cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers

The objective of this trial was to confirm the tolerability of prednisolone acetate 0.5% eye drops by testing the hypothesis that the ocular safety and tolerability of prednisolone acetate 0.5% eye drops are equivalent to vehicle. Thus healthy volunteers have been selected and have been treated by using a crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects of either gender, 18 years or older, who were able to give an informed consent
* A score for ocular discomfort of 0-20 mm on the visual analogue scale (VAS) prior to treatment

Exclusion Criteria:

* Known hypersensitivity to any of the constituents of the medications
* Known corticosteroid responder (elevation of intraocular pressure \[IOP\])
* Known allergic disposition (e.g. hay fever)
* Need of ocular antiallergic treatment
* Wearing of contact lenses
* Any kind of current eye disease (e.g. dry eye)
* Any kind of concomitant ocular treatment
* Any injury or infection in either eye during the last 3 months prior to the first application
* Any medication taken within the last 28 days prior to the first application, except hormonal contraceptives
* Concomitant or previous treatment with antihistamines within a week prior to enrolment
* Pregnant or breast feeding women
* Participation in another clinical study within 4 weeks prior to enrolment
* Hematological diseases such as aplastic anemia, panmyelopathy, or hemolytic icterus; with severe dysfunction of the liver.
* Any medical or laboratory condition which, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial per protocol
* Subjects with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exist, are excluded, with the exception of localized basal cell carcinoma of the skin
Cervical Gland Area as a Predictor of Success of Labour Induction

Women who fulfil the inclusion criteria and who are planned for labour induction will be recruited. Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process, and patient information and maternal and neonatal outcome will be documented following the delivery.

Patient consent to participate in the study will be retrieved following the medical decision of labor induction and the mode of induction and following the patient consent to the induction.

Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process.

The method of induction, data regarding patient demographics, the progress of labor, and the maternal and neonatal outcome will be documented following the delivery.

Eligibility Criteria:
Inclusion Criteria:

* Singleton and twins' pregnancies
* Pregnancy 34-41 weeks of gestation
* Vertex presentation
* Induction methods (Oxytocin, prostaglandin 1 (PGE1), prostaglandin 2 (PGE2), double balloon catheter, rupture of memebrane (ROM)

Exclusion Criteria:

* Intrauterine fetal demise (IUFD)
* Contraindication to vaginal delivery
* Status post cervical cerclage
* Previous attempt of labor induction
* History of cervical surgery
* Active vaginal bleeding
A Novel Carbohydrate Counting Smartphone App for Youth With Type 1 Diabetes

Type 1 Diabetes Mellitus (T1DM) is a common chronic disease of childhood. T1DM has substantial impact on quality of life (QOL), including burdensome dietary restrictions and the need to count carbohydrates in foods to safely dose insulin. Carbohydrate counting is challenging, inconvenient, and, if done wrong, can cause high or low blood glucose levels.

To address these challenges, iSpy, a novel smartphone application, was created to identify foods and determine their carbohydrate content using pictures or speech. This pilot study is to evaluate if using iSpy improves carbohydrate counting accuracy and efficiency. Pilot participants will have carbohydrate counting (accuracy and efficiency) and their overall QoL (with respect to carbohydrate counting) assessed at baseline and after 3-months.

The investigators hypothesize that using iSpy will make carbohydrate counting easier (by improving accuracy and efficiency) and enhance QoL for patients and/or their caregivers. If so, iSpy may help lessen the burden of living with T1DM.

Nutrition is an integral component of management of many chronic diseases and of overall wellness. Helping individuals to understand what they are eating can empower them to better manage their diseases. For example, the growing number of youth living with Type 1 Diabetes Mellitus (T1DM) struggle with carbohydrate counting, an essential and daily aspect of their lives, because of required reliance on memorization and numeracy skills. Effective carbohydrate counting has been demonstrated to improve blood glucose control, while inaccurate carbohydrate counting results in more variable blood glucose. Concerns related to carbohydrate counting accuracy can also limit food choices, provoke anxiety, and decrease quality of life. Since there is no cure for T1DM, enhancing patients' ability to understand and apply carbohydrate counting is an important part in helping them manage their condition most effectively.

iSpy is a novel healthcare application that addresses an important clinical need by facilitating carbohydrate counting using pictures or voice recognition. Proprietary algorithms adjust for portion size and identify hidden carbohydrates (such as in ketchup or other condiments) and quantify the amount of carbohydrates in a meal.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T1DM for ≥6 months;
* Completion of initial carbohydrate counting classes;
* Incorporating carbohydrate counting into treatment regimen;
* Having access to a smart phone and data plan;

Exclusion Criteria:

* Cognitive impairments or co-morbid physical or psychiatric condition (e.g. blindness, clinical depression, anxiety disorder) that might impact ability to use iSpy;
* Diagnosis of condition that affects dietary exposure (e.g. celiac disease);
* Participation in usability study;
Impact of Providing Nursing Support on Parental Stress Related to Preoperative Care of a Newborn with Hirschsprung's Disease

Impact of providing nursing support on parental stress related to preoperative care of a newborn with Hirschsprung's disease


Eligibility Criteria:
Inclusion Criteria:

* Families (one or two parents) with a newborn or infant under 2 months with confirmed or suspected Hirschsprung disease, for whom nursings are effective and performed 1 to 2 times a day while waiting for surgery.
* With a possible return home before surgery
* With an information leaflet and non-opposition form signed by one or both parent(s) or by the legal representative.

Exclusion Criteria:

* The absence of daily nursings
* Initial ineffectiveness of nursings requiring a digestive stoma
* Failure to return home before surgery
* Refusal of one or both parent(s) or legal representative(s)
Effectiveness of Antidepressant Treatment for Depression in People With Parkinson's Disease

This study will evaluate the effectiveness of atomoxetine in reducing symptoms of depression in people with Parkinson's disease.

Depression is a serious medical condition that affects people's thoughts, feelings, and ability to function in everyday life. Depression can happen to anyone, but it is more of a risk in people with Parkinson's disease, a progressive brain disorder that is caused by a loss of dopamine-producing brain cells. As many as half of people with Parkinson's may suffer from depression. These individuals experience different symptoms than those who have depression alone. For example, they are prone to higher rates of anxiety, sadness without guilt or self-blame, and lower suicide rates despite high rates of suicidal thoughts. Depression treatment can help people with Parkinson's disease who are depressed to manage both diseases and improve the quality of their lives. This study will evaluate the effectiveness of atomoxetine, an antidepressant medication, in reducing symptoms of depression in people with Parkinson's disease.

Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. All participants will report to the study site at baseline and Weeks 2, 4, and 8. Psychiatric, neuropsychological, and neurological assessments will be performed, including evaluations with the Inventory of Depressive Symptomatology (IDS) scale and the Clinical Global Impression-Improvement (CGI-I) scale. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease
* IDS score greater than 21
* Mini-Mental State Examination (MMSE) score greater than 15

Exclusion Criteria:

* Recent deep brain stimulation
* Currently participating in an antidepressant trial at a less than adequate dose and duration
* Severe depression or depression with suicide ideation
* History of liver toxicity
* Unstable medical disease or comorbid psychiatric disease
Immuno-Virological Efficacy of Combination With Trizivir +Tenofovir in Multiresistant HIV Patients

To evaluate whether the combined therapy of two nucleosides plus one nucleotide (Trizivir + TDF) manages to keep CD4 lymphocytes stable in patients with HIV infection on antiretroviral treatment that present virological failure and multiple resistance to antiretrovirals.

This study has been designed to determine whether the use of a regimen based exclusively on NTRI, containing tenofovir, zidovudine and lamivudine, is able to preserve immunological status in patients with detectable viral load for whom an efficacious salvage regimen cannot be designed, slowing the progression of the viral load and reducing antiretroviral treatment-associated toxicity. In order to complete the salvage regimen without increasing the number of tablets too much, Trizivir plus tenofovir as investigational treatment will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Age\>= 18 years.
2. HIV-1 infected patients.
3. Patients on antiretroviral treatment including NTRI + PI +/- NNRTI +/- fusion inhibitors at inclusion in the study.
4. Virological failure, defined as 2 determinations with viral load \>1,000 copies/mL in the last 6 months, during stable HAART therapy over the previous 6 months.
5. Genotype or phenotype resistance to three families of antiretrovirals (PI, NTRI and NNRTI) demonstrated in genotype study carried out in the last 48 weeks and defined as:

   * 3 or more TAMS of the following: M41L, E44D, D67N, V118I, L210W, T215Y/F, K219Q/E.
   * Existence of the M184V mutation or probable presence in the cellular archives.
   * 5 or more mutations that confer resistance to PI of the following: I10F/I/R/V, V32I, M46I/L, I54V/M/L, V82A/F/T/S/V, I84V/A/C, L90M.
   * Existence of 1 or more mutations that confer resistance to NNRTI, or probable presence in the cellular archives of: K103N, Y181C/I/Y, G190S/A/G.
6. CD4 lymphocytes \>- 300 cells/mm3 in the last two determinations.
7. Subject able to follow the treatment period.
8. Acceptance of the study and signature of the informed consent form.
9. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or must undertake to use a barrier contraceptive method during the study.

Exclusion Criteria:

* Suspicion of previous incorrect adherence.
* Pregnancy or breastfeeding
* Suspicion of intolerance to any investigational drug.
* Record of any disease which, according to clinical criteria, may reoccur with the proposed change of therapy (sarcoma, lymphoma, etc).
* CD4 Nadir below 200 cel/mm3.
* Acute intercurrent disease or fever in the 15 days before inclusion.
Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Horton's Disease

Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response \[1\]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.

The study is classified interventional because a lot of blood samples are taken.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Patients who have provided written consent
* Patients with national health insurance cover
* Age \> 50 years
* Patients with a diagnosis of Horton's disease, before any treatment

Horton's disease is defined by the American College Rheumatology ACR criteria \[2\], as the association of 3 of the following 5 criteria:

* age at disease onset 50 years or older
* recent onset localized headache
* indurated temporal artery or diminished/abolition of temporal pulse
* erythrocyte sedimentation rate (ESR) greater than 50 mm during the first hour (or C Reactive protein (CRP)\>20 mg/L)
* Positive temporal artery biopsy (TAB) showing vascularitis with infiltration by mononuclear cells or granulomatous inflammation with or without giant cells.

Control subjects

Control subjects will be healthy volunteers recruited among blood donors at Dijon University Hospital, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious, inflammatory or auto-immune diseases or cancer (CRP\<5mg/L) recruited in the investigating departments of Dijon Hospital. They will be matched for age and sex and must meet the following criteria:

* Age \> 50 years
* Patients with national health insurance cover
* Signed written informed consent form
* Absence of an inflammatory syndrome (CRP\<5 mg /L)

Exclusion Criteria:

* Adult under guardianship
* Persons without national health insurance cover
* Pregnant or breast-feeding women
* Patients treated with corticoids or immunosuppressants in the month preceding inclusion
* Patients treated with chemotherapy
Evaluation of the Clinical Performance of Reinforced Glass Ionomer Restorations

This study is conducted to evaluate the clinical performance of class I reinforced glass ionomer restorations (Zirconomer Improved and Equia Forte Fil)


Eligibility Criteria:
Inclusion Criteria:

* Normal occlusal relation with normal dentition.
* Absence of pain from the tooth to be restored.
* Absence of any active periodontal and pulpal diseases from the tooth to be restored.
* Medium-sized (buccolingually and mesio-distally) occlusal carious lesions extending into dentin.

Exclusion Criteria:

* Patients with a history of tooth sensitivity.
* Patients with bruxism.
* Defective restorations adjacent or opposing to the tooth.
* Abutment teeth used for fixed or removable prosthesis.
* Patients who refused to sign the consent form.
* Inability to return to recall appointments
Comparison of Two Embryo Culture Media for IVF and ICSI

In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used.


Eligibility Criteria:
Inclusion Criteria:

* Any IVF and IVF with ICSI procedure performed in the unit can be included in the study

Exclusion Criteria:

* refusal of patients to be randomized. In this case, the biologist chose the medium to be used and the IVF procedure will not be included in the statistical analysis
Effect of Different Courses of Lactobacilli Treatment on Bacterial Vaginosis and Pregnancy Outcomes

The purpose of this study is to examine the effect of lactobacillus preparation on Bacterial vaginosis (BV) in low-risk pregnant women and to evaluate the value of double courses for the patients with durative positive result. It is assumed that the living preparation of lactobacillus was beneficial for treatment of BV during pregnancy. The two-courses treatment can increase the response rate and improve pregnancy outcomes in the durative BV positive patients comparing with one-course one.

Research method: This was a single-blind randomized controlled trial.

Diagnostic standard: The study population is the women who have positive outcome of screened test for BV by sialidase method.

Allocation and follow up: Patients who were screened for BV by sialidase method and randomly allocated into control group、one-course group and two-course group. The patients in control group who were BV positive would receive lotion washout and be repeatedly evaluated BV status per two weeks and be followed up to the 4th～7th days of postpartum. The patients in one-course group and in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. The patients in two-course group will receive the second course treatment of Lactobacilli preparation if their BV test result were still positive after one-course treatment, but those in one-course group would NOT receive any treatment even though they would have the durative BV positive result after one-course of Lactobacilli. The patients in the two interventional groups would be repeatedly evaluated BV status at 28th gestational weeks and be followed up to the 4th-7th days of postpartum. All the inspection results of vaginal secretions and pregnancy outcome were recorded.

Outcome measures:

* The prevalence of BV,the response rates of lactobacillus preparation,the recurrence rate.
* The adverse pregnancy outcomes of mother.
* The adverse pregnancy outcomes of perinatal fetus.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at 16-18 gestational weeks with no history of premature labor or premature rupture of fetal membranes.

Exclusion Criteria:

* who have menstrual disorder or forget the last menstrual period, and have no type-B ultrasonic result, so the gestational week is not clear.
* Who have monilial vaginitis, trichomonas vaginitis, or sexual transmitted diseases.
* who have severe medicochirurgic diseases.
* multiple pregnancy.
* anomalies of genital tract
* fetal anomaly
Trauma-informed Intervention to Reduce Substance Use and to Support Community Transition

The overall aim of this study is to reduce overdose risk for criminal legal system (CLS) involved women during community re-entry through the adaptation and testing of an innovative, trauma-informed, relational intervention approach (Trust-Based Relational Intervention or TBRI).

R61 Phase (Intervention adaptation): The TBRI intervention will be strategically adapted for CLS-involved women during the R61 to achieve 2 specific aims: 1) Adapt TBRI by focusing on adapting two intervention components - prison group sessions and re-entry recovery support - using focus groups with key stakeholders (N=30) including administrators, practitioners, and women with "lived experience," and target alignment with the unique treatment needs of the women and establish intervention approach feasibility; and 2) Pilot test the adapted intervention components in one group of women (n=8) at the KCIW facility. Final adaptations will be made to the TRUST manual for the R33 implementation.

R33 Phase (Intervention testing): The R33 will test the effectiveness of the adapted TBRI-WRA to reduce overdose risk in the community following prison release, while also collecting data on key constructs hypothesized to influence successful intervention implementation. The primary aim of the R33 is to examine effectiveness of the adapted TBRI Women's Re-entry Approach (TBRI-WRA) in reducing overdose risk among women (N=264) in four sites following release from prison-based SUD treatment. Study conditions include (1) Treatment as Usual (TAU, standard in-prison SUD treatment, n=88), (2) In-prison TBRI (TAU + TBRI prison-based sessions only; n=88), and (3) TBRI + Re-entry Recovery Support (TAU + prison-based TBRI sessions + Re-entry Recovery Support; n=88). The R33 will also examine implementation factors associated with study preparation, launch, sustainability, and scalability.

Eligibility Criteria:
Inclusion Criteria:

* participating in prison-based SUD treatment program
* have a release date within 3 months
* self-identified history of violent victimization
* have no indication of current suicidal risk,
* able to identify one "Safe Support Person" (SSP) in the community who can be trusted to support recovery and is willing to be contacted about participation

Exclusion Criteria:

* release date greater than 3 months
* no self-identified history of violent victimization
* indication of current suicidal risk
* unable to identify one "Safe Support Person" (SSP) in the community who can be trusted to support recovery and is willing to be contacted about participation
Psychological Readiness of Injured Athlete to Return to Sport

Clinicians are recommended to assess athletes during the rehabilitation phase to identify athletes with potentially maladaptive psychological responses to injury. Therefore, the Psychological Readiness of Injured Athlete to Return to Sport (PRIA-RS) questionnaire was developed to assess the athlete's psychological readiness to return to sport. The aim of this study was to adapt the PRIA-RS questionnaire into Turkish and to establish its validity and reliability. Serial approach method will be used while translating the questionnaire into Turkish. In order to evaluate the validity of PRIA-RS, The Re-injury Anxiety Inventory and Tampa Kinesiophobia Scale will be applied to the participants.


Eligibility Criteria:
Inclusion Criteria:

* athletes who have missed at least 2 months of training due to injury
* having an upper, lower extremity or spine injury

Exclusion Criteria:

* having a psychological disorder
* regular use of psychiatric medication