Kornimate/medical-research-clean huggingface dataset:
the impact of daily sinus irrigation on nasal symptoms in continuous positive airway pressure (cpap) users - a pilot study

Conditions: Obstructive Sleep Apnea

Summary: continuous positive airway pressure (cpap) is the most commonly used treatment for obstructive sleep apnea. nasal symptoms such as dryness, itching and congestion are common in cpap users. nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. this is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using cpap, improves quality of life and cpap compliance.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * apnea/hypopnea index ≥ 10 * a documented successful cpap titration exclusion criteria: * conditions that in the judgment of the investigator would interfere with subject participation in the study * history of sinus or nasal surgery * history of psychiatric illness * use of sleep aids, sedatives or narcotics * use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin) * bilevel or other nocturnal ventilation other than cpap * use of supplemental oxygen * pregnancy or lactating * inability or unwillingness to provide informed consent * inability to perform baseline measurements * inability to be contacted by phone

Keywords: sleep apnea cpap saline irrigation
capecitabine and gemcitabine in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer; Colon Cancer

Summary: this study is for patients with colorectal cancer that has spread and has increased in size after standard treatments. this study is being done to find out how long it takes their tumors to grow after treatment with the chemotherapy drugs capecitabine and gemcitabine. capecitabine is a chemotherapy drug that has been approved by the fda for the treatment of colorectal cancer. we are adding another drug (called gemcitabine), which is approved by the fda for the treatment of cancer of the pancreas to see if the ability of capecitabine to shrink tumors can be improved by adding gemcitabine. the side effects of the combination will also be evaluated. another purpose of this study is to measure the levels of certain substances that affect how the body reacts to the chemotherapy agents in cancer cells (in the tumor). in addition, the genes (which are the cell's blueprint for these substances) will also be evaluated in the blood.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic adenocarcinoma of the colon or rectum, with measurable disease. the primary histologic diagnosis is sufficient if there is clear evidence by imaging and/or markers of metastatic disease sites. * patients must have failed cpt-11 and oxaliplatin based therapies. * patients must have received at least two prior chemotherapy regimens for advanced disease (completed \> 4 weeks prior to enrollment). * tumor must be accessible for biopsy or paraffin embedded tissue must be available for review. * swog performance status 0-2. * agc \>1000, platelets \>100,000. * total bilirubin \< 3 x upper limit of normal. transaminase (ast and/or alt) \< 2 x upper limit of normal or \< 5 x upper limit of normal in patients with liver metastasis. * patients must have a measured or calculated creatinine clearance greater than 35 ml/min obtained within 28 days prior to registration. * age greater than or equal to 18 years * patients should have hemoglobin \> 9 g/dl; patients may be transfused to achieve this level of hemoglobin. * except for cancer-related abnormalities, patients should not have unstable or pre-existing major medical conditions. exclusion criteria: * history of a malignancy other than colon or rectal cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years. * patients with brain metastasis. * history of recent (within one year) myocardial infarction or evidence of congestive heart failure. * patients that have psychological, familial, sociological, or geographical conditions that do not permit medical follow-up and compliance with the study protocol. * patients should not have any immediate life-threatening complications of their malignancies.
optimal drainage after flexible ureterorenoscopy; prospective assessment of perioperative outcomes and health-related quality of life through a randomized controlled trial

Conditions: Stones, Kidney

Summary: flexible ureterorenoscopy (furs) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (eswl) and in combination with percutanous nephrolithotomy (pcnl) for stones larger than 20 mm. at the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. it helps prevent obstructive symptoms and the development of strictures. drainage is done either by a ureteral catheter or by a double j stent. in the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined. the objective of this study will be to assess whether the type of postoperative drainage after urs for kidney stones can influence the perioperative outcomes and health-related quality of life.

flexible ureterorenoscopy (furs) is now recommended for the treatment of kidney stones smaller than 20 mm, as an alternative to extracorporeal shock wave lithotripsy (eswl) and in combination with percutanous nephrolithotomy (pcnl) for stones larger than 20 mm. at the end of the operation, a ureteral drainage is put in place for the treatment of residual fragments and the inflammation following the ureteroscopy. it helps prevent obstructive symptoms and the development of strictures. drainage is done either by a ureteral catheter or by a double j stent. in the literature, while drainage after ureteroscopy is recommended, the criteria for choosing between these two options are not clearly defined. the objective of this study will be to assess whether the type of postoperative drainage after urs for kidney stones can influence the perioperative outcomes and health-related quality of life.

Eligibility criteria:
inclusion criteria: * 1- adult patients (aged \>18 years) 2- undergo unilateral uncomplicated retrograde intrarenal surgery (rirs) using flexible ureterorenoscopy. exclusion criteria: 1. residual ureteral or renal stones after the procedure as documented by the surgeon 2. patients who will need auxiliary procedures (eswl , re-furs or pcnl) 3. preoperative febrile uti 4. pregnancy or breastfeeding 5. bilateral ureteroscopic surgery 6. single kidney 7. chronic kidney disease 8. cardiovascular or cerebrovascular disease 9. hepatic dysfunction 10. other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient qol

Keywords: kidney stones flexible ureteroscopy quality of life drainage
bloodpressure and nirs during the immediate transition

Conditions: Blood Pressure; Cerebral Tissue Oxygenation

Summary: blood pressure will be measured in min. 5/10/15 after birth. cerebral tissue oxygenation (crso2) monitoring with nirs in addition to routine arterial oxygen saturation (spo2) monitoring with pulse oximetry will be performed continuously during the first 15 minutes after birth


Eligibility criteria:
inclusion criteria: term and preterm neonates observed routinely immediately after birth at the resuscitation desk * decision to conduct full life support * written informed consent exclusion criteria: no decision to conduct full life support * no written informed consent * congenital malformation
a long term follow up study in late-onset pompe disease

Conditions: Pompe Disease

Summary: this study is to observe the progression of disease in late-onset pompe disease


Eligibility criteria:
inclusion criteria: * individuals with acid alpha glucosidase deficiency without obvious symptoms * parents signed inform consent exclusion criteria: * individuals with acid alpha glucosidase deficiency presenting symptoms

Keywords: pompe disease late onset
high resolution gastric mapping and gastroduodenal manometry

Conditions: Dyspepsia

Summary: dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (ge), impaired gastric accommodation, and increased gastric sensation. therapeutic options manage symptoms, and there is no fda approved medical therapy for dyspepsia. there is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia. the purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (bsgm), and pressure activity (manometry).


Eligibility criteria:
inclusion criteria * symptoms consistent with functional dyspepsia as defined by the rome iv criteria for 6 months * ability to perform appropriate informed consent exclusion criteria * known cardiac arrhythmia or major ecg abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree av block, prolonged qtc interval (\> 460 msec) or bradycardia (\< 45 beats/minute) * conditions precluding safe use of tavns * clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns * use of opioids * vulnerable study population * pregnant women
caregiver burden in huntington's disease

Conditions: Caregiver of Huntington's Disease Patient

Summary: huntington's disease (hd) is a rare inherited neurodegenerative disorder, progressing between 15 and 20 years and affecting one person out of 10.000. in france, it concerns some 6.000 patients symptomatic and 12 000 asymptomatic carriers. few extensive researches have been conducted on the progression of the disease, which is defined in the literature in 5 stages in a functional approach. therapeutically, no cure for hd is currently validated but only symptomatic treatments. there's various treatment options: medicated, humans (physiotherapy, speech therapist, occupational therapist, ..). although these treatment options do not prevent the progression of the disease, their combination associated with a stimulating environment may slow the decline of physical, intellectual and psychic abilities of patients. in social terms, patients with hd require sustained support, especially in cases of family isolation. the behavioural, gaiting and eating disorder as well as the communications difficulties make it difficult support daily for the entourage. the caregivers are sometimes dealing with untenable situations. home care services, which are crucial to alleviating dependency, relieve family caregivers but are for the most severe patient. moreover, the justified placement decision in an institution generates a feeling of guilt for the family. the caregiver is the person who brings non-professional assistance , partly or wholly , to a dependent member of his entourage , for the activities of daily living. this regular care may be provided permanently or not. it can take many forms, such as , care , nursing , support to education and social life , administrative procedures , psychological support . caregivers have their lives profoundly reshaped. they are often forced to give up some of their habits , give up their future plans , change their relationships. the commitment of caregivers with patients with huntington's disease actually sounds on their mental and physical health, as well as their social and professional life very few studies have been conducted to measure the difficulties and implications of these caregivers.


Eligibility criteria:
inclusion criteria * age ≥ 18 * primary caregiver of patient with huntington's disease * non- institutionalized patient * stage 1-4 (no institutionalization within 2 years) * written consent exclusion criteria - not agreement

Keywords: huntington's disease caregiver zarit burden scale
haplo-pbsc+cord vs haplo-pbsc+bm for hematological malignancies undergoing allo-hsct

Conditions: Hematological Malignancies; Hematopoietic Stem Cell Transplantation

Summary: the objective of this study was to explore whether the combination with umbilical cord blood (ucb) is associated with superior disease-free survival (dfs) in the setting of haploidentical donors (hid) transplantation.

the main causes of allogeneic hematopoietic stem cell transplantation (allo-hsct) failure are primary disease relapse and transplant-related complications, especially relapse. in recent years, with the development of transplantation technology, alternative donors such as hid and ucb have been widely used. but, these alternative donors are associated with high incidences of transplant-related complications and mortalities when compared with human leukocyte antigen (hla)-matched donors. some studies suggeted that mixed grafts might overcome the disadvantages of a single alternative graft. ucb transplant (ucbt) supported by third-party hid or hid transplants supported by third-party ucb has been reported to have rapid engraftment and low incidences of graft-versus-host-disease (gvhd), making survival improvement. however, most of these results came from single-arm studies. the comparative studies between haplo-pbsc+cord and haplo-pbsc+bm are scarce in the setting of hid transplantation. in a retrospective study, the investigators found haplo-pbsc+cord transplantation has superior dfs than haplo-pbsc+bm in hematological malignancies. to further confirmed this conclusion, the investigators plan to conduct a prospective, multicenter, phase 3 randomized controlled trial.

Eligibility criteria:
inclusion criteria: * patients with hematologic malignancies undergoing first hid allo-hsct * age 18 to 65 years old with ecog performance status 0-2 * received myeloablative conditioning regimens * sign informed consent form, have the ability to comply with study and follow-up procedures exclusion criteria: * received pbscs as only grafts * acute leukemia transformed from a myeloproliferative tumor * cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy) * respiratory failure ( pao2 ≤60mmhg) * hepatic abnormalities (total bilirubin ≥3 mg/dl, aminotransferase \>2 times the upper limit of normal) * renal dysfunction (creatinine clearance rate \< 30 ml/min) * ecog performance status 3, 4 or 5 * with any conditions not suitable for the trial (investigators' decision)

Keywords: hematological malignancies haploidentical transplantation umbilical cord blood disease-free survival
study of integrity of down inhibitor bundle at patients suffering of neuropathic pain

Conditions: Healthy Volunteers; Patients Suffering of Peripheral Neuropathic Pain

Summary: several studies showed that activity of down inhibitor bundle is weakened in different painful pathologies as the fibromyalgy or the trigeminal nevralgy. the purpose of the protocol is to study the working of down inhibitor bundle at patients suffering of neuropathic pain.

prospective study with comparison groups

Eligibility criteria:
inclusion criteria: * neuropathic patients group * patient suffering of peripheral neuropathic pain * 18 years old women or men at least exclusion criteria: * • healthy volunteers * 18 years old women or men at least

Keywords: neuropathic pain
trial evaluating dovitinib combined with fulvestrant, in postmenopausal patients with her2- and hr+ breast cancer

Conditions: Metastatic Breast Cancer

Summary: this trial is designed to enroll postmenopausal patients with locally advanced or metastatic, her2- and hr+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy. patients must undergo molecular pre-screening prior to entry.


Eligibility criteria:
inclusion criteria: * postmenopausal women with her2-, hr+ locally advanced or metastatic breast cancer * progression on or after endocrine treatment * measureable disease as per recist * ecog 0, 1 or 2 exclusion criteria: * evidence of cns or leptomeningeal metastases * previous treatment with fulvestrant * previous chemotherapy for locally advanced or metastatic breast cancer * cirrhosis or chronic active/persistent hepatitis other protocol-defined inclusion/exclusion criteria may apply

Keywords: breast cancer her2-, hr+ post-menopausal locally advanced or metastatic breast cancer (her2-, hr+)
effects of garston tool and neuromuscular reeducation in cervical headache

Conditions: Cervicogenic Headache

Summary: patients suffering from cervicogenic headache have restricted range of motion and pain which in turn causes functional disability and reduced quality of life. the aim of this research was to determine the effects of graston technique to improve range of motion, function, and reduction of pain and in patients having cervicogenic headache

a randomized controlled trial in which graston technique and neuromuscular re-education technique would be applied on patients presenting with cervicogenic headaches by using different tools and the changes would be examined pre and post intervention. the participants fulfilling inclusion criteria would be randomly allocated to two groups. both groups received different protocols and will be assessed on data collection tool on their first and last visit using goniometer, headache disability index (hdi), neck pain disability index (ndi) and numeric pain rating scale (nprs). participants of both groups will be pre-tested before the application of interventional techniques and post-tested after the application of respective intervention.

Eligibility criteria:
inclusion criteria: * age: minimum 20years- maximum 50 years (male/female) * unilateral pain * neck stiffness and rom restrictions * pain exacerbated by posture and neck movements * pain effecting qol * positive flexion-rotation test exclusion criteria: * headache not of cervical origin * congenital condition of cervical spine * headache with autonomic involvement, dizziness or visual impairment * inability to tolerate the flexion rotation test * conditions contraindicated for graston technique
pro 140 for human immunodeficiency virus

Conditions: HIV

Summary: pro 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial of observed systemic, long-acting, anti-hiv treatment with a monoclonal ccr5 antibody (pro 140) as an adjunct to a new, optimized, oral antiretroviral regimen in hiv-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen. eligible subjects (approximately 76) will be randomized 1:1 to receive an optimized background antiretroviral regimen (obr) plus supervised weekly subcutaneous treatment with either pro 140 or placebo. blood samples for safety and efficacy variables will be obtained over the 24 week duration of the study. safety will be monitored throughout the course of the study.


Eligibility criteria:
inclusion criteria: 1. exclusive ccr5-tropic virus as determined by as determined by the enhanced sensitivity trofile™ hiv tropism assay 2. males and females, age ≥ 18 years 3. screening plasma hiv-1 rna \> 1,000 copies/ml confirmed by second test while on the current antiretroviral regimen 4. history of non-prescription injection and/or non-injection recreational drug use 5. cd4 lymphocyte cell counts \> 100 cells/mm3 6. clinically normal resting 12-lead ecg at screening visit 7. women of reproductive potential must have a negative serum pregnancy test at late screening visit. within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through week 24. 8. non-adherent, history of poor adherence to a previous antiretroviral regimen. exclusion criteria: 1. cxcr4-tropic virus, dual/mixed tropic (r5x4) virus as determined by the enhanced sensitivity trofile™ hiv tropism assay 2. females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study 3. diagnosis of acute viral hepatitis (defined as any active infection with hepatitis a or a new diagnosis of hepatitis b or c within 24 weeks of dosing) 4. prior use of any entry, attachment, ccr5 coreceptor, or fusion inhibitor, including pro 140, experimental or approved 5. participation in an experimental drug trial(s) within 30 days of the early screening visit or during the study
increasing smoking cessation success through sleep-amplified memory consolidation

Conditions: Tobacco Use Disorder

Summary: the goal of this subproject is to examine the hypothesized improvement of treatment with chess-based training and sleep enhancement, both together and on their own, in smokers. participants will undergo fmri measurements, sleep monitoring. they will then be assigned to one of the four experimental groups, including high-intensity interval training with or without chess-based training.

this subproject aims to improve treatment outcome in patients with tobacco use disorder (tud) by enhancing cognitive control. evidence from the first funding period (1st fp) indicates that enhancing cognitive control using cognitive remediation training (crt, in our case chess-based) can improve outcomes of a standard smoking cessation program. the current project will harness three means to build on this success of enhancing cognitive control by: 1. using our tried-and-tested chess-based training, 2. improving sleep using high-intensity interval training (hiit), 3. increasing sleep-dependent consolidation of the chess-based training (see figure 1). we hypothesize that chess-based training and sleep enhance treatment outcome, both together and on their own. to test our hypotheses, we will combine smoking cessation treatment with the aforementioned approaches as app-based add-ons (chess-based training and hiit). this will not only allow us to apply the training in a cost-efficient way out-side the lab, it may also increase patients' compliance.

Eligibility criteria:
inclusion criteria: * severe tobacco use disorder (tud) according to dsm-5 * sufficient ability to communicate with investigators and answer questions in both written and verbal format * ability to provide fully informed consent and to use self-rating scales * right-handedness * hiit can be performed without the risk of side effect (medical sports check) exclusion criteria: * severe internal, neurological, and/or psychiatric comorbidities; other axis i mental disorders other than tud according to icd-10 and dsm 5 (except for mild depression, i.e. f32.0, adjustment disorder and specific phobias) in the last 12 months * history of brain injury * severe physical diseases * common exclusion criteria for mri (e.g. metal, claustrophobia) * positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines) * psychotropic medication within the last 14 days * pregnancy

Keywords: addiction nicotine smoking cessation relapse cognitive remediation exercise training