cyrilzakka/clinical-trials huggingface dataset:
The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i

Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.

We included severe ED patients that underwent radical prostatectomy at least one year previously and failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy. Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. This study further emphasises the need to study specific populations with unique etiologies causing ED.

Eligibility Criteria:
Inclusion Criteria:

* Post Radical prostatectomy
* ED of more than 6 months
* Rigidity score ≤ 2 during PDE5i therapy
* Stable heterosexual relationship for more than 3 months
* Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .

Exclusion Criteria:

* Prior surgery or radiotherapy in pelvic region
* Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Cardiovascular conditions that prevent sexual activity
Motivation of Patients Diagnosed With Multiple Sclerosis to Become Citizen Researchers

The study will based on qualitative methods investigate motivational factors among patients diagnosed with multiple sclerosis for registering nutrition, environmental factors, stress provoking factors and physical activity (NESPA). The aim is to gain knowledge on motivational factors for using a digital tool for collecting data on NESPA and incorporate this knowledge into a form which can be used in requirement specifications for such a digital tool.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Read, write and understand Danish

Exclusion Criteria:

* Aphasia
* Severe cognitive impairment
Red Light Ptosis Proof-of-Concept

This study tests a new treatment to help with droopy eyelids (ptosis) and eye movement problems (squint) in children and young people with genetically confirmed mitochondrial conditions - using red-light.

We use a torch to shine a red light through the closed eyelid for 3 minutes a day. The study will run for 18 months.

We believe that this treatment could help strengthen the muscle in the eyelid to make it easier to open the eyes, and could also help some children with squint.


Eligibility Criteria:
Inclusion: Age 3 to less than 18 years Genetically confirmed diagnosis of primary mitochondrial disease (known pathogenic mutation(s) in mitochondrial or nuclear DNA known to cause primary mitochondrial disease) Ptosis

Exclusion: Genetic diagnosis not consistent with primary mitochondrial disease. No genetic diagnosis Unable to cooperate with light treatment or ophthalmological assessments.
Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Safety and Efficacy of IDP-118 in the treatment of plaque psoriasis

A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, of any race, at least 18 years of age (inclusive).
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Key Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Safety and Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)

The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus anti-HIV drugs can help lower HIV levels in the blood (viral load).

At the time of study entry, all patients are receiving a HAART regimen consisting of three drugs from at least two classes of antiretroviral drugs. Upon entering the study, patients receive Remune or IFA at Weeks 0, 12, and 24. Patients remain on study for 40 weeks. Patients who have received three injections of Remune or IFA and whose plasma HIV-1 RNA level is less than 50 copies/ml at Week 26 discontinue HAART at Week 28. (If the patient has a plasma HIV-1 RNA level at or above 50 copies/ml at Week 26, he/she must have a measurement below 50 copies/ml at Week 27 to proceed with HAART discontinuation at Week 28. If by Week 27 the patient does not have a plasma HIV-1 RNA level below 50 copies/ml, the patient does not discontinue HAART but remains on study and has study visits at Weeks 34 and 40.) Patients who discontinue HAART have their plasma HIV-1 RNA levels measured on the day HAART is discontinued and at Days 3, 5, 7, 10, 14, 21, 28, 35, and 42 after discontinuation. Patients with a plasma HIV-1 RNA level of at least 5,000 copies/ml at Week 34 restart HAART at that time. (Patients whose plasma HIV-1 RNA level reaches greater than or equal to 100,000 copies/ml on two occasions before Week 34 have the option of restarting HAART immediately.) Patients whose plasma HIV-1 RNA level is less than 5,000 copies/ml at Week 34 do not restart HAART unless their level increases to at least 5,000 copies/ml. Patients who discontinue HAART are monitored intensively for the duration of the study. Patients have 27 visits if they stay on study until completion at Week 40.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are receiving an anti-HIV drug combination that contains three drugs from at least two classes of anti-HIV drugs (such as protease inhibitors). Patients must have been receiving this drug combination for at least 6 months before study entry. Before beginning this drug combination, patients must have taken either no anti-HIV drugs or only one or two nucleoside analogues (NRTIs).
* Had a viral load between 5,000 and 100,000 copies/ml before beginning their current anti-HIV therapy.
* Have a viral load below 50 copies/ml while on their current anti-HIV therapy within 2 weeks before study entry.
* Have a CD4 count greater than 350 cells/mm3 at the time of study entry.
* Are at least 13 years old (consent of parent or guardian required if under 18).
Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity

Iron deficiency (ID) anaemia (IDA) is a global public health problem, with the highest prevalence in Africa and in South-East Asia. While immunization programs have achieved high global coverage, vaccines often underperform in low- and middle-income countries (LMIC). The cause remains uncertain, but undernutrition, including ID, likely plays a role. Our recent in vitro and in vivo studies have shown the importance of iron status in adaptive immunity and vaccine response. Hypoferremia blunted T cell, B cell, and neutralizing antibody responses to influenza virus infection in mice, allowing the virus to persist. Iron deficient anaemic Kenyan women receiving intravenous iron at time of vaccination had a better immune response to the first dose of the ChAdOx Coronavirus 19 (COVID-19) vaccine and yellow fever vaccine. Japanese encephalitis and typhoid fever are endemic in Thailand. Vaccines are available but show variable efficacy. Whether ID impairs adult vaccine response to the live attenuated Japanese encephalitis (JE) and the Typhoid Vi polysaccharide (Vi-PS) vaccine and whether iron repletion via iron fortification improves vaccine response is uncertain.

The objective of this study is to assess whether IDA in Thai women impairs immune response to the JE and the Typhoid Vi-PS vaccine and whether fortification iron improves their response.

In this double-blind randomized controlled trial, IDA women will be assigned to two study groups: group 1 (fortification group) will receive iron-fortified biscuits (15mg iron as ferrous fumarate) for 56 days; group 2 (control group) will receive non-fortified biscuits for 56 days. All women will receive live attenuated JE and Typhoid Vi-PS vaccine on study day 28. Vaccine response will be measured 28 days after vaccination (on day 56) in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the trial.
* Female aged 18-49 years.
* Diagnosed with anaemia (i.e. hemoglobin (Hb) concentration \<12 g/dl), but no severe anaemia (Hb \<8 g/dl), and iron deficiency (ZnPP \>40 µmol/mol)
* Anticipated residence in the area for the study duration

Exclusion Criteria:

* Pregnant (confirmed by rapid test during screening and at time of vaccination), lactating or planning pregnancy during the trial.
* Blood transfusion or intravenous iron treatment within 4 months of study start
* Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
* Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)
* Treatment with supplemental iron two weeks prior to enrolment
* JE or typhoid vaccine within the past two years
Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a Karnofsky (adult) Performance Status of at least 70%.
* Patients must have adequate organ function

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Active viral, bacterial or fungal infection
* Patient seropositive for Human Immunodeficiency Virus (HIV-I /II); Human T-Cell Lymphotrophic Virus (HTLV -I /II)
* Presence of leukemia in the Central Nervous System (CNS).
Connected Through Coaching for Flourishing Families

Despite the known association between the quality of participant relational engagement with service providers and clinical outcomes, limited studies have examined caregiver Relational Responsiveness (RR) as a mechanism to achieve maltreatment prevention program outcomes. Using a realist-informed mixed method approach, this study will examine RR's role in mediating the effects of a community-based maltreatment prevention program, the Family Success Network (FSN) on protective factors against maltreatment and the contexts within which RR's mediation effects are activated or inhibited.

