Kornimate/medical-research-clean huggingface dataset:
a study of bms-663513 in combination with chemoradiation in subjects with non small cell lung carcinoma (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose and assess the safety and tolerability of escalating doses of bms-663513 when given in combination with either radiotherapy alone or radiotherapy plus paclitaxel and carboplatin.


Eligibility criteria:
inclusion criteria: * nsclc who are eligible to receive a 6 week course of rt * part 1 - not candidates for definitive rt * part 2 - candidates for definitive rt exclusion criteria: * severe copd, pulmonary infection or interstitial pneumonitis * recent cellulitis * autoimmune disease
evaluation of the intestinal microbiota and bacterial translocation in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the main objective of this study is to compare the intestinal microbiota in newly diagnosed rheumatoid arthritis (ra) with that from individuals without ra. the first analysis will compare the proportion of filamentous bacteria in the intestinal microbiota between the two groups.

the secondary objectives of this study are : * a. to compare between the two groups : * a. the proportion of proteus mirabilis in the intestinal microbiota; * b . the proportion of species producing peptidyl arginine deaminase (pad ) in the intestinal microbiota; * c . the number of species found in the intestinal microbiota. * b. to evaluate bacterial translocation (from the digestive tract) in newly diagnosed ra patients with and healthy volunteers without ra. (bacterial translocation is a phenomenon in which live bacteria or a part of bacteria (e.g. lps teichoïc acid) cross the intestinal barrier and reach the bloodstream.). * c. to describe the ecology of the intestinal microbiota of newly diagnosed ra patients (characterization of species found according to their respiratory metabolism, according to their bacteriological characteristics, and according to whether or not the species are found significantly more frequently in patients with ra than in individuals without ra).

Eligibility criteria:
inclusion criteria for ra patients: * the patient was correctly informed * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * no antibiotic treatments within the 30 days preceding inclusion * absence of digestive pathology * ra diagnosis made within the past 12 months exclusion criteria for ra patients: * the patient has participated in another study within the past 3 months * the patient is under judicial protection, or any kind of guardianship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has taken antibiotics in the 30 days preceding inclusion * ra was diagnosed more than 12 months ago * digestive pathology inclusion criteria for healthy volunteers (hv): * the hv was correctly informed * the hv must have given his/her informed and signed consent * the hv must be insured or beneficiary of a health insurance plan * absence of digestive pathology * no antibiotic treatments within the 30 days preceding inclusion * does not have ra exclusion criteria for hvs: * the hv has participated in another study within the past 3 months * the hv is under judicial protection, or any kind of guardianship * the hv refuses to sign the consent * it is impossible to correctly inform the hv * the hv is pregnant, parturient, or breastfeeding * the hv has taken antibiotics in the 30 days preceding inclusion * digestive pathology * joint pathology of any kind (including inflammatory pathologies)

Keywords: bacterial translocation intestinal microbiota
strong heart study analyses obesity and lipoproteins

Conditions: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Obesity

Summary: to examine the relationship of obesity and body fat distribution to lipoprotein concentrations in members of the strong heart study.

background: the strong heart study is a longitudinal cohort study of several american indian groups in three participating centers. the overall aim of the main study is to determine the role of various risk factors in the development of cardiovascular disease in this native american population. design narrative: data from the first and second clinical exams of the strong heart study were analyzed to determine if body fat distribution as measured by waist-to-hip circumference was a better correlate of lipoproteins than was body mass index. in addition, change in body mass index (bmi) and waist-to-hip ratio (whr) were correlated with change in lipoproteins. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
carbon peek versus titanium pedicle screws in the treatment of spinal tumors

Conditions: Spinal Tumor

Summary: radiation therapy is a cornerstone in the treatment of spinal neoplasms as radical resections are often limited anatomically. frequently, a surgical stabilization with implants is required. however, metallic implants not only make the ct-based planning of a subsequent radiation therapy more difficult, but might also have an uncontrolled dose modulating effect in adjuvant radiotherapy. at the spine, radiation is limited by the effective dose posed to the relatively radiosensitive spinal cord. while metallic implants might result in an inhomogeneous and uncontrollable dose distribution due to the interface effect, the use of new radiolucent implants consisting of carbon/polyether ether ketone (peek) might allow a more homogeneous and predictable dose distribution. this study aims to evaluate the potential benefits of the use of carbon/peek pedicle screws during adjuvant radiation therapy and follow-up imaging of spinal tumors. 60 patients will randomized 1:1 into either treatment arm (pedicle system carbon/peek vs. pedicle system titanium). the feasibility of planning the radiation therapy will be evaluated. the postoperatively administered total radiation dose is documented. the radiological visualization of the area of interest will be evaluated the surgical outcome is evaluated by fusion rate, implant integrity and anchorage. patients will be followed up for 12 months according to local standards.


Eligibility criteria:
inclusion criteria: * patients 18 to 99 years of age * primary and secondary spinal tumors of the thoracolumbar spine requiring posterior instrumentation and radiation therapy exclusion criteria: * need of cement augmentation or anterior cage support (corpectomy) * patients with contraindication against surgical resection * patients with incomplete medical records or insufficient imaging
modified trabeculectomy for glaucoma surgery

Conditions: IOP Decreased

Summary: a combination of hypotony, flat anterior chamber and choroidal detachment is the most common complications after filtering surgery. the purpose of this study is to present a new modification in standard trabeculectomy technique to reduce such complications.

recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. the dissection through the cornea is carried out with great care, leaving only thin corneal stroma over descement's membrane. application of direct heat cautery using a prob imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm. the horizontal distance between each point is 3.5 mm figure(1). the application of the cautery continue till the color of the tissue becomes brown. then with aid of a 23-gauge needle we penetrate these cauterized points to create 4 holes, each of them is nearly 0.3-0.5 mm in length (the opening of each hole takes the shape of a slit). through one of these holes iridectomy is done. these holes drain the aqueous under the scleral flap with anatomical preservation of tissue in between. close the scleral flap by two 10-0 nylon suture.

Eligibility criteria:
inclusion criteria: * 1ery glacouma exclusion criteria: * previous surgery
sodium bicarbonate for reducing radiation-induced oral mucositis in nasopharyngeal carcinoma.

Conditions: Nasopharyngeal Cancinoma (NPC)

Summary: to evaluate whether the use of 2.5% sodium bicarbonate mouthwash throughout the entire course of radiotherapy for nasopharyngeal carcinoma reduces the severity of radiation-induced oral mucositis and improves patient adherence to treatment.

with the improvement in the prognosis of locally advanced nasopharyngeal carcinoma (la-npc) patients, an increasing number of studys have turned their attention to the treatment-related toxicities in npc patients. common toxic reactions during the treatment of npc patients include radiation-induced oral mucositis, radiation-induced skin injury, dysphagia, xerostomia, and hearing loss, etc. among them, radiation - induced oral mucositis is one of the most common and severe complications during radiotherapy for npc patients. more than half of la-npc will experience grade 3 - 4 radiation-induced oral mucositis. current international guidelines, including those from nccn, esmo, and the multinational association of supportive care in cancer (mascc), provisionally endorse sodium bicarbonate mouthwash as an adjunctive measure for riom management. the proposed mechanisms involve ph modulation of the oral cavity, microbial load reduction, and anti-inflammatory effects. specifically: 1) nccn guidelines incorporate sodium bicarbonate into multi-agent regimens with analgesics/anesthetics; 2) esmo emphasizes its prophylactic potential in targeted therapy-associated mucositis; 3) mascc consensus acknowledges its role in maintaining oral hygiene. however, these recommendations carry low evidence grades, with all guidelines explicitly highlighting the paucity of robust clinical data to substantiate efficacy claims. to address this critical evidence gap, our research team proposes a randomized controlled trial to evaluate the efficacy of sodium bicarbonate mouthwash in mitigating riom severity throughout radiotherapy for la-npc. given the current lack of high - level research evidence, the results of future research are expected to further confirm the effectiveness of sodium bicarbonate mouthwash in relieving radiation-induced oral mucositis during radiotherapy for npc patients, improve the quality of life of npc patients.

Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed nasopharyngeal carcinoma. 2. no evidence of distant metastasis (m0). 3. scheduled to receive radical radiotherapy. 4. karnofsky scale (kps) \> 70. 5. age 18-70 years. 6. capacity for independent oral rinse administration without dysphagia. exclusion criteria: 1. patients receiving non-platinum-based concurrent chemotherapy regimens. 2. radiation fields encompassing level ib lymph nodes. 3. history of pre-existing oral mucosal disorders or recurrent oral ulceration. 4. prior radiotherapy history. 5. severe coexisting illness. 6. pregnancy or lactation.
expanded access to immunomodulatory avm0703 for solid tumor and blood cancer patients

Conditions: Glioblastoma; Squamous Cell Carcinoma; Hodgkin Lymphoma; Non-hodgkin Lymphoma; Breast Cancer; Prostate Cancer; Gastric Cancer; Ovarian Cancer; Acute Leukemia; Pancreatic Cancer; Spindle Cell Sarcoma; Cancer; Tumor, Solid; Tumor, Brain; Esophageal Andeocarcinoma; Mixed Phenotype AML; Desmoplastic Round Cell Sarcoma

Summary: avm biotechnology, inc., provides immunomodulatory avm0703 to solid tumor and blood cancer patients upon request by a us licensed md or do. as of july 2024, 37 patients have been treated through this fda-eap including patients diagnosed with relapsed or recurring glioblastoma, inoperable/chemotherapy ineligible cns squamous cell carcinoma, metastatic breast cancer, ovarian cancer, gastric cancer, hodgkin's lymphoma, mixed phenotype acute myelogenous leukemia, colon cancer, b-all, malignant myxoid spindle cell neoplasm, non-small cell lung cancer, dlbcl with cns involvement, metastatic prostate cancer, anaplastic t-cell non-hodgkin's lymphoma and metastatic pancreatic cancer. drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
metabolic effect of high-protein meals in men

Conditions: Healthy

Summary: the purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.

it was a double-blind, single center, randomized, crossover adaptive study design with 7 arms. the subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. the 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.

Eligibility criteria:
inclusion criteria: * 20 - 50 years, male * healthy as determined by a medical questionnaire * normal weight: bmi 20 - 24.9 kg.m-2 * normal fasting glycemia and insulinemia * normal fasting lipidemia (cholesterol and triglycerides) * normal liver function (transaminases, γ-gt) and kidney function (urea, creatinine) * capable of fast ingestion of the meal replacement (5-10 min) * having signed informed consent exclusion criteria: * intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance. * hypertension \>150/95 mmhg * have had a gastrointestinal surgery * have a regular consumption of medication * vegetarian, vegan, under dietary supplements * have an alcohol intake: \> 2 units a day or smoker * currently participating or having participated in a clinical trial during the last month * having given blood in the last month * more than 5 x 45 min of intense exercise per week * volunteer who cannot be expected to comply with treatment

Keywords: glucose insulin
safety, tolerability, and pharmacokinetics of bimatoprost in men with androgenetic alopecia (aga)

Conditions: Alopecia; Alopecia, Androgenetic; Baldness

Summary: this is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (aga).


Eligibility criteria:
inclusion criteria: * mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year exclusion criteria: * history of paget's disease, osteoporosis, or bone malignancy * history of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures * patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study * drug or alcohol abuse within 12 months * hiv positive * received hair transplants or had scalp reductions * use of hair weaves, hair extensions or wigs within 3 months * application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (nsaids) to scalp within 4 weeks
effects of coenzyme q10 supplementation on oxidative stress, antioxidant capacity, inflammatory responses, fatigue elimination, and exercise performance in athletes

Conditions: Athlete

Summary: the aims of the study are 1) to compare the differences in plasma coenzyme q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances in athletes (i.e., soccer, and taekwondo players) and healthy non-athletes; 2) to investigate the relationship between plasma coenzyme q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances; 3) to explore the influence on plasma coenzyme q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances after 12 weeks of coenzyme q10 intervention (150 mg/day and 300 mg/day).

the long-term high-amount and -intensity exercise training could cause oxidative damage, muscle impairment, inflammation and exercise fatigue to athletes easily. such above conditions will affect the exercise performances and health of athletes. the aims of the study are 1) to compare the differences in plasma coenzyme q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances in athletes (i.e., soccer, and taekwondo players) and healthy non-athletes; 2) to investigate the relationship between plasma coenzyme q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances; 3) to explore the influence on plasma coenzyme q10, oxidative stress, antioxidant capacity, muscle impairment, fatigue recovery, and inflammation and exercise performances after 12 weeks of coenzyme q10 intervention (150 mg/day and 300 mg/day). eventually, these results of this study can provide the information for the known to improve the oxidative stress, anti-oxidation and inflammation internal to the bodies of athletes for various competitions. as a consequence, the athletic performances can be further enhanced.

Eligibility criteria:
inclusion criteria: * athletes (soccer and taekwondo players) exclusion criteria: * antioxidant vitamins users * statins or aspirin therapy.
effectiveness of telerehabilitation in improving walking and balance among stroke survivors?

Conditions: Stroke

Summary: a good rehabilitation program may not be accessible for all individuals living with stroke due to cost, transportation and compliance. telerehabilitation is an alternative health care program that may help in overcoming this issue. in this study we aim to find if the use of telerehabilitation in saudi arabia would improve balance and walking in stroke survivors during this pandemic.

background: rehabilitation program is commonly provided after stroke to improve functional outcomes. a good rehabilitation program may not be accessible for all individuals living with stroke due to cost, transportation and compliance. telerehabilitation is an alternative health care program that has been used to provide therapy for stroke survivors living in rural areas. with covid-19 pandemic, many stroke survivors have lost their access to rehabilitation. therefore, telerehabilitation may help in overcoming this issue. in this study we aim to find if the use of telerehabilitation in saudi arabia would improve balance and walking in stroke survivors during this pandemic. methods: 2 stroke survivors ( male and female/ \>6 months post stroke) are included in this case study. participants will receive a task-specific activity training (3days/week moderate exercises for 4 weeks) both participants will provide feedback through questionnaires pre and post the 4 weeks intervention. we will use the activities- specific balance confidence (abc) scale, lower limb functional scale (lefs) and stroke severity quality of life scale ( ss-qol). • intervention: the participants will follow a home-based exercise through videos with follow up from the therapists for 4 weeks.

Eligibility criteria:
inclusion criteria: * subjects who have been diagnosed with stroke 6 months or more. * either right or left hemiparesis. * subjects able to walk with or without assistive device. * age between 40-70. 5) subjects can understand and follow commands. exclusion criteria: * subjects with uncontrolled blood pressure, heart rate or breathing problems. * having an orthopedic problem or pain that limits walking and standing. * subject with vestibular disorders. * subjects with cognitive disorders. 5) subjects with hemi spatial neglect
safety and efficacy study of a fluoroquinolone to treat complicated skin infections

Conditions: Skin Structure Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections

Summary: the purpose of this study is to assess the efficacy, safety and tolerability of rx-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.


Eligibility criteria:
inclusion criteria: * adult (≥18 years of age) men or women with csssi * diagnosis of one of the following 3 types of csssi: wound infection that has developed within 30 days of surgery, trauma, or a bite injury; abscess that has developed in the 7 days before enrollment; or cellulitis that has developed in the 7 days before enrollment * sexually active men and women of childbearing potential must agree to use an acceptable form of contraception, as determined by the investigator, during participation in the study and for 30 days after the final dose of study drug * the patient must be willing to comply with protocol requirements exclusion criteria: * medical history of hypersensitivity or allergic reaction to quinolones, tetracycline or tetracycline derivatives * chronic or underlying skin condition at the site of infection * infection involving prosthetic materials or foreign bodies (unless prosthetic material will be removed within 24 hours), infection associated with a human bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene or gas gangrene, burns covering ≥10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis * an infection that would normally have a high cure rate after surgical incision alone * any infection expected to require other antimicrobial agents in addition to study drug * receipt of \>24 hours of systemic antibiotic therapy in the 7 days before enrollment * a severely compromised immune system * history of child-pugh class b or c liver disease or severe renal impairment (creatinine clearance of \<30 ml/minute) * pregnancy or lactation

Keywords: complicated skin
7 year follow up analysis on the speed of progression of tooth wear using 3d subtraction

Conditions: Tooth Wear; Reflux Acid; Bruxism

Summary: prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. at the baseline and 1, 3 5, and the 7-year recall digital 3d scans will be made, which will be compared and subtracted.

prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. at the baseline and the 5-year recall digital 3d scans will be made, which will be compared and subtracted. per tooth the loss of material is measured in maximum loss in height (µm) and volume (mm3) per year, using best fit alignment and 3d subtraction. the loss of tooth material will be analyzed using descriptive statistics and possible effects of jaw type, tooth type and cusp type will be analyzed using multi level regression models. the use of index teeth will be analyzed.

Eligibility criteria:
inclusion criteria: * generalized tooth wear * a minimum of three posterior teeth (premolars and molars) per quadrant * a maximum of one edentulous space in need for treatment, with a maximum span of one tooth-width exclusion criteria: * asa 4 * edentulous space has a span exceeding 1 tooth-width, or more than one space * functional problems (mouth opening \<5cm, temporomandibular dysfunction) * severe periodontitis * strong gag reflex

Keywords: progression of tooth wear