cyrilzakka/clinical-trials huggingface dataset:
COMorbidities and EDucation in SPondyloArthritis Study

Giving both the gap existing between the current recommendations to prevent/detect comorbidities and the clinical practice in patients suffering from spondyloarthritis and also the specificity of some recommendations to rheumatic diseases, it seems logical to check these recommendations in a rheumatologic "environment".

This study with its two parts should be able to demonstrate:

* The importance of a systematic evaluation of comorbidities in Spondyloarthritis,
* The utility of a nurse-led program of self-assessment and self-management of the disease

Patients with spondyloarthritis will be invited by their rheumatologists to participate at this study in 21 centers in France.

500 patients are planned to be included.

After written informed consent will be obtained, the patients will be randomized in two arms:

* comorbidities
* self-assessment/self-management The patients will be seen again in the same center 12 months later in order to collect the outcome measures

The two primary objectives of this trial are :

* To evaluate the impact of a nurse led program of self-assessment of disease activity/severity and self-management on the level of satisfaction/coping
* To evaluate the impact of a nurse led program of assessment of comorbidities on the management of such comorbidities

The Secondary objectives are:

* To evaluate the prevalence of comorbidities in SpA;
* To evaluate the level of adherence to recommendations of prevention of comorbidities;
* To evaluate the impact of the nurse led program of self-assessment / self-management on the amount of NSAID (Non-steroidal Anti-Inflammatory Drugs) intake and the level of disability (e.g. functional disability)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female over 18 and under 80 years
2. Axial Spondyloarthritis according to the ASAS criteria (Assessment of SpondyloArthritis international Society)
3. Disease duration of at least one year
4. Activity of SpA to be stable according to the treating rheumatologist for at least three months before the date of inclusion
5. Lack of elective surgery during the 6 months after inclusion
6. Able to understand and adhere to the study treatments
7. Development of a medical examination results given to the patient
8. Informed Consent signed and dated

Exclusion Criteria:

1. Pregnant women (any method of contraception will be accepted)
2. Patients who have had a change in the treatment of SpA during the 3 months prior to inclusion
3. History of alcoholism, drug addiction, psychological problems, severe comorbidities that could possibly invalidate informed consent or limit patient compliance with the study protocol
4. No affiliation to a social security regime

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Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients

Celiac disease (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. This eviction generates many daily constraints that would explain that more than 50% of patients do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study is to develop an innovative nutritional approach in the form of a dietary supplement to improve quality of life of patients. The product is not intended to replace a strict gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to improve quality of life of patients. The expected benefits for people consuming the test product are an overall improvement in quality of life and an improvement in biological markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.


Eligibility Criteria:
Inclusion Criteria:

* celiac disease diagnosis at least 1 year ago
* diagnosis proven through biopsy report or general practioner letter or health insurance cover
* not following a strict gluten free diet (Pavie score 1-3)
* covered by health insurance
* not in exclusion period from another study

Exclusion Criteria:

* pregnant, breastfeeding women or planing pregnancy
* gluten intolerance of non celiac origin or any other dietary intolerance of allergy
* digestive pathology other than celiac disease
* chronic transit problems (diarrhoea or constipation)
* uncontrolled pathology
* diabetes
* medical treatment impacting outcome markers (corticosteroids, NSAIDS, immune suppressor drugs, pancreatic enzymes, amphetamines)
* recent or regular intake of prebiotics, probiotics, food supplements including B vitamins, iron or calcium.
* antibiotics in the past month
* excessive alcohol intake
* drug user
* planing to change tobacco use
* any other reason why the investigator feels the subject may not be compliant
* adults under judicial protection
CGM Use in COVID19 Patients (Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2))

The purpose of this research is to determine if CGM (continuous glucose monitors) used in the hospital in patients with COVID-19 and diabetes treated with insulin will be as accurate as point of care (POC) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.

Study participation involves placement of a continuous glucose monitor (CGM) on the abdomen of hospitalized patients who have a diagnosis of COVID19. The CGM will measure glucose levels every 5 minutes which will be accessible for viewing using a receiver phone placed outside the patient's room and/or an iPad located at the nursing station.

Alarm limits for hypoglycemia and hyperglycemia will be set on the receiver phone for nursing staff to review. These alarms settings will vary depending on whether the patient is on IV insulin infusion vs. subcutaneous (SQ) insulin. The number of glucose checks required with these two types of insulin varies significantly and requires separate handling.

Hospital glucometers will be used to confirm the accuracy of CGM readings during an initial "Adjustment Phase" of the study. If CGMs are found to be accurate, then finger-stick glucometer check frequency will be decreased, and some of the CGM values will be used to dose insulin therapy during the "Utilization Phase" of the study. The instructions for these phases will differ for patients on IV insulin infusion vs. SQ insulin infusion and are detailed in separate protocols. Nursing staff will choose the appropriate protocol at the time of CGM placement based on the type of insulin the patient is receiving.

Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. At the time of discharge, patients will receive a survey regarding satisfaction with the use of CGM monitors to manage their diabetes during their inpatient stay.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older.
* Patients with diagnosis of COVID-19 respiratory infection.
* Patient with recent positive SARS-COV2 infection and still positive polymerase chain reaction (PCR) admitted of non-respiratory diagnoses.
* Diagnosis of diabetes mellitus type 1 or type 2.
* Diagnosis of medication (steroid) induced hyperglycemia (persistent glucose more than 180 mg/dl).
* Taking insulin either SQ or IV.

Exclusion Criteria:

* Patient in shock.
* Patient intubated on mechanical ventilation.
* Patient placed on Extracorporeal membrane oxygenation (ECMO).
* Patient taking hydroxyurea.
* Patient taking more than 4g of acetaminophen in 24 hours or more than 1g acetaminophen in 6 hours.
* Pregnant or nursing female patients.
* Patients with skin lesions at the application site that may interfere with placement of the sensor.
* Patients with known allergy to medical grade adhesive.
A Study to Evaluate Ethanol-induced Symptoms and Safety in Breast Cancer Patients

The purpose of this study is to evaluate ethanol-induced symptoms and safety in breast cancer patients with neoadjuvant/adjuvant chemotherapy including Non-ethanol formulation docetaxel before and after surgery


Eligibility Criteria:
Inclusion Criteria:

* Those who voluntarily signed a written personal information collection and usage agreement after receiving an explanation about the objective and method, etc. of this clinical study.
* Those are confirmed to have primary breast cancers through histological diagnosis and one of the following are applicable.

  * Those who need neoadjuvant chemotherapy as breast cancer patients
  * Those who need adjuvant chemotherapy after breast cancer surgery
* Those who are scheduled to administer non-ethanol formulation docetaxel according to chemotherapy
* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria:

* Those are diagnosed with other primary cancer that can influence the treatment or prognosis of primary breast cancers.
* Those are diagnosed with secondary breast cancers.
* Those with Stage 0/1 (Tis, N0, M0) or Stage IV (any T, Any N, M1) breast cancers.
Supplementation of Galatonol 300 mg / Striatin 30 mg in Postpartum Lactating Mothers

This is a randomized, double-blind, and placebo-controlled study involving mothers as the participant and participant's babies evaluating the effect of a 15-day-supplementation with a product containing extracts derived from a combination of herbal plants (katuk \& torbangun leaves) and snakehead fish in stimulating breast milk production.

The study product is a herbal product containing 300 mg Galatonol bioactive fraction, enriched with 30 mg Striatin bioactive fraction. This lactation supplement has been granted the marketing authorization from Badan Pengawas Obat dan Makanan Republik Indonesia (BPOM RI) as traditional medicine with the indication to enhance breast milk production.

A total of 160 subjects (80 subjects in each group) who have just partus, are planned to participate in this study. Eligible subjects will be allocated in a random and blinded fashion to receive one of the two products (study product or placebo) and to come for follow-up visits at Day 4, 8 and 15 (End of Study).

