cyrilzakka/clinical-trials huggingface dataset:
Pedicle Screw Usage in Conventional Fixation Pattern Constructs Compared to Thoracic Hook Constructs in Scoliosis

Scoliosis is a deformity in which there is an abnormal curvature of the spine. Surgery is the main method of correcting this deformity. Rods are attached to the spine to make it strait. There are two ways to fix these rods to the bone of the spine: laminar hooks or pedicle screws. Hooks are an older form of fixation and do not penetrate the bone, but are instead placed over a part of the vertebra called the lamina. Screws are newer and do penetrate the bone. Screws are placed into the part of the vertebra called the pedicle. Most surgeons think screws correct scoliosis better than hooks. The current literature agrees that screws are better for deformity correction in the lumbar spine and patients with severe deformity. There is disagreement in the literature regarding which works better in the thoracic spine in less severe deformity. There are no randomized, controlled trials in the literature that examine whether constructs that use hooks in the thoracic spine and screws in the lumbar spine (called hybrid constructs) work as well as all-screw constructs. This clinical study is a randomized controlled trial being conducted to evaluate treatment outcomes in patients with scoliosis undergoing surgical correction for their curves using either all-screw or hybrid constructs as fixation devices. The study population is limited to those with less severe deformity and the investigators' hypothesis is that hybrid constructs will be as acceptable as screws in terms of correction.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of adolescent idiopathic scoliosis or neuromuscular scoliosis
* Fusion to include six of more levels in thoracic, thoracolumbar, or lumbar region
* Less than 21 years of age
* Able to undergo surgery based on physical exam, medical history, and surgeon judgement
* Willing to comply with the follow-up clinical and radiographic evaluation schedules
* Informed consent signed by patient and parent or legal guardian

Exclusion Criteria:

* Scoliosis with curvature greater than 100 degrees or less than 40
* Smaller juvenile subjects weighing less than 30 kg
* Rigid curves
* Infection in the disc or spine, past or present
* Subject is pregnant
* Evidence of abuse of alcohol and/or illicit drugs
* Subject is prisoner
* Subject has evidence of tumor(s), malignant disease or other significant illness with decreased life expectancy
* Subject is immunocompromised or being treated with immunosuppressive agents
Efficacy of Perioperative Anesthesia Care Bundle on Prognosis in Elderly Undergoing Hip Fracture Surgery

This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.

To evaluate the efficacy of perioperative anesthesia care bundle on prognosis in elderly undergoing hip fracture surgery; to assess the levels of compliance that current anesthesia management strategy of our hospital against the new "guidelines"; and to analyze the defects in the current anesthesia management strategy and collect data for further multi-center research, this single-center randomized controlled trial was conducted. The central stochastic system was adopted to determined the stratification factors by age, POSSUM score, whether there was tracheal intubation or laryngeal mask auxiliary ventilation. Therefore, there are two groups including the new version of "guidelines" anesthesia strategy group and existing anesthesia strategy group at a ratio of 1:1. The mortality is the primary indicator will be collected in 1,6,12 months after surgery. And VAS score, MMSE, length of hospital stay and so forth, which would be collected as the secondary indicators.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 75 years old;
2. Patients with hip fracture purely and surgical treatment is scheduled.

Exclusion Criteria:

1. Surgical treatment has been performed after entering hospital;
2. Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc.
3. Refuse to sign informed consent;
4. Investigator thinks he/she is inappropriate to carry out this study.
Two Measures of Tactile Acuity in CRPS Type I Patients

This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
* Patients diagnosed with a neuropathy of the median nerve
* Healthy Controls,matched in age and gender to both patient cohorts

Exclusion Criteria:

* intolerable hyperalgesia
* lesions at the fingertips
* high grade digit contracture
* central neurologic disorders
* psychiatric disorders
Dosing of Antibiotics During Reimplantation of Infected Knee and Hip Prostheses

The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses

The purpose of the study is to evaluate the concentrations of antibiotics (daptomycin, vancomycin, cefotaxime, ceftriaxone, cefepime) in serum and periprosthetic tissues(bone and synovial joint) used as empirical treatment during reimplantation of infected hip and knee prostheses (1-stage or 2-stage management).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged of 18 years or more) who undergo reimplantation surgery for infected hip or knee prosthesis (performed in 1 or 2-stage(s)), and for whom referral physicians plans to use an empirical antibiotic therapy including cefotaxime, ceftriaxone, cefepime, daptomycin, or vancomycin.

