Kornimate/medical-research-clean huggingface dataset:
treatment of patients with longstanding unexplained health complaints

Conditions: Somatization Disorder

Summary: the purpose of this study is to determine the effect of specialized treatment (including cognitive therapy, social counselling and a recommendation letter to the patients' primary care physician) on the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms.

medically unexplained or functional somatic symptoms are complaints, which are not attributable to any verifiable, conventionally defined disease, or which cannot adequately be supported by clinical or para-clinical findings. functional somatic symptoms are common in the population and in all clinical settings, both in primary and secondary care. the disorders range from mild, transitory cases, which are difficult to delimit in relation to normality, to severe chronic cases with multiple symptoms from different organ systems. chronic multiple functional somatic symptoms often cause frustration for both gps and patients due to lack of availability of specialized treatment offers. patients may have a high use of health care, and their social and functional level is low. in denmark, patients with chronic multiple functional somatic symptoms account for at least 10% of the early retirement pensions each year. diverse interventions have been effective in the management and treatment of patients with functional disorders. care recommendation letters for the gps have both helped reduce the patients' use of health care and improved their level of physical functioning. randomized controlled trials (rct) have shown that cognitive behavioral treatment (cbt) has effect on specific patient groups with functional disorders. through a combination of cognitive behavioral therapy, social counselling and recommendation letters, it is possible to offer patients with chronic functional somatic symptoms a presumably effective and cost-effective treatment.

Eligibility criteria:
inclusion criteria: * multiple somatic symptoms from several organ systems, without adequate medical explanation. * moderate to severe influence on daily life. * the disorder's functional component can easily be separated from a possible well-defined chronic somatic illness. * no lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (international classification of diseases \[icd-10\]: f20-29, f30-31, f32.3, f33.3) * the condition must have been present for at least 2 years. * patients of scandinavian origin who understand, read, write and speak danish. exclusion criteria: * no informed consent. * an acute psychiatric disorder that demands other treatment, or if the patient is suicidal. * abuse of narcotics or alcohol and (non-prescribed) medicine. * pregnancy. * current industrial injury case or other action for damages.

Keywords: functional somatic symptoms cognitive behavioral therapy somatization disorder sf-36 cost-effectiveness medically unexplained symptoms
depuy global unite shoulder system

Conditions: Osteoarthritis

Summary: to collect medium to long-term survivorship implant outcomes on the depuy global unite shoulder system


Eligibility criteria:
inclusion criteria: * patient greater than 18 years of age and skeletally mature * patient qualifies for primary or revision total or reverse shoulder arthroplasty based on diagnosis of investigator of osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, un-united humeral head fractures, irreducible 3- and 4- part proximal humeral fracture, avascular necrosis, or gross rotator cuff deficiency. * patient is willing and able to provide written informed consent and to complete scheduled follow up visits/evaluations/questionnaires exclusion criteria: * patient has one of the following compromise the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve, or a neuromuscular disease compromising the affected limb * patient has a known or suspected infection * patient is known to be pregnant * patient has a sensitivity or allergic reaction to one or more of the implanted materials * patient is unwilling or unable to provide consent or comply with follow up visits

Keywords: shoulder
cell therapy with bone marrow mononuclear cells in critical leg ischemia (cli)

Conditions: Critical Leg Ischemia

Summary: this study will treat by cell therapy 20 patients with critical leg ischemia (cli) not eligible for revascularization or angioplasty. it will use exactly the same protocol as published by tateishi-yuyama et al. (lancet 2002), using bone-marrow mononuclear cells (bmmnc).

patients will be included with cli according to the tasc criteria. under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. after isolation and concentration of the bmmnc in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product. patients will then be followed-up every week during one month and then every month during one year. this study was approved by the ethical committee of paris-broussais hegp (france) and our french regulatory agency (afssaps). it began including patients in january 2005 and will last until december 2007.

Eligibility criteria:
inclusion criteria: * age \> 18 * signature of informed consent * critical leg ischemia with ankle pressure \< 70 mmhg * ischemic ulcer or gangrene * no possibility of surgical revascularization * no possibility of angioplasty exclusion criteria: * cancer * suspicion of a cancer on x-ray, mammography or elevated psa * age \< 18 * life expectancy \< 6 months * active retinopathy * angioplasty or surgical revascularization within 3 months * stoke within 3 months * hiv + or hcv/hbc+

Keywords: critical leg ischemia pad cell therapy
booster of the "more time for patients" program

Conditions: Clinical Encounter Quality

Summary: the goal of this clinical trial is to determine if reactivating a hospital program called "plus de temps au service des patients" (ptp) can improve the quality of pain management for patients and increase job satisfaction among healthcare professionals. the main questions this study aims to answer are: * does reactivating ptp improve the quality of pain management? * does reactivating ptp increase healthcare professionals' job satisfaction? in this study, researchers will compare the effects of reactivating the program immediately to reactivating it after a 3-month delay. participants in the trial are healthcare professionals who will: * select 2 or 3 elements of the program they believe would be most beneficial to reactivate in their hospital units. * implement the selected elements for 3 months. * complete job satisfaction and burnout questionnaires before and after the study.


Eligibility criteria:
inclusion criteria for the units: * implementation of ptp finished at least 6 months previously * agreement to the study from both medical head of service and head of unit (ires) inclusion criteria for healthcare professionals: * healthcare professionals \>18 yo. * healthcare professionals working in a hug service of medicine or surgery. * healthcare professionals include physicians, nurses, assistant nurses, pharmacists, physiotherapists and other physical therapists. * provided general informed consent. inclusion criteria for patients * patients hospitalised in one of the boosted units. * cognitive ability to provide satisfaction assessment.

Keywords: health care quality, access and evaluation patient satisfaction job satisfaction inpatients pain management
effect of physical therapy on breast cancer related lymphedema

Conditions: Lymphoedema; Breast Cancer

Summary: the objective of this study is to investigate if complete decongestive therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.

physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'complete decongestive therapy' (cdt). cdt consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent. a randomized, single-blind, equivalence trial. a total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: a: complete decongestive therapya (incl. manual drainage) or b: complete decongestive therapyb (except manual lymphatic drainage

Eligibility criteria:
inclusion criteria: * the diagnose breast cancer regardless of date for operation and identified lymphoedema * precede ultrasonic scanning of axilla in order to exclude local relapse * lymphoedema \> 2 cm i.e. stage ii-iii * completed radiotherapy and/or chemotherapy at least 2 months prior inclusion exclusion criteria: * relapse of breast cancer * untreated infection * untreated heart failure * untreated renal failure * untreated deep venous thrombosis in the arm * unable to participate in physiotherapy treatment and/or not able to understand instructions
brainstem grey matter and cerebral autoregulation in migraine with aura.

Conditions: Migraine With Aura

Summary: migraine with aura (ma) is an independent risk factor for stroke and is associated with silent brain infracts and t2 white matter hyperintensities on mri. previous studies using transcranial doppler (tcd) have shown an impairment of cerebral autoregulation in ma patients. studies with positron emission tomography have demonstrated an activation of brain stem areas during migraine attack. an increased density of brain stem grey matter as measured on mri with voxel based morphometry (vbm) has been found in ma patients. as brain arteries and arterioles are innervated by ascending tracts from aminergic brainstem nuclei, th study hypothesize a negative correlation between the density of brainstem nuclei and the efficiency of cerebral autoregulation in ma patients compared with controls. brainstem grey matter density will be studied with a mri philips 3 tesla with a 32-channel antenna and voxel-based morphometry (vbm) cerebral autoregulation will be measured in the time domain using transcranial doppler (tcd) and the mx method. ma patients will be studied in a headache-free period. mri and transcranial doppler (tcd) are non-invasive technics and will be performed on the same day.


Eligibility criteria:
inclusion criteria: * migraine with aura patients : fulfilling the international classification of headache disorders-3 beta criteria of ma * control group : gender- and age-matched subjects without history of migraine with or without aura or any other headache exclusion criteria: * history of illness or injury of central or peripherical nervous system * previous history of a disease potentially impairing cerebral autoregulation (diabetes, sleep apnea syndrome, uncontrolled hypertension, cardiac arrhythmia, hearth failure, carotid stenosis) * contraindications related to mri * absence of temporal acoustic window * pregnancy

Keywords: cerebral autoregulation mri vbm doppler transcranial
immunity to serotype 19a streptococcus pneumoniae in children vaccinated with pcv10

Conditions: Pneumococcal Infections

Summary: the aim of the study are to assess the persistence of immunity against vaccine serotypes (vsts) and vaccine-related serotypes in pcv10 vaccinated children in finland.

the primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with pcv10.

Eligibility criteria:
inclusion criteria: * completed pcv10 vaccination with 3 or 4 doses (2+1 or 3+1 schedule) before blood sampling at age of 13 months * age at sample collection 13 months, 2 years or 3 years * pcv10 vaccination received 2-6 weeks before sample collection at the age of 1 year * informed consent obtained covering the planned analyses exclusion criteria: * pcv13 or ppv23 dose received * informed consent withdrawn

Keywords: streptococcus pneumoniae antibody
clinical trial to investigate the pharmacokinetic drug interaction between solifenacin and tamsulosin

Conditions: LUTS; Benign Prostatic Hyperplasia; Overactive Bladder

Summary: the purpose of this study is to investigate the pharmacokinetic drug interaction between solifenacin and tamsulosin in healthy male volunteers.

pharmacokinetic drug interaction between solifenacin 10mg and tamsulosin 0.4mg in healthy male volunteers

Eligibility criteria:
inclusion criteria: * 19\~45 years healthy male * body weight is over 55kg, bmi measurement 18.0kg/m\^2\~ 27.0kg/m\^2 * signed informed consent form from to participate voluntarily and to comply with the trial requirements. * researchers determined suitable volunteers through physical examination, laboratory tests exclusion criteria: * history of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.) * sitting sbp\>150mmhg or \ 100mmhg or \<60mmhg, after 3 minutes break * an impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. * have a gastrointestinal disease history that can affect drug absorption (crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery) * history of drug abuse * positive urine drug screening * administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study. * donated blood within 60 days prior to the first administration day in this study.

Keywords: α1-blockers antimuscarinic agent
longitudinal study: diagnosis and prediction of pre-eclampsia by using congo red dot test in bangladesh and mexico

Conditions: Preeclampsia

Summary: a population-based prospective cohort design will evaluate the progression of urine congophilia in pregnancy using the congo red dot test by following patients longitudinally across gestation in bangladesh and mexico city.

a population-based prospective cohort design will evaluate the progression of urine congophilia in pregnancy using the congo red dot test by following patients longitudinally across gestation in bangladesh and mexico city. a total of 2000 women presenting for prenatal care will be enrolled (1000 at each site). in bangladesh, pregnant women will be identified during monthly home visits of community health workers (chw) affiliated with matlab in chandpur and asked to participate. in mexico, women will be identified at routine antenatal appointments. if the woman agrees to participate, investigators will ask her to consent to donation of urine for testing (congo red dot test and proteinuria dipstick test) at the time of enrollment, four times during her pregnancy (first trimester 6-12 weeks; second trimester 13-28 weeks; third trimester 29-36 weeks; term 37-41 weeks) and possibly three times postpartum (24 hours after delivery and daily until discharge). as a result, the enrolled patients will be followed longitudinally throughout pregnancy until delivery of the baby either at term for an uncomplicated gestation or preterm/term for preeclampsia. the group of women who develop preeclampsia will represent the study group. at the end of the study, the results will be analyzed to identify how many weeks in advance the women who developed preeclampsia displayed congophilia.

Eligibility criteria:
inclusion criteria: * pregnant * willing to give urine samples at prenatal visits * eligible to consent to research exclusion criteria: - none

Keywords: congo red dot test
staged extended thoracoscopic sympathicotomy for palmo-axillo-plantar hyperhidrosis

Conditions: Hyperhidrosis

Summary: evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

this is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of t3 to t12 on combined palmar and plantar hyperhidrosis. ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

Eligibility criteria:
inclusion criteria: * patients with combined palmo-axillo-plantar hyperhidrosis of asa grade i and ii exclusion criteria: * patients under 16 years. * patients with bradycardia (heart rate \<80 beats per minute). * patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion. * patients with cardiac problems with ejection fraction less than 60%. * patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar hyperhidrosis. * patients suffering from craniofacial hyperhidrosis, either isolated or combined with other areas of hyperhidrosis.
a study to assess yh002 in combination with yh001 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: a multicenter, open-label, phase i dose escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of yh002 in combination with yh001 in subjects with advanced solid tumors


Eligibility criteria:
inclusion criteria: to be eligible for study entry patients must satisfy all of the following criteria: 1. subjects must have the ability to understand and willingness to sign a written informed consent document. 2. subjects must have histologically advanced or cytologically confirmed solid tumor and and must have at least 1 unidimensional measurable lesion by recist 1.1. 3. subjects have progressed on after treatment with at least one standard therapy, or intolerant of the standard therapy, or no standard therapy accessible to the patients due to any reason. 4. subjects must be age 18 to 80 years of age at the time of screening. 5. subjects must have an eastern cooperative oncology group (ecog) performance status of 0 or 1. 6. life expectancy ≥3 months based on investigator's judgement. 7. subjects have adequate bone marrow and other organ function at the screening visit. 8. women of reproductive potential must have negative serum beta human chorionic gonadotropin (β -hcg) pregnancy test within 7 days of the first dosing. women of reproductive potential are those who have not been post-menopausal for at least 12 months or who have not undergone bilateral tubal occlusion, hysterectomy, or bilateral salpingectomy. exclusion criteria: subjects who meet any of the following criteria cannot be enrolled: 1. subjects have another active invasive malignancy within 5 years. 2. previous exposure to tnfr such as anti-ox40 antibodies. 3. subjects must not have received any anticancer therapy or another investigational agent within the shorter of 4 weeks or 5 half-lives before the first dose of the study treatment(subject to the longer one). 4. continuance of toxicities due to prior radiotherapy or chemotherapy agents that have not recovered to ≤ grade 1 per ctcae 5.0, except alopecia ≤ grade 2. 5. primary central nervous system (cns) malignancies or symptomatic cns metastases. 6. subjects must not have a known or suspected history of an autoimmune disorder, including but not limited to inflammatory bowel disease, celiac disease, wegner syndrome, hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment. 7. clinically uncontrolled intercurrent illness, including but not limit to an ongoing active infection, active coagulopathy, uncontrolled diabetes (blood glucose \> 250 mg/dl), uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies 8. subjects must not have active infection of human immunodeficiency virus, hepatitis b, hepatitis c or covid-19.
"efficacy of 1.2% rosuvastatin gel in the management of infrabony defects"

Conditions: Adult Periodontitis

Summary: study aims to evaluate clinical and radiographic effectiveness of 1.2% rosuvastatin gel in the treatment of infrabony defects in chronic periodontitis patients.

source from where the patients will be selected: 10 patients with chronic periodontitis having two or more infrabony defects will be selected from the outpatient section of dept. of periodontology, dr. d. y. patil dental college and hospital, pimpri, pune - 18. a detailed clinical examination, case history and written consent will be obtained from all the participants. before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. a full-mouth phase i therapy will be performed. a periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. the selected sites will be divided randomly by using a sequentially numbered, opaque, sealed envelopes (snose) randomization into control and test sites. the control site will be treated with access flap surgery (afs), whereas test sites will be treated with afs and 1.2% rosuvastatin gel. suitable antibiotics and analgesics will be prescribed along with chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. patients will be examined at 4 weeks, 3 and 6 month after surgery.

Eligibility criteria:
inclusion criteria: * age group between 30-50 years * probing pocket depth ≥ 5mm following initial therapy. * suitable interproximal angular infrabony defects of ≥3mm. * involved teeth should be vital and asymptomatic. * systemically healthy patients. * patients who demonstrate acceptable oral hygiene prior to access flap surgery. * patients agreed to sign informed consent and willing to return for the follow up visits. exclusion criteria: * systemic statin therapy * known or suspected allergy to the statin group * allergy to sulfur containing drugs * history of aggressive periodontitis. * presence of gingival recession at the surgical site. * mobility of study teeth ≥ grade i. * use of tobacco in any form. * pregnant and lactating women. * patients who have received any anti-inflammatory drugs and antibiotics in the previous six months. * h/o osteoporosis.

Keywords: intervention study rosuvastatin periodontitis