bioihbjkbjnl/mcl2 huggingface dataset:
FRESH-DOSE: Families Responsibility Education Support Health-Dual Options for Sustained Effectiveness
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The objective of the study is to evaluate whether a less intensive intervention, Guided
      Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based
      Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness
      of both treatments will also be compared.
    

Detailed description: 
      The primary aim of this project is to determine whether gshFBT is non-inferior to FBT for
      childhood obesity on child weight loss. Four assessments will be conducted; baseline (month
      0), month 6 (post-treatment), and at month 12 and month 18. Assessments will include the
      following for child and parent: anthropometry, physical activity, nutrition, and
      cost-effectiveness. Cost-effectiveness will be calculated from a societal perspective and a
      third party payor perspective. This program of research has the potential to advance the
      standard of practice for children who are overweight or obese by providing a less intensive
      but more cost-effective intervention.
    

Intervention name(s): Family Based Behavioral Treatment; Guided Self-Help Fam. Based Bx Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment includes 20 90 minute visits over 6 months which include 60 min parent and child separate groups and 30 min behavioral coaching. FBT includes information regarding nutrition and physical activity, as well as behavior therapy skills, including parenting skills, self-monitoring, problem solving skills, motivation systems, emotional regulation, stress management, stimulus control, and relapse prevention.; Treatment includes 14 20 minute visits over 6 months. gshFBT is delivered to parent/child dyads and includes the same content in the FBT groups but it is provided in a manual. The 20-minute visits focus on clarifying information in the manuals, collecting weight and self-monitoring logs, and problem solving any barriers to implementation.
Other intervention name(s): FBT; gshFBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Overweight; Overeating; Body Mass Index; Treatment; Intervention; Family Based Therapy; Weight; Children
Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of this clinical study are to assess the safety, tolerability, blood levels, and
      disease impact of UPB-101 when given to adults with mild asthma. Eligible participant will be
      consecutively assigned to 1 of 3 to 5 planned treatment groups. Each treatment group will
      consist of 8 individuals, six of whom will receive active drug (UPB-101) and 2 who will be
      given placebo. Neither the study doctors nor the participants will know which participants
      were assigned to active study drug and which were assigned to placebo. The study will be
      performed at 3-4 experienced research sites in the United Kingdom.
    

Detailed description: 
      This is a two-part phase 1b, multi-center randomized, double-blind (Investigator and Subject
      blinded; Sponsor unblinded), placebo-controlled, multiple ascending-dose study to assess the
      safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of
      UPB-101 administered subcutaneously (SC) to adult subjects with asthma.

      The study consists of Part A and Part B. Part A includes 3 cohorts with pre-set dosing
      regimens. Part B (optional) includes up to 2 additional cohorts whose doses and dosing
      intervals will be decided based upon the safety, PK, and PD results from Part A (i.e., an
      adaptive design), as applicable. The regimens selected for Part B will not exceed the
      exposures (i.e., doses and/or dosing intervals) included in Part A. Eight subjects will be
      randomized per cohort (6 active, 2 placebo). Thus, a total of approximately 24 to 40 subjects
      will be enrolled in the study with 24 subjects in Part A and up to 16 if Part B cohorts are
      implemented.
    

Intervention name(s): UPB-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Other intervention name(s): Formerly ASP7266; 0.9% saline solution
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gastric Volume After Oral Ingestion of Water or Jelly in Volunteers
Condition: Fasting; Surgery; Ultrasound Therapy; Complications; Aspiration Pneumonia Due to Regurgitated Food
MeSH terms: Pneumonia; Pneumonia, Aspiration
Study type: Interventional

Summary: 
      The aim of the study is to understand whether the time that patients should fast after oral
      ingestion of jelly is similar to that of water, before elective surgery.

      International guidelines on perioperative fasting recommend 2 hours with no clear fluids
      ingestion to reduce the likelihood of regurgitation and aspiration pneumonia. But nothing is
      recommended about the perioperative management of jelly ingestion.

      25 adult volunteers will be included on a crossover study. The first intervention will be
      randomized (oral intake of water or jelly) and in a second moment all participants will be
      submitted to the opposite intervention. Gastric content and volume will be evaluated through
      ultrasound.

      Exclusion criteria include morbid obesity, pregnancy, alcohol abuse and diseases or drugs
      that can prolong or accelerate gastric emptying such as gastric or esophageal surgery,
      diabetes mellitus, prokinetic or opioid use.

      Nowadays, the benefits of reducing preoperative fasting time are well known, such as avoiding
      dehydration and metabolic complications like ketoacidosis. It can also improve patient
      satisfaction.

      Oral jelly may improve preoperative hydration while also providing some nutritional support
      prior to procedures.
    


Intervention name(s): water ingestion; jelly ingestion
Intervention type(s): Other; Dietary Supplement
Intervention description(s): ingestion of water after an 8h-fasting period; ingestion of jelly after an 8h-fasting period
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The first intervention will be randomized (oral intake of water or jelly) and in a second moment all participants will be submitted to the opposite intervention.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preoperative Fasting; Elective Surgery; Ultrasound; Gastric Volume; Jelly; regurgitation; Aspiration pneumonia
Hyperbaric Levobupivacaine for Spinal Anaesthesia
Condition: This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay
Study type: Interventional
Phase: Phase 4

Summary: 
      Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of
      regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space,
      generally through a fine needle.

      There is no generic hyperbaric form of levobupivacaine currently available so we aimed in
      this study that to find the appropriate concentration of the levobupivacaine which achieves
      unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less
      motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be
      suitable for outpatient anesthesia.
    


Intervention name(s): levobupivacaine; levobupivacaine; levobupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): levobupivacaine plus 60 mg dextrose; levobupivacaine plus 80 mg dextrose; levobupivacaine plus 100 mg dextrose
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
On-line Treatment for Conduct Problems
Condition: Conduct Disorder; Oppositional Defiant Disorder
MeSH terms: Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      The research evaluates the use of online versions of delivering an effective psychological
      treatment for children clinically referred for serious oppositional, aggressive, and
      antisocial behavior. The goal is to develop models of delivery that reach families in need
      that are not being served by in-person treatment. The project has immediate implications for
      the treatment of children but more generally addresses several issues critical to treatments
      that are based on Internet, telepsychiatry, and related technologies.
    


Intervention name(s): Online Parent Management Training (Interactive); Online Parent Management Training (Recorded)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Online treatment; Treatment of conduct problems; Parent training
A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look into insulin sensitivity (how the body responds to insulin) and effects
      of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has
      two treatment periods, each of which will last about four weeks. One drug (insulin peglispro
      or insulin glargine) will be administered in each period. Participants will receive both
      drugs during the study. Participants may remain on stable dose metformin, as prescribed by
      their personal physician.
    


Intervention name(s): Insulin Peglispro; Insulin Glargine; Insulin Lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered subcutaneously (SC), (U-100 formulation); Administered subcutaneously (SC), (U-100 formulation); Administered subcutaneously (SC), (U-100 formulation)
Other intervention name(s): LY2605541
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the effects on overall glycaemic control of two
      insulin intensification therapies.
    


Intervention name(s): Insulin Lispro Premix; Insulin Glargine; Insulin Lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participant dependent dose, administered subcutaneously for 24 weeks; Participant dependent dose, administered subcutaneously for 24 weeks; Participant dependent dose, administered subcutaneously for 24 weeks
Other intervention name(s): Humalog Mix25; Humalog Mix50; LY275585; Humalog; LY275585
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Insulin, Isophane; Biphasic Insulins; Isophane insulin, insulin lispro drug combination 50:50
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic Diseases; Diabetes Mellitus, Type 2; Glargine; Diabetes Mellitus; Insulin LISPRO; Insulin
Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women
Condition: Human Immunodeficiency Virus (HIV) Prophylaxis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a
      sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate
      (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following
      drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC
      ("Triple" IVR).

      TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc
    

Detailed description: 
      The broad long term goal of this project is to empower women to protect themselves from HIV
      through woman-controlled sustained local delivery of ARTs via intravaginal rings. The
      short-term general investigational plan is to evaluate IVRs releasing TDF, TDF-FTC and
      TDF-FTC-MVC in healthy women for up to 7 days in an open-label study to determine safety and
      drug concentrations in plasma and cervicovaginal lavage and secretions. Additional
      exploratory studies will be considered and planned based in part on the results obtained in
      this study. The long-term investigational plan is to evaluate the safety and efficacy of
      sustained release TDF, TDF-FTC and TDF-FTC-MVC for their ability to decrease HIV transmission
      to vulnerable women.
    

Intervention name(s): TDF IVR; TDF-FTC IVR; TDF-FTC-MVC IVR
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Single IVR; Dual IVR; Triple IVR
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TDF; FTC; MVC; TDF-FTC; TDF-FTC-MVC; IVR; ARV
The Core Body Temperature Rhythms: Distinguishing MCS From UWS
Condition: Disorders of Consciousness
MeSH terms: Consciousness Disorders
Study type: Observational [Patient Registry]

Summary: 
      In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients
      were measured every 2 hour for 168 h .
    

Detailed description: 
      Living beings have multicomponent biological rhythms. There was a research recorded 24-h
      virations in electroencephalographic patterns. In normal subjects, the circadian rhythms of
      core body temperature is close to 24 h. When the interference of environmental and mental
      elements were eliminated, circadian rhythm shows the endogenous circadian rhythm of body
      acquiescently (>24h ), which is also called free-running period.

      Measuring the continuous external auditory canal temperature of 4 unresponsive wakefulness
      syndrome (UWS) and 3 minimally conscious state(MCS) on the fluorescent lamp surrounding every
      2 hours for 168 hours starting at 00:00 on the first day to address circadian capabilities.

      Researchers expected to see the difference between MCS and UWS.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators chossen patients with UWS or MCS.The subjects include 4 UWS and 3 MCS.
      
Keywords: unresponsive wakefulness syndrome; minimally conscious state; circadian rhythms; free-running period
Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in Liver Cancer Patients
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation
      Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to
      determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment
      and prediction of prognosis.
    

Detailed description: 
      Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as
      perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.
    

Intervention name(s): Dynamic Contrast Enhanced Computed Tomography
Intervention type(s): Diagnostic Test
Intervention description(s): Patients will receive DCE-CT prior to the start of standard of care, Stereotactic Body Radiation Therapy (SBRT), as well as 6 hours post administration of SBRT and 6 weeks post administration of SBRT.
Other intervention name(s): DCE-CT; Perfusion CT
Intervention model: Single Group Assignment
Intervention model description: Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radiation; Metastases; Dynamic Contrast Enhanced Computed Tomography; Pilot
The Effect of External Pressure Applı̇ed to the Palm on Labor Paı̇n and Childbirth Experı̇ence
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The study was carried out to evaluate the effect of external pressure applied to the palm on
      labor pain and childbirth experience.The sample of the randomized controlled study consisted
      of 60 nulliparous (30 in the experimental group and 30 in the control group) pregnant women
      who presented to Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital
      between April and June 2020 to give birth and met the research conditions. The Descriptive
      Information Form, Follow-Up Form Related to Labor Action, Childbirth Experience Questionnaire
      (CEQ), and Visual Analogue Scale (VAS) were used in data collection. During the 5-6 cm, 7-8
      cm, and 9-10 cm cervical dilatation stages of the labor process, palm external pressure was
      applied to the pregnant women in the experimental group, while standard midwifery care was
      provided to the pregnant women in the control group. The VAS was applied to both groups at
      admission to the hospital, before and after the 5-6 cm, 7-8 cm, and 9-10 cm cervical
      dilatation stages, and also at the 30th minute postpartum. Data were analyzed Statistical
      Package for Social Sciences 24.0 program using number, percentage, mean, standard deviation,
      the Kolmogorov-Smirnov test, Levene's test and independent samples t-test, one-way ANOVA
      test, analysis of variance, and chi-square test. In all analyses, p<0.05 values will be
      considered statistically significant.
    

