bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea
Condition: Diarrhea, Infantile
MeSH terms: Diarrhea; Diarrhea, Infantile
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, open-label, multicenter, single-arm study evaluating the efficacy and
      safety of Racecadotril the treatment of children aged 3 to 60 months suffering from acute
      diarrhea
    

Detailed description: 
      Subjects presenting with acute diarrhea will be evaluated for eligibility. If eligible,
      demographics, number of stools during the last 12 hours will be assessed as baseline values.
      On Day 1, the subject will start with study treatment.

      Subjects will be treated with Racecadotril three times daily according to the body weight
      dose requirement on an out-patient basis for maximum 5 days in addition to ORS. ORS will be
      prescribed by the investigator. The parent(s)/caregiver(s)/legal representative(s) will be
      instructed to stop treatment when the patient recovered. Recovery is defined by the
      evacuation of the first of two consecutive normal stools or no stool within 12 hours. In the
      evening of each day, the parent(s)/caregiver(s)/legal representative(s) will fill in their
      diaries, documenting date and time of each individual stool, the stool consistency of each
      stool, ORS amount and the study drug intake. AEs are to be reported on an ongoing basis.

      The last dose of study drug intake will be the morning dose of day 6, if not recovered
      earlier. The parent(s)/caregiver(s)/legal representative(s) will visit the site for the end
      of study visit of the child. Data on vital signs, AEs, physical examination and concomitant
      medication will be collected. The parent(s)/caregiver(s)/legal representative(s) will return
      the diaries and unused medication.

      A phone call contact will be performed 5-7 days after the end of the treatment period or
      recovery for the safety follow-up.
    

Intervention name(s): Racecadotril plus ORS
Intervention type(s): Drug
Intervention description(s): 1.5 mg/kg of Racecadotril will be administered, 3 times daily, via the oral route (in addition to standard treatment i.e. oral rehydration solution).
In infants less than 9 kg: one 10 mg sachet 3 times daily. In infants from 9 kg to < 13 kg: two 10 mg sachets 3 times daily. In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily. In children of more than 27 kg: two 30 mg sachets 3 times daily.
Intervention MeSH terms: Racecadotril
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty
Condition: Total Hip and Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates two routinely used drug combinations for periarticular injection
      following total hip and knee arthroplasty for pain control. One group will receive liposomal
      bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive
      ropivacaine, clonidine, epinephrine and ketorolac.
    

Detailed description: 
      A key component of the multimodal approach to pain management is the intra-operative surgical
      site injection of a local anesthetic or drug cocktail. There are many formulations used for
      this purpose. A formulation documented in the literature was implemented by this institution
      which has dropped the average length of stay dramatically. Concern over the limited half-life
      of the administered anesthetic and the continued need for opioid administration has led to a
      search for better drug formulations and administration vehicles. Recently, the FDA approval
      of an extended release bupivacaine called liposomal bupivacaine was thought to extend the
      effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia.
      Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its
      recent approval and has been an integral part of the "same day total joint" movement.

      Studies have suggested improvement in pain control and shortened hospitalizations with the
      use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of
      this agent. Recently a randomized double blind study was performed with total knees which
      demonstrated no improvement in pain management with the addition of liposomal bupivacaine to
      the multimodal pain management protocol. This study has not been performed in the hip
      arthroplasty population.
    

Intervention name(s): Liposomal Bupivacaine; Ropivacaine; Bupivacaine; Clonidine; Ketorolac; Epinephrine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Periarticular injection; Periarticular injection; Included as an element of the Liposomal bupivacaine intervention periarticular injection; Included as an element of both interventions as a standard of care periarticular injection; Included as an element of both interventions as a standard of care periarticular injection; Included as an element of both interventions as a standard of care periarticular injection
Other intervention name(s): Exparel; Naropin; Marcaine; Duraclon; Toradol; Adrenaline
Intervention MeSH terms: Ketorolac; Clonidine; Epinephrine; Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to obtain data that well help inform the feasibility and design of
      a randomized control trial of the therapeutic Neuromuscular Electrical Stimulation (NMES)
      technique in improving the swallowing function of young infants presenting with severe
      dysphagia.
    

Detailed description: 
      Infants with severe neurologic disability often have difficulty in eating by mouth due to a
      disruption in the swallowing process. This swallowing dysfunction, also known as dysphagia,
      is often evident early in life and when severe can be permanent. Dysphagia can lead to an
      inability to take in enough food to maintain an adequate weight and result in malnutrition.
      It also can result in food going into the lungs instead of the stomach, resulting in an
      illness called aspiration pneumonia. Both of these complications may require feeding by tube
      either through the nose into the stomach or directly into the stomach via the abdominal wall,
      to bypass the swallowing process. This process is resource intense, can be associated with a
      number of complications and may result in a reduced quality of life for both the infant and
      caregivers. Currently, there are no effective treatments to change the natural course of
      dysphagia in this context.
    

Intervention name(s): Neuromuscular electrical stimulation (NMES)
Intervention type(s): Device
Intervention description(s): The intervention will consist of a period of treatment with NMES. This treatment will involve 20-45 minute feeding therapy sessions during which NMES will be administered by an Occupational Therapist. Frequency of therapy sessions will be 4 times per week for the first 2 weeks (as in inpatient, if hospitalized) and then biweekly for 14 weeks for a total of 36 sessions (over 16 weeks). For patients who are discharged prior to the first 2 weeks of treatment, outpatient sessions will be biweekly.
Other intervention name(s): VitalStim® therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; dysphagia
Sleep Extension and Blood Pressure
Condition: Sleep Extension
Study type: Interventional

Summary: 
      Emerging evidence suggests that approximately 30% of the US adult population sleeps less than
      7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular
      diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep
      deficiency can be corrected and its detrimental health consequences potentially reversed. The
      purpose of the present proposal is to investigate the cardiovascular and metabolic effects of
      sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual
      short sleep.
    


Intervention name(s): sleep extension; sleep maintenance
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Assess the Safety, Pharmacological Effect and Plasma Concentration of ASP7991 After Single Oral Administration to Healthy Volunteers
Condition: Healthy; Pharmacokinetics of ASP7991
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics
      of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is
      administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991
      in fasted and fed conditions are compared.
    

Detailed description: 
      This study consists of two parts. In Part 1, the study will begin as a single rising dose
      escalation design under randomized double-blind and fasting conditions. In each dose group,
      volunteers will be randomized to receive an oral administration of either active drug
      (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment.

      Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to
      volunteers under 2 conditions, fasting and fed, on 2-way crossover method.
    

Intervention name(s): ASP7991; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: ASP7991
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Plasma concentration; ASP7991; food effect; PTH (parathyroid hormone)
Cereal-based Products Fortified With Legumes and Effects on Glycemic Control and Appetite Regulation
Condition: Appetite
Study type: Interventional

Summary: 
      Legumes are rich source of proteins and dietary fibers which are associated with satiety and
      amelioration of postprandial glycemic response. The purpose of the study is to examine the
      effects of cereal-based products fortified with legumes on appetite regulation and body
      weight management.
    

Detailed description: 
      Postprandial glycemic response as well as response of hormones related to appetite regulation
      after consumption of cereal-based products fortified with legumes will be evaluated.
      Apparently healthy subjects with normal body weight and overweight subjects will participate
      in the study (two protocols). Certain effects on metabolites related to the composition of
      the different products will be examined. The results of the study will help in the design of
      a long-term clinical trial regarding the effects of the functional products on body weight
      management in overweight subjects.
    

Intervention name(s): Cereal-legume product 1; Cereal-legume product 2; Cereal product; Reference food
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The intervention examines the effect of cereal based product fortified with legumes-1 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.; The intervention examines the effect of cereal based product fortified with legumes-2 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.; The intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.; The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Healthy subjects with normal body weight receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated.
Overweight subjects receive different cereal-based products fortified with legumes or reference food in a randomized crossover design. Postprandial glycemic and hormonal responses are evaluated.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cereal-based products fortified with legumes; appetite regulation; postprandial glucose response; postprandial hormone responses
Barriers to Treatment in Obese Adolescents
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to identify significant racial and ethnical differences in risk
      factors for development of obesity and weight loss in adolescents in Central Virginia
    

Detailed description: 
      -  Participation for 6 months in a program incorporating exercise, nutritional counseling
           and behavioral support leads to measurable improvements in overall fitness, metabolic
           indicators and loss of body fat for obese adolescents.

        -  Degree of loss of body fat, improved overall fitness and improvements in metabolic
           indicators can be correlated with the degree of compliance and participation for 6
           months in the program.

        -  Parental involvement and support can be correlated with the degree of compliance and
           participation in the program.

        -  Socioeconomic factors can be correlated with the degree of compliance and participation
           in the program.

        -  Cultural differences in diet, attitudes toward body shape, and family dynamics can be
           correlated with success or failure in a weight loss program.

        -  Individual differences in self-esteem, self-discipline and feelings of connectedness
           with family members can be correlated with success or failure in a weight loss program.
    

Intervention name(s): Motivational Interviewing; Strength and Cardiovascular Conditioning; Food selection and portion control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Biweekly meetings with a behavior specialist to review subject's progress with the protocol and explore challenges subject is facing in adopting healthy lifestyle behaviors.; Subjects take part in an exercise program to include 30 minutes of cardiorespiratory exercise at 70% maximum heart rate, and 30 minutes of strength training on Nautilus machines.; Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pediatric Overweight,; African American;; Adolescent;; Intervention,; Teasing;; Self-esteem; Quality of Life; Metabolic syndrome; Insulin resistance; Diabetes; Nutrition; Motivation; Culture; BMI; Cardiorespiratory fitness; Resistance Training; Compliance
Effects of Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Cytokines
Condition: Endometrial Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the effects of local wound infiltration with ketamine versus
      dexmedetomidine when added to bupivacaine on inflammatory cytokine response after total
      abdominal hysterectomy.
    


Intervention name(s): Ketamine; dexmedetomidine; bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients receive local anesthetic wound infiltration with 1 mg /kg ketamine; patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine; patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline
Intervention MeSH terms: Dexmedetomidine; Ketamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase 2, Multi-center Study to Evaluate the Efficacy and Safety of ONO-2952 in Female Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in
      female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
    


Intervention name(s): ONO-2952; ONO-2952 Matching Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; IBS; ONO-2952
Pharmacokinetics of Propofol in Morbidly Obese Patients
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this study are

        -  To determine PK of propofol in bariatric patients

        -  To identify the physiological variables that induce propofol PK changes in bariatric
           patients, when compared to a normal-weight population.

        -  To define context-sensitive half-time profiles for propofol in bariatric patients.
    


Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
Other intervention name(s): Diprivan
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Bariatric surgery; Anesthetics, intravenous; Propofol; Pharmacokinetics
Salivary Evaluation in Healthy Volunteers
Condition: Healthy; Salivary Gland Disease
MeSH terms: Salivary Gland Diseases
Study type: Observational

Summary: 
      Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated
      several disorders of salivary glands. The purpose of this protocol is to obtain data from
      healthy volunteers for comparison with data from patients with salivary dysfunction. We plan
      to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid
      participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits
      that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry
      eye examination, and lip biopsy follow up, as needed. These are routine diagnostic
      procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro
      biochemical analysis or in vivo transplantation.

      Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary
      glands.
    

Detailed description: 
      -  Objective: To obtain data from healthy volunteers for comparison with data from patients
           with salivary dysfunction.

        -  Study population: Healthy volunteers aged 18-70 years old

        -  Design: Observational

        -  Outcome measures: Clinical and basic science data to serve as controls for comparisons
           with subjects presenting with salivary gland dysfunction

      Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated
      several disorders of salivary glands. The purpose of this protocol is to obtain data from
      healthy volunteers for comparison with data from patients with salivary dysfunction. We plan
      to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid
      participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits
      that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry
      eye examination, and lip biopsy follow up, as needed. These are routine diagnostic
      procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro
      biochemical analysis or in vivo transplantation.

      Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary
      glands.

      The outcome measurement for this study is to determine those healthy subjects whose data and
      specimens can be used as control comparison for our patient subjects in our
      Sj(SqrRoot)(Delta)gren s syndrome studies (15-D-0051, 99-D-0070, 11-D-0094 and/or 11-D-0172).
    

Keywords: Saliva; Parotid; Lip Biopsy; Health; Exocrine; Normal Volunteer
Microbial Community Transplantation on the Armpit.
Condition: Heavy, Bad Odour From Armpit
Study type: Interventional

Summary: 
      The malodour generation of a person's armpit is caused by the bacteria thriving on that
      armpit. In order to alter or reduce once bad body odour, the living microbial community on
      the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to
      the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the
      bacteria living on the armpit is examined by means of molecular techniques. The microbial
      transplantation and its follow-up happens under the supervision of a medical doctor.
    


Intervention name(s): Microbial transplant
Intervention type(s): Biological
Intervention description(s): Every subject has 2 armpits; 1 armpit is treated, the other one is not treated. There is a microbial transplant from armpit bacteria.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Myfortic on Gastrointestinal (GI) Prophylaxis in Maintenance Renal Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether maintenance renal transplant patients
      receiving Myfortic can reduce or discontinue GI prophylaxis medications.
    

Detailed description: 
      GI prophylaxis is common post kidney transplant and is routinely used in patients receiving a
      variety of different immunosuppressive regimens. Cellcept and prednisone are often the
      biggest concern for GI distress and GI ulcers. Routine use of GI prophylaxis medications
      post-transplant are potentially one mental obstacle to transplant clinicians being fully
      persuaded of the GI neutral effect of myfortic in the immunosuppressive regimen. Patients
      receiving myfortic (as part of the conversion in the US02 study) are theoretically at a
      reduced risk for GI upset and development of GI ulcers. These patients are ideal candidates
      to discontinue their GI prophylaxis medications while taking myfortic.
    

Intervention name(s): GI medication
Intervention type(s): Drug
Intervention description(s): Patients on daily dosing were asked to discontinue their GI medication at baseline. Patients on twice daily dosing were asked to reduce GI medication to once a day at baseline and asked to discontinue GI medication at day 30.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Kidney Transplantation; Gastrointestinal Agents