cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime

• To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-55 years of age (both inclusive).
2. Have a body mass index of 18-30 kg/m2 (both inclusive) calculated as weight (kg)/height (m2).
3. Medical history without any major pathology/surgery in the last 6 months prior to screening.
4. Resting supine blood pressure of 90-139 (systolic)/40-89 (diastolic) mmHg and a resting pulse rate of 40-100 beats per minute.
5. Calculated creatinine clearance ≥80 mL/min
6. Computerized 12-lead ECG recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the Principal Investigator.
7. Males willing to use double-barrier contraceptive measures and to not donate sperm until 90 days after the follow-up visit.
8. Females should not be pregnant or breast feeding (pregnancy will be confirmed by a urine pregnancy test at screening with confirmation by a serum pregnancy test at admission) or of non-childbearing potential at screening.
9. Females must be either post-menopausal for at least 1 year, surgically sterile (bilateral oophorectomy or hysterectomy), or practicing 1 of the acceptable methods of birth control.

Exclusion Criteria:

1. History/evidence of clinically relevant pathology.
2. History of clinically significant food or drug allergy, including known hypersensitivity to cefepime or any other related drugs.
3. A positive screen result for drugs of abuse/alcohol at admission to the study center.
4. Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy) including nonsteroidal anti-inflammatory drugs or sucralfate or herbal preparations.
5. Positive screen result for hepatitis B, hepatitis C, or human immunodeficiency virus at screening.
6. Any strenuous activity within 4 days prior to admission to the study center. Strenuous being defined as any hard labor or exercise outside of a subject's usual behavior.
7. History of blood donation of more than 500 mL in the last 2 months prior to screening.
8. Current use or has used tobacco- or nicotine-containing products.
Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns

The purpose of this study is to find out whether there is a correlation (link) between the level of potassium in blood samples drawn from a vein and those drawn from a heel stick in infants scheduled for elective surgery.

This is a prospective study which will take place at the Children's Memorial Hermann Hospital Operating Room.

After obtaining written informed consent from parents or guardians, infants and babies scheduled to have elective surgery under routine general anesthesia and are \<6 months of age will be included in the study. After the baby receives routine general anesthesia, a small amount of blood, 0.5 ml, will be drawn from a vein when an I.V. is started for the surgery. The largest possible cannula will be placed whenever possible to decrease hemolysis. If a baby has a central line, the blood sample will be drawn from it. If a baby has an existing peripheral I.V., a blood sample will be drawn from the I.V. cannula only if blood is freely running, to avoid hemolysis.

Blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml, will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis. The heel will be properly sterilized, and a proper size lancet will be used. The same operator will be performing the heel stick in each case.

Eligibility Criteria:
Inclusion Criteria:

* Infants and babies, ASA physical Status I-III, less than 6 month of age and scheduled to have elective surgery under routine general anesthesia at Children's Memorial Hermann Hospital will be included.

Exclusion Criteria:

* Babies and infants with documented anemia (\< 8 gm), who are bleeding, ASA Classification \>III, have sickle cell disease or trait, thalassemia, HIV or DIC will be excluded from the study. Babies with organ failure will be excluded.
Patient Narcotic Requirements After Outpatient Otolaryngology Procedures

Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.

It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe.

The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.

Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing one of the following outpatient procedure:

* Septoplasty
* Unilateral or Bilateral Functional endoscopic sinus surgery
* Tympanomastoidectomy
* Tympanoplasty
* Total or Partial Thyroidectomy
* Parathyroidectomy
* Parotidectomy.
* Age \>18 years and \< 89 years

Exclusion Criteria:

* Age \< 18 years or \> 89 years
* Post operative hospital admission
* Allergy to Hydrocodone
* Allergy or contraindication to Ibuprofen or NSAIDs
* Pregnancy
* Hepatic disease
* Chronic kidney disease
* Sickle cell anemia
A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema

Establish the efficacy of initial high frequency loading of intravitreal pegaptanib bi-weekly during the initial treatment period when the VEGF levels are the greatest and then gradually extending the administration frequency to monthly as homeostasis ensues for the treatment of DME, as measured by best-corrected visual acuity.

Determine if high frequency loading intravitreal pegaptanib will reduce the area and/or volume of DME, as assessed by Spectral Domain optical coherence tomography (SD-OCT) and to determine if this loading with gradual taper schedule of intravitreal pegaptanib will reduce the need for macular laser treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II diabetics, with an age of 18 years of older
* Vision of 20/40-20/400 in the Study Eye
* Diabetic Macular Edema as documented by SD-OCT and Fluorescein Angiogram.

Exclusion Criteria:

* Cannot attened all trail required visits
* Eyes in which retinal surgery is needed now are is likely to be needed within 6 months, which the surgeon believes will not respond to non-surgical intervention.
* Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion greater than 1 disc area involving the foveal avascular zone, epiretinal membrane associated with signs of contraction and/or significant opacification, or presence of chorioretinal atrophy involving the center of the macula.
* Vitreomacular traction determined clinically and/or by OCT, which, in the investigator's opinion, contributes to the macular edema, or causes associated foveal detachment, and would preclude improvement with pegaptanib sodium.
* Previous treatment with intravitreal corticosteroids in the study eye within 3 months of Day 0 visit.
* Previous treatment with intravitreal anti-angiogenic drugs in the study eye within 2 months of Day 0 visit.
* Previous intraocular surgery within 30 days of Day 0 visit.
* Any ocular or periocular infection within 30 days of Day 0 visit.
* Any of the following underlying diseases including:

History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 16.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrythmias requiring ongoing treatment.

History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.

History or evidence of clinically significant impaired renal or hepatic function Stroke (within 12 months of trial entry). Any major surgical procedure within one month of trial entry.

* Any treatment with an investigational agent in the past 30 days for any condition.
* Known serious allergies to the fluorescein dye used in angiography or to the components of pegaptanib sodium formulation.
Sexual Health Counseling Based on the BETTER Model

In this study, the investigators wanted to examine the effect of sexual health counseling to women in the postpartum period on the quality of life of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous,
* Have had a vaginal birth,
* Those who will live with their partner in the period after birth,
* Having started sexual intercourse before starting training,
* Without a diagnosed chronic disease (DM, HT, Heart disease, etc.),
* 18 years or older,
* Able to speak and understand Turkish,

Exclusion Criteria:

• Edinburgh Postpartum Depression Scale score of 12 and above,
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02

The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma
* measurable disease
* WHO perf status 0-3
* eligible for ASCT

Exclusion Criteria:

* previously treated
* peripheral neuropathy gr \>/= 2
* significant hepatic dysfunction
* severe cardiac dysfunction
* severe renal failure if not in dialysis
A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID

For this project the broad research objective is to evaluate the effectiveness of an enhanced digital wellbeing program in improving well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians. The intent of the investigators is that this will enable a proactive culture of well-being and mental health support for the broader healthcare workforce during the multiple phases of the pandemic.

The investigator's approach evaluates existing digital models which can be executed in a timely fashion and rapidly scaled for use across other health systems.

Aim 1: Conduct interviews of URM and women physicians to identify barriers and facilitators to accessing and receiving digital well-being, mental health, and culturally sensitive support resources.

Aim 2: Through a randomized controlled trial (RCT) investigate the immediate and long-term effect of a comprehensive well-being focused intervention (push text messaging, resource support, semi-facilitated peer groups hosted by Cobalt) vs. usual care on well-being, depression, anxiety, stress, resilience, and job satisfaction of physicians practicing in the era of COVID.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age;
* Interest in participating in an 18 month study and willing to complete regular surveys;
* Regular, daily access to a phone with texting capabilities
* Identify as a Physician at Penn Medicine;

Exclusion Criteria:

* Under 18 years of age;
* Not willing to sign informed consent document for an 18 month study;
* No access to a phone with texting capabilities;
* Not a Physician at Penn Medicine
Image Collection of Normal Eyes for Development of an EU RDB

This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database


Eligibility Criteria:
Inclusion Criteria:

1. Subject 22 years of age or older on the date of informed consent
2. Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subject presenting at the site with normal eyes\* (Cataracts and LASIK and PRK are allowed)
4. BCVA 20/40 or better (each eye)
5. Subject is able to comply with the study procedures in the view of the investigator \*Normal eyes are defined as eyes judged normal for the subjects age as determined by the PI or sub-investigator

Exclusion Criteria:

1.1. Subject unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. History of leukemia, dementia or multiple sclerosis
Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

The purpose of this study is to determine whether osteopathic manipulative treatment associated to Dentistry care and speech therapy improves pain and function in individuals with temporomandibular disorders.

A standardized TMD examination was executed in all patients by a dentist following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten items clinical exam. All these items are related to patients symptoms and signs; to mandibular functional impairment; and social-demographics, social-economics, psychological e psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and the second, as Axis II propose a chronic pain score that could quantify the psychosocial impairment and present a subjects profile.

Others assessment instruments utilized on the research were the VAS consists in a 10 cm horizontal line with "no pain" on the left side and "worst pain" on right side, then the subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03 mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal vertical distance of the incisors. The subjects were seated at 90° with neutral head position and solicited to open their mouths the maximum they can unassisted and without pain, maximum unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer for measuring sensitivity to pressure before it became painful. The masseters and temporalis muscles trigger point location were used as reference to guarantee the reproducibility of the proceeding as well as to assess the always the same site. The statistical analysis was performed using the means comparisons for the parametric tests through Student T test and for the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with frequencies analysis.

