Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of paltusotine for the treatment of acromegaly (pathfndr-2)

Conditions: Acromegaly

Summary: a randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (formerly crn00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with non-pharmacologically treated acromegaly.


Eligibility criteria:
inclusion criteria: 1. male and female subjects ≥18 years of age 2. confirmed diagnosis of acromegaly and either medically naïve, not currently treated, or willing to washout during the study screening period. 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. pituitary radiation therapy within 3 years of screening 2. prior treatment with paltusotine 3. history of ineffective or intolerance to octreotide or lanreotide 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. known history of hiv, hepatitis b, or active hepatitis c 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, or 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 currently or previously using pegvisomant or cabergoline (within 16 weeks prior to screening) or pasireotide lar (within 24 weeks prior to screening)

Keywords: acromegaly pathfndr paltusotine crn00808
evaluation of physiologic parameters to study the mechanism of action of the lung volume reduction coil in subjects with homogeneous emphysema

Conditions: Emphysema

Summary: the pneumrx lung volume reduction coil (lvrc) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. the mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. the objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.


Eligibility criteria:
inclusion criteria: subject \> 35 years of age ct scan indicates homogeneous emphysema subject has stopped smoking for a minimum of 6 months prior subject (and legal guardian if applicable) read, understood and signed the informed consent form exclusion criteria: subject has a history of recurrent clinically significant respiratory infection subject has uncontrolled pulmonary hypertension subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc subject is pregnant or lactating subject has an inability to tolerate bronchoscopy subject has clinically significant bronchiectasis subject has giant bullae subject has had previous lvr surgery, lung transplant or lobectomy subject has been involved in other pulmonary drug studies with 30 days prior subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Keywords: lvrs (lung volume reduction surgery) lvrc (lung volume reduction coil) emphysema coil repneu
preventing propofol-associated injection pain

Conditions: Pain

Summary: injection of propofol is associated with discomfort in subsets of patients. local anesthetics have been shown to attenuate this response in some patients. this randomized, double-blind, placebo-controlled trial tests the hypothesis that lidocaine mixed with propofol will be superior to lidocaine administered directly into the vein, under tourniquet control, prior to injection of propofol. both groups are expected to be superior to placebo.


Eligibility criteria:
inclusion criteria: * weight \>40kg, \<100kg * ambulatory surgery exclusion criteria: * allergy to propofol or lidocaine * taking opioids, benzodiazepines, or nonsteroidal antiinflammatory drugs (nsaids)

Keywords: propofol lidocaine injection pain
enhanced perioperative care for the prevention of colorectal anastomotic leakage

Conditions: Anastomotic Leak Small Intestine; Anastomotic Leak Large Intestine; Anastomotic Leak Rectum; Intraoperative Awareness

Summary: this multicenter open-label trial is designed to evaluate if the implementation of an enhanced peri-operative care protocol results in an optimal intraoperative condition of the patient and in a decrease in incidence of anastomotic leakage after colorectal resection as compared to current practice.

rationale colorectal anastomotic leakage (cal) remains a severe complication following surgery with a reported incidence of 3-19% worldwide. recent research has identified several modifiable peri-operative cal risk factors, suggesting that the intraoperative condition of the patient plays an important role in cal development. objective to successfully implement an enhanced perioperative care protocol, focusing on optimizing the intraoperative condition of the patient to minimalize exposure to cal risk factors. secondly, to investigate whether implementation of this new guideline results in a better intraoperative condition and a decreased cal rate as compared to current practice. study design an open-label multicenter design with historical cohort in nine participating hospitals. study population all adult patients that are scheduled for a colorectal resection with creation of a primary anastomosis. intervention an enhanced perioperative best practice protocol. the double check bundle exists out of interventions applicable without the introduction of new material to the operating room, on top of usual care. the protocol is based on the results of our previous large, multicenter, international observational cohort study (lekcheck study), systematic literature analyses, an inventory in current protocols on peri-operative care and expert opinion. consensus is reached with colorectal surgeons from all participating centers. the final protocol was reviewed critically by experts in the field of colorectal surgery before implementation. comparison 1592 historical patients that were treated with standard practice (lekcheck study group). in addition the anastomotic leakage rates from the national registry of the period after the lekcheck study and before the start of the double check study will be used for comparison. endpoints compliance to the study protocol, the patient's intraoperative condition and exposure to modifiable intraoperative risk factors, 30-day cal and other postoperative complications according to clavien-dindo classification. follow-up will be 90 days after colorectal resection.

Eligibility criteria:
inclusion criteria: * age 18 and above * bowel (small intestine/colon/rectal) resection with creation of a primary anastomosis * ability to give informed consent exclusion criteria: * the need for emergency surgery * scheduled operation concerning a reoperation for complications from recent surgery (within 3 months after the initial procedure). * the inability to read or understand informed consent material

Keywords: riskfactor colorectal resection intraoperative condition perioperative care
emst and tms for treatment of dysphagia in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of the study is to examine the effectiveness of different methods for the treatment of dysphagia in parkinson's disease (pd). more than 80% of patients suffering from pd develop dysphagia during the course of their disease leading to malnutrition, loss of life quality, weight loss and pneumonia, which is the leading cause of death in these patients. so far, only a few specific treatment approaches have been investigated in pd patients with swallowing disorders. the investigator want to compare a 4-week expiratory muscle strength training (emst), transcranial magnetic stimulation (tms), and combination of both with a sham therapy. dysphagia severity before and after intervention is measured by flexible endoscopic evaluation of swallowing (fees). for the evaluation of changes in cortical swallowing processing the investigators apply magnetoencephalography (meg).


Eligibility criteria:
inclusion criteria: * hoehn \& yahr stages ii-iv * parkinson-related dysphagia * oral nutrition * ambulant setting * no change of medication for at least 4 weeks before study inclusion exclusion criteria: * other causes for dysphagia * other neurological disease potentially causing dysphagia * dementia (mmse\<25; montreal cognitive assessment (moca)\<26) * severe depression (bdi\>19) * percutaneous endoscopic gastrostomy (peg)
comparing pump with subcutaneous injection delivery of pth 1-34 in the management of chronic hypoparathyroidism

Conditions: Hypoparathyroidism; Hypocalcemia

Summary: this study will evaluate the safety, biological activity, and pharmacokinetics of pth delivered by subcutaneous injection compared with an infusion pump. we anticipate pump delivery of pth will be more physiologic because it mimics normal parathyroid gland secretion of pth. we expect that pump delivery will simultaneously normalize blood and urine calcium, phosphorus and magnesium levels with minimal or no fluctuations throughout the day. pump therapy will require lower pth doses and should normalize markers of bone turnover. we expect the improved metabolic control during pump therapy will be especially evident in patients with more severe forms of hypoparathyrodism where there is an unmet need for improved therapy.

prior studies (92-ch-0011) have been important in establishing synthetic human parathyroid hormone 1-34 (pth) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. we are conducting a randomized crossover study comparing twice-daily subcutaneous injections vs. pth pump therapy. we hypothesize that pump delivery of pth 1-34, compared to twice-daily administration, will provide smoother metabolic control of serum mineral levels and normalization of urine mineral excretion. the two arms will be divided into an inpatient and an outpatient phase. there will be three inpatient admissions, baseline, 3 months, and 6 months. subjects will be randomized to either pump therapy or to twice daily injections at the beginning of the study and will cross over to the alternate pth delivery system (injections vs. pump) at the conclusion of the initial 3-month treatment period. patients between 10 and 70 years of age who have had chronic hypoparathyroidism for at least 1 year may be eligible for this study. participants have two 10- 12-day hospital admissions and one 5-day admission. the first two inpatient admissions are separated by 3-month outpatient periods. outpatient monitoring will require weekly blood tests and monthly urine tests to monitor mineral levels. after third hospital admission, patients will be placed on conventional therapy.

Eligibility criteria:
* inclusion criteria: this study will include patients of both genders (ages 7-70) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. twenty-four subjects will be enrolled. exclusion criteria: subjects who meet any of the following criteria are not eligible for the study: * pregnancy * patients who are calcium infusion dependent and/or do not respond to calcitriol therapy to maintain normal levels of serum calcium will be excluded. * seizure disorder requiring antiepileptic medications.

