cyrilzakka/clinical-trials huggingface dataset:
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A

The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.


Eligibility Criteria:
Inclusion Criteria:

* Severe Haemophilia A (FVIII:C \< 1%)
* Male patients \>= 18 years of age
* Previous treatment with a FVIII concentrate for at least 150 EDs
* Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start
* Immunocompetence (CD4+ count \> 200/uL)

Exclusion Criteria:

* Any coagulation disorder other than Haemophilia A
* Present of past FVIII inhibitor activity
* Severe liver or kidney disease
Visualization of Topical Zoryve vs. Vehicle Using Line Field Optical Coherence Tomography in Healthy Skin

The goal of this study is to visualize the deposition of topical 0.3% roflumilast (Zoryve) compared to vehicle using Line-Field Optical Coherence Tomography (LC-OCT) in vivo in healthy skin. We hypothesize that the application of topical 0.3% roflumilast (Zoryve) will result in distinct patterns of deposition within the epidermal and dermal layers compared to the vehicle. Specifically, we anticipate observing deeper penetration and more uniform distribution of roflumilast within the skin layers, indicative of enhanced efficacy, as visualized by LC-OCT imaging.

Primary Objective

Compare the deposition of Zoryve and the vehicle in the epidermal and dermal layers using LC-OCT.

Primary Endpoint

The primary endpoint of this study is a visual qualitative analysis of LC-OCT images conducted by an expert confocalist, Babar Rao MD. This analysis aims to assess the penetration of the active drug product compared to the vehicle.

Subjects will be instructed to apply topical 0.3% Zoryve once daily for seven consecutive days to a predetermined 2x2cm area on the dorsal surface forearm, as defined by the investigator. Additionally, participants will apply a topical cream vehicle provided by Zoryve to the dorsall side of the opposite forearm. Therefore, one forearm, will be designated for application of Zoryve, while the other forearm will the designated for application of the topical cream vehicle supplied by Zoryve. Subjects will apply the topical vehicle and roflumilast, daily, for 7 consecutive days. LC-OCT imaging will be conducted on both arms at various time points: baseline (T0A), 15 minutes (T0B), 1 hour (T0C), 8-12 hours (T0D), 24 hours (T0E), seven days after application (T7), and seven days after not applying cream (T14). LC-OCT imaging will follow a predefined image acquisition protocol, with investigators designating 2x2cm areas for imaging. The imaging protocol will include capturing 2D vertical photos, 3D photos, and 2D vertical videos per imaging site. Participants will be instructed to photograph the imaging sites to aid in the accurate application of the active drug product or vehicle cream base.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects over 18 years of age from the outpatient dermatology clinic, Rao Dermatology. All subjects must have provided written informed consent.

Exclusion Criteria:

* Subjects with a history of immune-mediated skin conditions will be excluded from participation. Additionally, participants who have received systemic therapy within the last 60 days will not be eligible. Those using topical therapy must have discontinued their current treatment for a minimum of seven days prior to enrollment.
Pemoline for Cocaine Abuse - 7

The purpose of this study is to evaluate the treatment of pemoline for cocaine abuse.


Eligibility Criteria:
Please contact site for information.
A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India

This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.

Exclusion Criteria:

* None
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT

We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.

From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 60 years old were eligible. Eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count (ANC) decreased to \< 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.

Eligibility Criteria:
Inclusion Criteria:

* Age 14\~60 years old
* Allogenic hematological stem cell transplantation(HSCT) patients.
* Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase \< 2 upper limit of normal, and/or total bilirubin \< 2.5 upper limit of normal, creatinine \< upper limit of normal.
* Informed consent.

Exclusion Criteria:

* Evidence of proven, probable or possible fungal infection at the time of enrollment.
* Patients were receiving anti-fungal treatment with proven SFI before transplantation.
* A history of hypersensitivity to G-CSF or GM-CSF.
Comparing the Effect of Metformin vs. Pep2dia as an Adjunct to Letrozole on Ovulation Induction and Pregnancy Outcomes in Overweight Women With PCOS

The goal of this clinical trial is to compare the effects of Metformin versus Pep2dia as adjunct treatments to Letrozole on ovulation induction and pregnancy outcomes in overweight women with polycystic ovary syndrome (PCOS). The main questions it aims to answer are:

Does Metformin improve ovulation rates more effectively than Pep2dia when used alongside Letrozole? Does Pep2dia enhance pregnancy outcomes compared to Metformin in this patient population?

Participants will:

Receive either Metformin or Pep2dia in addition to Letrozole. Undergo regular monitoring for ovulation and pregnancy outcomes. Researchers will compare the Metformin group to the Pep2dia group to see if there is a significant difference in ovulation and pregnancy rates between the two treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Anovulatory infertile women with PCOS for more than one year associated with overweight and seeking pregnancy.
2. Married women of reproductive age who lived with a husband and were sexually active.
3. Women with resistant to Letrozole.
4. Normal value of prolactin hormone.
5. Age group; 18-35 years
6. BMI ranging from 25 to 29 kg /m².
7. Standard parameters of the husband's semen
8. Diagnostic criteria for Rotterdam diagnosis of polycystic ovary syndrome:

Two of the following three criteria are required:

* Oligoovulation or Anovulation
* Hyperandrogenism: Clinical (hirsutism or less commonly male pattern alopecia) or Biochemical (raised free androgen index (FAI) or free testosterone).
* Polycystic ovaries on ultrasound (Christ et al., 2023).

Exclusion Criteria:

1. Hypersensitivity to letrozole, metformin or pep2dia.
2. Obese women with BMI ≥29 kg/m² or women with BMI \<25 kg/m².
3. FSH above 11 mg.
4. Any other cause of infertility other than anovulation due to overweight as uterine factor, tubal factor, male factor, ovarian pathology or endometriosis.
5. Any medical disorder that may affect pregnancy or systemic disease (cardiovascular, renal, hepatic, CNS diseases and hypo or hyperthyroidism)
6. Missed patient
7. Discontinuation of drug due to its side effects
Falls Prevention in Osteoporosis

The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.

Falling is a major health problem in the elderly causing physical and psychosocial problems. People with osteoporosis are at higher risk for fractures due to falling, because of decreased bone strength. The 'Nijmegen Falls Prevention Program" (NFPP) (Weerdesteyn et al, 2006) has been shown to reduce fall incidence rates by 46% in healthy community-dwelling elderly. This program was adapted in order to meet the specific demands and constraints of people with osteoporosis.

The contents of the program are an obstacle course, walking exercises, the practice of fall techniques, adjustment of gait abnormalities, weight bearing exercises and educational sessions.

The effectiveness of the program will be evaluated in a randomized clinical trial. Primary outcome measure is fall incidence. Additionally, laboratory assessments of gait and obstacle avoidance will be conducted in conjunction with questionnaires about balance confidence and activity level.

Eligibility Criteria:
Inclusion Criteria:

* osteoporosis (DXA T-score \< -2.5 in hip and/or vertebrae)
* able to walk at least 15 minutes without an helping device
* 65 years or older
* community dwelling
* at least one fall in the prior year

Exclusion Criteria:

* severe cardiac, pulmonary or musculoskeletal disorders
* pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease)
* use of psychotropic drugs
Efficacy Study of TEPSO® Socks in Improving Palmoplantar Pustulosis

The purpose of this study is to evaluate the efficacy of a special sock, manufactured using TEPSO®, compared to a normal cotton sock in the prognosis of symmetrical palmoplantar pustulosis present for at least one year.

The clinical manifestations of palmoplantar pustulosis have an important impact on well being and quality of life. The manifestation of the disease is often exacerbated by factors such as significant physical and mechanical stress resulting from repeated and prolonged pressure over the affected areas and by everyday clothing. These problems have led the textile industry Lenzi Egisto S.p.A. to conduct some preliminary analyses to find a fabric that meets the specific needs of psoriatic patients in relation to everyday clothing. This preliminary study led to the creation of a particular fabric, TEPSO®, with features specific to the identified needs. This material consists essentially of PTFE (commercially known as Teflon®) and thus presents interesting characteristics that make it suitable for creating garments for patients with psoriasis:

* Excellent flow properties and low surface friction
* non-stick
* Complete biocompatibility and chemical inertness

We can therefore speculate that in palmoplantar pustulosis high smoothness of the fabric and low coefficient of friction may translate into less discomfort felt by patients during normal physical activities, and into improved clinical course of the disease. In the end, it is expected that reduced mechanical compression and friction, would result into partial or complete clinical remission within a few weeks of use.

Therefore we propose to conduct a randomized controlled, double-blind, left-right clinical trial to assess the hypothesis that in palmoplantar pustulosis the use of TEPSO® could induce an improvement of disease and overall quality of life. To better assess the effects of treatment, the use of clothing in the study will be limited to symmetrical pustular lesions of feet in order to include areas that are comparable and relevant from a functional point of view.

Eligibility Criteria:
Inclusion Criteria:

* Palmoplantar pustulosis present for at least one year
* Symmetrical foot lesions with at least 5% of the skin surface involvement
* Difference less than or equal to 10% extension of lesions on both sides of the body
* Suspension for over 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)

Exclusion Criteria:

* Nonsymmetrical foot lesions or less than 5% of the skin surface involvement
* Difference of more than 10% extension of lesions on both sides of the body
* Patients who have performed, within 3 months before inclusion in the study, treatments with systemic drugs for psoriasis, immunosuppressive treatments (cyclosporine, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)
Vision Assessment With the Quick Contrast Sensitivity Function (qCSF) Method in Healthy Controls and MS

Victor2 is an observational cohort study over two years and is designed to investigate longitudinal changes of visual impairment in multiple sclerosis (MS). The investigators aim to recruit patients in the relapsing-remitting phase of the disease (n=50) as well as progressive MS patients (n=50). Both cohorts will be compared with age and gender matched healthy controls (HC). All participants undergo yearly clinical assessments including standard charts for visual acuity (Sloan, Snellen), a new computer adaptive test measuring the complete contrast sensitive function (CSF), optical coherence tomography and a vision related quality of life questionnaire (NEI-VFQ). The study aims to validate and extend previous finding from a cross-sectional study which found a better association between CSF and NEI-VFQ than for standard charts. Moreover, the study is designed to proof also a better association with anterior visual system integrity as assessed with OCT.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria relapsing-remitting MS

* Relapsing-remitting MS
* Expanded Disability Status Scale (EDSS) Score between 0 and 6.0
* No other major neurological or psychiatric disorder (such as major depression or schizophrenia)
* Age 18 - 65 years

Inclusion criteria progressiveMS

* Primary or Secondary-progressive MS according to the revised McDonald criteria
* Expanded Disability Status Scale (EDSS) Score between 3.0 and 6.0
* No relapse in the last 12 months
* No other major neurological or psychiatric disorder (such as major depression or schizophrenia)
* Age 18 - 65 years

Exclusion Criteria:

* Cataract and other major ophthalmological diseases (e.g. Uveitis, Glaucoma)
* Hyperopia \> 5 dpt, Myopia \> -7 dpt, Astigmatisms \> 3 dpt
* Neuromyelitis optica spectrum diseases
Vibration Response Imaging (VRI) in Dyspnea Patients Presenting to the ED

For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF causes is essential for proper management. The capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ED and required length of hospital admission.

The ability to assess pulmonary status rapidly by quantitative regional vibration technology offers significant potential advantage for earlier diagnosis. The VRI technique may provide a quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to pulmonary causes; thereby improving management and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide Informed Consent;

  -\>40 years of age;
* Estimated Body Mass Index \>19;
* Patient presented to the emergency department with a chief complaint of acute dyspnea.

Exclusion Criteria:

* Patients with obvious trauma or acute anxiety as a cause of dyspnea;
* Patient has already received directed therapy in the ED and symptoms are remarkably improved;
* Physician concern regarding possible harm to patient caused by positioning or ambulating the patient for VRI testing;
* Intubated or mechanically ventilated;
* Acute hemodynamic or ventilator instability requiring immediate resuscitation;
* Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
* Hirsutism.
Bed-rest, Muscle Mass and Insulin Sensitivity

In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber characteristics and insulin sensitivity will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Aged from 18-35 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* Smoking
* Performing regular resistance training (3+ times per week, carrying out progressive training) in the previous 6 months
* Hypertension (according to WHO criteria) and/or cardiovascular disease
* Any back/leg/knee/neck/postural complaints
* Use of any prescribed medication
* Type 2 diabetes mellitus
* Any family history of thrombosis
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Myocardial infarction within the last 3 years
* Use of anti-coagulants
Adverse Events Associated With Manual Therapies in Children

This study aims to evaluate the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger. A validated reporting system will be used to evaluate the adverse events and include a total of four questionnaires that are filled online. Adverse events will be evaluated immediately following the intervention and at 48h post-intervention.

The aim of this study is to investigate (1) the feasibility to conduct a prospective cohort study evaluating the adverse events associated with manual therapies in children of 5 years and younger and (2) to report preliminary data on the frequency and nature of the adverse events. Participating chiropractors will advertise the study in their private clinic through flyers and posters. Legal tutors interested to participate will access an information sheet and consent form using a link available on the flyers/posters. Legal tutors of participants will complete three questionnaires, one before the intervention to describe the child (e.g. age, sex, reason(s) to seek care), one immediately following the intervention to report immediate adverse events and one 48h following the intervention to report delayed adverse events. Clinicians will complete one questionnaire immediately following the intervention to describe the manual therapies delivered to the children. All questionnaires will be available online on a secured platform. The intervention will be determined by the clinician according the their evaluation of the child and could include spinal mobilization as well as soft tissue therapies.

Eligibility Criteria:
Inclusion Criteria:

* Children of 5 years or younger
* First or second treatment at one of the chiropractic clinic
* Spinal mobilization has to be clinically indicated

Exclusion Criteria:

* Children of 6 years or older
* Spinal mobilization not indicated
Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents

The purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (HPV) or Influenza.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Lives in United States
* Mother or female legal guardian of at least one child aged 9-13
* Able to understand English
* For HPV condition: Target child must not have received any doses of HPV vaccine
* For Flu condition: Target child must not have received the flu vaccine during the prior flu season

Exclusion Criteria:

* Under 18 years of age
* Not mother or female legal guardian of at least one child ages 9-13
* Not living in United States
* Not able to understand English and Spanish
* For HPV condition: Target child had already received at least 1 dose of the HPV vaccine
* For Flu condition: Target child received the influenza vaccine during the previous flu season
Erector Spinae Block, Epidural Analgesia and Intrathecal Analgesia in Thoracic Surgery

Pulmonary thoracic surgery is often responsible for severe postoperative pain, which is associated with an increase in postoperative morbidity and mortality. Moreover, postoperative thoracic pain has a strong impact on patient rehabilitation and is associated with an increase in hospital stay.

Various analgesic techniques allow effective management of pain in the context of thoracic surgery. Regional anesthesia, particularly, allows a powerful analgesia, and limits the use of opioids and their side effects. Among regional anesthesia techniques, thoracic epidural analgesia has become the gold standard for post-thoracotomy analgesia. However, it induces a sympathetic block that promotes in particular per and postoperative hypotension and acute urinary retentions. Thus, new regional anesthesia techniques have been developed and assessed in thoracic surgery in order to avoid side effects related to epidural analgesia, particularly paravertebral block and erector spinae block, but also intrathecal analgesia. Paravertebral block has shown analgesic efficacy after thoracic surgery, and its interest in reducing the risk of hypotension, acute urinary retention, pruritus and postoperative nausea and vomiting compared with the epidural analgesia. Erector spinae block, recently described and evaluated in this context of thoracic surgery, seems to have the same interests and to be easier to achieve than the paravertebral block, but has been little studied. Finally, intrathecal morphine is frequently used because of an easy and rapid realization, and because it allows an adequate analgesia and the reduction of the duration of stay in intensive care compared to the epidural one. However, despite its frequent use, very few studies have compared intrathecal anesthesia with the epidural and other peri-spinal blocks.

These three types of analgesia, epidural analgesia, intrathecal morphine, and erector spinae block are regional anesthesia methods regularly used for pulmonary surgery in the department of the investigators. All of these techniques have shown their analgesic efficacy, but each seems to have particular respective interests, in terms of achievement, management, or perioperative rehabilitation. The objective of the investigators study is to evaluate the effectiveness of each of its techniques to treat postoperative pain and improve the rehabilitation of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Thoracic surgery for pulmonary resection
* Scheduled regional anesthesia: epidural anesthesia, intrathecal morphine or erector spinae block

Exclusion Criteria:

* No epidural anesthesia or no intrathecal morphine or no erector spinae block performed