cyrilzakka/clinical-trials huggingface dataset:
Technology That Permits Focal Dose of Antibiotics to be Delivered to Lower Limb(s) of Diabetic Patients

The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.

During the PILP procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. Limb isolation is achieved by creating an "artificial" circuit where catheters are inserted into the major artery and vein of the lower limb.

Eligibility Criteria:
Inclusion Criteria:

* M or F subjects 18 - 90 years old
* Subject has pre-existing diabetes diagnosis
* Subject has significant infection below the ankle of soft tissue and may include bone, and IV antibiotics are needed in order to salve limb or life
* Consequence of infected wound would require Std of Care share debridement
* Subject willing and able to provide written informed consent
* Subject willing and able to comply with requirements of study protocol including pre-defined follow-up evaluations
* PROCEDURAL INCLUSION CRITERIA: successful cannulation of the femoral artery and vein and placement of the venous support device

Exclusion Criteria:

* Allergy to contrast media
* Known bleeding disorder including thrombocytopenia
* Recent AMI or elevated Troponin levels within last 30 days
* Penicillin sensitivity; Timentin sensitivity
* Female subjects known to be or suspected to be pregnant or lactating
* Subject unable to comply with instructions; especially to remain supine for duration of recirculation procedure
* Subjects who have participated in any other clinical trial or taken investigational drug within 30 days of study enrollment
* The PI determines the subject is not an appropriate subject for the study
* PROCEDURAL EXCLUSION CRITERIA: Subjects anatomy interferes with or is expected to prohibit successful cannulation of the femoral vessels or placement of the venous support device
* Known severe proximal femoral artery vascular disease precluding placement of perfusion catheters
Clinical Evaluation of Direct Composite Veneer Restorations

The objective of this research was to evaluate the clinical success of direct composite veneer restorations performed in permanent incisors affected by molar-incisor hypomineralization.


Eligibility Criteria:
Inclusion Criteria:

* Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
* Maxillary anterior teeth with MIH-caused coloring and opacity areas
* Fully erupted anterior teeth

Exclusion Criteria:

* Patients and parents of patients who accept to participate.
* Patients who are not in cooperation with the procedure.
Tiagabine for the Treatment of Cocaine Dependence - 1

The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.

To assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that tiagabine treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE). This is a double-blind, placebo-controlled, parallel-group design study, in which, after screening and a 2-week baseline assessment period, subjects will be equally randomly assigned to 1 of 2 treatment groups, tiagabine or matched placebo.

Eligibility Criteria:
Inclusion Criteria:

Must be at least 18 years of age and be seeking treatment for cocaine dependence. Have the ability to understand, and having understood, provide written informed consent. If female, agree to use a method of birth control as indicated by the clinician. Please contact the participating site in your area for more information.

Exclusion Criteria:

Please contact the participating site in your area for more information.
Preoperative Pain Catastrophizing and Its Association With Postoperative Pain After Lower Limb Trauma Surgery

The Pain Catastrophizing Scale (PCS) is a psychometric tool to identify PC. A positive correlation between PCS scores and various pain outcomes has been reported in acute and chronic pain settings. Preoperative catastrophizing is associated with an increased intensity of postoperative pain and more analgesic consumption. Likewise, a recent meta-analysis revealed that PC is a strong predictor of persistent postsurgical pain. The Nepali version of PCS has been validated recently in patients with chronic pain. However, it has not been used in patients with acute pain. Therefore, our aim is to assess the relationship between preoperative Nepali PCS (N-PCS) scores and postoperative pain intensity and total opioid consumption in patients with musculoskeletal trauma planned for surgery.

After approval from Institute Review Committee, we will assess eligibility of patients admitted in-patient-unit of orthopaedic ward planned for lower limb trauma surgery under spinal anesthesia. Recruited patients will be counseled and informed about the study and information sheet and consent form provided. Will obtain consent from the participant. patients will be asked to complete N- PCS questionnaire preoperatively a night before surgery in patient unit. On arrival to the operating room, standard monitoring will be applied. All the patients will receive spinal anaesthesia with 2.6 ml of hyperbaric bupivacaine (0.5%) and fentanyl 20 µg. NRS scale will be used to assess the intensity of their pain postoperatively on arrival to Post-anesthesia care unit, at 2, 4, 6, 12 h and 24 h after the end of surgery. One gram paracetamol IV and Ketorolac 30 mg IV will be given at the end of surgery and continued at 6 and 8 h intervals postoperatively. If the Numeric rating scale (NRS) for pain is \> 3 at rest, tramadol 50 mg IV bolus administered, and repeated at 10 min intervals until NRS was ≤ 3 for the first 24 h. Patients will be asked to rate their worst or maximum pain intensity during the first 24 hours after surgery, on an 11-point numerical rating scale. Socio-demographic variables (age, BMI, ethnicity, gender, socio-economic status, occupation and education), preoperative anxiety of the participant will be recorded.

