cyrilzakka/clinical-trials huggingface dataset:
DP Vs DFR for Management of Geriatric Distal Femur Fractures.

The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.

Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care.

The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement.

There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union.

Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence.

In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral fractures.

Eligibility Criteria:
Inclusion Criteria:

* AO 33 A3 and 33 C fractures
* Age group ≥ 60 years
* Closed fractures
* Neurovascular intact

Exclusion Criteria:

* Open fractures
* Non ambulant patients
* Patients with peripheral neurovascular diseases
* Peri-prosthetic fractures
* Associated other orthopedic injuries
* Poly-traumatized patients
* Pathological fractures
Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed Metastatic Melanoma
* At least 18 years old
* No other active malignancy
* Hemoglobin at least 9
* Platelet Count at least 100,000 cells/mm3
* ANC at least 1500 cells/mm3
* AST \& ALT less than 2.5X upper limit of normal
* Total bilirubin less than 1.5mg/dL
* Creatine less than 1.5 mg/dL
* Alkaline phosphatase less than 2.5X upper limit of normal
* Life expectancy of at least 12 weeks
* ECOG performance status of 0-1
* Patient must provide informed consent
* Patient must provide authorization to disclose

Exclusion Criteria:

* Evidence of active brain metastases
* The only evidence of metastasis is lytic or blastic bone metastases
* Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
* Received radiotherapy in last 4wks, except if to a non-target lesion only
* Clinically significant concurrent illness
* Investigator's opinion that patient unlikely to complete study
* Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks
* History of allergy/hypersensitivity to study drug
* Serious Medical Risk Factors determine by the investigator
SMS System for Patients With Uncontrolled Hypertension

This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital.

The pilot will evaluate the feasibility of implementing a Short Message Service (SMS) system and Home Blood Pressure Measurements (HBPM) in the Outpatient Internal Medicine (OPD) clinic at Wake Forest Baptist Hospital. Implementing a new short text messaging service will improve the health delivery system in three ways. 1) Increasing patient engagement: SMS and HBPM require an active commitment by the patients themselves in their medical care and results in a marked improvement in the adherence to medication. High adherence to home blood pressure (BP) measurements has also been reported to improve BP control. 2) Supporting patients outside of the office visits by identifying and resolving barriers to medication adherence earlier on (i.e. if patients are unable to get their prescriptions or are having significant side effects). 3) Adopting clinical guidelines to improve BP control in a vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with hypertension
* 18 and older
* stage 2 hypertension or greater systolic blood pressure \[(SBP)\>140 and diastolic blood pressure (DBP) \>90\] who are receiving antihypertensive treatment.

Exclusion Criteria:

* Pregnancy
* end-stage renal disease (on hemodialysis or peritoneal dialysis)
* hospice or nursing home care
* dementia
* Patients who do not have a phone with Short Message Service (SMS) capabilities will also be excluded.
Study Of The Metabolic Parameters Of Uterine Muscle Cells

To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time.

Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.


Eligibility Criteria:
Inclusion criteria:

* - Adult patient
* Patient benefiting from the routine management of a programmed hysterectomy by vaginal, laparoscopic or laparotomy for benign pathologies (fibroma, adenomyosis, genital prolapse,...) within the CMCO
* Patient consenting to the use of cells from her uterus for incineration for research purposes
* Patient giving her consent for the use of her medical data for the purposes of this research.
* Patient agreeing to participate in the study

Exclusion criteria:

* - Patient refusing to participate in the study
* Patient under the protection of justice
* Patient under guardianship or curatorship
* Suspicion of gynaecological malignant pathology
* Pregnant or breastfeeding woman
* Impossibility to give the subject informed information (difficulties in understanding the subject...)
Comparison of Endometrial Protein Profile in Spontaneous Versus Stimulated Menstrual Cycles in Poor Responders

Evaluation of endometrial protein profile in spontaneous and stimulated menstrual cycles


Eligibility Criteria:
Inclusion Criteria:

1. Primary infertility
2. Poor ovarian response

Exclusion Criteria:

1. Normal or high ovarian response to gonadotropin stimulation
2. Menstrual cycle disorders
3. Severe male cause of infertility
4. Preimplantation genetic testing
5. Pathological findings of the uterus (fibroids, endometrial polyps, adenomyosis) and fallopian tubes (distal occlusion of one or both fallopian tubes with hydrosalpinx).
Use of Dynamic Arm Supports to Promote Activities of Daily Living in Individuals With DMD

This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) Armon Ayura-Kinova and 2) JAECO WREX) to promote participation in activities of daily living (ADLs) in non-ambulatory individuals with Duchenne muscular dystrophy (DMD) with upper extremity weakness.

This study is a longitudinal, randomized control trial evaluating the use of two commercially available dynamic arm support devices (1) Armon Ayura-Kinova and 2) JAECO WREX) to promote participation in activities of daily living (ADLs) in non-ambulatory individuals with Duchenne muscular dystrophy (DMD) with upper extremity weakness. Up to 30 individuals will be enrolled to participate in this research study, which includes a two-week baseline data collection period, a four-week device trial and a two-week post device data collection period. Participants will be randomly assigned to trial one of the dynamic arm support devices during the four week in-home trial. The ActiGraph GT9x (name of device), a wrist worn activity monitoring device, will be worn during the baseline period, the device trial and the post device data collection period to capture upper extremity (UE) movement patterns. UE performance will be further quantified with use of a physical motor assessment, the Performance of Upper Limb (PUL) assessment and patient reported outcomes. Data gleaned will provide important knowledge and objective results regarding the potential benefit of dynamic arm supports in individuals with DMD with limited functional use of their upper extremities.

Eligibility Criteria:
Inclusion Criteria:

1. 14 years of age or older
2. Self-report diagnosis of Duchenne muscular dystrophy (DMD)
3. Use a wheelchair for mobility
4. Score 3-5 on the Brooke Upper Extremity (UE) Scale
5. Self-report of needs assistance/unable to achieve independently on at least 10 items on the Upper Limb Activities of Daily Living (UL ADL) self-report questionnaire
6. Able to follow instructions
7. Informed consent provided by self (18 and over) or by parent or legal guardian (if under the age of 18)

Exclusion Criteria:

1. Does not have minimum level of UE function to operate the assigned dynamic arm support (Score of 6 on the Brooke UE scale or any other impairment limiting use)
2. The assigned dynamic arm support is unable to be mounted to wheelchair (mounts will vary based on manufacturer/model of wheelchair)
Human Papillomavirus (HPV) Self-sampling as a Test of Cure After Treatment of Cervical Intra-epithelial Neoplasia

The purpose of this study is to evaluate the performance of HPV self-sampling (self-HPV) in detecting residual/recurrent disease in women treated by loop electro-surgical excision (LEEP) for CIN1+.

The HPV test is an efficient method to assess the long-term risk of residual/recurrent disease in women treated for cervical intraepithelial neoplasia grade 1 or worse (CIN1+).

Women treated by LEEP for CIN1+ will be invited to participate. Follow-up visits will be performed at 6 months and 12 months after treatment and will include cytology, colposcopy when indicated and HPV testing. Two weeks before each follow-up visit at the colposcopy clinic, a home-based Self-HPV will be organized. A sample of 168 women will be included. Agreement between the two methods (Dr-HPV vs. S-HPV) will be measured using the kappa statistic (κ).

the investigators expect to find that Self-HPV may be an accurate method to predict residual and recurrent disease in women previously treated by LEEP.

Eligibility Criteria:
Inclusion Criteria:

* attending colposcopy clinic
* biopsy-proven CIN1+ lesion
* understands study procedures and accepts voluntarily to participate by signing the informed consent form

Exclusion Criteria:

* pregnancy
Therapeutic Endometrial Biopsy

The aim of this study is to evaluate the potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth.

Further it is planned to aspirate secretions from the uterus and take blood samples during the treatment, which presumably can provide information about the mechanisms underlying the possible effect of the treatment.

Randomized controlled prospective clinical study.

Eligibility Criteria:
Inclusion Criteria:

* One or more previous failed implantation despite transfer of good quality embryons/blastocyst in a fresh IVF/ICSI treatment
* Planned Antagonist treatment
* Planned Standardized hormone treatment
* FSH: 2-12 IU/L
* Age: 18-40 years
* BMI: 18-32
* Regular menstrual cycles
* Written consent

Exclusion Criteria:

* Patients in need for a interpreter
* Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges)
* Planned use og Assisted hatching or use of specialized media
* Previous inclusion in the study
Effects of Vitamin D Supplementation on Immune Function in Infants

Current study shows that vitamin D deficiency might affect human's immune function. Although breast milk is the best food of infants, however the vitamin D content in breast milk is low. Thus, breastfeeding infants are at high risk of vitamin D deficiency.Children's development and health are always the most important issues for parents. However, high prevalence of allergy in infants in Taiwan were not only with environmental factor which may also relate to their nutritional status. The aim of this study was to enroll breastfeeding infant at age of 4 month, and provide vitamin D supplement 10 μg daily until 6 month, to discuss the effects of vitamin D supplementation on immune function in infants.

Study plan to enroll breastfeeding infant at age of 4 month, and provide vitamin D (vitD) supplement 10 μg daily until 6 month. we also enroll 6 month-old infant as control group.

All infants collected 5 ml artery blood and measured vitD nutritional status and immune function. Blood analysis contain complete blood count (CBC), differential count (DC), serum calcium, serum Parathyroid hormone (PTH), serum 25(OH)D3, serum total immunoglobulinE (IgE) and cell phagocytosis.

Peripheral blood mononuclear cell (PBMC) in blood was separated and cultured with complete medium contain 10% fetal bovine serum (CM10), or with different mitogens, include lipopolysaccharide (LPS), phorbol 12-myristate 13-acetate and ionomycin (PI) and house dust mite extract (HDM). PBMC are incubated at 37 ℃, 5% CO2 for 48 hours, and determined the expression of B cell with IgE receptor CD21 and CD23 and T regulatory cell with transcription factor Foxp3 by flow cytometry. All data were analyzed with SPSS 20.0. Infant sex and feeding type were analyzed by chi-square analysis. Difference between vitD supplement group and control group were analyzed by student's t test. Relationship between 25(OH)D3 and Calcium or PTH were analyzed by pearson correlation analysis. There was a significant difference when p-value was less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Breastfeeding healthy infants

Exclusion Criteria:

* heart disease
* liver disease
* lung disease
* Intestinal disease
Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension

This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
* Females must be post-menopausal or surgically sterile

Exclusion Criteria:

* Other types of glaucoma
* Eye pressure lowering surgeries
* A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug

Other protocol-defined inclusion/exclusion criteria may apply.
Changes in Glucose Tolerance in Patients With Cirrhosis Peri-Liver Transplant

The goal of this observational study is to establish risk factors for post-transplant in adult individuals with cirrhosis without diabetes undergoing liver transplant evaluation.

The question being addressed is: can laboratory work, anthropometric tests, functional tests, imaging, and advanced measurements such as wrist actigraphy, continuous glucose monitoring, or oral glucose tolerance testing predict the development of diabetes after liver transplant?

Participants will be asked to periodically participate in wearing a continuous glucose monitor and wrist actigraph and obtain an oral glucose tolerance test both before and after liver transplant.

Participants will be enrolled from the liver transplant clinic and will be given a continuous glucose monitor, a wrist actigraph, a home sleep apnea testing device, and a questionnaire packet to collect demographics, sleep quality, and physical activity information. They will be scheduled for an outpatient two-hour oral glucose tolerance test, which will use a frequently sampling protocol to allow for mathematical modeling of insulin secretion. They will undergo body composition measurements using a bio-electrical impedance analysis device. Subjects will undergo these tests, excluding the home sleep apnea test, every three months until and through liver transplantation, after which they will restart the protocol at three months, or one month after post-transplant steroids are weaned to their lowest level. After they are one year post-transplant, they will no longer participate in continuous glucose monitoring or oral glucose tolerance testing, but their care will be followed electronically to assess outcomes up to five years post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to liver transplant clinic with a diagnosis of cirrhosis.
* Age \>18 yrs.
* Ability to understand and sign written consent form, or have a legally-authorized representative or proxy who can be approached for consent

Exclusion Criteria:

* Patients without consent
* Patients with implantable cardioverter defibrillator devices or automated implantable cardioverter defibrillator devices will be excluded from the bio-electrical impedance analysis portion of the measurements.
* Patients with unremovable electrical medical devices or devices that cannot turn off will be excluded from the bio-electrical impedance analysis measurements
* Pregnant patients
* Incarcerated patients
* Patients with a history of type 2 diabetes mellitus diagnosed \> 5 years ago will be excluded from the Oral Glucose Tolerance Test portion of the study
Retrospective Evaluation of Efficacy of Meta-PENG Block

The components of the lumbar plexus and capture the articular branches of hip capsule may be effectively blocked by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine. We can provide both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. Here, we aimed to present our novel technique we named 'deep iliacus plane block (DIPB)'.

Many regional anesthesia techniques are used in hip surgeries for various goals, such as optimizing neuraxial positioning and relieving pain in the perioperative period, and have been the subject of clinical researches in the last few decades.

The lumbar plexus is important in administering anesthesia and analgesia during hip and knee surgeries. Comprising the femoral nerve (FN), lateral femoral cutaneous nerve (LFCN), and obturator nerve, it collaborates with the sacral plexus to ensure comprehensive innervation of the lower limb.

We hypothesized that by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine (AIIS), we could effectively block the lumbar plexus components and capture the hip capsule's articular branches. We can ensure both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. Here, we aimed to present our cadaveric evaluation and retrospective evaluation of patients underwent meta-PENG block, which we consider the proof-of-concept for our hypothesis of the technique we named 'deep iliacus plane block (DIPB)'.

Eligibility Criteria:
Inclusion Criteria:

* ASA-1, ASA-2 and ASA-3 patients who underwent hip surgery under spinal or general anesthesia

Exclusion Criteria:

Anticoagulant drug use Known allergy to the medications to be used Infection in the area where the needle will be inserted Missing data
Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury

This prospective comparative study aims to investigate the effect of Metabolic Syndrome (MetS) on the outcomes of a standardized rehabilitation program in patients with Rotator Cuff Injuries (RCI). Patients diagnosed with RCI will be divided into two groups based on the presence or absence of MetS, determined by NCEP-ATP III criteria. Both groups will receive the same 4-week physiotherapy protocol including hot pack, TENS, ultrasound, and therapeutic exercises. Pain intensity, pain threshold, muscle strength, kinesthesia, and shoulder functionality will be evaluated before and after treatment. The study hypothesizes that the presence of MetS negatively affects rehabilitation outcomes in patients with RCI by altering inflammation and tissue healing processes.

This study aims to investigate the differences in shoulder function and rotator cuff tear outcomes between individuals with and without Metabolic Syndrome (MetS). Participants will be divided into two groups: the MetS group, which meets at least three of the NCEP-ATP III criteria for Metabolic Syndrome, and the non-MetS group, which does not have MetS.

Both groups will undergo an initial assessment, focusing on shoulder function, rotator cuff tear status, and associated factors such as age, gender, and general health conditions. The study will explore how MetS may impact the recovery and function of the shoulder in individuals with rotator cuff tears, aiming to provide insights into potential treatment and rehabilitation strategies for this population.

Data will be collected at a single time point (cross-sectional study) to evaluate baseline conditions and differences between the two groups. Statistical analyses will be performed to compare outcomes and explore potential correlations with MetS criteria.

Eligibility Criteria:
* Inclusion Criteria for the Non-MetS Group:

  * Aged between 18-65 years
  * Willing to participate in the study
  * Unilateral Rotator Cuff Tear (RMY)
* Inclusion Criteria for the MetS Group:

In addition to the above criteria, meeting at least three of the NCEP-ATP III consensus criteria for Metabolic Syndrome Stable metabolic syndrome (e.g., no significant medical changes in the last 3 months)

- Exclusion Criteria for All Participants:

* Inability to cooperate with the tests or presence of mental health issues
* Presence of cervical radiculopathy symptoms
* Presence of other orthopedic pathologies in the same shoulder (e.g., fracture, prosthesis, avascular necrosis, advanced shoulder osteoarthritis, frozen shoulder, severe scapular dyskinesia, neurological diseases, etc.)
* Presence of function-limiting neurological, vascular, or cardiac issues
* Local steroid injection to the shoulder within the last 3 months
* Receipt of physiotherapy or rehabilitation within the last 3 months
* Systemic rheumatic or inflammatory diseases
* Surgical history due to chronic rotator cuff tear
* Diagnosis of glenohumeral joint or acromioclavicular joint arthritis
* Severe scapular dysfunction or significant postural abnormalities