Kornimate/medical-research-clean huggingface dataset:
adductor canal block and ipack block vs. isolated adductor canal block for post-operative analgesia following acl reconstruction with bone patellar tendon bone autograft:

Conditions: Anterior Cruciate Ligament Rupture

Summary: a randomized, single-blind, single-center study measuring the effects of adductor canal block combined with ipack infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing acl reconstruction with bone patellar tendon bone autograft

the protocol will determine if the addition of an ipack block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing aclr with bone patellar tendon bone autograft

Eligibility criteria:
inclusion criteria: * patients between 18 and 75 years of age * patients undergoing primary acl reconstruction with bptb autograft * asa i or ii exclusion criteria: * patients younger than 18 and older than 75. * patients with multi-ligament injury * patients undergoing concomitant cartilage procedure or osteotomy. * patients with a history of chronic pain that have used opioids for pain management for 3 months or longer. * patients who are allergic to oxycodone; * patients with diagnosed or self-reported cognitive dysfunction; * patients with a history of neurologic disorder that can interfere with pain sensation; * patients with a history of drug or recorded alcohol abuse; * patients who are unable to understand or follow instructions; * patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; * patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; * patients with a bmi over 45; * any patient that the investigators feel cannot comply with all study related procedures; * any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
two versus one week breast radiotherapy (rt)

Conditions: Breast Cancer

Summary: this study is comparing two different radiation therapy approaches for early breast cancer to see which one is better for patients. one group will receive radiation over one week (based on the fast-forward trial), and the other group will receive radiation over two weeks with an extra focused dose (called a "concomitant boost"). the study will look at how the treatments affect side effects, breast appearance, and cancer control in the breast. it also aims to find out if the two-week treatment does a better job at preventing cancer from coming back in the breast over the long term.

radiotherapy: one week (arm 1) 2600 cgy in 5 fractions whole breast radiotherapy over one week versus 2 weeks (arm 2), 3200 cgy in 10 fractions with a concomitant tumor bed boost to 3600 cgy. in arm 2, if no cavity is visible due to oncoplastic surgery, we will deliver 32 gy to the whole breast only, without a boost. hypothesis: a regimen of whole breast radiotherapy to 2600 in five fractions, the current uk standard for early breast cancer (arm 2), is not inferior to 3200cgy with a concomitant tumor bed boost to 3600 cgy in 10 fractions (arm 1), in terms of acute toxicity and long-term fibrosis, breast cosmesis and local control at 2 and 5 years. it will also test the hypothesis of superior local control at 10 years in arm 2 compared to arm 1.

Eligibility criteria:
inclusion criteria: 1. women status post segmental mastectomy. 2. if unilateral, pt1-2 breast cancer excised with negative margins. 3. if bilateral, pt1-2 breast cancer excised with negative margins and/or ptis excised with negative margins. 4. clinically n0 (cn0 as determined by ultrasound/sound criteria) or pn0-1 or nx or sentinel node negative. 5. ductal carcinoma in situ dcis with negative margins (no dcis on inked margins). 6. women with previous contralateral treated breast cancer can be enrolled in the trial. exclusion criteria: 1. previous radiation therapy to the ipsilateral breast. 2. \>90 days from last surgery, unless s/p adjuvant chemotherapy. 3. \>60 days from last chemotherapy. 4. male breast cancer. 5. ongoing treatment for severe autoimmune disease.

Keywords: accelerated radiotherapy prone position adjuvant setting non-inferiority concomitant boost
humidification needs

Conditions: Obstructive Sleep Apnea

Summary: a study undertaken to investigate mouth leak for airway discomfort/dryness while using cpap. this study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by utilizing different levels and types of humidification.


Eligibility criteria:
inclusion criteria: * aged 18 and over exclusion criteria: * inability to give consent * currently pregnant or think they may be pregnant * current nasal symptoms or chronic nasal disease * contraindicated for pap therapy
ucon treatment of the symptoms of faecal incontinence (fi)

Conditions: Faecal Incontinence; Faecal Incontinence With Faecal Urgency

Summary: ucon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (fi). it electrically stimulates the dgn through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient. this clinical investigation is designed as a single-arm, prospective, single-centre, early feasibility study.

the overall purpose of the current clinical investigation is to evaluate the medical device (ucon) with respect to initial safety and device performance in a cohort of spanish patients with fi over a treatment period of 4 weeks.

