cyrilzakka/clinical-trials huggingface dataset:
N-acetylcysteine to Prevent Renal Failure

The purpose of this study is to determine the possible effect nephroprotective of N-acetylcysteine in patients with chronic kidney disease undergoing elective coronary artery bypass grafting by serial evaluation of renal function and to evaluate whether treatment reduces cardiac mortality, cardiac events and Global mortality, if it interferes with oxidative stress and inflammation and the need for dialysis.

Renal failure is a serious and relatively frequent complication of cardiac surgery was observed, especially in diabetics and those with pre-existing renal dysfunction. Given that oxidative stress is elevated in diabetics and in renal and heart, it is reasonable to speculate on its involvement in the pathophysiology of this complication. It is unknown whether the incidence of postoperative renal failure can be reduced by antioxidants. N-acetylcysteine (NAC) is an antioxidant that prevents nephropathy induced by contrast medium and aminoglycosides and increases intracellular levels of cyclic guanosine monophosphate, acting as a vasodilator and platelet inhibitor.

Based on a knowledge of the pathophysiology of ARF, several interventions have been attempted over the past decades. However, various measures employed successfully in the prevention of experimental ARF did not result in success in clinical practice. Much of this failure is probably due to the difference between the experimental models of ARF that encountered in the clinic. Other factors that should be considered, and that may explain the poor results in clinical trials are: the time of use of the drug, dosage and route of administration, are not always adequate.

From the data in the literature, it remains doubtful whether the protective role of NAC is limited only to contrast nephropathy or whether it could have application in other clinical situations in which oxidative stress and vasoconstriction are determinants of injury, as occurs, for example, in CABG surgeries.

NAC is a drug of low cost and low toxicity, this paper intend to assess its role as prophylaxis of renal dysfunction in the postoperative period of CABG in patients with chronic kidney disease stages 3 and 4 (GFR between 15 and 59 mL/min/1, 73 m2 of body surface).

Eligibility Criteria:
Inclusion Criteria:

* adult patients aged 30 to 80 years old of both sexes
* indicated for elective CABG
* with glomerular filtration rate, assessed with the MDRD \<60 mL/min/1, 73 m2 and\> 15 mL / min / 1.73 m2 body surface

Exclusion Criteria:

* patients on chronic dialysis or with creatinine\> 5 mg / dL preoperatively; individuals allergic or intolerant to N-acetylcysteine
* pregnant women
* patients with cancer
* patients underwent re-surgery within the first 72 hours postoperatively
Effectiveness of Qualia NAD+ Supplementation on NAD Levels

The current study is designed as a randomized double-blind placebo-controlled parallel trial. It aims to investigate the efficacy of Qualia NAD+ on intracellular NAD levels in blood samples (primary outcomes) and health-related quality of life (secondary outcomes) in an adult population experiencing moderate to severe joint pain between ages of 40 and 65 years.


Eligibility Criteria:
Inclusion criteria:

Provide voluntary, written, informed consent to participate in the study Agree to provide a valid cell phone number and are willing to receive communications through text.

Healthy male and female participants between the ages of 40-65 years of age. Willingness to complete questionnaires, records, and diaries associated with the study.

Willing to not consume any supplements, energy drinks/shots, or other products containing any form of supplemental vitamin B3 (e.g., niacin, niacinamide, nicotinamide ribosome, NMN) starting about 2 weeks prior to the baseline NAD fingerstick test and continuing through the intervention period.

Willing to not begin taking any new supplements during the study period, and to continue taking any supplements they are currently using regularly (with the exception of vitamin B3 containing supplements).

Willing to self-administer the intracellular NAD fingerstick test kit at home for both a baseline and post-intervention blood sample, and to complete a release form that gives NHC access to the results of these tests.

