cyrilzakka/clinical-trials huggingface dataset:
IV Administration of ChromaDex's Niagen® as Compared to NAD+

This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV.

The purpose of this work is to establish and quantify the safety and efficacy of IV administration of ChromaDex's Niagen®, nicotinamide riboside chloride in comparison to currently available IV NAD+, a saline IV, and orally administered Niagen®

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness and demonstrated ability to comply with all study procedures, as well as availability for the duration of the study
* Lives within 100 miles of a NRI study site
* Any gender, aged 40+ (For the 5th arm, only males will be evaluated.)
* Good general health as evidenced by medical history
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of the study
* Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

* Current diagnosis of any seizure disorder, diabetes or insulin resistance, any kidney or liver disorder, heart disease, cancer, or Parkinson's disease,
* Pregnancy, trying to conceive, or breastfeeding
* Known allergic reactions to any components of the intervention
* Positive COVID-19 test within 30 days of the study period
* Recent dramatic weight changes (10% change in body weight in the last 6 months)
* Existing usage of a NAD+ or NAD precursor supplement in any form.
* Introducing a new investigational drug or other intervention within 30 days before the start of the study
Hypofractionated Radiation Therapy in Patients With Breast Cancer

The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast cancer patients for the last 4 decades. It is also a routine practice in UK and few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation help the radiation centers worldwide to meet the growing need for radiation in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study the investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will include 1000 patients, 500 in each arm, with breast cancer post mastectomy or after breast conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2 weeks in the study arm and 35Gy in 15 fractions over 3 weeks in the control arm. The primary endpoint of the study will be ipsilateral local tumour control. Secondary endpoints will be early and late adverse effects in normal tissues, quality of life, contralateral primary tumours, regional and distant metastases and survival.

Patients to be included in this study will be pre-operatively staged according to American Joint Committee on Cancer (AJCC) 7th edition, International Union against cancer ( which uses TNM staging ) as stage I-III of breast carcinoma. Total 500 patients of histologically proven post lumpectomy/mastectomy cases of carcinoma breast suitable for radiotherapy will be enrolled in this study. Patients would be evaluated at the Department of Radiotherapy PGIMER, Chandigarh by doing a thorough clinical examination followed by routine investigations which will include hemogram, liver function tests, kidney function tests, chest X-ray. Patients will be treated by standard rectangular tangential fields.

Eligibility Criteria:
Inclusion Criteria:

* Invasive carcinoma of the breast
* Breast conservation surgery or mastectomy
* Axillary staging \&/or dissection
* Complete microscopic excision of primary tumour
* pT1-3 pN0-2 M0 disease
* Written informed consent
* Able to comply with follow up

Exclusion Criteria:

* Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
* Contralateral breast cancer, including DCIS, irrespective of date of diagnosis
* Breast reconstruction using implants
* Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
Benefits of GIK in Cardiac Surgery Patients

The purpose of this study is to evaluate the effects of modified glucose - insulin - potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).

Cardiopulmonary bypass (CPB) is a necessary technique to maintain the circulation during cardiac surgery. But CPB itself is associated with a series of problems of organs, such as hyperglycemia induced by neuroendocrine stress. The research showed that hyperglycemia induced by stress would cause a worsened hospital outcome for patients undergoing cardiac surgery. Intraoperative and postoperative glucose control is beneficial for patients.

It has been for more than 40 year since the first application of glucose - insulin - potassium (GIK) in cardiac surgery but the clinical application of GIK shows controversial results. The beginning time of application and the ratio of glucose and insulin may be the key reasons for the controversy. In our pilot trial of 40 valve replacement cases, we found that perioperative treatment of GIK with an insulin-glucose ratio of 1:3 showed beneficial effects during heart surgery. Therefore, the investigators are planning to continue to test this modified GIK regimen for more heart surgery patients and determine whether GIK may have cardioprotective effects on patients undergoing CPB surgery.

Myocardial biopsies for biological mechanism analysis will be performed prior to CPB, 15 min after aortic cross clamp application and 15 min after reperfusion only in a small cohort. Myocardial biopsies will be snap frozen or fixed.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 70 years of age
* Elective cardiac surgery with first time cardiopulmonary bypass
* Left ventricular ejection fraction(LVEF) ≥ 30%
* Informed agreement signed

Exclusion Criteria:

* Previous cardiac surgery
* Emergent surgery
* Cardiac surgery without the use of cardiopulmonary bypass
* Diabetes mellitus
* Severe renal insufficiency
* Severe respiratory insufficiency
* Serious preoperative illness (sepsis, active infection or active malignancy requiring treatment)
* Pregnant woman or positive pregnancy test
* History of drug abuse
* Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
* Enrollment in another clinical study
* Lack of informed consent
Screening Anal HPV Colonization in Men Sex Men Using Pre-exposure Prophylaxis for HIV (ANAPreP'HPV)

This is an interventional study investigating HPV carriage and liquid-based cytology at anal level. It will be offered to all patients undergoing PreP consultations at Besançon University Hospital. The anal swab will be taken by the doctor using a cyto-brush during the consultation.

The duration of participation in the study is 3 months for the submission of the results of the samples. A medical proctology consultation may also be offered, depending on the results of the screening.

This will be carried out in addition to the anal swabs taken quarterly to screen for other sexually transmitted infections.

A questionnaire will be completed by the doctor to record the data of interest. From additional data already entered in the e-NADIS software will be included for study.

Eligibility Criteria:
Inclusion Criteria:

Men sex Men Using Pre-exposure Prophylaxis for HIV Follow up au CHU de Besançon.

Exclusion Criteria:

* Women
* No MSM
* Under 18
* History of HPV related cancer
Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children

Following the rapid development of significant drug resistance to both chloroquine and sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that this drug has been widely used for some time, the investigators propose to conduct an antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if this drug remains efficacious, or if significant resistance has emerged, in which case a new antimalarial strategy will need to be contemplated. The investigators hypothesize that the efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination therapies will be equally efficacious.

Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine (Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6-59 months
2. Axillary temperature ≥ 37.5º C or history of fever in the past 48 hours
3. Weight ≥ 5.0 kg
4. Slide-confirmed infection with P. falciparum, with parasitemia 2,000-200,000 asexual forms per μl
5. Live within the boundaries of the officially recognized catchment area of Miono Health Center.
6. Caregiver agrees to all blood draws and return visits.

Exclusion Criteria:

1. General danger signs or symptoms of severe malaria
2. Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean (National Center for Health Statistics \[NCHS\]/World Health Organization \[WHO\] normalized reference values)
3. Slide confirmed infection with any other Plasmodium spp. besides falciparum or mixed plasmodium infection
4. Severe anemia, defined as Hb \< 5 g/dl
5. Known hypersensitivity to any of the drugs being tested
6. Presence of febrile conditions caused by diseases other than malaria
7. Serious or chronic medical condition (heart failure, sickle cell disease).
8. Plan to travel or leave the area within the next 3 months.
9. Have been treated for malaria in the 2 weeks prior to enrollment.
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function

The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)
* Stable guideline directed therapy for heart failure including oral diuretics, ACEi, ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these medications in the past 2 weeks
* Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10 pmol/L)

Exclusion Criteria:

* Systolic blood pressure (SBP) \< 110 mm Hg at screening or pre-randomization
* Heart rate \< 50 beats per minute (bpm) or \> 90 bpm at screening or pre-randomization
* Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter
* Estimated glomerular filtration rate (eGFR) \< 15 ml/min/1.73 m2
* Ventricular assist device or prior heart transplant
* Prior solid organ transplant
* Body weight \< 45 kg or ≥ 140 kg
* Low quality echocardiographic visualization windows and image acquisition
* Permanent paced rhythm (VVI, DDD or BiV pacing)

Other protocol defined inclusion/exclusion criteria could apply
UVB Model Validation Study

Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.

Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.

Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema doses (MEDs). Read out to determine MED will be done within 24 h after UVR.

A training session (without study medication) using the MED definition areas will be performed in order to introduce subjects to the testing and rating procedures.

Subjects will come in within 14 days of screening to start the first Segment of the study. Eligible subjects will be randomised to receive either:

1. IB 600 mg, applied orally b.i.d., or
2. OP, applied orally b.i.d.

Allocation of topical treatment to these areas will be randomly assigned to:

1. PG, 15 μl/cm2 applied topically b.i.d., or
2. HC, 15 μl/cm2 applied topically b.i.d.

Defined areas will be irradiated with defined dosages of UVR. Assessment of hyperalgesia to heat and signs of inflammation (erythema, skin temperature) for all areas will be performed.

Subjects return within 4 to 11 days to the study site for the second segment of the study. Treatment allocation will be crossed-over and new treatment areas will be selected on the back.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

-
Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.


Eligibility Criteria:
Inclusion Criteria: - Male, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive). - Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: - Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening. - Use of tobacco and nicotine products, defined as any of the below: a) Smoking more than 5 cigarettes or the equivalent per day. b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s). - History\* of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. - Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma\*. - History\* or presence of pancreatitis (acute or chronic). \*As declared by subject.
Evaluation of the Vulnerable Carotid Atherosclerotic Plaque: A Clinical Multicenter Study

Evaluation of carotid plaque vulnerability based on ultrasound imaging features， proteomics and metabolomics: a clinical multicenter study

Carotid artery plaque tissue specimen for proteomics. Blood were collect for metabolomics.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the CEA surgical indications;
2. Age\>18 years old;
3. Patients who sign informed consent forms

Exclusion Criteria:

1. Those with severe calcification of plaques and obvious acoustic shadows, and poor image quality;
2. Contraindications to ultrasound contrast, such as those who are allergic to contrast agents;
3. Intracardiac right to left shunt;
Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin

The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.

A prospective, randomized, double-blinded crossover trial comparing topical diclofenac and placebo for 10 weeks in the treatment of 30 women with noncyclic mastalgia and surgical scar-related breast pain.

Eligibility Criteria:
Inclusion criteria

* Noncyclic mastalgia or surgical scar-related pain occurring at least 2 days per week and for which the patient desires treatment
* Duration of pain \> 2 months (noncyclic mastalgia) or \> 4 months (surgical scar-related pain)
* Age \> 18 years
* Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
* Satisfactory mammogram (all women \> 30 years of age) within 12 months
* Negative pregnancy test (all women who are premenopausal and have not had hysterectomy or tubal ligation)

Exclusion criteria

* Cyclic mastalgia (as defined above)
* Duration of pain \> 2 months (noncyclic mastalgia) or \> 4 months (surgical scar-related pain)
* Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
* Known pregnancy, lactation, positive pregnancy test, or anticipated pregnancy within 6 months
* Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
* Allergy, to diclofenac or any nonsteroidal antiinflammatory agents
* Rash or open lesions at the site on the breast where the topical agent would be applied
* Incomplete or abnormal healing (surgical scar-related pain)
* History of gastrointestinal ulceration, renal dysfunction (creatinine \> 1.5), hepatic disease (known liver disease or aspartate aminotransferase (AST) twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure \> 140/90)
Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation

Stunting and anemia amongst under-two children are attributable to poor nutrient intakes. The study evaluates the effectiveness of nutrition education on local specific food-based complementary feeding recommendation (CFR) to improve dietary patterns and nutritional intakes, as well as reduce stunting and anemia among under-two children.


Eligibility Criteria:
Inclusion Criteria:

* 6-11 months old at baseline
* living in selected area during the study
* apparently healthy
* willing to take part in the study and taken venous blood sample by getting signed consent from parents

Exclusion Criteria:

* the child does not present during venous blood sample collection
Benefits of Post-Pyloric Feeding Tubes in Critically Ill Patients

The purpose of this study is to determine the benefit of feeding critically-ill patients beyond the stomach (post-pyloric). Furthermore, because of the advent of two new post-pyloric feeding tubes (Tiger 2 and Syncro BlueTube) designed to improve post-pyloric placement, the investigators will be evaluating the benefits of those two tubes as well.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the ICU who are deemed by the attending critical care physician to warrant tube feeds and expected to receive tube feeds for more than three days
Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .

In this prospective observational study among sickle cell children aged 7 to 17 years, who face many experience of pain, pain will be assessed during incentive spirometry sessions. Then a relation between, inspiratory volume, pain and the length of hospital stay will be identified .

Currently, there is no scientific data regarding the correlation between acute pain during vaso-occlusive crisis, incentive spirometry and the impact on length of hospital stay. In fact, physiotherapist experience's in the pediatric department suggests that the pain expressed by the child is not always correlated with inspiratory capacity.

The absence of pain is one of the reasons for hospital discharge after decompensation in patients with sickle cell disease. However, no scientific study has linked incentive spirometry, pain and length of hospital stay.

Investigator assume that these children underestimate the real pain and its impact on breathing pattern, and presume that the maximal inspiratory volume during spirometry sessions will be a better reflect of pain than standard pain scale.

The aim of this study is to show that inspiratory volume would be a better indicator of discharge from hospitalization than actual pain scales.


Eligibility Criteria:
Inclusion Criteria:

* Sickle cell children aged 7 to 17 admitted to the pediatric ward
* Children receiving respiratory physiotherapy sessions under medical prescription
* Children hospitalized for more than 24 hours at the CHRO and benefiting from more than one physiotherapy session.
* Absence of opposition of one of the parents to the participation of their child in the study
* Absence of opposition of children able to understand the study

Non inclusion Criteria:

* Sickle cell children under the age of 7 or over 17
* Children with mental deficits
* Non-French-speaking parents
* Children receiving only one physiotherapy session and being hospitalized within 24 hours