Kornimate/medical-research-clean huggingface dataset:
laterally closed tunnel vs tunneling technique in recession type 2

Conditions: Gingival Recession

Summary: this study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.

tunneling with subepithelial connective tissue graft: at the recipient site (recession defect): after scaling and root planning. a sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. at donor site (palate): a connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision. then the graft is placed and secured in the recipient site using suture. the flap is displaced to be in a coronal position using a suture. tunneling technique with the laterally closed tunnel): after local anesthesia, root planing of the exposed root surface will be performed. an intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap. * donor sctg subsequently, a palatal sctg will be harvested by means of the single incision technique with immediate closure of the donor site. * recipient site; using either single or mattress sutures, the sctg will be pulled and fixed mesially and distally at the inner aspect of the pouch. the graft will be adapted to the cej by means of a sling suture. finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

Eligibility criteria:
inclusion criteria: * patients 18 years or older. * patients with healthy systemic condition * buccal recession defects with recession type 2 defects. * clinical indication and/or patient request for recession coverage. * o'leary index less than 20% exclusion criteria: * pregnant females. * smokers as it is a contraindication for any plastic periodontal surgery * unmotivated, uncooperative patients with poor oral hygiene * patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Keywords: tunneling laterally closed tunnel gingival recession recession type 2
womens study to alleviate vasomotor symptoms

Conditions: Hot Flashes

Summary: this study tests the hypothesis that a low-fat, vegan diet including soybeans reduces the frequency and severity of menopausal hot flashes, and tests the hypothesis that total isoflavone intake is associated with the reduction in the frequency and severity of hot flashes.

women with postmenopausal hot flashes will be recruited via social media and randomly assigned to an intervention or control group. the intervention group will be asked to consume a low-fat, vegan diet including ½ cup (86g) cooked soybeans (30 g uncooked) for 12 weeks. support will be provided by weekly meetings conducted via an internet video conferencing platform (e.g., zoom), along with individual counseling as needed. the control group will be asked to make no diet changes for 12 weeks but will be offered instruction in how to follow a vegan diet and about the potential role of soybeans after the 12-week point. the frequency and severity of hot flashes will be assessed before, during, and after the 12-week intervention.

Eligibility criteria:
inclusion criteria: 1. post-menopausal women aged 40-60 years 2. english fluency 3. moderate-to-severe hot flashes experienced at least twice per day 4. started menopause within the last 10 years 5. no menses in preceding 12 months 6. access to an iphone or android phone and willingness to install a hot-flash recording app. 7. willingness to participate in weekly classes 8. willingness to follow a low-fat vegan diet, including daily consumption of soybeans. exclusion criteria: 1. use of hormonal medications in the preceding 2 months 2. an explanation for hot flashes other than menopause (e.g., medication use, cancer treatment) 3. smoking during the past six months 4. history of an eating disorder or evidence of a current eating disorder (as determined by an eating disorder diagnosis, the discretion of a qualified medical professional, or an eating attitudes test-26 score \>20) 5. alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 6. use of recreational drugs in the past 6 months 7. use of weight-loss medications over the last 6 months or a current attempt to lose weight 8. body mass index \< 18.5 kg/m2 9. soy allergy

Keywords: soy menopause hot flash
a phase i study of pp-001 eye drops in healthy adult volunteers

Conditions: Keratoconjunctivitis; Ocular Surface Disease

Summary: in this study, pp-001 eye drops are assessed for safety and tolerability in healthy, adult volunteers. pp-001 is a novel, anti-inflammatory small molecule that inhibits a specific enzyme (dihydroorotate dehydrogenase). the study was amended and now includes patients with ocular surface inflammation.

in this prospective, single-centre, double blind (within each cohort), placebo controlled, randomised study, safety and tolerability of pp-001 eye drops is assessed in healthy, adult volunteers (cohorts 1-3) and in patients with ocular surface inflammation (cohort 4). pp-001 is a novel small molecule inhibitor of dihydroorotate dehydrogenase (dhodh) with anti-inflammatory properties.

