Kornimate/medical-research-clean huggingface dataset:
modality of induction of labor in obese women at term (modobat)

Conditions: Induction of Labor Affected Fetus / Newborn; Obese

Summary: in normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. in obese patients, this efficacy is not known, although inductions of labor are more frequent. modobat aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon foley catheter) in obese women at term.

obesity has for several decades become a global epidemic in developed countries. in case of pregnancy, obesity leads to an increased risk of obstetric complications, the indications of induction of labor are then more frequent. unfortunately the rate of failed induction is also higher and therefore the risk of caesarean section is increased in obese women compared to normal-weight patients when induction of labor is indicated. however, in this context effectiveness of each mode of induction is not known. some retrospective studies would suggest that the balloon would be more effective because it would not be affected by the increase in fat mass but this result are not , but the to confirm this hypothesis. the aim of this study is to describe the caesarean section rate in induction of labor by vaginal dinoprostone and single balloon foley catheter in obese women. patients in the vaginal dinoprostone arm will be included retrospectively and patients in the single balloon foley catheter arm will be included prospectively.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * medical indication of induction of labor * bmi ≥ 30 kg / m2 * bishop \< 6 * singleton * gestational age \> 36 sa + 6j * cephalic presentation exclusion criteria: * adults under guardianship or curatorship * scarred uterus * placenta praevia

Keywords: induction of labor bmi obesity caesarean c-section pregnancy balloon dinoprostone
the efficacy of different rehabilitation protocols after achilles tendon rupture surgery

Conditions: Achilles Tendon Rupture

Summary: this study is a prospective randomized controlled clinical study. after the achilles tendon rupture repaired , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , respectively, to study the difference in efficacy between the groups.

this prospective randomized controlled clinical study is designed to compare the treatment outcomes of different rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. the inclusion criteria are patients with an acute closed single-legged complete achilles tendon rupture, and an age of 18 to 60 years. the exclusion criteria are patients with prior achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. all patients will be treated surgically with the same suture technique.

Eligibility criteria:
inclusion criteria: * acute closed single-legged complete achilles tendon rupture . * age of 18 to 60 years. exclusion criteria: * patients with prior achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). * an inability to complete our suture technique (e.g., the distance from the rupture site to the achilles tendon insertion was less than 3.5 cm) . * those without rehabilitation or follow-up outcomes.

Keywords: traditional rehabilitation protocol accelerated rehabilitation protocol ultrasonic monitoring
treatment of retinal vein occlusion (rvo) with open-label anecortave acetate (15mg.)

Conditions: Retinal Vein Occlusion

Summary: retinal vein occlusion is a blockage of the blood vessels that drain out of the retina. complications of retinal vein occlusion which threaten vision include neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid "leaking" from abnormal blood vessels). currently, the treatment of retinal vein occlusion is laser photocoagulation. this treatment has found to have limited use in this type of condition.anecortave acetate is being considered as an attempt to control the growth of the abnormal blood vessels.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of patients retinal vein occlusion. 2. patients must be 18 years of age or older to receive treatment. 3. visual acuity of 20/30 to 20/320 study eye on the etdrs visual acuity chart. 4. visual acuity of 20/800 or better fellow eye on the etdrs visual acuity chart. exclusion criteria: 1. patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. 2. patients who have undergone intraocular surgery within last 2 months. 3. patient participating in any other investigational drug study. 4. use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. 5. inability to obtain photographs to document cnv (including difficulty with venous access). 6. patient with significant liver disease or uremia. 7. patient with known adverse reaction to fluorescein and indocyanine green or iodine. 8. patient has a history of any medical condition which would preclude scheduled visits or completion of study. 9. patient has had insertion of scleral buckle in the study eye. 10. patient has received radiation treatment. 11. patient is on anticoagulant therapy with the exception of aspirin. 12. patient is pregnant or nursing.
mri-targeted focal ablation of the prostate in men with prostate cancer

Conditions: Prostate Cancer

Summary: this is a prospective single center trial to examine the rate of negative biopsy result and quality of life after focal ablation by radiofrequency energy. the primary evaluation involves assessing the rate of negative biopsy result using mr-us fusion biopsy six months after focal ablation of the prostate. urinary and sexual quality of life will be assessed through validated measures. the hypothesis of our study is that focal ablative therapy will result in a greater likelihood of negative biopsy on followup biopsy than that observed in men who elect not to undergo therapy.


