Kornimate/medical-research-clean huggingface dataset:
dhea against vaginal atrophy - 3-month efficacy study

Conditions: Vaginal Atrophy

Summary: the purpose of this phase iii trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (dhea) in postmenopausal women with vaginal atrophy.


Eligibility criteria:
main inclusion criteria: * postmenopausal women (hysterectomized or non-hysterectomized) * women between 40 and 75 years of age. * willing to participate in the study and sign an informed consent. * women who have self-identified symptom(s)of vaginal atrophy. * for non-hysterectomized women, willing to have endometrial biopsy at screening and end of study. main exclusion criteria: * undiagnosed abnormal genital bleeding. * hypertension equal to or above 140/90 mm hg. * the administration of any investigational drug within 30 days of screening visit. * endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

Keywords: vulvar/vaginal atrophy atrophic vaginitis dehydroepiandrosterone dhea prasterone vaginorm menopause intrarosa
a multicenter study to evaluate the nutritional suitability of renastart

Conditions: Chronic Kidney Disease; Hyperkalemia

Summary: a multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (renastart, vitaflo international ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (ckd)

a multicenter, open label, uncontrolled study to evaluate the acceptability, tolerability, and nutritional suitability of a medical food (renastart, vitaflo international ltd) specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (ckd) primary objective to investigate the nutritional suitability of renastart in children aged 10 years and under with ckd, particularly with respect to the dietary management of hyperkalemia and the maintenance / improvement of growth. secondary objectives to investigate the acceptance, compliance, palatability, and tolerance of renastart in children aged under 10 years with ckd. a total of 15 children with ckd will be enrolled in the study.

Eligibility criteria:
inclusion criteria: 1. aged 10 years or under at the time of enrolment into the study. 2. diagnosed with chronic kidney disease 3. requirement for a low potassium diet, as evidence by elevated serum potassium levels (\> normal reference value which is 3.5-5.0 mmol/l) 4. requirement for a low potassium enteral formula to provide a minimum of 20% of daily energy (kcal) requirements. (calculated according to individual child's needs and according to local clinical practice) 5. written informed consent provided by parent/primary caregiver. 6. assent provided by child, if appropriate. exclusion criteria: 1. receiving total parenteral nutrition (tpn). 2. intolerance or allergy to cow's milk or any other ingredients in renastart. 3. prior intolerance of renastart formula. 4. any disorders which in the investigator's opinion may cause significant gastrointestinal malabsorption. 5. liver failure. 6. active infection or presenting with any signs or symptoms of an infectious disease at screening. 7. concurrent enrollment into another clinical trial.

Keywords: potassium chronic kidney disease ckd children
plantar fasciitis treated with dynamic splinting

Conditions: Plantar Fasciitis

Summary: the purpose of this study is to determine if the ankle dorsiflexion dynasplint system (ds) is effective in reducing pain from plantar fasciitis (fasciopathy).

to determine the efficacy of ankle dorsiflexion dynasplint system (ds) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.

Eligibility criteria:
inclusion criteria: patients enrolled will have been diagnosed with plantar fasciitis which is associated with significant pain and includes the following: * pain on the bottom of the heel * pain that is usually worse upon arising or after long periods of non weight bearing * pain that increases over a period of months * pain is worsened by walking barefoot on hard surfaces or by walking up stairs * morning mobility limitations * preference of patients to "walk on their toes" * paresthesias after non weight bearing (while sitting or lying down or both) * nocturnal pain * patients must be willing and able to sign the informed consent exclusion criteria: * achilles tendon injury * acute traumatic rupture of the plantar fascia * calcaneal bursitis * calcaneal neuritis * calcaneal stress fracture * lumbosacral radiculopathy of s1 nerve root * retrocalcaneal bursitis * tarsal tunnel syndrome

Keywords: dynamic splinting for low-load, prolonged-duration stretch
tau positron emission tomography (pet) longitudinal substudy associated with: study of crenezumab versus placebo in preclinical presenilin1 (psen1) e280a mutation carriers in the treatment of autosomal-dominant alzheimer's disease

Conditions: Alzheimer Disease

Summary: this substudy will evaluate the effect of crenezumab on the longitudinal tau burden in a subgroup of preclinical presenilin1 (psen1) e280a mutation carriers and non-carriers, who were enrolled in study nct01998841 (gn28352). participants will receive up to three intravenous (iv) injections of \[\^18f\] genentech tau probe 1 (gtp1) and will undergo a tau positron emission tomography (pet) scan after each iv injection of \[18\^f\]gtp1. the purpose of this substudy is to increase the understanding of disease progression in the preclinical stage of familial alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: - enrolled in main study nct01998841 (gn28352). exclusion criteria: - contraindication to pet scan procedures, possibly including, but not limited to current, past, or planned participation in studies involving radioactive agents, including the main study nct01998841 (gn28352) and this tau pet substudy, such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the u.s. code of federal regulations (cfr) title 21 section 361.
effect of nalbuphine and naloxone on experimentally induced skin sensitivity

Conditions: Healthy

Summary: in previous clinical studies of post-surgical pain the investigators found that nalbuphine (nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (narcan), a drug that is used to treat narcotic overdose. this finding was particularly true in men. the purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. a second reason for this study is to find out if study medications work more effectively in women or in men. subjects will come to the university of california at san francisco (ucsf) clinical research center (crc) for 4 study visits. the first visit will be a 2-hour screening to assess the subject for study eligibility. during the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. changes in pain will be measured following the intravenous (i.v.) administration of study drugs. three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. these drug combinations will be administered in random order; all subjects will receive all three combinations.


Eligibility criteria:
inclusion criteria: * age 18 - 40 * in stable health * speak, read, understand english language * if female, must be non-lactating and not pregnant exclusion criteria: * heat pain detection thresholds above 47 ºc/116.6 ºf * inability to develop secondary hyperalgesia from the heat and capsaicin stimulation performed at the screening visit * serious psychiatric psychopathology (psychotic disorder, substance abuse) * tattoos in the area of measurements * allergy to study drugs (nalbuphine, naloxone, or capsaicin) * current or recent use opioids
shp2 inhibitor bbp-398 in combination with nivolumab in patients with advanced non-small cell lung cancer with a kras mutation

Conditions: Non Small Cell Lung Cancer; Solid Tumor

Summary: this is a phase 1 study of bbp-398, a shp2 inhibitor, in combination with nivolumab, a pd-1 antibody, in patients with nsclc with a kras mutation. the study involves 2 parts: phase 1a dose escalation and phase 1b dose expansion.

the primary objective for phase 1a dose escalation is to evaluate the safety, tolerability, and rp2d of bbp-398, a shp2 inhibitor, when used in combination with nivolumab in patients with advanced nsclc with a kras mutation who have failed standard of care treatment. the primary objective for phase 1b dose expansion is to evaluate the antitumor activity of bbp-398, as defined by the orr (per investigator) according to recist v1.1, when used in combination with nivolumab in patients with advanced nsclc with a kras mutation who have failed standard of care treatment.

Eligibility criteria:
key inclusion criteria: * patients must have histologically documented, locally advanced and unresectable, or metastatic nsclc with documentation of a kras mutation within the 1 year prior to screening. * patients must have measurable disease by recist v1.1. * patients must have a minimum life expectancy of \>12 weeks after start of study treatment. * patients must have progression or disease recurrence on or after at least one prior line of systemic therapy, which must include platinum-based doublet chemotherapy and anti-pd-(l)1 therapy. * patients must have experienced progressive or recurrent disease occurring either during treatment or within 90 days after discontinuing anti-pd-(l)1 therapy. * patients must have an eastern cooperative oncology group (ecog) performance status (ps) 0-1. * patients must have adequate organ function. key exclusion criteria: * patients that have participated in an interventional clinical study within the last 4 weeks. * patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, or radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment. * patients with known central nervous system (cns) tumors or active cns metastases. * patients that have experienced progressive disease (pd) within the first 120 days of initiating treatment with an anti- pd-(l)1 agent (e.g., primary refractory). * patients that have a history of allogenic bone marrow transplant. * patients that have select known or suspected autoimmune disease. * patients that have a condition requiring systemic treatment with either corticosteroids (\>10 mg prednisone equivalent) or other immunosuppressive medication within 14 days of study start. * patients that have received any live/attenuated vaccine within 30 days of first study treatment.

Keywords: kras mutation mapk-pathway alterations nsclc shp2
safety and tolerability of agn-199201 in patients with erythema associated with rosacea

Conditions: Rosacea; Erythema

Summary: this study will evaluate the safety and tolerability of agn-199201 for the treatment of erythema associated with rosacea.


Eligibility criteria:
inclusion criteria: * facial erythema associated with rosacea on both sides of the face exclusion criteria: * laser light-source or other energy based therapy in the last 6 months * excessive hair around the treatment area
safety/efficacy study of sgn-15 (antibody-drug conjugate) combined with gemcitabine in patients with ovarian cancer

Conditions: Ovarian Neoplasms

Summary: this is an open-label, randomized phase ii trial comparing treatment with a monoclonal antibody (mab) drug immunoconjugate, sgn-15, administered weekly in combination with weekly gemzar® (gemcitabine) to treatment with gemzar® alone. the primary objectives of this study are to determine the toxicity and safety profile of the combination of sgn-15 and gemzar®, to estimate the clinical response rate and to estimate the duration of response of this combination therapy administered to patients with advanced ovarian cancer, compared to treatment with gemzar® alone.


Eligibility criteria:
brief overview of inclusion criteria: * patients must have pathologically confirmed ovarian cancer, which is advanced or recurrent carcinoma, who have failed at least two, but no more than three prior therapies for metastatic disease * patients must have \> 20% lewis-y antigen expression documented by immunohistochemistry * lvef \> 50% by echo or muga * must be platinum resistant as defined by: * progression while on initial platinum therapy or * progression while on retreatment with initial platinum regimen or * relapse \< 6 months after initial therapy brief overview of exclusion criteria: * patients who have had prior therapy with gemzar® * cumulative anthracycline exposure \> 300 mg/m2 * more than three prior chemotherapy regimens for ovarian cancer (retreatment with taxane/platinum after initial combination is considered only one regimen)
a trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of nnc0148-0000-0287 in healthy subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of nnc0148-0000-0287 (insulin 287) in a gipet® i tablet formulation in healthy subjects.


Eligibility criteria:
inclusion criteria: * body mass index 18.0-28.0 kg/m\^2 * subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * known or suspected hypersensitivity to trial products or related products * previous participation in this trial. participation is defined as randomised * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator * any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
transcranial direct current stimulation for dysphagia therapy in acute stroke patients

Conditions: Stroke; Dysphagia

Summary: the purpose of this study is to evaluate whether transcranial direct current stimulation of the cerebral swallow motor cortex in addition to standard care can enhance recovery of swallow function in acute dysphagic stroke patients compared to sham treatment plus standard care.


Eligibility criteria:
inclusion criteria: - dysphagia due to acute stroke exclusion criteria: * preexisting dysphagia * comorbidities that can possibly cause dysphagia * psychiatric comorbidities * pacemaker or other implanted electronic devices * inability to give informed consent

Keywords: transcranial direct current stimulation stroke-related dysphagia cortical plasticity
comparison study of electrocardiogram indexes in patients with epilepsy, patients with first seizure and normal population

Conditions: Patients With Epilepsy; Patients With First Seizure; Normal Population

Summary: according to recent advances in epileptic heart and sudden unexplained death in epilepsy, in this study the investigators aimed to compare ecg findings in patients with epilepsy, patients who had experienced their first seizure and patients without history of seizure.


Eligibility criteria:
inclusion criteria for group 1: * history of epilepsy for at least 2 years * taking antiseizure medications inclusion criteria for group 2: - solid history of first seizure confirmed by a neurologist inclusion criteria for group 3: - no history of seizure exclusion criteria: * history of known cardiac disease or medical condition precipitating cardiac disease * electrolyte imbalance taking medications with significant effect on ecg indexes

Keywords: electrocardiogram epilepsy seizure
developing an adaptive lifestyle intervention program in family medicine clinics

Conditions: Insulin Resistance; Obesity; Diabetes; Hypertension; Dyslipidemias; Metabolic Syndrome

Summary: the purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the uab family medicine clinic at highlands and to obtain preliminary data on the effectiveness of the adaptive treatment strategies being investigated to produce improvements in insulin resistance. this study is a sequential multiple assignment randomized trial (smart) with initial randomization groups of individualized nutrition counseling vs. individualized exercise counseling. note that these initial nutrition or exercise interventions are not intended to produce significant weight loss. participants that do not sufficiently improve their insulin resistance score after 8 weeks will be re-randomized to 2nd stage interventions of either receiving dietary counseling for weight loss or receiving a prescription for metformin. we will collect data on the effectiveness of the intervention to improve insulin resistance/metabolic health in the family medicine clinic as well as potential predictors or moderators of treatment success.


Eligibility criteria:
inclusion criteria: * male or female * any race or ethnicity * bmi \>27 kg/m2 * presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., stage 1 obesity) * prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease * stable medication type and dosage for ≥3 months exclusion criteria: * if type 2 diabetes, * currently prescribed metformin or prescribed within previous 3 months * hba1c concentration of \>12% * using exogenous insulin * pregnant or lactating within the past 6 months or trying to become pregnant * prescription for weight loss medications within the past 3 months * severe obesity-related complications that require immediate and more intensive clinical therapy (e.g., pharmacotherapy and/or bariatric surgery) as determined by study physician and/or referring practitioner at uab family medicine clinic. * history of kidney disease that may increase the risk of lactic acidosis with metformin. * currently prescribed the following medications that may increase the risk of lactic acidosis with metformin: acetazolamide (diamox), dichlorphenamide (keveyis), methazolamide, topiramate (topamax, in qsymia), or zonisamide (zonegran). * does not have a life-sustaining medical implant such as a pacemaker.

Keywords: insulin resistance
optimization of the care pathway for patients with chronic pain: assessing the value of integrating sleep specialists

Conditions: Chronic Pain

Summary: dolorepit is an interventional, riph 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.


Eligibility criteria:
inclusion criteria: * first consultation at the pain management center * patient with chronic pain as defined by the "haute autorité de santé". the pain must have several of the following characteristics: * persistence or recurrence * duration beyond what is usual for the presumed initial cause, especially if the pain has been evolving for more than 3 months; * inadequate response to treatment; * important and progressive deterioration of the patient's functional and interpersonal abilities in activities of daily living at home, school, or work due to the pain. * patients with chronic primary pain (according to the typology defined by the international classification of diseases-11) and classified into one of the 4 following categories: * chronic generalized pain * complex regional pain syndrome * chronic primary headache or orofacial pain * chronic primary musculoskeletal pain * pittsburgh sleep quality index (psqi) must be completed by the patient and the score must be available (for randomization purposes) * have access to an internet connection as a self-administered questionnaire is to complete online, and at least have access to the online platform for cbt treatment if insomnia is detected * affiliation to a french social security system * free informed consent exclusion criteria: * patients undergoing cancer treatment or who have completed treatment within the last 2 years * patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, chronic inflammatory bowel disease, horton's disease, wegener's disease, myositis, still's disease, lupus erythematosus, etc.) * immunocompromised patient * patient with severe psychiatric pathology that does not allow study follow-up (at the discretion of the investigator) * patient already treated for a sleep disorder by a sleep specialist (the only prescription of hypnotics is not considered as a criterion of non-inclusion) * patient follow-up difficult (for geographic motives or other reasons) * patient under judicial protection of incapable adults or guardianship * refusal to participate in the research
care study: improving treatment for the most severely ill with schizophrenia

Conditions: Psychosis, Schizophrenia

Summary: this is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two parallel groups. there is also an open-label extension phase of 18 weeks. both medications to be used in the study, clozapine and risperidone, are fully approved for the treatment of schizophrenia.

subjects may be inpatients or outpatients. all subjects will be treated throughout the study with clozapine, at a dose of 400 mg or more, unless limited by side effects. after screening, subjects will be augmented with placebo for 7 days. any subject with a reduction in panss total score of 20% or greater will be discontinued from the study. beginning on day 8, subjects will be randomized to continued augmentation of clozapine with placebo, or to augmentation with risperidone. the initial daily dose of risperidone will be 1.0 mg, increased in 1.0 mg increments to a total of 3.0 mg/day over a two week period. subjects unable to tolerate at least one tablet of study medication will be dropped from the study. at the end of 8 weeks following randomization, at the choice of the investigator, open-label risperidone augmentation can be started. the primary outcome measure is the panss total score at week 9. subjects will be classified as responders if the improvement in panss total score is 20% or greater, and the proportion of responders in each group will be determined. complementary outcome measures will be the cgi severity score, cgi improvement score, and sofas score. safety and tolerance will be assessed by reports of adverse events and clinically significant changes in vital signs, weight, waist circumference, extrapyramidal side effects, metabolic and hematological measures.

Eligibility criteria:
inclusion criteria: * subjects treated with clozapine for the indication of poor response to other antipsychotic medications. * treatment with clozapine is at a stable dose for at least 12 weeks. dose must be 400 mg/day or more, unless side effects limited increase of dose. exclusion criteria: * subjects with significant alcohol or substance abuse in the past 3 months. * subjects with a previous trial of risperidone augmentation of clozapine * subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception * subjects requiring treatment with anticonvulsants. * subjects with known hypersensitivity or allergy to risperidone. * subjects with hematological or other contraindications to continued clozapine treatment.

Keywords: psychosis, schizophrenia, schizoaffective, clozapine, risperidone