bioihbjkbjnl/mcl2 huggingface dataset:
Alleviation of Common Cold Symptoms
Condition: Common Cold; Pharyngitis; Fever; Congestion; Rhinorrhea; Cough; Sore-throat; Sore Throats Viral; Malaise; Headache; Runny Nose; Sneezing
MeSH terms: Pharyngitis; Common Cold; Headache; Rhinorrhea; Sneezing
Study type: Interventional
Phase: Phase 1

Summary: 
      Upper respiratory infections (URIs) have long posed a significant burden to the US healthcare
      system. Well before the coronavirus disease of 2019 (COVID-19) pandemic they have been among
      the most common acute outpatient illnesses, causing 75-100 million physician visits each year
      on average, and costing the health care system billions of dollars annually. This
      double-blind randomized placebo-controlled study tested the efficacy of two anti-inflammatory
      throat sprays against placebo and against a throat spray taken in conjunction with 325mg of
      aspirin, a well-known systemically administered cyclooxygenase (COX) inhibitor. Participants
      having common cold symptoms lasting less than two days were enrolled and given treatment to
      administer at home. Various common cold symptoms were assessed and measured via clinically
      validated self-assessment scales. Participants were screened for influenza and COVID-19
      before enrollment and were excluded if found positive.
    


Intervention name(s): Wintergreen Throat Spray and Aspirin Tablet; Aspirin Throat Spray and Placebo Tablet; Wintergreen Throat Spray and Placebo Tablet; Placebo Throat Spray and Placebo Tablet
Intervention type(s): Drug; Drug; Dietary Supplement; Other
Intervention description(s): The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Aspirin in a 325mg tablet; The liquid spray contained 6mg dissolved acetyl salicylic acid per dose, menthol, lactoferrin, lysozyme, aloe, and glycerin.
Placebo Tablet: Looked like the treatment aspirin tablet but contained no drug and only inactive excipients.; The liquid spray contained wintergreen oil, menthol, lactoferrin, lysozyme, aloe, and glycerin.
The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.; The placebo spray contained vehicle buffer, a sub-therapeutic dose of menthol, and a sweetener.
The placebo tablet looked like the treatment aspirin tablet but contained no drug and only inactive excipients.
Other intervention name(s): Group B; Group C; Group D; Group A
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Common Cold; Pharyngitis; Fever; Congestion; Rhinorrhea; Cough; Sore Throat; Malaise; Headache; Runny Nose; Sneezing; Inflammation
Young Adult Hypertension Self-Management Clinical Trial
Condition: Hypertension; Blood Pressure; Lifestyle Risk Reduction
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is a 5-year randomized controlled trial in two large healthcare systems (Madison and
      Milwaukee, WI) to evaluate MyHEART's (My Hypertension Education And Reaching Target) impact
      on blood pressure among 310 geographically and racially/ethnically diverse young adults.
    

Detailed description: 
      Aim 1. To evaluate the effect of MyHEART (home blood pressure monitor distribution and heath
      coaching) on clinical outcomes, the change in systolic and diastolic blood pressure (primary)
      and hypertension control (secondary) after 6 and 12 months, compared to usual clinical care.

      Aim 2. To evaluate the effect of MyHEART on hypertension self-management behavior (behavioral
      outcomes) at 6 and 12 months, compared to usual clinical care.

      Aim 3. To examine whether MyHEART's effects on self-management behavior are mediated through
      variables of perceived competence, autonomy, motivation, and activation (mediation outcomes).
    

Intervention name(s): Home Blood Pressure Monitoring; Telephone Health Coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls.; Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Young Adult; Self-Management; Health coach
Combination Chemotherapy for Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the objective tumor response of the first-line
      therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer
    


Intervention name(s): Gemcitabine; cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).; Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)
Condition: Complicated Intra-Abdominal Infections, cIAIs
MeSH terms: Infections; Intraabdominal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine the PK and safety and tolerability of aztreonam-avibactam (ATM-AVI) in the
      treatment of hospitalized adults with cIAI
    

Detailed description: 
      A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK)
      and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated
      Intra-Abdominal Infections (cIAIs) in hospitalized adults.
    

Intervention name(s): ATM-AVI; Metronidazole
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1:
(Creatinine clearance > 50 mL/min)6500mg ATM/1777mg AVI on day 1 followed by total daily dose of 6000mg ATM/1640mg AVI
Cohorts 2 and 3:
(Creatinine clearance > 50 mL/min) As above, or: 6500 mg ATM/2167 mg on Day 1 followed by a total daily dose of 6000 mg ATM/2000 m AVI
(Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1162 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/820 mg AVI, or:
4250 mg ATM/1417 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/1000 mg AVI; Metronidazole 500mg infused over 1 hour every 8 hours
Intervention MeSH terms: Metronidazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cIAIs in hospitalized adults
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety and efficacy of dose conversion from
      hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in
      subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention
      duration is 2 weeks during which time supplemental analgesic medication will be allowed.
    

Detailed description: 
      Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical
      experience indicating it to be safe and effective in a variety of therapeutic situations for
      the relief of moderate to severe pain.
    

Intervention name(s): Buprenorphine transdermal patch
Intervention type(s): Drug
Intervention description(s): Buprenorphine transdermal patch applied for 7-day wear.
Other intervention name(s): Butrans™
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis, opioid, transdermal
Transition to Rebif New Formulation
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in
      patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected
      interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while
      receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence
      of flu-like symptoms.
    


Intervention name(s): Rebif New Formulation + prophylactic Ibuprofen; Rebif New Formulation + ibuprofen PRN
Intervention type(s): Drug; Drug
Intervention description(s): Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected; Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.
Intervention MeSH terms: Interferon beta-1a; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind study comparing two different treatments for acute low
      back pain, oral ibuprofen and topical diclofenac. Participants will be randomized to one of
      three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical
      placebo; 3) Oral placebo + topical diclofenac. We will determine outcomes 2 days later.
    


Intervention name(s): Ibuprofen 400 mg; Topical diclofenac
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 400mg; Diclofenac 1% gel 4gm
Intervention MeSH terms: Ibuprofen; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if lubiprostone may change the rate of movement of
      food and activities in the stomach and intestines in subjects whose gastrointestinal (GI)
      tract is slower due to constipation.

      To be able to measure the time difference in the duration of transit of the FDA approved
      SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to
      lubiprostone.

      The investigators anticipate to capture the possibility to reduce/eliminate the small
      intestinal bacterial overgrowth in chronically constipated patients after administration of
      study drug- lubiprostone.
    

Detailed description: 
      Lubiprostone is an effective treatment for chronic constipation. The mechanism of action of
      lubiprostone is through increasing fluid and mucus secretion and improving lubrication of the
      intestinal lumen. The effects of lubiprostone on gastrointestinal (GI) transit and small
      bacterial overgrowth (SIBO) have not been sufficiently explored.

      The current study was designed to investigate whether: (a) lubiprostone alters GI transit and
      (b) affects SIBO in constipated patients.

      Twenty nine female patients (mean age of 39 year: range 19-64) with chronic constipation
      received 2 weeks of lubiprostone (24 mcg b.i.d., P.O.). Stool consistency based on Bristol
      stool scale and the frequency of bowel movements were recorded. Gastric emptying time (GET),
      small bowel transit time (SBTT), colon transit time (CTT), combined small & large bowel
      transit time (SLBTT) and whole gut transit time (WGT) were measured using wireless motility
      capsule. Small bacterial overgrowth (SIBO) status was assessed by the lactulose breath test.
    

Intervention name(s): Lubiprostone
Intervention type(s): Drug
Intervention description(s): 24 mcg twice a day (BID) for 2 weeks.
Other intervention name(s): Amitiza
Intervention MeSH terms: Lubiprostone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic constipation; constipation; idiopathic constipation; SmartPill; Wireless Motility Capsule; lubiprostone (Amitiza); small intestinal bacterial overgrowth
A Study of the Effect of Zinc-Hyaluronate on Ocular Surface Sensations in Patients With Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 4

Summary: 
      Hyaluronic acid, a natural polymer, helps to maintain ocular surface hydration and can
      already be found in several artificial tears recommended to alleviate symptoms of dry eye. A
      recent hyaluronate modification involves zinc-hyaluronate complex formation by adding
      zinc-chloride to an aqueous sodium-hyaluronate resulting in a very stable molecular
      structure, which functions as both a mechanical barrier and a biocompatible film on the
      ocular surface. Apart from its beneficial elastoviscous characteristics, previous results
      indicate that hyaluronate can also reduce the excitability of the peripheral nociceptor
      endings underlying pain. Although hyaluronate is widely used in artificial tears to improve
      tear film stability, its effect on ocular surface sensitivity was not evaluated in patients
      with dry eye. The aim of this study is to investigate the characteristics of ocular surface
      sensations and corneal sensitivity in dry eye patients before and after long-term tear
      supplementation with zinc-hyaluronate.
    


Intervention name(s): Ophylosa tear supplement
Intervention type(s): Device
Intervention description(s): Tear film dynamics is assessed by non-invasive tear film breakup time (NI-BUT) in parallel with continuous recordings of ocular sensations during forced blinking. Corneal sensitivity thresholds to selective stimulation of corneal mechanonociceptors, thermal receptors and chemical nociceptors are assessed using the Belmonte gas esthesiometer. All baseline measurements are repeated after one month of tear supplementation with zinc-hyaluronate (Ophylosa eye drop) 4x/day
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Monotherapy With Letrozole in Tubal Pregnancy
Condition: Tubal Pregnancy Unruptured
MeSH terms: Pregnancy, Tubal
Study type: Interventional

Summary: 
      It is hypothesized that the inhibition of estradiol production by letrozole may interfere
      with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of
      tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (MTX)
      in women refusing surgery. The aim was to compare the effectiveness of letrozole with MTX in
      the management of tubal pregnancy.
    

Detailed description: 
      A prospective cohort study is conducted among women with tubal pregnancy. Women with
      increasing B-human chorionic gonadotropin (B-hCG) concentrations are included.

      Two study arms were planned:

      i) women treated with MTX: MTX in a single dose of 100 mg intravenously on day 0; ii) women
      treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0.

      The inclusion criteria included B-hCG concentration up to 3000 mIU/ml and no
      contraindications to conservative treatment. Women who did not meet criteria for conservative
      treatment were excluded. Blood parameters (B-hCG, hemoglobin, creatinine, urea,
      alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days
      0,4,7. Cases of treatment failure were counted, i.e. the need to perform laparoscopy due to
      tubal pregnancy rupture, pain, increase in B-hCG concentration.

      The women were given the option to choose the treatment used in the study. All enrolled women
      gave informed written consent to participate in the study.
    

Intervention name(s): Letrozole as monotherapy; MTX as monotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Letrozole 5 mg daily orally for 10 days from day 0; MTX in a single dose of 100 mg intravenously on day 0
Intervention MeSH terms: Letrozole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tubal pregnancy; Methotrexate; Letrozole
Driving Pressure in Laparoscopic Surgery
Condition: Laparoscopy
Study type: Interventional

Summary: 
      The effect of driving pressure (DP)-guided positive end expiratory pressure (PEEP) on early
      postoperative pulmonary ventilation is to be determined for patients undergoing laparoscopic
      surgery. Patients are recruited to receive volume controlled ventilation with either a fixed
      PEEP (5cmH2O) or DP titrated PEEP. Early postoperative regional distribution of lung
      ventilation, expressed as center of ventilation (COV) is evaluated by electrical impedance
      tomography (EIT), a noninvasive, radiation free modality. Perioperative ventilatory
      parameters, arterial oxygenation index (PaO2/FiO2) , serum indicators and postoperative
      pulmonary complications are secondary outcome variables.
    

Detailed description: 
      After screened for preoperative risk factors, 48 patients undergoing elective laparoscopic
      surgery and planned to be extubated in the operating room are randomly assigned to two
      groups: (1) PEEP = 5cmH2O; (2) driving pressure (DP)-guided PEEP. The ventilation protocol
      consists of volume-controlled mechanical ventilation (Datex Ohmeda S/5 Advance; General
      Electric Company Healthcare, Helsinki, Finland) at a tidal volume (VT) of 8 ml/kg predicted
      body weight (PBW), fresh gas of 2 litre /min, inspiratory to expiratory ratio of 1:2, and a
      respiratory rate adjusted to normocapnia (arterial carbon dioxide partial pressure between 35
      and 45 mmHg). For group 2, trial for the lowest DP was started 10 min after pneumoperitoneum
      and position adjustment by increasing PEEP from 5 to 15 cm H2O incrementally. DP was
      calculated as "plateau pressure - PEEP". Each PEEP level was maintained for 10 respiratory
      cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP was
      identified and maintained intraoperatively. A plateau pressure of no more than 30 cmH2O is
      targeted in each group.

      Early postoperative distribution of regional ventilation as COV (center of ventilation) is
      the primary endpoint evaluated by EIT (electrical impedance tomography), which was performed
      by a trained technician who is blinded to randomization. Arterial blood gas is tested, with
      inflammatory and oxidative mediators from venous sample. Postoperative pulmonary
      complications within 3 days are also recorded.
    

Intervention name(s): PEEP
Intervention type(s): Procedure
Intervention description(s): different PEEP set on the anesthetic machine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Condition: Recurrent Miscarriages; Habitual Abortions
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Observational

Summary: 
      To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences
      three or more miscarriages, primarily this happens during the first trimester.

      These miscarriages often needs medical evacuation or a D & C. Surgery or retained tissue
      increases the risk of complications as infection and/or adhesions, known as asherman
      syndrome, which may result in subfertility.

      Recently chronic infection in the endometrium has been proposed to contribute to the
      condition, as protocols including treatment with antibiotics have led to birth at term for
      some of these women.

      Using the very minimal invasive office hysteroscopy, the investigators aim to describe the
      uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities
      in the endometrium and chromic infection.
    

Detailed description: 
      The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with
      recurrent miscarriages a year. Together with the current examination program, the
      investigators plan to describe the uterine cavity according to abnormalities as septa,
      adhesions and further the condition for the endometrium regarding infection and hormone
      receptors. This description will include descriptive office hysteroscopy with biopsies for
      histologic - and immunohistochemically examinations.
    

Intervention name(s): Office hysteroscopy
Intervention type(s): Other
Intervention description(s): Diagnostic hysteroscopy with biopsy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with recurrent miscarriages and refurred to the specialist facility af
        Rigshospitalet
      
Biospecimen description: 
      Two endometrial biopsies
    
Keywords: miscarriage; uterine abnormalities; Chronic infection