Kornimate/medical-research-clean huggingface dataset:
preterm delivery risk prediction by measurement of prenatal serum screening markers

Conditions: Preterm Delivery

Summary: this protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. the biological specimens will be used to determine the predictive power of biochemical markers routinely used in down syndrome screening in the assessment of patient's risk of preterm delivery.

the study will investigate whether the levels of individual maternal serum screening biomarkers, their combinations or temporal changes in the level can be associated with an increased risk of preterm delivery. blood samples at three time points in pregnancy will be collected from the study participants. the first two blood draws will be timed to coincide with the first and second trimester maternal serum testing. the third blood draw will coincide with the screening for gestational diabetes. pregnancy outcome information will be collected from the physicians and linked to the subject samples. subject samples from a case-control patient group will be analyzed by the serum screening biochemical assay. statistical analyses will be performed to achieve the study objectives. note: this study is recruiting in florida, usa. the laboratory data coordination is being performed in massachusetts, usa and new mexico, usa. new study locations will be identified on an ongoing basis.

Eligibility criteria:
inclusion criteria: * the participant understands the nature of the study and its requirements. to this end, we will require that the participants have command of the english language. * the participant consents to and signs the approved consent form. * the participant is 18 years of age or older. * the participant has a singleton pregnancy. * the participant is planning on continuing the pregnancy. * the participant has intent to clinically test for down syndrome risk. * the participant consents to the study at the first trimester of her pregnancy. * the participant understands the nature of the study and its requirements. to this end, we will require that the participants have command of either the english or spanish language. exclusion criteria: * n/a

Keywords: preterm delivery preterm labor maternal-fetal care maternal serum screening biomarkers alphafetoprotein afp human chorionic gonadotropin hcg unconjugated estriol inhibin a pregnancy associated plasma protein papp-a maternal screening
abdominal circumference and cardiorespiratory repercussions in patients submitted to physical therapy

Conditions: Obesity, Abdominal; Lung Disease

Summary: the purpose of this study is to determine whether the hospitalized patients with increased waist circumference exhibit cardiorespiratory alterations after chest physical therapy.

the physiotherapist assessment will consist of anthropometry (body mass index, abdominal circumference, adipometer); chest inspection and palpation, vital signs (blood pressure, heart rate, respiratory frequence, oxymetry), dyspnea index and capillar blood glucose; and later with pulmonary tests (thoracoabdominal perimetry, respiratory muscle strength and pulmonary volume and capacity). this will be a quasi-experimental study. patients will be divided into four groups according to waist circumference (increased or not, with respect to cardiovascular risk) and respiratory disorders (obstructive and restrictive). after this assessment, chest physical therapy will begin according to the protocol for obstructive and restrictive respiratory disorders. the treatment will have an average duration of 30 minutes. at the end of treatment (single session) the patient will be assessed again after five and thirty minutes.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years old), clinical stability characterized by axillary body temperature below 38 ° c, hemoglobin higher than 7 g / dl, oxygen saturation by pulse oximetry greater than or equal to 88%, mean arterial pressure (map) greater than 70 or less than 120 mm hg, heart rate between 50 bpm to 140 bpm ; ability to understand, carry out the commands appropriately for evaluative tests, with the glasgow coma scale score greater than 8, locomotor integrity of the lower limbs, spontaneous breathing, lack of hospital physiotherapy during hospitalization, prescription for respiratory therapy; bronchodilator, if applicable four hours before intervention. exclusion criteria: * inadequate perform to the maneuvers of the evaluation (e.g. spirometry), hemodynamic instability, thoracic dermal injury, disabling orthopedic complications that compromise the techniques of assessment and intervention, lymphedema of the trunk; sudden weight gain with edema in limbs, ascites, nephrotic syndrome, congestive heart failure, liver cirrhosis, erysipelas, deep vein thrombosis, heart bypass, heart transplantation, arrhythmias, atrioventricular block, severe dyspnea (borg\> 5), spinal cord injury, hemoptysis, osteoporosis, recent surgeries, coagulopathy, bronchopleural fistula, subcutaneous emphysema, presence of diabetes mellitus associated with cardiac autonomic dysfunction, bronchoconstriction.

