bioihbjkbjnl/mcl2 huggingface dataset:
Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
Condition: Repeated IVF Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in
      subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.
    

Detailed description: 
      NT-04 is a follow-up study that will include subjects who received at least one dose of study
      drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03.
      NT-04 does not involve the administration of study drug treatment.

      In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will
      undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last
      dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in
      NT-04.

      Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of
      gestation, at which time subjects will be contacted every two weeks until confirmation of
      delivery. Information about pregnancy status and use of prescription medications will be
      collected at these telephone interviews.

      Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.

      Following delivery, additional information will be obtained, including pregnancy outcome,
      gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn
      assessment.
    

Intervention name(s): Post dosing with NT100; Post dosing with Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effect of South Beach Diet (SBD™) Using SBD™ Products Compared to the American Diabetic Association (ADA) Diabetes Meal Plan on Body Weight and Satiety in Diabetic Women
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of the South Beach Diet and
      products compared to the American Diabetic Association Diabetes Meal Plan.
    


Intervention name(s): South Beach Diet with South Beach Diet Products; American Diabetes Association Diabetes Meal Plan
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: South Beach Diet™; overweight; obesity; satiety; weight loss; diabetes
Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      From the profiles of antibiotic susceptibility data following eradication therapy,
      tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the
      rescue treatment.
    

Detailed description: 
      The H pylori-infected adult patients with failure of standard triple therapy and H
      pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly
      assigned to either EAL (esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin
      500 mg o.d.) or EBTL (esomeprazole 40 mg b.d., bismuth 500 mg q.d.s., tetracycline 500 mg
      q.d.s., and levofloxacin 500 mg o.d.) therapy for 10 days. Repeated endoscopy with rapid
      urease test, histological examination and culture or urea breath tests is performed at six
      weeks after the end of anti-H pylori therapy.
    

Intervention name(s): esomeprazole+amox+levo; esomeprazole+bismuth+tetra+levo
Intervention type(s): Drug; Drug
Intervention description(s): esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.; esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
Other intervention name(s): esomeprazole 40 mg; amoxicillin 500 mg; levofloxacin 500 mg; esomeprazole 40mg; bismuth 120 mg; tetracycline 500 mg; levofloxacin 500 mg
Intervention MeSH terms: Amoxicillin; Levofloxacin; Ofloxacin; Tetracycline; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Eradication rate; Rescue treatment
An ACE Inhibitor (Perindopril) or an Angiotensin Receptor Blocker (Candesartan) as a Treatment for Methamphetamine Dependence
Condition: Methamphetamine Dependence; Methamphetamine Abuse; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the dose dependent effects of treatment with
      perindopril on methamphetamine (MA)-induced craving and on the reinforcing effects of MA
      indexed by MA self-administration. We will also determine the effects of treatment with
      candesartan on MA-induced craving and on the reinforcing effects of MA indexed by MA
      self-administration.
    

Detailed description: 
      Our preliminary data indicate that the ACE inhibitor perindopril can attenuate MA-induced
      drug craving, suggesting that perindopril should be evaluated as a treatment for MA
      dependence. Candesartan works similarly to perindopril but should lack the U-shaped dose
      response. Like perindopril, candesartan is used for hypertension. Whereas perindopril reduces
      the synthesis of angiotensin II, candesartan blocks angiotensin II receptors.
    

Intervention name(s): Perindopril; Placebo; Candesartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 mg taken orally from days 0 through 7.; Placebo treatment daily.; 16 mg taken orally from days 0 through 7.
Other intervention name(s): Aceon; Sugar pill; Atacand
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Perindopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Methamphetamine; Perindopril; Candesartan; Angiotensin receptor blocker; ACE Inhibitor
Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to examines the effectiveness of Core stabilization exercise on
      pain intensity at rest, functional disability, lumbar movement and ability to perform
      repositioning tasks (joint position sense) in patients with subacute non-specific low back
      pain.
    

Detailed description: 
      This study is to compare the effectiveness of Core stabilization exercise and physical
      therapy on pain intensity at rest, functional disability, lumbar movement and ability to
      perform repositioning tasks (joint position sense) in patients with subacute non-specific low
      back pain. There are 2 groups receiving 2 different kinds of intervention: treatment group
      receiving core stabilization exercise (CSE) and control group receiving physical therapy
      including therapeutic ultrasound and hydrocollator pack. Each intervention will perform for 7
      weeks. The patients will assess for all outcome measures at baseline, 7 weeks of
      intervention, and 1- month follow-up
    

Intervention name(s): Core stabilization exercise; Conventional treatment
Intervention type(s): Other; Other
Intervention description(s): 7-weeks of core stabilization exercise; 7-weeks of conventional treatment include therapeutic ultrasound and hot pack
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Feasibility of the YATAC Programme
Condition: Cancer
Study type: Interventional

Summary: 
      Young adult cancer survivors (YACS) aged 18-39 report physical and psychosocial late effects
      following cancer treatment, impairing quality of life and participation in everyday life. To
      address such multifactorial challenges complex or multicomponent rehabilitation interventions
      are needed. Based on this, the 'Young Adult Taking Action' (YATAC) programme was developed to
      increase participation in everyday life and improve health-related quality of life. The
      development of the intervention is guided by the British Medical Research Council's guidance
      (MRC) and the framework for the co-production and prototyping of public health interventions
      by Hawkins et al.

      The present study will investigate the acceptability and fidelity of the intervention at the
      research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care
      in Nyborg, Denmark. A mixed method one-armed feasibility study will be conducted and the
      results of the study will be used to revise version 1.0 of the programme.
    


Intervention name(s): A rehabilition programme for young adult cancer survivors
Intervention type(s): Other
Intervention description(s): The programme consists of 22 sessions focusing on; 1) everyday life (energy conservation, cognitive challenges, fatigue); 2) Physical activity; 3) psychological issues; 4) work and study d; 5) sexuality and relationship; 7) rights and finance, and 8) goal setting. The sessions include both education, workshops, and engagement in different activities and will be delivered by a multidisciplinary team.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rehabilitation; Young adults
Histamine Pharmacogenetics in Children With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      The primary goal of the study is to investigate the impact of a common genetic polymorphism
      in a histamine detoxification enzyme that may well have a common role in regulating the
      expression of atopic dermatitis (AD) and other related atopic diseases in children.
    

Detailed description: 
      Atopic dermatitis (AD) is a common condition in the pediatric population, affecting an
      estimated 15% of all children greater than 18 months of age in the United States. It is now
      recognized that AD is a disease of significant heterogeneity with respect to both disease
      severity and response to conventional pharmacologic therapies. With the recognition of this
      variability comes the understanding that, as with many other allergic disease, there exist
      many specific disease phenotypes that ultimately govern response to pharmacologic
      intervention. The characterization of these unique phenotypes and their associated biologic
      mediators is therefore of critical therapeutic importance in the development of disease and
      patient-specific treatment strategies.

      The long term objective of this research is to explore the effects of genetic, environmental
      and developmental influences on the primary determinants of histamine action in atopic
      children and to identify potential histamine "haplotypes" that may be predictive of disease
      severity, progression and/or response to therapy.

      The primary hypothesis is the presence of HNMT T314 allele and /or slow acetylation genotype
      is associated with childhood atopic dermatitis.
    

Intervention name(s): Buccal Swab
Intervention type(s): Other
Intervention description(s): collection of buccal swab
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Caucasian,AfricanAmerican and Hispanic children with a medical diagnosis of atopic
        dermatitis and healthy, age matched controls
      
Biospecimen description: 
      buccal-derived DNA
    
Keywords: Atopic Dermatitis; Eczema; Genetics; Histamine
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
Condition: HIV Infections; Pregnancy
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of
      nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to
      the mother during active labor, and when their neonates are dosed during the first week of
      life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who
      received nevirapine during active labor, and their neonates who received no dose, a single
      dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of
      life.

      Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic
      levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition,
      decreasing the neonate's risk of infection.
    

Detailed description: 
      Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic
      levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition,
      decreasing the neonate's risk of infection.

      Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the
      first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the
      second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine.
      If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single
      dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a
      single dose of nevirapine and their neonates will receive multiple doses of nevirapine to
      maintain an antiviral effect for 7 days.
    

Intervention name(s): Nevirapine
Intervention type(s): Drug
Intervention MeSH terms: Nevirapine
Primary purpose: Treatment
Keywords: Pregnancy; Pregnancy Complications, Infectious; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Nevirapine
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
Condition: Venous Insufficiency; Venous Reflux; Lower Extremity Ulcer
MeSH terms: Varicose Ulcer; Venous Insufficiency; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      This trial is a prospective, randomized, controlled, multi-center study of subjects
      presenting with chronic lower extremity venous ulcers. The study will evaluate the safety and
      effectiveness of MIST Therapy® plus standard of care (MIST+SOC) compared to Standard of Care
      (SOC) alone in the treatment of lower extremity venous ulcers.
    

Detailed description: 
      The study compared the treatment effect of non-contact low frequency ultrasound in addition
      to standard of care versus standard of care alone in healing chronic venous leg ulcers in
      subjects who had documented venous stasis and reflux. Subjects that were screened and met the
      major inclusion criteria received standardized treatment of 30 to 40 mmHg compression, moist
      wound healing dressings, and debridement for a two week run-in period. If their study ulcer
      did not decreased by greater than 30% they were eligible for randomization. The primary
      endpoint was wound area reduction after four (4) weeks of study treatment. The study was
      performed at 22 study centers. The study included two sub-studies: fluid and tissue analysis
      and a wound recidivism registry that are ongoing.
    

