bioihbjkbjnl/mcl2 huggingface dataset:
Fetal Copeptin After Oxytocin Challenge Test
Condition: Pregnancy
MeSH terms: Diabetes Insipidus
Study type: Observational

Summary: 
      The relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is
      studied.
    

Detailed description: 
      Background: Vaginal delivery evokes a dramatic surge in stress hormones facilitating the
      transition of the infant to extra-uterine life. Infants born by elective cesarean section
      (C-section) are known to have a higher risk for compromised birth adaptation. Labor is vital
      for vaginal delivery and triggers fetal stress hormone release. Fetal plasma copeptin, a
      surrogate marker of arginine vasopressin, has been found to be 100 to 1000-fold increased
      after vaginal delivery as compared to elective C-section. However, the relationship of labor
      intensity and fetal stress hormone release is largely unknown.

      Objective: The purpose of this study is to determine fetal copeptin in newborns delivered by
      C-section to mothers who had an oxytocin challenge test (OCT) just prior to birth as compared
      to those without OCT.

      Protocol: Pregnant women at term are eligible to participate if no uterine contractions are
      reported within the last 24 hours and no contractions are recorded in cardiotocogram over 30
      minutes. Further inclusion and exclusion criteria see below. After written informed consent,
      all participants get an infusion line and participants receive OCT or placebo. The OCT is
      standardized as follows: 5 IE Syntocinon (oxytocin) in 500 mL Ringer, infusion rate begins
      with 12 ml/h and is increased by steps of additional 12 ml/h until three contractions within
      ten minutes are recorded. Subsequently, infusion is stopped. The placebo is Ringer infusion
      without Syntocinon. C-section is done about 1 to 3 hours after OCT or placebo and arterial
      umbilical cord blood is collected at birth. Maternal and newborn data are recorded within the
      first few days after birth, including maternal blood loss, neonatal adaptation, and postnatal
      weight loss.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Primary care hospital, healthy pregnant women presenting for delivery at term
      
Biospecimen description: 
      EDTA plasma of arterial umbilical cord blood
    
Keywords: C-section
Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase IIIb, longitudinal, multicenter, randomized, open-label clinical trial to evaluate the
      efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg
      compared with fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the
      management of acute low back pain.
    

Detailed description: 
      Patients with back pain from the level of the lowest rib to the gluteal crease, with or
      without radiation to the legs, as a first-time episode or after another at least 6 months
      before and lasting no more than 6 weeks, that in the opinion of the doctor requires treatment
      with the combination of an anti-inflammatory and an analgesic. Study to evaluate the efficacy
      and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with
      the fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of
      acute low back pain. Evaluate and compare the average change in pain reported through the VAS
      at 3, 5 and 7 days with respect to its baseline measurement by treatment group. An
      exploratory analysis of the data will be carried out to identify aberrant, outliers, or
      missing values. To present the numerical variables, the measures of central tendency and
      dispersion appropriate to the distribution of the data will be used and the categorical
      variables will be expressed as frequency and percentage.
    

Intervention name(s): Etoricoxib 90 mg / Tramadol 50 mg; Acetaminophen 325 mg / Tramadol 37.5 mg
Intervention type(s): Drug; Drug
Intervention description(s): One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.; One tablet, every 8 hours of 325 mg/ 37.5 m
Other intervention name(s): E/T; A/T
Intervention MeSH terms: Acetaminophen; Etoricoxib; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Back pain; Etoricoxib; Tramadol; Fixed dose
The Relationship of TV Viewing to Energy Balance in Adults
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The specific objectives of this project are to:

        1. Investigate the effects of reducing TV viewing time on energy intake, eating behavior,
           and energy expenditure in overweight or obese adult subjects, thus providing a basis for
           evaluating if reducing TV viewing time might be a useful adjunct therapy in obesity
           prevention and treatment

        2. Analyze the types of foods eaten in conjunction with TV viewing

        3. Determine if there is an association between location of TV and BMI.
    


Intervention name(s): No TV viewing reduction; TV viewing reduction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In the control group, no intervention will be acted upon. This group will receive the exact same protocol as the intervention group, but with observation only.; In the experimental arm, TV viewing time will be reduced for half of the study protocol time (3-4 weeks of a 6-8 week protocol).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Role of the Rate of Force Application in Responses to Spinal Manipulation Therapy
Condition: Spinal Manipulation
Study type: Interventional

Summary: 
      The objective of the present study is to determine if spinal manipulations with a constant
      rate of force application but with different peak force and time to peak force lead to
      similar responses in healthy adults.
    

Detailed description: 
      Although there are indirect evidences that the rate of force application modulates
      neuromuscular responses to spinal manipulation therapy (SMT) through peak force or thrust
      duration modulations, such an assumption remains to be confirmed. Therefore, the objective of
      the present study was to determine if different SMT force-time profiles where a constant rate
      of force application would be maintained (through the modulation of the peak force and the
      time to peak force) lead to similar neuromechanical responses. Based on the available data
      relative to the effect of SMT biomechanical parameters modulation, it was hypothesized that
      neuromuscular responses would be similar across SMT force-time profiles, while vertebral
      displacements would increase as SMT peak force increases.
    

Intervention name(s): Spinal manipulation; Apparatus used to deliver spinal manipulations
Intervention type(s): Procedure; Device
Intervention description(s): Participants will lie down during the 45-minute experimental session. Vertebral displacements (cm) and muscle response amplitude (RMS value) will be recorded through kinematic markers (on T6, T7 and T8 spinous processes) and surface electromyography electrodes (on the left and right erector spinae at T6 and T8 vertebra level). Each SMT (4 per participant) will be delivered at T7 transverse processes by an apparatus. Responses during the thrust phase (duration equal to twice the time to peak force) and after the thrust (1,5s duration) will be compared between SMTs.; An apparatus using a servo-controlled linear actuator motor (Linear Motor Series P01-48x360, LinMot Inc., Switzerland) will be used to deliver spinal manipulations.
Other intervention name(s): Manual therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: electromyography; biomechanical phenomena; dose-response relationship; musculoskeletal manipulations; spinal manipulation
Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety and tolerability as well as the effects of
      RM-131 on colonic transit, bowel consistency, bowel habits, abdominal pain, and other
      abdominal symptoms in patients with chronic constipation.
    


Intervention name(s): RM-131; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double blind RM-131 (100 ug) will be delivered subcutaneously once daily for 14 days.; Placebo delivered subcutaneously once daily for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: constipation gastric emptying gastrointestinal motility ghrelin
Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The Sponsor is developing the test medicine, AZD6094 (Savolitinib) for the potential
      treatment of cancer. Cancer is a condition where cells in a specific part of the body grow
      and reproduce uncontrollably, causing a growth called a tumour. The test medicine works to
      inhibit a pathway within the body which promotes tumours to grow and spread. The study
      involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate
      the molecule within the body.

      The study will evaluate the absolute bioavailability of the test medicine (amount of the oral
      test medicine that enters the blood stream relative to the dose given into the vein), along
      with the mass balance (how much radioactivity can be recovered from the urine and faeces) and
      the rates and routes of elimination of [14C]savolitinib. It will also look to identify the
      breakdown products (metabolites) of the test medicine. The safety and tolerability of the
      test medicine will be assessed.

      The study will consist of two parts, involving a minimum of eight healthy male volunteers. In
      Part one, following a high fat breakfast, volunteers will receive a single oral dose of the
      test medicine, followed by an intravenous infusion (solution into the vein) of radiolabelled
      test medicine. Volunteers will remain resident in the clinical unit until 72 hours post-oral
      dose.

      There will then be a washout period of at least 14 days, after which the volunteers will
      return to the clinical unit for Part two. Volunteers will receive a single oral dose of
      radiolabelled test medicine as an oral solution. Blood, urine and faecal samples will be
      collected from volunteers whilst they are resident in the clinical unit for up to 168 hours
      postdose (Day 8). Volunteers will return for a follow-up visit at least 14 days after their
      last dose for safety assessments.
    


Intervention name(s): AZD6094 (Savolitinib) film coated tablets 600 mg; [14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL); [14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD6094 (Savolitinib) ilm Coated Tablet 200 mg x 3; 14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL); 14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)
Other intervention name(s): AZD6094 (Savolitinib) Film Coated Tablet 200 mg x 3; 14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL); 14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer
Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study consists of 2 parts: Part 1 and 2. The purpose of this study is to evaluate the
      pharmacokinetic, safety and tolerability of multiple doses of evobrutinib on single doses of
      digoxin, metformin and rosuvastatin in Part-1 and sumatriptan in Part-2 of the study.
    


Intervention name(s): Evobrutinib; Digoxin; Metformin; Rosuvastatin; Sumatriptan
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive evobrutinib film-coated tablet, twice daily under fed conditions from Days 4 to 12 in Part 1 and from Days 2 to 8 in Part 2 of the study.; Participants will receive digoxin tablet under fed conditions, once a day on Day 1 and Day 10 in Part 1.; Participants will receive metformin oral solution under fed conditions, once a day on Day 1 and Day 10 in Part 1.; Participants will receive rosuvastatin tablet under fed conditions, once a day on Day 1 and Day 10 in Part 1.; Participants will receive sumatriptan tablet under fed conditions, once a day on Day 1 and Day 8 in Part 2.
Other intervention name(s): M2951
Intervention MeSH terms: Metformin; Digoxin; Sumatriptan; Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical Pharmacology; Drug interaction; Evobrutinib; Digoxin; Metformin; Rosuvastatin; Sumatriptan
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX)
      fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative
      hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC))
      and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.
    