Exclusion criteria:

Women who are pregnant, breastfeeding, or planning to become pregnant during the trial Known food intolerances/allergy to any ingredients in the product Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer Having had a significant cardiovascular event in the past 6 months Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines On immunosuppressive therapy Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent
A Study to Learn About Abrocitinib in Adult Patients With Moderate to Severe Atopic Dermatitis.

The purpose of this study is to learn about the safety and effects of Abrocitinib in the real-life clinical setting given for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis, or AD, is a long-lasting disease that causes inflammation, redness, and irritation of the skin.

This study is seeking participant who are older than 18 years with moderate-to-severe chronic AD. Participants must have no underlying medical conditions that prevent them from taking Abrocitinib.

All participants in this study will receive Abrocitinib as a tablet once daily. They can take Abrocitinib and use medicated topical treatment for AD at the same time.

We will examine the experiences of patients receiving the study medicine. This will help us determine if the study medicine is safe and helps in treating AD.

Participants will take part in this study for 24 months. During this time, they will visit the study clinic about 5 times (about 1 time every 4 to 6 months).


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age at inclusion.
* Patients with clinical diagnosis of moderate-to-severe chronic atopic dermatitis (also referred to as atopic eczema) at inclusion according to the investigator and eligible for abrocitinib according to its marketing approval.
* Patients that have been informed of the study procedures and have signed the consent.

Exclusion Criteria:

* Patients for whom abrocitinib is contraindicated.
* Patients unable to follow and respect the study procedures and judged inapt to respond to the questions required for the study due to linguistical, psychological, social, or geographical reasons.
* Patients not affiliated to the French social security system.
* Patients deprived of liberty, under guardianship, or unable to provide oral consent.
* Patients participating in a clinical study assessing a medicinal treatment (patients can participate in registries and observatories).
Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age

This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra).

A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5.

All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female 18 through 85 years of age, both inclusive, at the time of study vaccine administration.
2. Provide written informed consent.
3. The subject is resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
4. Healthy, as determined by medical history and clinical assessment of the investigator.
5. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.

Exclusion Criteria:

1. Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject will be re-revaluated for eligibility).
2. History of any meningococcal vaccine administration.
3. Current or previous, confirmed or suspected disease caused by N. meningitidis.
4. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to vaccination.
5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
Effect of Acupuncture on Quiescent Crohn's Disease

To observe the clinical effect of acupuncture on quiescent Crohn's disease

To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease

Eligibility Criteria:
Inclusion Criteria:

1. aged 16-70;
2. Patients with disease in remission: CDAI \<150 and at least one of the following: serum C-reactive protein \<5mg/L, fecal calprotectin \<50μg/g or no ulcers on endoscopy;
3. Patients with more than 2 disease relapses in the past year;
4. patients were not taking medication or were only taking one or more of the following drugs: \[prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)\] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
5. those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
6. those who have never experienced acupuncture;
7. patients signing informed consent.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;
2. patients with serious organic diseases;
3. patients diagnosed as psychosis;
4. patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Weight Loss Effect of Akkermansia Muciniphila in Obese Patients

This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.


Eligibility Criteria:
Inclusion Criteria:

-

1) Age 18-65 years old; 2）28≤BMI≤35Kg/m2； 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss

Exclusion Criteria:

1. Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;
2. Oral antibiotics in the past 1 month prior to enrollment;
3. No use of probiotic prebiotic products before 3 weeks of intervention;
4. people without a fitness fat loss program or history of gastric surgery during the intervention period;
5. Patients with severe gastrointestinal diseases;
6. Those who are known to be allergic to synbiotics or similar products;
7. Patients with no self-awareness and those with mental abnormalities;
8. Have a history of organ transplantation or malignant tumor disease;
9. Concurrent use of other experimental drugs or in other clinical trials;
10. Have a history of alcohol, tobacco and other drug abuse;
11. Those who are expected to be unable to complete the magnetic resonance examination;
12. Combined with serious medical diseases or conditions: such as clinically serious (i.e., active) cardiac disease, severe, uncontrolled medical diseases and infections, severe uncontrollable digestive disorders, severe electrolyte disorders, active disseminated intravascular coagulation, major organ failure, such as decompensated heart, pulmonary, hepatic, renal failure, peripheral neuropathy symptoms, etc.
Study to Determine the Safety, Tolerability, and Pharmacokinetic (PK) Profile of EGT0001474 in Healthy Volunteers

This study evaluated the safety, tolerability and pharmacokinetics of single or multiple doses of EGT0001474.

EGT0001474 is an inhibitor of human sodium dependent glucose co-transporter II being developed for the treatment of Type II Diabetes mellitus.

This is a singe center, Phase-1, double blinded,placebo controlled, dose escalation study of single and multiple ascending doses of EGT0001474 in healthy male and female subjects.

In part-1, subjects were randomized to receive single doses of EGT0001474 at 2.5-150 mg or placebo in the ratio of 3:1. In part-2, subjects were randomized to receive 14 daily doses of EGT0001474 at 10, 50 and 150 mg or placebo in the ratio of 4:1. When the various doses were analysed, the maximum dose 150 mg was found to be tolerable. Although there was no serious adverse events, mild adverse events were observed.

This study provided information on human safety, tolerability, PK and pharmacodynamic effects of EGT0001474.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers between the ages of 18 and 55 years inclusive.
* In good health.
* Female subjects must be surgically sterilized or postmenopausal.
* Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 inclusive.
* Non-smoker.
* Negative drug and alcohol screens.

Exclusion Criteria:

* Abnormal ECG
* Sitting blood pressure above 140/90 mmHg on 2 evaluations at least 10 minutes apart at screening
* Treatment with an investigational drug within 30 days or 7 half-lives, whichever is longer.
* Previous treatment with EGT0001474.
* History of drug abuse.
* Febrile illness within 5 days prior to the first dose of study medication.
Groin Wound Infection Rate Using Prevena Compared to Standard Dressing in Vascular Surgery Patients With High Risk

Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.

Patients submitted to bilateral femoral endarterectomy will have one groin dressed with PrevenaTM and the contralateral one dressed with conventional bandage immediately after suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed before the patient discharge. Groin wound complications such as deep space infection, cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be observed in a 30-day evaluation window. This observation will be performed during the patient admission and in the post-operative standard of care visits among the first 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known bilateral vascular peripheral disease who are being evaluated for possible bilateral femoral endarterectomy
* Patients with one or more risk factor (diabetes mellitus, Obesity, heavy smoker, immunodeficiency disease, groin reoperation, prosthetic)
* Patients in follow-up at Clinic in the Vascular Surgery Department
* Sign of informed consent
* English speaking

Exclusion Criteria:

* Refusal to participate
* pregnancy
* unilateral femoral endarterectomy
* subjects for whom Prevena IMS is contraindicated
A Study to Describe Vascular and Renal Effects and Safety of Valsartan in Patients With High Blood Pressure

One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.


Eligibility Criteria:
Inclusion Criteria:

* Arterial hypertension without previous regular treatment
* Urinary albumin excretion rate above 30 mg / 24h
* 30-65 years old

Exclusion Criteria:

* Reno-vascular arterial hypertension
* Therapy resistant edema
* Chronic heart failure, angina pectoris
* Diabetes mellitus

Other protocol-defined exclusion criteria may apply
Prevelance of Molar Incisor Hypomineralization Among a Group of Egyptian Children

The purpose of this study is to find out the prevalence of molar incisor hypomineralization among a group of Egyptian children

Molar incisor hypomineralization is frequent in many population throughout the world and a wide variation of molar incisior hypomineralization 2.4_40% has been reported.To the best of our knowledge,there is no Sufficient information regarding the prevalence of molar incisor hypomineralization in Egyptian children therefore the aim of this study is to assess the prevalence of molar incisor hypomineralization among a group of Egyptian children.

Eligibility Criteria:
Inclusion Criteria:

- Patient seeks dental care in paediatric dentistry and dental public health department in Cairo university

* positive patient acceptance for participation in the study
* children with at least one of four permanent molars erupted or partially erupted

Exclusion Criteria:

* uncooperative children

  * children with appliance
  * children with systemic diseases
Effect of Aging on Postural Stability

Postural control of human body is a complex process involving visual , vestibular, somatosensory system and their central processing , add the vestibular system through its multiple connection coordinates movements of the head with movement of the eyes (to maintain clear vision ), trunk , and limbs (to maintain cephalic and postural stability ) via vestibulo-ocular and vestibulo-spinal reflexes respectively Global postural control shows alterations with aging increasing the chance of falls in the population aged 60 years or older, In older adults, poor postural balance can indicate an impaired ability to recover from small postural perturbations and be predictive of future falls


Eligibility Criteria:
Inclusion Criteria:

* Age: from 60 years to 80 years old.
* Sex: males and females
* All subject had no audio vestibular disease's.
* No evidence of cognitive dysfunction.
* No evidence of musculo-skeletal abnormalities.
* No motion intolerance.
* No history of any disease required to give treatment that could affect results

Exclusion Criteria:

* Old age person with cognitive dysfunction.
* Old age person with musculo-skeletal disorder.
* Adult person below age 60 years old.
* Old age person with neurological disease, motion intolerance, visual disorder, diabetes mellitus and hypertension.
Resiliency Training on the College Campus

This is a waitlist controlled study examining the initial efficacy of Resilience Training among college students at an elevated risk for a severe mental illness.


Eligibility Criteria:
Inclusion Criteria:

1. 18-30 years old
2. Enrolled in undergraduate program at the college or university where the intervention takes place
3. Students who endorse delusion-like experiences (DLEs): Peter's et al. Delusion Inventory (PDI) score \> 4 and/or
4. Students with mild to moderate depressive symptoms: Beck Depression Inventory (BDI) score ≥ 6

Exclusion Criteria:

1. Inability to provide informed consent
2. Not proficient in English
3. Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization
4. Current enrollment in psychological or behavioral health treatment.
5. Current use of psychotropic medications (other than stimulants) prescribed by a physician.
Older Person's Exercise and Nutrition Study

The novelty with the OPEN study is to evaluate the effects of the simple sit-to-stand exercise during routine care, in combination with an oral protein-rich supplement, on functional status and independence in frail older persons. In this study we will also explore the experiences among older persons in the intervention group as wells as among staff of promoting the sit-to-stand exercise and nutritional supplement to gain knowledge for implementation as a daily routine in nursing homes across Sweden.

Hypothesis The main hypothesis of the OPEN study is that physical exercise performed as a daily routine along with an oral protein-rich supplement, will result in improved functional status and independence in everyday life activities and thereby enhance health-related quality of life in older persons living in nursing homes. The primary outcome measure for functional status will be the number of sit-to-stands that the participant is able to complete in 30 seconds.

Specific aims Aim I: To study the effects of the sit-to-stand exercise combined with an oral protein-rich supplement on functional and nutritional status, and health-related quality of life, and the frequency and incidence of falls, pressure ulcers and incontinence in older persons living in nursing homes. Furthermore, the cost effectiveness of the combination of the sit to stand exercise and oral protein-rich supplement vs. the control group will also be examined.

Aim II: To describe the older persons' perceptions of daily being offered to conduct the sit-to-stand exercise and to drink the nutritional supplement.

Aim III: To describe staff's perceptions of supporting the sit-to-stand exercise and the nutritional supplement with older persons living in nursing homes.


Eligibility Criteria:
Inclusion Criteria:

* Able to rise independently from a seated position to standing-

Exclusion Criteria:

* BMI \>30
* severe dysphagia,
* tube feeding,
* severe kidney failure,
* bedridden people,
* terminal stage of life
* Lack of informed consent.