Kornimate/medical-research-clean huggingface dataset:
effects of systematic cervical exam training on labor and delivery care

Conditions: Delivery Problem; Cervix; Pregnancy; Pregnancy Related

Summary: all physicians, nurses, and nurse midwives working on labor and delivery will be required to complete cervical exam simulation training. data before and after institution of the training will be compared to determine if the training leads to less cervical exams during labor and increases consistency between examiners

the labor cervical exam is the cornerstone of the management of labor as the accurate assessment of cervical dilation and effacement are crucial in recognizing a normal labor from and abnormal one. to enhance accuracy and precision among healthcare providers working on labor and delivery we have created a high fidelity cervical exam simulator. all providers working on labor and delivery repetitive will be required to practice on the simulators until a pre-specified level or accuracy is achieved. we will prospectively and retrospectively assess the number of cervical exams a women receives and the discrepancy between exams performed by 2 different providers both before and after the training is instituted.

Eligibility criteria:
inclusion criteria: healthcare providers: • physicians, midwives, and labor and delivery nurses working on the labor and delivery unit within the wake forest baptist birth center patients: • any pregnant women receiving care on the labor and delivery unit of wake forest baptist birth center exclusion criteria: healthcare providers: • none patients: * placenta previa * vasa previa * any other contraindication to cervical exam

Keywords: vaginal delivery labor cervical exam labor and delivery
a study to evaluate the feasibility of a high add multi focal contact lens

Conditions: Presbyopia

Summary: the objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with purevision multi-focal contact lens on a daily wear basis.


Eligibility criteria:
inclusion criteria: * have physiologically normal anterior segments * be adapted wearers of soft contact lenses and wear a lens in each eye. * be presbyopic and require near add correction in each eye. * be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction. * have no active ocular disease or allergic conjunctivitis. * must not be using any topical ocular medications. * must habitually use a lens care product for lens cleaning, disinfecting, and storage. exclusion criteria: * any grade 2 or greater finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * anisometropia (spherical equivalent) of greater than 2.00 d. * any systemic disease affecting ocular health. * using any systemic or topical medications that will affect ocular physiology or lens performance. * allergic to any component in the study products. * ocular astigmatism of greater than 1.00 d in either eye. * have had any corneal surgery (ie, refractive surgery). * uses amo ultra care as their habitual lens care regimen. * is a toric contact lens wearer. * have worn gas permeable (gp) contact lenses within last 30 days or pmma lenses within last 3 months. * an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
investigation of the effect of hippotherapy simulator in children with spastic diplegia and cerebral palsy

Conditions: Cerebral Palsy; Balance; Distorted; Walking, Difficulty

Summary: the aim of the study is to examine the effect of hippotherapy simulator on trunk control, balance and gait in children with spastic diplegia cerebral palsy and its relationship with quality of life.

patients diagnosed with spastic diplegia cerebral palsy in the study; it will be classified according to gross motor function classification system (kmfss). the trunk control measurement scale will be used to assess trunk control. pediatric berg balance scale will be used to assess balance. the 1 minute walk test and the timed get up and go test will be used to assess walking. the weefim scale will be used to assess quality of life. the study sample will be divided into two groups. the first group will receive 45 minutes of conventional physical therapy. in addition to 45 minutes of physical therapy, the other group will receive 15 minutes of hippotherapy simulator. the results will be compared at the beginning and end of the study. then, individuals will be divided into two groups with a simple randomized method. traditional physical therapy will be applied to the control group for 45 minutes, 2 days a week, for 8 weeks. in addition to traditional physical therapy, 15 minutes of therapy training with a hippotherapy device will be applied to the experimental group. evaluation tests will be repeated at the beginning and end of the study. pre- and post-intervention data were statistically analyzed and compared.

Eligibility criteria:
inclusion criteria: * diplegic cerebral palsy between the ages of 4 and 16 * levels 1,2 and 3 according to kmfss * have not had botox or surgery in the last 6 months * able to perceive simple commands * patients who can sit in the hippotherapy simulator will be included. exclusion criteria: * with hip dislocation * those with hearing or visual disabilities * those who do not want to be involved in the study * adductor spasticity is stage 3 and above according to the ashworth spasticity scale. * with upper extremity amputation

Keywords: cerebral palsy hippotherapy walking balance life quality diplegia
vivo mapping protocol

Conditions: Ventricular Tachycardia; Ventricular Ectopic Beat(S)

Summary: this is a single centre study enrolling 15 subjects with structurally normal hearts that are already indicated for a ventricular ablation procedure (vt or pvcs). the purpose is to compare the accuracy of vivo and to assess its efficacy to decrease procedural time, and ideally, the procedural overall costs, as compared to standard of care ablation procedures. results will be compared with data from

vivo tm is a non invasive mapping system which can be used to localize pvc / vt origin prior to the ablative procedure. subjects scheduled for catheter ablation with vivo will undergo a ct scan prior to the procedure, which will be used to create a personalized 3d model. this will be merged with a 3d photograph (taken at the start of the procedure) of the ecg electrodes on the subject's torso. then, the recording of the 12 lead ecg will be imported into the vivo software. all of this data will be combined via the software and a mathematical algorithm will determine the origin of the arrhythmia. this will show the physician where to perform a successful ablation. after 3 months, the subject will return for follow up and will receive another ecg holter monitor (ecg recording) to determine ablation success. subjects will be exited from the study after the 3 month follow up visit. patients will receive standard clinical care prior to, during and after their scheduled procedure, as well as after being discarded from the trial. results will be analysed and compared to those from an historical cohort of patients (age / gender matched, undergone the same procedure) ablated by the same operator within the previous 5 years (from a database already collected). data will be anonymised as per current regulations.

Eligibility criteria:
inclusion criteria: 1. subjects who are at least 18 years or older 2. subjects who are scheduled for pvc/vt ablation procedure 3. subjects who have signed an irb/ec approved informed consent form and applicable subject privacy protection authorization per local law 4. subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements) 5. subjects with or without cardiac structural disease exclusion criteria: 1. reversible causes of pvc/vt 2. subjects with recent (within 3 months) acute coronary syndrome 3. subjects who are contraindicated for ct or mri (must be able to get one) 4. subject whose mri or ct scan does not comply with the requirements of this protocol 5. subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy: * inr \> 3.5 * active infection * pregnancy: females of childbearing potential with a positive pregnancy test. 6. existing mechanical heart valve 7. subjects with structural cardiac disease
lifestyle, exercise and nutrition study 1

Conditions: Breast Cancer; Weight Loss

Summary: the specific aims of this study are to determine the efficacy and cost-effectiveness of a weight loss program compared with usual care (control) treatment on 6-month changes in body weight, body fat, and serum hormones in breast cancer survivors.

proposed is a three-arm randomized controlled trial of 6-months of weight loss counseling (i.e., dietary-induced caloric restriction and physical activity) on clinically meaningful endpoints in 100 breast cancer survivors . the three arms will be: 1. in-person counseling, 2. telephone-based counseling, 3. usual care. women will be randomized into one of 3 study arms using a random permuted block design. research staff collecting body composition data, as well as reviewing forms and entering data, will be blinded to the participant's study group.

Eligibility criteria:
inclusion criteria: * american joint committee on cancer (ajcc) stages 0-iiic breast cancer * bmi \>25 kg/m2 * completed surgery, chemotherapy and radiation at least 2 months ago * physically able to exercise * agrees to be randomly assigned to either weight loss or control * gives informed consent to participate in all study activities * able to come for baseline and 6-month clinic visits * mentally competent exclusion criteria: -

Keywords: breast cancer survivorship weight loss
a study of pm8002 in combination with chemotherapy in patients with sclc

Conditions: SCLC

Summary: pm8002 is a bispecific antibody targeting pd-l1 and vegf. this study will evaluate the efficacy and safety of pm8002 in combination with paclitaxel as second line treatment for sclc.

this is a phase ii, single arm study assessing the efficacy and safety of pm8002 in combination with paclitaxel as second line treatment for sclc who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors therapy

Eligibility criteria:
inclusion criteria: 1. signed informed consent form before any trial-related processes; 2. age ≥18 years; 3. histologically or cytologically confirmed sclc; 4. advanced sclc who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors; 5. have adequate organ function; 6. the eastern cancer cooperative group (ecog) performance score of 0 or 1; 7. life expectancy of ≥12 weeks; 8. had at least one measurable tumor lesion according to recist v1.1. exclusion criteria: 1. history of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 2. evidence and history of severe bleeding tendency; 3. history of severe cardiovascular diseases within 6 months; 4. current presence of severe superior vena cava syndrome and spinal cord compression; 5. current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 6. history of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 7. history of alcohol abuse, psychotropic substance abuse or drug abuse; 8. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome; 9. pregnant or lactating women; 10. other conditions considered unsuitable for this study by the investigator.

Keywords: second line
a study of orx750 in participants with narcolepsy and idiopathic hypersomnia

Conditions: Narcolepsy Type 1; Narcolepsy Type 2; Idiopathic Hypersomnia

Summary: narcolepsy type 1 (nt1), narcolepsy type 2 (nt2), and idiopathic hypersomnia (ih) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \[eds\]). people living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities. while all conditions result in feeling sleepy, there are some differences in other common symptoms: * nt1: people with nt1 often feel very tired during the day and experience cataplexy. cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. this is often triggered by strong emotions, such as laughter or surprise. they may also have trouble sleeping well at night. * nt2: people with nt2 feel sleepy during the day, just like nt1, but they do not have cataplexy. * ih: people with ih feel tired during the day, even after sleeping a lot at night. they may sleep for long periods, take long naps, and find it hard to wake up. orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. orx750 is designed to mimic the action of orexin. the purpose of this study is to see how safe and tolerable orx750 is in nt1, nt2, and ih, and learn about what the drug does to the body. another goal of the study is to see if orx750 can help people with nt1, nt2, and ih feel less sleepy and make other symptoms better.


Eligibility criteria:
inclusion criteria: * 18-65 years of age * bmi ≥17 and ≤37 kg/m2 * meets the diagnostic criteria of narcolepsy type 1 (nt1), type 2 (nt2) or idiopathic hypersomnia (ih) according to icsd-3-tr criteria * is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia * is willing and able to adhere to additional protocol requirements exclusion criteria: * a medical disorder other than nt1, nt2, or ih that is associated with excessive daytime sleepiness (eds). * presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
a long-term safety study of bcx9930 in participants with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Hemoglobinuria; PNH

Summary: this study was designed to evaluate the long-term safety of daily oral treatment with bcx9930 in participants who had participated in a previous bcx9930 trial for pnh and showed a benefit of treatment as determined by the investigator. the study allowed continued access to bcx9930 for enrolled participants. the study also evaluated the long-term effectiveness and impact on quality of life and general well-being of bcx9930 treatment, and the participant's satisfaction with the medication.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female participants * successfully participated in a previous bcx9930 study of pnh and experienced improvement in their pnh exclusion criteria: * apart from a diagnosis of pnh, any clinically significant medical or psychiatric condition or medical history, other than those associated with pnh disease, that, in the opinion of the investigator or sponsor, would interfere with the participant's ability to participate in the study or participation would increase the risk for that participant * pregnant, planning to become pregnant, or having been pregnant within 90 days of day 1, or lactating note: other protocol-defined inclusion/exclusion criteria may apply

Keywords: bcx9930 factor d inhibitor pnh paroxysmal nocturnal hemoglobinuria oral treatment
topiramate augmenting strategies for the treatment of alcohol use disorder

Conditions: Alcoholism

Summary: this is a pilot study designed to evaluate the safety, tolerability of topiramate (tpm) + n-acetyl cysteine (nac) in combination versus topiramate (tpm) + placebo for the treatment of alcohol use disorder (aud).

this is a pilot study designed to evaluate the safety, tolerability of topiramate (tpm) + n-acetyl cysteine (nac) in combination versus topiramate (tpm) + placebo in 16 subjects enrolled in a 12 week, randomized, double-blind, outpatient trial. each subject will receive randomly one of the drug combinations for 12 weeks plus medication management. primary aim 1: to evaluate the safety, tolerability of topiramate (tpm) and n-acetyl cysteine (nac) in combination or topiramate (tpm) + placebo for the treatment of alcohol use disorder (aud). this aim will be accomplished by testing the following: •hypothesis 1 - the combination of topiramate (tpm) and n-acetyl cysteine (nac) will be well tolerated by participants as evidenced by less self-report cognitive side effects (word finding difficulties, difficulties with concentration, and confusion). secondary aim 1: the combination of topiramate (tpm) and n-acetyl cysteine (nac) or topiramate (tpm) + placebo will reduce alcohol drinking. this aim will be accomplished by testing the following: •hypothesis 2 - the combination of topiramate (tpm) and n-acetyl cysteine (nac) or topiramate (tpm) + placebo will reduced alcohol drinking , as evidenced by a statistically significant reduction in percentage of heavy drinking days (phdd) as compared to baseline.

Eligibility criteria:
inclusion criteria: * males and females * ages 18 and above * good physical health * current dsm-v diagnosis of alcohol use disorder * currently drinking ≥21 alcohol units/week for women and ≥28 alcohol units/week for men on average in the last 28 days prior to screen. * be seeking treatment for problems with alcohol * be able to take oral medication and be willing to adhere to the medication regimen. * be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in english and able to complete the questionnaires required by the protocol. * agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. * not have any unresolved legal problems that could jeopardize continuation or completion of the study. * the pregnancy test for females at screen and prior to randomization must be negative. additionally, women of childbearing potential must be using an acceptable form of contraception. these include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide. exclusion criteria: please contact site for additional information

Keywords: alcohol, alcohol dependence, addiction, alcohol use disorder
visualization versus intraoperative neuromonitoring of the recurrent laryngeal nerves during thoracoscopic esophagectomy

Conditions: Esophageal Cancer

Summary: the clinical value of intraoperative nerve monitoring (ionm) in thoracoscopic esophagectomy remains uncertain. the aim of this randomized clinical trial was to compare the impact of rln visualization versus ionm on their morbidity following thoracoscopic esophagectomy.

recurrent laryngeal nerves (rln) lymph nodes are the most common metastatic areas in esophageal squamous carcinoma. it is a clinical challenge to reduce high incidence of rln injury rate result from routine dissection of rln lymph nodes. thoracoscopic approach may provide a clear operative field and potentially less invasive surgery. but there are still high rln injury rate only depending on visualization of thoracoscopy. the use of intraoperative nerve monitoring (ionm) was shown very helpful to identify the rln and associated with a reduction of rln injury rate in thyroidectomy. however, there is no solid clinical evidence about the effectiveness of utility of ionm in thoracoscopic esophagectomy. thus, the aim of this randomized clinical trial was to compare the impact of rln visualization versus ionm on their morbidity following thoracoscopic esophagectomy.

Eligibility criteria:
inclusion criteria: 1. histologically proven primary intrathoracic middle and lower esophageal squamous cell carcinoma and will undergo mckeown mie and bilateral rln lymph ndoe dissection. 2. no superclavicular lymph node metastasis after preoperative examination. 3. no contraindication for esophagectomy. 4. expected surgical r0 resection. exclusion criteria: 1. pre-existed vocal cord dysfunction. 2. thorax pleural adhesion rendering minimal invasive approach unfeasible. 3. gastric tube cannot be used for reconstruction. 4. combined with hemorrhagic disease. 5. psychiatric patients. 6. inability to undergo curative resection and/or follow-up.

Keywords: esophageal cancer minimally invasive surgery recurrent laryngeal nerves intraoperative nerve monitoring
outpatient versus tele rehabilitation among post-surgical breast cancer survivors

Conditions: Breast Cancer

Summary: this study is comparing two interventions to identify effective treatment for breast cancer patients.

tele rehabilitation has gained popularity during covid 19 pandemic. all the studies carried out at that time was found effective in many countries. still a literature gap is present in tele rehabilitation in breast cancer patients in pakistan. prevalence of breast cancer is high in pakistan. now it is the best time to implement tele rehabilitation for breast cancer patients as it will reduce treatment costs and travel expenses. therefore, the goal of this rct is to consider tele rehabilitation as part of our treatment plan because if it is found effective for patients than it will be helpful in the field of health and technology.

Eligibility criteria:
inclusion criteria: * age 30 to 60 years. * breast cancer females who underwent mastectomy (simple total mastectomy). * breast cancer females without chemotherapy or radiotherapy treatment. * accessibility to smart phone. * internet access. exclusion criteria: * previous history of breast or any other cancer. * females with metastatic breast cancer. * any chronic pathology that will result in an increase in symptoms due to physical exercise. * any contraindications limiting physical activity. * shoulder radiculopathy, or fracture.

Keywords: shoulder functional independece