bioihbjkbjnl/mcl2 huggingface dataset:
The Safety of Ropivacaine TAP Block Combined With Intravenous Lidocaine in Patients Undergoing Colorectal Cancer Surgery
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Many studies have confirmed the analgesic effect of intravenous infusion of lidocaine in
      abdominal surgery. Transversus abdominis plane (TAP) block is also often recommended for
      abdominal surgery. Ropivacaine TAP block and intravenous lidocaine infusion are important
      components of multimodal analgesia for colorectal surgery. However, both of them are the
      local anesthetics and the safety of combination is unknown, so investigators design the study
      to explore the safety of the synergistic application of ropivacaine TAP block and intravenous
      lidocaine infusion in patients undergoing colorectal surgery.
    

Detailed description: 
      Transversus abdominis plane (TAP) block is often recommended for abdominal surgery.
      Ropivacaine TAP block and intravenous lidocaine infusion are important components of
      multimodal analgesia for colorectal surgery. However, both of them are the local anesthetics
      and the safety of combination is unknown, so investigators design the study to explore the
      safety of the synergistic application of ropivacaine TAP block and intravenous lidocaine
      infusion in patients undergoing colorectal surgery.
    

Intervention name(s): Ropivacaine Hydrochloride 10 MG/ML [Naropin]
Intervention type(s): Drug
Intervention description(s): According to the specified dosage, dilute 1% ropivacaine to 0.2% and inject 1/2 of the total amount on each side.
Intervention MeSH terms: Ropivacaine
Intervention model: Sequential Assignment
Intervention model description: Interventional Study Model: Sequential Assignment According to the principle of "the 3+3 design", 3 dose groups with 3 patients in each dose group will be set up. If no dose limited toxicity (DLT) is observed in three groups, a total of 9 patients will be included. If DLT is present in one dose group during dose escalation, 3 cases are amplified in this dose group; if no DLT is observed in 3 cases of amplification, proceed to the next dose group, and so on, up to 18 patients. DLT is defined as local anesthetic systemic toxicity. If blood samples cannot be obtained for any reasons, new patients will be recruited until there are at least 3 patients in each group with blood samples at every time point .
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in
      healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the
      pharmacokinetics of oral cabotegravir (CAB) 30 milligram ( mg). This study will evaluate the
      drug-drug interaction (DDI) potential between CAB and RBT to inform dosing strategies for
      tuberculosis in subjects receiving CAB for human immunodeficiency virus (HIV) treatment or
      prevention. In Treatment Period 1 (Treatment A) participants will receive CAB 30 mg once
      daily for 14 days, followed by Treatment Period 2 (Treatment B) where participants will
      receive RBT 300 mg once daily with CAB 30 mg once daily for 14 days. The total study duration
      will be approximately for 10 weeks. Approximately 15 healthy subjects will be enrolled to
      ensure that 12 subjects complete dosing and critical assessments.
    


Intervention name(s): Cabotegravir; Rifabutin
Intervention type(s): Drug; Drug
Intervention description(s): It will be available as a white aquarius film coated tablet for oral administration. CAB Tablet is composed of GSK1265744B (micronized) lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate; It will be available as an opaque red-brown hard gelatin capsules containing 150 mg of rifabutin for oral administration. These capsules are composed of rifabutin, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, and silica gel
Intervention MeSH terms: Rifabutin; Cabotegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 2-period crossover study in healthy adults
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis; Human Immunodeficiency Virus; Rifabutin; Drug-drug interaction; Cabotegravir
Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic Stroke
Condition: Nonhemorrhagic Ischemic Stroke; Motor Function
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the utility of the S-STREAM as an instrument to
      assess motor function in subjects who have experienced a nonhemorrhagic ischemic stroke.
    


Intervention name(s): Observational study
Intervention type(s): Other
Intervention description(s): This was an observational study and no study drug was administered.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants may be selected upon admission to an acute care emergency center, inpatient
        facility, or rehabilitation center.
      
Keywords: stroke
A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of double blind phase in this trial is to compare the efficacy and safety at
      the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label
      phase in this trial is to investigate the long term safety and efficacy of pramipexole in
      RLS.
    


Intervention name(s): Pramipexole 0.125 mg tablet; Pramipexole 0.5 mg tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ascending Dose Study of the Safety of AB-SA01 When Topically Applied to Intact Skin of Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the safety of ascending doses of AB-SA01 when topically applied to
      intact skin of healthy adults.
    

Detailed description: 
      AB-SA01 consists of three bacteriophages (viruses) that target Staphylococcus aureus
      bacteria.

      The safety of AB-SA01 will be assessed when topically administered once daily to the volar
      aspect of the forearm at a dose of 10^8 plaque forming units (PFU) per phage for 3
      consecutive days, and then at a dose of 10^9 plaque forming units (PFU) per phage for 3
      consecutive days. Both AB-SA01 and placebo will be administered to each subject to provide
      his/her own control for evaluation of skin reactions. The right or left placement of the
      placebo will be randomized and double-blinded.
    

Intervention name(s): AB-SA01 (10^8 PFU per phage); AB-SA01 (10^9 PFU per phage); Placebo (for Cohort 10^8); Placebo (for Cohort 10^9)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.; Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.; Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.; Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
Allocation: Randomized
Masking: Double (Participant, Investigator)
Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival
      ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication
      with only a third of survivors . It is due to a series of phenomena involving
      microcirculation disorders . Cerebral oximetry is a new technique to evaluate the
      microcirculatory status . To this day it is used in cardiovascular surgery at risk of
      cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia
      and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the
      outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of
      action seem to change all the phenomena responsible for microcirculatory reperfusion
      disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C.
      However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.

      The hypothesis of this study is that cerebral oximetry value will be different in patients
      subjected to two different levels of therapeutic hypothermia in the aftermath of an extra-
      hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying
      the benefit of this technique.
    


Intervention name(s): therapeutic hypothermia at 32 ° C; therapeutic hypothermia at 34 ° C
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiac arrest; Oxymetry; Hypothermia
Evaluation of the Stinging Potential of Products in Human Eyes
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      The objective of this study was to compare the human eye stinging potential of experimental
      formulas and an industry standard shampoo mixture. The study was conducted under the
      supervision of a Board Certified Ophthalmologist. The study design was a three cell, single
      blind study. Subjects were given the industry standard shampoo mixture in one eye and an
      exploratory sunscreen in the other as according to the randomization schedule.
    


Intervention name(s): BAY987516, Y55-170; BAY987516, X72-151; BAY987516, Y49-034; Standard shampoo mixture (control)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 uL in one eye; 10 uL in one eye; 10 uL in one eye; 10 uL in one eye
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion
Condition: Intrauterine Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      This study aimed To investigate the effects of estrogen in combination with aspirin and
      intrauterine balloon on the uterine endometrial repair and reproductive prognosis in patients
      after surgery for severe intrauterine adhesion .
    

Detailed description: 
      This cohort study was conducted to investigate whether aspirin could promote the endometrial
      growth and repair, reduce the recurrence of intrauterine adhesion and improve the
      menstruation and reproductive prognosis after surgery for severe intrauterine adhesion.
      Menstruation was evaluated for the first time with a method similar to visual analogue scale
      (VAS) in which the menstruation was assessed by the patients themselves with 0 as amenorrhea
      and 100 as normal menstruation. This evaluation avoids the vague terms (such as large or
      small menstrual blood volume) in previous evaluations and considers the individual difference
      in menstrual blood volume and different understanding about the menstrual blood volume. Thus,
      this evaluation is easy to master, quantify and analyze.
    

Intervention name(s): Aspirin; intrauterine balloon
Intervention type(s): Drug; Device
Intervention description(s): low dose of Aspirin after operation; insert intrauterine balloon after operation
Other intervention name(s): low dose of Aspirin; Balloon stent
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intrauterine balloon; uterine endometrial repair; intrauterine adhesion; aspirin
A Facebook Intervention for Young Sexual and Gender Minority Smokers
Condition: Tobacco Use; Smoking; Tobacco Dependence; Tobacco Use Disorder; Tobacco Use Cessation; Tobacco Smoking; Smoking Cessation; Smoking, Cigarette; Smoking, Tobacco
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial
      (N=120) compared to TSP and two historical control conditions. Participants will be young
      adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary
      outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months.
      Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco
      abstinence at 3 and 6 mos.
    

Detailed description: 
      Participants will be randomized to one of two conditions: (1) a Facebook-delivered
      intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook
      intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based
      messages and activities tailored to participants' readiness to quit smoking.

      Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include
      measures on smoking, thoughts about abstinence, and SGM identity experiences. All
      participants who report no past 7-day smoking will be asked to give biochemical verification
      of smoking status with saliva cotinine test kits that will be mailed to participants.
    

Intervention name(s): POP:; TSP:
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults; 90 days of Facebook messaging, weekly live sessions targeting tobacco use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco; Gender Identity Minority; Sexual Identity Minority; Cessation; Intervention; Young Adults; Social Media; Internet; Cigarette
Role of Tele-physical Therapy in Patients With Type 2 Diabetes Mellitus Following COVID-19 Infection.
Condition: Type 2 Diabetes Mellitus; COVID-19
MeSH terms: COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes mellitus (DM) is a chronic metabolic disease where the body is unable to metabolize
      carbohydrates properly either due to a lack of insulin production or abnormal insulin
      function. In recent times, it has been considered a global healthcare concern because of its
      high prevalence rate (9.2 %) and other associated health consequences. After being infected
      with Coronavirus disease-2019 (COVID-19), the Type 2 Diabetes mellitus (T2DM) sufferer
      experiences the following symptoms; reduced exercise tolerance, decreased muscle strength,
      altered respiratory functions, cognitive impairments and abnormal psychosomatic behaviour,
      which affects the overall well-being of the patient. To prevent or delay these clinical
      features and the associated consequences of type 2 Diabetes mellitus, the regular body works
      out and physical training is suggested either alone or in combination with diet modification.
      In this study, we tested the hypothesis that 12 months of supervised tele-physical therapy
      can positively influence patients with type 2 diabetes mellitus following COVID-19 infection.
      The reports of the study would be helpful for the clinicians and the physical therapists to
      make this as evidence for using tele-physical therapy in type 2 Diabates mellitus patients.
    


