cyrilzakka/clinical-trials huggingface dataset:
High FODMAP Diet with Metformin in PreDM

This is a prospective, double blinded, randomised cross over feeding trial examine high or low FODMAP diet in combination with metformin on postprandial glucose responses and gastrointestinal tolerability and gut microbiota profiles.

The trial will compare high or low FODMAP diet, each of 10 days duration in combination with 5 days metformin, separated by a washout period of at least 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years
2. Body mass index 18 to 40 kg/m 2
3. Prediabetes defined as impaired fasting PG 5.6-6.9 mmol/l and/or impaired glucose tolerance with 2-hour PG 7.8-11.1 mmol/l on 75g oral glucose tolerance test (OGTT) and/or HbA1c 5.7-6.4% at screening

Exclusion Criteria:

1. Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
2. Known current diabetes
3. Current or previous use of glucose-lowering or weight loss drugs in 3 months prior to screening
4. Concurrent participation in other weight loss or lifestyle intervention programmes
5. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
6. Recent intake of prebiotic/probiotic or antibiotic, immunosuppressants (within 8 weeks of randomisation)
7. Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
8. Known uncontrolled thyrotoxicosis
9. Known vitamin B deficiency
10. Known irritable bowel syndrome or gastrointestinal disorders
11. Estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 at screening
12. Current use of steroids
13. Have a known allergy to medical-grade adhesives
14. Known current or recent alcohol or drug abuse
15. Hypersensitivity to metformin
16. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma within 3 months of randomisation
17. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
18. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
19. Participants who are on a vegetarian or vegan diet as their habitual diet at screening.
20. Participants with clinically significant food allergy to components of the study diet
Evaluation of Mini and Macro-esthetics Following En- Masse Retraction Versus Two Step Retraction

There's a scarcity in literature concerning mini-esthetics specially maxillary gingival display changes following en-masse retraction and two-step retraction. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which technique of retraction will result in better esthetics upon smiling following en-masse retraction or two step retraction mechanics.

This study will be conducted in order to evaluate which technique of retraction will provide better outcome regarding mini and macro esthetics. In terms of mini esthetics, posed smiles will be analyzed to evaluate maxillary gingival display, as well as the analysis of smile arc, buccal corridor, inter-labial gap. In terms of macro esthetics, frontal and profile poses will be assessed to evaluate the nasolabial angle, mentolabial angle and upper and lower lip protrusion/ E- plane.

Eligibility Criteria:
Inclusion Criteria:

* Adults and Adolescent patients (both genders)
* Age range (16-24)
* Patients with maxillary protrusion requiring first premolars extraction (Bimaxillary Protrusion or Class II division 1 cases).
* Patients with fully erupted permanent teeth (not necessarily including the third molar).
* Cases requiring maximum anchorage during retraction.
* Good general and oral health

Exclusion Criteria:

* Patients suffering from any neural disorders or systemic diseases interfering with tooth movement.
* Patients with soft tissue problems such as cleft-palate patients
* Patients with extracted or missing permanent teeth. (except for third molars).
* Patients with badly decayed teeth.
* Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc....).
* Patients with previous orthodontic treatment.
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
* KOH positive at screening
* Willingness not to use any other products including nail polish applied to the toenails during the study
* Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period

Exclusion Criteria:

* Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
* History of any significant chronic fungal disease other than onychomycosis
* Significant confounding conditions as assessed by study doctor
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy or lactation
Epidemiological Study for Traumatic Humeral Shaft Fractures in Adults

Primary Objective :

To evaluate the incidence of radial nerve palsy for adult patients with humeral shaft fractures

Secondary Objective :

To establish management protocol for traumatic humeral shaft fractures in adults at AUH

Diaphyseal humeral shaft fracture is defined as an extra articular fracture of the humerus with Exclusion of both 5 cm of both upper and lower ends (Muller et al,1990) Within the last Century, many conservative and surgical techniques developed all over the world to solve this problem (Welter D et al, 1991) Conservative treatment was a gold standard since the full research which was published by Sarmiento (Sarmiento, 1977 ) Within the last few decades, with the establishment of osteosynthesis and surgical fixation of long bone which had better outcome in comparison to conservative treatment, it led to a changes in the protocols of treating fractures of the humerus (Muller et al,1990) Within the last decade, with the revolution of biological non anatomical fixation of the humeral shaft fractures, a new era of management was established and became popular all over the highly qualified trauma centres (Balam KM et al, 2014) So, the rational of this work, is to document different surgical strategies of biological fixation of humeral shaft fractures in adults with its results.

Eligibility Criteria:
Inclusion Criteria:

* All patients with traumatic humeral shaft fracture more than 16 years old who are admitted in Assiut University Hospital

Exclusion Criteria:

* Patients with humeral shaft fracture less than 16 years old or patients with pathological humeral shaft fracture
Brain Gym Exercises on Risk of Fall, Balance and Quality of Life in Obese Subjects

This study will be done to answer the following question:

Do brain gym exercises have an effect on risk of fall, static balance, dynamic balance and risk of fall and quality of life in obese subjects?

Obesity has now become a severe and inescapable worry for people of all generations. Obesity is associated with an excessive or inappropriate fat build-up that poses a health concern. A BMI of 25 or above is considered to be overweight, while a BMI of 30 is classified as obese. In 2017, nearly 4 million individuals died as a direct result of being overweight and obese, according to the global burden of sickness report. Postural equilibrium is required for us to function normally in our daily lives. The ability to manage the center of mass inside the base of support, which serves to maintain the body in balance, is characterized as equilibrium. Balance is described as the process of maintaining the body center of gravity within its support base, which necessitates regular modifications given by muscle activity and joint alignment . 1. Thirty-two obese subjects from both gender with age ranging from 18-50 years old . And BMI ≥ 30 kg/m2. They will be selected from faculty of physical therapy Kafr Elshikh university Group A (exprimental group): 16 subjects received brain gym exercises for 15-30 minutes per day, three times a week, for eight consecutive weeks . And traditional treatment in form of balance training included standing on one leg, standing in tandem mode, walking in a tandem mode (one foot in front of the other), walking on toes and heels, side walk, standing while one upper extremity and the opposite lower extremity were up, rotating the head from side to side, walking backwards for four steps, and shifting weight from one foot to the other. Periodic exercises were frequently performed for 45 min for 3 sessions per week for 8 weeks Group B (control group): 16 subjects will receive traditional treatment in form of balance training included standing on one leg, standing in tandem mode, walking in a tandem mode (one foot in front of the other), walking on toes and heels, side walk, standing while one upper extremity and the opposite lower extremity were up, rotating the head from side to side, walking backwards for four steps, and shifting weight from one foot to the other. Periodic exercises were frequently performed for 45 min for 3 sessions per week for 8 weeks

Eligibility Criteria:
Inclusion Criteria:1- Obese subjects from both gender age range from 18-50 years old (Cruz-Gomez et al., 2021) 2- BMI ≥ 30 kg/m2

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Exclusion Criteria:neurological conditions affect the balance as:

* Alzheimer's disease
* Parkinson's disease
* Head injuries
* Peripheral neuropathy
* Headaches or migraines 2. lower limb injuries 3. Postural hypotension 4. Motion sickness 5. Diabetes mellitus 6. Pregnancy 7. Rheumatoid arthritis 8. osteoporosis
A Study to Evaluate Visually Inspired Patient Education Material on Willingness to Pursue Radiation Therapy

This research study is being done in order to better understand and identify American Indian/Alaskan Native (AI/AN) cancer patients' attitudes and beliefs towards radiation therapy treatment plans and their willingness to pursue them.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years of age with cancer diagnosis.
* Radiation therapy is recommended for their cancer treatment as a next step in their cancer care.
* Cognitive capacity to complete a paper-and-pencil survey.
* Ability to communicate and understand English with proficiency to provide informed consent and complete a paper-and-pencil survey.

