bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Respiratory Muscle Strength in Young COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      The coronavirus disease 2019 (COVID-19) is a highly contagious disorder caused by the severe
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 is a multisystem disease and
      therefore presents a variety of symptoms in the acute phase, such as fever, dry cough,
      fatigue, sore throat, loss of taste or smell, shortness of breath, nasal congestion, chest
      pain, muscle or joint pain, headache, and nausea.

      COVID-19 primarily affects the respiratory functions of individuals. Although this situation
      is more difficult in hospitalized patients, it also causes severe effects in individuals who
      recover with home medication. It is thought that this damage caused by COVID-19 may cause
      permanent effects on individuals in the long term. During the COVID-19 period, individuals
      also had to maintain an inactive lifestyle due to quarantine. This decrease in physical
      activity capacity also causes permanent damage to the respiratory functions of individuals.
      In addition, studies have focused on this population, as COVID-19 usually affects older
      individuals. However, considering that young people are also exposed to the COVID-19 virus,
      the effect on respiratory functions in these individuals should also be examined. Combined
      with the available information on pulmonary functions, there is insufficient evidence about
      extrapulmonary features in post-COVID-19 patients who survive mild illness in the long term.
      It is also necessary to examine whether there is permanent damage to extrapulmonary features
      such as peripheral muscle strength in these individuals.

      Therefore, in our study, it is aimed to examine the long-term results of respiratory
      functions, respiratory muscle strength and peripheral muscle strength of young individuals
      who recovered from COVID-19 and recovered from mild disease.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        54 patients with post-COVID-19 and 54 healthy individuals will be included.
      
Keywords: COVID-19; Muscle Strength; pulmonary function; Physical activity; Dyspnea
Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence
Condition: Benign Paroxysmal Positional Vertigo; Vitamin D; Antioxidants
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Recurrence; Dizziness
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves the evaluation of 3 groups of subjects (3-arm study). Patients diagnosed
      with BPPV and "sufficient" serum concentrations of Vitamin D (>30 ng/mL, >75 nmol/L) at
      baseline may be treated with 2 tablets per day (morning and evening) of Vertistop® L (
      Alpha-lipoic acid, carnosine, zinc and curcumin) or untreated, on the basis of the
      randomization criterion to which they will be assigned. Patients with Vitamin D "deficiency"
      (<20 ng/mL, <50 nmol/L) or Vitamin D "insufficient" (20-30 ng/mL, 50-75 nmol/L) at baseline,
      or subsequent follow-up, they will be treated for 2 months with Vertistop® D (alpha-lipoic
      acid, carnosine and zinc, vitamin D3 and vitamins of the B complex) taking 1 tablet a day
      (before meals).

      The main purpose of the study is to evaluate, over a period of 6 months, the efficacy of
      Vertistop® D and Vertistop® L supplementation in preventing recurrences of BPPV (Benign
      Paroxysmal Positional Vertigo), in relation to blood levels of Vitamin D.
    

Detailed description: 
      Patients will be assigned to one of the three study groups following a randomization list
      with reference to groups 1 and 2 and according to the serum concentrations of 25(OH) Vitamin
      D, evaluated at the baseline visit, with reference to group 3.

      The determination of the Vitamin D concentration will be requested by the Investigating
      physician and the report will be evaluated during the randomisation visit (V1), Visit 2,
      (after 2 months from enrollment/start of treatment), Visit 3 (Follow-up visit up to 4 months
      from enrollment) and finally Visit 4 (Follow-up visit 6 months after enrollment).

      The blood sample and the Vitamin D dosage will be carried out the week before the day of the
      visit agreed with the Investigator, in a trusted laboratory of the patient, provided that it
      has the legal authorizations and the analytical methodology satisfactory the measurement
      intervals reported in Protocol.
    

Intervention name(s): Vertistop® D
Intervention type(s): Drug
Intervention description(s): Vitamin D supplementation
Other intervention name(s): Vertistop® L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Study to Determine if Tissue Scored With a Scalpel Results in Any Noticeable Marks
Condition: Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Mohs Micrographic Surgery is a well established method for treatment of cutaneous
      malignancies. Part of this technique requires marking skin surrounding the tumor. There are
      two ways of marking the tissue, lightly scoring it with a scalpel or marking it with a
      surgical marker.

      This study is to determine if there is a noticeable difference in outcome between patients
      who have their tissue lightly scored with a scalpel or marked with a surgical marking pen.
    

Detailed description: 
      Mohs Micrographic Surgery is a well established method utilizing microscopic margin
      controlled excision for treatment of cutaneous malignancies (See Appendix A). It has the
      highest cure rate of any of the methods used to treat common cutaneous malignancies and is a
      proven safe outpatient procedure. Part of the technique requires marking skin surrounding the
      tumor to correspond with tissue that has been removed and divided into pieces for processing
      and microscopic examination. Currently there are two established ways of marking the tissue;
      lightly scoring it with a scalpel or marking it with a surgical marker. Scoring tissue is
      faster, more accurate, and there is no risk of having the marking washed or rubbed away.
    

Intervention name(s): Scalpel for tissue scoring; Surgical marker for tissue marking
Intervention type(s): Device; Device
Intervention description(s): During Mohs surgery we will compare the outcomes of scarring, to determine whether a mark (with a pen) or a score with a scalpel will receive the best scar.; You will be asked to participate, examined, discuss participation have procedure and come in for follow up for photos and check up.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of REGN15160 in
      healthy participants, as measured by all treatment-emergent adverse events (TEAEs) and
      treatment-emergent serious adverse events (SAEs).

      The secondary objectives of the study are:

        -  To assess the concentration-time profile of REGN15160 in serum

        -  To assess the immunogenicity of REGN15160
    


Intervention name(s): REGN15160 (IV); Matching Placebo (IV); REGN15160 (SC); Matching Placebo (SC)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered in single intravenous (IV) dose; Administered in single IV dose; Administered in single subcutaneous (SC) dose; Administered in single SC dose
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vaccinated; Negative SARS-CoV2 Test Result
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
Condition: Hypertension; Diabetes
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is being done to see if a drug shown to lower the risk of heart failure is also
      effective in reducing the stiffness of the arteries.
    

Detailed description: 
      To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic
      patients on systolic blood pressure and diastolic blood pressure.
    

Intervention name(s): nebivolol; Metoprolol
Intervention type(s): Drug; Drug
Intervention description(s): Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached; Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Other intervention name(s): bystolic; lopressor
Intervention MeSH terms: Metoprolol; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: diabetes; hypertension; aortic impedance
Efficacy of Pre- and Post-Operative Oral Dextromethorphan
Condition: Efficacy of Dextromethorphan; Morphine Consumption; Pain
Study type: Interventional

Summary: 
      We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on
      analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare
      the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo
      (P)
    

Detailed description: 
      One hundred patients were randomized to two groups. Group DEX was given 30 mg tablets of oral
      dextromethorphan with their pre-medication and three more times in the first 24 hours after
      surgery. Group P received the placebo following the same schedule. Post-operative analgesic
      requirements were assessed using a patient-controlled analgesia system.

      Pain was assessed at rest using a visual analog scale in the post anesthetic care unit(PACU),
      6 and 24 hours after surgery.
    

Intervention name(s): pre-operatively followed by 30 mg three times per day after surgery
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: NMDAreceptor antagonist, dextromethorphan; pain, post-operative; opioid consumption, morphine
Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel
      works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate of patients with recurrent stage IIIB and IV non-small cell
           lung cancer treated with gemcitabine hydrochloride and docetaxel.

        -  Determine the overall and progression-free survival of patients treated with this
           regimen.

        -  Determine the toxic effects of this regimen in these patients.

      Secondary

        -  Determine the duration of response in patients treated with this regimen.

      OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel
      IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for survival.

      PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
    

Intervention name(s): docetaxel; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days; 800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.
Intervention MeSH terms: Gemcitabine; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer
Effects of Dapagliflozin+Saxagliptin in Addition to Metformin v/s Saxagliptin or Dapagliflozin in Patients With DM2.
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase IV, randomized, double-blind, single center pilot study in subjects with type 2
      diabetes poorly controlled with metformin therapy will be randomized to receive, on top of
      metformin: saxagliptin (5 mg/day) and dapagliflozin (10 mg/day) (Group 1);saxagliptin (5
      mg/day) and placebo (Group 2); dapagliflozin (10 mg/day) and placebo (Group 3) for 4 weeks.
    

Detailed description: 
      Dapagliflozin (Forxiga) currently is approved for the treatment of T2DM (6). Dapagliflozin
      inhibits SGLT2, promote the excretion of 80-90 grams of glucose per day in the urine, and
      lower the plasma glucose concentration. This class of drugs has been shown to effectively
      reduce the HbA1c at all stages of T2DM and can be used in combination of all other
      anti-diabetic agents including insulin.

      Saxagliptin is a highly potent DPP4 inhibitor.In patients with type 2 diabetes,
      administration of saxagliptin led to inhibition of DPP4 enzyme activity for a 24-hour
      period.After an oral glucose load,this DPP4 inhibition resulted in a 2- to 3-fold increase in
      circulating levels of active incretin hormones, including glucagon-like peptide-1 (GLP-1) and
      glucose-dependent insulinotropic polypeptide (GIP), decreased glucagon concentrations and
      increased glucose-dependent beta-cell responsiveness, which resulted in higher insulin and
      C-peptide concentrations.The rise in insulin from pancreatic beta-cells and the decrease in
      glucagon from pancreatic alpha-cells were associated with lower fasting glucose
      concentrations and reduced glucose excursion following an oral glucose load or a
      meal.Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose
      concentrations in patients with type 2 diabetes.
    

Intervention name(s): Dapagliflozin 10mg; Saxagliptin 5mg; Saxagliptin 5mg + Dapagliflozin 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dapagliflozin inhibits subtype 2 of the sodium-glucose transport proteins (SGLT2) which are responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter mechanism causes blood glucose to be eliminated through the urine.[; Inhibits DPP-4 and slows inactivation of incretin hormones, thereby increasing blood concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus; Please see Intervention 1 and 2
Other intervention name(s): forxiga; Onglyza; No other intervention name specified
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer
Condition: Non-small-cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      Objectives:

        1. Primary Objective:

           To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin
           in Taiwanese advanced NSCLC patients from that gained from Japanese population

        2. Secondary Objectives:

      A. To assess progression free survival B. To assess overall survival C. To bridge the safety
      profile by assessing the toxicities and tolerability
    


Intervention name(s): TS-1/Cisplatin
Intervention type(s): Drug
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study to evaluate efficacy and safety in subjects with moderate to severe Psoriasis treated
      with BMS-986165
    


Intervention name(s): BMS-986165; Placebo for BMS-986165
Intervention type(s): Drug; Drug
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exploring Medical Decisions Using Functional MRI
Condition: F-MRI Brain Imaging Data
Study type: Observational

Summary: 
      Hospital physicians are increasingly facing budgetary constraints that might have an impact
      on individual medical decisions (i.e. diagnostic or therapeutic decisions). This might
      translate into role conflict and ambiguity. We explore the medical decision-makingprocess of
      physicians usingfunctional MRI. Twenty hospital physicians will be asked to make simulated
      medical decisions during fMRI acquisitions, with and without explicit budgetary constraints.
      We will compare the fMRI data between the 2 modalities.
    


Intervention name(s): no intervention
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospital physicians
      
Keywords: Hospital, medical decision-making, role conflict, f-MRI
Clinical Efficacy and Safety of NEOIAL HC for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults.
      According to the Osteoarthritis Research Society International (OARSI), at least 40% of
      people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee
      osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to
      the World Health Organization.

      The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA)
      leads to a slow, prolonged pain relief (up to six months after the first injection); On the
      other hand, there is little evidence in the literature about the intra-articular use of
      isolated collagen or in combination with hyaluronic acid in the treatment of knee
      osteoarthritis.

      The present study showed a clinically good safety profile and provided preliminary evidence
      of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA
    


Intervention name(s): Neoial HC
Intervention type(s): Device
Intervention description(s): Patients with severe knee osteoarthritis were enrolled in the clinical study and treated with 3 injections of 40 mg NEOIAL HC (HA sodium salt at 2% with two molecular weights 20% with pm at 400 kD and 80% between 1200 and 1500 kD t + collagen) at a distance of 1 week from each other, followed by a fourth infiltration of the same product at a distance of 1 month from the third.Patients were followed up with baseline clinical evaluation, reporting of adverse events after each single infiltration and subsequently at the end of treatment, 3, 6 months follow-up.
Intervention model: Single Group Assignment
Intervention model description: Of the 36 screened patients, 15 had to be included and treated patients (15 as planned per-protocol). Of these, 14 patients completed the study and attended the visit at Month 6 . Since all patients were treated , the Full Analysis Set (FAS, all randomized and treated patients) was identical to the Safety Set (all treated patients).
The mean age at enrollment was 71±7 years (range 54-80;median 73), and 12 of patients were women (85.7%) and 2 male (14.3%) . The mean BMI were26.6±3.4 (range 21-30;median 28.5) . Overall patients had knee OA with a Kellgren-Lawrence grade II and III (50/50).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; knee; hyaluronic; collagen; neoial; gonarthrosis
A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerance of the combination of zidovudine (AZT) and didanosine
      (ddI) in children with HIV infection.

      New approaches to using available agents may provide increased or improved treatment options
      for AIDS. Combination therapy is expected to play a major role in improving survival and
      quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most
      extensively evaluated and for which the evidence for antiretroviral effectiveness is
      strongest.
    

Detailed description: 
      New approaches to using available agents may provide increased or improved treatment options
      for AIDS. Combination therapy is expected to play a major role in improving survival and
      quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most
      extensively evaluated and for which the evidence for antiretroviral effectiveness is
      strongest.

      Patients take AZT and ddI on an empty stomach; ddI is taken 2 minutes after taking antacid.
      Part A patients receive AZT plus ddI each at ranging doses. Patients in part B may receive a
      higher dose of ddI than patients in part A. The first patients enrolled are given the lowest
      dose. Subsequent patients receive increasingly higher doses until a dose limiting toxicity
      occurs.
    

Intervention name(s): Zidovudine; Didanosine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Didanosine
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Didanosine; Drug Evaluation; Drug Therapy, Combination; Zidovudine