cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis

This Phase II study is to evaluate the efficacy of SR-T100 gel with 2.3% of SM in Solanum undatum plant extract in patient with Actinic Keratosis (AK).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female; aged ≥ 18 years old.
2. Patient who accepts to enter the study by signing written informed consent.
3. Patient has 4 to 8 clinically diagnosed, discrete, non-hyperkeratotic, non-hypertrophic AK, located with or without a contiguous 25cm2 areas.
4. Patient allows biopsy to be performed on selected lesion.
5. Patient agrees to apply the study medication on prescribed treatment area with an occlusive dressing at least 20 hours per day.
6. Patient agrees photographs to be taken on selected lesion and used as part of the study data package.
7. Patient in good general health condition (performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
8. Sexually active female patient with child-bearing potential must take reliable contraception method(s) during the participation of the study.

Exclusion Criteria:

1. Patient with recurrent invasive squamous cell carcinoma (SCC).
2. Patient has grossly suspicious or inflamed lymph nodes on physical examination.
3. Patient has evidence of clinically significant or unstable medical conditions.
4. Patient has any skin condition in the treatment area that may be made worse by treatment.
5. Patient currently uses or had used on the treatment area(s) OTC retinol products, corticosteroids, cryosurgery, curettage, 5-fluorouracil (5-FU), imiquimod, topical diclofenac, retinoids, or other topical AK treatments (such as laser abrasion, dermabrasion, glycolic acids, or chemical peels) 28 days prior to screening visit.
6. Patient had received systemic cancer chemotherapy or immunosuppressant; on the target evaluation area that psoralen plus UVA therapy, UVB therapy were treated 6 months prior to screening visit.
7. Patient currently uses or has used prednisone and/or prednisolone (≥ 10 mg or the equivalent) more than 2 weeks continuously within 12 weeks prior to randomization visit.
8. Engaging in activities involving excessive or prolonged exposure to sunlight.
9. History of allergy or sensitivity to related compounds or other components of the investigational product formulation.
10. Woman who is pregnant, lactating or planning to become pregnant during the study.
11. Patient used any investigational drug within 8 weeks prior to the screening visit.
Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus

We performed a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c \>7.0% after an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus mitiglinide (Met+Mit) or metformin plus placebo (Met).

This was a 16-week, randomized, double-blind study for comparing metformin plus mitiglinide (Met+Mit) versus metformin plus placebo (Met+Pcb). An 8-week metformin run-in phase (500 mg twice a day for the first 4 weeks and 500 mg three times a day for the following 4 weeks) was followed by a 16-week trial phase (mitiglinide 10 mg or placebo three times a day added to metformin 500 mg three times a day). The subjects with an HbA1c \>7.0% at the end of the metformin run-in phase were randomized to a Met+Mit group or a Met+Pcb group of the trial phase.

Eligibility Criteria:
Inclusion Criteria:

* aged 30-70 years
* had a duration of diabetes of \<10 years
* body mass index (BMI) 20-35 kg/m2
* a plasma HbA1c level of 7.5-11% during the previous 4 weeks

Exclusion Criteria:

* subjects who were diagnosed with type 1 diabetes, gestational diabetes, or diabetes with any specific causes
* Subjects who had been treated with nateglinide, repaglinide, metformin (over 1,000 mg/day), or sulfonylurea (over a quarter of the maximum recommended dose) during the previous 8 weeks
Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.

Dried human amniotic membrane patches were obtained from National center for radiation research and technology, Egypt, under commercial name REGE pro.

Eligibility Criteria:
Inclusion Criteria:

* patients have unhealing ulcer

Exclusion Criteria:

* must stop other line of treatment
High Flow Nasal Oxygen Therapy an Implementation Study in Pediatric Wards

The purpose of this study is to prospectively evaluate the process of implementing HFNO in several MSF projects, varying according to geographical and programmatic contexts, population, health structures, human resources, and management. It will generate evidence on the operational feasibility (in terms of human resources, equipment, logistics and costs) of integrating HFNO into PICU standard of care, as well as on the users' and caregivers' perspectives on HFNO and on the children clinical outcomes observed where HFNO is implemented. This relevant information will guide MSF in the decision making of scaling up HFNO therapy in its projects.

Mixed method study: quantitative component for the data of the children and qualitative data for the perception for health staffs and parents

Eligibility Criteria:
Inclusion Criteria:

* prescription of HFNO by clinician
* parent consenting to the use of the data
Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients

Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes

Exclusion Criteria:

* positive history for taking anti-diabetes medications of any class in the past
* positive current history for taking over-the-counter vitamin or anti-oxidant supplements
* presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.
Paroxetine in the Treatment of Chronic Primary Insomnia

The goal of the study is to examine the role of paroxetine, an antidepressant medication, in the acute and continuation treatment of insomnia. Primary insomnia is a type of insomnia not directly resulting from general medical, chemical, or psychiatric conditions.

The primary aim of this study is to demonstrate the role of paroxetine in the acute treatment of chronic primary insomnia. Paroxetine taken on a nightly basis in combination with sleep hygiene therapy will produce a greater number of diagnostic responders in acute treatment, compared to a placebo and sleep hygiene control condition, in a randomized, double-blinded, six-week acute treatment trial. EEG sleep, sleep quality, and daytime well-being, and daytime functioning will also show superior treatment effects during acute treatment with paroxetine plus sleep hygiene, as compared with the placebo control condition.

A total of 66 patients with primary insomnia, as defined by DSM-IV criteria, will be randomized (1:1) to receive paroxetine plus sleep hygiene therapy (P+SH-a) or placebo plus sleep hygiene therapy (PL+SH-a) in weekly acute treatment sessions evolving over a six-week interval in a double-blinded, parallel group design.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 or older
* Diagnosis of chronic primary insomnia
* Score of 8 or higher on the Pittsburgh Sleep Quality Index
* free of all antidepressants and benzodiazepine for two weeks

Exclusion Criteria:

* lifetime diagnosis of any psychotic disorder,or bipolar disorder.
* DSM-IV diagnosis of dysthymia or generalized anxiety disorder
* Diagnosis of major depression within the past 6 months
* Alcohol or drug abuse within the past 6 months
* Contraindication to SSRI therapy
* History of seizure disorder
* Baseline apnea/hypopnea index score greater than 15
* Hyponatremia
Sexual Health Literacy Scale

According to the World Health Organization, sexual health is a state of well-being related to sexuality as a whole, not just the absence of disease or dysfunction or disability. sexual health; It requires a positive and respectful attitude, free from sexual coercion and discrimination, free of violence, enjoyable and safe experiences. It obliges the respect, protection and fulfillment of the sexual rights of every individual. sexual health; includes a safe and respectful framework free from violence and discrimination; it covers not only the reproductive period, but every age period; different sexual identities and forms of sexual expression, as well as livable and critical gender values, roles, expectations and power dynamics. Insufficient information, difficult access to health services and lack of a guiding structure; It negatively affects young individuals' ability to take responsible decisions with good knowledge about sexuality during their sexual development. Information is obtained from channels where erroneous and incorrect information transfer is intense, and the ways of accessing this information play an important role in the spread of sexual myths in society. Based on all these reasons; This study aimed to develop the Sexual Health Literacy Scale.


Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18 who are willing to participate in the study, without psychiatric illness,
* No physical or mental disability
* Able to speak and understand Turkish.

Exclusion Criteria:

* Not willing to participate in the study, with psychiatric illness,
* Physically and mentally handicapped
* 18 years and under,
* Does not speak Turkish
Shoulder Proprioception Following Open and Arthroscopic Instability Repair

Shoulder dislocations are common and may result in functionally disabling instability. Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related to poor proprioceptive and stabilizing capabilities of the joint. It has been demonstrated that surgical restoration of the normal glenohumeral capsular tensioning improves the proprioceptive capability of the shoulder and plays an important roll in restoring shoulder stability.

Several studies compared the proprioceptive capabilities of the shoulder between different surgical procedures, however only few have used the "dynamic unrestricted 3-dimensional arm movement model" that has been shown to be more appropriate for assessment of glenohumeral proprioception. To our knowledge, no previous study has compared proprioception measures of the glenohumeral joint following arthroscopic versus open repair for anterior shoulder instability, using the 3-dimensional unrestricted arm movement model.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least one year after a single operation for anterior shoulder instability of their dominant arm
* control subjects will be healthy volunteers with no history of shoulder complaints selected to match the age and gender of subjects

Exclusion Criteria:

* Neurological impairment involving the upper extremities
* Instability or recurrent dislocation of the operated shoulder
* Another surgery of the dominant extremity besides the single stabilization procedure
Decision Aid (DA) for Renal Patients

The objective of this study is to understand how patients make decisions about treating their kidney masses, and to identify key values and preferences for treating their kidney masses. The study team will develop a decision aid (DA) using the decision-analytic model to communicate personalized benefit/harm estimates to patients and promote patient-centered treatment of renal tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male and female post-op and pre-op patients, ages 18 and older, diagnosed with a localized renal tumor up to 4 cm in diameter.
* Patients scheduled for standard-of-care clinical exams with the NYU Urology Department

Exclusion Criteria:

* Stage IV cancer of any type
* Inability to provide informed consent
* Vulnerable subjects will not be recruited
Substrate Utilization and Hormonal Status in Women

Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal modifications, but results are confused regarding the impact on substrate utilization. In the present study, the aim is then to explore the effect of hormonal status on substrate utilization during sous-maximal exercise, comparing women with and without OC.

We hypothesised that women under OC have a lower Respiratory Exchange Ratio (RER) at exercise than women without contraception underlying a greater reliance on fat oxidation.

24 healthy young women (12 with OC and 12 without any contraception) will complete a maximal test on an ergometer cycle to obtain their maximal oxygen consumption (VO2max).Their body composition will be assessed by DXA. They will be asked to complete 3 experimental sessions.

During a first session the volunteers will remain inactive, and only a breakfast will be offered. During the second session, a breakfast will be offered and they will have to complete a sub-maximal exercise set at 60% of their VO2max 3 hours after breakfast. And the third session will consist in the realisation of exercise on fast state. Those three sessions will be realized in a randomized order. Several blood (catheter) and salivary samples will be collected during the three sessions, throughout the experimental day.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Adults between 19 to 30 years old
* Body mass index between 20 and 25 kg.m-²
* Oral contraception (half of the sample) : mini-dosed, and mono-phasic, ethinyl estradiol ≤ 30 µg
* Without contraception (half of the sample)
* Affiliated to National Health Insurance
* Subject giving her written informed consent
* Subject considered as normal after clinical examination and medical questionnaire.

Exclusion Criteria:

* Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
* Refusal to be registered on the National Volunteers Data file
* Being in exclusion on the National Volunteers Data file
* Practising intensive physical exercise
* Heavy consumer of alcohol or/and tobacco
* Previous medical and/or surgery judged by the investigator as incompatible with this study
* Pregnancy
Acupuncture as add-on to G-CSF for Febrile Neutropenia-related Hospitalization in Doxorubicin-treated Patients With Sarcoma

Chemotherapy-induced febrile neutropenia (CIFN) is a dangerous complication of many chemotherapy drugs, with current treatment with granulocyte colony-stimulating factors (G-CSFs) accompanied by adverse effects, primarily muscle and bone pain. Adult patients with sarcoma treated with doxorubicin-based chemotherapy have a high risk (\>40%) for developing CIFN. Acupuncture has been shown to have a potentially myelo-protective effect on bone marrow during chemotherapy, though its effect on the incidence of CIFN-related hospitalization has yet to be examined. In the proposed study, patients with sarcoma will be randomly allocated (in a ratio of 1:1) to Group A, receiving acupuncture during cycles 1, 3, and 5; or Group B, during cycles 2, 4, and 6, with the study oncologist blinded regarding allocation. Acupuncture will be administered on the first day (d1) and the 8th day (d8) of the chemotherapy cycles, with press-tack needles on d1 to d8, and patients will be taught to self-treat with acupressure from d8 to the next cycle. The incidence and duration of hospitalization due to CIFN will be examined, as will adherence to the chemotherapy regimen; G-CSF-related pain; and other outcomes using 3 quality-of-life-focused questionnaires. The study findings will have important implications regarding the role of acupuncture in the treatment of patients treated with chemotherapy drugs with a high risk for CIFN, such as those used in the treatment of sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* diagnosed with sarcoma of any stage
* scheduled for doxorubicin-based chemotherapy
* function ECOG status score of 0-1

Exclusion Criteria:

* not fulfilling all inclusion criteria
* unwilling or unable to provide written informed consent for study participation
Genetic Susceptibility to Factor VIII Inhibitors

This international study will identify genetic factors that may influence the development of inhibitory antibodies in patients with hemophilia A after treatment with factor VIII. Bleeding episodes in patients with inhibitors are often more difficult to treat. Previous research indicates that genetic factors play a role in the development of inhibitors. A better understanding of the influence of genes in this treatment complication may be helpful in predicting, treating or preventing inhibitors.

People in families in which one or more members have severe factor VIII deficiency and one or more have a history of an inhibitor may be eligible for this study. Participants fill out a form with questions about the person's relationship to other family members taking part in the study. Those with hemophilia provide a brief medical history, including hemophilia-related information, inhibitor history and the presence of other conditions such as hepatitis C and HIV. All participants have a blood sample taken for laboratory and research tests.

In collaboration with investigators of the Hemophilia Inhibitor Genetic Study (HIGS) multicenter study and the University of Lund, University Hospital, Malmo, Sweden, we propose to assess the role of genetic variants in the process of developing inhibitors to Factor VIII in persons with hemophilia. The discovery of genetic associations offers the potential to direct clinical management in order to prevent inhibitor development and improve clinical care in patients with inhibitors.

Eligibility Criteria:
* INCLUSION CRITERIA

DNA and relevant clinical data from properly consented hemophiliac subjects and family members (maximum estimated = 3500) will be provided to the LGD for genotyping and analysis.

EXCLUSION CRITERIA

No available subjects will be excluded to maximize power.
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)

This study will characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as an early response marker in recurrent, platinum-sensitive ovarian cancer treated with platinum-based therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient has ovarian, primary peritoneal, or fallopian tube cancer
* Patient has first or subsequent relapse
* Patient has had at least on prior platinum-based treatment for ovarian cancer
* Patient is scheduled to receive treatment with carboplatin or cisplatin monotherapy or combination where one of the drugs is a platinum
* Patient is not pregnant

Exclusion Criteria:

* Patient has had abdominal surgery within the last 6 weeks
* Patient has life expectancy \< 6 months
* Patient has had radiotherapy to the abdomen or pelvis within the last 6 months
* Patient has poorly controlled diabetes
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy

Exclusion Criteria:

* Patients with Type 1 diabetes mellitus
Physical Activity Intervention for Young Cancer Survivors

The proposed mixed methods pilot study will enroll 20 young breast cancer survivors into a 12-week technology-based, remotely-delivered, peer-moderated physical activity program to examine the effects of the intervention on objectively measured physical activity and multiple aspects of quality of life; and conduct qualitative analyses to refine the intervention for a future randomized controlled trial.

Young breast cancer survivors (i.e. those \< 50 years old) have lower survival rates than their older counterparts and experience unique physical and mental challenges associated with their cancer treatments. Depression, anxiety, and poor body image are common in young breast cancer survivors. Research in older breast cancer survivors has shown that physical activity can decrease cancer recurrence and mortality, and improve many aspects of quality of life. Few physical activity intervention studies have been conducted in young breast cancer survivors, despite the fact that young survivors would be best served by age-specific interventions designed to target their needs. Remotely-delivered, technology-based interventions may be important to help young breast cancer survivors overcome unique barriers to increasing physical activity and improving quality of life.

The study aims are: 1) Explore the feasibility and acceptability of a technology-based, remotely-delivered, peer-moderated physical activity intervention for young breast cancer survivors; 2a) Assess the invention's impact on change in physical activity; and 2b) Measure the intervention's effect on multiple aspects of quality of life

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer between 18-49 years old
* Completed active treatment (chemotherapy, radiation) at least 6 months prior to enrollment
* Self-report low levels of moderate to vigorous physical activity each week
* Accessible by phone or video chat
* Have a Fitbit compatible cellphone, tablet, or laptop with Internet

Exclusion Criteria:

* medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
* currently pregnant
* unable to commit to intervention schedule
* prisoner