cyrilzakka/clinical-trials huggingface dataset:
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.

Idiopathic pulmonary fibrosis (IPF) is a diffuse lung disease with a histological picture of usual interstitial pneumonia and a deteriorating clinical course. The prognosis is poor. Chronic alveolar inflammation with associated parenchymal remodeling is theorized to promote an ongoing abnormal fibrogenic repair response. Corticosteroids and immunomodulatory agents have not been shown to benefit IPF patients. Recently several published clinical studies have indicated a strong correlation between IPF severity and/or disease progression and the levels of specific plasma biomarker proteins related to epithelial cell health and extracellular matrix turnover.

PRM-151 is being developed for potential therapeutic uses to prevent, treat, and reduce fibrosis.

This study is the first intravenous multiple-dose study in humans, and will be conducted in patients with IPF. Patients will be randomized to receive either PRM-151 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Men or women of non-childbearing potential aged 40 to 80 years at screening.
* Diagnosis of idiopathic pulmonary fibrosis (IPF) as determined by high resolution computerized tomography (HRCT) and pulmonary function tests.

Exclusion Criteria:

* History or presence of connective tissue disorder, tuberculosis (TB), cystic fibrosis, sarcoidosis, amyloidosis or other pulmonary disease except idiopathic pulmonary fibrosis (IPF).
* History or presence of chronic pulmonary obstructive disease, severe pulmonary hypertension, drug-induced pulmonary toxicity, other forms of idiopathic pneumonia, or interstitial lung diseases associated with environmental exposure medication or systemic disease.
* High resolution computerized tomography (HRCT) findings inconsistent with idiopathic pulmonary fibrosis(IPF).
A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Three Preparations of Low-Dose Oral Alpha Interferon in HIV-Infected Patients With CD4+ Counts >= 50 and <= 350 Cells/mm3

To evaluate the effects of three preparations of low-dose oral interferon alpha (i.e., Alferon LDO, Veldona, and Ferimmune) on HIV symptoms in HIV-infected patients. To evaluate differences in response to oral interferon alpha according to gender, race/ethnicity, and use of antiretrovirals.

Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.

Previous or ongoing clinical trials to test the efficacy of low-dose oral interferon alpha have produced different results, and it is not clear whether the differences were due to the interferon alpha products used or to problems in the study design. Therefore, three preparations will be compared to evaluate their potential efficacies.

Patients are randomized to receive 6 months of Alferon LDO alone, Alferon with Veldona, Alferon with Ferimmune, or three placebos, with follow-up visits monthly.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Symptomatic HIV infection.
* CD4 count 50 - 350 cells/mm3.

Prior Medication:

Allowed:

* Prior antiretrovirals (dose must be stable for at least 6 weeks prior to study entry).
* Maintenance therapy for a chronic condition.

Exclusion Criteria

Patients with the following prior condition are excluded:

* Change in antiretroviral therapy within past 6 weeks.

Prior Medication:

Excluded:

* Oral IFN-alpha or other immune-based therapy within the past month.
* Therapy for any acute disease within the past week.
Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety


Eligibility Criteria:
Inclusion Criteria :

Inclusion criteria to be checked at the screening visit (SC):

1. Toddlers, children and adolescents:

   Sub-Group 1: from 12 months to 3 years of age on the day of inclusion

   Sub-Group 2: from 4 to 6 years of age on the day of inclusion

   Sub-Group 3: from 7 to 9 years of age on the day of inclusion

   Sub-Group 4: from 10 to 12 years of age on the day of inclusion

   Sub-Group 5: from 13 to 15 years of age on the day of inclusion
2. Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)

Inclusion criteria to be checked at the inclusion visit (V01):

1. Toddlers, children and adolescents:

   Sub-Group 1: from 12 months to 3 years of age on the day of inclusion

   Sub-Group 2: from 4 to 6 years of age on the day of inclusion

   Sub-Group 3: from 7 to 9 years of age on the day of inclusion

   Sub-Group 4: from 10 to 12 years of age on the day of inclusion

   Sub-Group 5: from 13 to 15 years of age on the day of inclusion
2. Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
3. Able to attend all scheduled visits and to comply with all trial procedures
4. Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
5. Subject HBsAg seronegative and ALT \<40 IU/l according to the screening results

Exclusion Criteria :

Exclusion criteria to be checked at the inclusion visit (V01):

1. Participation in another clinical trial in the 4 weeks preceding trial vaccination
2. Planned participation in another clinical trial during the present trial period
3. Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
4. Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
5. Chronic illness at a stage that could interfere with trial conduct or completion
6. Blood or blood-derived products received in the past 3 months
7. Any vaccination in the 4 weeks preceding the trial vaccination
8. Any vaccination planned in the 4 weeks following the trial vaccination
9. History of hepatitis A infection (confirmed either clinically or serologically )
10. Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
11. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
12. History of /current seizures
13. Clinical or serological evidence of systemic illness including Hepatitis C and HIV
14. Febrile (axillary temperature ≥ 37.1°C) or acute illness
Biofilm Infection in Adults and Children Burn Injury

The objective of the study is to analyze the different implications (such as graft loss and conversion of indeterminate depth burns) of biofilm infections in burn patients. Additionally, it also aims at comparing children's resistance to biofilm infection at wound site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.

Subjects will be recruited from three different age groups: 2-18 years old, 18-49 years old, and ≥ 50 years old. 150 patients will be enrolled in each age group for arms 1 and 2. Arm 3 consists of all patients enrolled in the study and involves drawing whole blood for analyzing cytokine response. Subjects will have at day 0, 3, 7, 14, 21, 28 +/- 2 days (as applicable until graft surgery occurs).At each study visit the following will be collected: burn wound data \[Lund-Brower Chart, TBSA burn size, date of onset, length, width, area, depth of burn injury (as applicable), Standard of Care (SoC) treatment for burn\] will be recorded, SoC labs since the onset of the burn wounds will be recorded (CBC w/ diff and glucose as applicable), digital imaging of the burn injury(s), Laser Doppler Imaging (LDI) will also be perfomed. Biopsies will be collected depending on the size of injury (4 from 2cm² burn size, to 10 from \>8cm² burn size). Blister fluid will be collected by draining the fluid with a needle and syringe.Subjects in arm 2 will receive their Standard of Care (SoC) dressing prescribed by their provider or will receive the study dressing, 4x4 Procellera that will be applied to a specific area of the burn injury.

2 weeks after the grafting surgery, subjects will return for study visits at day 14, 21, 28 post-grafting where the following activities will be completed - burn wound data and medication review, digital image of the burn injury(s), LDI imaging, HUSD imaging, trans-epidermal water loss (TEWL) measurement. Whole blood will be collected.

Each subjects' medical chart will be followed for 3 months post completion of the study to identify patient outcomes (i.e. wound closure data, infection status/type, treatment status, surgical outcomes/complications - graft loss, patient death as applicable).

Eligibility Criteria:
Inclusion Criteria (Aim 3 is included in all criteria):

Aim 1 and 2:

* Ages 2 yrs. and older

Aim 1:

* Thermal burns with 2-14% total body surface area (TBSA) injury
* Patients present within 3 days from the time of thermal burn injury
* Diagnosed by burn surgeon as having deep partial thickness or indeterminate depth burn (defined as uncertainty between deep second degree or third degree burns)

Aim 2:

* Thermal burns with ≥20% TBSA

Exclusion Criteria (Aim 3 is included in all criteria):

Aim 1 and 2:

* Patients with chemical or electrical burns
* Pregnant women
* Patient/legal guardian/or next of kin unable to consent

Aim 1:

* Immunosuppressed
* Taking immune modifying medications
* Patients requiring \>72 hrs. hospital stay
* Harmonic Ultrasound \& Doppler Imaging (HUSD) will be used to exclude burn wounds with thrombosed vessels at initial presentation
Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis

The aim of this trial is to evaluate if an enhanced information by using a mobile App can increase subjective information level in patients with severe aortic stenosis and may therefore improve patient-reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* severe aortic valve stenosis
* planned aortic valve replacement (TAVI)
* Patient is willing and able to complete the surveys in German language
* Written informed consent by the trial subject

Exclusion Criteria:

- Language barrier
Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery

Nerve blocks are used to decrease the amount of pain you have after surgery. We are asking you to take part in a research study. This research study will test whether adding a medicine called clonidine to nerve blocks helps to improve them. Nerve blocks typically last less than a day after surgery. We are looking for ways to make them work better and last longer. Clonidine is approved for use as a blood pressure medicine. Its use in nerve blocks is investigational, but it may help nerve blocks to last longer. Adding clonidine to nerve blocks may also decrease the amount of pain medicine a person has after surgery. All people who enter this study will receive a nerve block with the normal medicine, but half of people will also have clonidine added to their nerve block. This study will enroll 60 participants from UAB hospitals.


Eligibility Criteria:
Inclusion Criteria:

1. Patient undergoing foot or ankle surgery with popliteal nerve block planned for postoperative analgesia.
2. Adult, 19 years of age and older.
3. Subject classified as American Society of Anesthesiology (ASA) class 1, 2, or 3. The ASA defines these statuses as follows: 1-A normal healthy patient. 2-A patient with mild systemic disease. 3-A patient with severe systemic disease.

   -

Exclusion Criteria:

1. Any subject not classified as an ASA 1, 2, or 3.
2. Allergy/intolerance to local anesthetic, clonidine, and/or oxycodone.
3. Subject with a history of continuous opioid use for greater than one month prior to surgery.
4. Pre-existing neurologic deficit in lower extremity (surgical site).
5. Clinically significant coagulopathy (hemophilia, von Willebrand disease).
6. Patients who fail to follow the UAB Department of Anesthesiology Algorithm for the Preoperative Management of an Angiotensin Converting Enzyme Inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB). A copy of the algorithm can be found in Appendix 1. -
HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

We recently reported the superiority of the natural cycle to a natural cycle controlled by the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on endometrial receptivity.Based on the above findings we conducted the first prospective study that assesses whether there is a difference in pregnancy rate after intrauterine insemination (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural cycles controlled by hCG for final ovulation.


Eligibility Criteria:
Inclusion Criteria:

* age ≤ 36 years,
* regular menstrual cycles,
* body mass index (BMI) between 18 and 29 kg/m²,
* basal levels of FSH (≤ 12 IU/l),
* estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle, normal hysterosalpingography (maximum 3 months prior starting the cycle).
* The use of donor sperm was also accepted as inclusion criteria.

Exclusion Criteria:

* PCOS
* endometriosis
An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants

A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants with a body mass Index (BMI) of 18.0 kg/m\^2 - 30.0 kg/m\^2.
* Males and females not of child bearing potential.
* Participants in the Japanese Cohorts in Part C must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese.)

Exclusion Criteria:

* Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study.
* Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months.
* Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease
Application of Contrast Enhance Ultrasound to Evaluate Hemodynamics Change in MCA With Moderate to Severe Stenosis

Objective:

To monitor and evaluate the change of intracranial hemodynamics and MCA stenosis after 24-week atorvastatin treatment using CEUS, CTA and DSA.

Study design:

Total 30 patients (60 arteries) will be enrolled in this study, who had MCA infarction within 6 months prior to screening, and has not received any statins treatment before stroke.

Eligible patient will receive atorvastatin 40mg treatment for 24 weeks. Hemodynamics changes and MCA stenosis will be evaluated using CEUS at baseline, 3-month,and 6-month. MCA stenosis, bloodstream velocity, as well as clinical symptoms will be assessed at each visit and compared to baseline.

The cerebral infarction resulted from medially and heavily narrow MCA is determined by the three-type screen method .For the first screen cerebral infarction patients of MCA area who has the stroke or TIA history In 6 months are determined by the clinic stroke measure table,transstadial Doppler ultrasonography (TCD) carotid ultrasonography and skull CT. For the second the MAC area infarction and vessel narrow are determined by the skull magnetic resonance (MRI) and magnetic resonance vessel imaging (MRA) and the MCA trend bloodstream dynamics feature and narrow extent Are observed by the strengthened ultrasonography (CEVS) For the third, The MCA narrow extent is measured by the DSA test which is currently regarded as a gold standard and /or by the CTA .The atorvastatin 20mg Treatment is given to the patients who all use the antiplatelet medicine The clinic symptom improvement MCA narrow extent and bloodstream velocity are dynamically observed visited and analysed respectively at the basic line 3 and 6 months after treatment

Eligibility Criteria:
Inclusion Criteria:

* Patients who had MCA infarction of unilateral with moderate to severe stenosis within 6 months prior to screening, and has not received any statins treatment before stroke.

Exclusion Criteria:

* With side of extracranial carotid artery 70-100% severe narrow or block
* Vertebrobasilar artery lesions caused by cerebral infarction
* Have rheumatic heart disease, the atrial fibrillation of heart disease, those who Cerebral hemorrhage patients
* Serious liver and kidney function is not complete patients.
Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients

MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible.

The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients


Eligibility Criteria:
Inclusion Criteria (patients):

* cancer patients during chemotherapy, immune therapy or radiotherapy
* having symptoms/side effects that can be effectively treated by exercise (e.g. fatigue) and/or are interested in exercise oncology counseling

Inclusion Criteria (care providers)

- involved in the implementation process

Exclusion Criteria (both):

- Insufficient German language skills

Exclusion Criteria (care providers only):

- Duration employed \<6 months
Assessment of CXCL5 Level in SLE Patients and Its Correlation with Disease Activity

Assessment of CXCL5 biomarker in Serum of patients of SLE in comparison to healthy patients and its correlation with disease activity

Systemic lupus erythematosus (SLE) is a common autoimmune disease involving multiple organs and systems. SLE is characterized by the production of a large number of autoantibodies and the deposition of various immune complexes in target tissue .(1,2).

Chemokines are a large family of small secreted proteins that are identified as attractants of different types of leukocytes, including neutrophils, to sites of infection and inflammation. They are produced locally in tissues and act through interaction with specific G protein-coupled receptors that are predominantly expressed on leukocytes(3,4,5). Interaction between chemokines and their receptor plays an essential role in the development and homeostasis of the immune system as well as inflammatory response (6) . Although most chemokines promote locomotion of immune cells, some of them might inhibit leukocyte migration under certain circumstances (7).

We found in a study that serum CXCL5 levels were significantly lower in SLE patients than in healthy individuals and were negatively correlated with disease activity. By administering CXCL5 intravenously in a mouse model of lupus, mouse survival improved, and indices of disease activity reduced significantly(8,9). This finding suggests that homeostatic chemokines in peripheral blood might play an anti- inflammatory role and that serum levels of anti- inflammatory chemokines such as CXCL5 would be decreased in patients with autoimmune diseases (7) .

So in this study, we aim to determine level of CXCL5 in SLE patients , association of chemokine levels with demographics, clinical, and laboratory investigations of patients and its correlation with disease activity (7).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Patients who are diagnosed as SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) Citeria (10,11).

Exclusion Criteria:

* age \< 18 years old

  * Patients unwilling to participate in the study.
  * Patients with other autoimmune diseases.
  * Patients with malignancy or infections.
  * Pregnancy and lactation