Kornimate/medical-research-clean huggingface dataset:
ti-mesh frame comparison for alveolar bone augmentation

Conditions: Tooth Loss

Summary: this research compares a chairside titanium mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (cad-cam) titanium mesh frame. in addition, a novel method of measuring soft tissue thickness will be tested using an optical scanner at various times during the sequence of surgeries. the device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as micromesh). the construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. an alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. a digitally designed frame can then be printed using cad-cam software prior to surgery. this should reduce surgical time. a randomized control trial of 30 patients needing 3-d bone augmentation will be conducted comparing chairside fabrication of ti-mesh or test- cad-cam designed and preprinted ti-mesh to investigate these objectives: 1. compare the operative times required for placement and removal of two different ti-mesh frame fabrications 2. compare post-op wound healing -ti mesh exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.


Eligibility criteria:
inclusion criteria: * partially edentulous * adult dental patients that require moderate 3-d bone augmentation for dental implant site improvement exclusion criteria: * poor oral hygiene indices for microbial plaque (pi) and gingival inflammation (gi) * patients who have been on chemotherapy or radiation therapy within last 5 years. * patients under active treatment with following medications: bisphosphonates, gabapentin, glucocorticoids, methotrexate, or estrogen supplements. * subjects under the direct supervision of the pi * smoking more than 10 cigarettes per day * uncontrolled diabetes or other metabolic disorders

Keywords: conventional ti-mesh frame cad-cam printed ti-mesh frame dental implants 3-d alveolar bone augmentation surgery time post op mesh exposure post op bone added
artificial intelligence vs physicians for breast cancer patients' information

Conditions: Breast Cancer

Summary: chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. the use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health. in clinical studies, chatbots are useful in gathering information through questionnaires directly submitted during conversations or through keyword analyzes. there is no longer any delay between the moment the patient notices a side effect, for example, and the moment when the patient announces it during a consultation. the responses given by the chatbot do not constitute medical advice and only provide information on the treatments envisaged or in progress in the context of the management of breast cancer. the main objective of the study is to show that the chatbot vik's answers to the common questions asked by breast cancer patients about their therapeutic management are at least as satisfactory as answers given by a committee of multidisciplinary doctors

a total of 20 most frequently asked questions will be defined on a cohort of 150 breast cancer patients. these questions will be asked on the one hand to the chatbot vik and on the other hand to a multidisciplinary medical committee (surgeon oncologist, medical oncologist and oncologist radiotherapist). the scientific quality of the responses of the two groups will be validated by a second multidisciplinary group of physicians, independent of the first. a cohort of 150 patients will then be randomized blind and in 1 to 1 to receive the responses of the chatbot vik and the answers of the doctors' committee. each patient will then have to answer the eortc qlq-info255-7 questionnaire, evaluating the quality of the medical information.

Eligibility criteria:
inclusion criteria: * over 18 years * paitents with breast cancer exclusion criteria: * patient unable to formulate his opposition * patient with cancer other than breast cancer

Keywords: patient information natural language processing conversational agent chatbot
randomized phase iii study to evaluate the efficacy and safety of xyzal® (levocetirizine) vs zyrtec® (cetirizine) in subjects with dermatitis and eczema

Conditions: Dermatitis; Eczema

Summary: korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of xyzal® to zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms


Eligibility criteria:
inclusion criteria: * subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema * subjects who require and agree to the concomitant use of a topical steroid preparation. * subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period * written informed consent signed and dated by subject/legal guardian * female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test. exclusion criteria: * subjects with a known hypersensitivity to cetirizine or levocetirizine * any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety * have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol

Keywords: dermatitis eczema pruritus xyzal zyrtec levocetirizine cetirizine
the conquest-study. evaluation of clinical endpoints for treatment-induced changes in gerd-related symptoms (by1023/nl511)

Conditions: Gastroesophageal Reflux Disease; Non-erosive Reflux Disease

Summary: the aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (gerd)-related symptoms as assessed by the patient using the request™ questionnaire. the assessment is made in gerd-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.


Eligibility criteria:
inclusion criteria: * written informed consent * outpatients of at least 18 years of age * history of gerd-related symptoms of at least 6 months prior to baseline visit * endoscopically-confirmed gerd or non-erosive gerd exclusion criteria: * zollinger-ellison syndrome or other gastric hypersecretory condition * acute peptic ulcer and/or ulcer complications * pyloric stenosis * severe or unstable cardiovascular, pulmonary, and/or endocrine disease * pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential * intake of any medication for the purpose of eradication of helicobacter pylori (h. pylori) within the last 28 days prior to study start * intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (cox-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day

Keywords: gastroesophageal reflux disease (gerd) non erosive reflux disease (nerd)
quality control study of laparoscopic sentinel node biopsy in early gastric cancer

Conditions: Early Gastric Cancer

Summary: laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. multicenter phase iii trial is requred to validate this method. in this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.


Eligibility criteria:
inclusion criteria: * gastric adenocarcinoma in preoperative endoscopic biopsy * clinical stage t1-2n0 * long diameter of tumor \<4cm * distance between tumor and pylorus or cardia \>2cm * age: 20-80 * ecog: 1 or 0 * patients will undergo laparoscopic gastrectomy exclusion criteria: * definite criteria of endoscopic submucosal dissection (size\<2cm, differentiated type, no ulcer) * no indication for surgery for cardiovascular, pulmonary disease * pregancy * drug allergy or previous abdominal surgery, radiotherpy

Keywords: laparoscopic sentinel lymph node biopsy quality control study early gastric cancer
a safety and efficacy study of xyrem® (sodium oxybate) to treat fibromyalgia.

Conditions: Fibromyalgia

Summary: the objective of this trial is to evaluate the safety and efficacy of xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

the trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the american college of rheumatology. total duration is up to twenty-two (22) weeks of trial participation. subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined followed by baseline period lasting one (1) week. total treatment duration will be fourteen (14) weeks followed by a two week safety follow-up post treatment period. during the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed.

Eligibility criteria:
inclusion criteria: * male or female subjects, 18 years or older who meet the american college of rheumatology (acr) diagnostic criteria for fibromyalgia. exclusion criteria: * subjects will be excluded if they have a history of rheumatic disease or other disorders that may compromise reliable representation of subjective symptoms. * any other condition that will cause a risk to subjects if they participate in the trial is also a reason for exclusion.

Keywords: fms fibro pain body pain tenderness stiffness muscular pain joint pain
hand massage on fatigue with cancer receiving brachytherapy

Conditions: Hand Massage

Summary: this randomized controlled trial was designed to examine the effect of hand massage on the level of fatigue in patients receiving bt therapy. randomized controlled trial was conducted in the radioterapi outpatient clinic of university hospital located in a large city in turkey. when 12 patients were included in each group, it was determined that the power was 90% at the 5% type i error level, and a total of 24 women with gynecological cancer were included in the study. the primary outcome of this study was the mean difference in fatigue scores between the groups following the three brachtherapy cycles hand intervention. patient information form and brief fatigue inventory (bfi) used. this study predicted that hand massage applied in each session, starting from the first session of brachytherapy application, would reduce the level of fatigue in women.

therefore, this study aimed to compare the effects of hand massage intervention the level of fatigue in patients receiving bt therapy. . this randomized clinical trial was conducted.

Eligibility criteria:
inclusion criteria: * 18 years and over, * underwent bt regularly * patients who volunteered to participate in the study exclusion criteria: * having skin problems * with metastases, * have bleeding or coagulation disorders, * using complementary integrated therapy during the study, * having edema or wound in the hand area, * not wanting to get a massage * patients receiving general anesthesia during the procedure

Keywords: hand massage fatigue brachytherapy
families with substance use and psychosis: a pilot study

Conditions: Psychosis; Substance Use; Substance Use Disorders; Family; Tobacco Use; Nicotine Use Disorder; Cigarette Smoking; Cannabis; Marijuana; Alcohol Use Disorder; Alcohol; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Mental Disorder

Summary: the purpose of this study is to develop and evaluate an intervention that adapts community reinforcement and family training (craft) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). the intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (craft-ft). to assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. data on client relatives with psychosis will be collected for preliminary assessment purposes. client relatives will not complete the research study intervention.


Eligibility criteria:
inclusion criteria: * ages 18-70. * having a relative who: 1. is a patient with early course psychosis (dsm-5 schizophrenia, schizoaffective disorder, schizophreniform, psychosis not otherwise specified (nos), delusional disorder, brief psychotic disorder, major depression with psychosis, and bipolar disorder with psychosis) with first onset in the past 6 years, and 2. uses tobacco, alcohol, or cannabis in the past 90 days and/or has no apparent immediate interest in abstinence. * the person(s) who can best describe the client with psychosis. * at least 4 days per month contact with the client. * access to a computer with internet or mobile phone with video conferencing capabilities. * ability to provide written informed consent. * speak and read english. exclusion criteria: * dsm-5 moderate or severe substance use disorder in the past year. * lifetime psychotic disorder. * history of domestic violence with the identified patient (ip). * psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the treatment plan. inclusion criteria for client relatives: * ages 18-35. * first episode psychosis (fep) onset in the past 6 years with a dsm-5 diagnosis of affective (bipolar disorder or major depressive disorder with psychotic features) or non-affective psychosis (schizophrenia spectrum disorder). a. used tobacco, alcohol, or cannabis within the past 90 days and/or has no apparent immediate interest in abstinence. * ability to provide written informed consent. * speak/read english exclusion criteria: * n/a

Keywords: family substance use disorder psychosis
continuous oral contraceptives (cocs): are bleeding patterns dependent on the hormones given?

Conditions: Breakthrough Bleeding

Summary: while there may be a decrease in the total number of bleeding days women experience with continuous-dosed cocs (no menstrual withdrawal week), these regimens frequently result in an increased number of "breakthrough" or non-scheduled bleeding days. breakthrough bleeding is among the main reasons cited for discontinuation of combined cocs dosed traditionally (3 weeks of active pill, 1 week of placebo) or continuously, and may offset the perceived benefit of fewer withdrawal bleeding events for many women taking continuous-dosed cocs. the exact mechanisms responsible for breakthrough bleeding patterns during hormonal contraception are unknown and may be related to the pill formulation. this study is to determine whether progestin type or estrogen dose influences bleeding patterns, side effects, or satisfaction with combined oral contraceptives (coc) dosed continuously.


Eligibility criteria:
inclusion criteria: * age \> 18 to 49 years old * good general health * no medical contraindications to combined coc therapy. * in addition, all participants were required to have taken cyclic cocs for at least three months at the time of enrollment, in order to avoid common transition bleeding with the initiation of cocs.

Keywords: breakthrough bleeding while taking continuously dosed oral contraceptives
a french observational study of indocyanine green for patients with breast cancer having a sentinel lymph node biopsy.

Conditions: Breast Cancer

Summary: this prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer. the study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery. the study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mtechnetium dye). the study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mtechnetium dye. the study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.


Eligibility criteria:
inclusion criteria: * female * aged ≥18 years * undergoing breast cancer surgery with an indication for sentinel lymph node biopsy * receiving infracyanine® (indocyanine green; alone or in combination with blue dye or 99mtc) for intraoperative identification of sentinel lymph node according to the summary of product characteristics exclusion criteria: * male * pregnant or nursing female * previous allergy to indocyanine green or to any excipients * already included in a surgical trial * patient opposed to collection and processing of their data

Keywords: sentinel lymph node biopsy indocyanine green biopsy fluorescence blue dye technetium99
a study of cc-95266 in participants with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and preliminary efficacy of cc-95266 in participants with relapsed and/or refractory multiple myeloma (r/r mm).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * participant has a diagnosis of multiple myeloma (mm) with relapsed and/or refractory disease. participants must have confirmed progressive disease (as per imwg criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., chimeric antigen receptor (car) t-cell therapy) as their last treatment, who may enroll beyond 12 months. * participants in part a, and part b cohort a, and part b cohort b must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (hsct) and with or without maintenance therapy is considered one regimen).subjects in part b cohort c only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including: * autologous hsct, unless the subject was ineligible * a regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination * anti-cd38 (e.g., daratumumab), either alone or combination. subjects in cohort c do not require prior anti-cd38 antibody therapy. * measurable disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ function exclusion criteria: * known active or history of central nervous system (cns) involvement of mm * active or history of plasma cell leukemia, waldenstrom's macroglobulinemia, poems (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis * active autoimmune disease requiring immunosuppressive therapy * history or presence of clinically significant cns pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, or psychosis other protocol-defined inclusion/exclusion criteria apply.

Keywords: cc-95266 multiple myeloma relapsed and/or refractory
acute postthoracotomy pain - impact of gender

Conditions: Gender; Postoperative Pain; Thoracotomy; Analgesia

Summary: adequate analgesia in thoracic surgery is essential to prevent severe postoperative complications, especially respiratory problems. current knowledge about gender-related differences in pain states generally more frequent and intense pain and more demand for analgesics in women. results about postsurgical pain in particular are very inconclusive. the investigators tried to find out if gender has an influence on postthoracotomy pain and analgesics requirement.


Eligibility criteria:
inclusion criteria: * open lung surgery between july 2010 and december 2014 exclusion criteria: * redo-thoracotomy * chest wall or rib resection * other approach than lateral thoracotomy * additional incision at other site (e.g. laparotomy) * chest trauma * mesothelioma * hemofiltration or haemodialysis * longer than one day stay at intensive care unit * pre-existent chronic pain and/or chronic opioid intake * short stay in hospital