Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study evaluating ctx120 in subjects with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a single-arm, open-label, multicenter, phase 1 study evaluating the safety and efficacy of ctx120 in subjects with relapsed or refractory multiple myeloma.


Eligibility criteria:
key inclusion criteria: 1. age ≥18 years. 2. relapsed or refractory multiple myeloma, as defined by imwg response criteria and treatment with at least 2 prior lines of therapy. 3. eastern cooperative oncology group performance status 0 or 1. 4. adequate renal, liver, cardiac and pulmonary organ function 5. female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after ctx120 infusion. key exclusion criteria: 1. prior allogeneic stem cell transplant (sct). 2. less than 60 days from autologous sct at time of screening and with unresolved serious complications. 3. prior treatment with any gene therapy or genetically modified cell therapy, including car t cells or natural killer cells, or bcma-directed therapy. 4. evidence of direct central nervous system (cns) involvement by multiple myeloma. 5. history or presence of clinically relevant cns pathology such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with cns involvement. 6. unstable angina, clinically significant arrhythmia, or myocardial infarction within 6 months of enrollment. 7. active hiv, hepatitis b virus or hepatitis c virus infection. 8. previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years. 9. use of systemic anti-tumor therapy or investigational agent within 14 days prior to enrollment. 10. primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 11. women who are pregnant or breastfeeding.

Keywords: car t allogeneic multiple myeloma crispr-cas9
study to evaluate novel gastric space occupying device

Conditions: Obesity

Summary: this will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. no formal hypothesis testing will be conducted.


Eligibility criteria:
inclusion criteria: 1. age between 21-64 years 2. bmi 27-40 kg/m2 3. no history of weight reduction of more than 5% of total body weight in the past 6 months exclusion criteria: 1. have unstable angina, myocardial infarction within the past year, or heart disease classified within the new york heart association's class iii or iv functional capacity; 2. be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure; 3. be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months; 4. have type 1 diabetes or type 2 diabetes requiring oral medications or insulin; 5. history or symptoms of thyroid disease which is not controlled by medication; 6. have severe renal, hepatic, pulmonary disease or cancer; 7. past history of gastrointestinal surgery (excluding uncomplicated appendectomy); 8. have a history of adhesive peritonitis; 9. history or symptoms of esophageal and/or gastric varices; 10. have history or congenital or acquired gi anomalies (e.g. atresias, stricture, and /or diverticula); 11. history or symptoms of inflammatory bowel disease, such as chron's disease; 12. history of/ signs and /or symptoms of duodenal or gastric ulcer; 13. have gastroparesis; 14. pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential); 15. currently using pharmaceutical agents for weight loss;

Keywords: medical device, space-occupying device
prevail interdisciplinary track: a pragmatic randomized clinical trial

Conditions: Chronic Pain

Summary: the goal of this clinical trial is to \[primary purpose learn if a team that involves five types of pain specialists (interventional pain, psychology, pharmacy, nutrition, physical therapy) can treat chronic pain in veterans. the main questions it aims to answer are: * do patients report less pain after six months in the program? * do patients report that pain gets in the way of their life less after six months in the program? the researchers will compare participants who participate in the program to those that wait for six months before participating in the program. participants will * meet with the team of pain specialists to develop a plan to treat their pain * receive calls from a coach once per month * return to meet with the team of pain specialists for a six-month follow-up appointment * fill out surveys


Eligibility criteria:
inclusion criteria: * veteran receiving care at the salem va health care system (salem vahcs) per electronic medical record (emr) * patient participating in prevail interdisciplinary team track per emr * chronic pain diagnosis: defined as pain lasting more than three months per emr exclusion criteria: * diagnosis of mild neurocognitive disorder or major neurocognitive disorder based on diagnostic statistical manual of mental disorders, 5th edition, text revision (dsm-5-tr) per emr * veteran has a current acute physical injury that would artificially elevate pain scores during study period per emr * veteran intends to have a pain-related surgery during the study period per emr

Keywords: whole health rural health interdisciplinary team
evaluation phenobarbital as adjunctive therapy in participants with partial onset seizures

Conditions: Epilepsy

Summary: primary: - to evaluate the efficacy of phenobarbital in reducing seizure frequency. secondary: * to confirm dose response relationship, * to assess the effects on type i seizures, * to assess the safety of phenobarbital * to assess the drug tolerability.

primary: -to evaluate the efficacy of once daily (od) administration of 60 mg and 100 mg phenobarbital, in reducing seizure frequency in participants with partial onset seizures (type i seizures; complex or simple with motor symptoms only) not fully controlled despite treatment with 1 to 3 concomitant anti-epileptic drugs (aeds) or aeds with vagus nerve stimulator (vns) secondary: * to confirm dose response relationship of 60 and 100 mg phenobarbital doses, * to assess the effects of phenobarbital on type i seizures, * to assess the safety of phenobarbital * to assess the tolerability of phenobarbital

Eligibility criteria:
inclusion criteria: * participants from 17 to 70 years old; * history of type i partial onset seizures (complex or simple with motor symptoms only); * participants must have had electroencephalogram (eeg), magnetic resonance imaging (mri) or computed tomography (ct) with results consistent with diagnosis of partial-onset seizures; * participants having at least eight type i partial onset seizures during 8-week baseline period; * participants being uncontrolled while treated by 1 to 3 permitted concomitant anti-epileptic drug (aed) and/or vagus nerve stimulation (vns); * participant has been on a stable dose of their current anti-epileptic treatment regime exclusion criteria: * currently taking phenobarbital or primidone; * currently taking felbamate or vigabatrin; * history of prior allergic reaction to phenobarbital; * history of psychogenic seizures; * history or presence of status epilepticus; * history or presence of seizures occurring only in clusters; * participant taking any drug with possible central nervous system (cns) effects except if stable from 1 month prior visit 1; * history of cerebrovascular accident (cva) or transient ischemic attack (tia); * presence of any sign suggesting rapidly progressing brain disorder or brain tumor; * presence of unstable arteriovenous malformations, meningiomas or other benign tumors; * history of porphyria; * presence of clinically significant findings on physical exam, vital signs, electrocardiogram (ecg) or safety lab assessments, including renal or hepatic insufficiency; * history of alcohol or drug abuse within the year prior to screening; * participant who is known to be non-compliant; * participant who is male or female who refuses to use an acceptable form of contraception; * female who is pregnant or lactating or intends to become pregnant; * participant who has taken part in any investigational device or product within 2 months prior to the screening visit

Keywords: partial onset seizures
retinal pigment epithelial characteristics in eyes with neovascular age-related macular degeneration following long-term treatment with anti neovascular endothelial growth factor

Conditions: Neovascular Age-related Macular Degeneration

Summary: purpose: to assess retinal pigment epithelial (rpe) and retinal structural changes in eyes with neovascular age-related macular degeneration (amd) treated with anti-vascular endothelial growth factor (anti-vegf) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis. methods: 18 patients (18 eyes) with neovascular amd were recruited subsequent to completion the avastin versus lucentis in age related macular degeneration (manta) study following a mean period of 84 months (range: 69-93 months). after receiving a loading dose of 3 intravitreal anti-vegf injections subsequent to baseline of the manta study, patients were treated as-needed \[pro re nata (prn)\]. functional and morphological changes were assessed using spectral domain optical coherence tomography (sd-oct).


Eligibility criteria:
inclusion criteria: * inclusion and exclusion criteria corresponded to the criteria of the manta study exclusion criteria: * inclusion and exclusion criteria corresponded to the criteria of the manta study
effect of ultrasound cavitation on static and dynamic balance in obese postnatal women with diastasis recti

Conditions: Rectus Diastasis

Summary: the aim of this study is to investigate the efficacy of ultrasound cavitation on static and dynamic balance in obese postnatal women with diastasis recti

rectus diastasis defined as the widening of the linea alba by more than 2 cm at the midline. a great proportion of pregnant women are complaining from rectus diastasis during pregnancy reaching 100% of all women that may continue for years after delivery in 66% of women, and do not return to the first state automatically. this occurs due to a combination of physiologic, hormonal and mechanical factors, leading to reduction of abdominal muscle functional strength, increased low back pain out of increased lumbar hyperlordosis and postural instability, which may seriously disable woman from taking care of her baby, perform her daily activities. weight gain is one of the predisposing factors that increases the possibility of developing rectus diastasis postpartum. being obese increases liability to have rectus diastasis as carrying excess abdominal fats puts greater pressure against linea alba and can develop or aggravate symptoms for both men and women. this massively displaces the center of gravity anteriorly, disturbs body balance, increases joint loads and influences negatively pelvis posture leading to increased anterior pelvic tilt with subsequent exaggerated lumbar hyperlordosis. ultrasound cavitation is the most revolutionary method that destroys excess body fat through creating microbubbles and releasing energy that breaks down fat cells. this trial has two groups: one will be treated by low caloric diet regimen only and the second one will be treated by ultrasound cavitation in addition to low caloric diet regimen for eight weeks

Eligibility criteria:
inclusion criteria: 1. all women had a diastasis recti more than 2.5 cm and less than 4 cm in supra umbilical region. 2. their ages were ranged from 25: 35 years. 3. their bmi was more than 30 kg/ m2. 4. all women were with lumbar hyperlordosis. 5. all women were multipara. 6. their mode of delivery was normal vaginal delivery. 7. they were selected from 2: 5 months postnatal. exclusion criteria: 1. previous cesarean section. 2. previous abdominal and/ or back operation. 3. spinal disorders. 4. abdominal skin diseases. 5. serious diseases such as heart disease, pace maker, uncontrolled diabetes or hypertension, autoimmune disease, malignancy, gastric ulcer, liver or renal failure and any other contraindication for body sculpting-weight loss.

Keywords: ultrasound cavitation, static balance, dynamic balance
neurology inpatient clinical education trial

Conditions: Myasthenia Gravis; Guillain-Barre Syndrome; Multiple Sclerosis; Seizures; Parkinsonism; Meningitis; Encephalitis; Headache; Vestibular Disorder; Spondylosis; Normal Pressure Hydrocephalus

Summary: the objective of this study is to compare the effectiveness of a personalized patient education program to the current hospital education and evaluate its impact using patient satisfaction scores. the investigators hypothesize that a personalized patient education intervention will increase patient's understanding of their diagnosis and satisfaction with the care as reflected in the survey results.


Eligibility criteria:
inclusion criteria: * over the age of 18 * must have the capacity to consent and understand the study related activities and education materials. exclusion criteria: * under the age of 18 * have a condition that impairs the ability to understand the study, its risks, and appropriately consent for the study

Keywords: clinical education
prospective assessment of procedure-related and patient-reported outcomes after retrograde intrarenal surgery (rirs) for renal calculi less than 20 mm

Conditions: Renal Stone

Summary: the investigators aim at this study to prospectively assess procedure-related outcomes after rirs for renal calculi less than 20 mm, including stone free rate (sfr), predictors of successful outcome, complications types/rate, readmission rate and the need of auxiliary procedures. in addition, patient-reported outcomes after this modality of intervention are going to be assessed.


Eligibility criteria:
inclusion criteria: 1. ability to give informed consent. 2. stone criteria: * less than 20 mm. * infectious stone. * growing stone on follow-up. 3. kidney criteria: * obstructing stone causing hydronephrosis. * solitary kidney or bilateral renal stones. 4. patients criteria: * age ≥18 years. * symptomatic stone causing pain or hematuria. * patient comorbidity omitting other modalities as bleeding diathesis or skeletal deformities. * patient preference or patients' social situation concerning profession or amount of travel exclusion criteria: 1. inability to give informed consent. 2. stone criteria: * more than 20 mm. * peripheral calyceal asymptomatic stone static in size on follow-up. * unsuitable/failure of initial treatment modalities (oral dissolution therapy-swl) for stones less than 20 mm.

Keywords: renal stone calculi retrograde intrarenal surgery flexible ureteroscope
gene therapy for alpha-1 antitrypsin deficiency

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: this is a study of gene therapy to treat alpha-1 antitrypsin deficiency. this study aims to treat aat deficiency with a single administration of aav8haat(avl), a gene therapy that codes for an oxidation resistant form of the aat protein, which if safe and if efficacious, will protect the lung on a persistent basis. we hope to learn the safety/toxicity and initial evidence of efficacy of intravenous delivery of this gene therapy to alpha 1-antitrypsin (aat) deficient individuals.


Eligibility criteria:
inclusion criteria: * aat genotype zz, or z null heterozygotes, and if on augmentation therapy, pre-therapy aat serum levels \<11 μm * emphysema as assessed by chest high resolution computational tomography (hrct) * lung function parameters consistent with mild to moderate loss of lung function and the presence of emphysema. * troponin t within normal limits * normal liver ultrasound and serum alpha fetoprotein * normal kidney function * no contraindications to receiving corticosteroid immunosuppression exclusion criteria: * individuals receiving systemic corticosteroids or other immunosuppressive medications for pre-existing conditions. * inability to tolerate immunosuppression with corticosteroids (e.g., uncontrolled diabetes) * individuals with an immunodeficiency disease, or evidence of active infection of any type, including human immunodeficiency virus * evidence of major central nervous system, major psychiatric, musculoskeletal or immune disorder * prior history of myocardial infarction or cancer within the past 5 years (other than basal cell carcinoma of the skin) * decompensated heart failure (ny4a class iii-iv at time of baseline clinical assessment) * abnormal ecg at screening with findings consistent with cardiac disease * females who are currently pregnant or lactating * any history of allergies to drugs used for bronchoscopy, including xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic * individuals receiving experimental medications or participating in another experimental protocol for at least 3 months prior to entry to the study * use of oxygen supplementation * risk for thromboembolic disease * history of significant cardiovascular disease, hypertension, prior myocardial infarction and/or cerebrovascular event * individuals who are currently on beta-blockers, or other cardiac therapy related drugs * prior history of hypersensitivity or anaphylaxis associated with the administration of any aat product

Keywords: aat emphysema gene therapy dlco augmentation therapy
wide excision alone as treatment for ductal carcinoma in situ of the breast

Conditions: Ductal Carcinoma in Situ of the Breast

Summary: the purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (dcis) of the breast.

* patients with dcis are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. the purpose of this study is to evaluate whether localized low- or intermediate-grade dcis, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates. * follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. mammograms of the unaffected breast will be performed annually.

Eligibility criteria:
inclusion criteria: * patients must have high quality mammogram including magnification views of the area containing suspicious calcifications. * a specimen radiograph is required. if the specimen radiograph does not assure removal of all suspicious microcalcifications, a post-operative mammogram showing removal of all suspicious calcifications is required. * the clinical extent of dcis must be less than or equal to 2.5 cm. * grade 1 or 2 dcis; patients with lobular carcinoma-in-situ (lcis) in addition to dcis in the breast are eligible. negative margins are not required on the lcis. * patients must undergo a wide excision. a re-excision after the initial biopsy might be needed. complete resection of the area of dcis with a histologic margin of at least 1 cm must be achieved. * patients must be enrolled on this protocol within 3 months of the last surgical procedure. exclusion criteria: * patients with invasive carcinoma including microinvasive disease * carcinoma found in the sampled lymph nodes if axillary dissection is done * patients with nipple discharge * patients with adjuvant chemotherapy or tamoxifen * patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix. * patients with a history of ipsilateral or contralateral breast carcinoma or dcis or simultaneous bilateral dcis.

Keywords: ductal carcinoma in situ dcis wide excision
guided biaxial alveolar distraction device in posterior atrophic mandible

Conditions: Mandible; Deformity

Summary: atrophic alveolar bone presents a unique difficulty, preventing correct implant placement and affecting long-term results. there are different techniques that are recommended to restore the proper length of the posterior ridge of the mandible and thus achieve proper form and function, one of those is distraction osteogenesis. refinements in the technique of distraction can improve the treatment outcome and decrease postoperative complications.


Eligibility criteria:
inclusion criteria: * patients with the posterior atrophic mandible. * the distance from the alveolar crest to the upper border of the canal is not less than 5 mm. * adult patients from 30-60 years old with no gender predilection who agreed to present for follow-up visits for a minimum postoperative period of 4 months. * patientswithanadequateoralhygiene. * the patient should be psychologically accepting of the involved procedures. exclusion criteria: * medically compromised patients contradicting operation (asa iii, iv \& v). * patients receiving radiotherapy or chemotherapy or bisphosphonate. * bonediseases(osteoporosis,osteopetrosis,osteomalacia...etc.) * any habits that might retard healing such as heavy smoking and alcoholism. * a history of any grafting procedure at the designated area.