bioihbjkbjnl/mcl2 huggingface dataset:
Testing Informed Decision Making in Lung Cancer Screening
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Lung cancer screening rates are very low despite the fact that lung cancer screening could
      save many lives. People need to understand the risks and benefits to screening as well as
      their own beliefs about screening. This study builds an intervention in real world primary
      care that will help people make the right decision for them as well as help people to quit
      smoking. Interventions like this are needed to improve the screening rate and reduce death
      from lung cancer, which is the leading cancer killer.
    

Detailed description: 
      Lung cancer screening rates in the United States are very low- just 3.3% in 2010 and 3.9% in
      2015. There is a critical need to develop and implement effective strategies to engage
      high-risk patients in a coordinated program of lung cancer screening, which includes
      shared-decision making. The investigators proposed to modify and expand a shared decision-
      counseling intervention previously developed in one primary care practice. The investigators
      measured lung cancer screening in our intervention group compared to a propensity-matched
      usual care cohort. The investigators compared patients recruited to patients who are not in
      order to identify potential sources of disparity in future work and the investigators
      developed a more intense smoking cessation component. Model interventions for shared-decision
      making in clinical practice are needed across a wide range of diseases and decisions.
    

Intervention name(s): Shared Decision Making
Intervention type(s): Behavioral
Intervention description(s): Telephone delivered non-persuasive shared decision-making for lung cancer screening.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Family History on Insomnia During Sobriety in Alcoholics
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The investigators intend to assess the following:

        -  the efficacy of CBTi in treating insomnia during recovery,

        -  does a family history of alcoholism moderate the insomnia symptoms,

        -  does an improvement in insomnia lead to a decrease in impulsivity.
    

Detailed description: 
      The primary goals of this pilot study are the following:

      a) to assess for the difference in improvement insomnia, after 8 weeks of treatment with
      recommended CBTi, in Veterans with alcohol dependence during early recovery,

      The secondary goals include the following:

        1. to assess for any change in the alcohol consumption indices between the groups after 8
           weeks of CBTi,

        2. to assess for change in psychiatric symptoms of mood and anxiety across the groups,

        3. to assess for differences in insomnia in subjects, with and without a first degree
           family history of alcohol dependence,

        4. to evaluate for any change in impulsivity-related measure with insomnia treatment.
    

Intervention name(s): Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention type(s): Behavioral
Intervention description(s): Behavioral management of insomnia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fecal Microbiota Transplantation in Decompensated Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Cirrhosis of the liver is the culmination point of long-standing chronic liver disease
      hallmarked by the cardinal features of liver fibrosis and portal hypertension. The prognosis
      of patients with cirrhosis is punctuated by the onset of complications which denote the stage
      of decompensation characterized by ascites, hepatic encephalopathy (HE), and variceal
      bleeding.

      Patients with cirrhosis have been demonstrated to have significant changes in their gut
      microbiota characterized by alteration in the intestinal microbiome (gut dysbiosis) as well
      as small intestinal bacterial overgrowth (SIBO). Gut dysbiosis has been closely linked to the
      complications associated with decompensated cirrhosis. Several studies have documented the
      alteration of gut microbiota in patients with hepatic encephalopathy.

      Therapeutic modalities that restore normal gut flora and stabilize the gut liver axis are
      being extensively studied in the management of cirrhosis and its complications. Antibiotics,
      probiotics, and long-chain fatty acid supplementation are being evaluated as methods to
      restore the gut dysbiosis and consequently limit progressive liver damage.

      Fecal Microbiota Transplantation (FMT) involves the infusion of intestinal microorganisms by
      the transfer of stool from a healthy individual into a diseased individual for restoration of
      normal intestinal flora.The ultimate goal of FMT is to replace aberrant native microbiota
      with a stable community of donor microorganisms. The treatment is based on the premise that
      an imbalance in the community of microorganisms residing in the gastrointestinal tract (i.e.,
      dysbiosis) is associated with specific disease states. FMT has been well-established as a
      treatment modality to stably modify the gut microbiome and has been shown to be safe and
      efficacious in several disease states resulting from gut dysbiosis.

      With this background, a trial is proposed to determine whether an FMT from a healthy donor to
      a patient with advanced cirrhosis improves overall survival and prognosis.
    


Intervention name(s): Fecal Microbiota Transplantation; Standard of care
Intervention type(s): Other; Other
Intervention description(s): In the Fecal Microbiota Transplantation procedure 100 ml volume of strained and filtered stool will be delivered through a nasojejunal tube.The recipient patient will be kept nil per oral for at least 4 hours prior to the stool instillation. 100 mL of freshly prepared stool suspension will be given.; Nutritional supplementation and other supportive measures as per standard guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End-stage liver disease; Stool therapy; Microbiota; Related stool donor; Prognostic scores; Complications; Ammonia; Cytokines; Outcomes
A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Myeloproliferative Disorders
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Myeloproliferative Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety
      of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary
      assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing
      rearrangements of the MLL gene.

