bioihbjkbjnl/mcl2 huggingface dataset:
Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. Giving radiation therapy in different ways and combining it with chemotherapy may kill
      more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to
      the tumor.

      PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib,
      fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine treatment-related toxicity rates in patients with locally advanced cervical
           cancer treated with external beam radiotherapy and brachytherapy concurrently with
           celecoxib, fluorouracil, and cisplatin.

        -  Determine whether this regimen increases locoregional control rates, distant control,
           disease-free survival, and overall survival in these patients.

        -  Determine whether first-failure patterns in patients treated with this regimen are
           changed compared to historical controls.

      OUTLINE: This is a multicenter study.

      Patients undergo external beam pelvic radiotherapy once daily five days a weeks for 5 weeks
      beginning on day 1. Within 8 weeks, patients undergo low-dose or high-dose brachytherapy.
      Patients also receive concurrent chemotherapy comprising fluorouracil IV continuously over
      days 2-5, 23-26, and 44-47 and cisplatin IV over 4 hours on days 1, 22, and 43. Oral
      celecoxib is administered twice daily beginning on day 1 and continuing for 12 months.

      Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months
      for 2 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1.5 years.
    

Intervention name(s): celecoxib; cisplatin; fluorouracil; brachytherapy; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation; Radiation
Intervention MeSH terms: Celecoxib; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III cervical cancer; stage IB cervical cancer; stage IIB cervical cancer; stage IIA cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous cell carcinoma
Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose
      comparison with a open-label, crossover, formulation comparison.
    


Intervention name(s): Tetrodotoxin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15ug and 30ug once or twice a day for 1 or 2 days.; 1ml once or twice a day for 1 or 2 days.
Intervention MeSH terms: Tetrodotoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Comparison study
AZD5423 Multiple Ascending Dose Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male
      and female subjects
    


Intervention name(s): AZD5423; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.; Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability; healthy; inhalation; Healthy volunteers
Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Condition: Peptic Ulcer Hemorrhage
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators
      hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.
    

Detailed description: 
      A bleeding peptic ulcer remains a serious medical problem with significant morbidity and
      mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality
      in patients with bleeding peptic ulcers and is now recommended as the first hemostatic
      modality for these patients.

      In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after
      endoscopic therapy has been endorsed in some studies, two consensus statements and two
      meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of
      8 mg/h in these patients and obtained a good result .

      The objectives of this study are to assess the outcomes of two different regimens of high
      dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer
      bleeding.
    

Intervention name(s): pantoprazole; pantoprazole
Intervention type(s): Drug; Drug
Intervention description(s): pantoprazole 40 mg/q6h IV infusion for three days; pantoprazole 8 mg/h IV infusion for three days
Other intervention name(s): pantoloc; pantoloc
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: shock; peptic ulcer bleeding; rebleeding
Neuroimaging Studies of Smoking and Treatment
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The purpose of this research study is to examine changes in brain regions associated with
      cognitive control and reward processing during behavioral smoking cessation treatment.
    


Intervention name(s): Cognitive behavioral therapy; Health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Therapy focused on explaining the physiological and psychological effects of nicotine. Training is focused on adherence to smoking instructions, physiological and psychological effects of nicotine, reviewing reasons for quitting, and coping with smoking urges. Smokers will be asked to begin smoking on a set schedule leading up to their quit day.; Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
High Strength Cranberry Supplementation for Prevention of Recurrent Urinary Tract Infection
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is a Phase 2, multicenter, placebo-controlled, double-blind, parallel-arm
      study to evaluate the efficacy and safety of High Strength Cranberry (500mg Pacran®) in
      preventing UTI (cystitis) in women with a history of recurrent UTI (rUTI).
    


Intervention name(s): High Strength Cranberry; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Softgel capsule; Soy oil to match High Strength Cranberry Softgel Capsule
Other intervention name(s): 25,000mg Vaccinium macrocarpon; Placebo (for High Strength Cranberry)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: recurrent
Melatonin Treatment After Laparoscopic Cholecystectomy
Condition: Postoperative Complications; Fatigue; Dyssomnias
MeSH terms: Dyssomnias; Fatigue; Postoperative Complications
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized
      clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep
      disturbances and general wellbeing.
    

Detailed description: 
      Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The
      pathophysiological background is unknown, but several studies have shown disturbed melatonin
      secretion after surgery. It is unknown whether melatonin substitution will improve general
      wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. We set out to
      study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus
      placebo, on postoperative sleep disturbances, fatigue and general wellbeing.
    

Intervention name(s): melatonin
Intervention type(s): Drug
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: melatonin,; fatigue,; sleep quality,; circadian,; postoperative; Postoperative fatigue; postoperative sleep disturbance; general wellbeing
On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      Efficacy of an Internet-based self-guided intervention for promoting healthy habits and
      weight loss in hypertensive people with overweight and obesity: A Randomized Controlled Trial
    

Detailed description: 
      The prevalence of overweight and obesity is on the rise worldwide with severe physical and
      psychosocial consequences. Hypertension is one of the comorbidities associated with obesity.
      Changes in lifestyles through eating behavior and physical activity level are the critical
      components in the prevention and treatment for hypertension and obesity. Data from several
      studies indicate that the usual procedures to promote these healthy habits in health services
      are inadequate. ICTs has been demonstrated as an effective tool for implementation of
      psychological interventions focused on this type of population. This study aims to describe a
      totally self-applied online program (¨Vivir Mejor¨) to promote healthy lifestyles (eating
      behavior and physical activity) for obese participants with hypertension. Participants
      (BMI=25-35) will be recruited from users of a hypertension unit of a public hospital and will
      be randomized into two groups: experimental group "Vivir Mejor" and control group (treatment
      as usual). "Vivir Mejor" program is composed by 9 modules aimed for promoting healthy eating
      habits and increase physical activity. Modules will be sent via Internet periodically. After
      6 months, a follow-up testing phase and a tracking module will be set. The outcomes variables
      will include anthropometric data, changes in eating behavior and physical performance and
      cardiovascular variables.
    

Intervention name(s): Lifestyle on-line intervention
Intervention type(s): Behavioral
Intervention description(s): The self-applied on-line intervention will comprise a behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating habits and physical activity in participants (Themes: 1.motivation for change; 2. nutrition and physical activity education; 3. barriers to change, healthy eating principles and how to be active; 4. Influence of thoughts; 5. Emotional eating and self-control; 6. Problem solving; 7. Body image and assertiveness; 8. Relapse prevention)..The program will be established as follows: The first day the participant log in the website where can access the processing modules. A web page was developed specially for this study.
Other intervention name(s): VIVIR MEJOR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Internet intervention; Cardiovascular disease; Hypertension; Lifestyle intervention; Weight loss treatment
We-PAP: A Couples-based Intervention for Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to develop, refine and evaluate the feasibility of a novel
      couples-based intervention to improve adherence for patients with obstructive sleep apnea
      (OSA).
    

Detailed description: 
      This study will develop and test a novel couples-based intervention for the treatment of OSA
      and sleep health among older couples. The focus of this study is patient who are starting
      CPAP treatment and their partners. Couples will be randomized to a 3-session sleep health
      intervention delivered via telehealth or to standard educational support for CPAP. The
      intervention is based on a transdiagnostic model of sleep and circadian disorders (TransS-C)
      and rooted in the idea that older adults with OSA are often also having other sleep problems,
      and that OSA is best treated in the couples context.
    

Intervention name(s): Couples-based treatment; Standardized education
Intervention type(s): Behavioral; Other
Intervention description(s): Couples will attend 3, video based sessions for couples-based treatment; Patients will receive standardized educational materials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: OSA
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study was to evaluate the safety and efficacy of elsubrutinib,
      upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose
      combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus
      Erythematosus (SLE) in participants with moderately to severely active SLE and to define
      doses for further development.
    


Intervention name(s): Elsubrutinib; Placebo for elsubrutinib; Upadacitinib; Placebo for upadacitinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsule; Oral; Capsule; Oral; Film-coated tablet; Oral; Film-coated tablet; Oral
Other intervention name(s): ABBV-105; RINVOQ
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus (SLE); ABBV-105; Upadacitinib; ABBV-599; Elsubrutinib
Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple oral dose, randomized, double-blind, placebo-controlled study assessing
      the safety, tolerability and pharmacokinetics (PK) of SEP-363856 when administered qhs to
      Japanese subjects with schizophrenia.
    

