cyrilzakka/clinical-trials huggingface dataset:
Open Reduction Internal Versus Percutaneous Sacroiliac Screw Fixation in Unstable Posterior Ring Injury of Pelvic

Surgical trearment of unstable posterior pelvic injuries can be performed with open reduction and internal fixation, closed reduction with percutaneous sacroiliac fixation. Biomechanically, no significant difference was found between the two methods in the literature. The aim of our study is to compare the radiological and clinical functional results of these methods.

Pelvic injuries are usually encountered in patients with polytrauma. These are injuries that need to be treated with a multidisciplinary approach. The primary approach is to stabilize the patient hemodynamically. Mortality rate in pelvic injuries reaches 10-20%.

The pelvis has a ring-shaped structure. It is the sacrum that transfers the load from the lower extremities to the axial spine from this structure. The joint between the sacrum and the ilium, that is, the joint that is exposed to the load, is the sacroiliac joint. For this reason, surgical treatments have been developed to stabilize the posterior pelvic ring, to mobilize the patient as soon as possible, to walk in a balanced way without leg length difference, to prevent loss of work force, and to shorten the hospitalization period. Open reduction internal fixation and closed reduction percutaneous sacroiliac screw fixation surgical methods have been described to ensure the stability of the posterior pelvic ring In this study, we evaluated the radiological and functional results of patients with posterior pelvic ring injuries stabilized by open and closed surgical approaches; We have compiled and summarized the current literature on pelvic injuries. We aimed to contribute to the literature by sharing our knowledge and findings about these difficult, complex and prone surgical techniques.

marks of conformity

1. Surgical intervention for sacroiliac joint fracture-dislocation
2. 18-65 years old patient
3. Patients who come to clinical follow-ups for at least 6 months

Eligibility Criteria:
Inclusion Criteria:

* Surgical intervention for sacroiliac joint fracture-dislocation
* 18-65 years old patient
* Patients who come to clinical follow-ups for at least six months
* not paralyzed

Exclusion Criteria:

* Patients under 18 years of age
* Patients older than 65 years
* Patients who did not come for their follow-up in our clinic
* paralyzed patients
* mentally retarded patients
A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty

Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith \& Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo. The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith \& Nephew). This study is a randomized controlled study in patients undergoing unilateral total knee arthroplasty. A patient will undergo unilateral TKA with anatomically aligned or conventional TKA implant. The implant is determined using a random number table. Radiologic parameter, patients preference and clinical results was investigated in patients who received unilateral TKA during minimum 2 year follow up.


Eligibility Criteria:
Inclusion Criteria:

* Patients for bilateral total knee arthroplasty
* having medicare insurance

Exclusion Criteria:

* Rheumatoid arthritis
* Other inflammatory arthritis
* Crystal-induced arthritis
* Septic arthritis
* Neuropsychiatric patients
* Previous knee operation history
* Neuropsychiatric patients
* Patients with preoperative severe limitation of motion (Flexion contracture ≥ 20, range of motion ≤ 90)
* Patients with preoperative severe defomity of knee alignment (Varus or valgus angle ≥ 15)
* Severe obese patients (BMI ≥ 40)
The Effects of EXOPULSE Mollii Suit on Low Back Pain

Low back pain is a common musculoskeletal problem. It is the main cause of activity limitation and work absence and carries a huge medical burden and economic cost. Low back pain is considered "chronic" when it persists for more than 3 months. Chronic low back pain affects daily activities and constitutes a psychological burden, which could lead to anxiety and/or depression. Prevention of low back pain is recognized as a pivotal challenge in high-risk populations to help tackle high healthcare costs related to therapy and rehabilitation. Current pharmacological drugs, namely anti-inflammatory and narcotics medications, have limited efficacy and numerous side effects. In addition, most available treatment options only address single, targeted causes; however, given the complexity of low back pain, a multi-modal interdisciplinary approach is highly needed. Transcutaneous electrical nerve stimulation (TENS) is a safe alternative to current treatments. Many studies have shown its efficacy and benefit in reducing pain. However, it only targets a limited number of muscles. For this reason, transcutaneous stimulation using the EXOPULSE Mollii suit might help reduce pain and related outcomes in this context since it simultaneously targets several muscle groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years, with a definite diagnosis of Low Back Pain for at least 3 months, with absence of any surgical indication.
* Stable pharmacological treatment over the last three months
* Residual back pain post-spinal surgery with no new surgical indication
* Patients should be French speakers, able to understand verbal instructions, and affiliated to the national health insurance NHI.

