Kornimate/medical-research-clean huggingface dataset:
study of afimoxifene gel to treat cyclic mastalgia in premenopausal women

Conditions: Cyclic Breast Pain, Cyclic Mastalgia

Summary: the purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen (4-oht) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives.

this study is a phase ii, randomised, double-blind, placebo-controlled, two-dose, multicentre trial of 4-oht gel in approximately 130 otherwise healthy pre-menopausal women with a history of cyclical mastalgia, peaking during the second half of the menstrual cycle and decreasing significantly with the onset of menstruation, during the four months prior to study entry. the primary efficacy endpoint in this study is change in change in average pain visual analog scale (vas) scores for the seven worst pain scores within a cycle, from baseline to the fourth cycle after start of treatment.

Eligibility criteria:
inclusion criteria: * a woman is eligible for this study if she: * is pre-menopausal and at least 18 years of age. * has a history of cyclical mastalgia for each of the four months prior to study entry. * moderate or severe mastalgia as determined by \>40 mm on the vas for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period. * has a history of regular menstrual cycles of 28 plus/minus 3 days. exclusion criteria: -

Keywords: breast pain, tenderness, benign breast conditions
efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions

Conditions: Endoscopic Mucosal Resection; Colonic Neoplasms; Therapeutic Irrigation; Treatment Outcome

Summary: the objetive of this clinical trial is to evaluate the efficacy and safety of a solution for endoscopic mucosal resection of colonic lesions in patients undergoing endoscopic resection procedures. the main questions it aims to answer are: does the investigational solution improve the efficacy of endoscopic mucosal resection compared to standard practice? is the investigational solution safe for use in colonic lesion resection procedures? researchers will compare the investigational solution (demirex) to a standard or placebo solution to see if it improves procedural outcomes and safety profiles. participants will undergo endoscopic mucosal resection using either the investigational solution or the comparator, and will be monitored for procedural success, safety, and any adverse events.


Eligibility criteria:
inclusion criteria: * patients of any sex, \>18 years old, diagnosed with sessile or flat polyps, with a diameter greater than or equal to 2 cm, in the intestinal submucosa by the endoscopy unit. * the subject has understood and signed an informed consent form (icf) approved by a research ethics committee (rec) before any study evaluation and commits to completing the study as defined in the protocol. * not undergoing active treatment with antiplatelet or anticoagulant drugs. * after signing the informed consent, patients are scheduled for lesion resection within \<3 months from their diagnosis. exclusion criteria: * patients with documented allergy to any of the components of the mucosectomy solution or drugs used in sedation. * pregnant women. * patients on contraceptive treatment or post-menopausal. * hematological disorders with uncorrected coagulation abnormalities, with an inr \>= 1.5, or patients undergoing active treatment with antiplatelet or anticoagulant drugs. * patients with intestinal perforation or obstruction, toxic megacolon, diverticulitis, or inflammatory bowel disease. * patients with previous partial resection or pending resection. * patients with lesions classified as paris type iii and/or invasive intestinal carcinoma and/or metastases. patients with previous treatment of the lesion (radiotherapy, endoscopic, surgical, chemotherapy). * patients included in another study during the previous month. * conditions that, in the medical judgment, contraindicate polyp removal. * absence of a signed informed consent, non-acceptance, or contraindication of surgical or anesthetic techniques (patients with asa status: high anesthetic risk (asa score \> 3)) and difficulty in the patient's understanding of the conditions of the endoscopic procedure. * endoscopic appearance of invasive malignancy.

Keywords: demirex
survival and dialysis independency in highly sensitized patients after desensitization with imlifidase and tx of kidneys

Conditions: Kidney Transplantation in Highly Sensitized Patients

Summary: the goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (soc) in order to enable kidney transplantation in clinical study confides (20-hmedides-17, nct04935177).

this is an observational follow-up study subsequent to the confides study (20-hmedides-17, nct04935177) in highly sensitized patients who were randomized to imlifidase or soc desensitization prior to kidney transplantation with a deceased donor graft, or, if soc perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer. after the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the confides study. most of the assessments in this study are already part of the follow up within soc for these patients. during the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the confides study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated.

Eligibility criteria:
inclusion criteria: 1. signed informed consent obtained before any trial-related procedures. 2. previous participation in the clinical trial confides. exclusion criteria: 1. inability by the judgement of the investigator to participate in the trial for any reason.

Keywords: desensitization highly sensitized positive crossmatch unlikely to be transplanted renal transplantation deceased donor
evaluation of everlift in the performance of polypectomy for polyps 4-9mm

Conditions: Colo-rectal Cancer; Polyp of Colon; Adenomatous Polyp of Colon

Summary: the focus of the study is to evaluate impact of submucosal injection of everlift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.

the details of the proposed study are as follows: 1. experimental group: using everlift submucosal injection for polyps 4-9mm of the colon 2. control group: not using everlift submucosal injection for polyps 4-9mm of the colon 3. methods: 1. colonoscopy will be performed in the same standard of care manner as if no study was taking place. 2. if polyps 4-9mm are identified, the endoscopist is randomized to performing polypectomy with or without submucosal injection of everlift. 3. after removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion. 4. the polyp as well as well as the two biopsies are reviewed by a pathologist.

Eligibility criteria:
inclusion criteria: * patients 18 years or older * polyps 4-9mm exclusion criteria: * pregnant * inflammatory bowel disease * polyposis syndromes
nsaids vs opioids in tibial fractures

Conditions: Trauma

Summary: this study will attempt to determine if there is a statistic difference between the time to union, non-union rate and post-operative pain of patients who receive opioids for pain control vs. patients who receive nsaids and a reduced dosage of opioids for pain management

the study will be a prospective interventional study with two randomized parallel groups. randomization will take place immediately following the identification of a potential participant. the control group will receive the standard of care for diaphyseal tibia fractures. the standard of care consists of intramedullary nailing and post-operative opioids for pain control. the interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. the study group will receive nsaids and a reduced dosage of opioids for pain control. primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a vas pain scale. once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 105 * diaphyseal tibia fracture (ota/ao 42 a, b) exclusion criteria: -tibial fractures not treated with intramedullary nails
effect of dexmedetomidine on heart-rate corrected qt(qtc) interval prolongation during robotic-assisted laparoscopic radical prostatectomy -randomized blind clinical trial-

Conditions: Prostate Cancer; Robotic Surgery

Summary: sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under co2 pneumoperitoneum. stimulation of the sympathetic nervous system prolongs the qt interval and can increases the susceptibility to life threatening cardiac arrhythmias. dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected qt interval during robot-assisted laparoscopic radical prostatectomy. furthermore, the investigators evaluated the tp-e, tp-e/qt ratio and tp-e/qtc ratio as well.


Eligibility criteria:
inclusion criteria: 1. asa class i-ii 2. otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy exclusion criteria: 1. emergency operation 2. cardiac disease (unstable angina, congestive heart failure, valvular heart disease) 3. ventricular conduction abnormality 4. prior pacemaker insertion 5. abnormal electrolyte values 6. patients who take antiarrythmic agent 7. hepatic or renal failure 8. drug hyperactivity 9. neurological or psychiatric illnesses

Keywords: dexmedetomidine pneumoperitoneum trendelenburg position qtc interval tp-e interval robotic prostatectomy
post-approval study of melafind

Conditions: Melanoma

Summary: the purpose of this study is to collect data to describe the real-world use and safety and effectiveness of melafind® in a post-approval clinical setting.

the primary objective of this study to test the hypothesis that, among eligible and evaluable lesions with central histological reference standard status melanoma or high-grade lesion, the relative sensitivity ρ comparing enrolling dermatologists after melafind use with enrolling dermatologists if melafind were not available is greater than 110%. this represents a clinically meaningful increase in sensitivity. the secondary objectives of this study are to evaluate real-world use and safety and effectiveness of melafind in a clinical setting.

