Kornimate/medical-research-clean huggingface dataset:
role of n-acetylcysteine in treatment of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: n-acetyl cysteine (nac) is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.its effect in biofilms has been tested in several bacteria. biofilms have recently been observed in 90% of subjects with bacterial vaginosis (bv) with gardnerella vaginalis being the predominant species. although a wide range of antimicrobial agents are currently available, treatment options for controlling bv are still limited. furthermore, the number of relapses are increasing and require alternative treatments. this study is aiming to evaluate the role of nac in treatment of bv and prevention of recurrence.

bacterial vaginosis (bv) is the most frequent diagnosis made in women with lower genital tract symptoms. it has recently been observed that 90% of subjects with bv show the growth of bacteria in the form of biofilms,and that gardnerella vaginalis was the predominant species. the propensity of g. vaginalis to form biofilm is clinically relevant because this form of growth allows it to tolerate higher concentrations of certain antibiotics, thus increasing the possibility of recurrent bv even after apparently curative therapy. so new treatment strategies must be used to insure complete cure and prevent recurrence. nac is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.its effect in biofilms has been tested in several bacteria. this study aims to test the efficacy of nac in treatment of bv either alone or in combination with the traditionally used metronidazole. also the effect of using nac in prevention of recurrence of bv will be monitored.

Eligibility criteria:
inclusion criteria: * patients complaining bacterial vaginosis and proved to have bv using standard diagnostic methods for bv * patients with age between 20-50 exclusion criteria: * virgins and menstruating patients. * recent douching or sexual intercourse. * use of systematic or vaginal antimicrobial therapy or any vaginal suppositories or drugs. all patients will sign a written consent before starting the treatment

Keywords: bacterial vaginosis, recurrence, n-acetyl cysteine
clinical characteristics and outcome of patients with hemorrhagic stroke admitted in neurology department in a tertiary hospital

Conditions: Hemorrhage, Intracranial; Outcome Measure

Summary: the main aim of this study is to know about the clinical profile of patients who are diagnosed as hemorrhagic stroke as well as the factors that affect good and bad outcomes of those patients after 3 months. patients will be required to follow up in medical opd of the same institution after 3 months.

this was a prospective observational study conducted on 197 patients of ≥ 18 years of age admitted with the diagnosis of hemorrhagic stroke in tribhuvan university teaching hospital, a tertiary hospital in nepal from april 1 2023 to march 31, 2024. patients who do not give consent or with post-traumatic hemorrhages, hemorrhagic transformation of an ischemic stroke, or any intracranial hemorrhages other than primary intracranial hemorrhages were excluded from the study. the study protocol and design were reviewed and approved by the institutional review committee of tribhuvan university teaching hospital \[ref. 437 (6-11) e2\]. data was collected in a structured proforma. the primary outcome of this study was to assess the functional outcome of the patients at 3 months of follow-up. the modified rankin scale (mrs) was assessed in an outpatient setting during the follow-up. if patients did not attend the 3-month follow-up, mrs was assessed by telephone conversation. clinical outcome was dichotomously categorized as good outcome if mrs was 0-2 and bad outcome if mrs was ≥ 3. analysis for categorical data was done by chi-squared test, fisher's exact test. analysis for continuous data was done using either parametric tests like the t-test, or non-parametric tests like the mann-whitney u test depending on the distribution of data. predictors of clinical outcomes were analyzed using multivariate logistic regression.

Eligibility criteria:
inclusion criteria: * diagnosed case of hemorrhagic stroke exclusion criteria: * does not give consent * post-traumatic hemorrhages, hemorrhagic transformation of an ischemic stroke, or any intracranial hemorrhages other than primary intracranial hemorrhages were excluded from the study

Keywords: hemorrhagic stroke spontaneous intracerebral hemorrhage mrs scale functional outcome after stroke
lyon bji cohort study

Conditions: Bone and Joint Infection

Summary: the prospective cohort includes all patients with bone or joint infection (bji), with or without implant. the aim of this cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. various data of patients included are collected and will be analysed. patients with a bone or joint infection are treated at the department of infectious diseases, at infectious disease department of hospices civils de lyon. they have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. it allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment. several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of bji, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, asa score, implant or not. if there is an implant, the date of implantation and the number of the prosthesis infected are collected. this cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.


