Kornimate/medical-research-clean huggingface dataset:
special survey long-term treatment with tiotropium on copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: since spiriva inhalation capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.


Eligibility criteria:
inclusion criteria: 1. patients of chronic obstructive pulmonary disease 2. patients were expected to use the product for long period of time exclusion criteria: 1. patients with glaucoma 2. patients with micturition disorder due to prostatic hyperplasia etc. 3. patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product
aortic root enlargement in aortic valve replacement

Conditions: Aortic Valve Replacement

Summary: aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. aortic valve replacement is a usual operation but can be complicated by a small aortic annulus requiring the insertion of an aortic valve prosthesis. prosthesis-patient discrepancy results in worse outcomes.

prosthesis-patient discrepancy results in worse outcomes, including elevated left ventricular work, decreased left ventricular mass regression, and has also been linked with high mortality. therefore, aortic root posterior enlargement by autologous fixed pericardium to insert an aortic valve prosthesis with size suitable to patient body surface area to avoid the previous worse outcome of patient prosthesis mismatch. in this study the investigators will try to identify the benefits of aortic root enlargement in management of small aortic annulus in patients with severe valvular aortic stenosis

Eligibility criteria:
inclusion criteria: * 17-75 years old * patients with sever aortic valve stenosis undergoing valve replacement surgery * informed consent has been obtained exclusion criteria: * planned off-pump cardiac surgery * patients required intra-aortic balloon pump * under 17 years of age

Keywords: patients- prosthesis mismatching
impact of sustained virologic response on glycemic control among diabetic patients with hepatitis c virus related liver disease

Conditions: Hepatitis c

Summary: hepatitis c virus (hcv) is a major cause of chronic liver disease. the world health organization has reported that 170 million people are chronically infected with hcv globally. the highest prevalence of hcv infection worldwide exists in egypt (15%); 90% of infection among egyptian patients is due to genotype 4


Eligibility criteria:
inclusion criteria: * chronic hcv infection will be diagnosed based on positive testing for serum hcv rna and anti-hcv ab. * diagnosis of type 2 dm will depend on fasting level of serum glucose more than 126 mg/dl and/or serum level of hba1c more than 6.5 % on oral hypoglycemic therapy. exclusion criteria: * chronic hepatitis due to causes other than hcv infection * coinfection with hbv infection * hepatocellular carcinoma * child c stage of liver cirrhosis. * patients with type i diabetes mellitus. * cardiopulmonary diseases. * major illness. * patient receiving corticosteroids. * patient refused consent.
atypical hemolytic-uremic syndrome (ahus) registry

Conditions: Atypical Hemolytic-Uremic Syndrome

Summary: post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

the study will capture post-marketing safety data on patients treated with eculizumab or ravulizumab. additionally, the study will collect information on the progression of disease in all patients.

Eligibility criteria:
inclusion criteria: * male or female patients of any age, including minors, who have been diagnosed with ahus * patients with or without an identified complement pathogenic variant or anti-complement factor antibody * able to give written informed consent. patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent \[if applicable as determined by the central institutional review boards/independent ethics committees (irb/iec)\]. * adamts13 \> 5%, if performed. exclusion criteria: * hemolytic uremic syndrome (hus) only due to shiga toxin producing escherichia coli (stec). * unable to give written informed consent. patient or patient's parent/legal guardian unable to give written informed consent. patient (if minor) unable to give written informed assent (if applicable as determined by the central institutional review boards/independent ethics committees \[irb/iec\]).

Keywords: atypical hemolytic-uremic syndrome ahus thrombotic microangiopathy tma
using magnetic resonance (mr) to understand the effect of erythromycin on bowel motility

Conditions: Healthy

Summary: magnetic resonance imaging (mri) has proven to be a valuable imaging technique for suspected small bowel disease. this technique depends, in part, on adequate distension of the small bowel. this is accomplished by administering large volumes of a non-absorbable oral contrast material prior to the examination, which typically produces excellent distension of the distal small bowel and stomach, but poor distension of the proximal small bowel. erythromycin is a common antibiotic that is known to promote stomach emptying and is used to treat diabetics with gastroparesis (poor stomach emptying.) the hypothesis of this study was that erythromycin will increase gastric emptying and hence improve small and large intestinal distention during mri.

gastric, small, and large intestinal volumes were assessed with mri after ingestion of a low concentration of barium sulfate solution (1350 ml) and randomization to erythromycin 200 mg i.v.) or placebo in 40 healthy volunteers. magnetic resonance images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet.

Eligibility criteria:
inclusion criteria: * normal healthy adult volunteers without known gastrointestinal disease * aged 18-70 years * able to provide written informed consent before participating in the study * able to communicate adequately with the investigator and to comply with the requirements for the entire study. exclusion criteria: * known allergy to erythromycin; * use of drugs that have known contraindication with erythromycin (concomitant therapy with astemizole, cisapride, pimozide, or terfenadine) * corrected qt interval on ekg \>460 msec * certain medications (i.e., theophylline, digoxin, oral anti-coagulant, benzodiazepine, 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitors) will either be excluded from the study or, if medically safe, will be asked to discontinue the medication for 4 half-lives before beginning the study. * use of medications that alter gi motility e.g., narcotics, medications with significant anticholinergic effects * pregnant or breast-feeding females * known claustrophobia * known family history of sudden death or congenital qt prolongation * presence of pacemaker, internal defibrillator, or other non-mr compatible device * patients with known metal present within their abdomen

Keywords: healthy men women no known gastrointestinal disease aged between 18-70 years
hydration and acceptability of the genital and skin mucosa of a vaginal moisturizer in menopausal women

Conditions: Vaginismus; Vaginal Atrophy; Menopause

Summary: hyaluronic acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. hyaluronic acid promotes vaginal moisture, providing symptom relief in various situations such as: * vaginismus and other sexual dysfunctions related to penetration * users of hormonal contraceptives with lubrication loss * postpartum and lactational period * post antibacterial or antifungal therapies * during systemic oncological treatments (chemotherapy, radiotherapy, hormone therapy) * climacteric (urogenital atrophy) * post urogynecological surgeries (correction of urinary incontinence, genital dystopias, etc.) * post vulvovaginal abrasive, chemical, laser, or high-frequency therapies * post cosmetic and genital rejuvenation therapies


Eligibility criteria:
inclusion criteria: * healthy research participants, with an active sexual life; * intact skin and mucosa in the test region; * participants vaccinated for covid-19 (corona virus disease). * agreement to adhere to the study procedures and requirements and attend the institute on the day(s) and time(s) determined for the assessments; * ability to consent to participate in the study; * menopausal participants of any age, without systemic or topical hormone replacement therapy in the last 6 months * presenting mild to moderate vaginal dryness (≥0.5 and \<7.5) - according to the visual analogic scale * healthy research participants, with an active sex life (at least once a week) exclusion criteria: * skin pathology in the area of product application; * decompensated diabetes mellitus (tbd by the institute together with the sponsor); * immune insufficiency; * current use of the following topical or systemic medications: corticosteroids, immunosuppressants and antihistamines; * skin diseases: vitiligo, psoriasis, atopic dermatitis; * previous reaction to the category of the product tested; * other illnesses or medications that may directly interfere with the study or put the health of the research participant at risk. * have used vaginal moisturizing creams and/or intimate lubricants 5 days before the initial study visit; * have had sexual intercourse at least 48 hours before the initial study visit; * have been diagnosed with a urogenital or vaginal infection in the last 30 days; * have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last 30 days.
a study comparing the analgesic efficacy and safety of extended release hydrocodone/acetaminophen (vicodin® cr)and placebo in subjects with osteoarthritis

Conditions: Pain

Summary: the purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of extended release hydrocodone/acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.


Eligibility criteria:
inclusion criteria: * males or females ages 21 to 75 * has osteoarthritis of the hip or knee * requires therapeutic doses of medications for osteoarthritis * if female, must be of non-childbearing potential or practicing birth control * has sufficient pain to justify the use of round-the-clock opioids exclusion criteria: * has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe * has certain medical conditions which may interfere with pain assessments * is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen * has had certain infections, injuries or illnesses within the last month * has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting * is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years * has a history of major psychiatric disorders or requires treatment with certain drugs for depression * cannot discontinue pain medications, even for a short time, prior to the study start

Keywords: pain associated with osteoarthritis
quality of life the danish multiple myeloma patients

Conditions: Quality of Life; Multiple Myeloma

Summary: the aim of the project is to improve quality of life for multiple myeloma patients in the future.

multiple myeloma is an incurable malignancy of the bone marrow and the second most common type of haematological cancer. in denmark, about 320 patients are diagnosed annually with multiple myeloma, and the cancer often affects older people, but 30 % of the patients living with mm are of working age. the prognosis has improved markedly over the last two decades and is expected to improve further. systematic monitoring of symptoms, side effects and complications over time outside clinical trials has not been performed yet. knowledge of the elderly and frail patients´ perspective on the multiple myeloma disease is lacking, and the time after anti-myeloma treatment is left unstudied. a common side effect (up to 55 %) to specific types of anti-myeloma drugs is peripheral neuropathy (nerve injury), which can be temporary or permanent in the form of long-term sequelae of pain and numbness. information on this side effect from the patients´ perspective is missing. the design of the project is a prospective, population-based, national, longitudinal survey with retrospective data collection from more danish registers. we will include 800 previously untreated and relapsed multiple myeloma patients at treatment-demanding disease recruited from all danish haematological departments. at inclusion, demographic data and patient-related prognostic markers will be obtained. the patients will complete four validated qol instruments (eortc qlq-c30, my20, cipn20 and sf12v2) at 13 measuring points over a period of 24 months. the questions are concerning cancer and mm symptoms, peripheral neuropathy, other side effects, quality of life and functional capacity of a social, emotional and physical character. this project will provide real-time data collection of the symptoms, side effects, complications and quality of life from the general multiple myeloma patients´ perspective during and after anti-myeloma treatment. it will illuminate the reason for the patients´ high loss of working ability. the findings will be integrated in the future danish national treatment guidelines, and recommendation for rehabilitation in aspects of shared decision making.

Eligibility criteria:
inclusion criteria: * previously untreated or relapsed multiple myeloma patients and * treatment demanding multiple myeloma disease exclusion criteria: * inability to understand the danish language or * psychic or mental illness that prevents the patient from answering the questions in the questionnaires.
effect of laughter yoga therapy on postpartum depression

Conditions: Postpartum Depression

Summary: laughter yoga sessions, stretches and stretches, songs, clapping and body it starts with light warm-up techniques that include movements. these are to break down all kinds of inhibitions and it is aimed at developing the feelings of childlike play. breathing exercises lungs they are ready to laugh and are combined with the following series of laughing exercises. ly in order to provide group dynamics in therapy, the group should consist of at least 5-12 people. provided. real laughter is often experienced during laughter meditation; it's contagious and may trigger laughter in other people in the group, hence the group can establish greater connections with its members. laughter yoga sessions are always held at the same time and in the same place to encourage the participation of individuals. has been done.

laughter yoga sessions, stretches and stretches, songs, clapping and body it starts with light warm-up techniques that include movements. these are to break down all kinds of inhibitions and it is aimed at developing the feelings of childlike play. breathing exercises lungs they are ready to laugh and are combined with the following series of laughing exercises. ly in order to provide group dynamics in therapy, the group should consist of at least 5-12 people. provided. real laughter is often experienced during laughter meditation; it's contagious and may trigger laughter in other people in the group, hence the group can establish greater connections with its members. laughter yoga sessions are always held at the same time and in the same place to encourage the participation of individuals. has been done. therapy sessions are between 40-45 minutes. sessions started on time and was completed on time. in the research, a total of 6 sessions of laughter, once a week, yoga was done. the experimental group was interviewed in an online meeting prepared by a certified ly trainer. she received ly exercises once a week (40 minutes per session) for 6 weeks (6 sessions). each the meeting was organized with a maximum of 12 people.

Eligibility criteria:
inclusion criteria: * have a healthy baby exclusion criteria: * absence of a psychiatric illness no chronic disease the newborn has no health problems
conversion of tislelizumab combined with chemotherapy in unresectable esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma by AJCC V8 Stage; Unresectable

Summary: whether the introduction of immunotherapy can transform unresectable esophageal cancer into resectable, or even achieve r0 surgical resection, has not been reported yet. we plan to conduct a prospective, single-center, single-arm phase ii clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of unresectable esophageal squamous cell carcinoma.

for patients not eligible for r0 resection (defined as locally advanced unresectable esophageal cancer), preoperative treatment can theoretically transform the tumor into a resectable state. the current significance of transformation therapy is to reduce tumor volume and stage to achieve radical resection, eliminate micrometastases, and prevent a postoperative recurrence. there are few studies on the transformation therapy of esophageal squamous cell carcinoma. we plan to conduct a prospective, single-center, single-arm phase ii clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of t4a/n3 esophageal squamous cell carcinoma.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed esophageal squamous cell carcinoma; 2. unresectable ct4a/n3(stage ⅳa) (ajcc 8 tnm classification); 3. have a performance status of 0 or 1 on the ecog performance scale; 4. age 18-75 years old, both men and women; 5. be willing and able to provide written informed consent/assent for the trial; 6. demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation; 7. female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the study medication's first dose. if the urine test is positive or cannot be confirmed as unfavorable, a serum pregnancy test will be required; 8. be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. newly acquired is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on day 1. subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor. exclusion criteria: 1. prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer; 2. ineligibility or contraindication for esophagectomy; 3. has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 4. has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs); 5. has severe hypersensitivity and adverse events (≥grade 3) to any pd-1/pd-l1 inhibitors.
effect of nasopharyngeal airway-assisted deep sedation vs. endotracheal intubation general anesthesia on respiratory complications during ercp

Conditions: Biliary and Pancreatic Diseases; Endoscopic Retrograde Cholangiopancreatography (ERCP)

Summary: this study aims to investigate the impact of nasopharyngeal airway-assisted deep sedation versus endotracheal intubation general anesthesia on perioperative respiratory adverse events during ercp.

this study aims to investigate the impact of nasopharyngeal airway-assisted deep sedation versus endotracheal intubation general anesthesia on perioperative respiratory adverse events during ercp.

Eligibility criteria:
inclusion criteria： 1. ≥ 18 years old 2. american society of anesthesiologists classification (asa) 1-3. 3. patients who require elective ercp 4. voluntarily participate in this study and sign an informed consent form. if the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. if the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form. exclusion criteria： 1. altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction 2. coagulopathy or epistaxis tendency 3. cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias) 4. pulmonary diseases (e.g., asthma, copd) 5. prior hypersensitivity to anesthetic agents 6. active upper respiratory infection 7. hepatic/renal dysfunction 8. difficult airway (e.g., severe osa) 9. psychiatric disorders, cognitive impairment, critical illness, or pregnancy