Kornimate/medical-research-clean huggingface dataset:
chronic electrical stimulation of hypothalamus/fornix in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: alzheimer's disease (ad) is the most common cause of dementia for which no treatment has shown consistent efficacy to stop or slow down the disease. recent report of enhancement of memory abilities by bilateral chronic deep brain stimulation (dbs) of the fornix in the hypothalamus suggests that neuromodulation of circuits involved in memory processes may have therapeutic implications in ad patients with memory decline. the primary objectives of this prospective, non-controlled, pilot study are to evaluate the feasibility and safety of dbs in ad patients with mild cognitive and memory impairment, and to evaluate the efficacy of dbs to slow down or stabilize this decline. five patients with ad (dsm iv) diagnosed less than two years, with mild cognitive decline (mmse 20-24), and specific impairment of episodic memory will be included in a 2-year period. the evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event (ae). efficacy will be evaluated using numerous cognitive and memory testing. changes in behavioral and mood scales, and changes in hypothalamic functions (clinical, biological and hormonal assessment) will evaluate safety and tolerance. clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. bilateral electrodes (medtronic 3389) will be implanted, by mr-guided frame-based stereotaxy, in the hypothalamic part of the fornix, and then connected to the generator (kinetra, medtronic). chronic high-frequency stimulation will be delivered immediately after surgery. the investigators expect to slow down, or to stabilize the spontaneous decline of mmse and adas scores after 6, 12 and 24 months of stimulation. in case of efficacy, dbs might offer to ad patient the possibility to slow down/stabilize their symptoms, which no other treatment can currently offer, and to increase their quality of life.


Eligibility criteria:
inclusion criteria: * patients with ad (dsm iv) diagnosed less than 2 years * age between 50 and 65 * mild cognitive decline (mmse between 20 and 24) * specific impairment of episodic memory (evaluated by grober\&buschke scale) * able to give and sign an informed consent * affiliated to the french national health and pensions organization exclusion criteria: * associated dsm i axis pathology * contra-indication to surgery or mri * preoperative mri abnormalities * retraction of consent by the patient * decision of the promoter to stop the study
point-of-care-ultrasound in swiss air rescue rega

Conditions: Point-of-care-ultrasound; Emergency Treatment

Summary: the aim of the study is, on the one hand, to objectively investigate the patient-oriented benefits of prehospital point-of-care ultrasound (pocus) examinations under the conditions of the helicopter emergency medical services (hems) in switzerland. on the other hand, the study will show what the diagnostic quality of prehospital pocus examinations is and how emergency medical teams can be trained to use pocus in the future. hems crew members will answer a short online questionaire about how findings of their pocus examination has influenced their medical treatment, diagnosis and selection of target hospital for the patient (primary outcome parameters). in addition, a study nurse will query the findings of the in-hospital diagnostic tests and compare them with the findings of the pre-hospital pocus examination. this will enable the investigators to evaluate the diagnostic quality of the prehospital pocus examination and to identify which findings are often not recognised in the pocus. the subjective satisfaction and assessment of the benefit of the pocus examination by the respective users will also be recorded (secondary outcome parameters).


Eligibility criteria:
inclusion criteria: * all patients in whom the treating rega team uses pocus pre-hospital * existing written general consent (with permission to use patient data for research) exclusion criteria: * age \&lt;18 years

Keywords: pocus helicopter emergency medical service diagnostic quality
endometrial injury in women with unexplained infertility

Conditions: Unexplained Infertility

Summary: women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. in a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (study group) or no intervention (control group). natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.

a single site-specific hysteroscopic injury procedure (snip) will be performed using an office hysteroscopy (karl storz, germany). by means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath. the examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. subsequently, a claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (endometrial snip) at midline 10-15 mm from the fundus on d4 to d7 of the ongoing menstrual cycle. the depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). no premedications, antibiotics or hemostatics will be given after the procedure. natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 iu of hcg will be administered to trigger ovulation.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 39 years old. 2. normal hsg and/or diagnostic laparoscopy. 3. normal seminal profile. 4. regular ovulation confirmed by mid-luteal progesterone. 5. normal tvs criteria. exclusion criteria: 1. uterine fibroid. 2. pelvic endometriosis. 3. irregular menstruation. 4. ovarian cysts.
a study of brentuximab vedotin in adults with hodgkin's lymphoma

Conditions: Hodgkin Lymphoma

Summary: the main aim is to check how effective bv is for treating adults with hl. study medication will be prescribed according to the clinic's standard practice. participants will visit the study clinic 5 times, once every 12 weeks. when study treatment has completed, a follow-up visit will be scheduled every 3 months during the first year and every 4-6 months during the next year.

this is a prospective, observational study in participants with hl who underwent or are candidates for asct and receiving or will receive the standard treatment of bv. this study will assess the safety profile and effectiveness of bv in pre and post-asct in the real-world clinical practice. the study will enroll approximately 70 participants. the data will be collected and recorded in electronic case report forms (e-crfs) in scope of national drug program (ndp). all the participants will be assigned to two observational cohorts: * hl participants: bv salvage pre-asct * hl participants: bv consolidation treatment post-asct this multi-center trial will be conducted in poland. all participants will be followed up for 24 months. the overall duration of the study will be approximately 4.5 years.

Eligibility criteria:
inclusion criteria: 1. adult participant (aged greater than or equal to \[\>=18\] years) that underwent or are candidates for asct and were enrolled in bv hl ndp receiving treatment according to the summary of product characteristics for adcetris and ndp. exclusion criteria: 1. currently participates or plans to participate in any interventional clinical trial. 2. any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.

Keywords: drug therapy
the influence of sensory phenotype on the risk of developing neuropathic pain

Conditions: Neuropathic Pain; Polyneuropathy; Peripheral Nerve Injury

Summary: cross-sectional and longitudinal analysis of the somatosensory phenotype, assessed by quantitative sensory testing (qst) and information obtained by questionnaires to detect risk factors for neuropathic pain development and chronification in painless and chronic pain patients.


Eligibility criteria:
inclusion criteria: * chronic peripheral neuropathic pain or * painless patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced) exclusion criteria: * minors
prospective registration and assessment of serious adverse events within the afnet

Conditions: Atrial Fibrillation; Assessment of Serious Advers Events; Thromboembolic and Bleeding Complications; Complications of Antiarrhythmic Drugs or Invasive Procedures; Assessment by a Critical Event Committee

Summary: prospective registration and independent assessment of sae associated with atrial fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by a critical event committee.

atrial fibrillation (af), the most common sustained rhythm disturbance, is associated with a significantly enhanced mortality and morbidity due to thromboembolic events, and other cardiac and noncardiac complications. therefore the "network of competence on atrial fibrillation (afnet)" supported by the german ministry for education and research (bmbf) was established in order to collect clinical data on patients (pts) with af (paroxysmal, persistent, permanent) over a study period of 6 years with an expected sample size of 12,000 pts. incidence, clinical relevance and outcome after sae is recorded and assessed by a critical event committee (cec). the cec-members (experts in cardiology and neurology) defined as sae any death with or without relationship to af, cardio-embolic events (stroke, peripheral arterial embolism), bleeding complications due to antithrombotic therapy, acute heart failure, syncope, resuscitation; additionally, the complication of interventional strategies for af-treatment and other af-independent saes. over a 3-year follow-up period, during 6-monthly and unscheduled visits, the saes are systematically documented, blinded and their relationship to af will be interpreted in detail by the cec.

Eligibility criteria:
inclusion criteria: * atrial fibrillation documented by ecg not older then one year * age \> 18 years * informed consent exclusion criteria: * none

Keywords: atrial fibrillation critical event committee serious adverse events thromboembolic complications cardiac and noncardiac complications bleeding complications acute heart failure syncope resuscitation
atorvastatin for reduction of myocardial damage during angiography and its mechanism associated with imr

Conditions: Stable Angina; Unstable Angina; Acute Non-ST-segment Elevation Myocardial Infarction

Summary: the purpose of this study is to determine whether preoperative loading dose atorvastatin can prevent perioperative myocardial infarction during angiography and main adverse cardiac events 1 month after operation in stable angina, unstable angina and acute non-st-segment elevation myocardial infarction patients undergoing elective coronary angiography and pci, and determine whether its mechanisms are associated with microcirculation resistance.

