bioihbjkbjnl/mcl2 huggingface dataset:
Investigating Neural Processing of Social Stimuli
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The primary goal of the present study is to test whether neural activity in brain regions
      associated with processing threat and social stimuli may underlie paranoid thinking.
    

Detailed description: 
      Paranoia is a prominent symptom of psychosis that occurs in several other diagnoses, as well
      as the general population, and that is associated with significant distress and impairment.
      Previous research suggests that increased baseline activity of the amygdala and related
      neural circuits may serve as a mechanism for paranoid ideation. This exploratory study will
      use a paranoia induction procedure in healthy individuals who vary in pre-existing levels of
      paranoid ideation to test whether increases in self-reported paranoia are accompanied by
      increases in resting cerebral blood flow (CBF), decreased stimulus-driven neural activity in
      social processing networks, and increased behavioral perceptions of untrustworthiness.

      Participants will be randomly assigned to participate in a paranoia induction procedure or a
      control condition and will then complete neuroimaging and behavioral assessments.
    

Intervention name(s): Paranoia Induction
Intervention type(s): Behavioral
Intervention description(s): Behavioral procedure involving social exclusion and negative feedback to induce paranoia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive
      surgery is superior to cinacalcet for the treatment of persistent secondary
      hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly
      reduces the cost of treatment post transplant.
    

Detailed description: 
      Persistent hyperparathyroidism (HPT) with hypercalcemia is prevalent after transplant
      (affects up to 25% of patients) and negatively affects graft and patient outcome. The
      subtotal parathyroidectomy is the standard treatment, although currently has been replaced by
      the calcimimetic cinacalcet. Several studies guarantee that cinacalcet is effective in
      controlling hypercalcemia derived of persistent HPT after renal transplantation. However,
      maintenance treatment is need because hypercalcemia increases quickly after treatment is
      stopped. This fact makes increase a lot the cost of transplantation in these patients.

      The hypothesis of this study is that subtotal parathyroidectomy by minimally invasive surgery
      is superior to cinacalcet for treatment of persistent secondary HPT post renal transplant,
      with minimal morbidity and significantly reduces the cost of treatment after transplantation.
    

Intervention name(s): Subtotal parathyroidectomy; Cinacalcet
Intervention type(s): Procedure; Drug
Intervention description(s): The procedure of choice is subtotal parathyroidectomy if the intraoperative biopsy confirms multiglandular disease and at least 3 glands are removed leaving a remanent of one normal gland; Cinacalcet is initiated at a dose of 30 mg per day PO, adjusting the dose monthly (up to 90 mg per day PO) to achieve normocalcemia
Other intervention name(s): Parathyroidectomy
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplant; Hypercalcemia
Clofarabine-cyclophosphamide as Salvage Therapy for Refractory and Relapsed Acute Lymphoblastic Leukemia (ALL) Adults
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicentric, prospective pilot trial testing a Clofarabine-Cyclophosphamide
      combination to treat refractory and first bone marrow relapse adult ALL, for the achievement
      of a complete remission (CR) and the concurrent evaluation of biological response in ALL
      cells (minimal residual disease, apoptosis and DNA cell damage, pharmacogenomics).
    

Detailed description: 
      The proposed treatment schedule consists of a combination of Clofarabine plus
      Cyclophosphamide administered over 5 consecutive days (Treatment scheme). This is an open,
      nonrandomized prospective phase II trial aimed to evaluating (1) activity of this combination
      in terms of CR rate.

        -  STEP 1. All eligible patients will be screened for the availability of an HLA-matched or
           partially mismatched compatible HSCT donor, of both family related - or unrelated type
           (early activation required), including cord blood and haploidentical siblings. Moreover,
           pre-treatment investigation will include collection and storage of patient ALL cells for
           specific biological studies relating to sensitivity and response to study
           chemotherapeutic combination.

        -  STEP 2. Cycle 1 will be applied to all eligible patients once all enrollment criteria
           are confirmed.

        -  STEP 3. After cycle 1, response will be evaluated.

        -  STEP 4. After remission induction cycle 1, only responsive patients (CR or PR, see below
           for definitions) could be given cycle 2, according to the opinion of the responsible
           physician and with a minimum intercycle interval of 4 weeks from day 1 of cycle 1. All
           NR patients will be declared off study and will not be given a second course with study
           combination. The suggested treatment following cycle 2 (or cycle 1 if cycle 2 is
           omitted) is HSCT.
    

Intervention name(s): Clofarabine, Cyclophosphamide
Intervention type(s): Drug
Intervention description(s): The proposed treatment schedule consists of a combination of Clofarabine plus Cyclophosphamide administered over 5 consecutive days (Treatment scheme).
Intervention MeSH terms: Cyclophosphamide; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult patients; Refractory; Relapsed; clofarabine; cyclophosphamide; refractory and relapsed acute lymphoblastic leukemia; ALL
The Chemopreventive Effect of Metformin in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study
Condition: Familial Adenomatous Polyposis
MeSH terms: Adenomatous Polyposis Coli
Study type: Interventional
Phase: Phase 2

Summary: 
      Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon
      and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients
      to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs
      (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and
      duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and
      cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide, which
      is widely used for treating diabetes mellitus, has recently been suggested to have a
      suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant
      safety issues in long term use. The investigators devised a double-blind randomized
      controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in
      non-diabetic FAP patients.
    


Intervention name(s): Metformin; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.; Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.; Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chemoprevention, metformin, familial adenomatous polyposis
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
Condition: Pneumococcal Vaccines
MeSH terms: Pneumonia; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine
      (SPWCV) given with alum is safe and well tolerated by healthy adults.
    


Intervention name(s): Placebo; SPWCV+Alum 100 mcg; SPWCV+Alum 600 mcg; SPWCV+Alum 300 mcg
Intervention type(s): Other; Biological; Biological; Biological
Intervention description(s): 3 cohorts of normal saline injection; 3 injections 28 days apart; 3 injections 28 days apart; 3 injections 28 days apart
Intervention MeSH terms: Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Pilot Study of Diabetes Risk Reduction Program With WIC Mothers(The Special Supplemental Nutrition Program for Women, Infants, and Children) Overweight WIC Mothers
Condition: Prevention of Weight Gain
MeSH terms: Overweight; Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      1) to evaluate treatment fidelity of DRRP: study design, training of interventionists,
      delivery and receipt of the intervention, and application of the intervention in real-life
      settings; 2) to identify successful strategies for participant recruitment and maintaining
      active participation; 3) to collect and analyze preliminary indicators of DRRP's effect on
      dietary intake, physical activity, stress responses, and body weight; and 4) To evaluate
      sample representativeness of the target audience, implementation and acceptability of DRRP,
      and attrition rate.
    


Intervention name(s): lifestyle intervention
Intervention type(s): Other
Primary purpose: Prevention
Noradrenergic Activity and Attention
Condition: Aging
Study type: Observational

Summary: 
      Older adults demonstrate increased distractibility by task-irrelevant information which
      contributes to general cognitive impairment. However, it is yet unclear how changes in
      noradrenergic activity during aging influences attentional control. In the current study,
      tonic noradrenergic activity will be increased or decreased to investigate its behavioral and
      neural effects on attentional control.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young adults will be recruited from the student population at the University of Southern
        California. Older adults will be recruited from a volunteer registry.
      
Keywords: attention; arousal
An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC
Condition: Post-traumatic Stress Symptoms; Psychosocial Distress
Study type: Interventional
Phase: Phase 2

Summary: 
      To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with
      Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This
      study seeks to fill this gap by designing, implementing and testing such an intervention
      using both an intervention and waiting list control group.
    


Intervention name(s): Trauma-Focused Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trauma-Focused Cognitive Behavior Therapy; Sexually Exploited Girls; Post-traumatic Stress Symptoms; Psychosocial Distress
Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to collect safety information on rabeprazole 10 mg and
      20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16
      years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement
      of the symptoms of GERD and to explore the relationship of symptom relief to dose received,
      based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.
    


Intervention name(s): rabeprazole sodium
Intervention type(s): Drug
Intervention description(s): administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD
Comparing the Efficacy Between Lignocaine Given Via MADgic Atomizer and Lignocaine Pump Spray
Condition: Sore Throat; Cough; Hoarseness; Hemodynamic Instability
MeSH terms: Pharyngitis; Hoarseness
Study type: Interventional

Summary: 
      Comparing the efficacy between Lignocaine given via MADgic Atomizer and Lignocaine Pump Spray
      pre endotracheal intubation in adult undergoing General Anesthesia.
    

Detailed description: 
      Comparing the efficacy of Lignocaine given via 2 device (Lignocaine Spray and MADGIC
      Atomizer) on hemodinamic parameters postintubations and severity grading of post operative
      sore throat, cough and hoarseness of voice.
    

Intervention name(s): MADgic Atomizer; Lignocaine pump spray
Intervention type(s): Device; Device
Intervention description(s): Device to deliver directly lignocaine; Lignocaine 30 mg (3 puffs) given via 10mg Lignocain Pump Spray prior to endotracheal intubation
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized control study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lignocaine; MADgic Atomizer; airway anesthesia
Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy
Condition: Prostate Cancer; Perioperative Pain
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Acupuncture has been shown in several meta-analyses and clinical studies, in different
      surgical settings and chronic back pain, to be a safe adjuvant option for postoperative pain
      treatment. In this study, the investigator hypothesize that acupuncture can decrease
      postoperative pain intensity and amount of given analgesics, and accelerate recovery of bowel
      motility, in patients after open radical prostatectomy.

      The investigator will also investigate whether or not acupuncture with needle skin
      penetration is more efficacious than acupressure.
    

Detailed description: 
      This study will be a randomized, controlled and partially blinded study with three arms: 1)
      press tack needle acupuncture (ACU) and routine postoperative analgesic care, 2) press tack
      placebo acupressure (SHAM) and routine postoperative analgesic care, and 3) only routine
      postoperative analgesic care (CONTROL).
    

Intervention name(s): Acupuncture; Acupressure
Intervention type(s): Other; Other
Intervention description(s): On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack needles (diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).; On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack placebos (knob without needle, diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prostate cancer; pain management; acupuncture; acupressure
TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate in healthy volunteers how much and how fast the new
      suspension compared to the commercial darunavir tablet, given in combination with low-dose
      ritonavir, are absorbed into the body (called the relative oral bioavailability).
    

Detailed description: 
      The objectives of this trial are in Part 1 to compare the rate and extent of absorption of a
      single oral dose of 600 mg darunavir (DRV) administered as the suspension formulation F051
      (under fed and fasted conditions) to that of the commercial tablet formulation F016 (under
      fed conditions), in the presence of low-dose ritonavir in healthy volunteers; and to compare
      the rate and extent of absorption of a single oral dose of 600 mg DRV administered as the
      suspension formulation F051 under fed conditions to that under fasted conditions, in the
      presence of low-dose ritonavir in healthy volunteers. In Part 2 we want to assess multiple
      dose pharmacokinetics of DRV administered as the suspension formulation F051 (under fed or
      fasted conditions, based on the results of Part 1), in the presence of low-dose ritonavir in
      healthy volunteers. The short-term safety and tolerability of DRV will be evaluated following
      administration of 3 single oral doses of 600 mg (formulated as suspension and as tablet) and
      following administration of multiple oral doses (formulated as suspension), all in presence
      of low-dose ritonavir in healthy volunteers Part 1: during 3 sessions volunteers will orally
      receive 3 single doses of 600 mg darunavir (DRV): 2 tablets of 300 mg and 6 ml of suspension
      under fed conditions and 6 mL of suspension (100 mg/mL) under fasted conditions on Day 3.
      Part 2: subjects will receive DRV suspension, twice daily from Day 1 to 6, with an additional
      morning dose on Day 7. In Part I rtv 100 mg will be coadministered twice daily from Day 1 to
      Day 5 and in Part 2 from Day 1 to Day 9.
    

Intervention name(s): Darunavir
Intervention type(s): Drug
Intervention MeSH terms: Darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC114-TiDP29-C169; TMC114-C169; Darunavir (suspension formulation)
Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic
      biofortified bananas.
    


Intervention name(s): Provitamin A-biofortified transgenic bananas
Intervention type(s): Other
Intervention MeSH terms: Provitamins; Beta Carotene
Keywords: bananas; biofortified; carotenoids; vitamin A
Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Cough during emergence from general anesthesia is considered a critical event as it may lead
      to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in
      patients who are at risk of complications related to increases in intracranial or intraocular
      pressure. Lidocaine administration has been widely used for reducing cough during extubation
      due to its simplicity and lack of serious adverse effects; There are two major routes for
      lidocaine administration systemic intravenous injection and local direct application on the
      laryngeal inlets such as spraying lidocaine on the supraglottic and subglottic regions or
      applying lidocaine jelly or sprayed. Dexmedetomidine is a potent alpha 2 selective
      adrenoceptor agonist and the most characteristic features include sympatholytic sedation
      analgesia and lack of respiratory depression. The aim of this study is to compare the effect
      of intratracheal dexmedetomidine and lidocaine on cough reflex in cataract surgery.
    

Detailed description: 
      The patients were randomly allocated into three groups each containing (40) patient. Group D
      received (0.5 μg/kg) of dexmedetomidine diluted and completed to 5 ml saline, Group L
      received (5ml) 2% of lidocaine and Group C received 5ml saline. The drugs were sprayed down
      the intratracheal tube of patients.

      The following variables: Hemodynamic parameters HR, MAP, and SaO2 values in different times,
      preoperative IOP, cough, steward recovery score (SRS), detection of awareness and extubation
      time, the incidence of complications due to increasing IOP and surgeon satisfaction
    

Intervention name(s): intratracheal saline; intratracheal Dexmedetomidine; intratracheal Lidocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): At the end of the operation by 15min, 5ml of 0.9% normal saline was sprayed down the intratracheal tube of patients; At the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients; At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.
Other intervention name(s): Group C; Group D; Group L
Intervention MeSH terms: Lidocaine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intratracheal; dexmedetomidine; eye-surgery; lidocaine