cyrilzakka/clinical-trials huggingface dataset:
Psychologists' Lived Experience of Client Violence

The objective of the proposed research is to gain a detailed understanding and account of psychologists' experience of client violence in clinical practice. The emphasis is upon a detailed understanding of how psychologists perceive and understand their experience of client violence and its impact upon their identity as clinicians and as individuals.

This research is interested in Counselling and Clinical Psychologists who have experienced client violence at their work place. The main research question being asked is how do psychologists' understand their personal experiences of client violence. This is an important and interesting subject for Counselling and Clinical Psychologists as it provides a detailed personal account of the implications of violence upon their personal and professional identity, psychological well being and how they define violence. Furthermore, this research may help facilitate in designing a specific policy and help future research to issue guidelines for counselling and clinical psychologists in order to keep themselves safe within their professional practice. Psychologists working for the National Health Service will be recruited and provided with information regarding the research aims and objectives. There will be interviews held at their place of work for approximately one hour.

Eligibility Criteria:
Inclusion Criteria:

* Psychologist's who have experienced client violence

Exclusion Criteria:

-
A Comparison of Two Type of Stems in Revision Hip Arthroplasty

This study compares two different hip stem components. Both hip stems used in this study allow the femur bone to attach and grow into them for stability. The main difference between the two stems is that one of the stems, the Solution® Stem, is made from Cobalt Chrome, a type of metal, and does not have a hydroxylapatite (HA) coating, while the second stem included in the study, the Restoration hip stem, is made from titanium alloy, a different type of metal that has a roughened surface and allows for a hydroxylapatite (HA) coating to be applied to the entire length of the stem. The HA coating is a thin calcium phosphate layer on the stem to encourage the bone to grow into it. We are trying to see if there is any difference in the initial bony ingrowth between the two stems and to compare the results in patients over the first two years after the surgery and then again at the five-year period.

Revision total hip arthroplasty is becoming increasingly common due to the large number of primary total hip arthroplasties being performed annually. Failure of these arthroplasties has led to an increasing number of patients requiring revision arthroplasty. Various methods have been used to reconstruct the hip during a revision procedure. These have generally consisted of a cemented or uncemented femoral stem. It is now generally accepted that uncemented femoral stems have improved results over cemented stems, especially in those cases with compromised bone stock. There are two main alloys used for the femoral revision component, that is cobalt chrome and titanium. There may be certain advantages to the use of titanium, in particular, a reduction in future bone loss caused by stress shielding. Stress shielding is commonly seen with cobalt chrome implants. In order to assess this and the overall survival of these two different implants a randomized clinical trial is proposed.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for revision hip arthropathy

Exclusion Criteria:

* Under 21 years of age
Safety, Tolerability, and Pharmacokinetics of REGN5069 in Healthy Volunteers

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of REGN5069 administered intravenously (IV) and subcutaneously (SC) in healthy male and female participants.

The secondary objectives of the study are to characterize the pharmacokinetics (PK) profile of single IV and SC doses of REGN5069 in healthy participants and assess the immunogenicity of REGN5069 in healthy participants administered single IV or SC doses of REGN5069


Eligibility Criteria:
Key Inclusion Criteria:

* Participant is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and ECG performed at screening and/or prior to study drug dosing
* Participant is in good health based on laboratory safety testing obtained at the screening visit
* Willing and able to comply with clinic visits and study-related procedures
* Provide informed consent signed by study participant or legally acceptable representative

Key Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease
* Has any physical examination findings and/or history of any illness that might confound the results of the study or poses an additional risk to the subject by study participation
* Hospitalization for any reason within 60 days of the screening visit
* Current cigarette smoker or former smoker (cigarettes or e-cigarettes) who stopped smoking within 3 months prior to screening
* History of drug or alcohol abuse within a year prior to the screening visit
* Presence of HIV, hepatitis B, or hepatitis C seropositivity at screening or within 3 months prior to dosing with the exception of false positive screening tests as documented by polymerase chain reaction or Western blot
* Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus, that have been resected, with no evidence of metastatic disease for 3 years