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to participation in the study.
2. Generally healthy women aged \>= 18-35 years.
3. Having a full-term gestational age (37- 40 weeks, inclusive).
4. The infant to breastfed: having normal birth body weight (2500-4000 gr).
5. Giving consent and commitment to pursue an exclusive breastfeeding
6. Willing to comply with the study protocol.
7. Spontaneous delivery.
8. Healthy newborn baby

Exclusion Criteria:

1. Difficult breastfeeding due to organic defect;
2. Suspected COVID-19 by clinical symptoms.
3. LATCH Score \< 4;
4. Choosing not to breastfeed due to other subjective or objective reasons;
5. Having multiple birth;
6. Known major medical complications during delivery;
7. Known to have breast diseases, such as: mastitis, or malignancies
8. Breastfeeding prohibited due to clindamycin injection within the past week.
9. History of smoking, alcohol drinking, or any drug abuse
10. Known to have any relevant chronic infections or illness and gestational diabetes;
11. Known to have disorders of major organs ;
12. Taking any medication or supplementation known to have galactagogue properties within the last trimester of pregnancy;
13. Taking any non-pharmacological complementary treatment within the last trimester of pregnancy aiming to affect breast milk production.
14. Participation in any other interventional clinical studies within 30 days prior to Screening.
Comparison Between Efficacy of Topical Sildenafil 2% and Topical Minoxidil 5% in Treatment of Androgenic Alopecia

Androgenetic alopecia (AGA) is hair loss with specific clinical pattern, It Is characterized by follicular miniaturization, which occurs due to systemic androgens and genetic factors. Prevalence differs according to ethnic groups. It is more common and more severe in white men than in Asian and black men. The incidence increases with age. According to Hamilton's study, the prevalence is 30% in men at the age of 30, and 50% in the age of 50. Generally, the age of onset is the 3rd and 4th decade.

Androgenetic alopecia may affect self-esteem and quality of life in several affected individuals. There are two FDA-approved drugs for pattern baldness: topical minoxidil and finasteride, both of which require at least a 4- to 6-month trial before noticing improvement and must be used indefinitely to maintain a response. As such, medication adherence often can be poor. Furthermore, initiation of the drug may cause an initial shedding phase.

Minoxidil was the first and, so far, the only topical product that has been FDA approved for the treatment of AGA. Minoxidil was originally developed as an oral medication for hypertension. Hypertrichosis was found in 24-100 % of patients treated with oral minoxidil, which led to the treatment of AGA with topical minoxidil.

Androgenic Alopecia is caused by the overproduction of 5αdihydrotestosterone (5α-DHT), a potent androgen within the hair follicle, specifically the dermal papilla (DP) cells that are the main regulators of hair growth and are the only site of 5α-DHT action.

Sildenafil is a selective inhibitor of phosphodiesterase 5 and was originally developed as an anti-anginal drug due to its vasodilatory and antiplatelet coagulation properties. Sildenafil enhances the proliferation of human dermal papilla cells and up-regulates the mRNA expression of vascular endothelial growth factor and platelet-derived growth factor (PDGF) which are responsible for hair growth.

Topical sildenafil 1% has been used in the treatment of male androgenic alopecia.

Eligibility Criteria:
Inclusion Criteria:

* Subjects clinically and dermoscopic diagnosed with AGA.
* Age ranges from 18 to 45 years old.
* Males
* Willingness to provide pictures and follow-up studies.

Exclusion Criteria:

* Patients who received any topical or systemic treatment for AGA during the last 6 months,
* Patients who had other types of alopecia such as alopecia areata, alopecia totalis, telogen effluvium, anagen effluvium, and acquired cicatricial alopecia.
* Patients with anemia, thyroid disease, and vitamin D deficiency,
* Any autoimmune disease or chronic debilitating disease (chronic renal failure, congestive heart failure, hepatic patients, cancer patients).
An Evaluation of an Online Sexual Assault Resistance Program (IDEA3)

The goal of this randomized trial is to test whether the Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) sexual assault resistance education intervention reduces sexual violence victimization in undergraduate women.

Participants in the intervention group will be asked to attend four three-hour group sessions of a sexual assault resistance program called IDEA3 with a partner, as well as fill out a number of surveys. Participants in the control group will be asked to attend a one-hour consent workshop with a partner and fill out surveys.

Researchers will compare sexual assault victimization between the groups in the one year following the intervention.

Sexual violence (SV), which occurs along a continuum from unwanted sexual contact to rape, is common among young women, with some 40% experiencing sexual assault during their time in college. Given the numerous negative consequences associated with SV, developing effective SV prevention and resistance programs for young adult women is critical for reducing victimization and improving health outcomes for adolescent girls. The Enhanced Assess, Acknowledge, Act (EAAA) sexual assault resistance program has been shown to substantially reduce rates of SV (50% for rape and attempted rape) in young women attending university (ages 17-24). The purpose of the current study is to test the efficacy of the newly adapted Internet-Delivered Enhanced Assess, Acknowledge, Act (IDEA3) program in reducing sexual violence victimization among undergraduate women over 12 months of follow-up. IDEA3 is a 12-hour psychoeducational intervention that provides information, skills, and practice aimed at a) decreasing the time needed for young women to assess sexually coercive situations as dangerous and to take action, b) reducing emotional obstacles to taking action, c) increasing the use of the most effective methods of verbal and physical self-defense, and d) identifying sexual and relationship values and boundaries and reinforcing the right to defend them.

Eligibility Criteria:
Inclusion Criteria:

* 1st- and 2nd-year university students at one of the 4 sites
* female-identifying students
* students between ages of 17-24
* able to attend one of the scheduled program groups
* able and willing to be matched with another eligible student

Exclusion Criteria:

- None
ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool

The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria (IBD or IBS subjects):

* \>18 years of age
* Patient must present with signs and symptoms of IBS or IBD
* Patient must be scheduled for a colonoscopy
* All results of the colonoscopy including histology must be provided to study site and sponsor.
* Medical Chart review may be required to confirm diagnosis of IBS or IBD
* Patient must not have taken NSAIDs for at least 2 weeks prior to participating in the study. Patients may be advised of the study and if report taking NSAIDS may be enrolled in the study after the patient has stopped use of NSAIDS for a minimum of 2 weeks.
* For normal patient population - study participants must present with no signs or symptoms of IBS or IBD, must not have taken NSAIDs for at least a period of 2 weeks and must be willing to provide a stool sample.
* Sample must be collected at least 2-3 days prior to colonoscopy

Inclusion Criteria (normal subjects):

* Male or female, ≥18 years of age.
* No abdominal complaints and no history of IBS, IBD, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment.
* May have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy.
* Able to understand the study and the task required, and sign the ICF.

Exclusion Criteria:

Exclusion Criteria (IBD or IBS Subjects):

* patient under the age of 18
* Patient taking NSAIDs
* Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study. Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy.
* Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population

Exclusion Criteria (normal subjects):

* Unable or unwilling to provide a stool specimen.
* Have taken protein pump inhibitors (PPIs) or H2-receptor antagonists for control of upper GI disease within the previous 2 weeks.
* Have taken NSAIDs (including aspirin) on within 2 weeks of study enrollment.
A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) as monotherapy in patients with Parkinson's disease.

Parkinson's disease is a progressive disease which results in deterioration of motor function and is the result of dopamine depletion in specific brain structures. Current therapeutic approaches include dopamine replacement and the use of dopamine receptor agonist drugs. These therapies are effective but may be associated with unwanted complications like wearing off phenomena and involuntary abnormal movements (dyskinesia). Istradefylline may provide a nondopaminergic approach to the treatment of Parkinson's disease.

This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of Parkinson's disease with placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Early PD by UKPDS criteria
2. Mild to moderate difficulty daily activities
3. Females: Either postmenopausal or willing to use adequate contraception

Exclusion Criteria:

1. Unable to discontinue current PD medication
2. Exposure to Levodopa for more than 1 month
3. Symptoms that may suggest a diagnosis other than Parkinson's disease
4. Medical conditions and/or abnormal laboratory findings which preclude participation including cancer in the last 5 years, a history of drug abuse/dependence, abnormal cognitive status, a history of seizures, neuroleptic malignant syndrome, psychosis, or abnormal liver function tests