Kornimate/medical-research-clean huggingface dataset:
comparison of the effectiveness of 2 manual therapies on functional outcome in sub-acute and chronic non-specific low back pain

Conditions: Subacute and Chronic Non-specific Low Back Pain

Summary: the purpose of this study is to determine whether a standardised osteopathic manipulative treatment is more effective than a placebo of osteopathic manipulative treatment, in sub-acute and chronic non-specific low back pain on functional recovery at 3 months.

sub-acute (4-12-week duration) and chronic (more than 3-month duration) non-specific low back pain (lbp) is frequent, disabling and costly. the effectiveness of usual treatments (including pain killers, anti-inflammatory drugs, spinal injections, physiotherapy, spinal traction, transcutaneous electrical nerve stimulation, etc) may be not sufficient, and many patients resort to alternative therapies. manipulative treatments represent en emerging therapy in this area, although studies assessing their effectiveness are limited and often biased. the purpose of this study is to evaluate the efficacy of two manual therapies on improving functional recovery in sub-acute and chronic non-specific low back pain at 3 months. a standardised osteopathic manipulative treatment is compare to a placebo of osteopathic manipulative treatment.

Eligibility criteria:
inclusion criteria: * patient consulting for subacute and chronic non-specific low * male or female aged from 18 to 65 years (included) * patient can speak and understand french * patient giving his informed consent to participate in the study * patient affiliated to or beneficiary of social insurance exclusion criteria: * specific low-back pain caused by inflammatory, tumoral, infectious disease or a back traumatism in the 3 past months * history of back surgery and/or vertebral fracture in the previous 6 months * presence of a motor impairment related to the reason for consultation * the patient is a student or a practitioner in manipulative therapies * pregnancy * inability to understand the process of the study * the patient is already included in another clinical study

Keywords: low back pain manual therapy randomized controlled trial
18f-fdg and 68ga-fapi pet/ct in lung adenocarcinoma

Conditions: Lung Adenocarcinoma; 18F-FDG; 68Ga-FAPI; PET/CT

Summary: to evaluate the potential usefulness of 68ga-fapi positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions in lung adenocarcinoma, compared with 18f-fdg pet/ct.

participants with lung adenocarcinoma underwent contemporaneous 18f-fdg and 68ga-fapi pet/ct for an initial assessment. tumor uptake was quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 18f-fdg and 68ga-fapi pet/ct were calculated and compared to evaluate the diagnostic efficacy. in addition, the investigators further investigate the performance of 68ga-fapi pet/ct for differentiating invasive adenocarcinoma from adenocarcinoma in situ (pre-invasive lesion) or minimally invasive adenocarcinoma in participants with solitary ground-glass opacity nodules.

Eligibility criteria:
inclusion criteria: * (i) aged ≥ 18 years, with newly detected ggns ≤ 3 cm on ldct and suspected to be lung cancer, and with no prior treatment; * (ii) who accepted undergoing paired 18f-fdg and 68ga-fapi-46 pet/ct, with completion within one week of each other; * (iii) with planned surgical resection within one month after pet/ct examinations; * (iv) with an ability to provide informed consent according to the guidelines of the clinical research ethics committee. exclusion criteria: * (i) without surgical treatment; * (ii) receiving antitumor treatment prior to surgery; * (iii) whose postoperative pathology revealed adenocarcinoma beyond stage ia or benign pulmonary lesions; * (iv) with concurrent diagnosis of other malignant tumors; * (v) with poor image quality or lesions difficult to measure.

Keywords: lung adenocarcinoma fdg fapi pet/ct
oocyte survival after vitrification with slush nitrogen compared with liquid nitrogen

Conditions: Infertility

Summary: the purpose of this study is to determine if the use of slush nitrogen results in higher post-thaw survival rates for oocytes compared to conventionally used liquid nitrogen.

the study is a randomized, controlled trial which seeks to characterize oocyte survival rate following vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. after warming, fertilization and embryology outcomes will be assessed. oocyte donors and a single donor sperm source will be utilized. following enrollment, oocyte donors will undergo ovarian stimulation and oocyte retrieval. the mature (mii) oocytes obtained for each patient will then be assigned a number and randomized via block randomization to one of two treatment groups (liquid nitogen or slush nitrogen). through block randomization, this will create a paired population of oocytes so that half of each patient's oocytes will undergo cryopreservation with liquid nitrogen and half will undergo cryopreservation with slush nitrogen. timing of hyaluronidase stripping and vitrification will be consistent with current institutional clinical practice for oocytes. following cryopreservation, oocytes will be warmed and intracytoplasmic sperm injection will be performed and subsequent embryology outcomes tracked.

Eligibility criteria:
major inclusion criteria for oocyte donors: 1. age 30 years or younger who meet institutional criteria to be an oocyte donor. 2. patients who agree to donate oocytes for research purposes and agree to the study protocol. 3. the subgroup of oocyte donors age 35-38 will not be part of the primary analysis, and therefore will not be required to meet the age criteria listed above. the older group of donors will be chosen as the clinical discretion of the study investigators. no specific ovarian reserve cutoffs will be required, although factors related to ovarian reserve will be taken into consideration. major exclusion criteria for oocyte donors: 1. under 18 years old 2. all patients who do not voluntarily give their written consent for participation. 3. patients who do not meet standard institutional criteria for oocyte donation. 4. a diagnosis of polycystic ovarian syndrome (pcos).
improving traumatic brain injury rehab care with comm health services: a research project within the tbi model system

Conditions: Traumatic Brain Injury

Summary: tbi rehabilitation care transitions refer to the processes of preparing patients, families, and community-based healthcare providers for the patient's passage from inpatient rehabilitation to the home and community or to another level of care. persons with tbi have heterogenous neurological impairment (cognitive and behavioral foremost, along with motor, sensory, and balance), that limits their functional independence and participation, and increases their risk for secondary medical conditions, injuries, rehospitalizations and early mortality

once people with tbi and their care partners enter the post-acute care landscape, they must navigate fragmented health care systems, interact with providers who may be unfamiliar with tbi, and discover their own services and supports. inpatient rehabilitation provides high levels of structure and professional support that are impossible to replicate when constructing a home environment to independently manage day-to-day care. once home, the person with tbi's physical, cognitive, behavioral, and medical needs can easily overwhelm even the most committed care partners. community health workers (chws) through a combination of care coordination, advocacy, and direct service delivery, have the potential to address tbi care partners' needs, particularly those from low income and/or traditionally underserved minority groups. chws are well-suited to fill resource gaps that tbi care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) assisting with referrals; (3) providing health education and motivational interviewing to support behavioral health change; (4) collecting and managing clinical data; (5) facilitating productive relationships between health services and communities, and (6) offering psychosocial support.

Eligibility criteria:
inclusion criteria: * participants must be adults (age 18 or older). * must be primary person responsible for supervision/care needs of person with tbi post-irf discharge. * the person with tbi must have been admitted to the brain injury service unit at sai. * if the care partner does not live in the same residence as the person with tbi, they must provide multiple daily check-ins on day-to-day care. * must agree to use mhealth (texts, calls) and possess or be eligible to acquire a smart phone. exclusion criteria: * any severe cognitive impairment that precludes the ability to provide informed consent or safely function as the care partner for a vulnerable adult with tbi.

Keywords: community health services rehabilitation care transitions caregiver supports
a study to assess safety, tolerability, and pk of edg-5506 in healthy volunteers and becker muscular dystrophy adults

Conditions: Healthy Volunteer; Becker Muscular Dystrophy

Summary: edg-5506 is an investigational product intended to protect and improve function of dystrophic muscle fibers. this phase 1 study of edg-5506 will assess the safety, tolerability, and pharmacokinetics (pk) and of edg-5506 in adult healthy volunteers and in adults with becker muscular dystrophy (bmd).

enrolled participants in this study will receive a single oral dose or multiple oral doses of edg-5506 or a placebo. blood and urine samples will be collected to measure how edg-5506 is processed by the body and how the body responds when exposed to edg-5506. participants in the single ascending dose part of the study will remain in the clinic for 7 days with a 42-day follow-up period. participants in the multiple ascending dose part of the study will remain in the clinic for 16 days with a 13-day follow-up period. safety, tolerability, and pharmacokinetics of edg-5506 will be assessed in healthy volunteers prior to enrolling participants with becker muscular dystrophy.

Eligibility criteria:
inclusion criteria: * for all potential participants (healthy volunteers and bmd): male or for hv: female. for all: adults aged 18 to 55 years at time of consent. * for hvs: good general health, with no significant medical history, no clinically significant abnormalities on physical exam * for bmd: diagnosis of bmd based on documentation of mutation(s) in the dystrophin gene and bmd phenotype * for bmd: ability to ambulate * for all: weight greater than or equal to 50 kg and bmi less than 33 kg/m2 * for hv: females must be of non-childbearing potential. * for all: males with female partners must use a medically accepted contraceptive regimen from first dose through 90 days after the last dose * for all: non-smoker and must not have used any tobacco products within 3 months prior to the screening visit. * for all: able and willing to attend the necessary visits at the study center. exclusion criteria: * for all: history of, or physical exam findings indicating clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases that, in the opinion of the investigator, would render the subject being unsuitable for the study. * for all: unable to refrain from strenuous exercise for 3 days prior to check-in and during study. * for all: participation in any other investigational drug study within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.

Keywords: healthy volunteers becker muscular dystrophy
voriconazole as prophylactic therapy in lung transplant recipients

Conditions: Infection

Summary: the purpose of this study is to compare the safety and efficacy of voriconazole with itraconazole following lung transplantation.

all participants will receive itraconazole during their inpatient post transplant stay. as an outpatient, ten subjects will be randomized to receive itraconazole 200mg orally once daily for 6 month and ten patients to receive voriconazole 200mg orally twice daily for 6 months . all subjects will be followed in the clinic as per the standard transplant treatment

Eligibility criteria:
inclusion criteria: * bilateral-lung or single-lung transplant recipients between the ages of 18- 65 years old. * patients must be able to give informed consent prior to and again after transplantation exclusion criteria: * lung transplant patients unable to give informed consent. * prior adverse reaction to the drug itraconazole or voriconazole

Keywords: fungal infection prophylaxis lung transplant fungal infection post lung transplant
oral desensitization to peanut in peanut allergic children and adults using cpna peanut oit safety follow-on study

Conditions: Peanut Allergy

Summary: this is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with cpna in the subjects who participated in arc001.

this phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with ar101 in subjects who participated in study arc001 (nct01987817) as follows: * group 1 (arc001 placebo): subjects who received placebo in study arc001 * group 2 (arc001 ar101): subjects who received ar101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the dbpcfc at the end of study arc001 all subjects will receive daily oral dosing of peanut oit (oral immunotherapy) in the form of characterized peanut allergen (cpna). study duration - 12-90 weeks before reaching the extended maintenance phase. all subjects may continue extended maintenance phase until cpna becomes commercially available or the study is terminated.

Eligibility criteria:
key inclusion criteria: * completion of arc001 study * no change in the status of any longitudinally applicable arc001 inclusion criteria key exclusion criteria: * early termination from arc001 * failure to tolerate 300 mg of peanut protein in the arc001 exit food challenge * a lapse in dosing of more than 10 days from completion of arc001 * change in the status of any longitudinally applicable arc001 exclusion criteria

Keywords: characterized peanut allergen peanut oit oral desensitization peanut allergen peanut-allergic children children peanut-allergic adults
docetaxel, cisplatin, and amifostine in treating patients with advanced non-small cell lung cancer

Conditions: Drug/Agent Toxicity by Tissue/Organ; Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. purpose: phase i/ii trial to study the effectiveness of combining docetaxel, cisplatin, and amifostine in treating patients who have advanced non-small cell lung cancer that cannot be surgically removed.

objectives: i. determine the maximum tolerated dose of docetaxel when combined with amifostine and high dose cisplatin in patients with advanced non-small cell lung cancer. ii. determine the response rate and survival of these patients treated with this regimen. iii. determine the tolerability of this regimen in these patients. outline: this is a dose escalation, multicenter study of docetaxel. patients receive amifostine iv over 15 minutes, immediately followed by docetaxel iv over 1 hour, followed at hour 2 by amifostine as above, immediately followed by high dose cisplatin iv over 30 minutes. treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. cohorts of patients receive escalating doses of docetaxel until the maximum tolerated dose is determined. projected accrual: a total of 15-30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven unresectable advanced non-small cell lung cancer stable cns metastases allowed patient characteristics: age: over 18 performance status: ecog 0 or 1 life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 absolute neutrophil count at least 2,000/mm3 platelet count at least 100,000/mm3 hepatic: ast no greater than 2.5 times upper limit of normal (uln) and alkaline phosphatase no greater than uln or ast no greater than uln and alkaline phosphatase no greater than 4 times uln renal: creatinine clearance at least 60 ml/min other: not pregnant fertile patients must use effective contraception no peripheral neuropathy worse than grade 1 prior concurrent therapy: biologic therapy: not specified chemotherapy: any type and any number of prior chemotherapy regimens allowed and recovered greater than 3 months since prior cisplatin and recovered endocrine therapy: prior endocrine therapy allowed and recovered radiotherapy: prior radiotherapy allowed and recovered surgery: prior surgery allowed and recovered other: no other concurrent medications which could cause renal injury

Keywords: recurrent non-small cell lung cancer stage iv non-small cell lung cancer drug/agent toxicity by tissue/organ
edulcorants effect in caries risk schoolchildren

Conditions: Dental Caries

Summary: this double-blind rct aimed to evaluate the effect of sugar-free snacks on caries risk in 6-9 years-old schoolchildren. considering a 20% difference among groups, the number of subjects needed per group was set in 87. two-hundred-seventy-one children at risk for caries measured through cariogram were selected and randomly assigned to three groups consuming twice a day snacks containing stevia or maltitol or sugar for 42 days. parents filled out a standardized questionnaire regarding personal, medical and oral behavioural information. bleeding on probing, plaque ph and cariogenic microflora were assessed at baseline (t0), after 21 (t1) and 42 days of snacks' use (t2) and 120 days after the end of use (t3). cariogram was also repeated at t2.


Eligibility criteria:
inclusion criteria: * more than 1 initial carious lesion in the enamel (icdas 2-3), * but no manifest lesion in the dentine, * a salivary ms concentration ≥10\^5 cfu/ml. exclusion criteria: * subjects with a history of systemic diseases and antibiotic therapy within 30 days before baseline were excluded.
ketamine versus magnesium as analgesic adjuvants in pediatric adenotonsillectomy

Conditions: Post Operative Pain, Acute

Summary: adeno-tonsillectomy is one of the most common surgeries in children. the most common complication associated is postoperative pain. if not well controlled, especially in preschool children, it can lead to a longer recovery period, delayed discharge, and nutritional deficiencies resulting in dehydration. these factors will increase hospitalization period and the need for intravenous fluids. for this purpose, a large number of studies has been designed to evaluate the analgesic effects of various drugs during the perioperative period. opioids are associated with sedation and respiratory depression, nsaids increase the risk of reoperation for bleeding while local anesthetics may cause vasoconstriction of the operation site. for several years, n-methyl-d-aspartate (nmda) receptors antagonists, such as ketamine and magnesium, have been used successfully to decrease postoperative pain and analgesic requirements in adult patients undergoing a number of different procedures. ketamine reduces the needed analgesia after tonsillectomy. most studies have shown that ketamine administration has no side effects such as hemodynamic, respiratory complications and airway problems. magnesium is a physiological antagonist of the nmda receptor ion channel that plays a key role in central sensitization. many studies have investigated the effect of magnesium sulphate on postoperative pain and opioid consumption. however, results of those studies were variable. whereas most studies describe the reduction of postoperative analgesic requirements after magnesium sulfate, a few studies show insignificant beneficial effects. a previous study evaluated the effect of low dose ketamine (0.15 mg/kg) and magnesium sulfate (30 mg/kg) on post tonsillectomy pain in children, which did not demonstrate a decrease in pain or analgesic consumption in children undergoing tonsillectomy. in this study, the investigators will increase the dose of ketamine to (0.5 mg/kg) and magnesium sulfate to (40 mg/kg) to evaluate their effect on postoperative pain in pediatric patients undergoing adeno-tonsillectomy.


Eligibility criteria:
inclusion criteria: 1. both genders. 2. american society of anesthesiologists (asa) physical status class i and ll. 3. patients undergoing adeno-tonsillectomy. exclusion criteria: 1. inability to provide an informed consent. 2. patients with suspected difficult airway. 3. history of allergy to ketamine or magnesium. 4. metabolic and endocrine disorders. 5. growth developmental, and motor-mental retardation.
a dose ranging study of opt-302 with aflibercept for persistent diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: a two part, multi-center study consisting of a phase 1b open label, sequential dose escalation followed by a phase 2a randomized, double-masked, dose expansion evaluating opt-302 in combination with aflibercept in participants with persistent central-involved diabetic macular edema.

study opt-302-1003 was designed as a 2-part, multicenter study consisting of a phase 1b open-label, sequential dose escalation followed by a phase 2a randomized, parallel-group, sham-controlled, double-masked, dose-expansion evaluating intravitreal opt-302 in combination with aflibercept in participants with persistent central-involved diabetic macula edema.

Eligibility criteria:
inclusion criteria: * history of diabetic macular edema (dme) ≤ 2 year * persistent dme despite prior intravitreal anti-vegf-a therapy with a sub-optimal response * three or more prior anti-vegf-a therapy intravitreal injections * edtrs bcva score ≤ 73 and ≥ 24 letters exclusion criteria: * ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the study eye * hba1c ≥ 12% and/or recent signs of uncontrolled diabetes * any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) that would make the participant unsuitable for the study