cyrilzakka/clinical-trials huggingface dataset:
The Effect of Electrode Implantation for Deep Brain Stimulation (DBS) on Brain Function Using Single Photon Emission Computed Tomography (SPECT) With Technetium-99m-ethyl Cysteinatedimer (Tc-ECD)

The goal of this study is to explore the effect of subthalamic nucleus (STN)-DBS surgery and stimulation in PD (Parkinson's disease) patients on regional cerebral blood (CBF) flow during cognitive task performance or at rest.

In this study subjects undergo SPECT scans for CBF mapping. PD patients before the surgery and healthy controls undergo two scans. PD patients after the surgery undergo four scans. PD patients who undergo two scans before the surgery, undergo only two scans after the surgery.

Uptake of Tc-ECD, a CBF radiotracer, is done in the following conditions:

* For PD patients before the surgery - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).
* For PD patients after the surgery- during the performance of the semantic verbal fluency task or at rest, either at on-stimulation or off-stimulation condition (total of 4 scans). The stimulator is turned off by the neurologist for 10 min.
* PD patients before and after the surgery- during performance of the semantic verbal fluency task or at rest before the surgery and during performance of the semantic verbal fluency task or at rest after the surgery only at off-stimulation condition (Total of 4 scans).
* Healthy controls - during the performance of the semantic verbal fluency task or at rest (total of 2 scans).

Following the Tc-ECD injection, the subjects are scanned by Irix SPECT camera for 15min.

Scans are analyzed and the regional CBF is measured using imaging software. Statistical analysis is done to discover the effect of the surgery, stimulation and the disease on blood flow at rest and during task performance. In addition, differences between groups in number of words produced during the task are also statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Progressive idiopathic PD
* For control group - age-matched to study groups

Exclusion Criteria:

* Progressive dementia or other psychiatric disorders
* Other neurological conditions
* Other physical disease
* Intolerance of "off stimulation" state
* Involuntary head motions
* Hearing deficits
Satiating Effects of Isolated Soy Proteins

Proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. In this study, 2 differentially processed isolated soy proteins will be tested for satiety using subjective visual analogue scales. The amount of food consumed following intake of the isolated soy proteins will be measured 3 hours after consuming the proteins. The hypothesis is that differentially processed isolated soy proteins will show unique satiety responses.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 30 kg/m2
* Age between 18-65y
* Unrestrained eater (score\<12)
* Regularly consume 3 meals per day
* Moderate exercise (eg running, aerobics classes, other sports activities) of no more than 7 hours per week

Exclusion Criteria:

* use of drugs that influence carbohydrate or lipid metabolism (eg. hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication, and anti-diabetic medication)
* presence of any significant disease (eg gastrointestinal diseases, diabetes, a CVD event less than 12 weeks from study entry, current hepatic disease, etc)
* use of special dietary treatments within 4 weeks of study (eg weight loss diet, extremely high or low carbohydrate/protein/fat diet, use of meal replacements more than once a day)
* use of supplements within 1 week of study (does not include vitamin supplements or supplements which are routinely taken and were initiated 4 weeks before the study and which will be continued during the study period)
* restrained eater (score\>12)
* weight change (absolute body weight change of ≥ 10%) within the previous 6 weeks
* alcohol intake \>2 drinks/day
* food allergies of any kind
* swallowing difficulties
* exercising more than 7 hours per week
Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients

The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. A single ischemic stroke with Middle cerebral artery (MCA) stenosis
2. Men or women age 50-80 years
3. Physician's approvals to participate the study
4. Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment
5. The modified rankin scale level is 2 or 3

Exclusion Criteria:

1. History of serious diseases

   * Musculoskeletal diseases (Chronic arthritis, Lower spondylosis/spondylolisthesis with radiculopathy, Spinal deformity, Cervical spondylosis, Rheumatoid arthritis)
   * Cardiovascular diseases (Poorly control hypertension, Heart disease class C and D)
   * Neurological disorders (Peripheral neuropathy, Parkinson)
   * Respiratory diseases (Chronic Obstructive Pulmonary Disease)
   * Brain disorders (Cardioembolic, Severe dementia, Alzheimer's disease)
   * Medical condition precluding taking Anticoagulant and Statin drug
2. Temporal window were not found
mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer

This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or greater at the time of consent.
* Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated urologist performing this procedure.
* ECOG Performance Status of 0-3.
* Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).
* Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.

