Kornimate/medical-research-clean huggingface dataset:
botanical tincture for symptoms of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome Characterized by Constipation

Summary: the main purpose of this study is to investigate the feasibility of a follow-up larger rct on the efficacy of botanical tincture to relieve abdominal pain in people with irritable bowel syndrome constipation predominant (ibs-c).

the randomized pilot trial will address subject recruitment, retention, and subject compliance with protocol. a secondary is to learn if people with ibs-c are able to tolerate botanical tincture and the effect of taking botanical tincture on abdominal pain, bloating, and bowel movements.

Eligibility criteria:
inclusion criteria: * patients meeting rome iv criteria for the diagnosis of irritable bowel syndrome that requires that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with 2 or more of the following : * related to defecation (may be increased or unchanged by defecation) * associated with a change in stool frequency * associated with a change in stool form or appearance * abdominal pain intensity: average of worst daily (in past 24 hours) abdominal pain score of \>= 3 on a 0 to 10 point scale over last week * stool frequency: \< or = to 3 complete spontaneous bowel movement(csbm) in the previous week * reported bloating rating \> or = 2 on 5-point scale \[0 (absent) - 4 (very severe)\] in previous week * english speakers, as all surveys are in english exclusion criteria: * patients with known hypersensitivity to any component of the trial drugs * history of eating disorders * patients with a history of diseases with abdominal symptoms that can resemble ibs * presence of any other known acute or chronic gastrointestinal disorder * history of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously) * pregnancy or breast feeding * current or past history of alcohol dependence * based on lack of adequate scientific evidence to predict drug-drug interaction in vivo, current use of strong inhibitors or inducers for cyp enzymes and participants are instructed not to take any medications that are strong inhibitors or inducers for cyp enzymes during the course of the study * vulnerable subjects. the study will not include vulnerable subjects (such as, those with limited autonomy or those in subordinate hierarchical positions). children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity will not be included.
wish, feasibility of a factorial design

Conditions: Breast Cancer; Vulvovaginal Signs and Symptoms; Sexual Desire Disorder; Body Image

Summary: the primary aim of this study is to evaluate the feasibility of testing a multi-component intervention for sexual function using a factorial design.

this proposal builds upon a multi-component pilot study (wish), where women with a history of breast cancer participated in a two-component intervention to improve vulvovaginal atrophy with a vaginal moisturizer and sexual desire and body image with hypnotic relaxation (hr), a mind-body intervention that includes suggestions for relaxation, improved sexual desire, and body image delivered via audio file. this study seeks to further test wish by expanding vulvovaginal atrophy interventions to include either a polycarbophil-based vaginal moisturizer (replens™) or a hyaluronic acid-based moisturizer (hyalo gyn ®); and hypnosis relaxation (hr) or progressive muscle relaxation (pmr) interventions for sexual desire and body image. the primary outcome is the feasibility of a multi-component intervention for sexual function using a factorial design.

Eligibility criteria:
inclusion criteria: 1. age ≥18 female 2. ability to read and write english 3. history of any stage of breast cancer 4. completed primary treatment (chemotherapy, radiation and/or surgery) ≥3 months and ≤ 10 years prior to registration. participants may use concurrent adjuvant endocrine therapy or her2-targeted therapy while on study. 5. able to engage in sexual activity including penetration or insertion into the vagina 6. currently has a sexual partner. 7. responds "yes" to "do you currently experience vaginal or vulvar dryness and/or discomfort/pain with sexual activity?" 8. responds "yes" to at least one of the following questions: * "have you experienced negative changes in your body image since being diagnosed or treated for cancer?" or * "have you experienced negative changes in your sexual desire since being diagnosed or treated for cancer?" exclusion criteria: 1. antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change. 2. an active psychiatric disorder that is or causing you symptoms or distress, such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, ptsd, schizophrenia or borderline personality disorder (defined per medical history and/or patient self-report) 3. currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed). 4. previous participant in wish study 5. currently receiving active treatment 6. use of oral, transdermal or vaginal estrogen 7. allergy or intolerance to replens, hyalo gyn or any of their components.

Keywords: vulvovaginal atrophy libido hypnosis progressive muscle relaxation
feasibility study to evaluate a new energy storage and return prosthetic foot

Conditions: Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Knee

Summary: a prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the taleo, proflex xc, and the new revo prosthetic foot.

the purpose of the revo-m study is to characterize differences in performance and patient reported outcomes between the revo investigational prosthetic foot and a comparative prosthetic foot (taleo or proflex xc) when compared to the control foot which is the subject's currently used energy storage and return (esr) prosthetic foot. the data obtained from this study may also serve to determine the long-term performance of revo.

Eligibility criteria:
inclusion criteria: 1. person is 18 years or older. 2. currently uses an energy storage and return foot. 3. person has been a unilateral transfemoral (tf), or transtibial (tt) amputee using a prosthesis for at least 1 year. 4. for tf amputees, the person must be wearing an ottobock microprocessor-controlled knee (mpk) with a compatible prosthetic foot 5. person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm 6. person is a k3 ambulator based on medicare functional classification level (mfcl). 7. prosthetic foot size is 24 to 27 centimeters. 8. socket comfort score of at least 7 9. ability to read and understand english 10. a person is able and willing to give consent exclusion criteria: 1. current prosthetic foot is too old or worn out as assessed by the cpo. 2. tt subject with currently fit with a proflex xc or tf subject currently fit with a taleo. 3. patient is pregnant or planning to become pregnant. 4. person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease). 5. person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.). 6. ulceration or skin breakdown of the residual limb. 7. person currently has residual limb issues that significantly reduce their ability to load the prosthesis.

Keywords: prosthetic foot, lower limb amputation
a study on the pain control effect of the anesthetic method during prostate biopsy: comparison between pelvic plexus block and periprosthetic nerve block

Conditions: Transrectal Systematic Prostate Biopsy Related Pain

Summary: this study assesses differences in the effects of pelvic plexus block and periprostatic nerve block among various anesthetic methods that reduce the pain caused by prostate biopsy.

recently, various types of local anesthetic methods have been attempted to reduce biopsy-related pain leading to changes in the type of anesthetic agents and site of injection. of these anesthetics and combinations, pelvic plexus block and periprostatic nerve block seem to be the very effective way to control prostate biopsy-related pain. however, few studies have compared these two methods.

Eligibility criteria:
inclusion criteria: * abnormal prostate finding on digital rectal examination * serum psa level of \> 2.5 ng/ml * transrectal ultrasonographic abnormal lesion exclusion criteria: * under 50 years old * a history of previous trus-guided biopsy * chronic prostatitis/pelvic pain * neurological conditions (dementia, parkinson disease, or cerebral infarction) * bleeding diathesis * active uti * hemorrhoids/anal fissure/anal fistula * known allergy to lidocaine

Keywords: local anesthesia prostate, biopsy transrectal
flap sparing in postoperative radiotherapy of oral cavity cancers

Conditions: Oral Cavity Carcinoma; Flap; Radiotherapy, Adjuvant; Reconstruction Surgery

Summary: patients with oral cavity cancer treated by reconstructive surgery with a flap. patients will be treated in the study for : * experimental arm: post-operative radiotherapy with flap sparing * control arm: standard post-operative radiotherapy without flap sparing (current practice) radiotherapy by imrt using photons or proton therapy (impt)

patients with oral cavity cancer treated by reconstructive surgery with a flap. patients will be treated in the study for : * experimental arm: post-operative radiotherapy with flap sparing * control arm: standard post-operative radiotherapy without flap sparing (current practice) radiotherapy by imrt using photons or proton therapy (impt) our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older * performance status 0-2 * patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study * quality of resection with margins \> 1 mm * patient candidate to post-operative radiotherapy (intensity-modulated radiation therapy (imrt) or proton therapy) * concomitant chemotherapy is allowed (stratification parameter) * patient must have signed a written informed consent form prior to any trial specific procedures * patient affiliated to the social security system exclusion criteria: * local flap (small size limiting imrt modulation potential) * history of radiotherapy of head and neck area * metastatic disease * history of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma) * simultaneous participation in another clinical study may compromise the conduct of this study. * pregnant or lactating women * patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol * patient deprived of freedom or under guardianship

Keywords: protontherapy flap oral cavity carnicoma radiotherapy imrt
ns1209 and lidocaine in patients with peripheral neuropathic pain

Conditions: Pain

Summary: purpose: to evaluate the efficacy, tolerability and safety of ns1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.


Eligibility criteria:
inclusion criteria: * age \>18 years * neuropathic pain and allodynia after a peripheral nerve injury (vas \>= 4) exclusion criteria: * patients who cannot cooperate and do no understand danish * fertile women * clinically significant abnormality or disease * drug and alcohol abuse * clinically abnormal ecg * hypersensitivity to any of the treatments * patients in treatment with cimetedin, antidepressants, antipsychotics, antiepileptics except gabapentin, anticoagulants, na channel blockers and beta blockers * patients who have previously been treated in a ns1209 study * patients treated with an investigational drug

Keywords: peripheral neuropathic pain neuropathic pain chronic pain
evaluating the use of patient navigation to promote timely diagnostic evaluation during the covid-19 pandemic

Conditions: Breast Cancer

Summary: the primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (covid-19) pandemic. this project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. the investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

patients who meet the study selection criteria will be randomized into two groups in a 1:1 ratio: the usual care group and the intervention group. initially, patients will be invited to participate in the study via a brief statement included in the patient result letter informing patients of their abnormal screening mammogram result. the patient navigator will then follow up with each patient who expresses interest in the study via telephone to reiterate the details of the project, answer any questions that the patients might have, and invite the patients to participate in the project if the patients meet the study inclusion criteria. informed consent will be obtained from the study participants. the primary role of the patient navigator will be to identify and address barriers to accessing timely diagnostic care. the patient navigator's duties will also include providing an array of services aimed at improving health care access and engagement, including appointment reminder phone calls, health education, assistance with scheduling appointments, providing information about available transportation options to the clinic sites (e.g., shuttle service provided by the institution), helping patients to connect with language interpretation services, providing assistance with resolving insurance issues, and motivating and coaching patients on the importance of timely follow-up of abnormal breast imaging results. the services provided by the patient navigator will be tailored to the specific needs of each patient and will be aimed at helping patients to overcome personal, cultural and systemic barriers to successfully completing follow-up.

Eligibility criteria:
inclusion criteria: * patients who have an abnormal screening mammogram (i.e. given a breast imaging-reporting and data system \[bi-rads\] assessment category of 0) at the investigators' institution during the study period and have not yet undergone diagnostic evaluation exclusion criteria: * any study participant who is unable to provide consent to participate in the study will be excluded.
a study of rd14-01 in patients with relapsed or refractory b cell non-hodgkin lymphoma

Conditions: Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma; Follicular Lymphoma

Summary: this study is designed to explore the safety and tolerability of rd14-01 for patients with relapsed and/or refractory b-cell non-hodgkin lymphoma. and to evaluate the efficacy and pharmacokinetics of rd14-01 in patients.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 75 years. 2. diagnosis of r/r mcl, dlbcl, or fl (grade 1, 2 and 3a). 3. ecog: 0-1. 4. life expectancy greater than 3 months. 5. cardiac left ventricle ejection fraction ≥50%. 6. informed consent explained to, understood by and signed by the patient/guardian. patient/guardian is given a copy of informed consent. exclusion criteria: 1. pregnant or lactating. 2. hepatitis b surface antigen (hbsag) or hepatitis b e-antigen (hbeag) positive and peripheral blood hepatitis b virus (hbv) dna titer detection is not within the normal range; hepatitis c virus (hcv) antibody positive; human immunodeficiency virus (hiv) antibody positive; syphilis antibody positive; cytomegalovirus (cmv) dna positive; epstein-barr virus (ebv) dna positive. 3. central nervous system (cns) metastases. 4. participated in other clinical studies within 4 weeks prior to screening. 5. history of alcoholism, drug abuse or mental illness. 6. any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
safety and efficacy of idp-118 in the treatment of plaque psoriasis

Conditions: Plaque Psoriasis

Summary: safety and efficacy of idp-118 in the treatment of plaque psoriasis

a phase 3, multicenter, double-blind, randomized, vehicle controlled clinical study to assess the safety and efficacy of idp-118 in the treatment of plaque psoriasis

Eligibility criteria:
key inclusion criteria: * male or female, of any race, at least 18 years of age (inclusive). * freely provides both verbal and written informed consent. * has an area of plaque psoriasis appropriate for topical treatment that covers a bsa of at least 3%, but no more than 12%. the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * has a clinical diagnosis of psoriasis at the baseline visit with an iga score of 3 or 4. (the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment). key exclusion criteria: * has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. * presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
a study to evaluate the safety and tolerability of dapirolizumab pegol in study participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.


Eligibility criteria:
inclusion criteria: * the participant could, in the opinion of the investigator, benefit from long-term dapirolizumab pegol (dzp) treatment * the participant completed one of the parent studies within 4 weeks prior to entry to this study exclusion criteria: - study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (sle)) that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study. this includes study participants with a life-threatening condition or ongoing malignancies at the start of the study

Keywords: systemic lupus erythematosus dapirolizumab pegol sle dzp
admission glucose icu study

Conditions: Hyperglycemia

Summary: determine if routine bg testing at the time of icu admission is being done on all patients, irrespective of a prior diagnosis of diabetes mellitus, and whether it provides clinically important information.

this prospective, observational study was performed in the medical-surgical icu of a single hospital within a large multi-specialty healthcare system. it was determined that it was not standard care to do glucose testing on all patients admitted to medical/surgical icu's who did not have diagnosed diabetes and varied widely with the admitting service. the primary objective of the study was to assess the availability and clinical value of blood glucose testing at the time of icu admission after testing was implemented as routine care in the icu.

Eligibility criteria:
inclusion criteria: * icu admission exclusion criteria: * \< 18 years of age

Keywords: icu admission bg
effect of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt during olv

Conditions: Lung Cancer

Summary: the purpose of this study is to conduct a randomized controlled trial to evaluate the effect of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt in patients received one-lung ventilation

population: the target population comprises all adult aged 45-65 years who was diagnosed lung cancer and to receive video-assist thoracoscopic lobectomy under general anethesia.the study sample will include 50 subjects of both gender and any race or ethnicity. procedures: eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms:budesonide inhalation group vs normal saline inhalation group study duration: overall duration of the study is 10 months.

Eligibility criteria:
inclusion criteria: * aged 45 yr to 65 yr ,height 155-176cm,weight 45-75kg,body mass index(bmi)18-27kg/m2,asa physical status classifications i to ii,left-lateral position during olv ,normal cardiac and pulmonary function ,and no cardiac,hepatic,renal and endocrine diseases.diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia. exclusion criteria: * fev1/fvc\<70%,asthma,chronic obstructive pulmonary disease,acute lung infection,past history of thoracic surgery. preoperative glucocorticoid medication,preoperative chemotherapy,spo2 kept below 90% for more than 15 minutes during operation,blood transfusion during operation,olv less than an hour,occurrence of severe complications like allergic shock.