Eligibility criteria:
inclusion criteria (excerpt): cohorts 1-3: * male or female healthy volunteers 18 - 64 years of age * good general state of health and participants must not have a diagnosis of any eye disease that could effect the pharmacokinetics of pp-001 cohort 4: * male or female subjects 18-64 years of age with ocular surface inflammation in both eyes * ocular surface inflammation as defined per protocol * good general state of health exclusion criteria (excerpt): cohorts 1-4: * participation in other clinical trials within 30 days prior to dosing start (ocular and non-ocular clinical trials) * pregnant or nursing patients * regular use of any ocular agents within 60 days prior to start dosing
adjuvant axitinib therapy of renal cell cancer in high risk patients

Conditions: Clear Cell Renal Carcinoma

Summary: the purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

this is a prospective, randomized, double blind placebo controlled phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo. approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.

Eligibility criteria:
inclusion criteria: patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. patients must have no evidence of macroscopic residual disease or metastatic disease. 2. male or female, age \>=18 years (age \>=20 years in japan, korea and taiwan). 3. patients must be diagnosed with one of the following based on american joint committee on cancer (ajcc) tnm staging version 2010, eastern collaborative oncology group (ecog) performance status (ps): * pt2, pn0 or pnx, m0 and ecog ps 0-1 * pt3, pn0 or pnx, m0 and ecog ps 0-1 * pt4, pn0 or pnx, m0 and ecog ps 0-1 * any pt, pn1, m0 and ecog ps 0-1 4. patients must have histologically confirmed preponderant, defined as \>50%, clear cell rcc. 5. patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for rcc. 6. patients must not have received any previous anti angiogenic treatment. 7. patients must have adequate organ function. exclusion criteria 1. histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites. 2. national cancer institute (nci) common terminology criteria for adverse events (ctcae) grade 3 hemorrhage \<4 weeks of date of randomization. 3. diagnosis of any non-rcc malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months. 4. any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. 5. gastrointestinal abnormalities

Keywords: renal cell carcinoma axitinib tyrosine kinase inhibitor
examining the use of a novel immersive motion tracking upper extremity exercise program for acute hospitalized patients

Conditions: Kidney Transplant; Liver Transplant

Summary: the objective of this study is to evaluate the feasibility of the movemend health software program as an integrated supplement to traditional acute care/in-hospital occupational therapy for patients following liver and kidney transplants, as determined by recruitment rates, program completion, intervention adherence, safety incidence, and patient feedback on device/program performance.


Eligibility criteria:
inclusion criteria: * english speaking (software program is currently only available in english) * status post kidney or liver transplant this admission * physician orders for occupational therapy evaluation and treatment * orientation log \> 25 * negative for delirium per the confusion assessment method exclusion criteria: * orthopedic or surgical precautions that limits shoulder range of motion beyond 90 degrees * upper extremity hemiplegia with inability to lift upper extremity against gravity * accommodation code of intensive care unit
depression, experiential diversity, and behavioral novelty

Conditions: Depression

Summary: the purpose of the study is to test whether changes in behavioral patterns are related to changes in depression. depression is a psychological condition that involves persistent sad mood and/or an inability to enjoy pleasurable activities. very stable behavioral patterns may be related to symptoms of depression. the aim of this study is to learn more about the relationship between symptoms of depression and behavioral patterns that are collected via global positioning system location data from a smart phone.


Eligibility criteria:
inclusion criteria: * age 18-25 * possession and daily use of a smart phone * able to speak and read english * patient health questionnaire -8 (phq-8) \> 10 * behavioral activation for depression (bads) activation subscale \< 16 * ability to complete all study procedures exclusion criteria: * self-reported lifetime diagnosis of agoraphobia or bipolar disorder * severe neurodevelopmental disorder * major travel plans within study period

Keywords: behavioral activation mobile sensing
indocyanine green for solid tumors

Conditions: Solid Tumor; Neoplasms

Summary: according to the world health organization, cancer is a leading cause of death in men and women, accounting for 7.6 million deaths (around 13% of all deaths) in 2008. surgery remains the best option for patients presenting with operable stage i or ii cancers, however the five year survival rate for these candidates remains at a dismally low. the high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. by ensuring a negative margin through near-infrared imagery it would be possible for us to improve the rates of recurrence from patients and thus overall survival.


Eligibility criteria:
inclusion criteria: 1. adult patients over 18 years of age 2. patients presenting with a solid tumor presumed to be resectable cancer and are at risk for local recurrence on pre-operative assessment 3. good operative candidate as determined by the treating physician and multidisciplinary team 4. subject capable of giving informed consent and participating in the process of consent. exclusion criteria: 1. pregnant women as determined by urinary or serum beta hcg within 72 hours of surgery 2. subjects with a history of iodide allergies 3. vulnerable patient populations 1. people who would be easily lost to follow up 2. patients unable to participate in the consent process (children and neonates).

Keywords: solid tumor
a retrospective study of the itotal cr knee replacement system

Conditions: Osteoarthritis

Summary: this study involves retrospective collection of data regarding the first approximately 100 itotal knee replacement system surgeries and their short term outcomes at a small set of centers throughout the us.


Eligibility criteria:
inclusion criteria: 1. clinical condition included in the approved indications for use 2. has signed the informed consent form to allow review of medical records and collection of data therein. 3. \> 18 years of age exclusion criteria: 1. treatment with itotal in a manner inconsistent with instructions for use 2. unwilling to sign then informed consent form
domperidone for relief of gastrointestinal disorders

Conditions: Gastroparesis; GERD; Esophagitis; Dyspepsia; Chronic Idiopathic Constipation; Nausea; Vomiting

Summary: the purpose of this study is to make domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.

domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain gi conditions, including gastroparesis and other motility disorders. according to recent regulations, writing prescriptions for subject to obtain domperidone outside the united states has been determined to be illegal and the fda has issued warnings against pharmacies compounding domperidone. the legal way of administering domperidone is by obtaining an investigational new drug application. this study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.

Eligibility criteria:
inclusion criteria: * 18 years or older * symptoms or manifestations secondary to gerd (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy * subjects must have a comprehensive evaluation to eliminate other causes of their symptoms. exclusion criteria: * history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and torsade de pointes. subjects with minor forms of ectopy (pacs) are not necessarily excluded. * clinically significant bradycardia, sinus node dysfunction, or heart block. prolonged qtc (qtc \> 450 milliseconds for males, qtc \> 470 milliseconds for females.) * clinically significant electrolyte disorders. * gastrointestinal hemorrhage or obstruction. * presence of a prolactinoma (prolactin-releasing pituitary tumor.) * pregnant or breast feeding female. * known allergy to domperidone.

Keywords: domperidone gastroparesis
clobetasol propionate 0.05% shampoo in association with antifungal shampoo in scalp seborrheic dermatitis

Conditions: Scalp Seborrheic Dermatitis

Summary: the objective is to assess different treatment regimens with clobetasol propionate shampoo 0.05% in the treatment of scalp seborrheic dermatitis.

the objective is to assess different treatment regimens with clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (ketoconazole 2%) in the treatment of moderate to severe scalp seborrheic dermatitis compared to the antifungal shampoo alone.

Eligibility criteria:
inclusion criteria: * subjects with moderate to severe scalp seborrheic dermatitis exclusion criteria: * subjects suffering from psoriasis, * subjects with a known allergy to one of the components of the test products, * female subjects who are pregnant, nursing or planning a pregnancy during the study
clinical and multiomics study of first-line chemotherapy for advanced pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma, PDAC

Summary: the early symptoms of pancreatic cancer are not obvious, and the early diagnosis rate is low. for most patients with pancreatic cancer,palliative chemotherapy is the only choice .at present, the guidance of nccn guidelines on the selection of chemotherapy regimens for patients with advanced pancreatic cancer is only based on the physical condition(the ecog score), which is one of the important reasons for the poor efficacy of chemotherapy in patients with advanced pancreatic cancer.therefore, it is urgent to group pancreatic cancer patients according to tumor molecular typing and heterogeneity of response to chemotherapy drugs accurately,so as to guide the personalized treatment of patients.

based on the limitations of existing studies and the needs of clinical patients, the investigators chose two time points: after the diagnosis of pancreatic cancer (before the first-line chemotherapy), and after chemotherapy evaluation in this study, to obtain in situ samples of pancreatic cancer tissues by eus-fna.the samples are detected by dynamic multi-omics study before and after treatment(including genomics, transcriptomics, proteomics, metagenomics, etc.).combined with the drug reaction and clinical outcome of patients, a comprehensive model is established to predict the clinical outcome of patients with pdac and the choice of chemotherapy regimens, so as to screen the pancreatic cancer patients who are most likely to benefit from different chemotherapy regimens, and lay the foundation for the development of individual chemotherapy for advanced pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old, male or female; 2. locally advanced or metastatic pancreatic ductal adenocarcinoma confirmed by histopathology / cytology of the primary and / or metastatic lesions and not suitable for surgical resection, and don't receive chemotherapy; 3. according to the evaluation criteria of solid tumor efficacy(recist 1.1), there should be at least one measurable lesion (non nodular lesion with the longest diameter of 210 mm, or nodular lesion with the shortest diameter of more than 15 mm); 4. patients voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up. exclusion criteria: if any of the following criteria is met, the patient should be excluded: 1. pancreatic ductal adenocarcinoma is diagnosed without histopathology / cytology; 2. the target lesion has received local non-drug therapy (including radiotherapy, physical and / or chemical ablation, etc.), and there is no imaging progression; 3. if the central nervous system metastasis is known, mri should be performed to exclude it.
qlesp block in hip surgery

Conditions: Postoperative Pain

Summary: total hip arthroplasty (tha) is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. regional analgesia techniques are critical components of an optimal multimodal analgesia technique for tha, as they have been shown to improve pain relief as well as reduce opioid requirements. ultrasound-guided suprainguinal fascia iliaca (sfi) block has been recommended as a reliable analgesic option for tha. however, sfi block may lead to decreased motor strength of the surgical limb thereby hindering postoperative mobilization. recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (qlesp) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block. in this randomized trial, we aimed to compare ultrasound-guided qlesp with sfi block as a component of non-opioid analgesic regimen in patients undergoing tha. the primary outcome of the study was postoperative sufentanil consumption within the initial 24-h postoperative period after tha. the secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.


Eligibility criteria:
inclusion criteria: * 1. age 18-65 yrs 2. american society of anesthesiologists classification 1-3 3. body mass index between 20 and 35 (kg/m2) 4. undergo elective primary unilateral tha via a posterolateral approach 5. informed consent exclusion criteria: * 1. a known allergy to the drugs being used 2. pre-existing neuropsychiatric disorders or language barrier 3. analgesics intake, history of substance abuse 4. contraindications to peripheral nerve block 5. acute cerebrovascular disease 6. severe liver failure
guanfacine for ponv and pain after sinus surgery

Conditions: Postoperative Nausea and Vomiting; Pain, Postoperative

Summary: postoperative nausea and vomiting (ponv) and pain are the most common causes of post anesthesia care unit (pacu) discharge delay, with untreated ponv occurring in 20-30% of post-surgical patients. the effect of guanfacine (gf) administration on pain and nausea scores will be assessed with two groups. one group will receive 1 mg of gf to take orally and the other group will receive a similar appearing placebo (containing no drug) to take orally.

pain after surgery is commonly treated with narcotics which can potentiate ponv, further delaying pacu discharge. in multiple studies, alpha-2 agonists such as clonidine and dexmedetomidine reduce both the incidence of ponv and post-op pain, as well as requirements for postoperative analgesics. these actions are mediated via central alpha-2a receptors (a2ar). of the a2ar agonists, guanfacine, though a weak antihypertensive agent, has the highest selectivity for the a2ar, but to date is untested for its potential to treat either ponv or post-operative pain.

Eligibility criteria:
inclusion criteria: * vumc patients undergoing sinus surgery in mce or exclusion criteria: * inability to read and freely consent * patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine) * patients undergoing sinus surgery planned for greater than 3 hours * patients with significant pre-existing pain, on chronic pain (opioid, methadone) therapy, severe fibromyalgia or other pre-existing pain condition in any body part * patients with preoperative nausea/vomiting at baseline. * pregnant or lactating women