Kornimate/medical-research-clean huggingface dataset:
neoadjuvant psma-rlt in oligometastatic pca

Conditions: Prostate Cancer

Summary: prospective single-center phase ii study to evaluate the psa, imaging and pathological response, as well as oncological outcomes of systemic radioligand therapy \[177lu\]lu-psmai\&t (psma-rlt) in patients planned for radical prostatectomy (rp) for oligometastatic prostate cancer (pca) diagnosed using \[68ga\]ga-psma-11 pet examination. ten patients with oligometastatic primary pca diagnosed using \[68ga\]ga-psma-11 pet-ct/mri imaging will be included in this study.


Eligibility criteria:
inclusion criteria: * oligometastatic pca diagnosed using \[68ga\]ga-psma-11 imaging defined as m1a and/or m1b positive with ≤5 osseous metastases and/or m1c ≤3 lung metastases * eastern cooperative oncology group (ecog) performance status: 0-1 * patients must have adequate bone marrow reserve: wbc ≥1.5 x 109 /l, platelets ≥100 x 109 /l and haemoglobin ≥9 g/dl. * patients must have adequate renal function with egfr ≥ 50ml/min/1.73m2 using the modification of diet renal disease (mdrd) equation and an albumin level of ≥2.5 g/dl. * patients must be able to sign informed consent form exclusion criteria: * concomitant participation in any other interventional trial * concurrent severe oncologic and medical conditions that result in patients not having a life expectancy of longer than the duration of the trial. * nonmetastatic pca on \[68ga\]ga-psma-11 imaging * \>5 osseous metastases on \[68ga\]ga-psma-11 imaging * visceral metastases, apart from lungs * age \> 75 years. * ongoing or previous androgen deprivation therapy with agonist or antagonist therapies. * presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study. * complete urinary out-flow obstruction or severe unmanageable urinary incontinence

Keywords: [177lu]lu-psmai&t oligometastatic prostate cancer radical prostatectomy therapy toxicity
effects of nasal septal surgery on sleep quality, daytime and dream anxiety

Conditions: Nasal Septal Deviation

Summary: the aim of this report was to assess the frequency of poor sleep quality, daytime and dream anxiety and their response to subsequent surgical treatment for a representative group patients with nasal septum deviation.

prior to the surgery, nasal airflows and airway resistances were measured employing rhinomanometry and they were also asked to fill in the pittsburgh sleep quality index (psqi), the beck anxiety inventory (bai), and the van dream anxiety scale (vdas). and, a postoperative assessment for the same parameters was made at two months from the day of the surgery.

Eligibility criteria:
inclusion criteria: * all participants, 18 to 65 years of age, had septal deviation consistent with the presenting symptoms which last at least three months and persist after a three months trial of medical management, including topical nasal steroids, topical or oral decongestants, or an oral antihistamine/decongestant combination. exclusion criteria: patients were excluded from the study if they had nasal septal surgery performed for other reasons, such as * an access to nasal and sinus tumors, * pituitary surgery and as part of treatment for sleep apnea or with concurrent sinus surgery; * had rhinoplasty prior to submucous resection; * had acute nasal trauma; * had adenoid hypertrophy; * had uncontrolled asthma/nasal allergy; * had diagnosed or suspected (snoring with/without other symptoms, such as apneas referred by someone and/or somnolence) osa; * had obesity (bmi ≥ 30.0 kg/m2); * had an unstable physical disorder; * had a current or lifetime history of any functional or organic mental disorder; * had a history of seizures; * had a neurological disorder that significantly affects central nervous system functions; * had met criteria for substance abuse or dependence in the previous 12 months, including nicotine dependence; * were taking medications that may cause or exacerbate sleep problems, daytime and dream anxiety; had clinical or laboratory evidence of hypothyroidism without adequate and stable replacement therapy; * had a history of antidepressant or sedative-hypnotic medications for any current or past complaint; * were pregnant or breastfeeding; or * were women not using effective contraception.

Keywords: anxiety septal surgery septum deviation sleep
mechanisms of neural mobilization in the treatment of chronic pain

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this study was to determine the effect of a manual therapy technique (neural mobilization) on measures of clinical pain and function, experimental pain sensitivity, and on the function of the median nerve in individuals with carpal tunnel syndrome. the investigators hypothesized that individuals receiving a neural mobilization technique known to directly stress the median nerve would demonstrate greater improvements in clinical pain and function, experimental pain sensitivity, and median nerve function than those receiving a sham technique.


Eligibility criteria:
inclusion criteria: * 18 to 70 years of age * signs and symptoms of carpal tunnel syndrome for greater than 12 weeks exclusion criteria: * non english speaking * prior surgery for carpal tunnel syndrome * systemic condition known to affect sensation * chronic pain condition other than carpal tunnel syndrome

Keywords: manual therapy carpal tunnel syndrome central sensitization
biomarkers in the diagnosis and assessment of pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: the investigators hypothesize that baseline plasma brain natriuretic peptide (bnp) and migration inhibitory factor (mif) levels are surrogate markers of clinical severity of pah and that changes in plasma brain natriuretic peptide (bnp) and mif levels pre and post exercise.

as above

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pah, based on currently accepted gold standard for right heart catheterization. * patients with mean artery pressure of greater that 25 mm hg at rest or 30mm hg during exercise with pulmonary capillary wedge pressure less than 18mm hg on right heart catheterization. exclusion criteria: * significant left heart disease or renal insufficiency (serum creatinine \> 1.5 mg%).

Keywords: pah biomarkers mif bnp 6 minute walk (6mw)
descriptive study of the efficacy of treatments for blastic dendritic cell neoplasm (bpdcn)

Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm; Hematological Malignancies

Summary: blastic plasmacytoid dendritic cell neoplasm (bpdcn) is a rare disease characterized by an aggressive clinical behavior and a poor prognosis. it predominantly affects elderly males with an average age of 67 years at diagnosis and the affected organs are usually the skin, bone marrow, lymph nodes and the central nervous system. patients with bpdcn have poor outcomes with median overall survival (os) ranging in the largest series of patients from 8 to 12 months. patient care must be defined in this pathology. despite 40%-90% complete remission (cr) rates after initial chemotherapy, relapses are almost inevitable. the investigators have developed a national network to collect clinical and biological data of french patients diagnosed with bpdcn.


Eligibility criteria:
inclusion criteria: * patients diagnosed with blastic plasmacytoid dendritic cell neoplasm (bpdcn) from january 2000 to june 2013 in france. * diagnosis should be established by hematology laboratory of french blood agency of bourgogne franche-comté and/or by anatomopathological analysis (realized in local centres or by tony petrella at dijon university hospital) according to phenotypic and anatomopathological criteria published in the literature. exclusion criteria: * no exclusion criteria
evaluation of biomarker levels in blood, saliva and gingival fluid in periodontitis

Conditions: Periodontitis

Summary: the aim of this study was to compare ima, mda, cat, gsh and ada levels in gingival crevicular fluid, serum and saliva of periodontally hopeless, periodontitis and gingivitis teeth with healthy control groups.

the research methodology was approved by the van yuzuncu yıl university clinical research ethics committee. (decision number: 06.06.2018/09). the aim of this study is to compare ischemia-modified albumin (ima), malondialdehyde (mda), catalase (cat), glutathione (gsh) and adenosine deaminase (ada) levels in gingival crevicular fluid, serum and saliva of periodontally hopeless, periodontitis and gingivitis teeth with healthy control groups. in this study, 25 periodontally healthy individuals (control group) and 25 individuals with various levels of periodontal disease in different teeth will be included. gingival crevicular fluid, saliva and blood samples will be taken from patients with periodontally healthy teeth without any treatment. in patients diagnosed with periodontal disease, teeth will be divided into 3 subgroups as hopeless, periodontitis and gingivitis. in patients with a diagnosis of periodontal disease, saliva and blood samples will be taken twice, before and after the training of scaling and root planing, desperate tooth extraction, oral hygiene motivation.

Eligibility criteria:
inclusion criteria: systemically healhty non-smokers non-pregnants - exclusion criteria: - patients with systemic disease smokers pregnants

Keywords: periodontitis catalase malondialdehide
vestibular physical therapy for people with alzheimer disease

Conditions: Vestibular Diseases; Alzheimer Disease; Cognitive Impairment

Summary: the purpose of this study is to assess the tolerability and preliminary efficacy of an 8-week home-based vestibular physical therapy program in people with cognitive impairment.

this project uses a novel non-pharmacological treatment to improve balance and reduce falls in patients with alzheimer disease (ad) using a conceptual framework that combines current vestibular physical therapy (vpt) practice guidelines with the latest motor learning theories for cognitively-impaired patients. the modified vpt protocol for ad patients was developed by experts in vpt and motor learning in ad and will be tested. this pilot study will provide much-needed data about whether vpt can be adapted for patients with ad, and whether vpt shows promise in improving or stabilizing balance, spatial cognition, and gait function in patients with ad.

Eligibility criteria:
inclusion criteria: * mild-ad diagnosis * complaints or observation of gat disturbance exclusion criteria: * inability to stand for 3 minutes without rest * recent lower extremity fractures/severe sprains (within last six months) * incapacitating back or lower extremity pain * confounding neurologic or neuromuscular disorders * presence of benign paroxysmal positional vertigo * pain elicited during cervical range of motion or limited cervical range of motion
proteomic pattern associated with the diagnosis of chronic thromboembolic pulmonary hypertension

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: chronic thromboembolic pulmonary hypertension (cteph) is a rare but severe complication of pulmonary embolism (pe). cteph is evoked in patients with persistent dyspnea. according to international guidelines, symptomatic patients with perfusion defects on lung scan and pulmonary hypertension (ph)-likely transthoracic echo (tte) must be evaluated in pulmonary hypertension (ph)-centers with right heart catheterism, to confirm or rule out the presence of precapillary pulmonary hypertension (ph), and precise the group of pulmonary hypertension (ph).

however, persistent dyspnea and perfusion defects are frequent after pulmonary embolism (pe), and the accuracy of transthoracic echo (tte) is not great for precapillary pulmonary hypertension (ph). this study proposed to seek for a specific proteomic pattern in patients admitted for a suspicion of chronic thromboembolic pulmonary hypertension (cteph).

Eligibility criteria:
inclusion criteria: * patient with a suspicion of chronic thromboembolic pulmonary hypertension (cteph) with a combination of a perfusion lung scan and transthoracic perfusion scan and transthoracic echocardiography compatible with the diagnosis (according to french recommendations) * patients who require a right heart catheterization. * patient affiliated or entitled to a social security plan * patient having received informed information about the study informed about the study exclusion criteria: * patient with a normal perfusion lung scan * person under legal guardianship

Keywords: pulmonary hypertension; chronic thromboembolic pulmonary hypertension pulmonary embolism proteomic pattern
a post-authorisation safety study (pass) of patients treated with lonapegsomatropin

Conditions: Growth Hormone Deficiency

Summary: the goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.


Eligibility criteria:
inclusion criteria: * paediatric patients with ghd who are on treatment with lonapegsomatropin * patients being clinically managed in europe or the usa * appropriate written informed consent/assent as applicable for the age of the patient * patients willing to comply with follow-up requirements of the study exclusion criteria: * patients participating in any interventional clinical trial for short stature * patients being treated with a gh or igf-1 therapy, other than lonapegsomatropin, at enrollment * patients for whom treatment with lonapegsomatropin is contraindicated * patients with closed epiphyses * patients with active malignant tumours * patients under antitumour therapy within the past 12 months prior to instituting gh therapy * hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

Keywords: human growth hormone hgh rhgh ghd long acting growth hormone lonapegsomatropin prodrug growth failure growth hormone replacement therapy sustained release growth hormone growth hormone deficiency transcon hgh skytrofa skypass
evaluation of vision effects of a cosmetic tinted hydrogel contact lens

Conditions: Refractive Error

Summary: subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.


Eligibility criteria:
inclusion criteria: 1. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. the subject must be between 35 and 42 years of age (inclusive). 4. the subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 diopters (d) to +4.00 d in each eye. 5. the subject's refractive cylinder must be ≤ 0.75 d in each eye. 6. the subject must have best corrected visual acuity of 20/30 or better in each eye. 7. the subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of daily wear (dw) for a minimum of 1 month prior to the study). 8. the subject must have normal eyes (i.e., no ocular medications or infections of any type). exclusion criteria: 1. currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., hiv) by self-report. 4. clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 5. clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 6. any ocular infection. 7. any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (prk), laser-assisted in situ keratomileusis (lasik), etc.) 8. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 9. habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear. 10. participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. 11. employee of investigational clinic (e.g., investigator, coordinator, technician)
analgesic effect to postoperative pain after mastectomy: ultrasound-guided serratus anterior plane block

Conditions: Breast Cancer

Summary: ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.


Eligibility criteria:
inclusion criteria: 1. asa 1\~3 2. age 20\~80 3. breast cancer patient twho are scheduled for elective mastectomy exclusion criteria: 1. allergy to local anesthetics or contraindication to use of ropivacaine 2. pregnancy 3. severe cardiovascular disease 4. renal failure 5. liver failure 6. neurologic and psychologic disease 7. chronic treatment with analgesics 8. previous history of mastectomy or thoracic surgery.

Keywords: serratus anterior block ultrasound breast cancer postoperative pain
study of midazolam in healthy adults

Conditions: Status Epilepticus

Summary: this study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (pk) of a single im administration of 10 mg midazolam using rafa's auto-injector compared with seizalam in healthy adults. all subjects will participate in both study periods which will span 28 days following a pre study screening visit.


Eligibility criteria:
inclusion criteria: 1. can understand and provide signed informed consent 2. is a healthy male or healthy, non-pregnant, non-lactating female whose screening, physical exam, labs, vitals, and ecg are within normal range 3. has a willingness to comply and be available for all protocol procedures 4. is between age 18 and 55 years, inclusive on the day of injection 5. if the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to injection note: a woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation or successful essure placement with documented confirmation test at least 3 months after the procedure 6. if the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception up to 1 month after the end of study visit note: acceptable contraception methods are restricted to effective devices (approved oral contraceptives, intrauterine contraceptive devices, nuvaring®) 7. if the subject is male, he agrees to practice abstinence from sexual intercourse with women or use acceptable contraception up to 1 month after the end of study visit 8. has a body mass index (bmi) ≥18.0 and ≤26.0 kg/m2 at screening 9. has a negative urine drug screen 10. has a negative breathalyzer test 11. subject is not taking any medications or st. john's wort and agrees to avoid grapefruit juice and alcohol until study completion on day 28 12. subject agrees to not take any vitamins or supplements 48 hours prior to dosing 13. is available for follow-up for the duration of the study exclusion criteria: 1. received treatment with another investigational drug within 28 days of initial dosing 2. has a current or history of drug and /or alcohol abuse 3. is pregnant or breastfeeding woman 4. has hypersensitivity or allergy to midazolam 5. has hypersensitivity or allergy to benzodiazepines 6. has a history of cardiovascular, pulmonary, neurological, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or psychiatric disease or any other reason, in the opinion of the investigator, that the patient should not participate 7. tests positive for hiv-1, hiv-2, hbsag, hepatitis c antibody, or syphilis 8. has had a blood donation in the 8 weeks prior to the study period start date
the effect of nerve blockades in addition to general anesthesia in surgical fixation of ankle fractures.

Conditions: Ankle Fracture in Need of Surgical Fixation

Summary: this clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. in particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. in addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. this would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.


Eligibility criteria:
inclusion criteria: * age \>18 years * patients in need of anaesthesia for operative fixation of ankle fractures. * american society of anesthesiologists (asa) score 1-3. * bmi \> 18 og \< 35. * oral and written consent exclusion criteria: * weight \< 50kg * allergy towards drugs used in the study * patients for re-operation * other fracture at the same time * pregnancy * daily use of opioids within two weeks before operation * infection near the application site * patients in need of dialysis * patients with neuropathy in lower extremities
dry needling for cervicogenic headache

Conditions: Headache; Cervicogenic Headache

Summary: this is a single-blinded randomized clinical trial. the primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.

this is a single-blinded randomized clinical trial. eligible participants who agree to enroll in the study will be asked to attend four testing sessions. participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. all dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling. the aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.

Eligibility criteria:
inclusion criteria: * unilateral headache (ha) without side shift * h/o pain triggered by neck movement * limitation in cervical range of motion * ispilateral neck, shoulder or arm pain * intermittent pain with episodes varying in duration * head and neck pain is non-throbbing in nature exclusion criteria: * use of anti-coagulation medicine (except low dose aspirin) * pregnancy * acute or uncontrolled medical illness * opioid use within six months * fibromyalgia or diffuse painful syndromes in the ue or le * substance abuse * presence of fever, vomiting or visual changes

Keywords: headache dry needling