Eligibility criteria:
inclusion criteria: subject population: * men 40-80 years of age * diagnosis of adenocarcinoma of the prostate, confirmed by transrectal ultrasound (trus) biopsy * no prior treatment for prostate cancer * prostate cancer clinical stage t1c * prostate-specific antigen (psa)\<10 ng/ml (this will be the psa level prompting the initial prostate biopsy) * declined all standard treatment options pre-enrollment biopsy parameters: * minimum of 12 biopsy cores * gleason 6 (3+3) or 7 (3+4) final enrollment biopsy parameters after fusion biopsy: * 12 standard biopsy cores plus targeted regions based upon mri * gleason 6 (3+3) or 7 (3+4) * no demonstrated cancer diameter \>1.2 cm exclusion criteria: * histology other than adenocarcinoma * biopsy does not meet inclusion criteria * history of transurethral resection of prostate (turp) or other similar procedures transurethral microwave therapy (tumt), transurethral needle ablation (tuna) * history of prior pelvic radiation * men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (lhrh)-agonist; 5-alpha-reductase inhibitors) within the previous 12 months * contraindication for multiparametric-mri

Keywords: prostate cancer focal ablation mri-us fusion biopsy focal therapy
micropulse tlt - uk study

Conditions: Glaucoma; Glaucoma Eye; Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Angle-Closure; Glaucoma, Neovascular; Glaucoma Traumatic; Glaucoma Uveitic

Summary: this prospective interventional study will assess the efficacy of mptlt in the uk.

we are establishing a national study of mptlt procedures, co-ordinating with all uk treatment centres to capture prospectively, details of all mptlt surgical procedure and outcomes. this will create a national uk registry of mptlt, allowing us to comply with nice requirements while adding to the quality of evidence available to support this minimally invasive therapy.

Eligibility criteria:
inclusion criteria: * patients with glaucoma or ocular hypertension deemed clinically suitable for mptlt treatment by their treating ophthalmologist; this includes but is not limited to (a) need for lower iop, (b) need for fewer medications based on side effects, poor compliance, adverse effect on lifestyle or (c) evidence of disease progression based on function or structure * risk of invasive surgical procedure deemed too high by patient or surgeon * aged 18 years or older * the ability to understand and comply with the trial consent process and procedures * willingness to be part of a national registry * ability to attend for follow-up * ability to give informed consent, or consent given by relative or carer exclusion criteria: * clinical situations where in the opinion of the investigator, the ocular surface may be compromised by probe contact, including severe ocular surface inflammation * inability to give informed consent * unwillingness to have clinical data stored in a secure electronic format * inability to comply with the study or follow-up procedures

Keywords: glaucoma micropulse transscleral laser therapy cyclophotocoagulation
petal trial: impact of gallium-68 pentixafor pet-ct on surgical outcomes in primary aldosteronism

Conditions: Primary Aldosteronism; Secondary Hypertension; Aldosterone-Producing Adenoma; Idiopathic Hyperaldosteronism; Adrenalectomy

Summary: this study is a randomized controlled trial to assess the clinical utility of gallium-68 pentixafor pet/ct in the management of primary aldosteronism (pa). we aim to evaluate whether the addition of 68ga-pentixafor pet/ct to standard adrenal venous sampling (avs) improves surgical outcomes in patients with unilateral pa.

primary aldosteronism (pa) is a common cause of secondary hypertension. accurate subtype classification (unilateral vs. bilateral) is essential to determine whether patients should receive adrenalectomy or medical therapy. avs is the current gold standard but has limitations, including its invasiveness, technical difficulty, and risk of failure. recently, non-invasive imaging techniques such as 68ga-pentixafor pet/ct and 11c-metomidate pet/ct have emerged as promising alternatives for subtype classification. these pet-based methods target molecular markers (e.g., cxcr4, cyp11b2) and show moderate to high concordance rates with avs (66.7%-90% for pentixafor). however, there is insufficient prospective evidence on whether these modalities can improve treatment outcomes. this randomized controlled trial aims to assess whether adding 68ga-pentixafor pet/ct to standard avs improves surgical outcomes in patients with unilateral pa. participants are randomized 1:1 to undergo either avs alone or avs plus 68ga-pentixafor pet/ct. additionally, 11c-metomidate pet/ct is performed in the intervention arm purely for research purposes and will not influence treatment decisions. by improving the precision of subtype classification, this study aims to improve patient selection for adrenalectomy, and ultimately enhance clinical outcomes in primary aldosteronism.

Eligibility criteria:
inclusion criteria: * age ≥19 years * diagnosed with pa per 2016 endocrine society guidelines * underwent adrenal ct * signed informed consent exclusion criteria: * women who are pregnant, breastfeeding, or may become pregnant * individuals who refuse to undergo surgery * individuals for whom 68ga-pentixafor pet/ct, 11c-metomidate pet/ct, or adrenal venous sampling (avs) is not feasible or is refused due to underlying conditions * individuals who refuse or experience adverse effects from dexamethasone premedication required for 11c-metomidate pet/ct * individuals with a history of abdominal open surgery or retroperitoneal surgery on the same side as the planned adrenalectomy * any individual deemed unsuitable for the study at the discretion of the investigator

Keywords: primary aldosteronism gallium-68 pentixafor 11c-metomidate pet/ct adrenal venous sampling paso pamo adrenalectomy
phase 2 hyper-cvad/rituximab for untreated mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: rituximab and modified (hypercvad) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hypercvad) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Eligibility criteria:
inclusion criteria: * untreated mantle cell lymphoma exclusion criteria: * pregnant or breast feeding

Keywords: untreated mantle cell lymphoma
prospective randomized trial comparing endoscopic submucosal dissection against laparoscopic assisted gastrectomy for treatment of early gastric cancer

Conditions: Early Gastric Cancer

Summary: the investigators compared the perioperative, oncological, functional and immunological outcomes of endoscopic submucosal dissection against laparoscopic assisted gastrectomy for treatment of early gastric cancer. with virtually no abdominal incisions and minimal pain induced, endoscopic submucosal dissection is expected to be less invasive when compared to laparoscopic assisted gastrectomy for treatment of early gastric cancer. this study will show that endoscopic submucosal dissection is associated with a significantly better perioperative recovery and less immunological disturbance. moreover, it will also induce a better long term outcomes as the stomach can be preserved, hence the digestive function is maintained to prevent long term functional morbidities of the gastrointestinal tract. this study will be the unique first study in the literature to show that intramucosal early gastric cancer can be adequately treated by endoscopic submucosal dissection with better perioperative, functional and quality of life outcomes when compared to laparoscopic assisted gastrectomy.


Eligibility criteria:
inclusion criteria: 1. early gastric cancer with biopsy confirmed high grade dysplasia or adenocarcinoma (intestinal type) 2. preoperative investigation with magnifying endoscopy and / or eus predicted to be mucosal lesion 3. any tumor size if the early gastric cancer has no ulceration 4. tumor size ≤ 3cm if the early gastric cancer has ulceration exclusion criteria: 1. gastric cancer with preoperative magnifying endoscopy and / or eus predicted to beyond submucosal invasion 2. poorly differentiated or signet ring cell adenocarcinoma 3. age \> 80 or \< 16 4. pregnancy 5. asa \> iv
translation, cross-cultural adaptation and validation of pro-ctcae for italian-speaking cancer patients

Conditions: Cancer

Summary: the purpose of this study is to see if the italian language version of a questionnaire about symptoms that patients may have during cancer treatment is understandable to italian speaking patients. the questionnaire is called the pro-ctcae, and was originally developed at the u.s. national cancer institute to help get information about patients' symptoms directly from the patients themselves. the italian version of the questionnaire will be used in future studies to gain a better understanding of patient symptoms.

this study will be conducted in two steps. the first is the italian translation and cross cultural adaptation of the original us nci's version of the pro-ctcae questionnaire. the questionnaire will be translated and administered to a sample of 96 italian patients. after protocol amendment in november 2016, the second step was modified and consists of test-retest reliability assessment of the italian language version of the pro-ctcae questionnaire that was developed in the first step, with a minimum of 59 italian speaking patients to be enrolled. a validation study is planned and will be the subject of a separate protocol.

Eligibility criteria:
eligibility criteria for cross-cultural adaption phase: inclusion criteria: * patients receiving (or who have received within 6 months) chemotherapy or radiotherapy with curative or palliative intent for an advanced cancer at one of the study sites * ≥18 years of age * able to speak and understand italian * providing written informed consent exclusion criteria: • patients judged unable to report on their symptoms from the last seven days due to cognitive impairment. eligibility criteria for validation phase: inclusion criteria: * ≥18 years of age. * patient is able to complete pro-ctcae on two consecutive days. * patient is actively receivingmedical treatment for cancer or has completed treatment not more than 4 weeks before visit 1 * any type of cancer * able to complete questionnaire by themselves or with assistance. * providing informed written consent. * able to speak and understand italian exclusion criteria: * clinically significant cognitive or memory impairment in the opinion of clinical or research staff. * other important acute medical conditions that, in the opinion of the investigator, may prevent compliance..

