bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Gynecological Age on LH Sensitivity to Energy Availability
Condition: Anovulation; Amenorrhea; Infertility; Starvation
MeSH terms: Infertility; Anovulation; Starvation; Amenorrhea
Study type: Interventional

Summary: 
      The purpose of this experiment is to investigate whether the dependence of luteinizing
      hormone pulsatility on energy availability declines during adolescence.
    

Detailed description: 
      The incidence of menstrual disorders declines during adolescence. This has long been
      attributed to the gradual "maturation" of the hypothalamic-pituitary-ovarian axis, but the
      mechanism of this "maturation" is not known. Ovarian function critically depends on the
      pulsatile secretion of gonadotropin-releasing hormone (GnRH) by the hypothalamus and on the
      consequent and more readily assessed pulsatility of luteinizing hormone (LH) secretion by the
      pituitary. LH pulsatility has been shown to depend on energy availability, operationally
      defined as dietary energy intake minus exercise energy expenditure. The effects of energy
      availability on LH pulsatility are thought to be mediated by certain metabolic substrates and
      hormones.

      Comparison: By manipulating diet and exercise regimens, contrasting energy availability
      treatments of 10 and 45 kilocalories per kilogram of fat-free mass per day are being
      administered to adolescents with 5-8 years of gynecological age and to adults with 14-18
      years of gynecological age for five days in the early follicular phase of separate menstrual
      cycles. Effects of low energy availability on LH pulsatility and on selected metabolic
      substrates and hormones are being measured.
    

Intervention name(s): Energy availability
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: LH pulsatility; energy availability; exercise; diet; gynecological age
Study to Evaluate the Effect of CIN-107 on the Pharmacokinetics of the MATE Substrate, Metformin, in Healthy Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, two-period, crossover Phase 1 to assess the impact of
      CIN-107 on the pharmacokinetics (PK) of metformin and the safety and tolerability of
      coadministration of CIN-107 and metformin as compared to metformin alone.
    


Intervention name(s): Metformin; CIN-107
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg dose of immediate-release metformin; 10 mg dose of CIN-107
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outcome Following Truncation of Asparaginase
Condition: Relapse Leukemia
MeSH terms: Leukemia; Recurrence
Study type: Observational [Patient Registry]

Summary: 
      This study aimed to investigate the outcome of patients who had their asparaginase treatment
      truncated in the NOPHO ALL2008 protocol.
    

Detailed description: 
      Overall survival for children with ALL is now above 90% in several protocols, but
      asparaginase associated toxicities still constitutes a significant problem as they, besides
      causing acute morbidity and mortality, can cause truncation of treatment with a subsequent
      increased risk of relapse.

      The most frequent toxicities causing asparaginase truncations are hypersensitivity,
      pancreatitis and thrombosis. Especially hypersensitivity constitutes a problem due to
      silencing antibodies, not only in patients with clinical hypersensitivity but also in
      patients without clinical symptoms (silent inactivation).

      In the NOPHO ALL2008 protocol asparaginase associated toxicities and truncation of
      asparaginase have been registered since the protocol opened in 2008. In addition asparaginase
      enzyme activity measurements have been done before every asparaginase administration and
      analyzed retrospectively.

      The primary aim of this study was to investigate if patients with truncation of asparaginase
      or lack of asparaginase enzyme activity had a different risk of relapse compared to patients
      who received full asparaginase treatment. Secondary we aimed to explore if patients who
      received less than 50% of their planned asparaginase dosages had a different risk of relapse
      compared to those who received 50% or more.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children aged 1-17.9 years at time of diagnosis.
      
Keywords: Acute lymphoblastic leukemia; Asparaginase; Truncation; Toxicitities
Intensive tDCS for MDD: Feasibility Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This will be a prospective, open-label, single-arm study to determine the safety and
      feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for
      major depressive disorder (MDD). Participants will be age 18-65 with a diagnosis of unipolar
      MDD. Participants will receive an intensive treatment of tDCS over a 10-day treatment period
      and complete follow-up assessments at the end of treatment, 1, and 4 weeks post-treatment.
    

Detailed description: 
      This will be a prospective, open-label, single-arm study to determine the safety and
      feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for
      major depressive disorder (MDD). Secondary objective is to gather preliminary data on the
      clinical effects of the protocol. After assessment and inclusion into the study, participants
      will receive up to 50 tDCS sessions over 10 days.

      Study procedures:

      Daily assessments: brief questions before and after each tDCS session to evaluate potential
      adverse events as well as a verbal rating scale for pain.

      Questionnaires : a battery of mood questionnaires will be completed to inform findings
      regarding clinical effects of the treatment.

      Cognitive measures: a short cognitive assessment will be completed to inform findings
      regarding cognitive safety of the treatment.
    

Intervention name(s): transcranial direct current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): tDCS alters brain excitability using a weak electric field induced through two electrodes and could potentially improve symptoms of depression
Intervention model: Single Group Assignment
Intervention model description: Open label feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of an Adjuvanted Inactivated Subunit Influenza Vaccine to Those of a Non-adjuvanted Inactivated Subunit Influenza Vaccine, When Administered to Adults Affected by Chronic Diseases
Condition: Influenza Disease
MeSH terms: Influenza, Human; Chronic Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III is designed to confirm the previous trial results evaluating the safety,
      clinical tolerability and immunogenicity of the 2006-2007 formulation of Novartis Vaccines'
      adjuvanted influenza vaccine and subunit influenza vaccine in adults with underlying chronic
      diseases.
    


Intervention name(s): Adjuvanted influenza vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: influenza; influenza vaccine; adjuvanted influenza vaccine; H5N1 influenza antigen
CMV-TCR-T Cells for CM Virus Infection After HSCT
Condition: CMV Infection or Reactivation After Allogenic HSCT
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single cente, single arm, open-label, phase I study to evaluate the safety and
      effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.
    

Detailed description: 
      CMV infection is a common virus infection of HSCT, and which is highly related with the
      failure of transplantation and survival time of transplant patients. To evaluate the safety
      and efficacy of allogenic CMV-TCR-T cell therapy in subjects with CMV infection, patients
      with CMV emias or deseases will be enrolled, and donor derived
      CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of
      0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be
      monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
    

Intervention name(s): CMV-TCR-T cells
Intervention type(s): Biological
Intervention description(s): Patients with CMV emias or CMV disease will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with
      the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily)
      (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The
      first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed
      by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC
      for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for
      12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response
      will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4
      will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36
      weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an
      open-label basis for patients of Group 5 who failed treatment. Patients will receive
      RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The
      anticipated time on study treatment is 6-12 months.
    


Intervention name(s): Copegus; Copegus; Pegasys; Pegasys; RO5024048; RO5024048; RO5024048; RO5024048
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1000/1200mg po daily for 24 or 48 weeks; 1000/1200mg po daily for 48 weeks; 180 micrograms sc weekly for 24 or 48 weeks; 180 micrograms sc weekly for 48 weeks; 1000mg bid for 24 weeks; 500mg bid for 12 weeks; 1000mg bid for 8 weeks; 1000mg bid for 12 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF
      04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Itraconazole; Healthy Volunteers; Drug-drug interaction; PF-04958242
Evaluation of Technologies for Neonates in Africa
Condition: Neonatal Physiology
Study type: Observational

Summary: 
      This is a diagnostic accuracy evaluation and clinical feasibility study of investigational
      devices (EarlySense and ANNE systems) in a neonatal high dependency unit (nHDU) in a private
      teaching hospital and a government maternity hospital in Nairobi, Kenya. Neonates who are
      admitted for routine observation and care will be enrolled.
    

Detailed description: 
      To further reduce neonatal mortality rate in low resource settings (LRS) in Africa, research
      is needed to develop and optimize innovations in neonatal care, specifically technologies
      that are low cost, operator-independent, and highly efficient. The purpose of this study is
      to produce information and data regarding the performance of two existing multiparameter
      continuous physiological monitoring devices developed by device developers, EarlySense and
      Sonica. The clinical trial is intended to provide evidence to establish whether these
      investigational devices can reliably and accurately measure vital signs in neonates (when
      compared to verified reference devices) and to assess the feasibility, usability and
      acceptability of these devices for use in neonates in a LRS in Africa.
    

Intervention name(s): EarlySense Insight system; Advanced Neonatal Epidermal System
Intervention type(s): Device; Device
Intervention description(s): a small piezoelectric sensor pad that can be placed under the mattress and provide contact-free monitoring by measuring and recording a patient's vital signs and motion parameters; a system of neonatal non-invasive adhesive sensors. Sensors are attached directly on the patient's body and are capable of continuously measuring and recording heart rate, respiratory rate, oxygen saturation, and skin temperature.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates enrolled in the study will be representative of the ethnic demographics in
        Nairobi, Kenya. Both female and male neonates will be enrolled.
Dose Escalation Study of OMP-54F28 in Combination With Paclitaxel and Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and
      PK of OMP-54F28 when combined with paclitaxel and carboplatin. OMP-54F28 will be administered
      IV on Days 1 of each 21-day cycle. Paclitaxel (175 mg/m2) and carboplatin (AUC = 5 mg/mL •
      min) will be administered IV on Day 1 of each cycle. A total of 6 cycles of paclitaxel and
      carboplatin will be given. Additional cycles may be given as per institutional standard of
      care after discussion with the Medical Monitor. Treatment with OMP-54F28 will continue after
      completion of treatment with paclitaxel and carboplatin. The planned dose levels of OMP-54F28
      are 5 and 10 mg/kg.
    

Detailed description: 
      Depending on safety in this study, additional lower or intermediate dose levels may be
      evaluated. Depending on emerging safety data from the Phase 1a study 54F28-001 with
      continuing dose escalation, additional higher dose levels of OMP-54F28 may be evaluated in
      this study. Alternative dosing schedules of OMP-54F28 may be explored based on emerging
      nonclinical and clinical data for safety, PD, PK and efficacy. The starting dose for a new
      dosing schedule will be chosen to result in an AUC equivalent to the highest dose level that
      cleared on the previously studied dosing schedule. No dose escalation of OMP-54F28 will be
      allowed within a dose cohort.

      Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined,
      up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
      safety, tolerability and PK of OMP-54F28 combined with paclitaxel and carboplatin. Up to
      approximately 34 patients may be enrolled into the study.
    

Intervention name(s): OMP-54F28, Paclitaxel and Carboplatin
Intervention type(s): Drug
Other intervention name(s): OMP-54F28; Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Immunoglobulin Fc Fragments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platinum-Sensitive Ovarian Cancer
Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to observe and evaluate the efficacy and safety of A sintilimab
      plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced
      esophageal squamous cell carcinoma.
    


Intervention name(s): Sintilimab plus Chemotherapy
Intervention type(s): Drug
Intervention description(s): Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=5. Once every 3 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is a single center, double-blind placebo-controlled trial to assess the
      safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted
      for 28 days in 16 healthy, HIV-negative women.
    

Detailed description: 
      The objective of this trial was to evaluate the feasibility of using a platinum-catalyzed
      matrix vaginal ring, containing 25 mg of dapivirine, to deliver investigational product for
      28 continuous days. The specific objectives were to:

        1. Assess the safety and tolerability of the vaginal ring containing dapivirine, when used
           continuously for 28 days, compared to a placebo ring

        2. Assess dapivirine concentrations in plasma before, during and after 28 days' use of a
           silicone elastomer matrix vaginal ring containing dapivirine

        3. Assess dapivirine concentrations in vaginal fluids before, during and after 28 days' use
           of a silicone elastomer matrix vaginal ring containing dapivirine. Safety was evaluated
           from clinical evaluations, clinical laboratory test results and adverse events (AEs).
           The pharmacokinetic (PK) evaluation was made based on systemic absorption from plasma
           concentrations and local disposition from vaginal fluid concentrations.
    

Intervention name(s): Dapivirine Vaginal Ring; Placebo vaginal ring
Intervention type(s): Combination Product; Combination Product
Intervention description(s): A platinum-catalysed silicone elastomer matrix vaginal ring containing 25mg of dapivirine used over 28 days; Placebo vaginal ring containing no dapivirine
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Infections; HIV seronegativity
Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given
      in individual doses, according to a nomogram we have constructed based on our results from a
      previous study, results in more patients maturing 2-3 follicles compared to standard dose.
    


Intervention name(s): rFSH drug dose; "Standard" rFSH dose
Intervention type(s): Drug; Drug
Intervention description(s): "Individual" rFSH dose (50, 75 or 100 IU rFSH/day); "Standard" rFSH dose was 75 IU/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral
      Quantitative Computed Tomography) technology to detect minute changes in bone
      microarchitecture.
    

Detailed description: 
      The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at
      "microarchitecture" level, without the need for invasive bone biopsies. The primary objective
      is to evaluate the sensitivity of the technology to detect a difference between those treated
      with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with
      osteopenia have been chosen because they have a more rapid and higher level of bone loss
      during the first few years of the menopause.
    

Intervention name(s): Placebo comparator; risedronate
Intervention type(s): Drug; Drug
Intervention description(s): oral weekly for one year; 35 mg risedronate, once a week for one year
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason
Condition: Surgical Port Site Hernia
MeSH terms: Hernia
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ
      Close) by comparing it with the Carter-Thomason device.
    

Detailed description: 
      Port-site closure is a critical procedure after every laparoscopic surgery. Complications
      such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur
      during and after the procedure. Many devices were developed and utilized for the procedure
      and Carter-Thomason is one of the most commonly used device and validated with several
      studies. This study aims to evaluate the efficacy and safety of a novel port-site closure
      device (EZ Close) by comparing it with the Carter-Thomason device.
    

Intervention name(s): EZ close; Carter Thomason
Intervention type(s): Device; Device
Intervention description(s): EZ close used.; Carter Thomason used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention