Kornimate/medical-research-clean huggingface dataset:
comparison of remnant-preserving anterior cruciate ligament reconstruction with healthy controls

Conditions: Anterior Cruciate Ligament Injuries

Summary: anterior cruciate ligament reconstruction stabilizes the knee joint biomechanically and returns the patients back to the sportive activities. numerous techniques exist to perform an anterior cruciate ligament reconstruction surgery. remnant- preserving reconstruction technique is performed to increase surgery success rates and to accelerate the post-surgical return to sport process. in general, there is no consensus regarding the clinical outcomes of remnant-preserving anterior ligament reconstruction over standart procedure. the purpose of this study is to compare the patients who had remnant-preserving anterior cruciate ligament reconstruction with healthy controls in terms of muscle strength and proprioception.


Eligibility criteria:
inclusion criteria: * anatomical single-bundle acl reconstruction with am portal technique using hamstring autograft due to full-thickness acl tear, * endobutton technique was used for femoral fixation, * not having any trauma or surgery on the opposite knee, * patients with a follow-up period of at least 12 months after surgery. exclusion criteria: * fracture of lower extremity accompanying anterior cruciate ligament tear; posterior cruciate ligament, inner and outer lateral ligament tears, * patients who have undergone previous surgery on the knee to be evaluated, * cases with repeated anterior cruciate ligament reconstruction, * having a history of knee joint arthritis (osteoarthritis, inflammatory arthritis), * cases with neurological disease will be excluded from the study.
comparison h-fire and laparoscopic rp in treating men with localized prostate cancer

Conditions: Prostate Cancer; Treatment

Summary: this trial is comparing the functional and oncological outcomes in treating men with prostate cancer between high-frequency irreversible electroporation and laparoscopic radical prostatectomy.

two hundred and sixteen patients with localized prostate cancer will include in this study. the clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-frequency irreversible electroporation; group 2, laparoscopic radical prostatectomy. the primary outcome is the urinary function and sexual function.

Eligibility criteria:
inclusion criteria: 1. age less than 80 years old. 2. psa\<20ng/ml. 3. clinical stage ≤t2c. 4. biopsy gleason score ≤4+4. 5. no evidence of metastasis. 6. fully understand the clinical trial protocol and sign the informed consent exclusion criteria: 1. any previous treatment to pca. 2. any previous surgery within 3 months. 3. contraindications to mri, bone scan, or psma-pet (eg, metal implant, contrast agent allergy). 4. history of any other malignant tumour. 5. any other conditions that make the investigator judge that participants are not suitable for this trial.

Keywords: focal therapy radical prostatectomy high-frequency irreversible electroporation prostate cancer
bioflow-sv portugal registry

Conditions: Ischemic Heart Disease

Summary: assessment of the clinical safety and performance of the orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm

prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. a minimum of 1000 patients will be enrolled in approximately 15 sites in brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online qca.

Eligibility criteria:
inclusion criteria: * subject is ≥18 years of age * subject must sign a patient informed consent (pic) or a patient data release form (pdrf) * subject must agree to undergo all required follow-up visits exclusion criteria: * pregnant and/or breast feeding females at the time of enrolment * known allergies to acetylsalicylic acid (asa), clopidogrel, ticlopidin, heparin or any other anticoagulant /antiplatelet required for pci, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated * currently participating in another study that has not yet reached the primary endpoint
older patients with newly diagnosed breast cancer or colon cancer

Conditions: Breast Cancer; Cognitive/Functional Effects; Colorectal Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: learning about changes over time in older patients' ability to function after receiving chemotherapy for breast or colon cancer may help doctors learn about the long-term effects of treatment and plan the best treatment. purpose: this clinical trial is studying older patients with newly diagnosed breast cancer or colon cancer.

objectives: * determine the correlation between the vulnerable elders survey (ves-13) and the battery of comprehensive geriatric assessment tools among breast and colon cancer patients, 65 years and older, in an outpatient setting. * assess and compare the abilities of the ves-13 and the battery of comprehensive geriatric assessment tools to predict chemotherapy adherence among these patients. * examine the validity of the ves-13 screening tool to identify increased risk of death from all causes at one year after initial ves-13 screening in these patients. * examine the validity of the ves-13 screening tool to identify increased risk of functional decline at one year after initial ves-13 screening in these patients. outline: patients complete the vulnerable elders survey (ves-13) and a comprehensive geriatric assessment at baseline and 12 months later. variables collected include sociodemographics; cognitive, nutritional, psychosocial, and emotional status; tumor characteristics; therapy; and mortality. patients are followed for 1 year for chemotherapy adherence and survival.

