bioihbjkbjnl/mcl2 huggingface dataset:
PDA Post NICU Discharge
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational

Summary: 
      The purpose of this study is to track post-discharge outcomes on prematurely born infants who
      are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to
      report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac
      events in these infants. The goal is to identify risk factors associated with adverse
      outcomes in prematurely born infants who are sent home with a PDA.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This is a prospective multicenter descriptive study to collect data on neonatal outcomes
        and treatment modalities of neonates diagnosed with a patent ductus arteriosus by
        echocardiogram and have an active diagnosis of a PDA at discharge from the hospital.
Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are
      disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized
      by the body to form cysteine, an active compound that normalizes glutamate levels. The
      purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine
      dependent individuals.
    

Detailed description: 
      Currently, no effective pharmacological treatment exists for cocaine dependence. Long-term
      use of cocaine disrupts normal glutamate levels. If addicts stop using cocaine, glutamate
      levels drop, which encourages addicts to continue seeking the drug. NAC is a drug that
      increases intracellular cysteine levels, which in turn leads to normalization of glutamate
      levels. Currently, NAC is used for the treatment of cystic fibrosis, heart disease, and
      acetaminophen overdose. Since NAC has the capability of restoring normal glutamate levels, it
      holds potential as a treatment for cocaine dependence. The purpose of this study is to
      determine the safety and effectiveness of NAC in treating cocaine dependent individuals. In
      addition, this study will evaluate cocaine craving and withdrawal symptoms in individuals
      taking NAC.

      Participants in this double-blind, placebo-controlled trial will be randomly assigned to
      receive either NAC or placebo. All participants will undergo an initial evaluation, which
      will include a physical examination, an electrocardiogram, blood samples, urine tests, and
      cue reactivity measures. Participants in the NAC group will receive either 600 mg or 1200 mg
      of NAC, two times each day for 8 weeks. In addition, all participants will receive cognitive
      behavioral therapy throughout the study on a weekly basis. Cocaine use will be confirmed by a
      urine drug screen test, three times each week. Participants will be assessed on a number of
      biomedical and psychosocial variables known to influence cocaine treatment outcomes. After
      Week 2, participants will repeat the cue reactivity procedures, which will include measuring
      a participant's craving response when exposed to conditioned reminders of prior cocaine use.
    

Intervention name(s): N-Acetylcysteine; N-Acetylcysteine; Matching Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1200mg N-Acetylcysteine; 2400mg N-Acetylcysteine; Matching Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine Dependence
The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER)
Condition: HIV Infections; Depression; Mild Cognitive Impairment
MeSH terms: HIV Infections; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of ginkgo biloba (steady state) on the
      pharmacokinetics of a single dose of the UGT-substrate raltegravir. Furthermore the safety
      profile of the combination is studied.
    

Detailed description: 
      Ginkgo biloba is an alternative medicine that is popular among HIV-infected patients because
      if its claimed positive effects on memory, concentration and depression. Alternative medicine
      can cause drug-drug interactions with regular HIV-medication. Raltegravir is a newly
      developed HIV integrase inhibitor. It is metabolized in the liver by UGT1A1 and therefore its
      pharmacokinetic profile can be influenced by inhibitors or inducers of UGT1A1. So far there
      are no data of the potential effect of ginkgo biloba on glucuronidation in vivo. The current
      study is designed to evaluate the potential inductive effect of ginkgo biloba on the
      pharmacokinetics of raltegravir and the safety profile when used in combination.
    

Intervention name(s): raltegravir single dose; ginkgo biloba multiple dose
Intervention type(s): Drug; Drug
Intervention description(s): single dose 400mg raltegravir; 15 days ginkgo biloba 120mg BID
Other intervention name(s): Isentress; Tavonin
Intervention MeSH terms: Raltegravir Potassium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV infections; interaction; pharmacokinetics
A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, parallel-group, phase 1, single center study to assess the relative
      bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an
      autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy,
      adult subjects.
    


Intervention name(s): CSL312
Intervention type(s): Drug
Intervention description(s): Factor XIIa antagonist monoclonal antibody for subcutaneous use
Other intervention name(s): Gardacimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Postoperative pain, the great concern for the patients undergoing spine surgery, has led to
      common use of opioid-based intravenous patient-controlled analgesia (IV-PCA) postoperatively.
      Opioid-based IV-PCA offers better pain control, which could facilitate early recovery,
      rehabilitation and increase patient satisfaction. However, its use inevitably increases the
      incidence of postoperative nausea and vomiting (PONV), another great discomfort, as high as
      80% in patients with multiple risk factors.Therefore, there have been consistent efforts to
      prevent PONV with multimodal therapies such as risk stratification, modification and
      preventive use of antiemetics.

      Of all antiemetics, 5-hydroxytryptamine (5-HT3) antagonist, especially ondansetron, is most
      commonly used and extensively studied to reduce PONV because of its efficacy and fewer side
      effects.[8] However, its efficacy is not quite satisfactory when it comes to PONV associated
      with opioid-based IV-PCA. Recently, there are many reports comparing the antiemetic efficacy
      between ondansetron and the 2 newly developed 5-HT3 antagonists, ramosetron and palonosetron.
      Ramosetron is known to have a higher affinity and longer duration of binding to 5-HT3
      receptor, therefore exhibits potent and sustained anti-emetic effect than previously
      developed 5-HT3 antagonists.Palonosetron has a unique allosteric binding to the 5-HT3
      receptor, which brings a higher affinity, longer duration of action and longer elimination
      half-time.According to the previous studies, both ramosetron and palonosetron showed superior
      antiemetic efficacy for PONV associated with opioid-based IV-PCA to ondansetron as expected
      by their theoretical advantages. However, it has never been evaluated which one has superior
      antiemetic efficacy for opioid-based IV-PCA associated PONV. Therefore, in this study, we
      tried to evaluate the relative antiemetic efficacy of ramosetron and palonosetron in
      controlling opioid-based IV-PCA related PONV.
    


Intervention name(s): ramosetron; palonosetron
Intervention type(s): Drug; Drug
Intervention description(s): Ramosetron 0.3 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.; palonosetrno 0.075 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.
Intervention MeSH terms: Palonosetron; Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: palonosetron, ramosetron, PONV, opioid
Study of Growth Hormone and Bone in Obesity
Condition: Obesity; Osteopenia
MeSH terms: Bone Diseases, Metabolic; Obesity
Study type: Interventional

Summary: 
      Obesity is an important risk factor for osteoporosis and fractures. With the growing
      prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this
      population is of importance to public health. Growth hormone (GH) is a critical mediator of
      bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an
      important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of
      bone loss in obesity. The development of novel imaging techniques provides an opportunity to
      investigate the effects of GH on skeletal structure and strength, which will provide insights
      into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone
      loss in obesity may help identify new treatment targets for this important complication. The
      investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal
      health.
    


Intervention name(s): Growth hormone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Genotropin (Pfizer Inc.)
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Coordinated Return to Work Program
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      The aim of the study is to investigate the possibility that a diagnostic evaluation by a
      multidisciplinary team reduces the length of sick leave.
    

Detailed description: 
      Workers on sick leave due to back, neck or shoulder pain are randomized into 2 groups.
      Individuals in the intervention group are offered an extra multidisciplinary diagnostic
      evaluation. The multidisciplinary team consists of an occupational physician, a
      physiotherapist, a chiropractor, a psychologist and a social worker. The result is a
      coordinated evaluation of the individuals problems with suggestions as to further actions.
      The focus is on evaluating, if and when the individual can return to work. No treatment is
      given.

      Verbatim exemption from the local medical ethics board:

      "February 19, 2004 Journal no. VF 20040030 JK/csf Re: research project: A Coordinated Return
      to Work Program (KIA) The The Medical Ethics Committee of Vejle and Funen Counties has
      reviewed this research project at its meeting on February 9, 2004.

      The entire committee decided that this project is an HTA (Health Technology Assessment) study
      and not a biomedical research project.

      Therefore the committee decided that the project is not within the committee's legal
      competence areas, and is exempt from approval by a medical ethics committee before being
      carried out.

      The committee has no further comments to this case. on behalf of the committee Sincerely Erik
      Laier Jette Krarup

      _____________________________________________________________________________________________
      _____________________________________________________

      Odense University Hospital direct telephone: +45 6541 3425 Kløvervaenget 10, 2.sal e-mail:
      Vejle-fynkomiteen@ouh.fyns-amt.dk 5000 Odense C fax: +45 6619 4392 Denmark"
    

Intervention name(s): A multidisciplinary diagnostic evaluation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: back, neck, pain, sick leave
DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
Condition: Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This mechanistic study's aim is to assess the DNA damage repair capabilities of afamelanotide
      in healthy volunteers with skin type I-III following exposure to ultraviolet radiation
      (UVR)-induced DNA damage.
    


Intervention name(s): Afamelanotide
Intervention type(s): Drug
Intervention description(s): Up to 10 adult healthy volunteers will be enrolled in this study in which small areas of their skin will be exposed to UVR and skin samples taken. UV-induced DNA damage and repair will be analysed.
Intervention MeSH terms: Afamelanotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Skills for Change: Nutrition Education Program for Emirati Adults With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The "Skills for Change" Diabetes Nutrition Education Program was a one-year, community-based
      conducted in Ambulatory Health Care Services health centers in Al Ain. The project involved
      nutrition education to improve blood glucose control, diet and physical activity levels of
      Emirati adults with type 2 diabetes.
    

Detailed description: 
      Despite the high prevalence of diabetes and its complications in the UAE, very few diabetes
      education intervention studies have been conducted in a representative population in the
      country. The Skills for Change Program was a one-year, community-based, cluster randomized
      study involving Emirati adults with type 2 diabetes. We implemented a behavioral lifestyle
      intervention to improve glycemic control, food choices, and physical activity levels and to
      decrease sedentarity. The project was culturally adapted to Emirati adults with type 2
      diabetes and was driven by theoretical principles of behavior change and education to enhance
      intervention effectiveness.
    

Intervention name(s): Behavioral Lifestyle Intervention; Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In addition to usual care in the health center, the intervention included 7 visits with the health center dietitian for individual nutrition counseling, invitation for group nutrition education (5 sessions), individual counseling for physical activity, invitation for a 6-weekly structured group physical activity, DVD on physical activity to perform physical activity at home.; Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months. Visits with the health center dietitian were arranged as per physician referral.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster Randomized Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emirati Adults; United Arab Emirates; Lifestyle Intervention; Type 2 Diabetes
Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions
Condition: Post-stroke Elbow Spasticity
MeSH terms: Muscle Spasticity; Stroke
Study type: Observational

Summary: 
      Determination of which muscle is more spastic before injection of the botulinum toxin, and
      the application of the targeted treatment to that muscle results in more improvement in
      spasticity. It is known that the muscles that flex elbow in healthy individuals change
      according to forearm position. While the biceps brachii flexes the forearm in supination, the
      brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a
      primary flexor muscle when the forearm is in pronation.

      In this study, hypothesis is that the severity of spasticity differs depending on the forearm
      position.
    

Detailed description: 
      There are three main muscles that contribute to elbow flexor spasticity; musculus biceps
      brachii, musculus brachialis and musculus brachioradialis. Muscle selection in elbow flexor
      spasticity for botulinum toxin application has impact on treatment outcome. The
      superficiality of the biceps brachii muscle makes it an easy target for botulinum toxin
      injection. In dynamic electromyography studies, it has been reported that brachioradialis
      muscle is the most common contributor one to elbow flexion spasticity, followed by biceps
      brachii muscle. In the diagnostic selective nerve blocks, the brachialis muscle has been
      reported to be foreground.

      Determination of which muscle is more spastic before injection of the botulinum toxin, and
      the application of the targeted treatment to that muscle results in more improvement in
      spasticity. Can the target muscle selection clinically be performed instead of methods such
      as electromyography where equipment is required and the evaluation period is relatively long?
      Can semi-quantitative methods used to assess the severity of spasticity provide reliable
      information regarding the muscle or muscles that contribute to elbow flexor spasticity? It is
      known that the muscles that flex elbow in healthy individuals change according to forearm
      position. While the biceps brachii flexes the forearm in supination, the brachioradialis
      flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor
      muscle when the forearm is in pronation.

      The aim of this study is to investigate whether the severity of spasticity differs depending
      on the forearm position.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with post-stroke elbow flexor spasticity
      
Keywords: Elbow spasticity; Stroke
Effect and Safety of Surgical Intervention for Severe Spontaneous Intracerebral Hemorrhage Patients on Long-term Oral Antiplatelet Treatment
Condition: Severe Spontaneous Intracranial Hemorrhage; Long-term Antiplatelet Treatment; Emergency Surgery; Complications
MeSH terms: Cerebral Hemorrhage; Intracranial Hemorrhages; Emergencies; Hemorrhage
Study type: Observational

Summary: 
      Background: Despite the capability of emergency surgery to reduce the mortality of severe
      spontaneous intracranial hemorrhage (SSICH) patients, the effect and safety of surgical
      treatment for severe spontaneous intracranial hemorrhage (SSICH) patients receiving long-term
      oral antiplatelet treatment (LOAPT) remains unclear. In consideration of this, the cohort
      study is aimed at figuring out the effect and safety of emergency surgery for SSICH patients
      on LOAPT.

      Methods: As a multicenter and prospective cohort study, it will be conducted across 7
      representative clinical centers. Starting in September 2019, the observation is scheduled to
      be completed by December 2022, with a total of 450 SSIC H patients recruited. The information
      on clinical, radiological, and laboratory practices will be recorded objectively. All of the
      patients will be monitored until death or 6 months after the occurrence of primary
      hemorrhage.

      Results: In this study, two comparative cohorts and an observational cohort will be set up.
      The primary outcome is the effect of emergency surgery, which is subject to assessment using
      the total mortality and comparison in the survival rate of SSICH patients on LOAPT between
      surgical treatment and conservative treatment. The second outcome is the safety of surgery,
      with the postoperative hemorrhagic complication which is compared between the operated SSICH
      patients on and not on LOAPT. Based on the observation of the characteristics and outcome of
      SSICH patients on LOAPT, the ischemic events after discontinuing LOAPT will be further
      addressed, and the coagulation function assessment system for operated SSICH patients on
      LOAPT will be established.

      Conclusions: In this study, we will investigate the effect and safety of emergency surgery
      for SSICH patients on LOAPT, which will provide an evidence for management in the future.
    


Intervention name(s): Emergency neurosurgery; Conservative treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical evacuation for intracerebral hemorrhage; Standard treatment for intracerebral hemorrhage
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All severe spontaneous intracerebral hemorrhage (SSICH) patients except those not on
        long-term oral antiplatelet treatment (LOAPT) receiving conservative treatment.
Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This monocenter trial is conducted to obtain first data on safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677
      in humans. In addition, the trial should provide preliminary information on a possible
      influence of sex, food intake, and posology (once or twice daily administration of BYK324677)
      to support the further planning of the drug development programme.
    


Intervention name(s): BYK324677
Intervention type(s): Drug
Intervention description(s): capsules, administered orally
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment