleft palate who had undergone
        primary cleft lip repair surgeries during their first year of life at Sohag University
        Hospital from January 2006 to December 2020.
The Effect Of NS-0200 Versus Placebo On Hepatic Fat Content In Patients With Non Alcoholic Fatty Liver Disease
Condition: NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in
      patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare
      two doses of NS-0200 to placebo in NAFLD patients.
    

Detailed description: 
      This is a randomized, 16-week, placebo-controlled, double-blind study to evaluate the effect
      of two fixed-dose combinations of leucine, metformin and sildenafil, NS-0200 compared to
      placebo, on the reduction of liver fat in patients diagnosed with non-alcoholic fatty liver
      disease (NAFLD). Subjects meeting all the inclusion criteria and no exclusion criteria will
      be randomized to one of three study arms.

      The primary objective of this study is to evaluate the change in hepatic fat content assessed
      by proton-density-fat-fraction (PDFF) employing magnetic resonance imaging (MRI) in subjects
      from : Screening/Visit 2 (Day-7/Week-1) to Study Termination/Visit 8 (Day 112/Week 16)
      receiving two fixed-dose combinations of leucine, metformin and sildenafil compared to
      placebo. Secondary objectives will also assess changes in serum alanine aminotransferase
      (ALT) activity, change in circulating cytokeratin 18, a surrogate marker of
      necro-inflammation, change in HbA1c, change in fasting glucose, insulin and insulin
      sensitivity, change in blood lipids such as cholesterol, LDL, HDL, triglycerides, and changes
      in in C-reactive protein. In addition this study will evaluate the safety and tolerability of
      NS-0200.

      Patients will have two screening visits, the first to determine their eligibility based on
      lab tests and the second based on the percentage of hepatic fat assessed by MRI imaging. Once
      qualified, patients will be randomly assigned to either one of the treatment groups or the
      placebo control group and monitored for a total of 16 weeks. Patients will return to the
      clinic each month for lab tests, and routine examinations. At the conclusion of the treatment
      period patients will again undergo an MRI scan to examine the percentage of hepatic fat.
    

Intervention name(s): Leu-Met-Sil 0.5; Leu-Met-Sil 1.0; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NS-0200 low dose; NS-200 high dose; Placebo
Other intervention name(s): NS-0200-0.5; NS-0200-1.0; Control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Condition: Constipation
MeSH terms: Intestinal Diseases; Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      In the present study, the primary aim was to evaluate if oxycodone-naloxone combination
      compared to oxycodone reduced opioid induced constipation in patients with or without chronic
      opioid treatment undergoing spine surgery.
    


Intervention name(s): oxycodone-naloxone; Oxycodone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxycodone; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: constipation; opioid; Oxycodone; Oxycodone-naloxone; spine surgery
Pain Neuroscience Education in Chronic Musculoskeletal Pain
Condition: Chronic Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional

Summary: 
      Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high
      socio-economic costs, with many negative effects on quality of life. CMP affects the ability
      to perform work, social, recreational and domestic tasks by changing the mood and
      concentration of this population that suffers.

      In a study carried out in 2010, 17% of the Spanish population had experienced pain in the
      last month and according to the severity of symptoms 12% felt severe , 64% moderate and 24%
      mild pain. In this same study it is specified that 61% was due to back pain, 29% due to neck
      pain and 23% due to shoulder pain.

      Pain neuroscience education (PNE) has been shown as an effective treatment strategy in
      increasing knowledge and understanding of neurobiology, neurophysiology and pain processing,
      modifying beliefs about it, improving patient skills and encouraging to the accomplishment of
      physical and social activities in different chronic pathologies.
    

Detailed description: 
      Study design and setting: The design of the present study will be a quasi-experimental study
      with 2 follow-ups (one month and four months after intervention) that will be performed
      between Apr 2018 and Apr 2020 in public health system in Malaga, Spain. The outcomes will be
      assessed at baseline (t0), one month (t1) and four months after the physiotherapy treatment
      begins (t2). Written informed consent will be acquired for all participants prior to their
      participation.
    

Intervention name(s): PNE+Physiotherapy; Physiotherapy
Intervention type(s): Behavioral; Procedure
Intervention description(s): Physiotherapy cover kinesitherapy and exercises techniques. Besides that it will be covered the understanding and acknowledgement about how pain is processed.; Physiotherapy cover kinesitherapy and exercises techniques.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Education; Chronic pain; Musculoskeletal pain; Self-efficacy
Correlation Between Quality of Life and Severity of Parkinson's Disease
Condition: Parkinson Disease; Quality of Life
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This study aim to evaluate the correlation between Quality of Life (QoL) and severity of
      Parkinson's Disease (PD) by assessing the presence of an optimal cut-off point on the
      Parkinson's disease questionnaire (PDQ-39) as related to the Hoehn & Yahr (H&Y) scale in a
      cohort of Italian adults with PD.

      A multicenter, cross-sectional study was performed in central and northern Italy. This study
      was conducted on a cohort of consecutive individuals at three neurologic outpatient clinics.
      All participants were evaluated with the PDQ-39, and the severity of PD was recorded
      according to the H&Y scale by a neurologist. Receiver operating characteristic (ROC) curves
      and coordinates of the curve, which were visually inspected, were used to find cut-off points
      with optimal sensitivity and specificity. These were in turn used to determine the optimal
      PDQ-39 cut-off score for identifying disease severity according to H&Y stages.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H&Y scale by a neurologist.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fivehundred thirteen individuals with Parkinson's Disease (PD) were recruited, all of whom
        agreed to participate and were thus included in the study. From the general analysis
        resulted that the greatest number of participants were stage II, according to Hoehn & Yahr
        (H&Y), followed by stage III, stage I, and finally stage IV. Participants between the age
        of 50 and 69 were mainly stage I or II, while participants aged 70 to 89 had a greater
        severity of PD (stage II and III). Most women were in H&Y stage II and III, while most men
        were mainly in stage II, followed by stage I and III, with a very similar number of
        participants. A common result for all analyses was the presence of a very low number of
        participants with stage IV.
Using Question Prompt Lists During Pediatric Asthma Visits to Increase Adolescent Involvement
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized controlled trial with English and
      Spanish-speaking adolescents to compare the effectiveness of an adolescent "asthma question
      prompt list" with a supportive educational video intervention with usual care.

      The hypothesis of this study is that by showing the parents and adolescents the educational
      video and then providing the adolescents with the one-page "asthma question prompt lists" to
      use during their visits will improve: (a) asthma control, (b) adolescent self-efficacy in
      managing asthma, and (c) adolescent quality-of-life.
    

Detailed description: 
      The study uses a randomized controlled trial design stratified by provider to assess the
      impact of an adolescent "asthma question prompt list" combined with a supportive educational
      video emphasizing the importance of adolescent involvement and question-asking on
      communication during pediatric visits. This application is based on Social Cognitive Theory.
      Self-confidence or self-efficacy is a central component of Social Cognitive Theory (SCT)
      Application of Social Cognitive Theory (SCT) in asthma populations has shown that technical
      advice from providers is one external factor that can improve asthma management
      self-efficacy. Additionally, personal beliefs, such as outcome expectations, and family
      factors, such as parent and adolescent responsibility for asthma self-management, have been
      shown to affect adolescent self-efficacy and disease management outcomes. Prior work has
      found that adolescent self-efficacy in asthma management correlates strongly with health
      status, adherence, asthma medication device technique, asthma symptoms, and impact of illness
      on the family.

      All adolescents will have their medical visits audio recorded. The adolescent will be
      interviewed after his/her medical visit while his/her caregiver/parent completes a survey at
      the time of study enrollment. This same procedure will be used when the adolescent and
      caregiver/parents return for the 6- and 12-month follow-up visits.
    

Intervention name(s): Educational Video and Question Prompt List
Intervention type(s): Behavioral
Intervention description(s): Educational Video and Question Prompt List
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Communication; provider; caregiver; adolescent
Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder
Condition: SSRI-Refractory Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: Although atypical antipsychotic drugs (AAPDs) have been found effective in the
      augmentation of serotonin reuptake inhibitors (SRIs) for treatment-resistant
      obsessive-compulsive disorder (OCD) in short terms trials, there are few data on the
      effectiveness and safety of these agents in clinical settings over the long term.

      Method: Subjects (n=46) who responded to selective SRIs (SSRIs) in an initial 12-week trial
      were continued on SRI-monotherapy plus cognitive-behavioral therapy (CBT) for one year.
      Subjects (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such
      as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.
    

Detailed description: 
      More recently, second-generation atypical antipsychotic drugs (AAPD) that modulate both 5-HT
      and DA function, such as risperidone (RIS), olanzapine (OLZ) and quetiapine (QET), have been
      found effective in the augmentation of SSRIs for treatment-resistant OCD.

      Nevertheless, the AAPDs have been associated with common and serious adverse effects, such as
      body weight (BW) gain and metabolic dysregulation. Metabolic dysregulation includes
      glucoregulatory dysfunction and dyslipidemia. Indeed, studies of some AAPD in SSRI-refractory
      OCD patients have similarly reported significant BW gain. AAPD-induced BW gain may influence
      patients' adherence to medication and places them at risk for a broad range of medical
      problems.

      Most work on AAPDs in treatment-refractory OCD has been conducted in the form of short-term
      efficacy studies. There have been fewer studies of the effectiveness, safety, and
      tolerability of these agents in the context of a clinic where CBT is also provided, and where
      treatment is continued for a significant period of time. In the current effectiveness study,
      we sought to examine the response of SSRI-refractory patients to augmentation with AAPDs,
      comparing adverse events in such compared to a control group of SSRI responders.
    

Intervention name(s): atypical antipsychotic drug; exposure response prevention
Intervention type(s): Drug; Behavioral
Intervention description(s): For SSRI-refractory group, either atypical antipsychotic such as mean doses of RIS (3.1±1.9mg/day), of OLZ (5.1±3.2mg/day), and of QET (60.0±37.3mg/day) was added on ongoing SSRI(Paroxetine, Fluvoxamine).; After at least 12 weeks from treatment initiation, cognitive-behavioral therapy (CBT) using exposure and response prevention was added with psychoeducational interventions and behavioral analysis.
Intervention MeSH terms: Antipsychotic Agents
Keywords: obsessive-compulsive disorder; augmentation treatment; SSRI-refractory
Demographics and Clinical Characteristics of Paediatric Intraocular Inflammation in Singapore
Condition: Intraocular Inflammation in Children
MeSH terms: Uveitis; Inflammation
Study type: Observational

Summary: 
      Data on demographics, etiology, clinical features, diagnosis, secondary complications,
      treatment and outcomes of intraocular inflammation in children aged 16 years and below that
      presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to
      January 2017, will be retrieved and analyzed from the uveitis database retrospectively.

      The results will be compared with other published studies on different study populations.
    

Detailed description: 
      Data on demographics, etiology, clinical features, secondary complications, treatment and
      outcomes of intraocular inflammation in children aged 16 years and below that presented to
      uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989 to January 2017,
      will be retrieved from the uveitis database retrospectively.

      Data on demographics, etiology, clinical features, diagnosis, secondary complications,
      treatment and outcomes will be analyzed using statistical software.

      The results will be compared with other published studies on different study populations.

      The results of this study will lead to an improved clinical practice with better treatment
      selections and an optimised monitoring protocol for follow up care for our paediatric
      patients with intraocular inflammation. This will lead to better clinical outcomes and
      prevention of serious sight threatening complications.
    

Intervention name(s): No intervention. A retrospective case review
Intervention type(s): Other
Intervention description(s): No intervention. A retrospective case review on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre from January 1989 to January 2017.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 16 years and below diagnosed with intraocular inflammation in years and below
        that presented to uveitis clinic in Singapore National Eye Centre (SNEC) from January 1989
        to January 2017
To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalency of Cord's 100 mg Desipramine HCl tablets to
      Merrell Dow's 100 mg Norpramin tablets.
    


Intervention name(s): Desipramine HCL 100 mg Tablets Cord Laboratories; Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc
Intervention type(s): Drug; Drug
Intervention MeSH terms: Desipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Outcome of Sub-inguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchilagia With Normal Semen
Condition: Varices; Cord
Study type: Observational

Summary: 
      varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of
      varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes
      and others do not.

      Most study don't focus on varicocelectomy done for varicocele induced orchialgia,and those
      studies dont report on postoperative semen.

      This study will focus on the effect of operation on the semen postoperatively .
    


Intervention name(s): subinguinal varicocelectomy
Intervention type(s): Procedure
Intervention description(s): varicocele ligation done at the level of subinguinal region
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        there is no description
Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)
Condition: Hygiene
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the
      product Dermacyd Femina Delicata.
    


Intervention name(s): Lactoserum
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care