bioihbjkbjnl/mcl2 huggingface dataset:
Guided Self-Help for Parents of Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Cognitive-behavioral based guided self-help for parents of adolescents with
      Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and
      effectiveness study. The treatment is offered under routine-care conditions of the
      health-care system in Germany. Practicability, treatment participation and effectiveness is
      documented and tested in a one-group pre-test/post-test design.
    

Detailed description: 
      Self-directed interventions may overcome many of the barriers associated with accessing
      face-to-face services, as there is lowered stigma and significantly reduced or eliminated
      cost, transport, and timing difficulties. Families can complete self-directed programs at
      home, in their own time and at their own pace. Furthermore self-administered programs are
      often very cost-effective and their use can ease the financial burden of mental health of the
      community. These parenting programs can be particularly effective by reaching the populace.
      Moreover in primary care settings where financial resources, time and expertise might be
      lacking to provide behavioral interventions, self-directed programs might be a promising tool
      for disseminating effective parenting interventions more widely.

      Bibliotherapy is one form of self-directed therapy. In bibliotherapy a selected book is
      thought to meet the specific need of the person to be treated and reading is used as the
      therapeutic technique. In opposition to pure self-help programs, bibliotherapy in terms of
      guided self-help provides patients (or parents) with written instructions as well as
      therapeutic contacts at regular intervals. During these contacts, problems and questions can
      be discussed to give further support. Self-help interventions have already proven to be
      effective for adults with anxiety or affective disorders as well as for depressive
      adolescents. However there has only been little research concerning the reduction of
      children's and adolescent´s behaviour problems through parental self-help programs under
      minimal contact conditions.
    

Intervention name(s): CBT Based Self-help Workbook + Counseling Telepho
Intervention type(s): Behavioral
Intervention description(s): Over a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation. Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet.
Other intervention name(s): Guided self help; behavioral treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Program evaluation; ADHD
Intrapleural BG00001 in Treating Patients With Malignant Pleural Mesothelioma or Malignant Pleural Effusions
Condition: Cancer
MeSH terms: Mesothelioma; Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Using BG00001 to insert the gene for interferon-beta into a person's pleural
      cavity may improve the body's ability to fight cancer.

      PURPOSE: Phase I trial to study the effectiveness of intrapleural BG00001 in treating
      patients who have malignant pleural mesothelioma or malignant pleural effusions.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and toxicity of intrapleural BG00001 in patients with malignant
           pleural mesothelioma or malignant pleural effusions.

        -  Determine the maximum tolerated dose of this drug in these patients.

        -  Determine the success of gene transfer/interferon beta gene expression in patients
           treated with this drug.

        -  Determine systemic and intrapleural cytokine responses and cellular and humoral immune
           response in patients treated with this drug.

        -  Determine, preliminarily, tumor response in patients treated with this drug.

      OUTLINE: This is a dose-escalation study.

      Patients receive BG00001 via an intrapleural catheter on day 1.

      Cohorts of 3-6 patients receive escalating doses of BG00001 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients
      experiences dose-limiting toxicity.

      Patients are followed weekly for 1 month, biweekly for 1 month, monthly for 4 months, and
      then every 6 months for 15 years.

      PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
    

Intervention name(s): recombinant adenovirus-hIFN-beta
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: advanced malignant mesothelioma; male breast cancer; localized malignant mesothelioma; recurrent bladder cancer; recurrent renal cell cancer; recurrent urethral cancer; recurrent breast cancer; recurrent penile cancer; recurrent prostate cancer; recurrent anal cancer; recurrent colon cancer; recurrent esophageal cancer; recurrent gastric cancer; recurrent pancreatic cancer; recurrent rectal cancer; recurrent gastrointestinal carcinoid tumor; recurrent small intestine cancer; recurrent gallbladder cancer; recurrent extrahepatic bile duct cancer; recurrent adult primary liver cancer; recurrent non-small cell lung cancer; recurrent small cell lung cancer; recurrent thymoma and thymic carcinoma; recurrent melanoma; recurrent malignant mesothelioma; recurrent malignant testicular germ cell tumor; recurrent cervical cancer; recurrent ovarian epithelial cancer; fallopian tube cancer; recurrent vulvar cancer; recurrent vaginal cancer; recurrent gestational trophoblastic tumor; recurrent endometrial carcinoma; recurrent ovarian germ cell tumor; malignant pleural effusion
Mega-CHOEP: Conventional Chemo Vs HD Chemo Followed by Auto SCT in Younger Pts With Aggressive Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma (NHL)
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      According to amendment 3 this study addresses the question if intensification of
      administration of rituximab in standard treatment for patients with newly diagnosed
      aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better
      time to treatment failure (TTTF)
    

Detailed description: 
      This study was primarily designed to compare aggressive conventional chemotherapy with a
      repetitive high-dose (HD) therapy program using identical, effective drugs at highest
      possible dose and dose intensity with/without addition of rituximab (initially 4 treatment
      arms). In 2004 the first amendment had to be added in order to close two treatment arms
      without rituximab due to recent data revealing a significant advantage for rituximab-treated
      patients with CD20+lymphoma.

      A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in
      the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was
      raised from 6 to 12 administrations as recent publications gave hint for advantage. The last
      amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation
      problems.

      As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.
    

Intervention name(s): R-CHOEP 14 with 12x Rituximab
Intervention type(s): Drug
Intervention description(s): after amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle)
Other intervention name(s): 12 x Rituximab with 8 cycles of standard CHOEP-14
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Testing mTBI in Athletes
Condition: Mild Traumatic Brain Injury; Brain Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study will assess the effectiveness of a portable goggle system in the diagnosis of mild
      traumatic brain injury (mTBI) in athletes.
    

Detailed description: 
      The purpose of this research study is to assess oculomotor, vestibular and reaction time
      responses in mild traumatic brain injury (mTBI) athletes, as well as healthy individuals.
      These measurements will be recorded using a portable goggle system (IPAS). The goal is to
      determine whether this IPAS goggle system is effective at diagnosing mTBI. A secondary goal
      is to determine whether this IPAS goggle system is effective at ruling out the diagnosis of
      mTBI in athletes and non-athletes that do not have the condition.

      The IPAS is a portable 3D head mounted display. The IPAS goggles are programmed with a series
      of tests that track eye motions in response to a target. This device has been determined to
      be a Non-Significant Risk to study participants.

      There are three groups of interest in this study: athletes who suffer an mTBI, athletes who
      do have an mTBI, and healthy non-athletes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the population of athletes in the intercollege athletic
        programs at the University of Miami. This will include athletes in NCAA Sports as well as
        intercollege club sports. Aged and sex matched controls will be collected from the general
        student body of the University of Miami.
Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin
Condition: Dermatologic Conditions
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) used in this
      study is to collect clinical data for dermatologic conditions in which electrocoagulation and
      hemostasis is a viable mechanism for means of improvement.
    

Detailed description: 
      Up to 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2
      groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B
      will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus.
      Subjects will attend a screening/pretreatment visit which may be performed on the same day as
      the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).
    

Intervention name(s): Potenza; Morpheus
Intervention type(s): Device; Device
Intervention description(s): The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.; The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be treated with the Potenza device on one side of the face and will receive treatment with Morpheus device on the other side of the face.
Masking: Single (Participant)
Primary purpose: Treatment
Development and Testing of a Generic Screening for Use in Application Process of Medical Rehabilitation Services
Condition: Medical Rehabilitation
Study type: Observational

Summary: 
      The primary objective of this research is the development and testing of a brief
      cross-indication instrument (screening) for use in the approval process of medical
      rehabilitation services. In addition to the empirical foundation, this generic instrument
      should have a high level of acceptance of both applicants and payers of rehabilitation
      services. Furthermore, an everyday and economic use for the routine application process for
      medical rehabilitation services at the German statutory pension insurance scheme should be
      provided. In the first study phase, a long instrument was tested with a sample of
      rehabilitees that received approval of medical rehabilitation services. This assessment
      including the measurement of rehabilitation-related somatic, psychological and social
      impairments was first tested for its psychometric properties and then reduced to a short
      instrument (screening) using quantitative methods. In the second study phase, the
      then-existing screening will be part of the application documents for medical rehabilitation
      services to assess its management properties and practicability in everyday use of the German
      statutory pension insurance scheme.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Members of the German Federal Pension Insurance before their medical rehabilitation
Using of Extracorporeal Shockwave Therapy in Treatment Of Achilles Tendinopathy
Condition: Achilles Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of extracorporeal Shock wave therapy
      (ESWT) on functional activity and pain in patients with Achilles tendinopathy
    

Detailed description: 
      Fifty patients of both sexes with Achilles tendinopathy aged 18-40 years, were assigned
      randomly into two equal groups. The study group received ESWT in addition to a conservative
      physical therapy program for four weeks, while the control group received a conservative
      physical therapy program only. Pain and functional mobility were assessed before and after
      treatment through a visual analog scale (VAS) and Victorian Institute of sports assessment -
      Achilles questionnaire (VISA-A), respectively
    

Intervention name(s): Extracorporeal Shockwave Therapy(ESWT); Eccentric training of the calf muscle:; Gastrocnemius, soleus, and hamstring stretch
Intervention type(s): Device; Other; Other
Intervention description(s): Each session of Extracorporeal Shockwave Therapy(ESWT) consists of 2000 pulses with a pressure of 3 bars (equals an energy flux density of 0.1 mJ/mm²), and treatment frequency of 8 pulses/sec; The patients were asked to stand with all their body weight on the injured leg on a wooden step. From an upright body position and standing with all body weight on the forefoot, with the ankle joint in plantar flexion. The calf muscle is loaded by having the patient lower the affected limb down by dorsiflexion the ankle until the plantar aspect of the heel lay below the level of the step, and the ankle is in maximum dorsiflexion.; Stretching every muscle for 30 seconds. Each stretch was performed 3 times (holding for 30 seconds and rest for 30 seconds). All these stretches were performed directly after the eccentric exercises twice/day for 7 days/week for weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
EmbracePlus SpO2 Accuracy Validation
Condition: Oximetry
Study type: Interventional

