cyrilzakka/clinical-trials huggingface dataset:
Impact of Gum Acacia on Chronic Kidney Disease Patients

The aim of the study is to evaluate the impact of gum acacia on serum levels of protein-bound uremic toxins (indoxyl sulfate and p-cresyl sulfate).In addition to the evaluation of its effect on metabolic profile and disease progression in chronic kidney disease patients.

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Eighty chronic kidney disease patients,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH).

   The 80 participants will be randomly assigned into 2 arms.

   Control arm (n=40): will be treated with standard treatment without any herbal intervention.

   Intervention arm (n=40): will be treated with standard treatment in addition to gum acacia sachets. Each sachet contains 25 g of gum acacia powder to be taken on daily-basis for 3 months.
4. All patients will be submitted to :

   * Full patient history and clinical examination.
   * Blood withdrawal in order to conduct lab work.
5. Patients demographic data will be recorded with respect to age, weight and other co-morbidities.
6. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
7. Results, conclusion, discussion and recommendations will be given.

Eligibility Criteria:
Inclusion Criteria:

* Non-hemodialysis CKD patients (Stage III -V)
* Age: above 18 years

Exclusion Criteria:

* Hemodialysis patients
* Pregnancy \& lactation
* Patients recently treated with antibiotic regimen (2 - 4 weeks)
* Malignancy
* Inflammatory bowel disease
Hyperoxemia and Ventilator-associated Pneumonia

The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence.

* SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia.
* Patients with VAP will be prospectively identified.
* Patient characteristics and risk factors for VAP will be prospectively collected.
* Oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week, and at VAP occurrence.

Patients with VAP will be compared with those with no VAP


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the ICU
* Expected duration of mechanical ventilation \> 48h
* Signed informed consent
* Social insurance

Exclusion Criteria:

* Pregnancy or breast feeding
* No informed consent
* Hyperbaric oxygen treatment
* Prisoners and patients under guardianship
HCV Treatment in a Low-threshold Clinic

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo

The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f

The secondary aims are to:

* Evaluate adherence to DAA treatment (Work Package 1)
* Identify factors associated with SVR and adherence (Work Package 1)
* Characterize reinfection using next generation sequencing (Work Package 2)
* Identify factors associated with reinfection (Work Package 2)
* Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)
* Identify factors associated with changes in risk behaviours (Work Package 2)

The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours.

The study will include 300 patients and are close to achieving that aim the summer of 2019

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA positive Attending the low-threshold HCV clinic in Oslo

Exclusion Criteria:

-
Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?

Ankle sprain is one of the most common pathologies in the general population (between 2.1 and 3.2 per 1000 patients per year). Nearly 40% of patients will develop chronic instability in the year following the sprain. We also know that a premature return to sport is a risk factor for developing chronic instability. However, despite the consensus of experts on the subject which have shown the key physiological elements to evaluate before resuming sport, no test or cohort of tests are proposed to allow a safe return to sport by reducing the risks of relapse. Some very recent studies have appeared on non-operated subjects but this remains a subject that is still too little studied, where the lack of consensus and objective criteria increases the risk of instability. Surgical treatment remains an effective option to reduce the risk of recurrence but failure of the latter can occur in approximately 13-37% of patients depending on the population, due to a relapse or a return to sport which does not correspond to expectations. of the patient.

The objective of the study is therefore to evaluate the predictive nature of a composite test (ANKLE-GO) regarding the return to sport at the same level and the risks of recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patient with objective chronic ankle instability who has failed medical treatment and undergone lateral ankle ligament repair surgery
* Patient practicing a sporting activity at least 2 times a week
* Patient able to read, write and understand French
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Minor or over 50 years of age
* Pregnant or breast-feeding patient
* Patient under guardianship, deprived of liberty or under court protection
* Refusal to participate in research
* Patient unable to understand or give informed consent
* Patient having undergone associated surgical procedures modifying the postoperative course
* Patient having undergone revision surgery
Shanghai Eye Study for Adults

Blindness and visual impairment severely impact the visual health and life quality of people, particularly the 2.566 million senior citizens aged at 65 and above in Shanghai. The main reason is uncorrected refractive error, of which, 62.1% can be solved through refractive correction. For this reason, the uncorrected refractive errors of 154,000 senior citizens in Shanghai can be taken as a priority among the public health issues to prevent blindness. Now, with the aim to reduce the prevalence rate of blindness and visual impairment, it is planned to establish a public health service mechanism in terms of refractive error screening and correction for the elderly by relying on Shanghai's three-level (city-district-community) eye diseases prevention network, using proper refractive correction technology, and moving related services forward to communities in order to screen, identity, and correct blindness and visual impairment caused by refractive errors as early as possible.


Eligibility Criteria:
Inclusion Criteria:

* shanghai residents aged ≥18 years old

Exclusion Criteria:

* cognitive and/or mobility disorders; non-shanghai residents; younger than 18 years old.
A Study on Vonoprazan in the Real-world Clinical Practice in China

The purpose of this study is to evaluate the safety of Vonoprazan by assessing all adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine clinical settings in China.

This is a prospective, non-interventional study in Chinese participants with RE who are receiving or will receive the standard treatment of vonoprazan. This study will assess the safety and effectiveness of vonoprazan in the real-world clinical practice.

The study will enroll approximately 3000 participants. The data will be collected through participants' medical records, self-reported questionnaires, and recorded information on symptom via diaries. All the participants will be assigned to a single observational cohort:

• Participants with RE

The multi-center trial will be conducted in China. The standard treatment will be of 4 weeks or it may reach up to 8 weeks if the dosing proves insufficient. All participants will be followed up for additional 2 weeks after the standard treatment. The overall duration of the study will be approximately 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Must be undergoing treatment with Vonoprazan.
2. Must be at least 18 years old.
3. Provide signed informed consent indicating that they (or a legally acceptable representative) have been informed of all pertinent aspects of the study and are willing to participate.

Exclusion Criteria:

1. Are currently enrolled in or plan to participate in any other clinical trials (that is interventional study).
2. Are contraindicated for Vonoprazan according to Product Package Insert.
3. With a known hepatic function impairment, including jaundice.
Effect of Gel Renewal During In-office Dental Bleaching

Considering the lack of studies related to the violet LED light (405-410nm), applied to tooth whitening, as well as the lack of protocols for its use, this study aims to evaluate if bleaching gel renewal during dental office whitening associated with Violet LED light interferes with final color result and postoperative sensitivity in a randomized, blinded, split-mouth study. Thirty-three volunteers will be selected to participate in the study (n = 33), and the study groups will be: G1 (Permanence of the Whitening Gel on the tooth enamel for 15 minutes) and G2 (3 Whitening Gel renewal every 5 minutes - Total of 15 minutes). In both G1 and G2, teeth will be illuminated with the Violet LED (405-410nm). In the same patient the two treatments (G1 and G2) will be performed, with a split-mouth protocol. The primary outcome will be immediate and mediated color change, quantitatively assessed by colorimetric (color scale) and spectrophotometry tests. Dental sensitivity will also be evaluated during and after tooth whitening using the VAS pain scale. There will be 3 whitening sessions with a 7-day interval between them. The alteration of color and presence of sensitivity will also be evaluated at the times of 14 days and 2 months after the whitening ends. A gel containing 35% hydrogen peroxide will be used. The final color evaluator and responsible for interviewing the patient about the sensitivity will be blind as to which treatment was applied on each side of the patient's arcade.


Eligibility Criteria:
Inclusion Criteria:

* Good oral hygiene conditions
* Good general health conditions and without systemic disease
* Presence of all teeth, without caries, periodontal disease, restorations, endodontic treatment, crowns
* Patients with dental color A3 or darker, according to the VITA \* Classical Color Scale.

Exclusion Criteria:

* Pregnant and lactating female patients
* Presence of caries, periodontal disease or any other infectious source in the oral cavity
* Systematic use of tobacco and alcoholic beverages
* Chronic use of corticosteroids, as well as who makes use of analgesics or anti-inflammatories before or during 48 hours after dental bleaching
* Patients with dentin hypersensitivity
* Patients with tooth color alteration by tetracycline, fluorosis, endodontic treatment.
* Volunteers who use removable prostheses
Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia

A retrospective study over a period of 6 years to explore analgesic efficacy of 8% Capsaicin patch (QUTENZA®) in coccygodynic patients, as well as neuropathic predictive factors of therapeutic response.

Coccygodynia corresponds to a localized pain in the coccyx region, aggravated or triggered by sitting and/or by getting up from a seat. Even if there is no epidemiology of this pain in France, coccygodynia represents a frequent recourse to specialized consultations (Rheumatology or Algology). Currently in France, there is no recommendation on the management of chronic disabling coccygodynia. Treatments are proposed in accordance with known/presumed underlying pathophysiology. Anti-inflammatory drugs and manual therapy (pressure relief cushions) are thus always offered as first-line treatments. But despite their common use/prescription, their efficacy is variable, with low level of evidence. More over, upstream of invasive coccygectomy, therapeutic arsenal is largely deficient, inviting to explore new approaches. Considering frequent neuropathic expression in coccygodynic pain pattern (tingling, itching, pain cold sensation...), capsaïcine 8% patch (QUTENZA®) are often performed. And in the same way, no/few researches tried to measure real-life analgesic pain efficacy of QUTENZA® strategy. Observational retrospective study (non-interventional anonymized data) CAPSACOXp aims to assess analgesic efficacy of Capsaicin 8% patch (QUTENZA®) and explore possible neuropathic determinants of therapeutic response in coccygodynia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received topical Capsaicin 8% patch therapy for the treatment of their coccygodygnia between August 2016 and August 2022

Exclusion Criteria:

* Patients who have already received 8% Capsaicin patch topical treatment in coccyx area.
Low Frequency Ultrasound for Osteoarthritis Healing and Rehabilitation

The purpose of this study is to determine the safety and effectiveness (how well it works) of a new experimental ultrasound bath device that uses low frequency ultrasound (LFU) that may or may not help healing.

This initial study is a pilot study which is going to test the safety and efficacy of the developed ultrasound intervention for osteoarthritis, initially on osteoarthritis of the knee. This study is a pilot study to evaluate two distinct variables. The first is the safety and efficacy of the device, and the second is the potential impact the device may have on patients as their osteoarthritic joints react to the LFU, using patient-reported outcomes associated with this study. The ultrasound will be delivered at a frequency of 33 kHz at power levels of 4-10 Pascals with a program of 1.6 seconds on and 1.6 seconds off. The generators will be encased in epoxy within the Osteoarthritis baths. The intervention will be repeated on every second or third day to allow time for healing

Eligibility Criteria:
Inclusion Criteria:

1. Subject has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
2. Adults at least ≥40 years of age at the time of consent.
3. Chronic knee pain within the past 6 months.

Exclusion Criteria:

1. Any other arthritic condition clinically classified under ACR guidelines as different from an Osteoarthritic disorder.
2. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
3. History of replacement surgery, acupuncture therapy on the joint/knee under study within the past 6 months, or systemic corticosteroids within the study period and previous 30 days.
4. Subject's vitals are unstable or not in range for a safe study visit.
5. History of fecal incontinence.
6. Vomiting/Diarrheal illness within the past 7 days or at any time during the study.
7. Any clinically significant rash or formation of rashes or open sores, boils or infected wounds two weeks prior to or during the study.
8. Laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days (eg. vancomycin resistant enterococcus, methicillin-resistant Staphylococcus, Candida auris, extended- spectrum beta lactamase bacteria)
9. History of prior non-compliance or the presence or history of psychiatric conditions (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
10. Females who are pregnant or lactating.
11. Inability to comply with study protocol.
12. Incarcerated individuals.
13. Non-English speaking subjects.
14. Participant's weight must be \</= 350 lbs.
Pain Management During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Study

To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Eligibility Criteria:
Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

* Nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to lidocaine-prilocaine spray
Cancer Patient Empowerment Program: Phase 2 Feasibility Study

The Cancer Patient Empowerment Program is a comprehensive health promotion program aiming to improve the quality of life as well as both physical and mental health in cancer patients and survivors. The program includes daily email communications over 6 months that encourage strength and aerobic exercise, yoga, stress reduction techniques, dietary improvements, and more.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18.
* History of a cancer diagnosis as per the participant's report.
* Safe to exercise and do strength training. Participants who have recovered from a minor stroke or heart condition in the past will require approval from their Family Physician or Cardiologist to participate in the study.
* Participants with advanced cancer (including cancer spread to bones) will need approval from the Study Physician or their Oncologist to participate.
* Existing (or willingness to create) email account and willingness to access email daily.
* Ability to follow website links to watch YouTube videos.
* Ability to understand and speak English.
* Ability to participate in low to moderate levels of physical activity and strength training.
* Ability and willingness to fill out an online survey at baseline, and 6, 12 and possibly 24 months, and a weekly compliance survey for the six months of the program.
* Deemed to have an expected survival greater than 1 year and expected to be well enough to complete the six-month training

Exclusion Criteria:

* Patients deemed unfit to participate in low to moderate level exercise e.g., including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise.
* Unable to access the internet and lack of a computer or smartphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video.
* Those with a predicted survival less than 1 year, or not expected to be able to participate in the program for six months.
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia

The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Receiving stable maintenance hemodialysis 3 times a week
* Dialysis patients with hyperphosphatemia

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder
* Patients having severe gastrointestinal disorders
* Patients having severe hepatic disorders
Relevance of Ultrasound Screening for Foetal Macrosomia

Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.

The aim of the study is to describe management of women whose child is macrosomal but has not been screened g using ultrasound during the third trimester of pregnancy.

Eligibility Criteria:
Inclusion criteria : Patients (consecutive inclusions) :

Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.

Women for which the delivery is planned in the gynaecology and obstetrics department of the Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en Champagne General Hospital.

Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women having a contraindication to labour or vaginal delivery Women with a scarred uterus Women having a history of shoulder dystocia or obstetric trauma Women having a history of urinary or fecal incontinence Women having a history of bad birth experience with high psychological impact Women with maternal pathologies (excluding gestational diabetes) Women whose fetus is breech Women with twin pregnancy