cyrilzakka/clinical-trials huggingface dataset:
The Effects of Apple Consumption on Cardiovascular Health in Prediabetics and Type 2 Diabetics

The hypothesis of this study is that the daily consumption of 75 g dried apple powder for twelve weeks will improve arterial stiffness and blood pressure by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardiovascular risk and glycemic control compared to a macronutrient-matched control powder. 50 men and women between the ages of 45 and 65 with prediabetes or type 2 diabetes who are overweight or obese will be included in the study. After a two-week run-in phase, eligible men and women will be randomly assigned to one of two treatment groups: 1) 75 g dried apple powder; or 2) 75 g placebo powder daily for twelve weeks. After an initial telephone screening, all participants will be requested to report to the study site for their first visit. On the first visit (screening), participants will be provided with verbal and written explanation of the project. They will then be asked to sign an informed consent form, followed by measuring fasting glucose levels and a medical history questionnaire to confirm prediabetes or type 2 diabetes. Baseline assessments will be performed for medical history, medication use, dietary intake, and physical activity. Qualified participants will be scheduled for their second visit two weeks later (actual baseline data collection) and randomly assigned to their treatment group. On the second (baseline) visit between the hours of 6:00-11:00 A.M., blood pressure and vascular function will be measured followed by blood draw and urine collection. Anthropometrics will be measured. Participants will be provided with their assigned treatment and will receive standard instructions on how to fill out daily diaries for their treatment, and for food and physical activity records. Blood pressure, vascular function, blood draw, urine collection, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular measurements will be performed between 6:00 to 11:00 A.M., in a quiet temperature-controlled room in the supine position after an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Men and women (1 to 10 years postmenopausal)
* Aged 45-65 years
* Prediabetes or Type 2 Diabetes (Hemoglobin A1c ≥ 5.7%)
* Overweight or obese (body mass index between 25 and 40 kg/m2)

Exclusion Criteria:

* Diagnosed cardiovascular disease
* Uncontrolled hypertension (≥ 160/100 mmHg)
* Other active chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
* Participating in a weight loss program
* Heavy smokers (\> 20 cigarettes per day)
* Heavy drinkers (\> 12 alcoholic drinks per week)
* Consumption of more than two apples per week
* Body mass index less than 25 or greater than 40 kg/m2)
Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions

This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries.

Preemptive preoperative analgesia was first proposed, over the years it has been gradually regarded as an intervention given before incision, facilitating mobilization and functional rehabilitation after surgery, reducing postoperative opioid consumption, decreasing the incidence of adverse events and improving patient satisfaction.

The Mid Transverse Process to Pleura block, described by Costach et al. involves deposition of drug midway between the transverse process and pleura. Costach et al. postulated that the local anesthetic deposited at this point may reach the paravertebral space through several possible mechanisms, such as spread medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21- and65 years old
* American Society of Anesthesiologists (ASA) II-III
* Scheduled for posterolateral thoracotomy operation under general anesthesia

Exclusion Criteria:

* Patients with bleeding disorders,
* Mental or cognitive dysfunction
* History of chronic analgesic or drug abuse
* Allergy to local anesthetics
* Local infection at site of block
D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life

Vitamin D deficiency is common among otherwise healthy pregnant women and may have consequences for them as well as the early development and long-term health of their children. However, the importance of maternal vitamin D status has not been widely studied.

The present study is divided into a societal experiment (1) and a case-cohort study (2):

1. The present study includes an in-depth examination of the influence of exposure to vitamin D early in life and during critical periods of growth for development of type 1 diabetes (T1D), type 2 diabetes, gestational diabetes, pre-eclampsia, obesity, asthma, arthritis, cancer, mental and cognitive disorders, congenital disorders, dental caries and bone fractures during child- and adulthood. The study is based on the fact that mandatory fortification of margarine with vitamin D, which initiated in 1937, was terminated in 1985.

   Apart from determining the influences of exposure prior to conception and during pre- and postnatal life, the investigators examined the importance of vitamin D exposure during specific seasons and trimesters, by comparing disease incidence among individuals born before and after the fortification.
2. Additionally, a validated method was used to determine neonatal vitamin D status using stored dried blood spots (DBS) from individuals who develop the aforementioned disease entities as adults and their time and gender-matched controls.

Unparalleled, the study will help determine the effects of vitamin D exposure during critical periods in life. There are a sufficient number of individuals to verify any effects during different gestation phases and seasons of the year. The results, which will change our current understanding of the significance of vitamin D, will enable new research in related fields, including interventional research designed to assess supplementation needs for different subgroups of pregnant women. Also, other health outcomes can subsequently be studied to generate multiple new interdisciplinary health research opportunities involving vitamin D.


Eligibility Criteria:
Inclusion Criteria:

1. Born in Denmark around the fortification period
2. Sufficient amount of blood from the DBS

Exclusion Criteria:

1.Born outside Denmark

1. Born outside the fortification period
2. Insufficient amount of blood from the DBS or DBS not found
EmboTrap ® II Revascularization Device (Neuravi) in Acute Ischemic Stroke

The primary aim of Registrap study is to assess the safety and effectiveness of the EmboTrap®II Clot Retriever device (Neuravi) in patients with acute ischemic stroke from large vessel occlusion.

Registrap is a prospective, single-arm, multicenter, observational registry of the Embotrap®II Clot Retriever (NEURAVI) open to any Neurointerventional Department in Europe with experience in mechanical thrombectomy with the EmboTrap® II device Clot Retriever (5 cases already done) and a number of stroke procedures/year greater than 30.

The EmboTrap®II Clot Retriever (Neuravi) is CE-marked and represents one of the possible treatment devices, chosen by physicians according to their experience and practice, in acute ischemic stroke treatment.

Being REGISTRAP an observational registry and considering that different approaches and devices are available on the market, the investigators are aware that operators' preferences could represent a selection bias. The Screening Log will collect all the stroke cases treated from each centre during the enrollment period to show the rate of EmboTrap®II Clot Retriever (Neuravi) use over the total cases treated and the reasons for choosing other devices. The registry will enroll at least 100 consecutive patients presenting within 12 hours from symptom onset with a Large Vessel Occlusion (LVO) on CTA or MRA in the Anterior or Posterior Proximal Cerebral Vasculature up to A1, M1, Dominant M2, P1 who will be treated using the EmboTrap®II Clot Retriever (Neuravi) as first intention and used according to the Instructions For Use. The registry objectives are to evaluate the efficacy/safety of the device Embotrap II Clot Retriever(Neuravi), as first line treatment in the restoration of cerebral blood flow in cases of acute ischemic stroke from Large Vessel Occlusion. Efficacy is considered when a "modified Treatment in Cerebral Infarction" (mTICI) score of 2b or greater is achieved in the vessel treated with the (Neuravi). Safety refers to the rate of procedure-related and device-related hemorrhages. Number and severity of hemorrhages will be evaluated considering site and size. The first follow-up control will occur at 1 to 10 days post-procedure, the second at 90 days+/-14 days. In addition to the sample, the patients meeting the inclusion criteria and treated using the EmboTrap®II Clot Retriever (Neuravi) as second intention, will also be included in the study and considered only for a specific secondary endpoint.

Eligibility Criteria:
Inclusion Criteria

* Signed Informed Consent Form
* Large Vessel Occlusion on CTA or MRA in the Anterior or Posterior Proximal Cerebral Vasculature up to A1, M1, Dominant M2, P1
* ASPECTS ≥ 6
* Mismatch or good collaterals showed at MR or multiphasic CTA or pCT
* Groin Puncture performed within 12 hours from symptom onset
* Use of EmboTrap® II Revascularization Device (Neuravi) as the first or second line treatment

Exclusion criteria

* Informed consent not given
* Extracranial or tandem occlusion
Comparison of the Bilateral TAP Block Versus Curare in Muscle Relaxation of the Abdominal Wall During Laparoscopic Digestive Surgery: Prospective Randomized Study

This is a Biomedical Research, prospective, randomized, controlled single-blind mono centric, phase IV comparison trial of the bilateral TAP block versus curare in muscle relaxation of the abdominal wall during laparoscopic digestive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years and under 75 years
* Informed consent signed
* ASA I, II and III
* Patient affiliated to social security

Exclusion Criteria:

* ASA IV

  * BMI\> 35 kg / m
  * Personal or family history of malignant hyperthermia
  * History of allergy or hypersensitivity to intravenous anesthetics (remifentanil), local anesthetics or muscle relaxants
  * Contraindications to sevoflurane: a history of malignant hyperthermia, history of liver disease after sevoflurane anesthesia, halogenated agents or hypersensitivity to any of these components.
  * Contraindications to succinylcholine: hyperkalemia, plasma cholinesterase deficiency nickname, para or tetraplegia more than 24 hours, burns over 24
  * Contraindications to cisatracurium: myasthenia
  * Neuromuscular diseases
  * Contraindications to local anesthetics: hypersensitivity to local anesthetics of the amide, intravenous regional anesthesia, porphyria, ventricular atrial conduction disturbances, epilepsy uncontrolled by treatment
  * Pregnancy and lactation
  * severe coagulation disorders
  * Inability to understand and give informed consent
  * Patient under guardianship, curatorship or protected
  * Indication of use of a hypnotic ketamine (BIS change)
Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing

One of the most frequent surgical procedures in the pediatric population is circumcision, following which postoperative pain could be stressful. Usually, the most common approach is combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB) with general anesthesia (GA). The hypothesis of this study investigates ultrasound-guided DPNB plus sedation in spontaneous breathing.


Eligibility Criteria:
Inclusion Criteria:

* candidates to circumcision
* age between 6 months and 17 years
* American Society of Anesthesiologists (ASA) physical status \< 3
* written consent of the parents

Exclusion Criteria:

* allergies to local anesthetics
* younger than 6 months and older than 17 years
* ASA physical status =/\> 3
* no written consent of the parents
Safety Evaluation of ExAblate MRgFUS for Prostate Cancer

Evaluate the safety, compatibility and imaging quality of the ExAblate MRgFUS system.

The objective of this study is to evaluate safety, compatibility and imaging quality of the ExAblate MRgFUS system for prostate cancer, under simulated use conditions. No acoustic energy will be delivered and no focused ultrasound therapy will be performed. This is an imaging only study.

Eligibility Criteria:
Inclusion Criteria:

* Age of patients: up to 75 years.
* Men scheduled for radical prostatectomy due to prostate cancer.
* Patients who are able and willing to give consent and able to attend all study visits.

Exclusion Criteria:

* Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
* Severely abnormal coagulation (INR\>1.5)
* Patients with unstable cardiac status including: unstable angina pectoris on medication, patients with documented myocardial infarction within six months of protocol entry, congestive heart failure requiring medication (other than diuretic), patients on anti-arrhythmic drugs, severe hypertension (diastolic BP \> 100 on medication), and patients with cardiac pacemakers
* Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
* Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hrs.)
* Any rectal pathology preventing probe insertion, (as active proctitis, ulcerative colitis, fissure ani, diverticulitis, previous rectal surgery, IBD, etc...)
* Any spinal pathology that prohibits maintaining supine position for more then an hour
* Any previous radiation to the pelvis.
Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation

Assessment of the effect of Botulinum toxin injection on the frequency of luxation and TMJ Pain in patients with TMJ dislocation either chronic recurrent dislocation or subluxation

Diagnostic procedure:

1. Patient questionnaire: a questionnaire will be recorded by the examiner including the Chief complaint, Personal data, and Medical history.
2. Consent: Informed consent will be obtained from patients to participate in the study.
3. Clinical examination: TMJ examination with specific emphasis on the TMJ regarding pain, clicking, maximum inter-incisal mouth opening, lateral excursions, and muscle examination is done (Inspection and palpation).

   o operative procedures:

   • The surgical field will be scrubbed and prepared in a standard sterile fashion using alcohol and topical anesthesia is applied at point of needle insertion

   A-Botulinum Toxin Type A injection:

   BTX-A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.

   B-The placebo comparator Injection:

   Patients in the placebo arm will receive equivalent volumes of placebo solution (Normal Saline).

   • Procedure

   - With the patient sitting in an upright position on the dental chair, the lateral ptreygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection.

   According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A or normal saline

   - The patient will be instructed to remain in an upright position for 6 h (to reduce diffusion into pharyngeal muscles which may cause dysphagia and nasal regurgitation).

   - Patients will be recalled weekly during the first month, then monthly after 3 months
   * Post-operative care:

   Paracetamol 1000 mg will be prescribed as needed Any excessive mouth opening should be avoided Soft diets are advised in the first 48 hours after injection

Eligibility Criteria:
Inclusion Criteria:

1. patients with TMJ habitual or recurrent dislocation
2. Age ≥ 18 years
3. The willingness of the patient to receive relative painful injections and to follow instructions

Exclusion Criteria:

1. Patients with neurogenic cause of TMJ Hypermobility.
2. Drug-induced TMJ Hypermobility
Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's

The purpose of this study is to compare key clinical outcomes of collagenase clostridium histolyticum injections versus surgery for the management of Peyronie's Disease.

After eligible patients have been informed about the study protocol and risks and consent have been given, men will be randomly assigned into either the collagenase clostridium histolyticum + penile traction therapy (CCH + PTT) group or to the surgery + penile traction therapy (surgery + PTT) group. Those in the CCH + PTT group will receive the full 4 series of 8 Xiaflex injections with 1-3 days between each set of 2 injections and 6 weeks prior to the next series. Patients would then use the RestoreX traction device throughout the series to 3 months post-treatment. Those that were assigned the surgery + PTT treatment protocol would undergo surgery using either penile plication or incision and grafting, depending on the degree of curvature and erectile function. Traction using RestoreX will also be prescribed to these men 2-4 weeks post-operatively until 3 months post-treatment. Key clinical outcomes of both treatment protocols will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Men with PD
* \>18 years old
* Curvature ≥30 degrees
* Ability to achieve an erection satisfactory for intercourse with or without PDE5 inhibitors

Exclusion Criteria:

* Prior treatment with CCH or surgery
* Moderate (shadowing) or severe (\>1 cm) penile calcification
* Any contraindications to CCH, PTT, or surgery - as determined by the PI
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer

This trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer.

Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Normal-overweight (body mass index \[BMI\] of 18-30 kg/m\^2)
* Women will be postmenopausal, with no menstrual period in 12 months
* Non-smoking
* Consume fiber intakes of less than \< 20 g/d
* White blood cell count 3,000-11,000/mm\^3
* Platelet count 100,000-400,000 mm\^3
* Hematocrit 33-50% (women); 36-50% (men)
* Bilirubin 0.2-1.3 mg/dL
* Aspartate aminotransferase (AST) 0-35 U/L
* Alanine aminotransferase (ALT) 0-40 U/L
* Alkaline phosphatase 20-125 U/L
* Creatinine =\< 1.2 mg/dL
* Potassium 3.5-5.0 mmol/L

Exclusion Criteria:

* Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer \[HNPCC\], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer)
* Weight change greater than 4.5 kg within past year
* Oral or intravenous (IV) antibiotic use within the past 3 months
* Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
* Smoking or use of cannabis products
* Known allergy to fish
* Intention to relocate out of study area within next 4 months
Intelligent Moxibustion Robot in the Treatment of Low Back Pain

The intelligent moxibustion robot is applied to the clinical treatment of low back pain to verify its effectiveness and safety

Shanxi Acupuncture and Moxibustion Hospital and North University of China jointly developed an "intelligent thunder-fire moxibustion" robot with six degrees of freedom mechanical arm as the core and will be applied in clinical practice to verify its clinical efficacy. In clinical practice, patients with low back pain were recruited jointly by several hospitals and divided into two groups. Intelligent thunder-fire moxibustion robot and artificial thunder-fire moxibustion were respectively used for treatment. The clinical efficacy and safety of intelligent thunder-fire moxibustion robot were evaluated through comparative analysis of outcome indexes such as VAS pain scale and serum inflammatory factors.

Eligibility Criteria:
Inclusion Criteria:

* 1.It is consistent with the diagnostic criteria of low back pain and the syndrome differentiation criteria of cold and wet lumbar muscle strain.
* 2.There is no gender limitation, and the age should be between 25 and 70 years old
* 3.No treatment of traditional Chinese and western medicine related to lumbago was received in the past 2 weeks
* 4.The course of disease was controlled within 8 years
* 5.Informed consent, willing to cooperate with the whole treatment
* 6.Agree to record the scale score and volunteer to participate in this experiment
* 7.At least one contact information should be reserved for patients to receive follow-up visits
* 8.In order to reduce the rate of shedding, priority is included in hospitalized patients

Exclusion Criteria:

* 1.Patients do not meet the inclusion criteria Patients who do not meet the diagnostic inclusion criteria of this subject
* 2.The patient is in the pregnancy or lactation period
* 3.Patients are allergic to moxibustion smoke, and it is difficult to accept moxibustion treatment
* 4.The patient suffers from diseases of the blood and immune system
* 5.Patients with cardiac, liver and renal insufficiency
* 6.The patient suffers from mental illness and cannot cooperate with moxibustion
* 7.The patient suffered from lumbar spine tuberculosis, bone cancer and other diseases, which affected the experimental results