Kornimate/medical-research-clean huggingface dataset:
clinical efficacy of hormone replacement therapy in treating perimenopausal women with mgd

Conditions: Meibomian Gland Dysfunction

Summary: this project aims to evaluate the possible relationship between mgd and hrt in perimenopausal women

this project aims to: 1. evaluate the possible relationship between mgd and hrt in perimenopausal women; 2. to explore the mechanism of hrt treatment on mgd through clinical trials;3. optimize treatment methods by exploring the mechanism, and develop more personalized and systematic treatment plans for mdg patients in the perimenopausal period.

Eligibility criteria:
inclusion criteria: * perimenopausal women who did not undergo hrt exclusion criteria: * (1) patients who meet any of the following criteria will not be eligible for inclusion in the study: ① unable or unwilling to sign a consent form, or unable to follow study procedures. (2) have worn contact lenses in the past month, have had anterior segment surgery in the past 3 months, have a history of corneal refractive surgery, and have eye diseases other than dry eyes.use of topical medicines other than eye lubricants in the past 3 months.use of total body immunomodulators, tetracycline, or glucocorticoids in the past 3 months.occlusion of lacrimal dots or eye trauma in the past 3 months.③ is pregnant, nursing or breastfeeding, or has received hrt treatment. ④ all patients with de related diseases, such as diabetes mellitus, sjogren syndrome, stevens-johnson syndrome.all participants were free of cancer, liver disease, kidney disease, stroke, transient cerebral ischemia, myocardial infarction, peptic ulcer, gout, or mental illness.women who used anticoagulants, corticosteroids or vitamin a, vitamin e or beta-carotene were also excluded.
a study to assess the safety and tolerability of sobi003 in pediatric mps iiia patients

Conditions: Sanfilippo Syndrome Type A (MPS IIIA)

Summary: mps iiia, also known as sanfilippo a, is an inherited lysosomal storage disease (lsd). mps iiia is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal degradation of the glycosaminoglycan (gag) heparan sulfate (hs). the natural course of mps iiia is characterized by devastating neurodegeneration with initially mild somatic involvement. the aims of the present study is to assess the dose related safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of sobi003, a chemically modified recombinant human (rh) sulfamidase developed as an enzyme replacement therapy (ert).

this is an open-label, non-controlled, parallel, sequential ascending multiple-dose, multicenter study to assess the dose related safety, tolerability, pk and pd of sobi003 in pediatric mps iiia patients. patients between 1 and 6 years of age who have not received previous treatment for mps iiia with an ert, gene- or stem cell therapy will be eligible to participate in the study. the study is planned to consist of 3 dose cohorts, each comprising 3 patients. treatment initiations will be staggered within each cohort in order to be able to observe, interpret and treat possible adverse reactions. sobi003 is administered as weekly i.v. infusions over a period of 24 weeks. upon completion of the 24-week treatment period with satisfactory tolerability, the patient is offered to receive continued sobi003 treatment by participation in an extension study.

Eligibility criteria:
inclusion criteria: 1. informed consent obtained from the patient's legally authorized representative(s) 2. patients with mps iiia, as confirmed by both: * a documented deficiency in sulfamidase enzyme activity in concordance with a diagnosis of mps iiia, and * normal enzyme activity level of at least one other sulfatase measured in leukocytes 3. chronological age of ≥12 and ≤72 months (i.e., 1 to 6 years) at the time of the first sobi003 infusion and a developmental age ≥12 months at screening as assessed by the vineland adaptive behavior scales, second edition (vabs-ii) 4. medically stable patient who is expected to be able to comply with study procedures exclusion criteria: 1. at least one s298p mutation in the sgsh gene 2. contraindications for anesthetic procedures, surgical procedure (venous access port) mri scans and/or lumbar punctures 3. history of poorly controlled seizures 4. patients is currently receiving psychotropic or other medications which in the investigator's opinion, would be likely to substantially confound test results 5. significant non-mps iiia-related central nervous system (cns) impairment or behavioral disturbances, which in the investigator's opinion, would confound the scientific integrity or interpretation of study assessments 6. prior administration of stem cell or gene therapy, or ert for mps iiia 7. concurrent or prior (within 30 days of enrolment into this study) participation in a study involving invasive procedures
prophylaxis trial of posaconazole versus standard azole therapy for neutropenic patients (study p01899)

Conditions: Leukemia, Myelocytic, Acute; Myelodysplastic Syndromes; Neutropenia

Summary: this trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections. profound, prolonged neutropenia (absolute neutrophil count\<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome. treatment duration: maximum of 12 weeks follow-up 2 months. endpoints: incidence of proven or probable ifi according to eortc/msg criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.

this study is designed to determine the safety, tolerance and efficacy of poz used as prophylaxis if ifi in high-risk subjects with prolonged profound neutropenia. the primary objective is to assess the efficacy of sch 56592 vs fluconazole and itraconazole in preventing proven or probable ifi during neutropenic episodes.

Eligibility criteria:
inclusion criteria: * adults or adolescents (age\>13 years) and weight\> 34kg, either gender * disease definition: anticipated or documented prolonged neutropenia (anc\<500/mm3 2) eastern cooperative oncology group (ecog) performance score of less than 3. * female subjects of childbearing age must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). * female subjects of childbearing potential must have a negative serum pregnancy test (beta-hcg) at baseline or within 72 hours before the start of the study drug. exclusion criteria: * female subjects who are pregnant, intend to become pregnant, or are nursing. * excluded prior treatments: subjects previously treated with amb, flz, or itz for proven or probable ifi within 30 days of enrollment. * excluded treatments prior to specific study phases: subjects who have taken the following drugs: those known to interact with azoles and that may lead to life-threatening side effects. * subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry. * subjects who are participating in any other blinded clinical study within 30 days of study entry. * subjects with renal insufficiency (estimated creatinine clearance less than 20 ml/minute at baseline or likely to require dialysis during the study). * subjects having an ecg with a prolonged qtc interval by manual reading: qtc greater than 450 msec for men and greater than 470 msec for women. * subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase (ast), alanine aminotransferase (alt), or alkaline phosphatase levels greater than 5 times the upper limit of normal (uln), or a total bilirubin level greater than 3 times the uln.

Keywords: prophylaxis neutropenia aml mds fungal infections acute myelogenous leukemia anticipated prolonged profound neutropenia
study to assess the efficacy and long-term safety of dupilumab (regn668/sar231893) in adult participants with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objective of the study was to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroid (tcs) through week 16 in adult participants with moderate-to-severe atopic dermatitis (ad) compared to placebo administered concomitantly with tcs.


Eligibility criteria:
key inclusion criteria: 1. chronic ad that had been present for at least 3 years before the screening visit; 2. documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of out-patient treatment with topical ad medication(s). key exclusion criteria: 1. participation in a prior dupilumab clinical trial; 2. important side effects of topical medication (e.g. intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or treating physician; 3. having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, was likely to require such treatment(s) during the first 2 weeks of study treatment: 1. immunosuppressive/immunomodulating drugs (e.g, systemic steroids, cyclosporine, mycophenolate-mofetil, janus kinase inhibitors, interferon-gamma \[ifn-γ\], azathioprine, methotrexate, etc.); 2. phototherapy for ad; 4. treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit; 5. history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening; 6. positive hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), or hepatitis c antibody at the screening visit; 7. active or acute infection requiring systemic treatment within 2 weeks before baseline visit; 8. known or suspected history of immunosuppression; 9. pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the participant's participation in this study. note: the eligibility criteria listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
pragmatic trial of psilocybin therapy in palliative care

Conditions: Demoralization

Summary: this multicenter, triple-blind, phase 2, randomized controlled trial will evaluate the efficacy and safety of psilocybin therapy compared to an active control in treating demoralization in adults near the end of life (≤2 years life expectancy).

after providing written informed consent, participants deemed eligible for this trial will be randomized to a brief course of talk therapy plus 1 dose of oral psilocybin vs the same brief course of talk therapy plus 1 dose of oral ketamine (the active control). participants' degree of demoralization and other clinical outcomes (e.g., depression, anxiety) will be assessed at 1, 2, and 5 weeks after the study drug administration. after completing the study, participants will have the option of being told which study drug they took (aka, "unblinded"); those who were randomized to the active control will be offered another brief course of talk therapy plus 1 dose of oral psilocybin, and the same sequence of outcome assessments.

Eligibility criteria:
inclusion criteria: general * provision of signed and dated informed consent form and the capacity to consent to research. * stated willingness to comply with all study procedures and availability for the duration of the study * is currently a patient in a study-engaged clinical site * has a life-threatening illness and a life expectancy of ≤2 years * has moderate-to-severe demoralization * ability to take oral medication (capsules and liquid) exclusion criteria: general * known allergic or severe reactions to the non-psychoactive components of psilocybin capsules or liquid ketamine * treatment with another investigational drug or intervention within 1 month of signing informed consent form (icf) * if deemed by clinical judgment of the study investigators to be unsafe for undergoing the intervention neurological * cognitive impairment sufficient to impede the ability to complete study tasks * history of intracranial hemorrhage * recent embolic stroke * recent seizure * current intracranial mass * advanced stage of a neurologic disease that elevates risk for psychosis cardiovascular * uncontrolled hypertension * clinically significant cardiac disease respiratory * severe pulmonary disease * supplemental oxygen requirement gastrointestinal * current intractable nausea/vomiting/diarrhea * recent, clinically significant gi bleed * markedly abnormal liver function tests endocrine, renal, and reproductive * pregnancy or lactation * severe renal insufficiency * unstable insulin-dependent diabetes mellitus prohibited medications * antipsychotics (with exceptions) * antidepressants (with exceptions) * dopamine agonists * drugs known to have adverse interactions with psilocybin or ketamine

Keywords: palliative care serious medical illness life-threatening condition advanced and progressive illness
safety of acamprosate in treating alcohol use disorder in the post liver transplant populations

Conditions: Alcohol Use Disorder; Liver Transplant; Complications

Summary: acamprosate for alcohol use disorder may benefit liver transplant (lt) recipients with alcohol-associated liver disease (ald), yet data on feasibility and safety in lt recipients are lacking. this was a single-center unblinded randomized controlled trial of adults (≥18 years) with lt for ald enrolled between 2021-2023 who were randomized 2:1 to the intervention of acamprosate (666mg dose three time daily) or standard of care (soc) for 14 weeks. the primary outcome was safety \[prevalence of adverse events (ae)\]. secondary outcomes included feasibility (weekly survey response rate \>60%), adherence (self reported acamprosate use\>60%), and efficacy (reduction in penn alcohol craving scale \[pacs\]) and relapse). relapse was defined as blood phosphatidylethanol≥20ng/ml or reported alcohol use. all analyses were done in the intention to treat (itt) population and per-protocol population (ppp) (excluding withdrawals/acamprosate non-adherent).

acamprosate for alcohol use disorder may benefit liver transplant (lt) recipients with alcohol-associated liver disease (ald), yet data on feasibility and safety in lt recipients are lacking. this was a single-center unblinded randomized controlled trial of adults (≥18 years) with lt for ald enrolled between 2021-2023 who were randomized 2:1 to the intervention of acamprosate (666mg dose three time daily) or standard of care (soc) for 14 weeks. the primary outcome was safety \[prevalence of adverse events (ae)\]. secondary outcomes included feasibility (weekly survey response rate \>60%), adherence (self reported acamprosate use\>60%), and efficacy (reduction in penn alcohol craving scale \[pacs\]) and relapse). relapse was defined as blood phosphatidylethanol≥20ng/ml or reported alcohol use. all analyses were done in the intention to treat (itt) population and per-protocol population (ppp) (excluding withdrawals/acamprosate non-adherent).

Eligibility criteria:
inclusion criteria: * \>18 years of age * must have received a transplant for liver disease secondary to alcohol-associated hepatitis or alcohol-associated cirrhosis * greater than 24 hours of abstinence. exclusion criteria: * patients with hypersensitivity to acamprosate calcium or any of its components * severe renal impairment (creatinine clearance ≤30 ml/min) * substance dependence other than thc, alcohol, or nicotine * need for inpatient detoxification or inpatient treatment of alcohol use * participation in a clinical trial within the past 60 days * women of childbearing potential without a medically acceptable form of contraception
economic and psychological burden of infertility among women attending women health hospital, assiut university

Conditions: Burden, Infertility

Summary: rational of the study: infertility is a significant reproductive health issue for couples worldwide. the effects of infertility are wide-ranging-from mental health issues such as anxiety and depression to social and economic issues such as ostracization and economic problems. although infertility affects both men and women, the woman in a couple is most often blamed for the inability to bear children.

infertility is a disease of the male or female reproductive system, defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse (who). large numbers of people are affected by infertility in their lifetime, according to a new report published by world health organization. around 17.5% of the adult population - roughly 1 in 6 worldwide - experience infertility. the inability to conceive children is experienced as a stressful situation by individuals and couples all around the world. the consequences of infertility are manifold and may include societal repercussions and personal emotional suffering. the infertile couple experienced greater dissatisfaction with themselves and their marriages. females experienced greater discontent over time and had greater emotional problems than males because infertility had traditionally been viewed as a women problem and women have been expected to suffer greater emotional problems due to infertility. treatment for infertility provides an opportunity for women and men to become parents. the evolution of assisted reproductive technology (art) for the treatment of infertile couples is considered an extraordinary restorative accomplishment throughout the world. however accessibility of treatments such as ivf is limited to only those who can afford to pay out of pocket (oop). even among those who have the ability to pay, their willingness and financial ability to undergo multiple cycles of art often depends on oop payments incurred. however, due to the desire for a child, couples are often ready to make significant financial sacrifices often beyond their means. couples are frequently willing to suffer catastrophic financial hardship instead of forgoing infertility care, resulting in negative economic consequences. evidence suggests that in the absence of mechanisms for risk protection, oop payments can push households into poverty.

Eligibility criteria:
inclusion criteria: * • reproductive age group 15 - 49 * duration of marriage not less than 1 year. * has regular sexual intercourse without the functional use of contraceptive methods. * free from any other debilitating chronic illness. exclusion criteria: * women who have any previous psychological disease or treatment
endodontic post-operative pain evaluation of patients after using endomethasone n or endomethasone sp (endopop)

Conditions: Root Canal Obturation

Summary: the study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). the aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer endomethasone n rcs, compared to the hydrocortisone-free root canal sealer endomethasone sp rcs, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment. root canal treatment procedures will be in accordance with the allocation by randomisation of endomethasone n rcs or endomethasone sp rcs. the spontaneous and the masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max day 14).


Eligibility criteria:
inclusion criteria: * adult male or female (age ≥ 18 years); * patient requiring root canal treatment or retreatment; * patient who will need a single visit for the root canal therapy, for a mature molar or second premolar, with or without pre-operative pain * patient who received information and gave written consent (signed informed consent form); * subject affiliated to a health insurance system, or is a beneficiary (art. l.1121-11, code of public health, france). exclusion criteria: * pulpotomy or pulpectomy performed at a prior visit; * tooth with apical calcification (sealer unable to reach the root apex); * tooth with suspected root perforation; * immature tooth (too wide root apex requiring an apexification); * other dental treatment ongoing or scheduled within the study period; * at least one symptomatic tooth among those that are not included in this study * known hypersensitivity to steroids, local anesthetics, or any component of study medical devices; * subject using long term anti-inflammatory drugs; * use of illicit substances during the 48h before the first visit (cannabis, cocaine...); * presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator; * subject who cannot be contacted in case of emergency (phone number); * simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial; * vulnerable subjects (art. l.1121-5 and l.1122-1-2, code of public health, france; art. 66 of the regulation (eu) 2017/745 on medical devices)

Keywords: endodontics root canal sealer post-operative pain zinc oxide eugenol hydrocortisone corticoid root canal treatment
examination and treatment of pain in front foot

Conditions: Pain

Summary: tibial flat foot deformity is the most common reason for metatarsalgia. flat foot deformity is a sign of degenerated problems such as weakness in ligament or fractures. furthermore, metatarsalgia can be a sign of excessive load caused by sport activities or at work. the condition is very common at diabetics and patients with rheumatism. the purpose of the study is to examine the load under the front foot at health people and patients with metatarsalgia. furthermore, the researchers aim at being able to assess the best treatment of the flat foot deformity at each patient.


Eligibility criteria:
inclusion criteria: * examination and treatment of pain in front foot exclusion criteria: * normal gait * no pains

Keywords: pain front foot flat foot metatarsalgia