Eligibility criteria:
inclusion criteria: 1. participant is ≥ 18 years of age. 2. participant is showing symptoms of fi. 3. participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home. exclusion criteria: 1. participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation). 2. participant has an active infection in the genital area. 3. participant has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function). 4. participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). women of childbearing potential must maintain effective contraception\* during the interventional period judged by the investigator. 5. participant is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks to enrolment. 6. participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation, e.g., denervated patients and severe diabetic neuropathy. 7. participant is currently receiving cancer treatment. 8. participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs. 9. participant does not speak and understand spanish. * the following contraception is considered effective: intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.

Keywords: faecal incontinence faecal urgency neurostimulation dorsal genital nerve frequent bowel movements
effects of a resistance training period on blood pressure of hypertensive elderlies: influence of the polymorphism of the angiotensin converting enzyme

Conditions: Hypertension

Summary: the study aimed to evaluate the chronic effects of resistance training on blood pressure and biochemical exams in hypertensive elderlies and the influence of the polymorphism of the angiotensin converting enzyme in these response.

to investigate the chronic effects of resistance training on blood pressure and biochemical exams in elderly, 135 hypertensive elderlies were divided into 2 groups: trained and control. the trained group was submitted to a resistance training period. before the 16 weeks ace gene was genotyped (pcr). before and after 16 weeks, blood pressure (ambulatory), hdl-cholesterol, total cholesterol, glycemia, triacylglycerol (colorimetric assay) and plasminogen activator inhibition (pai-1), intercellular adhesion molecule (icam-1), vascular endothelial cell adhesion molecule (vcam-1), adiponectin, tumor necrosis factor alpha (tnf-alpha), c reactive protein, angiotensin ii, angiotensin converting enzyme, angiotensin 1-7, (elisa assay) were measured.

Eligibility criteria:
inclusion criteria: * hypertensives * age 60 to 85 years * nonactive exclusion criteria: * orthopedic problems or other problem that prevented the exercises * change in drug treatment during protocol * absence in more than 25% of the exercise sessions
percutaneous intradiscal radiofrequency as a treatment for radicular pain from lumbar disc herniation

Conditions: Disk Herniated Lumbar; Radicular Pain; Intradiscal Radiofrequency

Summary: the goal of this clinical trial is to demonstrate the efficacy of percutaneous intradiscal radiofrequency as a treatment for radicular pain from lumbar disc herniation. the main question it aims to answer is: • can percutaneous intradiscal radiofrequency lower the severity of radicular pain from lumbar disc herniation participants will be treated with percutaneous intradiscal radiofrequency and evaluated for radicular pain severity before and 3 months after the procedure. there is no comparison group.


Eligibility criteria:
inclusion criteria: 1. 18-85 year-old patients with radicular pain from lumbar disc herniation for ≥ 3 months 2. lumbar disc herniation ≤ 2 locations evidenced by mri, with ≥ 50% remaining disc height, without disc sequestration 3. previously treated with epidural steroid injection (esi) and achieved ≥ 50 % pain relief from local anesthetic effect, confirming radicular pain from lumbar disc herniation, but did not respond to esi (\< 50 % pain relief or pain relief \< 3 months) exclusion criteria: * patient refusal * discitis * previous lumbar spine surgery * progressive neurological deficit and/or cauda equina syndrome * coagulopathy * allergic to any medication in study protocols * unable to rate the pain * pain in any area worse than the radicular pain
interference of biotin supplementation in biotin-streptavidin platforms for hormone testing

Conditions: Thoracic Diseases; Parathyroid Diseases

Summary: the b vitamin biotin is widely available as an over the counter supplement, often advertised and used to promote health of hair, skin and nails. commercially available over the counter biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the recommended dietary allowance). the biotin molecule is also sometimes used as part of the lab technology to measure hormone and protein levels in the blood. it is possible that high doses of ingested biotin may interfere with accurate hormone or protein measurement using biotin related in vitro measurement systems. such interference, if present, could lead to misdiagnosis. the study will analyze laboratory levels obtained with streptavidin-biotin assay systems while ingesting biotin in currently available high dose supplements. the data will be compared to measurements obtained prior to and one week after stopping the biotin supplement.

specimens will be collected by venipuncture at 3 time points, including baseline (time 0), after one week of biotin supplementation (time 1, day 7), and then one week later (time 2, day 14). the time 1 specimen will be drawn approximately 2 hours after the last ingested dose of biotin on day 7. specimen collection will include three 10 ml red top (no gel) tubes at each timepoint. specimens will be separated for isolation of serum using routine methods of the clinical chemistry laboratory. serum will be stored at -80 degrees c until batch measurements as described measurements biotin levels will be measured on each sample. hormone measurements will be performed using specific commercially available streptavidin-biotin assays and using different analyzers as indicated below. immunoassay methods, not employing biotin-streptavidin methodology, will be used for negative assay controls.

Eligibility criteria:
inclusion criteria: healthy adults exclusion criteria: 1. pregnancy or lactation 2. known thyroid disease (goiter, abnormal thyroid state), 3. thyroid hormone treatment, 4. over the counter dietary/ nutritional supplement use currently or within the last 2 weeks (excluding standard multivitamin preparations containing no more than 100% of the daily value for biotin and calcium), 5. anticonvulsants, 6. night shift work, smokers, adults lacking capacity to consent for themselves

Keywords: biotin pharmacokinetic biotinylated assay hormone measurement thyroid parathyroid prolactin
assessment of the handling experience with the bi 695501 autoinjector in patients with rheumatoid arthritis followed by an extension phase using bi 695501 prefilled syringe

Conditions: Arthritis, Rheumatoid

Summary: this is an open-label, phase ii study of bi 695501 to assess handling experience of patients with rheumatoid arthritis using an autoinjector. the extension phase is to provide patients with additional exposure to bi 695501 and to enhance the safety database for this compound.


Eligibility criteria:
inclusion criteria: * moderately to severely active rheumatoid arthritis (ra) for at least 6 months, which is not adequately controlled by non-biologics dmards. * no contraindications to anti-tumor necrosis factor (tnf) agents. * either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen. * patients must be able and willing to self-inject bi 695501. further inclusion criteria apply. exclusion criteria: * experience with self-administration of medication using an autoinjector or pen. * american college of rheumatology functional class iv or wheelchair/ bed bound. * primary or secondary immunodeficiency. * history of tuberculosis (tb). further exclusion criteria apply.
evaluation of the effect of lurbinectedin (pm01183) on cardiac repolarization in patients with selected solid tumors

Conditions: Solid Tumors

Summary: study to assess the potential effects of lurbinectedin (pm01183) at a therapeutic dose on the duration of the qtc interval, measured by electrocardiograms (ecgs), to characterize the pm01183 plasma concentration/qtc relationship, and to explore related ecg parameters in patients with selected solid tumors.


Eligibility criteria:
inclusion criteria: * voluntarily signed and dated informed consent * normal cardiac conduction and function (centrally read) * blood pressure between 90 and 150 mmhg systolic, inclusive, and not higher than 90 mmhg diastolic. * specific serum electrolyte levels exclusion criteria: * age \> 65 years * performance status = 2 \[eastern cooperative oncology group (ecog)\] * heart rhythm disturbances * significant ischemic coronary disease, heart failure, myocardial infarction, or unstable angina within the last six months. * prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) \> 450 mg/m²
timing of low vision rehabilitation in anti- vascular endothelial growth factor (vegf) therapy

Conditions: Low Vision; Neovascular Age-related Macular Degeneration

Summary: the purpose of this research is to collect preliminary data in preparation for conducting a randomized clinical trial to determine the relative effectiveness of vision rehabilitation in improving overall visual ability (primary aim) and reducing depression (secondary aim) in patients receiving anti-vegf therapy for neovascular age-related macular degeneration integrated over time.

this is a pilot study to understand the feasibility of conducting a randomized, controlled trial regarding the timing for vision rehabilitation in patients receiving anti-vegf therapy for neovascular age-related macular degeneration. prior to initiating the clinical trial, the investigators must be assured that patients with loss in visual ability are willing to be randomized and amenable to deferring vision rehabilitation intervention. although it is typical for patients receiving usual care to present for vision rehabilitation services years after the onset of anti-vegf therapy, this manifestation may result from patients being unaware of the existence of vision rehabilitation services to enhance function and reduce depression. as part of the study recruitment, patients will be informed about vision rehabilitation care and, if suffering with difficulty performing everyday activities, they may be unwilling to defer vision rehabilitation. additionally, the study design may not be feasible to answer the aim should patients in the delayed intervention arms suffer progressive loss in visual ability and seek vision rehabilitation services, resulting in a high drop-out rate.

Eligibility criteria:
inclusion criteria: * age ≥ 50 years old * primary diagnosis of neovascular age-related macular degeneration in the index eye or in both eyes if habitual visual acuity (hva) is equivalent in both eyes * hva \< 20/25 to ≥ 20/500 in the index eye * confirmed active anti-vegf injections (a minimum of 2 injections in the past 3 months, a total of 8 injections maximum) in the index eye * full confrontational visual fields in the index eye * acknowledgement of having difficulty in visual ability function * visual ability estimates as measured by ≥ 2 goals identified on the activity inventory as important and with at least slight difficulty * telephone interview for cognitive status raw score is \> 29 * ability to return to clinic to participate in rehabilitation * no prior experience with vision rehabilitation service exclusion criteria: * other progressive ocular conditions likely to compromise va during the study period or upcoming eye surgeries * anti-vegf injections in the index eye 8 months prior to enrollment * unable to give written consent to the study * impaired hearing or cognitive ability that precludes telephone interviews * insufficient spoken english or reading ability to complete interviews and understand study materials * the index eye is defined as the eye with better hva, or the eye with more anti-vegf injections if both eyes are with the equivalent hva
the efficacy of the alma hybrid system for a new approach of facial skin treatment

Conditions: Rejuvenation

Summary: the study is aimed to evaluate the efficacy of the alma hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths. the study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.


Eligibility criteria:
main inclusion criteria: 1. male or female, 35 to 60 years of age, at the time of enrollment 2. fitzpatrick skin type i-iv 3. mild-moderate photo damages and wrinkles, with fitzpatrick-goldman wrinkle and elastosis score of 3-6 main exclusion criteria: 1. pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding 2. heavy smoker (\>1 pack of cigarettes a day) 3. unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study 4. previous rejuvenation treatments on the same area, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to the enrollment 5. prior use of collagen, fat injections, or other methods of skin augmentation within the past 12 months. 6. prior use of botox in the treatment area within 5 months 7. infection, dermatitis, rash, or other skin abnormality in the target area 8. history of any disease or condition that could impair wound healing 9. history of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
post-marketing surveillance study of the saphir stem in primary hip surgery

Conditions: Arthropathy of Hip

Summary: post-market clinical follow up investigation on the use of saphir stem and fin cup or dualis system in the treatment of pathologies requiring hip arthroplasty. the main object of the clinical investigation is the evaluation of long term survival rate of saphir stem.

the main object of the clinical investigation is the evaluation of stem (saphir) survival rate. the post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)

Eligibility criteria:
inclusion criteria: * patients\>18 years * candidate for primary total hip replacement with femoral stem and acetabular cup * if ostheoarthritis patients aged 18 to 85 years * if femoral neck fracture patients aged 18 to 90 years * patients with social security scheme * patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation * patients who gavee consent to partecipare in the clinical investigation exclusion criteria: * \<18 years * if female, pregnant * patient who has already had primary hip surgery on the same side * local or disseminated neoplastic disease * inability to understand the study and agree to partecipate * patients cancelling partecipation before surgery * patients under guardianship or curatorship * patients without a social security scheme * patients refusing to partecipate
prospective, randomized, controlled, clinical study on tolerability and efficacy of hmg-ibsa

Conditions: Infertility

Summary: purpose of the study is the evaluation of the tolerability (both local and systemic) and the clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly administered merional® (ibsa, lugano - ch) in patients undergoing controlled ovarian hyperstimulation (coh) in an art programme (ivf).


Eligibility criteria:
inclusion criteria: * female patients * aged between 20 and 40 years * undergoing ovarian stimulation for the purposes of oocyte retrieval in an assisted conception programme * body mass index (bmi) 20-28 kg/m2 * early follicular phase fsh level \< 9 iu/l. exclusion criteria: * ascertained or presumptive hypersensitivity to the active principle and/or their ingredients * primary ovarian failure * ovarian cysts or enlargement not due to polycystic ovarian syndrome * oocyte donation * abnormal bleeding of undetermined origin * patients who have exhibited poor response or requiring doses of more than 300 iu daily in previous treatment cycles or those who have received similar therapies (previous treatment cycles) in the 30 days prior to the beginning of the present study * uncontrolled thyroid or adrenal dysfunction * neoplasia * severe impairment of the renal and/or hepatic functions * diabetes and active thrombophlebitis, cardiopathies and epilepsy * presence of clinically significant systemic disease or any contraindication of being pregnant and/or carrying out a pregnancy to term * presence of any anatomical abnormality of the reproductive system * being pregnant or breastfeeding * menopause