Maltreatment prevention programs can promote public health by building protective factors among at-risk families. To maximize their benefits, programs should be delivered as intended by maintaining fidelity. Participant responsiveness (PR) is an under-studied fidelity construct defined as the degree to which participants "respond to or are engaged by" intervention at the behavioral, attitudinal, and relational levels. However, previous studies mostly focus on behavioral and attitudinal responsiveness such as attendance, follow-through, and satisfaction. The purpose of this study is to examine the role of participant Relational Responsiveness (RR) as a mechanism to increase protective factors against child maltreatment among the caregivers participating in the Family Success Network (FSN). The FSN is a community-based maltreatment prevention program piloted to serve 3 under-served counties in Ohio with high maltreatment rates. In FSN, coaches and families collaboratively develop a tailored plan of services designed to increase family protective factors. Focusing on primary and secondary prevention, FSN serves families with no history of substantiated maltreatment. Leveraging the parent study (clinicatrials registration currently in progress), which is a Randomized Controlled Trial (RCT) funded by the Children's Bureau, the proposed study will pursue the following aims; 1) To examine the structural validity of the Relational Responsiveness (RR) measure among FSN participants; 2) To determine the degree to which RR mediates FSN effects and whether RR's mediation effects are moderated by caregiver race and gender; 3) To identify contexts within which RR's mediation effects are activated or inhibited using a realist informed mixed-method approach. The parent study focuses on FSN outcome and process evaluations. Aims 1 and 2 of this study will utilize quantitative data collected through the parent RCT (protective factors and Working Alliance Inventory-Short Revised). Aim 3 will use mixed data involving the quantitative data collected through the parent RCT and the qualitative data to be collected in this study.

Eligibility Criteria:
Inclusion Criteria:

* Being an adult primary caregiver living in the tri-county area
* Having at least one child aged between 0-17
* Reporting at least one maltreatment risk factor at the time of intake
* Receiving family coaching services at Tier II and above in FSN.

Exclusion Criteria:

* Having a substantiated history of child maltreatment
Reactive Oxygen Species in the Pathogenesis of Diabetic Complications

Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy and incipient nephropathy in these models. In cultured vascular cells, it also reduces aldose reductase gene expression, activity, and sorbitol levels. It does so by activating the enzyme transketolase. α-lipoic acid, a potent antioxidant, has also been reported to reduce both diabetic microvascular and macrovascular complications in animal models. To determine whether benfotiamine in combination with α-lipoic acid would normalize markers of ROS-induced pathways of complications in humans, we performed a pilot study in subjects with Type 1 diabetes using one daily dose of benfotiamine in combination with α-lipoic acid.

The glycemic status of study patients was assessed by measuring baseline values of HbA1c, fructosamine, and fasting plasma glucose. Mean HbA1c was 8.7+ 0.7%, mean fructosamine was 421+29 mg/dl (normal range 174-286 mg/dl), and mean fasting blood glucose was 198+44 mg/dl.

At day 0, subjects levels of markers of two benfotiamine-sensitive pathways were determined: intracellular advanced glycation endproduct (AGE) formation, as reflected by a marker of increased intracellular methylglyoxal adducts in endothelial cells, angiopoietin 2 and hexosamine pathway activity, measured by determination of N-acetylglucosamine-modified protein in circulating monocytes. PKC activity in circulating monocytes could not be measured because the amount of blood required exceeded that approved by the Committee on Clinical Investigations. Serum levels of 6-keto-PGF-1 , a stable product produced by the nonenzymatic hydration of the antiatherogenic mediator prostacyclin were also determined. Subjects then took benfotiamine 300 mg twice a day, (Advanced Orthomolecular Research, Calgary, AB,CANADA) and slow-release α-lipoic acid (600 mg twice a day) (MRI, San Francisco, CA) for 28 days. Blood was obtained at day 0, day 15, and day 28.

Data were analyzed using 1-factor analysis of variance to compare the means of all the groups. The Tukey-Kramer multiple comparisons procedure was used to determine which pairs of means were different.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Type 1 diabetes duration between zero and fifteen years
* current insulin therapy

Exclusion Criteria:

* Female
* proliferative retinopathy
* microalbuminuria
* symptomatic diabetic neuropathy
* cardiovascular disease
* taking medications
* smoking
Serum Endostatin Type 2 Diabetic Patients

To assess the relationship between serum endostatin (ES) and Coronary artery calcification (CAC) in type 2 diabetic (T2DM) patients.

elevated serum endostatin levels were independently associated with increased risk, severity and progression of coronary artery calcification independent of traditional cardiovascular disease risk factors in T2DM subjects with known coronary artery disease. So, Measurement of serum ES levels can improve the diagnosis of coronary artery calcification and could be useful as a high sensitive marker for the presence and progression of atherosclerosis in T2DM patients.

Eligibility Criteria:
Inclusion Criteria: - Patients were between the ages of 50 and 70 years at enrollment.

* Symptomatic or previously recognized coronary artery disease for all the study population.
* Type 2 diabetic patients with the onset of type 2 diabetes occurred at age 30 years or older with no history of ketoacidosis for group II subjects.

Exclusion Criteria:

* left ventricular ejection fraction (LVEF) ≤40%, chronic heart failure, unstable angina, Myocardial infarction, arrhythmia, valvular heart disease, coronary artery bypass surgery, and history of stent placement, liver diseases, malignancy, glomerular filtration rate index \< 35 mL/min/m2, serum creatinine level above 4.5 mg/dL, body mass index \>30 kg/m2 or \< 15 kg/m2, pulmonary edema, stroke, acute infections, severe trauma, recent surgery, inflammatory conditions, thyrotoxicosis, pregnancy and known allergic reactions.
PP13 and Doppler Study to Predict Preeclampsia

Assessment of biochemical and sonographic marker to predict the risk for developing preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood flow through the uterine maternal arteries is assessed.

PP13 is produced by the placenta and released to the maternal blood circulation. It has been shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al., 2005). The purpose of this study is to combined the assessment of the biochemical markers with Doppler in the first and the second trimester to provide a comprehensive evaluation of various methods for sequential and combined analysis to assess the risk for developing preeclampsia.

This is a prospective observational study enrolling all comers who attend the prenatal clinic for first trimester assessment of the risk for Down syndrome. All women are providing medical and obstetric history, demography and blood samples along with Doppler pulsatility Index during the first and the second trimester at GA 10-13 weeks and 21-23 weeks. When possible - blood will be drawn at hospital admission for delivery. Measurements of sonography and serum markers are done blinded to pregnancy outcome.

Patients will be assigned to three groups:

1. All comers attending the prenatal testing at GA 10-13.
2. Patients with a history of at least 2 pregnancy loss or preterm delivery and treated with low molecular weight heparin at 40-80 mg/day from admission to until 12 weeks after delivery.
3. Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.

Eligibility Criteria:
Inclusion Criteria:

* Women age 16-45 with viable pregnancy as defined by CRL and after signing on an informed consent
* In group 1 all patients meeting the above are eligible when GA is below 14 weeks
* In grop 2 all patients

Exclusion Criteria:

* Gestation age at enrolment \> 13 weeks and 6 days by LMP verified by ultrasound at blood taking
* Mental retardation or other mental disorders that impose doubts regarding the patient's true willingness to participate in the Study
Promoting Repeated HIV Self-testing Among MSM in Hong Kong

In this longitudinal study, we will firstly construct a cohort of HIV negative MSM, who will be exposed to an online video-based intervention promoting HIV testing in general and real-time HIV self-testing with online counselling service (HIVST-online) in particular. Participants will receive intervention at baseline, Month 6 and Month 12.

500 MSM will be recruited via venue-based, online outreach, and NGO referrals. At baseline, Month 6 and Month 12, participants received online intervention promoting HIV testing in general and HIV testing with online real-time counseling service. Free HIV self-testing kits will be mailed to participants at baseline, Month 6 and Month 12. Upon appointment, a testing administrator will provide online real-time pre-test and post-test counseling service for HIV self-testing users.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese speaking men
* ≥18 years old
* Anal intercourse with at least one man in the last six months
* Access to online face-to-face communication tools (e.g., Line, Skype, WhatsApp)

Exclusion Criteria:

* Self-reported to be HIV positive