cyrilzakka/clinical-trials huggingface dataset:
Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: a Randomized Clinical Trial

The most common surgical approach to perform a total knee replacement is called medial parapatellar approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee but there is no convincing evidence on the literature supporting one or another approach. The objective of this study is to compare the medial vs lateral approach for total knee replacement on valgus knee.

Total knee replacement is a procedure for the treatment of advanced knee osteoarthritis. The most common surgical approach to perform a total knee replacement is called medial parapatellar approach, or simply medial approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. It's also called lateral parapatellar approach. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee. Theoretically, the Keblish approach can promote better soft tissue balance and patellar tracking, but there is no convincing evidence on the literature supporting one or another approach for a total knee replacement on valgus knee. The objective of this prospective and randomized clinical trial is to compare the medial vs lateral approach for total knee replacement on valgus knee.

Eligibility Criteria:
Inclusion Criteria:

* Severe osteoarthritis (Kellgren \& Lawrence grade 4)
* Valgus deformity of the knee
* Read and sign the informed consent form

Exclusion Criteria:

* Severe pain in other joint (VAS\>6)
* Comorbidities or any condition that contraindicate the procedure
* Previous arthroplasty on the index knee
A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors

QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid tumors harboring a KRAS G12D mutation. The FIH study includes dose escalation, PK expansion, and efficacy expansion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
2. Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
3. Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
4. Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria.
5. ECOG PS score: 0 or 1;
6. Expected survival time ≥ 3 months;
7. Adequate organ function at screening:

Exclusion Criteria:

1. Previously treated with inhibitors against KRAS G12D mutation;
2. The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives
3. Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
4. Presence of other active malignant tumors in addition to primary tumors;
5. Presence of serious lung diseases at screening;
6. Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption;
7. Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders;
8. Complicated with clinically significant cardiovascular and cerebrovascular disorders;
9. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
10. Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements;
11. the investigator determines that participation in the study is not in the best interest of the subject.
Understanding the Phenomena of Aging and Rupture of Breast Implants

Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography.

The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.


Eligibility Criteria:
Inclusion criteria:

* Female adult (≥18 years old)
* operated on at the HUS for a change of breast prosthesis, aesthetic or reconstruction, between 2022 and 2024
* having not expressed, after information, her opposition to participate in this research.

Exclusion criteria:

* Women who have expressed their opposition to participating in the study
* ruptured prosthesis, associated with a LAGC-AIM, excessive perspiration
* interfering treatments and associated diseases, history
Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma

Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.

Primary Outcome Measures:

• 2-year overall survival rate

Secondary Outcome Measures:

* 2-year progression free survival rate
* overall response rate
* safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
2. New-diagnosed and untreated;
3. Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
4. Ann Arbor stage I to stage IV disease;
5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
2. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
3. Presence of Grade III nervous toxicity with two weeks;
4. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
5. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)\> 1×10'4copies/ml;
6. CNS or meningeal involvement;
7. Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
8. Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
9. Active and severe infectious diseases;
10. Major surgery within three weeks;
11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
12. In any conditions which investigator considered ineligible for this study.
13. Known sensitivity or allergy to investigational Product.
Impact of Medical Follow-up Discharge Package

The post discharge time is a vulnerable time for general medical in-patients, with high rates of adverse events that may cause unnecessary readmissions and even death. A recent study of 415 patients discharged from the general medical wards at Groote Schuur Hospital, demonstrated a very high 12 month mortality of 35%. The majority of these deaths were classified as "unexpected". The reasons for this were not further examined, but it was speculated, given the authors' knowledge of the public sector in Cape Town, that three related factors contribute significantly to this early mortality: i) a lack of continuity of care, with patients not necessarily accessing the primary care support treatment that they need or being able to access early post discharge follow-up (for example for anti-retroviral or anti-tuberculous care); ii) the inability of primary care to deal with the complex nature of the discharged patients, most whom have significant co-morbid disease; iii) A lack of optimisation of therapy for chronic disease after acute discharge.

The investigators hypothesise that an integrated post-discharge transitional care package, which includes an early medical specialist follow-up in the first 3 months after hospital discharge will decrease the 6- and 12-month mortality and re-admission rate amongst general medical hospital admissions in Cape Town, South Africa. Our study will compare an integrated package, suitable to implementation if effective, with current standard discharge packages.


Eligibility Criteria:
Inclusion Criteria:

1. Patients referred for admission to general medical wards (including within hospital transfer e.g. ICU discharge)
2. \>18 years and willing to give informed consent

Exclusion Criteria:

1. Patient admitted directly to intensive care unit
2. Patient refusing consent or \<18 years old
3. Patients electively admitted
4. Patients without phone numbers who cannot provide any telephone contact details for a co-habitant, relative or neighbour.
A Study to Evaluate CLn® BodyWash As Added Therapy in Eczema Patients

The purpose of this study is to determine if CLn BodyWash, a novel new gel cleanser formulated with surfactants and preserved with sodium hypochlorite, is effective at decreasing severity, body surface area and itching for patients with Atopic Dermatitis, or eczema.

Staphylococcus aureus colonization and potential infection represent a common clinical finding in patients with atopic dermatitis (AD) and may contribute to exacerbation of the disease. Atopic patients are commonly colonized with S. aureus on both lesional and non-lesional skin. Antibiotic treatment of clinically infected patients can often improve the bacterial infection as well as reduce the overall severity of AD. More recently, measures to reduce S. aureus colonization have been shown to decrease the clinical severity of Atopic Dermatitis in patients with clinical signs of secondary bacterial infection of the skin.

Given the increasing incidence of recurrent skin infections caused by S. aureus, measures such as dilute sodium hypochlorite (bleach) baths have been adopted by many physicians in an effort to decrease infection rates and disease severity in patients with atopic dermatitis, recurrent impetigo, cellulitis, folliculitis, boils and abscesses. There is some controversy in the literature regarding the efficacy of anti-staphylococcal treatments in improving AD in patients without active clinical infection as one review noted limited benefit while another study showed that dilute bleach baths improved AD.

Bleach baths are widely used in pediatrics and adult medicine. A common regimen consists of adding ½ cup of household bleach into ½ tub of warm bath water, resulting in a 0.009% sodium hypochlorite concentration. (www.bleachbath.com) CLn® BodyWash contains several common surfactants to clean the skin and 0.006% sodium hypochlorite concentration for preservation, and is further diluted when lathered onto the skin with water. This over the counter product is delivered in a sealed, easy to use dispenser, which can be used in the bath or shower, lathered on and rinsed off after 1-2 minutes of skin contact. CLn® BodyWash may be a convenient alternative to bleach baths.

Eligibility Criteria:
Inclusion Criteria:

* 6 months to 18 years
* moderate to severe Atopic Dermatitis
* positive staphylococcus aureus skin culture

Exclusion Criteria:

* active clinical infection
* on antibiotics in the last 4 weeks
* on immunosuppression drug in the last 4 weeks
* using bleach bath in the last 2 weeks
* able to maintain current regimen
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections

This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections


Eligibility Criteria:
Inclusion Criteria:

* Subjects presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days will be targeted. Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4
* Not an operative candidate as per RI joint replacement surgeon OR
* Subjects who do not desire joint replacement surgery after consultation with RI joint replacement surgeon
* Male or non-pregnant female older than 18 years of age
* willing and able to sign the IRB-approved informed consent document.

Exclusion Criteria:

* Any steroid injection in hip within 90 days
* Local infection at injection site or active systemic infection
* Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and RFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
* AICD with inability to utilize magnet for RFA per treating cardiologist
* Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
* Allergy or severe renal impairment precluding iodionated contrast or magnavist injection despite standard premedication protocol
Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age at least
* Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present:

  * current regular use of insulin for the treatment of diabetes
  * current regular use of oral hypoglycemic agents for the treatment of diabetes
  * diabetes as defined by american Diabetes Association (ADA)
  * symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eighth-hour fasting plasma glucose \> 126 mg/dl
* Diabetic macular edema clinically observable associated with diabetic retinopathy:

  * without prior foveal treatment with laser therapy
  * if photocoagulation or peripherical or macular laser, at least 3 months
  * absence of macular ischemia by fluorescein angiography on baseline visit
* BCVA score between 20 letters (20/400 ETDRS)e 70 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
* Retinal thickness \> 275um by OCT
* One eye per patient will be chosen for the study. In case of both eye eligible, it will be chosen an eye to be treated with study medication and another eye treated with laser
* Taught hyaloid syndrome

Exclusion Criteria:

* Uncontrolled systemic disease
* Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
* Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
* Any ocular condition in the study eye that in the opinion of the investigator would prevent a 2 lines improvement of visual acuity (e.g. severe macular ischemia)
* Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
* Presence of an epiretinal membrane in the study eye
* History of IOP elevation in response to steroid treatment in either eye
* History of glaucoma or optic nerve head change consistent with glaucoma damage
* Ocular hypertension requiring more than 1 anti-glaucoma medication to maintain IOP \< 11mmhg at qualification visit
* Presence of anterior chamber intraocular lens in the study eye
* Active optic disc or retinal neovascularization in the study eye at qualification visit
* Active or history of choroidal neovascularization in the study eye
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in the Treatment of Allergic Conjunctivitis

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* History of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees withing the past 24 months
* Successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more

Exclusion Criteria:

* Active ocular infection
* Clinically significant blepharitis
* Follicular conjunctivitis
* Pterygium
* Narrow angle glaucoma
* Dry eye dyndrome
* Ocular surgery within past 6 months
* Pregnancy or lactation
Effects of Pulse Consumption on Bone Health of Postmenopausal Women

This study will investigate the effects of the addition of 100 grams/day of cooked pulses (i.e. lentil, pinto beans, peas, chickpeas, kidney beans) to the diet of postmenopausal women for 12 weeks on gut health, metabolic outcomes and bone biomarkers.

With approximately 1.3 million women reaching menopause each year in the US and about one-third of a woman's life is spent in this state, it is imperative to identify effective, safe, and economical approaches that can minimize disease risk that is associated with this phase of life. Pulses are excellent source of fiber, protein, essential amino acids, vitamins, minerals and phytochemicals, that can act as prebiotics and prevent gut dysbiosis and promote a healthy gut. A few studies in overweight or obese adults have shown the health benefits of pulses, including gut modulating potential. However, studies examining the use of pulse crops are limited, especially in alleviating health risks associated with menopause. The objective of this study is to evaluate the prebiotic potential of pulse-based diet and consequent effects on metabolic and bone biomarkers in postmenopausal women. We hypothesize that daily intake of pulses, due to its nutrient content and many other bioactive compounds including fiber content, will beneficially affect gut health and subsequently improve metabolic outcomes and bone markers in postmenopausal women. To accomplish our objectives, 40 postmenopausal women (50- 65 y old and ≥ 1 y menopause) will be recruited and will be asked to consume 100 g/d of pulse (alternate between lentils, pinto beans, peas, chickpeas, and kidney beans) for 3 months. Pulse intake, anthropometric measures, markers of gut and bone health, and metabolic outcomes will be assessed at baseline and at the end of pulse consumption.

Once the study was underway and we got more funding, women were given the option to continue pulse supplementation for another six months to examine changes on bone density.

Eligibility Criteria:
Inclusion Criteria:

* 1 year without menstrual cycle

Exclusion Criteria:

* any medication use (for the past 6 m) that affects glucose, lipids, bone and inflammation markers, dietary supplements, and non-steroidal anti-inflammatory medications
* allergy to pulse crops
* tobacco use
* excessive alcohol intake
* antibiotic use
* major surgery within 6 m of study enrollment
Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

Dental pain and anxiety are quite common in pediatric patients. However, due to children's inability to express their fears and lack of knowledge about the procedures to be performed, these symptoms have often been misunderstood and inadequately treated in pediatric settings. Children have consistently experienced high rates of emergence anxiety during the recovery process after general anesthesia. Emergence anxiety can be harmful to the patient, leading to bleeding at the surgical site, displacement of intravenous catheters, parental anxiety, additional care needs, and delays in hospital discharge. Inhalation anesthetics are preferred for pediatric surgeries because they promote faster recovery. However, inhalation anesthetics often lead to a high rate of emergence anxiety, ranging from 25% to 80% depending on the scoring scale used, the child's age, and the type of surgery performed. Additional sedative or analgesic drugs, such as midazolam, dexmedetomidine, or propofol, have been used to prevent emergence anxiety.

Dexmedetomidine is a selective α2-agonist with sedative and analgesic effects, but it can cause mild respiratory depression. Numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs. It has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression. However, although intranasal dexmedetomidine initially has relatively rapid absorption, the absorption process may take longer compared to intravenous administration, implying that the child's hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety.

The aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2

Exclusion Criteria:

* Cardiac disease,
* Psychiatric disease,
* Coronary artery disease,
* Long-term sedative drug use,
* Pulmonary disease,
* Known allergy to planned drugs