Kornimate/medical-research-clean huggingface dataset:
the use of integra in coverage of radial forearm free flap donor site defect

Conditions: Head and Neck Cancer

Summary: the purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. the study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.

the radial forearm fasciocutaneous free flap (hereafter referred to as rfff) was described more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. it was soon after established as a safe and reliable flap for transfer of fascia and cutaneous tissue. currently, it is used to repair any defect in which a relatively thin island of skin is needed with a fascial strength layer . while the flap itself is very reliable, it leaves a donor site that can be very unsightly and has multiple known complications including loss of pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. the donor site is typically covered with a split thickness skin graft (hereafter referred to as stsg). in an effort to minimize these complications, several groups have described a technique of placing integra© dermal substitute (hereafter referred to as integra) underneath the stsg to provide a thicker support and decrease overall morbidity associated with the defect. these studies have shown success in decreasing overall morbidity including increasing range of motion and improving aesthetic quality of the donor site. however, the largest study to date has included only 29 subjects. furthermore, these studies do not provide a comparative cohort of subjects repaired with a classic stsg to show effectiveness of this technique when compared to a classic repair. our goal is to perform a prospective study comparing subjects repaired with a classic stsg and those repaired with one step integra and stsg applied at the same time. these subjects will be evaluated for overall donor site aesthetic quality and functional outcome as described below.

Eligibility criteria:
inclusion criteria: * all subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction. * have had a distal, anterograde fasciocutaneous flap * age ≥ 18 years * ability to understand and the willingness to sign an irb-approved informed consent document. * smokers and tobacco users will be included in this study exclusion criteria: * subjects who have had an osteocutaneous or musculocutaneous flap. * subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a "reverse" radial forearm flap * pregnant women will be excluded due to the lack of clinical studies evaluating integra template in pregnant women.

Keywords: traumatic defect chronic wounds
geko™ cross therapy registry - wound

Conditions: Wound; Venous Leg Ulcer; Diabetic Foot Ulcer; Arterial Leg Ulcer

Summary: the geko™ cross therapy registry - wound is a prospective, observational, anonymised data collection registry with no experimental treatment that will fulfil an unmet need for an observational registry to provide long-term clinical data to demonstrate patient benefit and regulatory compliance.

the geko™ cross therapy registry - wound represents a long-term project to integrate prospectively and systematically collected clinical data on all geko™ w wound devices (or w device variants) used in sc pathways for wound management allowing for the monitoring of patient outcomes during a follow-up period of up to four follow-up visits. the clinical database collected for the geko™ ctr - wound will form part of the overall post-market clinical follow-up strategy for the device and post market surveillance to support device safety and performance. there will be up to 50 contributing centres globally. participants are asked at the time of signing up for the geko™ cross therapy registry - wound (at the recruitment / baseline visit) to attend as many follow up visits as possible (up to a maximum of 4).

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years 2. intact healthy skin at the site of geko™ device application. 3. willing and able to give written informed consent 4. presence of an ulcerative wound to the lower leg 5. identified to receive geko™ therapy as part of their standard care for wound management. exclusion criteria: 1. pregnancy or breast feeding. 2. use of any other neuro-modulation device. 3. current use of tens in the pelvic region, back or legs 4. trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. 5. no response to geko™ therapy i.e., no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting

Keywords: geko wound therapy medical device registry
postoperative analgesic efficacy of trans abdominis plane block

Conditions: Post Operative Pain; Cesarean Section Complications

Summary: transverse abdominis plane (tap) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. it is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. we conducted this study to see the analgesic effect of tap block after caesarean section.

the study is being conducted, at combined military hospital sargodha, pakistan, to compare the analgesic efficacy of tap block in providing post-caesarean analgesia with the control group, in terms of mean postoperative use of opioids after caesarean delivery. sixty patients have been randomly selected using non-probability, consecutive sampling, and applying inclusion and exclusion criteria. the study design is a randomized controlled trial with thirty patients in each group undergoing elective caesareans. all patients will be given spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section. patients in group a will receive bilateral tap block with 20ml of 0.25% bupivacaine while 20 ml of saline will be injected in patients of group b on both sides of midline after caesarean section, in addition to intravenous ketorolac 8hrly. the intensity of pain, total opioid consumption, presence of vomiting, and sedation will be noted until 24 hours after the surgery.

