Kornimate/medical-research-clean huggingface dataset:
the effect of intra-vaginal conjugated estrogen cream on ring pessary use for pelvic organ prolapse

Conditions: Pelvic Floor Prolapse

Summary: the primary purpose of this two-arm randomized clinical trial is to determine if in women desiring use of a pessary for pelvic organ prolapse (pop) and are successfully fit, if 1-year use and patient impression of improvement is superior in women using vaginal estrogen cream versus those using a vaginal placebo cream.

the study is a multi-center, randomized trial of women with symptomatic utero-vaginal or post-hysterectomy vaginal vault prolapse desiring non-surgical treatment with a pessary. this study will compare outcomes in women randomized to vaginal estrogen cream or vaginal placebo cream. women who meet the inclusion/exclusion criteria will be evaluated. a pessary (ring with support) will be fit by an experienced physician. after successful pessary fitting, they will be randomly divided into experimental active medication and control groups. the experimental group will start intravaginal estrogen cream, and the control group will start intravaginal estrogen-free cream. then patients will be followed every 3months until 1year. the purpose of this trial is to evaluate the effect of intravaginal estrogen use on pessary treatment for pelvic organ prolapse, including short-term and long-term use rate, patient impression of improvement, improvement in symptom-specific quality of life and complication incidence.

Eligibility criteria:
inclusion criteria: 1. symptomatic pop, stage ii, stage iii or stage iv 2. postmenopausal women (patients with serum fsh\>40lu/l; or amenorrhea for 12 months) 3. successfully fit with ring with support pessary 4. ability to attend the clinical trial and follow-up 5. patients and their families understand the study, are willing to participate for up to 1 year and can provide written informed consent 6. willing and able to place vaginal cream exclusion criteria: 1. acute infection of internal genital tract 2. hormone replacement therapy in recent 3 months 3. suspected or untreated lower genital tract tumor 4. genital fistula 5. abnormally elevated intra-abdominal pressure (eg ascites, tumor, etc) 6. life expectancy less than 1 year 7. vaginal estrogen contraindications, including known or suspected estrogen dependent malignancies (endometrial carcinoma, melanoma), endometrial hyperplasia (thickness of endometrium≥5mm), thrombophlebitis or thromboembolic disease, undiagnosed irregular vaginal bleeding, known or suspected breast cancer, allergy to any component of the estrogen cream and severe liver disease, breast cancer 8. the volume of post-voiding residual is more than 250ml. -

Keywords: vaginal estrogen cream
safety of terbogrel in patients with primary pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19)


Eligibility criteria:
inclusion criteria: patients who * completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19) * provide informed consent to participate in this trial * are in a stable or improving medical condition, in the opinion of the investigator * enter the study immediately upon their completion of the preceding double-blind trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim exclusion criteria: * development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel * premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason * pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control
development and pilot testing of a phci for emergency department patients who decline rapid hiv/ hcv screening

Conditions: Hiv; Hepatitis C

Summary: the centers for disease control and prevention (cdc) recommends that emergency departments (eds) and other health care facilities conduct hiv and hcv screening to identify and link to care those with undiagnosed infections. screening for both infections in eds is preferable due to: the shared overlap of some risk behaviors for hiv and hcv acquisition (e.g., drug use) the relatively high co-occurrence of these infections in some populations the more complex medical needs and worse sequelae for those co-infected, and efficiency. although some eds have experimented with dual hiv and hcv screening, best practices on how to conduct screening so as to maximize patient screening uptake have yet to be identified. in this pilot rct, the investigators will examine the efficacy of the persuasive health communication intervention in convincing adult ed patients who decline rapid hiv/hcv screening to be tested for these infections. adult ed patients who decline rapid hiv/hcv screening will be randomly assigned to the ed medical staff arm or the hiv/hcv counselor arm. within each arm, participants further will be randomly assigned to receive the persuasive health communication intervention or to watch a cdc hiv/hcv testing brochures-based video. following the intervention or control condition, all participants will be offered rapid hiv/hcv testing again.

the investigators will conduct this r34 project at the rhode island hospital ed, the primary site for many of the research team's previous hiv (human immunodeficiency virus) and hcv (hepatitis c virus) testing studies. dr. beaudoin (pi) is an attending physician at the rhode island hospital ed. our multi-disciplinary team consists of researchers with extensive experience in hiv and hcv testing research, intervention development and testing, and qualitative, quantitative and cost-effectiveness research. first, the investigators will examine our primary objective in this r34 pilot rct( randomized controlled trial) of comparing the persuasive health communication intervention to the video. second, the investigators can compare within study arms (hiv/hcv counselor arm, ed medical staff arm) and across these study arms uptake of hiv/hcv testing among participants. second, the design permits the investigators to obtain initial efficacy data of the persuasive health communication intervention when used by hiv/hcv counselors vs. ed medical staff (across study arms), as well as compared to the video (within study arms). third, the design replicates our subsequent r01 rct when the investigators compare hiv/hcv screening uptake when conducted solely by hiv/hcv counselors vs. ed medical staff.

Eligibility criteria:
inclusion criteria: * 18-64 years old * english or spanish speaking exclusion criteria: * hiv positive; hcv positive in an hiv vaccine trial * on hiv pre-exposure prophylaxis medication * in an hiv or hcv testing study * tested for hiv and hcv within the past year (per emr(electronic medical record) review and patient report)
multi-modality therapy for untreated patients with resectable or marginally resectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: to assess the ability of a combination of updated and approved modalities in the treatment of first line pancreatic cancer patients to increase the time to progression free survival

for resectable patient; surgery with intraoperative radiation therapy (iort). radiation therapy within 6-8 weeks after surgery followed by folfirinox every 2 weeks starting within 12 weeks of surgery. for marginally resectable patients; the patients will have 2-3 cycles of neoadjuvant chemotherapy of folfirinox and then restaged, undergo surgery with iort within 2-4 weeks following chemotherapy. then radiation therapy starting within 6-8 weeks. followed by folfirinox every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles.

Eligibility criteria:
inclusion criteria: * histologically proven exocrine adenocarcinoma of the pancreas * clinically resectable or marginally resectable disease * no prior radiation or chemotherapy for carcinoma of the pancreas * ecog performance status of 0-1 * patients must be medically able to undergo surgical resection * patients of child bearing potential must follow study specific precautions * women that are lactating will not be excluded on the condition that they dispose their breast milk. * adequate hematologic and biochemical parameters. exclusion criteria: * prior treatment for pancreatic cancer. * concurrent investigational treatments. * unresectable pancreatic mass. * neuroendocrine histological pancreatic cancer * distant metastatic disease * any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements

Keywords: pancreatic pancreas intraoperative radiation therapy chemotherapy
effect of a fruit- and chaya-based diet on genomic instability and biochemical markers in women with breast cancer receiving chemotherapy

Conditions: Breast Cancer

Summary: this exploratory, non-randomized clinical study aims to evaluate the potential impact of a diet enriched with fruits and chaya (cnidoscolus aconitifolius) infusion on genomic instability and selected biochemical parameters in women with breast cancer undergoing neoadjuvant chemotherapy (nac). participants are assigned to either a control group receiving a conventional diet or an experimental group receiving the modified diet. blood samples are collected at three time points during chemotherapy: prior to the first session, after the second cycle, and after the third cycle. the study involves the analysis of genomic instability using the comet assay, along with standard hematological and biochemical testing. the study was reviewed and approved by the research ethics committee of the graduate and research unit of the faculty of medicine at the universidad autónoma de yucatán. it is being conducted between august 2022 and september 2024.


Eligibility criteria:
inclusion criteria: * female participants aged 20-65 years * histologically confirmed breast cancer diagnosis * scheduled to undergo neoadjuvant chemotherapy * ability to consume chaya infusion and fruits as part of diet * provided informed consent exclusion criteria: * diabetes mellitus or other uncontrolled metabolic diseases * severe hepatic or renal insufficiency prior to nac * allergy or intolerance to any component of the experimental diet * participation in other clinical trials during the study period

Keywords: breast cancer cnidoscolus chayamans genomic instability
combined cataract surgery and planned descemetorhexis

Conditions: Fuchs' Corneal Dystrophy; Cataract

Summary: a pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of fuchs' corneal dystrophy.


Eligibility criteria:
general inclusion criteria: * patient \>18 years old * willing and able to provide informed consent ocular inclusion criteria (all ocular inclusion criteria apply only to the study eye): * fuchs' corneal dystrophy diagnosed * cataract present * best corrected visual acuity ≤ 20/40 * candidate for current endothelial transplant procedure (dsaek, dmek) general exclusion criteria: * \<18 years old * medically unstable patient * monocular patient * unwilling or unable to provide informed consent ocular exclusion criteria (all ocular exclusion criteria apply only to the study eye): * corneal dystrophy other than fuchs' * central corneal scar or central opacity not related to fuchs' * severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy * history of prior vitreoretinal surgery * advanced or unstable glaucoma * known steroid responders with glaucoma
pharmacodynamics and safety of cdfr0209

Conditions: Stomach Ulcer; Gastroesophageal Reflux

Summary: this is a randomized, open-label, two-way crossover study to investigate the pharmacodynamics(24 hour gastric ph) and the safety between repeated doses of cdfr0209 and losec in healthy male volunteers

eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ecg) and clinical laboratory tests within 4 weeks before study drug administration. subjects suitable for this study were admitted to the clinical trial center of ajou university medical center on the 2 day before dosing (day -2). on day -1 around 8 am, ambulatory intragastric ph recording was performed using zephr® ph monitoring system (sandhill scientific, inc., highlands ranch, co, usa) without dosing for 24 hours. on day 1, subjects was dosed losec 40 mg or cdfr0209 (omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 am and ambulatory intragastric ph recording was continued upto 24 hours after dosing. from day 2 \~ 6, subjects were dosed losec 40 mg or cdfr0209 around 8 am. on day 7, subjects was dosed losec 40 mg or cdfr0209 (omeprazole 40 mg \& sodium bicarbonate 1,100 mg) around 8 am and ambulatory intragastric ph recording was performed upto 24 hours after dosing. after 14 days of washout period, subjects was dosed losec 40 mg or cdfr0209 by crossover manner and ambulatory intragastric ph recording was performed.

Eligibility criteria:
inclusion criteria: * healthy male subjects aged 20 - 45 years * with in 20% of ideal body weight, {ideal body weight=\[height(cm)-100\]\*0.9} * agreement with written informed consent exclusion criteria: * clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (past history or present) * inadequate result of laboratory test (especially, ast/alt \> 1.25 x unl, total bilirubin \> 1.5 x unl) * positive reaction in the hbs ag, anti-hcv ab, anti-hiv ab, vdrl test and helicobacter ab igm * positive result in urea breath test * taking otc(over the counter)medicine including oriental medicine within 7 days * clinically significant allergic disease (except for mild allergic rhinitis and dermatitis seems to be not need for medication) * subject with known for hypersensitivity reaction to omeprazole and sodium bicarbonate * previous whole blood donation within 60 days or component blood donation within 30 days * previous participation of other trial within 90 days * continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day) * an impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Keywords: immediate release omeprazole integrated gastric acidity
annexin a3 (anxa3) as protein-based marker for non-invasive molecular diagnostics of prostate carcinoma

Conditions: Prostate Cancer; Benign Prostatic Hyperplasia; Prostatic Intraepithelial Neoplasia

Summary: emerging from a differential proteomic study of sample pairs of prostate cancer and benign tissue, annexin a3 (anxa3) was chosen as a potential novel biomarker for the early and non-invasive diagnosis of prostate cancer. we wanted to show or investigate, that: * anxa3 can be detected in urine after standard digital rectal examination. * anxa3 has better specificities than tpsa, in particular in the grey zone of psa * anxa3 can help avoid unnecessary biopsies * anxa3 can in the long run replace psa as a marker

the aim of this multi centre and double-blinded study was to investigate specificities and sensitivities of early detection of prostate cancer with a new protein biomarker, annexin a3, using urine after digital rectal examination/massage (exprimate urine) in direct comparison to the corresponding measurements of the gold standard, total psa. the material obtained by this non-invasive procedure was moreover used to determine appropriate cut-off values and optimal fractions (e.g. after centrifugation) and calibrations for quantitative measurements of this novel marker. patients (500-750) were (and are) continuously recruited from four clinical centres in germany (berlin, tübingen, ludwigshafen) and austria (innsbruck). the major aspect was: • can annexin a3 provide a better specificity than tpsa, in particular in the grey zone of psa (2-10 ng/ml) and can annexin a3 thus contribute to a significant reduction of invasive transrectal biopsies?

Eligibility criteria:
inclusion criteria: * patients with a histological confirmation of adenocarcinoma of the prostate * patients with benign prostatic hyperplasia (confirmed by histology of lance biopsies or tur-p) exclusion criteria: * patients with rectal extirpation * patients with renal or bladder tumors

Keywords: prostate cancer annexin a3 early detection exprimate urine
multitarget strategy for primary podocytopathies

Conditions: Nephrotic Syndrome

Summary: the goal of this clinical trial is to verify whether a cell culture system can be used to evaluate the presence of a factor capable of causing proteinuria in the serum of patients with primary podocytopathies. this system will also be used to evaluate the in vitro efficacy of a combined therapy for the treatment of this disorder. researchers will compare samples from patients with primary podocytopathies with those obtained from healthy subjects and patients with other renal disorders. participants will be asked to visit the clinic at regular intervals for up to 36 months, and to provide blood and urine samples (and a sample of the discarded plasmapheresis effluent in case the procedure is performed).


Eligibility criteria:
inclusion criteria: * signature of informed consent for study participation * one of the following conditions: 1. patients with primary podocytopathies (with a histological diagnosis of fsgs or mcd) showing clinical and/or histological evidence of post-transplant recurrence. 2. patients with primary podocytopathies (with a histological diagnosis of fsgs or mcd) without clinical and/or histological evidence of post-transplant recurrence. 3. patients with primary podocytopathies in their native kidneys in an active clinical phase of the disease. 4. patients with podocytopathies presenting clinical features compatible with a secondary form due to another condition. 5. patients with glomerulonephritis other than primary podocytopathies (e.g., iga nephropathy, systemic lupus erythematosus, membranous nephropathy). 6. patients with no history of renal diseases exclusion criteria: * subjects affected by primary podocytopathies or other glomerulonephritides in clinical remission or with esrd (egfr \< 15 ml/min) and/or on renal replacement therapy * individuals unable to understand and consent to the study procedures * any clinical condition that, according to the investigator's judgment, could compromise patient safety during study participation

Keywords: podocytopathy transplant
randomized study of growth hormone on bone mineral density in patients with adult onset growth hormone deficiency

Conditions: Osteoporosis; Growth Hormone Deficiency

Summary: objectives: i. compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (gh) vs placebo. ii. determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with gh. iii. compare the quality of life of these patients treated with these 2 regimens. iv. determine the side effects of gh in these patients.

protocol outline: this is a randomized, double blind, placebo controlled, multicenter study. patients are randomized to 1 of 2 treatment arms. arm i: patients receive growth hormone subcutaneously (sc) daily for 2 years. arm ii: patients receive placebo sc daily for 2 years. quality of life is assessed at the initial eligibility screening, then again within 1 month after the initial screening, and then at 1, 3, and 6 months during study therapy.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of adult onset growth hormone deficiency --patient characteristics-- * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception

Keywords: disease-related problem/condition endocrine disorders growth hormone deficiency osteoporosis quality of life rare disease
comparison of two different approach tap block on pain management of laparoscopic nephrectomy

Conditions: Analgesia, Patient-Controlled; Postoperative Pain, Acute

Summary: primary aim is to compare the effectiveness of the posterior approach transversus abdominis plane block (p-tap) and the lateral approach transversus abdominis plane block (l-tap) technique on the pain management of the laparoscopic nephrectomy in terms of visual analog pain scale and postoperative opioid consumption. secondary aim is to compare complication rates of the two techniques.

patients included in the study will be randomized into two groups (group l and group p) in the preoperative period. following routine anesthesia induction tap block will be applied to group l patients with the lateral approach technique, and to group p patients with the posterior approach technique. regional block complications will be recorded. standard laparoscopic nephrectomy surgical method will be applied. 1g of paracetamol and 4mg of dansetron will be administered to both groups 15 minutes before the end of the operation. the pain intensity of the patients will be questioned and vas values will be recorded at 0, 1, 2, 6, 12 and 24 hours postoperatively.

Eligibility criteria:
inclusion criteria: * asai-iii patients undergoing laparoscopic nephrectomy * 18\<bmi\<40 exclusion criteria: * infection at the block site * coagulation disorder * pregnancy * kidney failure * liver failure * heart failure * allergy to local anesthetics * patient refusal
a clinical trial to assess the impact of an alcohol alternative herbal tincture on signs of stress anxiety and sleep quality.

Conditions: Anxiety; Stress

Summary: this is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. the trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. the study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.


Eligibility criteria:
inclusion criteria: * aged 21-65 years * male or female * good general health * experience daily feelings of stress and anxiety within the past two weeks * experience daily problems with sleeping, reduced energy levels, and fatigue over the past two weeks * have used alcohol products to help relax or sleep within the past two weeks * experience tension in the body within the past two weeks * experience problems with relaxing in the evening within the past two weeks * willing to abstain from alcohol for the duration of the study * willing to maintain stable use of other herbal supplements, over-the-counter medications, or prescriptions during the study exclusion criteria: * chronic health conditions, including oncological and psychiatric disorders * taking ssris, sedative, or blood pressure-lowering medications * pregnant, breastfeeding, or planning to conceive within the next three months * currently enrolled or planning to enroll in another research trial over the next eight weeks * history of substance abuse * known serious allergic reactions requiring an epi-pen

Keywords: sleep quality sleep tracker relaxation herbal tincture