Kornimate/medical-research-clean huggingface dataset:
proton therapy for locally advanced cervical cancer

Conditions: Cervical Cancer; Proton Therapy; Radiotherapy Side Effect

Summary: the purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (igabt) in patients with locally advanced cervical cancer (lacc). the over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.


Eligibility criteria:
inclusion criteria: * inclusion criteria: * cancer of the uterine cervix considered suitable for curative treatment with definitive radio- (chemo) therapy including igabt * positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix. * staging according to intenational federation of gynecology and obstetrics (figo) and tnm guidelines * t1-3n1m0 (figo stage iiic1 (with ≥3 pelvic lymph node metastases) and iiic2) * para-aortic metastatic nodes below l1-l2 are allowed (figo stage ivb) * magnetic resonance imaging (mri) and positron emission tomogaraphy-computerized tomograpy (pet-ct) of the retroperitoneal space and abdomen at diagnosis * patient written, informed consent * age≥18 years * patients must be able to understand a danish or swedish exclusion criteria: * other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin * metastatic disease beyond para-aortic region (l1-l2 interspace) * previous pelvic or abdominal radiotherapy * combination of preoperative radiotherapy with surgery * patients receiving neoadjuvant chemotherapy * contra indications to mri * contra indications to igabt * contra indications to protontherapy * small cell histology (neuroendocrine tumors) * active infection or severe medical condition endangering treatment delivery * pregnant, lactating or childbearing potential without adequate contraception * human immune deficiency virus (hiv) * patients with no possibility of follow up
profile fecal analysis of neutropenic enterocolitis

Conditions: Neutropenic Enterocolitis

Summary: a prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary acute myeloid leukemia (aml), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis


Eligibility criteria:
inclusion criteria: * patient\>= 18 years old; * cytological diagnosis of de novo acute myeloid leukemia (aml) (\>20% myeloid blasts); * eligible for intensive chemotherapy (no severe co-morbidity); * not having received any prior chemotherapy; * affiliation to the national social security system. exclusion criteria: * acute promyelocytic leukemia (aml 3); * inability to understand the nature of investigations or to give informed non-opposition; * person subject to a legal protection measure.
a comparison of conventional physical therapy, powered exoskeleton, and hybrid physical therapy with exoskeleton

Conditions: Stroke

Summary: the purpose of this investigator-initiated study is to establish if powered exoskeleton therapy as a part of a rehabilitation program can be used as a standard of care in stroke rehabilitation.

this prospective randomized control trial with three treatment arms will begin by: * determining if the subject is a candidate for exoskeleton treatment. * randomly assigning subjects to three groups (physical therapy only, exoskeleton only, or a hybrid of physical therapy and exoskeleton). * body measurements to individualize the fit of the exoskeleton to each subject at each session. * activities-based balance confidence (abc) questionnaire will be administered before and after the study begins. * timed up and go test (tugt). * ten-meter walk test (10mwt). * six-minute walk test (6mwt) * berg balance test (bbt). * five times sit to stand (5xsts). * heart rate through a portable heartrate monitor.

Eligibility criteria:
inclusion criteria: * males and females 18 years of age or older post-stroke * 3 ashworth score are involved in a standing program less than 220 lbs 5'0" through 6'4" have the ability to follow one-step commands near normal range-of-motion for the knees, hips, and ankles exclusion criteria: * exclusion criteria will include those who have already experienced powered exoskeleton therapy.

Keywords: stroke exoskeleton gait physical therapy motor-learning
effect of pneumoperitoneum on the continuous and non-invasive hemoglobin monitoring

Conditions: Gastric Cancer

Summary: the primary purpose of this study is to investigate the effect of pneumoperitoneum on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy


Eligibility criteria:
inclusion criteria: * laparoscopic gastrectomy under general anesthesia exclusion criteria: * atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
prevalence of cytomegalovirus, epstein barr virus and human herpes 6 virus in inflammatory bowel disease

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: an increase prevalence of cmv, ebv and or hhv-6 in diseased tissue of inflammatory bowel disease would suggest a role for these viruses in the etiology and/or exacerbation of ibd, whereas their absence would preclude such association.

the protocol is designed to evaluate the following objectives: 1. the prevalence of cytomegalovirus, epstein barr virus and human herpes 6 virus dna in inflamed intestinal mucosa of patients with crohn's colitis and ulcerative colitis compared to their prevalence in healthy intestinal mucosa of patients not affected by these conditions; 2. to evaluate the prevalence of cytomegalovirus, epstein barr virus and human herpes 6 virus dna in the intestinal mucosa of patients with crohn's colitis and ulcerative colitis compared to that in inflamed mucosa caused by other conditions (non specific colitis); 3. to compare the prevalence of cytomegalovirus, epstein barr virus and human herpes 6 virus dna in inflamed and healthy tissue in the same patients with crohn's colitis and ulcerative colitis; 4. to determine whether the presence of cytomegalovirus, epstein barr virus and human herpes 6 virus dna detected by npcr correlates with immunohistochemical detection of viral protein in colonic tissue. 5. to determine whether the relative viral quantity of cmv, ebv or hhv-6 is related to severity of disease activity.

Eligibility criteria:
inclusion criteria: * documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed. * participants, male or female, aged 18-70, identified as having crohn's colitis, uc and patients undergoing biopsy for other inflammatory disorders (non specific colitis) and for suspected intestinal malignancy. exclusion criteria: * known human immunodeficiency virus (hiv) infection * post organ transplant patients.

Keywords: crohn's disease ulcerative colitis cytomegalovirus epstein bar virus human herpes virus 6
improvement of pprom management with prophylactic antimicrobial therapy (iprompt)

Conditions: Preterm Premature Rupture of Membrane; Pregnancy, High Risk; Preterm Birth

Summary: to conduct an unblinded pragmatic randomized controlled trial (prct) "improvement of pprom management with prophylactic antimicrobial therapy (iprompt)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of pprom \<34 weeks.

preterm prelabor rupture of membranes (pprom) is the most common identifiable risk factor associated with preterm birth and affects 1 in 3 pregnant individuals in the united states with spontaneous preterm birth. individuals diagnosed with pprom who meet criteria for expectant management are currently admitted to the hospital for observation until delivery, which is generally recommended at 34 weeks' gestation unless indicated sooner. initially upon admission, a course of prophylactic antibiotics is administered as this has been shown to prolong pregnancy and improve neonatal outcomes. the standard antibiotic regimen, primarily based on data published in 1997, includes ampicillin followed by amoxicillin with erythromycin or azithromycin for a total of 7 days. ongoing studies are needed to determine the optimal prophylactic antibiotic regimen given changes in bacterial sensitivities over time, lack of adequate coverage for common organisms including genital mycoplasma, inadequate placental transfer of currently used antibiotic agents, ineffective antibiotic response at reducing the fetal inflammatory response, and new promising antibiotic agents that address these limitations. a promising expanded-spectrum alternative regimen with proof-of-concept is ceftriaxone, clarithromycin, and metronidazole. observational studies have shown successful eradication of intraamniotic inflammation/infection using this new regimen. this regimen offers multiple potential advantages, including: higher bioavailability, higher transplacental transfer, and effectiveness against genital mycoplasma (clarithromycin), greater anaerobic coverage (metronidazole), and a longer half-life and expanded coverage against gram-negative bacteria (ceftriaxone) compared with the current standard regimen.

Eligibility criteria:
inclusion criteria * admitted to the inpatient unit for expectant management of pprom until delivery * age ≥ 18 years with the ability to provide informed consent * gestational age between 23 0/7 and 32 6/7 weeks exclusion criteria * having received more than one dose of any prophylactic antibiotic * suspected or confirmed infection requiring treatment with antibiotics * allergy or contraindication to an antibiotic in either arm * maternal immunosuppression

Keywords: pregnancy preterm premature rupture of membranes latency chorioamnionitis antibiotic prophylaxis
droxidopa in treating patients with neurogenic hypotension

Conditions: Shy-Drager Syndrome; Orthostatic Hypotension

Summary: please note that the continuation study can be found at http://clinicaltrials.gov/show/nct00633880. rationale: neurogenic hypotension is a fall in blood pressure that occurs when one moves from a lying down to a standing position or after eating a meal. it causes one to feel dizzy, light headed, and weak. neurogenic hypotension is caused by a problem in the part of the nervous system that controls such functions as heart rate and blood pressure. droxidopa, a drug that may increase blood pressure, may be an effective treatment for neurogenic hypotension. purpose: clinical trial to study the effectiveness of droxidopa in treating patients who have neurogenic hypotension.

protocol outline: patients receive escalating doses of droxidopa or placebo for 7-14 days. patients undergo blood pressure measurements hourly in both supine and standing positions.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * orthostatic hypotension due to autonomic nervous system failure fall in systolic blood pressure (supine to standing) of at least 20 mm hg and diastolic blood pressure of at least 15 mm hg and symptoms of hypotension such as dizziness, light-headedness, unsteadiness, dimming or blurred vision * history of syncope or near-syncope --prior/concurrent therapy-- * endocrine therapy: no concurrent adrenergics concurrent fludrocortisone allowed * other: concurrent indomethacin, support garments, and high salt diets allowed

Keywords: shy-drager syndrome cardiovascular and respiratory diseases neurologic and psychiatric disorders orthostatic hypotension rare disease
comparison of tacrolimus 0.1% and clobetasol 0.05% in the management of symptomatic oral lichen planus

Conditions: Oral Lichen Planus

Summary: this clinical study is carried out to assess the efficacy of tacrolimus and clobetasol in symptomatic oral lichen planus.


Eligibility criteria:
inclusion criteria: * clinically and histologically proven oral lichen planus * symptomatic exclusion criteria: * topical/ systemic medication for olp in the previous three months * contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus * immunosuppression, or pregnant / lactating females * lichenoid reactions either drug induced or due to dental amalgam * diabetes mellitus and on oral hypoglycemic drugs * systemic involvement such as concurrent skin/genital lesions
effectiveness of a digital health application for primary hypertension (liebria)

Conditions: Hypertension

Summary: this clinical trial with 328 patients with primary hypertension aims to investigate the effectiveness of the self-guided digital application liebria for patients with primary hypertension.

this clinical trial with 328 patients with primary hypertension aims to investigate the effectiveness of the self-guided digital application liebria for patients with primary hypertension. inclusion criteria are: age ≥ 18; presence of primary hypertension (confirmed by medical certificate or equivalent); unmedicated or with existing antihypertensive drug therapy (with stable dose in the past 6 weeks prior to study enrolment); last reported office-based systolic blood pressure (sbp) ≥ 140 mmhg followed by home-based sbp ≥ 135 mmhg; consent to participate. exclusion criteria are: home-based sbp \> 180 mmhg; \> triple combination of antihypertensive medication; history of secondary hypertension (e.g., thyroid disease, kidney disease); pregnancy. patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to liebria in addition to treatment as usual (tau, n = 164), or to a control group, in which they will receive a relevant brochure from the deutsche hochdruckliga (german hypertension league) in addition to tau (n = 164). tau is defined as any therapy prescribed or recommended by the gp or specialists (e. g. cardiologist). the primary endpoint will be home-based sbp, with 6 months post-allocation being the primary time point for assessment of effectiveness. three months post-allocation will be used as an additional endpoint. secondary endpoints will be patient activation, social and work-related functioning, medication adherence, home-based diastolic blood pressure (dbp), and pulse pressure. analysis of effectiveness of the intervention will be performed by ancova of the primary endpoint and all secondary endpoints, in which the posttreatment scores will be compared between treatment groups (intervention group vs. control group), using the baseline scores of the respective outcome as a covariate.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * presence of primary hypertension, confirmed by submission of a medical certificate or equivalent (e.g., informal letter signed by primary care physician); relevant icd-10-gm diagnoses: * i10.00 (benign essential hypertension: without indication of hypertensive crisis) * i10.90 (essential hypertension, unspecified: without indication of hypertensive crisis) * unmedicated or with existing antihypertensive drug therapy (with stable dose in the past 6 weeks prior to study enrolment) * last reported office-based systolic blood pressure (sbp) ≥ 140 mmhg followed by home-based sbp ≥ 135 mmhg * consent to participate exclusion criteria: * home-based sbp \> 180 mmhg * \> triple combination of antihypertensive medication * history of secondary hypertension (e.g., thyroid disease, kidney disease) * pregnancy
high-dose sequential therapy and single autologous transplantation for multiple myeloma

Conditions: Multiple Myeloma

Summary: this study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to treat multiple myeloma. the study is being performed to evaluate the efficacy and side effects of treatment. specifically, the study is designed to reduce the risk of interstitial pneumonitis.

analysis of 196 previously treated patients demonstrated a median event-free survival (efs) of 36 months with a median overall survival of more than 6 years. the main toxicity of this therapy is related to carmustine-induced pneumonitis or interstitial pneumonitis (ip). this complication is related to the dose of carmustine. institutional experience in myeloma patients using this dose of carmustine indicates an incidence of ip of34%. there have been recent studies evaluating the role of tandem autologous transplants for patients with multiple myeloma. these trials were based upon the hypothesis that performing tandem high-dose therapy regimens would lead to increased tumor cell kill, decreased tumor burden and an improvement in overall survival. our results with high-dose sequential therapy including the dose-intense carmustine/melphalan transplant demonstrates similar median efs and overall survival (os) when compared with the results of tandem transplant approaches.the proposed trial will continue to use a high-dose sequential transplant approach, however, we will use a reduced dose of carmustine which we expect to be associated with a lower incidence of ip.

Eligibility criteria:
inclusion criteria * stage ii to iii multiple myeloma, or progression after initial treatment of stage i disease; early or relapsed * age 18 to 75 years. * pathology reviewed and the diagnosis confirmed at stanford university medical center. * patients with amyloidosis may be eligible for this trial, with approval by the principle investigator. * patients must have a karnofsky performance status \> 70%. * aspartate aminotransferase (ast) must be \< 2 x upper limit of normal (uln) * alanine aminotransferase (alt) must be \< 2 x uln * total bilirubin \< 2 mg/dl. * serum creatinine \< 2.0 or 24-hour creatinine clearance ≥ 60 ml/min. * patients must be hiv-negative. * patients must provide signed, informed consent. exclusion criteria * severe psychological or medical illness * prior autologous hematopoietic cell transplantation * pregnant * lactating women * smoldering multiple myeloma, * monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded from this study
urdu translation of wayfinding questionnaire for stroke patients

Conditions: Stroke

Summary: descriptive analytical study to translate wq in urdu language. the wq is in english language the name of the author of wq is van der ham et al and firstly introduced in 2013. the reliability of this english tool is 0.70 to 0.80 it has been translated in various languages i.e hungarian, dutch and chinese and suffering from stroke. but it was not translated in urdu language. no such study has been previously conducted in pakistan region which translates the scale and follows the proper cross-cultural adaptation

for resolving such problem wq play pivotal role in accessing navigation problem of stroke patients it is a very reliable tool for accessing navigation issue. the scale consists of 22 items. all the items dated from 01 to 07 in which stroke patients are accessed. the patients who are taken in the study age from 18 to 65 years. as the wq is a well-developed measurement scale for accessing navigation in stroke patients. it is meaningful to validate its urdu version. the translation and cultural adaptation process would start after obtaining approval from the developer of the original wq. this would be done according to bitten guidelines. the purpose will be to gain uniformity in the translation of both the target language and source language. this will involve 5 steps which is forward translation, synthesis 1, back translation, synthesis 2 and pallet testing. the second step would be done according to the beaton guidelines in which psychometric properties will be measured that is internal consistency, test retest reliability, discriminant validity, convergent validity, content validity and factor analysis

Eligibility criteria:
inclusion criteria: * age group 45-65 years * male and female. * both ischemic and hemorrhagic stroke * patient may have first or recurrent stroke. * recovery is \> 6 months of first stroke event * mmse score \> 25 exclusion criteria: * population suffering from severe global aphasia. * population suffering from severe mobility problem. * any other neurological disease dementia * alzheimer's * cognitive decline before stroke

Keywords: way finding questionnaire, navigation, cognition.
gw873140 in combination with kaletra in hiv infected subjects

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection

Summary: this study is a 96-week study designed to evaluate the safety and efficacy of gw873140 in combination with kaletra in hiv infected, untreated subjects.

a phase iib, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of gw873140 in combination with kaletra (lopinavir and ritonavir) in hiv-1 infected antiretroviral therapy naive subjects

Eligibility criteria:
inclusion criteria: * hiv infected, therapy-naive subjects. * females must be of either non-childbearing age, or have a negative pregnancy test. * all subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study. * screening lab result of plasma hiv-1 rna greater than or equal to 50,000 copies/ml and cd4 cell count greater than or equal to 100 cells/mm3. * have cc chemokine receptor5-tropic (r5-tropic) or cc chemokine receptor5/cxc chemokine receptor4-tropic (r5/x4-tropic) virus based on viral tropism test at screening visit. * be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (pi) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (nrti/ ntrti), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (nnrti). * prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed. * be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions. * signed and dated written informed consent prior to study entry. exclusion criteria: * no detection of cxc receptor4-tropic (x4-tropic) virus only, based on viral tropism test at screening. * no active class c aids-defining illness. * no laboratory abnormalities at screen. * no significant blood loss prior to study start. * no pregnant or breastfeeding women. * additional qualifying criteria to be determined by the physician.

Keywords: hiv infected therapy-naive subjects