Kornimate/medical-research-clean huggingface dataset:
long-term study to evaluate different dental implant alloys in straumann 3.3mm diameter bone level implants

Conditions: Jaw, Edentulous

Summary: patients with an edentulous mandible restored with implants who have participated in the core study cr 04/07 will be recruited for this extension study. no further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires. patients will not receive an investigational treatment in this study. patients will be followed at 5 to 10 years from the date of the original implant loading

the primary study objective is to compare implant survival with the titanium zirconium (roxolid™) implant compared the titanium grade iv (slactive®) implant between baseline (surgery) and 10 years. the following outcome parameters will be evaluated at 5 and 10 years post surgery for the two different implant types straumann® bone level slactive, diameter 3.3 mm, titanium-zirconium (roxolid®) vs. straumann® bone level slactive implant, diameter 3.3 mm, titanium grade iv: * implant survival * implant success according to buser et al. (1990) * crestal bone level change measured by orthopantomogram (opt) * soft tissue health * clinical measurements * prosthetic parts assessments: success and maintenance * oral health related quality of life (ohrqol) * product safety (adverse events and device deficiencies)

Eligibility criteria:
inclusion criteria: * subjects must have voluntarily signed the informed consent form * patients must be committed to participate in the study until the ten year follow-up examinations * subjects must have received treatment in the cr 04/07 core study * subjects must have completed 3 year visit of core study exclusion criteria: * physical handicaps that would interfere with the ability to perform adequate oral hygiene or attend follow up visits * use of any investigational drug or device during the study * conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability
analgesic effects of intravenous paracetamol on labor pain

Conditions: Labor Pain

Summary: the purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical class i-ii * term patients (≥ 37 weeks of gestation) exclusion criteria: * previous cesarean section * hypertension, pre-eclampsia, eclampsia * intra-uterine growth retardation * intrauterine fetal death * morbid obesity (body mass index ≥ 35) * allergy to any of the study drugs
treating emotional processing impairments in individuals with tbi

Conditions: Traumatic Brain Injury

Summary: the current project will examine the impact of an emotional processing intervention on emotional processing abilities in a sample of 50 persons with moderate to severe tbi. outcome will be assessed across 3 domains. we will document changes resulting from treatment: (1) in emotional processing tasks (2) in other areas of function including qol, social functioning, mood and cognition that are also likely to be impacted (3) in brain structure and function. the examination of efficacy in the above three areas will further our knowledge of emotional processing deficits in tbi and more importantly, identify an effective means of treating such deficits.

emotional processing deficits have a significant negative impact on the lives of persons with tbi. there is emerging research indicating that, in addition to cognitive and behavioral impairments, social and emotional difficulties following tbi are common and are related to significant problems in social relationships, poor social participation, impaired empathy, and a high degree of caregiver stress. emotional processing is a critical component of social cognition, including the abilities to both identify and discriminate basic universal emotions. the stability of emotional processing deficits following tbi indicates that these impairments likely impact individuals with tbi consistently across the lifespan, and do not appear to resolve with time. the goals of the trial are to (a) evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with tbi, (b) evaluate the improvement of secondary outcomes of psychological, cognitive, and functional abilities following the emotional processing intervention in individuals with tbi, (c) to examine differences in brain activation patterns during emotional processing following treatment in individuals with tbi, bold activation in the experimental group will be compared to bold patterns of the control group during performance of the qfdt, a facial affect recognition task.

Eligibility criteria:
inclusion criteria: * diagnosis of traumatic brain injury (tbi) * can read and speak english fluently exclusion criteria: * prior stroke or neurological disease. * history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of major depressive disorder, schizophrenia, epilepsy, bipolar disorder * significant alcohol or drug abuse history

Keywords: emotional processing cognition traumatic brain injury intervention
bio-electrical impedance analysis derived parameters for evaluating fluid accumulation

Conditions: Critically Ill

Summary: the purpose of this study is to assess fluid accumulation (fa) in the body using bia (bioelectrical impedance analysis) in critically ill patients treated in the icu. this study is an observational cohort with an initial phase that analyzes prospective individual patient data

this research will begin by identifying subjects through the collection of initial data. the identification of subjects will involve using bia (bioelectrical impedance analysis) equipment. subsequently, the subjects will be divided into two groups based on the initial bia test results of body fluid balance. the first group will comprise patients with a body fluid balance exceeding 500cc, while the second group will consist of patients with a body fluid balance of 500cc or less. throughout the study, various bia-derived parameters will be closely monitored for both groups, starting from the initial bia test until the patients are discharged from the icu or for a maximum of 7 days of icu care from the time of the first test.

Eligibility criteria:
inclusion criteria: * new patients admitted to intensive care unit cipto mangunkusumo hospital and indonesia university university * willing to be included in this research and signed the consent form exclusion criteria: * obesity(bmi\>35kg/m²) or underweight (bmi \< 18,5 kg/m²) * pregnant or breastfeeding

Keywords: bio-electrical impedance analysis fluid accumulation
data collection after intensity iol implantations

Conditions: Cataract

Summary: hanita lenses new intensity iol and intensity toric were been designed to have very high efficiency of light leading to a high mtf, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. the main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

different multifocal intraocular lens (miol) designs have been used for more than 25 years1. unlike conventional mono focal intraocular lenses (iols), which bend light to a single focus point on the retina, miols are designed to help patients to see at varying distances using different points of focus2. miols used in clinical practice were either refractive initially, or later diffractive in their optical design. refractive miols incorporate a lens optic with different optical powers in different parts of the lens, while diffractive miols use diffractive steps on the lens to distribute light rays into two or more principal foci. irrespective of the design type, however, all miols involve some form of optical compromise and a process of neuroadaptation for the patient. intensity sl intraocular lenses (iols) represent the latest in premium lens technology. intensity sl lenses provide clear vision at all distances - from near to far - thus offering the best chance of true spectacle independence. despite the promising results obtained with the latest generation of miols, many surgeons remain reluctant to implant these lenses. visual symptoms such as glare and haloes, reduced contrast sensitivity and night vision problems are all known complications of multifocal implants and have served to hamper wider acceptance of these iols4. hanita lenses new intensity iol and intensity toric were been designed to have very high efficiency of light leading to a high mtf, wide focal ranges of far, intermediate and near vision and minimal loss of light energy. the main purpose of this study is to collect existing post-operative data based on standard of care follow up visits at the clinic.

Eligibility criteria:
inclusion criteria: * patient over the age of 18 * patient who underwent bilateral implantations with hanita lenses intensity iol exclusion criteria: * patients who don't have any follow up visits after implantation

Keywords: intra ocular lens intensity sl hanita lenses cataract
treatment results for patients with central centrifugal cicatricial alopecia (ccca): a multicenter prospective study

Conditions: Central Centrifugal Cicatricial Alopecia (CCCA)

Summary: the objective of this study is to examine photos of ccca patients taken before and after treatment to compare treatment outcomes between different treatment groups

treatment groups that patients will be randomized to include 1) topical steroid plus oral antibiotic group, and topical minoxidil after 8 months 2) topical steroid plus intralesional steroid group and topical minoxidil after 8 months. both these regimens are used as the first-line treatments by clinicians. the objective of this study is to examine photos of ccca patients taken before and after treatment to compare treatment outcomes between different treatment groups. in this study, the investigators are looking to determine how standard treatment affects the outcome of central centrifugal cicatricial alopecia; to determine if topical steroid with with doxycycline has better outcome than topical steroids with intralesional steroids in central centrifugal cicatricial alopecia, and to determine how the addition of topical minoxidil as a treatment changes the outcome of central centrifugal cicatricial alopecia.

Eligibility criteria:
inclusion criteria: * african-american women, ages 18-60 years old * with a clinical diagnosis and biopsy-proven ccca, with central scalp alopecia scale severity 1 through 4 will be included in this study * these subjects will be seen and treated in wake forest baptist health dermatology outpatient clinic exclusion criteria: * patients with other forms of hair loss in addition to ccca will be excluded * other patients to be excluded are those with other forms of inflammatory scalp disease (with the exception of mild seborrheic dermatitis) * patients who have had topical treatment for ccca within the past 4 months (including topical steroids, topical minoxidil, or any other topical hair regrowth medication) * patients who have been on a long-term oral antibiotics for hair loss within the past year * patients who have undergone more than two rounds of intralesional steroid injections to the scalp in the past one year.