Exclusion Criteria:

* Patients with multiple prosthetic joint infections, or with curative antibiotic therapy ongoing within two weeks or less prior to surgery, or for whom an antibiotic prophylaxis is decided by referral for the reimplantation surgery, or for whom an antibiotic-loaded cement containing the same antibiotic chosen for empirical therapy after reimplantation was used in case of 2-stage exchange
HPI (Hypotension Prediction Index) Care Trial

A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients requiring cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are at least 18 years of age
2. Subjects who have signed the Informed Consent Form
3. Subjects with planned pressure monitoring with an arterial line
4. Subjects with planned sternotomy
5. Subjects with planned general anesthesia
6. Subjects who have ASA Physical Status ≤ 4
7. Subjects with planned cerebral oximetry monitoring
8. Subjects with planned overnight hospitalization
9. Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery

Exclusion Criteria:

1. Subjects with a physical site area too limited for proper Sensor placement
2. Subjects with contraindications for Arterial Line Placement;
3. Subjects participating in another (interventional) study
4. Subjects in whom an intraoperative MAP target will be \< 65 mmHg
5. Subjects with pre-op or pre-pump or post-pump LVEF \< 15%
6. Subjects requiring heart transplant
7. Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass
8. Subjects requiring emergency surgery
9. Subjects with known or identified severe PAH (defined as pulmonary systolic pressure\> 70mmHg or mean pressures \> 55mmHg) as determined by a pre-operative echo or intraoperative Swan-Ganz
10. Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run
A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab

The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasian participants.


Eligibility Criteria:
Inclusion Criteria:

* Must be first or second generation Japanese of full parentage residing outside of Japan for less than 10 years. First generation participants will have been born to two parents and four grandparents also born in Japan of full Japanese descent. Second generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet or participants must be Caucasian and not of Hispanic ethnicity.
* Body Mass Index (BMI) is \>= 18.5 and \<= 29.9 kg/m2 (after rounding to the tenths decimal) at Screening. BMI is calculated as weight in kilograms (kg) divided by the square of height measured in meters (m).

Exclusion Criteria:

* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
* Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator.
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
* Any evidence of a concomitant disease judged as clinically relevant by the investigator.
A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors

This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of etigilimab in combination with nivolumab in participants with locally advanced or metastatic solid tumors. Participants will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 milligrams \[mg\] every 2 weeks).

This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in participants with locally advanced or metastatic solid tumors. Participants will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks) and will continue until either unacceptable toxicity or disease progression. Participants may continue to receive treatment beyond documented Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) or disease progression. Participants who are both checkpoint inhibitor (CPI) naive as well as participants who have received or progressed following a CPI will be eligible and include the following tumor types: head and neck squamous cell carcinoma (HNSCC), cervical carcinoma, gastric or gastroesophageal carcinoma, endometrial carcinoma, tumor mutation burden high (TMB-H), select rare tumors and ovarian carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of a relevant tumor type as per the study protocol and not candidates for curative surgery or radiation therapy
* Available tumor tissue (archival or newly obtained core or excisional biopsy)
* Adequate hematologic and end organ function as measured by laboratory screening panel in the 14 days prior to treatment
* Life expectancy greater than 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate contraception for women of childbearing potential
* Pre-specified wash-out of prior anti-PD1/PDL-1 therapy

Exclusion Criteria:

