bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
Condition: Safety Issues; Immunogenicity
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent,
      children and infants.
    

Detailed description: 
      To describe the safety of this vaccine following one dose immunization in adults, adolescent,
      children and infants.

      To assess immunogenicity following one dose of Vi-DT vaccine immunization. To compare the
      safety and immunogenicity of Vi-DT to Vi polysaccharide vaccine in adults, adolescents, and
      children groups.

      To compare the safety and immunogenicity of Vi-DT to IPV vaccine in infants groups.

      Kinetics of Vi-specific IgG antibodies up to 6 months and 1 year after administration of 1
      dose of vaccine.

      To evaluate the safety and immunogenicity of Vi-DT co-administered with MR vaccine in infants
      (≥ 9months -23 months old).

      To evaluate the safety and immunogenicity of MR vaccine co-administered with Vi-DT vaccine in
      infants (≥ 9months -23 months old).
    

Intervention name(s): Vi-DT Vaccine; Vi Polysaccharide Vaccine; IPV Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 dose of Vi-DT Vaccine; 1 dose of Vi Polysaccharide Vaccine; 1 dose of IPV Vaccine
Other intervention name(s): Typhoid Conjugate Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subject aged 2 - 40 years old:
Randomized, observer-blind, superiority design compared to Vi polysaccharide vaccine.
Subject aged 6-23 months old:
Randomized, observer-blind, superiority design compared to Inactivated Poliomyelitis Vaccine (IPV).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High Order Spectral Analysis of Local Field Potential Data on a Subgroup of Parkinson's Disease Patients Who Are Carriers of Mutations in the Glucocerebrosidase (GBA) Gene Undergoing DBS Electrode Placement
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The aim is to study a specific group of PD patients, carriers of mutations in the
      glucocerebrosidase (GBA) gene, which is the most common genetic risk factor for PD and is a
      harbinger of aggressive cognitive and motor decline. Approximately 12-17% of PD patients
      undergoing DBS are GBA mutation carriers. GBA mutation carriers with PD have a specific
      phenotype characterized by more significant motor dysfunction and reduced short-term visual
      memory function compared with their non-GBA counterparts. Thus as GBA mutation carriers have
      a "signature" phenotype, the investigators hypothesize that these GBA mutation carriers have
      a unique "signature" of oscillatory activity that can be distinguished from non-mutation
      carriers during motor activation and during cognitive tasks. Identification of this
      "signature" will provide critical information that is required to: 1) understand the
      underlying neurophysiological mechanisms responsible for the aggressive disease course of GBA
      associated PD, and 2) further develop customized adaptive DBS systems.
    


Intervention name(s): collection of LFPs
Intervention type(s): Other
Intervention description(s): collection of local field potentials (LFPs) at rest and during hand opening and closing
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson's disease (PD) with and without mutations in the GBA gene who
        already have an implanted deep brain stimulator (DBS) device or those patients with PD-GBA
        mutation carrier who will be undergoing placement of a DBS device using standard technique
        with sedation and local anesthesia.
Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence
Condition: Cocaine Abuse; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Cocaine dependence is a major public health problem; an effective primary treatment for
      cocaine dependent individuals has yet to be found. The purpose of this study is to examine
      the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In
      addition, this study will examine the effects of incentive rewards for treatment compliance.
    

Detailed description: 
      Cocaine is a strong central nervous system stimulant that is widely abused throughout the
      United States. Due to its widespread use, it is important to develop an effective treatment
      for cocaine dependence. Levodopa is a medication that is used alone or in combination with
      carbidopa to treat Parkinson's disease. The purpose of this study is to determine the
      possible interactions between behavioral interventions and carbidopa/levodopa in order to
      treat cocaine dependent individuals.

      This study will last 12 weeks and will involve two phases. The first phase will include three
      therapy conditions: 1) clinical management only, 2) clinical management and relapse
      prevention therapy, and 3) clinical management, relapse prevention therapy, and contingency
      management. All of the conditions in the first phase will be evaluated incrementally under
      active and placebo conditions while participants receive carbidopa/levodopa.

      The second phase of the study will examine the contingency management procedure applications.
      Each of the three contingency management procedure applications targets specific behaviors
      that, when reinforced, may interact with carbidopa/levodopa to produce clinical benefits.
      Participants will receive relapse prevention therapy combined with a contingency management
      procedure that targets clinic attendance, medication compliance, and cocaine abstinence.
      Study visits will occur weekly throughout the study. In addition, participants will complete
      a one-year follow-up visit.
    

Intervention name(s): Levodopa; Carbidopa; Clinical Management; Relapse Prevention Therapy; Contingency Management
Intervention type(s): Drug; Drug; Behavioral; Behavioral; Behavioral
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cocaine addiction; cocaine treatment
The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
Condition: Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      This randomized, placebo-controlled, double-blind study evaluates the efficacy and
      tolerability of the allogeneic human adipose derived stem cell component extract on
      androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of
      allogeneic human adipose derived stem cell component extract per month or a placebo for 16
      weeks.
    

Detailed description: 
      This randomized, placebo-controlled, double-blind study evaluates the efficacy and
      tolerability of the allogeneic human adipose derived stem cell component extract on
      androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of
      allogeneic human adipose derived stem cell component extract per month or a placebo for 16
      weeks. Hair count and thickness will be primary outcomes.
    

Intervention name(s): stem cell component extract
Intervention type(s): Other
Intervention description(s): The Allogeneic Human adipose derived stem cell component extract
Other intervention name(s): Tiara hair toninc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Cognitive Remediation for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate treatments designed to improve cocaine treatment
      success by combining medications that target cocaine-related cognitive impairments.
    


Intervention name(s): levodopa/carbidopa; Ropinirole 2 mg/d; Placebo; Ropinirole 4 mg/d
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 800/200 mg/d; 2 mg/d; sugar pill; 4 mg/d
Other intervention name(s): ldopa; Requip; Requip
Intervention MeSH terms: Levodopa; Carbidopa; Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine; cognition; medication; treatment
Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the dose response effect of probiotic capsules for
      the prevention of antibiotic-associated diarrhea (AAD).
    


Intervention name(s): Probiotic; Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day; L. acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antibiotic; diarrhea; probiotic
A Study of MK0657 in Parkinson's Disease Patients (0657-006)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      In this clinical trial, the safety of MK0657 when given with levodopa will be assessed in
      patients with Parkinson's Disease. This study will also measure the effectiveness of MK0657,
      when given in combination with levodopa, to improve motor symptoms and ameliorate dyskinesias
      (uncontrolled movements of a part of the body) as compared to placebo.
    


Intervention name(s): MK0657; Comparator: Placebo (unspecified); Comparator: levodopa; Comparator: carbidopa
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 7mg MK0657 capsules; 7mg MK0657 Pbo capsules; levodopa >/=1.0 mg/kg/hr dose of levodopa. levodopa infusions will occur over a 2 hour period; carbidopa 25mg administered 3 times: at 1 hour before levodopa infusion and at 1 and 3 hours after the start of levodopa infusion.
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intervention Study to Compare the Natriuretic Effects of Enalapril on Low and High Salt Diet
Condition: Salt-sensitive Hypertension
MeSH terms: Hypertension; Hypersensitivity
Study type: Interventional

Summary: 
      The kidney plays a crucial role in maintaining salt balance by two opposing physiological
      mechanisms: the renal dopaminergic system which enhances salt excretion and the
      renin-angiotensin system (RAS) which causes salt retention. Salt-sensitive hypertension
      occurs when this balance is altered or abnormal. We hypothesized that this balance is
      influenced by salt intake: therefore dietary salt affects the natriuretic response to the
      renal dopaminergic agonist Fenoldopam, and the Angiotensin Converting Enzyme inhibitor,
      Enalapril.

      In this trial we study normal salt balance mechanisms in salt resistant adults with normal
      blood pressure.
    

Detailed description: 
      Eight adults of both genders and all races were studied in this double blind placebo
      controlled cross over study with randomization of the order of interventions. After 5 days
      each on low salt (about 1 gram/day) and high salt (about 6 grams/day)diet, with a washout
      period of at least four weeks in between, every subject was treated with Enalapril and
      Placebo on two consecutive days, followed by a Fenoldopam infusion for three hours, during
      which natriuresis and renal function testing were performed.
    

Intervention name(s): Fenoldopam
Intervention type(s): Drug
Intervention description(s): Intravenous infusion at 0.5 mics/Kg/min for three hours
Other intervention name(s): Enalaprilat; Corlopam
Intervention MeSH terms: Fenoldopam; Enalaprilat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Salt; Balance; Renin Angiotensin System; Fenoldopam\blood Pressure; Sodium
Investigation of the Effect of Body Mass Index and Anxiety on Masseter Muscle Thickness on Ultrasonography
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The aim of this study is to determine the effect of body mass index (BMI) and anxiety on
      masseter muscle thickness by using ultrasonography.
    

Detailed description: 
      The aim of this study is to determine the effect of body mass index (BMI) and anxiety on
      masseter muscle thickness by using ultrasonography.

      A total of 68 patients were included in this study. Height and weight of the patients were
      measured. BMI was calculated. The Control Group Without Anxiety - Normal BMI (15 patients)
      was composed of patients in general. Working groups were formed as High BMI & Anxiety Normal
      (19 patients), Normal BMI & High Anxiety (15 patients), and High BMI & High Anxiety (19
      patients). The Hospital Anxiety Depression Scale (HADS) was applied to the participants.
      Muscle thickness measurements were first measured by using the high-frequency linear scanning
      probe of an ultrasound device to measure the contraction and relaxation of the right masseter
      muscle. Then, the contraction and relaxation of the left masseter muscle was measured.
    

Intervention name(s): ultrasonography
Intervention type(s): Device
Intervention description(s): We used ultrasonography to measure the patients' masseter muscle thickness. Measurements were performed simultaneously for both the right and left sides using a high frequency linear scanning probe (13-6 MHz) of an ultrasound device (Fujifilm Sonosite Edge II). In order to prevent possible artifacts and oblique imaging, the probe was kept perpendicular to the skin surface, and the distance between the location of the hyperechoic linear appearance of the mandibular and temporal bone in the transverse section and the muscular fascia were measured.
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals in the Turkish population aged 18-45
      
Keywords: anxiety; body mass index; masseter muscle; obesity; ultrasonography
Assessment of ICP in Idiopathic Intracranial Hypertension Using Transocular Ultrasound and Transcranial Doppler
Condition: Idiopathic Intracranial Hypertension
MeSH terms: Intracranial Hypertension; Pseudotumor Cerebri; Hypertension
Study type: Interventional

Summary: 
      Idiopathic Intracranial Hypertension (IIH) is a rare disease, primarily affecting overweight
      females of child-bearing age. Patients suffer from increased intracranial pressure (ICP),
      typically resulting in headaches, visual disturbances and bilateral papilledema, pulsatile
      tinnitus and cognitive deficits. The disease is difficult to diagnose, treat and monitor. The
      only current method of measuring the ICP in day-to-day clinical practice is by lumbar
      puncture. This procedure is invasive, and often painful for the patient. There is an unmet
      need of methods that can reliable measure or estimate ICP in a non-invasive manner.
      Ultrasound is one such potential method, and the aim of this study is to investigate the use
      of ocular ultrasound and transcranial doppler to measure or estimate ICP.
    

Detailed description: 
      This study is a prospective cohort study. Investigators plan to include 50 patients in whom
      the IIH-diagnosis is suspected. Patients are referred from general practitioners,
      neurologists or ophthalmologists to the Danish Headache Center or admitted to the Neurology
      ward when the IIH diagnosis is suspected.

      As part of an established routine clinical work-up to establish the diagnosis of IIH, all
      patients will undergo (according to the Friedman criteria) the following examinations:

      A)

        1. An interview (history taking) and clinical examination

        2. Routine laboratory tests (blood tests)

        3. Ophthalmological examination

        4. Lumbar puncture with measurement of the ICP

        5. Magnetic resonance imaging (MRI) of the brain

      Additionally the following investigations will be performed at baseline (before and after
      lumbar puncture):

      B) Transorbital sonography (TOS) C) Transcranial Doppler When the patient is seen at the
      clinic for their regular follow-up visits the same measurements will be done.

      A control group of healthy participants (NR=25) will be included in whom TOS (B) and TCD (C)
      will be performed in order to compare the values between the patient group (IIH) and control
      group. Controls will be included to match the patients according to BMI, age and gender.

      All ultrasound images- and films will be saved, and evaluated by a blinded investigator.
    

Intervention name(s): TOS and TCD
Intervention type(s): Diagnostic Test
Intervention description(s): TOS: Transorbital sonography TCD: Transcranial Doppler
Intervention model: Single Group Assignment
Intervention model description: Single group, prospective cohort study with healthy controls.
Masking: None (Open Label)
Primary purpose: Diagnostic
Retrospective Study in FFPE Samples From Younger Patients With Rhabdomyosarcoma
Condition: Alveolar Childhood Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma
MeSH terms: Rhabdomyosarcoma; Rhabdomyosarcoma, Embryonal
Study type: Observational

Summary: 
      This retrospective study is looking into mechanisms of drug therapy resistance in FFPE
      samples in recurrent and refractory Rhabdomyosarcoma (RMS) in pediatric patients who have
      experienced lung recurrence. The study employs advanced techniques such as single-cell
      transcriptomics and spatial transcriptomics to gain a comprehensive understanding of these
      mechanisms.
    

Detailed description: 
      This research seeks to enhance our understanding of drug resistance mechanisms in recurrent
      and refractory RMS in pediatric patients, particularly in the context of lung recurrence. The
      utilization of cutting-edge techniques like single-cell transcriptomics and spatial
      transcriptomics allows for a more in-depth and comprehensive analysis of the molecular and
      spatial aspects of drug resistance in this challenging pediatric cancer.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All participants have previously been diagnosed with RMS, a rare and aggressive form of
        pediatric soft tissue cancer. Importantly, their RMS cases are characterized by recurrence,
        indicating that the cancer has returned after initial treatment, and refractoriness,
        meaning it has not responded well to standard therapies.

        A defining feature of the study population is the presence of documented lung recurrence.
        This signifies that the RMS has re-emerged specifically within the lung tissue. Lung
        recurrence is a critical clinical aspect being investigated in this study.
      
Biospecimen description: 
      FFPE samples
Thermal Suit With Forced-air Warming in Breast Cancer Surgery
Condition: Hypothermia, Accidental
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      The aim of this clinical investigation is to prove that the thermal suit with forced-air
      warming is more effective to prevent inadvertent intraoperative hypothermia than conventional
      warming methods. The study group will have the thermal suit from arriving to the hospital
      until to the ward after surgery. In the operating theatre forced-air warming device will be
      connected to the trouser legs of the thermal suit and the device will be turned on during
      surgery. The control group will have normal hospital clothes. Intraoperative warming will be
      managed with the warming mattress and a forced-air warming blanket. The primary endpoint is
      core temperature after arriving to the post-anaesthesia care unit.
    


Intervention name(s): Thermal suit; Conventional hospital clothes
Intervention type(s): Device; Device
Intervention description(s): Forced-air warming device will be connected to the trouser legs of the thermal suit.; The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: intraoperative hypothermia; thermal suit; forced-air warming
Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning in Impaired Glucose Tolerant (IGT) Men
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of feeding frequency on glucose and
      insulin metabolism and substrate partitioning in impaired glucose tolerant (IGT) men.
    


Intervention name(s): low feeding frequency (3x); High feeding frequency (14x)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 meals a day; 14 meals a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Insulin Metabolism; Glucose Metabolism; Substrate Partitioning; Muscle Biopsies; Feeding Frequency; Insulin
Geriatrics Balance and Low Back Pain Study
Condition: Distorted Balance; Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of standard of care treatments (physical therapy versus
      manual therapy) in older adult patients who have balance problems with or without low back
      pain.
    

Detailed description: 
      This study uses a randomized controlled research design and will enroll up to three hundred
      patients. Treatment will take place in outpatient facilities. It is hypothesized that among
      older adults with low back pain manual therapy will reduce low back pain and improve balance
      more than physical therapy; and that among older adults without low back pain manual therapy
      and physical therapy will be equally efficacious in improving balance. The results of this
      study will help to further define effective treatment protocols.
    

Intervention name(s): chiropractic; physical therapy
Intervention type(s): Other; Other
Intervention description(s): chiropractic; physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Balance; Falls; Low back pain; Geriatric