Exclusion Criteria:

* Patient \< 18 years of age.
* Patient does not have a cancer diagnosis.
Efficacy of an Onlay Mesh for Prevention of Incisional Hernia After Loop Ileostomy Closure

The aim of the present study is to determine the efficacy of the placement of an onlay mesh to prevent incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer

The primary aim of the study is to determine the efficacy of the placement of an onlay mesh for prevention of incisional hernia after loop ileostomy closure in patients with a prior rectal resection for cancer. The efficacy will be evaluated by physical examination 3, 6 and 12 months after surgery and by abdominal CT scan one year after stoma closure.

Secondary aims are to evaluate the tolerability and safety of the prothesis; complications, quality of life and the need for further treatments will be compared between the groups.

This is a multicentric study that will include patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer. Elective surgery for loop ileostomy closure with ASA\<4. Exclusion criteria include patients with allergy or intolerance to polypropilene, with a prior mesh on the abdominal wall, ASA ≥IV, patients with a life expectancy of \<12 months, chronic renal failure in haemodialysis and patients on steroid therapy.

Patients that agree to participate in the study will be randomized using an electronic formula (Excel) of a uniformly distributed variable assigning case/control randomly until the total number of patients are included.

In the control group, after the digestive tract is reconstructed, the closure of the abdominal wall will be performed with a continuous suture of PDS loop 1/0 following Jenkins 4:1 rule and the skin will be closed using a subcutaneous purse-string closure. Patients in the study group will have the same procedure performed, and after the aponeurosis closure with PDS loop, an onlay light polypropilene mesh will be placed.

Each participant will have an assigned code depending on the participating Centre that will maintain anonymity at all times. All of the information will be registered in a database specifically designed for the study.

Statistical analysis will be performed by a descriptive study of the demographic variables and the incidence of incisional hernia after loop ileostomy closure. A comparative study between the groups will be performed using X2 test for categorical variables and t Student test or U-Mann for continuous variables. A binary logistic regression will also be performed to analyse the influence of each variable and to predict if the interventions produce incisional hernia.

Eligibility Criteria:
Inclusion Criteria:

* patients operated on in hospitals in Catalunya for loop ileostomy closure after a prior rectal resection for rectal cancer.
* elective surgery for loop ileostomy closure
* ASA (American Society of Anesthesiologists)\<4

Exclusion Criteria:

* allergy or intolerance to polypropilene
* patients with a prior mesh on the abdominal wall
* ASA ≥IV
* patients with a life expectancy of \<12 months
* chronic renal failure in haemodialysis
* patients on steroid therapy
A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices

Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced liver disease regarding eradication, bleeding, mortality, complication and recurrence rates.


Eligibility Criteria:
Inclusion Criteria:

* advanced liver disease (Child-Pugh ≥ 8 points)
* medium and/or large esophageal varices

Exclusion Criteria:

* prior endoscopic treatment.
* history of shunt operation
Neutralizing Power of Anti-SARS-CoV-2 (Anti-COVID-19) Serum Antibodies

Natural infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). This neutralizing power is recognized as a correlate of protection against a (new) infection. This study aims to measure the neutralizing power of the serum of patients (whether or not they have been infected with SARS-CoV-2) according to the treatments and/or vaccines received and to assess the durability of this power in the time.

Infection, vaccines and treatments (like monoclonal antibodies) lead to the appearance of a neutralizing power in the serum (due to induced or injected antibodies). This neutralizing power is recognized as a correlate of protection against (new) infection. The purpose of this study is to measure the neutralizing power of the serum of patients (whether or not they have been infected with SARS-CoV-2) depending on the treatments and/or vaccines received and to assess the durability of this power over time.

The main objective is to measure and describe the evolution of the serum humoral response (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies).

The secondary objectives are:

* to measure and describe the antibody response at the level of the nasal mucosa (titer and neutralizing capacity of anti-SARS-CoV-2 antibodies, collected by means of a nasal swab) following any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies SARS-CoV-2.
* to describe the incidence of COVID in the study patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers for the study, having received or about to receive any intervention inducing or conferring neutralizing anti-SARS-CoV-2 antibodies (vaccines - whatever the mode of action -, monoclonal antibodies).
* Having given their consent to participate in the study

Exclusion Criteria:

* Minors
* Pregnant women
* Persons under tutorship or curatorship
* Protected adults
* Person under legal protection
* Person not affiliated to a social security scheme
* Persons unable to express their consent
The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion

Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.

Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage.

Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.

Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.

Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.

Eligibility Criteria:
The inclusion criteria:

* Patients to be female, aged 18-45 years
* Without previous dilatation and curettage
* Undergoing dilatation and curettage for the current delayed miscarriage
* All participants should be with normal liver/rental function and without systemic disease
* Agree to use adequate forms of contraception throughout the study
* Be in good compliance with the follow-up examination according to the study protocol.

The exclusion criteria:

* Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives
* Genital tract malformation
* Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract
* Suspected genital tuberculosis
* Abnormal blood coagulation
* Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness
* Acute or severe infection
* Autoimmune diseases.
Hydration Amongst Nurses and Doctors Oncall

The main purpose of this study is to assess and compare the hydration status of medical and nursing staff and to investigate the relationship between the hydration status, cognitive function and serum cortisol (marker of stress).

We hypothesise that a significant proportion of doctors and nurses will be dehydrated at the end of their working day. Some, as in other occupations, may be dehydrated at the start of their working day. This is likely to be associated with impairment in cognitive performance at the end of the working day compared to the beginning and expected to be more pronounced after a night shift. There may be less noticeable difference amongst nursing staff given the protected break time. Dehydration and associated impairment in cognition is of important clinical value as it can impact patient care. participants will be involved in the study for two shifts (one day and one night), aiming at 15 medical and 15 surgical nurses as well as 15 medical (total 15 day and 15 night shifts from each group) and surgical doctors (total 15 day and 15 night shifts from each group). Those that do not work both day and night shifts will participate for only one shift and a new participant will be recruited until target number of shifts is achieved.

End points

1. To assess the hydration status of hospital staff nurses and doctors oncall at work by measuring the following:

   1. Urine and serum osmolality
   2. Urine mass produced during the shift
   3. Kidney function (U \&Es)
   4. Bioimpedance measures

      2- To assess the effect of hydration on status of cognitive function and subjective feelings.

      3- To assess the association between hydration status on stress hormone (cortisol) levels.

      Inclusion criteria All medical and nursing staff working on acute medical and surgical admissions at the Queens Medical Centre Nottingham.

      Exclusion Criteria:

      Pregnancy Pre-existing kidney disease Patients on diuretics Unwell in the past 6 week with acute illness that warrants hospital admission or prescribed medication.

Eligibility Criteria:
Inclusion Criteria:

* All medical and nursing staff working on acute medical and surgical admissions at the Queens Medical Centre Nottingham

Exclusion Criteria:

* Pregnancy Pre-existing kidney disease Patients on diuretics Unwell in the past 6 week with acute illness that warrants hospital admission or prescribed medication.
Withdrawal of Artificial Nutrition at the End of Life (PERCEPAL)

Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines.

The benefit of artificial nutrition in terminally ill patients has been a highly debated issue for the past 30 years, and abundant data are available regarding its effects on patients. Several clinical guidelines have specified the criteria to be considered before initiating artificial nutrition or hydration. If these guidelines appear consensual in theory, the situation is much less straightforward in practice. The attitude of physicians appeared very variable when it came to prescribing or withholding artificial nutrition or hydration, and the lack of training, among other parameters, seemingly encouraged health care professionals to prescribe artificial nutrition or hydration. Furthermore, the decision of the care provider is unconsciously complicated due to figurative representations associated with food regarding, among other aspects, the mother-child relationship, social cohesion, or religious beliefs.

These differences are more important since the opinion of physicians and nurses is the one that carries the most influence on the patients' decision when deciding to initiate artificial nutrition and because artificial nutrition and hydration are a common source of ethical dilemmas in health care teams. Furthermore, stopping artificial nutrition or hydration could be misconstrued as euthanasia.

Eligibility Criteria:
Inclusion Criteria:

* nurses, and nurses' aides working in medicine, surgery, and palliative care departments of the regional hospital of Metz-Thionville

Exclusion Criteria:

* Care providers working in pediatrics, gynecology and obstetrics, psychiatry, and emergency departments