Intervention name(s): MIST Therapy
Intervention type(s): Device
Intervention description(s): Non-contact low frequency ultrasound therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Venous Insufficiency; Reflux; Lower Extremity Ulcer
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
Condition: Renal Impairment; Healthy Volunteers
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      It is hoped that mobocertinib will eventually help people with cancer with severely reduced
      kidney function. The main aim of this study is to learn about the levels of mobocertinib in
      the blood and urine of participants with severely reduced kidney function and participants
      with healthy kidneys. These participants do not have cancer. The information from this study
      will be used to work out the best dose of mobocertinib for people with cancer with severely
      reduced kidney function in the future.

      At the first visit, the study doctor will check who can take part. Participants who can take
      part will be placed into 1 of 2 treatment groups. Participants with severely reduced kidney
      function will be in 1 group. Participants with healthy kidneys will be in the other group.
      Participants in both groups will receive the same treatment and the group results will be
      compared.

      Participants from both groups will take 1 capsule of mobocertinib. They will stay in the
      clinic for 10 days so the study doctors can check the amount of mobocertinib in the blood and
      urine of these participants over time. The study doctors will also check if the participants
      have any side effects from this treatment.

      The clinic will call the participants 30 days after they took mobocertinib to check if they
      have any more side effects from their treatment.
    

Detailed description: 
      The drug being tested in this study is called mobocertinib. This study is to assess the
      pharmacokinetic (PK) of mobocertinib and its active metabolites (AP32960 and AP32914) in
      participants with severe RI compared to matched-healthy participants with normal renal
      function.

      The study will enroll approximately 24 participants. Participants will be assigned to 1 of
      the following 2 treatment groups:

        -  Severe RI: Mobocertinib 80 mg

        -  Normal Renal Function: Mobocertinib 80 mg

      Healthy participants with normal renal function will be recruited to match severe RI by age
      (mean plus or minus [+-] 10 years), gender (+-2 participants per gender), and body mass index
      (BMI), (mean +- 10 percent [%]). All participants will be asked to take single dose of
      mobocertinib on Day 1.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is 51 days. Participants will be contacted by telephone 30 days
      after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Mobocertinib
Intervention type(s): Drug
Intervention description(s): Mobocertinib capsule.
Other intervention name(s): TAK-788; AP32788
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
Condition: Lung Neoplasms; Early Detection of Cancer; Decision Support Techniques; Primary Health Care
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The primary objective of this study is to assess the effect of the decision aid on measures
      of decision-making such as knowledge, screening attitudes, decisional conflict, and screening
      intent.
    

Detailed description: 
      Using a single group, pre-post design, we aim to assess the effect of the decision aid on
      screening knowledge, screening attitudes, decisional conflict, and screening intent within 3
      months of decision aid viewing.
    

Intervention name(s): Pre/Post Test of a Lung Cancer Screening Decision Aid
Intervention type(s): Behavioral
Intervention description(s): After completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety and toleration of single oral doses as
      well as the time course of PF-04418948 concentration in the blood following dosing by oral
      solution.
    


Intervention name(s): PF-04418948; PF-04418948; PF-04418948; PF-04418948; PF-04418948; PF-04418948; PF-04418948
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): solution, 30 mg, single; solution, 100 mg, single; solution, 300 mg, single; solution, 1000 mg, single; solution, 3000 mg, single; solution, 4500 mg, single; solution, 6000 mg, single
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Extract of Curcuma Longa Complexed With Phosphatidilcholine(Motore®)in the Treatment of Adults With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two
      hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be
      randomly allocated to one of two treatment groups , and treatment group 01 will be the dried
      extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02
      will ibuprofen (Alivium®).
    

Detailed description: 
      This study evaluate the efficacy and safety of Dry Extract of Curcuma Longa complexed with
      phosphatidilcholine (Motore®) Compared to Ibuprofen (Alivium® ) in the treatment of adults
      with knee osteoarthritis. The study population will consist in participants of both sexes,
      aged between 40 and 80 years old with a clinical diagnosis of knee osteoarthritis
      (tibiofemoral joint) based on clinical and radiological criteria (Grades 2 and 3 Kellgren and
      Lawrence) and who had osteoarthritis symptoms in the last six (06) months preceding the start
      of the study. They will be randomly allocated to one of two treatment groups , and treatment
      group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine
      (Motore®), and treatment group 02 will ibuprofen (Alivium®).
    

Intervention name(s): Motore; Alivium
Intervention type(s): Drug; Drug
Intervention description(s): 250 mg; 600 mg
Other intervention name(s): Group 1; Group 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment