bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura
Condition: Trichuris Trichiura; Infection
MeSH terms: Trichuriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study rationale is to provide evidence on effective doses of moxidectin and/or
      moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura.
      The study will take place on Pemba Island, Tanzania.
    


Intervention name(s): Moxidectin 8mg; Moxidectin 8 mg + albendazole 400 mg; Moxidectin 16 mg; Moxidectin 16 mg + albendazole 400 mg; Moxidectin 24 mg; Moxidectin 24 mg + albendazole 400 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): Participants will receive the tablet with clean water and a package of biscuits.; Participants will receive the tablets with clean water and a package of biscuits.; Participants will receive the tablets with clean water and a package of biscuits.; Participants will receive the tablets with clean water and a package of biscuits.; Participants will receive the tablets with clean water and a package of biscuits.; Participants will receive the tablets with clean water and a package of biscuits.; Participants will receive the tablet with clean water and a package of biscuits.
Intervention MeSH terms: Albendazole; Moxidectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Trends in Breastfeeding Disparity in U.S. Infants by WIC Eligibility and Participation
Condition: Breast Feeding
Study type: Observational

Summary: 
      This is a secondary data analysis study that uses nationally representative data to examine
      the trends in breastfeeding disparities between Women, Infants, and Children (WIC) program
      eligible children vs. non-eligible children and eligible participants vs. eligible
      non-participants.
    


Intervention name(s): WIC program participation
Intervention type(s): Other
Intervention description(s): WIC program is a welfare program in the U.S. to provide nutritional supplements to low-income women, infants, and children.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A nationally representative sample surveyed in NHANES 1999-2014
Infraclavicular Perineural Dexmedetomidine
Condition: The Analgesic Effects
Study type: Interventional

Summary: 
      Infraclavicular block is one of the peripheral nerve block used in upper extremity surgery.
      Adjuvant agents are used in peripheral nerve blocks to increase the duration and block
      quality. We investigated that the effects of patient-controlled perineural dexmedetomidine
      application on postoperative analgesia.
    


Intervention name(s): Bupivacaine; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): patient- controlled infraclavicular perineural marcaine infusion; patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: perineural dexmedetomidine; infraclavicular perineural catheter; postoperative analgesia
A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention for
      children with anxiety disorders (AD) is undeniable. However, most children with AD have
      limited access to CBT. There is some controversial evidence on group CBT in AD involving
      families in treatment of their children and a published article on efficacy of a parent only
      group CBT for these children. Considering these data, the investigators hypothesized that
      teaching anxiety-fighting skills to parents of children with AD would diminish anxiety
      symptoms of both parents and children and improve family relational functioning.
    

Detailed description: 
      All children and their parents were interviewed using K-SADS-PL-Persian Version, a
      semi-structured diagnostic interview to confirm the diagnoses and assess possible
      comorbidities. All diagnostic assessments were conducted by a fellowship of child and
      adolescent psychiatry. Following assessment, once the participants reached twenty members,
      they were invited to complete child and parent self-report measures. The level of child
      functioning and family relationship functioning were also evaluated. Then they were randomly
      allocated to either parent training (N=20) or a 6 week wait-list (N=22) groups. During 2
      weeks after treatment the assessments were repeated and satisfaction ratings were collected
      for the intervention group.
    

Intervention name(s): Group cognitive behavioral intervention
Intervention type(s): Other
Intervention description(s): A Group cognitive behavioral intervention _based on parent training component of FRIENDS program_ was performed.The program protocol was translated to Persian, using the back translation method.The intervention was delivered in 6 two-hour weekly sessions. Two intervention groups ran, each group included 10 parents.The therapy was provided by an attending board certified child and adolescent psychiatrist and co lead by a fellow of child and adolescent psychiatry who distributed psychometric procedures and completed treatment adherence ratings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: parents; group cognitive behavioral intervention; anxiety disorder; children; FRIENDS program
Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
Condition: Graft vs. Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell
      (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30
      post-hematopoietic cell transplantation (HCT).
    

Detailed description: 
      This is a comparative study to assess the biologic and clinical activity of the agent
      ustekinumab when given in concert with our established regimen of SIR/TAC. Patients will be
      randomly assigned between the standard regimen of tacrolimus/sirolimus (TAC/SIR + placebo)
      vs. the investigational regimen of tacrolimus/sirolimus/ustekinumab (TAC/SIR/U) in a 1:1
      scheme.
    

Intervention name(s): Ustekinumab; Placebo; Tacrolimus (TAC); Sirolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One subcutaneous injection administered on day -1 and repeated on day +20 after transplant; Subcutaneous injection of sterile saline (identical volume to that of ustekinumab) administered via the identical route and schedule as ustekinumab.; Administered starting day -3 according to Blood and Marrow Transplant (BMT) Program standard operating procedures. TAC levels to be monitored and maintained at a target range of 3-7 given concurrent administration with sirolimus. Specific dose adjustments within this therapeutic range to be determined by the treating physician.; Administered initially as an oral loading dose on day -1. Thereafter, SIR to be administered as an oral regimen daily. The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program. SIR levels to be monitored according to standard procedures. Dose adjustments to be made according to drug levels, with target range of 5-14ng/mL (therapeutic range by Abbott Architect instrument at Moffitt).
Other intervention name(s): STELARA; saline; TAC; Protopic; Prograf; Hecoria; SIR; Rapamune
Intervention MeSH terms: Sirolimus; Ustekinumab; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute Graft vs. Host Disease (aGVHD); Graft vs. Host Disease (GVHD)
Acceptance of Human Papillomavirus Vaccination in Postpartum Women
Condition: Human Papilloma Virus; HPV; Post Partum
MeSH terms: Papilloma
Study type: Observational

Summary: 
      Worldwide cervical cancer remains a major cause mortality among women. It is estimated that
      each year over 490,000 women are diagnosed with cervical cancer and more than 270,000 die
      from the disease. While the implementation of widespread screening programs has reduced the
      burden of cervical cancer, a large percentage of the population still remains unscreened or
      is underscreened. It is now recognized that human papillomavirus (HPV) is a necessary
      precursor for the development of cervical cancer. The first vaccine to prevent HPV was
      recently approved by the Food and Drug Administration and is now available at doctors
      offices. Despite the availability of a safe and effective means for the prevention of
      cervical cancer, widespread implementation of vaccination has been extremely difficult.
      Several potential issues have limited the development of widespread HPV vaccination programs,
      including cultural and religious beliefs, and limitations in the practicality of
      administering the vaccine. The overall goals of our work are to improve access to preventive
      strategies for cervical cancer. In this proposal we will examine the strategy of HPV
      vaccination for women who have just given birth. We believe that HPV vaccination of these
      women will be associated with a high level of patient satisfaction and acceptance. If
      successful, this strategy could play a major role in advancing the acceptance and
      implementation of HPV vaccination in the United States.
    

Detailed description: 
      Primary Objective

      1. To estimate compliance with the HPV vaccine series when initiated in postpartum women.

      Secondary Objectives

        1. To determine patient acceptance and satisfaction with HPV vaccination administered in
           the postpartum period.

        2. To determine predictors of compliance with the HPV vaccination series.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women, aged 18-26, hospitalized during the postpartum period after a normal spontaneous
        vaginal delivery, assisted vaginal delivery or Cesarean section.
      
Keywords: Human Papilloma Virus vaccines; HPV; Gardasil; Post partum
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      the aim of this study will be to investigate the effect of lumbar proprioception training on
      primary dysmenorrhea.
    

Detailed description: 
      Although previous studies reported the effect of physiotherapy practices through therapeutic
      exercises on primary dysmenorrhea as core muscles strengthening, core stability exercises,
      connective tissue massage and classical massage, relaxation, strengthening, stretching,
      aerobic exercises, pelvic floor muscle strengthening exercises, yoga and Pilates. None of
      them have investigated the effect of lumbar proprioception training on primary dysmenorrhea.
      Therefore, this study will be the first one which aims to investigate the effect of lumbar
      proprioception training on primary dysmenorrhea. This trial will include 2 groups; group A
      composed of 20 females that will receive hot packs and pelvic rocking exercises for 4 weeks
      and group B also composed of 20 females that will receive hot packs and pelvic rocking
      exercises in addition to lumbar proprioception training for 4 weeks.
    

Intervention name(s): lumbar proprioception training; Hot packs; Pelvic rocking exercise
Intervention type(s): Other; Other; Other
Intervention description(s): a) Sensorimotor training: Sensorimotor training and reconditioning of proprioceptive senses have recently been found to be helpful in increasing motor performance and coordination, muscle strength, sensorimotor abilities, increasing intermuscular control, and improving one's response to sensory information and muscle tone. Reconditioning of proprioceptive senses and sensorimotor training increases one's muscle adjustment ability, maximizes the sensory input in different parts of the body and aids in improving one's motor adjustment ability (Hwang et al ., 2013).
Position Exercise methods as Hollowing exercise: Participants will be asked to contract the abdominal muscles, raising the center of movement toward the navel in a quadruped position.; hot application in the form of hot packs on the lower abdomen and lower back for a total duration of 30 minutes, once per day, during the first two days of menstruation; Pelvic rocking exercise
Other intervention name(s): lumbar proprioception exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lumbar proprioception training; pelvic rocking exercises; primary dysmenorrhea
Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Observational

Summary: 
      Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump
      offers the advantage of flexibility and precision to administering insulin and has been
      proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there
      are extremely limited studies on the difference between insulin pump compared to MDI on the
      incidence of hypoglycemia and other acute complications during fasting Ramadan

