bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Study to Evaluate the Effects of CTP-543 on the QT/QTc Intervals in Health Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of
      the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in
      healthy volunteers
    


Intervention name(s): CTP-543; CTP-543; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CTP-543 12 mg (1 x 12 mg tablet), dosed with water; CTP-543 48 mg (4 x 12 mg tablet) dosed with water; Moxifloxacin (1 x 400 mg tablet) dosed with water; Placebo (1 tablet) dosed with water
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: CTP-543
Social Support Intervention for Self-management of Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study will assess the effect of a social support intervention for self-management of
      type 2 diabetes mellitus (DM2) in adults. This intervention is based on a medium-range
      nursing theory of individual and family self-management. Findings will be evaluated using the
      nursing outcomes "self-management: diabetes" and "social support" from the Nursing Outcomes
      Classification (NOC).
    

Detailed description: 
      Diabetes mellitus is responsible for 1.6 million deaths a year, becoming one of the world's
      21st century health emergencies.

      DM2 is the most frequent form of diabetes, accounting for 90% of all cases of this chronic
      condition. If this trend continues, by 2045 about 693 million people will have diabetes.

      People with chronic diseases have changing perspectives, in addition to suffering physical
      alterations, their psychological, emotional and social state is also compromised, presenting
      themselves as a need to modify lifestyle to improve prognosis, facing alterations in the
      ability to socialize and with death or a great loss. Few studies comprehensively address
      these dimensions.

      The literature reports that DM2 self-control has a direct effect in improving clinical
      results, reducing complications and quality of life. Therefore, the patient must make
      multiple decisions every day regarding diet, physical activity, glucose control, and
      medication compliance.

      However, intervention studies that seek to improve self-management behaviors in people with
      DM2 are characterized by emphasizing the transmission of knowledge and establishing
      compliance with prescribed treatments, but they do not address social and emotional elements
      such as social support. Additionally, most of these interventions do not show the use of
      theoretical models that provide explanations of human responses to disease and other
      phenomena important to practice.

      Studies using the Nursing Outcomes Classification to assess the effect of social support
      interventions are scarce.
    

Intervention name(s): Social support for diabetes self-management
Intervention type(s): Behavioral
Intervention description(s): Four individualized intervention sessions, every two weeks with a duration of 40 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nursing Outcomes Classification Terminology; Self-management; Social support
Local Anesthetic Injection Into Both Angles of the Rectus Sheath Incision
Condition: Postoperative Cesarean Delivery Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Local anesthetic will be injected into both angles of the rectus sheath incision in an
      attempt to block sensory nerves in this area that cause the sensation of pain from lscs
      wound.
    


Intervention name(s): 10ml of bupivacaine 0.5%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs; 10 ml of saline will be injected as a placebo and the investigator and the patient and the data assessor are all blinded to what the patients received.
Other intervention name(s): saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study Between Atovaquone and Antiretroviral Agents in HIV-1 Infected Patients
Condition: HIV Infections; Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Malarone® (atovaquone/proguanil) is frequently used in malaria prophylaxis. Unfortunately,
      there are indications that certain anti-HIV agents may decrease atovaquone plasma levels by
      induction of atovaquone metabolism.

      For travelling HIV patients, the clinical consequences of these possible drug drug
      interactions are serious, since a diminished exposure to the anti-malarial drug will result
      in suboptimal prophylaxis of malaria and potential development of drug resistant strains of
      Plasmodium falciparum.

      The purpose of this study is to find out if HIV patients using HAART regimes with either
      lopinavir/ritonavir, atazanavir/ritonavir or efavirenz have lower atovaquone plasma levels
      than healthy volunteers after a single dose of atovaquone/proguanil.
    


Intervention name(s): Atovaquone / Proguanil
Intervention type(s): Drug
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Malaria prophylaxis; Treatment Experienced
Investigation of FOL-005 on Clinical Safety and Effect on Hair Growth
Condition: Hypertrichosis; Alopecia; Hirsutism
MeSH terms: Alopecia; Hirsutism; Hypertrichosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study to investigate clinical safety and effect on hair growth of FOL-005 in healthy
      volunteers. The study is divided in two parts, a single ascending dose (SAD) part and a
      multiple dose (MD) part.
    

Detailed description: 
      SAD part:

      A total of 3 weeks dosing, the two lowest concentrations in week 1, dose 3 at week 2 and
      finally dose 4 at week 3.

      MD part:

      In total 12 weeks of dosing where group A will be dosed twice weekly and group B three times
      weekly

      Each injection will be administered into one of five of the six randomized areas (10 cm
      apart, left and right side) from the subject's defined investigational skin areas. One area
      will be completely untreated.
    

Intervention name(s): FOL-005; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intradermal injection of 50 μl solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Charge: A Text Messaging-based Weight Loss Intervention
Condition: Weight Loss; Obesity
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This study evaluates different versions of a text messaging-based app for weight loss. This
      study will place participants to 1 of 32 experimental conditions that reflect different
      texting components and levels. Participants will be randomized to a condition. The
      investigators will recruit 448 adults into a 6-month weight loss program, with an additional
      follow-up 6-months after the intervention ends.
    

Detailed description: 
      Standalone text messaging-based weight loss treatments are scalable and can achieve
      population reach. However, these interventions are also modular; they can be delivered
      independently to maximize cost-effectiveness or combined with other approaches (e.g. provider
      counseling) to maximize outcomes. This study is a 12-month experimental trial among 448
      adults with obesity. All participants will receive a core 6-month weight loss texting
      intervention that includes tailored behavior change goals, interactive self-monitoring,
      automated feedback, and skills training. Participants will be randomly assigned to 1 of 32
      different experimental conditions.
    

Intervention name(s): Charge
Intervention type(s): Behavioral
Intervention description(s): Text messaging-based study to determine effect of different components on weight loss.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The investigators will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging (self- vs expert-generated), texting frequency (daily vs weekly), reminders (one reminder v. multiple reminders), feedback type (summary score v. specific feedback) and comparison unit (to self v. to a group of people). The full factorial design is power efficient, logistically feasible (because we manipulate conditions using technology) and will allow the investigators to examine the most important main and interaction effects among components.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: text message; digital health; weight loss; personalized
Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      Itopride is a compound already marketed in Japan and in some countries of Eastern Europe
      under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients
      suffering from this condition have difficulties digesting food. Patients feel full after
      eating; they have bloating and have stomach pain. The goal of this study is to see if
      itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.
    

Detailed description: 
      All patients who have completed study ITOFD04-03 will be offered to continue to be treated
      with itopride for a period of up to one year in duration. A target of 300 patients will be
      followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an
      additional 6 months.

      Patients will need to come to the clinic for evaluations every 8 weeks during the trial.
      Evaluations done at these visits will include: lab tests, evaluation of the heartburn
      condition, and a questionnaire needed to be completed by the patient to see if the drug is
      helpful in relieving their symptoms.
    

Intervention name(s): Itopride
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Abdominal Symptom Relief; Fullness; Bloating; Indigestion; Functional dyspepsia
Gala Treatment for Chronic Bronchitis in Canada
Condition: Chronic Bronchitis; COPD
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Interventional

Summary: 
      Feasibility trial (FIH) to assess the safety and clinical utility in patients with chronic
      bronchitis in Canada.
    

Detailed description: 
      The Gala Airway Treatment system is a device-based, energy delivery system that delivers high
      frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The
      energy is delivered via a proprietary catheter through the bronchoscope.

      Two sessions of treatment will be delivered one month apart. The right lung is treated at the
      first treatment session and the left lung is treated at the second treatment session
      (approximately one month after the right side is treated). Treatment will be delivered by a
      respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a
      bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is
      anticipated that the bronchoscopic procedure will last less than 60 minutes in total.
      Treatment will be deemed to have been delivered following the successful treatment during the
      two bronchoscopies.

      A third bronchoscopy will be performed three months following the second treatment session
      where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that
      have been treated during the two previous bronchoscopic treatment session to evaluate the
      effect of the treatment on the airways producing excessive mucous.

      Subjects will be required to submit to several tests during the study including two CT scans
      (lung), respiratory function tests, exercise testing.
    

Intervention name(s): Gala Airway Treatment System
Intervention type(s): Device
Intervention description(s): The Gala Airway Treatment system is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
Other intervention name(s): GATS
Intervention model: Single Group Assignment
Intervention model description: Treatment with Gala Airway Treatment System
Masking: None (Open Label)
Primary purpose: Device Feasibility
Causes of Comorbid Infertility Among Women With Rheumatoid Arthritis
Condition: Infertility; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Infertility
Study type: Observational

Summary: 
      The purpose of this study is to increase our understanding of infertility in women with
      Rheumatoid Arthritis (RA). In this study the study team will compare the differences in
      ovarian reserve (the ability to provide egg cells that are capable of fertilization), the
      frequency of ovulation and the number of pregnancies between women with and without RA. It is
      possible that RA activity and medications limit ovarian reserve and ovulation, which may
      increase infertility among women with RA. There are several suspected causes for infertility
      in RA, including age-related fertility decline, inflammatory changes that impact endometrial
      receptivity and discourage implantation, accelerated ovarian decline due to certain arthritis
      medications and increased frequency of anovulation (a menstrual cycle during which ovaries do
      not release an egg) due to RA activity.

      This study is the first step toward our long term goal of increasing the ability of all women
      with RA to build the family they desire.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Rheumatoid Arthritis Women and Health Control Women
      
Biospecimen description: 
      blood tests
    
Keywords: Infertility; Rheumatoid Arthritis
A Safety, Tolerability and Pharmacokinetics Study of ZB001 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigational drug, ZB001 is a humanized IgG1κ monoclonal antibody (mAb) targeting
      human IGF-1R. This clinical trial will examine the safety, tolerability, and pharmacokinetics
      (PK) of single ascending doses of ZB001 in healthy Chinese subjects.
    


