Kornimate/medical-research-clean huggingface dataset:
evaluating the efficacy and safety of preoperative administration of duloxetine for pain management in women undergoing hysterectomy via vaginal route

Conditions: Vaginal Hysterectomy; Postoperative Pain; vNOTES

Summary: hysterectomy performed through the vaginal route (hvr) is the preferred method for women seeking hysterectomy to address uterine concerns such as premalignant conditions and fibroids. compared to abdominal or laparoscopic approaches, hvr has shown to lead to quicker recovery times and faster resumption of daily activities. however, effectively managing postoperative pain remains a significant challenge for hvr patients. duloxetine, a serotonin-norepinephrine reuptake inhibitor typically prescribed for major depression and anxiety, has also been utilized in treating chronic pain conditions like osteoarthritis and musculoskeletal pain. however, research into its use for alleviating acute postoperative pain is currently limited to a single trial. additionally, it's unclear whether perioperative duloxetine could enhance overall recovery quality after surgery. this study hypothesized that perioperative duloxetine could improve postoperative recovery for hvr patients, with evaluation using the quality of recovery-15 questionnaire (qor-15).


Eligibility criteria:
inclusion criteria: * patients undergoing hvr ( vaginal natural orifice transluminal endoscopic surgery) hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, colporrhaphy, or sentinel lymphadenectomy * american society of anesthesiologists grade 1-3 exclusion criteria: * patients with chronic non-gynecologic conditions (liver-renal or pulmonary disease) * those using psychiatric drugs (antidepressants, neuroleptics, lithium) in the last 1 year, * those with duloxetine allergy * those using opioids for gynecologic or non-gynecologic conditions * additional concurrent abdominal procedures * total vaginal prolapsus (popq 4)
surgical treatment comparison for recurrent lumbar disc herniation

Conditions: Low Back Pain; Recurrent Lumbar Disc Herniation

Summary: the purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.

lumbar disc herniations are quite common and typically improve after surgical correction. however, some patients develop recurrent herniations at the same level. controversy exists as to why reherniated discs occur. moreover, existing research does not settle the issue of whether a second decompression/discectomy or a repeat decompression/discectomy with pedicle screw fusion is the more successful treatment. this study is designed to compare differences in patient-reported pain, physical function, and satisfaction between the two types of surgery patients.

Eligibility criteria:
inclusion criteria: * recurrent lumbar disc herniation by mri or ct with history of decompression at the same level in the past * recurrent symptomatic history (with or without back pain) with radicular leg pain that improved following the first surgery * male or female 18-75 years old * flexion and extension x-rays that demonstrate an absence of sponylolisthesis or spondylolisthesis with less than 3 mm of movement exclusion criteria: * recurrence of disc herniation within 3 months of first decompression * multiple level herniated discs * no history of lumbar back surgery except as in inclusion criteria above * documented severe osteoporosis or osteopenia * symptoms of low back pain only * diabetes mellitus * patients with suspected or diagnosed psychological/psychiatric problems that could compromise the reliability of their results * lumbar spondylolisthesis on flexion/extension x-rays \> 3 mm * history of lumbar spine fractures (new or old) * any concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study * autoimmune diseases * age less than 18 or greater than 75 years

Keywords: lumbar disc herniation discectomy fusion spine
role of serotonin in acute and subacute mdma effects

Conditions: MDMA Mechanism of Action

Summary: the purpose of this study is to measure the effects of mdma (particularly its emotional effects) and to determine the role of serotonin in these effects. serotonin is a neurotransmitter, which is a chemical that is released by some brain cells to communicate with other brain cells. many of the effects of mdma are thought to be the result of increased serotonin release. in order to understand the effects of mdma and role of serotonin in these effects, we will administer mdma alone and in combination with the antidepressant citalopram (one trade name for this is celexa). citalopram decreases the ability of mdma to release serotonin. citalopram will therefore decrease any of mdma's effects that are the result of serotonin release; we want to measure this.


Eligibility criteria:
inclusion criteria: * healthy men or women aged 18 to 50 years * experienced with mdma exclusion criteria: * significant physical or psychiatric illness which might impair the ability to safely complete the study or that might be complicated by the study drugs, including prior seizures (after age 8), history of major depression, or other active neurological disease or clinically significant abnormalities on physical examination or screening laboratory values

Keywords: mdma citalopram serotonin psychedelic
effectiveness and safety of lactobacillus rhamnosus lcr35® in the treatment of recurrent aphthous stomatitis

Conditions: Aphthous Stomatitis

Summary: recurrent aphthous stomatitis (ras) is a frequent condition characterized by recurrent and painful oral ulcers with unknown pathophysiology. recent studies suggest that a dysregulation of the oral microbiota may be implicated. currently, therapies for ras are limited by severe side effects or inconstant effectiveness. the aim of this study is to assess the effectiveness and safety of a probiotic, the lactobacillus rhamnosus lcr35® , in the treatment of ras. a placebo-controlled, parallel study will be conducted in 40 subjects with ras. treatment consisted on the administration of the daily probiotics or placebo during 3 months.all patients will be then followed up for additional 3months without treatment. the main outcome measure will be the number of occurring aphtae.

recurrent aphthous stomatitis (ras) is the most common chronic disease of the oral cavity, affecting 5-25% of the population. this condition is characterized by recurrent and painful oral ulcers. the discomfort of ras can impact negatively on quality of life that is why the therapeutic demand is strong. currently, there is no curative treatment for ras, and suspensive treatments such as colchicine and thalidomide are no definitive or can induce severe side effects. the pathophysiology of ras remains largely unknown. recent studies suggest that a dysregulation of the oral microbiota may be implicated. increasing data underline the potential interest of using probiotics in conditions due to microbiota disorder. to the best of our knowledge, no study has evaluated the effectiveness of probiotic in ras. the main objective of this double blind clinical trial is to evaluate the effectiveness and safety of a probiotic, the lactobacillus rhamnosus lcr35®, in the treatment of ras in adults. 40 patients suffering from minor ras for 6 months will be included and randomly assigned to 2 group of 20. patients of group a will took the lactobacillus rhamnosus lcr35® orally daily for 3 months and patients of group b will took the placebo similarly. all patients will be then followed up for 3 additional months without treatment. the primary outcome measure will be the monthly number of aphthae occurring during the 3 months of treatment. the secondary outcomes measures will be the monthly number of aphthae occurring during the 3 months of follow up, the pain reduction, the impact on quality of life according to the ohip-14 score and the side effects.

Eligibility criteria:
inclusion criteria: * 18 year-old or more * recurrent idiopathic aphtous stomatitis with at least one new lesion per month during the past 6 months. exclusion criteria: * symptomatic aphtosis associated with crohn or behcet disease * concomitant use of probiotic for any other reason * systemic use of colchicine or steroids or immunosuppressive drugs during the past 3 months

Keywords: aphthous stomatitis [c07.465.864.750]
pet imaging-guided chemoradiotherapy in esophageal squamous cell carcinoma

Conditions: Neoplasm, Esophageal; Squamous Cell Carcinoma

Summary: since multiple studies have demonstrated that pet can identify responders and non-responders to induction chemotherapy, using fdg-pet imaging to guide treatment decisions has prompted interest in clinical practice. the aim of this study was to evaluate whether changing chemotherapy regimen during radiation based on pet response to induction chemotherapy can improve clinical complete response (ccr) in patients with unresectable esophageal squamous cell carcinoma (escc).

a total of 216 patients with baseline pet scan were randomized to one of 2 induction chemotherapy arms: paclitaxel/cisplatin (tp) on days 1, 22 or folfox (oxaliplatin, leucovorin, 5-fu) on days 1, 15, 29. repeat pet was performed on days 36-42 and changes in max standardized uptake value (suvmax) from baseline were assessed. using a predefined cut-off value of a 35% decrease in suvmax, pet responders (≥35% decrease in suvmax) continued on the same chemotherapy regimen during radiotherapy, whereas pet non-responders (\<35% decrease in suvmax) crossed over to an alternative chemotherapy regimen concomitantly with radiation. all patients received external-beam radiation using intensity-modulated radiotherapy. the prescribed dose is generally 50-60 gy in 25-28 fractions, 5 days per week.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma of the esophagus; 2. absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (eus) and pet-ct scan (according to uicc tnm version 8); 3. not suitable for surgery (either for medical reasons or patient's choice); 4. age at diagnosis 18 to 70 years; 5. eastern cooperative oncology group performance status ≤ 2 6. no prior cancer therapy; 7. no history of concomitant or previous malignancy; 8. hematologic function: wbc ≥ 4.0×109/l, plt ≥ 80×109/l, hb ≥ 10mg/dl; 9. renal function: cr ≤ 1.25×unl; 10. hepatic function: bil ≤ 1.5×unl, alt/ast ≤ 2.5×unl; 11. documented informed consent to participate in the trial. exclusion criteria: 1. younger than 18 or older than 70 years of age; 2. ecog performance status of 3 or above; 3. other cancer history; 4. previous radiotherapy history; 5. subjects with distant metastases; 6. pregnancy or breast feeding. women of childbearing age must use effective contraception; 7. serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension); 8. evidence of bleeding diathesis or serious infection.

Keywords: esophageal squamous cell carcinoma pet definitive chemoradiotherapy induction chemotherapy
investigation of vasodilation and intensity of headache triggered by glucagon like peptide-1 in humans

Conditions: Headache, Migraine

Summary: studying glucagon-like peptide-1 (glp-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura.

the purpose of this study is to examine the association between vasodilation and intensity of headache triggered by glucagon-like peptide 1 (glp-1) in healthy volunteers and migraine patients without aura.

Eligibility criteria:
criteria for the healthy volunteers group inclusion criteria: * healthy men/women. * age 18 to 60 years old. * weight 50 to 100 kg. exclusion criteria: * tension headache more than 5 days a month in the preceding year. * all other primary headache types. * headache on the examination day or within 48 hours before infusion of the study drug. * smoking. * daily intake of medicine of any kind except for peroral contraceptives. * women, who on the day of examination is 2 days before or 3 days from the first day of bleeding. * hypertension or hypotension. * coronary heart disease of any kind, as well as cerebrovascular disease. * pulmonary disease. * allergy to contents in the study drug. * psychiatric disease or substance abuse. * disease of any kind which the examining doctor deems relevant for participation in the study. * renouncing the right to information concerning own health. criteria for the migraine patients group inclusion criteria: * migraine patients, who fulfill the ichd-3 criteria for migraine without aura. * age 18 to 60 years old. * weight 50 to 100 kg. exclusion criteria: * tension headache more than 5 days a month in the preceding year. * all other primary headache types. * headache on the examination day or within 48 hours before infusion of the study drug. * smoking. * daily intake of medicine of any kind except for peroral contraceptives. * women, who on the day of examination is 2 days before or 3 days from the first day of bleeding. * hypertension or hypotension. * coronary heart disease of any kind, as well as cerebrovascular disease. * pulmonary disease. * allergy to contents in the study drug. * psychiatric disease or substance abuse. * disease of any kind which the examining doctor deems relevant for participation in the study. * renouncing the right to information concerning own health.
self-cerv pivotal study: self-collection for cervical cancer screening

Conditions: Hpv; HPV 16 Infection; HPV Infection; High Risk HPV

Summary: the goal of this method comparison study is to compare the detection of hrhpv collected using the teal wand self-collection device to hrhpv detected from hcp (health care provider) cervical collection using primary hpv testing assays. participants will be asked to use the teal wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrhpv. secondary measure will include usability and preferences.

to demonstrate that participants who are representative of the intended use population can understand the instructions for use (ifu) and appropriately use the teal self-collection device to collect adequate vaginal cells/material for use in primary hrhpv screening (primary outcome). to produce sufficient primary hrhpv test results following self-collection, as compared to the current soc method of hcp specimen collection, when paired samples are tested using fda approved primary hrhpv assays (roche cobas and/or bd onclarity). primary effectiveness objective • to evaluate the performance of a self-collect device for hrhpv detection as compared to standard of care (soc) by: * agreement of hrhpv self-collected sample(s) as compared to hcp-collected sample results. * calculating the invalid rate of tested samples.

Eligibility criteria:
group 1: inclusion criteria - general population group 1. participant is 25 to 65 years of age and willing to provide informed consent. 2. participant has an intact cervix. group 2: inclusion criteria - enriched population group 1. participant is 25 to 65 years of age and willing to provide informed consent. 2. participant has an intact cervix. 3. one or more of the below: * prior diagnosis of hrhpv within previous 6 months and/or * positive cervical pap cytology result (ascus, asc-h, lsil, hsil, scc, ais) within previous 6 months and/or * presenting for colposcopy/leep/excisional intervention exclusion criteria - all groups 1. participant has impaired decision-making capacity or is unable to provide informed consent. 2. participant has undergone partial or complete hysterectomy including removal of the cervix. 3. participant on whom any form of cervical tissue alteration or surgery has been performed within the prior \< 5 months, including: conization, loop electrosurgical excision procedure (leep), laser ablative surgery, or cryotherapy. 4. participant is pregnant (based on self-reporting). 5. participant who reports or is experiencing menstrual bleeding. 6. participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study. 7. any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.

Keywords: screening self-collect hpv cervical cancer screening
effect of a psychological intervention on antiretroviral therapy and mental health outcomes in hiv-positive adults in zimbabwe

Conditions: Mental Disorder; HIV Infections

Summary: the aim of the study is to examine the effect of a psychological intervention on antiretroviral therapy outcomes and symptoms of common mental health disorders among adults living with hiv and common mental disorders in rural zimbabwe.

common mental disorders are highly prevalent among people living with hiv. left untreated, common mental disorders cause substantial disability and undermine individuals' ability to adhere to antiretroviral therapy, leading to poor antiretroviral therapy outcomes. a recent cluster-randomized controlled trial from harare, zimbabwe showed that the friendship bench intervention (i.e. six sessions of problem-solving therapy delivered by lay health workers followed by a peer support group) effectively reduced symptoms of common mental disorders, but the effect of the intervention on antiretroviral therapy outcomes and its effectiveness in the rural setting has not been studied. to examine the effect of the friendship bench intervention on antiretroviral therapy outcomes and symptoms of common mental disorders among adults living with hiv and common mental disorders in rural zimbabwe, a cluster-randomized trial is conducted.

Eligibility criteria:
inclusion criteria: * age ≥18 years * use of first-line antiretroviral therapy for at least 6 months * resident in bikita district * knowledge of english or shona language * ability to comprehend the information on the study * positive screening for common mental disorders (ssq-14 score ≥9) * providing informed consent exclusion criteria: * current psychosis / cognitive impairment * clinical aids (who clinical stage 4) * known pregnancy or ≤3 months postpartum
efficacy and safety of systematic therapy and bronchoscopic interventional treatment for pulmonary mucormycosis

Conditions: Pulmonary Mucormycosis

Summary: evaluation of the effectiveness and safety of transbronchoscopic local precision infusion of amphotericin b + transoral nebulized inhalation of amphotericin b + transbronchoscopic interventional debridement + liposomal amphotericin b + posaconazole or isavuconazole multimodal treatment of pulmonary mucormycosis

key rationale for the treatment of mucormycosis is early surgical intervention, including local debridement and removal of infected tissues or organs if possible. systemic antifungal therapy is also necessary for mucormycosis, including amphotericin b liposomes and deoxycholates, isavuconazole, posaconazole, and so on. antifungal drug therapy has a mortality rate of up to 40%, which can be reduced to 23% when combined with surgical treatment. however, some patients who are unable to tolerate surgical procedures on the chest when in bad condition, especially patients with hematological malignancies undergoing hematopoietic stem cell transplantation, are susceptible to multiple mucormycosis of the lungs, and the mortality rate of untreated systemically disseminated mucormycosis infections is high at 80%. isavuconazole, so we aim to explore the multimodal treatment of liposomal amphotericin b + posaconazole or esaconazole + transbronchoscopic localized precise instillation of amphotericin b + oral nebulized inhalation of amphotericin b + transbronchoscopic interventional debridement to alleviate the pulmonary mucormycosis in chest imaging and reduce the mortality rate of patients with mucormycosis infection.

Eligibility criteria:
inclusion criteria: * subjects suspected of pulmonary mucormycosis by clinical radiology will be enrolled in the study if the pathologic or microbiological diagnosis of mucormycosis (smear showing sterile mycelium, culture or molecular evidence of mucormycosis) is confirmed. * cases of diffuse mucormycosis will only be included if lung infection is confirmed pathologically or microbiologically by respiratory secretions or biopsy samples. * ability to tolerate bronchoscopy. exclusion criteria: * pregnant and breastfeeding female patients * age \<18 years * patients with hiv infection * contraindications to bronchoscopy (including platelet count \< 100 x 109/l, active hemoptysis, severe respiratory or heart failure, severe arrhythmia, unstable angina or hypertension, severe pneumothorax or mediastinal emphysema, patients with acute myocardial infarction, cerebral infarction, and cerebral hemorrhage within 3 months * patients unable to tolerate bronchoscopy

Keywords: pulmonary mucormycosis bronchoscopy treatment
ligation of inter-sphincteric fistula tract for management of anal fistula

Conditions: Anal Fistula

Summary: after abscess formation, an anal fistula is a common consequence, with crypto-glandular infection being the most commonly accepted causative cause. the goal of this study was to see how well closure of the inter-sphincteric fistula tract affects the outcome of trans-sphincteric fistula surgery. patients with perianal trans-sphincteric fistulas who underwent ligation were studied prospectively. all patients had the identical anesthetic approach, followed by the operation with two years' follow-up.


Eligibility criteria:
inclusion criteria: * men and women with trans-sphincteric peri-anal fistulas (according to magnetic resonance fistulogram) of crypto-glandular source with no previous fistula surgery exclusion criteria: * individuals with recurrent fistulae or had specific pathology, like crohn's disease.
effects of different techniques of the method pilates in chronic low back pain

Conditions: Low Back Pain

Summary: the purpose of this study is to compare different methods of application of the pilates method with exercises in controlling in low back pain in women aged between 45 and 60 years. two groups will be formed. one will do pilates exercises with stabilization segmental. the other group will do classic pilates exercises. will be measure pre and pos intervention of the responses already shown above.

the purpose of this study is to identify what type of pilates exercise is more effective in controlling low back pain is exercise that uses the method of the classical manner or trunk mobilizations with exercises that target the neutral position of the lumbar spine and deep muscles and focus on stabilizing the trunk.

Eligibility criteria:
inclusion criteria: * chronic low back pain classified by visual analogue scale being 3-6 points to more than 3 weeks * not be performing any other type of physical therapy exclusion criteria: * pregnant women * back surgeries * cardiovascular and rheumatic diseases

Keywords: lumbago exercise therapy spine