with 20 years of popularity of the clinical applications of percutaneous coronary intervention (pci), increasing attention has been paid to postoperative myocardial injury (mi) after pci. naples ii1 and armyda2studies have shown that loading dose statin therapy before pci for acs patients can reduce perioperative myocardial infarction and major adverse cardiac events (mace) and mortality 1 year after pci. the core mechanism about the effects of statins on the clinical outcomes above-mentioned, which can not been completely explained by the lipid-lowering effect, so far have not been discovered in previous studies. thus the interest of some researchers turned to the other point of view, such as coronary microcirculation. mi after pci is a kind of non-st-segment elevation myocardial infarction (nstemi) related to coronary microcirculation, which can not been detected by coronary angiography, but can be detected by index of microcirculatory resistance (imr) examination. in this study, we will recruit stable angina, unstable angina and acute non-st-segment elevation myocardial infarction patients who have been confirmed by coronary angiography. at the time of enrollment, patients will be randomly assigned to loading dose group (atorvastatin 80 mg 12 hours before pci and 40 mg 2 hours before pci and then 20mg/d after pci) or control group (atorvastatin 20 mg 12 hours before pci and then 20mg/d after pci). when pci is performed, index of microvascular resistance (imr) will be measured before and after the procedure. periprocedural myocardial infarction will be defined by post-pci cardiac biomarker. all patients will be followed for adverse cardiac events for 1 month.

Eligibility criteria:
inclusion criteria: * patients with stable angina * patients with unstable angina patients * patients with acute non stsegment elevation myocardial infarction * patients willing to accept the need regular follow-up of this study * patients 18-75 years of age * patients who signed an informed consent form exclusion criteria: * st segment elevation acute myocardial infarction * emergency coronary angiography in patients * patients with abnormal liver function * heavily calcified, distortions coronary lesions * lvef \<30% of patients * egfr\<30ml/min/1.73 square meters * liver disease or a history of muscle disease

Keywords: stable angina unstable angina acute non-st-segment elevation myocardial infarction pci perioperative myocardial infarction major adverse cardiac events
identification of molecular signatures of high-risk oncogenic hpv and study of their associations with the presence of high-grade lesions and/or anal cancer 10 years after inclusion in the anrs ipergay trial

Conditions: HPV Infection; Anal Cancer

Summary: hpvsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the hpv substudy of the anrs ipergay trial. the study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (hra) during the hpvsign study and/or diagnosed since the end of participation in the anrs ipergay trial.

the study aims to enrol 80 to 100 participants in french clinical centres. all the participants have participated to the ipergay hpv substudy. the study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (hra) during the hpvsign study and/or diagnosed since the end of participation in the anrs ipergay trial. also, the study proposes to: * study the association between the presence of hsil and/or anal cancer and hpv molecular signatures during participation in the anrs ipergay trial and 10 years after. * study the evolution of hpv molecular signatures from participation in the anrs ipergay to current study * compare hra results with anal cytology results * compare the results of anal cytology concomitant with hra with those obtained during participation in the anrs ipergay trial. * study factors associated with the presence of hsil and/or anal cancer. * compare the presence of different hpv virus types in the oropharynx concomitant with hra and during participation in the anrs ipergay trial.

Eligibility criteria:
inclusion criteria: * participant in the anrs ipergay clinical trial who was included in the initial hpv sub-study; * informed and written signed consent * participant with regular health insurance exclusion criteria: * participant under guardianship or curatorship * participant with free state medical assistance * participant who disagrees with the use of data collected as part of their participation in the anrs ipergay trial.

Keywords: hsil
an study to evaluate the safety and efficacy of paltusotine for the treatment of acromegaly (acrobat edge)

Conditions: Acromegaly

Summary: an open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly crn00808) in subjects with acromegaly that are treated with somatostatin analogue (ssa) based treatment regimens.