Keywords: hypoparathyroidism parathyroid hormone 1-34
testicular versus ejaculated spermatozoa for ivf/icsi in men with high sperm dna damage

Conditions: Infertility, Male; DNA Damage

Summary: the purpose of this study is to determine whether couples undergoing ivf/icsi with male factor infertility, specifically with elevated sperm dna damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * be considered infertile (\>1 year of unsuccessful attempts of conception * any race * male partner with persistent sperm dna damage, dfi\>=30% * candidates for intracytoplasmic sperm injection (icsi) exclusion criteria: * significant female factor infertility contributing to the couple's infertility * female partner older than 38 years * male or female patients with genetic abnormalities * patients unable or unwilling to give consent after properly informed * couples unsuitable for ivf/icsi * male patients in whom testicular procedures were contraindicated

Keywords: failure to conceive due to infertility of male partner dna damage
vestibulectomy surgical techniques comparison study

Conditions: Vulvar Pain; Vulvodynia

Summary: vestibulectomy surgical techniques comparison study

vestibulectomy: a prospective comparison of two surgical techniques for the treatment of provoked localized vulvodynia (pvd)

Eligibility criteria:
inclusion criteria: 1. reported provoked tenderness to the vestibule for at least 3 months in non-pregnant, estrogen-replete healthy subjects aged 18 years or over meeting friedrich's criteria for pvd44-45 and supported by the issvd terminology consensus definition45 for vulvar pain. subjects who are \>45years of age must have either have a maturation index52 of \< 10% parabasal cells or willingness to participate in local estrogen replacement until achieving this same clinical result. 2. cotton swab test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum 3. ability to insert a regular tampax® tampon 4. baseline tampon test verbal pain score ≥430 f. phone and internet access e. willingness to engage in pelvic floor physical therapy (pt) exclusion criteria: 1. pregnancy 2. any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus) 3. unable or unwilling to complete baseline assessments 4. prior vestibulectomy or hymen surgery 5. prior or current use of testosterone dosed for gender affirmation
vaccine immune recovery after leukemia

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Summary: this observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children, adolescents, and young adults who recently completed treatment for acute lymphoblastic leukemia (all). several children's hospitals in the united states are participating in the study, which will enroll up to 90 pediatric participants and up to 270 healthy control patients. the study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.


Eligibility criteria:
inclusion criteria: * children, adolescents, and young adults diagnosed with b or t all at age 12 months or older * completed all chemotherapy within the past three months or will complete all chemotherapy in the upcoming three months * three years of age or older at time of enrollment exclusion criteria: * diagnosis of infant all * evidence of disease relapse * history of primary immunodeficiency (except related to down syndrome) * history of a stem cell transplant or cellular immunotherapy * history of prior malignancy or condition requiring chemotherapy other than for current all diagnosis

Keywords: acute lymphoblastic leukemia chemotherapy antineoplastic agents varicella vaccine chickenpox vaccine pneumococcal vaccines measles vaccine
cyclophosphamide and busulfan as conditioning regimen before allogeneic hsct

Conditions: Myeloid Leukemia; Precursor Myeloid Neoplasms; Lymphoid Neoplasms

Summary: the aim of this study is to test the hypothesis, that the order of application of busulfan (bu) and cyclophosphamide (cy) has an impact on toxicity after allogeneic hematopoietic stem cell transplantation (hsct) and that cy-bu reduces liver toxicity compared to bu-cy.


Eligibility criteria:
inclusion criteria: * patients planned to undergo an allogeneic hsct with myeloablative conditioning * age 18 - 65 years * myeloid leukemia respectively related precursor neoplasms (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome), or lymphoid neoplasms (acute lymphoblastic leukemia/lymphoma, mature b-/t-/natural killer (nk)-cell neoplasms). * human leukocyte antigen (hla)-identical sibling donor or matched unrelated (min. 10/10 ag matched) * patients with a history of hepatitis might be included, if no contraindication for hsct exists. * patient must give written informed consent exclusion criteria: * indication other than myeloid leukemia respectively related precursor neoplasms, or lymphoid neoplasms. * severe liver damage for \> 2 weeks (bilirubin \> 3xupper limit normal (uln) or asat/alat \> 5xuln) * hiv infection * donor other than hla-identical sibling or min. 10/10 matched unrelated donor * pregnant or lactating women * lack of written informed consent
an extension study to evaluate the long-term safety and efficacy of ptc518 in participants with huntington's disease (hd)

Conditions: Huntington Disease

Summary: the primary goal of this study is to evaluate the long-term safety and pharmacodynamic effects of ptc518 in participants with hd.

participants who completed the treatment period in the parent phase 2a study ptc518-cns-002-hd (nct05358717), fulfilled the enrollment criteria, and chose to enroll in this extension study will undergo baseline evaluations and be assessed for 30 additional months. all participants will receive active ptc518 in this extension study. participants who received ptc518 in the parent study ptc518-cns-002-hd will continue at the same dose level they received in that study in a blinded fashion (5, 10, or 20 milligrams \[mg\]). participants who received placebo in the parent study ptc518-cns-002-hd will be allocated to a ptc518 dose level according to the same dosing group in which they were previously randomized (5, 10, or 20 mg). the 20 mg dosing arm will be open for randomization only if and when the data safety and monitoring board from the parent study ptc518-cns-002-hd recommends initiating this dosing level based on an unblinded review of safety data from that study.

Eligibility criteria:
inclusion criteria: * participant who has completed the treatment period in study ptc518-cns-002-hd. exclusion criteria: * participants who have not previously completed the treatment period in study ptc518-cns-002-hd. note: other inclusion and exclusion criteria may apply.

Keywords: neurodegenerative disorder rare disease
surgical treatment of gingival recessions

Conditions: Clinical Trial; Connective Tissue; Gingival Recession; Microsurgery

Summary: the purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on cpfs plus sctgs for the treatment of localized gingival recession defects (miller class i or ii) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. we hypothesized that root coverage achieved through microsurgery in miller i or ii gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. miller class i and ii gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.


Eligibility criteria:
inclusion criteria: - all participants were: * adults aged 18 years or over * systemically and periodontally healthy * met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the miller classification scheme exclusion criteria: - exclusion criteria included the following: * medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis; * a history of chemotherapy or radiotherapy; * a history of alcoholism or drug abuse; * a history of previous mucogingival surgery at the gingival recession site; * medications known to affect gingival tissues; * antibiotic treatment in the past 6 months; * smoking \>10 cigarettes per day for \>5 years, and; * current pregnancy or lactation.
perifosine in treating patients with locally advanced, unresectable, or metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. purpose: phase ii trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer.

objectives: * determine the activity of perifosine, in terms of objective response, in patients with locally advanced, unresectable, or metastatic pancreatic cancer. * determine the response duration, progression-free survival, and overall survival of patients treated with this drug. * determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients receive oral perifosine every 6 hours for a total of 6 doses and then once daily in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 3 years. projected accrual: a total of 35-84 patients will be accrued for this study within 21 months.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the pancreas * locally advanced, unresectable, or metastatic disease * measurable disease * no known brain metastases patient characteristics: age * 18 and over performance status * ecog 0-1 life expectancy * not specified hematopoietic * wbc at least 3,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10 g/dl hepatic * ast no greater than 2 times upper limit of normal (uln) * bilirubin no greater than 2 times uln renal * creatinine no greater than 1.4 mg/dl cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no ongoing or active infection * no psychiatric illness or social situation that would preclude study compliance * no other concurrent illness that would preclude study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy for pancreatic cancer * more than 6 months since prior chemotherapy for other diseases endocrine therapy * not specified radiotherapy * at least 4 weeks since prior radiotherapy and recovered surgery * at least 4 weeks since prior surgery and recovered other * no other concurrent investigational agents for pancreatic cancer * no concurrent combination antiretroviral therapy for hiv-positive patients

Keywords: adenocarcinoma of the pancreas stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer