cyrilzakka/clinical-trials huggingface dataset:
The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine

First, the aims of this study are to explore the effect of vitamin D versus placebo in the prevention of episodic migraine. Second, we would like to compare and evaluate the effect of vitamin D plus omega-3 fatty acids versus placebo plus omega-3 fatty acids in terms of migraine frequency, symptom severity, and associated complications.

The purpose of this study is to investigate the effects of supplementing with Omega-3 fatty acids and vitamin D on the prevention of muscle atrophy and lifestyle performance in migraine patients. Furthermore, it aims to understand the biological mechanisms of action of Omega-3 fatty acids and vitamin D in decreasing migraine attacks, the severity of headaches, and associated complications, as well as inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20-65 years
2. Episodic migraine diagnosis with ICHD-3
3. Baseline migraine days between 4 and 15 days per month
4. Episodic migraine without or without aura
5. Blood Vit D\< 30ng/mL at baseline
6. With completed informed consent

Exclusion Criteria:

1. Non-migraine (ex: tension-type headache or secondary headache)
2. Having major head trauma in the past
3. Alcoholism within 1 year
4. Patients with abnormal liver and kidney function and patients with other serious diseases such as infection with any inflammation
5. Pregnant women or women who are still breastfeeding
6. Those who are unable to cooperate with the progress of the trial and who have participated in other clinical studies.
7. Patients with abnormal coagulation function or taking anticoagulant drugs
8. Weight \< 45 kg or \> 80 kg
9. Abnormal parathyroid function, intestinal dysfunction, hypercalcemia (total calcium ion concentration in blood\> 2.6 mmol/L)
10. Conditions with high risk of hypercalcemia, such as: Metastatic cancer, Sarcoidosis, Multiple myeloma, Primary hyperparathyroidism
11. Those who are allergic to fish or fish oil
12. Vegetarian
13. Taking beta-blockers, antiepileptic drugs, calcium ion blockers, antidepressants or hormonal preparations in the past month
14. Using vitamin D (\> 3000 IU/day), calcium tablets, estrogen drugs, bisphosphonates, and other drugs to treat bone diseases.
Hemi-diaphragmatic Paresis After Erector Spinae Plane Block

To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block

The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. The aim of the study is to assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 85 years
* American Society of Anesthesiology (ASA) I-III
* elective carotid endarterectomy

Exclusion Criteria:

* patient's refusal
* under 18 years of age or over 65 years of age
* ASA IV and above
* known allergy to local anaesthetic drugs
* the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
* history of neurological and/or neuromucular disease
* history of severe bronchopulmonary disease
* a moderate to severe decrease in preoperative pulmonary function, or abnormality in preoperative chest radiography data (pleural effusion, pneumothorax, or hemidiaphragm elevation)
* emergency surgery
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.

In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years;
2. Historically confirmed rectal adenocarcinoma;
3. Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;
4. cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;
5. No evidence of distant metastases;
6. A maximum of 5cm in diameter;
7. Body mass index (BMI) ≤ 30 kg / m2;
8. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion);
9. Willing to undergo surgery;
10. Sign the informed consent;

Exclusion Criteria:

1. Presence of lateral/inguinal lymph node metastases;
2. Previous history of malignant colorectal tumor;
3. Multiple primary colorectal tumors;
4. Neoadjuvant therapy;
5. Salvage surgery for endoscopic surgery;
6. History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion;
7. Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease;
8. Comorbid with other malignancies within 5 years;
9. ASA ≥ IV and/or ECOG performance status score ≥ 2;
10. Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases;
11. Serious mental illness;
12. Pregnant or lactating women;
13. Uncontrolled infection;
14. Abnormal anal function or anal stenosis;
Giochiamo 626 - Gaming for Health and Safety in Workplaces

The aim of the "626 Giochiamo" project is to realise and evaluate the effectiveness of a training course involving the use of games, which helps to convey the basic principles of health and safety in the workplace.

The seminar on health and safety in the workplace and basic principles will be presented to the recruited workers. At the end of the intervention they will be divided into two groups: the control group and the intervention group. The intervention group will be involved in a meeting dedicated to games in three different types, board, card and role-playing games.

A questionnaire on occupational health and safety knowledge will be administered to all study participants before the seminar (T=0), after the seminar (T=1) and after the intervention group has played (T=2).

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* No worker
Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants

The purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), and non-comparative study, in participants with schizophrenia. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); Acute Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by additional Extension phase 2 (48 weeks). Total study duration per participant will be 96 weeks. Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory scores. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are diagnosed with schizophrenia (diagnosis criteria: Diagnostic and Statistical Manual of Mental Disorders, fourth edition \[DSM-IV\])
* Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-Lack of efficacy, lack of tolerance or lack of compliance
* Participants who are capable of and willing to fill out the questionnaire for themselves
* Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
* Participants who are compliant with self-medication or can receive consistent help or support

Exclusion Criteria:

* Participants with the past history of neuroleptic malignant syndrome (NMS), or with allergy or hypersensitivity to risperidone or paliperidone
* Participants who have taken clozapine within one month before screening
* Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
* Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile)
* Participants with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled experimental setting. This is a translational study in which healthy participants are phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard FDA drug liking metric) following equianalgesic doses of the two drugs.


Eligibility Criteria:
Inclusion Criteria:

* Intact cognitive status and ability to provide informed consent
* Ability to read and write in English sufficiently to understand and complete study questionnaires
* Age 18-65
* Opioid-naive status (defined as no use of full mu-opioid receptor (MOR) agonist, partial MOR agonist, or mixed agonist/antagonist medications for the prior 3 months by patient report

Exclusion Criteria:

* Liver/kidney disease
* Chronic pain
* Current/prior substance use disorder
* Pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm eligibility)
* Seizure disorder
* Certain psychiatric conditions (severe depression, bipolar disorder, psychotic disorders)
* Recent use of medications that may interfere with study drug metabolism
* Recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each lab session)
* The presence of any medical conditions felt by the study physician to render participant unsafe
* Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs (explicitly including moderate-to-severe nausea or vomiting with prior opioids)
* Recent use of marijuana, delta-8 THC, CBD, and similar products
* Recent use of kratom
* Severe asthma
* Long QT syndrome
* Parkinson disease
* Weight \<60 kg
Puerarin Effects on Alcohol Drinking

This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.

Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* moderate to heavy alcohol drinkers (20+ drinks per week)

Exclusion Criteria:

* alcohol dependence or treatment-seeking drinkers
* other drug abuse or dependence
* psychiatric disorders
L-arginine Therapy on Endothelium-dependent Vasodilation & Mitochondrial Metabolism in MELAS Syndrome

MELAS patients suffer from exercise intolerance, weakness, poor vision or blindness, poor growth, developmental delay, and deafness. They also have unique 'stroke-like' episodes (SLEs) which are not due to blockages of large or medium arteries. These 'strokes' are thought to be due to energy failure of very small brain blood vessels combined with energy failure in the mitochondria (cell battery) of the brain cells, especially in the back region of the brain in the vision centre. This leads to visual loss and paralysis. The overall goal of this study is to better understand the mechanism of these SLEs at the level of the brain cells and small blood vessels.

We will study a family of 3 siblings, each with different severities of MELAS, using safe, non-invasive tests. We will determine whether there is a decrease in the ability of small brain blood vessels to increase blood flow by dilating in response to certain stimuli such as increased blood carbon dioxide levels or in response to brain cell activation in the vision centre by visual stimuli. We will use a technique called BOLD-fMRI which can detect changes in brain blood flow. As exercising muscle also depends on increased blood flow and mitochondrial energy, we will study different measures of aerobic energy metabolism in exercising muscle using cycle exercise testing and special phosphorus-magnetic resonance spectroscopy which measures the changes in the major chemicals of muscle energy metabolism. The dietary amino acid L-arginine is known to dilate blood vessels increasing blood flow and to decrease toxic free radicals that are generated by dysfunctional mitochondria. We will determine the effect of a single dose and a 6 week trial of oral L-arginine, on brain blood vessel reactivity, brain cell activation and muscle aerobic function to see how useful this would be in the treatment of these patients and other mitochondrial disorders which present with strokes.

Eligibility Criteria:
Inclusion Criteria:

Experimental Siblings with MELAS (A3243G) syndrome

* 17-23 years
* Followed Neurometabolic Clinic at the Hospital for Sick Children will be studied.
* Normal electrolytes, glucose, renal and liver functions \& no history of gastrointestinal, respiratory or cardiac problems.

Controls

-Aged 17-23- Sex matched to the MELAS subjects

Exclusion Criteria:

Controls

* Experience migraines
* Have a metabolic disorder
* Taking medications predisposing to lactic acidosis or vasodilatation
* Neuromuscular/neurologic condition
* Cardiac or pulmonary disease
* Visual abnormalities
* Hypertension, anemia and prothrombotic state. Control subjects
* Contraindication for MRI (pacemaker, ocular metal, claustrophobia, tattoos) will be excluded from the study.
Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

The objective of this research is to study the sphincter activity during ejaculation in patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this purpose, using a catheter the protocol plans to measure the sphincter pressures during ejaculation. Moreover, cardiovascular parameters will be measured continuously during the ejaculatory test.


Eligibility Criteria:
Inclusion Criteria:

* Patients evaluated by ejaculatory test during their usual care
* Men with spinal cord injury between 18 and 65 years old
* Patients who have given their informed consent
* Patients with social insurance affiliation

Exclusion Criteria:

* Minors
* Patients with justice protection
* Patients over 65 years old
Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU

The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.


Eligibility Criteria:
Inclusion Criteria:

* 37 weeks or more postmenstrual age
* Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician
* Inpatient at Baylor University Medical Center NICU

Exclusion Criteria:

* Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician
* Bilateral complete cleft lip and palate
A Randomized Controlled Clinical Trial With Orphans and Widows Who Experienced the Rwandan Genocide

In the framework of the epidemiological study, local psychologists are trained in Butare in carrying out diagnostic interviews with orphans and widows who experienced the Rwandan genocide. With the aid of standardized questionnaires they will assess trauma related symptoms as well as Prolonged Grief Disorder. Under the supervision of clinical experts from the University of Konstanz the local psychologists will carry out a randomized house to house survey (Phase 1).

As a second step, a controlled randomized clinical trial will be carried out. Local psychologists will be trained in applying Narrative Exposure Therapy and Interpersonal Psychotherapy. Genocide survivors that will be identified with a PTSD diagnosis will randomly be assigned to either the treatment condition or a waiting list. The treatment group will receive 5 individual sessions of NET in addition to 3 individual IPT sessions. Subsequent 3-months and 6-months post-tests will serve to evaluate the efficacy of this treatment module in alleviating trauma related symptoms and symptoms of prolonged grief. We expect a significant symptom reduction in the experimental group and no significant symptom reduction in the waiting list. After the 6-months post-test, the trained psychologists will train other psychologists in applying this treatment module under the supervision of clinical experts from the University of Konstanz. Afterwards, they will apply therapy to the victims from the waiting list.

A 12-months follow-up will serve to evaluate the long-term effect of the NET/IPT combination.


Eligibility Criteria:
Inclusion Criteria:

* widows and orphans
* confrontation of the Rwandan genocide
* clinical diagnosis of PTSD

Exclusion Criteria:

* mental retardation
* psychotic symptoms
* current drug or alcohol
The Clinical Efficacy of Non-steroidal Anti-inflammation Drugs in Patients With Benign Prostatic Hyperplasia

Non-steroidal Anti-inflammation Drugs can effectively reduce the lower urinary tract symptoms from benign prostatic hyperplasia


Eligibility Criteria:
Inclusion Criteria:

* Who had the treatment of BPH with alpha-1 blockers for more than 3 months
* Who have the IPSS(International Prostatic Symptom Score) \>= 15
* Who have the maximum flow rate(Qmax) \< 15 with voided volume \> 150mL
* Who have the PPBC(patient's perception of bladder condition) \>= 3 (The PPBC was assessed by the use of a six point ordered categorical scale(1-6 point). The higher score means the higher bother)
* Who had the PSA level \< 4 ng/mL within 6 months (But, the patient who are revealed not to have prostate cancer by prostate biopsy can be included even if he had PSA level of 4-10 ng/mL)
* Who underwent the transrectal ultrasound of prostate within 6 months
* Who can understand this study and can give the informed consent

Exclusion Criteria:

* Who had regular intake of 5-alpha reductase inhibitor or NSAID within 6 months before screening
* Who have peptic ulcer and/or asthma
* Who have urologic malignancies such as prostate cancer and bladder cancer
* Who have urethral strictures, large bladder diverticuli, and bladder neck contractures
* Who had surgical treatment for BPH
* Who have histories of bladder and/or urethra
* Who have serum PSA level more than 10 ng/ml
* Who have histories of orthostatic hypotension
* Who have serum creatinine level more than 2.0 mg/dl
* Who have serum ALT and/or AST level more than 1.5 times of normal upper limit
* Who have heart failure
* Who have histories of bacterial prostatitis within 1 year
* Who have histories of active urinary tract infection within 1 month
* Who have histories of the biopsy of bladder and prostate within 1 month
* Who are unable to void
* Who use pads because of incontinences
* Who have hypersensitivities for alpha blockers that include quinazoline, NSAID, aspirin, sulfonamide
* Who have histories of unstable angina, myocardial infarction, and cerebrovascular accident within 6 months
* Who have neurogenic bladder due to multiple sclerosis, Parkinson's disease, Spinal injuries and etc.
* Who have thinking disturbances
* Who have histories of abuses of alcohol and/or other drugs
* Who seem to be not fit to this study by the decision of investigators
Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.

Exclusion Criteria:

* Current therapy with any DMARD
An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, Hispanic (self-reported), \> 12 years of age
* Moderate to severe asthma requiring treatment with an inhaled corticosteroid
* Diagnosis of asthma for at least 6 months

Exclusion Criteria:

* Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
* Any significant disease or disorder that may jeopardize a subject's safety
A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza

At present influenza immunity can only be reliably confirmed by a blood test. This test is invasive for the patient. This study is intended to validate an oral fluid/saliva antibody test for the variant Swine Influenza H1N1. If such a test were available, this painless and non invasive test will improve direct clinical care to an individual as well as significantly help guide future public health management of the pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Participants of the clinical service evaluation of novel H1N1v vaccine
* First or second blood sample for the clinical service evaluation successfully collected

Exclusion Criteria:

* Withdrawn from clinical service evaluation of novel H1N1v vaccine
* Second blood sample for the clinical service evaluation not collected.