cyrilzakka/clinical-trials huggingface dataset:
ACUTE EFFECT OF CONSUMPTION OF GROUND OR WHOLE FLAXSEEDS ON BLOOD GLUCOSE IN PEOPLE WITH TYPE 2 DIABETES

This study aimed to evaluate the effect of consuming a portion of French bread combined with whole or ground flaxseed on the glycemia of people with DM 2 in a randomized, crossover clinical trial conducted with 16 people with DM 2 who were not using insulin.

The main questions of the study were:

1. Is flaxseed able to control the glycemia of people with type 2 diabetes?
2. What is the best way to consume flaxseed to control the glycemia of people with type 2 diabetes?

The 3 types of bread (whole flaxseed, ground flaxseed and control) were evaluated in interventions, with a 7-day interval between them, for the consumption of the bread and evaluation of the behavior of the glycemia and insulin curve.

This study aimed to evaluate the effect of consuming a portion of French bread combined with whole or ground flaxseed on the blood glucose levels of people with DM 2 in a randomized, crossover clinical trial conducted with 16 people with DM 2 who were not taking insulin.

The main questions of the study were:

1. Is flaxseed able to control the blood glucose levels of people with type 2 diabetes?
2. What is the best way to consume flaxseed to control the blood glucose levels of people with type 2 diabetes? People with type 2 diabetes mellitus participated in the study, divided into three groups for random consumption of the breads: French bread without flaxseed (control bread), French bread with 30g of whole flaxseed, and French bread with 30g of ground flaxseed. The design was crossover and had a 7-day washout. Capillary blood glucose levels were monitored during fasting and at 15, 30, 60, 90 and 120 minutes after ingestion of the breads, while serum glucose and insulin levels were measured during fasting and at peak blood glucose levels, at 60 minutes. In addition, sociodemographic and clinical data (medication use, duration of DM2, bowel habits, sleep, and physical activity), nutritional status, and pre-intervention food consumption with a 24-hour dietary recall were evaluated. The data were analyzed in the R statistical software, through the Shapiro-Wilk normality test, one-way ANOVA, with Tukey or Kruskal-Wallis post-hoc. The analyses had a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* The selection included individuals with DM 2
* Of both sexes
* Adults and elderly individuals without risk of dysphagia
* Aged 18 years or older
* Without allergies to the test foods
* With the habit of having breakfast (≥4 days a week, with an intake of ≥100 kcal within two hours of waking up)
* Availability of time for the days planned for the research.

Exclusion Criteria:

* The exclusion criteria were applied to individuals diagnosed with another type of Diabetes
* Using exogenous insulin
* Pregnant or lactating women
* Smokers
* With diseases that affect taste
* The gastrointestinal system, and who reported the last intestinal frequency according to the Bristol scale 1, 2, 5, 6 and 7.
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms

This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 - 100 years old
* English-speaking
* Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines
* Speech frequency pure tone average (0.5- 4 kHz) \>25 db in the better-hearing ear; adult onset hearing loss
* Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision
* Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms

Exclusion Criteria:

* Current self-reported use of hearing aid or amplification device
* Medical contraindication to use hearing aids ( e.g. draining ears)
* Inability to participate in the 1-month follow up
An Open-label, Randomized, Parallel-arm Study Investigating the Efficacy and Safety of Intravenous Administration of Pamrevlumab Versus Standard of Care in Patients With COVID-19

This is a randomized, open-label, parallel-arm study to investigate the efficacy and safety of pamrevlumab in patients with documented SARS-CoV-2 infection. The study consists of screening, a treatment period, and a follow-up period.

The study will enroll patients who have been hospitalized and who are not currently on invasive mechanical ventilation. The treatment period is open ended, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio according to a pre-generated randomization list. Pamrevlumab dosing, 30 mg/kg IV, will be administered at day 1, day 7 and day 14. Based on Investigator's decision, treatment may be continued every 3 weeks after day 14, up to 11 weeks. A follow-up by visit or phone call will be performed 8 and 12 weeks after the end of the last dose of treatment. The treatment period for an individual patient will not exceed 11 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Documented COVID-19 infection
* Age \>=18 to \<=80 years
* Interstitial pneumonia (findings of consolidation or ground glass opacities as assessed by chest HRCT)
* Respiratory distress, defined as PaO2/FiO2 ratio of \>=100 \<=300 mmHg, requiring supplemental oxygen and hospitalization

Exclusion Criteria:

* Invasive mechanical ventilation at screening
* Pregnancy
* Incapacity to express a valid informed consent
* Known hypersensitivity to monoclonal antibodies used as experimental drugs for any clinical indication
CAT Score and Airway Limitation in Adult Smokers

This study aimed to show the relationship between CAT Score and airway limitation in smokers who applied to MSKU Chest Diseases Polyclinic with respiratory complaints (shortness of breath, cough, sputum, etc.) and underwent respiratory function tests. CAT Score is a measurement used to evaluate the quality of life of Chronic Obstructive Pulmonary Disease (COPD) patients. CAT Score is a scale used to assess patients' symptoms (such as shortness of breath, cough, and sputum) and problems affecting their daily activities. CAT Score usually takes a value between 0 and 40, and a high score may indicate that the patient's quality of life is low. There are studies on the usability of CAT Score in Bronchiectasis, Tuberculosis, and Asthma Diseases other than COPD. We hypothesize that there is a positive correlation between CAT Score and airway limitation in smokers before COPD develops. The study was planned as cross-sectional. Between July 2024 and December 2024, patients who apply to MSKU Chest Diseases Polyclinic with respiratory complaints and have a history of smoking will have their CAT scores, 6-minute walking test, and height and weight measurements performed and recorded. In our study, the comparison of CAT Scores of individuals who smoke and have normal respiratory function test parameters with those who are not normal but excluded from COPD is planned as the primary endpoint, and comparisons of CAT Scores with exercise capacities and body mass indexes are planned as the secondary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Smoking history Being over 18 years old Being symptomatic

Exclusion Criteria:

* Having a diagnosis of chronic respiratory disease (COPD, Asthma, IPF)
Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus

This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

Males and females aged 18-35 years initially (subjects aged 8-17 may be included at a later stage, starting with age 12-17 years, followed by age 8-11 years).

Body weight between 40-120 kg initially (subjects weighing 21-39 kg may be included at a later stage).

Recent onset type 1 diabetes mellitus, diagnosed with 100 days of first dose. Peak stimulated C-peptide levels \>/= 0.2 pmol/L following mixed meal tolerance test

Exclusion Criteria:

Any form of diabetes other than auto-immune type 1 (eg, type 2 diabetes, maturity onset diabetes of the young, latent autoimmune diabetes of the adult).

Diabetic ketoacidosis within 2 weeks of screening. Pregnancy or lactation. Recent (within 2 weeks of screening), ongoing, chronic or recurrent infectious disease.

Active infection with hepatitis B or C, Epstein-Barr virus, cytomegalovirus, or HIV.

Tuberculosis infection. Other protocol-defined inclusion/exclusion criteria may apply
A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants For the Improvement of Skin Quality

Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in the treatment of fine lines and improving skin quality.

VOLITE is an investigational device being developed for improving skin quality. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of skin quality, especially hydration and radiance, in the treatment area will be enrolled. Around 135 participants will be enrolled in the study at approximately 6 sites in China.

Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months.

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, and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin types II-IV
* Participants' FACE-Q Satisfaction with Skin Questionnaire scores must meet the following criteria:

  * Participants must have FACE-Q Satisfaction with Skin Questionnaire sum of raw scores of 39 or less
  * Participants must score "Very Dissatisfied" or "Somewhat Dissatisfied" on the following two questions:

    * How hydrated your facial skin looks?
    * How radiant your facial skin looks?

Exclusion Criteria:

* Any skin condition in the face area that might not be suitable for injection
* Uncontrolled systemic disease
* History of anaphylactic shock, or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study
* Active autoimmune disease
* Tendency to develop hypertrophic scarring
* Currently undergoing chemotherapy/radiotherapy
* Is undergoing orthodontia before enrollment or is planning to undergo it during the study
Micron Tracker: Computer-Assisted Orthognathic Surgery With a Third Generation Optic Repositioning System

The main objective of this study is to validate a simplified platform of a repositioning system in orthognathic surgery (a third generation optic repositioning system called MicronTracker) compared with the actual clinically validated one (Orthopilot system).

For the past 10 years, the use of computer-assisted surgery has expanded and is now widely spread in the orthopaedic domain, but not in maxillary-facial surgery. The main disadvantages of this technique are the necessity to fix a mark on the eyebrow with two transcutaneous pins, which is a long and invasive act, and to connect the infrared transmitter which is in contact with the patient with the computer in a limited surgery area. In this study, we want to show that the new repositioning optic systems are performing similarly to the actual validated one, that they permit to suppress the transcutaneous pins and the computer connection, and that it reduces the financial cost of this surgery. Neither the surgery technique, nor the pre-operative check-up will be modified in the study. The two repositioning systems will be used simultaneously during the mandibular osteotomy.

Eligibility Criteria:
Inclusion Criteria:

* Mandibular orthognathic surgery

Exclusion Criteria:

* Age \<18 years
Oral Nutrition Supplementation in Hospitalized Patients

The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplement (ONS) on physical function and functional performance in malnourished elderly patients.

The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplementation (ONS) on muscle accretion and functional performance in malnourished elderly patients. The objectives of this study are to determine feasibility of recruitment, adherence to intervention and retention of the sample, as well as the capacity of subjects to complete functional and muscle mass measures for a planned multi-centre Randomized Controlled Trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* admitted to a general medical ward and recruited within 48 hours
* over the age of 65 years
* malnourished (subjective global assessment categories B or C patients)

Exclusion Criteria:

* have an allergy or intolerance to any component of the oral supplement
* are designated palliative care
* are currently suffering from refeeding syndrome
* have a pre-existing medical condition that prevents oral intake of full fluids,
* have an expected length of stay of less than 48 hours from the time of assessment
* have suspected ischemic stroke as cause for admission
* reside in a residential care home
* are unable to walk prior to current illness.
* are pregnant/breastfeeding
* have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
Vitamin B12 Pregnancy Supplementation

Pregnancy is associated with increased requirements for iron and increased blood volume of up to 40%. Because expansion in plasma volume is higher than the increase in the mass of red blood cells, there is a fall in hemoglobin concentration, which leads to physiological anemia, characterized with lower hemoglobin (Hb), hematocrit and red blood cells, but without changes in mean corpuscular volume (MCV). Anemia in pregnancy is defined with Hb values under 110 g/L in the first trimester and under 105 g/L in the second and third trimester.

Iron deficiency is thought to be the most common nutrient deficiency among pregnant women. Consequences of anemia include delayed fetal growth, premature delivery, intrauterine fetal death, postpartum depression and delayed psychomotor development of a child. It is known that in women that are not anemic daily iron supplementation of 27 mg/day is sufficient, which can be obtained from adequate nutrition or body supplies. Iron supplementation is pregnancy has been recommended by the WHO (World Health Organisation) since 1959, and this recommendation was confirmed by numerous professional associations. However, in women with anemia, or women subjected to particular dietary regimens with diminished quantity of iron, including vegetarian or vegan diet, required supplementation dosage is higher, and estimated in the literature to be 120 mg/day.

The aim of this study was to analyze whether adding vitamin B12 (5 µg /100 days), along with folic acid and iron as supplement in pregnant women who are not anemic and who need only iron supplementation, will result in improvements of hematological and biochemical markers.


Eligibility Criteria:
Inclusion Criteria:

* healthy women from 8th week of pregnancy

Exclusion Criteria:

* existence of hypertension
* existence of diabetes
* existence of genetic abnormalities
* smoking
* previous miscarriage
Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome

This single-center study aims to evaluate both immediate and long-term outcomes of stellate ganglion block (SGB) in a cohort of rigorously phenotyped patients with Postural Tachycardia Syndrome (POTS). By assessing the effects of SGB, this study seeks to determine its viability as an intervention for symptom control in POTS.

Postural Tachycardia Syndrome (POTS) is a heterogeneous condition affecting approximately 0.2% of the global population, predominantly young women of childbearing age. It is characterized by significant functional impairment and a constellation of symptoms, including lightheadedness, cognitive dysfunction, blurred vision, irritability, palpitations, and chest discomfort, which occur upon standing and improve when lying down. Although current pharmacological and non-pharmacological treatments alleviate symptoms for some patients, many remain significantly disabled. These challenges highlight the urgent need for novel treatment strategies, particularly non-pharmacological approaches.

This study is a randomized controlled trial with a control group. The study team will enroll 20 patients with POTS, assigning 10 to the intervention group and 10 to the control group.

The goal of the study is to evaluate the effectiveness of SGB in improving heart rate, markers of sympathetic hyperactivity, and POTS symptoms comparing to a sham saline injection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years of age) diagnosed with POTS
* Ability to provide informed consent
* Ability to comply with 3 follow up visits
* English speaking and capable of signing informed consent and complying with protocol requirements

Exclusion Criteria:

* Allergy to local anesthetics
* Severe coagulopathy
* History of or currently being treated for clinically significant ongoing cardiac arrhythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis or other pulmonary diagnosis that in the investigator's opinion may contribute to symptoms of POTS
* Inability to maintain a stable medication regiment for the duration of the study
Role of Chewing Gum in Reducing Post Operative Ileus After Reversal of Ileostomy

Postoperative ileus is generally referred to as the transient impairment of bowel motility after abdominal or other surgery and diagnosed by postoperative abdominal pain vomiting constipation and distension.

The potential complications of prolonged POI include increased postoperative pain, increased nausea and vomiting, pulmonary complications, poor wound healing, delay in resuming oral intake, delay in postoperative mobilization, prolonged hospitalization, and increased health-care costs. The estimated economic impact of POI in the United States is $7.5 billion per year, excluding the expenses of work loss.

In view of these complications and economic burden a number of pharmacologic and non-pharmacologic strategies have been adopted by the doctors all over the world to reduce the burden of postoperative ileus.These programs involve transverse or curved surgical incisions, removal of nasogastric tubes at the end of anesthesia, intraoperative and postoperative analgesia, early postoperative feeding, mobilization, and gum chewing.

The use of gum chewing has emerged as a new and simple modality for decreasing POI. And reviews have concluded that there is consistent benefit for patients from gum chewing after the intestinal surgery; colonic surgery and gynecological surgery.

This study is based on the hypothesis that postoperative gum chewing is beneficial in prevention of postoperative ileus after reversal of ileostomy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of either gender with age ranging from 15 to 60 years.
2. Patients whose ileostomies were made for typhoid or tuberculous perforation
3. Patients with no distal obstruction on loopogram.

Exclusion Criteria:

- 1. Patients with age less than 15 years and greater than 60. 2. Patients having co-morbid factors such as diabetes and ischemic heart disease.

3. Patients whose ileostomy was made for any condition other than typhoid or tuberculosis.
PROLONG Prospective, Multi-center, Open-label, Post-market Study

Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must provide written informed consent prior to any clinical investigation related procedure.
2. Patient has a spinal cord stimulator implanted for chronic, intractable pain.
3. Patient has inadequate pain relief from their current SCS system.
4. Patient has a pain NRS ≥ 6.
5. Physician has determined that the patient's original pain is still addressable with neurostimulation.

Exclusion Criteria:

1. Patient is enrolled, or intends to participate, in a competing clinical study, as determined by Abbott.
2. Patient is seeking care for a new pain complaint outside of the original indication for SCS.
3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the clinical investigation or to comply with follow-up requirements.
4. Physician has determined that patient's pain relief is inadequate due to a malfunction or damage to the existing system.
5. Patient requires frequent MRI.
6. Patient is involved in active disability litigation related to their pain or seeking worker's compensation.
7. Patient is part of a vulnerable population.
Handgrip Exercise for Arteriovenous Fistula Maturation

The purpose of this study is to investigate whether post operative progressive forearm exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease patients.

The arteriovenous fistula is considered to be the gold standard form of access for haemodialysis patients, however only 37% of haemodialysis patients have this form of access. A possible explanation for this could be the high fistula failure rate due to the lack of maturation. Therefore interventions aimed at enhancing fistula maturation are warranted. One such intervention could be forearm exercise, however this recommendation is not evidence based. Therefore, the purpose of this study is to investigate whether a program of post operative progressive hand grip exercise can improve fistula maturation.

Eligibility Criteria:
Inclusion Criteria:

* Stage 4-5 chronic kidney disease, attending for arteriovenous fistula creation in forearm

Exclusion Criteria:

* Are under the age of 18years;
* Not able to exercise forearm safely (as decided by the patients consultant)
* Have any other uncontrolled medical condition
* Unable to withstand transiently raised systolic blood pressure by 35 mmHg and diastolic by 25 mmHg
* Or are unable to give consent