bioihbjkbjnl/mcl2 huggingface dataset:
Manual Therapy and Exercise in Patients With Cervicogenic Headache
Condition: Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper
      thoracic thrust manipulation will demonstrate significant and clinically important changes in
      outcomes when compared to the mobilization and exercise group.
    

Detailed description: 
      Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks
      of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical
      and upper thoracic non-thrust mobilization and range of motion, strength and postural
      exercises.
    

Intervention name(s): Thrust Manipulation; Non-thrust Mobilization and Exercise
Intervention type(s): Other; Other
Intervention description(s): Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.; Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.
Other intervention name(s): High-velocity low-amplitude thrust manipulation of the spine; Non-thrust mobilization to cervical and thoracic spines; Cervical range of motion, strength, and postural exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervicogenic; Headache; Neck Pain; Manipulation; Mobilization; Exercise
To Compare Ilioinguinal/Iliohypogastric Block to Wound Infiltration for Pain Relief After Hernia Repair in Adults
Condition: To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair
MeSH terms: Hernia; Wounds and Injuries
Study type: Interventional

Summary: 
      This study was conducted to assess the postoperative painscores in patients undergoing open
      inguinal hernia repair between two groups receiving either U/S guided
      ilioinguinal/iliohypogastric nerves block with Ropivacaine or wound infiltration with
      Ropivacaine.The safety of two analgesic interventions(ilioinguinal/iliohypogastric nerves
      blocks and wound infiltration) was measured alongwith comparison of opioid use between the
      two groups over 24 hours postoperatively was made. Patient satisfaction between the two
      groups was also assessed by the Likert scale.
    

Detailed description: 
      Pain is a concerning problem in patients with open inguinal hernia repair. Hence, multi modal
      analgesia is recommended to overcome this issue. Therefore this randomized controlled trial
      was conducted to compare the analgesic efficacy of ultrasound guided
      Ilioinguinal/Iliohyphogastric nerve block vs. local anaesthetic infiltration of wound with
      Ropivacaine on postoperative pain after open repair of unilateral inguinal hernia in adults.

      This study was conducted at Aga Khan University Hospital Karachi.It is a Randomised
      controlled trial conducted from March 2019 to October 2019. 60 participants for elective
      unilateral open inguinal hernia repair were included. Patients were randomly allocated (30
      each) to one of the two groups. Group I received ILI/IHG nerve block where 20mls 0.25%
      Ropivacaine was infiltrated around the nerves under U/S guidance, and group II received local
      anaesthetic infiltration (Ropivacaine 20mls 0.25%) at the end of surgery at the incision site
      to provide postoperative analgesia. Postoperative pain at rest (static) and on movement
      (dynamic) was assessed on VRS scale at 0= no pain , 1-3=mild pain, 4-6=moderate pain,
      7-10=severe pain at 0, 2,6, 12, 24 hours, either in person or telephone. Total tramadol
      consumption and time for first tramadol requirement was noted.

      In addition complications related to IHG block and LA infiltration were observed.Patient
      satisfaction was also gauged by the LIKERT scale in the questionairre.
    

Intervention name(s): Block/Local infiltration
Intervention type(s): Procedure
Intervention description(s): One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief
Other intervention name(s): ILI/IHG Block; Local Infiltration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block
Masking: Single (Participant)
Primary purpose: Treatment
Anti-Inflammatory Diet Effect in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The current study pretends to clarify, whether or not a healthy anti inflammatory diet
      improves different health-related outcomes in participants with rheumatoid arthritis.
    

Detailed description: 
      The current study pretends to clarify, whether or not a healthy anti-inflammatory diet
      improves different health-related outcomes: clinical, analytical, anthropometric and
      psychological outcomes in participants with rheumatoid arthritis. Due to the intervention has
      been based in a dietary advise, one of the goals of this study is also to evaluate the role
      of dietary advice in changing effectively the dietary patterns of the patients.
    

Intervention name(s): Antiinflammatory Diet; Control Diet
Intervention type(s): Other; Other
Intervention description(s): The intervention group is recommended to follow a diet, inspired in mediterranean diet, rich in anti-inflammatory foods. They are provided with a table with the recommended foods as well as the frequency of daily/weekly/biweekly consumption.; The control group is recommended to follow their usual diet. Only in the case of detecting a serious nutritional problem the participant is recommended to correct it with the appropriate advice of the nutritionist.
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Rheumatoid Arthritis; Diet; Antiinflammatory diet; Nutrition
Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women
Condition: Eating Behavior
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Exciting advances have led to the concept that hormones can modulate appetite and food
      intake. Oxytocin is a peptide hormone that is released in regions throughout the brain,
      including areas involved in food motivation. Animal studies suggest that oxytocin may reduce
      food intake. The effects of oxytocin administration on eating behavior in humans, which could
      have important implications in eating-related disorders ranging from obesity to anorexia
      nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of
      single-dose oxytocin administration investigates whether:

        1. Caloric intake will decrease following administration of oxytocin versus placebo

        2. Appetite will decrease following administration of oxytocin versus placebo

        3. Resting energy expenditure will increase following administration of oxytocin versus
           placebo
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal oxytocin 24 IU single-dose administration; Intranasal Placebo single-dose administration
Other intervention name(s): Syntocinon (Novartis)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Eating behavior; Appetite; Oxytocin; Neuropeptide
Alternative Blood Pressure Measurements in OB Patients
Condition: Obesity; Blood Pressure
Study type: Interventional

Summary: 
      The incidence of obesity has been increasing worldwide. In women with obesity, the
      anthropometric differences in the distribution of subcutaneous tissue can make accurate
      measurement of blood pressure difficult. A large upper arm circumference can prevent the use
      of a brachial artery blood pressure cuff and often prompts the use of alternative methods for
      blood pressure measurement, including measurements on the wrist or forearm. Outside of the
      obstetric population, there is evidence that if measurement of the blood pressure at the
      upper arm is not possible then measurement at the wrist can be used. Despite this evidence in
      non-pregnant patients, there is limited evidence in pregnancy regarding the accuracy of blood
      pressure measurements on the forearm or wrist. Accurate measurement of blood pressure is
      especially important in pregnancy to allow for prompt treatment of severe hypertension and
      for accurate diagnosis of hypertensive disorders of pregnancy. Error in measurement could
      lead to iatrogenic preterm birth or under treatment of severe hypertension, both which can
      lead to severe maternal and fetal morbidity and mortality. Additionally, it is biologically
      plausible that an increase in subcutaneous edema and vascular changes in pregnancy could lead
      to a larger discrepancy in blood pressure measurements between upper arm, forearm and wrist
      measurements.

      Due to the increasing epidemic of obesity and the increasing need for accurate alternative
      blood pressure measurements the investigators propose a prospective observational study of
      pregnant women ≥18 years old admitted to labor and delivery for any indication or seen for
      prenatal care in OBGYN clinic. A total of 20 women in each BMI class (normal, overweight
      (25-29.9), class 1 (30-34.9), class 2 (35-39.9), class 3 (>40) will be enrolled (100 total).
      Participation will include a total of 9 blood pressure measurements, biometric measurements
      on the patient's upper arm, forearm, and wrist and a brief questionnaire. The investigators
      hypothesize that there will be a discrepancy between blood pressure measurements on the upper
      arm and forearm or wrist.
    


Intervention name(s): Blood pressure measurement
Intervention type(s): Diagnostic Test
Intervention description(s): Study subjects will have a total of 9 blood pressure measurements taken (3 on upper arm, 3 on lower arm, and 3 on wrist)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals
Condition: Influenza, Human; Human Immunodeficiency Virus I Infection
MeSH terms: Influenza, Human; Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      Investigators in the Division of Infectious Diseases are carrying out a study to determine if
      human immunodeficiency virus (HIV)-seropositive patients receiving the Seasonal Influenza
      vaccination develop an adequate antibody response. The study group will consist of
      individuals seen in the Infectious Diseases Clinic who are HIV-seropositive and receive the
      Seasonal Influenza vaccine.
    

Detailed description: 
      This is a study to establish the immunologic response in HIV-seropositive individuals to the
      FDA approved seasonal influenza vaccine when it is available. HIV-seropositive individuals
      seen in the Infectious Diseases Clinic at George Washington University, Medical Faculty
      Associates and receive this vaccination, on label, as part of standard of care will be
      invited to participate.

      The study will require a 10-ml sample of whole blood to be drawn from each participant prior
      to the dose of the seasonal influenza vaccine and at 3 weeks after the vaccine dose and at 3
      months after the vaccine dose. No additional samples are envisioned. Serum will be separated
      and will frozen and stored in the Clinical Trials Unit until all patient samples have been
      obtained. At that time the antibody levels to the vaccine antigens will be measured.

      Data that will be collected from the subject's medical record includes the following:

        -  Age, gender, race

        -  CD4 count

        -  HIV viral load

        -  History of prior influenza immunization including the 2009-2010 trivalent vaccine

        -  HIV antiviral medication history

      Data that will be collected from the subject during participation in study

        -  Antibody levels prior to vaccination

        -  Dose date of the seasonal influenza vaccination

        -  Antibody levels 3 weeks after the vaccination
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV positive individuals receiving influenza vaccine as part of standard of care.
Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
      given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin
      (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous
      therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage
      of participants achieving sustained virologic response 24 weeks after completion of all study
      therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is
      greater than 20% (historical data of standard of care treatment).
    


Intervention name(s): vaniprevir; peg-IFN; ribavirin
Intervention type(s): Drug; Biological; Drug
Intervention description(s): vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks; peg-IFN 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks; Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight (600 mg/day to 1000 mg/day), for 24 weeks
Other intervention name(s): MK-7009; PegIntron®; REBETOL®
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is being conducted in the U.S. and Europe to evaluate the safety and
      efficacy of daclizumab for the treatment of multiple sclerosis (MS).
    

Detailed description: 
      PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
    

Intervention name(s): Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)
Intervention type(s): Drug
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal; Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Multiple Sclerosis, MS, CNS, Daclizumab
Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions
Condition: Intermittent Claudication
MeSH terms: Intermittent Claudication
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol
      Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions
      using a single-dose, randomized, 3-treatment, 3-period, crossover design.
    


Intervention name(s): Cilostazol
Intervention type(s): Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function
Condition: Erectile Dysfunction; Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to investigate and compare the effect of TPN171H on subjects with mild and
      moderate hepatic impairment compared to healthy subjects.
    


Intervention name(s): TPN171H
Intervention type(s): Drug
Intervention description(s): 10 mg TPN171H tablets，single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Intracranial Aneurysm in Hong Kong Chinese
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a
      catastrophic disease, with half of the victims died and many of the survivors disabled. There
      is currently no data in the literature for the Chinese population concerning the prevalence,
      characteristics (location and size) and risk of harboring an unruptured intracranial
      aneurysm. In this study, the investigators aim to study the population prevalence and
      characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its
      cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA),
      with a 3-T magnetic resonance system, which is a well-established non-invasive method for
      intracranial aneurysm detection.
    

Detailed description: 
      As charted below.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hong Kong Chinese without a history of known intracranial pathologies
      
Keywords: Chinese; intracranial aneurysm; magnetic resonance imaging
Effects of Acute Intermittent Hypoxia on Sensory Function in Healthy Adults
Condition: Sensitivity
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Exposure to acute intermittent hypoxia (AIH) can facilitate of motor output but no studies of
      sensory effects has been reported.
    

Detailed description: 
      Despite the strong results of motor studies, the affects of AIH on sensory function has not
      been established. We will use a commercially-available hypoxicator that can be programmed to
      achieve a targeted level of arterial oxygen saturation. We plan to compare 3 previously
      published protocols that have generated motor facilitation (and a sham condition) to
      characterize and effects on sensory function in healthy adults.
    

Intervention name(s): Intervention 1; Intervention 2; Intervention 3; Intervention 4 (sham)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 15 bouts of 2mins:1min hypoxia:hyperoxia; 15 bouts of 1mins:1min hypoxia:hyperoxia; 8 bouts of 2mins:1min hypoxia:hyperoxia; 15 bouts of 1min:1min normoxia
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Within subjects design with randomization of presentation of four different hypoxia/normoxia intervals.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: thermal threshold; pressure pain threshold; temporal summation
Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
Condition: Sunburn
MeSH terms: Sunburn
Study type: Interventional
Phase: Phase 3

Summary: 
      Diclofenac sodium 0.1% will be applied to sunburned skin when the intensity of pain reaches a
      certain level in order to evaluate the efficacy and safety of the treatment on this induced
      pain.
    


Intervention name(s): Diclofenac sodium 1mg/g
Intervention type(s): Drug
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Sunburn, diclofenac, topical NSAID
A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received
      either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular
      Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3
      years after the last vaccination) will assess the antibody concentrations in children who
      previously completed Wyeth study 0887X-101518.
    


Intervention name(s): Blood draw
Intervention type(s): Procedure
Intervention description(s): One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Prevenar; Pneumococcal disease
Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor.

      PURPOSE: This randomized phase II trial is studying two different schedules of everolimus to
      see how well they work in treating patients with recurrent or metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of 2 different treatment schedules of everolimus, in terms of
           clinical/radiological response and early progression, in patients with recurrent or
           metastatic breast cancer.

      Secondary

        -  Determine the time to progression and response duration in patients treated with these
           regimens.

        -  Determine the toxic effects of these regimens in these patients.

        -  Correlate molecular markers of mTOR activity in tumor tissue with objective tumor
           response in patients treated with these regimens.

      OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
      according to presence of visceral metastases (yes vs no) and prior chemotherapy regimens for
      recurrent disease (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral everolimus once daily on days 1-28.

        -  Arm II: Patients receive oral everolimus on days 1, 8, 15, and 22. In both arms, courses
           repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed at 4 weeks and then periodically
      until disease progression.

      PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): everolimus
Intervention type(s): Drug
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IV breast cancer; male breast cancer