Detailed description: 
      Labor pain adversely affects pregnant women's perception of the labor process and childbirth.
      When not taken under control, it causes pregnant women to have negative experiences about the
      labor process and consequently leads to a decrease in their satisfaction with childbirth. For
      this reason the study was carried out to evaluate the effect of external pressure applied to
      the palm on labor pain and childbirth experience. Hypotheses of the research; H 1 : External
      pressure applied to the palm during labor reduces the level of labor pain. H 1 : External
      pressure applied to the palm during labor increases the positive birth experience.
    

Intervention name(s): External pressure to the palm
Intervention type(s): Procedure
Intervention description(s): During the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages of the labor process, palm external pressure was applied to the pregnant women in the experimental group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: external pressure; labor pain; childbirth experience; non-pharmacological method; midwifery care
Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH
      patients, two medications indicated in BPH belonging to two different pharmacological
      classes, as evaluated from the point of view of patient's perception of his pathological
      condition and of the impact of the disease on general health and quality of life
    


Intervention name(s): Tamsulosin; Finasteride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tamsulosin; Finasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Mode of Action (MoA) Study of TOTUM-63 in Individuals at Increased Cardio-metabolic Risk
Condition: Prediabetic State; Dysglycemia; Overweight and Obesity
MeSH terms: Overweight; Prediabetic State
Study type: Interventional

Summary: 
      This clinical study aims to investigate the effects of TOTUM-63, a mix of 5 plant extracts,
      consumed at the daily regimen of three times per day, on cardiometabolic health and gut
      microbiota profile in overweight-obese individuals.
    

Detailed description: 
      In 2019, over 460 million adults had diabetes worldwide. Moreover, it was estimated by the
      International Diabetes Federation that about 700 million adults will have type 2 diabetes
      (T2D) by 2045. Valbiotis is a research & development company dedicated to scientific
      innovation for preventing and reducing the risk of metabolic and cardiovascular disease (CVD)
      using specific combinations of plant-based molecules. Valbiotis developed a formula
      (TOTUM-63) which is composed by the association of five plant extracts.

      Given the results obtained in pre-clinical studies, as well as the good tolerance and first
      efficacy results of TOTUM-63 in two clinical trials on human subjects, this research aims to
      investigate the effects of TOTUM-63 on cardiometabolic health and gut microbiota profile in
      overweight-obese individuals. TOTUM-63 will be tested (5g acutely and 5g/d over 8 weeks of
      supplementation) on energy metabolism, post-prandial nutrients metabolism and hepatic health
      in overweight and obese subjects. Blood and feces samples collected before, and after the
      supplementation will allow to perform metabolomic, transcriptomic and metagenomics analyses
      to further explore the potential mechanisms of action of TOTUM-63.
    

Intervention name(s): TOTUM-63
Intervention type(s): Dietary Supplement
Intervention description(s): 5-g per day dose of TOTUM-63 supplement, a mix of 5 plant extracts. Daily dose for 8 weeks followed by a 4 weeks follow-up period without supplementation.
Intervention model: Single Group Assignment
Intervention model description: Open-label, single center, single arm
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dysglycemia; Prediabetes; Diabetes risk; Cardio-metabolic risk; Diet supplement; Plant extracts; Polyphenols; Microbiota; Magnetic Resonance Imaging