Eligibility criteria:
disease characteristics: * histologically confirmed breast or colon cancer * newly diagnosed disease * any stage disease * undergoing treatment at the ireland cancer center, university hospitals case medical center site * scheduled to start a new chemotherapy regimen (objective ii only) * not concurrently enrolled in a gem trial (objectives ii, iii, and iv) * hormone receptor status not specified patient characteristics: * understands english * menopausal status not specified prior concurrent therapy: * see diseases characteristics

Keywords: psychosocial effects of cancer and its treatment cognitive/functional effects breast cancer colon cancer
ohrqol and accelerated orthodontics with micro-osteoperforations

Conditions: Malocclusion

Summary: ohrqol assessment using ohip-14 between sliding anterior retraction with self-ligating brackets and micro-osteoperforations for accelerated orthodontics in orthognathic surgery patients who were assigned for pre-molar extraction and decompensation

our patients are participants in a randomized clinical trial, an ongoing study about the effectiveness of micro-osteoperforations to accelerate tooth movement. the study sample consisted of 22 consecutive subjects - 12 females and 10 males - between the ages of 18 and 35, who were selected for ortho-surgical treatment and pre-molar extraction assigned for decompensation. the participants were randomly allocated to two groups: control (anterior retraction was performed using implant-assisted sliding mechanics with self-ligating brackets) and experimental (micro-osteoperforations were performed in the activation appointments for anterior retraction using implant-assisted sliding mechanics). for immediate and follow-up assessment of patients' perceptions, comparing regular orthodontic activation and activation with accelerated orthodontics, subjects were asked to complete an electronic questionnaire ohip-14, to assess the participants' comfort level, experiences, and qol impact.

Eligibility criteria:
inclusion criteria: * maxillomandibular discrepancy indicative for orthognathic surgery, no previous dental extractions, good oral and general health, non-smokers, and no use of systemic corticosteroids or biphosphonates exclusion criteria: * any tooth absence/previous tooth extraction
burst optimized stimulation study

Conditions: Chronic Pain

Summary: this purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.

this is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms. subjects will be randomized 1:1:1 to one of the three groups. each group will evaluate all 3 stimulation paradigms in different order.

Eligibility criteria:
inclusion criteria: * subject has been implanted with a commercially available sjm spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain; * subject has been exclusively using burst stimulation for at least three months; * subject is 18 years of age or older; * subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation; * subject agrees not to add or increase pain-related medication from enrollment through the study duration; * subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits; exclusion criteria: * subject is currently participating in a clinical investigation study that includes an active treatment arm; * subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation; * subject has a non sjm neuromodulation device
national tunisian registry of percutaneous coronary intervention

Conditions: ACS - Acute Coronary Syndrome; Angor Pectoris; Myocardial Infarction; Myocardial Ischemia

Summary: the national tunisian registry of percutaneous coronary intervention is an observational, prospective and multicenter study aiming to assess coronary intervention strategies in tunisian departments of cardiology. cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. data will be captured electronically by dacima clinical suite, according to fda 21 cfr part 11 (food and drug administration 21 code of federal regulations part 11), hipaa (health insurance portability and accountability act) \& ich (international conference on harmonisation) requirements.


Eligibility criteria:
inclusion criteria: * tunisian patient needing pci (percutaneous coronary intervention) at the enrollment period * informed and signed consent exclusion criteria: * withdrawn consent

Keywords: acs pci mi
an evaluation of the safety and efficacy of methylone for the treatment of ptsd

Conditions: Post Traumatic Stress Disorder

Summary: this study is evaluating the safety and efficacy of methylone in adults with ptsd. the study is conducted in two parts. * part a is open-label and will enroll up to 15 participants with ptsd * part b is randomized (1:1:1), single-blind and will enroll up to 45 participants with ptsd eligible participants will enter a 3-week treatment period (part a) or 4-week treatment period (part b) where they will receive methylone once weekly. following the treatment period, participants will enter a 6-week follow-up period (part a) or 8-week follow-up period (part b).


Eligibility criteria:
inclusion criteria: * meets dsm-5 criteria for severe ptsd diagnosis, with a symptom duration of at least 6 months. * tried at least one treatment for ptsd (either psychotherapy or pharmacological treatment). * proficient in reading and writing in local language sufficient to complete questionnaires. * free from any other clinically significant illness or disease. exclusion criteria: * primary diagnosis of any other dsm-5 disorder. * body mass index (bmi) \<18kg/m2 or ≥40 kg/m2. * smokes an average of \>10 cigarettes and/or e-cigarettes per day. * uncontrolled hypertension at screening. * use of prohibited concomitant medications or therapies. * current or previous history of clinically significant cardiovascular/cerebrovascular conditions.

Keywords: methylone impact-2 ptsd neuroplastogen tsnd-201
hemostasis assesment after application of lyophilisate collagen in nail surgery

Conditions: Nails, Ingrown; Coagulation Defect; Bleeding

Summary: the objective of this study is to evaluate the hemostatic capacity of two types of collagen hemostatic sponges in nail surgery. it is a randomized triple-blind clinical trial with two experimental groups (medium porosity collagen and high porosity collagen) and control group ( non collagen).

to evaluate bleeding, all patients with onychocryptosis will be operated on with the same technique. in the experimental groups, once the surgical procedure has been completed on both edges of the nail, hemostatic collagen will be applied in the experimental groups (experimental group 1- medium porosity collagen and experimental group 2-high porosity collagen) in all groups, including the control, once the intervention was finished, the same bandage was performed with the same number of gauze pads. at 72 hours, the gauze set will be removed to weigh it using a precision balance and quantitatively evaluate the amount of bleeding. in this way, a comparative study can be carried out between the 3 groups and determine if there are statistically significant differences or not, and can determine if lyophilized hemostatic collagen is useful in nail surgery and if there are significant differences between both experimental groups, determining if the percentage of porosity in a hemostatic is relevant in the hemostatic effect.

Eligibility criteria:
inclusion criteria: * stadium i, ii, or iii (kline classification) without infective onychocryptosis (cellulitis) on both edges of the hallux * susceptible to phenol-alcohol technique with suppan i modification exclusion criteria: * platelet antiplatelet therapy * oral anticoagulant therapy * history of congenital or acquired hemorrhagic syndrome * alteration in the following parameters (platelet count, prothrombin time, activated thromboplastin time, and plasma fibrinogen)

Keywords: collagen nail ingrown bleeding surgery
a positive psychology intervention for fibromyalgia patients using ict´s

Conditions: Fibromyalgia; Chronic Pain

Summary: this study is aimed to test the efficacy of a positive psychology intervention (best possible self, bps) over optimism, future expectancies and positive affect at mid-term, in comparison to a control group, in fibromyalgia patients. the principal hypothesis is that the bps intervention will enhance significantly the levels of optimism, positive future expectancies and positive affect in comparison to the control group at short and mid-term.

previous studies have demonstrated the effects of positive psychological factors in pain adjustment. specially, optimism has been linked to lower pain sensitivity, better physical functioning, less psychological distress and pain catastrophizing. until recently, the beneficial effects of optimism on pain have been studied mostly in correlational studies or in experimental interventions in laboratory settings. to address the gap between research and clinical practice, the aim of this study is to test the efficacy of the best possible self intervention (bps) using information and communication technologies (icts) with fibromyalgia patients. bps is a guided imagery exercise that requires participants to envision themselves in the future, achieving desired goals in different areas of their lives. this exercise has shown efficacy improving optimism, future expectancies and positive affect compared to a control condition, in general population (meevissen, peters \& alberts, 2011; sheldon \&lyubomirsky, 2012; peters, flink, boersma \& linton, 2010). taking into account the prior literature, the aim of the present study is to carry out a randomized controlled study in order to replicate the findings about the effects of bps on optimism, mood and affect in a chronic pain population. the exercise will be applied through a positive technology system and the effects will be analyzed during four months. the design employed in this study is similar to the used in other studies (meevissen et al, 2011; renner, schwarz, peters \& huibers, 2014; sheldon \& lyubomirsky, 2006).

Eligibility criteria:
inclusion criteria: * patients have to fulfill the american college of rheumatology criteria for primary fms. * sign a consent form stating their willingness to participate exclusion criteria: * presence of another severe physical illness * presence of severe psychological disorders * be currently involved in another psychological treatment

Keywords: best possible self positive psychology optimism positive technologies future thinking pain catastrophizing
using npt to evaluate providing ppc as elnec-ppc wbt for nurses

Conditions: Cancer; Cardiac Anomaly; Cystic Fibrosis; Muscular Dystrophy; HIV/AIDS; Batten's Disease; Cerebral Palsy

Summary: the purpose of this study is to explain the provision of palliative care at the end of life by the implementation of the elnec course, as wbt program using the normalization process theory, that focus attention on how complex interventions become routinely embedded in practice. in addition to, identify the changes implemented by the participant nurses (intervention group) in their clinical practice, after participating in wbt program to provide palliative care alongside with usual care versus usual care only (control group) for children with life-limiting conditions or in the case of accidents/sudden death, at the end of life. and finally, provide findings that will assist in the interpretation of the trial results.


Eligibility criteria:
inclusion criteria: * the health care centers where the intervention will be administered include 1) imam sadiq (peace be upon him) teaching hospital; 2) babylon maternity and children teaching hospital; 3) al-noor hospital for children; 4) morgan teaching hospital, and 5) babylon oncology center. * the study population will be included all college nurses who completed their bachelor's degree and who have (master's or doctorate) degree in nursing sciences, that being employed for at least three months and not expected to be transferred to another unit within the study period during either morning or evening shifts and provides nursing care for both male and/or female of hospitalized patients 18 years. * use a computer (desktop or laptop) with access to the internet at home or work (phone line or internet access), or use a smartphone (with at least android 6.0+ or ios11. 0+) with internet access (wi-fi and/or mobile data) to join the online training course. * have a working email address and/or a working mobile number and have access to a computer or smartphone with internet access to complete questionnaires in a web browser. exclusion criteria: * not interested. * not being employed for at least three months. * academic nurses who employed and continuing to work with other than selecting units, due to the carefully chosen only units that provide nursing care for both pediatric and adults or for pediatric, in order to achieve the study objectives. * enrolled in another experimental trial.

Keywords: life-limiting illnesses pediatric palliative care normalization process theory end-of-life care web-based training intervention
effectiveness of metformin compared to insulin in pregnant women with mild preexisting or early gestational diabetes

Conditions: Non Insulin Dependent Diabetes; Pregnancy

Summary: many women come into pregnancy with diabetes that is controlled with either metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. what remains unproven is the ability of metformin to adequately control glucose in women during pregnancy. our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based regular and neutral protamine hagedorn (nph) insulin or metformin. our hypothesis is that metformin will provide glycemic control that is equivalent to insulin in these women.


Eligibility criteria:
inclusion criteria: * receiving prenatal care at university of north carolina (unc), chapel hill obstetric clinics and planning delivery at unc women's hospital * diagnosis of diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control * diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (nddg)criteria * less than 24 weeks at study enrollment * singleton or twin pregnancy * english or spanish speaking * able to give informed consent exclusion criteria: * end organ complications of diabetes (retinopathy, renal insufficiency, etc.) * prior need for insulin for glycemic control * history of diabetic ketoacidosis (dka) or hyperosmolar state * prior adverse reaction (ie. lactic acidosis) or allergy to metformin * kidney or liver disease * significant medical co-morbidities (lupus, cystic fibrosis, etc.) hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.

Keywords: non insulin dependent diabetes pregnancy
pharmacodynamics and pharmacokinetics of insulin detemir in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin nph in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * subjects treated with insulin for minimum 3 months * duration of diabetes for at least 12 months * body mass index (bmi) below 30 kg/m\^2 * hba1c maximum 10% based on analysis from central laboratory exclusion criteria: * current treatment with insulin above 1.2 u/kg/day * current treatment with insulin glargine * current treatment with drugs known to interfere with glucose metabolism * current treatment with oral antidiabetic drugs