bioihbjkbjnl/mcl2 huggingface dataset:
German Preoperative Adriamycin Docetaxel Study
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to determine the rate of pathologically complete
      remissions following a preoperative dose-intensified therapy with doxorubicin and docetaxel
      with or without tamoxifen in patients with operable carcinoma of the breast. Secondary aims
      are to assess the rate of clinical complete and partial responses, of breast-conserving
      operations, and the toxicity of chemotherapy with and without tamoxifen.

      Women meeting the following criteria will be eligible for the study: operable breast cancer
      (T³3cm N0-2 M0), histologically confirmed diagnosis by core-cut needle or incisional biopsy,
      and measurable disease by mammography or sonography or breast MRI (best appropriate method
      has to chosen by investigator). After the patients have given written informed consent, they
      will be randomised to the study treatments. All patients are scheduled to receive 4 cycles of
      combination chemotherapy consisting of doxorubicin 50 mg/m² (15-min i.v. infusion) and
      docetaxel 75 mg/m² (1-h i.v. infusion). The patients allocated to group I additionally
      receive oral doses of tamoxifen 30 mg once daily, starting on the first day of chemotherapy,
      while chemotherapy alone is administered to patients of group II. Cycles should be repeated
      every 14 days, followed by surgery 8 weeks after initiation of the trial. Surgery consists of
      removal of the remaining tumour (breastconserving resection or mastectomy) and axillary
      dissection. Patients with no response or even progression of the primary tumour can be
      treated to the discretion of the investigator but should be followed up according to
      protocol. If a partial or complete tumour response has been achieved, radiotherapy is given
      to the remaining breast in patients undergoing breast conserving therapy, and tamoxifen
      treatment is continued for a further 5 years.

      Response will be assessed between the 4th cycle and surgery, using the best appropriate
      method. Clinical evaluation should be performed after each cycle. It is planned to recruite
      200 patients during a period of 1 year.
    


Intervention name(s): doxorubicin, docetaxel, tamoxifen; doxorubicin, docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion) with tamoxifen (30 mg tablet p.o. for 5 years post surgery); Every 14 days to a total of 4 cycles of doxorubicin (50 mg/m², 15 minutes i.v. infusion) and docetaxel (75 mg/m², 1 hour i.v. infusion)
Intervention MeSH terms: Tamoxifen; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; doxorubicin; docetaxel; tamoxifen
Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution
Condition: Brief Psychotic Disorder; Psychosis; Episode
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The main aim of the study is to evaluate the effectiveness of Individualized Meta-Cognitive
      Training (EMC +), in people with psychosis of brief evolution on symptoms, especially on
      positive symptoms. Secondary aims would be to assess the effect of EMC+ in metacognition,
      psychosocial and neuropsychological functioning, and to assess the maintenance of program
      effects on 6 months.
    

Detailed description: 
      This is a randomized clinical trial in which some patients receive the EMC+ and others
      treatment as usual.The evaluator will be blind to the group to which the patients belong. The
      sample for the overall project will be a total of 70 people with a diagnosis of psychotic
      spectrum, less than 5 years of experience and with a score => 3 positive PANSS (last month)
      and treated in one of the participating institutions. The evaluation was performed at
      baseline, at post-treatment and at 6 months follow up. Symptoms, metacognition, psychosocial
      and neuropsychological functioning were assessed.

      The EMC consists of 10 therapeutic units with weekly sessions of 45-60 minutes. The material
      available for the Individualized Metacognitive Training (EMC) program is made up of
      power-point presentations.
    

Intervention name(s): MCT+
Intervention type(s): Behavioral
Intervention description(s): Metacognitive training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This is a randomized and comparative prospective test, monocentric and controlled (mirror
      therapy versus bimanual rehabilitation exercises), in single-blind (investigator and
      occupational therapist " 1 " do not know the type of rehabilitation performed).
    


Intervention name(s): mirror therapy; bimanual rehabilitation exercises
Intervention type(s): Procedure; Procedure
Intervention description(s): During a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image; During a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: unilateral cerebral palsy; children; upper-limb; mirror therapy; bimanual coordination; kinematics analysis
Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors
Condition: Diffuse Intrinsic Pontine Glioma; Brain Tumor, Recurrent; Solid Tumor, Recurrent; Neuroblastoma, Recurrent, Refractory; Ewing Sarcoma, Recurrent, Refractory; Rhabdomyosarcoma, Recurrent, Refractory; Osteosarcoma, Recurrent, Refractory; Rhabdoid Tumor, Recurrent, Refractory
MeSH terms: Neoplasms; Glioma; Brain Neoplasms; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Diffuse Intrinsic Pontine Glioma; Rhabdoid Tumor; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin
      dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse
      intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant
      brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).
    

Detailed description: 
      Stratum A- Appropriate dose RT will be administered in 30-33 fractions over approximately 6
      weeks for Stratum A patients. Treatment with abemaciclib (LY2835219) will start on the same
      day as radiation therapy (RT) and continue twice daily during and after RT for a maximum
      treatment duration of 2 years. Investigators plan to treat a maximum of 4 cohorts of research
      participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib (LY2835219)
      starting with dose level 1 (80% of adult dose). A cycle is defined as 28 days and the first 6
      weeks of therapy will constitute the dose-limiting toxicity (DLT)-evaluation period.
      Participants must take abemaciclib by mouth as intact capsules.

      Stratum B (no longer enrolling) - Abemaciclib (LY2835219) will be administered orally on a
      twice daily basis continuously for 28 days, which defines one cycle. The maximum treatment
      duration will be 2 years. Investigators plan to treat a maximum of 4 cohorts of research
      participants (dosage levels 1, 2, 3, and 4) with escalating doses of abemaciclib starting
      with dose level 1 (80% of adult dose). Dose escalation will be independent of Stratum A
      escalation. A cycle is defined as 28 days and the first 4 weeks of therapy will constitute
      the DLT-evaluation period. Participants must take abemaciclib by mouth as intact capsules.

      Enrollment for Stratum B closed December 27, 2018.
    

Intervention name(s): Abemaciclib
Intervention type(s): Drug
Other intervention name(s): LY2835219
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ranibizumab to Treat Choroidal Neovascularization (CNV) in Patients With Pseudoxanthoma Elasticum (PXE)
Condition: Choroidal Neovascularization
MeSH terms: Choroidal Neovascularization; Pseudoxanthoma Elasticum; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in
      the treatment of choroidal neovascularization in underlying angioid streaks due to
      Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye
      over a period of one year.
    

Detailed description: 
      Pseudoxanthoma elasticum (PXE) is a rare hereditary systemic disease affecting mainly the
      skin, eyes and the cardiovascular system. Commonly, complicating choroidal neovascularization
      (CNV) of the central retina lead to a severely decreased visual acuity in the course of the
      disease. Onset of the symptoms varies with the extend of the PXE-associated findings.

      In the past there has been no effective treatment for the disease's ocular complications.
      Recent studies in a limited number of patients with CNV treated with intravitreal injections
      of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF), have shown
      a preservation of function and regression of CNV. An increase of visual acuity was reported
      in a subset of patients. Bevacizumab is a humanized antibody of which ranibizumab is a
      fragment.

      This trial is initiated in order to investigate the effect of ranibizumab on functional
      outcome measures such as preservation of visual acuity as well as morphological outcome
      measures such as regression of CNV in angiography.

      The safety and tolerability of ranibizumab will be investigated as well. As it has been
      tested on large numbers of patients suffering from age-related macular degeneration with only
      rare significant side effects or adverse events being reported, a good safety profile is
      assumed.

      The study is conducted in a non-randomized, uncontrolled prospective setting at one center.

      Patients will receive monthly injections over a period of one year.
    

Intervention name(s): Intravitreal injection ranibizumab
Intervention type(s): Drug
Intervention description(s): Monthly intravitreal injection of 0.5mg ranibizumab in one eye over one year
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: choroidal neovascularization; angioid streaks; pseudoxanthoma elasticum; Groenblad-Strandberg-Syndrome; therapy; ranibizumab; lucentis; Choroidal neovascularization in patients with PXE
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
Condition: Postmenopause
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of
      Premarin®/medroxyprogesterone (MPA).
    


Intervention name(s): Premarin/MPA; Premarin/MPA; Provera 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.625 mg/2.5 mg X4; 0.625 mg/5 mg X 2; 2.5 mg of MPA, 4 tablets dissoved in water
Intervention MeSH terms: Medroxyprogesterone Acetate; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to
      evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's
      Disease.
    


Intervention name(s): MABT5102A; MABT5102A; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Repeating subcutaneous injection; Repeating intravenous infusion; Repeating subcutaneous injection; Repeating intravenous infusion
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing
Condition: Motivation; Self Efficacy
Study type: Interventional

Summary: 
      The aim of this study is to identify effective methodologies to help people to improve their
      awareness of change, motivation, self-confidence and self-efficacy, compliance in behavioral
      change and psychological well-being.
    

Detailed description: 
      Subjects involved will have the opportunity to partecipate in a two-weeks course: two SDT
      (Self Determination Theory) psychological interviews are scheduled (1 per week) to help the
      participant increase his motivation and awareness about the problem reported during the
      counseling session.

      For this purpose, the use of an APP with a CA (Conversational Agent) will be implemented as a
      support to help people to identify one's thoughts and emotional states as well as increase
      their awareness about themselves.

      Test will be administered at the beginning (T1) and at the end of the meetings (T2).

      Participants will be randomly divided into one of two groups to understand whether APP and CA
      has a significant impact in increasing motivation and awareness of the need for a pathway
      with a professional.
    

Intervention name(s): SDT; APP + CA
Intervention type(s): Behavioral; Device
Intervention description(s): Standard 2 SDT (Self Determination Theory) psychological interviews.; An APP with a CA (Conversational Agent).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pre-intervention test will be administered to the participants (T1) to assess their psychological well-being, motivation, awareness of change, self-confidence and self-efficacy.
Participants will be randomly divided into two group: the experimental group will receive the standard 2 Self Determination Theory (SDT) psychological interviews with the support of the APP with the Conversational Agent (CA), while the control group will receive the 2 SDT (Self Determination Theory) psychological interviews.
At the end of the pathway post-intervention test (T2) will be administered to the participants with the same questionnaire of the beginning.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Motivation; Self efficacy
Mindfulness-based Cognitive Therapy for Chronic Depression
Condition: Chronic Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive
      Therapy (MBCT, Segal, Williams, & Teasdale, 2002) for patients suffering from Chronic Major
      Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis
      System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's
      efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).
    

Detailed description: 
      Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a treatment approach
      specifically developed for the treatment of chronic depression. CBASP aims to change
      dysfunctional interpersonal patterns. Mindfulness-based Cognitive Therapy (MBCT) has recently
      been proposed as a further treatment option for chronic depression. MBCT trains patients to
      step out of negative ruminative states of mind. There are no direct comparisons of the
      psychological treatment options for chronic depression.
    

Intervention name(s): Mindfulness-based Cognitive Therapy; The Cognitive Behavioral Analysis System of Psychotherapy; Standard psychiatric care
Intervention type(s): Behavioral; Behavioral; Biological
Intervention description(s): Mindfulness-based Cognitive Therapy is based on an integration of aspects of cognitive behavioral therapy for depression (Beck et al., 1979) with components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions; The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.; Antidepressant medication and medical care.
Standard psychiatric outpatient care:
All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist
Other intervention name(s): Psychiatric care; neurologic care; ambulant setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder; Psychotherapy
Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
Condition: Lymphoma; Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to
      explore the effect of maintenance therapy with lenalidomide versus placebo on
      progression-free survival (PFS) in patients treated with R-CHOP responding to induction
      therapy

      For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for
      Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs
      73.6%), is considered clinically relevant.
    

Detailed description: 
      Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21
      regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local
      preferences.

      Patients can be registered to participate in the study at two time points:

        -  At time of initial diagnosis and study enrolment (signature of informed consent) before
           the first cycle of treatment with R-CHOP.

        -  At randomization (signature of informed consent) after treatment in first line with
           R-CHOP and have reached at least PR or CR.

      Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria for
      Malignant Lymphoma(2007).

      Stratification: Before randomization, the patients will be stratified according to the
      country and the response to R-CHOP (PR vs CR).

      Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with
      lenalidomide or placebo.
    

Intervention name(s): Lenalidomide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily for 3 weeks every 4 weeks for 24 months; Daily for 3 weeks every 4 weeks for 24 months
Other intervention name(s): Revlimid
Intervention MeSH terms: Lenalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lenalidomide (Revlimid); diffuse large B-cell lymphoma; phase III study; after R-CHOP; Maintenance treatment; Maintenance
Characterization of Residual Limb Volume Changes in Transfemoral Amputees
Condition: Amputation Stump
Study type: Observational

Summary: 
      This study quantifies residual limb volume fluctuations affecting transfemoral amputees due
      to the prosthesis doffing, physical activity, and testing time.
    

Detailed description: 
      The first test session aims at measuring residual limb volume at 7 time-points, with 10
      minute intervals, after prosthesis doffing. This allows for evaluating the time required for
      volume stabilization after prosthesis removal, for each amputee. In subsequent sessions, 16
      residual limb scans in a day for each amputee are captured to evaluate volume changes due to
      prosthesis removal and physical activity, in two times per day (one in the morning, one in
      the afternoon). These measurements are repeated in three different days, a week apart from
      each other, for a total of 48 scans for each amputee.
    

Intervention name(s): 3D optical scan
Intervention type(s): Other
Intervention description(s): The clinical protocol consisted of four test sessions in four different days for an overall duration of 3 weeks. During the 1st session, amputees' residual limb volume was measured 7 times at intervals of 10 minutes after the prosthesis removal. During the subsequent sessions, the residual limb volume was measured immediately after the prosthesis doffing and after the amputee's stabilization time, before and after 15-min of walking on a treadmill, both in the morning and in the afternoon.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        transfemoral amputees
      
Keywords: Amputee; Prosthetic socket; Transfemoral residual limb; Volume change; 3D scan
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single
      rising oral doses of BI 10773 to healthy male subjects.
    


Intervention name(s): BI 10773 single rising dose; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment