cyrilzakka/clinical-trials huggingface dataset:
The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA

This interventional study aims to compare the effectiveness of local multimodal drug periarticular injection in TKA patients with the standard pain control regime that includes opioids, NSAIDs, and other analgesics.

The main questions The investigators strive to answer are:

Is there a significant difference in the severity of pain and functional outcomes when applying periarticular injections? Are there any increased complications when applying the periarticular injections?

The best pain control regime following TKA is controversial. While opioids have an excellent analgesic effect, they also have many side effects. The investigators are conducting a randomized controlled trial to compare the severity of pain following primary unilateral TKA when multimodal drug periarticular injunction is used with the standard pain control regime. The investigators will enroll patients undergoing primary unilateral TKA and randomly allocate them into one treatment group. The first will undergo the procedure with periarticular injection before the closure is composed of a mixture of 20ml of low body weight bupivacaine 5mg/ml plus 1ml of ketorolac 30mg/ml plus 0.5ml adrenaline 1mg/ml injected in medial and lateral retinaculum, medial and lateral collateral ligaments, quadriceps and patellar tendon, joint capsule, subcutaneous fat, and the second will go standard TKA with pain control using opioids, NSAIDS, and paracetamol. The severity of postoperative pain is the primary outcome studied, as well as preoperative complications and any drug side effects, the data will be collected by a fellow researcher who is blinded to the interventions, and the patients will be blinded too. Randomization will be done by a research fellow who is not involved in patient treatment or care.

Eligibility Criteria:
Inclusion Criteria:

* all patients with end-stage arthritis of the knee going primary unilateral total knee arthroplasty.

Exclusion Criteria:

* inflammatory and secondary arthritis of the knee.
* Patients who are allergic to one or more of the drugs used in the injections.
* Patients who are already taking opioids for whatever reason or have a history of addiction.
* BMI less than 20 and more than 35.
* patients with intra-operative complications that would affect the outcomes measurement.
* Patients who are going through complex primary or revision TKA.
* Pregnancy, renal or liver failure.
* Patients who are classified as grade 3 or more according to ASA.
Kintsugi Voice Device Pivotal Study

A prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-RV) for up to 1000 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks


Eligibility Criteria:
Inclusion Criteria:

Age \>22 at the time of informed consent Self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exercise, diet, or recreation) Access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the Internet Stated willingness to be video and audio recorded as part of the study Stated willingness to comply with all study procedures and availability for the duration of the study Functional English capacity in the home environment Availability for the duration of the study Resides in the United States at the time of consent and during completion of study

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Exclusion Criteria:

* Participants with at least one of the following conditions will be excluded:

Any impairment that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., visual impairment, motor impairment, and/or hearing impairment) Any lifetime history of neurological disease that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., Central Nervous System disorders, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and/or Parkinson's Disease) Any lifetime history of Stroke, cognitive defect (E.g., dementia or Alzheimer's disease), and/or Traumatic Brain Injury Presence of voice disorders that impacts their ability to speak (E.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia) Past or active heavy smokers (an average of \>20 cigarettes per day) Subjects who have previously participated in any Kintsugi-sponsored study
Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated

The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients combined with Androgen Deprivation Therapy.

Additional objectives of the study for high-risk (non-metastatic) prostate cancer patients are as follows:

1. Analysis of number of circulating tumor cells in peripheral blood as a prognostic/predictive factors for survival.
2. Analysis of miRNA expression levels (100, 141 and 143) in peripheral blood as a prognostic and predictive factors.
3. Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
4. Evaluation of the usefulness of the expression level of antigen-specific T cells, B-and NK cells as a prognostic factors.
5. Evaluation of usefulness of the fiducial markers for localizing the prostate gland position during irradiation for the selected control imaging methods (2DkV, CBCT, MVCT).

Eligibility Criteria:
Inclusion Criteria:

* men from 40 to 75 years old with confirmed prostate adenocarcinoma, prostate biopsy will be performed \<180 days before the date of randomization,
* completed assessment of tumor differentiation according to Gleason grading allows to perform stratification; Gleason score ≤ 7 versus Gleason score\> 8,
* general condition according to the classification of the Eastern Cooperative Oncology Group (ECOG) 0 - 1), (Appendix 1),
* Androgen Deprivation Therapy: prior Radiotherapy (RT) (minimum 3 months before the start of RT), concurrently with RT and after RT during follow-up (24 months) ,
* high risk of Prostate Cancer progression defined as presence of at least one of the following factors: cT3, Gleason\> 7, PSA\> 20 ng / ml or presence of at least two of cT2c, Gleason 7, PSA in the range of 10.1 ng / ml to 19.9 ng / ml, cT defined by AJCC staging 7 edition, (Appendix 2),
* PSA identified at least 10 days after the biopsy or before, and patients receiving fiansteryd 30 days after the cessation of therapy,
* no regional and distant metastases confirmed by bone scintigraphy, chest radiograph, computed tomography/magnetic resonance imaging of the pelvis,
* signing an informed consent to participate in a medical experiment (radiotherapy + biological material samples) (Annex 3),
* morphological and biochemical parameters within normal limits.

Exclusion Criteria:

* the presence of active cancer except skin cancer preceding period of 5 years prior to randomization,
* Early surgery (radical prostatectomy) or pelvic RT,
* earlier hormonal therapy than is advocated in this study,
* co-morbidities that may significantly affect the expectancy life of the patients
* do not meet the criteria for inclusion.
No Power Bionic Lower Extremity Prosthesis

Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.

Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active. Here we will test this device to determine how it affects the user's mechanics during running and walking. Participants will come to a research laboratory for three test sessions where they will run and walk in their current foot, a commercial high-activity foot, and the prototype CAESAR foot.

Eligibility Criteria:
Patient Population:

Inclusion Criteria:

* At least 18 years old
* Transtibial amputation of one or both legs
* Classified as K3 or K4 on the Medicare Functional Classification Level
* Use of a well-fitting prosthetic socket and prosthetic foot for at least 6 months
* Able to walk and run without assistance

Exclusion Criteria:

* Significant injury to intact limb
* History of balance impairments or neurologic disorders
* Significant cardiovascular or respiratory disease
High Flow Therapy (HFT) to Treat Respiratory Insufficiency in Chronic Obstructive Pulmonary Disease (COPD)

The aim of this study is to see if the Vapotherm High Flow Therapy (HFT) device is effective to provide breathing support to patients with Chronic Obstructive Pulmonary Disease or COPD. The investigators believe that patients using HFT will not require as much use of therapies that provide pressure through a face mask, and are already recognized by FDA as support therapies for respiratory insufficiency.

The overall objective of this study is to demonstrate that Vapotherm High Flow Therapy (HFT) via nasal cannula provides respiratory support to patients with COPD as a primary diagnosis, who present with respiratory insufficiency in the Emergency Department. We intend to demonstrate that Vapotherm HFT via nasal cannula will result in at least equivalent patient outcomes as the current standard of care, while eliminating the need for other non-invasive respiratory support devices cleared for the treatment of respiratory insufficiency. The current standard of care will include the use of other devices cleared by the FDA as respiratory assist devices for the treatment of adult respiratory insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Present to the Emergency Department with a history of COPD and with symptoms consistent with a diagnosis of respiratory insufficiency and exacerbation of COPD
* Must be hemodynamically stable as judged by treating clinician in the ED
* Primary complaint is shortness of breath, and presumed diagnosis is exacerbation of COPD

Exclusion Criteria:

* Fever
* Radiographic evidence of pneumonia
* Glasgow Coma score \< 14 or unable to correctly answer at least one study-specific question
Impact of Ginger on Menopausal Symptoms

This study aimed to examine the impact of one gram of Zingiber Officinale powder on menopausal symptoms since a large number of menopausal women in this region (Duhok city in the North of Iraq) are reluctant to take the conventional treatment for improving their menopausal symptoms and they prefer of taking the ginger powder and surprisingly many of those patients reported positive effects on their symptoms and general well being.

After taking the scientific and ethical approval from the College of the Pharmacy/ University of Duhok and the Directorate of Duhok Health (reference number 24102021-10-36) to look at the impact of Zingiber officinale on menopausal symptoms in women between 45 and 60 years old. A clinical interventional study was launched at the Gynecology Department in Azadi Teaching Hospital in Duhok Governorate, Iraq, from December 2021 to May 2022. This study initially recruited seventy women who matched the inclusion criteria. All the recruited women were informed about the study protocols, and they had the option to withdraw from it anytime. After giving written consent, they were randomly divided into one of two research groups through a random number generator software. Thirty-five women functioned as controls and were given placebo capsules for twelve weeks (A professional pharmacist formulated a 50mg starch purchased from the local market to look similar to the ginger capsule). The other thirty-five women were given pure Zingiber Officinale powder (500mg) in capsules twice daily for twelve weeks (Zingiber Officinale capsules were purchased from Pure Mountain Botanicals, 1712 Pioneer Ave # 1139 Cheyenne Wyoming 82001 (USA)). Twenty women completed the study in the placebo group, while thirty women completed the survey in the Ginger group. Unfortunately, fifteen participants from the control group and five women from the treatment group didn't finish the study and were excluded as they were not tighter to the project protocol.

The frequency and severity of menopausal symptoms were assessed using an internationally recognized questionnaire menopausal rating scale (MRS). Percentage differences between pre-treatment were compared to post-treatments.

The serum estrogen, progesterone, FSH, and LH levels were measured before and after treatment using a suitable kit for each hormone by Cobas e 411 analyzers (Roche Diagnostics).

Eligibility Criteria:
Inclusion Criteria:

* Women living in Duhok city with self-reported menopause symptoms
* Aged between 45 and 60 years

Exclusion Criteria:

* Not on treatment for menopausal symptoms
* Patients Having chronic diseases like hypertension, Ischemic heart diseases or Diabetes mellitus
* Patients having coagulopathies
* Patient's having hormone-dependent malignancies
Effects on Nurses' Quality of Working Life of an Educational Intervention to Strengthen Their Humanistic Practice

Haemodialysis (HD) patients constitute a vulnerable population with considerable health needs. They are often older persons with comorbid chronic conditions. Despite the substantial technical care they receive, these patients indicate that the quality of the human relationship that develops with nurses-the pivotal element in the care this population receives-can become therapeutic. This feature of the human relationship constitutes the cornerstone of the humanistic practice (caring practice) that all nurses should adhere to. However, according to some authors, such practice tends to fade over time. In 2012, a pilot study allowed to test an educational intervention based on Watson's Theory of Human Caring, the aim of which was to optimise nurses' humanistic practices. The intervention, first developed in Quebec and adapted in Switzerland by a committee of experts, was delivered to a group of nine HD nurses (Canton of Vaud, Switzerland) and evaluated. Preliminary results (qualitative and quantitative) showed the intervention to be highly feasible and acceptable. Moreover, in terms of preliminary outcomes, participating nurses appeared to strengthen their caring attitudes/behaviours toward HD patients post-intervention. Quantitative analyses of patients' questionnaires showed that HD patients perceived significant changes in nurses' caring attitudes/behaviours and maintained their level of quality of life (QoL) over time, which is a definite gain for this population. In light of these positive results, it is important to pursue this line of investigation in order to examine more accurately the intervention's effects on both nurses and patients. To this end, the investigators propose conducting a mixed-methods cluster randomised controlled trial (RCT) to assess the effects of an educational intervention to strengthen humanistic practice among nurses working in HD units in French Switzerland, on perceived quality of the nurse-patient relationship (NPR), nurses' team cohesion, nurses' quality of working life (QoWL), and HD patients' QoL. Knowledge acquired in the course of the study will contribute to strengthen nurses' humanistic practice, a key factor in HD patients' QoL.


Eligibility Criteria:
Inclusion Criteria:

* Nurses:

  1. have at least 6 months' work experience in the department;
  2. consent to take part in the study. In addition, nurses who intend to leave the HD unit in the 3 months to come will be excluded
* Patients

  1. be at least 18 years of age and under active treatment for at least 6 months;
  2. understand and read French;
  3. able to provide informed consent.

Exclusion Criteria:

* Nurses:

  1. intention to leave the HD unit in the 3 months after the beginning of the project
* Patients

  1. being diagnosed with dementia
  2. being a new HD patient
A Post-marketing Observational Study on Risk Factors for Hepatic Encephalopathy in Participants With Unresectable Hepatocellular Carcinoma

This study is a post-marketing observational study of lenvatinib in participants with unresectable hepatocellular carcinoma. The primary objective of this study is assessment of risk factors for hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* Participants with unresectable hepatocellular carcinoma who were administered the lenvatinib mesilate for the first time within the registration period.
* Have provided informed consent.
* Underwent case registration by 14 days after the start of administration of drug.
The Life After Stopping Tyrosine Kinase Inhibitors Study (The LAST Study)

This is a non-randomized, prospective, single-group longitudinal study. The purpose of this study is to improve the decision making process used by physicians and patients when they are considering stopping their Tyrosine Kinase Inhibitor (TKI) medication.

This is a non-randomized, prospective, single-group longitudinal study. The overall objective is to improve decision making for TKI discontinuation in eligible chronic myelogenous leukemia (CML) patients. Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (\> 4 log reduction) molecular response (\>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) \< 0.01%, for at least two years. The study will closely monitor patients using standard real-time Quantitative Polymerase Chain Reaction (RQ-PCR) testing for molecular recurrence, testing them monthly for six months, then every other month until 24 months, and then quarterly until 36 months. Concurrently, the study will assess a wide range of patient-reported outcomes (PROs) before stopping TKIs and after discontinuation in conjunction with Polymerase Chain Reaction (PCR) testing, though at fewer time points, utilizing online and/or phone questionnaires. Patients who have molecular CML recurrence based on RQ-PCR will restart imatinib, dasatinib, nilotinib, or bosutinib and will continue to be monitored for disease status and health status until the end of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older at time of study entry
2. Willing and able to give informed consent
3. Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein
4. Currently taking imatinib, dasatinib, nilotinib or bosutinib
5. Patient has been on TKI therapy for at least 3 years
6. Documented BCR-ABL \<0.01% (\>MR4 i.e. \>4 log reduction) or undetectable BCR-ABL by PCR for at least 2 years according to the patient's local lab
7. Documented BCR-ABL \<0.01% (\>MR4 i.e. \>4 log reduction) or undetectable BCR-ABL at least 3 times prior to screening according to the patient's local lab
8. Two (2) Screening PCRs have been completed and both results are \< 0.01% (\>MR4 i.e \> 4 log reduction) by central lab
9. Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed)
10. Patient has been compliant with therapy per treating physician

Exclusion Criteria:

1. Prior hematopoietic stem cell transplantation
2. Poor compliance with taking TKI
3. Unable to comply with lab appointments schedule and PRO assessments
4. Life expectancy less than 36 months
5. Patients who have been resistant to previous TKI therapy are not eligible
6. Pregnant or lactating women
Carboplatin AUC-10 With Early PET Scanning in Metastatic Seminoma

This study evaluated the safety, efficacy and toxicity of carboplatin area under the curve (AUC)-10 in metastatic seminoma to see if, by using fluoro-deoxyglucose (FDG) positron emission tomography-computed tomography (PET-CT) to assess metabolic response, the number of patients requiring 4 cycles can be reduced. Carboplatin AUC-10 was given every 21 days. A PET-CT scan was carried out on day 17-21 of the first cycle. If the PET - CT scan showed a complete response patients received 3 cycles of treatment. If the PET - CT scan did not show a complete response patients received 4 cycles of treatment. After treatment, patients were followed up for 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic seminoma with International Germ Cell Consensus Classification (IGCCCG) good prognosis.
2. Glomerular filtration rate (GFR) by Ethylenediaminetetraacetic acid (EDTA) clearance over 25 ml/min.
3. Eastern Cooperative Oncology Group (ECOG) Performance status 0-3.
4. Normal Alpha-fetoprotein (All levels of Human chorionic gonadotropin and Lactate dehydrogenase are acceptable).
5. Males aged ≥18 and ≤75 years.
6. Able to give written informed consent prior to study entry.
7. Patients must be sterile or agree to use adequate contraception during the period of therapy.

Exclusion Criteria:

1. Metastatic seminoma with any non-pulmonary visceral metastases.
2. Raised Alpha-fetoprotein.
3. Any previous chemotherapy or radiotherapy.
4. Currently enrolled in any other investigational drug study.
5. Other malignancy except basal cell.