cyrilzakka/clinical-trials huggingface dataset:
Multi-limb Dual-task Control in Parkinson's Disease

People with Parkinson disease commonly experience difficulty driving, which requires the arms and legs to do different tasks simultaneously. Driving difficulties can lead to isolation, depression, loss of independence and mobility, and increased incidence of car accidents. Through understanding the impact of Parkinson disease on mechanisms underlying attention and multi-limb control, training and rehabilitation programs can better focus on the needs of drivers with Parkinson disease. The proposed study aims to address this need by taking measures of simulated driving at one point in time. Subjects with PD are tested at a single time point when they are at their "best" point in their day and on another day when they are at their worst and are about to take their next dose of medication. Healthy age-matched subjects are not taking anti-parkinson medication so are tested at only one point.


Eligibility Criteria:
Inclusion Criteria:

* have a clinical diagnosis of mild to moderate idiopathic PD (Hoehn \& Yahr stages 1-3),
* hold a valid driver's license and drive at least once a week, and
* be capable of providing informed consent and complying with study procedures. Control group participants will be healthy, neurologically intact individuals, age-matched to within 2 years of the PD subjects.

Exclusion Criteria:

* impaired global cognition (i.e., a score of \< 20 on the Montreal Cognitive Assessment (MoCA) screening tool)
* sensory loss in the lower limb as assessed by clinical test of vibration perception at the ankle,
* orthopedic, visual, or neurological conditions that would prevent performance of the experimental tasks,
* inability to complete and pass the assessment testing,
* history of neurological illness such as head trauma, previous stroke, epilepsy, demyelinating disease, or
* complicating medical problems such as diabetes.
Efficacy of Triclosan-coated Sutures in the Episiotomy

Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.

Women undergoing planned were randomized to either episiotomy suture with VICRYL PLUS or VICRYL. The primary outcome measures were number of sutures used and the development of hematoma, seroma, surgical site infection (SSI) or wound disruption one week after episiotomy. Secondary outcome measures were the cost of the treatment with or without infection, and scar evaluation (wound complication).

Data were analyzed according to the intention to treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who had had an episiotomy at the delivery
* vaginal delivery
* no further perineal or vaginal lesions present

Exclusion Criteria:

* collagen disease
* known immunodeficiency
* Clinical signs of infection at the time of episiotomy
* History of keloids and a medical disorder that could affect wound healing
* Hypersensitivity to any of the suture materials used in the protocol
* Diabetes mellitus
* Disorders requiring chronic corticosteroid use or immunosuppression
* Instrumental extraction
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil

Data on the burden of MIP in low transmission areas, such as Latin America, are very limited; there is even less information on the efficacy of case management of MiP. The treatment recommendations for MiP in Latin American countries have been changing rapidly in recent months; currently, either artemether-lumefantrine (AL) or mefloquine-artesunate (MA) is the first line treatment for P. falciparum (depending on country); however, no data exists on the efficacy of these drugs for the treatment of malaria in pregnancy in Latin America to support their use.

We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety and efficacy of the present therapies, AL and MA. We hypothesize that the drugs will both be efficacious for use in pregnant women in Brazil.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age \>16 weeks (determined by LMP and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus
2. Normal fetal heart beat detected by Doppler
3. Presence of any P. falciparum parasitemia ≤ 50,000 parasites/microliter (thick film)
4. Willing to sign or thumb print informed consent
5. Willing to return for scheduled follow up visits for treatment and observation until delivery
6. Willing to deliver in health facility

Exclusion Criteria:

1. Pregnancy \< 16 weeks
2. Microscopically confirmed P. vivax or mixed infection/ parasitemia (P. falciparum and another species of Plasmodium, i.e. P. vivax, P. ovale, or P. malariae)
3. History of allergy or hypersensitivity to interventional drugs
4. Exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including AL and MA)
5. Patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin)
6. History or family history of epilepsy or psychiatric disorder
7. Presence of signs and symptoms of severe malaria
8. Hemoglobin \< 7 g/dl
9. Inability to tolerate oral medication (repeated vomiting, impairment of consciousness).
10. History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, HIV or AIDS, known hemoglobinopathy
11. Participant's inability to return for follow up visits
12. Age \<15 years
How Our Immune System Can Help Fight Cancer

There is growing evidence that our immune system can help fight cancer. This has stimulated interest in the development and application of tumor vaccines for several human solid tumors, including epithelial ovarian cancer (EOC). A major obstacle to the development of these vaccines is that there are specialty cells called regulatory T cells that prevent the immune system from attacking all of our organs. These regulatory T cells also prevent our immune system for attacking cancer cells.

Indoleamine 2,3-dioxygenase (IDO), an enzyme that degrades an essential amino acid tryptophan that is necessary for T cells to multiply, however regulatory T cells are less susceptible to low levels of tryptophan, and can still multiply. This allows cancer growth and progression. This may be explained by genetic polymorphisms (changes) in the IDO gene, which may alter its function. Five of these changes in the IDO gene have been described. In this research project, we are asking if you would donate a small piece of your tumor and ascites to see if we can examine your IDO gene in the tumor cells and see if any of these gene changes are present. We hope that this will help us understand how the immune system works in EOC.

We hypothesize that genetic polymorphisms within the IDO gene alter its enzymatic activity and affect the outcome of ovarian cancer patients. These findings have the potential to translate into a method for predicting successful immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* females aged 20-90 who are having surgery to confirm epithelial ovarian cancer.

Exclusion Criteria:

* patients who have a diagnosis of non-epithelial histology.
Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)

The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.

Women who are planning a pregnancy will be recruited into a parallel groups randomised controlled trial where the intervention will consist of high intensity training and time-restricted eating. The intervention will continue throughout pregnancy. The investigators will assess whether this lifestyle intervention can effect maternal and offspring cardiometabolic health.

Eligibility Criteria:
Inclusion Criteria:

* contemplating pregnancy within the next six months
* At least one of the following criteria: BMI ≥ 25 \< 40 kg/m2, gestational diabetes in a previous pregnancy, previous infant \> 4.5 kg, fasting plasma glucose \> 5.3 mmol/L, or Non-European ethnicity

Exclusion Criteria:

* On-going pregnancy
* Trying to conceive ≥ 6 cycles at study entry
* Known diabetes (type 1 or 2)
* Shift work that includes night shifts \> 2 days per week
* Previous hyperemesis
* Known cardiovascular diseases
* High intensity exercise ≥ 2 hours/week the last 3 months
* Habitual eating window ≤ 12 hours
A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors

This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>/= 40 kilogram (kg) at the time of screening
* Diagnosis of severe congenital hemophilia A
* Documentation of the details of prophylactic or episodic FVIII treatment and of number of bleeding episodes for at least the last 24 weeks
* Adequate hematologic function
* Adequate hepatic function
* Adequate renal function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (\<) 1 percent (%) per year during the treatment period and for at least 5 elimination half-lives (24 weeks) after the last dose of study drug

Exclusion Criteria:

* Inherited or acquired bleeding disorder other than hemophilia A
* Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
* Conditions that may increase risk of bleeding or thrombosis
* History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection
* Known human immunodeficiency virus (HIV) infection with cluster of differentiation (CD) 4 count \<200 cells per microliter (cells/mcL) within 24 weeks prior to screening. Participants with HIV infection who has CD4 greater than (\>) 200 and meet all other criteria are eligible
* Use of systemic immunomodulators at enrollment or planned use during the study, with the exception of anti-retroviral therapy
* Participants who are at high risk for thrombotic microangiopathy (TMA) (for example, have a previous medical or family history of TMA), in the investigator's judgment
* Concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose additional risk, or would, in the opinion of the investigator, preclude the participant's safe participation in and completion of the study
* Planned surgery (excluding minor procedures) during the study
* Receipt of emicizumab in a prior investigational study; an investigational drug to treat or reduce the risk of hemophilic bleeds within 5 half-lives of last drug administration; a non-hemophilia-related investigational drug concurrently, within last 30 days or 5 half-lives, whichever is shorter
* Pregnant or lactating, or intending to become pregnant during the study
Does Thiamine Help Vomiting and Nausea in Pregnancy?

There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.

* Research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less
* After basic examinations and hydration, the women will randomized to thiamine or promethazine treatment.
* If no improvement is shown, the patient will be treated with the other drug
* The patients will be interviewed on their current visit and every two weeks until 14th week of gestation
* The interview includes medical history and details about their illness, other treatments, hospitalization etc.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women until 12th week of gestation
* The women visit the ER because of nausea and vomiting
* The women didn't received thiamine yet

Exclusion Criteria:

* Pregnant women over 12th week of gestation
* Women that received thiamine before
* women that allergic to the studied drugs
Group B Streptococcus Infection and PROM Incidince

To investigate incidince of prom with GBS infection and role of prophylaxis against it


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with prom after 34 wks festation

Exclusion Criteria:

* Bleeding disorder
* emergency conditions
Does Vitamin D Supplementation Enhance Resolution of Inflammation After Community-acquired Pneumonia?

Previous research has shown that people who have been hospitalised for pneumonia are more likely to die of conditions such as heart attacks, stroke and cancer in the weeks to months after their illness. This risk is linked to raised levels of inflammation. Laboratory research shows that vitamin D can help to clear inflammation. Vitamin D deficiency is very common in the United Kingdom. The investigators are conducting this study to find out if taking vitamin D can hasten long-term recovery from pneumonia by reducing inflammation.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥50 years of age
2. Vitamin D deficiency at entry, defined as a serum total 25(OH)D concentration \<50 nmol/L
3. Admission to hospital with an acute illness (≤21 days) consistent with community-acquired pneumonia - at least one symptom of a lower respiratory tract infection (cough, sputum production, dyspnoea, wheeze, chest discomfort or pain, fever) and new infiltrate on chest radiograph
4. Adequate mental capacity to give informed consent for participation in the study and gives written informed consent

Exclusion Criteria:

1. Currently taking any vitamin D supplementation
2. Known HIV infection, other condition causing immunosuppression, current immunosuppressive therapy or systemic corticosteroids
3. Known malignancy not in remission for \>3 years or terminal illness with prognosis \<1year
4. History of smoking within the previous 1 year
5. Known or suspected diagnosis of chronic obstructive pulmonary disease (COPD)
6. Previous hospitalisation within 10 days of admission
7. Aspiration pneumonia diagnosed by the clinical team
8. Known diagnosis of cystic fibrosis, bronchiectasis or interstitial lung disease at screening
9. Complications of pneumonia such as empyema or lung abscess at entry
10. Recent acute coronary syndrome within the previous 1 month
11. Long term oxygen therapy, chronic mechanical ventilation dependency or other contraindication to sputum induction
12. Serum corrected calcium concentration \>2.65 mmol/L at entry
13. Chronic kidney disease stage 4-5 (estimated glomerular filtration rate \<30ml/min) on an existing blood sample from the current hospital admission
14. Known clinical diagnosis of liver failure
15. Known or suspected diagnosis of active pulmonary tuberculosis
16. Known diagnosis of primary hyperparathyroidism
17. Known diagnosis of sarcoidosis
18. Known diagnosis of nephrolithiasis
19. Taking carbamazepine, phenytoin, phenobarbital, primidone, cardiac glycosides or benzothiadiazines with concomitant calcium supplementation at entry
20. Known allergy to vitamin D or its excipients
21. Currently taking part in another research study
Isotonic Solutions and Major Adverse Renal Events Trial in the Medical Intensive Care Unit

The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-MED will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge).

SMART-MED is a large, cluster-randomized, multiple-crossover trial of 0.9% saline versus physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasma-Lyte© A) with regard to the incidence of major adverse kidney events by 30 days in patients admitted to the medical intensive care unit. Between June 2015 and April 2017, all patients admitted to the medical intensive care unit at Vanderbilt University medical center who are 18 years or older will be enrolled. The study will occur in one-month blocks. The ICU will be randomized to an initial fluid group (0.9% saline or physiologically balanced crystalloids). The assigned fluid will be used exclusively for all patients receiving isotonic crystalloid for the duration of the month-long block (except in the presence of pre-specified contraindications). The assigned study fluid will switch at the end of each month-long block such that half of the months are assigned to 0.9% saline and half of the months are assigned to physiologically balance fluid. It is anticipated that around 5,300 patients will be enrolled from the medical ICU during the study period. All aspects of study design, intervention, and data collection will be harmonized with an independent study addressing the same question in the non-medical intensive care units at Vanderbilt University during a similar study period (SMART-SURG). A pre-specified data analysis plan will dictate the harmonized analysis of SMART-MED and SMART-SURG.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the medical intensive care unit (ICU) at Vanderbilt University Medical Center

Exclusion Criteria:

* Age\<18 years old
Comparison Between Volume Controlled Ventilation and Pressure Controlled Ventilation

To assess the potential benefits on mechanical ventilation plateau pressure of pressure controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese patients (BMI \> 35). High plateau pressures encountered in obese patients due to their reduced pulmonary compliance could be lowered using pressure controlled mechanical ventilation.

All patients are over 18 years old and give their inform consent after approval of the study protocol by an ethic committee. Anesthesia is standardized and all patients are intubated. Precise protocols are used to perform pressure and volume controlled ventilation in order to regulate End-Tidal CO2 between 33 and 35 mmHg. Primary goal is comparison of plateau pressures observed in the 2 ventilation modes after 45 minutes of pneumoperitoneum. Secondary goals are : comparison of PaO2 and PaCO2 after 45 minutes of pneumoperitoneum and after 2 hours spent in post-anesthesia care unit ; comparison of total respiratory resistances and peak flow generated between the 2 modes.

Eligibility Criteria:
Inclusion Criteria:

* patients are over 18 years old and give their inform consent
* morbid obesity(BMI\>35)
* laparoscopic bariatric surgery

Exclusion Criteria:

-
Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes

Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood. Here we aim to assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC.

Currently, therapeutic options for severely brain-injured patients with disorders of consciousness (DOC), including patients in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS), are limited and still need to be improved to influence long-term outcomes. Non-invasive brain stimulations (NIBS) techniques have recently shown promising results in DOC. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood.In the present protocol, the investigators will assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC in a double-blind sham-controlled design. One anodal and one sham tDCS will be delivered in a randomized order in chronic (\>28 days post-onset) severely brain-damaged patients. The stimulation will have an intensity of 2 mA and will last 20 minutes. The anode will be placed on the left dorsolateral prefrontal cortex and the cathode on the right supraorbital region. Ten minutes of high-density EEG will be recorded using a 256-channel saline electrode net (Electrical Geodesics) directly before and after each tDCS session. Behavioral assessments will be performed using the Coma Recovery Scale-Revised before and after each session by an investigator blinded to the treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* post-comatose patients
* patients in vegetative state/unresponsive wakefulness syndrome or in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma
* patients \< 28 days after the acute brain injury
* patients with a metallic cerebral implant/a shunt
* cranioplasty
Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment

In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus (1 or2)
* decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity\<69 letters using E.T.D.R.S testing)
* macular edema

Exclusion Criteria:

* history of severe cardiac disease
* stroke within 12 months
* intraocular inflammation