bioihbjkbjnl/mcl2 huggingface dataset:
Pre-meal Load of Raw Almonds and Postprandial Hyperglycemia
Condition: Intervention
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      A few studies show the effect of almonds on postprandial hyperglycemia (PPHG); high blood
      glucose after meals. In our previous study on intervention with almonds, we observed a
      significant decrease in HbA1C and a small decrease in fasting blood glucose indicating a
      possible effect of almonds on PPHG. Studies have shown that a preload of a food article that
      is high in protein, mono-unsaturated fatty acids, fiber, and low in carbohydrates, such as
      almonds could be helpful in stimulating insulin secretion and help improve postprandial
      hyperglycemia. The proposed study shall be undertaken to assess the effect of almond
      supplementation on postprandial hyperglycemia in Asian Indians with prediabetes.
    

Detailed description: 
      -  Acute Phase Study: Randomized controlled cross over study design Number of arms: 2,
           almond and control, n=60 needed (30 in each arm) Subjects randomized to almonds arm are
           given a preload of 20 g of almonds 30 minutes prior to ingestion of 75 g of glucose,
           while those in the control arm do not have any food/almonds before OGTT. Blood samples
           are collected at (minutes): -30, 30, 0, 30, 60, 90 and 120. Cross over of these subjects
           is done and OGTT repeated in a similar manner. Assessment of blood glucose, serum
           insulin, glucagon, C-peptide, serum triglycerides, free fatty acids, DPP-IV, and GLP1
           levels are done at these time points.

        -  Sub-Acute Study:

      Three-day almond preload study monitored with CGMS, n=60 needed. All study participants
      undergoing OGTT are further studied with CGMS for three days each and then crossed over.
      Those in almonds arm continue to receive preload of almonds (20g almonds, 30 minutes before
      breakfast, lunch and dinner)for three days and then studied without almond preload after
      cross over. A washout period of 7 days separates cross-over period.

      o Chronic Phase Study: Ninety days almond preload study monitored with self-monitoring of
      blood glucose; n=60 needed.

      This is a randomized controlled parallel-arm study to evaluate the long-term effect of
      preload of almonds on hyperglycemia. Subjects fulfilling the inclusion/exclusion criteria are
      randomized to either the control arm or the almond arm.
    

Intervention name(s): almonds
Intervention type(s): Dietary Supplement
Intervention description(s): almond intervention (20 g) before three major meals (60g per day) for 3 days in subacute phase, before OGTT in the acute phase ad for 3 months in chronic phase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: almonds; Asian Indians; Prediabetes
Irinotecan and Capecitabine in Treating Patients With Solid Tumors
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating
      patients who have solid tumors that have not responded to previous treatment.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose and toxic effects of irinotecan and oral
      capecitabine in patients with gastrointestinal or other solid tumors. II. Characterize the
      relationship at the recommended phase II dose between thymidine synthase and thymidine
      phosphorylase expression and tumor response and/or toxic effects in these patients.

      OUTLINE: This is a dose escalation study. Patients receive oral capecitabine twice daily
      every twelve hours for 14 days, and IV irinotecan over 30 minutes once every 3 weeks
      beginning on day 1. Treatment continues for at least 2 courses in the absence of disease
      progression or unacceptable toxicity. The dose of capecitabine and irinotecan is escalated in
      cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is
      defined as the dose at which 2 of 6 patients experience dose limiting toxicity.

      PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
    

Intervention name(s): capecitabine; irinotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Capecitabine; Irinotecan
Primary purpose: Treatment
Keywords: stage III colon cancer; stage IV colon cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage III gastric cancer; stage IV gastric cancer; recurrent gastric cancer; stage IIIB breast cancer; stage II pancreatic cancer; stage III pancreatic cancer; recurrent pancreatic cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; stage IV anal cancer; recurrent anal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; stage IIIA anal cancer; stage IIIB anal cancer; recurrent esophageal cancer; regional gastrointestinal carcinoid tumor; metastatic gastrointestinal carcinoid tumor; recurrent gastrointestinal carcinoid tumor; localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; small intestine adenocarcinoma; small intestine lymphoma; small intestine leiomyosarcoma; unresectable gallbladder cancer; recurrent gallbladder cancer; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer; recurrent small intestine cancer; unspecified adult solid tumor, protocol specific; newly diagnosed carcinoma of unknown primary; carcinoma of the appendix; recurrent carcinoma of unknown primary; stage IV pancreatic cancer
Single-injection Adductor Canal Block for Total Knee Arthroplasty Under Spinal Anesthesia
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      This study evaluates the effect of the single-injection adductor canal block in patients
      receiving total knee arthroplasty under spinal anesthesia.
    

Detailed description: 
      This study aims to evaluate the effect of the single-injection adductor canal block in
      patients receiving total knee arthroplasty under spinal anesthesia. The effect of the
      single-injection adductor canal and continuous adductor canal block in patients receiving
      total knee arthroplasty under general anesthesia has been well established. However, due to
      the residual effect of spinal anesthesia, the effect of the single-injection adductor canal
      block needs to be determined. The investigators hypothesize that the single-injection
      adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.
    

Intervention name(s): adductor canal block; control group
Intervention type(s): Procedure; Procedure
Intervention description(s): After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of 0.5% ropivacaine 15ml is given.; After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of normal saline15ml is given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics of the CORT125134 Phase 2 Formulation in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study designed to characterize the pharmacokinetic (PK) profile of CORT125134 following a
      single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male
      subjects.
    

Detailed description: 
      Following an overnight fast, subjects will be administered a single 150-mg oral dose of
      CORT125134 capsules on the morning of Day 1. Blood samples for determination of PK parameters
      will be collected predose and at serial time points up to 120 hours after study drug
      administration. The secondary objective of the study is to characterize the PK profile of
      metabolite CORT125201 following a single 150-mg oral dose of the Phase 2 capsule formulation
      of CORT125134 in 8 healthy male subjects.
    

Intervention name(s): CORT125134
Intervention type(s): Drug
Intervention description(s): CORT125134 150-mg capsule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Resveratrol in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1)
      each morning daily for 1 month with primary outcome measures of the score change on
      depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times
      over the study period (before, in the middle, after the intervention, and in 2 week follow
      up).
    


Intervention name(s): Resveratrol Pill; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Resveratrol 500 mg; Placebo Pills
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate the persistence of bactericidal antibodies in
      adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY
      Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also
      enroll age-matched subjects who have never received any other meningococcal vaccine (naïve
      subjects) to serve as an additional control group.
    


Intervention name(s): MenACWY-CRM conjugate vaccine; Licensed comparator
Intervention type(s): Biological; Biological
Other intervention name(s): Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Adolescents; Persistence
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).
Condition: Peripheral Arterial Disease (PAD)
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, multiple ascending dose study will assess the safety, tolerability,
      pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers
      and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will
      receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total
      of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either
      3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or
      placebo iv every 28 days for a total of three infusions. The study will have an adaptive
      design with ongoing assessment of safety and tolerability prior to initiation of the next
      dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals.
      The anticipated time on study treatment is 3-12 months, and the target sample size is <100
      individuals.
    


Intervention name(s): RO4905417; RO4905417; RO4905417; placebo; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3mg/kg iv every 28 days for 3 infusions; 20mg/kg iv every 28 days for 3 infusions; 7mg/kg iv every 28 days for 3 infusions; 3mg/kg iv every 28 days for 3 infusions; 7mg/kg iv every 28 days for 3 infusions; 20mg/kg iv every 28 days for 3 infusions
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Insulin Dosage Software Program for People With Type 1 and Type 2 Diabetes
Condition: Diabetes; Insulin
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effectiveness and safety of the computer
      software program in providing insulin dosage recommendations. Participation in the study for
      60 research subjects will last for 16-weeks and includes 3-4 clinic visits and a series of
      weekly telephone calls from the study team (minimum of 12 calls). Participants will be
      provided with weekly Study Log Sheets to record their daily blood glucose readings, insulin
      doses, grams of carbohydrate eaten at each meal (if they have type-1 diabetes) and any
      changes in their health (e.g., hypoglycemic episodes, illnesses). Participants will fax or
      drop off a copy of the Study Log Sheet. This information will be entered by the IDC study
      team into the computer software program. The IDC study team will review the information from
      the software and, based on the IDC's study team approval, any insulin dose changes will be
      communicated back to the patient by phone or fax.
    

Detailed description: 
      Hygieia, Inc. is developing a device intended for use by insulin-requiring patients with
      diabetes. It will be a pocket-sized, hand-held device, combining a glucose meter with
      software that analyzes blood glucose levels recorded in the device's memory, and periodically
      recommends modifications in insulin dosage. The already developed software algorithms are
      based on the way an endocrinologist evaluates and frequently adjusts insulin dosage in a
      patient with diabetes.
    

Intervention name(s): insulin dose software
Intervention type(s): Device
Intervention description(s): The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.
Other intervention name(s): blood glucose meter
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insulin; dosage software
Docetaxel and Gemcitabine in Hormonal Refractory Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to determine the optimal dose of the combination of docetaxel and
      gemcitabine in patients with hormone refractory prostate cancer, and evaluate this dose with
      respect to efficacy and toxicity in a phase II trial.
    


Intervention name(s): docetaxel; gemcitabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hormonal refractory, chemotherapy, docetaxel, gemcitabine
Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose:

      This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel
      plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free
      survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an
      acceptable toxicity profile and its association with the expression of Retinoic acid receptor
      beta 2 (RAR-beta2) as a response biomarker.

      Patients and Methods:

      Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC).
      Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior
      to treatment until completing two cycles. RAR-beta2 expression was analyzed by
      Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
    

Detailed description: 
      Purpose:

      This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel
      plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free
      survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an
      acceptable toxicity profile and its association with the expression of Retinoic acid receptor
      beta 2 (RAR-beta2 ) as a response biomarker.

      Patients and Methods:

      Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC).
      Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior
      to treatment until completing two cycles. RAR-beta2 expression was analyzed by
      Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
    

Intervention name(s): ATRA; PLACEBO
Intervention type(s): Drug; Other
Intervention description(s): Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin; Patients were randomized to receive or placebo (P/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: All-trans retinoic acid; non-small cell lung cancer; retinoic acid receptor beta; chemotherapy
A Study to Compare PK, PD and Safety of CKD-381 in Healthy Subjects
Condition: GERD
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in
      healty subjects
    

Detailed description: 
      A randomized, open-label, multiple-dose, and crossover study to compare pharmacokinetics,
      pharmacodynamics and safety of CKD-381 and D027 in healthy subjects
    

Intervention name(s): CKD-381; Nexium
Intervention type(s): Drug; Drug
Intervention description(s): Test drug: CKD-381; Reference drug: Nexium
Other intervention name(s): Esomeprazole 20mg+Sodum bicarbonate 800mg; Esomeprazole magnesium trihydrate 22.3mg
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GERD; CKD-381; Nexium; Bioequivalence
Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The study investigates the effect of 40IU of intranasal vasopressin on cooperative behavior
      in patients with schizophrenia
    


Intervention name(s): Vasopressins; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced; 40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After completion of clinical assessments all subjects will receive either 40 IU of vasopressin or saline in counterbalanced order on two separate days and perform the behavioral tasks
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Effect of Parental Presence on Dental Fear
Condition: Dental Fear
Study type: Interventional
Phase: Phase 4

Summary: 
      150 children aged between five and seven years presenting for the first dental visit, whose
      parents consented to participate in the study were selected from patients reporting to the
      dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Pulse
      rate for each patient was measured at different clinical situation starting from patient
      parent separation until end of appointment using a pulse oximeter, Data which collected was
      statistically analyzed using appropriate statistical analyses using SPSS ver.19 data
      processing software.
    

Detailed description: 
      150 children aged between five and seven years presenting for the first dental visit, whose
      parents consented to participate in the study were selected from patients reporting to the
      dental clinics Riyadh Colleges of Dentistry and Pharmacy using convenience sampling. Only
      children who were classified as anxious but able to cope were included in the study (Rating 2
      on the Venham's scale).

      Pulse rate for each patient was measured at six different clinical situations. 1) Baseline 2)
      Seating of the child at the chair, 3) Arrival of the dentist, 4) Administration of local
      anesthesia 5) During the procedure, 6) End of Appointment.

      Based on the accompanying person the children were classified as children accompanied by
      mothers alone, children accompanied by fathers alone, children accompanied by both parents.

      The behavior of the child at each situation was recorded using the modified Venham's scale at
      each interval. The heart rate and oxygen saturation were recorded using pulse oxymetry
    

Intervention name(s): Restorative procedure; Maxillary infiltration anesthesia with 2%Lidocaine
Intervention type(s): Procedure; Drug
Intervention description(s): A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time; 1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle
Other intervention name(s): Dental Filling; 2% Lignociane
Intervention MeSH terms: Lidocaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic