Kornimate/medical-research-clean huggingface dataset:
testosterone gel in poor responders undergoing ivf

Conditions: Infertility

Summary: the main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or dehydroepiandrosterone (dhea) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (ivf).

a randomized controlled multiple centers study. the study is designed as a superiority trial. the sample size for this trial of 120 subjects in both groups, based upon the primary endpoint of the number of oocytes retrieved. ivf patients who have failed to conceive and had poor ovarian response (oocytes retrieved ≤ 3) in the last stimulated cycle though using the maximal dose, which is ≥ 300 iu follicle-stimulating hormone (fsh) or human menopausal gonadotropin (hmg). patients will be randomized to use dhea or testosterone gel as pretreatment. randomization will be performed using sealed envelopes developed via a computer generated list with blocks of four. doctors will be blinded to the randomization, but not patients and nurses. * study group 1 use 10 mg transdermal testosterone gel per day. * study group 2 use 75mg dhea per day. serum testosterone are measured before treatment. duration of androgen supplement is 6-8 weeks. after completing the pretreatment, patients are asked to come back when they have menses to begin ivf treatment. serum testosterone is measured again after the pretreatment in both groups. patients will be interviewed for side effects and compliance of treatment. after treatment, patients in both group undergo ivf treatment. ivf treatment will then be performed for all patients, according to the current hospital treatment protocols. patients will be followed up until 7th week of gestation, if they have positive pregnancy test after embryo transfer. data analysis and statistics: the investigators use statistical package for the social sciences (spss) software 20th version to analyze data. the primary end-point mean of number of retrieved oocytes will be compared between two groups using the student's t test. the secondary end-points will also be compared between the 2 groups using either the student's t test or chi-square test.

Eligibility criteria:
inclusion criteria: to be eligible for enrolment into this trial, each female subject must fulfill all of the following criteria at the start of enrolment, unless specified otherwise: * had one or two previous failure ivf cycle, using gnrh antagonist protocol (≥ 300 iu fsh/hmg per day) and the number of retrieved oocytes are ≤ 3; * antral follicle counts (afc) \< 6 or anti-mullerian hormone (amh) \< 1.26 ng/ml exclusion criteria: to be eligible for enrolment in this study each subject must not meet any of the following criteria: * oocyte donation cycle * patients have thyroid disease * patients have liver or kidney dysfunction * patients have abnormal puberty or genital development. * patients have previous surgery on ovaries

Keywords: ivf, testosterone gel, dhea, poor responder.
allo bmt in advanced leukemia or high grade lymphoma

Conditions: Lymphoma, Non-Hodgkin; Leukemia; Blood and Marrow Transplant (BMT); Lymphomas: Non-Hodgkin

Summary: to evaluate the role of ablative allogeneic hematopoietic cell transplantation in the treatment of advanced leukemia or lymphoma.

to determine the disease free survival and overall survival of patients with all and anll after induction failure, in relapse, or subsequent remission from cml in several phases or recurrent lymphoblastic lymphoma who receive fractionated tbi, etoposide and cyclophosphamide followed by allogenic bone marrow grafting from histocompatible sibling donors. fractionated total body irradiation (ftbi), etoposide (vp-16) and cyclophosphamide (cy) followed by allogeneic bone marrow transplantation for patients with advanced leukemia or high grade lymphoma

Eligibility criteria:
inclusion criteria:hla identical donor * adequate organ function * other life threatening disease
modified water vapor thermal therapy in management of patients with large-volume benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: water vapor thermal therapy (rezum) is a minimally invasive treatment for benign prostatic hyperplasia (bph) that uses injections of sterile water vapor directly into the prostate for tissue ablation. although rezum is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, the guidelines offer no recommendation with regards to rezum therapy for those with large-volume glands.

for prostates larger than 80ml, open or transurethral anatomical enucleation is recommended. open prostatectomy has a higher risk of bleeding and slower postoperative recovery, with a higher probability of requiring blood transfusion. the incidence of urinary incontinence after transurethral enucleation ranges from 3.33% to 20%, possibly due to excessive traction and compression on the external urethral sphincter, leading to partial muscle fiber rupture. the rate of erectile dysfunction after enucleation is 8.82%, while retrograde ejaculation occurs in 6.37% of cases, especially for patients with larger prostates. once these complications occur, they are often difficult to recover from and severely impact the patient's quality of life. in our center, the technique of rezum has been further improved by incorporating ultrasound and mri imaging guidance. the investigators design a reasonable and comprehensive ablation plan that ensures accurate positioning of enlarged prostate glands for complete and thorough ablation while ensuring efficacy and safety.

Eligibility criteria:
inclusion criteria: 1. male subjects ≥ 45 years of age who have obstructive symptoms secondary to bph requiring invasive intervention. 2. ipss score of ≥ 13. 3. qmax: peak flow rate ≤ 15 ml/sec. 4. post-void residual (pvr) \< 300 ml. 5. prostate volume between 80 to 120 ml. 6. subject able to complete the study protocol in the opinion of the principal investigator. exclusion criteria: 1. history of any illness or surgery that in the opinion of the principal investigator may confound the results of the study. 2. any prior minimally invasive intervention or surgical intervention for the symptoms of bph. 3. currently enrolled in another clinical trial. 4. confirmed or suspected malignancy of prostate or bladder. 5. documented active urinary tract infection by culture or bacterial prostatitis. 6. neurogenic bladder or sphincter abnormalities. 7. urethral strictures, bladder neck contracture or muscle spasms. 8. bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion). 9. subjects who are interested in maintaining fertility. 10. significant urge incontinence. 11. unable or unwilling to sign the informed consent form. 12. any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the principal investigator regarding the study.
ckd-702 plus irinotecan in gastric cancer

Conditions: Gastric Cancer

Summary: ckd-702 is a tetravalent bispecific igg1 targeting hepatocyte growth factor receptor (met) and epidermal growth factor receptor (egfr). the investigators will test a hypothesis that ckd-702 may augment the efficacy of biweekly irinotecan as a 3l or later therapy for gastric cancer overexpressing either met or egfr.


Eligibility criteria:
inclusion criteria: * failed 2 or more lines of chemotherapy * tumor overexpressing either met or egfr * measurable lesion exclusion criteria: * prior treatment with anti-met/egfr bispecific antibody
safety and efficacy study of single-port robotic versus multi-port robotic radical rectal cancer surgery

Conditions: Rectal Cancer; Surgery

Summary: this study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. the single-port robot is a further extension of minimally invasive surgery by placing multiple instruments through a single incision. most studies have reported on the perioperative outcomes of robotic versus conventional laparoscopic surgery in the treatment of colorectal cancer. however, there are limited data comparing the perioperative outcomes of single-port robotics and multi-port robotics in the treatment of colorectal cancer，especially in rectal cancer surgery. the purpose of this study is to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

Eligibility criteria:
inclusion criteria: * 18 years \< age ≤80 years * tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge) * pathological rectal carcinoma * clinically diagnosed c/yct1-3n0-1m0 lesions according to the 8th edition of ajcc cancer staging manual * tumor size of 10 cm or less * no history of other malignant tumors * ecog score is 0-1 * asa score is ⅰ-ⅲ * informed consent exclusion criteria: * body mass index (bmi) \>35 kg/m2 * familial adenomatous polyposis (fap) * inflammatory bowel disease (ibd) * multiple malignant colorectal tumors * pregnant woman or lactating woman * severe mental disease * previous gastrointestinal surgery (except appendectomy ） * combination of intestinal obstruction, bleeding, perforation requiring emergency surgery * requirement of simultaneous surgery for other disease * serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery. * patients or family members who cannot understand the study program.

Keywords: rectal cancer robotic surgery
effect of rate-responsive compared to vdd pacing in cardiac resynchronization therapy recipients

Conditions: Heart Failure, Wide QRS Complex

Summary: this study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.

cardiac resynchronization therapy (crt) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. however, bradycardia and chronotropic incompetence are common in this patient population. despite neutral results on hard clinical outcomes of the atrial support in crt patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability. the aim of this study is to assess the impact of rr pacing compare to vvd pacing in patients implanted with crt devices in term of functional capacity, measured by the six-minute walking test (6mwt). this simple test has shown to be an independent predictors of mortality in this cohort of patients.

Eligibility criteria:
inclusion criteria: * patients willing to participate in the study and signing the approved patient informed consent (pic) form; * patients with approved indication for crt by european society of cardiology/european heart rhythm association guidelines (esc/ehra). * sinus rhythm at the time of crt device implantation with heart rate at rest above 50 bpm. exclusion criteria: * permanent atrial fibrillation; * inability to perform 6mwt; * suboptimal hf drug therapy; * heart rate at rest above 50 bpm.

Keywords: atrial pacing cardiac resynchronization therapy heart failure implantable cardioverter defibrillator rate-adaptive pacing
the predictors for activity and participation in children with asd: a follow-up study

Conditions: Autism Spectrum Disorder

Summary: developmental function and participation in life and school activities in patients with autism spectrum disorder: a follow-up study

most asd studies have explored the body functions and core symptoms in children with asd by follow-up, but less studies explore the activities and participation by follow-up, especially the changes in different ages. although studies explore many predictors to predict the activities and participation in children with asd, but less studies explore sensory perception to predict the activities and participation in children with asd.

Eligibility criteria:
inclusion criteria: * patients with autism spectrum disorder * age 2-18 y/o * agree to sign informed consent exclusion criteria: * active medical condition (e.g. infection) * concurrent progressive or degenerative disease (e.g. neurogenerative disease) * concurrent illness or disease not typically associated with asd (e.g. pneumonia)

Keywords: autism activity and participation sensory perception facial expression developmental functions predictors follow-up study
effectiveness of surgery for atraumatic shoulder instability

Conditions: Atraumatic Shoulder Instability

Summary: we will conduct a randomised clinical trial with the primary aim of determining whether surgical intervention followed by physiotherapy rehabilitation improves pain and disability outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic shoulder instability associated with bony/capsulolabral damage. the results of this study will have direct and immediate impact on clinical decision making by establishing definitively if patients presenting with joint damage associated with atraumatic shoulder instability should be referred for surgery before commencing physiotherapy rehabilitation. the results of this study may also result in significant cost savings to the national health service if surgical intervention for atraumatic shoulder instability does not result in greater improvement than physiotherapy alone.

a two-arm, patient, physiotherapist and assessor-blinded, randomised controlled clinical trial will be conducted. 140 patients will be randomly allocated into one of 2 groups: a stabilisation surgery group and a control group. primary outcomes (pain and disability) and secondary outcomes (participant-reported improvement and incidence of shoulder dislocations) will be evaluated at baseline and 6, 12 and 24 months after randomisation. additional secondary outcomes of shoulder rotation range of motion and strength will be evaluated 6 months after randomisation.

Eligibility criteria:
inclusion criteria: * feelings of insecurity (apprehension) at their shoulder joint * provocation of apprehension with drawer and apprehension tests * evidence labral/capsular injury in the shoulder joint exclusion criteria: * a history of a high collision shoulder injury precipitating apprehension symptoms * evidence of bony injury around glenoid rim/and or humeral head * a pristine joint i.e. no evidence of any structural injury to the joint, capsule or labrum. * a rotator cuff tear * neural damage affecting the upper limb * previous shoulder surgery

Keywords: shoulder instability atraumatic
efficacy, safety and cost of remote monitoring of patients with cardiac resynchronization therapy

Conditions: Heart Failure; Cardiac Resynchronization Therapy

Summary: the primary objective is to determine whether comprehensive remote follow-up in hf patients with crt will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.


Eligibility criteria:
inclusion criteria: * patient more than 18 years old, newly implanted, in accordance to the latest european guidelines, with a crt-p or crt-d device (upgrading is tolerated but no device replacement), with home-monitoring® activated * patient willing and able to comply with the protocol and who has provided written informed consent exclusion criteria: * lead model under advisory * non-functional lead except particular case of non-functional or deactivated right atrial lead due to atrial fibrillation * known drug or alcohol abuse * pregnant woman or woman who plan to become pregnant during the trial (the data will be collected by querying the patient without a pregnancy test is required) * participation (ongoing or planned during the trial) in another interventional clinical study, and/or another remote monitoring and/or follow-up concept, unless authorized by the executive committee * participation (ongoing or planned during the trial) in an investigational hf program (e.g. prado, pimps, osicat, cardiauvergne) * estimated life-expectancy, regardless of the cardiovascular condition, \<1year * patient under- or planned for - ventricular assistance * patient not living in metropolitan france and/or not geographically stable

Keywords: remote monitoring
radiotherapy treatments for the treatment of thoracic district tumors

Conditions: Thoracic Neoplasms

Summary: evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of thoracic radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the thoracic anatomical region.

approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment. various primary tumors as well as metastases of various origins can be localized in the thoracic anatomical region. patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments. treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects. the collection of data related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. the availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies. this project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms of the thoracic region for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility criteria:
inclusion criteria: 1. patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the thoracic region include those with: * primary bone tumors, * primary soft tissue tumors, * primary tumors of the cardio-circulatory system, * primary tumors of the lymphatic system, * primary tumors of the nervous system and skin, * secondary metastases from various origins localized in the thoracic region. 2. signed informed consent exclusion criteria: 1. radiotherapy in districts other than the thoracic region.
cognitive behavioral smoking cessation intervention for adults with chronic pain

Conditions: Smoking Cessation

Summary: millions of individuals with chronic pain smoke and our preliminary research suggests that currently available strategies to help people quit smoking may not be effective for individuals with chronic pain. this is important in that smokers with chronic pain have worse pain-related health outcomes compared to nonsmokers with chronic pain. the primary aim of this research project is to develop a smoking cessation intervention for specific use in an outpatient clinical setting for smokers with chronic pain.


Eligibility criteria:
inclusion criteria: * chronic pain * age \> 18 years * cigarette smoker \> 10 per day exclusion criteria: * concurrent substance use disorder other than nicotine dependence * concurrent major psychiatric disorder

Keywords: smoking cessation nicotine dependence chronic pain
psychosocial stimulations and treatment outcome of severe acute malnourished children

Conditions: Malnutrition Severe

Summary: a playroom and a playground are already part of the stabilization unit and are furnished with basic facilities for engaging the sam children in play-based motor, language, and personal-social activities. the severely acute malnourished children in the intervention group will be sent to a development pediatrician who will do a developmental assessment of the child and stimulation. a sensory therapist, an occupational therapist, and a physiotherapist will also be available for sessions.

the world health organisation (who) also suggests including psychological stimulation in the treatment of severe acute malnutrition. however, there is limited evidence that these interventions are beneficial for sam children, especially when there are severe food shortages and a lack of a balanced diet. there is limited available research in pakistan examining the impact of psychosocial stimulation on severely malnourished children and a significant gap in its implementation. it is obvious that current implementation research is needed to understand how to improve brain development in children with sam who require inpatient care in a practical and pragmatic approach. the purpose of this study is to present data on the efficacy of these therapies, which may help shape future sam treatment plans and policies. mitigating the physical and mental dimensions of malnourishment can result in more enduring and significant consequences, ultimately enhancing the standard of living for millions of children around the globe.

Eligibility criteria:
inclusion criteria: * all children aged 6m to 59 months admitted to stabilization centre fulfilling criteria of severe acute malnutrition will be included in study. exclusion criteria: * children with chronic diseases like cystic fibrosis, cerebral palsy, celiac disease, chronic kidney disease, chronic liver failure, congenital heart disease, inborn error of metabolism, cleft lip and palate will be excluded from study.