Kornimate/medical-research-clean huggingface dataset:
phase ib study of gemcitabine, docetaxel and bevacizumab in patients with soft tissue sarcoma

Conditions: Sarcoma

Summary: 1.1 to determine the recommended phase ii dose for gemcitabine in combination with a fixed dose of docetaxel and bevacizumab. 1.2 to determine the efficacy of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma 1.3 to determine the toxicity profile of the combination of gemcitabine, docetaxel, and bevacizumab in patients with soft tissue sarcoma

because the combination of gemcitabine and docetaxel has shown impressive activity in soft tissue sarcoma, we hypothesize that the addition of an antiangiogenesis agent (bevacizumab) would enhance the anticancer activity, as shown in other tumor types.

Eligibility criteria:
inclusion criteria: * all patients, 18 years of age or older, with chemotherapy naive soft tissue sarcoma are eligible if there is measurable disease prior surgery or radiotherapy for the primary tumor is allowed but needs to have been completed at least 2 weeks from entry, and patient should have completely recovered from the procedures. * patients must have a life expectancy of at least 12 weeks. * patients must have a zubrod performance status of 0-2. * patients must sign an informed consent. * patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement. * patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and serum glutamate oxaloacetate transaminase (sgot) or serum glutamate pyruvate transaminase (sgpt) \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal. exclusion criteria: * patients with symptomatic brain metastases are excluded from this study. * pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception. * patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.

Keywords: soft tissue sarcoma phase i gemcitabine docetaxel bevacizumab vascular endothelial growth factor
surgically treated displaced mid-diaphyseal clavicle fractures

Conditions: Clavicle Fracture

Summary: this prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (proms) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.

given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique, we do not believe there is clinical equipoise required for a randomized clinical trial. this study is a multi-centre, prospective cohort study (11 sites confirmed to date) of all operatively treated clavicle fractures, in order to objectively evaluate all current surgical techniques used across canada. this pragmatic approach will allow us to observe surgical decision-making, rationale for implant removal, and report on clinical, radiographic, and patient-reported outcomes for all techniques over a 2-year follow-up timeframe, for the first time. all enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively. this will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported.

Eligibility criteria:
inclusion criteria: * treated with surgical fixation for a displace mid-diaphyseal clavicle fracture. * aged 18 years of age or older and skeletally mature. * enrolled within 21 (+3 days) of injury. * willing and able to complete consent and study participation. exclusion criteria: * pathological fractures. * clavicle non-unions. * current or prior ipsilateral upper extremity injury that may impact functional outcomes. * polytrauma patients with injuries projected to affect rehabilitation course. * active malignancy. * inability to provide consent or complete follow-up. * incarcerated patients.
evaluation of efficacy and safety of leukotac (inolimomab) in pediatric patients with sr-agvhd

Conditions: Steroid Refractory GVHD

Summary: a phase 3, multicenter, open label, study to evaluate the efficacy and safety of leukotac® (inolimomab) in pediatric patients with steroid resistant acute graft versus host disease (sr-agvhd)


Eligibility criteria:
inclusion criteria: * patients who develop a first episode of agvhd stage ≥ ii (przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/kg methylprednisolone equivalent dose) * age 28 days to \< 18 years old * allo-hsct with any type of donor, stem cell source, gvhd prophylaxis or conditioning regimen * patients receiving allo-hsct for any indication (i.e. malignant or non-malignant disease) * signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s) exclusion criteria: * isolated stage 1 skin sr-agvhd * overlap chronic gvhd as defined by the nih consensus criteria (jagasia mh, 2015) * acute gvhd after donor lymphocytes infusion (dli) * relapsed/persistent malignancy requiring rapid immune suppression withdrawal * other systemic drugs than corticosteroids for gvhd treatment (including extra-corporeal photopheresis). drugs already being used for gvhd prevention (e.g. calcineurin inhibitors) are allowed. * active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy * known allergy or intolerance to leukotac of one of its ingredients * pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential * other ongoing interventional protocol that might interfere with
[68 ga]-dotanoc pet/ct in gep-nets

Conditions: Gastroenteropancreatic Neuroendocrine Tumors

Summary: somatostatin receptors are overexpressed in gep-nets and can be visualized in vivo by radiolabeled somatostatin-analogs. during the last decades, conventional scintigraphy using 111in-dtpa-octreotide (often named somatostatin receptor scintigraphy or srs) was considered as the gold standard nuclear imaging technique in the evaluation of gep-nets. however, srs may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for sst2 only. its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent spect-ct cameras. mri have also a higher sensitivity than ct and srs for the detection of liver metastases from gep-nets. in recent years, positron emission tomography (pet) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. it has also been evaluated in gep-nets with somatostatin agonists (ssta) radiolabelled with gallium-68 \[68ga\], a positron emitter with very promising results. its diagnostic sensitivity is clearly superior to srs and many european centers have already replaced srs by \[68ga\]-pet-ssta. currently, three different \[68ga\]-coupled peptides can be used in trials: dota-toc, dota-tate and dota-noc with excellent affinities for sst2 (ic50: 2.5; 0.2 and 1.9 nm, respectively). sensitivities of dota-toc and dota-tate pet/ct are quite similar. \[68ga\]-dotanoc which also binds to sst5 was recently found to detect significantly more lesions than the sst2-specific radiotracer \[68ga\]-dotatate in patients with gep-nets but this requires further evaluation. it is therefore important to determine the interest of \[68ga\]-dotanoc combined with the standard diagnosis strategy in gep-nets and evaluate medicoeconomic impact of adding \[68ga\]-dotanoc in the work-up of patients. the investigators hypothesis is that \[68ga\]-dotanoc will modify the management in at least 20% of patients in a more adapted way according to the 2012 enets guidelines in comparison to the decision based on the standard imaging work up (multiphasic wb ct, liver mri and srs). 110 patients will be included prospectively in 5 different french experienced centers (marseille, bordeaux, toulouse, paris, clermond-ferrand).


Eligibility criteria:
inclusion criteria: 1. age\> 18 years, with affiliation to the social security. 2. written consent of the patient. 3. patients with any of the following 5 situations: * geps without metastasis. * geps with unilateral liver metastases candidates to unilateral hepatectomy. * geps with unknown primary tumor. * geps with livers metastases candidates to liver transplantation. * metastatic geps with grade 1 or 2 tumour and negative srs. 4. reference imaging within the last 3 months : multiphasic total body ct scan, liver mri and srs (spect/ct). exclusion criteria: 1. minor subject. 2. pregnant or breast-feeding. 3. absence of therapeutic alternatives in metastatic gep. 4. undifferentiated gep and/or metastatic geps with grade 3 tumours.
imaging correlates of renal cell carcinoma biological features

Conditions: Renal Cell Carcinoma

Summary: this pilot study is designed to evaluate imaging parameters indicative of underlying tumor biology. patients with large renal masses (\>3 cm, or at the discretion of the investigator) who are planning to undergo nephrectomy will be identified, and recruited to undergo a contrast-enhanced magnetic resonance-fluorodeoxyglucose-positron emission tomography (mr-fdg-pet) scan.

this pilot study is designed to evaluate imaging parameters indicative of underlying tumor biology. patients with large renal masses (\>3 cm, or at the discretion of the investigator) who are planning to undergo nephrectomy will be identified, and recruited to undergo a contrast-enhanced magnetic resonance-fluorodeoxyglucose-positron emission tomography (mr-fdg-pet) scan. samples collected from their tumor after it is removed will undergo a variety of laboratory tests, including biomarker assessments and genotyping. by examining primary renal masses via a combination of mr and fdg-pet functional imaging in concert with tissue based tests, areas of hypermetabolism and hypervascularization will be evaluated as features of hif activation or tumor subtype.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age (no upper age limit) * informed consent obtained and signed * clinically suspected rcc based on imaging performed prior to enrollment * planned nephrectomy schedule that can accommodate a mr-fdg-pet scan within 4 weeks prior to surgery * willing to undergo gadolinium enhanced mri with simultaneous acquisition of fdg-pet uptake by the tumor within 4 weeks prior to nephrectomy * willing to consent for genetic and proteomic analysis of tumor and germline nucleic acids * women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to fdg-pet-mri * breast feeding women cannot do so for 24 hours after fdg injection * patient is willing to fast for 4 hours, including avoiding any sugar-containing drinks. * patient is willing to drink at least 32 ounces of water (or other no-sugar-containing fluids) within 4 hours prior to arriving for scans. exclusion criteria: * history of severe reaction to gadolinium-enhanced mri * poorly controlled diabetes mellitus * inability to tolerate pet and/or mri * presence of pacemaker or intracranial aneurysm clip * gfr \< 30ml/min as measured via cockcroft-gault equation * inability to lie flat for \>1 hour * pregnant female * history of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer, low risk prostate cancer, or other low risk tumor history at the discretion of the investigator. * substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study

Keywords: [18f] fluorodeoxyglucose positron emission tomography-magnetic resonance imaging fdg-pet-mri renal cell carcinoma pilot study lccc 1213 unc lineberger
prospective, randomized, parallel clinical controlled study of early diet opening on postoperative gastrointestinal hemorrhage in patients with colonic polyps

Conditions: Colonic Polyp

Summary: currently, hemorrhage remains the most common postoperative complication in patients with colon polyps, with an incidence of approximately 1.5%. the main reasons for postoperative hemorrhage are: the patient's own condition, the nature of the polyp and the operation. the number of patients treated for colon polyps has increased, postoperative care is confusing, medical resources are wasted, and the time span for postoperative diet recovery is large. however, studies on the effect of postoperative dietary recovery timing on postoperative polyp bleeding are rare.


Eligibility criteria:
inclusion criteria: * age 18-75, no gender restrictions, * patients with colonic polyps identified by colonoscopy and requiring endoscopic treatment, * polyp size 0.5cm-2cm, * patients agreed to enroll and signed a written informed consent, * adherence is good and agrees to be treated and evaluated as required by the study protocol. exclusion criteria: * patients with contraindications to endoscopic treatment of colonic polyps, including platelets ≤50×109/l, prothrombin time prolonged by 4 seconds or more, and inr≥2.0, * patients with severe heart, brain, lung, blood system diseases, uremia, connective tissue disease, * patients requiring treatment with nsaids, aspirin, glucocorticoids, or clopidogrel within the first 7 days of the study, * during the course of the study, due to other concomitant/complications, patients who need to use drugs that affect the efficacy of the trial, including various anticoagulants, antiplatelet drugs and hemostatic drugs, * alcoholics, drug addicts or those with uncontrollable neuropsychiatric diseases and others who are not suitable for participating in the trial, * pregnant, breastfeeding women, or women in childbearing age who wish to become pregnant, * patients with malignant tumor of digestive system, * other circumstances in which the investigator believes that the patient should not participate in this trial

Keywords: colonic polyp gastrointestinal hemorrhage
a single dose trial in growth hormone deficient children investigating safety, pharmacokinetics and pharmacodynamics of long acting growth hormone

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (nnc126-0083) in growth hormone deficient children.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of growth hormone insufficiency as defined by two different gh provocation tests, defined as a peak of gh level less than 7ng/ml * pre-pubertal children * growth hormone replacement treatment for at least three months exclusion criteria: * evidence of tumour growth or malignant disease * growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)
a study to understand the usage of an artificial intelligence technology called darwen for eye disorders and to find out the factors influencing treatment frequencies in people with namd and rvo

Conditions: Neovascular Age-related Macular Degeneration; Retinal Vein Occlusion

Summary: this is an observational study in which data already collected from people with the eye disorders below are studied. in observational studies, only observations are made without participants receiving any advice or any changes to healthcare. neovascular age-related macular edema (namd): an eye disorder caused by the lack of oxygen in the retina. the lack of oxygen leads to the increase of a protein called vascular endothelial growth factor (vegf). vegf causes new, weak blood vessels to grow. these vessels can leak fluid or blood into the central part of the retina at the back of the eye (macula). this leads to blurring or a blind spot in the central (straight ahead) vision needed for reading or threading a needle. retinal vein occlusion (rvo): an eye disorder where a blood vessel that carries blood away from the retina (vein) becomes blocked. the blocked vein causes a lack of oxygen in the retina which leads to the increase of vegf and then vision disturbances. these eye disorders can be treated with a type of medicine called anti-vascular endothelial growth factor (anti-vegf). anti-vegf treatment helps control the growth of new blood vessels in the eye and is given via injection into the eye. darwen ai is a system using artificial intelligence (ai) technology. it has been proven that darwen ai can be used to extract data accurately and efficiently in multiple disease areas, including breast cancer, lung cancer, ambulatory care diseases and skin disorders. the main purpose of this study is to validate if darwen ai can extract and sort through information from participants' health records accurately to identify those who need more frequent injections and those who do not. the secondary purpose of this study is to use darwen ai to describe the factors influencing treatment frequencies in participants with namd or influencing treatment discontinuation in participants with rvo. the data will come from the participants' information stored in eyedoc electronic medical records (emr) at st. joseph health care in london. data collected are from january 1, 2009, to may 31, 2023.


Eligibility criteria:
inclusion criteria: * all patients with the diagnosis of namd or rvo (branch or central) who are patients of dr. tom sheidow listed in the eyedoc ehr with available patient records from jan 1, 2009 to may 31, 2023. exclusion criteria: * not applicable.

Keywords: namd rvo central retinal vein occlusion crvo branch retinal vein occlusion brvo
phamacokinetics and safety profiles of da-1229_01 5/1000mg in healthy subjects at fasting state

Conditions: Healthy

Summary: this phase i clinical study is to evaluate the safety/tolerability and pharmacokinetics of da-1229_01 (5/1000 mg x1 tablets) at fasting state.


Eligibility criteria:
inclusion criteria: * healthy volunteers * bmi between 18 and 30 kg/m2 * body weight : male≥50kg, female≥45kg exclusion criteria: * allergy or drug hypersensitivity * clinically significant medical history
comparing irinotecan and 5 fu/fa to 5-fu/fa after resection of liver metastases for colorectal cancer

Conditions: Colorectal Neoplasms; Liver Neoplasms

Summary: to see if disease free survival (dfs) is improved when complete surgical resection of liver metastases (r0) is followed by chemotherapy with cpt-11 and 5-fu/fa as folfiri regimen, compared to 5-fu/fa alone.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour. * complete surgical resection (r0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion. * exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases. exclusion criteria: * prior hepatic radiation or resection. * prior radiofrequency ablation or cryoablation incomplete surgical resection of liver metastasis (es). * prior chemotherapy for metastatic disease.
transplantation for patients with chronic lymphocytic leukemia

Conditions: Leukemia, Lymphocytic, Chronic

Summary: to evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell transplantation for the treatment of chronic lymphocytic leukemia.

to determine effectiveness of allogeneic transplantation in eradicating chronic lymphocytic leukemia.

Eligibility criteria:
inclusion criteria:- adequate organ function * normal bone marrow cytogenetics exclusion criteria:- active cns disease * for autologous patients more than 30% bone marrow involvement
a study to evaluate the efficacy and safety of sage-217 in participants with severe postpartum depression (ppd)

Conditions: Depression, Postpartum

Summary: the purpose of this study is to determine if treatment with sage-217 reduces depressive symptoms in females with severe postpartum depression (ppd) as compared to placebo.

this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (ip) on day 1 until 7 days after the last dose of ip. * participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by structured clinical interview for diagnostic and dsm-5 clinical trial version (scid-5-ct). * participant is ≤12 months postpartum at screening and day 1. exclusion criteria: * participant is at significant risk of suicide or has attempted suicide associated with the current episode of ppd. * participant has active psychosis per investigator assessment. * participant has a medical history of nonfebrile seizures. * participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. * participant has a history of sleep apnea. note: other protocol-defined inclusion/exclusion criteria applied.

Keywords: sage-217 postpartum depression
the use of a pacifier to correct malocclusions in young children

Conditions: Malocclusion

Summary: the aim of the study is to investigate the effect of a pacifier (102 medical pacifier, curaprox, switzerland) on malocclusions like posterior crossbite, anterior open bite, larger overjet and tongue dysfunction in young children.


Eligibility criteria:
inclusion criteria: * children who are sucking the pacifier and / or baby bottle for the last 6 months in use. * manifesting posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite. and / or - manifesting anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust. exclusion criteria: * children who are thumb- or fingersucking (or sucking other objects) * syndromic or cleft patients * patients with history of cranio-facial trauma, history of temporomandibular joint infection or musculo-skeletal asymmetry (e.g. scoliosis, torticollis) * patients with systematic diseases * patients currently under or after orthodontic treatment * patients with ankylosed teeth (e.g. after dental trauma).