Exclusion Criteria:

* Prior TURBT within 120 days of study entry.
* Prior therapy for bladder cancer within 120 days of study entry.
* Inability to tolerate mpMRI or associated contrast.
* Inability to tolerate TURBT or associated anesthesia.
* ECOG Performance Status of 4.
* Female patient who is known to be pregnant or breastfeeding.
Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C

Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3


Eligibility Criteria:
Inclusion Criteria:

Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment

Exclusion Criteria:

Liver cirrhosis HBV-coinfection Bilirubin \>1.5 times ULN or ALT \>7 ULN Hepatocellular carcinoma Immunodeficiency
Oxidative Stress as an Acute Exercise-induced Mechanism of Stem and Progenitor Cell Mobilization

It is already known from literature that exercise mobilizes stem and progenitor cells into the peripheral blood. However, the exact mechanisms thereof remain to be fully elucidated.

The investigators hypothesize that exercise-induced oxidative stress could be at least one of the responsible mechanisms and therefore want to study the exercise-induced stem and progenitor cell mobilization in a group of healthy young men when they exercise with, compared to when they exercise without antioxidative supplementation.

The primary outcome is numbers of stem and progenitor cells in the peripheral blood after an acute bout of exercise. As a secondary outcome, numbers of apoptotic mature and immature cells in the blood will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking
* Healthy
* Normal Body-Mass-Index (BMI): 18.5-24.9 kg∙m-2
* Active (fulfill World Health Organization-guidelines for recommended levels of physical activity for adults aged 18 - 64 years)
* Willing to adhere to the study rules

Exclusion Criteria:

* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Regular intake of medication
* Regular intake of antioxidant supplementations
Mitochondrial DNA in Fresh Versus Frozen Embryo Culture Media of PCOS Women Undergoing In Vitro Fertilization

Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.The template DNA prepared and the dilution standards prepared will be used for qPCR to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green PCR Kit

Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.The template DNA prepared and the dilution standards prepared will be used for qPCR to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green PCR Kit (Qiagen)

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-35 yrs.
2. BMI: ≤25.
3. PCO: diagnosed by Rotterdam criteria (at least two of the following):

   1. Polycystic ovary morphology with one ovary being sufficient for diagnosis.
   2. Hyperandrogenism: clinically or biochemically.
   3. Anovulation or oligo-ovulation.
4. Gravidity and parity: Nulligravida.
5. Compliance: primary infertility

Exclusion Criteria:

* Known medical problems as diabetes mellitus, hypertension, cardiac, hepatic or renal problem.
* Special habits of medical importance as smoking.
* Other endocrinopathies
Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience

The aim of this study is to use a brain stimulation tool called transcranial direct current stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily influence the way the stimulated part of the brain functions. With this method, the involvement of specific parts of the brain can be investigated in the working of the brain as a whole.


Eligibility Criteria:
Inclusion Criteria:

* Right handed healthy male and female adults aged 21-50
* No contraindications to fMRI scanning
* At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

* Current or past history of major medical, neurological, or psychiatric illness
* Claustrophobia
* History of head trauma
* Instability of responses to experimental pain
* Non-fluent speaker of English
* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
* History of alcohol/substance abuse
XCHT for Irinotecan-Induced Gut Toxicities (Randomized Controlled Trial)

Randomized double-blind placebo-controlled trial (RCT) study, to determine the impact of XCHT on irinotecan-induced severe delayed-onset diarrhea (SDOD), and to determine the feasibility of using plasma raloxifene-4'-glucuronide as a probe for intestinal UGT activity.

A total of 98 patients, who are planning to recieve at least 3 cycles of irinotecan chemotherapy, will be randomly assigned, at a 1:1 ratio, to XCHT group or placebo group, using a central randomization system. Patients will be administered with XCHT/placebo (9 g, qd, po) for 5 days each cycle of chemotherapy for 3 cycles. The XCHT/placebo administration begins 3 days before chemotherapy in each cycle, that is the chemotherapy begins on the 4th day of XCHT/placebo administration. Plasma will be collected for pharmacokinetic testing (using raloxifene 60mg po as probe), on the day before chemotherapy, that is on the 3rd day of XCHT/placebo administration in each cycle. The purpose of this study includes 1) to determine the safety and efficacy of XCHT for prevention of irinotecan-induced diarrhea; 2) to determine the PK profile of SN-38, SN-38G, raloxifene, raloxifene-glucuronide, and XCHT components; and 3) to validate the use of raloxifene-4'G as a probe for irinotecan-induced diarrhea.

Eligibility Criteria:
Inclusion criteria:

1. Malignant tumor confirmed by histology or cytology;
2. Age ≥ 18 years old, ≤ 75 years old;
3. ECOG score of the patient ≤ 2 points;
4. Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);
5. Patients who plan to receive 3 cycles of irinotecan chemotherapy (the dose of irinotecan ≥ 125mg/m2);
6. Normal organ functions which can meet the requirements for systemic chemotherapy:

   * Normal bone marrow function: absolute neutrophil count (ANC) ≥ 1.5×109/L, PLT ≥ 100×109/L, hemoglobin ≥ 90g/L;
   * Normal renal functions: serum creatinine ≤ 1.5mg/dl (133μmol/L) and/or creatinine clearance ≥ 60ml/min;
   * Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤ 2.5× ULN; AST \& ALT ≤ 5 × ULN if abnormal hepatic functions are caused by a potentially malignant tumor.
7. Patients who can understand and complete the questionnaires in the case report form;
8. Patients who can understand and sign the informed consent form, is well compliant, and can be followed up.

Exclusion Criteria:

1. Patients with diagnosed depression, obsession or/and schizophrenia;
2. Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)
3. Patient with active tuberculosis and other uncontrolled infections;
4. Patient who has previously received radiotherapy on the abdominal cavity or pelvic cavity;
5. Pregnant or lactating women;
6. Patient who previously had or is now having thromboembolic events.
Using FAPI PET/MRI to Evaluate Prostate Cancer

The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer.

Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able and willing to provide informed consent
* Known diagnosis of prostate cancer with established or suspected non-osseous, non-nodal metastases
* Scheduled for or recently performed (within 4 weeks) standard-of-care PSMA PET
* Optional: Scheduled for SOC biopsy of an established or suspected non-osseous, non-nodal metastases.
* Willing and able to undergo PET/MRI as part of this research

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Contraindication(s) to or inability to undergo PET/MRI
* Participants for whom PET/MRI will delay timely delivery of treatment
* Participants requiring intravenous (IV) conscious sedation for imaging care; those requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
* Have their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of this medication
* Come to the research visit with a driver
Study to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Psoriasis Treated With Subcutaneous Risankizumab Injection According to Standard of Care

Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis.

Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel.

Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe psoriasis.
* Prescribed risankizumab as the standard treatment for psoriasis, according to the local label. The decision to prescribe risankizumab will be made solely by the physician, based on his clinical judgment, and is done prior to any decision to approach the participant to participate in this study.
* Willing to be involved in the study, to sign an informed consent form and complete study questionnaires.
* Participants participating in digital component: Pruritus Numeric Rating Scale (PNRS) score \>=4 at baseline.

Exclusion Criteria:

* Participants participating in a concurrent clinical interventional study or within 30 days.
* Participants treated with risankizumab prior to baseline visit.
Comparison of Two New Silicone Hydrogel Multifocal Products

The purpose of this trial is to compare the performance of two multifocal contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* At least 35 years of age
* Best-corrected visual acuity of at least 20/40 in each eye.
* Spectacle add between +0.75D and +1.50D (inclusive).
* Able to be fit in available study sphere powers (-0.50 to -5.50D).
* Currently wearing soft contact lenses at least 5 days a week.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in an ophthalmic Clinical Trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Previous refractive surgery.
* Astigmatism \> 1.00D.
* Currently wearing ACUVUE OASYS for PRESBYOPIA.
* Other protocol inclusion/exclusion criteria may apply.
Effects of Intraarterial Octreotide on Pancreatic Texture

The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant.

A primary end-point of the study is a change in pancreatic texture.

A secondary end-point is the rate of postoperative pancreatic fistula.

Soft pancreas is an established risk factor for the development of postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy. Octreotide is believed to harden the pancreas. This theory is based on the results of a single animal experiment and a small case series in humans. This hardening effect of octreotide has not quantitatively been proven in humans and its mechanism is not clear. Histomorphologic correlates of pancreatic hardness are unknown.

In this study all patients who are eligible for pancreatoduodenectomy and sign the informed consent for participation in the study will be recruited. Those of them who prove to have a soft pancreas intraoperatively will receive a single bolus of 500 µg Octreotide in the gastroduodenal artery after its proximal division. Pancreatic hardness in the region of the resection margin will be quantitatively assessed by a Shore durometer before the intervention and at several time-points after it. The suture-holding capacity of pancreatic tissue at the resection margin will be quantitatively assessed by a dynamometer. Histomorphological features of pancreatic tissue will be characterized in details at the Institute of Pathology in order to define possible correlates of pancreatic hardness.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 an 90 years
* planned pancreatoduodenectomy
* signed informed consent
* pancreatic hardness equal or less than 40 SU as measured by durometer
* normal vascular anatomy of the hepato-pancreatic region

Exclusion Criteria:

* planned distal pancreatic resection
* planned non-resectional pancreatic surgery
* acute pancreatitis at the time of surgery
* pancreatic hardness before intervention higher than 40 SU as measured by durometer
* intraoperatively unstable patient
* intraoperative complications
* allergy towards octreotide
* anatomical variation of the vascular supply of the liver or pancreas posing an increased risk for octreotide distribution in other organs than pancreas
* lacking gastroduodenal artery or technically impossible cannulation of the artery