bioihbjkbjnl/mcl2 huggingface dataset:
Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia
Condition: Leukemia, Myeloid, Chronic; AML; MDS; Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      In this study our hypothesis is that infusion of donor lymphocyte immune cells from the
      subject's bone marrow donor will activate the subject's immune system to attack their cancer.
    

Detailed description: 
      We will collect immune cells or lymphocytes from the donor's blood using a cell separator.
      The blood lymphocytes will be given to the subjects through a catheter. If the subjects have
      no complications of the first course of infusions, we may decide to give them "lymphocytes"
      aa second time while subjects are in remission in an attempt to prevent their disease from
      relapsing. A bone marrow test will be taken prior to infusion of lymphocytes as part of the
      clinical evaluation to receive this treatment. After lymphocyte infusions, a bone marrow will
      be examined about every three months for the first year to monitor progress from this
      therapy.
    

Intervention name(s): Donor Lymphocyte Infusion
Intervention type(s): Procedure
Intervention description(s): Certain immune cells in your donor's blood called "lymphocytes" have been shown to fight cancer after bone marrow transplantation. We plan to transfuse large numbers of donor's "lymphocytes" in the hope of activating the recipient's immune system to attack cancer.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Donor Lymphocyte Infusion; relapse; post-transplant
Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin
Condition: Healthy
Study type: Interventional

Summary: 
      The current study is part of a large multi-investigator grant to look at the pharmacogenetics
      of a number of membrane transporters. Previously, we have recruited a cohort of healthy
      volunteers (Studies of Pharmacogenetics in Ethnically-diverse Populations, or SOPHIE) and
      have resequenced the coding region of a number of membrane transporter genes to identify
      genetic polymorphisms in these genes. We plan to take a genotype-to-phenotype approach to
      study the influence of specific polymorphisms in the intestinal transporters, such as the
      novel organic cation transporters 1 and 2 (OCTN1 and OCTN2) genes on the bioavailability of
      gabapentin in healthy subjects. Eligible subjects will have a single inpatient study visit,
      during which they will take a single dose of gabapentin, and provide blood and urine samples
      over the course of 36 hours (5 terminal elimination gabapentin half-lives) for
      pharmacokinetic analysis.
    

Detailed description: 
      Detailed description pending
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention description(s): Subjects will take a single dose of 400 mg of gabapentin
Other intervention name(s): NEURONTIN
Intervention MeSH terms: Gabapentin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity
      of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when
      administered at 0, 6 months
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): Engerix™-B; HBV-MPL 208129; Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; Intramuscular injection, 2 doses; experimental formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis B; Engerix™-B; Recombinant hepatitis B vaccine; Adjuvant
Weight Loss for Couples
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Obesity risk is shared within married couples yet most existing weight loss programs focus on
      individuals and not the marital dyad. This project will test the effects of a couples weight
      loss program that teaches spouses how to provide each other with autonomy support and create
      an interpersonal environment that promotes sustained behavior change.
    


Intervention name(s): TEAMS (Talking about Eating, Activity, Mutual Support); Need Support Training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: couples; weight loss treatment; home environment
FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will comprise primarily a single-ascending dose (SAD) escalation component.
    

Detailed description: 
      Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7
      cohorts of healthy participants.
    

Intervention name(s): GFB-887; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IMP; Matching
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose escalation, parallel assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Glomerulosclerosis; proteinuria; nephrotic syndrome; nephrosis; focal segmental glomerulosclerosis; kidney diseases; urologic diseases; glomerulonephritis; nephritis; diabetic kidney disease; diabetic nephropathies; endocrine system diseases; diabetes complications
Menstrual Cycle Characteristics of Healthcare Professionals
Condition: Menstrual Irregularity; Covid 19
MeSH terms: COVID-19; Menstruation Disturbances
Study type: Observational

Summary: 
      The Covid-19 pandemic has impacted healthcare workers physically and psychologically. The aim
      of this study is to examine whether there is a change in menstrual cycle characteristics
      during pandemia. The aim of this study is to investigate whether there is an association
      between covid infection and menstrual cycle changes.
    

Detailed description: 
      The Covid-19 pandemic has impacted healthcare workers physically and psychologically.
      Healthcare workers have ben required to work under stressful conditions and take difficult
      decisions involving ethical implications. Increasing work demands on healthcare professionals
      conflict with their duties to family and friends, which causes psychological stress. All of
      these factors may negatively affect their menstrual cycle.

      The aim of this study is to examine whether there is a change in menstrual cycle
      characteristics during pandemia. Second aim is to investigate whether there is an association
      between Covid 19 infection and menstrual cycle changes.

      This cross-sectional study is conducted with healthy female participants who are working at
      Haydarpasa Numune Research and Training Hospital in Turkey. The researcher investigates the
      characteristics of menstrual cycle in female healthy workers employed in Covid 19 pandemic
      inpatient and outpatient clinics. The participants who are sure about their pertinent
      information are enrolled in the study. The exclusion criteria includes pregnancy, history of
      hysterectomy, oophorectomy, diseases like Asherman's syndrome and also history of endocrine
      disorders (progesterone deficiency, thyroid disorders and diabetes mellitus), oral
      contraceptive use, malignancy, primary amenorrhea, menopause and lactation.

      After informed consent, detailed information is collected using structured questionnaires
      about their reproductive factors and menstrual cycles by direct interviews. The questionnaire
      contains questions about age, work experience, marital status, height, weight, working hours,
      use of medication, menstrual cycle characteristics (including cycle duration, duration and
      amount of bleeding, bleeding during the cycle, regular or irregular menstrual cycles) and
      dysmenorrhea. Also, the difference in menstrual cycle characteristics between covid positive
      and negative healthcare professionals is investigated.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy female healthcare workers at Covid 19 pandemic hospital
      
Keywords: health care professionals; menstrual cycle; Covid 19; Pandemia
Intravenous Lidocaine for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations
      were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical
      scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline
      for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.
    

Detailed description: 
      Thirty patients ranging in age from 18 to 60 years, with fibromyalgia (American College of
      Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a
      minimum of 11 out of 18 tender points) were studied. Other manifestations were also recorded:
      sleep disorders, fatigue, subjective edema, depression, and paresthesia.

      Criteria for exclusion were alterations in thyroid, rheumatological, renal and hepatic
      function; trauma; rheumatic, neuromuscular or psychiatric disease; infectious arthropathy;
      other pain syndromes; drug hypersensitivity, and pregnancy.

      All patients received amitriptyline at a dose of 12.5 mg in the first week and 25 mg over the
      subsequent 4 weeks. Patients of group 1 (n = 15) received 125 mL 0.9% saline and patients of
      group 2 (n = 15) received 240 mg lidocaine diluted in 125 mL 0.9% saline. The solutions were
      infused over a period of 1 h, once a week, for 4 weeks (T1, T2, T3 and T4).
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): Intravenous lidocaine once a week
Other intervention name(s): Lidocaine infusion; Saline infusion
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lidocaine; fibromyalgia; intravenous lidocaine; manifestations
The Effect of Nasal Continuous Positive Airway Pressure (N-CPAP) on Arterial pCO2 During Spinal Anesthesia
Condition: Knee Replacement Surgery
Study type: Interventional

Summary: 
      The proposed study intends to investigate several aspects of the respiratory effects of
      intravenous sedation of patients undergoing spinal anesthesia for knee replacement surgery.
      The study will include assessment of PaCO2 during the intraoperative period. PaCO2 is
      expected to be elevated as a result of intravenous sedation and postural factors. Further,
      the study will investigate how application of Nasal Continuous Positive Airway Pressure
      (N-CPAP) may impact PaCO2.
    


Intervention name(s): Nasal Continuous Positive Airway Pressure (NCPAP)
Intervention type(s): Other
Intervention description(s): Subjects will receive NCPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: NCPAP
A Clinical Trial for Post Traumatic Stress Disorder
Condition: Post Traumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      he purpose of this study is to test whether a medication, called mifepristone (commonly known
      as the ³Morning-After-Pill²), can help to prevent emotional problems after someone has
      survived a traumatic experience. We are studying this medication for the treatment of
      Post-traumatic Stress disorder (PTSD.
    

Detailed description: 
      PTSD is an emotional illness that can develop in people after they have experienced a
      traumatic event. It involves symptoms such as poor sleep, nightmares about the trauma,
      unwanted daytime memories of the trauma (flashbacks), jumpiness, and trouble looking forward
      to things in the future. Once people develop PTSD, the symptoms tend to last a very long
      time.

      We are testing the idea that mifepristone, which blocks the effect of the hormones
      progesterone and cortisol, will help treat PTSD. Progesterone is a hormone made in the bodies
      of both men and women and its main role is in regulating the menstrual cycle and in
      pregnancy. Cortisol is also a hormone made in the body of both men and women and helps the
      body respond to stress. Cortisol also has a role in making emotional memories more intense
      than other memories. We are testing whether blocking the effect of cortisol with mifepristone
      as you recall your trauma may be able to decrease the intensity of your traumatic memories.
      This medication will not completely block out your memories of the traumatic experience but
      may decrease how much your thoughts are drawn back to the memory of the traumatic event.
    

Intervention name(s): Medicane (mifepristone); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 doses of 1200mg, Administered 2-3 days apart; 2 doses of 1200mg, administered 2-3 days apart
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sexual; combat; PTSD; Clinical trial; Trauma; PTSD treatment; PTSD medication; Post traumatic stress disorder
The Impact of Contrast Media Used in Epidural Steroid Injections on Thyroid Function Tests
Condition: Lumbar Radiculopathy; Lumbar Spinal Stenosis; Cervical Radiculopathy; Cervical Stenosis
MeSH terms: Spinal Stenosis; Radiculopathy; Constriction, Pathologic
Study type: Observational [Patient Registry]

Summary: 
      This study is aim to disclose the effect of contrast media, which used in epidural steroid
      injections, on the parameters of thyroid function tests (TFTs). The patients who underwent an
      epidural steroid injection were included. The investigators hypothesized that contrast media
      owing to contain iodine may impair the values of TFTs.
    