Summary: 
      The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild,
      moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood);
      ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing
      the reading of the the subject device during brief, steady state hypoxia with a gold-standard
      measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial
      blood sample processed in a laboratory.
    


Intervention name(s): EmbracePlus
Intervention type(s): Device
Intervention description(s): A device intended for use by researchers and healthcare professionals for continuous collection of physiological parameters in home and healthcare settings.
Parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oximetry; Wearable; SpO2
Observational Maternal COVID-19 Vaccination Study
Condition: Pregnancy
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This is a prospective, observational study. During the study, pregnant women will be followed
      post COVID-19 vaccination.

      Injection-site (local) and systemic reaction data will be assessed on vaccination day and
      during the 7 days following the second vaccination using either identical web-based or paper
      diaries, depending on study participant preference.

      Maternal serum samples will be collected for antibody titers relevant to COVID-19 at time
      points that include: prior to vaccination, ~29 days post second vaccination, and at delivery.
      At Duke University, maternal and infant cord blood will be collected at delivery and analyzed
      for the same antibody titers. At other clinical sites, these delivery samples will only be
      collected if feasible.

      Pregnant women will be followed through 90 days postpartum. with comprehensive obstetric and
      neonatal outcomes obtained from medical record review.
    


Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Observational
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        350 adult pregnant women aged 18-45 years at < 34 weeks gestation who plan on receiving
        COVID-19 vaccination during the current pregnancy in accordance with the Advisory Committee
        on Immunization Practices (ACIP) and American College of Obstetricians & Gynecologists
        (ACOG) national recommendations.
      
Biospecimen description: 
      serum
    
Keywords: COVID-19 Vaccination; Immunizations in Pregnancy
Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      The purpose of the research is to determine if eating sweetened, dried cranberries or
      strawberry fruit pieces will increase the types of different E. coli bacteria in the
      intestines which may reduce the likelihood of a major, or highly harmful urinary type of
      bacteria which cause urinary tract infections in susceptible women.
    

Detailed description: 
      This is a research study about the number and types of bacteria that cause urinary tract
      infections (E. coli strains) that are present in the intestine. The bacteria will be
      collected and analyzed before and after eating either sweetened, dried cranberries or
      strawberry fruit pieces. This study will help us learn more about whether or not the
      components of consumed sweetened, dried cranberries or strawberry fruit pieces reduce the
      numbers of harmful E. coli bacteria in the vaginal and intestinal tracts, thereby reducing
      the number of urinary tract infections among women.
    

Intervention name(s): Sweetened, dried cranberries; Strawberry Fruit Pieces; Sweetened, dried cranberries; Sweetened, dried cranberries; Strawberry Fruit Pieces; Observation
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.; 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.; 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.; 1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.; 1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.; Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Urinary Tract Infection; UTI
A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Participants With Stable Schizophrenia
Condition: Stable Schizophrenia
MeSH terms: Anhedonia; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether motivation/reward deficits observed in
      schizophrenia are attenuated and whether cognitive impairment associated with schizophrenia
      is improved by add-on TAK-041 administration to antipsychotics in participants with stable
      schizophrenia.
    

Detailed description: 
      The drug being tested in this study is called TAK-041. TAK-041 is being tested to treat
      people who have stable schizophrenia. This study will look whether motivation/reward deficits
      observed in schizophrenia are attenuated and whether cognitive impairment associated with
      schizophrenia is improved in people who take TAK-041 in addition to standard care.

      The study will enroll approximately 32 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) in 1:1 ratio to one of the two treatment sequences -which will
      remain undisclosed to the patient and study doctor during the study (unless there is an
      urgent medical need) to receive either TAK-041 40 mg or Placebo first and then will be
      crossed over to receive the opposite Intervention.

      All participants will be asked to take oral suspension on Day 1 of each Period. There will be
      a wash-out Period of 35 days between the dosing days in Period 1 and 2.

      This single-center trial will be conducted in the United Kingdom. The overall time to
      participate in this study is approximately 126 to 154 days. Participants will make multiple
      visits to the clinic plus a final visit 77 days after receiving their last dose of drug for a
      follow-up assessment.
    

Intervention name(s): TAK-041; Placebo; Second Generation Antipsychotics (SGA)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-041 suspension; TAK-041 placebo-matching suspension; Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone.
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy