Kornimate/medical-research-clean huggingface dataset:
micra atrial tracking using a ventricular accelerometer 2

Conditions: Atrioventricular Conduction Block

Summary: the purpose of the micra atrial tracking using a ventricular accelerometer 2 (marvel 2) study is to demonstrate safe and effective operation of the marvel 2 features for providing av synchronous pacing in patients with normal sinus node function and av block

the marvel 2 study is an acute, prospective, global, multi-center, software-download clinical study. the study is planned to be conducted in us, europe, and asia. the study is expected to be conducted at approximately 15-20 centers in up to 100 subjects to obtain at least 70 usable holter datasets to meet the objectives of the study. the expected total study duration (from first subject enrollment to the exit of the last subject) is approximately 6-months; this represents the time necessary to enroll the target sample size of at least 70 subjects with usable holter datasets. software will be downloaded into patients implanted with a micra device to allow the new algorithm performance to be measured in patients where a micra device has already been chosen as most appropriate for the patient. most enrolled subjects will complete the study procedures during a single study visit. however, subjects enrolling in the study at the time of their micra implant (anticipated to be approximately 10 subjects) will have the investigational algorithm downloaded following micra implant, prior to hospital discharge, and approximately 1-month post-implant. this subset of subjects with de novo micra implants will allow the marvel 2 features to be tested at multiple points in the device life cycle. since the download algorithm running in a micra device significantly increases current drain, a 2-4 hour acute study is used to limit the reduction in device longevity.

Eligibility criteria:
inclusion criteria: * subject has been implanted with a micra tps (model mc1vr01) with remaining device longevity of 6 years or more or is expected to be implanted with a micra tps. * subject has history of av block\* * subject is ≥ 18 years old and as per required local law. * subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements. * subject is willing and able to comply with the protocol. \*this includes subjects with normal sinus function and persistent 3rd degree av block and subjects with other forms of av block. exclusion criteria: * subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the medtronic clinical research specialist. * subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to marvel 2 study procedures). * subject meets any exclusion criteria required by local law (age or other).
ql1203 in combination with chemotherapy for metastatic colorectal cancer to determine efficacy and safety

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to determine the treatment effect of ql1203 in combination with mfolfox6 compared to placebo in combination with mfolfox6 as first line therapy for metastatic colorectal cancer.

the study is a randomized, double-blind, placebo-controlled, multi-center phase iii study. it is planned to enroll 590 patients with previously untreated wild-type ras metastatic colorectal cancer. subjects are randomized into the ql1203 combined with oxaliplatin/5-fluorouracil/ leucovorin or placebo combined with oxaliplatin/5-fluorouracil/ leucovorin treatment group by a ratio of 2:1.

Eligibility criteria:
inclusion criteria: * diagnosed as metastatic colorectal adenocarcinoma and is not suitable for local treatment such as radical resection, radiotherapy, radiofrequency and so on. * man or woman at least 18 years old. * at least one measurable lesion can be evaluated according to response evaluation criteria in solid tumors 1.1（recist1.1） criteria. * eastern cooperative oncology group (ecog) performance status should be 0-1 before randomization. * the level of organ function must meet the requirements before randomization. * prior to randomization, the damage caused by other treatments had recovered to \< grade 2 (ctcae version 4.03). exclusion criteria: * prior systemic or local chemotherapy for colorectal cancer，except in the following cases: the interval between the last dose of neoadjuvant or adjuvant therapy and recurrence\> 6 months。 * prior epithelial growth factor receptor(egfr)-targeted drugs for colorectal cancer. * presence of central nervous system (cns) metastases before the informed consent was signed, except for those who had stabilized cns metastases for more than 4 weeks and had no symptoms after treatment. * history of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment. * history of interstitial lung disease. * existing intestinal obstruction before randomization, active inflammatory bowel disease. * patients with non-healing abdominal fistula and gastrointestinal perforation before randomization. * there were severe active infections or uncontrollable infections that required systemic treatment and could not be enrolled at the decision of the investigator within 14 days before randomization.
effect of extended cannabis abstinence on ptsd symptoms

Conditions: PTSD; Cannabis Use; Cognitive Symptom; Comorbidities and Coexisting Conditions

Summary: this will be a 12-week randomized trial. outpatients and patients from the mood and anxiety program at the centre for addiction and mental health (camh) with a current diagnosis of post-traumatic stressed disorder (ptsd) and cannabis-use disorder (cud) will be randomized to receive individual motivational interviewing therapy and contingency management (n = 12) or individual motivational interviewing therapy alone (control group, n = 12) after enrolment.


Eligibility criteria:
inclusion criteria: 1. subjects aged between 18 and 55 years (from both sexes \[or genders\]); 2. diagnosed with cud (moderate or severe) according to the structured clinical interview for dsm-iv (scid) (mode of cannabis consumption can be inhalation or ingestion); 3. diagnosis of current (past 30 days) ptsd, using the caps-5 on screening; 4. on antidepressant medication(s) for at least 1 month (to ensure safety and homogeneity as ptsd treatment of our population); 5. be able to provide written informed consent; and 6. be able to communicate in english. exclusion criteria: 1. diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per the study physician; 2. diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder or current acute psychosis or mania based on dsm-5 criteria; 3. current suicidality risk as indicated by the columbia suicide severity rating scale (c-ssrs) with concurrence after the study physician's evaluation if the response to c-ssrs questions 1 or 2 is "yes" 34; and 4. have pain interfering with normal function as reported by the 12-item short form survey (sf-12) (moderate or higher interference).
effect of brimonidine tartrate ophthalmic solution 0.15% on pupil diameter in normal eyes

Conditions: Healthy

Summary: the objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic solution 0.15% (alphagan p) on pupil diameter under different luminance conditions.


Eligibility criteria:
inclusion criteria: * adult active duty personnel between 18 and 50 years of age with best corrected visual acuity of 20/20 or better. exclusion criteria: * patients not meeting above stated age criteria * females that are pregnant or lactating (non pregnant females of childbearing potential will have pregnancy test prior to participating in study) * history of serious ocular, neurological, cardiovascular disease * history of severe systemic disease * history of arrhythmias or high blood pressure * patients currently taking any type of ocular or systemic medications except multivitamins. * patients with abnormal pupil shape, addie's pupil, anisocoria, or abnormal pupil defect.

Keywords: large pupils rendering night vision difficulties such as haloes, glare, and monocular diplopia
efficiency of fractional-laser resurfacing followed by topical tacrolimus 0.03% cream vs tacrolimus alone in vitiligo

Conditions: Stable Vitiligo

Summary: the aim the clinical trial was to find out whether fractional co₂ laser sessions in combination with application of daily topical tacrolimus 0.03% would enhance the action of the drug and pose as a possible combination treatment option for stable vitiligo lesions. this combination treatment was applied to one side of the body and the response was compared to the response of the lesions on the other side of the body to daily topical tacrolimus 0.03% alone, which was used as control.

each patient included in the study received treatment a on the lesions on one side of his/her body, and treatment b on the other side. treatment a included 4 monthly sessions of fractional co₂ laser on the lesions plus application of topical tacrolimus 0.03% (tarolimus) on the lesions 6 hours after each session and twice daily in between the sessions and for 1 month after the last session. treatment b included only the application of topical tacrolimus 0.03% (tarolimus) on the lesions twice daily for 5 months. fractional laser the device used was deka, smartxide dot (dermal optical thermolysis), italy fractional carbon dioxide laser (fig. 8). this device is an ablative fractional 10,6000 nm co² laser with variable pulse duration (0.2-2 ms), 350-μm beam spot size, scanner area of 15x15 mm and penetration depth between 200 to 1,500 μm. tacrolimus ointment 0.03% (tarolimus) applied on the lesions treated by fractional co² laser 6 hours after each laser session, then twice daily in between the sessions and 1 month after the last session. applied on the lesions on the other half of the body (not treated with fractional co² laser) twice daily for 4 months.

Eligibility criteria:
inclusion criteria: * patients with stable vitiligo for at least 6 months, stability being defined as no eruption of fresh lesions and no extension of pre-existing lesions. * age ≧ 12 years. * symmetrical vitiligo. * three month treatment-free period. exclusion criteria: * patients younger than 12 years of age. * non-stable lesions. * non-symmetrical vitiligo. * patients currently on other lines of treatment.

Keywords: vitiligo fractional carbon dioxide laser tacrolimus drug delivery
sentinel node and endometrial cancer

Conditions: Endometrial Neoplasms

Summary: the purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. sentinel node is thought to reflect the status of lymph node. only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. in breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.

to investigate the relevance of sentinel node in endometrial cancer. sentinel node is though to reflect the status of lymph node. only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. in breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. the objective of our trial is to validate the concept of sentinel node in endometrial cancer.

Eligibility criteria:
inclusion criteria: * patient over 18 years old with a surgery planned for endometrial cancer * endometrial cancer proved by biopsy * early stage of endometrial cancer (figo stage 1-2) * without contraindication to surgery * inform consent signed * affiliated to general health system exclusion criteria: * endometrial cancer figo stages 3-4 * previous history of surgery modifying lymphatic drainage (conization myomectomy) * pregnant women or breast feeding

Keywords: sentinel node procedure radiocolloid patent blue
trial comparing alignment techniques - rsa of attune knee system

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the attune s+ cr-fb knee system using model-based rsa over the first 2 post-operative years.

this is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the attune s+ fixed bearing tkr system. patients will be randomized to two study groups: 1. neutral mechanical alignment; 2. anatomical alignment. the principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the attune s+ cr-fb knee system using model-based rsa over the first 2 post-operative years. secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery.

Eligibility criteria:
inclusion criteria: 1. symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty 2. varus knee deformity of 0 to 10 degrees 3. sufficient ligamentous function to warrant retention of the posterior cruciate ligament 4. between the ages of 21 and 80 inclusive 5. patients willing and able to comply with follow-up requirements and self-evaluations 6. ability to give informed consent exclusion criteria: 1. active or prior infection 2. medical condition precluding major surgery 3. inflammatory arthropathy 4. prior patellectomy 5. pcl deficiency 6. major coronal plane deformity 7. valgus alignment 8. bone defects requiring augments, cones and/or stemmed implants 9. body mass index 45 or more
the alteration of gut microbiota and analysis of related factors in newly diagnosed type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: this study aims to compare the characteristics of gut microbiota between the newly diagnosed t2dm and healthy subjects, and analysis the related clinical indicators that may affect the composition of gut microbiota.

previous studies have shown that gut microbiota imbalance is closely related to a variety of diseases, such as inflammatory bowel diseases (ibd), colorectal cancer (crc), alzheimer's disease (ad) and cardiovascular diseases. in recent years, more and more studies have found that gut microbiota plays an important role in chronic metabolic diseases such as obesity, fatty liver and diabetes. gut microbiota disorder may lead to insulin resistance，pancreatic islets injury and disorder of glycolipid metabolism through multiple metabolic pathways such as endotoxin, short chain fatty acids, bile acids, amino acids, promote the occurrence and development of t2dm. at present, there are relatively few population-based studies to assess the relationship between gut microbiota and diabetes, and the results are inconsistent or even contradictory, which may be due to the influence of the research population, disease status, diet, drugs and even detection technology. therefore, the purpose of this study is to explore the difference of intestinal microbial characteristics between the initially diagnosed t2dm and the control group by using 16s rrna gene sequencing analysis technology, so as to increase the understanding of the possible relationship between t2dm and intestinal microbiota, and provide theoretical support and direction guidance for the future biological treatment of diabetes.

Eligibility criteria:
inclusion criteria: 1）18-65 years old 2）have no history of diabetes 3）fasting blood glucose \<5.6 mmol/l 4) hba1c\<6.0%. exclusion criteria: 1）bmi≥28kg/m2 2) people with type 1 diabetes, special type diabetes and pregnancy diabetes 3) use antispasmodics, expanders, probiotics, prebiotics, antibacterial drugs or other drugs that affect intestinal microorganisms in the past month 4) having inflammation, tumor, ulcer and other intestinal organic diseases, tumor, etc 5) history of abdominal surgery or gastrointestinal surgery 6) suffer from mental illness or alcoholism, drug abuse or drug abuse. 7) combined with other serious systemic diseases, such as cardiovascular disease, digestive disease, endocrine disease, skin disease, autoimmune disease, tumor, etc.
effects of subanesthetic concentrations of isoflurane/nitrous oxide - 3

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. to evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.


Eligibility criteria:
please contact site for information.

Keywords: nitrous oxide isoflurane subjective effects psychomotor healthy volunteer drug interaction
microlyte dressing in the management of wounds

Conditions: Wound Heal

Summary: the purpose of this pilot study is to assess the efficacy of microlyte ag wound dressing when used in complex skin wounds. microlyte ag is a class-ii medical device cleared by the fda for prescription and over the counter use in humans. primary clinical end point of study is percentage change in wound size from initiation of microlyte ag treatment through 90 days or until wound closure. patient population comprises patients referred to mission's wound healing and hyperbaric center for management of their wounds. targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer \[dfu\] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).


Eligibility criteria:
inclusion criteria: * men and women ≥18 years of age, inclusive * venous stasis ulcer, dfu, pressure ulcer, or other wound sufficiently complex as to be referred to clinical investigators at mission's wound care and bariatric center * patient must be competent to consent for self exclusion criteria: * patients younger than 18 years of age * women who are pregnant or nursing * prisoners
an intervention to promote self-determination in young adults with autism: the team_young adults program

Conditions: Autism

Summary: the goal of this clinical trial is to test the benefits of a program to develop self-determination in young adults with autism. being self-determined means acting or causing things to happen in your life. it involves deciding, acting and believing in one-self. the main question this clinical trial aims to answer is: is the program developed useful to improve self-determination of young adults with autism? participants will receive a group intervention to support the development of their self-determination-related skills during 20 sessions (1 session/week). researchers will compare the self-determination outcomes between the group that receives the intervention and another group that is in a waiting list (and will receive the intervention later) to see if the changes are due to the intervention.

this clinical trial employed a convergent mixed methods design. quantitative and qualitative data were collected from the same participants and analyzed separately within a similar timeframe. the quantitative strand used self-reported and proxy-reported questionnaires to evaluate the impact of the team_young adults program on the self-determination of young adults with autism. the quantitative data was collected at baseline and at the completion of the program, after 5 months (20 sessions). in the qualitative strand, focus groups were used to explore changes in self-determination perceived by the participants that received the program and their acceptance of the intervention. the focus groups were conducted when finishing the group and after the self-reported questionnaires are answered. proxy-reports were answered after the realization of the focus groups.

Eligibility criteria:
inclusion criteria: * to have a diagnosis of autism spectrum disorder in accordance with the criteria of the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), or of asperger's syndrome, according to he dsm-iv * to be between 17 and 30 years old. * to have a verbal comprehension index higher than 70 in the wechsler adult intelligence scale-iv (wais-iv), to ensure a good comprehension of the program exclusion criteria: * not having spoken language * having a condition that could significantly interfere in the group functioning, such as an acute psychotic disorder or challenging behavior

Keywords: self-determination intervention young adults mixed-methods