Intervention name(s): Tele physical therapy; Patient educationa and Conventional exercises
Intervention type(s): Other; Other
Intervention description(s): Before commencing training, warm-up exercises involving upper and lower extremity joint movements were performed for 10 times. During the first and second weeks, the third and fourth weeks, the fifth and sixth weeks and the seventh and eighth weeks, the exercises were performed 10-15, 15-20, 20-25 and 25-30 times per session, respectively. Each session lasted for 10 minutes of warm up, 60 minutes of training and 10 minutes of cool down phase. The participants in the TPG received training four times a week, for 8 weeks, each session lasted for 60 minutes.; They were informed to do their normal daily activities, avoid a sedentary lifestyle, perform regular physical activities such as household activities, maintain a balanced diet and have 6-8 hours of sleep per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were randomized into either of these two groups in 1:1 ratio through two block (block size 12-15) simple random sampling method. Tele - physical therapy group (TPG; n = 68) and a control intervention group (CIG; n = 68). To ensure allocation concealment, an independent therapist randomly picked up an envelope that contained patient information, in a blinded fashion and segregated the patient into either of these two groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Integrative Migraine Pain Alleviation Through Chiropractic Therapy
Condition: Migraine; Migraine Disorders; Migraine With Aura; Migraine Without Aura; Migraine, Classic
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional

Summary: 
      This pilot study evaluates the addition of chiropractic treatment to conventional
      neurological care in the treatment of migraine headaches in adult women. Half of the
      participants will receive 10 chiropractic treatments in addition to their usual care over a
      14 week period, while the other half will continue their usual medical care alone, as
      prescribed by their physician during that time period.
    

Detailed description: 
      Chiropractic care is a commonly used therapeutic intervention for the treatment of pain
      disorders, and some smaller studies have shown that it might be helpful for migraines. This
      pilot study will use a comprehensive model of chiropractic treatment which can include soft
      tissue mobilization, spinal manipulation, and postural and spinal stabilization and
      correctional exercises.

      Specific Aims:

      Aim #1 - Determine the feasibility of conducting a randomized control trial (RCT) of
      chiropractic care in adult women with migraine.

      Aim #2 - To provide preliminary data on the safety and effectiveness of chiropractic care on
      migraine frequency, severity, duration, and medication use in adult women with migraine.

      Aim #3 - To provide preliminary estimates of the effects of chiropractic on disability,
      health-related quality of life, and psychosocial well-being.
    

Intervention name(s): Chiropractic Treatment
Intervention type(s): Other
Intervention description(s): The treatment plan will be customized to the patient's needs. The chiropractic interventions are summarized as follows:
posture correction/spinal stabilization exercises
soft tissue relaxation techniques
spinal manipulation (i.e. chiropractic adjustment)/mobilization
breathing and relaxing techniques
stretches, self-care
ergonomic modifications
bracing and supports
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Women; Adult; Feasibility; Safety; Pilot Randomized Trial; Randomized Control Trial; Chiropractic
Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
Condition: Lymphoma
MeSH terms: Mycoses; Lymphoma; Mycosis Fungoides
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to
      stop cancer cells from dividing so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating
      patients who have stage IIB, stage IVA, or stage IVB recurrent or refractory mycosis
      fungoides.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of doxorubicin HCl liposome, in terms of response rate
           (complete response and partial response), in patients with stage IIB, IVA, or IVB
           recurrent or refractory mycosis fungoides.

      Secondary

        -  Determine the time to progression and duration of response in patients treated with this
           drug.

        -  Determine the toxicity of this drug in these patients.

      OUTLINE: This is an open-label, nonrandomized, multicenter study.

      Patients receive doxorubicin HCl liposome IV over 1 hour on days 1 and 15. Treatment repeats
      every 28 days for up to 6 courses in the absence of disease progression or unacceptable
      toxicity or until a maximum cumulative anthracycline(s) dose of 400 mg/m^2 has been reached
      (including anthracyclines from prior treatment).

      Patients are followed every 12 weeks until disease progression.

      PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1 year.
    

Intervention name(s): pegylated liposomal doxorubicin hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome; stage IV cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma