Kornimate/medical-research-clean huggingface dataset:
periodontal treatment associated with hyperbaric oxygen therapy

Conditions: Periodontal Disease

Summary: evaluation of the clinical effect of hyperbaric oxygen therapy (hbot) adjunctively to scaling and root planing (srp) in the treatment of severe case of chronic periodontitis.

materials and methods: in 20 patients diagnosed with severe generalized chronic periodontitis (pockets\>7mm) with bleeding on probing, srp was rendered in all pockets. additionally, five consecutive hyperbaric sessions were administered in 10 patients after random allocation (srp+hbot). clinical parameters were assessed at baseline up to 6 months: plaque index (pi), bleeding on probing, probing depth, clinical attachment level and bana test. results: srp+hbot resulted in greater probing reduction and attachment gain than srp alone 3 months after treatment (p\ 0.05). conclusion: these preliminary data suggest that hyperbaric oxygen therapy had a short-term beneficial effect on pocket reduction and bacterial elimination, and may be considered a potential therapy option to improve the clinical outcomes of scaling in severe cases of chronic periodontitis.

Eligibility criteria:
inclusion criteria: * this preliminary (pilot) study was designed with twenty subjects (12 men, 8 women, mean age 37.3 years) selected from a pool of 360 patients referred to the periodontal clinic of the school of dentistry at bahian science foundation (fbdc, bahia, brazil). * the patients had an initial diagnosis of severe generalized chronic periodontitis (aap 1999). exclusion criteria: * patients were excluded according to the following criteria: * smoking * pregnancy or lactation * antibiotics or periodontal treatment within the last 6 months * a diagnosis of aggressive periodontitis * trauma from occlusion or endodontic lesions * according to an accurate clinical examination performed by a hyperbaric medical doctor (md), the hbot contra-indications (iazzeti \& mantovani 1998) served as exclusion criteria. * the only absolute contraindication to hyperbaric oxygen therapy was from patients with untreated pneumothorax * relative contraindications were considered: * upper respiratory infections * high fevers * emphysema with co2 retention * historic of thoracic surgery * malignant disease and middle ear barotrauma * patients taking or have recently taken the following drugs: * doxorubicin (adriamycin®) * disulfiram (antabuse®) * cis-platinum and mafenide acetate (sulfamylon®).

Keywords: periodontitis hyperbaric oxygen therapy
loading dose or standard dose of intravenous ibandronate in treating patients with lung cancer and skeletal metastasis

Conditions: Lung Cancer

Summary: the objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous bondronat in reducing pain in patients with lung cancer and bone metastatic disease.

patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. some researches have reported that loading doses bondronat (6mg bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. so,we designed this clinical trial to compare the efficacy and safety profiles between loading doses bondronat and standard dose bondronat.enrolled patients will receive an intravenous infusion of either 6mg bondronat on three consecutive days or 6mg bondronat on one day. the targeted sample size is 120 individuals. primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). secondary outcome measures will be efficacy including ecog performance status, analgesic consumption, bone markers, and safety profiles including ae and laboratory parameters.

Eligibility criteria:
inclusion criteria: * written informed consent * age ≥ 18 years * histological or cytological evidence of lung cancer * presence of bone metastases documented on bone x-ray, bone ect, ct scan or mri scan * mean pain score ≥ 4 during 3-day baseline period on the worse pain scale of the vas * patients must be on a stable dose of analgesics over the 3-day baseline period (maximum 15% variation is allowed) * ecog performance status of 0-3 (patients with ps of 3 must have their score based on bone pain, not underlying neoplastic disease) * adequate renal function: creatinine clearance ≥ 50 ml/min (cockroft formula) and serum creatinine ≤ 2.0mg/dl (168 µmol/l); alt or ast within 2 times the upper limit of the normal range exclusion criteria: * patients with an uncontrolled infection * hypocalcemia * patients who have received a bisphosphonate within 3 weeks of the start of the baseline period or who are currently receiving another bisphosphonate * patients with known hypersensitivity to any of the components of ibandronic acid * patients who are pregnant or lactating * radiotherapy to bone within the 28 days prior inclusion or during the trial duration * patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing

Keywords: ibandronate, lung cancer, bone metastasis
study of taxotere, cisplatin, 5-fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck

Conditions: Squamous Cell Carcinoma; Carcinoma of Head and/or Neck

Summary: the purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. we will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.

* patients will be premedicated at home with dexamethasone and leucovorin. * on the first day of treatment, the patient will receive taxotere intravenously for one hour. approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. the infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. this process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy. * during each cycle blood tests will be performed weekly. during the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle. * at the end of each cycle the impact of the chemotherapy will be assessed. if after 2 cycles the cancer has not responded the treatment will end. if significant reduction in the size of the tumor is observed, a third and final cycle will be done. * after the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.

Eligibility criteria:
inclusion criteria: * histologic documentation of squamous cell carcinoma of head and neck * patients will previously untreated stage iii or iv squamous cell carcinoma. * patients with locally recurrent disease after surgery. * life expectancy of longer than 3 months. * kidney function: 1.5 or a 24 hour creatinine clearance of \> 30ml/min * liver function: sgot \< 1.5 x upper normal limit and alkaline phosphatase of \< 2.5 x upper normal limit. * wbc greater than or equal to 4,000/mm * platelet count greater than or equal to 100,000/mm * hemoglobin greater than or equal to 10gm/dl * patients of child-bearing age must use effective methods of contraception. exclusion criteria: * patients treated with previous chemotherapy or radiotherapy for head and neck cancer. * patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix. * pregnant or breast-feeding women

Keywords: squamous cell carcinoma taxotere carcinoma of head/neck cisplatin 5-fluorouracil leucovorin
evaluation of the harm for the detection of a cerebral ischemia in tia/tna patients

Conditions: TIA; Stroke; Ischemia; Diagnoses Disease

Summary: the research project investigates the incidence of the hyperintense acute reperfusion marker (harm) in patients with transient ischemic attack (tia) or transient neurological attack (tna). initially, harm was described after acute ischemic stroke and is caused by a blood-brain barrier disorder after recanalization of an acute vessel occlusion and consecutive reperfusion. these result in a contrast agent extravasation into the subarachnoid space, which can be easily detected on fluid attenuated inversion recovery (flair) images. tia is defined as a transient focal neurological deficit with a probably cerebrovascular cause. in contrast, tna is defined as a transient non-focal neurological deficit with multiple causes, including cerebrovascular. the clinical diagnosis of tia is often flawed and the delineation of tia and tna can be difficult. mri is the most important diagnostic method for the detection or exclusion of cerebral ischemia in patients with tia/tna in daily clinical practice. however, on diffusion-weighted imaging (dwi) approximately two-thirds of tia cases and only one-fifth of tna cases demonstrate acute cerebral ischemia. supplementary perfusion-weighted imaging (pwi) scans can only slightly increase this percentage. the well-known harm could prove to be complementary to dwi and pwi and close or at least reduce the existing gap. in the case of tna in particular, this could be of clinical relevance in order to avoid mistreatment or even dismissal without further clarification after supposedly inconspicuous imaging. therefore, the aim of this study is to record the incidence of harm in a statistically significant number of cases of patients with tia and tna and to investigate relationships with symptom duration and anatomical localization. in addition, the dynamics of contrast enhancement in the subarachnoid space in tia and tna cases with harm will be analyzed in detail.


Eligibility criteria:
inclusion criteria: * transient focal neurological symptoms (aphasia, facial paresis, hemiparesis, hemihypaesthesia, double vision, hemianopia, hemiataxia, etc.) * transient non-focal neurological symptoms (confusion, dizziness, memory deficits, gait insecurity, bilateral weakness, etc.) * mri examination possible within 24 hours of symptoms * able to give informed consent exclusion criteria: * persistent symptoms * symptoms lasting more than \> 24 h * clinical suspicion of other cause of symptoms (seizures, intoxication, hypoglycemia, psychogenic) * contraindications for mri (pacemaker, metallic splinter, cochlear implants, etc.) * unable to give consent

Keywords: tia stroke ischemia mri flair hyperintense acute reperfusion marker
td-9855 mass balance study

Conditions: ADHD; Fibromyalgia

Summary: the purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (adme) of a single oral dose of \[14c\]td-9855


Eligibility criteria:
inclusion criteria: * healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone \[fsh\] \>40 iu/ml) * body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg * negative for hepatitis b, hepatitis c, and hiv antibody exclusion criteria: * have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease * subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the c-ssrs (item 2 or higher on ideation). subjects with any history of suicide attempts * any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract \[including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas\]) * infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to day -1. subject is unable to provide a fecal sample prior to study drug dosing on day -1 or day 1.

Keywords: adhd fibromyalgia
application and clinical effectiveness of pelvic reconstruction in robot-assisted radical cystectomy-orthotopic ileal neobladder in the male

Conditions: Bladder Cancer

Summary: to study the effect of pelvic reconstruction on early return of continence after robot-assisted radical cystectomy-orthotopic ileal neobladder in the male.

this study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy-orthotopic ileal neobladder. the patients will be distributed into two comparable groups according to whether received pelvic reconstruction or not. patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility criteria:
inclusion criteria: 1. male patients aged 18 or older. 2. patients those who are diagnosed with urothelial carcinoma. 3. patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder. 4. patients those who are able to cooperate and complete the follow-up. 5. patients those who volunteer to participate in this study and sign the informed consens. exclusion criteria: 1. patients thsoe who are diagnosed distant metastasis before surgery. 2. patients those who are diagnosed with other malignancies. 3. patients those who had received pelvic radiotherapy or major pelvic operation.
objective brain function assessment of mtbi/concussion in college athletes

Conditions: Brain Injuries, Traumatic; Concussion, Mild; Concussion, Brain; Concussion, Intermediate; Concussion, Severe

Summary: this study (part 1) is designed to build a database including eeg, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal eeg based algorithm for the identification of concussion and tracking of recovery. in addition, neuroimaging will be conducted at time of injury and following return to play (rtp).

injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. matched controls will be tested following the same schedule as the injured athletes. in addition, the study will include an additional pool of contact and non-contact athletes who are not head injured and will be assessed prior to the season and then after the season has ended. this data will be used to populate a database for the purpose of deriving a multimodal concussion index.

Eligibility criteria:
inclusion criteria: * concussion-injury subjects will be defined as follows: any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice. 1. if loss of consciousness, total duration less than \<20 minutes 2. no evidence of abnormality visible on computerized tomography (ct) of the head related to the traumatic event (note: neuroimaging is not required for enrollment) 3. no hospital admission due to either head injury or collateral injuries for \>24 hours. 4. gcs is between 13-15. exclusion criteria: 1. evidence of illicit drug usage 2. do not speak or read english 3. current cns active prescription medications, with the exception of medications being taken for the treatment of attention deficit disorder (add) 4. skull abnormalities, e.g. metal plate 5. history of brain surgery or neurological disease.

Keywords: concussion mild traumatic brain injury sport related concussion
effect of kinesiotaping augmented by resistive exercise on fatigue, physical strength, quality of life in breast cancer survivors

Conditions: Breast Cancer; Fatigue; Quality of Life

Summary: the purpose of the study will be to investigate the effect of kinesotaping augmented by resistive exercise on fatigue, muscle strength, and qol in breast cancer survivors.

the present study will provide an evidence base to women's health care providers about the effect of strength training augmented by kinesotaping on fatigue, qol and muscle strength in breast cancer women compared to strength training alone

Eligibility criteria:
inclusion criteria: * patient's age will range from 40- 55 years. * their body mass index (bmi) will be from 25 to 29,9 kg/m2. * they suffer from breast cancer. * they will receive chemotherapy within previous 3 months. * they complain from fatigue, deterioration in their daily living activity (adl) and feeling of weakness in their muscles. exclusion criteria: * respiratory or heart problems affecting mobility * marked skeletal deformity. * visual system affection. * cognition problems. * previous surgeries at their back and/or lower limbs.
effect of an intervention program of adapted physical activity combined with compensatory nutrition in patients with constitutional thinness

Conditions: Constitutional Thinness

Summary: constitutional thinness (ct) is a form of stable thinness without malnutrition but with resistance to weight gain, affecting approximately 1% of the general population. the clinical consequences are numerous and the pathophysiology remains poorly understood. currently, conventional management involves a high-calorie and frequent diet, combined with the avoidance of endurance physical activity, although there is no significant evidence of its effectiveness. our hypothesis is that an adapted physical activity program (apa) combined with compensatory nutrition (cn) could help these patients gain lean mass (muscle mass).


Eligibility criteria:
inclusion criteria: * gender: female * bmi: ≤ 18.5 kg/m² * weight stability: stable weight for at least 3 months * age: 18 to 50 years old at the inclusion visit * diagnosed with constitutional thinness exclusion criteria: * pregnancy, parturition, or lactation * legal restrictions: individuals deprived of liberty, involuntarily hospitalized, or hospitalized for reasons other than research purposes, adults under legal protection (guardianship or curatorship) or unable to provide consent * eating disorders: individuals with eating disorders (dsm iv and 5 criteria) * excessive alcohol consumption: consumption exceeding the equivalent of 10 glasses of wine per week * severe progressive conditions: progressive severe conditions (e.g., diabetes) * intense physical activity: individuals engaging in intense physical activity (\> 3 sessions per week) * heavy smoking: significant smoking (\>10 cigarettes per day) * psychiatric conditions: presence of depressive or psychiatric conditions requiring antidepressant or psychotropic treatment * medical or surgical history: medical or surgical history deemed incompatible with the study by the investigator * mri contraindication: individuals with contraindications to mri will not undergo spectro-mri analyses

Keywords: constitutional thinness (ct) adapted physical activity compensatory nutrition lean and muscle mass gain resistance to gain weight
bilateral cochlear implantation in children with the med-el cochlear implant

Conditions: Hearing Loss

Summary: the purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with med-el combi 40+ / pulsarci100/sonatati100 cochlear implant systems.


Eligibility criteria:
inclusion criteria: * between 12 and 36 months of age at time of implantation * profound bilateral sensorineural hearing loss * english as the primary language in the home * realistic expectations of guardians * child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills * willing and available to comply with all scheduled procedures as defined in the protocol audiological: * profound bilateral sensorineural hearing loss with average thresholds between ears of 90 db hl or greater at 1000 hz and above, and must demonstrate minimal functional benefit from conventional amplification * behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually) * children accepted into the study must be able to demonstrate a consistent response to sound. if a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli. * all children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study. medical: * good general health status, as judged by primary investigator * patent cochleae bilaterally, as indicated by radiological evaluation * no contraindications for surgery, in general, or cochlear implant surgery in particular exclusion criteria: * prior experience with any cochlear implant system * younger than 12 months or older than 36 months at time of implantation * audiological: presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy medical: * evidence of ossification that would prevent full insertion of the standard c40+ / pulsarci100 /sonatati100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation * abnormal or malformed cochlea(e) to be implanted * severed or non-functional auditory nerve in the ear(s) to be implanted * central auditory lesion * cognitive and/or neurological dysfunction * auditory neuropathy

Keywords: cochlear implant hearing loss
study to assess the reliability of pasi scoring using digital-based images

Conditions: Plaque Psoriasis

Summary: this is an open-labeled study to evaluate the reliability of digital photographs for the remote assessment of the disease severity of plaque psoriasis.

this study is being conducted to evaluate the reliability of digital photography for the remote assessment of psoriasis disease severity using the psoriasis area and severity index (pasi) compared to in-person evaluations. approximately 30 adult subjects will undergo in-person assessments of the severity of the disease and have digital photographs taken for comparative remote evaluations.

Eligibility criteria:
inclusion criteria: 1. male and female subjects aged 18 to 75 years, inclusive, at the time of consent. 2. subject has at least a 6-month history of plaque psoriasis prior to screening visit (information obtained from medical chart or subject's physician, or directly from the subject). 3. subject has plaque psoriasis covering at least 0.5% his/her total bsa at screening/day 1 visit. 4. subject has a pga score ≥2 at screening/day 1 visit. exclusion criteria: 1. subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.

Keywords: psoriasis remote assessment digital photographs