cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study

The authors hypothesize that, in patients with low volume tumors identified according to anatomo-pathological criteria and imaging, and under active surveillance focal, therapy by unilateral embolization of prostatic arteries will provide local control of the tumor via selective ischemia


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is between 18 and 80 years old
* Patient has unilateral prostate cancer, stage TNM\<T2b with an MRI PiRAds target ≥ 3 in concordance with biopsy result
* Biopsy gives a Gleason score ≤ 6 with more than 3 positive biopsies per lob and at least 50% the length of the positive biopsy; patients over 70 years old with a Gleason score = 7 (3+4) can be included
* Patient has a life expectancy of over 10 years
* PSA \<10ng/ml; patients with a large prostatic volume and PSA ≥ 10ng/ml can be included according to doctor discretion.

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient unresponsive to active surveillance
* Patient refusing active surveillance
* Patients in a state unfit to express personal consent cannot be solicited (eg patients undergoing psychiatric treatment with mental difficulties rendering consent impossible)
* Contraindication for MRI (pacemaker incompatible with MRI, claustrophobia, metal device, prosthetic hip replacement)
* Patient with hemostasis disorder.
* Cancer in both prostate lobes
Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis

Naxozol is a combination product of naproxen, a non-steroidal anti-inflammatory drug (NSAID) and esomeprazole, a proton pump inhibitor which is designed to improve symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The purpose of this study is to investigate whether naxozol protects the gastrointestinal tract effectively compared to celecoxib, a COX-2 inhibitor.

A total of 10 orthopedic investigators will participate in this study. The effectiveness in gastro-protection of study drug will be assessed by Leeds Dyspepsia Questionnaire (LDQ). The orthopedic investigators will be trained with this questionnaire administration by an expert gastroenterologist prior to starting this study.

Eligibility Criteria:
Inclusion Criteria:

* Koreans given informed consent
* Patients who have ability of reading comprehension and completing questionnaires (EQ-5D and VAS)and have willingness to follow-up 12 weeks
* Patients with osteoarthritis symptoms confirmed by his/her medical history and with pain-VAS of 40 and more

Exclusion Criteria:

* Patients who participate into other interventional study or had participated within 30 days before screening
* Alcohol or drug abuse within 6 months or alcohol consumption of 21 units and more in a week
* Peptic ulcers accompanied with a complication such as bleeding, perforation, penetration or gastric outlet obstruction within 5 years, or a history of active peptic ulcer or peptic ulcer without a complication within 6 months at screening
* Patients who are known with Helicobacter pylori infection but have not received any bacteriostatic treatment
* Known gastroesophageal reflux disease (GERD)
* Any following joint diseases which may significant effect to the efficacy and safety assessments: septic arthritis, inflammatory joint arthritis such as rheumatoid arthritis, gout, recurrent pseudo-pain, Paget's disease, joint fracture, joint ochronosis, acromegaly, hematochromatosis, Wilson's disease, primary osteochondrosis, Ehlers Danlos Syndrome, or other collagen genetic disorder
* Patients who are scheduled admissions to hospital for elective surgery during this study
* History of gastrointestinal cancer
* Gastrointestinal disorders related to drug malabsorption
* Gastrointestinal bleeding, cerebral bleeding, other bleeding disorders, or severe hematological disorders
* Clinically significant diseases such as moderate or severe liver diseases (Child Pough Class II or more), severe heart failure or a history of coronary artery bypass graft (CABG), severe kidney diseases (CrCl\<30ml/min)
* Know allergy experiences with any ingredient of study drugs or with other NASIDs or protocol pump inhibitors (PPIs)
* Patients who had had a joint surgery for osteoarthritis within 1 year
* Women of childbearing potential who do not agree with clinically appropriate contraception during this study
Qigong Exercise May Benefit Patients With Fibromyalgia

The long-term goal of our research program is to develop an effective and cost-saving mind-body therapy to help patients with FM. The objective of this pilot study is to gather pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients using a specific type of qigong exercise, i.e. "six healing sound" qigong. Changes in relevant brain activity will be monitored in study subjects before and after the qigong exercise program, which may help us in better understanding the underlying mechanism of the qigong exercise. Data collected in this pilot study will help the investigators in preparation for a future clinical trial with a larger sample size. Our central hypothesis for the future clinical trial is that qigong exercise will lead to a significantly greater improvement in pain, fatigue, sleep quality, and quality of life in the experimental group compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of primary FM, based on the 1990 American College of Rheumatology criteria (Wolfe et al, 1990),
* between the ages of 18 and 70 years;
* willing to withdraw from CNS-active therapies commonly used to treat FM; willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender- and trigger-point injections, acupuncture, and anesthetic or narcotic patches;
* with a raw score \> 4 on the physical function component of the Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt et al, 1991);
* and a mean visual analog scale (VAS) pain score \> 40 on a scale from 0 to 100.

