bioihbjkbjnl/mcl2 huggingface dataset:
Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
Condition: Complex Regional Pain Syndrome Type I
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Background:

      Research on the treatment of CRPS-I, as described in the Dutch evidence based treatment
      guidelines (Richtlijn Complex Regional Pain Syndrome type I, 2006), mainly showed improvement
      at the level of pain and coping with pain. Only little improvement in functional restoration
      was found. Research in other pain populations such al neck- and back-pain patients has shown
      that pain related fear contributes to the development of functional disability. GEXP in vivo
      which aims on systematically reducing fear of movement, shows promising results in CRPS-I
      patients (de Jong et al., 2005).

      Objective:

      The objective of the proposed project is to compare the effectivity of GEXP in vivo with that
      of standardized physiotherapy in CRPS-I patients with pain related fear.

      Design:

      The study concerns a single blinded, single center, randomized clinical trial. The treatment
      will be preceded by two pre-measures. After treatment there will be one post-measurement and
      3, 6 and 12 month follow-up measurements.

      Population:

      The study population will consist of chronic CRPS-I patients between 18 and 65, with pain
      related fear (PHODA-LE-score ≥ 35 and PHODA-UE-score ≥ 32).

      Intervention:

      The two interventions that will be compared are GEXP in vivo (de Jong et al., 2005) and
      standardized physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo en
      Goris (1999). The GEXP in vivo comprises 17 sessions of one hour, the physiotherapy treatment
      of 34 sessions of 30 minutes. Both treatments will be given over a period of 17 weeks.
    


Intervention name(s): Graded exposure in vivo; Physiotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Graded exposure in vivo according to the protocol of de Jong et al. (2005); Physiotherapy according to the protocol of Oerlemans, Oostendorp, de Boo and Goris (1999)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Complex regional pain syndrome type I; Graded exposure in vivo; Physiotherapy; Pain-related fear
.Exercise and Follow-up After a Mastectomy
Condition: Mastectomy; Lymphedema
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      A Randomized Control Trial (RCT) on the effect of education and Exercise on women after a
      mastectomy found positive results in range of motion of the affected shoulder and quality of
      life in the intervention group.
    

Detailed description: 
      Background: Breast cancer ranks highest in incidence and mortality among females and ranks
      second when both genders are combined. Lebanon has the second highest rate of breast cancer
      worldwide for the 35-39 age group and the highest in the 40-49 age group. Mastectomy often
      results in deceased shoulder and arm mobility, and decreased Quality of Life.

      Objective: The objective of this study was to assess the effect of an educational program of
      therapeutic exercises on the quality of life and functional ability in women after a
      mastectomy Methods: Sixty women undergoing mastectomy were randomly assigned to an
      intervention and control group. The intervention group received extensive teaching
      pre-surgery education as well as training on therapeutic exercises. Follow up phone calls to
      the Intervention group were made to assure that the exercises were being done. Both groups
      were visited at home at four and eight to obtain the outcome variables. The Breast Cancer
      Patient Version was used to asses quality of life and the "Goniometer" was used to assess the
      range of motion of the affected shoulder.
    

Intervention name(s): education
Intervention type(s): Behavioral
Intervention description(s): The intervention group received pre-surgery education and training on therapeutic exercises in addition to the routine hospital care. The educational material was developed by the principal investigator (PI) and included a power point and a booklet with instructions on the exercises as well as information about the surgery and what to expect after the surgery. The educational material was based on previous research and adopted to our population after consultation with a panel of experts including two nurses and three physicians. Eligible women were approached while waiting for their appointment with their surgeon. If they showed interest in participating they signed a consent form. The PI explained the study and what is involved in participating including the weekly phone calls for women in the intervention group. Participants were told that they will visited at home by the PI to assess their ROM and to fill out a questionnaire.
Other intervention name(s): Exercise Modeling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to a control of experimental group by flipping a coin
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: mastectomy; education; exercise
Glycemic and Insulinemic Impact of Selected Canadian Beans
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The objective of this study is to compare the glycemic and insulinemic response elicited by ½
      cup servings of 6 beans to those elicited by ½ cup servings of mashed potato, macaroni, rice
      and corn.
    

Detailed description: 
      In order for a food to be able to claim a reduced glycemic response, it must be shown that a
      typical serving of the food elicits a significantly lower blood glucose responses compared to
      a serving of an appropriate control food. While many studies have examined the GI of beans,
      few studies have compared the glycemic impact of a typical serving of beans to a typical
      serving of other starchy foods. Therefore, there are insufficient data to allow for a claim
      that beans have a low glycemic response. In addition, in order to make a claim of a reduced
      glycemic response, regulatory agencies also require that the insulinemic response to a food
      is not disproportionately increased.
    

Intervention name(s): Bean Type; Starchy Foods
Intervention type(s): Other; Other
Intervention description(s): 1/2 cup of freshly boiled beans will be eaten by participants on separate study visits; 1/2 cup serving of one of 4 starchy foods will be eaten by participants on different study visit
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pulses; beans; blood glucose; insulin
Study of ABT-767 in Subjects With Breast Cancer 1 and Breast Cancer 2 (BRCA 1 and BRCA 2) Mutations and Solid Tumors or High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Fallopian Tube; Primary Peritoneal Cancer; Solid Tumors (e.g. Breast, Ovarian, Prostate, or Pancreatic) and Ovarian
MeSH terms: Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and
      pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or
      BRCA2)-mutated solid tumors and high grade serous ovarian, fallopian tube, or primary
      peritoneal cancer.
    

Detailed description: 
      This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and
      pharmacodynamics of ABT-767 in subjects with advanced BRCA1 or BRCA2-mutated solid tumors and
      high grade serous ovarian, fallopian tube, or primary peritoneal cancer. ABT-767 is a potent
      oral inhibitor of the enzymes poly (ADP-ribose) polymerase 1 and 2 (PARP-1 and PARP-2).
      Malignancies with deficiencies in homologous repair, such as BRCA-1 and BRCA-2 deficient
      tumors, are more dependent on PARP for deoxyribonucleic acid (DNA) repair than normal cells
      and, thus, are thought to be more sensitive to PARP inhibition. The study design is a
      single-arm dose escalation study to determine dose-limiting toxicities, maximum tolerated
      dose and the recommended Phase 2 dose (RPTD) of orally administered ABT-767 in subjects with
      BRCA mutations and malignancies. In order to further evaluate the safety and tolerability of
      ABT-767 at the RPTD, 20 additional subjects will be enrolled in an expanded safety cohort
      consisting of BRCA1- or BRCA2-mutated Breast cancer and Ovarian cancer.
    

Intervention name(s): ABT-767
Intervention type(s): Drug
Intervention description(s): ABT-767 once or twice daily for a 28 day cycle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid Tumor; BRCA 1 and BRCA 2 Mutations; Breast Cancer 1; Breast Cancer 2; High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancers; Solid Tumors
Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The aim of the current study is to compare agonist trigger and HCG luteal support vs standard
      HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation
      cycle as regards to clinical pregnancy rate.
    

Detailed description: 
      Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian
      hyperstimulation.

      All patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno
      Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle
      count (AFC).

      After 6 days of stimulation, FSH will be adjusted according to ovarian response.

      Premature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono
      International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size
      of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according
      to the protocol assigned for each group.

      Group 1:

      A single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and
      follow up with daily 125 IU HCG injections

      Group 2:

      A single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg
      IM (Prontogest®).
    

Intervention name(s): hCG; Progesterone; Triptorelin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Prontogest; Decapeptyl
Intervention MeSH terms: Triptorelin Pamoate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Primary Chemoprevention of Familial Adenomatous Polyposis With Berberine Hydrochloride
Condition: Colorectal Adenomas
MeSH terms: Adenoma; Adenomatous Polyposis Coli
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In recent years, Berberine hydrochloride has been reported to inhibit cancer cell
      proliferation and to be cytotoxic towards cancer cells. Patients with familial adenomatous
      polyposis have a nearly 100 percent risk of colorectal cancer. The aim of this study is to
      investigate the chemopreventive effects Berberine hydrochlorid on the regression of
      colorectal adenomas.
    

Detailed description: 
      Familial adenomatous polyposis is an autosomal dominant syndrome caused by a germ-line
      mutation of the adenomatous polyposis coli (APC) gene located at chromosome 5q21. The
      disorder is characterized by the development of hundreds of colorectal adenomas during
      adolescence. Colorectal cancer will develop in nearly all affected persons by the sixth
      decade of life if prophylactic colectomy is not performed. Because the adenoma-to-carcinoma
      sequence in familial adenomatous polyposis resembles sporadic colon carcinogenesis, studies
      of familial adenomatous polyposis may contribute to the prevention of sporadic adenomas and
      colon cancer.

      BBR, an isoquinoline alkaloid, is a natural compound in numerous Chinese herb plants such as
      Berberisaristata, Coptischinensis, Coptis rhizome, etc. In recent years, Berberine
      hydrochloride has been reported to inhibit cancer cell proliferation and to be cytotoxic
      towards cancer cells. The aim of this study is to investigate the regression effect of
      Berberine hydrochloride on the colorectal adenomas in patients with familial adenomatous
      polyposis.
    

Intervention name(s): 100mg Berberine hydrochloride; 300mg Berberine hydrochloride; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months; patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months; patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months
Other intervention name(s): 100mg Berberine hydrochloride tablet ("Sine Tianping"); 300mg Berberine hydrochloride tablet ("Sine Tianping"); Placebo (for Berberine hydrochloride)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Panblok H7 Vaccine Adjuvanted With AS03 or MF59
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess the safety and ability of a Panblok H7 influenza
      vaccine adjuvanted with AS03 or MF59 to generate an immune response after 2 doses separated
      by 28 days. Three different antigen dose levels of Panblok H7 will be tested.
    

Detailed description: 
      This is a randomized, double-blinded, phase 2 study to assess safety and immunogenicity of
      Panblok H7 vaccine at three antigen dose levels (3.75, 7.5, and 15 μg) adjuvanted with AS03
      or MF59. The main purpose of this study is to assess the safety and ability of the
      recombinant Panblok H7 influenza vaccine adjuvanted with AS03 or MF59 to generate an immune
      response after 2 doses separated by 28 days in healthy males and nonpregnant females, aged 18
      to 49 years, inclusive. The expected study duration is approximately 13.5 months per
      participant.
    

Intervention name(s): 3.75 ug Panblok H7; 7.5 ug Panblok H7; 15 ug Panblok H7; MF59; AS03
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.; Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.; Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.; 0.5 mL MF59 (39 mg squalene/mL ) adjuvant.; 0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of the six treatment groups at Day 1 and will receive the assigned dose of antigen and adjuvant on Day 1 and Day 29.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; human; Influenza in Birds; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; MF59; AS03; Adjuvants; Immunologic
Patient Training About the Safety of Warfarin Therapy
Condition: Warfarin Knowledge Level; International Normalized Ratio Control; Patient Training
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of patient training about the safety of
      warfarin therapy on related knowledge levels and on International Normalized Ratio (INR)
      control.
    

Detailed description: 
      Although warfarin is widely used in the treatment and prophylaxis of thromboembolic diseases,
      it is an oral anticoagulant with serious adverse effects. Therefore, the patient must be
      informed about its safe use.

      A patient's level of knowledge concerning the drug plays a key role in the effective and safe
      use of warfarin. In the Joint Commission International (JCI) National Patient Safety Goal
      (NPSG) guideline for 2014 education on treatment for patients taking oral anticoagulants was
      recognized as a vital factor. Previous studies have reported that a positive relationship
      between patients' anticoagulant knowledge levels and the INR number in the therapeutic range.

      For this reason there is a need for effective education programs to increase patients'
      knowledge concerning warfarin and to keep it up to date. Education and information services
      provided to patients using anticoagulants will reduce the costs of treatment by reducing
      risks such as thromboembolism and bleeding. When planning education, individual
      characteristics and needs must be kept in mind, and group education in addition to individual
      sessions and the use of written and visual material will increase the effectiveness of the
      education.
    