      The investigators hypothesized that insulin pump would be associated with less hypoglycemic
      events during fasting Ramadan compared to MDI without deterioration in glycemic control.
      Results of this study are descriptive but will fill a current gap in knowledge and may
      contribute to development of future guidelines for the management of type1DM during Ramadan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The target population of our study is all patients with type1DM treated at three National
        Guard institutiuons in three different cities of Saudi Arabia (Riyadh, Alahsa, Dammam) with
        either insulin pump or MDI
      
Keywords: Ramadan; Fasting; Diabetes; Type1; Insulin; Pump
Neural Mechanisms of Disulfiram Effects
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 4

Summary: 
      This study combines functional MRI with medication treatment in order to understand the
      neural mechanisms by which disulfiram, a currently approved medication for alcohol use
      disorder, changes behavior. Disulfiram is a medication that prevents drinking by causing a
      highly unpleasant physical reaction when alcohol is consumed while it is being taken. Thus,
      it provides a means for studying the general neural mechanisms by which awareness of risks
      impacts behavior change in alcohol use disorder.
    

Detailed description: 
      The overall goal of this project is to combine functional brain imaging and clinical methods
      in order to examine how treatment with disulfiram (DIS) alters neural activity related to
      alcohol-seeking motivation in patients with alcohol use disorder (AUD). DIS is an
      established, effective, FDA-approved medication for AUD that causes a highly aversive
      physical reaction if alcohol is consumed while it is being taken. The mere awareness of the
      risk or threat the DIS-alcohol reaction deters alcohol use, i.e. it is not necessary to drink
      alcohol while taking DIS to change behavior. By uncovering the neural mechanisms underlying
      this risk/threat-based psychological effect, it will be possible to integrate DIS with
      biologically based treatments targeted at these neural mechanisms, with the goal of improving
      the efficacy of DIS. Furthermore, the results will shed light on the general neural
      mechanisms by which awareness of risks of substance use impacts addictive motivation. This is
      a core process in a number of behavioral treatments for substance use disorders, such as
      Motivational Interviewing and Contingency Management, as well as in behavior change in
      non-treatment settings.
    

Intervention name(s): Disulfiram
Intervention type(s): Drug
Intervention description(s): Patients will be hospitalized on an inpatient psychiatric unit for 1-7 days to initiate abstinence. An fMRI scan will be performed to examine neural mechanisms of alcohol motivation. Prior to discharge, patients will receive the first dose of disulfiram 500 mg. They will then attend an outpatient clinic every other day for 14 days. At each clinic visit, they will receive 500 mg of disulfiram under supervision. Another fMRI scan examining alcohol motivation will be performed. Following this, all patients will attend the clinic weekly, and will be prescribed disulfiram 250 mg daily to take at home. This will be followed followed by an optional extension of weekly visits taking disulfiram 250 mg daily for another 28 days, for a total of 70 days of disulfiram treatment.
Other intervention name(s): Antabuse
Intervention MeSH terms: Disulfiram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alcohol; Craving; Functional MRI; Cognitive control; Risky decision-making; Disulfiram
Urinary Retention in Orthopedic Patients
Condition: Urinary Retention; Orthopedic Patients; Spinal Anesthesia
MeSH terms: Urinary Retention
Study type: Observational

Summary: 
      The participants were hospitalized in Orthopedic and Traumatology Departments in Military
      Institute of Medicine, Warsaw, Poland.

      The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and
      (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered
      during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder
      catheterization was perform during the surgery were excluded from the study.

      The participants were randomly divided into the study and control groups. No oral
      premedication was administered. All the patients were asked to empty their urinary bladders
      before arrival to the operating theatre. When the standard monitoring (continuous
      electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous
      premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric
      0.5% solution of bupivacaine hydrochloride was performed.

      In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride
      was administered intramuscularly. The decresed intravascular volume was corrected with
      cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay
      scale, level of sedationt was obtained with midazolam and/or propofol. All the participants
      received a questionaire in which we asked the questions about (1) the duration of anesthesia,
      (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower
      abdomen, (4) the incidence of the urinary bladder catheterization and time to
      catheterization. On the next day after the surgery the questionaires were collected. In
      cases, when the patient's dischaged from the hospital was planned during the weekend, he or
      she was asked to pass on the questionaire to the nurses.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for orthopedic surgery under spinal anesthesia.
Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America. The aim of this trial is to
      investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the
      effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in
      Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity
    


Intervention name(s): NNC9204-0530; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once-daily subcutaneous (s.c., under the skin) administration.; Once-daily subcutaneous (s.c., under the skin) administration.; Once-daily subcutaneous (s.c., under the skin) administration
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment