cyrilzakka/clinical-trials huggingface dataset:
Neuromodulation for Central Post-stroke Pain: Mechanism, Safety and Outcome

Central post-stroke pain (CPSP) is an often pharmacorefractory type of neuropathic pain that develops in 8% of stroke patients. CPSP has been treated with three distinct types of neuromodulation (deep brain stimulation of the sensory thalamus (Vc-DBS), motor cortex repetitive transcranial magnetic stimulation (M1-rTMS), and motor cortex stimulation (MCS)), but the level of evidence for these procedures is very low. Moreover, data on the changes in pain brain circuitry in CPSP, and the effect of neuromodulation on this circuitry is very limited.

In this project, we propose a prospective double-blind randomized crossover on/off study in 32 CPSP patients. These patients will undergo M1-rTMS and either MCS or Vc-DBS. Before and after active and inactive stimulation they will be assessed with clinical scales for pain, function, quality of life and depression. Adverse events will be monitored. This allows to measure the outcome and safety of neuromodulation in CPSP.

In addition, we will have functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) use. This will provide insight into the pathological changes in the pain circuitry, and the influence of neuromodulation.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide voluntary written informed consent of the participant prior to any screening procedures
2. Male or female patients
3. Aged 18-70 years
4. Diagnosed with definite CPSP (Treede-Klit criteria) (1, 9), which is pharmacorefractory (i.e. amitriptyline 75mg/d 4w, lamotrigine 200mg/d 8w and pregabalin 600mg/d resulting in \<50% VAS reduction and/or intolerable side-effects)

Exclusion Criteria:

1. Aphasia
2. Pregnancy or intention to become pregnant in the following year
3. Medical inoperability
4. Impossibility to temporarily withhold anticoagulation or anti-platelet medication
5. Impossibility to undergo MRI, fMRI and/or PET imaging
6. Complete destruction of the stimulation target region (M1 or Vc)
7. Uncontrolled seizures
8. Expected relocation in the following year.
Family Workshops for Bipolar Disorder

This pilot study is looking at the effects of a brief psychoeducational workshop. These one day workshops are designed to increase family members knowledge about bipolar disorder and to help with processing emotions that go along with having a relative with bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* self-identified adult relatives of people diagnosed with bipolar disorder between ages 18 and 64; up to two persons per family can participate in the multifamily group

Exclusion Criteria:

* relative with bipolar disorder will not be involved in the workshop
Neurophysiological Evaluation of Schizophrenia Patients After Cognitive and Physical Intervention

Neurophysilogical, neuropsychological evaluation and cognitive and physical training

24 sessions (8 weeks, 3 times per week) of cognitive and physical training via computer. Each session consisted of 45 minutes of cognitive traing (BrainHQ platform https://www.brainhq.com/) and 45 minutes of physical training (FitForAll platform https://www.fitforall.gr/play/app/). Cognitive training included memory, attention, velocity, intelligence etc. Physical training included aerobic, strength flexibility and other excercises. All evaluations were performed 1-14 before the initiation of the interventions and 1-14 after their completion. Neurophysiological evaluation consisted of EEG with the use of 128 electrode-machine and the protocol included 5 minuted of eyes closed and 5 minutes of eyes open. Neuropsychological evaluation included Trail Making Test (A \& B), Verbal Fluency, Stroop test, Wechsler Memory - Cubes (visuospatial), MoCA, FAB (Screening for frontal damage) and Eyes Test (Theory of Mind). Also, the physical condition evaluation included 6-Minute Walking Distance (6MWD), ΒΜΙ, HandGrip Strength Test, Short Physical Performance Battery Protocol.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of schizophrenia disorder according to ICD10 criteria
* clinically stable patients (no recent change in psychotropic medication except benzodiazepines)
* sufficient acculturation and fluency in Greek language
* assent of the attending physician for participation in the study

Exclusion Criteria:

* co-morbidity with neurological disorders (e.g.epilepsy) or head injury
* a pathological or other somatic disorder that contraindicate physical exercise
* alcoholism and substance abuse within the previous 3 months (except caffeine and tobacco)
* abstainance from intervention for more than 12 days
* cognitive decline
* treated with Benzodiazepine
Shear-wave Elastography Diffuse Liver Disease

The aim of this study is to correlate between quantitative results of shear wave elastography and CT picture in diffuse liver disease, including liver cirrhosis.