Exclusion Criteria:

* Patient with VAS \< 4
* Presence of any surgical indication (i.e,. isthmic spondylolisthesis, herniated disc, Spinal canal stenosis, Vertebral fracture, Degenerative Spondylolisthesis, scoliosis)
* Failed Back Surgery Syndrome (FBSS)
* Presence of spinal infection
* Presence of obstetrical or gynecological cause of the low back pain (ovarian torsion, ovarian cyst, endometriosis, menses)
* Retroperitoneal tumors - Spinal tumors - Being included in another research protocol during the study period
* Inability to undergo medical monitoring for the study purposes due to geographical or social reasons
* Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump, or other contraindications to using EXOPULSE Mollii suit
* Being pregnant
* Having a change in their pharmacological therapy in the last three months.
* Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain)
* Having a body mass index above 35 Kg/m2
* In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period
* Patients under juridical protection (" mesure de protection judiciaire : tutelle, curatelle, sauvegarde de justice ")
* Prisoners
Effects of Active Video Games in Physically Inactive Children

Inactivity was reported to be high in children and considered to be the fourth common cause of death in all ages. The reason for children is usually the increasing indoor use of sedentary screen time. Active Video Games (AVG) have recently been introduced for decreasing the sedentary time for children and directing them to physical activity (PA) at home.The aim of this study is to show the quantitative effect of games on physical fitness parameters like weight, body mass index (BMI) and fat ratio (FR). The study also aims at the factors for motivation or continuance of the games as self-perception and enjoyment levels together with qualitative effects of games on satisfaction and attitude changes in inactive children.

Research related a causal association between inactivity, low esteem, and excess weight for children. For this reason, academic performance decreases and obesity associated diseases such as hypertension, diabetes, coronary heart diseases, depression, and cancer might ensue. Children usually do not prefer to perform outdoor PA due to several causes including low sense of self perception.

So far studies have shown an almost equivalent energy spent through AVGs to the physical activity of moderate intensity. Games have been previously demonstrated to prevent excess weight. There were no studies of AVG in children with varying weights, inactivity and technology preoccupation. Similarly, no qualitative research of AVG in children exploring enjoyment levels and attitude changes were encountered.

Thus, the investigators aim to find the quantitative effect of AVG on physical fitness parameters like weight, BMI and FR. Other aims are studying factors for motivation or continuance of the games as well as the feelings and perspectives of the participant children's parents for the games.

Eligibility Criteria:
Inclusion Criteria:

1. Being 8-13 years old
2. Being preoccupied with technology
3. Being physically inactive

Exclusion Criteria:

1. Having circulatory, respiratory and musculoskeletal disease
2. Having neuropsychiatric diseases
3. History of syncope or seizures
4. History of exercise induced anaphylaxis
5. Morbid obesity
6. Short stature
Early Warning Scores in Pregnant Woman

Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

Our study aims to evaluate the use of early warning scores as a screening tool to predict obstetric mortality and morbidity in pregnant women who will undergo cesarean section.

This prospective study included 304 patients undergoing cesarean section at Suleyman Demirel University between April 2022 and April 2023. Physiological parameters were assessed in all 304 pregnant women before the operation. Maternal early warning scores, including modified early obstetric warning score (MEOWS), maternal early warning score (MEWC), and maternal early warning triggers (MEWT), were calculated for each patient. Patients triggering the system were classified as Group 1 (risky patients), while those not triggering the system were classified as Group 2 (risk-free patients).

Eligibility Criteria:
Inclusion Criteria:

* All patients who are pregnant and undergo cesarean section

Exclusion Criteria:

* None
A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of a predefined dose range of co-administered Baclofen and Memantine in non-obese (Part A) and obese (Part B), otherwise healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males or females aged 18 to 45 years inclusive;
2. Subjects with body mass index:

   For Part A: ≥18 kg/m² and ≤25 kg/m²; For Part B: ≥33 kg/m² and ≤40 kg/m².
3. Subjects with a total body weight of ≥50 kg (Part A and Part B);
4. Subjects who are healthy as determined by the Investigator based on pre study medical history, physical examination, vital signs (blood pressure, pulse rate, respiratory rate and body temperature) and 12-lead ECG at screening and each admission;
5. Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator at screening and each admission;
6. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and bilirubin ≤1.5 x upper limit of normal (ULN);
7. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
8. Subjects who are negative for drugs of abuse and alcohol tests at screening and each admission;
9. Subjects who are non-smokers or who have not smoked or used nicotine-containing products for at least 3 months prior to screening;
10. Subjects with an estimated creatinine clearance ≥100 mL/minute for male subjects or

    ≥90 mL/minute for female subjects (Cockcroft-Gault method) at screening;
11. Subjects who are able and willing to give written informed consent.
Biotin Sample Collection Study

This protocol has been designed for a collection of urine samples from volunteers who will be given high dose biotin supplements over a period of 5 days, in order to provide a research sample bank to examine for biotin excretion rates

This is a sample collection study from a minimum of 10 volunteers who will be required to take a Biotin supplement daily for a period of 5 days.

Each volunteer will be asked to read the volunteer information sheet and if they wish to participate in the study, the study admission form will be completed and the volunteer will be asked to sign a consent form.

