Kornimate/medical-research-clean huggingface dataset:
focal ablation of cervical precancer

Conditions: High-grade Cervical Intraepithelial Neoplasia

Summary: this is a pilot cohort study of women undergoing focal ablation for high-grade cervical intraepithelial neoplasia (hgcin). the cohort was recruited from the ucsf dysplasia clinics. the standard treatment involves treatment of the entire cervix. women with hgcin meeting inclusion criteria were recruited for enrollment into the pilot study of focal treatment. upon enrollment, they underwent focal ablational treatment rather than standard ablational treatment of the cervix. follow-up visits were conducted at 2 weeks and 6 months to assess safety, feasibility, and acceptability. the 6-month recurrence rate of hgcin will be calculated.


Eligibility criteria:
inclusion criteria: * age 21-45 yo * biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3 * satisfactory colposcopy, i.e., the entire transformation zone is visible * lesion occupying \<= 2 quadrants of the cervix. exclusion criteria: * unsatisfactory colposcopy. * colposcopic lesion extending into the endocervical canal beyond colposcopic visualization. * endocervical curettage positive for high-grade cervical intraepithelial neoplasia. * suspicion for invasive cancer on colposcopic exam. * glandular dysplasia or atypical glandular cells on cytology. * unreliable for follow-up. * immunosuppression (hiv, transplant recipient, etc.)
proximal priority versus distal priority robotic priming effects in patients with chronic stroke

Conditions: Stroke

Summary: this is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). the fugl-meyer assessment upper extremity subscale, medical research council scale, revised nottingham sensory assessment, and wolf motor function test will be administered at baseline, after treatment, and at the 3-month follow-up. two-way repeated-measures analysis of variance and the chi-square automatic interaction detector method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.

background. the sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. this study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (pri) and distal priority robotic priming and impairment-oriented training (dri). methods. this is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. participants will be randomized into pri or dri groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). the fugl-meyer assessment upper extremity subscale, medical research council scale, revised nottingham sensory assessment, and wolf motor function test will be administered at baseline, after treatment, and at the 3-month follow-up. two-way repeated-measures analysis of variance and the chi-square automatic interaction detector method will be used to examine the comparative efficacy and predictors of outcome, respectively, after pri and dri.

Eligibility criteria:
inclusion criteria: * the inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe ue motor impairment (i.e., total ue score of the fugl-meyer assessment \[fma\] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified ashworth scale score \ 24), no ue fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies. exclusion criteria: * the exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.

Keywords: upper extremity rehabilitation proximal priority distal priority robotic therapy bilateral motor priming impairment-oriented training task-oriented training
an implantable microstimulator for the chronic treatment of urinary urgency-frequency syndrome

Conditions: Overactive Bladder

Summary: the goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat urinary urgency-frequency syndrome.


Eligibility criteria:
key inclusion criteria: * age 18 years and above. * diagnosed with urinary urgency-frequency syndrome. * have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor. * have normal upper urinary tract function. * be capable of giving informed consent. * be capable and willing to follow all study related procedures. key exclusion criteria: * have any active implantable device regardless of whether stimulation status is on or off. * are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 month period. * less than one year post partum and/or are breast-feeding. * have any large passive implant that contains metal located within 30 cm of the chair pad while seated (e.g., hip replacement). * have conditions requiring magnetic resonance imaging (mri) evaluation. * have conditions requiring diathermy procedures. * have an inability to operate the bion remote control and bion recharging system either by self or caregiver. * have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes. * have history of coagulopathy or bleeding disorder. * have pelvic pain in the absence of voiding dysfunction. * have anatomical restrictions such that the study device placement is not possible. * are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function. * cannot independently comprehend and complete the questionnaires.

Keywords: urgency-frequency syndrome urinary refractory stimulation nerve neuromodulation microstimulator bion pudendal overactive bladder
pilot study of safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors

Conditions: Pediatric Brain Tumors

Summary: this is a single arm pilot trial within the pacific pediatric neuro-oncology consortium (pnoc). the pilot study will look at the safety and toxicity of acquiring hyperpolarized carbon-13 imaging in children with brain tumors.

this is an open label trial to assess the safety and tolerability of the adult tolerated dose of hyperpolarized pyruvate (hp) for metabolic imaging in children with brain tumors who do not require sedation for their mr imaging. nine patients will receive a single mr imaging examination that includes the acquisition of hyperpolarized 13c metabolic data in combination with anatomic, diffusion, perfusion and lactate edited 1h spectroscopic imaging data. the data will be processed using custom designed software to estimate changes in levels of lactate/pyruvate and to relate them to abnormalities observed in the data from other mr modalities. the results of this study will provide the safety data required to move this type of metabolic imaging into therapeutic trials to assess the utility of hp 13c lactate/pyruvate as a new surrogate marker of drug tumor penetration and early response to therapy in children with brain tumors.

Eligibility criteria:
inclusion criteria: * children ≥ 3 years and ≤ 18 years of age with a diagnosis of a brain tumor and who do not require sedation for mr imaging * karnofsky ≥ 70 for patients ≥ 16 years of age, and lansky ≥ 70 for patients \< 16 years of age (see appendix 1 performance status criteria) * patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent * patients must not be pregnant or breast feeding. women of childbearing potential are required to obtain a negative pregnancy test within 14 days of starting treatment. effective contraception (men and women) must be used in subjects of child-bearing potential * ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent exclusion criteria: * patients who are not able to comply with study and/or follow-up procedures * patients receiving active therapy on an investigational trial at the time of enrollment should consult with the study chair regarding potential interactions with other study agents. patients who are enrolled in a clinical trial but are off- therapy and in follow up are eligible. * patients with history or evidence of cardiac dysfunction

Keywords: brain tumor children
a prospective cohort study of patients suffering from hand osteoarthritis symptoms

Conditions: Hand Osteoarthritis

Summary: the late-stage forms of degenerative osteoarthritis (oa) are very debilitating and less affordable to therapy. the main objective is to identify early onset symptoms of hand oa patients through imaging techniques (such as ultrasound and mri). our primary endpoint is to specify patients with high risk of radiological profression (x-ray).


Eligibility criteria:
inclusion criteria: - early digital osteoarthritis must combine the clinical and radiological definition. clinical definition: at least one of the following 4 criteria: pain or stiffness or swelling or deformity of a digital joint (ipp and / or ipd) a breach of at least one ppi and / or ipd age under 60 at the time of the first symptoms clinical symptoms have been changing for less than 3 years radiographic definition: the presence of the achievement of at least one ppi and / or ipd. presence of at least two of the following three criteria: pinching, marginal subchondral condensation, marginal osteophyte erosion on radiography is not an exclusion criteria - consent form signed exclusion criteria: * patients suffering from rheumatoid arthritis, rheumatoid psoriasis or any other inflammatory rheumatism * patients suffering from metabolic diseasis such as gout, hemochromatosis, wilson's disease; or from congenital disease such as displasie, osteogenesis, * presence of advanced radiographic osteoarthritis based in kellgreen lawrence score (=4) in one joint among the 10 previous sites. * not able to provide a sample of blood for any reasons * mri contraindication * being in exclusion period determined by another previous study * subject non affiliated to social insurance * pregnant or lactating women * vulnerable people based in l1121-5 article of csp * elderly subject or protected subjects disabled to give their consent * subjects private of freedom by court or administrative order

Keywords: hand osteoarthritis prospective cohort cartilage mobility
serratus plane block versus serratus plane block plus parasternal block combination for breast surgery

Conditions: Analgesia; Cancer, Breast

Summary: mastectomy is a technique often used in breast cancer surgery. patients experience moderate to severe pain postoperatively after this procedure. various plane blocks, nsaids, and opioid analgesics can be administered to these patients as components of multimodal analgesia. in the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologist's physiologic state i-iii patients 2. to undergo mastectomy surgery 3. being between the ages of 18-65 years exclusion criteria: * having a known heart, kidney, liver or hematological disease * having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain * routine analgesic use and history of analgesic use in the last 24 hours * not willing to participate in the study * uncooperative patients who have coagulopathy or use anticoagulant drugs * to be allergic to one of the drugs to be used
a phase iii open-label study of gabapentin as adjunctive therapy in japanese pediatric patients with partial seizures

Conditions: Epilepsies, Partial

Summary: examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in japanese pediatric patients with partial seizures


Eligibility criteria:
inclusion criteria: * japanese male or females, ages 3-15 years old at acquisition of informed consent, 15 years old or less at the baseline visit * seizures are classified as simple partial, complex partial or partial becoming secondarily generalized (defined according to the international league against epilepsy) * have not been able to achieve adequate seizure control with antiepileptic drugs exclusion criteria: * seizures related to drugs or acute medical illness * history of any serious medical or psychiatric disorder * diagnosis or history of a structural cns lesion or an encephalopathy shown to be progressive
transcranial magnetic stimulation in disorder of consciousness in acute severe cerebrovascular disease patients

Conditions: Ischemic Stroke; Consciousness Disorder; Transcranial Magnetic Stimulation

Summary: this study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with doc while assessing patients with a hybrid neural network evaluation model. this model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with doc.

despite continued advances in life-sustaining intensive care for severe brain injury patients, little can be done to promote behavioral recovery in patients with disorder of consciousness (doc). arousal is the primary task in the rehabilitation of patients with impaired consciousness. evidence suggests that some medications and physical therapies can induce wakefulness by reactivating specific pathways that lead to impaired consciousness. however, due to the complexity of the type, degree, location, and other related influencing factors of brain injury, the current commonly used treatment options are not effective for patients with impaired consciousness, and the theoretical basis for benefit is not sufficient. this study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with doc while assessing patients with a hybrid neural network evaluation model. this model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with doc. before and after a course of treatment (20 days), activation and connectivity of patients' arousal centers will be assessed through a hybrid neural network evaluation model, which consists of comprehensive cortical connectivity parameters (perturbational complexity index and evoked high-frequency oscillations) and region-specific cortical connectivity parameters (short-latency afferent inhibition and mismatch negativity). each parameter is clinically used to assess a patient's level of cortex connectivity. this hybrid evaluation model may give a comprehensive evaluation of a patient's degree of awareness, and enhance our understanding of the mechanisms underlying these conditions.

Eligibility criteria:
inclusion criteria: * 7-28 days after ischemic stroke * behavioral profile consistent with a uws or mcs as assessed with the coma recovery scale revise * prestroke modified ranking scale(mrs) ≤2 exclusion criteria: * history of vascular malformation or aneurysmal sah or untreated aneurysm prior to stroke * disorder of consciousness prior to stroke * impairment of hearing * metal implants, e.g. stenting, pacemaker, etc. * contraindications to mri, such as claustrophobia * history of epilepsy or epileptic episodes * suffering from serious diseases such as malignant tumors, etc., with expected survival time \<1 year * patient is currently involved with other trials

Keywords: ischemic stroke consciousness disorder transcranial magnetic stimulation hybrid neural network evaluation model
no-touch radiofrequency ablation for recurrent hepatocellular carcinoma using triple cooled-wet electrodes

Conditions: Recurrent Hepatocellular Cancer; Chronic Liver Disease and Cirrhosis

Summary: to evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes


Eligibility criteria:
inclusion criteria: * child-pugh class a or b * chronic hepatitis b or chronic hepatitis c or liver cirrhosis * presence of recurrent hepatocellular carcinoma (hcc) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (ct) or magnetic resonance imaging (mri) according to liver imaging reporting and data system (li-rads) v2018 * single lesion less than or equal to 5 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment exclusion criteria: * number of recurrent hccs, equal or more than 3 * largest recurrent hcc size over 3 cm * presence of vascular invasion by hcc * platelet count less than 40,000 per mm3 or international normalized ratio (inr) prolongation over 50% * presence of extrahepatic metastasis

Keywords: no-touch radiofrequency ablation combined energy delivery mode triple cooled-wet electrodes
a coronary ivus study to compare torcetrapib/atorvastatin to atorvastatin alone in subjects with coronary heart disease

Conditions: Coronary Disease; Coronary Arteriosclerosis; Hyperlipidemia

Summary: the torcetrapib project was terminated on december 2, 2006 due to safety findings. to look at ultrasound images taken in the blood vessels of the heart and to look at various lipids in the blood of people with known coronary heart disease

for additional information please call: 1-800-718-1021

Eligibility criteria:
inclusion criteria: * angiographic evidence of coronary atherosclerosis exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant. * subjects with a clinically indicated need for statin (hmg-coa reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on ldl-c and hdl-c including fibrates and nicotinic acid. * subjects taking any drugs known to be associated with an increased risk of myositis in combination with hmg-coa reductase inhibitors. * subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study.
a study to evaluate the safety and efficacy of fb102 in patients with non-segmental vitiligo

Conditions: Vitiligo

Summary: a randomized, double-blind, placebo controlled, multi-center study to evaluate the safety and efficacy of fb102 in patients with non-segmental vitiligo.

approximately 16 participants who meet all the screening eligibility criteria will be randomized to receive fb102 or placebo.

Eligibility criteria:
inclusion criteria: 1. males and females aged ≥ 18 to 65 years at time of screening. 2. must have confirmed non-segmental vitiligo criteria at the screening visit and the baseline visit, as assessed by the study investigator. 3. if receiving concomitant medications for any reason other than vitiligo, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to day 1. participant must be willing to stay on a stable regimen during the duration of the study. note: there are additional inclusion criteria. the study center will determine if participant meets all of the criteria exclusion criteria: 1. currently have active forms of other hypopigmentation (including but not limited to vogt-koyanagi-harada disease, malignancy-induced hypopigmentation \[melanoma and mycosis fungoides\], post-inflammatory hypopigmentation, pityriasis alba \[minor manifestation of atopic dermatitis\], senile leukoderma \[age-related depigmentation\], chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, melasma, and congenital hypopigmentation disorders including piebaldism, waardenburg syndrome, hypomelanosis of ito, incontinentia pigmenti, dyschromatosis symmetrica hereditaria, xeroderma pigmentosum, and nevus depigmentosus). 2. currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (including but not limited to morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the screening or day 1 visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment. 3. greater than approximately 33% leukotrichia (depigmentation of the hair) in areas of vitiligo on the face as assessed by a healthcare professional at the time of screening. note: there are additional exclusion criteria. the study center will determine if participant meets all of the criteria
pmcf study on the safety, performance and clinical benefits data of the quattro x broadband

Conditions: Rotator Cuff Tears; Rotator Cuff Injuries

Summary: the study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. the purpose of this study is collect data confirming safety, performance and clinical benefits of the quattro® x suture anchor with broadband™ tape and instruments when used in rotator cuff repair. the primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). healing will be assessed by the investigator using proms and clinical outcomes of the patient. the clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. constant \& murley and eq-5d-5l) at 1 year post-operative. the safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.

the quattro® x suture anchor with broadband™ tape is intended for use in rotator cuff repairs. it is intended for for the reattachment of soft tissue to bone. up to three sites will be involved in this study. the aim is to include a total of 109 consecutive series cases who received the quattro® x suture anchor with broadband™ tape. all potential study subjects will be required to participate in the informed consent process. baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. during follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. moreover, a clinical assessment will be conducted. in addition, any complications and adverse events will also be collected during these follow-up visits.

Eligibility criteria:
inclusion criteria: 1. subject treated with the quattro® x suture anchor with broadband™ tape for rotator cuff repair; 2. older than 18 years and skeletally mature; 3. willing and able to comply with the study procedures; 4. subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program; 5. subject is able to read and understand the icf and has voluntarily provided written informed consent. exclusion criteria: 1. presence of infection; 2. insufficient or immature bone; 3. insufficient blood supply or previous infections which may hinder the healing process; 4. foreign body sensitivity; 5. subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant); 6. the subject is unwilling or unable to give consent or to comply with the follow-up program; 7. subject meets any contraindications of the appropriate instruction for use.

Keywords: post-market clinical follow-up study medical device performance safety clinical benefits