cyrilzakka/clinical-trials huggingface dataset:
GluCoach - Technology-enabled Lifestyle Intervention Study

This study seeks to address two questions. Firstly, how might a suite of interventions and data feedback (activity, diet, mood\*, continuous blood glucose) through coaching be effective in influencing behaviour change for individuals at-risk of developing type 2 diabetes? Secondly, what elements of coaching might be extracted for automated implementation in a scalable coach-light model?

Face-to-face health coaching is a common lifestyle intervention for healthy individuals who are at risk of chronic diseases such as diabetes. However, it is highly resource-intensive and has limitations in scaling up to reach wider populations. Advances in technology present opportunities to scale health coaching to the wider population through automation, enabling the delivery of personalised messages for individuals via mobile applications.

In addition, continuous glucose monitoring (CGM) devices could also potentially augment the effectiveness of health coaching by providing coaches with a tool for coachees' self-discovery of their individual physiological responses to lifestyles and modifications such as diet and exercise.

As such, the present study seeks to leverage smart wearable devices (e.g., Bluetooth smartwatches) and CGM devices accompanying a customized mobile application to deliver lifestyle coaching interventions. This suite of lifestyle interventions, including feedback about their own blood glucose levels, aims to influence participant's lifestyles and behaviours through guided self-discovery and face-to-face coaching. This intervention will be compared with a control group to examine its effects on lifestyle change, anthropometric measures and biometric measures. In addition, the findings from this study will contribute to the development of a novel coach-light intervention that can be implemented at a wider population level via Singapore's Health Promotion Board's (HPB) existing programmes and channels.

Eligibility Criteria:
Inclusion Criteria:

1. Singaporean Citizens and Permanent Residents
2. Aged 21 to 55
3. Must be literate in English (i.e. able to read and communicate in English) because the primary mode of communication is English
4. Willing and able to use a smartphone
5. Must be at risk of developing Type 2 Diabetes, defined as:

i) Glycated haemoglobin (HbA1c) - At least 5.7% to 6.5% OR Fasting blood glucose of 6.1 to 6.9mmol/L, AND ii) BMI of at least 20kg/m2

Exclusion Criteria:

1. Non-Singaporean Citizens and Permanent Residents
2. Under age 21 or above age 55
3. Ever diagnosed as Type 1 or Type 2 Diabetic (does not include previously diagnosed GDM)
4. Pregnant or planning to be pregnant in the next 6 months or lactating
5. History of skin allergies
6. Taking medications that are known to alter blood sugar levels/ glucose tolerance e.g.

glucocorticoids g) History of mental illness/conditions h) Work requirement that does not allow the carrying of electronic devices (e.g., phone and smartwatch) i) Frequent overseas travelling (e.g., more frequently than once a month, daily or weekly commuting across borders etc.)
The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery

Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis, prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to pain, therefore the most common problems after surgery are postoperative pain and anxiety during removal of the nasal packing. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics, local anesthetics infiltration into nasal packing).

Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain. Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces postoperative nausea and vomiting incidance.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing nasal surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
The Role of a Natural Product, Containing Nanovesicles From Citrus Limon (L.) Juice, on Different CV Risk Factors

Clinical trial about beneficial effects of natural supplement in a spray-dried formulation, citraVes™, obtained from Citrus Limon (L.) juice on general body health.

This is one randomized, double-blind, placebo-controlled study. The aim of the present study is to investigate the role of a natural product, citraVes™ on several cardiovascular risk factors.

The research hypothesis is to evaluate whether this natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (Navhetec S.R.L., Palermo, Italy) may improve different cardio-metabolic parameters in subjects with the metabolic syndrome. All subjects will be evaluated at baseline, after 1 month and after 3 and 6 months of supplementation with natural product or placebo.

Eligibility Criteria:
Inclusion Criteria:

* men and women \> 18 years old;
* body mass index (BMI) \> 25 kg/m²;
* subjects who are able to swallow;
* subjects who are willing to participate in the study and therefore, to sign informed consent prior to any study procedure;
* the inclusion criteria for patients with MetS was also the diagnosis of MetS, as defined by international consensus \[Alberti KG, et al. Circulation. 2009; 120:1640-5\].

Exclusion Criteria:

* pregnancy or the willingness to become pregnant;
* severe renal or hepatic impairment;
* known severe infections (such as HIV, HBV, HCV)
* any neoplasms;
* the exclusion criteria for healthy volunteers were also diagnosis of any one of the following diseases: hypertension, diabetes mellitus, dyslipidaemia or metabolic diseases.
Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis

Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. This observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.


Eligibility Criteria:
Inclusion criteria:

* Metastatic melanoma BRAF mutated
* Initially treated by a doubled targeted therapy anti BRAF/anti MEK
* With an intra cerebral progression of the tumor
* Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy
* between 01/2019 et 01/2022

Exclusion criteria:

- Other condition
The Effect of Wearing Orthokeratology on Objective Visual Quality

The visual quality indexes of these patients before and after Orthokeratology treatment were compared: 4 mm higher strehl ratio (SR) , 4 mm higher order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Comas, Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

USING OPD-SCAN III instrument method: Drag The joystick to focus on the screen prompt, and the device automatically starts to measure the aberration when the yellow focus is shown; Simk will change from black to rose red when the aberration is measured to start measuring the corneal topography, prompting the patient to blink the tear film evenly and press the button on the joystick when the focus is completed.The following data were obtained and analyzed: 4 mm high order STREHL rate (SR) , 4 mm high order corneal aberration (Hoa ) , Spherical Aberration (SA) , Coma Aberration (Coma) , Trefoil Aberration (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

Eligibility Criteria:
Inclusion Criteria:

* The subject understands the purpose of this clinical trial and is willing, able and committed to return to the center for all clinical trial visits and to complete all research related procedures

Exclusion Criteria:

* 1. Associated with corneal abnormalities, such as active Keratitis (corneal infection) , corneal dystrophy, Keratoconus, corneal Leukoplakia, corneal hypoesthesia, or previous corneal surgery, or a history of corneal trauma;
* 2, there are other eye diseases, such as Dacryocystitis, dry eye disease, conjunctivitis, blepharitis, Uveitis, and other inflammation, Glaucoma, cataracts, fundus disease, eye tumors, ocular trauma, squint patients;
* 3. A history of allergy to contact lens or contact Lens Solution.
* 4. Test results indicate that subjects with contraindications or unsuitable for wearing Orthokeratology.
Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics.

The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 40 participants suffering from periodontitis and rheumatoid arthritis will be referred from the Badr Hospital (Faculty of Medicine, Helwan University) to Misr international university's dental clinic complex. Gingival crevicular fluid (GCF) samples will be collected from the patients before performing periodontal therapy (baseline). Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome at baseline and after 3 months. Assessment of 2ry outcomes includes clinical periodontal and RA parameters at baseline and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid patients fulfilling the ACR criteria for the classification of RA

  * 18 years
* Both genders
* Presence of at least 8 teeth

Exclusion Criteria:

* Smoking
* Diabetes Mellitus
* Pregnant females
* Patients who had undergone periodontal treatment within last 3 months
* Antibiotic therapy during last 3 months
* Other autoimmune diseases
Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.

Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. Refining the diagnostic capability of this test would further improve maternal-fetal outcomes and the use of optic nerve sheath diameter (ONSD) measurement could make the difference.

The purpose of the present study is to correlate the measurement of ONSD with serum angiogenic factor (AF) values in patients with pre-eclampsia and to determine its predictive ability for adverse perinatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 24 and 40 weeks of gestation.

Exclusion Criteria:

* Multiple gestation
* Maternal vasculitis
* Previous cesarean section (3 or more)
* Brain or eye tumors
* Neurological conditions
* Chronic renal disease
* Purpura
* Heart disease
Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength

The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.


Eligibility Criteria:
Inclusion Criteria:

* Elective bilateral knee arthroplasty
* Must speak and understand Danish
* Musk be able to gave oral and written consent.
* Females must be post-menopausal, and last menstruation must be minimum of one year ago.

Exclusion Criteria:

* Alcohol or medicine abuse
* Treatment with opioids
* Allergy to local anaesthetics
* Allergy to active substances i fibrin sealant
* Age below 18
Combination Therapy for First Line Treatment of Advanced Cervical Cancer

This is a single center phase 1 trail to observe safety and efficacy of Paclitaxel plus Cisplatin\\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib as first-line regimen to treat the patient with metastatic 、persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both (Stage IA-IVA).

Advanced cervical cancer patients with metastatic, persistent or recurrent disease after radical surgery、radical platinum-based concurrent chemoradiotherapy or both will be treated by Paclitaxel plus Cisplatin\\Carboplatin, PD-L1 antibody Toripalimab and Anlotinib.

Eligibility Criteria:
Inclusion Criteria:

1. female patients aged≥18 years.
2. Histologically confirmed cervical squamous cell carcinoma or adenocarcinoma, without uncontrolled pleural effusion or ascites.
3. Patients with advanced or metastatic disease who have disease progression after radical surgery、radical platinum-based concurrent chemoradiotherapy or both （Stage IA-IVA）, with measurable lesions.
4. ECOG performance status 0 or 2, expected lifetime≥3 months.
5. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥100x109/L, Hemoglobin (Hb) ≥100g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
6. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
7. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
8. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

1. Pregnancy or children bearing potential.
2. brain or meningeal metastasis.
3. With second primary malignant diseases.
4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
5. With uncontrollable complications
6. Inadequate organ function
7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
8. known hypersensitivity reaction to any of the study drugs or components.
9. Other unsuitable conditions determined by investigators.
Observational Clinical Investigation of EKG Diagnostic Performance of the Apple Watch Augmented With an AI Algorithm

This observational prospective clinical investigation will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

Each patient hospitalized for ablation or cardioversion and having given consent to participate in the clinical investigation will have ECG recordings by Apple Watch performed simultaneously with a 12D ECG measurement by a cardiologist before and/or after treatment, in accordance with the existing patient monitoring protocol. Similarly, patients attending a rhythmology consultation or hospitalized in the cardiology department will have simultaneous ECG recordings with an Apple Watch during the scheduled routine 12D ECG recording.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 22 or older, able and willing to participate in the study
* Patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who comes for regular rhythmology consultations or hospitalized in cardiology department
* Patient who has read the information note and has given his or her consent before any procedure related to the study
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device.
* Subject related to the investigator or any other staff member directly involved in the conduct of the study
* Patient incapable of giving consent, minor or adult patient protected by law
Determination of the Optimal Nutrient Mix to Acutely Increase Plasma Ketones

This study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (MCTs)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (BMI: 25-35 kg/m2) individuals. Since the aim is to induce a mild ketogenic state, a 25g MCT-based nutrient mix, a 25g MCT-based nutrient mix + cofactors, or a non-ketogenic control will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60-80 years
* Body mass index (BMI) 25-35 kg/m2
* Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months)
* Participants are able to provide signed and dated written informed consent prior to any study specific procedures

Exclusion Criteria:

* Type 2 diabetes
* Pre-diabetes based on one or a combination of the following criteria:

  * ImpairedFastingGlucose(IFG):Fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l.
  * HbA1c of 5.7-6.4%.
* Participants with active congestive heart failure and/or severe renal and or liver insufficiency
* Uncontrolled hypertension
* Alcohol consumption of \> 3 servings per day for man and \> 2 servings per day for woman
* Unstable body weight (weight gain or loss \> 5 kg in the last 3 months)
* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results
* Significant food allergies/intolerance (seriously hampering study meals)
* Participants who do not want to be informed about unexpected medical findings
* Blood donation during or within 2 months prior to the study
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Hip Arthroscopy

The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after hip arthroscopy.

Hip arthroscopy (HAS) is a standard procedure with good mid and long-term results. Postoperative pain is a great concern and postoperative pain management of great importance. High demand for opiates and the associated side effects especially nausea limit the postoperative rehabilitation.

Promising results to reduce postoperative pain and nausea have been achieved by perioperative dexamethasone, which has a strong anti-inflammatory effect reducing pain and inflammation as well as a strong anti-emetic effect, especially in total hip replacement.

It is our goal to compare the effect of perioperative intravenous dexamethasone (3x 4mg Amp. Fortecortin =12mg prior to surgery and 3x4mg Amp. Fortecortin = 12mg at 8.00am of the first postoperative day in 250ml saline solution) to a control group (placebo) (1x 250ml saline solution postoperative day 1 at 8.00am) regarding pain level, opiate consumption, postoperative nausea and patient satisfaction.

A double-blinded prospective randomized control trial including 60 patients receiving elective unilateral HAS will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* • Age ≥ 18 years

  * general anasthesia
  * Elective isolated unilateral HAS for any reason
  * No Prior hip surgery
  * Written informed consent as documented by signature (Appendix Informed Consent Form)
  * Competent German language skills

Exclusion Criteria:

* • Chronic pain patient, chronic lower back pain

  * Steroid or immunosuppressive drugs used within 6 months of surgery
  * Renal failure, hepatic failure
  * Relevant allergies
  * Pregnancy/ Breast feeding
  * Contraindications for Fortecortin treatment according to Swissmedic
  * Previous enrollment into the current study
  * Participation in another study with investigational drug within the 30 days preceding and during the present study
  * Known or suspected non-compliance, drug or alcohol abuse
  * Illness according to "Warnings and Precautions of Dexamethasone and NaCl"
The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction

This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction will be discharged 3 days sooner due to less postoperative pain and complications.

as written above

Eligibility Criteria:
Inclusion Criteria:

* All patients clinical suspected for perforated peptic ulcer

Exclusion Criteria:

* Pregnancy
* Younger than 18 years
* Unable to sign consent form
Phytoestrogens and Memory Decline in Menopause

The purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline.

Accumulating data has indicated that estrogens mediate enhancing effects on cognition and mood and may play a prophylactic role against age- and disease-related cognitive-cerebral decline. Phytoestrogens are plant-derived substances that have demonstrated estrogenic activity, but there is little prospective research regarding their effects on mental function. Mental health practitioners generally do not prescribe phytoestrogens. However, many women experiencing peri- and post-menopausal symptoms use marketed phytoestrogens under the perception of general health benefits, including presumably enhanced mental function. The purpose of this study is to develop preliminary data regarding the efficacy of isoflavone phytoestrogens in improving cognitive function in late middle-aged and elderly postmenopausal women with symptoms of memory impairment.

Participants in this study will be randomized to receive either isoflavone supplementation or placebo. The study will last for 16 weeks, during which participants will take the supplement pill or placebo three times a day. Participants will be assessed at study entry and at Week 16 for changes in basal cortisol levels, mood, and neuropsychological measures of executive function ability and episodic memory.

Eligibility Criteria:
Inclusion Criteria

* Postmenopausal women
* Mild memory or cognitive decline that does not meet the criteria for probable dementia

Exlcusion Criteria

* Hormone replacement therapy within 2 months prior to study entry
* Psychiatric medications within 30 days prior to study entry