Detailed description: 
      The objective of this study is to reveal the impact of contrast media, whether they change
      the values of TFTs in participants who had been performed any kind of epidural steroid
      injection such as Lumbar, cervical and caudal epidural steroid injection. The inclusion
      criteria were participants who had normal values of TFTs, being between the ages of 18 and 65
      and had an epidural steroid injection. Patients with impaired parameters of TFTs or had
      thyroid surgery, systemic and/or local infections, malignancy, bleeding diathesis, acute
      fracture, known allergy to contrast material and/or local anesthetic substances, known
      history of any psychiatric disorder, and patients with a history of pregnancy were excluded
      from the study. Verbal and written informed consent was obtained from all patients
      participating in the study.

      In conjunction with the recording of the demographic data of the patients participating in
      this study (age, sex, duration of symptoms, etc.), their contrast medium doses and the values
      of TFTs (free T3, free T4 and Thyroid-stimulating hormone) were employed before the procedure
      and 3rd week after the procedure.
    

Intervention name(s): Epidural Steroid Injection
Intervention type(s): Procedure
Intervention description(s): This intervention is applied mostly for cervical or lumbar radiculopathy. The intervention was carried out under sterile conditions with the C-arm fluoroscopy guidance. It is performed via spinal needle and the needle is inserted into the epidural space, then a combined local anesthetic and glucocorticoids are delivered to the epidural space.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients, between the ages of 18 and 65, who have normal values of thyroid function tests
        and who will be performing an epidural steroid injection.
      
Keywords: thyroid functions; epidural steroid injections
A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      A study comparing the topical application of Aczone® plus Differin® versus Duac® plus
      Differin® in patients with severe facial acne (facial acne vulgaris).
    


Intervention name(s): Dapsone plus Adapalene; Clindamycin/benzoyl peroxide plus Adapalene
Intervention type(s): Drug; Drug
Intervention description(s): Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.; Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks
Other intervention name(s): Aczone® Gel 5%; Differin® 0.3% Gel; Duac® Topical Gel; Differin® 0.3% Gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Dapsone; Adapalene; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
Condition: Hepatic Failure
MeSH terms: Liver Failure; Hepatic Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic
           impairment to subjects with normal hepatic function.

        2. To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and
           subjects with normal hepatic function.

        3. To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic
           function.
    


Intervention name(s): Dimebon; Dimebon; Dimebon; Dimebon
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dimebon 5mg in healthy controls; Dimebon 5mg in mild hepatic impairment patients; Dimebon 5mg in moderate hepatic impairment patients; Dimebon 5mg in Severe Hepatic Impairment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dimebon Hepatic Impairment
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis
Study type: Observational

Summary: 
      The primary objective of this study is to retrospectively investigate the safety and efficacy
      of the Integra Sundt™ carotid shunt during endarterectomy procedures.
    


Intervention name(s): Sundt carotid shunt
Intervention type(s): Device
Intervention description(s): The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects participating in the study have undergone a carotid endarterectomy procedure with
        the use of the Sundt™ carotid shunt prior to study initiation.
Time to Thrombocytic Inhibition After Supine and Upright Ingestion of Efient
Condition: Heart Disease; Ischemic Heart Disease; ST-elevation Myocardial Infarction
MeSH terms: Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The purpose of the study is to clarify wether body posture during ingestion of 60mg Efient, a
      thrombocytic inhibitor, has influence on the time to thrombocytic inhibition.

      The study aims to mimic the treatment Danish patients receive when admitted to the hospital
      with a ST-elevation myocardial infarction since these patients are refereed to acute
      Percutaneous Coronary Intervention (PCI) necessitating fast and efficient thrombocytic
      inhibition.

      Current guidelines recommend the administration of Efient right before the PCI procedure,
      while the patient is lying down, either in the ambulance or in the operating room. We, the
      investigators, believe that this is suboptimal for the patient, since any sort of prolonged
      inhibition time will possibly worsen the patients prognosis and make the patient more prone
      to later clotting issues.

      Our hypothesis is that by making the patients ingest the tablets in a 90 degrees upright
      position and making them sit up for 2 minutes after ingestion, the effect of the pills will
      commence faster than if taken in a supine position. This will possibly lead to faster
      inhibition of the thrombocytes, which we believe will lead to a lower incidence of clotting
      issues during and after the procedure.
    

Detailed description: 
      The study will be divided into two sessions: first session will be the control arm- ingestion
      of Efient in supine position.

      14 days later, the same test-persons will be doing the intervention- ingestion of Efient
      sitting upright for 2 minutes. Besides this, the second session will be exactly the same as
      the control arm.
    

Intervention name(s): Upright position
Intervention type(s): Other
Intervention description(s): The test person will ingest Efient in an upright position and remain upright for 2 minutes. After 2 minutes, the test person will lie down, and remain supine for 2 hours, the same way as the person did in the control arm
Other intervention name(s): Efient; Prasugrel; PCI
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCI; STEMI; Interventions; Heart disease; Thrombocytic inhibition; Cross-over study; Percutaneous coronary intervention