Intervention name(s): ZB001 for injection; ZB001 for injection; ZB001 for injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose Cohort1 (3mg/kg) ZB001 of single IV injection; Dose Cohort2 (10mg/kg) ZB001 of single IV injection; Dose Cohort3 (20mg/kg) ZB001 of single IV injection
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploring the Cortical Hemodynamic Variability of Four Weeks iTBS on a Healthy Participant: a Case Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study will investigate the effect of caffeine and time of day on brain excitability
      using excitatory brain stimulation. The investigators will recruit a healthy participant and
      conduct a concurrent iTBS/fNIRS protocol for 20 consecutive sessions over four weeks with or
      without caffeine consumption before the stimulation. Moreover, the experiment will be
      conducted at different times of the day (morning or afternoon)
    

Detailed description: 
      One healthy participant will be recruited for this study. The participants will be subjected
      to concurrent TBS/fNIRS, to which the iTBS will be applied on the left DLPFC and the NIRS
      will measure the prefrontal hemodynamic response simultaneously.
    

Intervention name(s): caffeine; Experimental time
Intervention type(s): Other; Other
Intervention description(s): The investigators will ask participant to only intake 200 mg of caffeine one hour before the experiment (no other caffeine intake since the wake-up) or avoid caffeine intake at all before the experiment; The investigators will ask participant to attend the experiment in the morning or afternoon
Intervention MeSH terms: Caffeine
Intervention model: Single Group Assignment
Intervention model description: One healthy participant will undergo four weeks of concurrent TBS/fNIRS to investigate the cortical hemodynamic variability
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Theta-Burst stimulation (iTBS); Functional near-infrared spectroscopy (fNIRS); Concurrent TMS/fNIRS; Prefrontal hemodynamic response; Longitudinal effects
The Effect of Meal Composition on Blood Lipids
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study is to see if a high-protein meal leads to a better postprandial
      (after a meal) blood lipid profile compared to a high-monounsaturated meal.
    

Detailed description: 
      The effect of a high-protein diet compared to a high-monounsaturated fat diet on fasting
      lipids is controversial (1,2), In addition, these studies did not examine the effect of a
      high-protein compared to a high-monounsaturated meal on postprandial lipid concentrations.
      Postprandial lipid responses are important to examine since they are associated with heart
      disease (3,4). In addition, most individuals in Western countries are in a postprandial state
      for majority of the day. The present study will compare the effect of a high-protein meal
      versus a high-monounsaturated fat meal on postprandial lipid responses.
    

Intervention name(s): High-Protein Condition; High-Monounsaturated Fat Condition
Intervention type(s): Other; Other
Intervention description(s): The participants will be fed a high-protein meal; The participants will be fed a high-monounsaturated fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of NGM313 in Obese Participants
Condition: Obese
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in
      obese participants
    


Intervention name(s): NGM313; Pioglitazone
Intervention type(s): Biological; Drug
Intervention description(s): Subcutaneous injection; White to off-white round tablet
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Daclatasvir From Daktavira 60 mg Film Coated Tablets ( European Egyptian Pharmaceutical Industries, Egypt) Versus Daklinza 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Daclatasvir from Daktavira 60 mg film coated tablets ( European
      Egyptian Pharmaceutical Industries, Egypt) versus Daklinza 60 mg tablets (Bristol-Myers
      Squibb Pharma, UK) in Healthy Human Volunteers Under Fasting Condition
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Daktavira; Daklinza
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 60 mg Daclatasvir; 1 tablet contains 60 mg Daclatasvir
Other intervention name(s): Daklinza
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics
      of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin.
      PF-04950615 (RN316) is an investigational drug that is currently being studies as a
      cholesterol lowering therapy.
    


Intervention name(s): 4 mg/kg; 0.5 mg/kg
Intervention type(s): Biological; Biological
Intervention description(s): RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.; RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
Other intervention name(s): PF-04950615 (RN316); PF-04950615 (RN316)
Intervention MeSH terms: Bococizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Dyslipidemia; LDL; Cholesterol; High Cholesterol; PF-04950615; RN316
Radical Prostatectomy and Perioperative Fluid Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The optimal amount of fluid a patient need under surgery is not clear. Both to much and to
      little fluid can damage the organ functions.

      A strategy called "Goal directed therapy", where the fluid amount a patient need is guided by
      the stroke volume, has shown to minimize post-operative nausea and vomiting.

      The investigators intend to investigate if patients treated after these standards, has a
      better outcome then patients treated after normal regimes, regarding post-operative
      orthostatic-intolerance.
    


Intervention name(s): Standard therapy; Maximization of cardiac stroke volume with fluid infusion
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard therapy; Maximization of cardiac stroke volume with fluid infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: patients with cancer in the prostate