cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects.

This study is designed to evaluate the safety, tolerability and pharmacokinetics of single and multiple-dose escalation of RSV604 administered intravenously in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 18-50 years of age, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Vital signs within the following parameters:

oral body temperature between 35.0-37.5 °C systolic blood pressure, 85-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 100 beats per minute (bpm)

* Female subjects must have been surgically sterilized at least 6 months prior to screening, with supportive clinical documentation OR Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
* Body mass index (BMI) must be within the range of 18 to 30 kg/m2. Subjects must weigh at least 50 kg to participate in this study.

Exclusion Criteria:

* Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as any subject who reports tobacco use or has a urine cotinine greater than 300 ng/ml
* Participation in any clinical investigation involving medical intervention within 4 weeks before study start
* Donation or loss of 400 ml or more of blood within 8 weeks prior to before study start
* Significant illness within 2 weeks before study start
* A past personal or close family medical history of clinically significant ECG abnormalities or of a prolonged QT-interval syndrome.
* History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension).
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated),
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug particularly benzodiazepines.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study, including bowel, gastrointestinal, renal, pancreatic, hepatic, hematological, immunological, or neurological disorders.

Other protocol-defined inclusion/exclusion criteria may apply
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates

Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over 1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering vancomycin as a continuous infusion will result in improved attainment of target concentrations in blood at steady state (when the drug is in equilibrium) compared to intermittent infusion.


Eligibility Criteria:
Inclusion Criteria:

- Neonates in the neonatal unit with an infection requiring treatment with vancomycin as determined by the treating physician.

Exclusion Criteria:

* Infants with a corrected gestational age \< 25 weeks.
* Allergy to vancomycin or other glycopeptide antibiotic
* Vancomycin administered within the previous 72 hours
* Renal impairment
* Prior enrolment in the study
* Need for drug that is incompatible with vancomycin (if no other IV line is available)
P4 (Pregabalin for Peripheral Posttraumatic Pain)

To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event

Exclusion Criteria:

* Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
* NeP not due to trauma, and not peripheral pain
Evaluation of a Six-session Psycho-education Group Program

The aim of this project is to analyze the impact of a psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.

The aim of this project is to analyze the impact of a six session psycho-educational group program on the family members and close friends of persons with eating disorders and co-morbid personality disorders.

Measurements: General health, perceived caregiver burden, and relation to the patient at the following point of time: pre -, post- and follow up, with waiting list control.

Eligibility Criteria:
Inclusion Criteria:

* Relatives and close friends to persons receiving treatment for their eating disorder and comorbid personality disorder.
* \> 18 years,
* Speak and understand norwegian language, and
* Informed consent to participate for both relative and patient.
The Effect of Motor Learning on Balance, Mobility and Performance of Activities of Daily Living Among Post-Stroke Patients

The primary objective of this study is to assess - through a randomized controlled trial - the effectiveness and long-term improvement of motor relearning program on balance, mobility and performance of activities of daily living among post-stroke patients. In this two-armed randomized controlled clinical trial, a total of 66 sub-acute stroke patients who meet the trial criteria will be recruited. The patients will randomly receive task-specific training based on a motor relearning program (MRP) or a conventional physical therapy program (CPT). Twenty-four rehabilitation sessions will be conducted for eight weeks. Both interventions will be followed by analysis of patients' balance, gait and performance of activates of daily living at two time period; post-intervention and follow-up after 3-months, using clinical outcome measures and instrumental analysis of balance and gait.


Eligibility Criteria:
Inclusion Criteria:

* First-ever subacute (1-6 months) stroke patients;
* Able to give informed consent;
* Patients with hemiparesis: muscle power of 2-4 on Medical Research Council-MRC Muscle Scale in the affected upper and lower limbs;
* Able to stand independently for at least one minute;
* Can ambulate 25 feet/10 meter (with or without assistive device).

Exclusion Criteria:

* Post-stroke patients with major cognitive deficits (Montreal Cognitive Assessment- MoCA score ≥ 20) and/or communication impairments that don't allow patients to follow directions (i.e., deafness, aphasia, etc.);
* Patients who are receiving other related therapy through the study, which may affect efficacy of this study;
* Any medical contraindications to start rehabilitation;
* History of disability related to neurological deficits other than stroke.
Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool

Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of lung cancer patients is a cytological test and serves as an initial diagnosis. These cells can then be used to prepare a cell block for staining and further tests.