Keywords: physical therapy modalities respiration disorders respiratory therapy
time lag for oocyte denudation: a better choice for icsi outcome?!

Conditions: Infertility, Female

Summary: this study aiming to investigate if difference in the timing of cumulus removal post retrieval would have any critical impact on fertilization and embryonic development.

patients under 37 year old who were treated with controlled ovarian stimulation for icsi were randomly divided into 2 groups; group a: oocytes were denudated immediately after oocyte retrieval , group b: oocytes were denudated 2 hours after retrieval and both groups were microinjected at 4 hours from ovum pickup. microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.the rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups.

Eligibility criteria:
inclusion criteria: * women 24-37 years old * with good ovarian reserve * induction using long agonist protocol * unexplained infertility exclusion criteria: * severe male factor * testicular samples for icsi * poor ovarian reserve * no of oocytes collected less than 4

Keywords: denudation timing icsi timing oocyte aging
functional voice and speech outcomes following surgical voice restorations: a comparison of pharyngeal construction approaches

Conditions: Larynx Cancer

Summary: the purpose of this study is to evaluate the nature and quality of speech after removal of the voice box and all or part of the swallowing tube. the study is evaluating which type of surgery provides patients with the best speech and voice. these data will be used to help surgeons to design better ways to restore voice function after removal of the voice box. information about disease, its treatment, quality of life, and physical and vocal function will be collected. an audio recording of vocal tasks will also be done. all of this information will be analyzed and the two different subject groups will be compared to see if there are differences.


Eligibility criteria:
inclusion criteria: * subjects who have undergone removal of the larynx and the entire pharynx by either traditional reconstruction or more advanced reconstructive techniques, which involve the use of tissue, such as skin or bowel, from other parts of the body. there is no time frame for reconstruction. all subjects who have previously undergone reconstruction are eligible. * subjects who use the tracheoesophageal puncture method of voice restoration as their primary communication technique. * \> or equal to 18 years old exclusion criteria: * do not have functional voice restoration. * do not speak english as a functional language.
an open label study to determine the safety and efficacy of replacement factor viii protein (known as rfviiifc) in previously untreated males with severe hemophilia a

Conditions: Hemophilia A

Summary: the primary objective of the study was to evaluate the safety of rfviiifc (biib031) in previously untreated participants (pups) with severe hemophilia a. the secondary objectives were to evaluate the efficacy of rfviiifc in the prevention and treatment of bleeding episodes in pups, to evaluate rfviiifc consumption for the prevention and treatment of bleeding episodes in pups, and to describe experience with the use of rfviiifc for immune tolerance induction (iti) in participants with inhibitors.


Eligibility criteria:
key inclusion criteria: * ability of the participant's legally authorized representative (e.g. their parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. * weight \>=3.5 kg at the time of screening. * severe hemophilia a defined as less than (\<) 1 iu/dl (\<1%) endogenous fviii documented in the medical record or as tested during the screening period. key exclusion criteria: * any exposure to blood components, factor viii replacement products, including commercially available rfviiifc at any time prior to or during screening. * history of positive inhibitor testing. a prior history of inhibitors was defined based on a patient's historical positive inhibitor test using the local laboratory bethesda value for a positive inhibitor test (ie, equal to or above lower level of detection). * history of hypersensitivity reactions associated with any rfviiifc administration. * other coagulation disorder(s) in addition to hemophilia a. * any concurrent clinically significant major disease that, in the opinion of the investigator, would make the participant unsuitable for enrollment. * current systemic treatment with chemotherapy and/or other immunosuppressant drugs. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: prophylaxis treatment hemophilia a hemophilia episodic treatment
immunogenicity and safety of gsk biologicals' live attenuated varicella vaccine (varilrixtm).

Conditions: Varicella

Summary: this study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation.


Eligibility criteria:
inclusion criteria: screening phase: * a male or female ≥ 18 years of age at the time of study entry. * written informed consent obtained from the subject prior to study entry. * patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation. * subjects who the investigator believes can and will comply with the requirements of the protocol * if the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation. active phase: * patients who are confirmed to have undergone autologous peripheral stem cell/ bone marrow transplantation. * if the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation. exclusion criteria: screening phase: * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation. * history of allergy to any component of the vaccine. * patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation. * current drug and/or alcohol abuse. active phase: * use of any investigational or non-registered product (drug or vaccine) during the active phase of the study period. * use of immunosuppressants or other immune-modifying drugs within 14 days preceding the administration of the first dose of the study vaccine or planned use during the active phase of the study period. * use of rituximab (mabthera) more than 60 days after transplant. * administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation. * history of allergy to any component of the vaccine * patients with vzv disease after transplantation and prior to vaccination. * ongoing requirement for antiviral therapy with anti-vzv activity beyond 4 months post-transplantation * patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation. * current drug and/or alcohol abuse.

Keywords: varicella varilrixtm
clinical study into the cosmetic results of leukosan adhesive

Conditions: Wound Healing Cosmetic Result

Summary: this clinical study aims to assess whether the benefits of using leukosan adhesive on trocar incisions are greater or equivalent to those provided by the standard therapy of transcutaneous sutures. in particular, it tests the long-term cosmetic result after 3 months, the safety and tolerance, as well as the practicality of treatment with leuksan adhesive. an open, randomised, controlled, prospective, single location, clinical study of women of ages between 18 and 60 years within the time span of march 2013 and april 2013.

the medical devices compared were eu (european union) approved market-ready products with relevant designation according to the legal requirements for medical devices and according to council guideline 93/42/ewg dated 14th july. leukosan adhesive is a sterile, ultra high viscose adhesive for external skin closure. due to the skin's moisture, this skin adhesive polymerizes within seconds into a flexible film firmly holding the edges of the wound together and protecting the wound itself. premilene dsmp 24, 3/8 needle, thread 3/0 denier was used a a comparison. this suture material was the standard suture material used in the study centre.

Eligibility criteria:
inclusion criteria: * female between 18 and 60 * undergone laparoscopic operation with 2 mirror image trocar incisions * willing to attend examination at clinic at 7-12 days and 10-14 weeks * signed agreement by participant exclusion criteria: * length of laparoscopic operation more than 2 hours * hospitalisation due to complications * circumstances leading to difference in trocar incisions * existing scar less than 3 cm from the operation point * diabetic condition melitis hba1c\>9mg/d * known allergy to tissue adhesive * participation in another study within 30 days

Keywords: wound healing cosmetic results trocar incision
hd il-2 + ipilimumab in patients with metastatic melanoma

Conditions: Metastatic Melanoma

Summary: phase iv, open-label, randomized, two-arm, multi-center study in patients with metastatic melanoma who are treatment naïve or have previously received a single non-immunologic therapy. treatment arm 1: "hd il-2 first, then ipilimumab" patients will receive two courses (four cycles) of high dose interleukin-2 (hd il-2) followed by one course (four doses) of ipilimumab. treatment arm 2: ipilimumab first then hd il-2 patients will receive one course (four doses) of ipilimumab followed by two courses (four cycles) of hd il-2.

all patients will receive il-2 at 600,000 international units per kilogram (kg) by intravenous bolus (ivb) every 8 hours for up to 14 planned doses with an additional cycle 14 days after the first. ipilimumab 3mg/kg iv infusion q3 weeks up to 4 doses4 doses a 3-6 week interval been the administration of the two drugs to allow for resolution of treatment-related toxicities. if corticosteroids were required during ipilimumab administration, a 2-week period from discontinuation of steroid treatment to start of hd il-2.

Eligibility criteria:
inclusion criteria: * male or female patients 18 years or older * confirmed and measurable metastatic melanoma with at least one measurable lesion for evaluation of response * meets the requirements for hd il-2 therapy per institutional guidelines * meets the requirements for ipilimumab therapy per institutional guidelines * treatment naïve or has received only one systemic therapy apart from adjuvant therapy. * at least 4 weeks since last adjuvant therapy or other cancer treatment * willing and able to give informed consent and participate in study procedures as described in the 12plk02 and 10plk13 protocols. patients consented for 12plk02 will also be asked to participate in the 10plk13 proclaim registry study. exclusion criteria: * patients with known or suspected infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv), hepatitis b virus (hbv) or other infectious hepatitis * pregnant, nursing or planning to become pregnant * untreated brain metastases. (brain metastases that have been treated, which no longer require corticosteroid therapy and are without progression by mri at least 6 weeks after definitive therapy are acceptable.) * received prior ipilimumab therapy (prior adjuvant ipilimumab and adjuvant interferon are permitted with a minimum 4 week washout) * received prior hd il-2 therapy. * received investigational drug within 30 days prior to study dosing. patients may participate in non-interventional or observational clinical studies, including the 10plk13 proclaim registry study. * concomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.

Keywords: melanoma metastatic skin cancer stage iv interleukin-2
effect of low-dose versus standard-dose iron supplementation on the gut microbiome

Conditions: Iron Deficiency (Without Anemia)

Summary: iron deficiency is a common problem that is often treated with the administration of oral iron. most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria. this influence is usually undesirable and should be kept as small as possible. with lower iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the intestinal bacteria composition is to be expected.

iron deficiency affects about one in five premenopausal women. the first line treatment for patients with iron deficiency is an oral therapy with iron-supplements, another option is the intravenous iron supplementation. the oral supplementation causes side-effects such as nausea, vomiting, abdominal pain and many more in a lot of patients. there is a positive correlation between the appearance of gastrointestinal side-effects and the applicated iron dose. only a low fraction of orally taken iron is actually absorbed, even in patients with iron-deficiency. since only a fraction of the orally administered iron is actually absorbed, the toxicity of high concentrations of iron in the gastrointestinal tract and the altered selection advantages of the bacteria presumably leads to microbiome changes. the unabsorbed iron is potentially changing the microbiome, which leads to undesirable side effects. with low-dose iron-supplementation the amount of unabsorbed iron is smaller, therefore a dosage dependent microbiome change would be expected. the aim of the study is to determine the magnitude of the microbiome response to daily iron substitution with 12mg and 100mg.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * female gender * premenopausal * age \> 18 years * regular menstrual cycle * bmi in normal range (18-25kg/m2) * serum-ferritin ≤30ng/ml * no anemia (hemoglobin ≥117g/l) * no intake of dietary supplements for at least 4 weeks exclusion criteria: * pregnancy * hypermenorrhea (more than 5 unties/tampons per day) * chronic inflammatory disease, psychiatric disorders * hypersensitivity to iron supplements * chronic kidney disease (creatinine \>80 µmol/l) * liver disease (alt \>35 u/l) * hypo- or hyperthyroidism (tsh not between 0.16-4.25 mu/l) * intake of medicines that interact with oral iron supplementation (e.g. ppi)\*

Keywords: iron microbiome gut bacteria
primary hpv-based cervical cancer screening algorithms in botswana

Conditions: Cervical Cancer; Prevention

Summary: primary high-risk human papillomavirus (hpv) testing has become first line screening for cervical cancer in high-income countries. the feasibility of this approach in low- and middle-income countries (lmics) is less clear, as is the role of hpv testing among women living with human immunodeficiency virus (hiv). the proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary hpv testing followed by various forms of visual evaluation, including visual inspection with acetic acid (via), colposcopy and automated visual evaluation (ave) for the detection of high-grade cervical dysplasia, using histology as the gold standard. we will validate the ampfire assay for hpv self-sampling in our setting. we will determine safe screening intervals in women living with hiv (wlhiv) in an hpv-based cervical cancer screening program and compare triage strategies for positive hpv results at who recommended screening intervals for wlhiv. we also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, hpv testing, and self-sampling, for women in botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk hpv testing in botswana.


Eligibility criteria:
inclusion criteria: 1. cis-gender female or transgender male (must have a cervix) 2. ≥25 years of age 3. competent to understand study procedures and give informed consent. exclusion criteria: 1. currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy) 2. previous hysterectomy 3. previous diagnosis of cervical cancer