Intervention name(s): training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Patient training; Warfarin; International Normalized Ratio; Nursing
Effect of Breathing Circuits on Intraoperative Body Temperature
Condition: Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      To evaluate differences in intraoperative body temperature between heated huimid breathing
      circuit and conventional breathing circuit
    


Intervention name(s): Group C; Group E; Group M
Intervention type(s): Device; Device; Device
Intervention description(s): non-heated, non-humidified conventional breathing circuit was used in group C patient; breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient; Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
Other intervention name(s): conventional circuit; Evaqua™ Breathing Circuits manufactured by Fischer & Paykel; Mega Acer kit manufactured by Acemedical,Seoul Korea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: core body temperature; humidity; circuit temperature
Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining
Condition: Lung Neoplasm; Segmentectomy;Intersegmental Plane
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to
      identify the intersegmental plane,not only on the pleural surface but also the parenchyma of
      the lung.
    

Detailed description: 
      This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to
      identify the lung intersegmental plane. This is relevant because the detection of small and
      early lung cancer is becoming increasingly common. segmentectomy may become a more prominent
      procedure for early-small lung cancer. One of the most difficult aspects of complete
      segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical
      margin and remaining lung function. The method used to detect the intersegmental plane
      remains controversial. It is hoped that this technology can be used to recognize the
      intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots
      of money for patients in developing countries.
    

Intervention name(s): Iron Sucrose Injection
Intervention type(s): Drug
Intervention description(s): The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.
Intervention MeSH terms: Ferric Oxide, Saccharated
Intervention model: Single Group Assignment
Intervention model description: After the investigators cut the pulmonary vessels and ligate the segmental bronchus. The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
Masking: None (Open Label)
Primary purpose: Treatment
ESP Block in Radical Prostatectomy
Condition: Erector Spinae Plane Block
Study type: Interventional

Summary: 
      Our study aimed to examine the effects of ultrasound guided erector spinae plane block in
      radical prostatectomy surgery on pain and surgical stress response, to reduce adrenocortical
      and sympathetic discharge due to anesthesia and surgery, and to reduce peroperative opioid
      analgesic consumption.
    

Detailed description: 
      In this study 46 patients between the ages of 30-74, American Society of Anesthesiologists
      (ASA) score I-II and undergoing radical prostatectomy surgery at T.R. Ministry Of Health
      İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital were included. The patients were
      randomly divided into two groups as ESPB applied Group B (n=23) and not Group K (n=23).
      Patient-controlled analgesia (PCA) was initiated in all patients for postoperative analgesia.
      Patients' demographic data (age, gender, ASA score), intraoperative hemodynamic data,
      intraoperative and postoperative additional narcotic consumption, postoperative Numeric
      Rating Scale (NRS) scores (postoperative 0, 5 and 20 minutes and Then, 1, 3, 6, 12, 18 and 24
      h), postoperative nausea-vomiting scores and possible complications related to block and / or
      surgery were recorded.Intraoperative MAP, HR, SpO2, BIS values of patients in both groups
      were recorded every 5 minutes. Blood glucose, insulin, cortisol, prolactin and C-reactive
      protein (CRP) were studied three times; preop morning at 6:00, intraoperative when surgical
      incision closing and postoperative 24h. in order to evaluate the surgical stress response in
      the patients.
    

Intervention name(s): ESP block
Intervention type(s): Procedure
Intervention description(s): Before general anesthesia, ESP block was applied from the T12 vertebra level with 10 ml 0.5% bupivacaine HCL 5 ml 2% lidocaine HCL 5 ml 0.9% isotonic NaCl mixture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erektor Spinae Plane Block; Postoperative Analgesia; Surgical Stress Response
MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation on Pre-pubertal Children
Condition: Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 3

Summary: 
      1. To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens

        2. To specify the best period of treatment

        3. To assess the efficacy of treatment based on final adult height of these children
    


Intervention name(s): somatropin; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): 0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years; 0.2 IU/kg/day 7 days per week given continuously for 3 years
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment