cyrilzakka/clinical-trials huggingface dataset:
Clinical Results After Judet Quadricepsplasty for Post-traumatic Knee Stiffness

The Post-traumatic Extension Contracture of the Knee (PECK) is a common complication following knee traumas. It is characterized by a restricted Range of Motion (ROM), pain, and discomfort in the affected knee.

Various factors can cause PECK, primarily inflammation and scar tissue formation. The underlying inflammatory state leads to the development of scar tissue, which - when combined with immobilization - results in the progressive stiffness of the knee. Additionally, prolonged immobilization leads to muscle atrophy and, consequently, reduced mobility and increased rigidity.

All these conditions contribute to a limited ROM, making it challenging to perform various daily activities.

Sometimes conservative treatments can be effective, but surgery is often necessary to restore joint functionality and alleviate pain.

Historically, various surgical approaches have been proposed to address post-traumatic knee stiffness.

Open surgery is typically reserved for cases where arthroscopic adhesion release and manipulation under anesthesia have not been successful. Over the last century, various open surgical techniques have been proposed.

In particular, arthromyolysis according to Judet was first described in the 1950s by the French orthopedic surgeon Jacques Judet. This technique involves a series of incisions and soft tissue releases, allowing the surgeon to resolve the stiffness of the quadriceps tendon caused by trauma or prolonged immobilization.

Although effective in restoring knee joint functionality, arthromyolysis according to Judet is not without risks and potential complications. These include infection, massive bleeding, nerve and muscle-tendon injuries, and residual stiffness.

The purpose of this study is to analyze our case series related to arthromyolysis according to Judet for PECK. Clinical outcomes, complications, and patient satisfaction following this type of intervention will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients underwent surgical intervention for arthromyolysis according to Judet with modified surgical technique for knee stiffness from January 2008 to December 2019.
2. Patients with post-traumatic injuries (fractures treated surgically).
3. Patients with a minimum of 4 years of follow-up.
4. Completeness of clinical documentation.

Exclusion Criteria:

1. Patients who underwent surgical intervention for arthrolysis (both arthroscopic and non-arthroscopic) or arthromyolysis according to Judet with minimally invasive technique.
2. Patients who underwent surgery to address knee stiffness due to other causes (rigid prosthesis, limb lengthening, etc.).
3. Incomplete clinical documentation.
Evaluation of Two Enteral Nutrition Strategies in Mechanically Ventilated Patients

The aim of this study is to compare two strategies of early enteral nutrition in terms of efficacy and complications in mechanically ventilated patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 ans)
* Mechanical ventilation for \> 72 hours
* Planned enteral nutrition
* Informed consent

Exclusion Criteria:

* Body Mass Index \< 20 kg/m2
* Enteral nutrition non indicated (ileus, splanchnic ischemia..)
* Shock (use of catecholamines, arterial blood pressure \< 90 mmHg, peripheral hypoperfusion, elevation of lactates \> x 1,5 normal value)
* Contraindications for gastric tube
* Pregnancy
* Previous enrollment in the present study
Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)

The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years of age or older, who have Chronic Low Back Pain after the discontinuation of their previous medication for their condition.
* Patients should have at least 3 months of Low Back Pain.
Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD

This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.


Eligibility Criteria:
Inclusion Criteria:

* At least 40 years of age and no older than 80 at Screening
* Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit.
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking
* Pre- and post-bronchodilator FEV1/FVC ratio of \<0.70
* Post-bronchodilator FEV1 must be \<80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥30% of predicted normal value.

Exclusion Criteria:

* Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period.
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period.
* Subjects who have clinically significant uncontrolled hypertension.
* Subjects who have cancer that has not been in complete remission for at least five years.
* Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing.
* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
* Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study.
* Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnose: suspected CML (hematology and/or myelogram and/or immunophenotyping and/or Leukocyte alkaline phosphatase \[LAP\]) to be confirmed, after, by cytogenetic and/or molecular biology. OBS: only CML Ph+ newly-diagnose in chronic or accelerate phase; resistant CML Ph+ to Interferon α (INF-α), Hydroxyurea and/or low-dose ARA-C in chronic or accelerate phase; CML Ph+ with cytogenetic relapse after BMT, that didn't use Imatinib previously, in chronic or accelerate phase.
2. Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used. Pregnant women won't be included.
3. Karnofsky and Lansky scale: ≥40.
4. Life expectation \> 8 weeks.
5. Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP \< 3 x ULN and albumin \> 2 g/dl.
6. CNS toxicity ≤ II
7. Cardiac function: normal ejection fraction.
8. Signed ICF by child legal responsible.

Exclusion Criteria:

1. Patient receiving any other tyrosine kinase inhibitor (TKI).
2. Pregnant patient or breastfeeding.
3. Patient considered incapable to follow purposed treatment.
4. Patients with molecular relapsed.
5. Medications:

   * Colony stimulating: it cannot be administered at least 1 week before treatment.
   * Anticonvulsants: Imatinib is metabolized by P-450 enzyme, thereby subject cannot receive drug that activates the P-450 system. The anticonvulsants allowed are valproic acid and benzodiazepines.
   * Anticoagulants: The use of warfarin (Marevan) is not allowed. If anticoagulant is needed, low-molecular-weight heparin (LMWH) can be used. Avoid anticoagulants with platelets \< 50000.
   * INF-Α 48h before D1.
   * Hydroxyurea 24h before D1.
   * ARA-C doses \>100 mg/m2 for 5-7 days, 14 days before D1.
   * Anthracyclines, Mitoxantrone or Etoposide 21 days before D1.
   * Any other chemotherapeutic agent 28 days before D1.
   * Hematopoietic Cell Transplantation (HCT) 6 weeks before D1.
Comparison of Uterine Repair Methods for Cesarean Delivery

This study is designed to compare the exteriorization of the uterus versus the in situ repair for closure of the hysterotomy incision with a completely standardized anesthetic protocol.

Two well-known uterine repair techniques are described; the uterus can be repaired in situ within the peritoneal cavity (intraabdominal) or exteriorized temporarily from the abdomen for the closure of the hysterotomy incision (extraabdominal). 3 meta-analysis on the topic were unable to demonstrate the superiority of one technique regarding maternal morbidities. However, there is a paucity of studies with a standardized anesthetic protocol evaluating these outcomes.

This study will evaluate the impact of the uterine repair technique on different maternal morbidities; focusing on intra-operative nausea and vomiting under a standardized anesthetic protocol.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean delivery
* Term gestation, 37 weeks or more
* Healthy parturients (ASA 1 and 2)
* Spinal anesthesia

Exclusion Criteria:

* Conditions at risk of uterine atony and/or postpartum hemorrhage (multiple gestation, placenta accrete / previa, pre-eclampsia / eclampsia, uterine leiomyomata, polyhydramnios)
* Morbid obesity (BMI \> 35 kg / m2) at delivery
* Coagulopathy
* Active labor
* Cardiomyopathy
* Emergency cesarean section
* Refusal/Inability to consent
* Language other than English or French
Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

This research aims to evaluate the prevalence and predictors of Occult HCV among hemodialysis (HD) patients who achieved 24 weeks sustained virological response (SVR) after treatment with direct-acting antiviral agents (DAA) by detection of viral RNA in their peripheral blood mononuclear cells.

In maintenance hemodialysis (MHD) patients, hepatitis C virus (HCV) infection is common and may be associated with poor clinical outcomes. A lot of treatment options for HCV have rapidly evolved over the past 5 years and various treatment choices for patients with advanced CKD are currently available.1 The reappearance of HCV infection months or years after sustained virologic response (SVR) may be due to the persistence of HCV in tissue cells in spite of being undetected in serum. This situation is known as occult hepatitis C infection (OCI).2 OCI is now a challenging entity in the field of post hepatitis management and follow-up. OCI is described when HCV-RNA is detectable in liver and/or peripheral blood mononuclear cells (PBMCs) in patients with undetectable serum HCV-RNA. To our knowledge , this is the first research to issue this problem in dialysis patients after treatment with direct acting antiviral drugs.

Eligibility Criteria:
Inclusion Criteria:

* Patients on regular hemodialysis treatment for more than 6 months.
* Achieved sustained virological response 24 weeks after the end of treatment with directly acting antiviral drugs (DAADs).

Exclusion Criteria:

-
Online Course Teachning Adults With ADHD How to Use a Smartphone

This study is a randomized controlled trial (RCT) to evaluate the effect of an internet-based, guided self-help course for individuals who have recivied an ADHD diagnsis or struggle with organizing daily life and/or easily get distracted. The course (vardagsSMART) teach the participants how to use a Smartphone to better organize their everday life and will be compared to a wait list control group (CONT) that later will recieve the same course without guidance from a supervisor(selfSMART). It is hypothesized that VardagsSMART will be superior to CONT on ability to organize everyday life and ADHD-symptoms, and that vardagsSMART will be superior to selfSMART on adherence, understanding and perecived usefullness.

Smartphones have a potential to improve the life of individuals who have major problems with structure and remembrance of everyday tasks. The automation by smartphones of these tasks away from caregivers to the individual is a process that is both time saving and positive for the individuals sense of autonomy.

There is too little research to date to say with clarity that smartphones is this tool for most of the patient group but many patients with ADHD report that a smartphone system for organisation and remembrance is a key that helps many live a more meaningful life.

The best way to teach these skills has not yet been proven. There is a clear advantage with teaching courses concerning IT in an online setting since hyperlinks and other texts can be easily forwarded and the course participants can easily use premade calendars and other tools. This research will try to determine if this type of online course is helpful for these patients.

VardagsSMART is an online course which will be compared to a waiting list controll group (CONT) which weekly records how they manage their ADHD symptoms.

The main purpose of this study is to examine whether the VardagsSMART course have a positive effect for the patient group. An untreated control group is used to ensure that the effects are not only due to spontaneous improvement. The control group will afterwards be offered the course without therapist support (SelfSMART), in order to make a preliminary evaluation of the importance of therapist support.

Eligibility Criteria:
Inclusion Criteria:

* have problems organizing daily activity measured by more then 17 points on the ASRS questionaire item 1-4 and 7-11-
* has acces to a smartphone (android or iphone) with internet acces.
* at least 18 years
* speaks, writes and read Swedish
* can not foresee any practical barriers to participation.

Exclusion Criteria:

* has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview.
* somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders).
* have severe depression, defined as MADRS-S over 30 or suicidal risk judged by more than 4 points on the MADRS-S question 9 or according to the structured telephone assessment.
* currently undergoing some form of treatment that focuses on reducing symptoms of ADHD.
Tucidinostat Plus Apatinib for Advanced Osteosarcoma

This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥10 years, ≤ 75 years;
2. Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ；
3. Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide;
4. Eastern Collaborative Oncology Group (ECOG) 0\~2；
5. Tumor size is measurable according to RECIST1.1 criteria；
6. Adequate organ function；
7. Life expectancy is more than 3 months；
8. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors;
2. Urine protein≥ ++;
3. FBG\>10mmol/L;
4. Uncontrolled blodd pressure (ystolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg);
5. Known active CNS metastases and/or carcinomatous meningitis;
6. Not able to take medicine orally;
7. Coagulant function abnormality (PT\>16s, APTT\> 43s, TT\>21s, FIB）\<2g/L);
8. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease;
9. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

The 1,132 patients with resectable or borderline resectable PDAC who underwent surgery between 2007 and 2021 were retrospectively reviewed. Patients with resectable PDAC without contact of major vessels (R-no contact) (n=651), with contact of portal vein or superior mesenteric vein (PV/SMV) ≤180° (R-contact) (n=306), and borderline resectable PDAC without arterial involvement (BR-V) (n=175) were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)
* Between January 2007 and June 2021 at Seoul National University Hospital

Exclusion Criteria:

* Patients who had borderline resectable PDAC with arterial invasion
* Patients who received chemotherapy as initial treatment and did not undergo surgery
* Incomplete follow-up data for analysis
A Study to Evaluate Spine Motion in Older Adults

This study is being done to measure real-world motions and forces in the spine during everyday activities. This information will be used to develop and validate a computer model of how the spine moves and determine injury risk.

Kinematic motion data will be collected at 120 Hz using a 14-camera Real Time Motion Analysis system. Cortex software (Motion Analysis Corp., Rohnert Park, CA) will be used to visualize the data during physical activities. A developed Matlab code will be used for data analysis. Statistical parametric mapping (SPM) will be used to collect the entire kinematic motion waveforms to compare motion profiles of different individuals. Also, the peak values for each activity will be captured for statistical analysis. Muscle response and electrical activity, which will be used to estimate muscle forces, will be recorded during gait analysis from the paraspinal lumbar muscles using an EMG system. Surface electrodes will be attached to the lumbar spine. EMG data will be collected at 2400 Hz. For each participant, the investigators will record five trials per activity.

Additionally, gait speed as well as static and dynamic balance will assess. Knee and grip strength will also be measured. Finally, physical activity levels will be assessed both objectively and subjectively.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 and over
* Ability to perform trunk flexion, lateral bending, and axial rotation, as well as lift at least 5 pounds of weight from the floor

Exclusion Criteria:

* Spinal pathologies
* Physiological and neuromuscular disorders
* BMI\>35
* Knee or hip replacement in the past 12 months
* Use of assistive devices
* Frailty: with FRAIL score of 3 or greater
Effects of Including Sprints During Low-intensity Cycling Exercises on Performance and Muscle/Blood Characteristics

To investigate the effects of Including 30-s sprints during low-intensity cycling exercises during a training camp on performance and muscle/blood characterisitcs in elite cyclists

Inclusion of sprint intervals during low-intensity training (LIT) sessions has been suggested as a potential mean to improve endurance performance in elite cyclists, facilitated by muscular or systemic physiological adaptations. So far, the effects of such training has been studied exclusively in context of short-lasting low-intensity sessions, representing a scenario with suboptimal ecological validity for such highly trained athetes.

This study will investigate the effects of including sprints during prolonged LIT-sessions sessions during a 14-day training camp focusing on LIT, followed by 10 days recovery (REC), on performance and performance-related measures in elite cyclists. During the training camp, a sprint training group will conduct 12x30-s maximal sprints during five LIT sessions, whereas a control group will perform distance-matched LIT-only. Overall, the training camp will lead to substantial increases in training load compared to habitual training in both intervention groups, followed by subsequent reductions during REC. Performance tests will be conducted before the training camp (T0) and after REC (T2). Muscle biopsies, hematological measures and stress/recovery questionnaires will be collected Pre (T0) and after the camp (T1).

The study was pre-registered at Norwegian Center for Research Data (14/08/2017, Norwegian): http://pvo.nsd.no/prosjekt/55322

Eligibility Criteria:
Inclusion Criteria:

* VO2max \> 65ml/kg/min

Exclusion Criteria:

* VO2max \< 65ml/kg/min
* Average endurance training per week \>10hrs/wk during the four weeks leading up to the study
Radicle ACES: A Study of Commercially Available CBD Used in the Real-world Setting

A randomized, open-label study of commercially available, orally ingestible, Cannabidiol (CBD) products used in the real-world setting for pain, sleep, and anxiety.

Radicle ACES is a real-world evidence study that aims to determine the effect of CBD on overall well-being, anxiety, sleep, and pain over a 28-day period in treatment groups compared to a waitlist control group.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 21 years of age
* Live in the USA
* Endorse symptoms of anxiety, chronic pain, or sleep disturbances as a primary reason for taking a CBD product
* Must have regular access to a computer, mobile device, and/or the internet to complete surveys

Exclusion Criteria:

* A person pregnant, trying to become pregnant or breastfeeding
* Anyone diagnosed with liver disease or considered a heavy drinker
* Anyone taking medication that warns against grapefruit consumption