Note: Other protocol Inclusion/Exclusion Criteria apply
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fed Conditions

To compare the single-dose bioavailability of Ondansetron ODT 8 mg and Zofran 8 mg

To compare the single-dose bioavailability of Kali's Ondansetron ODt 8 mg with that of GlaxoSmithKine's Zofran 8 mg under fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting all of the following criteria may be included in the study
* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent from duly signed by the subject.
* Males and females aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report.
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without ant clinical significance and must be recorded as such in the CRF ( laboratory tests are presented in section 7.1.3)
* Healthy according to the laboratory results and physical examination.
* Normal cardiovascular function according to the to ECG.
* Non or ex-smokers.

Exclusion Criteria:

* Significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
* Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease.
* Females who pregnant, lactating or are likely to become pregnant during the study phases.
* Females or childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study.
* Positive pregnancy test before and during the study.
* Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease.
* Any clinically significant illness in the previous 28 days before day 1 of this study.
* Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)
* Participation in another clinical trial in the previous 28 days before day 1 of this study.
* Donation of 500 mL of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study.
* Positive urine screenings of drugs of abuse (drug names are presented in section 7.1.4).
* Positive results to HIV, HBsAg or anti-HCV tests.
* History of fainting upon blood sampling.
Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI).

This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI). The intervention is a rapid, multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample collection. Randomization is at the individual patient level. Intervention patients will receive usual care plus the rapid multi-respiratory pathogen test. Control patients will receive physician-directed usual care without the rapid, multi-respiratory pathogen test, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary outcome is antibiotic administration or prescription during the initial ED episode of care. The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be associated with a ≥15% reduction in antibiotic use in intervention patients, relative to control patients (usual care). The investigators secondary outcome is administration or prescription of antivirals during the initial ED episode of care. The investigators secondary hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza medication use in intervention patients (composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients), relative to control patients receiving usual care alone.

Eligibility Criteria:
Inclusion Criteria:

* University of California, Davis (UC Davis) Emergency Department patients evaluated for influenza like illness and/or upper respiratory infection by an ED physician who consent and agree to have a nasopharyngeal swab collected for the study
* English speaking or Spanish speaking patients

Exclusion Criteria:

* Neonates
* Prisoners
* Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator
* Non-English, non-Spanish speaking patients
Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function

The goal of this study is to determine if 8-week dietary treatment with the omega-3 fatty acid docosahexaenoic acid (DHA) improves attention performance and associated cortical activity and metabolism in 8 - 10 year old males that were not breast-fed during infancy.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects between the ages of 8 - 10 years.
2. Not breast-fed during infancy
3. Right hand dominant
4. Attending school at appropriate grade level
5. Normal body-mass index (BMI)
6. Ability and willingness to provide assent and informed, written consent from at least one biological parent.
7. Present with biological parent
8. No current general medical or psychiatric illness.
9. Medication free.
10. Normal intelligence as assessed by the Kaufman Brief Intelligence Test.
11. Willingness to maintain current dietary habits.

Exclusion Criteria:

1. Inability or unwillingness to provide consent.
2. Antecedent or concurrent serious medical illness.
3. A lifetime history of any significant axis I psychiatric disorder ( i.e. bipolar disorder, schizophrenia)
4. Patients who have received any psychoactive medications, current and lifetime.
5. Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
6. History of seizures, excluding febrile seizures in childhood.
7. Patients requiring treatment with any drug which might obscure the action of study the study treatment.
8. Less than normal intelligence.
9. Pacemaker
10. Cerebral aneurysm clip
11. Cochlear implant
12. Metal fragments lodged within the eye
13. Claustrophobia
14. Necessity of sedation (no sedation will be given).
15. History of loss of consciousness \> 10 minutes in duration
16. Adopted
Induced-T Cell Like NK Cellular Immunotherapy for Cancer Lack of MHC-I

T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform anti-cancer therapy, especially for those cancers that are lack of MHC-I molecule expression. We have finished pre-clinical investigations for the ITNK or CAR-ITNK cell therapy and scheduled to start a clinical phase I study.

One gene can be knockout of the T cells to produce a T-like NK cells which obtain killing function of both T effector cells and NK cells. We will collect appropriate patient's T cells, produce T-like NK cells (ITNK), and infuse the ITNK/CAR-ITNK cells back to the patients to treat various of cancers.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced cancer, which express low or no MHC-I.
2. Life expectancy \>12 weeks
3. Adequate heart,lung,liver,kidney function
4. Available autologous T cells
5. Informed consent explained to, understood by and signed by patient/guardian. 6. Patient/guardian given copy of informed consent.

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV,HCV,HIV,et al
3. Known HIV positivity
4. History of liver or other organ transplantation
5. Active infectious disease related to bacteria, virus,fungi,et al
6. Other severe diseases that the investigators consider not appropriate;
7. Pregnant or lactating women
8. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
9. Other conditions that the investigators consider not appropriate.
Study of CM313 in Healthy Subjects

This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects age ≥ 18 years \& ≤50 years.
* Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion Criteria:

* With history of malignant tumors;
* Plan to undergo major surgery during the research period
* Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients;
* With any voluntary blood donation or any other form of blood loss exceeding 400 mL;
* The average daily smoking volume within the first three months of screening is greater than 5 cigarettes;
* Positive results in baseline alcohol breath test or urine drug abuse screening.
Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In Chronic Iateral Epicondylitis

this study will be conducted to compare between mulligan mobilization and instrument assisted soft tissue mobilization on pain intensity, range of motion, hand grip strength, and hand function in the treatment of chronic lateral epicondylitis

Lateral epicondylitis is one of the elbow conditions that affects about 1-3% of the population at large. It produces a heavy burden of workdays lost and residual impairments. Although many treatment modalities are used, few of them rest on scientific evidence and none has been proven more effective than the others. This lack of evidence on treatments for lateral epicondylitis may stem from several sources, including the possible self-limiting nature of the condition, the lack of pathophysiological data, the methodological shortcomings of available studies, and the existence of numerous factors influencing the outcome. The physiotherapeutic treatment has been shown to be effective. In general, it must include manual therapy to relieve the pain and improve the joint's range of motion (ROM), taking into account that it must be performed under the pain threshold. Mulligan mobilization with movement (MWM) is a modern technique developed by Mulligan for treating lateral epicondylitis (LE). Instrument-assisted soft tissue mobilization is a form of augmented soft tissue mobilization (IASTM) in which stainless steel instruments are utilized to apply controlled microtrauma to the affected soft tissues. sixty patients will be allocated randomly to three groups; the first one will receive mulligan mobilization with movement, the second one will receive instrument-assisted soft tissue mobilization and the third one will receive traditional therapy three times a week for four weeks

Eligibility Criteria:
Inclusion Criteria:

All patients will be diagnosed with chronic lateral epicondylitis from both genders.

Patients with chronic lateral epicondylitis were diagnosed by orthopedists. Positive clinical manifestation in all patients. Patients' age will be ranged from 18 to 80 years, Pain onset is more than 3 months. All participants must be medically stable and not be treated with analgesics or any medication which may cause misleading results.

All patients have a body mass index between 18.5 and 29.9 kg/m2.

Exclusion Criteria:

Patients who received an intra-articular injection for a duration of less than 3 months.

Patients receiving oral or injected corticosteroids for the last 3 months at least.

History of elbow surgery/fracture. Acute synovitis/arthritis including infectious. Presence of malignancy. Pregnancy. Patients with, topical lesions, contact dermatitis, and a history of cutaneous hypersensitivity
The Pain Control in Rib Fracture With Non-invasive Stabilization (RCT)

Brief summary:

Background: Rib fractures are one of the most common causes of trauma disabilities and have become an important health issue. Patients usually suffer from severe pain. A rapid and adequate pain control is considered as a priority to improve respiratory mechanics and reduce the risk of pulmonary and systemic complications. So far, there was no gold standard regarding pain control for rib fractures.