Many pathophysiological processes can lead to diffuse parenchymal liver diseases and the end-result of all chronic liver diseases is healing by fibrosis and regeneration. Liver fibrosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue ended with liver cirrhosis, with a variety of causes, including viral, drug induced, autoimmune, cholestatic, and metabolic diseases.

Liver biopsy is the gold standard but limited due to its invasiveness, sampling error, and intra- and interobserver variability. Non-invasive tests are preferred in the management of chronic liver diseases. Several serum tests for liver function and markers of liver fibrosis are available and have moderate sensitivity and specificity; however, they are confounded by a wide range of extra-hepatic diseases.

Currently, several methods are available for assessing hepatic fibrosis and progression of fibrogenesis including scintigraphy, magnetic resonance diffusion weighted imaging, and magnetic resonance spectroscopy could differentiate between cirrhosis or severe fibrosis and normal liver. However, an accurate staging of fibrosis or diagnosis of mild fibrosis was often not achievable. Shear-wave elastography (SWE) is a real-time freehand ultrasonography-based elastography method for liver stiffness measurement.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes are included: patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions.

Exclusion Criteria:

* Lactating and pregnant women
* Patients known to had high serum creatinine
DP-R208 Pharmacokinetic Study

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* BMI 18\~30
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 14 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
EEG Alterations of Uterine Contractions in the First Stage of Labor Predicting Postpartum Depression

Severe uterine contractions in labor can trigger emotional disorders including postpartum depression in women during the puerperium. Numerous studies have shown that resting frontal electroencephalogram (EEG) asymmetry is closely related to depression. Therefore, the investigators hypothesize that the frontal alpha asymmetry in EEG during uterine contractions in the first stage of labor be associated with the risk level of postpartum depression. The objective of this research is to investigate, in a 1-year period, the incidence of postpartum depression in natural birth mothers in relation to frontal alpha asymmetry in EEG during uterine contractions and resting state.

Severe uterine contractions in labor can trigger emotional disorders including postpartum depression in women during the puerperium. It is characterized by lack of motivation and behavioral changes, potentially producing serious negative consequences for offspring.

In addition, EEG alpha asymmetry is one of the commonly studied biomarkers for depression. There are multiple previous studies regarding the symmetry of EEG in left and right brain hemispheres, especially at frontal electrodes. Besides, there are many other EEG indicators that predict depression which are also likely to be strong contributors to postpartum depression.

The objective of study is to investigate if there is any association between EEG alterations of uterine contractions in the first stage of labor and factors that are associated with postpartum depression.

Eligibility Criteria:
Inclusion Criteria:

* parturient women with a singleton pregnancy;
* capable of understanding the research requirements and willing to cooperate with the study instructions;
* aged 18-45;
* American Society of Anesthesiologists(ASA) physical status I or II;
* right handed;
* not taking any drug known to influence the EEG;
* EPDS scale (Edinburgh Postnatal Depression Scale, EPDS) is used in the last prenatal examination in outpatient clinics , with scores \< 10;
* informed consent is gained from all individual subjects taking part in the study.

Exclusion Criteria:

* history of neurological or psychiatric disease;
* personality disorder;
* cerebral disease;
* epidural anesthesia contraindication;
* multiparous pregnancy.
Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus

The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.


Eligibility Criteria:
Inclusion Criteria:

* patients who has succesfully completed the lead-in study MRZ 92579-0707/1

Exclusion Criteria:

* Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)
Low Dose Cyclophosphamide Treats Genital Warts

Condylomata acuminata (CA) caused by human papillomavirus (HPV) is a common sexually transmitted disease with half a million new cases diagnosed in the United States per year. Recurrence is a major challenge for CA treatment. The investigators have demonstrated that FOXP3+ regulatory T (Treg) cells mediate the immunosuppression in large genital warts. And low-dose cyclophosphamide (CY), a conventional chemotherapy drug, has been reported to selectively deplete Treg cells in cancer patients. Therefore, the investigators hypothesized that low-dose CY can be used to treat genital warts. In this study, 104 CA patients have been recruited for clinical trial with a 1:2 randomization. Among them, 64 patients received low-dose cyclophosphamide and 32 received placebo. In 8 extra patients, high-dose cyclophosphamide was given.

Patients were first treated with CO2 laser therapy, and then treated with low-dose CY, orally 50 mg per day for 7 days.The CA recurrence were observed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of large genital warts

Exclusion Criteria:

* HPV type 6 or 11 was detected negatively by PCR method.
General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19

It is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients.

There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.

After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.


Eligibility Criteria:
Inclusion Criteria:

* Any healthcare worker providing medical care or support for COVID-19 patients
* English-speaking
* Age \>18
* Medically stable
* Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
* If on psychotropic medication stable for prior 60 days

For phase II additional inclusion criteria:

- Current diagnosis of PTSD

Exclusion Criteria:

* Current significant unstable medical illness precluding regular session attendance or assessment completion
* Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk
* Lifetime or current diagnosis of schizophrenia or other psychotic disorder
* Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.
The Effect of Whole-Body Vibration Treatment Before Total Knee Arthroplasty

The study's objective is to investigate the effects of whole-body vibration therapy administered before surgery on various factors related to patients who undergo total knee arthroplasty. These factors include pain, swelling, skin temperature, normal joint movement, knee joint position sense, knee extensor muscle strength, functional status, and patient satisfaction.

The study will include participants aged 50-80 who are planning to undergo total knee arthroplasty. According to the sample size analysis, a total of 40 people will be included in this study. The enrolled participants will be randomly assigned to one of two parallel groups: the whole-body vibration group or the sham whole-body vibration group. Both groups will receive standard patient education and exercise training.The experimental group will receive whole-body vibration along with exercise on the whole-body vibration device, while the control group (sham group) will receive sham vibration on the same device. All participants will receive treatment for a total of 5 days, one session per day.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced idiopathic knee OA and scheduled for unilateral total knee arthroplasty will be considered candidates for the present study and will be asked to participate

Exclusion Criteria:

* if they had undergone another hip or knee joint replacement in the previous year
* if they had any medical condition in which exercise was contraindicated
* if they had any disease that affected functional performance
Effect of Hyperglycemia on Microvascular Perfusion in Healthy Adults

The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults

The investigators will study 22 healthy subjects (18-35 yrs) four times as follows:

1. Saline + Octreotide + euglycemia;
2. Octreotide + hyperglycemia;
3. Octreotide + hyperglycemia + insulin clamp and
4. Octreotide + Euglycemia + insulin clamp.

The sequence of admissions will be assigned randomly. The investigators will assess function in conduit (pulse wave velocity-PWV, augmentation index-AI and flow-mediated dilation-FMD), resistance (post-ischemic flow velocity-PIFV) and heart and skeletal muscle microvascular (contrast enhanced ultrasound-CEU) vessels.

This work will:

a) identify whether vascular stiffness and indices of NO action are impaired throughout the arterial tree with hyperglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy with no chronic illness
* Age 18-35
* Normal BMI (18-25)
* Normal screening labs or no clinically significant values

Exclusion Criteria:

* First degree relative with Type 2 Diabetes
* Smoking presently or in the past 6 months
* Medications that affect the vasculature
* Overweight or other indications of insulin resistance
* Elevated LDL cholesterol \> 160
* Elevated BP \> 140/90
* History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease, bleeding disorders
* Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease
* Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
* Pregnant or breastfeeding.
* Known hypersensitivity to perflutren (contained in Definity)
The Effect of Prebiotics on Endurance Performance

The aim of this study is to investigate the effect of a six-week period personalised food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults.

The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.

a prebiotic supplement will be selected based on a participants gut microbiota. 1 sachet of prebiotic or placebo will be given twice a day over a period of 6 weeks.

Before the start of the study, a VO2max test will be performed. Subjects will bring faecal samples which is collected at home. A time to exhaustion of approximately 80% of their VO2max will be performed at baseline and after the 6 weeks intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 - 40 y
* BMI range 18.5 - 25 kg/m2
* Recreational active (performing non-competitive physical endurance exercise at least two times per week with a minimum duration of 60 minutes per exercise bout)

Exclusion Criteria:

* Smoking
* Performing regular resistance training (3+ times per week, carrying out progressive overload training)
* Subject following an overly imbalanced or restrictive diet as per nutritional advice
* Participants who received antibiotics in the 90 days prior to the start of the study
* Self-admitted lactose intolerance
* Administration of probiotic or prebiotic supplements in the 14 days prior to the study
NYU/Bellevue WTC Health Impacts Research Registry

The American Red Cross has funded a multidisciplinary, comprehensive evaluation and treatment program for target individuals with suspected World Trade Center (WTC)-related health problems. The populations served consist predominantly of a) local residents who were impacted by the disperion of the WTC dusts and fumes, b) individuals involved in cleaning and debris removal of local commercial spaces, and c) responders to the WTC collapse. These populations are recruited from past and ongoing programs that we have developed as well as from ongoing collaborations with community organizations that include: the Beyond Ground Zero Network, 9/11 Environmental Action committee, and the WTC Residents Coalition. In addition, there is collaboration with the Charles B. Wang Community Health Center and the centers involved in the ongoing WTC Workers and Volunteer Medical Screening and Monitoring Program. We would now like to access the data from this treatment program to create a NYU/Bellevue WTC Health Impacts Research Registry to increase knowledge about the health effects of exposure to World Trade Center dust.


Eligibility Criteria:
Target populations who will participate in the Bellevue Hospital Red Cross WTC Health Impacts Program will include:

* residents (children and adults) of Lower Manhattan communities at the time of the attacks, who remained or returned to their homes soon after the attacks
* individuals involved in debris removal in surrounding commercial and residential buildings,
* individuals involved in rescue, recovery and debris removal who have been previously screened through the World Trade Center Worker and Volunteer Medical Screening Program and are in need of continued treatment.
Pudendal Block Versus Caudal Block for Hypospadias

The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.

In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* aged 1 to 10 years scheduled undergoing hypospadias surgery

Exclusion Criteria:

* history of allergic reactions to local anesthetics
* rash or infection at the injection site
* anatomical abnormality
* bleeding diatheses, coagulopathy, liver diseases
Urdu Version of Tinetti Balance and Gait Assessment Scale,(POMA),Reliability and Validity Study

In this study we will observe the reliability and validity of Tinetti Balance assessment scale,(POMA) in Urdu language in Pakistani geriatric population with balance impairment. Also, check the improvement in assessment and rehabilitation in geriatrics with balance problem.

The aim of study is to translate and culturally adapt Tinetti balance assessment scale (POMA) into Urdu language and secondly to investigate the reliability and validity of Tinetti Balance assessment scale (POMA) in geriatrics Pakistani population.This study will be cross sectional survey study in which convenience sampling technique will be used. Two scales will be performed by patient Tinetti Balance assessment scale and Berg Balance Scale (evaluate balance), Timed Up and Go Test (TUGT) (measure functional mobility) for comparison and data will be collected. The results of study will help to know the validity and reliability of Tinetti Balance assessment scale (POMA) in Urdu version with balance impairments in geriatric population.

Eligibility Criteria:
Inclusion Criteria:

* ability to walk a minimum of 6m with or without a walking Aid
* observed balance impairment evaluated subjectively by a physical therapist during the initial training session (Berg Balance scale and time up and go test )

Exclusion Criteria:

* people with amputated lower extremities using prosthetic leg
* those who underwent orthopedic surgery within the last 6 weeks
* Dependent on wheel chairs and bed ridden patients
* Dementia and Alzheimer's patients
* illiterate people