After informed consent each volunteer will be assigned a unique volunteer number for the duration of the trial to provide anonymity. The volunteer will be provided with a daily diary, urine collection material and a full set of volunteer instructions.

The daily diary will collect the following information;

* Date
* Whether or not supplement was taken and time taken
* sample collection times during the day

Volunteers will be requested to:

Day 1: Collect a urine sample from every void during the day. Days 2-6: Take biotin supplements with their evening meal and collect a urine sample from every void during the day Day 7: Collect a urine sample from every void during the day

All samples will be stored in the SPD Bio-bank until required for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Willing to take biotin supplements and collect urine samples
* Has regular menstrual periods
* SPD employee or partner of SPD employee

Exclusion Criteria:

* Taking any other supplements or medication (other than contraceptive pill)
* Taken Antibiotics in the last 4 weeks
* Diagnosed with metabolic disorder, kidney or liver disease
* Known Pregnancy or seeking to conceive
* Breast feeding
* Undergoing medical investigation for hormone imbalance
* Condition that contra-indicates pregnancy
* Condition that contra-indicates use of biotin supplements
A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.

This is an outpatient study. All subjects enrolled in this study will receive a combined regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject will be assessed at the end of each cycle to determine if the subject can continue to the next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.

If a subject discontinues treatment with at least stable disease (SD) that subject will complete follow-up visits every 12 weeks for 2 years or until initiating another systemic anti-breast cancer treatment, exhibiting progressive disease (PD), or death.

Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible
* No prior chemotherapy regimen for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
* The subject's life expectancy is estimated to be \> 12 weeks at the Baseline Visit
* The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period

Exclusion Criteria:

* Hypersensitivity to docetaxel or polysorbate 80
* Neuropathy ≥ Grade 2 at the Baseline Visit
* Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
* The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody
The Specific Lung Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients in Supine and Prone Position

The investigators aim is to study the specific lung elastance in ALI/ARDS patients during invasive mechanical ventilation, in supine and prone position.

In sedated and paralyzed ALI/ARDS patients, we study and compare the specific lung elastance in supine and prone position during invasive mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* ALI/ARDS patients during invasive mechanical ventilation

Exclusion Criteria:

* Haemodynamic failure, pneumothorax
The Effect of Growth Hormone Replacement on Liver Fat

We will examine a cohort of growth hormone deficient adults starting growth hormone (GH) replacement. The purpose of this study is to determine whether GH replacement reduces the fat content of the liver.

To compare the results we will include growth hormone deficient patients who do not start GH replacement as controls.

Adults with untreated growth hormone deficiency (GHD), a condition mostly due to pituitary disease, often show metabolic features similar to those described in the 'metabolic syndrome'. Growth hormone (GH) replacement has been shown to reverse many of these unfavorable changes, with a particular evident reduction of visceral fat. In recent years, a strong correlation between fat accumulation in the liver and features of the metabolic syndrome (particularly visceral fat) has been identified, and 'fatty liver' is now being referred as the hepatic feature of the 'metabolic syndrome'. The effect of GH replacement on liver fat, however, has never been systematically studied.

We will assess 15 patients with GHD before and 6 months after starting GH replacement. We will also assess 15 control patients with GHD but who don't go on GH replacement for various reasons.

Liver fat will be assessed using MR spectroscopy. Changes in liver fat will be correlated to changes in insulin sensitivity and changes in various inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* 20-70 years of age
* Growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (GH) replacement
* clinically stable

Exclusion Criteria:

* known hepatic disease
* Acromegaly
* Diabetes mellitus
* growth hormone replacement within the last 12 months
* cushing's disease, if not cured for at least 12 months
* any contraindication to MR studies as set out in the MR safety questionnaire
A Study of Napabucasin (BBI-608) Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer

This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have histologically or cytologically confirmed non-squamous NSCLC.
* Must have progressed following treatment with platinum-based combination chemotherapy for metastatic disease, and patients with an EGFR or ALK/ROS1 genetic aberration must have received appropriately targeted treatment.
* Must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD1 or anti-PD-L1 therapy, unless medically contraindicated
* Weekly paclitaxel must be an acceptable treatment option
* Must submit tumor tissue for correlative analyses
* Women of child-bearing potential and partners of women of child-bearing potential must take measures to avoid pregnancy while receiving and for a period of time following protocol therapy
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, adequate organ function, and a life expectancy of ≥ 3 months

Key Exclusion Criteria:

* Has squamous NSCLC
* Has received prior systemic treatment with a taxane for advanced/metastatic disease
* Has received systemic anti-cancer therapy within the 14 days prior to randomization
* Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
* Has brain metastases with evolving neurologic symptoms or a steroid requirement.
* Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
* Has a corrected QT interval (QTc) \> 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
* Has peripheral neuropathy ≥ Grade 2 (NCI-CTCAE)
* Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
* Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator