Kornimate/medical-research-clean huggingface dataset:
seated physical activity in ageing

Conditions: Frail Elderly Syndrome; Frailty; Physical Activity

Summary: this trial will take the form of a feasibility study; designed to assess the feasibility of a proposed future clinical trial in this setting. this proposed future clinical trial is proposed to assess the impact of physical activity, in the form of specialised chair based physical activity interventions, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a clinical hospital ward setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. this feasibility study is single-centre (taking place in the harborne ward of the queen elizabeth hospital birmingham, mindelsohn way, edgbaston, birmingham, united kingdom).


Eligibility criteria:
inclusion criteria: * temporary residents within the harborne 'living lab' ward of the queen elizabeth hospital birmingham, edgbaston, birmingham, united kingdom * ≥ 65 years of age * frail according to the fried frailty criteria: meeting at least three of the five characteristics of frailty (fried et al. 2001) * have the capacity to speak and read in english * anticipated by their care team to remain on the ward for approximately 14 days post enrolment into the study. this will be advised by the patient's care team. exclusion criteria: * currently taking part in any other clinical trial which could potentially have an impact upon or influences the findings of the current study * currently terminally ill with life expectancy which is less than the duration of the study's interventions * severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.
multicenter study evaluating the performance of the assay of anti-hinge region antibodies in the diagnosis of progressive forms of iga nephropathy

Conditions: IgA Nephropathy

Summary: the anti-hinge region antibodies would be a relevant biomarker of iga nephropathy. beyond a prognostic value (which could increase the risk of renal absolute), the longitudinal monitoring for these antibodies could be of interest: (1) in the monitoring of patients (in place including a possible repetition renal biopsy); (2) to guide treatment decisions and (3) in clinical research, as an outcome (in substitution for the occurrence of kidney failure) in therapeutic trials iga nephropathy. this research project constitutes the first step in validating these antibodies biomarker of iga nephropathy and its main objective is to study the performance of the blood levels of anti-hinge region antibodies in the diagnosis of progressive forms of histologically iga nephropathy as defined by the renal risk absolute. the secondary objectives of this project are to establish a bio-collection that will allow us to search for other prognostic factors (genetic, cellular and serum) of iga nephropathy and to evaluate the performance of renal absolute risk by integrating oxford score, the new international histological classification.


Eligibility criteria:
inclusion criteria: * major patient * diagnosis of a primitive form of iga nephropathy histologically proven exclusion criteria: * suspicion of secondary iga nephropathy forms * less than 5 glomeruli present on renal biopsy
to evaluate the efficacy and feasibility of modified reduce-volume target imrt in the treatment of patients with non-metastatic npc

Conditions: Nasopharyngeal Carcinoma

Summary: this is a retrospective real-world study to evaluate the efficacy and feasibility of modified reduce-volume target imrt in the treatment of patients with non-metastatic npc


Eligibility criteria:
inclusion criteria: 1. pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; 2. newly diagnosed, non-metastatic and treated with modified reduce-volume imrt; 3. patients with baseline mri date of nasopharynx and neck, and completed the first course of treatment in our hospital; 4. diagnosis time: november 1, 2014 to december 31 , 2017 exclusion criteria: 1. disease progression during imrt; 2. previous malignancy or other concomitant malignant diseases; 3. the evaluation information of tumor efficacy can not be obtained; 4. receive blind treatment in other clinical research.
effects of antenatal exercises on maternal birth outcomes

Conditions: Pregnancy Related

Summary: the study is aimed to determine the effects of pelvic floor stretching vs strengthening on maternal birth outcomes and postpartum urogenital distress in primigravida.

the effects of pelvic floor muscle exercises on the symptoms of postpartum urinary distress is not known, so there is a need to determine whether strengthening or stretching of pelvic floor muscles help in reducing the risk of developing urogenital distress in postpartum period of females. the positive effect of pelvic floor muscle training on duration of labor and maternal birth outcomes is understood. as stated in a systemic review of pelvic floor interventions during pregnancy. the researches done on effect of pelvic floor muscle exercises, included once a week supervised session of sustained pelvic floor muscle contractions with rest intervals and fast contractions with respective rest intervals along with daily home sessions of the same exercises.

Eligibility criteria:
inclusion criteria: * primigravida exclusion criteria: * any contraindications to performing an exercise during pregnancy based on recommendations of the american college of obstetricians and gynecologists (acog) * females opting for elective c section

Keywords: pregnancy related pelvic floor muscle weakness delivery delayed
pain inhibitory effects of other pain induced by mechanical pressure at different intensities

Conditions: Healthy

Summary: the objective is to estimate the effects on pain thresholds of a painful mechanical stimulus on the upper trapezius at moderate intensity compared to mild intensity or non-painful.

the mechanical stimulus produced in manual therapy (mt) techniques elicits neurophysiological responses within the peripheral and central nervous system responsible for pain inhibition. almost all types of mt elicit a neurophysiological response that is associated with the descending pain modulation circuit. but it has not been demonstrated whether this inhibition occurs through a conditioned pain modulation mechanism induced by painful mechanical stimulation that is carried out with manual therapy techniques.

Eligibility criteria:
inclusion criteria: * healthy male or female between 18 and 65 years * free of pain and with no history of chronic pain exclusion criteria: * pregnant or having given birth within the last year

Keywords: conditioned pain modulation manual therapy physiotherapy physical therapy
open-label, phase i/iia study of vac-3s in hiv-1 patients who showed an immune response to vac-3s during ivvac-3s/p1

Conditions: HIV

Summary: the purpose of this study is to evaluate the safety and tolerability of vac-3s in controlled hiv patients receiving standard of care antiretroviral treatment.


Eligibility criteria:
inclusion criteria: * hiv-1 infected patient, * age between 18 and 60 years, * art (anti retroviral therapy) initiation ≥ 1 year ago, * plasma hiv rna ≤ 200 copies/ml in the past 12 months, * plasma hiv rna ≤ 50 copies/ml at the screening visit, * cd4+ t cell count ≥ 200 cells/mm3, * nadir cd4+ t cell count ≥ 100 cells/mm3, * contraception in women with child-bearing potential, * a total anti-3s titer ≥ 20 a.u. at any time point of ivvac-3s/p1 clinical trial, * per protocol subject having completed the ivvac-3s/p1 study. * patient affiliated to a social security system, * patient who has understood the protocol design and provided a signed written informed consent form, * patient who is willing and capable of cooperating to the extent and degree required by the protocol, * patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site. exclusion criteria: * administration of vac-3s in the past year, * chronic active liver disease, * history of hcv co-infection or ongoing replicating hcv (positive rt-pcr) or hbv (positive hbs ag) coinfection, * any immunotherapy (e.g. il-2, il-7, growth hormone...) in the past year at the exception of vac-3s, * any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month, * ongoing pregnancy, * breastfeeding women, * patient with known sensitivities to investigational drug (see please the cib), * history of allergy to any vaccine, * any severe chronic condition that would interfere with the study, * history of auto-immune disease, * organ transplant, * splenectomy, * psychiatric disorder significant enough to hinder participation as assessed by the investigator, * patient who has participated in a clinical research trial in the 30 days preceding the screening visit (v-1m-1). * patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system, * any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
a study of ly3841136 in overweight and obese participants

Conditions: Obesity; Overweight

Summary: the main purpose of this study is to assess the safety and tolerability of ly3841136 when administered in combination with tirzepatide in overweight and obese patients. the study will last up to approximately 42 weeks.


Eligibility criteria:
inclusion criteria: * male and female participants who are overtly healthy as determined by medical evaluation * have a stable body weight and body mass index in range of 27 to 45 kilogram per meter square (kg/m²). * have clinical laboratory test results within normal reference range * have venous access sufficient to allow for blood sampling * are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures exclusion criteria: * have type 1 or type 2 diabetes mellitus * have an abnormal 12-lead electrocardiogram (ecg) * have a history or presence of psychiatric disorders * have abnormal blood pressure and pulse rate * are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.

Keywords: safety tolerability body weight
factors sustaining tobacco abstinence in cancer patients treated with radio-chemotherapy or radiotherapy

Conditions: Smoking Cessation; Nicotine Addiction; Nicotine Dependence; Smoking; Head and Neck Neoplasms

Summary: the tabac stop orl poumon study aims to evaluate the factors influencing long-term smoking cessation in patients with head and neck cancer (hnc) or lung cancer undergoing radiotherapy or chemoradiotherapy. this is a single-center observational study, following patients at 1, 6, and 12 months after treatment completion. the primary objective is to determine the proportion of abstinent patients at 6 months, while secondary objectives analyze factors influencing abstinence, smoking trajectories, and reasons for relapse. a total of 100 patients will be included to ensure robust statistical analysis.

the tabac stop orl poumon study is a prospective, single-center observational study aiming to understand factors influencing long-term smoking cessation in patients treated for head and neck or lung cancer. tobacco is a leading cause of death and disease, particularly in areas like hauts-de-france with high smoking rates. eligible patients, undergoing radiotherapy or chemoradiotherapy, are enrolled during the final week of treatment, completing questionnaires assessing nicotine dependence and alcohol use. follow-ups are scheduled at 1, 6, and 12 months, through clinic visits or phone interviews. the primary endpoint is the proportion of patients who remain smoke-free at 6 months. secondary endpoints include factors influencing smoking cessation, reasons for relapse, and changes in nicotine and alcohol dependence. the study will enroll 100 patients, expecting 81 evaluable cases, with data quality ensured through regular checks and source verification.

Eligibility criteria:
inclusion criteria : * patient aged 18 years or older * diagnosed with head and neck cancer or lung cancer * undergoing curative treatment with chemoradiotherapy, radiotherapy alone, or stereotactic radiotherapy * current or former smoker * patient covered by a social security scheme * patient informed and having given consent for data collection patients with human papillomavirus (hpv) may also be included exclusion criteria : * patient receiving palliative treatment * patient under guardianship or curatorship study exit criteria : - protocol-defined exit : after the 12-month consultation early exit : * withdrawal of consent for data collection * death of the patient

Keywords: tobacco abstinence head and neck cancer smoking cessation nicotine dependence cancer treatment
neuroinflammation/oxidative stress/cardiac surgery

Conditions: Neuroinflammation

Summary: the prospective observational study delves into the complex relationship between neuroinflammation and oxidative stress in post-cardiac surgery complications, focusing on postoperative cognitive dysfunction.

the prospective observational study meticulously examines the interplay between neuroinflammation and oxidative stress in the realm of post-cardiac surgery complications, specifically targeting postoperative cognitive dysfunction. its primary objective is to comprehensively assess the sustained influence of these intricate processes on cognitive function and overall well-being, extending beyond the immediate aftermath of surgery. the research endeavors to probe deeply into the molecular mechanisms and clinical ramifications associated with neuroinflammation and oxidative stress, centering on their pivotal role in shaping the onset and trajectory of postoperative cognitive dysfunction.

Eligibility criteria:
inclusion criteria: * undergoing cardiosurgical operation * absence of previous neurological disease * signed informed consent document exclusion criteria: * presence of neoplasms * neurological disease * refusal to participate in the clinical trial
safety and efficacy of pneumostem® in premature infants at high risk for bronchopulmonary dysplasia (bpd) - a us study

Conditions: Bronchopulmonary Dysplasia

Summary: pneumostem® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hucb-mscs) and it is intended for use as a cellular therapy product for prevention of bronchopulmonary dysplasia (bpd). this study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of pneumostem® in premature infants at high risk for bpd.


Eligibility criteria:
inclusion criteria: * a male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth) * a subject whose gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (ga) \< 28 weeks) * a subject whose birth weight is between 500g and 1000g, inclusive * a subject who is intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (fio2) of 0.25 or greater at screening * a subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment * a subject whose parent/guardian can give a written informed consent exclusion criteria: * a subject who has a congenital heart defect, except for patent ductus arteriosus (pda), atrial septal defect (asd) or a small, restrictive ventricular septal defect (vsd) * a subject who has a serious malformation of the lung such as pulmonary hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly * a subject who has a chromosomal abnormality (e.g., trisomy 18, trisomy 13 or trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies) * a subject who has had a severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, hiv, etc.) * a subject who has evidence of severe sepsis or septic shock due to an active infection at screening * a subject who underwent a surgical procedure within 72 hours before study drug administration or who is anticipated to have a surgical procedure within 72 hours before or following study drug administration * a subject who was administered surfactant within 24 hours before study drug administration * a subject who has had a bilateral grade 3 or 4 intracranial hemorrhage * a subject who has active pulmonary hemorrhage or an active air leak syndrome at screening * a subject who is currently participating in any other interventional clinical trial * a subject who is, in the opinion of the principal investigator, considered inappropriate for the trial due to any reasons other than those listed above

Keywords: mesenchymal stem cells human umbilical cord blood premature infants bronchopulmonary dysplasia chronic lung disease cell therapy
corneal collagen cross-linking with hypotonic riboflavin in corneas thinner than 400 microns

Conditions: Keratoconus

Summary: corneal ectasia is a relative weakness in the structure of the cornea, which produces a progressive change in its shape which results in visual distortion. it is known that collagen cross-linking in the cornea occurs naturally with age, and in diabetes, both of which seem to prevent progressive ectasia. corneal collagen cross-linking with riboflavin on corneas thicker than 400 microns has been shown to stabilize the cornea in keratoconus, and prevent progression of the disease. the purpose of this study is to determine whether corneal collagen cross-linking with riboflavin in a hypotonic solution, with uv light, on corneas less than 400 microns thick, leads to stabilisation of corneal ectasia.

when cross-linking corneas of \> 400 microns, riboflavin in a solution with high molecular weight dextran t500 is used to prevent corneal swelling during the administration of the drops and the uv treatment. however if riboflavin is applied to a cornea in a hypotonic solution (saline), then transient corneal oedema is created with thickening of the corneal stroma. in this way it is thought that the temporarily thickened cornea can be treated with uv whilst still providing a sufficient thickness to absorb the uv to an extent that endothelial cell damage is avoided.

Eligibility criteria:
inclusion criteria: * keratoconus * corneas thinner than 400 microns, but thicker than 250 microns exclusion criteria: * evidence of other corneal disease in the eye to be treated (e.g., herpes simplex keratitis) * women who are pregnant or nursing at the time of the initial treatment

Keywords: keratoconus collagen cross-linking riboflavin uv light
an online intervention to reduce self-harm among persons with high emotion-related impulsivity

Conditions: Suicidal Ideation; Deliberate Self-harm; Impulsivity

Summary: the goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity.

participants will be asked to complete 7 brief online modules to cover how to understand emotion-triggered impulsivity, to better detect states of high emotion and arousal, to learn new strategies for self-calming high arousal, and to pre-plan how to cope with high arousal states. as part of the program, participants receive daily texts and prompts to remind them of the intervention content and skills. at baseline and follow-up, participants will complete measures of emotion-related impulsivity, self-harm, and suicidality.

Eligibility criteria:
inclusion criteria: * at least 13 years of age * engaged in mental health care * evidence of either self-harm or suicidal urges or behavior in the past 3 months * high levels of emotion-related impulsivity. exclusion criteria: * inability to adequately take part in the online measures due to problems with intellectual function, language, or other conditions, * psychosis, * not currently living in california, * lack of access to a device to privately complete online modules.
a study to assess nomlabofusp in adolescents and children with friedreich's ataxia

Conditions: Friedreich Ataxia

Summary: the goal of this clinical trial is to evaluate the safety and tolerability of nomlabofusp (cti-1601) in adolescents and children with friedreich's ataxia (frda).

this is a randomized, double-blind, placebo-controlled study evaluating a weight-based dose of nomlabofusp versus placebo in adolescents and children with frda. the study will consist of at least two cohorts with at least 12 to 15 participants in each cohort. participants will be dosed once daily (qd) for 7 days.

Eligibility criteria:
inclusion criteria: 1. subject has genetically confirmed diagnosis of frda manifested by homozygous gaa repeat expansions, with repeat sizing (if available) included on the diagnosis report. 2. male or female subjects ≥ 2 to \< 18 years of age at screening. 3. subjects must weigh ≥ 10.0 kg. 4. subject must be able to traverse a distance of 25 feet with or without some assistive device (e.g., cane, walker, crutches, self-propelled wheelchair) and meet the following requirements: 1. be able to sit upright with thighs together and arms crossed without requiring support on more than 2 sides; 2. be able to transfer from bed to chair independently or with assistance if, in the opinion of the investigator, the degree of physical disability does not result in undue risk to the subject while participating in the study; and 3. perform basic age-appropriate daily care, such as feeding themselves and personal hygiene, with minimal assistance. exclusion criteria: 1. subjects who are confirmed as compound heterozygous (gaa repeat expansion on only 1 allele) for frda. 2. subject has any condition, disease, or situation, including a cardiac condition or disease, that in the opinion of the investigator could confound the results of the study or put the subject at undue risk, making participation inadvisable. 3. subjects currently receiving or having received omaveloxolone within 30 days prior to screening.
local injection of ozone versus methylprednisolone acetate in carpal tunnel syndrome of scleroderma patients

Conditions: Carpal Tunnel Syndrome; Chronic Pain; Scleroderma

Summary: carpal tunnel syndrome is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent local ozone therapy could offer symptom improvement in scleroderma patients with carpal tunnel syndrome

carpal tunnel syndrome (cts) is the most common compression syndrome the upper extremities. its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. it occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. a lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves. scleroderma patients are a special group which usually sufferers from such problem

Eligibility criteria:
inclusion criteria: * adult patients with scleroderma * complaining of carpal tunnel syndrome of 3-month duration or more * diagnosed axonal neuropathy using electrodiagnosis, nerve conduction study exclusion criteria: * patient refusal * infection at the site of intervention * previous injection in the recent 3 months * coagulopathy