Eligibility Criteria:
Inclusion Criteria:

Patients with traumatic lower-limb injury scheduled for lower-extremity surgery under spinal anaesthesia.

American Society of Anaesthesiologists physical status I or II, Age between 18 and 65 years of age

Exclusion Criteria:

* Non- responders, Those unable to read and write; or Patients with known psychiatric disorder, Prior intake of pain medication, and Chronic pain.
Pharmacokinetic Drug Interaction Between Revaprazan and Itopride HCl in Healthy Male Subjects

To evaluate drug-drug interaction

The main objective is to evaluate the pharmacokinetic profile of the 50mg Revaprazan plus 50mg Itopride compared to 50mg Revaprazan or 50mg Itopride alone in healthy Korean subjects

Eligibility Criteria:
Inclusion Criteria:

* Males aged 20 to 50 years old, with a body mass index (BMI) between 19 and 27 kg/m2
* Acceptable medical history, physical exam,laboratory tests and EKG, during screening
* Eligible for blood sampling during study period
* Provision of signed written informed consent

Exclusion Criteria:

* History of any clinically significant disease
* History of drug/chemical/alcohol abuse
* Clinically significant illness or within 30days before the first dose
* Use of medication known to chronically alter drug absorption or elimination processes within 30days before the first dose of investigational product
* Use of prescribed medication during the 14 days before administration of the first dose of investigational product
* Use of any non-prescribed medication during the 7 days before administration of the first dose of investigational product - Use of any oriental medication medication during the 30 days before administration of the first dose of investigational product
* Participated in a clinical study involving administration of an investigational drug (new chemical entity) or a marketed drug within past 90 days
* Consuming more than 21 units of alcohol per week
* Smoking more than 20 cigarettes per day or consuming more than 5 cups of caffeinated beverages.
PETS-D (Parent Education Thru Simulation-Diabetes)

Hypothesis: Parents who receive Parent Education Thru Simulation-Diabetes (PETS-D) will have significantly higher diabetes knowledge (cognitive visual schemata), better technical and problem-solving competence and confidence, and lower fear and stress/anxiety levels; and provide better diabetes management at 14 weeks compared to those parents receiving standard diabetes education.


Eligibility Criteria:
Inclusion Criteria:

* parents 18 years and older who have a child newly diagnosed with type 1 diabetes mellitus (T1DM) from 5 years old to under 13 years of age

Exclusion Criteria:

* exclude children with developmental delays (such as Down Syndrome, Autism) or steroid induced diabetes (cancer treatment related or cystic fibrosis)
* exclude parents who require insulin treatment -or- those that have another child with TIDM
A Phase II Optimization Study of BMS068645 and Sestamibi Planar Imaging

The primary purpose of this study is to determine the optimal time for myocardial perfusion imaging with Technetium Tc99m Sestamibi following the administration of BMS068645. The safety of BMS068645 will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Have known or suspected heart disease
* Have undergone a clinically indicated SPECT MPI study with adenosine in the last 24 hours to 14 days.
* Weigh between 88 and 250 lbs.

Exclusion Criteria:

* Allergic reaction to Technetium Tc99m Sestamibi or any of its components
* History of asthma or lung disease
* Ingestion of caffeinated substances within 12 hours prior to the study
Study of Non-invasive Acupuncture-like Transcutaneous Electrical Nerve Stimulation (Altens) to Help Alleviate Xerostomia After Radiation Therapy for Cancers of the Head and Neck

The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.

In this study the investigator would like to better understand if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth. Acupuncture has been shown to help some people with symptoms of dry mouth, and low-level electrical stimulation of acupuncture points has been shown to have similar results as acupuncture treatment with needles.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* No restrictions on gender or ethnicity
* Ability and willingness to present for ALTENS therapy over 12 weeks
* Previous radiation to the head and neck with a dose \> 50 Gy
* Subjective complaint of dry mouth
* No evidence of active malignancy in the head and neck region
* Minimum of 3 months post initial curative therapy with no evidence of active disease by standard of care surveillance scans for said disease site

Exclusion Criteria:

* Age under 18 years of age
* Inability to present for ALTENS therapy
* Inability to fill out quality of life questionnaires
* Ability and desire to receive concurrent chemoradiation therapy
* Because ALTENs may stimulate nerves similar to those of pilocarpine, the following exclusions are noted as theoretically ALTENS could produce worse symptoms

  * Unstable Angina
  * Unstable cardiac disease with hospitalization in the last 6 months
  * Presence of a pacemaker, ICD, or other electronic implanted device that could be affected
  * Myocardial infarction in the last 6 months
  * Symptomatic arrhythmia in the last 6 months
  * Severe COPD with exacerbation causing hospitalization within the last 6 months
* Pregnancy or the possibility of pregnancy
Behavioral Health Evaluation and Intervention Program for Patients Undergoing Craniotomy

This is a single center non-randomized, single-arm feasibility trial of the implementation of virtual behavioral health counseling sessions alongside standard-of-care treatment.

PRIMARY OBJECTIVE:

I. Determine the feasibility of implementing behavioral health counseling sessions alongside standard of care treatment for brain tumor participants scheduled to undergo craniotomy for treatment.

SECONDARY OBJECTIVE:

I. To assess the acceptance of virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor.

II. To explore the rates of pre- and post-surgical mental health disorders in participants newly diagnosed with a brain tumor.

III. To explore pre- and post-surgical quality of life with virtual behavioral health counseling sessions during the initial management of a newly diagnosed brain tumor.

OUTLINE:

Participants will be given the opportunity to participate in virtual behavioral health counseling sessions at three time points relative to the scheduled tumor resection operation. All participants will receive questionnaires related to mental health, quality of life, and satisfaction with the study intervention. Participants who do not want to participate in the counseling sessions will be provided the option to complete the assessment tools related to mental health and quality of life only. Participants will be assessed over the course of 9 months related to standard-of-care treatment at the following time points: before the operation (baseline), 4 to 6 weeks following the operation, and 6 to 9 months following the operation. At each time point, the participants will fill out the questionnaires and engage in the virtual counseling sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years of age or older.
2. Able to understand study procedures and to comply with them for the entire length of the study.
3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. Documented diagnosis of a brain tumor.
5. PHQ-9 screening score of \>= 5.
6. No prior surgical intervention, other than biopsy, for brain tumor.
7. Scheduled for craniotomy for brain tumor resection.

Exclusion Criteria:

1. Contraindication to any study-related procedure or assessment.
2. PHQ-9 scores of:

   1. \< 5
   2. \>= 20
   3. \>= 1 point on Question number 9 - thoughts of self-harm or suicidality.
3. Require urgent or emergent surgical intervention or admission to the hospital prior to the scheduled surgery.
4. Prior surgical intervention for brain tumor.
5. Prior suicide attempt.
6. Prior hospitalization for psychiatric treatment.
7. Currently undergoing mental or behavioral health-related counseling or psychotherapy, other than currently taking an anti-depressant medication.
Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. The definition of difficult cannulation is defined according to the literature.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.

Exclusion Criteria:

* Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.
Evaluation of Vertebroplasty Associated With Radiotherapy for Spine Metastases (EVAR)

A randomized phase III study of palliative external beam radiotherapy (RTOG 97-14) has shown that 8 Gy in a single fraction is very effective in providing pain relief, with complete or partial improvement in pain seen in 66% of patients with bone metastases. Percutaneous vertebroplasty (PV) is a technique designed to consolidate pathologic vertebral bodies through the injection of orthopaedic cement under fluoroscopic guidance. Consolidation provides rapid pain relief to painful vertebral body lesions secondary to osteoporosis, haemangiomas, myeloma and metastatic diseases, with complete or partial improvement in pain seen in 70-85% of patients. To date, no randomized trial has tested the association of vertebroplasty and radiotherapy to enhance pain relief for patients with painful osseous spine metastases.

A randomized trial has been designed to determine whether vertebroplasty and radiotherapy (8 Gy in a single fraction) provide enhancement pain and narcotic relief compared to radiotherapy alone for patients with painful osseous spine metastases

Patients with 1 to 4 painful osseous spine metastases are randomized to 1 of 2 treatment arms:

* Arm 1: 8 Gy in a single fraction
* Arm 2: 8 Gy in a single fraction followed by vertebroplasty of the vertebral bodies, within 14 days after radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Osseous spine metastases from squamous cell carcinoma or adenocarcinoma
* One to four painful metastases located between the second cervical vertebra and the fifth lumbar vertebra
* Moderate to severe pain
* No spinal cord compression
* Karnofsky performance status \> 40

Exclusion Criteria:

* Previous radiotherapy or surgery
* Vertebral fracture or any other formal indication of stabilization of the rachis by surgery or vertebroplasty
* Spinal cord compression
* Known anomaly of the haemostasis, or needed anticoagulant treatment
Periodontal Profile of Hypogonadic Men

The aim of this study is to assess if hypogonadic men with periodontitis benefit from testosterone replacement therapy before being submitted to periodontal treatment. Fifty hypogonadic men (Total Testosterone \<200ng/dL) will be recruited from the Clinics Hospital at Federal University of Paraná and subjected to periodontal evaluation by a trained and calibrated researcher. The subjects presenting with periodontitis (assessed by clinical parameters) will be randomly allocated to "testosterone replacement therapy" (TRT) group or "placebo" for 3 months. After that time, all patients will receive nonsurgical periodontal treatment, which will be reassessed after 45 days. Clinical parameters (such as probing depth, gingival and plaque index, clinical attachment loss, bleeding on probing), sub gingival plaque and gingival crevicular fluid will be collected at baseline, just before therapy and 45 days after therapy.


Eligibility Criteria:
Inclusion Criteria: total testosterone \<200ng/dL in two assessments; at least 20 teeth present.

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Exclusion Criteria: systemic diseases such as hormonal, inflammatory and immune alterations.

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Bioavailability of Lesinurad and Intravenous [14C]Lesinurad

This study will assess the absolute bioavailability of a single oral dose of lesinurad and evaluate the pharmacokinetic (PK) parameters of lesinurad and \[14C\]lesinurad in healthy adult male subjects.

In this study a single dose of lesinurad will be administered after an overnight fast followed by a single 15-minute infusion of a radiolabeled intravenous micro tracer dose of \[14C\]lesinurad to assess the in vivo performance of lesinurad.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment

Exclusion Criteria:

* Subject has a history or suspicion of kidney stones.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject donated blood or experienced significant blood loss (\>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
* Subject does not have a normal or clinically acceptable physical examination, per the Investigator's judgment.
* Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
* Subject has Screening clinical safety laboratory parameters (serum chemistry, hematology, or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
* Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
* Subject has a Screening serum urate level \> 7 mg/dL.
* Subject had radiation exposure that exceeds 5 mSv in the last 12 months or 10 mSv in the last 5 years. This includes radiation exposure from the present study or other clinical studies, including diagnostic X-rays and other medical exposures but excluding exposure to background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

The aim of the study is to explore the concept of GnRH-agonist triggering in combination with elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting. The question asked is: "Does GnRH-agonist triggering and cryopreservation work", in terms of efficacy and safety, when applied to a larger cohort of patients, and by a number of different centres with different clinical routines.


Eligibility Criteria:
Inclusion Criteria:

* Indication for IVF with ICSI
* Age \< 40 years
* \< 4 failed previous IVF attempts with embryo transfer
* ovarian stimulation with GnRH-antagonist and gonadotrophins
* \>20 follicles \>11 mm in mean diameter or E2 \>4500 pg/ml on the day , on which it was planned to administer hCG
* willing to participate and able to consent
* patient has not previously received GnRH-agonist as a trigger of final oocyte maturation

Exclusion Criteria:

* None
Noise, Oxidative Stress and Cardiovascular System

Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* both genders
* good self-reported health

Exclusion Criteria:

* diabetes mellitus
* arterial hypertension or other cardiovascular diseases
* kidney diseases
* pregnancy
* malignant diseases
* mental diseases
Methylene Blue and Ozone in Early Sepsis

effects of methylene blue and ozone O3 therapy effects in early sepsis management , and their implications upon outcome

effects of methylene blue on inducible nitric oxide messenger RNA transcription and protein expression are well evident in vasoplegia ,and septic shock . In the same time , ozone O3 therapy is also valuable in immune-modulation in multiple pathologies . our study collaborate both methylene blue and Ozone in early sepsis management , and we will evaluate the global medical progress , ICU stay , Morbidity and mortality

Eligibility Criteria:
Inclusion Criteria:

* early sepsis Adults patients

Exclusion Criteria:

* cardiac problems Glucose-6-Phosphate-Dehydrogenase Insufficiency Ozone Allergy Recent Myocardial Infarction Active Hyperthyroidism Thrombocytopenia Pregnancy Contraindications