In some research despite clinical suspicions, the cytological diagnosis is negative, due to the specimen containing too few cells or damage to the cells whilst the specimen is processed. A new method of identifying rare cells in a fluid is by immunomagnetic separation. Using this method, an antigen binds to proteins in the cell wall that are unique to tumor cells. When the fluid is passed through a magnetic field, separation occurs of the cells with the magnetic tags from the remainder of the cells. The separated cells can then be stained or cultured.

The currently approved method of immunomagnetic detection has been approved for clinical use in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli Biotech company has developed an advanced technology that allows identification of a larger number of cells without causing morphological damage to the cells.

The purpose of the current study is to examine the technique of immunomagnetic separation in pleural effusion of lung cancer patients in comparison to the cytological tests. In the future it is hoped that a larger number of patient samples will be included and further characterization of the cells will be possible to be compared to the clinical and cytological characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Lung Cancer Patients in the Lung Department or Oncology Department with spread to the pleural cavity.

Exclusion Criteria:

* Under age 18
Fresh Fruit and Vegetable Purchasing Behavior

Primary objective is to determine the impact of messages related to conventionally grown and organically grown produce on purchasing behaviors in low-income individuals.

Secondary objective is to assess knowledge and attitudes about conventionally and organically grown fruit and vegetable in low-income individuals.

This is a cross-sectional study that will evaluate consumer behavior related to the purchasing of fresh produce in the low-income population through a self-report survey questionnaire.

A sample size of 500 subjects is planned. A screening questionnaire will be provided to each subject to determine their eligibility to be in the study. The screening questionnaire consists of 6 questions related to household income level, grocery shopping frequency, employment field, and age. For subjects who are determined to be eligible, they will be asked to complete the study survey questionnaire.

The survey questionnaire consists of 53 questions to assess subject's beliefs and knowledge about organic and conventional fresh fruits and vegetables and how their beliefs and knowledge affect their purchasing behavior related to organic and conventional fresh produce. There are five major categories in the survey to assess different dimensions that influence subjects' purchasing decisions regarding fresh produce. The categories are issue awareness, purchasing behavior, message framing, credibility, and demographics. Issue awareness is used to assess the subjects' previous knowledge, beliefs and attitude towards organic and conventional fresh produce. Purchasing behavior is used to understand why subjects purchase organic or conventional fresh produce. Message framing is used to determine whether message framing has an impact on the self-reported likelihood to purchase organic or conventional fresh produce. Credibility is used to find which source subjects trust the most regarding fresh produce information. Lastly, demographic information will be obtained to analyze characteristic differences.

Eligibility Criteria:
Inclusion Criteria:

* Low income equal or less than 250% above the poverty level.
* 18 years of age and older
* People who do some or most grocery shopping

Exclusion Criteria:

* Employment in any of the following fields: Print, Online/Broadcast Media, Market Research, Advertising, Health, Nutrition, Public Relations
* Rarely or never purchases groceries
* Does not meet low-income qualification criteria
Effect of Moringa Oleifera Leaf Extract on Postoperative Pain and Bacterial Reduction in Mandibular Premolars

The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using Moringa oleifera leaf extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit


Eligibility Criteria:
Inclusion Criteria:

1. Systematically healthy patient (ASA I,II).
2. Age between 20 and 55 years
3. Male or female.
4. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with apical periodontitis.
5. Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.
3. Teeth with:

   * Immature roots
   * Vital pulp tissues.
   * Association with swelling.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III.
   * Previously accessed or endodontically treated
   * Deep periodontal pockets more than 4 mm
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
4. Patients who could not interpret the NRS.
5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer

This study examines Stress Management and Resilience Training (SMART) for family caregivers (FCG) of patients receiving chemotherapy for advanced cancer to potentially help with the stressful aspects of providing care. All participants will receive the SMART intervention.

FCGs experience stress and extensive demands in providing care for those with head and neck cancer. Teaching the principles of mindfulness and compassion to FCGs has the potential to protect their psychological health and well-being. This may allow them to provide effective, compassionate care to patients, which ultimately puts the needs of the patient first.

Mindfulness interventions have demonstrated decreased stress and anxiety, and improved self-compassion for individuals, but entail numerous sessions over several weeks, a barrier for caregivers. The SMART program, a brief mindfulness program, has demonstrated improvements in resilience, anxiety, perceived stress, and mindfulness for healthcare providers and patients.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of patient with advanced head and neck cancer receiving chemotherapy, living with the patient at least 50% of the time during treatment, able to read and speak English, cognitively intact, able to take SMART class within 2 weeks of enrollment

Exclusion Criteria:

* Self-identified mental health diagnoses, less than 18 years of age, not living with patient at least 50% of the time, unable to read and speak English
Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds

There are currently 28 million child refugees worldwide - approximately 1 in every 200 children on earth. To date, nearly one million forcibly displaced child migrants have been resettled in the United States. It is well documented that refugee and immigrant youth, especially forcibly displaced ethnic and cultural minority youth, present with alarmingly high rates of stress-related psychiatric illness (e.g., PTSD, depression, anxiety) and are grossly underserved by current mental health, medical, and social services. Previous research found that in a sample of 144 Somali refugee children resettled in the United States, only 8% of those who met full clinical criteria for PTSD received any mental health services. Through a process of community-based participatory research with refugee and immigrant communities and stake-holders the investigators have developed a multi-tiered psychological and systems intervention for refugee youth and families, Trauma Systems Therapy for Refugees (TST-R), that includes community outreach and advocacy, group psychological treatment, office-based psychotherapy, and home-based services.

Whereas TST-R is one of the only empirically-based behavioral health treatment models for refugee youth, it has only been studied as a full intervention model; financial and staffing resource barriers have limited the wide-spread adoption of the model. This obstacle noted, implementing one high-impact component of this multi-tier intervention (i.e., protocol-driven group treatments) may provide significant benefit while also being easily scalable. Implementing time-limited (i.e., 10 week) manual-based group psychological interventions focused on culturally-responsive strategies to support refugee youth with, and at-risk for, PTSD, depression, and anxiety, may be an efficient and cost effective means of (1) reducing psychiatric symptoms for refugee and migrant youth with present symptoms, (2) preventing symptom onset for those at risk, and (3) enhancing cultural identity self-concept, subjective social belongingness, and psychological resilience (e.g., ability to thrive in the context of adversity). Furthermore, if effective, treatment groups can importantly function as a destigmatizing treatment gateway and triage to other services for youth who require a higher level of care (e.g., individual psychotherapy and medication management).


Eligibility Criteria:
Inclusion Criteria:

* Age 15-18 years old living in the Greater Boston Area.
* Of refugee or immigrant background (e.g., youth or a parent arrived to the USA as a refugee or immigrant)
* No current plans to move from Greater Boston Area within the next 6 months
* Conversationally proficient in English language

Exclusion Criteria:

* Not able to attend group once a week for 10 weeks
* Medical, cognitive, or other health or psychosocial issue that would prevent consistent and engagement and participation in group.
Proof of Concept: Socket Seal

It is planned to evaluate if a porcine collagen matrix (Mucograft Seal) is offering comparable results to free gingival grafts (FGG) in post-extraction tissue preservation. If so, this would provide a substantial benefit to the patient as the second intervention on the palate and the subsequent morbidity of the donor site is omitted.

In a proof of concept 5 groups are compared in preserving soft- and hard tissue after tooth extraction in the esthetic zone:

1. Mucograft® Seal + Bio-Oss®
2. Free Gingival Graft (FGG) + Bio-Oss®
3. Free Gingival Graft + Gelatine sponge (Spongostan®)
4. Spongostan®+ Mucograft® Seal
5. Spongostan®

Volumetric changes of hard and soft tissues are recorded , 2/4/8 weeks and 3/6/12 months after extraction.