Objective: To assess the effect of the newly-designed Prosthorax Thoraxbelt in addition to oral analgesics on pain control of rib fractures

Method: There will be two groups of patients in this study. One group will be the patients with rib fractures who are necessary for in-hospital intense pain control. The other will consist of follow-up patients with rib fractures at an outpatient clinic. The investigators will aim to recruit 30 and 82 patients respectively.

The study has been approved by the hospital research ethics committee.

Arm1: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (inpatients)

Arm2: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (outpatients)

Primary outcome:

1. inpatient: Visual analog scale (VAS) for 6 hours, 12 hours and 24 hours after the surgery
2. outpatient: Visual analog scale (VAS) for the times at emergency room; 3 days, 3 weeks and 3 months after rib fracture at an outpatient clinic.

Secondary outcome:

* inpatients

  1. The accumulated dose of the inter-venous patient-controlled analgesic drug within 6 hours, 24 hours and 48 hours after the surgery
  2. Complication during the hospital stay
  3. Hospital stay
  4. VAS before discharge
  5. Unanticipated events (ICU admission, a second surgery, death)
  6. VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery
  7. An X-ray examination at an outpatient clinic
  8. Compliance on ThoraxBelt after discharge
* outpatients

  1. Complication during the follow-up period
  2. Unanticipated events (ward admission, ICU admission, a surgery, OHCA)
  3. Compliance on ThoraxBelt after discharge
  4. An X-ray examination at an outpatient clinic

Eligibility Criteria:
Inclusion Criteria:

* The adult patients with rib fractures (inpatients/outpatients)
* The patients will be assessed to the further admission (inpatients)
* The patients will be assessed to be at follow-up clinic visit (outpatients)

Exclusion Criteria:

* The accident of rib fractures has been occurred over 24 hours. (inpatients/outpatients)
* Refuse to be arranged to the admission (inpatients)
* Refuse to receive the CT scan (inpatients/outpatients)
* Chest wall infection or other diseases (inpatients/outpatients)
* Chest wall infected by rumors (inpatients/outpatients)
* Pregnancy (inpatients/outpatients)
* Further complications arise (inpatients/outpatients)
* Known allergy to ThoraxBelt (inpatients/outpatients)
Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH

This was a randomized, open-label clinical trial. We will enroll patients with symptomatic neurogenic OH and randomize them to 1 of 2 treatments: (1) midodrine only, (2) atomoxetine only. We will follow up patients at 1 and 3 months after treatment. If the patients meet BP criteria for OH at 1 month, they will receive combination treatment with both midodrine and atomoxetin. The primary outcome measure is amelioration of questionnaire score evaluating OH-associated symptoms at 3 months. Secondary end-points were improvement in orthostatic blood pressure (BP) drop at 1 and 3 months.

Visit 1.

1. Enroll, baseline evaluation of the patients
2. Questionnaire

   * Evaluate orthostatic hypotension symptom: Orthostatic Hypotension Questionnaire (OHQ)
   * Quality of life: Korean version of Short-form 36
   * Depressive symptom: Korean version of Beck Depression Inventory(BDI)-2
3. Blood test (6cc): ELISA for alpha 1,2 and beta 1,2 adrenergic receptor antibody and nicotinic acetylcholine receptor antibody. Preserve sample for genetic testing.
4. Randomization: randomize patients to three group in 1:1 ratio (Midodrine 5mg/day single, Atomoxetine 18mg/day single)
5. Treatment education Visit 2. 1 month after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire If the patients meet BP criteria for OH, initiate combination treatment (Midodrine 5mg/day+Atomoxetine 18mg/day) Visit 3. 3 months after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Age \>=19 patients who complained of dizziness
* Orthostatic hypotension after 3-minute standing (systolic blood pressure drop \>=20 or diastolic blood pressure drop \>=10

Exclusion Criteria:

* Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
* Heart failure or Chronic renal failure
* Severe supine hypertension (Systolic Blood Pressure \>180 or Diastolic Blood Pressure\>110mmHg)
* Pregnant women, breast-feeding
* Unable to perform questionnaire