bioihbjkbjnl/mcl2 huggingface dataset:
Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
Condition: Skin Aging
Study type: Interventional
Phase: Phase 1

Summary: 
      The Researchers are trying to study a cosmetic skin care product called human platelet
      extract (HPE) to see if it can be used as a possible treatment for skin anti-aging and skin
      rejuvenation. They are trying find out the safety and tolerability of topical HPE after
      multiple doses of topical administration
    


Intervention name(s): Human platelet extract (cosmetic product); Vanicream Gentle Facial Cleanser; EltaMD UV Daily Broad-Spectrum SPF 40; EltaMD PM Therapy Facial Moisturizer; Vanicream Lite Lotion
Intervention type(s): Biological; Other; Other; Other; Other
Intervention description(s): A leukocyte depleted allogeneic product derived from human U.S. sourced pooled apheresed platelets (derived from screened healthy donors). Applied to face twice daily for 12 weeks.; A mild cleanser specifically formulated for daily facial use. Applied to face twice daily for 12 weeks; A daily moisturizer with a lightweight formula that provides broad-spectrum sunscreen protection. EltaMD UV Daily Broad-Spectrum SPF 40 provides powerful protection against the sun's harmful UV rays, as it hydrates and is gentle enough for post-procedure skin. Powered by hyaluronic acid, this face sunscreen plumps the skin with lightweight moisture, while micronized zinc and octinoxate shield skin from UVA/UVB rays to prevent the visible signs of environmentally caused aging. Applied to face once daily for 12 weeks.; A fortifying face moisturizer to repair elasticity and vitality. EltaMD PM Therapy Facial Moisturizer restores youthfulness while strengthening the skin's natural moisture barrier. Niacinamide blends with antioxidants to boost the skin color and tone, as it speeds up the skin's repair processes. Rice protein peptides aid in encouraging cell growth, promoting collagen formation and improving elasticity. Applied to face once daily for 12 weeks.; Lotion to restore and maintain a normal moisture level. Applied to face twice daily for 12 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Investigate the Bioequivalence of Two Different Forms of Entrectinib (Forms A and C) Under Fasted Conditions in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to demonstrate similarities between two different forms of entrectinib (A and
      C) when administered under fasted conditions in healthy subjects.
    


Intervention name(s): Entrectinib Form A; Entrectinib Form C
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single oral dose of entrectinib form A under fasted conditions.; Participants will receive a single oral dose of entrectinib form C under fasted conditions.
Intervention MeSH terms: Entrectinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents
Condition: Posttraumatic Stress Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This project will provide initial feasibility and efficacy data for the implementation of
      Narrative Exposure Therapy (NET) to urban, at-risk youth. Posttraumatic stress and substance
      use outcomes, as well as participant responses to the intervention, will be examined.
    

Detailed description: 
      The goal of the proposed study is to gather preliminary feasibility and efficacy data for an
      innovative intervention (Narrative Exposure Therapy: NET) to promote adolescent mental health
      related to interpersonal trauma (IPT). Among those at highest risk for interpersonal violence
      and its sequelae are youth from urban, low-resourced neighborhoods. Post-traumatic stress
      disorder (PTSD) is a common outcome associated with IPT. Substance misuse (SUB) is a frequent
      concomitant of PTSD. NET is a promising intervention to reduce PTSD symptoms and associated
      psychological distress, via the supported reconstruction (narrative telling) of the traumas.
      NET has a critical advantage over existing PTSD treatments in that it can be delivered in a
      brief format, in community settings where at-risk adolescents are likely to be found. Despite
      its promise in treating adolescent distress, NET has yet to be tested as an intervention for
      those who have interpersonal trauma-related PTSD. Further NET's influence on SUB has not been
      examined.

      Accordingly, the objective of this project is to conduct a pilot study (N=30) to estimate NET
      treatment effects on PTSD symptoms and SUB in IPT-exposed urban adolescents (ages 16-21).
      Both feasibility and preliminary efficacy data will be collected to serve as pilot work for a
      larger-scale NIH proposal. Recruitment and intervention will be set within community partners
      where the adolescents already are connected and are receiving social or psychological
      services. Outcome data will be collected at: (T0) Baseline, and at 1(T1), and 3 months (T2)
      follow-up assessments. Participant responses to the intervention will be assessed
      post-intervention. Change in PTSD, SUB will be estimated with effect sizes and inferential
      tests. Preliminary evidence of efficacy and feasibility will pave the way for further NET
      development to offer a patient-oriented, community-based, intervention that will promote
      adolescent mental health for those at greatest risk for health access and outcomes
      disparities.
    

Intervention name(s): Narrative Exposure Therapy
Intervention type(s): Behavioral
Intervention description(s): brief, trauma-focused treatment.
Other intervention name(s): NET
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
Condition: Open Cracked Heel in Diabetic Patients With Polyneuropathy
MeSH terms: Polyneuropathies
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in
      the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.
    


Intervention name(s): Tested product : V0111 cream; Placebo
Intervention type(s): Device; Device
Intervention description(s): Application twice a day during 28 days; Application twice a day during 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diabetic Neuropathies; Diabetes Mellitus; Diabetic Foot; Diabetes Complications
Low Field Magnetic Stimulation in Mood Disorders Using the LFMS Device
Condition: Depression; Bipolar Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Bipolar Disorder
Study type: Interventional

Summary: 
      This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some
      of the symptoms of depression in bipolar disorder or major depression.
    

Detailed description: 
      This study involves a screening visit with the study physician and a treatment visit.
      Participants will be asked to complete several questionnaires about their mood during both
      visits. The treatment visit will involve use of the LFMS device. Participants will place the
      top of their head inside the device for approximately 20 minutes. Participants will receive
      either the actual treatment or a sham treatment and will not know which they receive. This
      device produces weak electromagnetic fields. There is no discomfort or even sensation caused
      by the device. The device has been declared to be a "non-significant risk device" by the FDA,
      and there are no known risks associated with its use.
    

Intervention name(s): Low Field Magnetic Stimulation Device
Intervention type(s): Device
Intervention description(s): The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1 kHz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. Subjects will receive one 20 minute treatment.
Other intervention name(s): LFMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Major depression; Bipolar Disorder; Bipolar depression; LFMS; low field magnetic stimulation; mood disorders; affective disorders
Safety and Repeatability of Bronchial Challenge With Grass-pollen
Condition: Allergic Asthma
Study type: Observational

Summary: 
      The study is meant to establish a one-step challenge with grass-pollen in patients sensitized
      for grass-pollen. Therefore the investigators compare a multi-step challenge with
      grass-pollen with an one-step challenge in order to survey the repeatability and safety.
    

Detailed description: 
      Background:

      Specific provocation with inhaled allergens is an established tool in clinical practice and
      research, supporting the understanding of pathophysiology of allergic asthma, and analysing
      the efficacy of new therapies. This study examines the repeatability of a bolus-dose
      inhalative allergen challenge with grass pollen.

      Method:

      Forty grass pollen allergics should undergo an incremental-dose grass pollen challenge to
      calculate their PD20-dose. This calculated dose will be applicated twice to analyse the
      repeatability of the bolus dose challenge. Before and twenty-four hours after the
      provocation, exhaled nitric oxid (FeNO) will be determined as a marker of bronchial
      inflammation.
    

Intervention name(s): inhalative grass-pollen provocation
Intervention type(s): Procedure
Intervention description(s): Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In subjects, who develop a fall in FEV1 of more than 20%, this will be followed by two single-step challenges.
Other intervention name(s): Viasys APS, Allergopharma allergen
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In
        those subjects, who develop a fall in FEV1 of more than 20%, this is followed by two
        single-step challenges in an interval of at least seven days.
      
Keywords: PD20 FEV1; grass pollen; one-step
Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      IRB4729 Study Hypothesis: Is there a significant difference in the hard and soft tissue
      response comparing immediate with delayed implant after tooth removal, with immediate
      provisionalization, in maxillary anterior sites.

      The purpose of this study is to determine and compare the crestal bone levels as the primary
      endpoint variable for implants placed and temporized in extraction sites, to implants placed
      into extraction sites after the extraction site has been grafted and healed for 4 months, all
      immediately restored with an anatomic provisional restoration.
    


Intervention name(s): Dental Implant
Intervention type(s): Procedure
Intervention description(s): This is designed to compare the response of the crestal bone after implants are placed whether delayed or immediately after tooth extraction in the maxilla.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Partial edentulism; Bone atrophy; Bone healing
PTH And Calcium Responses to Exercise (PACE) in Older Adults
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Exercise that causes a decline in serum Calcium (Ca) as a result of dermal Ca loss stimulates
      bone resorption via an increase in Parathyroid Hormone (PTH).
    

Detailed description: 
      Determine whether the magnitude of dermal Ca loss (i.e., sweating) during exercise is a
      determinant of the decline in iCa and increases in PTH and carboxy-terminal collagen
      crosslinks (CTX; marker of bone resorption). The proposed experiment will address this by
      manipulating the rate of dermal Ca loss (moderate vs high sweating rate) to determine whether
      this is the trigger for the cascade described in Figure 1. This will be achieved by having
      participants perform two identical exercise bouts under different thermal conditions (warm vs
      cool).
    

Intervention name(s): Treadmill Exercise; Magnitude of Ca loss during Exercise at 26 degrees Celcius
Intervention type(s): Procedure; Procedure
Intervention description(s): 2 (two) 1-hour of vigorous exercise bouts under different thermal conditions; Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: parathyroid hormone (PTH); bone mineral density (BMD)
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes
Condition: Narcolepsy With Cataplexy
MeSH terms: Narcolepsy; Cataplexy
Study type: Interventional
Phase: Phase 1

Summary: 
      To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus
      on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine
      changes.
    


Intervention name(s): Sodium Oxybate (Xyrem)
Intervention type(s): Drug
Intervention description(s): Active Substance: Sodium Oxybate
Pharmaceutical form: Oral Solution
Concentration: 500 mg/mL oral solution from 4.5 to 9 g/day divided into two equal doses during 12 weeks
Route of administration: Oral
Other intervention name(s): Xyrem
Intervention MeSH terms: Sodium Oxybate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endocrine Evaluation cataplexy; sodium oxybate (xyrem)
Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong
      insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.
    

Detailed description: 
      This is a double blinded cross-over study. Subjects will be asked to wear infusion set either
      a standard infusion set or an extended wear infusion set. They will wear each infusion set
      twice, and the order of infusion set wear will be randomized with the first infusion set wear
      and then alternated over 4 weeks. By performing a cross over study using both experimental
      infusion sets and standard infusion sets, the investigators hope to see whether there is a
      benefit to using an extended wear infusion set.
    

Intervention name(s): Extended Wear infusion set; Standard Infusion set; Heparin
Intervention type(s): Device; Device; Drug
Intervention description(s): For two of the 4 weeks the Extended Wear insulin infusion set will be used.; For two of the 4 weeks the Standard infusion set will be used
Other intervention name(s): Minimed
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation
      and instillation of liquid surfactant to the airway.
    

Detailed description: 
      Treatment will not be masked. The study objective is to document that aerosolized Infasurf is
      superior to "usual care" and provides for some patients effective surfactant therapy with
      less need for endotracheal intubation and instillation of a surfactant suspension into the
      airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth
      who develop RDS in the first hours of life and (b) patients who received instillation of
      surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.
    

Intervention name(s): Aerosolized Calfactant; Solarys
Intervention type(s): Drug; Device
Intervention description(s): Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.; Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Other intervention name(s): Infasurf; Calfactant
Intervention MeSH terms: Calfactant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aerosol; surfactant; calfactant; Infasurf; Respiratory Distress Syndrome; RDS; Premature; Neonates
Physical Co-morbidity, Poor Health Behaviour and Health Promotion in Verona Patients With Functional Psychoses
Condition: Psychotic Disorders; Bipolar Disorders
MeSH terms: Bipolar Disorder; Psychotic Disorders
Study type: Interventional

Summary: 
      The study evaluates the efficacy of health promotion strategies on diet and physical activity
      in patients with psychosis. Half of the participants will receive an intervention protocol
      based on education and behavioural change, while half will not receive it.
    

Detailed description: 
      Epidemiological studies investigating the mortality and physical health of mental patients
      have provided substantial evidence of an excess mortality and of a substantially higher
      prevalence of physical co-morbidity as compared to the general population. These findings
      have been related to a higher prevalence of risk factors like high blood pressure, high
      plasma cholesterol and obesity, unhealthy lifestyles, medication side-effects.

      The number of clinical trials and intervention studies in this area is still scanty and their
      scientific strength is relatively modest. The present research project aims at implementing
      preventive strategies related to dietary habits and physical exercise, and studying their
      efficacy with a randomized controlled study.
    

Intervention name(s): Health Promotion Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention package consists of the following elements:
i. educational sessions on the importance of diet and fitness; ii. motivational interviews to maintain participants in the program, to discuss participants' physical conditions, habits and opinions as to diet and fitness; iii. monitoring the participation in the program and health behaviour, specifically for diet and fitness, and adherence to the intervention on diet and fitness; iv. regular physical exercise under the guide and supervision of an expert trainer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: health promotion; lifestyles; physical comorbidity; risk factors; behavioural change
Olanzapine Versus An Active Comparator in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine how Olanzapine compares to an active comparator in
      the treatment of schizophrenia
    


Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Investigate the Effect of SFF on Glucose and Insulin Responses
Condition: Postprandial Glycemic Response
Study type: Interventional

Summary: 
      This goal of this clinical study is to investigate the postprandial glycemic and insulinemic
      response in healthy adults after the consumption of:

        1. Sugars from Fiber in comparison with dextrose

        2. Sugars from Fiber incorporated into chocolate chips in comparison with regular chocolate
           chips
    


Intervention name(s): SFF; Glucose; SFF chocolate chips; Regular chocolate chips
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Ingestion of 20g of SFF after 10-14 hours of fasting; Ingestion of 20g of glucose after 10-14 hours of fasting; Ingestion of 50g of chocolate chips made with SFF after 10-14 hours of fasting; Ingestion of 50g of regular chocolate chips after 10-14 hours of fasting
Intervention MeSH terms: Iproplatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study of Cell Phone SMS to Improve Adherence to ART in HIV Positive Young Women
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      There has been increasing use of technology in delivery of healthcare and increasing use of
      cellular phone and text messaging services to help with various healthcare related issues
      including but not limited to medication adherence and clinic attendance. Mobile phones
      technology has been used for healthcare delivery and prevention strategies such as smoking
      cessation. In the present era, cell phones have become part of daily life for most people
      even among those in lower economic groups. There have also been several studies looking at
      cell phone text messaging services to improve adherence to ART among HIV infected subjects
      but no studies have so far been done in HIV infected young women to help retention and
      adherence to care. The overall goal of this study is to evaluation of the impact of texting
      intervention to improve adherence to care and treatment in HIV infected young women.

      Study Hypothesis:

      Text message intervention will improve adherence to ART in HIV infected young women.
    


Intervention name(s): cell phone SMS text messaging
Intervention type(s): Behavioral
Intervention description(s): This study will utilize mobile texting services to send text messages to enrolled subjects on a weekly basis. The text would convey messages that promote better awareness and knowledge on HIV and its treatment, reminders for medication adherence and clinic appointments. The text content would also be customized based on individual subject requirements. English will be used in texting. We would also assess the subjects for traditional demographic items (e.g., age, marital status, education, number/age of other children, employment, and religion), and potential environmental barriers (e.g., transportation and childcare).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care