cyrilzakka/clinical-trials huggingface dataset:
Innovations in Genicular Outcomes Registry

The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\]).


Eligibility Criteria:
Inclusion Criteria:

1. Planned to receive treatment for knee OA pain including, but not limited to, knee injections, nerve blocking procedures, or knee arthroplasty within 60 days of screening
2. Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator
3. Have access to a smartphone or internet access with a computer/tablet to complete the questionnaires using the registry application

Exclusion Criteria:

1. Actively enrolled in an investigational trial that would preclude patients from receiving the site's standard of care for knee OA pain or knee arthroplasty recovery protocol
2. Planning to have a surgery other than on the target knee
Outcome of Transforminal Epidural Injections in Patients with Lumbar Radicular Pain

Back pain is the most common chronic pain disorder of adult population. Lumbar radicular pain occurs due to irritation or compression of the nerve roots in the lower back. Various non-surgical methods can also be exercised that have been used to treat lumbar radicular pain since the ancient times. Despite the availability of various treatment options, achieving optimal pain relief and functional recovery remains challenging. Lumbar Transforaminal Epidural Steroid Injections (TFESI) are commonly used to manage this condition, but there is variability in patient response and limited data on the effectiveness of TFESI in different demographic and clinical subgroups.


Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Aged between 45 and 80 years
* Experiencing lumbar radicular pain

Exclusion Criteria:

* History of spinal fracture or previous spinal surgery
* Recurrent pain within 3 months of prior treatment
* Ongoing steroid therapy
* IKnown allergy to dexamethasone or lidocaine
Effects of Different Colors of Light on Human Physiology

This study will determine which color of light is most effective in stimulating a range of biological functions in humans including activation of sleep-wake regulatory system (alertness, performance, microsleeps, brain activity), activation of the nervous system (heart rate, temperature, blood pressure, breathing rate), and shifting the timing of the internal 24-hour (circadian) pacemaker.

Light has long been proposed to have a stimulatory effect on a range of biological functions in humans including increased feelings of activation, such as improved alertness or ability to perform. The mechanisms underlying how light stimulates these neurobiological systems remain to be elucidated. We propose to investigate the effects of different colors of light on human physiology, and in particular, test the claims that specific colors of light preferentially stimulate neurobiological, physiological and hormonal systems. Using classical photobiological techniques, we will construct action spectra for the effects of different colors of light on a range of non-image forming responses in humans.

We will test the hypotheses that: 1) light-induced activation of the neurobiological sleep-wake regulatory system, as indicated by increased alertness, faster reaction time, suppression of EEG alpha activity, microsleeps and slow rolling eye movements, and suppression of pineal melatonin, is most sensitive to retinal exposure to short wavelength blue light (460 nm) compared to equal photons of other colors of visible light; 2) light-induced activation of autonomic and hypothalamic-pituitary-adrenal axis measures of arousal, as indicated by increased heart rate variability, core body temperature, blood pressure, respiration rate, plasma cortisol levels and urinary catecholamines, is most sensitive to exposure to short wavelength blue light (460 nm) compared to equal photons of other colors; 3) phase shifts of the human circadian pacemaker, as assessed by changes in temperature, melatonin and cortisol rhythms, are most sensitive to exposure to short wavelength blue light (460 nm) compared to equal photons of other colors. The resultant action spectra will help to identify the photoreceptor mechanism(s) by which light activates arousal and circadian resetting, these non-image-forming physiological responses and enable us to distinguish between major candidate photoreceptive mechanisms, including potential novel photoreceptor systems, that might mediate such responses.

Eligibility Criteria:
Inclusion Criteria:

* Free from any acute, chronic or debilitating medical, psychological, or ophthalmological conditions
* Drug-free (including caffeine, nicotine, and alcohol) for entire study duration

Exclusion Criteria:

* History of drug or alcohol dependency
* History of psychiatric illnesses or evidence of psychopathology according to standardized questionnaires, or in a structured clinical interview
* Night shift work during the past 3 years
* Transmeridian travel in the last 3 months
RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties

This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.

Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.

A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary TKA.

Eligibility Criteria:
Inclusion Criteria:

* Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis
* All eligible male or female patients between the ages of 20 years to 100 years old
* All included study participants must be able to give an informed consent.

Exclusion Criteria:

* Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
* The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
* Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
* Presence of previous prosthetic knee replacement devices (of any type)
* Metastatic disease
* Psychiatric illness
* Drug or alcohol abuse
* Body mass index (BMI) \> 40 kg/m2
Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury

We will utilize a set of imaging modalities including computed tomography (CT), positron emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI).

We will recruit mTBI subjects and control subjects. Each subject will undergo the set of imaging modalities, and the results will be analyzed for differences at the structural, physiological, and molecular levels. The long term goal of this research is the development of a method to diagnose mTBI based on physical markers. This is a phased project beginning with a pilot study followed by future studies with larger sample sizes.

Eligibility Criteria:
Inclusion Criteria:

Study group:

* Between 18 and 55 years of age inclusive.
* Potential participant verbally verifies diagnosis of mTBI at pre-screen.
* Diagnosed with mild traumatic brain injury by a VAMC physician according to standard diagnostic criteria \[12\],\[13\], to be verified by chart review.
* Less than 24 months from trauma resulting in mTBI.
* Able to read and write in English.
* Willingness to refrain from nicotine, and beverages containing either alcohol or caffeine for at least four hours prior to the imaging session.
* Have signed the consent form for the study.

Control Group:

* Between 18 and 55 years of age inclusive.
* Potential participant verbally denies history of mTBI at pre-screen.
* Able to read and write in English.
* Willingness to refrain from nicotine, and beverages containing either alcohol or caffeine for at least four hours prior to the imaging session.
* Have signed the consent form for the study

Exclusion Criteria:

* Conditions that would preclude the completion of a MRI, PET, or CT exam such as claustrophobia, pacemaker, metal objects in body, and/or pregnancy.
* Serious, unstable medical or mental illness.
* Medical contraindication to any element of the study procedure.
* Have not read and signed an informed consent form, or do not understand its contents.
Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer

This study is investigating the biological characteristics of early oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) in older woman (aged \> 70 years) who were treated with adjuvant endocrine treatment (ET). It will use surgical tissue previously collected as part of routine care from patients aged 70 years or older at diagnosis with ER positive, HER2 negative stage I-III BC treated The Royal Marsden NHS Foundation Trust (RMH).

The overarching aim of this study is to define the biological characteristics of early BC in older women in terms of tumour microenvironment (TME), molecular and genomic features. This analysis will include assessment of tumour infiltrating lymphocytes (TILs), and gene expression profiling with NanoString using the Breast Cancer 360 (BC360TM) assay measuring ribonucleic acid (RNA) expression signatures of genes involved in proliferation, endothelial, angiogenesis, cytotoxicity, stroma, inflammatory chemokines, and apoptosis. This analysis will examine various biological pathways, aiming to inform suitability for certain treatments including cyclin-dependent kinase inhibitors (CDKi), chemotherapy, immunotherapy, or targeted treatments such as phosphoinositide 3-kinases (PI3K) inhibitors, or deoxyribonucleic acid (DNA) damage response.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women aged \>70 years at the time of diagnosis of invasive breast cancer.
* ER positive (Allred score \>5/8), HER2 negative early invasive BC.
* Stage I-III BC.
* Surgical tissue available.
* No pre-surgical systemic therapy (i.e., no pre-operative ET or chemotherapy).
* Planned adjuvant ET with an aromatase-inhibitor.
* No adjuvant chemotherapy.
* Surgery was performed between 1st January 2014 and 31st December 2016.

Exclusion Criteria:

* Pre- or perimenopausal.
* ER negative or HER2-positive BC.
* Multifocal cancer where not all of foci ER positive HER2 negative
* Bilateral breast cancer.
* Stage IV breast cancer.
* Benign histology or DCIS.
* Pre-surgical treatment.
* Prior chemotherapy for BC.
Comparison of Minisling Suburethral Sling and Laparoscopic Buch Colposuspension

When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI.

When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. To be between the ages of 18-80
2. Isolated genuine stress incontinence or accompanying pelvic organ prolapse
3. Having accepted surgery for stress urinary incontinence -

Exclusion Criteria:

* 1. Previously undergo pelvic organ prolapse surgery 2. Having a chronic lung disease such as asthma or Chronic obstructive pulmonary disease (COPD) 3. Having juvenile diabetes mellitus 4. History of gynecological cancer 5. Mesh allergy
Thinking Healthy Program-Technology Assisted (THP-TA)

Background

The Thinking Healthy Program (THP) is an evidence based task-shifted low intensity psychosocial intervention, recommended by the World Health Organization for the treatment of perinatal depression. The investigators developed a technology-assisted version of Thinking Healthy Program (THP-TA) which allows peers to deliver the THP, while ensuring minimal resources for training of delivery agents and ensuring adequate fidelity.

Method

This is a non-inferiority, pragmatic cluster randomized controlled trial designed to test the primary hypothesis that technology assisted delivery of THP is not worse than THP intervention delivered by community health workers, in increasing perinatal depression remission rates at 3 months postnatal. In addition, this study will also test the effectiveness of the THP-TA in improving recovery from perinatal depression at 6 months postpartum, quality of life and social support. This study also aims to evaluate the cost-effectiveness of the THP-TA.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with current major depressive episode in their second or third trimester (4 to 8 months of pregnancy).
2. Aged 18 years and above
3. Intent to stay in the study area for at least 1 year.

Exclusion Criteria:

1. Women requiring inpatient care for any reason (medical or psychiatric) as determined by their primary health care professional
2. Those who do not comprehend Urdu language will be excluded.
Changes in Pleural Cavity Volume and Surgical Exposure

The investigators want to investigate if a diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.

A visually good surgical field is essential in performing safe and optimal dissection of anatomical structures during Video Assisted Thoracoscopic Surgery (VATS). A number of patients referred to VATS-surgery appear with an elevated diaphragm, reducing visibility and complicating safe surgical techniques, thus entailing conversion from VATS into an open Thoracotomy. Some surgeons handle the decreased visibility due to an elevated diaphragm by increasing the amount of ports during VATS. Others have benefited from attaching a traction suture on the diaphragmatic posterior tendinous part, thus flatting the diaphragmatic dome when the suture is tightly retracted through the camera-port. It turns out that most thoracic surgery clinics are not familiar with this technique. There are also no articles regarding this topic in medical literature. We want to investigate if the diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* known or suspected lung cancer
* scheduled for VATS-surgery
* perioperative finding of elevated diaphragma

Exclusion Criteria:

* not willing to give informed consent.
* perioperative finding of pleural adherences
* perioperative finding without an elevated diaphragma
A Study of Soticlestat in Adults and Children With Rare Epilepsies

The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment.

Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study.

Study treatments may continue as long as the participant is receiving benefit from it.

The drug being tested in this study is called soticlestat (TAK-935). This global, open-label extension (OLE) study will assess the long-term safety and tolerability of soticlestat in participants with developmental and epileptic encephalopathy (DEE) who participated in previous short-term efficacy/safety studies of soticlestat. All participants will receive Soticlestat treatment.

Participants who rollover from previous blinded study will undergo up to 2 weeks of Dose Optimization Period (depending on the previous study) followed by Maintenance Period. Participants who rollover from an open-label study will continue on their current dose until development is stopped by the sponsor, or the product is approved for marketing, or at any time at the discretion of the sponsor. There will be a 4-week Safety Follow-up Period after the last dose in Maintenance Period, including a 2-week dose Tapering Period.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have participated in a previous soticlestat study and meet one of the following conditions:

   * Successfully completed a soticlestat clinical study.
   * Received at least 10 weeks of treatment with the study drug in an antecedent placebo-controlled blinded soticlestat clinical study and the participant did not have a serious or severe AE that, in the investigator's or sponsor's opinion, was related to the study drug and would make it unsafe for the participant to continue receiving the study drug.
2. In the opinion of the investigator, the participant has the potential to benefit from the administration of soticlestat

Exclusion Criteria:

1. Clinically significant disease, that, in the investigator's opinion, precludes study participation.
2. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving Soticlestat).
3. Participant is currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration.
4. Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as 'yes' to suicidal ideation question 4 or 5 on the C-SSRS at Screening) or appearing suicidal per investigator judgment.
Randomized Comparison of Curved Cutter Stapler and Linear Stapler

This study aims to compare the safty and technical accessibility of linear stapler and curved cutter stapler during mid to low rectal cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of rectum.
* Preoperative stage I-III
* Patient who is expected to undergo low anterior resection at Samsung Medical Center.
* Age \> 19 years old

Exclusion Criteria:

* Patient with complicated rectal cancers(obstruction, perforation, abscess)
* Patient who needs to undergo emergency operation.
* Patient who can not undergo general anesthesia.
* Patient who does not agree with the informed consent or does not have the ability to understand content of the trial .
Comparison of Side Effects of Morphine and Hydromorphone Patient-Controlled Analgesia (PCA)

Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for abdominal surgery requiring post-operative PCA
* ASA = I or II

Exclusion Criteria:

* preoperative pain or use of pain medication
* narcotic allergy
* morbid obesity (Body Mass Index \> 30)
* diagnosis of sleep apnea
* hepatic or renal disease
* use of medications that would affect narcotic pharmacodynamics
* preoperative nausea, vomiting, or pruritis
* diagnosis of alcoholism
Epidemiology of Diverticulitis in Lung Transplant Recipients

The purpose of this study is to assess incidence, treatment modalities and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) in order to establish improved treatment strategies in this high risk patient collective.

Sigmoid diverticulitis is common and potentially problematic in immunosuppressed patients. The choice between conservative and surgical treatment for uncomplicated diverticulitis remains unclear, as well as the value of the Hartmann's procedure (HP) for complicated diverticulitis.

Our aim is to assess incidence, treatment options and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) by retrospectively analysing our prospective database of around 400 lung transplant recipients transplanted between 1992 and 2013.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipient
* Diverticulitis

Exclusion Criteria:

* none
PerClot Compared to Usual Care in Gynaecology Procedures

This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care. PerClot is a CE marked device and is currently used as a haemostat in gynaecological surgery throughout Europe. The purpose of this study is to collect additional post market data on its use in this indication.

This study is a post market, multi-centre, randomised study evaluating PerClot compared to usual care.

All subjects in this randomized study will undergo a laparoscopic or open gynecological procedure such as hysterectomy, cystectomy, myomectomy, endometrial excision or ablation. Subjects will be randomized to receive PerClot or usual care.

This research will utilize a multi-center, prospective, randomized controlled study. The study will be conducted in2 study sites in Europe. An assumed sample of 90 subjects will be enrolled to evaluate the time to haemostasis. The enrollment of subjects to receive treatment will be based upon specific inclusion and exclusion criteria. Subjects will be randomized on a 1:1 basis to receive either PerClot or usual care. Data collected from both arms will be compared.

Usual care will be at the discretion of the surgeon and may include any other haemostat or diathermy/electrocautery.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subject is undergoing gynecological procedure
* Subject is willing and able to comply with the protocol and follow up period
* Subject is willing and able to give written informed consent

Exclusion Criteria:

* • Subject with a history of pelvic or abdominal radiotherapy (within 8 weeks)

  * Subject is pregnant or actively breastfeeding
  * Subject has a ruptured ectopic pregnancy
  * Subject has a medical history of abnormal coagulopathy or bleeding
  * Subject has a sensitivity to starch or starch derived materials
  * Subject has active or potential infection at the surgical site
  * Subject is currently enrolled in another study