Kornimate/medical-research-clean huggingface dataset:
caring for family caregivers:a research-action study

Conditions: Depressive Symptoms; Anxiety; Emotions

Summary: the purpose of this study is to evaluate the effectiveness of the problem solving technique (pst) in reducing symptoms of anxiety and depression among primary caregivers of chronically ill patients. and also to describe and evaluate the process carried out by nurses when implementing the pst as a useful tool for care for family caregivers.

background: in spain, home care for the chronically ill and their family caregivers should be a priority in health and social policies due to the aging of the population and the progressive increase in dependent individuals. in our case, 88% of healthcare within dependency care is provided by the family and only 12% by health professionals. the family requires comprehensive and multidisciplinary ongoing care, in which the primary healthcare nurse plays a leading role. one of the areas involved is home-based nursing and counselling for family caregivers, in order to improve the quality of the care provided and to prevent issues arising that may adversely affect the caregiver's life. method: this is a research-action study with a mixed analysis methodology. quantitative analysis was used to evaluate the effectiveness of the problem solving technique in reducing symptoms of anxiety and depression among family caregivers. the clinical trial involved a control and experimental group and pre-post intervention measurements, using the goldberg scale of anxiety and depression. the sample consisted of 122 caregivers who presented one of these positive subscales. the technique's application process was evaluated for the qualitative analysis, with a content analysis of the records of 10 nurses performing the experimental intervention.

Eligibility criteria:
inclusion criteria: caregivers of chronically ill patients included in the atdom programme, who at the time of the intervention had a positive score on the goldberg scale for anxiety and/or depression. exclusion criteria: professional caregivers

Keywords: family caregivers dependency problem solving technique home based nursing
conservative treatment in patients with symptomatic femoroacetabular impingement

Conditions: Symptomatic Femoroacetabular Impingement

Summary: this is a single-group, prospective, intervention study. a total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study. the intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home training). the training includes physical exercises routinely used worldwide in clinical settings. no control intervention group was included into the study because nowadays there is no standard conservative treatment for patients with symptomatic femoroacetabular impingement. assessments will be performed at (1) baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. clinical, functional, neuromuscular and self-reported parameters will be collected during assessments.


Eligibility criteria:
inclusion criteria: * diagnosis of unilateral symptomatic fai according to clinical, radiographic and magnetic resonance imaging criteria * living place: canton of zurich or neighbouring cantons * signed written informed consent to participate into the study exclusion criteria: * previous hip surgery * any surgery to the lower limbs in the prior 6 months * congenital/developmental dysplasia * hip osteoarthritis * initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days * bmi \>35 kg/m2 * significant cardiorespiratory diseases
influence of anesthetic technique on acute and chronic neuropathic pain

Conditions: Acute Pain; Chronic Pain; Hernia; Anesthesia, Intravenous; Anesthesia, Intratracheal

Summary: research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. there is also data to support that an increased level of stress hormones leads to increased pain after surgery. the primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. in this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either total intravenous anesthesia (tiva) maintained with propofol or balanced inhaled anesthesia (bia) maintained with sevoflurane. this will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.


Eligibility criteria:
inclusion criteria: * all male patients undergoing herniorrhaphy surgery that requires general anesthesia. exclusion criteria: * subjects unable to communicate directly with the investigators, due to being non-english speaking, loss of hearing, or incompetence. * a history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization. * pain-related disorders such as fibromyalgia or other chronic pain syndromes. * emergency surgery.
amic vs. mfx in the ankle

Conditions: Osteochondral Lesion of Talus; Chondral Defect; Microfracture

Summary: this clinical investigation is a prospective, double blind, single-centre, randomised controlled trial comparing arthroscopic autologous matrix induced chondrogenesis (amic®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of amic® procedure versus microfracture (mfx).

this clinical investigation compares arthroscopic autologous matrix induced chondrogenesis (amic®) to microfracture alone in the treatment of osteochondral and chondral lesion in the ankle to evaluate effectiveness, performance and safety of amic® procedure versus microfracture (mfx). it is a prospective, double blind, single-centre, randomised controlled trial. the objective of this clinical investigation is to evaluate performance, effectiveness, and safety of amic® procedure versus microfracture (mfx). the effectiveness of the treatment is measured by the difference in the walking/standing- part score taken from the manchester oxford foot questionnaire (mox-fq) from baseline to 12 months. the secondary endpoints concern clinical safety and performance. patients will be randomized into two groups: microfracture alone (mfx) or bone marrow stimulation (microfracture) with chondro-gide® (amic®). the investigational device will be assessed within its intended use.

Eligibility criteria:
inclusion criteria: * signed written informed consent * diagnosis of symptomatic osteochondral or chondral lesion of the talus, deemed by surgeon amenable to arthroscopic treatment with debridement and microfracture * age of 18-65 years * subject is willing and able to comply with all study procedures, including visits, diagnostic procedures, the rehabilitation protocol and responding to patient questionnaire follow up exclusion criteria: * lesions smaller 1 square centimeters and greater than 4 square centimeters based on the mri * malalignment which is not corrected prior to or as part of same surgery * established significant hindfoot arthritis * patients who are unable to have an mri scan * chronic inflammatory arthritis or infectious arthritis * history of autoimmune disease or immunodeficiency * history of connective tissue disease * intra-articular steroid use within the 3 months prior to enrolment * other intra-articular injections (e.g., hyaluronic acid) within 3 months prior to enrolment * the patient is currently being treated with radiation, chemotherapy, immunosuppression, or systemic steroid therapy with a dose equivalent to more than 5 mg prednisolone * pregnancy or lactation * enrolled in another study, involved in the study (as a researcher/investigator/sponsor), or relative of someone directly involved in the clinical investigation * active infection of the index ankle * has been prescribed medication to treat osteoporosis * any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric, or cognitive conditions

Keywords: double-blind randomised controlled trial (rct) chondro-gide® amic®
qmoli- a qualitative assessment of misoprostol or oxytocin for labour induction

Conditions: Pre-Eclampsia

Summary: q moli is an alongside qualitative study, for the 'misoprostol or oxytocin for labour induction' (moli) pragmatic, open-label, randomised controlled trial, comparing a misoprostol/misoprostol regime vs the standard misoprostol/oxytocin induction of labour regime.1000 patients with hypertensive disease in pregnancy will be recruited, over 24 months, in nagpur, india.

qualitative study involving semi-structured interviews, with participants (pregnant women with hypertension/pre-eclampsia participating in the 'misoprostol or oxytocin for labour induction' (moli) study who consent to enter the qualitative study) in a randomised trial, pre and post induction of labour and focus group discussions with healthcare professionals involved in the study (moli study staff; practitioners who are involved in screening, recruiting, randomising and consenting participants to the moli study). the investigators aim to assess the priorities, experiences and acceptability of women being induced for hypertension in pregnancy in india, and clinician's views on the feasibility, usability, acceptability and barriers to implementation of various induction protocols. 1. explore patients' perceptions, expectations, priorities, understanding of and concerns around induction of labour, prior to induction. 2. to explore the experiences, acceptability and satisfaction of patients post induction and any differences between the two rct groups; misoprostol/misoprostol vs misoprostol/oxytocin regimes. 3. to better understand the feasibility, usability and acceptability of the different induction regimes to health care professionals. to explore potential barriers for implementing research findings into clinical practice and potential solutions. 4. to explore patients' and staff perspectives of the fetal monitoring regimens during the induction process.

Eligibility criteria:
moli rct participants (women being induced) inclusion criteria * women who are recruited to the moli rct and are either antenatal, or post-induction and meet all of the eligibility criteria: * women who consent to join the qualitative study exclusion criteria * women who are not recruited to the moli rct * women who lack the capacity to make an informed decision * women under the age of 16 * women who have had a stillbirth in this pregnancy * women who are distressed/in pain * women too unwell to take part in interviews, or who need urgent intervention (in less than 2 hours) * where delay in starting the iol process due to time of interview could cause harm to the patient * women who do not give consent to be in the study moli practitioners inclusion criteria • practitioners who are involved in screening, recruiting, randomising and consenting participants to moli rct exclusion criteria * staff who do not wish to be included * staff who do not give their consent to participate

Keywords: induction of labour intrapartum fetal monitoring qualitative semi-structured interview focus groups
a multi-site trial comparing lichtensteins operation and prolene hernia system in inguinal hernia repair

Conditions: Inguinal Hernia

Summary: patients with a primary unilateral inguinal hernia are randomized to lichtenstein's operation or prolene hernia system to repair their groin hernia. follow up for three years with a total number of 4 clinical examinations. end point is postoperative pain and recurrences.


Eligibility criteria:
inclusion criteria: * primary unilateral groin hernia in adult exclusion criteria: * recurrence warfarin treatment bilateral groin hernia

Keywords: surgery lichtenstein prolene hernia system postoperative pain recurrence
mandibular overdentures retained by conventional or mini implants

Conditions: Edentulous Mouth; Edentulous Jaw

Summary: this study aims to compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. we will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.


Eligibility criteria:
inclusion criteria: * complete edentulism; * request of implant stabilization of the existing lower conventional denture; * clinically acceptable maxillary and mandibular complete dentures; * adequate space in the anterior mandible for the placement of four mini implants and two conventional implants (regular diameter); * ability to maintain adequate oral hygiene and clean dentures; * systemic health status that permits minor surgical procedures; * adequate understanding of written and spoken portuguese; * capacity of giving written informed consent. exclusion criteria: * lack of minimum vertical mandibular bone height of 11mm in the interforaminal region; * acute or chronic symptoms of parafunctional disorders; * history of radiation therapy to the orofacial region; * specific conditions that may jeopardize the treatment, i.e. alcoholism and smoking; * severe/serious illness that requires frequent hospitalization; * impaired cognitive function; * impossibility to return for evaluations/study recalls.

Keywords: cost estimates complete denture dental economics dental implants dental prosthesis, implant-supported denture retention edentulous edentulism mini dental implant oral health-related quality of life overdenture patient acceptance of health care quality of health care quality of life patient satisfaction
ocriplasmin research to better inform treatment (orbit)

Conditions: Symptomatic Vitreomacular Adhesion

Summary: this is a multicenter, prospective, observational, phase 4 study that will assess clinical outcomes and safety of jetrea® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (vma) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 usa retina sites.

the sites will prospectively enroll consecutive patients eligible for participation in the study. informed consent will be obtained prior to any data being collected. this study is observational; therefore, all treatment decisions and assessments are at the discretion of the patient's treating physician and are not mandated by the study design or protocol. patients will be enrolled at a routinely scheduled visit, on the day of jetrea® administration after the jetrea® injection. no specific visits, examinations, laboratory tests or procedures are mandated as part of this study. there is no pre-set visit schedule, and the frequency and timing of actual patient visits is at the discretion of the treating physician following standard of care. all available and relevant data will be collected prospectively.

Eligibility criteria:
inclusion criteria: * adults 18 years or older diagnosed with symptomatic vma treated with jetrea ® at the physician's discretion in a manner consistent with the product label. * willing and able to provide written informed consent exclusion criteria: * patients who are treated with jetrea® for medical conditions outside of the us product label. * concurrent participation in a research study that prescribes ocular treatment, imaging and/or interventions
novel exhaled breath aerosol collection devices in patients with lower respiratory tract infection - a performance and acceptability study

Conditions: Pneumonia; Lower Respiratory Tract Infection (LRTI)

Summary: this study will assess the performance of two novel breath collection devices and their subsequent detection of respiratory pathogens compared to sputum samples in patients with lower respiratory tract infections.


Eligibility criteria:
inclusion criteria: * able to understand the scope of the study and provide written informed consent * age \>18 years * speaking german * health status (assessed by study personnel at local site) well enough to use the breath collection devices * willing to provide all three study samples (sputum and two breath samples) required for the study * clinical diagnosis of a lower respiratory tract infection (lrti) defined as: (i) new infiltrate (chest x-ray, ultrasound, or ct scan), and (ii) at least one clinical symptom suggestive of lrti (fever ≥38°c, chills, new or worsening cough, new or worsening sputum production, new or worsening dyspnea, tachypnoea, chest pain) exclusion criteria: * patients for whom the collection of all three study specimens within 24 hours of initiating antibiotic treatment is not feasible * patients with known cystic fibrosis or bronchiectasis * critically ill patients at the discretion of the investigator * patients on oxygen supplementation with a face mask, high-flow-oxygen, non-invasive or mechanical ventilation; oxygen supplementation via nasal cannula will be permitted. * patients with proven acute pulmonary embolism * patients with best supportive care * patients with severe hypoxemia (spo2 \<88%) despite oxygen supplementation * hospitalization within the last 14 days prior to admission

Keywords: respiratory tract infections pneumonia communicable diseases infections breath
comparison of sensory analysis after superficial and deep parasternal intercostal plane blocks

Conditions: Pain, Postoperative

Summary: postoperative pain following cardiac surgery is a common issue that can negatively impact patients' quality of life. effective perioperative pain management is crucial to improving patient outcomes. pain is typically most intense during the first two postoperative days, and inadequate management can lead to chronic pain, further diminishing quality of life. recent advances in ultrasound-guided regional anesthesia, including superficial and deep parasternal intercostal plane blocks, have enhanced acute pain control. these blocks aim to provide analgesia by targeting the anterior cutaneous branches of the t2-6 thoracic nerves. while their efficacy is recognized, sensory evaluation and dermatomal analysis remain unexplored. cadaver studies suggest that the deep block may cover more parasternal space than the superficial block.

this observational study evaluates sensory blocks in patients undergoing open-heart surgery who receive superficial or deep parasternal intercostal plane blocks. sensory assessment, conducted by a blinded researcher 30 minutes post-block, involves applying small ice tubes with cold sensations categorized as normal, reduced, or no cold. a successful block is defined as the loss or reduction of cold sensitivity, while normal cold sensation indicates block failure. assessments start at the midline, moving laterally to the anterior axillary line. marked areas are digitally analyzed. block regression is evaluated at 12 and 24 hours post-procedure using the same cold assessment criteria.

Eligibility criteria:
inclusion criteria: * patients who will undergo effective open heart surgery with median sternotomy * patients who have undergone superficial or deep parasternal intercostal plane block exclusion criteria: * patients with severe psychiatric illnesses such as psychosis or dementia that would prevent communication with the patient * patients who do not want to participate in the study * redo surgeries * patients whose block is considered unsuccessful with the cold application test at the 30th minute * patients who cannot be extubated 12 hours post-block.

Keywords: analgesia pain management sensory assessment
transcranial direct current stimulation in offenders

Conditions: Aggression; Risk-Taking; Antisocial Behavior

Summary: this study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. in the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex and sham stimulation. after each stimulation session, neural activity and behavioral responses to tasks assessing risk-taking and aggressive behavior will be recorded. the effect of tdcs on violent offenders will also be assessed in comparison to age and gender-matched healthy controls.


Eligibility criteria:
inclusion criteria: * between 18 and 50 years of age * able to understand the nature of the study and give informed consent * individuals in the violent offender group must have a record of repeated violent criminal offending (at least 2 felonies). * individuals in the violent offender group must have been convicted solely due to crimes involving violence motivated by impulsive aggression. exclusion criteria: * presence of any contraindications for functional magnetic resonance imaging (fmri) * history of significant medical illness * history of any neurological condition * diagnosis of schizophrenia * history of epilepsy * head injury * mental retardation
safety, toleration and efficacy of cp-741,952 for the treatment of obesity

Conditions: Obesity

Summary: the purpose of this study is to determine whether cp-741,952 is effective in the treatment of obesity and to determine 12 week safety and toleration.

following review of the preliminary data from completed study a7081004, the development program for cp-741,952 was terminated on 15 march 2007. primary reasons for program termination included a lack of significant efficacy at all doses investigated and an increased incidence of mild to moderate elevations in serum transaminases, primarily alanine aminotransferase (alt), and liver fat content, in treated compared to placebo subjects. a synopsis will be created and will include greater detail on these findings.

Eligibility criteria:
inclusion criteria: * bmi of 30-40 kg/m2 exclusion criteria: * women of childbearing potential