Eligibility criteria:
inclusion criteria: 1. male and female subjects 18 to 75 years of age 2. confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens 3. females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. willing to provide signed informed consent exclusion criteria: 1. treatment naïve acromegaly subjects 2. prior treatment with paltusotine 3. pituitary surgery within 6 months prior to screening. subjects receiving radiation therapy may be eligible with some restrictions. 4. history or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 5. use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. positive test at screening for hiv, hepatitis b surface antigen (hbsag) or hepatitis c antibody (hcv-ab) or has a history of a positive result 7. history of alcohol or substance abuse in the past 12 months 8. any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. cardiovascular conditions or medications associated with prolonged qt or those which predispose subjects to heart rhythm abnormalities 10. subjects with symptomatic cholelithiasis 11. subjects with clinically significant abnormal findings during the screening period, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or ability to complete the study 12. subjects taking octreotide lar at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide lar at a dose higher than 60 mg 13. subjects who usually take octreotide lar or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Keywords: acromegaly acrobat edge paltusotine
study to evaluate botulinum neurotoxin serotype e (eb-001) in reducing musculoskeletal pain in abdominoplasty

Conditions: Abdominoplasty

Summary: to determine the safety and efficacy of single intra-operative treatment of botulinum neurotoxin serotype e (eb-001) intramuscular (im) injections into the rectus abdominus (ra) in participants undergoing abdominoplasty.


Eligibility criteria:
inclusion criteria: 1. men or women 23 to 55 years of age, inclusive 2. scheduled to undergo elective abdominoplasty surgery with full length plication from xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal or otherwise) without liposuction 3. american society of anesthesiologist (asa) physical class 1-2. exclusion criteria: 1. history of prior major abdominal surgery as judged by the investigator 2. pre-existing lung disease that could impact participant safety in the opinion of the investigator 3. pre-existing disorders of the neuromuscular junction (myasthenia gravis, eaton- lambert syndrome, or amyotrophic lateral sclerosis) 4. at high risk of deep vein thrombosis as judged by the investigators determined by a caprini score of 3 or higher 5. slow vital capacity that is below 80% of normal value for respective race, age, height, and gender or below 2.5 liters (l) of absolute volume 6. pulse oximetry below 95% 7. body weight less than 50 kg (110 pounds) or a body mass index (bmi) of ≥ 32 8. reported use of any botulinum toxin within 3 months prior to the date of surgery 9. use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery 10. aminoglycoside intake within 48 hours prior to or during surgery 11. participants on anti-depressant or anti-psychotic medications 12. reported pain score of 2 or more at screening on the 11-point scale numerical pain rating scale-administered after an activity (nprs-a) following an activity after and walking approximately 10 feet.

Keywords: pain, neurotoxin
music therapy in alzheimer's disease

Conditions: Alzheimer's Type Dementia

Summary: the primary purpose of the protocol is to demonstrate that the use of music therapy may make it possible to discontinue at least one of neuroleptic treatment in patients with ad or related symptoms complicated by behavioral disorders such as agitation and aggressiveness evaluated using the neuropsychiatric inventory (npi). the study hypothesis is that music therapy may have a positive impact on patients with ad complicated by behavioral disorders by reducing the intensity of oppositional behaviour and aggressiveness and allowing a diminution of neuroleptic treatment.

a technique of receptive music therapy to induce relaxation has been developed in the university hospital of montpellier: the "u" sequence. the musical sequence lasts 20 minutes and is made up of several phases that progressively induce a relaxed state in the patient. this effect is obtained by modulating the rhythm of the music, the orchestral formation, frequencies and volume. the phase of maximum relaxation is followed by a stimulating phase. these musical sequences have been specially designed by the music publishers music care©.

Eligibility criteria:
inclusion criteria: * subjects of either sex aged 65 years and over, living in an institution for the dependent elderly for at least 3 months * subjects with alzheimer-type dementia (dsm-iv and national institute of neurological and communicative disorders and stroke - alzheimer's disease and related disorders association (nincds-adrda) criteria)or related symptoms * if treated, treated for at least 6 months with a stable dose of cholinesterase inhibitor or memantine * mini-mental state examination (mmse) score between 5 and 20 * patients with disruptive behaviour (at least one disruptive item on the npi: oppositional behaviour/aggressiveness/agitation, aberrant motor behaviour, with a severity score grater than or equal to 4) and treated with at least one neuroleptic whose dose which could not be decreased because of persistence of the behavioural problems for at least 15 days. exclusion criteria: * decompensated physical disease * inability to give informed consent * lack of health insurance coverage * non-corrected hearing impairment * treatment ongoing with two or more neuroleptics

Keywords: alzheimer's disease neuroleptics music therapy