Kornimate/medical-research-clean huggingface dataset:
prophylactic radiotherapy optimization for enhanced thyroid function protection in npc

Conditions: Nasopharyngeal Carcinoma; Quality of Life; Thyroid Diseases; Radiotherapy Side Effect; Radiotherapy

Summary: this study is a multicenter, non-inferiority, open-label, randomized controlled phase iii clinical trial. it aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas iii/iva in nasopharyngeal carcinoma. the study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 18-70 years; 2. pathologically confirmed nasopharyngeal carcinoma; 3. no positive lymph nodes in unilateral or bilateral regions iii and iva; 4. clinical stage i-iva (ajcc/uicc 8th edition), with no evidence of distant metastasis; 5. normal thyroid function; 6. ecog performance status of 0-1; 7. treatment-naïve patients who have not received any prior antitumor therapy; 6. no contraindications to radiotherapy or chemotherapy; 9. adequate organ function, meeting the following criteria: hematologic criteria: wbc ≥ 4.0 × 10⁹/l, anc ≥ 1.5 × 10⁹/l, plt ≥ 100 × 10⁹/l, hgb ≥ 90 g/l (no transfusion, blood products, or hematopoietic growth factors used within the past 7 days); biochemical criteria: alt and ast \< 1.5 × uln, alp \< 2.5 × uln, total bilirubin \< uln, bun and creatinine ≤ 1.5 × uln or creatinine clearance rate ≥ 60 ml/min (calculated using the cockcroft-gault formula). 10. voluntarily agreed to participate in the study, signed the informed consent form, demonstrated good compliance, and agreed to follow-up. exclusion criteria: 1. history of other malignant tumors (excluding basal cell carcinoma/squamous cell carcinoma of the skin or cervical carcinoma in situ); 2. history of radiotherapy (excluding radiotherapy outside the planned target area for conditions such as melanoma); 3. history of neck surgery; 4. any severe comorbidities that may pose risks to the study or affect compliance, such as unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \> 1.5 × uln), or psychiatric disorders; 5. history of hyperthyroidism, hypothyroidism, or immune-related thyroid disorders; 6. other family or social factors, as judged by the investigator, may force the study's early termination, compromise patient safety, or affect the collection of trial data.

Keywords: nasopharyngeal carcinoma quality of life thyroid function protection radiotherapy
a clinical study to evaluate the efficacy and safety of ospemifene in the treatment of vulvar and vaginal atrophy (vva) in postmenopausal women

Conditions: Atrophy; Vaginal Diseases

Summary: the purpose of the study is to assess the efficacy, safety and tolerability of ospemifene 5 mg, 15 mg, and 30 mg in the treatment of vva in postmenopausal women to find the minimum effective dose below the lowest dose of 30 mg tested earlier in phase ii.


Eligibility criteria:
inclusion criteria: * naturally or surgically menopausal * vaginal ph greater than 5.0 * 5% or fewer superficial cells in maturation index of vaginal smear exclusion criteria: * evidence of endometrial hyperplasia, cancer or other pathology * abnormal pap smear * uterine bleeding of unknown origin or uterine polyps * current vaginal infection requiring medication * use of hormonal medications * clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Keywords: menopausal symptoms urogenital atrophy vulvar and vaginal atrophy in postmenopausal women vaginal atrophy
effectiveness of pr013 topical ophthalmic drops compared to vehicle for the treatment of allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: to evaluate the efficacy and safety of pr013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis using a modified conjunctival allergen challenge model (ora-cac®).

a multi-center, double-masked, randomized, phase 2 evaluation of the effectiveness of pr013 topical ophthalmic drops (0.045% and 0.06%) compared to vehicle of pr013 topical ophthalmic drops for the treatment of allergic conjunctivitis using a modified conjunctival allergen challenge model (ora-cac®)

Eligibility criteria:
inclusion criteria: * be at least 10 years of age of either sex and any race * have a positive history of ocular allergies and a positive skin test reaction to a perennial allergen (cat dander, dog dander, dust mites, cockroaches) and a seasonal allergen (trees, grasses, and/or ragweed) as confirmed by an allergic skin test within the past 24 months. * have a calculated visual acuity of 0.7 logmar or better in each eye as measured using an early treatment diabetic retinopathy study (etdrs) chart exclusion criteria: * have known contraindications or sensitivities to the use of the investigational product or any of its components * have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye) * have had ocular surgical intervention within 3 months prior to visit 1 or during the study and/or a history of refractive surgery within the past 6 months * have a known history of retinal detachment, diabetic retinopathy, or active retinal disease * have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit * use any of the disallowed medications\* during the period indicated prior to visit 1 and during the study * have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease \[including arrhythmias\] the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens; * have planned surgery (ocular or systemic) during the trial period or within 30 days after; * have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial; * be a female who is currently pregnant, planning a pregnancy, or lactating
the association between severity of hypertensive disorder during pregnancy and endothelial dysfunction

Conditions: Endothelial Dysfunction

Summary: preeclampsia toxemia (pet) is a pregnancy related complication that is usually expressed as new onset hypertension and proteinuria after 20 weeks of gestation. scarce data exists regarding the effectiveness of pat plethysmography use in women with pet and whether adverse results are found compared to healthy gravidas. thus, we aimed to assess endothelial function using pat plethysmography in women with pet and compare their results to both healthy gravidas and those with only gestational hypertension. .

preeclampsia toxemia (pet) is a pregnancy related complication that is usually expressed as new onset hypertension and proteinuria after 20 weeks of gestation. although the exact pathophysiology is unclear, it's related to abnormal placentation and subsequent vascular pathology. endothelial dysfunction was found to play a significant role in the risk of cardiovascular event in general. moreover, few studies found a relation between endothelial dysfunction and pet. there are several methods for the assessment of endothelial function, with peripheral artery tone (pat) plethysmography being an emerging non-invasive promising technique. however, scarce data exists regarding the effectiveness of pat plethysmography use in women with pet and whether adverse results are found compared to healthy gravidas. thus, we aimed to assess endothelial function using pat plethysmography in women with pet and compare their results to both healthy gravidas and those with only gestational hypertension.

Eligibility criteria:
inclusion criteria: 1. maternal age 18-40 years old 2. 27 and above weeks of gestation 3. singleton pregnancy 4. agreed to participate in the study and signed on informed consent form. exclusion criteria: 1. known ischemic heart disease or angina pectoris 2. active smoker 3. dyslipidemia, chronic hypertension. renal disease, diabetes mellitus (gestational or pregestational) 4. active treatment with anti-hypertensive medication, anti-aggregation medication or lipid lowering agents.
design of a prototype garment adapted to demented elderly subjects with disturbing behavioral problems in the management of sphincter disorders

Conditions: Adapted Garment Prototype; Elderly; Problem Behavior; Dementia; Sphincter Disorders

Summary: alzheimer's disease and related disorders (adrd) are diseases whose frequency is increasing in elderly subjects. their evolution is marked by the occurrence, in addition to cognitive disorders, of increasingly disruptive behavioral disorders that interfere with their management, as well as impairment of basic functions, including the occurrence of sphincter disorders responsible for daytime and nighttime urinary and fecal incontinence. these disorders are present in more than 80% of lam patients and are of multifactorial origin. it is difficult to get patients to accept wearing the necessary protection. they tend to remove or tear them off. this can frequently lead to stressful situations of agitation and inappropriate behavior for patients and uncomfortable continence management for caregivers. in order not to be forced to use heavy physical restraints or therapeutics that promote drowsiness so that the patient cannot remove his or her protections, the only effective response today is to wear a garment. unfortunately, the ones that exist today are strictly functional and are worn at night. the use of such garments, during the day, in this indication, is therefore a common and usual practice today. this results in an ethical problem for the caregivers. indeed, worn during the day, rompers give the impression to the latter that they show a devaluing, infantilizing or even degrading image of the elderly person. this practice, although common and accepted because it is the only recourse to physical and chemical restraints to preserve the cleanliness and presentation of elderly patients, could lead to an impaired dignity which could be badly experienced by their close circle of friends and family as well as by the carers and could also have an impact on the overall effectiveness of the care . this is the first time that a multi-professional team integrating doctors, caregivers, occupational therapists and engineers have reflected on the design of a garment that meets the expectations of caregivers, patients and their families. the romper thus designed must be able to retain the aesthetic characteristics of a garment that meets the tastes of the elderly while respecting their dignity.


Eligibility criteria:
inclusion criteria: * patients hospitalized in a cognitive-behavioral unit or long-term care or residents of the ehpad at the st-victor center - chu amiens-picardie, * patients with behavioral and sphincter disorders justifying the prescription of a romper. * signature of a consent exclusion criteria exclusion criteria: * no next of kin * patients in terminal palliative care * patients whose morphology does not allow the use of prototypes (no adapted size)

Keywords: adapted garment prototype patient dignity elderly behavioral troubles dementia sphincter disorders
ligation of intersphincteric fistula tract (lift) versus lift-plug procedure for anal fistula repair

Conditions: Anorectal Fistula; Extracellular Matrix Alteration

Summary: the purpose of this study is to validate the effect of ligation of intersphincteric fistula tract (lift) versus lift-plug procedure for anal fistula repair.

the management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. the ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. ligation of the intersphincteric fistula tract (lift) and lift reinforced with a bioprosthetic graft (biolift) are two recently reported procedures that showed improved healing results. in the lift, rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. the following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. ellis et al subsequently described a modified lift procedure (biolift procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (biolift procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment. the investigators modified the lift procedure by combining lift with the technique of anal fistula plug. the bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after lift procedure. the present study was designed to assess the preliminary results of lift-plug technique prospectively. the purpose of this study is to validate the effect of ligation of intersphincteric fistula tract (lift) versus lift-plug procedure for anal fistula repair.

Eligibility criteria:
inclusion criteria: * male or female subjects over eighteen years old or less than 65 years old. * able to understand and provide informed consent or have a legally authorized representative capable of providing consent. * clinical diagnosis of primary anal fistula categorized as trans-sphincteric fistula tract determined to be of cryptoglandular origin (primary or recurrent). exclusion criteria: * presence of horseshoe fistula. * history of immunosuppression therapy/treatment within previous six months. * fistulas with active abscess, infection, or acute inflammation * history of choron's disease * history of ulcerative colitis * history of hiv or other immune system disease * history of collagen disease * history of radiation to the anorectal region * allergies to pig tissue or pig products * religious or cultural objection to the use of pig tissue

Keywords: anorectal fistula acellular dermal matrix ligation of intersphincteric fistula tract ligation of intersphincteric fistula tract and plug complications of treatment recurrence
chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs

Conditions: Hemorrhagic Cystitis

Summary: to assess the efficacy of oral chlorophyllin tablets for urinary bleeding following radiation therapy for cancers of pelvic organs.

radiation therapy to the pelvis is a commonly used treatment modality for urological, gynaecological and rectal cancers. intensity modulation and image guidance have improved the delivery of radiation therapy in recent times. however, this does not eliminate the risk of radiation-induced damage to the adjacent healthy tissue - in this consideration, the bladder. hemorrhagic cystitis accounts for 5-7% of emergency urology admissions. the procedure for the management of radiation cystitis proceeds from non-invasive oral drugs and hbot to minimally invasive treatment like intravesical therapy and angioembolization, to more morbid procedures like cystectomy and urinary diversion. although these treatment modalities have shown some success, most patients continue to have recurrent/persistent hematuria. there is a need to explore options of other oral/intravesical agents which can aid in mucosal healing and stop hematuria with lasting effects. sodium-copper-chlorophyllin (chl) is a phytopharmaceutical drug obtained from green plant pigment, chlorophyll. it is a semi-synthetic mixture of sodium copper salts derived from chlorophyll. chlorophyllin scavenges radiation-induced free radicals and reactive oxygen species. research at barc has shown that chlorophyllin prevents radiation-induced toxicity in normal hematopoietic tissues and normal epithelial cells. a phase 1 clinical study in healthy volunteers indicate that chl is safe and tolerable in humans and has not shown any severe adverse events. the purpose of this study is to evaluate the safety and efficacy of oral sodium copper chlorophyllin in hemorrhagic cystitis secondary to radiation therapy for pelvic malignancy.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age with a history of radiotherapy for pelvic malignancy in the past more than 3 months back. * any grade of radiation-induced cystitis as per rtog criteria (rtog grade 1-4 equivalent to ctcae grade 1-3). * adequate liver function defined as alt/alt ≤ 3 times uln and total bilirubin ≤ 2 times uln. elevated transaminases up to 5 times uln is allowed in patients with liver metastasis. * adequate renal function defined as creatine clearance ≥ 30 ml/min (by cockcroft-gault formula). exclusion criteria: * known hypersensitivity or contraindications against sodium chlorophyllin. * hemodynamically unstable patients not responding to initial resuscitation. * patients with life-threatening hemorrhagic cystitis requiring urgent invasive intervention (ctcae grade 4).
improving access to control of diseases for women

Conditions: Cardio-vascular Disease; Stroke Cancer; Breast Cancer; Oral Cancer; Cervical Cancer

Summary: the aim of this study is to evaluate the feasibility and acceptability of the model of delivering chw-driven home-based comprehensive ncd control services aimed to prevent premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in the hard-to-reach women.

specific objectives of this study are the evaluation of: 1. the social, cultural and behavioral factors that impact the uptake of the ncd control services among rural women using the rapid assessment, response and evaluation (rare) approach; 2. the feasibility and acceptability of the strategy to deliver the following ncd control services to the rural women at their homes by the trained chws: * counselling of the tobacco habitués to give up the practice * early detection of hypertension and diabetes to ensure prompt and regular treatment * creating breast awareness and ensuring access to prompt diagnosis and treatment of the women with symptoms suggestive of breast cancer * screening for cervical cancer by self-collected hpv test and ensuring prompt treatment of screen detected precancers and cancers * screening of the habitual tobacco/alcohol users for oral cancer by ove and ensuring prompt treatment of screen detected precancers and cancers

Eligibility criteria:
inclusion criteria: * women between 30 to 60 years residing in the villages of the gogunda block in the district of udaipur in rajasthan, india, will be eligible to participate. exclusion criteria: * women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.

Keywords: cardio-vascular disease stroke cancer breast cancer oral cancer cervical cancer
chloroquine and coartem for treatment of symptomatic children with plasmodium falciparum in guinea bissau

Conditions: Malaria, Falciparum

Summary: this study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in guinea-bissau. the genetic basis of the parasites for developing resistance will be examined. children coming to one of the health centres with symptoms of malaria and a positive malaria test will be included. the children will be followed weekly until day 70. in case of reappearance of parasites the child will be re-treated with the opposite study drug.

this study compares treatment of uncomplicated malaria in children in guinea-bissau with artemether-lumefantrine (coartem) with that of treatment with chloroquine 50 mg/kg. furthermore, the genetic basis of anti-malarial resistance in guinea-bissau will be studied by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples from this in vivo trial. we also intend to study whether the recent report that chloroquine sensitive parasites are selected at recrudescence after coartem is confirmed in bissau. following consent to participate, children visiting one of the health centres in the study area with mono-infection with plasmodium falciparum are by block-randomization allocated to one of the treatment groups. the treatment is given supervised by one of the health workers and malaria film taken on day 2 and 3. the children are visited and malaria films obtained once weekly until day 70. on day seven, 100 microliter of capillary blood are drawn for analyses of analyses of drug concentrations in whole blood. on inclusion and whenever a child has recurrent parasitaemia, a filter-paper blood-sample is collected for later pcr analysis. on the day of inclusion, on day 42 and on day 70 the haemoglobin level is measured. if parasites reappear in 50% or more of at least 40 children in one of the treatment groups this treatment arm should be terminated. during the study parents are recommended to bring the child to the health centre in case of any illness. participating children will be examined and treated free of charge. the opposite study drug will be used for re-treatment of children in case of recrudescence, and the child will be followed as previously planned. the results from this study could be used for the planning of the recommendations for treatment of malaria in guinea-bissau. it will provide the national malaria programme with information of the efficacy of coartem before it is implemented.

Eligibility criteria:
inclusion criteria: * children presenting at one of the health centres in the study area * symptoms suggestive of malaria * at least 20 p.falciparum parasites per 200 leucocytes * living in the study area (to enable follow-up) exclusion criteria: * danger signs * by the responsible doctor evaluated to need to be transferred to the national hospital as an in-patient * previous idiosyncratic reactions to any of the study drugs

Keywords: malaria plasmodium falciparum children guinea-bissau artemether lumefantrine chloroquine coartem