Exclusion Criteria:

* severe psychiatric illness;
* a current major depressive episode (as determined by a Beck Depression Inventory (Beck et al, 1961) score \>25);
* significant suicide risk;
* abuse of alcohol, benzodiazepines, or other drugs; a history of behavior that would prohibit compliance for the duration of the study;
* active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that had been stable for 3 months before screening);
* current systemic infection; active cancer (except basal cell carcinoma); unstable endocrine disease; severe sleep apnea;
* prostate enlargement or other genitourinary disorder (male patients);
* or pregnancy or breastfeeding (female patients).
EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.

Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section. So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.

Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section.

So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective. It seems to be very useful to compare, in randomized controlled study, global morbidity of caesarean section and vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. In start of study, all women were included, for randomisation ("section cesarean prophylactic" versus "vaginal delivery") if an anal sphincter rupture is diagnosed with anal endosonography before second delivery. . Currently, in case of refusal randomisation, women are proposed to participate to the ancillary study (cohort study).

The primary endpoint is comparison of median incontinence score of VAISEY in the two arms after 6 months. The secondary endpoints are urinary incontinence, quality of life and global morbidity between the two arms after second delivery. The investigators estimated, needing 123 women in each arm.

Hospital investigators are: BICHAT Claude Bernard (Pr LUTON), Armand Trousseau (Pr BENIFLA), Jean VERDIER (Pr CARBILLON), BEAUJON (Pr LUTON), Louis MOURIER (Pr MANDELBROT), Versailles (Dr PANEL). Inclusion will be for 6 years and 9 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Having health insurance
* Second pregnancy
* Inclusion in the third trimester
* First delivery was traumatic
* No anal incontinence
* Accept to participate, sign the informed consent
* Prior medical examination

Exclusion Criteria:

* Monitoring impossible
* Woman who have an anal operation
* Caesarean section
* First delivery with anal break stage 4
* Indication of a scheduled caesarean section not for proctologic reason
* Patient physically, mentally or legally incompetent to give informed consent
Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases

Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo.

This study is a multicenter randomized, paralleled, double blind, controlled trial. This study will include 260 patients from Lerdsin hospital, Chest institute, Phramongkutklao hospital, Maharaj Nakorn Chiang Mai Hospital and Paolo Memorial Phaholyothin hospital who would like to quit smoke. Patients will be assigned into two groups, Vernonia cinerea group (n=130) and placebo group (n=130), both groups will be instructed to take one lozenge three times a day for three months. The two groups will receive individual counseling about smoking cessation technique by trained healthcare professional on every visit. The main primary outcome for this study is continuous abstinence rate (CAR), define as self-report of no cigarette smoking, not even a puff since target quit date, plus passed biochemical validation for 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years old
* Have at least 1 underlying non-communicable disease include hypertension, diabetes, dyslipidemia, cardiovascular diseases, cerebrovascular diseases, stable asthma (defined as no asthmatic exacerbation for the preceding 4 weeks necessitating oral prednisolone or an increased use of inhaled corticosteroid, the use of rescue treatment no more than three times a week, and with no clinical indication for change in treatment medication) COPD stage A-C according to GOLD guideline, chronic kidney diseases
* Smoke 10 cigarettes or over per day at least 1 month prior to study
* Desired to quit smoking
* Consent to participate in study

Exclusion Criteria:

* Renal dysfunction (GFR \< 30 ml/mins/1.73m2)
* Liver dysfunction (Child-Pugh score C)
* Hyperkalemia (serum potassium ≥ 5 mEq/L)
* Documented of active depression or psychosis
* Active cancer
* History of acute coronary syndrome in previous 4 weeks
* Known case of pregnancy or lactation
* Use other tobacco products or other addictive substances except alcohol
* Use other smoking cessation drugs
Dimethyl Fumarate (DMF) Observational Study

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

Patients aged 12 to under 18 may be included where enrollment of pediatric patients in this study is considered observational and is permissible by local regulations.

Eligibility Criteria:
Key Inclusion Criteria:

- Patients with multiple sclerosis (MS) who are newly initiating treatment with dimethyl fumarate (DMF) under routine clinical care are eligible to participate in the study.

Key Exclusion Criteria:

* Patients with previous exposure to dimethyl fumarate (DMF), Fumaderm (fumaric acid esters), or compounded fumarates.
* Patients participating in other clinical studies.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Active Cycle of Breathing Techniques on Respiratory Distress Symptom Cluster

This study was designed as a randomized, control group, experimental study to examine the effect of Active Cycle of Breathing Techniques application on respiratory distress symptom cluster in patients with lung cancer.

The sample of the study will consist of patients who received chemotherapy treatment with the diagnosis of Stage IV non-small cell lung cancer in the outpatient chemotherapy service of a training and research hospital and met the inclusion criteria. Data in the study will be collected using the Patient Information Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale, Cancer Dyspnea Scale, Leicester Cough Questionnaire and Cancer Fatigue Scale. In order to test the applicability and comprehensibility of the forms to be used before the study, a preliminary application will be made with 5 patients. This study is planned to prepare a video describing the application for patients to use while performing the Active Cycle of Breathing Techniques application. On the 1st day of the study, a 10-minute face-to-face training will be given to the intervention (experimental) group by the researcher using the video about the Active Cycle of Breathing Techniques. In the research, the intervention (experimental) group will be asked to follow the video to be prepared and apply the Active Cycle of Breathing Techniques twice a day for 28 days. The intervention (experimental) group will be monitored by telephone call once a week and 3 times using the Patient Follow-up Form (days 7, 14 and 21). On the other hand, only the pre-test and post-test will be applied to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older
* Being diagnosed with stage IV non-small cell lung cancer
* Being diagnosed with lung cancer in the type of adenocarcinoma and squamous cell carcinoma
* Receiving outpatient chemotherapy treatment
* Receiving the first course of chemotherapy treatment
* ECOG Performance Scale Score \< 3
* Having all the symptoms of dyspnea, cough, and fatigue
* Not having a cognitive disorder or a diagnosed psychiatric illness
* Being able to speak Turkish
* Volunteering to participate in the research

Exclusion Criteria:

* Experiencing a chronic obstructive pulmonary disease (COPD) exacerbation in the last 4 weeks
* Having an active lung infection
* Not volunteering to participate in the research
* Not having dyspnea, cough, and fatigue symptoms
* Not speaking Turkish
Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability

The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. In the study group, both side hamstring muscle were evaluated at the velocities of 60 and 180 deg/s for the following parameters: peak torque, torque in 30 degree of the knee flexion, angle of peak torque and peak torque hamstring to quadriceps ratio (H/Q ratio).

The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. The study group consisted of 20 girls and 13 boys with average age at the time of the study 16.2 years (range: 8 to 17 years, SD 2.7). For the purpose of the study, a control group of 18 healthy subjects (12 girls and 6 boys) aged on the average 15.7 years (range:13 to 17 years, SD 1.5), was recruited.

The following study inclusion criteria were applied: recurrent patellar dislocation, correctly completed testing protocol, age under 18 years at the time of testing. Subjects with osteochondral fracture and those with a history of the knee surgery were excluded.

Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio).

Isokinetic measurements were made by a trained, experienced physiotherapist. After a proper warm-up and instruction, the test performed 10 full repetitions, the best result was recorded. The results of the peak torque (PT) of both test and control limbs were then compared with the normative data for age and gender available in the literature. In addition, we compared the peak torque (PT), torque in 30 degrees of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio) of involved and uninvolved knee flexor strength in the study group. Depending on the data distribution, the nonparametric Wilcoxon's test or the parametric t-test for the related data was applied. Statistical significance was assumed for p\<0.05. The study was approved by our Institutional Review Board. Informed consent was obtained and the rights of subjects were protected.

Eligibility Criteria:
Inclusion Criteria:

* recurrent patellar dislocation,
* correctly completed testing protocol,
* age under 18 years at the time of testing

Exclusion Criteria:

* osteochondral fracture
* those with a history of the knee surgery
Corn and Heart Health Study

The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.

Dietary fibers are extremely complex and foster health in a variety of ways that are not fully understood. The Adequate Intake of fiber (14 g per 1000 kcal consumed) is based on data that strongly support a relationship with cardiovascular disease prevention (Slavin, 2013). While cereal fibers have been shown to be most effective at reducing cardiovascular disease risk (IOM, 2002), the components of dietary fiber (e.g. germ, bran) that exert this effect remain inadequately studied in cardiometabolic outcomes. Further, specific types of dietary fiber (natural and synthetic) have been shown to increase beneficial microbial species in the gastrointestinal tract, which are accompanied by improvements in inflammatory and metabolic disease markers. Very little is known about how isolated or intact fiber in whole grains solicit beneficial health effects via microbial mechanisms. Our goal is to study both changes in cardiometabolic outcomes and the gut microbiome after consuming different types of corn-based meals.

Aim 1: To evaluate cardio-metabolic outcomes (primary outcome: LDL cholesterol) after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.

Aim 2: To evaluate changes in the gut microbiome after consuming 48 g/d of whole grain corn flour, 50% refined corn flour + 50% corn bran derived from whole corn meal, and refined corn flour for 4 weeks in adult males and females with elevated LDL cholesterol in a crossover design.

Eligibility Criteria:
Inclusion Criteria:

* Healthy English and Spanish speaking males and females with elevated circulating cholesterol levels (LDL-c ≥ 120 mg/dL).
* Individuals with LDL-c \> 190 mg/dL will be permitted to participate but must provide a letter from their doctor stating that they are comfortable with their participation in the study.

Exclusion Criteria:

* recent weight fluctuations (\> 5 lb in past 3 months), following specialized or restrictive diets (e.g. carbohydrate restriction, veganism)
* use of supplements (antioxidants, fiber, botanicals)
* allergies to dairy, egg, wheat, corn or gluten
* use of antibiotics in the past 2-3 months
* use of lipid lowering medications
* regular physical activity ≥ 30 min/d for ≥ 5 days/wk
* history of thyroid disorders, diabetes, heart disease, cancer, hepatitis, inflammatory conditions and/or gastrointestinal disorders which may impact gut function and metabolism
* anyone with a fear of needles or blood draws
* If female, women may not be pregnant or lactating during the study.
* Unwillingness to comply with study protocols will also result in exclusion from the study.
* Participants in this study will not be eligible if they are participating in other research studies at the same time.