Kornimate/medical-research-clean huggingface dataset:
topical omega-3 fatty acids (remogen® omega) in the treatment of dry eye

Conditions: Dry Eye Syndromes

Summary: the primary objective of this study is to evaluate the efficacy of remogen® omega in reducing dry eye syndrome (des) symptoms.


Eligibility criteria:
inclusion criteria: * male or female patient between 18 and 80 years of age and in good general health condition. * signed written informed consent. * existence of moderate to severe des symptoms defined as break-up time (tbut) ≤ 10 s (mean of 3 consecutive measurements) and osdi questionnaire ≥ 20. exclusion criteria: * contraindication for the use of the products (e.g. hypersensitivity to the constituents of the test products) or any study procedure. * concomitant or previous participation in a clinical investigation within the last 3 months. * concomitant therapies/manipulations that affect either the tear film, tear secretion or ocular surface integrity or would alter the effect of the devices being evaluated. * concurrent (systemic) des-associated diseases that are not on a stable therapy since at least 1 month (therapy not expected to change) * glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected to change) * any diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation * pregnant or lactating females. * participants of childbearing age who do not use adequate methods of birth control. * subjects unable to understand the informed consent or having a high probability of noncompliance to the study procedures and/or non-completion of the study according to investigator's judgment (e.g. illiteracy, insufficient knowledge of local language). * subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.

Keywords: tear film omega-3 fatty acids eye drops
homocyst(e)ine, vitamin status, and cvd risk

Conditions: Cardiovascular Diseases; Cerebrovascular Accident; Coronary Disease; Myocardial Infarction; Heart Diseases; Hyperhomocysteinemia

Summary: to test the hypotheses that the risk of myocardial infarction and/or stroke is associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins b12 and b6.

background: elevated plasma homocyst(e)ine is a risk factor for vascular disease in middle-aged men. supplementation with folate, and to some extent vitamins b12 and b6, can reduce plasma homocyst(e)ine levels. there is also evidence from in vitro studies that the adverse atherogenic or thrombotic effects of lp(a) may be greatly enhanced by homocyst(e)ine. the high prevalence of low levels of folate and vitamins b12 and b6 among the elderly in the united states has led to the hypothesis that a substantial portion of cardiovascular morbidity and mortality among older persons could be prevented by increasing intake of these nutrients to reduce plasma levels of homocysteine. little is known, however, regarding the relationship of homocysteine, folate, b vitamins, and lp(a) to cardiovascular disease among the elderly, among whom cvd represents the leading cause of morbidity and mortality. design narrative: in this ancillary study to the prospective cardiovascular health study (chs), a case-cohort design was used to test hypotheses that the risk of myocardial infarction and/or stoke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins b12 and b6. further, a determination was made whether elevated plasma levels of homocysteine and lp(a) interacted to increase substantially the risk of myocardial infarction and/or stroke above that due to either factor alone. the sub-cohort was used to study the relationship between the factors under study and progression of sub-clinical atherosclerosis. for each case and sub-cohort member, an aliquot of fasting plasma drawn at baseline was analyzed for homocysteine, folate b12, and b6 concentrations. \[values of plasma lp(a) were determined at baseline.\] results of these assays were combined with other chs data to address the hypothesis that the risk of myocardial infarction and/or stroke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins b12 and b6.

Eligibility criteria:
no eligibility criteria
the epley maneuver versus cawthorne-cooksey exercises in the treatment of benign paroxysmal positional vertigo (bppv)

Conditions: Benign Paroxysmal Positional Vertigo

Summary: observation of the effects of cawthorne-cooksey exercises applied after the epley maneuver on balance, vertigo symptoms, and quality of life in bppv patients.

study objective: to observe the efficacy of cawthorne-cooksey exercises applied after the epley maneuver on balance, vertigo symptoms, and quality of life in patients with posterior canal bppv. study design: single-blind randomized controlled study sample size: thirty-six patients were recruited in the study and were randomized equally into epley maneuver (epleym) and epley maneuver and exercise (epleym\&exe) groups. study method: all patients were treated with the epley maneuver, while cawthornecooksey exercises were given to the epleym\&exe group as home exercises for 6 weeks. static and dynamic balance, vertigo and associated symptoms, and quality of life were assessed with the nintendo wii balance board, berg balance test, vertigo symptom scale, and dizziness handicap inventory, respectively. the assessments were repeated at the 1st, 3rd, and 6th weeks.

