bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Sodium Thiosulfate on Urine Chemistries of Hypercalciuric Stone Formers
Condition: Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional

Summary: 
      Sodium thiosulfate may be useful to prevent recurrence of calcium-containing kidney stones.
      It will be studied in people with high amounts of urine calcium.
    

Detailed description: 
      The investigators study is designed as a pilot study to study the effect of STS on urine
      chemistries in stone formers and normal controls. It is expected to continue for a duration
      of 1 year and will have two groups: 20 normal controls, who are healthy subjects without
      known kidney disease or nephrolithiasis, and 20 subjects with documented recurrent
      nephrolithiasis and hypercalciuria. Patients will be recruited from Dr Goldfgarb's stone
      clinic at VA Hospital and controls would be voluntary participants from NYU School of
      Medicine. Subjects who are pregnant or nursing, taking alcohol or drugs, have known CKD or
      are unable to give consent would be excluded from the study. Any diuretics or citrate
      containing drugs would be held for a period of 2 weeks during the study period to achieve
      washout of the effects of those drugs on urine chemistries. Oral STS 10mmol (10ml of 25% STS)
      BID will be administered to both groups for 7 days; four 24 hour urine collections, 2 prior
      and 2 at the end of the study, would be done with all participants. A diet diary would be
      maintained by subjects concomitantly during the study periods. The investigators then plan to
      compare the two groups in terms of urine chemistries to detect any changes in these
      parameters with thiosulfate administration. Based on prior animal experiments and human
      studies with STS the investigators anticipate that it would have a favorable effect on the
      supersaturation of Ca oxalate/phosphate and therefore its long term use would be helpful in
      preventing nephrolithiasis.
    

Intervention name(s): Sodium thiosulfate
Intervention type(s): Drug
Intervention description(s): Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days
Intervention MeSH terms: Sodium thiosulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nephrolithiasis; calcium stones; kidney stones; hypercalciuria; sodium thiosulfate; Calcium containing kidney stones
Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury
Condition: Traumatic Brain Injury; Cognitive Dysfunction; Blast Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Blast Injuries; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study investigates the efficacy of a novel neurorehabilitation program combining
      noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive
      therapy, on cognitive function and quality of life in individuals with blast-induced
      traumatic brain injury (bTBI).
    

Detailed description: 
      The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive
      deficits, such as executive functioning and memory. This study evaluates a combined
      rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for
      treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is
      not painful and does not involve any needles or any form of surgery. It acts by delivering a
      magnetic stimulation to a particular brain region. Half of the study participants will
      receive cognitive intervention with active TMS, and a control group will receive cognitive
      intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston
      Healthcare System and Beth Israel Deaconess Medical Center.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS); Cognitive Intervention
Intervention type(s): Device; Behavioral
Intervention description(s): Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.; Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI.
All participants receive weekly cognitive treatment sessions for 10 weeks.
Other intervention name(s): Transcranial Magnetic Stimulation; Noninvasive Brain Stimulation; Magstim Corporation; Cognitive Rehabilitation; Cognitive Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: Blast Traumatic Brain Injury; Cognitive Rehabilitation; Transcranial Magnetic Stimulation; Combined Treatment
Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception
Condition: Ovulation Inhibition
Study type: Interventional
Phase: Phase 4

Summary: 
      Quick starting combined oral contraception containing estradiol hemihydrate/nomegestrol
      acetate is effective to inhibit ovulation in healthy reproductive age women and
      non-inferiority to combined oral contraception containing ethinyl estradiol/gestodene.
    

Detailed description: 
      This study is a randomized control, non-inferiority trial which compare the proportion of
      ovulation between two oral combined pills when delay starting the first tablet at
      mid-follicular phase of menstrual cycle in 18 - 40 year old, healthy women with prior normal
      and regular periods. Participations will be undergone trans-vaginal or trans-rectal
      ultrasonography between day 1 - 3 of menstrual period for evaluation of ovarian follicle/cyst
      (if present). Only women who have normal looking of ovaries without dominant ovarian follicle
      will be included in study-protocol. Immediately after trans-vaginal/trans-rectal ultrasound
      between day 7 - 9 of menstrual period, all participants will be randomly assigned to receive
      one pack of investigated pills (1.5 mg estradiol hemihydrate/2.5 mg nomegestrol acetate or 20
      mcg ethinyl estradiol/75 mcg gestodene) and to take the first tablet under direct observation
      by research-nurse. Participants will take one consecutive tablet at about the same time each
      day until complete pack. The next appointments will be every 2 - 3 days to monitor ovarian
      function by using Hoogland score until ovulation or follicular quiescence will be presented.
      The last visit will be about 1 week after complete pack to monitor adverse effect and safety
      through out the protocol.
    

Intervention name(s): Zoely; Meliane ED
Intervention type(s): Drug; Drug
Intervention description(s): quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate; quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene
Other intervention name(s): estradiol hemihydrate combined pills; ethinyl estradiol combined pills
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two intervention groups
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: quick starting contraception
Emotion Regulation in Trait Schizotypy
Condition: Trait Schizotypy
Study type: Interventional

Summary: 
      Our aim is to compare state anger and state emotion regulation strategies in healthy
      individuals with high trait schizotypy and to look at differences of induced anger, negative
      emotions, decrease of positive emotions and aggressive behaviour after anger induction. Our
      further aim is to compare conditions where an instruction to suppress or reappraise emotions
      is given with a control condition with no instruction.
    


Intervention name(s): instruction to suppress; instruction to reappraise; control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): "It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort. Next, try not to think of the situation that makes you angry, mad or irritated. Please try as much as you cannot to think about the situation, don't think about how you feel or what had happened, and try to suppress your emotions and not to feel them. It's very important to try as much as you cannot to think about the situation that makes you angry, mad or irritated." (Szasz, Szentagothai, & Hoffmann, 2011); "It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort. Next, please try to tell yourself that or would be preferable that the others are nice and/or fair to you, but if they are not, it does not mean that you or they are worthless human beings. It would be preferable that the others be nice and/or fair to you but if they are not, remember that it is only (very) bad), not catastrophic (the worst thing that could happen to you). It would be preferable that others are nice and/or fair to you, but if they are not, you can tolerate it, and go on enjoying life, even if it's more difficult at the beginning." (Szasz et al., 2011); No instruction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Physical exercise has been identified as a major item of many chronic diseases and cancer
      rehabilitation. It contributes to an improvement in the quality of life and to a decrease in
      the current treatment side effects and mortality. Cancer in association with treatment
      toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems
      in daily activities. The physical capacity and the tolerance for exercise fall simultaneously
      leading to a deconditioning vicious circle which increases physical, psychological and
      emotional symptoms of fatigue. Therefore, physical activity for health is a valid and
      relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the
      study is the assessment of the effects of a physical activity retraining program on aerobic
      capacity, strength and fatigue, in a breast cancer population treated by adjuvant or
      néoadjuvant chemotherapy.
    


Intervention name(s): physical activity
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the pharmacological and cognitive effects of MDA
      in healthy humans.
    


Intervention name(s): MDA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subjects will receive a single oral dose of MDA 98mg/70kg body weight; Subjects will receive a single oral dose of placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: MDA; MDMA; Ecstasy; entactogen; pharmacokinetics; pharmacodynamics; Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers
Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation
Condition: Wounds
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate safety and efficacy of topically applied
      Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic
      surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower
      eyelids. The study will observe the effects of the topical agent over the course of 1 month
      following the initial treatment.
    


Intervention name(s): GLYC-101 Gel (0.1%); GLYC-101 Gel (1.0%); GLYC-101 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.; Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.; Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: burn wounds; wound healing
Near Infrared Technology for the Detection of Proximal Caries
Condition: Caries,Dental
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      This study aims to determine the effectiveness of an intraoral scanner with near-infrared
      imaging (NIRI) for the diagnosis of proximal caries.
    

Detailed description: 
      A total of 639 proximal surfaces (mesial-distal) of 22 volunteers without restoration of
      premolars and molars were examined. Results were scored for 4 different examination methods;
      intraoral examination by visual-tactile method (VTM), bitewing radiography (BWR), panoramic
      radiography (PR) and near-infrared imaging (NIRI). Scoring was made according to the type of
      lesion (0:no caries, 1:early enamel lesion(EEL), 2:lesion involving the
      dentin-enamel-junction (DEJ). Data were analyzed with IBM-SPSS-V23. McNemar-Test was used for
      comparison between the methods. The Kappa Test was used to examine the agreement between two
      methods in categorical data, and the Fleiss-Kappa Test was used to assess the agreement
      between more than two methods. The analysis results are presented as
      frequency(percentage).The significance level was considered p<0.05.
    

Intervention name(s): Near infrared imaging
Intervention type(s): Device
Intervention description(s): In the study, all volunteers are recorded with the itero Element 5D by activating the NIRI mode. The recording method does not involve ionizing radiation. 850 nm wavelength beams are used.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients who have treatment appointments at Marmara University Faculty of Dentistry,
        Department of Restorative Dentistry
Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine whether treatment with a single 800mg dose of
      AZD9056, a medication which has been developed as a possible treatment for Rheumatoid
      Arthritis, has an effect on the function of the retina
    


Intervention name(s): AZD9056; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet, 800mg, one single administration; Single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Electroretinography; Rheumatoid Arthritis; Anti-TNF; Disease Modifying Anti-Rheumatic Drugs (DMARD)
Pilot Study of Deep Brain Stimulation (DBS) in Area LC for Chronic Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and effectiveness of deep brain stimulation (DBS) for
      patients with a big or very big problem with tinnitus (a sensation of noise in the head).
    

Detailed description: 
      This is a single institution, open-label, phase I clinical trial to estimate the treatment
      effect size and to assess preliminary safety and tolerability of DBS in the caudate nucleus
      (area LC) in adults with a big or very big problem (tinnitus functional index TFI>50) with
      chronic tinnitus. Up to 10 subjects will be implanted. The DBS stimulation parameters are
      patient-specific and will be allowed to vary over the course of the treatment periods,
      calibrated by the TFI. During Period I, stimulation will be continuous. During Period II,
      there will be three stimulation OFF/ON epochs, where the stimulation will be turned OFF and
      then turned back ON when the tinnitus loudness returns to a certain level (based on a change
      in the TFI score). During Period III, stimulation will be "on demand," i.e. controlled by the
      subject and determined by subject preference. An important goal is to determine whether
      tinnitus can be controlled through optimization of stimulation parameters.
    

Intervention name(s): Deep Brain Stimulation (DBS)
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulation (DBS) bilaterally in area LC.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: deep brain stimulation
Analgesic Current Therapies for Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Does the use of analgesic current therapies increase the effectiveness of neck stabilization
      exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a
      randomized, controlled, single-blind study
    

Detailed description: 
      Analgesic therapies; such as interferential current (IFC) and transcutaneous electrical nerve
      stimulation (TENS) have been applied solo or combined with exercise for management of neck
      pain (NP), however, the efficacy of these combinations are unclear. In this study, our
      objective were to determine if TENS or IFC increase the effectiveness of neck stabilization
      exercises on pain, disability, mood, and quality of life for chronic NP. 81 patients with
      chronic NP were included in the study. Patients were randomly assigned into 3 groups; Group
      I: neck stabilization exercise, Group II: TENS+ neck stabilization exercise and Group III:
      IFC+ neck stabilization exercise. Patients' pain levels (visual analogue scale (VAS)),
      quality of life (short form- 36), mood (Beck depression inventory (BDI)), levels of
      disability (Neck Pain and Disability Index) and the need for analgesics were evaluated prior
      to treatment, at 6th and 12th week follow-up. All participants had group exercise accompanied
      by a physiotherapist for 3 weeks and an additional 3 weeks of home exercise program.
    

Intervention name(s): Neck stabilization exercise; TENS; IFC
Intervention type(s): Other; Other; Other
Intervention description(s): Exercise; Transcutaneous electrical nerve stimulation (TENS); Interferential current therapy(IFC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: TENS; interferential current therapy; Chronic neck pain
EUS-Guided Cryothermal Ablation in Patients With Stage III Pancreatic Adenocarcinoma (HybridTherm Study)
Condition: Pancreatic Adenocarcinoma Non-resectable
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      In patients with locally advanced tumour, neoadjuvant treatment has been proposed in various
      modalities as a way to decrease size and downstage the tumour leading to a re-sectable
      disease. The HybridTherm probe (HTP), (ERBE Elektromedizin GmbH, Tübingen, Germany) combines
      bipolar RF-ablation with cryogenic induced cooling. A bipolar radiofrequency system creates
      ablation with less collateral thermal damage than standard monopolar systems but with the
      trade-off to lose overall efficiency.
    

Detailed description: 
      About 40% of patients with pancreatic cancer have no metastasis at the moment of diagnosis,
      but in 20% of patients surgery is not feasible due to vascular invasion or poor general
      conditions. These patients with stage III pancreatic cancer (locally advanced or borderline
      resectable) may benefit from neoadjuvant chemotherapy or chemoradiotherapy. The HybridTherm
      probe is a new, minimally invasive device that can be safely applied under EUS guidance to
      locally ablate the pancreatic tissue adding a local efficacy to the systemic activity offered
      by chemotherapy and could give these patients a bigger chance of survival. The present study
      is an interventional randomized controlled phase II/III trial (device), that assigns patients
      into two groups: patients receiving standard chemotherapy alone and those receiving
      chemotherapy plus EUS-guided HybridTherm ablation. The randomization is performed at the time
      of EUS diagnosis and staging.
    

Intervention name(s): Cryothermal ablation
Intervention type(s): Device
Intervention description(s): Procedures are performed with patients sedated by anaesthesiologists. Device setting and application time are set and recorded on a computer, that analyzes the changes of the tissue's properties. The setting of the maximal application time is based on the results of our previously described ex-vivo and in-vivo studies and is adjusted to the tumour's size, thus ensuring a reduction of procedure-related complications. Application of Power Doppler makes the procedure safer. The HybridTherm probe is guided under real-time EUS into the tumour, and the success of its placement is an index of the treatment's feasibility. The system analyzes the effects on the tissue and EUS records the changes of the tissue, the growing edema around the treated area, and the tissue devitalization.
Other intervention name(s): HybridTherm probe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic adenocarcinoma; Cryothermoablation
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Condition: NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      BRB-018-001 is a multicenter, adaptive design, randomized, parallel group study to evaluate
      the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects with NAFLD.
    

Detailed description: 
      BRB-018-001 will be conducted as a multicenter, adaptive design, randomized, parallel group
      study to evaluate the safety, tolerability, and PK of repeat IV doses of RYI-018 in subjects
      with NAFLD. Subjects in each cohort shall be randomized to either RYI-018 or placebo as
      weekly injection for four weeks. The active doses of RYI-018 will be as follows: Cohort 1:
      0.6 mg/kg, Cohort 2: 1.2 mg/kg, and Cohort 3: 2.5 mg/kg. Primary endpoints include safety and
      tolerability. Secondary endpoints include pharmacokinetics and immunogenicity.
    

Intervention name(s): RYI-018; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Anti-CB1 monoclonal antibody; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, placebo controlled, with 3 sequential cohorts
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NAFLD, CB1 receptor blockade, anti-CB1 monoclonal antibody