Detailed description: 
      This multicenter study will be conducted in 2 cohorts (Cohort 1 and 2). Cohort transition
      will be determined by the Safety Review Team (SRT) before the start of Cohort 2.

      For each cohort, the target number of subjects completing the treatment period is defined as
      8 for SEP-363856 group and 4 for placebo group. Subjects will be randomly assigned to either
      group. Dosing of the SEP-363856 group in Cohort 1 will be initiated at 50 mg SEP-363856 as an
      oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once
      daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily
      dose for 7 consecutive days. The SEP-363856 group in Cohort 2 will be dosed at 25 mg
      SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 50 mg SEP-363856 as
      an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once
      daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily
      dose for 7 consecutive days. In the placebo group, placebo will be orally administered
      according to the same administration schedule as the SEP-363856 group in each cohort.
    

Intervention name(s): SEP-363856; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosing of the SEP-363856 group in Cohort 1 will be initiated at 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days. The SEP-363856 group in Cohort 2 will be dosed at 25 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days.; Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SENOC-I Det Sunda Huset II - Sensitization of Occupants of Water Damaged Buildings.
Condition: Upper Airway, Irritation Inflammation, Discomfort
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is focussed on two main questions:

        1. The importance of dampness of the building and home dust as a factor of the subjects=
           responses.

        2. Can measures used in KLINIR predict the subjects' responses to the dust?

      This study therefore was arranged to test the following hypotheses:

        1. Does dust in general cause inflammatory/body perceptions through e.g. an irritation
           symptoms index.

        2. Does the dust include effective odorants which affects an IAQ index?

        3. Does dampness increase the content of organic or inorganic compounds e.g. of microbial
           origin that causes the dust to be more reactive? (Differences between the two types of
           dust)

        4. Is the sensitivity of the subjects explaining the responses to exposures in a, b, or c?
           (Subject group and sensitivity index)

      As explorative investigations biomarkers for exposures and sensitivity for practical usage
      are tested.
    

Detailed description: 
      The study is focussed on two main questions:

      c. The importance of dampness of the building and home dust as a factor of the subjects=
      responses.

      d. Can measures used in KLINIR predict the subjects' responses to the dust?

      As explorative investigations biomarkers for exposures and sensitivity are tested for
      practical use.

      These investigations are made during experimental exposures of subjects to dust from dry and
      water damaged buildings. The responses of healthy KLINIR-sensitive subjects are predicted
      using personal sensitivity measures.

      The design is a 3x3 Latin square design (cross-over design). The subjects will be their own
      controls and comparisons to placebo (clean air) were made. The study was double blinded and
      the subjects were only informed about details on design and exposures after the experiment
      and only if they asked.

      This design eliminated effects of any learning or training during the investigations, and
      also the effects of season and weekday was eliminated. The subjects were exposed with 3-4
      weeks interval to eliminate carry-over of effects from one exposure session to the next.

      The design was replicated three times on three different groups of subjects each including 9
      subjects. Each group of nine were divided into three groups of three subjects.
    

Intervention name(s): House dust
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Upper airway, irritation inflammation, discomfort, house dust, damp buildings, climate chamber, humans
The Efficacy of Targeted Training on the Postural Control and Gross Motor Function in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The project aims to test the effectiveness and explore the possibility of performing a novel
      therapeutic approach, targeting to increase strength and coordination around the trunk,
      giving a more active and functional seating and head control in those children with cerebral
      palsy (CP) who are wheelchair users. The project will also try to determine the muscle
      physiological effect of treatment using indirect measures of strength in the spinal
      musculature.
    


Intervention name(s): Regular physiotherapy; Targeted Training
Intervention type(s): Other; Other
Intervention description(s): The child's regular physiotherapy; Targeted training, 5 days a week for 6 months, up to 30 minutes a day
Other intervention name(s): Physiotherapy; The Movement Centre
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postural control; Targeted Training; Gross motor function; Cerebral palsy