cyrilzakka/clinical-trials huggingface dataset:
Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.


Eligibility Criteria:
Inclusion Criteria:

* Participant is 18 years of age.
* Participant weighs ≥ 34kg.
* Participant was hospitalized and had dialysis dependent End-Stage Renal Disease or Acute Kidney Injury and was prescribed acute intermittent renal replacement therapy.

Exclusion Criteria:

* Treatments isolated to ultrafiltration only.
* Any documented condition the Physician feels would prevent the participant from successful inclusion in the study.
Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty

No randomized trials have tested the effectiveness of acupuncture as a supplement to rehabilitation after total knee replacement. Studies from related fields, however, have shown reduction of symptoms as a result of acupuncture treatment in patients with knee pain caused by severe osteoarthritis in the knee. Furthermore, studies have reported that the need of pain medication was lower when acupuncture treatment was performed immediately after knee surgery.

The aim of this study is to test whether acupuncture can reduce pain and improve disability as a supplement to rehabilitation after total knee replacement.

One hundred and seventy patients will be allocated by drawing lots to either a treatment group receiving exercise therapy and acupuncture or a group receiving exercise therapy alone. Treatment will start 3 weeks after surgery at the latest.

Outcome of treatments will be measured at completion of treatment and at 3 months follow-up by pain- and disability questionnaires as well as the recording of walking capacity.


Eligibility Criteria:
Inclusion Criteria:

* Hemi- or total knee arthroplasty.
* 18 - 70 years of age.

Exclusion Criteria:

* Concurrent diseases that compromises treatment, i.e.hip disease, rheumatoid arthritis, migraine).
* Bleeding disorders.
* Heart disease or use of pacemaker.
* Lack of patient cooperation, i.e. psychological disorders, alcoholism, problems with language).
* Infection.

Exclusion criteria during intervention:

* Infection.
* Cicatrice-burst.
The Impact of Preoperative Olanzapine on Quality of Recovery After Discharge from Ambulatory Surgery

The primary objective of this phase 2 randomized controlled trial is to determine whether the pre-operative administration of olanzapine (5 mg PO) improves quality of recovery (assessed by the Quality of Recovery-40 (QoR-40) survey) on postoperative day 1 in patients having ambulatory surgery with general anesthesia.

The secondary objectives of this study are to determine whether there are differences in quality of recovery on postoperative day 2, presence of post-discharge nausea, presence of severe post-discharge nausea, recovery room length of stay and opioid consumption in patients who receive the study drug versus placebo.

Up to 37% of patients undergoing ambulatory surgery experience postdischarge nausea and vomiting (PDNV), and PDNV represents a major barrier to improving a patient's quality of recovery. Because olanzapine has been shown to be an effective drug for PDNV prevention, but carries the risk of sedation, this study seeks to identify if the administration of olanzapine is an intervention that improves a patient's overall quality of recovery.

The study population includes women between 18 and 50 years-old who are undergoing ambulatory (outpatient) surgery at Yale New Haven Hospital. This represents the population that is most susceptible to post-discharge nausea and vomiting (PDNV) and is therefore most likely to benefit from an intervention that reduces PDNV to impact overall quality of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Female aged 18-50
* Scheduled to undergo ambulatory surgery under general anesthesia
* Access to smartphone device or computer with internet connection and has an email address

Exclusion Criteria:

* Non-English speaking
* Unable to swallow pills
* Current use of anti-psychotic medications
* History of allergy to olanzapine
* Pregnancy/Lactation
* Current use of antihypertensive medication
* Diabetes Mellitus
* Clinically significant cardiovascular disease defined as follows:

  1. Myocardial infarction or unstable angina within 6 months prior to the day of planned surgery.
  2. History of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on anti-arrhythmic medication.
  3. New York Heart Association Class II or higher congestive heart failure.
  4. Postural hypotension or vasovagal syncope within 6 months of planned surgery.
* Hypotension on day of surgery, defined as a systolic blood pressure \< 90mmHg
* Seizure disorder
* Clinically active prolactinoma
* Hepatic disease
* Narrow angle glaucoma
* Parkinson's disease
* Lewy body dementia
Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke

The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR).

A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).

Assessments:

- Demographic Data Form: The researchers created a form to include the information on age, gender, stroke onset date, lesion type, affected side, and dominant extremity.

- Fugl-Meyer Upper Extremity Assessment: This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients (18). It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. The affected upper extremities are assessed with the subject in a seated position.

- Wolf Motor Function Test: This test was created to evaluate the motor ability of the upper extremity (19). The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The total score is used for the functional ability of the patients. The two items of muscle strength evaluation were not used in this study.

- Trunk Impairment Scale: This scale evaluates static and dynamic sitting balance and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. The test-retest and inter-rater reliability coefficients of the scale have been shown to be 0.85-0.99 (21).

Eligibility Criteria:
Inclusion Criteria:

* Age 40-85 years and having had a stroke in the last six months,
* Mini-Mental State Assessment score \>20,
* Able to sit safely,
* No neglect issue,
* Fugl-Meyer Upper Extremity Assessment score \<58.

Exclusion Criteria:

* Modified Ashworth Scale \>2,
* Severe reduction in visual acuity,
* Participation in another rehabilitation program,
* Subluxation or pain in the shoulder region.
Evaluation and Management of Parturients' Pain Intensity

The primary objective of this study is to examine the effects of Attentional Bias Modification (ABM) on the labor pain in parturients. One-third of the participants will undergo ABM training away from affective pain stimuli. One-third of the participants will undergo ABM training away from sensory pain stimuli. The rest of participants will be the control group.

In recent years, significant attention has been paid to the attentional bias in patients with chronic pain. Studies found that Attentional Bias Modification (ABM) could reduce the pain intensity in participants with chronic pain. The investigator's goal is to evaluate the effects of ABM on labor pain and patient satisfaction with the labor and delivery experience.

Eligibility Criteria:
Inclusion Criteria:

* Parturients who are at 36 weeks gestation (at time of starting the study)

Exclusion Criteria:

1. Any patient who refuses
2. Patients with impaired decision-making capacity
3. Patients who are blind or extremely visually impaired
4. Patients who cannot understand or read English
MACE and First Operating Room Systolic Blood Pressure in Patients Undergoing Non-cardiac Surgery Implications for the Hypertension Threshold

To find the threshold of First operating room SBP above which MACE risk increases.

To find the threshold of First operating room SBP above which MACE risk increases. By reviewing data from 2012-2017 in PKU first hospital.

Eligibility Criteria:
Inclusion Criteria:

* 18-100yr non-cardiac surgery

Exclusion Criteria:

* missing data file
Manual Implantation of Full-Thickness Skin Microcolumns

The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

Previously three patients have been successfully treated with the use of manual FTSM for wound coverage. To provide additional proof of concept data, this study will validate manual FTSM implantation on a larger scale with a 10-patient population. This will be measured by the following hypothesized parameters: time to re-epithelization, pigmentation, wound contraction, scar thickness, pain at the donor site and injury site healing outcome. The approach to testing this hypothesis will be to perform manual FTSM harvest, placement on the injured site, covered by an inert dressing for 10 patients with open wounds necessitating tissue coverage. The rationale is that although preliminary proof of concept data has already been obtained from three patients treated with FTSM implantation, additional proof of concept data would strengthen the conclusions made based on these cases.

Eligibility Criteria:
Inclusion Criteria:

* 8-85 years of age
* 10-125 cm2 open wound on the scalp, neck, torso or extremities necessitating tissue coverage
* Sufficiently healthy skin to serve as a donor site

Exclusion Criteria:

* Wound area involving the face\*
* Wound area involving joints\*
* Pregnancy
* Prisoner
* Active wound infection at potential treatment sites
* Exposed muscle, joint, tendon, or bone within the wound bed
The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer

This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.

This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6). Patients are allocated through computer-generated randomization into one of the three groups: Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer (pET) after identification of the personalized window of implantation using the endometrial receptivity analysis (ERA) test, all of them following the usual clinical practice in a same-cycle embryo transfer.

A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with elective blastocyst transfer are randomized in this prospective, multicenter, open label and controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patients indicated to undergo a cycle of IVF/ICSI with their own oocytes.
2. Age ≤ 37 years
3. BMI: 18.5 to 30
4. Normal ovarian reserve (AFC ≥ 8; FSH \< 8)
5. The most appropriated stimulation protocol will be decided by their doctor.
6. Blastocyst transfer (on day 5 or 6)
7. Blastocyst vitrification with open protocols (Cryotop, Cryoleaf, or Cryolock) or closed protocols (Cryotip or CBSStraw.)
8. Any pathology affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx affecting the endometrial cavity must be previously operated.

Exclusion Criteria:

1. Patients with recurrent miscarriages (\> 2 previous biochemical pregnancies or \> 2 spontaneous miscarriages)
2. Patients with a severe male factor (spermatozoa \< 2 million/ml)
3. Patients with implantation failure (\>3 failed cycles with good quality embryos)

Post-Randomization Exclusion Criteria:

1. Endogenous progesterone level ≥ 1,5 ng/ml at the day of hCG administration in all groups.
2. Absence of blastocysts (day 5 or 6) for embryo transfer.
3. Risk of ovarian hyperstimulation syndrome in any of the three groups and therefore a clinical indication to cancel the transfer cycle where the stimulated patient is from group A (ET).

Note: PGT-A is not an inclusion criteria neither an exclusion criteria, therefore those cycles in which PGT-A was performed will be included
A Retro-prospective Study of Total Hip Arthroplasty With EMPERION Modular Primary Stem in Australian Centres (HISTORIC)

This is a retro-prospective, single arm, sequential enrolment study to collect relevant clinical and radiological data in at least 156 subjects, at up to 10 sites in Australia, who have been implanted with the EMPERION™ Modular Hip System in primary THA procedures to assess its safety and efficacy over 5 years post-surgery.

The main aim of the study is to demonstrate that there is no significant difference in survivorship at 5 years in the EMPERION™ primary stem compared to other primary stems for total hip arthroplasty.

Investigational site personnel will review and screen clinical records for potential subjects to be included in the study. Eligible patients will be contacted and follow-up status and implant revision status will be assessed at this initial contact. The subject will be given the option to participate in a prospective 5-year on-site follow-up visit for which they will provide written informed consent. An HREC waiver of informed consent for study participation will be obtained for subjects who are lost to follow-up, deceased or are unwilling/unable to participate in a prospective on-site 5-year follow-up visit, allowing the inclusion of data from all patients implanted with the study device regardless of follow-up status and therefore eliminate selection bias.

Data will be collected retrospectively from the subject pre-surgery, during surgery, at discharge and at 1-year follow-up found in their medical files and prospective data will be collected from the subject's 5-year Follow-up visit and documented on specially designed Case Report Forms (CRFs).

Data to be collected include:

* Subject demographics
* Primary diagnosis for THA
* Additional relevant history and physical findings
* Post-operative follow-up findings at 1 and 5 years
* Radiological Assessment
* Revision by time points
* Adverse Events

Eligibility Criteria:
Inclusion Criteria:

1) Subject has undergone primary total hip arthroplasty with the EMPERION™ Modular hip system

Exclusion Criteria:

1. Subject received the EMPERION™ THA on the affected hip as a revision for a previously failed THA
2. At the time of surgery, subject had an active infection or sepsis (treated or untreated)
3. At the time of surgery, subject had presence of malignant tumor, metastatic or neoplastic disease
SI-613 Study for Knee Osteoarthritis

The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.


Eligibility Criteria:
Inclusion Criteria:

* Provides their written informed consent.
* Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
* Is willing to switch to using acetaminophen as a rescue medication

Exclusion Criteria:

* Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
* Secondary OA
* Is a female subject who is pregnant or lactating.
* Is currently hospitalized or has a planned hospitalization during the life of the study.
Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination

The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol.

The develop of contaminants in blood cultures is a problem of great impact to health institutions and patients, as they represent a waste of resources, and additionally increases the patient's hospital stay. The principal source of contaminant is the bacteria in the skin flora, so the greatest way to improve the sensibility of this test is to do an optimal skin antisepsis. It has been reported that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior that other skin disinfectants, and that 70% isopropyl alcohol has a high efficacy reducing the presence of bacteria on the skin, so both antiseptics are good options for skin antisepsis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected blood stream infection.
* Patients allocated in admission, hospitalization and intensive care units.

Exclusion Criteria:

* Patients with a single peripheral hemoculture.
Study of Utilization Patterns of Dimethyl Fumarate in Germany

The primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users; To describe the duration of therapy in participants newly initiating DMF treatment; To describe the medical specialties of DMF prescribers.

Dimethyl fumarate will not be provided to participants as a part of this study.

Eligibility Criteria:
Key Inclusion Criteria:

* New users of dimethyl fumarate will be included in the analysis

Key Exclusion Criteria:

* Patients for which data is not available for the 6 months period prior to the index date (baseline observational period)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Leukocyte Esterase Sensor Test

The primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical LE biosensor for periprosthetic joint infection (PJI). The secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to LE in making a diagnosis of PJI.


Eligibility Criteria:
Inclusion Criteria:

1: consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection

Exclusion Criteria:

1. known active gout flare
2. existing corrosion or metallosis
3. inflammatory arthritis
4. preexisting diagnosis of infection in the same joint
5. patients undergoing second-stage procedure for infection.
Virtual Single-energy Imaging and De-metallic Artifact Technology in Reducing Spinal Metallic Artifacts

1. Compare the effect of virtual single energy imaging and virtual single energy combined with MAR technology to remove metal artifacts in the spine. 2. Discuss the most suitable KeV of virtual single energy imaging combined with MAR technology to remove metal artifacts.

The virtual single-energy imaging of energy spectrum CT combined with the metal artifact reduction technology MARS Multi Artifact Reduction System\] can effectively reduce the interference of metal artifacts. This is because MAR technology corrects the image through an iterative algorithm, improves the spatial resolution, and restores the details of the adjacent tissue of the metal object. Virtual single-energy imaging technology can effectively reduce hardening artifacts. The two are used in combination to achieve the purpose of reducing metal artifacts. There have been articles about virtual single energy combined with MAR technology to reduce metal artifacts. However, the current researches mostly focus on the comparison of virtual single energy combined with MAR technology and conventional CT examination and virtual single energy imaging. There are few evaluations on the severity of metal artifacts after spinal surgery. According to different surgical methods, metal The difference in the number of implants will result in different artifact reduction effects. Secondly, the current research on the suitable KeV of virtual single energy combined with MAR technology to reduce metal artifacts is less discussed and reported.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery due to lumbar disc herniation or prolapse
* Patients undergoing surgical correction due to vertebral deformities.

Exclusion Criteria:

* The scan image quality caused by the patient's movement and other factors is too poor to meet the diagnostic requirements.
* Patients with only spinous processes and intervertebral spaces undergoing metal fixation after spine surgery
* Patients after spinal cord tumor surgery.