cyrilzakka/clinical-trials huggingface dataset:
Embryonic Dopamine Cell Implants for Parkinson's Disease

The purpose of this trial is to determine if patients who received embryonic dopamine cell implant surgery showed significantly greater improvement in their Parkinson's disease than a control group undergoing the placebo treatment, and to determine if the cell implant surgery was more effective in younger or older patients.

Parkinson's disease is caused by the death of a small number of nerve cells that produce a critical chemical called dopamine. The drug L-dopa can partially make up for the lack of dopamine. As time goes on, however, most patients notice that the drugs do not work as well. Oftentimes, patients develop great fluctuations in motor control. Off drugs they cannot move, and on drugs they have excess, exaggerated movements. Research in animals over the last 20 years has shown that dopamine cells can be replaced by transplants of new cells obtained from fetal brain tissue. For the past 14 years, several laboratories around the world have been performing similar transplants of human fetal brain tissue on patients with Parkinson's disease. So far, it has been impossible to compare results from the different groups because no two centers are performing transplants in the same way.

This study seeks to get around that problem using a controlled clinical trial that compares the embryonic dopamine cell implant surgery with a placebo treatment. A total of 40 patients were recruited--half received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants. At present, this study is providing long-term follow-up evaluation and treatment for the subjects.

Eligibility Criteria:
INCLUSION CRITERIA:

* Idiopathic Parkinson's disease of at least 7 years duration and responsive to levodopa. Other Parkinson syndromes excluded.
* Patients previously tried on other available forms of medical treatment.
* Age between 20 and 75 years.
* Presence of an intractable problem, such as "off" periods, dyskinesias, or "freezing," not controlled by dopamine agonists such as levodopa or pergolide.
* No serious depression and no cognitive impairment.
* Successful completion of home diary by patient or responsible party.
* Successful videotape recordings at home of "on" and "off" status.
* Normal MRI of brain within the last 18 months.
* Fluorodopa PET scan compatible with idiopathic Parkinson's disease.
* Medically fit to undergo implant surgery with certification by the patient's physician.
* Able to financially cover expenses not paid for by NIH grant (between $1,000 and $2,000 for unreimbursed travel, video camera, and blood screening as specified in the consent form.

EXCLUSION CRITERIA:

* Severe or moderately severe depression or cognitive impairment.
* Previous brain surgery.
* Presence of diabetes mellitus, severe cardiopulmonary disease or other severe medical disease, or MRI evidence of cerebrovascular disease.
* Not medically cleared to undergo a surgical procedure.
The Effect of Oral Health Education in Pregnancy

Periodontal diseased during pregnancy are associated with many unpleasant prenatal consequences including preeclampsia, preterm labor, and low birth weight (LBW). Treatment of such diseases and observance of oral and dental hygiene may to some large extent prevent such consequences. Unfortunately previous studies have shown that pregnant women have very little knowledge of oral and dental health implications. Given the fact that pregnancy my be a unique opportunity to initiate correct hygienic behaviors in young women, this paper has focused on studying the effects of oral and dental health education during pregnancy.

In this single blind clinical trial study,140 pregnant women receiving care from Khaje Rabi Regional Health Center in Mashhad city who were members of a community based multi-center were chosen by systematic clustering methods and randomly allocated into test and control groups. After intervention, two questionnaires were completed for demographic and pregnancy details of the participants. Knowledge, health belief and health behavior were assessed before intervention. The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy. women in the control group received no education. Knowledge, health belief and health behavior were assessed immediately after and one month after intervention of all participants. Analysis of data was done using SPSS, t-test and chi-square tests.

In this clinical trial study,140 pregnant women receiving care from Khaje Rabi Regional Health Center in Mashhad city who were members of a community based multi-center were chosen by systematic clustering methods and randomly allocated into test and control groups. After intervention, two questionnaires were completed for demographic and pregnancy details of the participants. Knowledge, health belief and health behavior were assessed before intervention. The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy. women in the control group received no education. Knowledge, health belief and health behavior were assessed immediately after and one month after intervention of all participants. Analysis of data was done using SPSS, t-test and chi-square tests.

Eligibility Criteria:
Inclusion Criteria:

* Spoke Persian
* minimum education margin of primary school studies
* Gestational age between 12 and 32 weeks
* lacked any type of physical or mental problem
* lacked of any disease that could prevent from taking dental care

Exclusion Criteria:

* who did not attend the education sessions
* failed to complete the questionnaires
* receive any special education between post-test and stability test
Mindfulness for Alzheimer Caregivers

Mindfulness Based Health Care (MBHC) includes meditation techniques to help caregivers of Alzheimer patients to be made more aware of their experience in the present moment. Half of the caregivers will learn the practice of mindfulness meditation once a week through 8 classes, and the other half will not receive any therapy. The primary purpose of this study is to explore the effects of this mindfulness program for caregivers on the neuropsychiatric symptoms in Alzheimer patients, as well as on anxiety and depression symptoms in their caregivers. Secondarily, to examine the effect of this program on cognitive function, daily activity living and quality of life in Alzheimer patients, as well as on the burden of caregiving, quality of life, psychological well-being, occupational balance, executive function and self-compassion in their caregivers.

Alzheimer's disease is a progressive brain disorder that involves the loss of the ability to live independently, functional capacity and safety. Thus, patients often suffer neuropsychiatric disorders and need help from another person to live every day. Due to the burden of caregiving, the main caregivers can have anxiety and depression symptoms. With this scenario, we will conduct this randomized controlled trial aimed to evaluate the effect of mindfulness program for caregiver's vs control group on: 1) neuropsychiatric disorders, cognitive function, daily activity living and quality of life in Alzheimer patients; 2) anxiety and depression symptoms, burden of caregiving, quality of life, psychological well-being, occupational balance, executive function and self-compassion in their caregivers.

Eligibility Criteria:
Inclusion Criteria of Caregivers:

* be a caregiver of Alzheimer disease patient
* age over 18 years
* Score Mini Mental State Examination ≥26 points

Inclusion Criteria of Patients:

* Score of Scale Global Deterioration from 3 to 7 points (inclusive)
* Alzheimer disease diagnostic
* Non-institutionalized

Exclusion Criteria:

* Patient or caregivers with central nervous system disease with a neurological alteration (acquired brain damage, epilepsy, traumatic brain injury, multiple sclerosis and other movement disorders).
* Patient or caregivers with current or past history of alcohol or drug abuse
* Patient or caregivers with visual or hearing impairment
* Patient or caregivers with serious psychiatric illness (depression, psychosis, schizophrenia)
Nicotinamide Riboside in Ulcerative Colitis

This is a randomized, double-blind pilot study of Nicotinamide Riboside (NR) in Pediatric-onset Ulcerative Colitis (UC).

The investigators hypothesize that NR will alleviate mitochondrial dysfunction and restore metabolic homeostasis in the intestinal epithelium in pediatric patients with UC.

The purpose of the study are:

1. To establish the feasibility of an Randomized Clinical Trial (RCT) investigating the effects of NR in pediatric patients with UC.
2. To evaluate the effects of Nicotinamide adenine dinucleotide (NAD)+ repletion on intestinal epithelial mitochondrial structure and function in human UC patients. The investigators hypothesize that daily NR supplementation will restore NAD+ levels, enhancing Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1α) activity and mitochondrial structure/function.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients (≤18yo);
* Diagnosis of mild to moderate ulcerative colitis as determined by Pediatric Ulcerative Colitis Activity Index (PUCAI) and endoscopic scoring (Mayo) at the time of colonoscopy;
* Although the investigators will target newly diagnosed patients (therefore, treatment naïve), patients with established disease will also be enrolled.

Exclusion Criteria:

* Patients with acute severe ulcerative colitis;
* Concurrent gastrointestinal infection (ie. Clostridium difficile, Cytomegalovirus, etc.);
* A diagnosis of Crohn's disease;
* Indeterminate colitis/IBD-U;
* In general, patients that have been treated with steroids or antibiotics in the past three months. Patients on Biologic medications may be enrolled if their dose has been stable for at least three months. Final determination of eligibility will be at the discretion of the treating investigator. After the initiation of the study, subjects may receive any medication to treat their disease as dictated by their care providers;
* Patients who have other chronic inflammatory/autoimmune disorders or prior malignancy;
* Pregnant women (All women of childbearing age will be required to use contraception at the time of inclusion).
* Patients with existing renal or hepatic dysfunction;
* Per standard of care guidance, subjects with platelets \<50,000 do not undergo endoscopy and, therefore, are not eligible.
Plicated Laparoscopic Adjustable Gastric Banding (Lap Band)

This is a dual site, prospective study which will compare plicated-Laparoscopic Adjustable Gastric Banding (PLAGB) to standard LABG (SLAGB) to identify significant differences in bariatric surgical outcomes

* Weight Loss
* Co-morbid disease resolution


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following criteria to be eligible for study entry:

* Age between 18 - 80 years, and
* Severely or Morbidly obese:

  * BMI \> 35, or
  * BMI \> 30 + co-morbid obesity related disease condition
* Without any contraindications to bariatric surgery, and
* Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)
* Patients who have had previous LAGB surgery requiring revision for complications such as slippage, stalled weight loss or weight regain

Exclusion Criteria:

Subjects meeting the following criteria will be excluded from study entry:

* Any patient not meeting the inclusion criteria
* Patients with any major medical problems contraindicating surgery
* Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
* Patients who elect to undergo a surgery other than a PLAGB or SLAGB
* Pregnant or planning pregnancy within 12 months
* Alcohol or drug addiction
* Established infection anywhere in the body at the time of surgery
* Previous history of other bariatric surgery (except LAGB)
* Family or patient history of autoimmune disease
High Dose vs. Standard Influenza Vaccine in Adult SOT

The study will test whether a high dose influenza vaccination results in improved immunogenicity in adult SOT recipients as compared to standard vaccine. This will be a single center prospective observer-blind randomized controlled trial conducted at the Toronto General Hospital Multi-Organ Transplant Unit, University Health Network, Toronto, Ontario, Canada.

Influenza virus is an important cause of morbidity and mortality in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that standard vaccine has poor immunogenicity. Currently, there are no studies that define the effect of high-dose vaccine in adult transplant recipients even though this population could potentially benefit from it. The study will compare the immunogenicity of two different types of the influenza vaccine in 240 solid organ transplant patients during the 2016-2017 season. Patients will be randomized to receive either high-dose or standard dose influenza vaccine. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. The hypothesis is that the patients who receive the high-dose influenza vaccine will reach a significantly greater response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients. Results from this study have the potential to directly improve patient care. If the use of the high-dose influenza vaccine is successful, this strategy may lead to significant reduction in burden of disease, hospitalization, and long-term morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Organ transplant recipient on at least one immunosuppressive
* Age \>=18
* Outpatient status
* Greater than 3 months post transplant

Exclusion Criteria:

* Has already received influenza vaccination for 2016-2017 season
* Egg allergy or allergy to previous influenza vaccine
* Febrile illness in the past one week
* Active Cytomegalovirus viremia
* Use of Rituximab in the past 6 months
* Ongoing or recent (in past 30 days) therapy for acute rejection
* Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent
* Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
* Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next 4 weeks
Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis

The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.


Eligibility Criteria:
Inclusion Criteria:

* age 14 or more
* a history of solid tumor
* a new clinical neurological signs and symptoms
* a typical CT(Computerized Tomography,CT) or MRI(Magnetic Resonance Imaging,MRI) imaging findings
* tumor cells in cerebrospinal fluid

Exclusion Criteria:

* KPS score \<60
* the tumor patients with organ failure
* bacteria, fungi or viral meningitis
Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea

Incomplete recovery of neuromuscular function after surgery can lead to respiratory complications. Patients with obstructive sleep apnea (OSA) are prone to respiratory complications after surgery. Neostigmin and sugammadex are used for neuromuscular reversal.

The aim of this study was to compare sugammadex and neostigmin regarding efficacy, incidence of respiratory complications and cost in patients undergoing surgery for OSA

This prospective double blind controlled study will be conducted after obtaining informed written patient consent.

Simple randomization will be accomplished with a computer-generated sequence of numbers and sealed envelopes will be used to allocate patients into 2 groups.

Group N will receive 50 µg kg-1 neostigmin,+05 mg atropin Group S will receive sugammadex 2mg kg-1 sugammadex at the and of surgery. Patients will enter the operation room without receiving premedication Heart rate, noninvasive blood pressures, body temperature, BIS, end-tidal respiratory gases and neuromuscular function (acceleromyography) will be monitored Propofol will be used for anesthesia induction Rocuronium 0.6 mg kg-1 will be used to facilitate intubation Anesthesia will be maintained with sevoflurane in oxygen and nitrous oxide, BIS will be maintainen between 40-60 Additional rocuronium doses will be administered when the TOF T2 is observed At the end of surgery, volatile anesthesia will be discontinued, the study drug will be administered according to group allocation and the TOF response at this time will be recorded Time to obtain TOF0.9 will be recorded Time to extubation, time to recovery, time spent in the operation room will be recorded Respiratory and cardiovascular complications (bradycardia, tachycardia, hypertention, ritmia, bronchospasm, laringospasm, breath holding, cough, desaturation, hypoxia, NIMV, reintubation) and treatments during anesthesia emergence will be recorded Patients will be transfered to the PACU, time spent in PACU and respiratory and cardiovascular complications (bradycardia, tachycardia, hypertention, ritmia, bronchospasm, laringospasm, breath holding, cough, desaturation, hypoxia, NIMV, reintubation) and treatments during PACU stay will be recorded After achieving an Aldrete score \>9 patients will be transfered to the ward. Patients who can not achieve Aldrete score \>9 after 1 hour will be transfered to the ICU.

Respiratory and cardiovascular complications and treatments in the ICU will be recored

Eligibility Criteria:
Inclusion Criteria:

ASA I-III Schedulled for surgery for obstructive sleep apnea -

Exclusion Criteria:

Neurouscular disorders hepatic or renal dysfunction allergy to study drugs using medication that could interfere with NMBAs pregnancy breasth feeding

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Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy

Bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies.

Many patients with Bell's palsy will develop some complications such as synkinesis, crocodile tears and 'sweating' of the ear while eating Commonly used medications to treat Bell's palsy is Corticosteroids Cerebrolysin stimulates the regeneration of the nervous tissue with protective action we aim to study the efficacy of cerebrolycin in Bell's palsy


Eligibility Criteria:
Inclusion Criteria:

* unilateral acute facial palsy of no identifiable cause

Exclusion Criteria:

* Recurrent facial Bell's palsy
* Pregnancy
* Diabetes
* Epilepsy
* Severe hypertension,
* Renal or hepatic disease,
* Gastric or duodenal ulcer
* presence of acute otitis media or ipsilateral chronic otitis
* Recent head injury,
* psychiatric disease
* If there is any contraindications for corticosteroids
Fifteen Year Follow-up of 5,500 Black and 5,500 Other Hypertensives

To seek predictors of mortality, hospitalization, and dialysis using data from a hypertensive population which began treatment in 1974.

DESIGN NARRATIVE:

Patients dying before 1989 were identified using the VA's Beneficiary Identification Records Location Subsystem and the National Death Index (NDI). Using NDI information to locate them, death certificates were obtained on all dead patients. Arrangements were made to collect data on the VA hospitalizations occurring after antihypertensive treatment had begun, and application was made to match patients against the USRDS Dialysis and Transplant Registry. The basic clinical data were collected in 32 VA Hypertension Screening and Treatment Program (HSTP) clinics during the 40 month period beginning in 1974. Approximately 30,000 completed Screening and Evaluation Forms and 75,000 Treatment Visit Forms were completed during the 40 months of data collection. The collected information was entered into the HSTP Master File at the VA Computer Center in Austin, Texas. Predictors were sought for (1) all-cause mortality, (2) cause-specific mortality (obtained from death certificates and hospitalization and clinic records), (3) endstage renal disease (obtained from the USRDS Dialysis and Transplant Registry), (4) VA hospital usage combined with other data related to cost care.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Genomic Imprinting and Assisted Reproductive Technologies

Genomic imprinting, referring to an epigenetic marking resulting in monoallelic gene expression, plays a critical role in development. Recently, various imprinting diseases were reported in animals (Large Offspring syndrome (LOS)) and humans (Beckwith-Wiedemann syndrome (BWS) and Angelman syndrome (AS)) born after ART. In all cases, an imprinting defect was involved (loss of methylation at ICR2 in BWS, at SNRPN in AS and at IGF2R DMR2 in LOS). These data suggest that ART procedures may impair the establishment or the maintenance (following fertilization) of methylation marks at maternally imprinted loci. In view of these data, the aim of this study is to determine if children born following ART exhibit an increased risk of imprinting defects. If the answer is yes, the second objective is to identify the problematic step in the ART procedure and thus to suppress or modify this step.

Methodology: assessment of the methylation status at 9 different imprinted loci (using Southern blot and methyl-specific quantitative PCR) in 3 groups of patients: 150 children naturally conceived, 150 children conceived after ovarian stimulation but with in vivo fertilization, and 150 children conceived after ovarian stimulation and in VITRO fertilization. These analyses will be performed on cord blood. Fragments of placental tissue will also be collected for further analyses. Patients will be selected in maternity hospitals associated with ART departments ( ANTOINE BECLERE HOSPITAL, Cochin HOSPITAL, Saint-Vincent de Paul HOSPITAL, Jean VERDIER HOSPITAL, Tenon HOSPITAL and Dijon Hospital).

This work is also a unique opportunity to establish a DNA, RNA and tissue collection allowing further investigation regarding other epigenetic modifications than DNA methylation, not only at imprinted loci, but also in other genomic regions regulated by epigenetic modifications.

Eligibility Criteria:
Inclusion Criteria:

Mother :

* Age: 26 to 40 at conception
* Single foetus pregnancy
* Signed informed consent
* Affiliation to French health benefits
* Absence of maternal pathology
* Normal foetal karyotype (if available)
* Known procedure of ovarian stimulation
* ART procedure without sperm or oocyte donation
* ART in a participating ART departments
* Delivery in a participating hospital

Father

* Age : 18 to 50 at conception
* Signed informed consent

Exclusion Criteria:

* Abnormal foetal karyotype (if available)
* Delivery before 35 weeks of amenorrhea
* Delivery in not participating hospital
* Delivery complication leading to the absence of sample collection