Eligibility criteria:
inclusion criteria: * patients with bone or joint infection, with or without implant

Keywords: infection bone and joint infection relapse adverse event
puberty in girls followed for cystic fibrosis

Conditions: Cystic Fibrosis

Summary: in the general population, age of puberty, and age of menarche in girls, are closely correlated with those of their mother. the severity of chronic disease has an impact on the stature, the weight gain and the onset of puberty: age of menarche is even later that chronic illness is serious. cystic fibrosis is one of the major chronic diseases of children. neonatal screening is organized since 2002, most girls with cystic fibrosis therefore currently have a very specialized and early care. older patients were diagnosed during childhood. the optimization of the nutritional and respiratory management has allowed over the past two decades a significant improvement in the survival of these patients. most young people reach adulthood, puberty and reproductive desire are a crucial issue in the care of these young adults. in literature, it is often noted an age of menarche delayed an average of 2 years compared to the general population, but correlated with the age of menstruation from the mothers. the factors involved in the conduct of cycles in the girl followed for cystic fibrosis are poorly known and there are few data on the characteristics of cycles. the menstrual irregularity and amenorrhoea episodes concern nearly half of women. on the pathophysiological level, studies in animals show that there is a direct effect of cftr (cystic fibrosis transmembrane regulator) on the hypothalamic pituitary gonadal and reproductive capacity in mice. the literature data on the pubertal development, fertility and hormonal profile of these girls are for studies with low numbers and are very old. there is to date no french cohort study on this topic. the study is a multicenter cross-sectional descriptive study for pubertal and gynecological characteristics in girls followed annually in the reference centers cystic fibrosis two inter-region.


Eligibility criteria:
inclusion criteria: * patient diagnosed with cystic fibrosis * girl aged 8 years of age, adolescents and young adults, had period or not, * visit the reference and competence center of cystic fibrosis. * affiliated to a social security scheme exclusion criteria: * lack of consent of the legal representative or the relevant patient. * patient majoring in legal disability or minor patient whose legal representative is legal disability

Keywords: cystic fibrosis menstrual cycle puberty
peroral endoscopic remyotomy for failed heller myotomy

Conditions: Esophageal Achalasia

Summary: achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. with respect to long-term efficacy, heller myotomy (hm) using an open or a laparoscopic approach has gained wide acceptance as the procedure of choice for the management of patients with primary achalasia in recent years. although good or excellent long-term symptomatic response rates can be achieved in more than 90% of patients undergoing hm, recurrence or persistence of symptoms occurs in approximately 20%. controversy exists regarding the therapy of patients with failed success after hm. peroral endoscopic myotomy (poem) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia. our purpose was to evaluate the efficacy and the feasibility of poem for patients with failed hm.

1. patients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary hm with an eckardt symptom score ≥ 4. the diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the les on established methods (barium swallow, manometry, esophagogastroduodenoscopy (egd)). exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of \> 7 cm). 2. all patients were scheduled for a follow-up visit at 1 month after poem for egd and manometry. symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires. 3. the primary outcome of the study was therapeutic success (a reduction in the eckardt score to ≤3) at the follow-up assessment. the secondary outcomes included procedure-related adverse events, les pressure on manometry pre- and post poem, reflux symptoms and medication use before and after poem, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * recurrence/persistence of symptoms after primary hm with an eckardt symptom score ≥ 4 * the diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the les on established methods (barium swallow, manometry, esophagogastroduodenoscopy) exclusion criteria: * severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk * pseudoachalasia * megaesophagus (diameter of \> 7 cm)

Keywords: peroral endoscopic myotomy heller myotomy persistent/recurrent achalasia.
trial comparing barbed and non-barbed suture for uterine incision closure at cesarean section

Conditions: Cesarean Section

Summary: this was an unblinded randomized controlled trial. women were randomized to uterine closure with the knotless barbed suture (stratafix pds, ethicon) or vicryl (ethicon) at the time of elective cesarean. the primary outcome was closure time of the uterine incision. also measured were blood loss during incision closure and the use of additional hemostatic sutures. informed consent was obtained


Eligibility criteria:
inclusion criteria: * elective cesarean * elective repeat cesarean exclusion criteria: * emergent or urgent cesarean * prom * chorioamninitis * placental abruption * placenta previa or accreta * known uterine fibroids * women with known medical problems such as coagulopathy

Keywords: cesarean, incision, suture,
safety and immunogenicity of a new formulation of a bivalent killed, whole-cell oral cholera vaccine

Conditions: Cholera

Summary: the purpose of this study is to evaluate the safety and immunogenicity of a new formulation of a locally-produced bivalent, (o-1 and o-139) killed whole cell oral cholera vaccine among vietnamese adults.

cholera remains to be a serious public health problem worldwide. in the mid-1980s following technology transfer from sweden, vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for vietnam's public health programs. a 2-dose regimen of this vaccine has been shown to be safe and efficacious. subsequently, a bivalent vaccine was developed containing the newly emergent o139 v. cholerae. this vaccine has several advantages over the existing swedish vaccine. it confers protection against the el tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. however, this vaccine is not licensed for use in countries other than vietnam. in order to make this vaccine available to other countries, the ivi has provided technical assistance to produce this vaccine following the who good manufacturing practices standards. a new formulation of the current oral cholera vaccine was produced following these guidelines. since this vaccine is slightly different from the previous vaccine, a study is necessary to demonstrate safety and immunogenicity for local licensure and larger phase iii studies in other countries.

Eligibility criteria:
inclusion criteria: * healthy non-pregnant adults * available in the study area for 1 month exclusion criteria: * diarrhea for the past week * antibiotic use in the past week * intake of anti-diarrheal medicines in the past week * one or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months * abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours * pregnancy

Keywords: watery diarrhea cholera vaccine
longterm follow-up of subjects treated with bb2121

Conditions: Multiple Myeloma

Summary: this is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory b cell maturation antigen (bcma)-expressing multiple myeloma. bb2121 is defined as autologous t lymphocytes (t cells) transduced ex vivo with anti-bcma02 car lentiviral vector encoding the chimeric antigen receptor (car) targeted to human bcma suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. no investigational treatment will be administered in this study. after completing the parent study, eligible subjects will be followed for up to 15 years after their last bb2121 infusion in the parent study.

the ltf-305 study has completed enrollment and is scheduled to be closed. all patients participating in this study have discontinued from follow-up or have been transferred into the gc-ltfu-001 study for further observation (similar to time frames established in the ltf-305).

Eligibility criteria:
inclusion criteria: * provision of written informed consent for this study by subjects * were administered bb2121 in the parent clinical study * able to comply with the study requirements exclusion criteria: * subject has disease progression and subject has undetectable vcn (\<0.0003 vector copies per diploid genome) in peripheral blood cells for 2 consecutive measurements at least 1 month apart, at least 12 months after drug product infusion
study to evaluate the effect of torcetrapib/atorvastatin in patients with genetic high cholesterol disorder

Conditions: Hypercholesterolemia, Familial

Summary: the torcetrapib project was terminated on december 2, 2006 due to safety findings. to evaluate the efficacy and safety of the lipid drug torcetrapib/atorvastatin in patients with genetically known disorder of extremely high cholesterol

for additional information please call: 1-800-718-1021

Eligibility criteria:
inclusion criteria: * diagnosis of homozygous familial hypercholesterolemia exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant. * subjects with a clinically indicated need for statin (hmg-coa reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on ldl-c and hdl-c including fibrates and nicotinic acid * subjects taking any drugs known to be associated with an increased risk of myositis in combination with hmg-coa reductase inhibitors * subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study
the effect of perioperative lidocaine infusion on neutrophil extracellular trapping

Conditions: Urologic Cancer

Summary: this study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.

neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3

Eligibility criteria:
inclusion criteria: * patients scheduled robot-assisted prostatectomy exclusion criteria: * lidocaine allergy hx * hemodynamic unstable patients * weight \< 40kg * arrhythmia or bradycardia
effects of jnj-53718678 in adult and adolescent participants who had a hematopoietic stem cell transplantation and who are infected with respiratory syncytial virus (rsv)

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to evaluate the effect of jnj-53718678 on the development of respiratory syncytial virus (rsv) lower respiratory tract infection (lrtis) in adult hematopoietic stem cell transplant (hsct) recipients with rsv upper rti.

rsv is recognized as major respiratory pathogen in infants and young children and causes upper and lower respiratory illness among all age groups, often going undiagnosed. immunocompromised (ic) participants have a reduced ability to combat infection due to an impaired or weakened immune system. within the ic population, hsct recipients are generally regarded as having a particularly high risk for more severe disease caused by rsv, representing a substantial unmet need for antiviral treatment of rsv infections in this participant population. jnj-53718678 is an investigational, potent, small molecule, respiratory syncytial virus (rsv)-specific fusion inhibitor. the study will include a screening period (day -2 to day 1), a treatment period (day 1 to day 21), and a follow-up period (1 year). assessments like chest x-ray, pulse/heart rate, respiratory rate, electrocardiogram (ecg), etc will be performed. safety and efficacy will be assessed through the study. the total study duration for each participant will be approximately 49 days.

Eligibility criteria:
inclusion criteria: * received an autologous or allogeneic hematopoietic stem cell transplant (hsct) using any conditioning regimen * absolute lymphocyte count (alc) less than (\<) 1,000 cells/microliter (ml) * participant has laboratory confirmed rsv diagnosis within 48 hours of randomization * new onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing * peripheral capillary oxygen saturation (spo2) greater than or equal to (\>=) 92 percent (%) on room air exclusion criteria: * admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator * requires supplemental oxygen at screening or any time between screening and randomization * documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the screening visit, if determined by local soc testing (additional testing is not required) * clinically significant bacteremia or fungemia within 7 days prior to or at screening that has not been adequately treated, as determined by the investigator
implantable cardiac defibrillators for the prevention of sudden death in patients with cardiac sarcoidosis

Conditions: Sarcoidosis of the Heart; Cardiomyopathy

Summary: the purpose of this study is to identify patients with cardiac sarcoidosis who may be at risk for sudden death.

sarcoidosis is an inflammatory disease that can effect many organ systems. patients with sarcoidosis involving the heart are at risk of sudden death related to ventricular arrythmias. however, we currently do not have a clinical test which can predict sudden cardiac death in these patients. while implantable cardioverter defibrillators(icds) can prevent sudden cardiac death in high risk patients, we do not know which patients will benefit from implantation of these devices. this clinical problem is important because we would like to identify patients at risk for sudden death who will benefit from icd implantation. additionally, we would like to avoid the risks to patients and financial expenses of inserting icds in patients who will not benefit from them.

Eligibility criteria:
inclusion criteria: * diagnosis of cardiac sarcoidosis * previous implantable cardioverter defibrillator (icd)

Keywords: implantable cardioverter-defibrillator (icd)- pre-existing
intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Summary: the purpose of this study is to evaluate the safety of intramuscular infusion of autologous bone marrow stem cells in patients with amyotrophic lateral sclerosis by a prospective, single-center, randomized, parallel, double-blind, placebo-controlled phase i clinical trial.


Eligibility criteria:
inclusion criteria: * diagnosis of definite or probable als according to the criteria established by the world federation of neurology * patient that provides reasonable assurance of adherence to protocol. * neurophysiological data confirming affectation of lower motor neurons in the lumbar region. * assessment of motor deficits in dorsiflexion of both feet (4 or 5 points on the mrc scale) * the patient must fulfill all inclusion criteria. exclusion criteria: * diabetes mellitus. * other diseases that may present with polyneuropathy. * previous history of stroke. * prior pathology of the peripheral nervous system affecting one or both lower limbs with or without clinically evident neurological sequelae. * pregnant or breastfeeding patients active. * patients physiologically capable of becoming pregnant, unless they are using reliable contraception. * patients with cardiac disease, renal, hepatic, systemic, immune that may influence patient survival during the test. * positive serology for hepatitis b, hepatitis c or hiv. * clinical and anesthesiologic criteria, contraindicating either sedation or extraction of mo (altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin puncture site, etc.) * included in other clinical trials in the last 6 months.