bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Parents and Friends on Children and Adolescents
Condition: Healthy
Study type: Observational

Summary: 
      The objective of this study is to directly compare the effects of parents and friends on
      overweight and non-overweight children and adolescents' food intake and food selection using
      a cross-sectional design. Overweight and non-overweight children (5-6 year-old) and
      adolescents (13-14 year-old) will share a meal with a friend and with a parent on separate
      occasions. Participants' food selection and the amount of food they consumed will be compared
      across conditions.

      Hypothesis 1: The investigators hypothesize that overweight children and adolescents will
      select more unhealthy food items and eat more in the presence of an overweight friend than
      when eating with a lean friend; whereas lean participants eating with an overweight friend
      will eat a similar amount of food than lean youth eating with a lean friend.

      Hypothesis 2: The investigators predict that overweight children and adolescents (but not
      lean children and teens) will consume more food in the presence of their mother than in the
      presence of a friend.

      Hypothesis 3: The investigators also predict that overweight youth's energy intake will be
      related to parental prompts.

      Hypothesis 4: The investigators expect greater similarities in terms of food selection and
      food intake between adolescents and their friend than between adolescents and their parent.
    


Sampling method: Probability Sample
Study population: 
        Boys and girls ages 5-6 yrs and 12-14 yrs and their mothers.
      
Keywords: social influences; meals; obesity; amount of food consumed
A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the pharmacokinetics and safety of LY03003 in patients with
      advanced-stage PD.
    


Intervention name(s): LY03003
Intervention type(s): Drug
Intervention description(s): Rotigotine,extended-release microspheres
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parkinson disease; LY03003
Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
Condition: Blepharoptosis
MeSH terms: Blepharoptosis; Pain, Postoperative
Study type: Interventional

Summary: 
      Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a
      posterior approach. Patients who undergo this procedure are often given local anesthesia to
      alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal
      nerve block or subconjunctival injection combined with sedation in most cases. Both
      techniques are currently acceptable options for local anesthesia, however postoperative pain
      has not been systematically evaluated between these two techniques.

      The investigators aim to compare intra-operative and postoperative pain with these two
      techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will
      be randomized to receive local anesthesia via frontal nerve block or via subconjunctival
      injection. In addition, the investigators will measure the surgical outcomes of the ptosis
      surgery with standard measures.
    


Intervention name(s): Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine; Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
Intervention type(s): Procedure; Procedure
Intervention description(s): Frontal Nerve Block 5 cc will be administered preoperatively once.; Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Conjunctival Mullerectomy; Blepharoptosis; Ptosis surgery; Pain Control
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
Condition: Moderate to Severe Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional

Summary: 
      This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have
      therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two
      nonsteroid anti-inflammatory drops with topical corticosteroids.
    


Intervention name(s): nonsteroid anti-inflammatory drops; nonsteroid anti-inflammatory drops; corticosteroids; artificial tear substitute
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): nonsteroid anti-inflammatory drops plus artificial tear substitute; nonsteroid anti-inflammatory drops plus artificial tear substitute; corticosteroids plus artificial tear substitute; artificial tear substitute alone
Other intervention name(s): prunoprefen; bronuck; Fluorometholone
Intervention MeSH terms: Fluorometholone; Anti-Inflammatory Agents; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D, Blood Pressure, Lipids, Infection and Depression
Condition: Hypovitaminosis D
MeSH terms: Infections; Rickets; Avitaminosis; Vitamin D Deficiency; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      There are numerous indications for a relation between low serum levels of 25(OH)D and blood
      pressure, lipid levels, frequency of infections and tendency towards depression. Whether it
      is a causal relationship it is not known, and can best be studied with a vitamin D
      intervention. The investigators hypothesis is that supplementation with a high dose vitamin D
      (40.000 IU per week) will have a beneficial effect on these parameters.
    


Intervention name(s): Cholecalciferol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40.000 IU cholecalciferol per week for 6 months; placebo
Other intervention name(s): Decristol
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D; blood pressure; lipids; infection; depression
Bladder Wall Blood Perfusion Pattern and Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms, and the Association of That Perfusion Pattern and Therapeutic Efficacy of Antimuscarincs for Female Overactive Bladder Syndrome.
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Overactive bladder syndrome (OAB) affects around 17 % of female population. However, the
      etiology of OAB is complicated and unclear in many aspects. Bladder wall thickness had been
      reported to be strongly associated with OAB, but its use as a screening tool remains
      controversial. Besides, few studies reported patterns of sexual dysfunction in female
      patients with lower urinary tract symptoms (LUTS). Therefore the aims of our study were to
      analyze the bladder wall blood perfusion pattern in female LUTS patients, the association of
      between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic
      treatment for female OAB, and the patterns of sexual dysfunction in the female LUTS patients.
    


Intervention name(s): Tolterodine SR
Intervention type(s): Drug
Intervention description(s): Tolterodine SR 4 mg qd
Intervention MeSH terms: Tolterodine Tartrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LUTS
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass
Condition: Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit
      than the gastric bypass
    

Detailed description: 
      In the obese patient population, the frequency of patients presenting a severe morbid obesity
      (40 >= BMI <= 50), a super obesity (BMI >50), a super super obesity (BMI>60), and obese
      patients (BMI>35) with a failure of gastric banding is constantly increasing. In these
      patients, the surgery risk is proportionate to the weight and / or gastric surgery records.

      This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the
      evaluation of new procedure to reduce the morbidity allowing the reduction of morbid
      /mortality associated with the intervention.
    

Intervention name(s): Sleeve gastrectomy; Gastric Bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity; Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity
Other intervention name(s): SLEEVE; BYPASS
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Morbid obesity; Sleeve gastrectomy; Gastric bypass; Complications; Efficacity; Safety; Compare
Asthma Inpatient Research on Education
Condition: Asthmatic Attack
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Children with asthma are admitted for asthma attacks very frequently in the U.S. The families
      and children are given basic education about asthma but studies are needed to improve this
      education so that it makes a meaningful difference in health outcomes and asthma care. This
      study compares two inpatient education models for children hospitalized with asthma.
    

Detailed description: 
      The current standard is to review an asthma action plan with families and to review inhaler
      medication administration. In this study, investigators will be assigning families to either
      a control (current standard education) or and intervention group. In the intervention group,
      participants will receive interactive education based on learning theories that are thought
      to enhance long term memory. Participants in the interactive group will build their own
      action plan using colored templates and pictures. Participants will also learn to use their
      inhaler using teach-back methodologies. Investigators will then compare the two groups in
      terms of ER visits, hospitalizations, family confidence in managing asthma, asthma knowledge,
      and quality of life.
    

Intervention name(s): Interactive Asthma Education; Standard Asthma Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Active participation to develop asthma action plan and teach back cycles for asthma inhaler teaching/training; Basic review of asthma action plan and inhaler use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effect of Early Coma Arousal Therapy on Conscious Level Recovery and Cognition in Traumatic Brain Injury
Condition: Traumatic Brain Injury With Loss of Consciousness
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Unconsciousness; Wounds and Injuries
Study type: Interventional

Summary: 
      PURPOSE:

      The aim of this study is to investigate the effect of early coma arousal therapy on conscious
      level and cognitive function in sever traumatic brain injury patients.

      BACKGROUND:

      Traumatic brain injury (TBI) could be simply defined as an alteration in brain function due
      to external forces and is considered as one of the leading cause of death and disability
      worldwide, especially among young adults and the elderly. Current estimates imply that annual
      incidence of TBI is 50-60 million worldwide, and specifically for Europe and USA, 0.5% of
      Europeans and 1.1% of Americans are experiencing a TBI each year.

      The original scale has since been revised and is known as the Rancho Los Amigos Revised Scale
      (RLAS-R). One of the limitations of the original eight level scale was that it did not
      accurately reflect the individuals with higher levels of recovery. Two more levels were added
      to the initial eight level Ranchos Scale to create a more comprehensive ten level scale named
      the Rancho Los Amigos Revised Scale (RLAS-R).
    

Detailed description: 
      The aim of this study is to examine the early effect of coma arousal therapy on Conscious
      Level Recovery and Cognition in Traumatic Brain Injury. forty two patients will be selected
      and they will be assigned in to two different group, a study group where will they recieve
      coma arousal therapy in addition to conventional therapy and a control group where they will
      recieve only the conventional physical therapy program.
    

Intervention name(s): Coma arousal therapy; Selected physiotherapy program
Intervention type(s): Other; Other
Intervention description(s): early coma arousal therapy program in addition to selected physical therapy program (positioning, breathing exercise, passive movement of the four limbs).; selected physiotherapy program only (positioning, breathing exercise, passive movement of the four limbs).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after
      repeated oral dosing to patients with schizophrenia.
    


