Kornimate/medical-research-clean huggingface dataset:
study on the effect of combined estrogen and progestogen therapy on endometrial repair after induced abortion

Conditions: Pregnancy Complications

Summary: induced abortion is a common method to terminate pregnancy, but during the operation, it is necessary to dilate the cervix and aspirate the uterine cavity. repeated induced abortions may increase the risk of uterine damage, leading to cervical stenosis or intrauterine adhesions, thinning of the endometrium, which may affect the implantation of fertilized eggs and the development of embryos, and ultimately may lead to infertility or miscarriage. this study aims to explore the effects of combined estrogen and progesterone on endometrial repair and ovarian function recovery after induced abortion.

postoperative care after induced abortion should prioritize the issue of endometrial repair. in 2021, the family planning branch of the chinese medical association published the "expert consensus on promoting endometrial repair after induced abortion" \[10\], emphasizing the importance of endometrial repair for high-risk populations following induced abortion. currently, clinically, methods to promote endometrial repair include estrogen-progestin medications, compound short-acting oral contraceptives, traditional chinese medicine, and bioelectric stimulation. however, controversies still exist regarding endometrial repair, and selecting an effective and safe treatment plan remains crucial. this study aims to prospectively evaluate the efficacy and safety of estradiol/estradiol/dydrogesterone in endometrial repair after induced abortion through clinical research, providing a basis for endometrial repair and ovarian function recovery post-abortion.

Eligibility criteria:
inclusion criteria: * 1. age between 18 years old (inclusive) and 40 years old (inclusive); 2. body mass index (bmi) ranging from 18.5kg/㎡ to 23.9kg/㎡; 3. experienced at least 2 abortions or had a missed abortion; 4. confirmed gestational age of no more than 10 weeks, and the ultrasonic examination within three days prior to the surgery shows a gestational sac (average of three diameters) of at least 1.0cm, with an embryo length of no more than 3.0cm; 5. normal preoperative examination results as per the "clinical diagnosis and treatment guidelines and technical operation standards: family planning volume (2017 revision)"; 6. capable of regular follow-ups and willing to sign the informed consent form. exclusion criteria: * 1. individuals with contraindications to estrogen and progesterone therapy; 2. history of uterine adhesions confirmed by hysteroscopy, or a history of uterine cavity surgery or uterine malformation correction; 3. subjects who require placement of an intrauterine device or administration of oral contraceptives or subcutaneous implants after the procedure; 4. individuals with mental status or cognitive function abnormalities who are unable to cooperate with the treatment process; 5. subjects who, in the opinion of the investigator, have potential risks or any other factors that may interfere with the study.

Keywords: induced abortion intrauterine adhesion estrogen endometrial repair
clinical trial to evaluate the efficacy of oc-02 nasal spray on signs and symptoms of dry eye disease (the pearl study)

Conditions: Dry Eye Disease

Summary: the objective of this study is to evaluate the safety and effectiveness of oc-02 nasal spray as compared to placebo on signs and symptoms of dry eye disease.

this was a phase 2, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of oc 02 nasal spray in adult participants with dry eye disease. approximately 160 subjects, at least 22 years of age, with a subject-reported history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of oc-02 or placebo at visit 1 and visit 2.

Eligibility criteria:
inclusion criteria: * have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1 exclusion criteria: * have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of visit 1 * have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with ded are allowed. * have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.) * have a known hypersensitivity to any of the procedural agents or study drug components * have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
performance evaluation of system eos imaging in pelvimetry versus pelvi-scanner

Conditions: Radiation; Obstetric Labor Complications; Pregnancy Complications

Summary: the purpose of this study and demonstrate the reliability of eos imaging system in the measurement of internal diameters of obstetrical pelvis versus "goldstandard current "that is the pelviscanner.


Eligibility criteria:
inclusion criteria: * pelviscanner indication in women exclusion criteria: * in the disqualification of another study or under the "national register of volunteers."

Keywords: eos imagery
panton valentine leucocidin

Conditions: Staphylococcus Aureus Pneumonias

Summary: staphylococcus aureus expresses a variety of virulence factors, including panton valentine leukocidin (pvl), a cytotoxin. pvl is specifically associated with primary skin and soft-tissue infections and severe necrotizing pneumonia (gillet et al. lancet, 2002;359:753-9). pvl-positive s. aureus pneumonia is often preceded by influenza-like symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute respiratory distress, leukopenia and a high fatality rate (65%) (gillet et al. lancet, 2002;359:753-9). ten year after the first description of this disease and a number of controversies in the scientific literature, the question arise as to whether pvl remains an independent factor of severity in s.aureus pneumonia. in addition, numerous questions remain unanswered yet; these are: * (i) which factors, including treatment regimen, are associated with favourable outcome?, * (ii) what is the susceptibility toward antibiotics of strains associated with this disease ? * (iii) is there any genetic susceptibility of the host to explain both the rarity, and the explosive presentation of the disease ? to address the above questions a prospective observational study at the nationwide level will be set up. all french hospitals will be invited to describe the clinical features of all new cases of s. aureus community-acquired pneumonia with severity criteria, regardless pvl production. the study will include an investigation of a possible innate immune dysfunction in collaboration with the inserm-u550 (génétique humaine des maladies infectieuses, faculté necker, paris). hence, in addition to collecting clinical and biological data from all pneumonia cases as well as all strains of s. aureus isolated, the patients with pvl-positive pneumonia will be sampled for immune genetic studies (orfeome sequencing and functional studied)


Eligibility criteria:
inclusion criteria: * 2-month-old patient at minimum and weighing at least 5 kg * informed consent * subjects affiliated (or beneficiary) to a national medical insurance * presence of clinical, biological and radiological signs of pneumopathy to s. aureus whose clinical state justifies a hospitalization in a icu or in a reanimation * presence of pvl- positive s.aureus producer (for immunogenetic study) exclusion criteria: * patients infected by the hiv * patients hospitalized for more than 48 hours at the time of the diagnosis of pneumonia, * patients hospitalized during the previous three months excepted outpatients

Keywords: pvl pneumonias staphylococcus aureus
a study of the safety and efficacy of tofimilast in adult asthmatics

Conditions: Asthma

Summary: this is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma


Eligibility criteria:
inclusion criteria: * mild to moderate persistent asthma (naepp/gina step 2-3) * reversibility to albuterol at least 12% and 200 ml exclusion criteria: * any significant co-morbid disease, particularly cardiovascular * use of any maintenance therapy except short acting bronchodilators * smoking history \> or = 10 years
long term safety study of praluent

Conditions: Heterozygous Familial Hypercholesterolemia; Non-familial Hypercholesterolemia

Summary: the primary objective of the study was to evaluate the long term safety of praluent in participants with heterozygous familial hypercholesterolemia (hefh) or non-familial hypercholesterolemia (fh) participants at high or very high cardiovascular risk who completed the neurocognitive function study r727-cl-1532 (nct02957682). the secondary objectives of the study were: * to evaluate the effect of praluent on low-density lipoprotein cholesterol (ldl-c) * to evaluate the effect of praluent on other lipid parameters * to evaluate the effect of praluent on gonadal steroid hormones


Eligibility criteria:
key inclusion criteria: participants randomized into the neurocognitive function study (r727-cl-1532) who completed treatment and the end of study (eos) visit with no premature or permanent discontinuation of study drug. key exclusion criteria: 1. significant protocol deviation in the parent study (neurocognitive function study r727-cl-1532: nct02957682) based on the investigator's or sponsor's judgment, such as noncompliance 2. any participant who experienced an ae leading to permanent discontinuation from the neurocognitive function study r727-cl-1532 (nct02957682). 3. any new condition or worsening of an existing condition which, in the opinion of the investigator or per the praluent local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (ole) study 4. known hypersensitivity to monoclonal antibody or any component of the drug product 5. pregnant or breastfeeding women note: other inclusion/ exclusion criteria apply
bone remodeling around ha-coated acetabular cups.

Conditions: Coxarthrosis

Summary: this study was designed to investigate the influence of ha-coating on bone remodeling around the cup in cementless tha. 100 patients gave informed consent to participate in a controlled randomized study between porous coated trilogy® versus trilogy calcicoat®. the cup was inserted in press-fit fixation. the femoral component was a cementless porous coated titanium alloy stem (bi-metric®), with a modular 28 mm crco head. effect parameters were harris hip score (hhs) and bone mineral density (bmd) determined by dexa scanning. measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. patients with body mass index above normal regained more bone mineral than patients with normal weight. this finding supports the assumption that load is beneficial to bone remodeling. advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

this study was designed to investigate the influence of ha-coating on bone remodeling around the cup in cementless tha. 100 patients gave informed consent to participate in a controlled randomized study between porous coated trilogy® versus trilogy calcicoat®. the cup was inserted in press-fit fixation. the femoral component was a cementless porous coated titanium alloy stem (bi-metric®), with a modular 28 mm crco head. effect parameters were harris hip score (hhs) and bone mineral density (bmd) determined by dexa scanning. measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. patients with body mass index above normal regained more bone mineral than patients with normal weight. this finding supports the assumption that load is beneficial to bone remodeling. advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

Eligibility criteria:
inclusion criteria: * patients eligible for cementless tha exclusion criteria: * medical conditions interfering with bone metabolism

Keywords: tha
the efficacy of doxazosin for cocaine users

Conditions: Cocaine Dependence

Summary: doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. this study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants.

the ne system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. the results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using doxazosin or related alpha 1 receptor antagonists for cocaine addiction. this 17-week double-blind, placebo controlled clinical trial includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17). qualifying subjects will be randomized to receive doxazosin 8 mg/day, or placebo during the study participation. medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows: 1. dox-fast group: defined as participants reaching the target dose after a 4-week titration period. participants will be stabilized on doxazosin or placebo over weeks 4-13 (for dox-fast group) 2. dox-slow group: defined as participants reaching the target dose after an 8-week titration period. participants will be stabilized on doxazosin or placebo over weeks 8-13 (for dox-slow group) both groups will be tapered off doxazosin or placebo over study weeks 14-17.

Eligibility criteria:
inclusion criteria: * meets dsm-iv diagnosis criteria for cocaine dependence, as determined by self-reported use of cocaine at least once weekly for at least 1 month prior to study entry; a positive urine test for cocaine; and a score greater than 3 on the severity of dependence scale * if female, willing to use contraception throughout the study exclusion criteria: * meets dsm-iv diagnosis criteria for dependence on any drugs other than cocaine, or tobacco * current major psychiatric illness, including schizophrenia, bipolar disorder, or other psychotic disorder * current suicidal or homicidal ideation * current use of a prescribed psychotropic medication that cannot be discontinued * history of or current major medical illness, including major heart, kidney, endocrine, or liver disorder; abnormal liver function (sgot or sgpt levels three times greater than normal); or high blood pressure or low blood pressure * high risk factor for heart disease, seizure disorders, or any illness for which disulfiram or methadone treatment would be inadvisable * currently taking metronidazole or clotrimazole * pregnant or breastfeeding

Keywords: cocaine dependence substance related disorders
clinical study of generic and brand bupropion in depression

Conditions: Major Depressive Disorder

Summary: determine bioequivalence between branded and generic bupropion extended release (xl) products (and between generic products) at steady state in patients with major depressive disorder.

the protocol is a prospective, randomized, double-blinded, crossover study with major depressive disorder (mdd) receiving bupropion hcl 300mg xl (branded or generic). subjects will be studied in 4 phases for a total of approximately 28 weeks: phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics).

Eligibility criteria:
inclusion criteria each subject must meet all of the following criteria: 1. adult outpatients age 18-75 years 2. currently on once daily bupropion hcl 300mg xl (brand or any generic), for a minimum of 4 months 3. major depressive disorder (mdd), in partial or full remission for at least 4 months, as confirmed by the structured clinical interview for dsm-iv axis i disorders (scid). spontaneous relapse of depression unrelated to medication changes is less likely - about 5% chance per year - after remission has been maintained for at least 4 months.2 4. ability to understand and willingness to comply with study procedures, and to provide written informed consent exclusion criteria subjects will not be enrolled if any of the following criteria exist: 1. remission from depression not clearly attributed to bupropion treatment 2. current severe side effects attributable to bupropion 3. poor adherence to bupropion treatment per patient self- report and history of refill persistence 4. history of active seizure disorder, or seizure treatment within past year 5. history of significant hepatic or renal disease, based on physician assessment 6. currently taking drugs or natural products known to influence cytochrome p450b6 (cyp2b6) activity 7. currently taking drugs for hepatitis c or multiple sclerosis, due to their ability to cause depression 8. dementia or other significant cognitive impairment, per diagnosis or investigative team's assessment 9. lifetime diagnosis of schizophrenia, schizoaffective or schizophreniform dis-order, delusional disorder, or current psychotic symptoms diagnosed by scid 10. abuse of or dependence on alcohol or other substances within the past 6 months as determined by scid, and confirmed by study physician interview 11. current suicidal ideation

Keywords: major depressive disorder bupropion xl wellbutrin xl
a study of immediate 9 months adjuvant hormone therapy with triptorelin 11.25 mg versus active surveillance after radical prostatectomy in high risk prostate cancer patients.

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the benefit of immediate hormonal treatment after radical prostatectomy in chinese and russian patients with high risk prostate cancer. to reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin. both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months

this trial is a phase iv (in russia and china) as approved indication is locally advanced or metastatic prostate cancer in both countries.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed adenocarcinoma of the prostate * radical prostatectomy with curative intent performed no more than 8 weeks before randomisation * high risk criteria of disease progression, defined as follows: gleason score ≥8 on prostatectomy specimen, and/or pre rp psa level ≥20 ng/ml, and/or primary tumour stage 3a (pt3a) (with any psa level and any gleason score) * post-rp psa levels ≤0.2 ng/ml at 6 weeks exclusion criteria: * evidence of lymph nodes or distant metastasis * positive margins * evidence of any other malignant disease, not treated with a curative intent * had surgical castration
patient understanding of end of life care

Conditions: Advance Directives; Resuscitation Orders

Summary: this study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. based on patient responses, factors that affect choices of code status would be analyzed. we will also evaluate if a standardized explanation improves patient understanding of end of life issues. this would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire


Eligibility criteria:
inclusion criteria: * age \>18 years * admitted to regular nursing floor exclusion criteria: * altered mental status * admitted in icu * positive screening for depression * terminal illness defined as life expectancy\< 100 days * inability to consent
a cariprazine study in the prevention of relapse in bipolar i disorder patients whose current episode is manic or depressive, with or without mixed features

Conditions: Bipolar I Disorder; Mania; Depression

Summary: 1) to evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar i disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) to evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar i disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day


Eligibility criteria:
inclusion criteria: * currently meet the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for bipolar i disorder, and at least one of the following two criteria: * current episode manic, with or without mixed features, having a total young mania rating scale (ymrs) total score ≥ 20 and a score of at least 4 on 2 ymrs items (irritability, speech, content, or disruptive/aggressive behavior); * or current episode depressive, with or without mixed features, having a montgomery-asberg depression rating scale (madrs) total score ≥ 23 and a score of at least 3 on 2 madrs items (apparent sadness, reported sadness, inner tension or inability to feel). exclusion criteria: * four or more episodes of a mood disturbance within the 12 months before visit 1; * diagnosis of another psychiatric disorder other than bipolar disorder with the exception of specific phobias.