Eligibility Criteria:
Inclusion Criteria:

• Planned extraction in the upper front or premolar region

Exclusion Criteria:

* General risk situation (antiresorptive therapy, antiangiogenic therapy, history of local radiation therapy, heavy coagulation disorder, relevant allergies, dysregulated Diabetes mellitus, malignant diseases)
* Acute gingivitis
* Deep pockets (\>5.5mm)
* Apical periodontitis on neighboring teeth
* Heavy smoker (\>10/d)
Insulin Regulation of Lipolysis and Lipolysis Proteins

These studies will define the abnormalities in the adipocyte proteins that are involved in the failure of insulin to suppress lipolysis normally in humans with upper body obesity and will help discover the mechanism by which pioglitazone, a medication used to treat type 2 diabetes and improve insulin resistance, improves insulin-regulation of adipocyte fatty acid metabolism.

1. The investigators will determine whether impaired insulin-induced suppression of lipolysis (as measured by IC50) is related to the above mentioned lipolysis proteins in groups of volunteers known to vary widely with regards to abdominal adipocyte size and regulation of adipose tissue lipolysis.
2. The investigators will determine whether the improved insulin regulation of lipolysis resulting from treatment with the PPARγ agonist pioglitazone, with or without weight loss, can be linked to specific changes in sets of PPARγ-responsive adipocyte lipolysis proteins in UBO adults.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women between the ages of 18 and 55.
* Women will be premenopausal
* Non obese adults BMI between 18-25
* Obese BMI 30-38

Exclusion Criteria, Pioglitazone package insert of contraindications for use:

* Initiation in patients with established New York Heart Associations (NYHA) class III or IV Heart failure.
* Use in patients with known hypersensitivity to pioglitazone or any other component of ACTOSE.
Stress Response and Hemodynamic Changes Associated With Intrathecal Anesthesia Versus Caudal Epidural Anesthesia in Infants Undergoing Laparoscopic Inguinal Herniorrhaphy

The aim of this work was to assess stress response and hemodynamic changes associated with intrathecal anesthesia versus caudal epidural anesthesia in infants undergoing laparoscopic inguinal herniorrhaphy.

Inguinal hernia repair is the most frequent surgical procedure in early childhood. Various regional anesthetic techniques have been employed to provide optimum intraoperative and postoperative pain control after this procedure.

Introduced decades ago, the use of intrathecal (spinal) anesthesia and caudal block in procedures for different types of laparoscopic abdominal surgery is safe and efficient.

Caudal block is now frequently used in intraoperative and postoperative analgesia for pediatric surgery. In infants and children, central neuraxial block is an important modality for acute postoperative analgesia in addition to combined anesthesia, the goals of postoperative analgesia in children are pain eradication, expedient recovery to daily activities, and prevention of progression of acute postsurgical pain to chronic pain or hyperalgesia

Eligibility Criteria:
Inclusion Criteria:

* Age from full term one month to one year.
* Both sexes.
* Patients with clinical criteria of laparoscopic inguinal herniorrhaphy.

Exclusion Criteria:

* Refusal of patients' parents.
* Diseases of the central nervous system.
* Patients with metabolic and coagulation defects.
* Pre-term infant.
* Infection at the site of injection.
* Congenital anomaly in vertebral column.
* Patient treated with corticosteroids.
* Patients with respiratory dysfunction.
Psychiatric Disorder and Postoperative Morbidity in Hip and Knee Artroplasty

It has been established that patients with psychiatric disorders tend to do worse in a surgical setting. Some types of surgery with greater impact than others, including orthopedic surgery. In our research group the investigators have shown this to be the case for hip and knee replacements within the mentioned patient category. However, the role of psychiatric disorder and use of different psychopharmacological drugs in relation to perioperative morbidity and mortality have not been thoroughly examined. The objective of this study is to shed light on the issue.

Recent studies have shown that different types of psychiatric disorder influence surgical outcome differently. This emphasizes the need for specific knowledge regarding psychiatric diagnoses preoperatively. In this study around 2000 patients with or without psychiatric disorder of any kind will be studied preoperatively, which according to our previous study will include more than 200 patients receiving psychopharmacological treatment. The specifics that characterize every patient's psychiatric trades will be included in a validated questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen. Preoperative information regarding their mental condition and medicine will be linked to surgical outcome in order to identify potential hazards in the perioperative period.


Eligibility Criteria:
Inclusion Criteria:

* All patients planned for elective unilateral fast-track hip or knee arthroplasty.
* Age \> 18.
* Can understand and read danish.

Exclusion Criteria:

-