Intervention name(s): SOF/VEL/VOX; VOX; Norgestimate/ethinyl estradiol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400/100/100 mg FDC tablet administered orally once daily; 100 mg tablet administered orally once daily; Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert
Other intervention name(s): Epclusa®; GS-9857; Ortho-Tri-Cyclen® Lo
Intervention MeSH terms: Ethinyl Estradiol; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults
Condition: HIV
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The proposed research will include adolescent and young adult Hispanic/Latino men who have
      sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13
      ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial
      services to the target group. In 10 of the 13 sites, comparisons will be made between
      alternative venue-based testing (AVT) and social and sexual network-based interviewing and
      HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective
      means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk
      Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying
      undiagnosed HIV in our target group of adolescents and young adults. All study participants
      will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening.
      Participants with presumptive HIV positive screening results will be referred to the local
      AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical
      care. Linkage to care for ATN 096 study participants will be conducted in accordance with the
      Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of
      Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a
      collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as
      part of this protocol are linked with treatment and care.
    


Intervention name(s): Effectiveness of different strategies in HIV testing and linkage to care
Intervention type(s): Behavioral
Intervention description(s): HIV testing Linkage to Care
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescent and young adult Hispanic/Latino MSM and heterosexual men and women, aged 13-24
        years, who meet all eligibility requirements for enrollment into the AVT or SSNIT component
        of the study.
      
Keywords: HIV testing; Latino; Latina; Men who have sex with men
The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital
Condition: Nonunion Fracture
MeSH terms: Fractures, Bone; Femoral Fractures; Fractures, Ununited
Study type: Interventional
Phase: Phase 2

Summary: 
      Because the rate of non union of long bone in lower extremities specially in tibia in this
      two last decade due to malnutrition and smoking and other risk factors was increased, so many
      patient in our country suffer from non union on the other hand it seems that the use of the
      mesenchymal stem cells can irritate the union rate. Therefore the investigators decide to
      inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll
      procedure to non union site in patient that are resistant to other treatment. Then the
      investigators will follow the patient with monthly radiography and evaluate the callus volume
      and clinical union and any side effect of this treatment.clinical union consider to relief
      pain in non union site and be stable in examination.
    


Intervention name(s): injection the mesenchymal stem cell in non union site
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nonunion; mesenchymal stem cell; long bone
VELCADE® Plus Rituximab in Non Hodgkin's Follicular Lymphoma
Condition: Non Hodgkin's Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the efficacy and safety of the combination of Velcade
      and Rituximab in patients with relapsed Non Hodgkin's Follicular Lymphoma.
    

Detailed description: 
      Eligible patients will receive the combination Velcade-rituximab for up to a total of 6
      cycles of Velcade and 6 infusion of rituximab.

      Patients will be evaluated for clinical, laboratory, imaging parameters at baseline, during
      study treatment, at the end of the treatment and during follow up (every 6 months for 3
      years). In the first stage, 17 patients will be treated. An interim analysis will be
      performed after recruitment of the first 17 evaluable patients. Aim of this analysis is to
      determine preliminary the activity of the treatment.If > 7 responses are observed, the
      accrual is continued and 24 additional patients are treated up to a total of 41. If ≤ 21
      respond, the treatment is rejected as ineffective. If 22 or more respond, the treatment is
      judged promising for further development.
    

Intervention name(s): Bortezomib (VELCADE); Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): 1,3 mg/m2, intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of each 21 day cycle. Number of Cycles: 6.; 375 mg/m2 as intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI.
Other intervention name(s): VELCADE; Mabthera
Intervention MeSH terms: Rituximab; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non Hodgkin's Follicular Lymphoma; relapsed; progressed
Exenatide for Stress Hyperglycemia
Condition: Stress Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non
      diabetic patients.

      It has been shown that perioperative hyperglycemia is an independent risk factor of
      postoperative mortality and morbidity.

      The Leuven et al.'s study suggested that strict glycemic perioperative control using an
      intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's
      patients. This study included a majority of cardiac surgery patients. Others studies have
      suggested that the beneficial effect of insulin-based tight perioperative glycemic control
      might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain
      perioperative glycemic stability in most patients.

      Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect
      that depends on the blood glucose level.

      We hypothesize that continuous intravenous infusion of exenatide could improve perioperative
      glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared
      to a conventional insulin therapy during the perioperative period of cardiac surgery.
    

Detailed description: 
      The phase II of the study will assess the safety and the efficacy of a continuous intravenous
      infusion of exenatide for the management of post operative stress hyperglycemia after planned
      coronary artery graft bypass (CABG) surgery.

      A nested cohort study will concern the 24 first patients included in the study (12
      patients/group) to assess the impact of a continuous intravenous infusion of exenatide on
      post operative glycemic variability after planned CABG surgery.

      The aim of the phase III of the study will compare the efficacy of a continuous intravenous
      infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of
      short-acting insulin, for the management of post operative stress hyperglycemia after planned
      CABG surgery.
    

Intervention name(s): Exenatide; Insulin
Intervention type(s): Drug; Drug
Other intervention name(s): Byetta; Exendin-4; Incretin; Humalog Insulin Lispro Human Analog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Exenatide; Insulin Lispro; Incretins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress Hyperglycemia; Perioperative glycemic control; Cardiac surgery; Coronary artery bypass surgery