bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Attention Deficit/Hyperactivity Disorder; Developmental Delay
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      There are three purposes to this study. The first purpose is to evaluate the value of a
      genetic test in determining risk for autism spectrum disorder. Processing for genetic samples
      will be completed at the Cleveland Clinic using research equipment provided by IntegraGen.
      The second purpose is to identify genetic changes that may be associated with autism spectrum
      disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether
      genetic differences and changes may predict which individuals benefit from medicine used to
      treat attention problems or other psychiatric difficulties.

      Between 600-800 people are expected to participate in this study - approximately 300
      individuals with an autism spectrum disorder, 75 individuals with attention
      deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy
      siblings, and 125 unrelated individuals without a developmental or psychiatric disorder.

      Study procedures will vary based upon the specific group participants are suspected to fall
      into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental
      delay, healthy sibling, or unrelated healthy control).

        -  All individuals will be asked to participate in a cheek swab (gently swabbing the inside
           of your cheek) to obtain cells used for genetic testing. Genetic material will be stored
           with identifiers such as numbers, letters or codes.

        -  Parents or caregivers will be asked to complete questionnaires that examine medical and
           family history as well as current symptoms and quality of life for the participant.

        -  Participants may undergo speech and language testing. This involves answering questions,
           looking at pictures or identifying items.

        -  Information recorded in participant medical records will be reviewed and collected for
           this study.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        About 600 people will take part in this study - 300 individuals with an autism spectrum
        disorder, 75 individuals with attention deficit/hyperactivity disorder or another
        developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals
        without a developmental or psychiatric disorder.
      
Biospecimen description: 
      Genetic material via a cheek swab will be collected.
    
Keywords: Autism Spectrum Disorder; Attention Deficit/Hyperactivity Disorder; Developmental Delay
BG00012 Regional Absorption Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of
      monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part
      1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.
      The secondary objective of this study is to evaluate the safety and tolerability profile
      following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying
      regions within the GI tract in healthy volunteers.
    


Intervention name(s): dimethyl fumarate
Intervention type(s): Drug
Intervention description(s): tablet
Other intervention name(s): DMF; Tecfidera; BG00012
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AFF008E: Observational Phase 1b Follow-up Extension Study for Patients With Parkinson's Disease After Immunization With AFFITOPE® PD01A
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      AFF008E is set-up to assess the long term effects of the 4 PD01A vaccinations that have been
      applied during AFF008 with regard to safety as well as immunological-, radiological and
      clinical activity. Accordingly, during AFF008E, no further vaccine dose will be applied.
      Instead, patients who were participating in AFF008 will be assessed for another 52 weeks at
      the occasion of 4 quarterly visits. This is offered to patients who received PD01A
      vaccinations but also to the patients who served as controls in AFF008. Thus, AFF008E will
      ensure standardized and controlled management of individuals who have received PD01A as part
      of AFF008, the Phase I study analyzing for the first time in humans this first in class
      candidate.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only participants of AFF008 will be offered participation in AFF008E.
      
Biospecimen description: 
      Analyzing patients' DNA (isolated out of whole blood) for polymorphisms in genes/regions like
      REP1 or alpha-synuclein to correlate results with the progression rate of the disease.
Immediate Effects of Dry Needling and Tens in Chronic Neck Pain
Condition: Myofascial Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determinate the effects of percutaneous electrical nerve
      stimulation in the short-term for pain in patients with myofascial chronic neck pain.
    


Intervention name(s): Dry Needling; "TENS" and "dry needling"
Intervention type(s): Other; Other
Intervention description(s): Needling with acupuncture needle in a myofascial trigger point.; Application of TENS current after dry needling technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Neck pain; Myofascial pain syndrome; Soreness
Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction between Erdosteine and
      Bepotastine besilate in healthy adult volunteers.
    


Intervention name(s): Erdos; Talion; Erdos, Talion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): capsule, 300mg; tablet, 10mg; capsule 300mg and tablet 10mg
Intervention MeSH terms: Bepotastine besilate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Calorie Restriction, Protein Supplementation and Metabolic Health
Condition: Obesity; Menopause; Osteoporosis; Sarcopenia
MeSH terms: Osteoporosis; Sarcopenia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether consuming additional protein during calorie
      restriction induced weight loss has beneficial or harmful effects on multi-organ (liver,
      muscle, adipose tissue) insulin sensitivity, colonocyte proliferation rates, the gut
      microbiome, muscle mass and function, and bone mineral density in obese, postmenopausal
      women.
    


Intervention name(s): Weight loss with normal protein intake; Weight loss with protein supplementation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).; Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      To develop a pragmatic migraine model the investigators will induce headache in healthy
      volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO)
      donor. If the headache responds to sumatriptan, the model can be used to test new drug
      candidates.
    

Detailed description: 
      There remains a great need for more effective anti-migraine drugs with fewer side effects.
      Human experimental models are valuable in early phase development of new anti-migraine drugs
      but useful models have not yet been developed. The investigators' group has shown that
      Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, induce headache/migraine in both
      healthy volunteers and in patients with migraine without aura (MO). To validate this model,
      the headache must respond to specific migraine treatment with sumatriptan.

      Hypothesis: 5-ISMN induces a migraine-like headache in both healthy subjects and in
      MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.

      Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs
    

Intervention name(s): 5-ISMN (isosorbide-5-mononitrate); Sumatriptan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan; 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Other intervention name(s): Imdur; Imigran
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Different Techniques of Crestal Sinus Lift
Condition: Crestal Sinus Lift
Study type: Interventional

Summary: 
      Sixteen patients will be selected from those attending the outpatient clinic of the Oral &
      Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range
      from 20-50 years seeking implantation of their lost posterior maxillary teeth, [premolar and
      molars] with limited bone height below the floor of the maxillary sinus, secondary to sinus
      pneumatization.

      Group I (N = 8): The sinus membrane will be elevated by using balloon technique with
      simultaneous Implant placement.

      Group II (N = 8): The sinus membrane will be elevated by using Densah burs with simultaneous
      Implant placement.
    


Intervention name(s): crestal sinus lift using ballon technique; crestal sinus lift using densah burs
Intervention type(s): Procedure; Procedure
Intervention description(s): The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.; The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment
Condition: Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor; Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor; Haemophilia A
MeSH terms: Hemophilia A; Deficiency Diseases
Study type: Observational

Summary: 
      This multicenter, non-interventional, prospective study will collect information about
      activity status, bleeds, health-related quality of life (HRQoL), health status, and safety in
      participants with moderate or severe haemophilia A without factor VIII (FVIII) inhibitors,
      who are being treated in accordance with normal clinical practice.
    


Intervention name(s): Standard of Care for Haemophilia A
Intervention type(s): Drug
Intervention description(s): There is no pre-determined studied medicinal product. Any treatment (including treatments started during the observational period) will be administered according to standard clinical practice, independently of participation in the current study, according to clinician's independent therapeutic decision.
Intervention MeSH terms: Factor VIII
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 150 participants overall, 125 with severe haemophilia A and 25 with moderate
        haemophilia A without inhibitors against factor VIII (FVIII), are planned to be enrolled at
        sites across Italy.
      
Keywords: Hemophilia A; Factor VIII
Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients
Condition: Pulmonary Atresia With Ventricular Septal Defect; Tetralogy of Fallot With Pulmonary Atresia
MeSH terms: Heart Septal Defects; Tetralogy of Fallot; Heart Septal Defects, Ventricular; Pulmonary Atresia
Study type: Interventional

Summary: 
      The aim is to compare effective growth true hypoplastic pulmonary arteries using Right
      Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and
      systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)
    

Detailed description: 
      The use of femoral allogenic vein valve conduit for Right Ventricle Outflow Tract
      Reconstruction is good alternative systemic-to-pulmonary artery shunts (modified
      Blalock-Taussig shunt). Main advantages is straight, symmetrical, pulsating, systolic blood
      flow in hypoplastic pulmonary artery, which stimulate growth and prepares for a radical
      repair. Taking into account the absence randomized studies in this area of medicine,
      providing investigation evaluating parameters of safety for both methodics is very actual.
    

Intervention name(s): Experimental: RVOT reconstruction by femoral allogenic vein valve conduit; Systemic-to-pulmonary artery shunts
Intervention type(s): Procedure; Procedure
Intervention description(s): Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation; Modified Blalock-Taussig shunt performed between the right subclavian and pulmonary arteries or the left subclavian and pulmonary arteries of the type "end to side".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Femoral Allogenic Vein Valve Conduit; Rehabilitation of native pulmonary arteries
A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a
      monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral
      neuropathy (DPN)
    


Intervention name(s): PF-05089771 150 mg; Matched placebo for PF-05089771 150 mg and pregabalin 300 mg; Pregabalin 300 mg; PF-05089771 150 mg + Pregabalin 300 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.; Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.; Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.; PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Manual and Automatic Lancets on Pain and Stress in Newborn Capillary Heel Blood Collection
Condition: Newborn; Pain; Stress
Study type: Interventional

Summary: 
      Heel blood sampling is a routine but painful procedure for newborns. A limited number of
      international studies have shown that automatic lancets are more effective with less pain and
      tissue damage than manual lancets.

      In line with this information, this study was planned to investigate the effects of manual
      and automatic lancets on pain and stress in newborn capillary heel blood collection.
    


Intervention name(s): Automatic lancet
Intervention type(s): Device
Intervention description(s): An automatic lancet, which can reach a depth of 2.4 mm-3 mm, was used for safe piercing in babies.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Salt-FA to Increase Folate Levels
Condition: Neural Tube Defects; Folic Acid Deficiency; Spina Bifida; Anencephaly-Spina Bifida
MeSH terms: Spinal Dysraphism; Neural Tube Defects; Anencephaly; Folic Acid Deficiency
Study type: Observational

Summary: 
      Question: How effective is folic acid-fortified iodized salt in increasing serum folate
      concentrations among non-pregnant and non-lactating women of reproductive age? Hypothesis:
      Folic acid-fortified iodized salt can increase serum folate levels and serve as a policy
      consideration in salt fortification with both iodine and folic acid to reduce serious and
      fatal birth defects.
    

Detailed description: 
      Salt is an ideal vehicle for fortification because its universal consumption and often
      centrally processed with established distribution channels. Over 70% of households globally
      have access to iodized salt. Considering the success of salt iodization, it is logical to use
      the existing infrastructure to provide folic acid through this dietary mechanism.

      AIM:To assess increase in blood folate concentrations among women of reproductive age after
      they consume folic acid-fortified iodized salt.

      OBJECTIVES :

        1. To examine the effect of consumption of salt fortified with folic acid on serum/plasma
           folate concentrations among women of reproductive age.

        2. To estimate the raise in serum iron, B12 and folate levels after 3 months of study salt
           consumption.
    

Intervention name(s): Folic acid fortified iodized salt
Intervention type(s): Dietary Supplement
Intervention description(s): addition of folic acid to iodized salt to be consumed daily and assess rise in serum folate levels.
Intervention MeSH terms: Folic Acid
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women of childbearing age who are non-lactating and willing to consume the study salt for
        the duration were recruited for voluntary participation into the study.
Autonomic Cardiovascular Control in Response to Blood Volume Reduction in Blood Donors
Condition: Autonomic Dysfunction; Autonomic Imbalance; Blood Loss
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias; Hemorrhage
Study type: Observational

Summary: 
      The function of the autonomic nervous system can be assessed using baroreflex sensitivity
      (BRS) and heart rate variability (HRV). Decreased HRV has been shown to be predictive of
      morbidity and mortality in diverse medical conditions such as acute myocardial infarction,
      aneurysmal subarachnoid haemorrhage, autoimmune diseases, sepsis and surgery.

      The function of the autonomic nervous system has not yet been investigated in a "pure
      hypovolemia" model. The aim of the current study is therefore to investigate and describe the
      function of the autonomic nervous system prior to, during and after reduction of blood volume
      in healthy blood donors.
    


Intervention name(s): Monitoring of the autonomic nervous system
Intervention type(s): Device
Intervention description(s): Monitoring of the autonomic nervous system using E-patch, LiDCO and Root-Massimo.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy male volonteers, aged 30-45, that are eligable for blood donation following the
        Danish legislation
      
Biospecimen description: 
      10 mL of blood stored in a biobank
    
Keywords: Heart rate variabilty; Baroreceptor sensitivity; Autonomic nervous system; Acute blood loss; Blood donors; Autonomic cardiovascular control
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
Condition: Cow Milk Allergy
MeSH terms: Milk Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of a new Amino-acid based formula on
      allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to
      extensively hydrolysed formulas;
    


Intervention name(s): Amino acid based formula
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypersensitivity; Milk Hypersensitivity; Immune System Diseases; Food Hypersensitivity
Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary
      from patient to patient. The study population are HIV+ Thai individuals.
    

Detailed description: 
      This study will assess the inter-individual variability of indinavir drug levels, boosted
      with ritonavir, in Thai patients. Data will be collected in patients participating in the
      randomized study, "Monitoring Highly Active Antiretroviral Therapy (HAART) in HIV-infected
      patients in Thailand (PHPT-3)" (HSC 10668). The first 20 patents in PHPT-3 will have
      steady-state pharmacokinetic sparse sampling performed at pre-dose, and 1, 2.5, 4 and 12
      hours after drug intake 1 and 2 months after initiating IDV/r 400/100 mg, twice daily. IDV/r
      plasma concentrations will be determined by high performance liquid chromatography. This
      spare PK data will be pooled with indinavir concentration data collected within an intensive
      pharmacokinetic studies of IDV/r [Cressey TR, et al 2005, JAC, 55, p1041-44]. Population
      means and variances of indinavir and ritonavir pharmacokinetic parameters were estimated
      using non-linear mixed effects regression models (NONMEM Version VI). The validity of the
      final model was evaluated using a visual predictive check (VPC) and bootstrap re-sampling
      techniques.
    

Intervention name(s): Ritonavir-boosted indinavir
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Indinavir
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected Thai adults
      
Keywords: indinavir, HIV, ritonavir, pharmacokinetics, Thailand