Intervention name(s): Lu AF35700; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Thyroxin in Subclinical Hypothyroidism
Condition: Sub Clinical Hypothyroidism; Pregnancy Loss
MeSH terms: Hypothyroidism
Study type: Interventional

Summary: 
      Subclinical hypothyroidism(SCH) is the elevated thyroid stimulating hormone (TSH) with normal
      free Thyroxine levels and it is a mild or compensated form of primary hypothyroidism. It has
      been suggested that SCH is more prevalent in infertile women (especially in women with
      ovulatory disorders.Various rates of SCH was reported in infertile women in different
      populations
    

Detailed description: 
      Despite well-established recommendations on screening and treatment of overt hypothyroid in
      infertile women, there is a controversy regard the treatment of SCH in infertile women .

      There are few published data on the prevalence of SCH and the outcome of treatment of SCH in
      infertile women, many were conducted during IVF cycles . Moreover there are inconsistent
      results in these studies being authors advised to treat SCH before IVF and some other
      articles find out no any benefit regarding treatment with Thyroxine in SCH
    

Intervention name(s): Thyroxine
Intervention type(s): Drug
Intervention description(s): Thyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed
Other intervention name(s): Euthyrox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Unexplained Infertility, pregnancy rate,hypothyroidism
Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional
Phase: Phase 4

Summary: 
      Haemorrhoids are vascular cushions in the anal canal that help in the control of stool. When
      inflamed they become pathological and may present with protrusion and bleeding. A randomized,
      triple blind , controlled study will be conducted to compare the efficacy of calcium
      dobesilate against flavanoids in the management of early haemorrhoidal disease.
    


Intervention name(s): Flavonoids; CDobi
Intervention type(s): Drug; Drug
Intervention description(s): Daflon is administered; Calcium dobesylate is administered
Other intervention name(s): Daflon; dobesilate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the
      "revitalizing" activity of a face cream applied twice a day, morning and evening, for an
      uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face
      ritidosis and women aged 55-65 years not habitual user of antiage-creams.

      The study foresaw the comparison within subjects of the study product versus placebo (half
      face method).

      It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the
      volunteers and tolerance both by investigator and volunteers.
    


Intervention name(s): plantaricin a (active product); placebo product
Intervention type(s): Other; Other
Intervention description(s): Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage; Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: skin aging; anti-aging cream; wrinkles
Echinacea Junior vs Vitamin C in Children 4-12 Years Old
Condition: Respiratory Tract Infection Viral
MeSH terms: Infections; Respiratory Tract Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg)
      in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract
      infections.
    

Detailed description: 
      200 children aged 4-12 years are recruited by pediatricians and general practitioners and are
      allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C.
      Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment
      break and an intermediate study visit (V2). Thereafter children continue with preventive
      Treatment for another 2 months, followed by exclusion visit (V3).

      Parents are required to contact a study coordinator at the occurrence of acute respiratory
      Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode
      parents will sample nasal secretion, which will be analysed for common respiratory agents.
    

Intervention name(s): Echinaforce
Intervention type(s): Drug
Other intervention name(s): Echinacea purpurea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate Drug-Drug Interaction of TAK-788 With Itraconazole and Rifampin in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the effect of itraconazole (Part 1) and rifampin
      (Part 2) on the single-dose pharmacokinetics (PK) of TAK-788 and its active metabolites
      (AP32960 and AP32914) in healthy adult participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-788 (Mobocertinib). The study assessed the
      drug-drug interaction of TAK-788 with either a strong cytochrome P-450 (CYP)3A inhibitor,
      itraconazole (Part 1) or with a strong CYP3A inducer, rifampin (Part 2) in healthy adult
      participants.

      The study enrolled 24 healthy participants. The study was designed to consist of 2 parts:
      Part 1- TAK-788 assessment with itraconazole Part 2- TAK-788 assessment with rifampin. Part 1
      had 2 cohorts:

      Part 1: Participants (n = 12) received a single oral dose of 20 mg capsule of TAK-788 on Day
      1 of Period 1 followed by 200 mg itraconazole oral solution once daily (QD) in Period 2 on
      Days 1 to Day 14 and a single oral dose of TAK-788 20 mg capsule were coadmistered on Day 5
      of Period 2.

      In Part 2 participants (n = 12) received a single oral 160 mg dose of TAK-788 capsules in
      Period 1 of Day 1 followed by 600 mg capsules of rifampin QD in Period 2 Days 1 to Day 13 and
      a single dose of 160 mg TAK-788 capsules was coadministered on Day 7 of Period 1. There was a
      washout period of 7 days between the dose of TAK-788 on Period 1 and the first dose of
      rifampin in Period 2.

      This single-center trial was conducted in the United States. The overall time to participate
      in this study was approximately 120 days (including screening period). Participants were
      contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-788; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-788 Capsules; Itraconazole Oral solution; Rifampin Capsules
Other intervention name(s): Mobocertinib
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy