bioihbjkbjnl/mcl2 huggingface dataset:
Sweet Taste Receptors and the Secretion of Glucagon-like Peptide-1 and Peptide YY
Condition: Appetite and General Nutritional Disorders; Hormone Replacement
MeSH terms: Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the functional significance of sweet taste
      receptors in the secretion of GI satiety peptides by using a specific sweet taste receptor
      antagonist to block sweet taste perception in the gut.
    

Detailed description: 
      There is strong evidence that taste signaling mechanisms identified in the oral epithelium
      also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense
      nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon
      like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled
      receptors have been identified in the human gut, including the sweet taste responsive
      T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for
      unsaturated long-chain free fatty acids.The functional significance of sweet taste receptors
      in glucose stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion
      of 75 g glucose with different concentrations of lactisole (150 ppm, 300 ppm and 450 ppm)in a
      double blind, 4-way crossover trial including 16 healthy subjects.
    

Intervention name(s): lactisole
Intervention type(s): Dietary Supplement
Intervention description(s): lactisole (flavoring agent/sweet taste antagonist) dissolved with 75 g glucose in 300 mL tap water; administered via intragastric tube
Other intervention name(s): Glucose; water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection After Total Knee Arthroplasty (TKA)
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      his study is being done because total knee replacements can leave patients with considerable
      pain after surgery. Therefore, many studies have been done to find the best ways to control
      knee pain after the surgery. Currently, a popular approach is to use many different
      techniques to control the pain. This includes injecting freezing (local anesthetic) into the
      spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and
      using various kinds of medications (e.g. narcotics and anti-inflammatory medications).
      Studies have shown using this a combination of techniques can reduce pain and allow earlier
      discharge from the hospital. However, one downside to this approach is it does not usually
      control the pain in the back of the knee. One new technique has been used to try and overcome
      this. This technique is called a "posterior cruciate ligament block" or "PCL block". It
      involves injecting a drug into the back of the knee which will block the nerves in this area.
      Sometimes the investigators refer to this as "freezing".

      The purpose of our study is to determine whether this "PCL Block" will improve pain after the
      total knee replacement surgery. The investigators will also determine whether this technique
      will improve movement in the knee and lessen narcotic usage after the surgery.
    


Intervention name(s): transcruciate injection of 20cc of normal saline; transcruciate injection of 20 cc of 0.5% Ropivacaine
Intervention type(s): Procedure; Procedure
Intervention description(s): Group 2 (control group) will receive a transcruciate injection of 20cc of normal saline through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).; Group 1 (study group) will receive a transcruciate injection of 20 cc of 0.5% Ropivacaine through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of
      SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety
      in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.
    


Intervention name(s): TBPM-PI-HBr
Intervention type(s): Drug
Intervention description(s): TBPM-PI-HBr (2 x 300mg tablets) a total of five doses
Other intervention name(s): TBPM-PI-HBr oral capsule; SPR994
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; TBPM-PI-HBr; tebipenem; alveolar macrophages (AM); epithelial lining fluid (ELF); intrapulmonary
A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy
      adult subjects. This is conducted as part of standard drug development.
    


Intervention name(s): PF-04447943; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of PF-04447943 administered as an extemporaneously prepared solution; Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution; Single oral dose of moxifloxacin administered as tablet
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Therapeutic Alliances in Alcoholism Treatment
Condition: Alcohol Use Disorders
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      This project is studying the role of the therapeutic alliance between the therapist and
      patient in the outpatient treatment of persons with alcohol use disorders.
    

Detailed description: 
      This project is studying the role of the therapeutic alliance between the therapist and
      patient in the outpatient treatment of persons with alcohol use disorders. Alliances are
      assessed over the course of treatment and will be reviewed in the context of posttreatment
      functioning.
    

Intervention name(s): Cognitive-behavioral treatment; Cognitive-behavioral treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive-behavioral treatment of alcohol use disorders; Cognitive-behavioral treatment for alcohol use disorders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alcohol use disorders; Treatment; Outpatient; Therapeutic alliance
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
Condition: Labor, Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of rhRlx for cervical
      ripening, when compared to a placebo.
    

Detailed description: 
      A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy
      female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A
      dose-escalation portion of the study is followed by a randomized, double-blind,
      placebo-controlled portion of the study. The endpoints include cervical ripening, as well as
      progression to labor and delivery.
    

Intervention name(s): Serelaxin; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: relaxin; pregnancy; cervical ripening; normal pregnancy at least at 40 weeks of gestation
Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters
Condition: Hepatitis B; Liver Fibrosis
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis; Liver Cirrhosis; Fibrosis
Study type: Observational [Patient Registry]

Summary: 
      The aim of our prospective study is to construct and validate a non-invasive model consisting
      biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis
      caused by hepatitis B virus in mainland China.
    

Detailed description: 
      Up to Oct, 2015,total of 1800 patients with chronic HBV infection were enrolled. Paired blood
      and liver biopsy samples were collected. Blood samples stored at -80 degree Celsius. Liver
      biopsy samples were judged by three pathology experts.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients infected with hepatitis B virus for at least 6 months
      
Biospecimen description: 
      liver biopsy samples and blood samples
    
Keywords: Fibrosis; Liver Cirrhosis; non-invasive; biopsy; hepatitis B virus
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the ability a colostrum containing diet to limit
      gastrointestinal toxicity including chemotherapy induced inflammation in children treated for
      acute lymphoblastic leukemia.
    

Detailed description: 
      Acute lymphoblastic leukaemia (ALL) is the most common form of childhood cancers. Cure rates
      are improving, but the intensity of treatment is limited by toxicity. 2-5% of patients die of
      treatment related complications, mostly related to therapy-induced toxicity and immune
      suppression. The aim of the present study is to evaluate the ability a colostrum containing
      diet to limit gastrointestinal toxicity including chemotherapy induced inflammation. The
      study is based on patients treated according to the current NOPHO protocol.
    

Intervention name(s): Bovine Colostrum; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
Other intervention name(s): Colodan, Biodane-Pharma.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Lymphoblastic Leukemia; Bovine Colostrum; Inflammation; Infection; Toxicity
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to establish the efficacy and safety of two different doses of
      alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in
      comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who
      had received an adequate trial of disease-modifying therapies but experienced at least 1
      relapse during prior treatment, and who met a minimum severity of disease as measured by
      magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive
      testing every 3 months.
    

Detailed description: 
      Every participant received active treatment; there was no placebo. After Amendment 2, the 24
      mg alemtuzumab dose was closed to enrollment so newly enrolled participants were randomly
      assigned to treatment with either 12 mg alemtuzumab or interferon beta-1a in a 2:1 ratio
      (that is, 2 given 12 mg alemtuzumab for every 1 given interferon beta-1a). Alemtuzumab was
      administered in two annual courses, once at the beginning of the study and again 1 year
      later. Interferon beta-1a was self-injected 3 times per week for 2 years. All participants
      were required to return to their study site every 3 months for neurologic assessment. In
      addition, safety-related laboratory tests were performed at least monthly. Participation in
      this study ended 2 years after the start of treatment for each participant. Additionally,
      participants who received alemtuzumab might be followed in the CAMMS03409 Extension Study
      (NCT00930553) for safety and efficacy assessments. Participants who received interferon
      beta-1a and completed 2 years on study might be eligible to receive alemtuzumab in the
      Extension Study.
    

Intervention name(s): Alemtuzumab 12 mg; Alemtuzumab 24 mg; Interferon beta-1a
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.; Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.; Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
Other intervention name(s): Lemtrada; Lemtrada; Rebif®
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Alemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis
Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess if injection of local anesthetic to the
      laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain
      after surgery.
    

Detailed description: 
      The growing interest in minimally invasive gynecologic surgeries have increased the number of
      patients undergoing laparoscopic hysterectomies. Although many patients are being discharged
      home the same day of surgery, majority of patients complain of immediate postoperative pain
      after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves
      over a short period of time, infiltration of local anesthetic to trocar insertion sites might
      alleviate the patient's discomfort during the recovery period. Immediate post-operative pain
      relief further facilitates early discharge and faster patient recovery.

      Published data regarding the effects of preemptive port site local anesthesia in gynecologic
      operative laparoscopy have been limited and controversial. Visceral pain control through
      afferent nerve block could minimize pain perception especially during the first postoperative
      hours. This study aims to assess the influence of infiltration of local anesthetic to trocar
      insertion sites after laparoscopic hysterectomy on postoperative pain.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Other intervention name(s): Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Local; Anesthesia; Pain; Laparoscopic hysterectomy; Trocar site; Port site
Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate drug-drug interaction
    

Detailed description: 
      The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus
      50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects
    

Intervention name(s): Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Period1(A) Period2(B) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days); Period1(C) Period2(A) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days); Period1(B) Period2(C) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days); Period1(C) Period2(B) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days); Period1(B) Period2(A) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days); Period1(A) Period2(C) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interaction; revaprazan; Itopride HCI
"Mandometer®" Study for Managing Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      We run a successful clinic in Bristol for children with severe obesity who already
      demonstrate many features to suggest they are at increased risk of early diabetes and heart
      disease. However, we have found that young children respond better to simple interventions
      than do adolescents. We have used a new treatment regimen "Mandometer®" to help our most
      difficult adolescent cases lose weight. We would like to do a study to see if all adolescents
      might improve weight loss using this technology compared to what we routinely offer
    

Detailed description: 
      Childhood obesity is rapidly reaching epidemic proportions in the United Kingdom. Recent
      studies have indicated a prevalence level for obesity of 15% at 15 years of age. The
      implications for metabolic, cardiovascular and cancer risk in later life are enormous. The
      International Obesity Task Force (IOTF) and the European Association for the Study of Obesity
      (EASO) have identified childhood obesity as a matter for urgent attention. However, there are
      very few obesity clinics for children in the UK and effective treatment regimens are simply
      not available. We have developed an obesity clinic at the Royal Hospital for Children in
      Bristol and observed effective weight reduction in pre-pubertal children. Our simple
      treatment framework has proved far less effective in adolescence. We have therefore
      collaborated with an eating disorder clinic from the Karolinska Institute in Sweden to
      develop a novel therapy to treat obesity using modified equipment originally designed to
      treat adolescents with DSM-IV eating disorders. Pilot data indicate that adolescents are
      better able to address the issue of weight reduction within this treatment modality. Having
      established the software and treatment process we now wish to perform a randomised, control
      trial to test the efficacy of this new treatment against that currently provided.
    

Intervention name(s): Mandometer; Lifestyle
Intervention type(s): Device; Behavioral
Intervention description(s): A computerised device, Mandometer, providing real time feedback to participants during meals to slow down speed of eating and reduce total intake; standard lifestyle modification therapy.; Typical dietary and activity advice as normally provided in clinic (control).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood; Obesity; Behavior modification; Insulin resistance
Dynamic MRI Evaluation Post Operative Stapled Trans Anal Rectal Resection (STARR) Procedure
Condition: Obstructive Defecation Syndrome; Outlet Obstruction
MeSH terms: Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to assess the effects of the Stapled Trans Anal Rectal Resection
      (STARR) procedure for patients with obstructive defecation syndrome. This involves a dynamic
      pelvic MRI and obstructive defecation score (ODS) at 6 month post STARR procedure.
    

Detailed description: 
      The use of dynamic pelvic MRI has greatly impacted our preoperative evaluation of pelvic
      floor disorders, both anatomically and functionally. The STARR procedure is a new approved
      procedure for patients with obstructive defecation, who have failed conservative therapy of
      medications and aggressive pelvic floor retraining. Most patients have also been screened for
      colonic transit problems. The traditional study for evaluating these patients was defecating
      proctograms. With the advent of the dynamic pelvic MRI, we are now beginning to understand
      the interaction of the entire pelvic structure in the complex act of defecation. This study
      is providing us a different view of the pelvic structures to better understand the
      pathophysiology of this disorder. The defecating proctogram, though informative in certain
      cases, lacks information outside the rectum. We wish to evaluate and compare our preoperative
      dynamic pelvic MRI with a six month dynamic pelvic MRI in 10 patients. We also will compare
      pre and post op obstructive defecation scores (ODS). We expect this small sample to direct us
      to a much more pointed evaluation of this disorder.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had STARR procedure performed at Mayo Clinic - Jacksonville
      
Keywords: dynamic pelvic mri; dynamic mri; STARR procedure; STARR; ODS; obstructive defecation syndrome; outlet obstruction; obstructed defecation; stapled trans anal rectal resection