bioihbjkbjnl/mcl2 huggingface dataset:
Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
Condition: Schizophreniform Disorder; Schizoaffective Disorder; Psychosis; Depressive Disorder, Major; Bipolar Disorder
MeSH terms: Depressive Disorder; Bipolar Disorder; Psychotic Disorders; Mental Disorders; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients,
      aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for
      7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically
      appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI)
      Schizophrenia Research Unit (SRU) inpatient facility.
    

Detailed description: 
      This study is an open-label assessment of the feasibility of treating adolescents with
      psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not
      otherwise specified [NOS], major depressive disorder with psychotic features, and bipolar
      disorder with psychotic features) in an inpatient and day hospital setting with ziprasidone
      (Geodon). Ziprasidone is a second-generation antipsychotic (SGA) that is FDA-approved for the
      treatment of schizophrenia and for the treatment of the manic phase of bipolar disorder in
      adults. It is also used clinically in the treatment of psychotic disorders in children,
      adolescents and adults. This protocol will help to elucidate the feasibility of studying the
      treatment of psychotic disorders with ziprasidone in adolescents 13-17 years and help
      facilitate the further study of the treatment of psychosis with novel agents that have a
      favorable side effect and weight gain profile.

      The duration of the study can be up to 7 weeks. Depending on the level of symptom severity
      patients will be managed on either the Schizophrenia Research Unit (SRU) (GAS<35, CGI-S>5),
      or the Children's Day Unit (CDU) of the NYSPI. The seven weeks would encompass a 3 day period
      at the beginning of the study including time for screening and reviewing lab results. Over a
      period of one to two weeks patients will be titrated up to 120 mg/day (80 mg for patients
      under 45kg), and, if necessary, cross tapered off of another SGA that had not been working
      successfully. Subjects who do not respond to the medication after 1 week at the target dose
      will be discontinued from the study.
    

Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): subjects will use ziprasidone
Intervention MeSH terms: Ziprasidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychosis NOS; MDD w/ psychotic features; bipolar disorder w. psychotic features
Psychosocial Treatment for Women With Depression and Pain
Condition: Pelvic Pain; Depression
MeSH terms: Pelvic Pain; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Patients with depression and pain have poorer outcomes in response to depression treatments
      than depressed patients without pain. While psychotherapy treatment studies have demonstrated
      improvement in pain and depression, no psychosocial interventions have been developed and
      tested prospectively specifically for patients with both conditions. Interpersonal
      psychotherapy (IPT), an effective treatment for depression, has been adapted successfully for
      physically ill patients and demonstrates good adherence, treatment satisfaction, and
      depression outcomes. The investigators propose to test a modified form of IPT-P for depressed
      patients with co-morbid pain.
    


Intervention name(s): Interpersonal Therapy for Pain (IPT-P); Enhanced Support and Connection to Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): IPT-P focuses on improving relationships as a way to improve depression and pain. The patient and therapist work together to improve communication and enhance relationships and social support. Patients choose a problem focus and goal related to both their pain and depression. Up to 8 IPT-P sessions are provided regardless of ability to pay.; Research staff connect patients with the Strong Family Therapy Services, Women's Behavioral Health Service, or other appropriate mental health care and reduce potential barriers from making it to the initial appointment. This support includes navigating insurance issues, addressing issues of childcare and transportation, helping to schedule the initial appointment, reminder calls, and follow-up after the scheduled intake. Research staff will also check-in monthly to see if the patients require any additional support to remain in mental health treatment. Up to 8 therapy sessions are covered regardless of ability to pay.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate whether administration of two investigational malaria vaccines
      (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection
      against malaria infection as compared to protection induced by the 257049 vaccine alone. The
      study will also evaluate the safety and the immune response to the new combination of the two
      experimental malaria vaccines.
    

Detailed description: 
      Approximately 168 healthy, malaria-naïve volunteers aged 18 - 50 years, divided into 2 groups
      (84 in each group), will receive either one dose of Ad35.CS.01 followed by two doses of
      257049 at monthly intervals or 3 doses of 257049 vaccine at monthly intervals. Of these, a
      maximum of 138 vaccinated volunteers will be challenged with P. falciparum infected
      mosquitoes. The challenge will occur 2 weeks following the third immunization. A group of up
      to 18 infectivity controls will begin participation in the study at the challenge stage.
      These controls receive no vaccine and are enrolled for malaria-challenge only in order to
      provide comparison group for vaccinated individuals.
    

Intervention name(s): Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01); GSK Biologicals' malaria vaccine 257049 (2 doses); GSK Biologicals' malaria vaccine 257049 (3 doses); Sporozoite challenge
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): One dose will be administered intramuscularly at Study Day 0.; Two doses will be administered intramuscularly at monthly intervals; Three doses will be administered intramuscularly at monthly intervals; Subjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: safety; Vaccine; Phase 1/2; immunogenicity; Malaria; efficacy; sporozoite challenge
Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI
Condition: Infertility Indicated for ICSI
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      study the effect of aromataze inhibitor induction together with short stimulation protocol by
      gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before
      ICSI
    

Detailed description: 
      This is a prospective randomized case control study will be conducted in Maternity hospital
      IVF unite Minia University after being approved by local ethical committee of obstetrics and
      gynecology department faculty of medicine, all study details will be explained to patients
      and informed consent will be obtained before inclusion in the study . enrolled patients will
      be randomized into two groups using simple randomization by sealed opaque envelops contain
      serial computer generated numbers Control group will receive HMG 300 IU daily start at first
      day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three
      follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least
      three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than
      three follicles cycle will be cancelled .

      Study group will receive same management plus letrozole 2.5mg daily start at the first day of
      menses for 5 days and continue with same protocol
    

Intervention name(s): induction with aromataze inhibitor; HMG; GnRh a; HCG
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): letrozole 2.5mg once daily start in the first day of menses for 5days; HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter; antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection; 10.000 IU HCG injection when at least three follicles reach 17mm in diameter
Other intervention name(s): letrozole; merional; decapeptyl; choriomon
Intervention MeSH terms: Letrozole; Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: aromataze inhibitor, poor responder ,induction
A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
Condition: Early Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves a two-part design. Part 1 is designed to determine the optimal dose of
      subcutaneous (SC) Perjeta, injected alone or mixed with Herceptin, that results in comparable
      exposure to intravenous (IV) Perjeta. Exposure between SC Perjeta and IV Perjeta will be
      compared using a compilation of pharmacokinetic (PK) parameters such as area under the
      concentration-time curve (AUC), maximum serum concentration (Cmax), time of maximum
      concentration (Tmax), and serum trough concentration (Ctrough). Part 2 is designed to confirm
      the dosing regimen in women with EBC on the basis of safety, tolerability, and PK
      assessments.
    


Intervention name(s): Trastuzumab; Pertuzumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single dose of trastuzumab 600 mg SC separately, co-mixed or co-formulated with pertuzumab.; Participants will receive pertuzumab as a single agent injection, co-mixed or formulated as FDC with trastuzumab depending upon cohort. The dose will range from 400 to 1200 mg.
Other intervention name(s): Herceptin, RO0452317; Perjeta, RO4368451
Intervention MeSH terms: Trastuzumab; Pertuzumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Castror Oil for Labor Induction in Women With Previous Cesarean Section
Condition: Induction of Labor
Study type: Interventional

Summary: 
      Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five
      pregnancies requires induction of labour. The use of non-pharmacological methods (methods
      without using medication) has been gaining popularity for women who are not good candidates,
      such as women with previous Caesarean scar, for induction with medications such as
      prostaglandin. Labour induction with prostaglandin carries a higher risk of uterine rupture
      and thus it is not routinely offered to women with previous Caesarean delivery in Cairo
      University Hospital. Non-pharmacological methods of induction of labour appear to be safe in
      women with previous Caesarean delivery. However, various methods are available and the
      efficacy among them remain in doubt.
    

Detailed description: 
      In Cairo University Hospital, castor oil, which is a type of induction methods, is routinely
      offered to women with previous Caesarean delivery who require induction of labor. However,
      castor oil may not exert its labor induction effect immediately and the delivery may be
      delayed by up to 8 days. This may render a proportion of women resort to repeated Caesarean
      section for failed induction. Castor oil is traditionally given by midwives in order to
      induce labor.

      The investigators are intent to recruit 70 healthy pregnant women with a history of previous
      one cesarean section and with no contraindication to trial of labor after cesarean . Women
      will be randomly and blindly divided into equal-sized intervention group and control group.
      Intervention group will be given a single dose 60 mL of castor oil in 140 mL of orange juice,
      while control group will be given a placebo with similar texture. Primary outcomes to be
      tested are the percentage of women entering active labor within 24 hours of castor oil or
      placebo administration and the number of successful vaginal deliveries after cesarean.
    

Intervention name(s): Castor Oil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention group will be given 60 mL of castor oil in 140 mL of orange juice; the control group will be given a sunflower oil as a placebo with a similar texture to castor oil
Intervention MeSH terms: Castor Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
Condition: Herpes Genitalis; Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster; Herpes Genitalis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety and tolerability of single rising doses
      of ASP2151 under fasted condition in healthy male subjects.

      The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under
      fasted versus fed conditions in healthy male subjects.
    

Detailed description: 
      Study will be divided into two parts. Part 1 will evaluate the safety and tolerability of
      ASP2151 single rising doses in groups A-H in fasted condition and to determine the maximum
      tolerable dose (MTD) if possible.

      Part 2 will evaluate the effect of fasted versus fed conditions on the safety, tolerability
      and PK of a single dose of ASP2151 in two treatment cycles. The wash-out period between the
      two treatment cycles will be at least 5 days and not shorter than five times the average
      elimination half-life of ASP2151, as determined in part 1 of the study.
    

Intervention name(s): ASP2151; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety of ASP2151; Phase 1; Pharmacokinetics; Healthy male subjects; Tolerability; Food effect of ASP2151
Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational
      AAB-001 Vaccine in Japanese patients with Alzheimer's disease.
    


Intervention name(s): bapineuzumab; bapineuzumab; bapineuzumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.; The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.; The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Alterations in Serotonergic Functions in Cocaine Addicts - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate alterations in the serotonergic system in cocaine
      addicts and attempt to dissociate changes secondary to cocaine use from those associated with
      premorbid characteristics.
    


Intervention name(s): M-CPP
Intervention type(s): Drug
Primary purpose: Treatment
Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma
Condition: Follicular Non-Hodgkin's Lymphoma; Nodal Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 3

Summary: 
      This international multi-center, randomized, controlled, open-label study investigated the
      pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: rituximab, CJSC
      Biocad) versus MabThera® (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a
      monotherapy of patients with indolent non-Hodgkin's lymphoma.

      Patients were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for
      4 weeks or MabThera® at the same regimen.
    


Intervention name(s): rituximab
Intervention type(s): Biological
Intervention description(s): Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
Other intervention name(s): Biological: BCD-020, MabThera
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma, non-Hodgkin's
Evaluation of Potential Causes of Nap Modulated Tinnitus
Condition: Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases
MeSH terms: Tinnitus; Ear Diseases; Hearing Disorders; Otorhinolaryngologic Diseases
Study type: Observational [Patient Registry]

Summary: 
      The proposed research is a non-interventional study made to evaluate different measurements
      on 1 group of participants, before and after taking a nap, aiming to potentially guide future
      investigations on nap-modulated tinnitus to better understand this phenomenon.

      The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus
      intensity.
    

Detailed description: 
      1. - Background : Tinnitus is a really important concern due to its high prevalence (10%
           world population) and its deteriorating effects on life quality. Subjective tinnitus
           still remains a scientific enigma because of its partial elucidation. The limited
           knowledge on its causes can be partially attributed to its intrinsic heterogeneity. In
           questionnaires previous to this study, 34% of participants showed a characteristic
           symptomatology of interactions between tinnitus and their sleep : they feel their
           tinnitus at its maximum intensity after sleeping periods (nap and sleep). In most cases
           they describe a frank rise of the intensity, compared in scientific papers to the
           "exploding head syndrome". Therefore this study aims to determine what are the main
           physiopathological processes correlated to the rises of tinnitus

        2. - Objectives : Estimate the correlations between tinnitus intensity changes (before and
           after the nap) and the number of sleep apneas. Secondary measurements are described in
           the outcome field.
    

Intervention name(s): Napping
Intervention type(s): Other
Intervention description(s): Patients are already equipped with electrodes when they pass a test battery before the nap to evaluate mechanisms potentially correlated with tinnitus modulation. Then they do a nap, the nap is stopped when several periods of sleep are seen on EEG (electroencephalogram). Then the test battery is done backwards to evaluate the same measures.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population is recruited through questionnaires done on different platforms including
        : SIOPI app, previous potential participants or associations. A lesser part of the study
        group comes from suggestions of ENTs/Doctors.
      
Keywords: Nap modulated tinnitus; Sleep modulated tinnitus; sleep apneas
Corneal Changes After Retinal Surgery
Condition: Rhegmatogenous Retinal Detachment
MeSH terms: Retinal Detachment
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the corneal changes after performing 20 gauge
      vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal
      detachment.
    

Detailed description: 
      Patients submitted to 20-gauge vitrectomy associated with scleral buckling were evaluated
      with corneal topography before surgery and in the 7,30 and 90 days after surgery to asses
      corneal curvature changes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with rhegmatogenous retinal detachments