Kornimate/medical-research-clean huggingface dataset:
open label ganciclovir therapy for sight- or life-threatening cytomegalovirus disease in the immunocompromised patient

Conditions: Cytomegalovirus Infections; Cytomegalovirus Retinitis; HIV Infections

Summary: to make intravenous (iv) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening cytomegalovirus (cmv) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy. to determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir iv followed by a maintenance course of ganciclovir iv for an indefinite duration. to tabulate the patient's clinical response.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * cytomegalovirus (cmv) disease who meet the criteria for a treatment ind protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral cmv retinitis in patients with aids. * mild to moderate cmv infections who fail to meet the severity criteria. cmv syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening. * transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible. * children with congenital or neonatal cmv where there is not a documented primary or acquired immunodeficiency. * hypersensitivity to acyclovir or ganciclovir. * receiving antimetabolite treatment that cannot be discontinued. concurrent medication: excluded: * antimetabolites. * alkylating agents. * nucleoside analogs (topical ophthalmics are permitted). * interferon. * foscarnet. * cytokines. patients with the following are excluded: * cytomegalovirus (cmv) infection who meet the criteria for a treatment ind protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral cmv retinitis in patients with aids. * mild to moderate cmv infections who fail to meet the severity criteria. cmv syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening. * transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible. * children with congenital or neonatal cmv where there is not a documented primary or acquired immunodeficiency. * hypersensitivity to acyclovir or ganciclovir. * receiving antimetabolite treatment that cannot be discontinued. patients must qualify as follows: * previously enrolled in compassionate use study (icm 1257/1257a) or have terminated from another syntex ganciclovir study. * diagnosis of aids and life-threatening cytomegalovirus (cmv) infection. * diagnosis of other immunodeficiencies other than aids, with life-threatening or sight-threatening cmv disease.

Keywords: retinitis aids-related opportunistic infections immune tolerance injections, intravenous ganciclovir cytomegalovirus infections acquired immunodeficiency syndrome
prospective evaluation of the proceed ventral patch with and without laparoscopic evaluation

Conditions: Umbilical Hernias; Ventral Hernias

Summary: for small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues. about 5 years ago the ventralex patch was introduced, which combines a layer of ptfe mesh with a small polypropylene mesh and includes a circular memory ring. despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3). with the recent development of the proceed ventral patch (pvp), new elements have been introduced to overcome some of these issues. the aim of this study is to evaluate the efficacy of clinical placement of the pvp in the intra-abdominal position in the treatment of small ventral hernias.


Eligibility criteria:
inclusion criteria: * adult patient * written informed consent * umbilical, primary ventral hernias smaller than 3cm diameter exclusion criteria: * hernias larger than 3cm * recurrence * children * emergency cases * incisional hernias

Keywords: umbilical and small ventral hernias less than 3cm diameter
sophie trial: surgery in ovarian cancer with prehabilitation in eras

Conditions: Advanced Ovarian Cancer

Summary: the treatment of choice in advanced ovarian cancer is a cytoreductive surgery combined with chemotherapeutic treatment. this complex and aggressive surgery is associated with high postoperative complication rates that may result in a strong negative impact on the clinical results due to the delay with the start of adjuvant chemotherapy as well as the costs from the surgical process. multimodal prehabilitation has emerged as an innovative intervention that focuses on optimizing physiological and psychological resilience to withstand the upcoming stress of surgery. it has been shown to reduce postoperative complications in major abdominal surgery, but has not been assessed yet in abdominal onco-gynecological surgery.

main objective: to determine the efficacy of multimodal prehabilitation in decreasing postoperative complications in patients undergoing gynecological cancer surgery of high complexity by laparotomy (primary cytoreductive surgery, interval surgery and secondary cytoreductive surgery in advanced ovarian cancer). design: multicenter randomized controlled clinical trial. subjects: 146 patients: 73 in the intervention group and 73 in the control group. intervention group: prehab intervention consists on: 1. high-intensity endurance exercise training program and physical activity promotion remotely controlled with ict (information and communications technologies). 2. nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements. 3. psychological coping. control group will receive standard preoperative care. both groups will receive perioperative care in accordance with the enhanced recovery after surgery (eras) guidelines. measures: aerobic capacity (incremental stress test), physical activity, operative complications and hospital length and associated costs.

Eligibility criteria:
inclusion criteria: 1. patients with advanced ovarian cancer subject to primary debulking surgery or interval surgery after 3-4 cycles of chemotherapy or secondary and / or tertiary debulking surgery . 2. patients with eastern cooperative oncology group (ecog) performance status 2-0. 3. adherence of at least 75 % of the program or minimum of 6 sessions. exclusion criteria: 1. surgery without a minimum of 3 weeks of prehabilitation time. 2. unstable respiratory or heart disease. 3. locomotor or cognitive limitations that makes not feasible the adherence to the program. 4. refusal of the patient.

Keywords: prehabilitation advanced ovarian cancer cytoreductive surgery postoperative complications exercise training nutrition physical activity mindfulness meditation
narrowband uvb light therapy to patients with dark skin types who have 10% of their body involved with psoriasis vulgaris.

Conditions: Psoriasis Vulgaris

Summary: this study offers narrowband uvb light therapy to patients with both light and dark skin types who have 10% of their body involved with psoriasis vulgaris.

two groups of patients, having 10% of their body surface area involved with psoriasis vulgaris, will receive narrowband phototherapy. one group will have skin type i-iv, or light skin and the second group will have dark skin, or type v-vi. all patients will receive phototherapy, with narrowband uvb, three times a week for six weeks, or a total of 18 treatments. 6mm punch skin biopsies will be done prior to starting therapy and at the completion of the study. clinical assessments and photography will be done parallel to the skin biopsies. results (clinically and histologically) of both groups will be compared.

Eligibility criteria:
inclusion criteria: patients must have stable psoriasis vulgaris, which covers at least 10% of their bodies, for at least six months. patients can not have not been treated with narrowband uvb in the past, although other light therapies are acceptable (i.e. broadband uvb and puva). patients are not allowed to receive other therapies for their psoriasis, internal and topical, while they are participating in the study. patients may continue using non-medicated moisturizer. - exclusion criteria: -
the effect of dairy and non-dairy snacks on food intake, subjective appetite in children

Conditions: Food; Eating; Appetite

Summary: dairy products have the potential to be healthy snack foods for children and are provided in a variety of food matrices. for instance, milk represents a fluid product, yogurt can be classified as a semi-solid food, and finally, cheese is the example of solid food. this experiment is aimed to examine the effect of dairy products with different food matrices on satiety and food intake in children. dairy products will be compared with other non-dairy snacks popular among children including cookies and potato chips.


Eligibility criteria:
inclusion criteria: * born at full-term within the normal weight range * 9-14 year old exclusion criteria: * food sensitivities or allergies, * dietary restrictions, * health, learning, emotional or behavioural problems * receiving medication

Keywords: snacking food intake satiety obesity
retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer

Conditions: Infertility, Female

Summary: a multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rfsh or hp-hmg alone or co-administration of rfsh and hp-hmg)

a multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rfsh or hp-hmg alone or co-administration of rfsh and hp-hmg) to infertile female patients undergoing assisted reproductive technology to controlled ovarian hyperstimulation

Eligibility criteria:
inclusion criteria: * first ivf-et cycle patients exclusion criteria: poor ovarian responder - at least two of the following three features must be present: (i) advanced maternal age (≥ 40 years) or any other risk factor for poor ovarian response (por); (ii) a previous por (≤ 3 oocytes with a conventional stimulation protocol); (iii) an abnormal ovarian reserve test (i.e. afc \< 5-7 follicles or amh \< 0.5-1.1 ng/ml)
salvage radiotherapy after radical prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of this study is to describe the urinary morbidity as a result surgery and radiation therapy, in patients treated for prostate cancer. all the patients will undergo a urodynamic examination to verify the grade of urinary morbidity.

introduction: there is a little knowledge on long-term urinary morbidity in patients treated with radical prostatectomy (rp) and salvage radiotherapy (srt). both treatments are potentially curative for localized prostate cancer (pc). improved long-term survival makes the awareness of late effects from radiotherapy important. purpose: the purpose of this study was to access, late urinary morbidity in patients treated with srt. the patients included in this study will have an urodynamic examination. the results from the urodynamic examination will help us with a better understanding of the different symptoms and their grade, after treatment with rp and srt because of pc. materials and methods: a total of 67 patients will be invited to participate in this urodynamic study. the patients will undergo a urodynamic examination, included biomechanical examination of urethra. the examination is a standard procedure at the department of urology, aarhus university hospital, denmark. the patients will, in relation to the urodynamics, have taken two blood samples. the blood samples, will later on, be used to detect some of the genetic reasons for morbidity after radiotherapy. endpoint: the primary endpoint is the outcome of different parameters as a result of the urodynamic examination. perspective: the perspective of this study is to help understanding the efficacy og morbidity of salvage radiotherapy. the investigators hope to get a better understanding of the mechanisms related to urinary morbidity.