Eligibility criteria:
inclusion criteria: * the lesion is pigmented (i.e., melanin, keratin, blood) * clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion * the diameter of the pigmented area is between 2 and 22 millimeters * the lesion is accessible to the melafind hand-held imaging device * the patient, or a legally authorized representative, has consented to participate in the study and has signed the informed consent form exclusion criteria: * the patient has a known allergy to isopropyl alcohol * the lesion has been previously biopsied, excised, or traumatized * the skin is not intact (e.g., open sores, ulcers, bleeding) * the lesion is within 1 cm of the eye * the lesion is on mucosal surfaces (e.g., lips, genitals) * the lesion is on palmar hands * the lesion is on plantar feet * the lesion is on or under nails * the lesion is located on or in an area of visible scarring * the lesion contains foreign matter (e.g., tattoo, splinter, marker)

Keywords: pigmented skin lesions dermatology skin cancer melanoma melafind
smart measurement of circulating tumor dna

Conditions: Colorectal Neoplasms; Colorectal Neoplasms Malignant; Colorectal Neoplasms, Hereditary Nonpolyposis; Hereditary Nonpolyposis Colon Cancer

Summary: the goal of this study is to develop a blood-test which can detect colorectal cancer in early stages. participants will be asked to take an extra blood test, which will be analyzed further in the lab.

lynch syndrome (ls) carriers have a predisposition to develop various types of cancer, especially colorectal cancer (crc) and endometrial cancer (ec). ls patients are advised to undergo surveillance by colonoscopy every 2 year and gynaecological surveillance. this surveillance is deemed burdensome and fails to detect a small part of the developing crcs and the majority of extra-colonic cancers. to ensure prevention and early detection of cancer, a reliable and accessible test is needed. recent studies have shown the potential of the detection of tumor-derived dna fragments (circulating tumor dna; ctdna). various molecular characteristics can be used to discriminate ctdna from healthy circulating cell-free dna. current ctdna assays with the highest sensitivity and specificity to detect for example minimal residual disease (mrd) after surgery are mostly tumor-informed, which means prior information is needed from the tumor tissue about the molecular alterations present. as this information is not available for the detection of newly arising tumors, the aim of this study is to evaluate the use of an optimized combination of tumor agnostic ctdna characteristics for the detection of newly developing tumors.

Eligibility criteria:
inclusion criteria: (suspect) lynch syndrome carriers who: * have proven lynch syndrome (mmr-gene or epcam mutation), or have a proven microsatellite instability high (msi-h)tumor; * are at least 18 years old; have been diagnosed with any form of cancer at the time of inclusion, but have had no treatment yet; * have granted informed consent to participate in this study. exclusion criteria: (suspect) lynch syndrome carriers who: * are unwilling to undergo extra blood sampling; * are under the age of 18; * have no newly diagnosed tumors at time of inclusion; * have been treated for their tumor at time of inclusion; * are not able to read or understand dutch language or are mentally not capable.

Keywords: liquid biopsy colorectal cancer early detection prevention surveillance screening
a comparative study of combination antiretroviral therapy in children and adolescents with advanced hiv disease

Conditions: HIV Infections

Summary: to compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with hiv infection. the duration of clinical benefit from zidovudine (azt) may be limited because of development of viral resistance to the drug. use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

the duration of clinical benefit from zidovudine (azt) may be limited because of development of viral resistance to the drug. use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance. in stage 1 of the study, a minimum of 22 patients are randomized to each of three treatment arms: didanosine (ddi) plus azt plus nevirapine (nvp); ddi plus azt; and ddi plus nvp. after 12 weeks of treatment, the study proceeds to stage 2 provided at least 40 percent of patients in stage 1 show a reduction of at least 40 percent from baseline icd p24 antigen of greater than or equal to 70 pg/ml and fewer than two patients experience grade 4 rash. patients in stage 1 continue treatment for an additional 36 weeks. in stage 2, additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered. stage 2 patients receive treatment for at least 48 weeks. as per amendment 02/12/97: as of 2/28/97, patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks (until 6/30/97). patients will be unblinded on or about 5/23/97.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * erythropoietin. concurrent treatment: allowed: * transfusion. patients must have: * progressive hiv disease. * at least 24 weeks prior cumulative nucleoside analog antiretroviral monotherapy or combination therapy. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active malignancy requiring chemotherapy. * currently receiving therapy in an actg primary therapy or salvage protocol who have not met an endpoint on that study. * known intolerance (other than hematologic) or toxicity to ddi, azt, or nvp at the doses used in this study. concurrent medication: excluded (unless exemption made by study chair): * oral anticoagulants (warfarin, dicumarol). * oral contraceptives. * digitalis glycosides. * phenytoin. * theophylline. patients with the following prior conditions are excluded: * history of clinical pancreatitis. * history of grade 2 or worse peripheral neuropathy. prior treatment: excluded: * acute treatment for a serious bacterial, viral, or opportunistic infection within 14 days prior to study entry.

Keywords: didanosine drug therapy, combination acquired immunodeficiency syndrome aids-related complex zidovudine nevirapine
knowledge of vital pulp therapy in permanent teeth among a group of dental students in egypt

Conditions: Vital Pulp Therapy

Summary: conducting this questionnaire will help in collecting information about the extent of knowledge of vital pulp therapy in permanent teeth among dental students in egypt. this will aid in identifying the knowledge gap, interest, and challenges regarding utilization of vital pulp therapy in permanent teeth.


Eligibility criteria:
inclusion criteria: * dental students who live in egypt. * dental students who are willing to participate * fifth-year students. exclusion criteria: -responses with incomplete information

Keywords: vital pulp therapy vpt permanent teeth dental students egypt
safety and efficacy of alv003 for the treatment of celiac disease

Conditions: Celiac Disease

Summary: a phase 2a study to evaluate the safety and efficacy of alv003 to treat celiac disease.

double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of alv003 in patients with well-controlled celiac disease. approximately 110 biopsy proven celiac disease patients will be randomized to treatment with alv003 or placebo in a 1:1 ratio. patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.

Eligibility criteria:
inclusion criteria: * history of biopsy-proven celiac disease * adherence to a gluten-free diet * tg2 antibody negative * signed informed consent exclusion criteria: * active dermatitis herpetiformis * history of ige-mediated reactions to gluten * use of specific medications 6 months prior to entry * history of alcohol abuse or illicit drug use * current untreated or gi disease * positive pregnancy test * received any experimental drug within 14 days of randomization * uncontrolled chronic disease or condition * uncontrolled complications of celiac disease * any medical condition, which could adversely affect participation

Keywords: celiac disease coeliac disease celiac sprue keliakia
a phase 1, single dose study to evaluate the safety and pharmacokinetics of medi0382 in healthy volunteers

Conditions: Healthy Volunteers

Summary: a phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of medi0382 in healthy volunteers.

this is a first-time-in-humans (ftih), randomized, double-blind study designed to evaluate the safety, tolerability, and pk of medi0382 administered as single-ascending sc doses to healthy subjects (age 18-45). eight subjects per cohort will be enrolled in a total of 8 cohorts. the decision whether or not to dose escalate will be based upon data review by the dose escalation committee (dec). within each cohort, the subjects will be randomized to medi0382 or placebo (3:1). following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.

Eligibility criteria:
inclusion criteria: * healthy volunteers, ages 18-45 * must provide written informed consent * bmi \>22 and \ 70kg * venous access suitable for multiple cannulations * vital signs within normal specified ranges * females must be non-lactating and non-childbearing potential * males must practice 2 effective contraceptive measures if sexually active exclusion criteria: * any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product * history or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * history of cancer, with the exception of non-melanoma skin cancer * any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing * positive hepatitis b, hepatitis c or hiv test or use of antiretroviral medications at screening. * concurrent or previous use of a glp-1 receptor agonist * current or previous use of systemic corticosteroids within the past 28 days prior to screening * use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited. * known or suspected history of alcohol or drug abuse within the past 3 years. * positive drug screen * current smoker

Keywords: medi0382, diabetes
development of a head cooling device

Conditions: Body Temperature Changes

Summary: this study is testing a head-cooling device on volunteers to assess temperature reduction.


Eligibility criteria:
inclusion criteria: * healthy humans exclusion criteria: * pregnant * refusal of consent for registration with the over-volunteering protection scheme