Eligibility criteria:
inclusion criteria: 1. having posterior semicircular canal bppv with upbeating-torsional nystagmus and positional vertigo as evaluated by the dix-hallpike test 2. agreeing to undergo the epley maneuver after that test 3. agreeing to participate in the study exclusion criteria: 1. having history or symptoms of vestibular system disorders other than bppv or central nervous system disorders causing dizziness 2. having cervical and/or lumbar pathology due to which the epley maneuver could not be performed 3. having lower extremity pain or an operation that prevented standing and/or weight bearing 4. having anterior or horizontal canal bppv 5. having previously undergone a vestibular rehabilitation program
pressure injury prevention in the icu with multi-layer foam dressings

Conditions: Pressure Incidence Prevention

Summary: a multi-centre, open, non-controlled, clinical investigation to evaluate the user friendliness and wear time of multi-layer foam dressings with safetac® for pressure injury prevention in the intensive care unit

this was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the united states of america (usa). the study was conducted on subjects at risk of developing pis according to investigators' judgment and facility protocol being treated in icus. the target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. an evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. there were two parts to the study: part a: mepilex border/protect sacrum; part b: mepilex border/protect heel (on both left and right heels), used within intended use and according to ifu.

Eligibility criteria:
inclusion criteria: * patient is at risk for developing a pressure injury to the heels and/or sacrum * aged ≥ 18 years * patient or his/her legal representative is able to understand and voluntarily sign the informed consent * estimated treatment period in icu for patient at least 4-6 days exclusion criteria: * patient has a pressure injury or blistering on sacrum and/or heels * patient with known or suspected sensitivity to any of the components of the products being evaluated * patient included in other clinical investigations at present or within the last 30 days
comparison of target controlled infusion anesthesia and inhalation anesthesia in pediatric laparoscopic surgeries

Conditions: Laparoscopic Surgery; Target Controlled Infusion

Summary: comparison of target controlled infusion anesthesia and inhalation anesthesia in pediatric laparoscopic surgeries

in pediatric age group patients undergoing laparoscopic surgery, total intravenous anesthesia (tiva) and inhalation anesthesia methods are used as anesthesia methods in the intraoperative period; it is compared in terms of its effects on blood pressure, pulse, postoperative awakening time and awakening agitation.

Eligibility criteria:
inclusion criteria: * children aged 3-12 years * patients weighing over 10 kilograms * patients who will undergo inguinal hernia surgery * asa (american society of anesthesiologists) classification i and ii pediatric patients. exclusion criteria: * absence of systemic illness. * asa (american society of anesthesiologists) classification iii and above pediatric patients.

Keywords: pediatric laparoscopic surgery target controlled infusion propofol sevoflurane
hboc-201 expanded access protocol for life-threatening anemia for whom allogeneic blood transfusion is not an option

Conditions: Anemia

Summary: the purpose of this protocol is to provide treatment with hboc-201 to patients with life-threatening anemia for whom blood is not an option. such patients may also be referred to in this document as patients who refuse blood transfusion (pwrbt). other patients who potentially may require hboc-201 treatment include those with red blood cell alloantibodies for whom immunologically compatible red blood cell units cannot be found, although these patients are less common than pwrbt.

this is an open label intermediate-size patient population expanded access ind protocol. due to our experience with management of severely anemic patients for whom blood is not an option, we anticipate encountering future patients with life-threatening anemia for whom blood is not an option. blood is not an option in the following circumstances: * refusal of transfusion * lack of compatible red blood cells due to alloimmunity all patients with life-threatening anemia for whom blood is not an option will be treated as per the standard procedure. if those measures are not successful and the life-threatening anemia persists, then at the investigator's discretion treatment with hboc-201 will then be considered.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age 2. critically ill patients with hemoglobin \< 5 g/dl (or 6-7 g/dl with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits 3. patients or their legally authorized representative who are able and willing to provide informed consent 4. blood is not an option due to: * refusal of transfusion * lack of compatible red blood cells exclusion criteria: 1. patients with known hypersensitivity or allergy to beef products 2. patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis\* 3. patients who are eligible for blood transfusions 4. patients who are \> 80 years old\* 5. pregnant 6. lactating * on a case by case and quality of life determination
comparing the quality of life between ladg and tldg for gastric cancer_klass07 (cklass01)).

Conditions: Quality of Life; Gastric Cancer; Surgery; Surgical Complication

Summary: the present randomized study is designed to compare the quality of life between the patients undergoing laparoscopy-assisted and totally laparoscopic distal gastrectomy for gastric cancer, and therefore to evaluate the superiority of totally laparoscopic distal gastrectomy to laparoscopy-assisted distal gastrectomy.

the primary endpoint of this trial is the early postoperative morbidity, that is defined as complications that occur within 30 days after surgery. early postoperative morbidity is classified as follows: (1) wound morbidity (2) surgical site morbidity: anastomosis bleeding or leakage, duodenal stump leakage, postoperative bleeding, afferent loop or efferent loop obstruction, etc.; (3) lung morbidity: atelectasis, pleural effusion, empyema, pneumothorax, etc.; (4) intestinal obstruction morbidity (5) urinary tract morbidity (6) intra-abadominal abscess (7) postoperative pancreatitis (8) pancreatic fistula (9) intestinal fistula 10) others: lymphorrhea, diarrhea, etc. the secondary end point is the questionnaire score regarding qol. this is assessed by the korean versions of the eortc qlq-c30 (version 3.0) and sto22 questionnaires.

Eligibility criteria:
inclusion criteria: * histologic proven gastric adenocarcinoma (by preoperative gastrofiberscopy) * age between 20 and 80 years old * eastern cooperative oncology group performance statu of 0 or 1 * clinical stage ia (t1n0m0) or ib (t1n1m0 / t2n0m0) according to the 7th edition of the american joint committee on cancer system10 (clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography) * scheduled for laparoscopic distal gastrectomy with d1+ or d2 lymphadenectomy, and possible for r0 surgery by this procedures (lymphadenectomy is performed on the basis of the criteria of the japanese gastric cancer treatment guidelines 2010 (ver.3).) * patients who gave a consent and signed the formal paper permitted by institutional review board (irb) after hearing a full description of the study (purpose and contents) prior to the participation exclusion criteria: * patients who received stomach surgery (i.e. gastrectomy or gastrojejunostomy) in the past * patients with intraabdominal adhesion due to previous intraperitoneal surgery * patients who recently diagnosed with gastric cancer and received either anticancer treatment or radiation therapy * patients who requires combined organ resection due to aggression of gastric cancer or other diseases * patients who received surgeries due to primary cancer of other organs, or had anticancer treatment or radiation therapy in the last five years (patients whose skin basal cell carcinoma and insitu cervical cancer are completely cured are exceptions). * vulnerable people who can't communicate or are pregnant (or planning to be pregnant) * patients who are currently participating or participated in other clinical trials in the last six months.
impact of deutetrabenazine on functional speech and gait dynamics in huntington disease

Conditions: Huntington Disease

Summary: examine the effects of deutetrabenazine on functional speech and gait impairment

this is a two-year, prospective, single-arm study examining the effects of deutetrabenazine on functional speech and gait impairment. participants will undergo comprehensive evaluations of speech production, fine motor skills, gait, and balance both before and after the initiation of deutetrabenazine. the investigators will utilize a variety of standardized, well-validated assessments as well as 3d motion analysis of both speech and gait parameters to determine the functional impact of deutetrabenazine on speech and motor performance.

Eligibility criteria:
inclusion criteria: * diagnosis of hd with documented cag repeat ≥ 37 * uhdrs total maximal chorea score of ≥ 8 * able to walk at least 10 meters * medically stable outpatient, based on the investigator's judgment * willing and able to give written informed consent prior to performing any study procedures * have completed at least 10th grade * montreal cognitive assessment score ≥ 22 on screening * female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion exclusion criteria: * severe depression or suicidal ideation * history of suicidal behavior * unstable or serious medical or psychiatric illness * renal or hepatic impairment * severe speech impairment or anarthria * inability to swallow study medication * women who are pregnant or breast feeding * history of alcohol or substance abuse within the last 12 months * current use of vmat2 inhibitor (tetrabenazine, deutetrabenazine, valbenazine) * concurrent participation in any other investigational drug trials * ekg qtcf\> 500 mse
improved rehabilitation after surgery and hypnosis: benefits potentiated by a preoperative consultation

Conditions: Gynecological Disease

Summary: today, patient management in the context of scheduled surgery must meet new requirements. the understanding of surgical aggression, the evolution of anesthesia and surgery techniques have allowed the birth of the protocol of improved rehabilitation after surgery. the objective is a pain-free surgery, with a minimum of risks, with a global management of the patient and an active participation. in 2019, the nice university hospital developed this program. other non-medicinal techniques could promote the evolution of this program such as integrative medicine with, in this study case, hypnosis. since 2002, thanks to its widely recognized effectiveness in the treatment of pain and in helping with care, its use has developed. a hypnosis session, proposed in the preoperative period, would considerably reduce the patient's anxiety, postoperative pain, a better and faster recovery with an easier healing: objectives of the improved rehabilitation after surgery program. the patient's satisfaction would also be improved thanks to his active participation, in a greater comfort, which the investigators want to demonstrate by our work.


Eligibility criteria:
inclusion criteria: * female gender * age ≥ 18 years * indication for laparoscopic gynecological surgery eligible for the improved rehabilitation after surgery protocol * understanding of french essential * signature of informed consent * affiliation to a social security system exclusion criteria: * patient with a history of psychiatric pathologies (schizophrenia, psychosis, bipolarity) * deafness, intellectual deficiency not allowing comprehension * pregnant or breastfeeding women * women of childbearing age who are not using an effective method of contraception (pill, intrauterine device, vaginal ring, contraceptive skin patch, subcutaneous hormonal implant, surgical sterilization) * patient under guardianship or deprived of liberty

Keywords: laparoscopic gynecological surgery
prevention of post-partum haemorrhage

Conditions: Postpartum Haemorrhage; Immediate Postpartum Hemorrhage

Summary: the primary purpose of the trial is to evaluate whether the management of placental delivery with controlled cord traction (cct) reduces the incidence of postpartum haemorrhage, compared with management waiting for clinical signs of spontaneous placental separation, in women with vaginal delivery receiving prophylactic oxytocin for the management of the third stage of labour. the hypothesis is that cct, by reducing the length of the third stage of labour, facilitates early postpartum uterine contraction and local haemostasis and decreases post partum blood loss.

in this randomized controlled trial, conducted in 6 maternity units, information will be provided to eligible women during a prenatal visit in late pregnancy. once in labour ward, during labour and before delivery, and if eligible and willing to participate, the woman will be randomly allocated to the intervention or reference group. in all women, immediately after the birth of the baby, 5 iu prophylactic oxytocin will be intravenously administered, the umbilical cord will be early clamped and cut, and a collector bag placed under the woman's buttocks. in the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs. in the reference group, clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure. all other aspects of the management of the third stage will be standardized and common to all women. on day 2 postpartum, a venous blood sample will be collected to measure plasma haemoglobin and haematocrit. on the same day, a questionnaire will be filled in by the woman to assess her satisfaction.

Eligibility criteria:
inclusion criteria : * age ≥ 18 * expected vaginal delivery * gestational age ≥ 35 weeks * singleton pregnancy exclusion criteria : * age \<18 * planned caesarean delivery * severe hemorrhagic disease * multiple pregnancy * placenta praevia * intra uterine fetal death * no health insurance coverage

Keywords: postpartum haemorrhage third stage of labour controlled cord traction randomized controlled trial prevention
gemcitabine with peptide vaccine therapy in treating patients with bile duct cancer

Conditions: Bile Duct Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, and immune response of different doses of urlc10 peptide emulsified with montanide isa51 in combination with gemcitabine. recommended phase ii dose will be also determined.

our previous studies have demonstrated that up-regulated lung cancer 10 (urlc10) has been identified as a new target of tumor associated antigen using cdna microarray technique combined with the expression profiles of normal and cancer tissues. we have also found that 100% of tissue samples from bile duct cancer express urlc10. we have determined the hla-a\*2402 and hla-a\*0201 restricted epitope peptides derived from urlc10.these epitope peptides have shown to induce specific cytotoxic t lymphocytes (ctl). furthermore, 60% and 20% of japanese population have hla-a\*2402 and hla-a\*0201, respectively. therefore, these peptides are suitable for clinical trial. on the other hand, gemcitabine is a drug approved against bile duct cancer. recent studies has reported that gemcitabine has an additional ability to improve immune response. from these results, synergistic effect between vaccine therapy and chemotherapy using gemcitabine will be expected. in this clinical trial, we evaluate the safety, tolerability, and immune responses of different doses of urlc10 peptide emulsified with montanide isa51 as immunochemotherapy in the patients with unresectable or recurrent bile duct cancer. toxicity profiles will be monitored, and antigen specific t cell responses will be described.

Eligibility criteria:
inclusion criteria: disease characteristics 1. advanced bile duct cancer precluding curative surgical resection and recurrent bile duct cancer 2. measurable disease by ct scan, ultrasonography, or other imaging modalities. patients characteristics 1. ecog performance status 0-2 2. life expectancy \>3 months 3. laboratory values as follows 2,000/mm³\< wbc \< 15,000/mm³ platelet count ≥ 75,000/mm³ bilirubin ≤ 1.5 x the institutional normal upper limits ast, alt, alp ≤ 2.5 x the institutional normal upper limits creatinine ≤ 1.5 x the institutional normal upper limits 4. hla-a\*2402 or hla-a\*0201 5. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) 2. breastfeeding 3. serious or uncontrolled infection 4. prior chemotherapy (except gemcitabine), radiation therapy, or immunotherapy within 4 weeks. 5. other malignancy within 5 years prior to entry into the study 6. concomitant treatment with steroids or immunosuppressing agent 7. disease to the central nervous system 8. decision of unsuitableness by principal investigator or physician-in-charge