* Concurrent active malignancy
* Major surgery within 4 weeks of treatment
* Participants with active, known or suspected autoimmune diseases
* Prior treatment with cluster of differentiation (CD) 137 agonists, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and anti-T-cell immunoreceptor with immunoglobulin (Ig) and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) antibodies
* History of any Grade 3 or 4 immune-related adverse event (AE) toxicity from prior immunotherapy that resulted in treatment discontinuation
* History of immune-related adverse events that lead to discontinuation of anti-PD-1 or PDL-1 therapy
* Active infections of human immunodeficiency virus (HIV), hepatitis B, hepatitis C
* Medical illness or abnormal laboratory finding that would, in the Study Investigator's judgement, increase the risk to the participant associated with participation in the study
* Pregnancy in female participants
Mind-Body Rehabilitative Program for Veterans With mTBI (Mild Traumatic Brain Injury)

The broad aim of the proposed study is to evaluate the comprehensive benefit of a novel mind-body therapeutic intervention, Mind-Body Bridging (MBB), in Veterans who suffer from mTBI and sleep disturbance co-morbid with PTSD and/or pain at the VA Salt Lake City Health Care System (VASLCHCS). Evidence for comprehensive benefit includes, but is not limited to, the average difference in outcomes between MBB and an active control, sleep education (SED), both integrated with the usual care for mTBI Veterans. The long-term goal of the proposed project is to introduce, implement and establish mind-body intervention programs as a behavioral health intervention modality that would serve as a generally sustainable health care intervention program before, during, and after deployment for military personnel.

Traumatic brain injury represents a dynamic spectrum of physiologic and cognitive dysfunction that exerts effects at multiple levels of human health. Mild traumatic brain injury (mTBI) is a multi-factorial illness that is an increasingly serious public health issue for military and civilian personnel. The assessment of neurocognitive deficits in mTBI has been suggested to be less conclusive, presumably because of the predominating influence of PTSD and other co-morbid factors. Recent research suggests that psychological factors play a substantial role in TBI-related impairments in self-reported health and cognition function. Furthermore, research has shown that TBI is rarely an isolated finding in military combat settings and that persistent post-concussive symptoms are commonly associated with post-traumatic stress disorder and chronic pain, a constellation of findings that has been termed the "polytrauma clinical triad". Indeed, significant numbers of returning Veterans of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) display the polytrauma clinical triad (PCT) of pain, posttraumatic stress disorder (PTSD), and traumatic brain injury. The proposed project will: 1) elucidate best practices for treating mTBI with co-occurring symptoms (pain, sleep disturbance, PTSD) encompassing cognitive, emotional, and psychological functioning; and 2) address psychosocial aspects of managing pain and co-morbidities associated with mTBI through integrative and complementary and alternative approaches.

Eligibility Criteria:
Inclusion Criteria:

* Veteran from OEF/OIF
* has been diagnosed with mTBI
* has current sleep disturbance as indicated by a score of 35 or greater on the MOS-Sleep Scale (MOS-SS)

Exclusion Criteria:

* serious psychiatric comorbidity
* active intense suicidal intent
* inpatient admission to psychiatric ward in the last 3 month
* the presence of co-occurring progressive/advanced neurodegenerative disease
* terminally ill
* unstable chronic medical conditions
* untreated sleep apnea
* presence of substance dependence disorder
* narcolepsy
* frequent nocturia
* delayed sleep phase syndrome
* advanced sleep phase syndrome
Effectiveness of Mobile Messenger-initiated Reminder on Biannual Mammography Adherence in Breast Cancer Screening

Female breast cancer is the most common cancer and fifth leading cause of cancer death worldwide. In the past decade, breast cancer consistently to be the most common cancer for women in Hong Kong, so much that it accounts for 27% of all female cancers, with 4,600 new cases of breast cancer registration every year and the lifetime breast cancer risk for females is 1 in every 14. At the same time, breast cancer ranks the third in cancer death in Hong Kong, with a five-year relative survival rate of 84%. Regular mammography screening has been shown to reduce the mortality of breast cancer. International guidelines recommend annual or biannual mammography screening for women aged 50 or above.

The adherence to regular mammography screening remains a challenge. Studies had shown that the adherence decreased over time. Mailed and telephone reminder were being proven to be effective tools to increase the adherence to regular breast screening using mammography. However, both mailing and telephone strategies are associated with labor intensity and high cost.

Over the past two decades, the advent of internet and smartphone provided a fertile platform for the development of mobile-health technologies. WhatsApp Messenger is one of the most frequently used free-of-charge mobile messenger that permits users to send secure messages across different device platforms. A recent randomized controlled trial from our team has suggested its clinical utility in improving adherence to regular colorectal cancer screening using fecal immunochemical test. This encouraging data prompted us to investigate the potential role of WhatsApp Messenger in breast cancer screening. We hypothesized that text reminder sent via WhatsApp Messenger improves the longitudinal adherence to biannual mammography in a community-based, opportunistic breast screening program.


Eligibility Criteria:
Inclusion Criteria:

* Women with negative mammography results which are defined as BI-RADS (Breast Imaging-Reporting and Data System) 1 or 2 in the first round of mammography screening of the existing opportunistic breast cancer screening cohort
* Due for second round of biannual follow up of mammography
* Consented to be contacted via WhatsApp Messenger

Exclusion Criteria:

* Those without access to WhatsApp Messenger or disagreed to be contacted via WhatsApp Messenger
IASTM Versus PRT in Patients With Chronic PF

The goal of this clinical trial\] is to compare between the effect of instrument assisted soft tissue mobilization and positional release technique in patients with chronic plantar fasciitis

The main question\[s\] it aims to answer are:

1. Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on pain pressure threshold in patients with chronic plantar fasciitis?
2. Is there a difference between the effect of instrument assisted soft tissue mobilization and positional release technique on foot function level in patients with chronic plantar fasciitis?

Design of the study:

Pretest - posttest randomized controlled trial.

Subjects selection:

Sixty patients their age range from 30-50 years of both genders with chronic plantar fasciitis will participate in this study according to sample size calculation.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed cases of plantar fasciitis not less than 3 months.
2. Heel pain felt maximally over plantar aspect of heel.
3. Pain in the heel on the first step in the morning.
4. Their age ranging from 30-50 years.
5. Body mass index range from (18.5 to 24.9 kg/m2).

Exclusion Criteria:

1. Subjects can't tolerate close physical contact.
2. Athletes.
3. Subjects with skin infections.
4. Subjects with recent fracture with incomplete bony union.
5. Subjects with acute inflammatory or infectious process.
6. Subjects with hematoma.
7. Subjects with osteoporosis.
8. Subjects with foot deformity.
9. Subjects that take medications that may increase blood clotting.
10. Surgery to the ankle or foot.
Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer

The investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cancer
* Patient over 70 years old hospitalized 48 hours or more
* Patient identified as eligible for medical prescription of Adapted physical activity
* Mastery of the French language ;
* Patient affiliated to a social security scheme
* Patient giving written consent

Exclusion Criteria:

* Patient totally unable to communicate
* Patient in terminal palliative care
* Patient with a size \<1m35 or\> 2m and / or a weight\> 130kg
* Patient unable to perform Adapted physical activity sessions
* Patient unable to wear a restraint harness.
* Patient deprived of liberty or under guardianship
* Patient unable to comply with protocol requirements for geographical, social or psychopathological reasons
BAY59-7939 in Atrial Fibrillation Once Daily (OD)

This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial fibrillation (originally described in Japanese).


Eligibility Criteria:
Inclusion Criteria:

Japanese subjects with non-valvular AF who met all of the following criteria:

* Male subjects aged 20 years or older and postmenopausal female subjects
* Subjects with persistent or paroxysmal non-valvular AF with \>/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
* Subjects who were at risk for stroke as follows:
* Subjects with at least one risk factor for thromboembolism (hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).
* Subjects aged 60 years old and above regardless of the existence of above risk factors.

Exclusion Criteria:

* History or presence of stroke or transient ischemic attack.
* History of intracerebral hemorrhage.
* History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.