cyrilzakka/clinical-trials huggingface dataset:
Effect of Lifitegrast 5% on Tear Film Markers

The purpose of this study is to assess the duration of time (in weeks) for improvement in objective dry eye markers for people who are placed on lifitegrast 0.5% (Xiidra®), an FDA-approved therapy for dry eyes.


Eligibility Criteria:
Inclusion Criteria:

* Signs or symptoms of Dry Eye Disease
* 18 years or older
* Abnormal MMP9 (positive as read by 2 blinded investigators with both in agreement) and/or Abnormal tear osmolarity (greater than or equal to 308 or an inter-eye difference \>=8 mOsm/mL)

Exclusion Criteria:

* Active eye infection. Patients with blepharitis may be enrolled.
* Any eye drop that was instilled within 2 hours of the Baseline eye exam
* Current contact lens wearer. Subjects who have not worn contact lenses 30 days prior to baseline and have no intention to wear CLs during the study duration may enroll.
* History of ocular herpes simplex
* Active episcleritis, scleritis, iritis or uveitis
* Active keratitis secondary to any etiology other than dry eyes
* History of refractive surgery (LASIK or PRK) or penetrating corneal transplant (PK)
* Uses eye drops (ex. glaucoma or allergy drops) for indications other than dry eyes
* Active allergic conjunctivitis
* Current use of punctal plugs or anticipation of use during the study
* Use of topical ophthalmic steroids within 14 days of the Baseline Visit or anticipated use during the study
* Use of lifitegrast 5% or Restasis within 30 Days of the Baseline Visit.
* Allergy to lifitegrast 5%
Probiotics Role in HPV Cervico-vaginal Infection Clearance

Vaginal infections demonstrated to be implicated in the persistence of HPV, activating a vicious circle of vaginal microbial perturbations. HPV infection can destroy the biofilm barrier formed by the local vaginal immune microenvironment, leading to a condition called dysbiosis. Contemporarily, the resulting local microecological imbalance in the vagina can subsequently upregulate the expression of the HPV protein, increasing HPV-related cytological alterations.

A total of 483 women affected by different vaginal infections and concomitant HPV-positivity were enrolled between 2018 and 2020 at Department of Gynecological, Obstetrical and Urological Sciences, University "Sapienza" of Rome (Rome, Italy) and 2nd Division of Obstetrics and Gynecology, Azienda Ospedaliera Universitaria Pisana, University of Pisa (Pisa, Italy). Women with positive swabs for infections were randomized in two groups, standard specific treatment (n=231) versus the standard treatment plus long-lasting (9 months) vaginal and oral probiotics implementation (n=252).

Eligibility Criteria:
Inclusion criteria

* age \> 18 years
* positive swabs for vaginal infections detected during colposcopy check
* HPV test positivity

Exclusion Criteria:

* pregnancy or breastfeeding
* concomitant malignancies
* immunological diseases
* severe comorbidities
* prolonged corticosteroid treatment
Response of Inflammatory Markers to Circuit Weight Training in Diabetic Patients

Study group included 30 male diabetic patients , they performed circuit weight training exercises for 12 weeks in addition to their medications. However, the control group included 10 patients received medical treatment.

Interleukin 6 and tumor necrosis factor alpha were measured before and after the study duration for both groups.

The study group included 30 male diabetic patients who participated in circuit weight training (CWT) program as following; 60 minutes training\\day for 3 days per week for a period of 12 weeks.

The training session started by a proper warm up for 5-10 min in the form of mild stretching of the muscles of upper limb(pectorals,shoulder girdle muscles) and muscles of lower limb(flexors, extensors, abductors and adductors of the hip and knee) ( to minimize the risk of musculoskeletal injury). Then start the active phase of resisted exercises through using free weights ( dumbbels for upper limb and sand bags for lower limb) The frequency and intensity increased gradually as follows; Intensity of progress of CWT gradually increased intensity by 2.5% of one repetition maximum every two weeks. Moderate resistance used in which of 60-65% of 1RM in the first month then the intensity increased to 70-75% of 1RM in the second month and finally the intensity of exercises increased to 75-80% of 1RM during the third month. The sets of exercises intervened by 1 min rest in between each set of repetitions. At last the session ends by 10 min of cooling down in the form of relaxation exercises.

Statistical procedures:

In this study, the descriptive statistics (the mean, the standard deviation, maximum, minimum, and range) will be calculated for all subjects in the study including IL6 and tumor necrosis factor alpha variables.

* Paired sample t-test will be used to compare the difference between before and after treatment results of IL6 and tumor necrosis factor alpha in each group.
* Paired T test to compare means of variables before and after training.

Eligibility Criteria:
Inclusion Criteria:

* The selected subjects are diagnosed clinically and laboratory with diabetes mellitus type 2 by physicians.
* All patients have moderate hyperglycemia tested by fasting plasma glucose and a two hours plasma glucose ≥ 200 mg/dl (11.1mmol/l) during an oral glucose tolerance test (OGTT).
* The onset of the disease will be more than 10 years.
* All patients follow an oral hypoglycemicdrug.

Exclusion Criteria:

* Hepatic diseases.
* Cancer patients.
* Renal failure patients.
* Orthopedic problems or fractures of extremities.
* Neurological problems.
* Severely hypertensive patients.
A Smartphone-based Intervention to Promote an Active Lifestyle in Low Educated Working Young Adults

The aim of this smartphone-based intervention study is to determine whether a newly developed app is effective in promoting an active lifestyle in low educated working young adults.

A stepwise approach was used to develop a new native Android smartphone app (Active Coach). This app aims to promote an active lifestyle (through physical activity and active transport) in low educated working young adults. The development of this app is based on theory, evidence and user's experiences. The app focuses on four determinants (knowledge, attitude (perceived benefits and perceived barriers), social support and self-efficacy) and includes several behavioral change techniques (self-monitoring, goal-setting, feedback on behavior, review behavior goals, instruction on how to perform the behavior, information about health consequences, enhancing network linkages and prompts/cues). Furthermore, the app works in combinations with a wearable activity tracker (Fitbit Charge) to track users activity behavior.

For the smartphone-based intervention, 120 low educated working young adults are being recruited via purposeful convenience sampling though companies and employers. Participants can not have any medical conditions that prevent them from being physically active and they need to own an Android smartphone. Fitbit Charge activity trackers will be provided. The participants will be randomly divided in the intervention group or the standard information control group. The intervention period will be nine weeks. At the beginning and the end of the intervention period, physical activity levels will be objectively measured with accelerometers. Follow-up measurements will be conducted 12 weeks after the end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 28 years old
* low educated (maximum secondary school, no higher education (university or college)
* employed
* dutch speaking
* owning an Android smartphone

Exclusion Criteria:

* being very physically active (already reaching the recommended 30 minutes of physical activity a day)
Knowledge, Attitudes, And Perceptions of a Group of Egyptian Dental Students Towards Artificial Intelligence

In the context of this ongoing AI revolution, it is essential to ensure that current and future clinical practitioners are up to date regarding this technology's current state and potential. It is valuable to assess the current attitude of clinical dentists and undergraduate students in dentistry regarding the future role of AI.

To the best of the author's knowledge, there is no study about Egyptian dental students' views and attitudes regarding the application of AI in dental practice. Therefore, this study aimed to evaluate the attitudes and perceptions of a group of dental students in Egypt towards AI.

Data will be collected using a questionnaire. The survey will be distributed to dental students at the Faculty of Dentistry, Cairo, and Egyptian Russian universities through Google Forms. The questionnaire comprised 3 sections and 22 questions. The survey consisted of a question on demographics and educational information about dental students, knowledge of and attitudes towards AI, future application areas of AI in dentistry, and topics of AI in dental education. The first part of the survey. Informed consent will be obtained from all the participants before completing the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

- Dental students

Exclusion Criteria:

* Graduates
Seasonal Malaria Chemoprevention With or Without Lipid-based Nutrient Supplement in Children Aged 6-59 Months in Mali

SMC LNS Mali is a interventional matched-pair clustered cohort carried out between August and November 2017 in 18 health areas in Kolokani Circle, Koulikoro region, Mali.

The objective of this study is to determine whether the association SMC and LNS reduces the number of confirmed malaria cases among children 6-59 months during the monthly SMC distribution sessions.

Main objective:

To compare confirmed cases of malaria among children aged 6-59 months between the group receiving SMC combined with LNS (intervention group) and the group receiving only SMC (control group) during the monthly SMC distribution sessions (4 rounds)

Secondary objectives:

To compare among children aged 6-59 months between two groups

* Fever cases
* Acute malnutrition cases (global, moderate and severe)
* Medical referral cases and their reasons

Study site:

The study is conducted in 18 health areas in Kolokani Circle, Koulikoro region, Mali. Each group (intervention and control groups) is composed of 9 health areas.

Number of participants:

Between 17500 and 22000 in each group (estimation)

Eligibility Criteria:
Inclusion Criteria:

* Being between 6 and 59 months old
* Resident in the study area
* Signed informed consent of the mother or the child's guardian

Exclusion Criteria:

* Children allergic to milk, peanuts, sulfadoxine-pyrimethamine or amodiaquine
Vascular Health and Risk Factors in Children With Down Syndrome

This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with Down Syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* All children with Down Syndrome (10.0-18.0 years of age)
* Children with translocations and mosaicism
* Children with and without CHD

Exclusion Criteria:

* Patients with a history of hypoplastic arch, coarctation or catheter or surgical based aorta interventions
* Patients who are currently treated or have been treated with chemotherapy for cancer or a myeloproliferative disorder within 1 year of the study
* Participants whose parent/legally authorized representative (LAR) perceives the child is not able to cooperate with vascular imaging studies
An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1

This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C genotype 1
* Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
* Confirmed serum positive HCV RNA
* Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment

Exclusion Criteria:

* Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
* Co-infection with hepatitis B or HIV
* Post-transplant patients
* End stage renal disease (creatinine clearance \< 15 ml/min)
* Patients treated with immunotherapy
* Pregnant women and male partners of women who are pregnant
* Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter
The Effect of the Brochure on Testicular Self-Exam

This study aims to examine the effect of the educational brochure given to university students on testicular cancer and its early diagnosis on their health beliefs and self-examination; In non-randomized groups, pretest-posttest was conducted in a quasi-experimental design with control group. The research was carried out with students studying in the psychological counseling and guidance department of a state university in Turkey. The study group consisted of 92 students, 48 of which were experimental and 44 were control. Only the experimental group was given an educational brochure about testicular cancer and testicular self-examination. Data; Personal information form, testicular cancer and health beliefs scale about testicular self-examination were collected with the form for self-examination. In the evaluation of the data; Mann Whitney U, Wilcoxon and chi-square analyzes were performed.


Eligibility Criteria:
Inclusion Criteria:

* To study in the Department of Psychological Counseling and Guidance
* Studying in 3rd and 4th grade

Exclusion Criteria:

* Any previous diagnosis of cancer
* Having received previous training in Testicular Self Examination
Adult Pilot Study for Reference Ranges and Optimal Cut-offs for the Sucrose Challenge Test and Sucrose Breath Test

An adult pilot study to establish the normal reference range and optimal cutoffs for the oral 50g Sucrose Challenge Test (SCT) and the 50g 13C-Sucrose Breath Test (CBT) for patients with CSID and healthy controls. This study will enroll 120 healthy controls and 50 CSID patients. No study drug will be administered during this study.

In an effort to mimic the real-world diagnostic setting for these tests, this study will be conducted virtually using a central site with telemedicine capabilities and electronic data capture software to collect data in real time via a mobile app. Subject will complete 3 visits within 21 days. Eligible subjects will undergo the following tests:

1. 50g 13C-Sucrose Breath Test (CBT)
2. Sucrose Intolerance Hydrogen Methane Breath Test (HBT)
3. Sucrose Challenge Test (SCT)
4. Buccal swab for CSID Genetic Testing (GT)

The primary aim is to establish the reference/normal ranges and optimal cutoff values for the SCT and CBT.

Eligibility Criteria:
Inclusion Criteria:

* Subject must provide informed consent prior to any study procedures being performed.
* Subject is a U.S. resident, and speaks and understands English
* Subject is male or female, ≥ 18 years old.
* CSID Cases must have been on Sucraid for at the last 12 months.
* Healthy Volunteers do not have a CSID diagnosis or other chronic gastrointestinal conditions.
* Subject must have their own Android or Apple device to access the mobile patient app.

Exclusion Criteria:

* Females who are lactating or pregnant.
* Subjects with allergy to sucrose.
* Subjects with causes of abdominal pain or altered bowel habits other than symptoms -related to CSID (in CSID group) such as SIBO, IBD, celiac disease, pancreatitis, or -gastrointestinal bleeding.
* Diabetes mellitus.
* Use of systemic antibiotics, had a barium study, colonoscopy, unexplained runny diarrhea, or similar within 14 days prior to informed consent. Potential subjects can be re-screened once they meet this criterion.
* Recent febrile illness.
* Subject has major physical or psychiatric illness within the last 6 months that in the opinion of the investigator would affect the subject's ability to complete the trial.
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Clopidogrel

This is a single center, open label, single sequence, two treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of multiple doses of clopidogrel


Eligibility Criteria:
Inclusion Criteria:

* Motivated and available for duration of study and willing to adhere to protocol
* Males who are unable to procreate or agree to contraception throughout study
* Females who are postmenopausal or surgically sterile
* BMI between 18.5 and 30 kg/m2
* Weighing greater than or equal to 50kg
* Normal lab results
* No known diseases or significant findings on physical exam

Exclusion Criteria:

* Females of childbearing potential
* Reactions/infection at injection site
* Hypersensitivity to any drugs or similar drugs to those used in the study
* Conditions or disease that may interfere with study drug
* Any significant diseases
* Known history or familial history of bleeding disorders
* Drug dependency or abuse
* Illness within 28 days
* Previous exposure to other investigational drug within 28 days
* Blood donations within 28 days
Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals

Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Raspberries are rich in phenolic and polyphenolic compounds, in particular procyanidins, ellagitannins and anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk have shown promising results. However, to date, very few human studies have specifically investigated the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects. Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time in the blood and urine. Therefore, the investigators will investigate the presence of plasma and urinary raspberry-derived metabolites 24h post-consumption. To the investigators knowledge, the effects of red raspberry consumption on vascular function in humans have not been investigated before. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims to investigate the potential role of red raspberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects (no clinical signs or symptoms of cardiovascular disease)

Exclusion Criteria:

* Cardiovascular disease
* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* C - reactive protein \> 05 mg/dL
* malignant disease
* raspberry allergy/intolerance
* hypotension (≤100 / 60 mm Hg)
Evaluation of the iMBC/ECD Model in Ghana

The Duke research team will work with Catholic Relief Services (CRS) and lead the design and implementation of a cluster-randomized trial in Northern Ghana to assess the impact of the Integrated Mothers and Babies Course \& Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones.

Maternal psychological disorders around the time of pregnancy and childbirth have been identified as a key risk factor for poor child development outcomes in growth, cognition, and overall child health in low- and middle-income countries (LMICs). Maternal depression during a child's infancy predicts negative behavior and lower achievement scores, as well as increased absences in elementary school), and has been identified as a significant risk factor for poor infant growth in the developing world. There is considerable evidence to suggest that a community-based intervention, delivered by trained community volunteers, can have a significant impact on perinatal depression and child development outcomes. This cluster-randomized trial in Northern Ghana will assess the impact of the Integrated Mothers and Babies Course \& Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones. In Ghana, the iMBC/ECD will be implemented in the context of the Rural Emergency Health Service and Transport project (REST II). A key activity of REST II is Community Pregnancy Surveillance and Targeted Education Sessions (C-PrES). Routine C-PrES is delivered via educational group sessions that promote the adoption of key Maternal, Neonatal and Child Health and Nutrition (MNCHN) behaviors (e.g. newborn care, exclusive breastfeeding, etc.) among pregnant women and mothers of children under age two.

Eligibility Criteria:
Inclusion Criteria (Mother):

* 16 years or older
* Currently pregnant
* Attends C-PrES groups at the time of the baseline survey (West Mamprusi and Nabdam District)
* Plan to maintain residence in the community for at least 6 months
* Agrees to voluntary participation

(The participation of the child falls under the mother's consent. Once born, the child will be followed along with its mother as long as the mother continues participation in the study.)