      Currently this study is in the MLL-r restricted/expansion phase and is only enrolling
      patients with rearrangements involving the MLL gene, including 11q23 or partial tandem
      duplications (PTD).
    

Detailed description: 
      A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)
      harbor rearrangements of the MLL gene, which are detected either by cytogenetic or
      fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L
      plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule
      that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of
      patients with MLL-rearranged leukemias.

      The dose escalation portion has been completed. Currently this study is in the expansion
      phase and patients with MLL-r and MLL-PTD will receive EPZ-5676 as a 28-day continuous
      intravenous infusion (CIV).
    

Intervention name(s): EPZ-5676
Intervention type(s): Drug
Intervention description(s): MLL-r and MLL-PTD 28-day continuous IV infusion of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity develops.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia; Advanced hematologic malignancies; Epizyme; Phase 1; Mixed Lineage Leukemia (MLL)
Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Condition: Arthropathy Shoulder; Shoulder Pain; Shoulder Osteoarthritis; Shoulder Arthritis; Shoulder Arthropathy Associated With Other Conditions; Necrosis of Bone; Arthritis; Inflammatory Arthritis
MeSH terms: Arthritis; Shoulder Pain; Joint Diseases; Osteonecrosis; Necrosis
Study type: Interventional

Summary: 
      Participants who choose to participate in this study, will either have their tendon repaired
      to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
    


Intervention name(s): ReUnion TSA, pegged design; ReUnion TSA, keeled design
Intervention type(s): Procedure; Procedure
Intervention description(s): ReUnion total shoulder arthroplasty system, pegged design; ReUnion total shoulder arthroplasty system, keeled design
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during
      dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C
      infection
    


Intervention name(s): Daclatasvir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, Oral, Approximately 182 days from initial dosing; Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to establish the bioequivalence (BE) of single 100 mg doses of
      glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation
      compared to the Phase 2 formulation.
    


Intervention name(s): Glasdegib; High Fat, High Calorie Meal; Rabeprazole
Intervention type(s): Drug; Other; Drug
Intervention description(s): Subjects receive 100 mg single dose of ICH glasdegib under fasted condition with washout and then 100 mg single dose of Phase 2 tablet under fasted condition with washout in a randomized fashion. Finally subjects either receive a 100 mg single dose ICH tablet after a high fat, high calorie meal or receive a 100 mg single dose of ICH tablet after repeated daily dosing with rabeprazole.; A subset of subjects in the study will receive a high fat, high calorie meal prior to being administered a single 100 mg tablet ICH tablet of glasdegib.; A subset of subjects will receive repeated daily dosing of 40 mg rabeprazole for 7 days with 100 mg single dose of ICH glasdegib being administered on Day 7.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glasdegib; PF-04449913; Pharmacokinetics; Bioavailability
Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers
Condition: Hypertension With Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      study to evaluate drug-drug interaction following oral administration of
      telmisartan/amlodipine and atorvastatin in healthy adult volunteers
    


Intervention name(s): telmisartan/amlodipine and atorvastatin
Intervention type(s): Drug
Intervention description(s): Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination; Amlodipine, atorvastatin drug combination; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      Effects of serotonin 2A/1A receptor stimulation by psilocybin on alcohol addicted patients: a
      randomized double-blind placebo-controlled study
    

Detailed description: 
      Two billion people globally consume alcohol, leading in 2016 to 2.8 million deaths (5.2% of
      all deaths) and 99.2 million Disability Adjusted Life Years (DALYs) lost (4.2% of all DALYs).
      Of all the diseases, conditions, and injuries attributable to alcohol use, alcohol use
      disorders (AUDs) create the largest health burden globally. However, approved pharmacological
      treatments for alcoholism are limited in their effectiveness. A recent proof of- concept
      study testing psilocybin in ten alcohol dependent patients provides encouraging efficacy
      results and safety data. The investigators, therefore, propose to test the efficacy of
      psilocybin for treating alcohol use disorder and study its underlying neurobiological
      mechanisms in a randomized, placebo controlled, double blind study. To evaluate effects of
      psilocybin on alcohol use behaviour, clinical symptoms, neurocognitive and emotional measures
      in patients with alcohol use disorder.

      The present clinical trial aims at investigation the clinical and mechanistic effects of
      Psilocybin in Alcohol Addicted Patients.

      Patients with alcohol use disorder who have undergone withdrawal treatment within the last 6
      weeks will be investigated in a single-centre, double-blind, placebo-controlled,
      parallel-group design clinical trial contrasting the acute and persisting effects of
      psilocybin to those of placebo. Patients will be randomly assigned to psilocybin or placebo
      group with a 1:1 allocation ratio. The study comprises a total of 6 visits during 6 weeks and
      two follow-up online surveys (3 and 6 months after treatment). In addition, two follow-up
      surveys that can be completed from home will guarantee monitoring of long-lasting changes in
      symptomology and ensure all potential side-effects can be captured. On the treatment visit, a
      single dose of psilocybin (25mg) or placebo will be administered. Patients will be monitored
      until all effects have worn off.
    

Intervention name(s): Psilocybin; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): single dose of psilocybin (25mg). orally in form of a capsule; single dose of mannitol (100%)
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase II, randomized, double blind, placebo controlled, parallel group, single center study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcoholism; Psilocybin; Psychedelics; clinical efficacy; autobiographical memory; cue-reactivity exposure; placebo-controlled; proof-of-concept
Whole Body Cryotherapy and Morphological and Rheological Indicators
Condition: Quality of Life
Study type: Interventional

Summary: 
      The aim of the planned study was to evaluate the effect of repeated cryostimulation
      treatments on immunological, morphological, and biochemical indicators of the peripheral
      blood of healthy, young Men
    

Detailed description: 
      A group of 18 healthy men aged 19-26 participated in the study. The group included a group of
      ten students with high physical activity and a group of eight students with moderate physical
      activity.

      Whole-body cryotherapy was performed in a cryochamber located in the Malopolska Cryotherapy
      Centre in Krakow (Poland) in the spring of 2013 and in the winter and spring of 2014.

      The temperature inside the vestibule during the procedure was about -60 ºC and in the actual
      chamber about -120 ºC. The concentration of oxygen in the air of the cryochamber was kept
      constant at 21-22% and continuously controlled by two independent oxygen probes.

      The participants of the study were subjected to 24 whole-body cryotherapy treatments (one
      treatment three times a week for two months). Before the procedure, they were informed about
      how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by
      a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects
      entered the cryochamber for three minutes. During the treatment, the men wore short trousers,
      woollen socks and gloves, hats or headbands to protect against freezing and clogs. Moreover,
      the mouths and noses of the participants were covered with surgical masks, secured with a
      strip of gauze. During the procedure, the subjects were in permanent eye contact with the
      doctor and the staff.
    

Intervention name(s): whole body cryostimulation
Intervention type(s): Other
Intervention description(s): Whole-body cryotherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: whole-body cryotherapy; healthy men; blood components
Essential Oils and Post COVID-19 Fatigue
Condition: Covid19; Fatigue
MeSH terms: COVID-19; Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of plant based aromas on energy levels
      among otherwise healthy female survivors of COVID-19.
    

Detailed description: 
      After being informed about the study, participants will provide informed consent, then will
      be randomized into one of two groups in a 1:1 ratio. Participants will either inhale an inert
      blend twice a day or an active aroma twice a day for 14 days.
    

Intervention name(s): Aromatherapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.; The placebo intervention consists of inhaling an oil extracted from inert plant matter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: essential oils; aromatherapy; energy
Safety and Feasibility of Electrical Muscle Stimulation During Stem Cell Transplantation or Intensive Chemotherapy
Condition: Electric Stimulation Therapy
Study type: Interventional

Summary: 
      Intensive chemotherapy, with or without following autologous or allogeneic stem cell
      transplantation (HSCT), is often the only curative treatment option for patients with
      haematological malignancies, leave many survivors physically and psychologically impaired
      because of side effects, many caused by weeks of immobilisation. Electrical muscle
      stimulation (EMS) is a proven training tool to improve physical performance in seniors and
      patients with chronic disease. The investigators therefore intend to evaluate the safety and
      feasibility of EMS in patients undergoing autologous HSCT, allogeneic HSCT and intensive
      chemotherapy. To assess feasibility all patients are asked to document training time during
      hospitalization in an EMS diary.

      Furthermore, physical Performance will be measured using the 6-minute-walking distance (6MWD)
      and Short Physical Performance Battery (SPPB) as well as psychological performance using the
      Multidimensional Fatigue Inventory (MFI) and EORTC QLQ-C30 at the start of chemotherapy (T1)
      and when patients are discharged from hospital (T2).

      At the time intensive chemotherapy is started and all inclusion and no exclusion criteria are
      met, patients will receive an EMS device with electrodes and will be instructed on how to use
      the device. After that, baseline tests using the above mentioned tools will be performed.

      EMS will be conducted with a "Myopuls 2000" (Curatec Services GmbH, Moers, Germany) device
      using 13 cm x 5 cm electrodes. Electrodes are placed subsequently on both thighs and upper
      arms with instructions to stimulate each limb for at least 15 minutes on at least 5 days per
      week. Stimulation settings were as follows: 300 µs pulse width, 60 Hz frequency, 5 seconds
      on, 5 seconds off. The amplitude is initially set to elicit a visible muscle contraction and
      patients are encouraged to increase the amplitude as much as tolerated. After an initial
      training session, patients are to use the devices on their own and document their activities
      in an EMS diary.

      Patients are then asked to use EMS throughout their therapy in addition to physical therapy
      until the day of their discharge when the initially performed tests are repeated.

      The investigators hypothesis is, that EMS can be safely applied in patients undergoing
      intensive chemotherapy regimens and that patients are able to administer EMS by themselfs.
    


Intervention name(s): Myopuls 2000D
Intervention type(s): Device
Intervention description(s): Device: Myopuls 2000D (Curatec Services GmBH, 47443 Moers, Germany)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Stem cell transplantation; Chemotherapy; Rehabilitation; Electrical muscle stimulation