Eligibility Criteria:
Inclusion Criteria:

* subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (VAS) who need dental treatment.

Exclusion Criteria:

* continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to TMD and being under orthodontic or TMD treatment.
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

Approximately 275 patients will be randomized to receive benralizumab 30 mg SC or matching placebo. After enrolment, eligible patients will enter a 6-week screening/run in period. Patients who meet eligibility criteria will be randomised 1:1 at Week 0 (Day 0) to receive either placebo or benralizumab 30 mg SC every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48). An end of treatment visit will be conducted at Week 56.All patients who complete the 56-week DB treatment period on investigational product (IP) may be eligible to continue into around one year OLE, during which all patients will receive 8 doses of benralizumab 30 mg. Patients in Benra arm during DB period will receive one dummy dose. The last study visit will occur at 8 weeks after the last dose of IP (Week 112/FU). Patients who do not enter OLE, will have their last study visit at Week 56 (EoDB) for follow-up and without administration of IP.

Eligibility Criteria:
Inclusion criteria:

1. Female or male patients aged 18 to 75 years inclusive
2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
5. Ongoing symptoms for at least 12 weeks prior to enrolment
6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
7. Bi-weekly mean NBS ≥ 1.5 at randomization
8. SNOT-22 total score ≥ 20 at enrolment and randomization
9. Documented physician-diagnosed asthma
10. Blood eosinophil count of \>2% or ≥150/μL at enrolment

Exclusion criteria:

1. Any nasal and/or sinus surgery within 3 months prior to enrolment
2. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:

   * Unilateral antrochoanal polyps
   * Nasal septal deviation that occludes at least one nostril
   * Current rhinitis medicamentosa
   * Allergic fungal rhinosinusitis or allergic fungal sinusitis;
3. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
6. Currently pregnant or breastfeeding
A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients

A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion.

The objective of research:

The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models.

1. Research period: 4 years
2. Patients age: 0-21 y.o.
3. Group size: 200 patients (100 patients in each group)
4. Assignment of patients to study groups in a randomised manner


Eligibility Criteria:
Inclusion Criteria:

* Signing of informed consent to participate in the experiment by the participant or the participant's parent/legal guardian
* Diagnosis of SMA (spinal muscular atrophy 1-4) confirmed by genetic testing, symptomatic or pre-symptomatic
* Age between 0 and 21 years of age (will be determined on the day of starting participation in the project based on the date of birth)
* Treatment under a drug program for spinal muscular atrophy, provided that the patient has a diagnosis of spinal muscular atrophy at the date of eligibility.

Exclusion Criteria:

* Cardio-respiratory disorders requiring invasive ventilation
* Advanced osteoporosis with multiple fractures prior to treatment
* Functional deterioration during the rehabilitation process in the range of scales appropriately selected for the SMA type: Prechtl, HINE, CHOP-INTEND, HFMS, RULM
* Lack of cooperation with the therapist
* Other functional indications preventing exercise
Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

The goal of this clinical trial is to investigate if plasma ctDNA and eccDNA before resection for suspicion of pancreatic ductal adenocarcinoma (PDAC) can predict early recurrence and overall survival, and to investigate if plasma ctDNA combined with CT scan and endoscopic ultrasound surveillance increases the median overall survival compared with standard-of-care surveillance.

The aim of the CIRCPAC study is to evaluate if plasma ctDNA from patients scheduled for surgical resection of PDAC can identify patients who will benefit from surgery and if plasma ctDNA can identify recurrence earlier and improve the survival and quality of life of the patients compared with standard-of-care surveillance.

Patients operated for PDAC will be included in this Danish multicenter study including an observational study (Sub-study 1: 700 patients) and an interventional randomized trial (Sub-study 2: 410 patients).

In Sub-study 1, patients will have blood samples drawn prior to surgery, 4 weeks after surgery, and 6 months after surgery.

In Sub-study 2, patients without recurrence 4 months after surgery, will be randomized in a 1:1 manor to an experimental arm (arm A) with ctDNA guided surveillance, or to a control arm (B) with standard surveillance.

Eligibility Criteria:
Inclusion Criteria:

* Sub-study 1: Suspicion of PDAC tumor stage I-III, scheduled for pancreatic resection, with or without preoperative neoadjuvant chemotherapy.
* Sub-study 2: .

  * PDAC tumor stage I-III
  * Has received intended curative resection (R0/R1) of PDAC
  * No signs of local recurrence or metastatic disease at a CT scan 4 months after the operation

Exclusion Criteria:

* Other cancers (excluding skin cancer other than melanoma) later than 3 years before inclusion
* Patients who are unlikely to comply with the protocol, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study