Kornimate/medical-research-clean huggingface dataset:
pentoxifylline for primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: primary biliary cirrhosis (pbc) is cholestatic liver disease characterized by progressive destruction of small bile ducts within the liver that can lead to end stage liver disease and all its complications. although ursodeoxycholic acid (udca) is associated with increased survival in many patients with pbc, there is absence of an adequate response to udca in a significant proportion of pbc patients. tumor necrosis factor alpha (tnf-alpha) is a cytokine that plays an important role in the pathogenesis of pbc. other fibrosis biomarkers such as tissue metallo proteinase 1 (timp-1) are associated with progression of liver fibrosis in pbc. pentoxifylline (ptx) is a methylxanthine derivative that inhibits pro-inflammatory cytokines and also has shown anti-fibrotic effects in serum of patients with pbc. furthermore, ptx has well known clinical and safety profiles. the main hypothesis of this study is that therapy with pentoxifylline (ptx) will result in improvement of liver disease in pbc patients who are incomplete responders to udca. the focus of this proposal is on the effectiveness of ptx in improving laboratory parameters of liver disease and levels of cytokines involved in the pathogenesis of the disease in patients with pbc.


Eligibility criteria:
inclusion criteria: * male and female patients ages 18 to 76 years. * established diagnosis of pbc based on at least three of the following criteria: * detectable anti-mitochondrial antibodies (ama) * cholestatic biochemical pattern * liver biopsy compatible with pbc * appropriate exclusion of other liver diseases. * therapy with udca at adequate dose (13-15mg/kg/d) for at least six months and evidence of suboptimal response defined by alkaline phosphatase levels that did not normalize and remain elevated by at least 1.5 times the upper limit of normal. * no history or present hepatic decompensation (e.g. variceal hemorrhage, encephalopathy, or poorly controlled ascites). exclusion criteria: * findings highly suggestive of liver disease of other etiology. * a score \>=10 points on the revised scoring system for autoimmune hepatitis (aih), supporting a diagnosis of pbc/aih overlap. * patients on steroids (systemic), immunosuppressants, or immunomodulatory agents within the previous 6 months. * patients with clinical or laboratory evidence suggestive of decompensated cirrhosis. * hypersensitivity to ptx or the methylxanthines (caffeine, theophylline, theobromine). * history of cerebral or retinal hemorrhage. * other medical comorbidities (such as cardiac, renal, cancer) that would interfere with completion of the study. * patients taking theophylline or coumadin because of potential drug-drug interactions with ptx. in addition, patients taking low molecular weight heparin preparations. * pregnant or nursing women.

Keywords: biliary cirrhosis
circadian intraocular pressure patterns in patients with sleep apnea syndrome and treatment with continuous air pressure

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate the influence of sleep apnea-hypopnea syndrome (sahs) syndrome and treatment with continuous air pressure (cpap) on the circadian intraocular pressure (iop) patterns and its structural impact on the nerve fiber layer of the retina to analize the relationship between sahs and glaucoma. objectives: 1. to study the pio and its fluctuations in patients with sahs before starting treatment with cpap. objective 2. to assess the effect of cpap on circadian iop patterns. 3. evaluate the effect of changes in iop in patients with osa treated with cpap in the nerve fiber layer of the retina. methods: a prospective study to be monitored continuously for 24 hours iop by contact lens device sensimed triggerfish (sensimed ag, switzerland). objective 1. to monitore and compare the iop for 24 hours at 74 patients diagnosed with sahs before starting treatment with cpap and 37 patients without osa. objective 2. to study the impact of cpap treatment by a study design in two stages cpap / sham cpap. a first monitoring of iop will be compared before starting treatment with cpap, with monitoring a month (cpap-sham cpap) and 12 months after initiation of treatment with cpap. objective 3. to correlate the values obtained from the monitoring of iop in the thickness of the nerve fiber layer of the retina, as measured by optical coherence tomography, at baseline and at 12 months after starting treatment with cpap.


Eligibility criteria:
inclusion criteria: * being over 18 years of age * seeking a sleep study using a cardio-respiratory polygraph study * having spherical refraction between -5d and 3d, cylinder correction \<2d, as well as a slit lamp examination with anterior chamber normal and an open irido-corneal angle exclusion criteria: * presence of severe drowsiness or risk profession that requires urgent treatment with cpap * any known intolerance to silicone, any alteration in the anterior pole of the eye that contraindicates the use of a contact lens, severe dry eye, keratoconus or any other corneal alteration, a history of conventional intraocular or laser surgery, whether for cataracts, glaucoma, refractive or retina surgery. * glaucoma patients will be excluded at the start of the study. * when both eyes of each patient meet the inclusion criteria, the investigator will randomly select the eye to be studied.

Keywords: obstructive sleep apnea circadian rhythms intraocular pressure
continuous wearable monitor for the detection and release of freezing of gait.

Conditions: Parkinson Disease

Summary: the proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (fog) in people with parkinson's disease (pd). and triggers external cueing stimuli to unfreeze the individual. the purpose of the overall phase ii study is to: (1) develop a production ready system, (2) develop a companion mobile app for the proposed system and refine previously developed fog detection algorithms, and (3) validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. this study will focus on validating the system and demonstrating efficacy through in-community testing.


Eligibility criteria:
inclusion criteria: * ability to provide and provision of signed and dated informed consent form. * age 45-80 * diagnosis of idiopathic pd, as determined by a movement disorders neurologist in accordance with the pd society brain bank diagnostic criteria. * evidence of presence of freezing gait as a symptom. determined from combination of clinical examination (observation of freezing) and new freezing of gait questionnaire (nfog). * able to complete a 2-minute walk test at the pre-treatment visit. * currently on a stable prescription medication regimen for pd and willing to adhere to the regimen during the study. * ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention. exclusion criteria: * non-english speaking * history of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment. * other significant neurological disorders that may affect participation or performance in the study. * neuropathy at the ankle assessed at the pre-treatment visit using the haptic module. * hallucinations * non-ambulatory * legally blind * symptomatic hypotension

Keywords: freezing of gait
study protocol to evaluate clinical and imaging results of knee fresh osteochondral allografts

Conditions: Osteochondral Defect

Summary: the main objective of this study is to assess the clinical and radiological results after carrying out a transplant of fresh osteochondral allograft in the knee.

fresh osteochondral allograft transplantation allows treatment of large osteochondral lesions of the knee in young patients. real-world, patient-centered data on clinical and imaging results after fresh osteochondral allograft transplantation are needed. this study is a prospective, observational, unicenter, patient-centered outcomes research study. patients undergoing cartilage repair with fresh osteochondral allograft transplantation for osteochondral knee lesions are eligible to participate. clinical results are evaluated from baseline to 3 months, 6 months, 9 months, 12 months and 15 months postoperatively. at each time point, participants respond to several patient-reported outcome instruments to measure clinical results (ikdc, kujala, womet and tegner) and patient satisfaction is captured. imaging results are evaluated with mri (9 months and 15 months postoperatively) using the ocamriss evaluating cartilage features, bone features and ancillary features; and with ct (1 day, 3 months, 6 months and 12 months postoperatively) evaluating subchondral bone and osseous integration. variations will be explored using additional or alternative covariates such as concomitant surgery procedures, osteochondral allograft morphology, age, sex at birth, imc, living situation and employment status.

Eligibility criteria:
inclusion criteria: patients undergoing cartilage repair with fresh osteochondral allograft transplantation for large focal full-thickness chondral and osteochondral defects (\>2 cm2) on the tibial plateau, femoral condyles, trochlea and/or patella bipolar lesions are included. exclusion criteria: * bmi\> 30 kg / m2 * systemic inflammatory diseases * inflammatory arthritis * advanced osteoarthritis * tricompartmental degenerative process * active infection * patients who are unable to provide written informed consent.

Keywords: fresh osteochondral allografts integration osteochondral defect knee chondral lesion
flushes and sertraline trial

Conditions: Menopause-Hot Flashes

Summary: the primary outcome of fast (a randomized double-blinded, placebo controlled, trial of the effect of sertraline vs. placebo in reducing the incidence and severity of hot flushes in healthy women) is to determine if 6 weeks of treatment with sertraline (50mg daily for 2 weeks, followed by 100mg per day for 4 weeks, if tolerated) results in a greater reduction in hot flush score (frequency \* severity) compared to placebo among women with moderate to severe hot flashes. the secondary aim is to determine the effect of treatment with sertraline on quality of life, sleep, sexual function, and mood.

the primary aim of fast is to determine if 6 weeks of treatment with sertraline (50 mg daily for 2 weeks, followed by 100 mg per day for 4 weeks, if tolerated) results in greater reduction in hot flush score (frequency x severity), frequency and severity compared to placebo among women with moderate to severe hot flushes. the secondary aims:to determine the effect of treatment with sertraline on quality of life, sleep, sexual function, mood, and cognitive function. to determine if a modified, short version of a sexual function instrument is valid.

Eligibility criteria:
inclusion criteria: * age 40 - 60 years old * report \> 14 hot flushes per week * willing to be randomized to sertraline or placebo * sign informed consent exclusion criteria: * history of bilateral oophorectomy * breast or ovarian cancer * liver disease * kidney disease requiring dialysis * history of major depression (reported history of depression requiring therapy, hospitalization for depression, taking antidepressant drugs, history of suicide attempt) * history of bipolar affective disorder (reported history of bipolar disorder requiring therapy, medications, hospitalized for bipolar disorder) * seizure disorder * history of hypersensitivity to sertraline or to ssris * pregnancy or breast feeding * any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial; * no estrogens or progestins for 3 months prior to screening or during enrollment * selective estrogen receptor modulators (serms) * the following medications: clonidine, gabapentin, tricyclic antidepressants, monoamine oxidase (mao) inhibitors, selective serotonin reuptake inhibitors (ssris), megesterol , oral contraceptives, androgens; and medications that are listed on the pfizer pharmaceutical drug insert as "contraindicated"

Keywords: menopausal symptoms hot flashes
breathing-based leg resistance exercise improves wound healing, blood sugar and quality of life for diabetic foot ulcers

Conditions: Diabetic Foot; Resistance Exercise; Wound Healing; Hyperglycemia; Quality of Life

Summary: the purpose of the study was designed leg resistance training combined with breathing approach, and evaluated its effect on wound healing, blood sugar control and quality of life in type 2 diabetic patients with foot ulcers.

a randomized controlled trial was used. type 2 diabetic patients who suffered from foot ulcers were recruited from one medical center of northern taiwan, and randomly assigned into the exercise or control group. the control group received usual care for diabetic foot. the exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. outcomes were measured by wound healing area, the fasting of blood glucose, hemoglobin a1c (hba1c), and the world health organization quality of life-bref (whoqol-bref) before the intervention as baseline, and the 4th, 8th and 12th weeks during the intervention period.

Eligibility criteria:
inclusion criteria: * patients 20 years or older * who were diagnosed with type 2 diabetic foot * ulcers of meggitt-wagner grade 1-2 * who were conscious and could perform the prescribed exercise. exclusion criteria: * peripheral arterial occlusion disease * osteomyelitis * inability to perform exercise as assessed by physicians.
study of prrt in metastatic, world health organization (who) grade 1 or 2, sstr positive, gep-net who are candidates for cytoreductive surgery

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Summary: the purpose of this study is to learn about the feasibility and safety of using peptide receptor radionuclide therapy (prrt) before and after surgical removal of a tumor. prrt treatment is based on the administration of a radioactive product, 177-lu dota-0-tyr3-octreotate (lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with sstr-positive gastroenteropancreatic neuroendocrine tumors gep-nets.

primary objective(s) * to assess feasibility and safety of combination of perioperative 177lu dotatate and cytoreductive surgery in metastatic gep nets secondary objective(s) * to assess response rate (rr) after 2 cycles 177lu dotatate * to assess recurrence free survival (rfs) of the overall treatment strategy * to assess overall survival (os) of the overall treatment strategy

Eligibility criteria:
inclusion criteria: 1. metastatic gastroenteropancreatic net with lymph nodes or liver metastases only. 2. who grade 1 or 2, ki 67 ≤ 20% (to be confirmed at stanford) 3. must be a candidate for cytoreductive surgery with the goal of r1 resection as determined by a multidisciplinary tumor board discussion 4. measurable disease as determined by recist v1.1 5. confirmed presence of somatostatin receptors on all target lesions as determined by 68ga dota tate pet scan 6. patients ≥ 18 years of age. 7. eastern cooperative oncology group (ecog) performance status (ps) ≤ 1 8. appropriate hematologic, liver and kidney function 9. patients on octreotide long-acting release (lar) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study exclusion criteria: 1. prior 177lu dotatate treatment 2. any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (ebrt) to \> 25% of bone marrow, at any time 3. any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study 4. known brain metastases 5. known bone or peritoneal metastases
are there differences between carriers of haemophilia a and b?

Conditions: Hemophilia

Summary: this study aims to develop a systematic genetic screening strategy for (potential) female carriers of haemophilia by identifying as many female carriers as possible within the families of haemophilia patients regularly followed at cliniques universitaires saint-luc (cusl) and to search for differences between female carriers of haemophilia a (ha) and b (hb).

in order to complete our local registry of female carriers, the family trees of haemophilia patients will be systematically updated during their follow-up consultations at the haemophilia centre. female carriers not yet known in our centre, identified by the updating of pedigrees, will be invited to present themselves in the haematology consultation and to participate in the study by means of an invitation and information letter which will be given/sent to them by the index haemophilia patient. female carriers already known for whom missing data and/or the indication of regular follow-up have been identified during the file review will also be invited to attend a consultation within the framework of the study. at these consultations, (potential) carriers will be given information about haemophilia, the mode of genetic transmission and the implications of carrier status on patients' lives (bleeding prevention, reproductive choices, current haemophilia treatments and future prospects). we will then determine the bleeding phenotype of each patient by taking a comprehensive bleeding history. with the consent of the participants concerned, the familial genetic variant responsible for haemophilia will be sought in them in order to definitively establish their carrier status. the basal level of coagulation factors viii (ha)/ix (hb) will also be determined. if a deficiency is found, haemostatic treatment adapted to the patient's situation will be initiated and clinical follow-up outside the study recommended. after completion of the data collection, the data will be analyzed and compared between ha and hb carriers in order to identify possible differences between these two populations.

Eligibility criteria:
inclusion criteria: - family member affected by haemophilia a or b and potential/obligate carriership of ha/hb. exclusion criteria: * none.

Keywords: hemophilia a hemophilia b genetic testing carriers
safety and anti-leukemic activity of vodobatinib (k0706) for treatment of ph+ cml resistant/intolerant to ≥3 prior cml therapies

Conditions: Healthy (For Part A); Chronic Myeloid Leukemia (for Part B and C)

Summary: phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of vodobatinib (k0706) in treatment-refractory/intolerant cml

part a ( for healthy volunteers) of the study is completed. part b dose-escalation study is completed. recruitment in dose expansion is completed. part c study in subjects with treatment-resistant/intolerant is ongoing for the enrolled subjects.

Eligibility criteria:
inclusion criteria: * willing and able to give written, and dated, informed consent * male or female aged ≥ 18 years * willing and able to comply with the scheduled visits * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * subjects diagnosed with ph+ cml-cp, ph+ cml-ap, ph+ cml-bp, who are resistant and/or intolerant to ≥ 3 prior tkis one of which includes ponatinib (part c). exclusion criteria: * presence of t315i (part c) * any major surgery, as determined by the investigator, within 4 weeks of imp administration * inability to undergo venipuncture and/or tolerate venous access * positive exclusion tests: urine pregnancy tests (if applicable), hiv, hepatitis b surface antigen, or hepatitis c virus * known or suspected history of significant drug abuse as judged by the investigator * received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of imp administration * subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant * another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ

Keywords: cml chronic myelogenous leukemia k0706 vodobatinib ponatinib-refractory/intolerant treatment refractory chronic myeloid leukemia ponatinib
patient decision aid for antidepressant use in pregnancy

Conditions: Pregnancy; Depression

Summary: the purpose of this pilot study is to examine the feasibility of conducting a multi-site randomized controlled trial whose aim will be to evaluate the effectiveness of a patient decision aid (pda) for antidepressant use in pregnancy.

depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. patient decision support tools can address such barriers. we have created a patient decision aid (pda) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. the overall objective of this project is to inform the development of a larger, international rct to assess the efficacy of our pda for antidepressant use in pregnancy. to achieve this objective, we will assess the feasibility of our clinical trial protocol to evaluate the pda and determine the preliminary effect size for a larger multi-site efficacy study. the primary outcome for this pilot study is the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the pda. this includes feasibility (how well the trial protocol can be implemented), acceptability (usability and tolerability of the intervention) and adherence (the degree to which the trial protocol is followed). we hypothesize that our protocol will be feasible, that the pda will have a high degree of acceptability, and that adherence to the protocol will be high.

Eligibility criteria:
inclusion criteria: 1. are females aged \>18 years old, and 2. are either planning a pregnancy or are \<30 weeks gestation at enrollment, and 3. have been offered to start or continue ssri or snri anti-depressant medication as a treatment option for depression by their clinical provider at one of the study sites, and 4. have moderate-to-high decisional conflict (score of \>25 on the decisional conflict scale) exclusion criteria: 1. have had alcohol or substance abuse or dependence in the previous 12 months, or 2. have active suicidal ideation or psychosis, or 3. are incapable of consenting to participation, or 4. have any major obstetrical complications or fetal cardiac anomaly in the current or in a past pregnancy (as this changes the risk/benefit ratio discussion in regards to antidepressant use), or 5. are unable to read or unable to speak or understand english and do not have someone that can read the pda to them, or 6. have a visual impairment that would prevent them from being able to view the website.

Keywords: pregnancy depression antidepressant use decision aid