Keywords: patient reported outcomes
post-market study of comprehensive reverse augmented glenoid and mini humeral tray in total shoulder arthroplasty

Conditions: Arthropathy of Shoulder Region; Grossly Deficient Rotator Cuff; Osteoarthritis of the Shoulder; Rheumatoid Arthritis Without Humeral Metaphyseal Defects; Post-Traumatic Arthritis

Summary: this study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. the primary objective of this study is to confirm the safety and performance of the comprehensive reverse shoulder system when used with the comprehensive porous augmented glenoid baseplate and/or comprehensive mini humeral tray in primary and revision reverse shoulder arthroplasty.

the comprehensive reverse porous augmented glenoid baseplate and comprehensive mini humeral tray belong to the comprehensive reverse shoulder arthroplasty system. they were developed to provide patients with grossly deficient rotator cuffs with another surgical option. the aim of the comprehensive reverse shoulder system is to increase shoulder function while reducing pain. a maximum of 7 sites will contribute to this study. enrollment of 7 sites on a global scale will allow for assessment of device consistency across different regions. enrollment per site will not exceed 45 shoulders. 146 implants will be included in this study with competitive enrollment. all potential study subjects will be required to participate in the informed consent process.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older. * patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid. * patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. * patient must be able and willing to complete the protocol required follow-up. * patient must be able and willing to sign the institutional review board/ethics committee approved informed consent. exclusion criteria: * patient is a prisoner. * patient is a current alcohol or drug abuser. * uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * patient presents with osteoporosis. * patient has a metabolic disorder that may impair bone formation. * patient has osteomalacia. * patient has distant foci of infections which may spread to the implant site. * patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Keywords: reverse shoulder arthroplasty medical device performance safety shoulder prosthesis glenoid erosion
a 10-week efficacy and safety study for of gabitril in the treatment of adults with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (gad)


Eligibility criteria:
inclusion criteria: * subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the dsm-iv-tr criteria for gad, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., ham-a, hads, madrs and cgi-s). exclusion criteria: * have been previously unresponsive to two or more adequate courses of pharmacological treatment for gad * have been diagnosed with any other psychiatric axis i disorder (except gad) as a principal diagnosis within the past six months * have been diagnosed with any eating disorder within the past six months * have any history of ocd, psychotic disorder, bipolar disorder or antisocial personality disorder * have any history of alcohol or substance abuse within the past 3 months * have any history of seizures, including febrile seizures * have any history of head trauma associated with loss of consciousness within the past 15 years
muscle o2 saturation and hemoglobin levels during rehabilitation from arthroscopic surgery

Conditions: ACL Injury; Hip Injuries

Summary: this study will utilize the moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (acl or hip arthroscopy) to evaluate their return-to-play. the acquired data will complement current protocols utilized by dr. voos and dr. salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.

patients with a diagnosis of acl tear or hip pathology will undergo surgery. following surgery, patients will report to clinic for scheduled physical therapy per their institution's injury-specific physical therapy protocol. at set time points (6-week, 12-week, 6 months, and 9 months) during their recovery, patients will be assessed for muscle oxygen saturation and hemoglobin levels with the moxy sensor. this sensor is a non-invasive device placed over the rectus femoris to monitor oxygen and hemoglobin levels. the patient will then follow the therapy as instructed by the physical therapist and perform the protocol-specific exercises with the sensor in place. the measured parameters will be recorded and stored per patient. the injured patients will be compared to healthy control patients undergoing a similar one-hour exercise session while wearing the moxy sensor for comparison of results. the goal of this study is to use the data obtained from the moxy sensor device to further predict recovery of function in muscles supporting injured soft tissues to determine safe return to sport.

Eligibility criteria:
inclusion criteria: * age range: patients age 14 to 30 years * patients with acl injury requiring surgical correction * patients undergoing arthroscopic hip surgery * healthy individuals with no history of acl, arthroscopic knee or arthroscopic hip surgery exclusion criteria: * patients below 14 years or above 30 years * non-english-speaking subjects * pregnant individuals