Eligibility criteria:
inclusion criteria: * elective caesarean section * asa 1-3 * 20yrs to 45yrs exclusion criteria: * emergency surgery * known allergy to local anaesthetic * severe pre-eclampsia * placenta accreta * asa 4 * coagulopathy * hemodynamically unstable

Keywords: tap block, c-section, spinal anesthesia, localized field effects, analgesia, postoperative pain and opioids
a phase i study of mk-4827 for treatment of solid tumors (mk-4827-005)

Conditions: Neoplasms; Solid Tumors

Summary: this study will evaluate whether oral administration of mk-4827 to participants with advanced solid tumors is generally safe and well tolerated.


Eligibility criteria:
inclusion criteria: * participant must have a histologically or cytologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. there is no limit on the number of prior treatment regimens. * participant has a performance status of 0 or 1 on the eastern cooperative oncology group(ecog) performance scale * participant must have adequate organ function (per prespecified laboratory values). exclusion criteria: * participant has had major surgery, chemotherapy, radiotherapy, hormonal or biological therapy within 4 weeks (6 weeks for nitrosoureas, mitomycin c, or bevacizumab) prior to entering the study. * participant has known central nervous system metastases or a primary central nervous system tumor. * participant is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study. * participant is known to be human immunodeficiency virus (hiv)-positive. * participant with active hepatitis b or c. * participant has symptomatic ascites or pleural effusion. * participant has interstitial lung disease as a history or current evidence. * participant has known bleeding tendency or coagulation disorder as a history or current evidence, and/or participant is taking any anti-coagulant and/or antiplatelet therapies. * participant has uncontrolled persistent or active infection (acute infection which requires antibiotic or anti-fungal treatment). * participant has participated in a clinical trial with a known poly (adp-ribose) polymerase (parp) inhibitor.

Keywords: poly (adp-ribose) polymerase (parp) inhibitor tumor cancer
a three-arm comparative trial for the treatment of mac bacteremia in aids: a clarithromycin/ethambutol regimen containing rifabutin (450 mg) or rifabutin (300 mg) or placebo

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (cfus) by 2 or more logarithms in patients with mycobacterium avium complex bacteremia and maintaining this response until 16 weeks post-randomization. to assess survival and comparative tolerability among the three treatment regimens.

patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. treatment continues indefinitely. as per amendment 04/19/94: doses of rifabutin have been lowered.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * isoniazid for tb prophylaxis only. patients must have: * hiv infection. * mac infection. * life expectancy of at least 16 weeks. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * perceived unreliability or unavailability for frequent monitoring. concurrent medication: excluded: * antimycobacterial drugs other than the study drugs. * carbamazepine. * terfenadine. * theophylline. patients with the following prior condition are excluded: history of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol. prior medication: excluded within 7 days prior to study entry: * rifabutin. * rifampin. * ethionamide. * cycloserine. * clofazimine. * ethambutol. * amikacin. * ciprofloxacin. * ofloxacin. * sparfloxacin. * azithromycin. * clarithromycin. * pyrazinamide. excluded within 14 days prior to study entry: * carbamazepine. * terfenadine. * theophylline.

Keywords: rifabutin mycobacterium avium-intracellulare infection drug therapy, combination ethambutol acquired immunodeficiency syndrome clarithromycin
a training program of drug allergy for healthcare professionals

Conditions: Drug Allergy

Summary: drug allergy is often under-recognized, yet over- (mistakenly) diagnosed, especially in hong kong. there is also a dire shortage of allergy specialists and facilities to tackle the overwhelming drug allergy pandemic. fortunately, when trained, non-specialist physicians and nurses have demonstrated comparable capabilities in drug allergy evaluation compared to specialists. to potentially promote and propagate the role of non-specialist physicians and nurses toward drug allergy care, the investigators propose a study to investigate the impact of an intensive and focused drug allergy educational course conducted at the university of hong kong.

two identical didactic courses on drug allergy were designed. each course will last 12 hours and conducted over 2 consecutive days (6 hours each day). all candidates will attend physically and on-site. various aspects of drug allergy with pre-set learning objectives will be taught in-person by instructors (physicians or nurses specializing in drug allergy nominated by the university of hong kong). course materials and instructors will be identical for each course. aims of the study primary objective * investigate the change in knowledge among participants of a 2-day drug allergy educational course * investigate the change in clinical practice among participants of a 2-day drug allergy educational course secondary objectives * investigate the sustained change(s) in knowledge (if any) of participants of a 2-day drug allergy educational course * investigate the sustained change(s) in clinical practice (if any) of participants of a 2-day drug allergy educational course hypothesis the investigators hypothesize that candidates (practicing physicians and nurses) of the drug allergy course will gain knowledge on drug allergy, which in turn will influence and change their clinical practice.

Eligibility criteria:
inclusion criteria: * registered nurses or doctors actively practicing in hong kong * english speaking; * able to complete quizzes and questionnaires; * aged 18 or above exclusion criteria: * people who are unable to communicate in cantonese or mandarin * people who are participating in other drug allergy training course

Keywords: drug allergy
local tranexamic acid during vaginal hysteractomy to reduce blood loss

Conditions: Blood Loss

Summary: assessing the efficiency of prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation

this randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy. the investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; local 1gr tranexamic acid diluted in 10 ml saline and local 10 ml saline at the beginning of surgery.

Eligibility criteria:
inclusion criteria: * 20-90 years old female patients going through vaginal hysterctomy exclusion criteria: * massive bleeding during operation due to major vessles injury * known coagulopathies * sensitivity to tranexamic acid * medical need in tranexamic acid administration during operation due to bleeding
the effect of lumify™ eyedrops on eyelid position

Conditions: Eyelid Droop

Summary: the purpose of the research is to see if lumify™ has an effect on eyelid position.


Eligibility criteria:
inclusion criteria: * adults age 18 and above able to provide informed consent to participate * subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention exclusion criteria: * adults unable to consent * prisoners * pregnant women. * known contradictions or sensitivities to study medication (brimonidine) * ocular surgery within the past 3 months or refractive surgery within the past six months * grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery * variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm) * significant pre-existing ptosis of any cause (defined as margin reflex distance 1 \< 1mm) * any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters * presence of an active ocular infection * prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents * inability to sit comfortably for 15 - 30 minutes
a study of donafenib monotherapy in advanced oesophageal cancer

Conditions: Oesophageal Cancer

Summary: this open-label, one-center, noncomparative, two-stages phase 1b trial assessed the tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced, inoperable oesophageal cancer progressing after chemotherapy . the primary endpoint is the safety.the secondary endpoints are tumor response and progression-free survival.

this open-label, noncomparative, two-part phase 1b trial recruited patients with advanced, inoperable oesophageal cancer. the primary objectives were to assess the safety for donafenib tosylate tablets .the secondary objectives were to estimate tumor response, progression-free survival, duration of response, and disease control rate (response plus stable disease); to evaluate changes in quality of life(qol); this study is 2-stages designing. the investigators plan to enroll 19 patients in the first stage study. the investigators will start the secondary stage study if the disease control rate \>=8/19.

Eligibility criteria:
inclusion criteria: * all patients provided written, informed consent. * have histologically confirmed advanced oesophageal squamous-cell carcinoma, or type i/ii siewert junctional tumours. * have received up to two previous chemotherapy regimens( platinum containing regimens \& paclitaxel / docetaxel containing regimens). * have an eastern cooperative oncology group performance status of 0-1. * have ability to swallow tablets. * no contraindications to sorafenib or donafenib. * have either measurable or evaluable lesion on ct. exclusion criteria: * patients with brain metastases. * patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks. * patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease) .

Keywords: donafenib
clinical trial to assess the efficacy of µsmin® plus

Conditions: Chronic Venous Disease

Summary: this study evaluates treatment with the dietary supplement µsmin® plus in a group of patients suffering from chronic venous insufficiency in comparison with a similarly-sized group of patients receiving placebo evaluated by quality of life questionnaires, vas pain scale, cvi symptomatology, and change in the circumference of the affected leg at calf level

in this study we use a dietary supplement - µsmin® plus - for symptomatic treatment of cvi and we will monitor its impact on cvi symptoms, features, and consequences (item) of the disease listed below: limb edema, walking, daily tasks performance, pain/burning symptoms, pruritus/paresthesis, sensation of heaviness/fatigue, time wasted in the management of the disease, social burden, disease impact on self-confidence, and its impact on physical exercise/recreational activities. results of related clinical trials were published before showing that this is an active field in clinical reasearch.

Eligibility criteria:
inclusion criteria: * male or female with age ≥18 and ≤60 with chronic venous insufficiency; * the chronic venous insufficiency must be graded between c2-c4 on the clinical-etiology-anatomy-pathophysiology (ceap) classification system; * able to communicate adequately with the investigator and to comply with the requirements for the entire study; * capable of and freely willing to provide written informed consent prior to participating in the study; * light smokers (\<10 cigarettes per day). exclusion criteria: * patients suffering from other or associated vascular diseases, diabetes or bleeding disorders; * oedema of the lower limbs of cardiac, renal or hepatic origin; * presence of symptoms and/or trophic disorders of arterial, metabolic, neurological or orthopedic origin including traumas, arthritis, neuropathy; * one or more factors likely to affect venous symptoms such as recent childbirth, recent stripping, or deep or superficial venous thrombosis of the lower limbs during the previous 6 months; * obese subjects (bmi \> 30); * hypersensitivity to active principles contained in the tested food supplement (diosmin); * patients considered smokers (≥10 cigarettes/day); * patients with concomitant or history of addiction to alcohol, spices or drug abuse; * pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception; * participation in an interventional clinical study in the previous 30 days; * presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
a study of fluzoparib in combination with mfolfirinox in patients with advanced pancreatic cancer

Conditions: Advanced Pancreatic Cancer

Summary: the study is being conducted to: a) evaluate the tolerability and safety of the co-administration of fluzoparib and mfolfirinox followed by fluzoparib maintenance monotherapy in patients with advanced pancreatic cancer, and establish the maximum tolerated dose and recommended phase ii dose of the combination; and b) assess the efficacy of the co-administration of fluzoparib and mfolfirinox followed by fluzoparib maintenance monotherapy in patients with advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * expected survival ≥ 6 months. * histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma. * documented mutation in germline brca1/2 or palb2 that is predicted to be deleterious or suspected deleterious. * adequate organ performance based on laboratory blood tests. * presence of at least of one measurable lesion in agreement to recist criteria. * women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients who have received any chemotherapy for the treatment of pancreatic cancer prior to entering the study. * previous treatment with any poly adp-ribose polymerase (parp) inhibitor. * patients who have had radiotherapy or participated in another clinical trial with any investigational agents within 28 days of enrolment (day 1 visit). * history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-fluorouracil or other agents used in the study. * previous treatment using cyp3a4 inducers within 3 weeks or inhibitors within 2 weeks of enrolment (day 1 visit). * patients with known or suspected brain metastasis. * significant cardiovascular disease such as new york heart associate class iii/iv, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ecg within 6 months prior to enrolment. * patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. * patients with myelodysplastic syndrome/acute myeloid leukaemia. * patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy. * known active hepatitis b or c infection. * history of immunodeficiency (including hiv infection) or organ transplantation. * other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.