cyrilzakka/clinical-trials huggingface dataset:
PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

The investigators set up a randomized controlled clinical trial to evaluate the effectiveness of plasma rich in growth factors (PRGF) injections into the masseter muscle trigger points for myofascial pain treatment. The investigators also seek to compare PRGF injections effectiveness with local anesthetic injections.

Dry needling and local anesthetics injections release trigger point by disrupting the membranes of a tout band. However, the injected substance itself does not affect the pathophysiological mechanism of the trigger point.

It is known that the platelets release growth factors who can enhance muscle regeneration processes and moreover reduce chronic pain.

The investigators raised a hypothesis that PRGF injections into the trigger points in masseter muscle can be an effective treatment method for the myofascial pain.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients.
* Diagnosed myofascial pain syndrome in one side of the masseter muscle (diagnosis is based on diagnostic criteria described by Travell and Simons: 1) palpable taut band, 2) spot tenderness in a taut band, 3) pain recognition.
* Patients have never had injections into their masseter muscle.

Exclusion Criteria:

* Myofascial trigger points in other masticatory muscles.
* Head and neck region inflammations that causes pain.
* Temporomandibular joint pathology which causes pain.
* Trigeminal nerve neuralgia.
* Head and neck region oncological diseases.
* Myofascial trigger points in both sides of masseter muscles.
A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 in participants with presbyopia (inability to focus on items close-up).


Eligibility Criteria:
Inclusion Criteria:

* Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living

Exclusion Criteria:

* Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study
* Corneal abnormalities in either eye that interfere with visual acuity
* History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery
* Diagnosis of glaucoma or ocular hypertension.
EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS

Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings in the intensive care unit.

Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings and met the inclusion criteria in the Intensive Care Unit between 01.08.2023 and 01.02.2024

Eligibility Criteria:
Inclusion Criteria:

* C-reactive protein (CRP) ≥ 100 mg/l
* Procalcitonin (PCT) \< 2 ng/l
* Patients aged 18-80 years who were treated with cytokine adsorption due to vasoplegic shock

Exclusion Criteria:

* Patients under 18 years of age
* Patients with suspected or proven bacterial cause of vasoplegic shock.
* Those who did not approve to participate in the study
* Patients without vasoplegic shock
* Patients with CRP \< 100 mg/l, PCT ≥ 2 μg/L
Pharmacokinetics, Efficacy, Gametocyte Carriage, Birth Outcomes Following Sulfadoxine-pyrimethamine Intermittent Presumptive Treatment in Pregnant Women

The main purpose of this study is to compare the drug levels of sulfadoxine-pyrimethamine found when given to pregnant women for the prevention of malaria to those found in pregnant women given the same drug with artesunate for the treatment of malaria, and also with those drug levels found in non-pregnant women in other malaria treatment studies.

Pregnancy increases the risk of malaria progression and complications with up to a 10-fold increase in the malaria case fatality rate in areas of low transmission. Sulfadoxine-pyrimethamine (SP) is used widely in Africa for the systematic intermittent presumptive, or preventive, treatment (IPTp) during the second and third trimester of pregnancy and a national program of IPTp with SP has been implemented recently in Mozambique. There is evidence that the kinetics of several other antimalarial drugs are altered in pregnancy to the extent that doses are not adequate in pregnancy, however no published study has included a pharmacokinetic component to confirm that standard doses of SP are optimal in this vulnerable patient group. This study therefore creates the opportunity to study whether the pharmacokinetic properties of SP are altered by physiological changes that occur during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female, older than 18 years, \> 35kg.
* Gestational age \> 16 weeks (fundal height \> 16cm) and below 36 weeks gestation.
* Documented informed consent.
* Lives close enough to the study site for reliable follow up and is willing to attend ANC and follow-up visits regularly.

Exclusion Criteria:

* Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia
* Has received anti-malarial treatment in the past 7 days and/or sulfadoxine-pyrimethamine in the past 28 days.
* Known hepatic or renal impairment
* Has received chloramphenicol, cotrimoxazole or tetracyclines (including doxycycline) in the past 7 days or is likely to require these during the study period.
* History of G6PD deficiency.
* Has a history of allergy to any of the study drugs (including other sulphonamides e.g. cotrimoxazole).
* Serious underlying disease that in the opinion of the clinic team and/or Principal Investigator would make the patient unsuitable for the study in terms of their safety or study analysis.
* Imminent delivery expected.
* Prior inclusion in this study.
Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the ICU based on inflammatory markers has not been extensively studied.

Procalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill patients and can be used to monitor disease activity in sepsis and systemic inflammation. This study will examine the effect of PCT guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU
* Age \> 18 years
* Antibiotic therapy for sepsis with a suspected or proven focus of infection

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, Toxoplasmosis, Legionellosis, Listeriosis)
* Indication for prolonged systemic prophylactic antibiotic therapy
* Severe viral or parasitic infections (hemorrhagic fever, malaria)
* Antibiotic therapy started 48 hours before enrollment
* Severe immunocompromised patients (AIDS with a CD4 count \< 200cells/mm3, severe neutropenia(\<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation)
* Patients foregoing life sustaining treatment
Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

* The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation.
* In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
* History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days
* (12) months prior to enrollment
* At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
* Refractory to at least one Class I-IV anti-arrhythmic drug (AAD)
* Eighteen (18) years of age or above

Exclusion Criteria:

* Previous left atrial ablation procedure
* Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
* Known severe cerebrovascular disease or history of cerebrovascular event (\< 1 month)
* Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding
* Active infection or fever (\>100.5 F/38 ◦C)
* Sepsis
* Cardiac surgery within the past two months.
* Short life expectancy (\<1 yr.) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease Significant anemia (hemoglobin \< 8.0 mg/dL)
* Severe uncontrolled systemic hypertension (systolic pressure \> 240 mm Hg within the last 30 days)
* Documented anaphylaxis during previous exposure to angiographic contrast media
* Uncontrolled congestive heart failure (NYHA1 Class III or IV)
* Unstable angina or acute myocardial infarction within the past three months
* Bleeding, clotting disorders, or known thrombosis
* Severe Peripheral vascular disease
* Uncontrolled diabetes
* Heart valve replacement
* Mitral clip (E-valve)
* Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study
* Active participation in another investigational protocol currently or the last 30 days
* Unable or unwilling to take anti-coagulants
* Unwilling or unable to comply with any protocol or follow up requirements
Implementation of the Intravitreal Injection Administered by Nurses

Introduction:

Intravitreal injections involve medication administration into the eye to treat ocular diseases and protect vision. Through an injection, the medication is introduced into the vitreous cavity, an area located at the back of the eye, behind the lens. The intravitreal injection (IVI) is a minimally invasive process administered at personalized regular intervals. It is a common procedure in ophthalmology for patients who require it. International experiences demonstrate that administering intravitreal injections, especially by nurses trained in aseptic techniques, is feasible without compromising patient safety. The project presented is based on a new care model rooted in interdisciplinary collaboration in the IVI process, operationalizing it as a functional unit. This is a great opportunity to expand the scope of practice for nurses and to demonstrate, as has been done in other countries, that the same procedure currently performed by ophthalmologists can be carried out with equal safety.

Objective:

To evaluate the safety of implementing a program incorporating nurses trained in administering intravitreal injections within the functional unit of Ophthalmology at Corporation Parc Tauli.

Method:

Observational evaluation study of a care process within the functional Ophthalmology Unit, consisting of protocol application for intravitreal injection by trained nurses. Data will be collected from users receiving care from the intravitreal injection service administered by nurses under a consensual procedure within the unit. Users meeting the inclusion criteria will be eligible. Nurses will be trained internally at CCSPT by the ophthalmology team. User participation will be voluntary. Informed consent will be obtained. Data collection during the process of care will include recording selected variables. Data collection will be carried out between 2024 and 2025. The study will be conducted over 3 years.

Application and Impact:

The development of this project will allow for a safe, more efficient redistribution of our resources. The functional unit is based on a group of professionals who work and make decisions jointly. The new distribution will enable ophthalmologists to expand their availability for more complex procedures. In the future, it is expected to increase the number of users who can benefit from the IVI service and to initiate advanced competencies in the role of the ophthalmology nurse.


Eligibility Criteria:
Inclusion criteria

- People over 18 years of age who require intravitreal therapy in the ophthalmology service

Exclusion criteria

* Non-collaborators in the technique for physical, psychological or nystagmus reasons.
* Have recent evidence of blepharitis or conjunctivitis ≤15 days (ex, red eye or thick discharge) to avoid the risk of introducing infection into the eyeball.
* Suffer ischemic heart disease or recent stroke ≤3 months to avoid the risk of precipitating another vascular ischemic attack.
* With intravitreal steroid implant.
* Pregnant women: Due to the potential teratogenic effect of anti-FCEV
Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge

The aim of this study was to evaluate clinically and radiographically the splinted short implants' and single short implants' stability and bone condition before and after loading, in atrophic posterior mandibular alveolar ridges.

A prospective study was conducted on 16 Patients with missing posterior molars. Group A: 8 patients had 2 short implants placed in atrophic posterior mandibular alveolar ridge. Group B: 8 patients had a single short implant placed in atrophic posterior mandibular alveolar ridge.

Eligibility Criteria:
Inclusion Criteria:

* Missing Posterior teeth, indicated for short implant placement.
* Residual alveolar ridge at 6-8 mm height and at least 7mm width.
* Healthy band of keratinized attached mucosa.
* Good Oral hygiene.
* Medically fit patient, free from relevant diseases.

Exclusion Criteria:

* Medically compromised patients.
* Imunnocompromised patients
* Patients with Para-functional habits.
* Smokers
* Poor Oral hygiene.
* Patient refuse to undergo the surgery.
Breast Cancer, Sexuality and Black Cohosh

The purpose of this study is to evaluate the Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen or aromatase inhibitor through questionnaires.

For the study will be recruited 60 women treated with breast cancer, using tamoxifen or aromatase inhibitor, are in menopause, hot flashes and has with or without sexual life. They will answer the questionnaires: Kupperman, World Health Organization Quality of Life (WHOQOL) and those sexually active will have Female Sexual Function Index (FSFI). The control group will have 30 patients using tamoxifen alone or inhibitor. The other group will have 30 patients receiving tamoxifen or inhibitor and will start with 2 tablets per day of dry extract of Cimicifuga racemosa. They will be followed for 6 months and answer questionnaires at the first visit, 3-month and 6-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor.
* With hot flashes and with or without active sexual life.

Exclusion Criteria:

* Women did not have breast cancer
* do not use tamoxifen or aromatase inhibitor
* not in menopause and not have hot flashes
Omega 3 FA Supplements as Augmentation in the Treatment of Depression

To assess the efficacy of Omega 3 Fatty acid (Omega 3 FA) augmentation of desvenlafaxine (DVS) compared to placebo augmentation of DVS when used to treat depression and anxiety symptoms in patients with select medical conditions (cancer, cardiovascular diseases and diabetes).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosed with depression and have cardiovascular disease, diabetes or cancer.
* Able to provide written informed consent prior to initiation of any study-related procedures.
* Able to understand and comply with the requirements of the study.

Exclusion Criteria:

* Hospitalized patients or psychotherapy for depression begun within 4 weeks.
* Patients with medically reversible causes of depression (e.g. hypothyroidism).
* Patients with significant comorbid symptoms (e.g. pain, insomnia) that have a direct causal relation to depressive and anxiety symptoms with these comorbid symptoms dominating the clinical scenario. Patients will be enrolled in the study if these comorbid symptoms merely coexist with depressive and anxiety symptoms and are not dominating the clinical scenario as judged by the study investigator
* Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.
* Patients with any clinically significant unstable or inadequately treated co-morbid medical condition which, in the opinion of the investigator, would make the patient unsuited for the study
* Patients with currently active or with significant history of other clinically significant psychiatric disorders such as bipolar disorder, schizophrenia etc.
* Pregnant patients, breastfeeding or those planning to become pregnant during the study.
* Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment in the study, including known or suspect history of allergy to fish oil, fish or desvenlafaxine.
Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Exclusion Criteria:

* Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Study Design :

- A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Primary Objective:

- To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Healthy Caucasian volunteers
* Non smokers or mild smokers

Exclusion criteria:

* Pregnancy and/or breast-feeding
* Participation in another clinical trial within 60 days prior to Period 1
FT819 in Subjects With B-cell Malignancies

This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility Criteria:
Key Inclusion Criteria:

Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:

B-Cell Lymphoma:

* Histologically documented lymphomas expected to express CD19
* Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy

Chronic Lymphocytic Leukemia (CLL):

* Diagnosis of CLL per iwCLL guidelines
* Relapsed/refractory disease following at least two prior systemic treatment regimens

Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):

* Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
* Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen

ALL SUBJECTS:

* Capable of giving signed informed consent
* Age ≥ 18 years old
* Stated willingness to comply with study procedures and duration
* Contraceptive use for women and men as defined in the protocol

Key Exclusion Criteria:

ALL SUBJECTS:

* Females who are pregnant or breastfeeding
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
* Body weight \<50 kg
* Evidence of insufficient organ function
* Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
* Currently receiving or likely to require systemic immunosuppressive therapy
* Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T
* Receipt of an allograft organ transplant
* Known active central nervous system (CNS) involvement by malignancy
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Clinically significant cardiovascular disease
* Positive serologic test results for HIV infection
* Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection
* Positive serologic and PCR test results for Hepatitis C (HCV) infection
* Live vaccine \<6 weeks prior to start of lympho-conditioning
* Known allergy to albumin (human) or DMSO