Eligibility criteria:
inclusion criteria: * patients treated with salvage radiotherapy at aarhus university hospital in the period from 2006-2010. exclusion criteria: * other cancer types * severe comorbidity

Keywords: urodynamics late effects urinary incontinence
escitalopram in adult patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.


Eligibility criteria:
inclusion criteria: * patients must meet diagnostic and statistical manual, fourth edition, text revision (dsm-iv-tr) diagnostic criteria for major depressive disorder. * the patient's current depressive episode must be at least 8 weeks in duration. exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control. * patients with a history of meeting dsm-iv-tr criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder. * patients who are considered a suicide risk * patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.

Keywords: depression major depressive disorder escitalopram
tailored mediterranean lifestyle education in patients with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: evidence suggests that a mediterranean diet can have a beneficial effect on brain health. mild cognitive impairment (mci) describes problems with brain function such as difficulty with day-to-day memory and concentration. it is at this stage that mediterranean diet could prove beneficial in terms of prevention. previous research by queens university investigated the opinions of patients with mci and their care givers to inform the development of mediterranean diet education material to encourage behaviour change. the study suggested that mci patients lacked awareness of the link between mediterranean diet and brain function, although were interested to learn more. feedback on the developed educational material was positive although there were suggested improvements such as tailoring information to memory loss, a potential staged approach to delivery and adaptations to the material content. this present study aims to pilot test refined educational material among mci participants to evaluate the feasibility of encouraging dietary behaviour change among this patient group.

this study aims to evaluate the feasibility of a theory-based, tailored mediterranean lifestyle education intervention to encourage behaviour change in patients with mci. the proposed study will be a 6 month rct with a total of 60 mci patients who will be randomised to 1 of 3 groups: 1. group 1 will receive the mediterranean lifestyle education resource on one occasion at baseline 2. group 2 will receive the mediterranean lifestyle education resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian 3. group 3 will receive standard care (control group). participants will receive the mediterranean lifestyle education resource after their final 6 month study visit (i.e. delayed intervention).

Eligibility criteria:
inclusion criteria * diagnosis of mild cognitive impairment by their physician * mediterranean diet score (mds) less than or equal to 4 (estruch et al., 2006) * willing to make changes to their diet exclusion criteria: * diagnosis of dementia * patients with visual or english language impairment * psychiatric problems * significant medical comorbidity * body mass index (bmi) ≤ 19 and ≥ 40 kg/m2 * excessive alcohol consumption * taking high dose nutritional supplements * dietary restrictions/allergies that would substantially limit ability to complete study requirements * inability to provide informed consent * history of, or comorbid condition which may alter performance on cognitive tests e.g. stroke, head injury, parkinson's disease, learning disability

Keywords: mediterranean diet lifestyle
intraperitoneal ropivacaine nebulization for pain control after gynecologic laparoscopic surgery

Conditions: Ovarian Cysts

Summary: the purpose of this study is to assess if intraperitoneal nebulization of ropivacaine 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery.

in a recent study the investigators found that nebulization of ropivacaine 30 mg before or after gynaecologic laparoscopic surgery significantly reduces postoperative pain and postoperative morphine consumption. ropivacaine was effectively administered with non-heating nebulizers (aeronebpro®). however, almost all patients still use morphine after surgery. the investigators hypothesize that intraperitoneal nebulization of ropivacaine 150 mg may prevent the use of morphine after the laparoscopic ovarian cyst surgery.

Eligibility criteria:
inclusion criteria: * females 18-65 years old * asa score i-iii * scheduled for ovarian cyst laparoscopic surgery * free from pain in preoperative period * not using analgesic drugs before surgery * without cognitive impairment or mental retardation * written informed consent exclusion criteria: * emergency/urgency surgery * postoperative admission in an intensive care unit * cognitive impairment or mental retardation * progressive degenerative diseases of the cns * seizures or chronic therapy with antiepileptic drugs * severe hepatic or renal impairment * pregnancy or lactation * allergy to one of the specific drugs under study * acute infection or inflammatory chronic disease * alcohol or drug addiction

Keywords: ovarian cysts nebulization ropivacaine
fertility and pregnancy after avelumab treatment

Conditions: Gestational Trophoblastic Tumours; Immune Checkpoint Inhibitors

Summary: immune checkpoint inhibitors (icis), such as anti-pd-1/pd-l1 agents, initially evaluated in advanced non-curative pathologies, are now being evaluated in adjuvant or even neoadjuvant curative treatment conditions. this paradigm shift is leading to the treatment of young women, particularly in the context of gestational trophoblastic tumours. given the potential autoimmune side-effects affecting endocrine functions, as well as their impact on maternal-foetal tolerance mechanisms, accurate assessment of post-ict fertility is necessary. in the coming years, treatment with anti-pd-l1 (avelumab) could become a cornerstone of the therapeutic strategy for patients with gestational trophoblastic tumours. however, these patients are often young and of childbearing age, so safety of use in terms of fertility and successful pregnancies is an essential factor in the widespread use of immunotherapy as a treatment option. some studies have reported the possibility of conceiving after avelumab treatment, but no cohort has been reported. this study aims to explore fertility and the course of potential pregnancy in 50 patients treated with anti-pd-l1 (avelumab) over the last 5 years in several french centres.


Eligibility criteria:
* inclusion criteria : * patient aged over 18 years * have received avelumab treatment for gtt in the trophimmun or trophamet trials, or have received avelumab outside the trial for gestational trophoblastic tumour. * did not object to participating in the study * exclusion criteria : * patient who has died * patient who has had a hysterectomy

Keywords: immune checkpoint inhibitors gestational trophoblastic tumours young women childbearing age pregnancy
efficacy evaluation of great occipital nerve electrical stimulation on rebound headache

Conditions: HEADACHE

Summary: sengo-cam study is a sham-controlled simple blind trial which aim is to study the efficacy of great occipital nerve stimulation (gons) associated with medication withdrawal in the treatment of medication overuse headache occurring in migraine patients.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * migraine patient with medication overuse headache by non specific analgesics according to the ichd-ii diagnostic criteria * failure of outpatient withdrawal * signature of informed consent. * affiliation to french national health and pensions organization exclusion criteria: * pregnancy (positive pregnancy test at pre-study) and breast-feeding * patients with medication overuse headache by specific antimigraine treatment (triptans or/and ergot derivatives) according to the ichd-ii diagnostic criteria * previous surgical treatment targeting great occipital nerves
acupuncture on anxiety and inflammatory events following surgery of mandibular third molars

Conditions: Tooth Extraction; Molar, Third; Pain, Postoperative; Trismus; Edema; Anxiety

Summary: the aim of this study was to compare the effect of acupuncture and placebo acupuncture for the control of pain, edema, and trismus following the extraction of third molars and control of preoperative anxiety. patients who met the study criteria were randomized to the type of acupuncture (active acupuncture or placebo acupuncture) and to the side of the first surgery (right or left).

studies using acupuncture have shown promising results in the control of pain, edema, trismus and anxiety control. the use of this technique is interesting considering the negative effects of excessive use of medicines and the side effects of medications which are the most common treatment used for the control of these complications. however, there are no reports in the literature that evaluated the effects of acupuncture on the control of these variables following mandibular third molar extraction, using the placebo-needle design and blinding the patients, operators, and evaluators. therefore, the aim of this split-mouth randomized triple-blind clinical trial was to compare the efficacy of acupuncture and placebo acupuncture for the control of pain, edema, trismus and preoperative anxiety in the extraction of third molars.

Eligibility criteria:
inclusion criteria: * patients with indication for bilateral extraction of asymptomatic mandibular third molars in the position class iib, according to the classification of pell \& gregory (1933). exclusion criteria: * previous use of any type of medication in the 15 days prior to the study; * hypersensitivity to drugs, substances or any materials used in this experiment; * pregnancy or lactation; * previous case of pericoronitis; * people who have previously undergone any kind of acupuncture treatment.

Keywords: third molar acupuncture pain edema trismus anxiety