Keywords: alopecia hair loss female hair loss minoxidil topical steroid
a study of safety and efficacy comparing abt-874 versus methotrexate in subjects with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: this study is being conducted to compare the efficacy of abt-874 versus methotrexate in subjects with moderate to severe plaque psoriasis.

this study is only being conducted in the eu and canada

Eligibility criteria:
inclusion criteria: * diagnosis of psoriasis for 6 mo.. bsa 10%, pasi 12 or above, pga 3 or above exclusion criteria: * previous exposure to anti-il 12

Keywords: psoriasis
a study to evaluate the safety and tolerability of efgartigimod ph20 sc given by prefilled syringe in kidney transplant recipients with antibody-mediated rejection (amr)

Conditions: Antibody-mediated Rejection

Summary: the purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod ph20 sc given by a prefilled syringe in participants with antibody-mediated rejection (amr) after kidney transplantation. after a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. the study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). at the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). the participants will be in the study for up to 78 weeks.


Eligibility criteria:
inclusion criteria: * the participant is within the ages of 18 and 80 years old * the participant had a kidney transplant (living or deceased donor) at least 6 months before the study * the participant has received a diagnosis of active or chronic active antibody-mediated rejection (amr) with detectable donor-specific antibodies at time of the study * a participant may be allowed into the study if they receive the following medications: 1. received mycophenolate mofetil for at least 20 weeks before the study 2. has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study 3. has remained on tacrolimus doses between 5 to 10 ng/ml at least 4 weeks before being allowed to participate in the study 4. steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study exclusion criteria: * confirmed t-cell or mixed rejection at time of the study * recent change in immunosuppressive therapy agents * any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk * pregnant or lactating state or intention to become pregnant during the study the complete list of criteria can be found in the protocol

Keywords: active amr chronic active amr late amr
a study of reduced-dose radiation in people with metastatic tumors with a genetic change

Conditions: Metastatic Cancer

Summary: this study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an atm mutation. the researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.


Eligibility criteria:
inclusion criteria: * histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy * pathogenic mutation in atm (somatic and germline allowed) * ecog performance status 0-2 * age ≥ 18 years. * able to provide informed consent. * patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments. * expected life expectancy of at least 6 months exclusion criteria: * previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. * serious medical co-morbidities precluding radiotherapy. * pregnant or breast-feeding women. * lesions excluded from de-escalation include regions in which the risk of local disease progression is unacceptably high, including cns disease and cord compression, and areas in which re-irradiation would not be feasible, including spinal cord overlap.

Keywords: reduced-dose radiation pathogenic mutations atm (ataxia telangiectasia mutated) 21-310
a study of tirzepatide (ly3298176) in japanese participants with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purposes of this study are to determine: * the safety of tirzepatide and any side effects that might be associated with it. * how much tirzepatide gets into the bloodstream and how long it takes the body to remove it. * how tirzepatide affects the levels of blood sugar. this study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (sc) injections just under the skin. the study will last about 16 weeks (total), including screening and follow-up. this study is for research purposes only and is not intended to treat any medical conditions.


Eligibility criteria:
inclusion criteria: * have t2dm controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin or dipeptidyl peptidase \[dpp\]-iv inhibitors) * have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive exclusion criteria: * have known allergies to tirzepatide, glucagon-like peptide (glp)-1 analogs, or related compounds * have had more than 1 episode of severe hypoglycemia, as defined by the american diabetes association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion of the investigator, increases the risks associated with participating in the study * have a history or presence of pancreatitis or gastrointestinal (gi) disorder or any gi disease which impacts gastric emptying or could be aggravated by glp-1 analogs or dpp-iv inhibitors
vitus post-market registry

Conditions: Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease

Summary: to collect post marketing surveillance data on consecutive patients with peripheral arterial occlusive disease (paod) intended to be or treated by the vitus peripheral drug-coated dilatation catheter when used according to the instructions for use and treating physician decision. data will be collected in order to assess the long-term safety and performance of the vitus peripheral drug-coated dilatation catheter in routine clinical practice.

the multicenter, prospective registry population consists of consecutive patients with peripheral arterial occlusive disease (paod) who undergo percutaneous transluminal angioplasty (pta) intervention and are intended to be or treated by the vitus peripheral drug-coated dilatation catheter (according to the instructions for use) as part of routine clinical care. approximately 284 patients from approximately 15 centers in europe will be entered into the registry. patients entered into the registry are followed for three years. the registry is considered finished when all patients have completed the 36-month follow-up. a follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, and 36 months. follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Eligibility criteria:
inclusion criteria: * consecutive patients intended to be or treated by the vitus peripheral drug-coated dilatation catheter as per physicians' decision and according to ifu in the setting of routine clinical care are entered into the registry * the lesion to be treated should be shorter than the nominal length of balloon at a reference vessel diameter of 2.0 mm up to 7.0 mm. * if lesion is longer than the individual balloon, more than one dcb can be used for longer lesions with the mandatory overlapping balloons of 10mm to avoid any geographical miss. * rutherford clinical categories 2-5 exclusion criteria: * the patients are excluded from registration if any of the following conditions apply: * high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * currently participating in another investigational drug or device study in which a routine angiographic follow-up in peripheral arteries is planned * a life expectancy of \<1year * explicit refusal of participation in the registry * residual stenosis \>50% after vessel preparation

Keywords: peripheral arterial disease (pad) peripheral disease percutaneous transluminal angioplasty (pta) drug-coated balloon drug-coated catheter drug coated balloon (dcb)
treatment of chlamydia infection comparing wc2031 tablets with vibramycin

Conditions: Urogential Chlamydia Trachomatis Infection

Summary: evaluate the clinical efficacy and safety of wc2031 200 mg tablets taken orally once a day for 7 days versus vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital chlamydia trachomatis infection. primary efficacy endpoint is microbiological cure at day 28. safety assessments are adverse events, changes in vital signs and laboratory test results.


Eligibility criteria:
inclusion criteria: * 19-45 years of age, male or female * presumed diagnosis of urogenital c. trachomatis infection * use condoms during sexual activity during study (enrollment thru day 28) exclusion criteria: * clinical diagnosis pelvic inflammatory disease or epididymitis at baseline * diagnosis of n. gonorrhoea * hiv infection * active hepatitis b or c infection * prior hysterectomy (partial or total) * treatment with antimicrobial therapy with known activity against urogenital c. trachomatis within 28 days of enrollment

Keywords: chlamydia
treatment of metastatic melanoma with autologous melan-a/mart-1 specific ctl clones

Conditions: Immunotherapy

Summary: most of hla-a2 melanomas express melan-a/mart-1 antigen and are recognized by tumor reactive melan-a specific t lymphocytes. by using blood samples from hla-a2 melanoma patients (stage iii and iv), our goal is to produce a tumor reactive melan-a specific t cell clones and to conduct a phase i-ii clinical trial, based on the infusion of several millions to several billions of these lymphocytes to the patient, in order to induce passive immunity against this antigen. production of the clones will be performed in the unit for cellular and gene therapy from nantes university hospital. therapeutic response, safety treatment but also localization and survival of infused t cell clones will be assessed. this approach is expected to precise the ability of the clones to migrate within the tumor and to transfer specific immunity.


Eligibility criteria:
inclusion criteria: * hla-a2 melanoma patients with : * either loco-regional or lymph node metastasis * transit nodules not surgically resectable * measurable cutaneous or visceral metastasis * patients' tumor express melan-a/mart-1 antigen. * no chemotherapy treatment (except for deticene used before the first t cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion. * no other melanoma treatment during the protocol. * life expectancy should be greater than 6 months. * general state with karnowsky greater than 80, ecog = 0, 1 or 2. * patient should be negative for hiv and b and c hepatitis. * biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal. * signed informed consent exclusion criteria: * cardio-vascular pathologies, evoluting and uncontrolled, (severe hta), cardiac deficiency, severe angor, severe arrhythmia. * infectious pathologies evoluting and requiring antibiotherapy. * patients hiv+. * transplanted patients or patients suffering from severe auto-immune disease. * psychiatric troubles that do not allow the protocol follow-up. * pregnant or breast-feeding women. * no contraception.

Keywords: melanoma, melan-a tumor reactive t cell clones, immunotherapy hla-a2 melanoma patients with either loco-regional or lymphnode metastasis transit nodules not surgically resectable -measurable cutaneous or visceral metastasis . patients' tumor express melan-a/mart-1 antigen.