bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study of GH001 in Depression
Condition: Treatment Resistant Depression; Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to investigate the safety of GH001 (containing
      5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of
      depressive symptoms, and its dose-related psychoactive effects in patients with
      Treatment-Resistant Depression (TRD).

      The study is comprised of two open-label, single-arm study parts where Part A evaluates
      single doses of GH001 at two dose levels and Part B evaluates a specific individualized
      dosing regimen of GH001.
    

Detailed description: 
      Phase 1 (Part A):

      The primary objective of this study is to assess the safety and tolerability of single doses
      of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT) in patients with TRD.

      The secondary objectives of the study are to assess the effects of single doses of GH001 on
      various measures of depression, and on dose-related psychoactive effects.

      Phase 2 (Part B):

      The primary objective of this study is to assess the effects of an individualized dosing
      regimen of GH001 on the severity of depression.

      The secondary objectives of the study are to assess the safety and tolerability of an
      individualized dosing regimen of GH001 in patients with TRD and its effects on the severity
      of depression, other measures of depression, and on dose-related psychoactive effects.

      Study design: Phase 1/2 study in two parts.

      Intervention: In the Phase 1 (Part A), a single dose of GH001 will be administered per
      patient. Two different dose levels will be investigated with four patients at each dose
      level. In the Phase 2 (Part B), an individualized dosing regimen will be administered.

      In both parts, GH001 will be administered via inhalation.
    

Intervention name(s): 5 Methoxy N,N Dimethyltryptamine
Intervention type(s): Drug
Intervention description(s): GH001 administered via inhalation
Other intervention name(s): GH001; 5-MeO-DMT
Intervention MeSH terms: N,N-Dimethyltryptamine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Phase 1 (Part A): Two dose levels of GH001 investigated in single doses. Phase 2 (Part B): GH001 investigated in an individualized dosing regimen.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment; 5-MeO-DMT; 5-methoxy-dimethyltryptamine
The Purpose of the Study is to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR in Healthy Subjects Under Fasting and Fed Conditions
Condition: Healthy Subjects in Fasted and Fed State
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bioequivalence study of two doses of the dapagliflozin/metformin XR tablet
      manufactured at two different plants.
    

Detailed description: 
      This is a two part, open-label, randomized, 4-period, 4-treatment (per study part) crossover
      study in healthy subjects (males and females of non-childbearing potential), performed at a
      single study center, conducted to establish the bioequivalence of 2 strengths of
      dapagliflozin/metformin XR tablets manufactured at two different plants.
    

Intervention name(s): Dapagliflozin/metformin XR 5/500mg; Dapagliflozin/metformin XR 5/500 mg; Dapagliflozin/metformin XR 5/500mg; Dapagliflozin/metformin XR 5/500mg; Dapagliflozin/metformin XR 10/1000mg; Dapagliflozin/metformin XR 10/1000mg; Dapagliflozin/metformin XR 10/1000mg; Dapagliflozin/metformin XR 10/1000mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration, once daily, once per treatment period; Tablets for oral administration, once daily, once per treatment period; Tablets for oral administration, once daily, once per treatment period; Tablets for oral administration, once daily, once per treatment period; Tablets for oral administration, once daily, once per treatment period; Tablets for oral administration, once daily, once per treatment period; Tablets for oral administration, once daily, once per treatment period; Tablets for oral administration, once daily, once per treatment period
Other intervention name(s): Mt Vernon plant; Humacao plant; Dapagliflozin/metformin XR 5/500mg Mount Vernon plant; Humacao plant; Mount Vernon plant; Humacao plant; Dapagliflozin/metformin XR 10/1000mg Mount Vernon plant; Dapagliflozin/metformin XR 10/1000mg Humacao plant
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy,; fasted,; fed
Eltrombopag and High-dose Dexamethasone as First Line Treatment for IT
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the response rate and response duration with the
      combination of eltrombopag and high-dose dexamethasone
    

Detailed description: 
      Immune Thrombocytopenia is an autoimmune disorder characterized by formation of
      autoantibodies against platelet antigens leading platelet destruction.

      Corticosteroids increase the platelet count in about 80 percent of patients.However, many
      patients have a relapse when the dose of corticosteroid is reduced. Debilitating side effects
      are common in patients who require long-term corticosteroid therapy to maintain the platelet
      count. Eltrombopag, it is a small molecule agonist of the c-mpl (TpoR) receptor, which is the
      physiological target of the hormone thrombopoietin, has been shown to be effectively raise
      the platelet count in adult patients (aged 18 years and over) who have had their spleen
      removed or where splenectomy is not an option and have received prior treatment with
      corticosteroids or immunoglobulins, and these medicines did not work (refractary ITP). There
      are a few case reports where eltrombopag was an option as first line treatment for IT.

      The purpose of this study is to determine the response rate and response duration with the
      combination of eltrombopag (50mg PO once a day for 4 weeks) and high-dose dexamethasone (40mg
      PO days 1,2,3,4) in untreated adult patients immune thrombocytopenic or in patients with less
      than 7 days of treatment with corticosteroids.

      A complete platelet response is defined as an increase in platelet counts to >150×109/L on
      two consecutive occasions. A partial response is defined as an increase in the platelet count
      to between 50 and 150×109/L on two consecutive occasions, 1 week apart. Duration of response
      is considered from the day of the initial administration to the first time of relapse
      (platelet count <30×109/L)or to time of analysis.

      At the end of the first 5 weeks, the patients will followed by 6 months every month.
    

Intervention name(s): Eltrombopag and dexamethasone
Intervention type(s): Drug
Intervention description(s): Eltrombopag 50 mg PO days 5-32 Dexamethasone 40 mg PO days 1-4
Other intervention name(s): Revolade
Intervention MeSH terms: Dexamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eltrombopag; Dexamethasone; High-dose; ITP
Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or
      sister may be an effective treatment for kidney cancer.

      PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone marrow
      transplant works in treating patients with relapsed or refractory metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell
           transplantation in patients with relapsed or refractory metastatic renal cell carcinoma.

        -  Determine the toxic effects of this regimen in these patients.

      OUTLINE: This is a pilot study.

        -  Conditioning regimen: Patients receive cyclophosphamide IV on days -7 and -6 and
           fludarabine IV on days -5 to -1. Patients receiving 5/6-mismatched cells also receive
           anti-thymocyte globulin IV on days -5 to -3.

        -  Allogeneic peripheral blood stem cell (PBSC) infusion: Patients undergo allogeneic PBSC
           or bone marrow transplantation on day 0.

        -  Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral mycophenolate
           mofetil twice daily on days 0-30. Patients receive tacrolimus IV continuously or orally
           twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD.

        -  Donor lymphocyte infusion: Patients with partial or complete T-cell chimerism receive up
           to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease.

      After completion of study treatment, patients are evaluated periodically for 3 years.

      PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
    

Intervention name(s): anti-thymocyte globulin; graft-versus-tumor induction therapy; therapeutic allogeneic lymphocytes; cyclophosphamide; fludarabine phosphate; mycophenolate mofetil; tacrolimus; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Tacrolimus; Antilymphocyte Serum
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent renal cell cancer; stage IV renal cell cancer
Pilot Study of Patients Chronic Hepatitis C in Co-infected HIV Patients Relapsers After Previous Therapies
Condition: Chronic Hepatitis C; HIV Infections
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy and safety of Peginterferón alfa-2a (40 KD) plus Ribavirin in
      patients who have relapsed or not responded to a previous suboptimal therapy based in
      Interferon.
    

Detailed description: 
      An important number of co-infected patients were treated suboptimally in the past with others
      ineffective therapies interferon-based.

      All co-infected patients should be an opportunity of retreatment with actually therapies.
    

Intervention name(s): Peginterferon alfa-2a plus ribavirin adjusted to body weight
Intervention type(s): Drug
Intervention description(s): PegInterferon 180 mcg/week, Adjusted body weight Ribavirin (1000 mg <75 kg, 1200 mg >75 kg)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: co-infected HCV/HIV; relapsers
Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This adaptive design study will evaluate the safety, pharmacokinetics, and effect on
      hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV
      infection. The study will consist of 4 parts evaluating participants infected with specific
      hepatitis C virus genotypes and up to 10 panels allowing for additional participants to
      enroll in each panel as specified in the study analysis. The hypothesis evaluated in the
      study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple
      dose administration of MK-8876 in participants with HCV infection.
    


Intervention name(s): MK-8876
Intervention type(s): Drug
Intervention description(s): MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is meant to assess the effect of IW-3718 as an added treatment to ongoing
      once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience
      symptoms of their gastroesophageal reflux disease (GERD).
    


Intervention name(s): IW-3718; Matching Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Chiropractic Care and Children With Subclinical Spinal Pain
Condition: Subclinical Spinal Pain
Study type: Interventional

Summary: 
      There is growing evidence that chiropractic care positively impacts various aspects of
      central and autonomic nervous system function.This study aims to investigate short term and
      long-term effects of Chiropractic care (CC) on neurological, behavioral, immunological
      functions and health-related quality of life in children with subclinical spinal pain.
    

Detailed description: 
      There is growing evidence that chiropractic care positively impacts various aspects of
      central and autonomic nervous system function. A single chiropractic adjustment session has
      been shown to alter pre-frontal cortex (PFC) activity in adults, but there is a lack of
      robust research investigating any long-term benefits of such PFC changes in children. This
      study aims to investigate short term and long-term effects of Chiropractic care (CC) on
      neurological, behavioral, immunological functions and health-related quality of life in
      children with subclinical spinal pain. In this parallel-group randomized controlled trial,
      participants aged 10-18 years with subclinical spinal pain will be randomly allocated to
      receive either 12 weeks of CC intervention or control intervention. Primary outcomes include
      functional near-infrared spectroscopy, heart rate variability (HRV) and resting-state
      electroencephalography (EEG). The secondary outcomes include executive functions measured by
      cognitive testing, immune and inflammation status, and health-related quality of life. As
      data collected in the project is the combination of extrinsic (sociodemographic, clinical
      questionnaires etc.) and intrinsic physiological data (physiological measures like EEG, HRV
      etc.), we will utilize the advances in machine learning or artificial intelligence (AI) to
      help inform the development of optimal chiropractic care plans in future.
    

Intervention name(s): Chiropractic care; Control Group
Intervention type(s): Other; Other
Intervention description(s): The mechanical properties of chiropractic adjustment have been investigated; and although the actual force applied to the patient's spine depends on the chiropractor, the patient, and the spinal location of the subluxation, the general shape of the force-time history of spinal adjustments is very consistent68 and the duration of the thrust is always less than 200 milliseconds.; The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity
Condition: Muscle Spasticity; Cerebrovascular Accident
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this clinical study is to investigate the efficacy and safety of Dysport® in
      patients with early onset of upper limb spasticity within 2-12 weeks after stroke.
    


Intervention name(s): Botulinum toxin type A; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 1 injection, 500 U at day 0. The study will last for 6 months in each patient.; 1 injection at day 0. The study will last for 6 months in each patient.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Periodontal Changes Following Mid Maxillary Distraction
Condition: Cleft Lip and Palate; Periodontal Pocket; Attachment Loss, Periodontal
MeSH terms: Cleft Lip; Periodontal Pocket; Periodontal Attachment Loss
Study type: Interventional

Summary: 
      To evaluate the health status of the periodontium and dentition at the distraction
      osteogenesis site in CLP subjects using mid maxillary distraction (MMD).
    

Detailed description: 
      Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting
      buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was
      performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters
      were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was
      collected . Soft tissue healing was evaluated clinically and histologically after
      distraction.
    

Intervention name(s): A Involvement with the osteotomy site of the surgery
Intervention type(s): Procedure
Intervention description(s): A Involvement with the osteotomy site of the surgery
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inflammation; Healing; Distraction; Periodontium
First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I first-in-human is designed to evaluate the safety, tolerability and
      pharmacokinetics of single ascending doses of M201-A administered by single continuous
      intravenous injection in Healthy Japanese subjects.
    

Detailed description: 
      Not Provided
    

Intervention name(s): M201-A Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Substance: M201-A Route of administration: continuous intravenous injection; Saline Placebo for M201-A Route of administration: continuous intravenous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Training Second-grade Dyslexic Students Using a Computerized Program in Assiut, Egypt
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      Dyslexia is a specific learning disability that is neurological in origin. It is
      characterized by difficulties with accurate or fluent word recognition, by poor spelling and
      decoding abilities, difficulty reading words in isolation and difficulty with oral reading
      (slow, inaccurate, or labored). These difficulties typically result from a deficit in the
      phonological component of language that is often unexpected with other cognitive abilities
      and the provision of effective classroom instruction. The phonological deficit hypothesis is
      the dominant explanatory theory of developmental dyslexia. Despite this, impaired
      phonological processing alone cannot explain all clinical symptoms of dyslexia. Many students
      with dyslexia have multiple deficits other than phonological deficits. Of these accused
      deficits are visual perceptual processing deficits, auditory processing deficits,
      multisensory spatial attention deficits as well as cerebellar dysfunction. The current
      mandatory criterion for the diagnosis of dyslexia, below-average achievement, implies waiting
      to failure. This approach for diagnosis (must fail approach) would delay intervention for
      rehabilitation.

      Furthermore, the cut-off scores would result in over or under inclusion of cases and appear
      to be the least reliable and valid approach to diagnosis. Both methods lack a deeper
      understanding of the underlying reading difficulty, their neurobiological basis, and hence
      represent barriers against scientifically-based interventions. However, improved
      understanding of the neurobiological basis of dyslexia will facilitate evidence-based
      effective intervention.
    

Detailed description: 
      This study will be carried out along seven stages; 1- Identification of students with reading
      disability using Arabic Reading Achievement test (RAT); 2- Construction of a computerized
      Arabic Cognitive Abilities diagnostic battery for Reading (CADB-R); 3- Standardization of the
      constructed battery; 4- Detailed study of the cognitive profile; 5- Construction of a
      Computerized Cognitive abilities training battery for reading (CATB-R); 6- Application of the
      training battery; 7- Reassessment.
    

Intervention name(s): Computerized Cognitive abilities training battery for reading (CATB-R)
Intervention type(s): Behavioral
Intervention description(s): Specially designed Arabic computerized training program for dyslexia
Intervention model: Single Group Assignment
Intervention model description: compare scores before and after the intervention
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslexia; Training; Egypt