Kornimate/medical-research-clean huggingface dataset:
nutraceutical support with omega-3

Conditions: Retinal Disease

Summary: although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular amd, a significant percentage of patients continue to lose visual acuity. moreover, monthly intravitreal injections represent a burden for society as well as the caregiver. combination therapy with either topical 0.1% pranoprofen or nutraceutical support with areds2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.


Eligibility criteria:
inclusion criteria: * provision of written informed consent and compliance with study assessments for the full duration of the study * age \> 40 years * presence of treatment-naïve neovascular amd exclusion criteria: * any previous intravitreal treatment * previous laser treatment in the study eye * myopia \> 7 diopters in the study eye * concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma) * concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal * known sensitivity to any component of the formulations being investigated.
growth study using else toddler nutritional drink vs. a. dairy based toddler drink (control) in healthy toddlers

Conditions: Weight Gain

Summary: the aim of the study is to investigate the growth of healthy toddlers fed with toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in healthy toddlers


Eligibility criteria:
inclusion criteria: 1. gestational age between ≥37 weeks + 0 days and ≤41 weeks + 6 days, 2. weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific world health organization (who) growth charts 3. length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific world health organization (who) growth charts 4. weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific world health organization (who) growth charts 5. consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions) 6. consuming and tolerating almond on more than one occasion in age appropriated doses, to ensure no reaction to study formula e.g. 2 teaspoons almond butter in one portion or 500 ml/16 fl oz per day exclusion criteria: 1. toddler with any positive food allergy test food allergy or intolerance to any foods 2. participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study

Keywords: toddler growth nutrition
early rectal cancer: endoscopic submucosal dissection or transanal endoscopic microsurgery?

Conditions: Anal Cancer

Summary: local excision for early rectal cancer has proven its feasibility and oncological safety. indeed, lymph node invasion does not exceed 1% and 10% in pt1sm1 and pt1sm2 rectal carcinomas respectively. two procedures are currently performed in these early cancers as well as in preneoplastic lesions. transanal endoscopic microsurgery (tem), which has proven its superiority over traditional transanal excision, is a surgical approach associated with a 92% r0 excision rate, a survival comparable to radical anterior resection and a low morbidity. it consists of a full-thickness excision. the second procedure is a recently introduced technique: the endoscopic submucosal dissection (esd), which encompasses only the mucosa and submucosa. esd enables endoscopists to achieve higher en bloc resection rates than standard mucosectomy and is associated with a 88% r0 resection rate, which decreases to 65% in the subgroup of european series. though very promising, the role of esd remains controversial in malignant lesions with few published reports. there are therefore 2 different techniques with 2 different dissections (full-thickness vs. submucosal) to achieve the same oncological treatment. so far, only one retrospective single-center study including 63 patients has compared tem and esd in early rectal cancer without finding any difference between the 2 procedures, and there are no other available studies comparing tem and esd for any type of colorectal tumor. the aim of the present research is to compare esd with tem for early rectal cancer and rectal adenomas for short- and long-term outcomes.


Eligibility criteria:
inclusion criteria: * presenting with an ert (i.e. rectal adenoma or rectal carcinoma tis or staged ust1n0 on endorectal ultrasound) that can be alternately resectable by tem or esd * histology proved by a preoperative biopsy exclusion criteria: * " palliative " excision t2/3/4 or n+ * preoperative radiochemotherapy (down-staging) * metastatic cancer * pregnant or breast-feeding women
an expanded access protocol for a single subject who has completed 24-weeks of treatment in pr0140_cd02 study

Conditions: HIV

Summary: the primary objective is to provide continued access to pro 140 to a subject who has completed participation in pro140_cd02.

this is an open label, single center study designed to provide continued access to pro 140 to a subject who have completed participation in pro140_cd02 and continue to receive clinical benefit. the subject will receive weekly pro 140 sc injection along with oral art regimen during the treatment phase. the study treatment (pro 140 sc injections) will be administered by a qualified medical professional or self-administered by the subject.

Eligibility criteria:
this study will recruit one treatment-experienced, hiv-1 infected patient with ccr5-tropic virus, who has participated in pro 140_cd02 clinical trial and is continuing to derive clinical benefit from pro 140 treatment.
testing mywhi: online self-guided programs for migraine

Conditions: Migraine Headache

Summary: the goal for this pilot study is to assess the acceptability of two online self-guided programs for migraines. the programs are part of the investigators' collection of "my wireless headache interventions" (mywhi). the specialized program for headache reduction (sphere) is a program that teaches cognitive and behavioural skills/techniques to help manage headaches. the personalized intervention for self-management of migraine (prism) helps users to discover their headache triggers and provides recommendations for managing them. this pilot will also assess the feasibility of the study protocol to inform a full scale randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: * aged 14-35 years * fluent in the english language (i.e., speaking, reading and writing); * suffer from headaches for a minimum of one year * stable pattern of headache symptoms (e.g., headache frequency, severity, location of pain, symptoms associated with headache) for the past 6 months * suffer from migraine headaches as indicated with a score of 2 and above on the id migraine * use the smartphone for activities other than texting and calling (e.g., email, facebook) * have daily internet access from their smartphone * minimum of four headache days during 4 weeks of using an electronic headache diary exclusion criteria: * health care professional has not ruled out any underlying medical condition related to their headaches (e.g., head trauma, meningitis) * are pregnant, planning to get pregnant (in the next 4 to 6 months), or breastfeeding * have an impairment which compromises their ability to give informed consent * having been diagnosed with psychosis and/or schizophrenia * they complete less than 50% of daily entries (i.e., less than 14 daily entries) in an electronic headache dairy
a study of ak112 with or without ak117 in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this trial is a phase ii study. the purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ak112 with or without ak117 in participants with metastatic colorectal cancer who are not suitable for surgery.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of colorectal adenocarcinoma * part1: subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy * part2: subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-egfr antibodies or could not tolerate or have contraindications to standard treatment * eastern cooperative oncology group performance status of 0 or 1 * measurable disease as defined by recist v1.1 * adequate hematologic and organ function exclusion criteria: * known msi-h(microsatellite-instability-high) or dmmr(mismatch repair-deficient) * prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway * history of autoimmune disease * prior allogeneic stem cell or solid organ transplantation * positive test for human immunodeficiency virus,active hepatitis b or hepatitis c * receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment * pregnancy or lactation * dysphagia
multi-gyn actigel plus for treatment of bacterial vaginosis

Conditions: Bacterial Vaginoses

Summary: this is a randomized, double-blind, placebo-controlled clinical investigation. the objective of the study is to confirm the efficacy of multi-gyn actigel plus to treat bv as compared to a placebo control. treatment arm 1: multi-gyn actigel plus treatment arm 2: placebo gel both the multi-gyn actigel plus and the placebo will be applied twice a day for 7 consecutive days. visit 2 will be performed at 3 weeks after start of treatment a phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at visit 2. the total duration per subject is estimated 5 weeks and the total study duration is 13 months. sample size is 100 subjects per treatment arm.


Eligibility criteria:
inclusion criteria: * women diagnosed with bv (3 out of 4 amsel criteria positive, with at least presence of clue cells (\>20%)) * women of childbearing potential * aged \>18 years * signed written informed consent form * willing to comply to the follow-up schedule exclusion criteria: * current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis) * presence of trichomonas and/or candida albicans in vaginal smear during examination of the smears for amstel criteria (clue cells detection) * current genital malignancies * chemotherapy for any reason in last 6 months * radiotherapy in the genitourinary system in the last 12 months * use of antibiotics for any reason in the last 14 days * use of intravaginal devices during the investigation or in the last 14 days * pregnancy or currently attempting to conceive * lactation * use of other treatment for vaginal conditions during the course of the clinical investigation * known allergies to ingredients of the product * concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
effect of peer-mentor mediated interventions on cardiovascular risk factors at worksites

Conditions: Cardiovascular Disease

Summary: the investigators propose conducting a pilot study to identify 6 worksites (2 india, 2 sri lanka, 2 bangladesh) explore barriers to optimum cardiovascular disease(cvd) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention to improve life style and enhance medication adherence among those at moderate to high risk of cardiovascular disease (cvd).

eligibility criteria - all employees aged above 35 years at selected workplaces. study design - mixed methods methods phase 1 - qualitative study; phase 2 - quantitative - single group, non-randomized before-after comparison study + kap survey sample size - approximately 334 participants. the study entails the following steps - step 1 - an evaluation for knowledge, attitudes and practices (kap) related to cardiovascular health/ disease at worksites. step 2 - a qualitative study for barriers and facilitators of behaviors associated with optimal cardiovascular health step 3 - baseline assessment of cardiovascular risk using a non-lab based risk assessment score step 4 - piloting a trained peer mentored educational/ intensive follow-up intervention for 3 month with a re-assessment at 3 months.

Eligibility criteria:
inclusion criteria: * all criteria must be met to be eligible 1. employees (men \& women) above the age of 35 years. 2. permanent employees with at least 6 months for retirement. 3. willing to provide informed consent. exclusion criteria: * subject ineligible if even one criterion is met 1. pregnant or intent to get pregnant in one year. 2. inability to attend follow up visits. 3. any active malignancy or known malignancy on treatment. 4. will relocate during the study period. 5. unwilling or unable to comply with study procedures.

Keywords: cardiovascular disease education peer mentor
the impact of postoperative catheterization time after stress incontinence surgery to success of surgery

Conditions: Stress Urinary Incontinence; Surgery

Summary: after incontinence surgery, the patients randomly will be divided two groups. in group a postoperative urinary catheterization time will be applied one day, in group b catheterization will be applied two days. after removal of urinary catheter, residual volume will be measured and voiding function will be controlled. in postoperative period; third, sixth month and one year after surgery stress test will be applied to control success of surgery


Eligibility criteria:
inclusion criteria: * stress incontinence * resistant to medical treatment exclusion criteria: * had no surgery before * has no accompanying uterine descensus * has no neurogenic disorder
lofexidine for opiate withdrawal - 1

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to evaluate lofexidine for opiate withdrawal.

an 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

Eligibility criteria:
inclusion criteria: male or female as least 18 yrs of age \& above with a current dependence on heroin, morphine or hydromorphone according to dsm4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method. exclusion criteria: additional criteria available during screening at the site

Keywords: opiate dependence
orthopaedic specimen pathology and early diagnosis of attr cardiopathy (attr-ortho)

Conditions: ATTR Amyloidosis; Cardiopathy; Carpal Tunnel Syndrome; Lumbar Spine Stenosis; Hip Prosthesis; Knee Prosthesis

Summary: the goal of this observational study is to learn about the frequency of attr amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. the main questions to be answered are: 1. what is the frequency of attr deposits in samples retrieved during surgery? 2. what is the frequency of cardiac involvement in attr positive patients? 3. what are the preoperative predictors of attr deposits? participants will * have operative samples stained by congo red in search of amyloid, which will be typed by immunochemistry in positive samples, * undergo a multimodal imaging search for cardiac involvement, if attr is identified, * undergo a preoperative complete clinical examination, including collection of medical history, ecg, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and mri + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis) * attr positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement. researchers will assess the frequency of attr deposits at each operated site, the frequency or attr cardiopathy in attr + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without attr deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries


Eligibility criteria:
inclusion criteria: 1. patients aged 50 or over 2. having signed an informed consent form 3. undergoing surgery for 1. idiopathic carpal tunnel syndrome 2. or lumbar spinal canal stenosis 3. or prosthetic replacement of a hip or knee for primary osteoarthritis exclusion criteria: 1. secondary carpal tunnel syndrome (inflammatory rheumatism, diabetes, hypothyroidism, etc.) 2. indication of prosthesis for a condition other than primary osteoarthritis. 3. known amyloidosis 4. refusal of consent 5. inability to understand the study 6. age \< 50 years

Keywords: attr amyloidosis cardiac amyloidosis orthopaedic surgery
1,3,7-trimethylxanthine as a treatment of covid-19: results of a controlled study

Conditions: Coronavirus Disease 2019

Summary: this is observational study to assess the prognosis of patients hospitalized with covid-19 confirmed by rt-pcr and exposed to trimethylxanthine (tmx). trimethylxanthine is the active molecule present in coffee. due to the lack of etiologic treatments and considering interest about old treatments as an avenue for research, we conducted a comparative study aiming to evaluate the effect of 1,3,7-trimethylxanthine on covid-19 infected patients. this is actually a study about methodology. the objective of this study is therefore not to demonstrate the effect of the substance on the disease but the importance of a rigorous methodology in scientific research. this project is called "method and teaching of scientific studies".


Eligibility criteria:
inclusion criteria: * age \> 18, * no trimethylxanthine contraindications (defined as allergy, previous reported secondary effects), * infectious disease unit admission. exclusion criteria: * secondary effects about trimethylxanthine, * refuse to participate
d-chiro-inositol and endometrial thickness

Conditions: Endometrial Diseases

Summary: investigation of the effects of d-chiro-inositol supplementation in women with altered endometrial thickness.


Eligibility criteria:
inclusion criteria: - altered endometrial thickness exclusion criteria: * patients with cancer * patients under hormonal treatments (progestogens and/or estrogens) * patients supplemented with inositols
safety and efficacy of libigel® for treatment of hypoactive sexual desire disorder in postmenopausal women

Conditions: Hypoactive Sexual Desire Disorder

Summary: this study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of libigel in the treatment of hsdd in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of hypoactive sexual desire disorder (hsdd).


Eligibility criteria:
inclusion criteria: postmenopausal female subjects * at least 50 years of age * with at least two points of cardiovascular risk * with a clinical diagnosis of hsdd. exclusion criteria: subjects must not * require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators, * have used androgen therapy within 2 months of randomization, * have a history of estrogen-dependent neoplasia or any gynecologic cancer, * have a history of cancer of any kind in the past 10 years prior to randomization, * have a history of malignant melanoma or a history of invasive cancer at any time, * have a screening mammogram with any finding that requires follow up within 6 months of randomization, * have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization, * have any medical condition associated with predicted survival of less than 3 years in the judgment of the investigator.

Keywords: cardiovascular event breast cancer testosterone menopause hypoactive sexual desire disorder
external versus internal feedback in patients with chronic ankle instability

Conditions: Ankle Injuries; Ankle Inversion Sprain

Summary: although altered biomechanics has been well documented as an impairment associated with chronic ankle instability (cai), effective interventions targeting biomechanics with long-term outcomes measuring patient-reported outcomes (pros) are absent. evidence suggests that external focus of attention (exfocus), internal focus of attention (infocus) feedback, and auditory feedback during movement training can alter biomechanics in other patient populations, with exfocus and auditory enhancing retention of learned biomechanics. therefore, this randomized controlled trial will determine if a 4-week (12 session) impairment-based rehabilitation program that includes feedback (exfocus or infocus or auditory) can (1) decrease ankle inversion kinematics and lateral plantar pressure during walking and (2) improve self-reported function.


Eligibility criteria:
inclusion criteria: * characterized as having chronic ankle instability (cai) by reporting a history of recurrent ankle sprains, with the first sprain occurring longer than 12 months ago. participants will have lingering symptoms, and disability, but have not actively sought treatment for their cai. * all participants will be physically active: participating in some form of physical activity for at least 20 min per day, three times per week. exclusion criteria: * neurological or vestibular disorders affecting balance * currently seeking medical care for cai * history of ankle surgery * history of ankle sprain within the past 6 weeks * history of other musculoskeletal injuries within the past 6 weeks * current/previous self-reported disability due to lower extremity pathology that may adversely affect neuromuscular function