cyrilzakka/clinical-trials huggingface dataset:
Late Compared to Early Physiotherapy Following Knee Dislocation

A knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. When the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. Not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. Current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (ROM) and activity than conservative management. Post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee ROM and functionality. Experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. The investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. The physiotherapy progams will be identicalbe in all aspects except for progam initiation.


Eligibility Criteria:
Inclusion Criteria:

* Ambulation without aids in pre-morbid condition
* Multi-ligament knee injury with or without associated peri-articular fracture
* Operative management within three weeks of the injury

Exclusion Criteria:

* Poly-trauma with life-threatening injuries preventing rehabilitation
* Patients unable to comply with intensive rehabilitation
* Patients unable or unlikely to maintain follow-up
Reduction of Breast Enlargement Using the Da Vinci Xi Robot

Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove.

The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.

Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloid scarring, especially in young women.

The current research project is based on the hypothesis that the same technique could be used in the context of a reduction of breast enlargement on a smaller surface allowing the determination of a perimammary "halo" of scar retraction. The project consists in removing a breast disc at the base, thus causing a sagging skin cut of 2 to 3 cm but this time, circular.

The expected result is to achieve a reduction in breast enlargement with no visible scar, using Da Vinci Xi robot.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18
* Category 1 or 2 according to the classification of Regnault
* Breast size cup c or more
* Areola "looking in front", ie a distance between point A (at noon at the top of the areola) at the mid-sternal point of about 16 cm to 24 cm
* Ptosis (distance between the lowest part of the breast and the furrow under the breast) to a maximum of 7cm (measurement in sitting position)
* Expected correction of ptosis by half with reduction of 1 to 3 cup sizes
* Good quality thick skin
* Affiliated patient or beneficiary of a social security scheme
* Patient requesting breast reduction
* Patient who signed free and informed consent

Exclusion Criteria:

* Areola "look down"; point A more than 25 cm
* Ptose greater than and equal to 8 cm
* Thin skin
* Smoker
* Patient on anti-coagulant
* Patient participating in another clinical study
* Protected patient: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision;
* Pregnant, lactating woman
An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe

This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions.

Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. A wide range of such enzymes called tyrosine kinases are targeted.

In 2013, regorafenib was approved in Europe for doctors to prescribe to people with mCRC who have previously been treated or cannot receive other available treatments. It is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. However, little information is available on the doses of regorafenib given in France, Italy, and Belgium in usual practice.

In this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mCRC in France, Italy, and Belgium:

* at the beginning
* during, and
* at the end of the regorafenib therapy.

In addition, the study team will collect data about/if:

* the treatment duration at each treatment dose of regorafenib,
* the number of people who received reduced initial dosing of regorafenib in real word settings in France, Italy, and Belgium,
* reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment.

To answer these questions, the researchers will look back at cases that have already happened when the study begins. The data will be collected through an online case report form. The doctors will provide case histories of mCRC patients who started regorafenib treatment in most recent 3 years and 4 months (from January 1, 2019 to Apr 30, 2022) or up until 3 months prior to the date of data collection.

Besides this data collection, no further tests or examinations are planned in this study.

There are no required visits or tests in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histopathological or cytological diagnosis of colorectal cancer and metastatic disease (stages IVA, IVB, or IVC)
* Patients must have initiated regorafenib as monotherapy, regardless of line of therapy, from January 1, 2019 to December 31, 2021 (or up until 3 months prior to date of data collection, whichever occurs latest)
* Aged ≥18 years at index date

Exclusion Criteria:

* Patients with regorafenib treatment prior to January 1, 2019
* Patients who have participated in a clinical trial
Improving the Health of Parents and Their Adolescent and Transition-age Youth With Intellectual and Developmental Disabilities

This study will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities. Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes.

A well-functioning system of care should provide a broad array of services that can support families with a child with complex health care needs. Nonetheless, adolescents and transition age youth with intellectual and developmental disabilities experience rates of unmet need for health care up to 6 times higher than others resulting in poor health and quality of life for themselves and their families.

The system of care approach has achieved positive impacts for children with intellectual and developmental disabilities and their families, but updates call for training to help parents develop advocacy skills on behalf of their children. Prior research on diverse populations indicates that parent advocacy skills are a promising target for increasing parent self-efficacy, which in turn is associated with better parent and youth health outcomes. Parent advocacy skills can be increased through a psycho-educational advocacy skills curriculum or through parent-directed peer-learning. However, the comparative effectiveness of these two strategies for families raising youth with intellectual and developmental disabilities is not yet known.

This study has two objectives. First, it will determine the comparative effectiveness of Go Act, a tailored advocacy curriculum versus Peer parent-directed peer learning for increasing parent activation for parents of youth with intellectual and developmental disabilities . Second, it will determine the comparative effectiveness of the two study arms for improving parent and youth health outcomes while assessing whether parent activation serves as a mechanism that mediates their effects on health outcomes.

Eligibility Criteria:
Inclusion Criteria:

Parents

* Bringing their adolescent or young adult child (age 11-27), with diagnosed or suspected intellectual or developmental disability, to one of the participating clinics
* Able to attend group sessions
* Able to give informed consent
* Resident of North Carolina Youth
* Being between the ages of 11 and 27
* Having diagnosed or suspected intellectual or developmental disability
* Being present for a visit at one of the study clinics

Exclusion Criteria:

Parents

* Having evidence of emergency mental health needs
* Not willing to be recorded
Myocardial Stress Perfusion Imaging With Dual Source CT

The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.


Eligibility Criteria:
Inclusion Criteria:

* A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram
* Age \> 40 years old
* Able to comprehend and sign the consent form.

Exclusion Criteria:

* Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
* Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
* Premenopausal women who have a positive pregnancy test.
* Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency.
* Known allergy to iodinated contrast agents
* Atrial fibrillation
* Asthma
* Critical aortic stenosis
* Systolic blood pressure \< 90 mmHg
* Advanced heart block
Quality of Life in Multiple Myeloma Patients Treated With Bortezomib

This observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.

Many clinical studies for the treatment of multiple myeloma have been conducted in Korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma. Most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited. This study will observe the degree of change in the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.. Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma
* Patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included

Exclusion Criteria:

* Patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity
* Patients with severe hepatic impairment
* Pregnant women
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)

This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Willing and able to provide government-issued identification
* Has a BMI of 18.0-40.0 kg/m\^2
* Has a physiologic dependence on opioids
* Is voluntarily seeking treatment for opioid use disorder and willing to completely withdraw from his/her opioid use throughout the study with desire for or motivation for antagonist therapy
* Wiling to abide by the contraception requirements for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Is pregnant, planning to become pregnant or breastfeeding during the study
* Has used Buprenorphine within 7 days prior to randomization
* Has used Methadone within 14 days prior to randomization
* Has a history of VIVITROL use within 90 days prior to screening or has used oral naltrexone within 14 days prior to randomization
* Has a history of seizures or has received anticonvulsant therapy within the past 5 years
* Has a condition, disease state, or previous medical history that would preclude safe participation in the study or affect the ability to adhere to the protocol visit schedule, requirements, or assessments
* Has a current diagnosis of schizoaffective disorder, bipolar disorder, or untreated and unstable major depressive disorder
* Is currently physiologically dependent on any psychoactive substance (except opioids, caffeine, or nicotine) requiring medical intervention for detoxification
* Has a history of hypersensitivity or adverse reaction to Buprenorphine, Naltrexone, or Naloxone
* Has a history of more than 3 unsuccessful inpatient or medically assisted outpatient opioid detoxifications during his/her lifetime
* Has significant suicidal ideation or behavior within the past year
* Is currently participating, or has participated, in a clinical trial of an investigational drug, device, or biologics within 3 months prior to screening
* Has a history of accidental opioid drug overdose in the past 3 years whether or not medical treatment was sought or received
* Is court mandated to receive treatment for opioid use disorder
* Additional criteria may apply
NitrX Total Knee Arthroplasty RSA

Metal hypersensitivity is a recognized complication in some patients following total joint arthroplasty. This can result in a reaction to metal particles from the implants placed in the joint and cause tissue injury. The Evolution® NitrX™ (MicroPort Orthopaedics, Memphis, TN) knee implant was designed with the addition of a coating meant to create a barrier against the release of metal ions. The primary purpose of this study is to compare the Evolution and Evolution NitrX implant (implants your surgeon uses in total knee arthroplasty surgery). This study will compare the stability of these knee implants (any movement the implant makes after surgery) through the use of specialized xrays, called "radiostereometric analysis" (RSA for short). The investigators will also compare levels of circulating metal particles with blood draws and the effects of any circulating metal with MR imaging. The investigators will also be looking at the participants clinical outcomes using joint function and patient satisfaction questionnaires. A total of 50 patients will be enrolled into the study.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
* Varus knee deformity of 0 to 10 degrees
* Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
* Between ages of 21 and 80 inclusive
* Patients willing and able to comply with follow-up requirements and self-evaluations
* Ability to give informed consent
* No contraindications to Magnetic Resonance Imaging (MRI)

Exclusion Criteria:

* Active or previous infection
* Medical condition precluding major surgery
* Inflammatory arthropathy
* Prior Patellectomy
* PCL deficiency
* Major Coronal plane deformity
* Valgus deformity
* Bone defects requiring augments, cones and/or stemmed implants
Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea

The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.


Eligibility Criteria:
Inclusion criteria:

* Obstructive apnea-hypopnea index \> 15 events/hour
* Patients who do not tolerate or do not accept positive airway pressure therapy

Main exclusion criteria:

* Body mass index \< 18.5 or \> 32 kg/m2
* Unable or incapable of providing informed written consent
* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
* Significant co-morbidities making the patient unable or inappropriate to participate in the trial
SK-1403 Long-term Treatment Study; Long-term Study in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Serum PTH\>240 pg/mL at the screening
* Serum corrected Ca≥8.4 mg/dL at the screening
* Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration

Exclusion Criteria:

* Primary hyperparathyroidism
* Severe liver disease
* Severe cardiac disease
* History or family history of long QT syndrome
* Malignant tumor
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* A history of severe drug allergy
Intermittent Hypoxia-Hyperoxia Training in Cerebral Venous Outflow Disorders (IHHT-CVOD)

This study aims to investigate the safety and efficacy of intermittent hypoxia-hyperoxia treatment in patients with cerebral venous outflow disorders.

Cerebral venous outflow disorder (CVOD), resulting from internal blockage, external oppression, or jugular valve incompetence, can cause hemodynamic disturbance and abnormal perfusion status. Restricted applicable populations and limited benefits constrain the application of existing CVOD management approaches. Previous studies indicate intermittent hypoxia hyperoxia training (IHHT) might improve circulatory status via hypoxic stimulation and allow hypoxic-related symptom amelioration through oxygen supply. Thus, IHHT might be a promising therapy for the CVOD population. Studies have so far proved inconclusive as to whether IHHT is safe and effective for CVOD. Therefore, the present study aimed to investigate the safety and feasibility of IHHT in patients with cerebral venous outflow disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Age range from 18 to 80 years.
2. Diagnosis of CVOD confirmed by CE-MRV, DSA, CTV, or ultrasound, including cerebral venous sinus stenosis (CVSS), internal jugular venous stenosis (IJVS), or internal jugular venous valve incompetence.
3. Unexplained chronic neurological deficits or other symptoms \> 3 months.
4. Signed informed consent from the patient or legally authorized representative.

Exclusion Criteria:

1. Life-threatening comorbidities.
2. Clinical symptoms and signs explained by other diseases.
3. Intracranial hypertension; moderate to severe intracranial/extracranial arterial stenosis.
4. History of ischemic/hemorrhagic stroke or cerebral endovascular surgery.
5. Intracranial abnormalities, such as tumors, abscesses, vascular malformations, or cerebral venous sinus thrombosis.
6. Confirmed sleep apnea, plateau residency, traveling history of altitude \> 1000m, or relative hypoxic exposure within last six months.
7. Poor compliance.
Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)

This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

Patients with chronic hepatitis C.

* Patients are serogroup 1(genotype I (1a) or II (1b)).
* The HCV-RNA level in the blood is more than 10\^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method

Exclusion Criteria:

* Patients with a history of hypersensitivity to test drugs or other interferon preparations
* Patients with a history of hypersensitivity to biological products, such as vaccines
* Patients being treated with Shosaikoto
* Patients with autoimmune hepatitis
* Pregnant women, women who may be pregnant, and nursing mothers
* Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
* Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
* Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
* Patients with chronic renal failure or renal function disorder with creatinine clearance of \<=50 mL/min
* Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
* Patients with serious hepatic dysfunction
* Patients with autoimmune hepatitis