Kornimate/medical-research-clean huggingface dataset:
a phase 1 dose escalation study to evaluate safety and pharmacokinetics (pk) of vx-840 in healthy participants

Conditions: APOL1-mediated Kidney Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, and pk of single and multiple ascending doses of vx-840 in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * female participants must be of non-childbearing potential * body mass index (bmi) of 18.0 to 32.0 kilograms per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kg key exclusion criteria: * history of febrile illness or other acute illness within 14 days before the first dose of study drug * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
exploring engagement dynamics among individuals impacted by bladder cancer

Conditions: Bladder Cancer

Summary: the study seeks to delve into the firsthand experiences of patients diagnosed with bladder cancer who partake in a separate clinical trial featuring a specific medical intervention. the primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. by joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future bladder cancer patients and play an active role in advancing medical research.


Eligibility criteria:
inclusion criteria: * patient has self-identified as planning to enroll in a clinical trial * patient has been diagnosed with bladder cancer * patient is a minimum of 18 years or older exclusion criteria: * patient does not understand, sign, and return consent form * inability to perform regular electronic reporting * patient is pregnant

Keywords: bladder cancer
repetitive transcranial magnetic stimulation in the treatment of depression

Conditions: Depression

Summary: subjects received rtms daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.during the rtms session, the coil was centered flat over the right parietal cortex. we follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales. we hypothesized that rtms has a positive effect in the treatment of depression


Eligibility criteria:
inclusion criteria: * in and outpatients aged between 16 and 65 who met dsm-iv criteria for major depressive episode, and who had a score of 25 or higher on the 10-item montgomery asberg depression rating scale (madrs) were included exclusion criteria: * a history of epilepsy and any other medical disorder that should preclude the administration of rtms. only ssri's, mirtazapine and promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of promethazine had not been changed for 2 weeks prior to inclusion. antidepressive medication had to remain stable during the 14 weeks of the study. furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.
protracted effect of the ultrasound-guided saphenous block

Conditions: Arthrosis, Unspecified, Ankle and Foot

Summary: this study focuses on optimizing the postoperative pain treatment after major foot and ankle surgery by prolonging the duration of the ultrasound-guided saphenous block. the currently used single shot saphenous block only covers half of the pain intensive period from the saphenous territory, which results in a sharp, break-through pain requiring opioids. the hypothesis is that this protracted mixture will keep the patients free of pain without the use of opioids for the entire pain intensive period and thus increase rehabilitation and patients' satisfaction.

half of the patients will receive a single shot saphenous block with 10 ml bupivacaine-adrenalin and 1 ml of sodium chloride solution, while the other half will receive 10 ml of bupivacaine-adrenalin and 1 ml of dexamethasone. the block is strictly a sensory block because it is a selective, sub-sartorial saphenous block at mid-thigh level without any anesthetic effect on the femoral nerve. the adjuvant dexamethasone has increasingly become a subject of interest regarding a protracted effect, which has been shown in several studies. however, the precise mechanism of action remains speculative, and the results are contradictory regarding the discussion whether the effect is systemic or local. the effect may stem from decreased nociceptive c-fibre activity via a direct action on glucocorticoid receptors and inhibitory potassium channels. another suggestion is a vasoconstrictive effect, which reduces the systemic uptake of local anaesthetics or a systemic anti-inflammatory effect. prolonging the effect of the single shot saphenous block by adding dexamethasone will reduce the need for opioids, which will reduce the risk of adverse effects like nausea, vomiting and respiratory depression. furthermore, newer studies show that inadequate pain alleviation in the early postoperative period is a risk factor in developing chronic persistent pain.

Eligibility criteria:
inclusion criteria: * elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis or (3) subtalar arthrodesis * age ≥ 18 * american society of anaesthesiology classification i-iii * informed consent both orally and in writing after the patient has fully understood the protocol and its limitations. exclusion criteria: * communication problems or dementia * allergies to any medical product used in the study * neuropathy of the sciatic or femoral nerve prior to the operation * morbus charcot-marie-tooth disease, diabetic neuropathy, peripheral vascular disease * bmi \> 35 * pregnancy * daily use of opioids * coagulation disorders * infection at the site of injection or systemic infection
phase 1 every-3-week dosing of sch 727965 in patients with advanced cancer (study p04630)

Conditions: Solid Tumors; Lymphoma, Non-Hodgkin; Multiple Myeloma

Summary: part 1 and part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of sch 727965 administered every 3 weeks as a 2 hour intravenous (iv) infusion (part 1), and as an 8-hour or 24-hour iv infusion (part 2). each 3-week period is considered one treatment cycle. part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of sch 727965 administered as a 2 hour iv infusion once every 3 weeks.


Eligibility criteria:
inclusion criteria: * age \>=18 years, either sex, any race. * subjects must have histologically proven solid tumors, non-hodgkin's lymphoma, or multiple myeloma. * there must be no known standard therapy, or disease must be refractory to standard therapy. * eastern cooperative oncology group performance status of 0, 1, or 2. * adequate hematologic, renal, and hepatic organ function and laboratory parameters. exclusion criteria: * symptomatic brain metastases or primary central nervous system malignancy. * previous radiation therapy to \>25% of the total bone marrow. * previous treatment with sch 727965. * known hiv infection.
establishment of a tissue bank (blood, csf) for the understanding of motor neuron disease (mnd)

Conditions: Amyotrophic Lateral Sclerosis

Summary: biomarkers are essential for the identification of disease states. there are no early diagnostic or prognostic markers for als. the purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of als patients and to collect data to better understand disease progression.

amyotrophic lateral sclerosis (als) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. there is no reliable early diagnostic test for als making identification of the disease difficult at its earliest stages. early detection is critical to the initiation of early neuroprotective therapy. by the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. the purpose of the current project is to establish a bank of blood samples (serum and protein/rna/dna from blood cells) and csf for use in the development of an early diagnostic test for als and to better understand the progression of this disease. samples from patients that have a confirmed or unknown diagnosis of motor neuron disease will be examined. als and suspected neuromuscular disease (control) samples will be collected for comparison. investigators will examine various biochemical, metabolic and genetic markers from these samples in hopes of finding differences in the expression between control subjects and als patients and how these biomarkers vary during disease progression. participants will be asked to complete an optional questionnaire to collect data including medication and vitamin use and medical and disease history. this data will be linked to the patient's samples; however, all samples will be deidentified and coded to avoid the possibility of linking results to the patient. results will not be stored in the patient's medical record.

Eligibility criteria:
inclusion criteria: * 18 years old or older exclusion criteria: * less than 18 years old

Keywords: amyotrophic lateral sclerosis motor neuron disease biological markers biomarkers
healthy lifestyle intervention for high-risk minority pregnant women

Conditions: Emotional Disturbances; Depression; Pregnancy Late; Post-Partum Depression; Anxiety; Nutritional Deficiency

Summary: the overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. this randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (cbsb) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (jacobi medical center, new york city and the ohio state university total health and wellness clinic, and the ohio state university wexner medical center ob/gyn columbus, ohio.

a randomized controlled trial will test a cognitive behavioral skills building intervention (cope-p) in black and hispanic women experiencing emotional distress in two sites (new york and ohio) to determine if the intervention leads to better health behaviors, better psychosocial health (anxiety, stress, and depressive symptoms), and improved birth and post-natal outcomes in women experiencing emotional distress. developing scalable prenatal interventions designed to improve birth outcomes as well as maternal physical and psychosocial health is essential to decrease health disparities in pregnant minority women.

Eligibility criteria:
inclusion criteria: * pregnant women between the ages of 18-40 years old * pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks * self-identified as either black or hispanic * able to read and speak english. * the child participants born to the participants will have their record accessed for data collection. exclusion criteria: * women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy. * women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.

Keywords: emotional distress pregnancy disparities minority depression
pegylated interferon therapy for acute hepatitis c infection in hiv-infected patients

Conditions: Hepatitis C; HIV Infections

Summary: the purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis c infection in hiv-coinfected individuals.

background:hiv-infected individuals are at higher risk of developing a chronic course of hepatitis c after infection. moreover, chronic hepatitis c is less well treatable in hiv-coinfected than in hepatitis c monoinfected patients. there is basic research and clinical data on hepatitis c mono-infection supporting high sustained response rates of hepatitis c when treatment is started in the acute phase of infection. aim of the study: to determine whether pegylated interferon therapy is effective to treat acute hepatitis c infection in hiv-coinfected individuals. methods: prospective, open-label, historical controlled trial. eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose. weight-adjusted ribavirin comedication is recommended for hcv-genotypes 1 and 4. treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis c infection.

Eligibility criteria:
inclusion criteria: * documented acute hepatitis c infection with detectable hcv-rna (pcr-assay) and elevated serum alanine transferase (alt) levels. an acute infection is defined by fulfilling two of the following 3 criteria within the preceding four months: 1. known or suspected exposure to hcv, 2. documented seroconversion to positivity for antibodies against hcv, 3. a serum alanine transferase (alt) level of more than 350 u/l with a documented normal level during the year before infection. * documented hiv-infection * cd4 cells \> 300 /µl * ability to understand and sign a written consent form * women of child-bearing age: negative pregnancy test exclusion criteria: * autoimmune hepatitis or other autoimmune disease * decompensated liver disease * decompensated renal disease, i.e. creatinine clearance \< 50 ml/min, according to cockcroft-gault * acute or chronic hepatitis b infection * acute infection with hepatitis a or other hepatotropic viruses * new aids defining event less than 1 month prior to enrolment * malignancy other than cutaneous kaposi sarcoma treated with systemic chemo-therapy * history of severe psychiatric conditions, in particular severe depression * history of seizures * history of organ transplantation * thyroid disease not medically compensable * severe heart disease * severe retinopathy * known allergy to the study drug or one of the galenic compounds * hypersensitivity to interferon a * thrombocytes \< 90 g/l, neutrophils \< 1.5 g/l, hemoglobin must not be \< 12g/dl (female) or \< 13 g/dl (male) * treatment with corticosteroids less than 3 months prior to enrolment * alcohol abuse or use of other recreational drugs * older than 65 years of age, younger than 18 years of age * pregnancy, breast-feeding

Keywords: acute hepatitis c hiv pegylated interferon
pharmacokinetics, pharmacodynamics, and safety of single-dose sotrovimab in high-risk pediatric participants with mild to moderate covid-19

Conditions: COVID-19

Summary: this phase 2b study will evaluate the pharmacokinetics (pk), pharmacodynamics (pd) and safety of sotrovimab in pediatric participants from birth to less than (\<)18 years old with mild-to-moderate coronavirus disease-2019 (covid-19) at high risk of disease progression.


Eligibility criteria:
inclusion criteria: * participant must be 32 weeks estimated gestational age (ega), day of life (dol) 0 to \<18 years of age inclusive, at either the time of participant's signed assent (if age-appropriate) or parent(s)/legally authorized representative signing the informed consent. * participants with mild-moderate covid-19. * participants at risk of disease progression with at least one of the following criteria: age \<1 year; diabetes mellitus; genetic or metabolic diseases; obesity ); cardiovascular disease; sickle cell disease; pulmonary disease; neurologic disease; immunosuppressed ; baseline medical complexity (gastrostomy- or jejunostomy-dependence, parenteral nutrition dependence, tracheostomy-dependence, baseline oxygen requirement, use of continuous positive airway pressure \[cpap\]/ bilevel positive airway pressure \[bipap\]/ventilator support). exclusion criteria * participant is pregnant or breastfeeding. * participant is currently hospitalized, or judged by the investigator as likely to require hospitalization in the next 24 hours, due to severe or critical covid-19. * multisystem inflammatory syndrome in children (mis-c). * prior, current, or planned future use of any of the following treatments during the study period: covid-19 convalescent plasma, monoclonal antibodies (mabs) against severe acute respiratory syndrome coronavirus-2 (sars-cov-2) (for example \[e.g.\], casirivimab/imdevimab), intravenous immunoglobulin (ivig) for any indication, or dexamethasone specifically for treatment of covid-19. * current use of covid-19 treatment (authorized, approved, or investigational). * the following exclusions related to use of an authorized or approved vaccine for sars-cov-2 are applicable: 1. receipt of any authorized or approved vaccine for sars-cov-2 within 48 hours prior to dosing. 2. planned use of any authorized or approved vaccine for sars-cov-2 within 90 days of study drug administration per current centers for disease control and prevention (cdc) recommendations. * receipt of any non-sars-cov-2 vaccines within 14 days (for non-live vaccines) or 28 days (for live vaccine) of screening. * currently enrolled in another clinical study. * infants \<24 weeks of age: maternal receipt of ivig, sars-cov-2-directed convalescent plasma or sars-cov-2-directed mab(s) within 3 months prior to birth or within 5 half-lives of the investigational product (whichever is longer).

Keywords: covid-19 pharmacokinetics safety pharmacodynamics sotrovimab pediatric intravenous intramuscular
reiki effects on bone marrow transplant patients

Conditions: Bone Marrow Transplant Complications; Fatigue; Vital Signs; Reiki

Summary: the aim of the study is to examine the effect of reiki on fatigue, vital signs, and engraftment in bone marrow transplant patients.

cancer is a serious and chronic disease, the number of which is increasing rapidly in our country and in the world. today, cancer accounts for 70% of all disease diagnoses and it is estimated that the number of new cancer cases will rise to 22 million in about twenty years. although hematopoietic stem cell transplantation is a promising treatment for remission and complete recovery in cancer patients, the symptoms after transplantation seriously affect the quality of life of individuals. in addition to psychosocial problems, patients experience serious physical problems such as suppression of the immune system and fatigue after transplantation. energy therapies are widely used to provide general health and well-being and to reduce or relieve the symptoms of many chronic diseases. as a result of many studies on conditions such as fatigue, pain, and anxiety, it has been determined that reiki energy has a positive effect. when we searched the literature, it was seen that there were not enough studies examining the fatigue, vital signs, and immune systems of bone marrow transplant patients. this randomized controlled prospective study is conducted with bone marrow transplant patients between august 2022 to february 2023. the data of the study will collect using "personal information form (pif)", "visual analog scale (vas)", and "national cancer institute (nci) -common terminology criteria for adverse events (ctcae)". also, vital signs and laboratory findings will be recorded. pif, vas, and ctcae will be applied to the patients who meet the inclusion criteria. patients will be randomized 1:1 into groups to the block randomization method. there are two arms in the study; reiki (n=21) and control group (n=21). a second-degree reiki practitioner will apply reiki to the patients for 30 minutes. on the second day and the third day, 30 minutes distance reiki will be applied to the patients. in the control group, nothing will be done. post-tests will be applied to all patients after one week and vital signs and laboratory findings will be recorded.

Eligibility criteria:
inclusion criteria: * being over 18 years old * not having a communication problem, * autologous bone marrow transplantation has been performed * willingness to participate in reiki practice, * to be competent to answer the data collection tools to be used in the research. * not using complementary practices (energy therapies) in the last six months. exclusion criteria: * having a communication problem * application of allogeneic bone marrow transplantation * not being willing to engage in reiki practice * reiki practitioner or instructor, * have received energy therapy sessions such as reiki/therapeutic touch/healing touch in the last six months * application of bone marrow transplantation for hematological cancers

Keywords: reiki fatigue vital signs engraftment bone marrow transplant patients
a phase ii/iii study of cysteamine (mercaptoethylamine) and zidovudine for the treatment of hiv disease

Conditions: HIV Infections

Summary: to determine the safety and tolerance of low-dose versus high-dose cysteamine administered concurrently with zidovudine (azt). to determine the pharmacokinetics and effects on immune function and viral load in patients receiving these drug regimens.

patients receive high or low doses of cysteamine plus azt or placebo plus azt. the target dose of cysteamine is determined by titration of the dose over a 6-week period, after which the patient receives 24 additional weeks of treatment. an initial cohort of 36 patients will be enrolled in a 10-week pilot phase. accrual will be temporarily suspended while data from the pilot phase is assessed.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * chemoprophylaxis for pneumocystis carinii pneumonia, candidiasis, mycobacterium tuberculosis, and herpes as prescribed by the investigator. * recombinant erythropoietin and g-csf if clinically indicated. patients must have: * documented hiv infection. * cd4 count 300 - 500 cells/mm3. * prior azt therapy for at least 3 months but less than 12 months prior to study entry. * no past or current aids-defining opportunistic infection. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * kaposi's sarcoma requiring systemic therapy. * active malignancy other than basal cell carcinoma or in situ cervical carcinoma. concurrent medication: excluded: * antiretroviral therapy other than azt. * immunosuppressive drugs. * investigational hiv drugs/therapies other than study drug. * interferon. * steroids. * hematopoietins. * cytotoxic chemotherapy including adriamycin, bleomycin, and vincristine. concurrent treatment: excluded: * radiation therapy. patients with the following prior condition are excluded: history of treatment-limiting intolerance to 500-600 mg azt daily as manifested by the same recurrent grade 3 toxicity or any prior grade 4 toxicity. prior medication: excluded: * prior antiretroviral therapy other than azt. required: * azt for at least 3 months but no more than 12 months prior to study entry.

Keywords: drug therapy, combination aids-related complex zidovudine cysteamine