bioihbjkbjnl/mcl2 huggingface dataset:
First-In-Human Clinical Study of the C3 Complement Inhibitor AMY- 101 in Healthy Male Volunteers
Condition: Complement Mediated Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a Single Ascending
      Dose (SAD) and a Multiple Dose (MD) of the complement inhibitor AMY-101. A prospective,
      single-center, open-label, First-In-Human (FIH) clinical study in healthy male volunteers.
    

Detailed description: 
      AMYNDAS is developing a novel peptidic complement inhibitor AMY-101, based on the
      third-generation compstatin analogue Cp40. AMY-101 is a selective inhibitor of complement
      activation in humans and in NHP. It binds to the complement component C3, the central
      "functional hub" that controls the upstream activation/amplification and downstream effector
      functions of complement. By binding to C3, AMY-101 inhibits the cleavage of native C3 to its
      active fragments C3a and C3b. As a consequence, the deposition of C3b, amplification via the
      alternative pathway and all downstream complement responses are prevented. AMY-101 is being
      developed to treat complement-mediated diseases, which are largely driven by aberrant C3
      activation.

      This first-in-human study of the C3-targeting complement inhibitor AMY-101 investigates the
      safety and PK/PD profile of AMY-101 in healthy male volunteers after Single Ascending Dose
      (SAD) and Multiple Doses (MD) using subcutaneous (SQ) or intravenous (IV) administration. The
      study is a prospective, single-center, open-label evaluation in healthy male volunteers.
    

Intervention name(s): AMY-101
Intervention type(s): Drug
Intervention description(s): AMY-101 is a selective inhibitor of complement activation, which binds to the complement component C3.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a prospective, single-center, open-label FIH study investigating the safety, tolerability, PK and PD after single and multiple doses of AMY-101 in healthy male volunteers. In the SAD part of the study, a single dose at ascending dose levels of AMY-101 will be administered to different cohorts, following a careful dose-escalation strategy. In the MD part of the study, multiple doses will be administered using different dosing intervals; the cohorts will include a minimum of four (4) subjects each. Additional subjects may be added in the cohorts if necessary.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: complement inhibition; C3 complement inhibitor; AMY-101; Compstatin Cp40; Paroxysmal Nocturnal Hemoglobinuria (PNH); C3 glomerulopathy (C3G); Periodontal disease; Age-related macular degeneration (AMD); ABO incompatible kidney transplantation
Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with
      hepatitis C.
    


Intervention name(s): VX-950; ribavirin; peginterferon alfa-2a
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Depression: The Search for Treatment-Relevant Phenotypes-Pilot Study
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      We are doing this pilot study to learn more about four aspects of treating depression:

        1. The features of a depressed person's mood and anxiety and how these features affect a
           person's capacity to get better and stay better.

        2. If depressed people with certain features of mood and anxiety respond better to therapy,
           medication or a combination of therapy and medication.

        3. Whether or not a person's personality traits affect how they respond to treatment.

        4. The gene involved in processing antidepressant medication
    

Detailed description: 
      This pilot study is an experimental investigation designed so that consenting subjects are
      randomly assigned to pharmacotherapeutic or psychotherapeutic interventions for depression.

      For the initial phase of treatment, subjects will be randomly assigned to treatment with an
      SSRI, (escitalopram oxalate or citalopram hydrobromide), or with interpersonal psychotherapy
      (IPT). Escitalopram will be prescribed for all patients randomized to the medication arm of
      the study, unless the study psychiatrist determines that citalopram is more clinically
      appropriate. Escitalopram and citalopram are FDA-Approved SSRI antidepressants indicated for
      the treatment of depression. In order to optimize outcomes and emulate usual clinical
      practice, subjects who do not meet response criteria (defined as a 50% reduction in baseline
      Hamilton Rating Scale for Depression [HRS-D]) or meet stabilization criteria (defined as a
      mean HRS-D < 7 for 3 weeks) at acute phase Visit 7 or Visit 13 of treatment will have the
      other treatment added. Subjects who meet stabilization criteria (mean HRS-D < 7 for 3 weeks)
      at any time between acute phase Visit 13 and 21 will enter the 6-month continuation phase and
      continue with the treatment that led to their stabilization. Subjects who have not met
      stabilization criteria by acute phase Visit 21 will remain in active treatment and be offered
      alternative pharmacotherapy. Subjects who have not responded by acute phase Visit 32 will be
      discontinued from the protocol and referred for alternative treatment and care.
    

Intervention name(s): escitalopram; Interpersonal Psychotherapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the palatability and compare acceptability of
      brensocatib oral solutions.
    


Intervention name(s): Brensocatib
Intervention type(s): Drug
Intervention description(s): Brensocatib oral solutions will be expectorated following the tasting.
Other intervention name(s): INS1007; AZD7986
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dynamic Imaging of Variation in Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Observational

Summary: 
      To use a variety of renal imaging modalities, including diffusion weighted imaging (DWI),
      blood oxygen level dependent (BOLD) imaging, T1rho (T1rho) imaging, and dynamic contrast
      enhanced magnetic resonance imaging (DCE-MRI) to evaluate the intra-renal blood flow,
      perfusion, cellularity, fibrosis and atrophy within the kidneys of patients with lupus
      nephritis (LN) and compare these parameters to renal biopsy findings to determine whether
      DWI, BOLD, T1rho, and DCE-MRI may provide a set of non-invasive tools to assess renal
      function and pathology in LN.
    


Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): This is a multicenter, non-interventional, pilot study. Eligible subjects will have a baseline MRI of the kidney, including anatomical, DWI, BOLD, T1rho, and DCE-MRI, utilizing a macrocyclic gadolinium-based contrast agent (GBCA), followed by planned standard of care (SOC) renal biopsy and clinical laboratory assessments. Additional serum and urine will be collected from subjects at baseline for analysis of research biomarkers. Following the results of the biopsy and clinical laboratory assessments, subjects will be treated for their underlying disease at the discretion of the investigator.
At 6 months, subjects will return to the clinic for a second MRI, SOC clinical and laboratory evaluation and collection of serum and urine for analysis of research biomarkers.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Lupus Nephritis or IgA neuropathy selected at academic sites listed.
      
Biospecimen description: 
      To collect blood and urine samples for future research to identify biomarkers specific to
      systemic lupus erythematosus and to LN.
A Gardening Program to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children
Condition: Overweight
MeSH terms: Overweight; Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study is to examine the impact of a summer gardening program on summer
      weight gain in overweight middle school children.
    

Detailed description: 
      In the past two decades, the combination of unhealthy eating and physical inactivity has
      contributed to doubling the percentage of children and adolescents who are overweight.
      Childhood overweight is known to lead to increased risk for several morbidities in childhood
      and into adulthood including type 2 diabetes mellitus, hypertension, and cardiovascular
      disease. Recent data shows that children experience greater and more variable increases in
      BMI during summer vacation than during the school year. Our project aims to determine whether
      summer weight gain is due to a decrease in physical activity or an increase in daily calories
      as well as to assess the effectiveness of a summer gardening program on preventing summer
      body fat gain. We will randomize 40 middle-school children who are above the 95th percentile
      for BMI into either a control or intervention group. The control group will receive the
      standard of care and the intervention group will participate in Garden Fit, a summer
      gardening project at Troy Gardens in Madison, WI. As part of Garden Fit, subjects will
      participate in weeding, landscaping and trail maintenance activities as well as preparing
      meals twice a week with fresh foods from the gardens. We hypothesize that summer weight gain
      is due to a worsening of healthy lifestyle (decreased physical activity from school to summer
      and increased eating of high calorie snacks). Additionally, we hypothesize that an
      intervention that increases physical activity and provides increased access to healthy foods
      will reduce the trend of summer BMI increase.
    

Intervention name(s): Garden Fit
Intervention type(s): Other
Intervention description(s): 8-week summer gardening program. 9am-12pm on Monday, Wednesday, Friday and 9am-12:30pm on Tuesday and Thursday. Activities included gardening (preparing soil for planting, planting seeds and seedlings, mulching, weeding, watering, and harvesting), preparing meals with fresh foods from the garden, and other garden activities and games.
Other intervention name(s): Garden Fit 2009
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Childhood overweight; Gardening; Summer weight gain
Mollii - Personalized Suit for Treatment of Spasticity, GFMCS 3-5
Condition: Spastic Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      The objective of this study was to examine the effect on spasticity and function of
      multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.
    

Detailed description: 
      In this prospective cohort study, the participants (children with predominantly spastic CP,
      GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators
      evaluated level of spasticity using the modified Ashworth scale (MAS) and other related
      measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were
      defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural
      ability scale (PPAS) were performed.
    

Intervention name(s): TENS incorporated into the Mollii suit
Intervention type(s): Device
Intervention description(s): trans cutaneous electric stimulation,
Intervention model: Single Group Assignment
Intervention model description: prospective cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mollii suit;; Goal Attainment Scale;; Reciprocal inhibition;; modified ashworth scale,; trans cutaneous electric stimulation, TENS; Spasticity reduction,
Contingency Management for Smoking Cessation in Homeless Smokers
Condition: Smoking; Homeless Persons
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of an internet-based contingency
      management program for smoking cessation in persons who are homeless. Thirty homeless smokers
      will be enrolled in the study. Participants will receive payment based on their own low
      carbon monoxide readings, which indicate being quit from smoking. Participants will be
      prescribed nicotine replacement (patches and either gum or lozenge)and bupropion. All
      participants will receive a four sessions of smoking cessation counseling, and will be
      trained to perform carbon monoxide monitoring with a device provided by the study. They will
      also be provided with a mobile phone equipped with a video camera, and will use this
      equipment at home to monitor their carbon monoxide . Participants will record videos of
      themselves taking a carbon monoxide reading and displaying the results, and will upload the
      videos to a secured website that is only accessible by the research team members and the
      participant. Payment will be based on providing carbon monoxide readings that indicate
      abstinence.

      The study is designed to address the following aims:

      Specific Aim 1: To evaluate whether it is feasible to use internet-based contingency
      management for helping smokers who are homeless stop smoking.

      Specific Aim 2: To evaluate how effective internet-based contingency managementis on
      decreasing smoking in smokers who are homeless.
    


Intervention name(s): Bupropion; Nicotine replacement therapy; Contingency Management
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): All participants who are medically eligible to take Bupropion will receive this study medication one week prior to their smoking quit date.; All participants will receive two forms of nicotine replacement therapy - nicotine patches and a rescue method (either gum or lozenge).; All participants will be asked to provide home carbon monoxide monitoring with equipment that is loaned to them. When participants provide readings that are low enough to suggest abstinence from smoking, they are provided monetary reinforcement (i.e., money).
Other intervention name(s): Zyban; Nicoderm CQ, Nicotine patch; Nicotine polacrilex, nicotine gum; Nicotine lozenge
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking; homelessness; contingency management
Sayana® Press Self-injection Study in Malawi
Condition: Contraception
Study type: Interventional

Summary: 
      The feasibility of Sayana Press self-injection and the potential for this practice to
      increase contraceptive continuation has never been assessed in family planning programs in
      low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for
      International Development (USAID) Malawi Mission requested the Advancing Partners and
      Communities (APC) project to assess self-injection of Sayana Press to inform their
      decision-making for procurement of Sayana Press and distribution through the health system in
      Malawi.
    

Detailed description: 
      Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a
      prefilled, auto-disabled injection system called Uniject (Pfizer, Inc., USA). Sayana Press
      was registered with the Medicines and Health Care Products Regulatory Agency (MHRA) and
      several other national regulatory agencies. The addition of this method is anticipated to aid
      in improving provision of family planning services in low-resource settings. As such, Sayana
      Press could be particularly useful in a country such as Malawi where injectable contraception
      is the most common method used. DMPA clients and providers are ready to explore the potential
      of self-injection of Sayana Press. A study conducted in a large family planning clinic in
      Edinburgh, Scotland found self-administration of DMPA-SC feasible and associated with similar
      continuation rates and satisfaction to clinician-administered DMPA-IM. A non-comparison study
      conducted in Planned Parenthood clinics in Florida found continuation of self-injected
      DMPA-SC high (74%) at the fourth injection. Participants in this study reported the injection
      to be easy and convenient and were likely to recommend self-administration to other women.
      Moreover, on September 29, 2014 Pfizer submitted a request to the MHRA to change the Sayana
      Press label to include self-injection.

      If self-injection is found feasible, the results from this research will inform
      self-injection training materials, messages for providers and clients, and future scale-up
      efforts in Malawi and elsewhere in sub-Saharan Africa.
    

Intervention name(s): Sayana Press
Intervention type(s): Drug
Intervention description(s): Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject
Other intervention name(s): depot medroxyprogesterone acetate (DMPA)
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: DMPA-SC: depo medroxyprogesterone acetate sub-cutaneous; DMPA-IM: depo medroxyprogesterone acetate intramuscular
Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence
Condition: Medication Adherence
Study type: Interventional

Summary: 
      In pharmacotherapy trials involving drug-dependent individuals, medication compliance is a
      significant issue, as rates tend to be low and adherence to medication may predict improved
      outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010).
      However, methods commonly used to determine compliance may result in inaccurate measurement
      of adherence. In this study, we propose to assess the effectiveness and safety of the ID-Cap
      System, a novel compliance measurement device, in a healthy population.
    

Detailed description: 
      The primary objective of this clinical trial is to evaluate the acceptability, tolerability,
      and efficacy of the ID-Cap system in a healthy population. The ID-Cap is an ingestible
      medical device for detecting the presence of an ingested capsule inside the gastrointestinal
      (GI) tract.

      Participation in the study takes 3 visits over a period of approximately six weeks. The first
      visit is a screening visit to determine if participants are eligible to participate. After
      the initial assessment visit, participants will be randomized to one of two groups. Group 1
      will have adherence measured by self-report, pill count, and urine riboflavin levels. This
      group will not receive capsules containing ingestible sensors, but will receive their
      medication in a bottle capped with a MEMS Track Cap, which records when the medication bottle
      is opened and closed. Group 2 will receive capsules containing an ingestible sensor and will
      have adherence measured by self-report, pill count, urine riboflavin levels as needed, and
      data collected by an ID-Cap reader. Participants randomized to this group will also receive
      reminder calls and/or text messages to ingest the study medication if a signal is not sent
      from the ID-Cap reader to the study team within one hour of the scheduled medication
      administration time. They will also be using biometric identification technology to confirm
      subject identity, specifically electrocardiogram (ECG).

      After the initial screening visit, participants will be required to attend two clinic visits
      during the six-week study, a randomization visit and a one-week follow-up visit approximately
      one week after last medication dose.
    

Intervention name(s): MEMS Cap; ID-Cap
Intervention type(s): Device; Device
Intervention description(s): MEMS Track Cap records when the medication bottle is opened and closed; ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Drug study; Medication compliance