cyrilzakka/clinical-trials huggingface dataset:
Fixation of Fracture Neck of Femur in Children

Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique

In the pediatric population, fracture of the neck of femur is relatively uncommon usually caused by high-energy trauma, but with high complication rates, despite appropriate diagnosis and management. The high rate of complication is due to the vascular anatomy of proximal femur.

Fracture neck of femur can be classified into transphyseal , transcervical (which is commonest), basal and pertrochanteric.

Complications include avascular necrosis, delayed union and non-union. Multiple fracture fixation methods have been used, with the overall goal being anatomic reduction with stable fixation.

Methods of fixation vary based on age, Delbet classification and dispalcement of the fracture.

Two types of fixation of pediatric fracture NOF of interest are cannulated screw (CS) and the Wagner technique.

Most studies agree that 3 screws are enough, and they should be inserted parallel in triangular arrangement with an inverted triangle. The CS should apply compression to the fracture (compression screws) to minimize the remaining fracture gap and accelerate the healing process. The use of washers allows for higher compression forces and thus increases the initial stabilization. CS shouldn't pass the physis in pediatrics to allow normal continuation of growth in children. The stability of fixation by CS has been shown to be affected by several factors: screw type, number, thickness, position and direction. Some of CS disadvantages are that they are mechanically unstable, failure of stabilization leads to varus malunion and it may lead to slipped capital femora epiphysis (SCFE) above the tips of the screws(especially short working distance in transcervical fractures).

The Wagner technique consists of the use of two or three k-wires bent as close as possible to the shaft and fixed to the shaft by two cerclage wires. Some advantages of this method are that k-wires can cross the physis and give good stability to the fracture with normal continuation of growth(especially in transphyseal \& transcerviacal fractures). Hip spica is recommended to give more stabilization to the fixation and neutralize forces around the fixed fracture.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of fracture neck of femur
* children with age less than 14 years old

Exclusion Criteria:

* pathological fracture
* patients with cerebral palsy
* Associated ipsilateral femoral shaft fracture
* comminuted fractures
* old fracture ( \> 2 weeks)
Health Care Provider Preventiomter Study

The purpose of this study is to evaluate health care providers' perceptions, ratings and motivation to adopt a novel and state of the art physical wellness assessment device, the Preventiometer.

The Preventiometer is a physical wellness tool that assesses multiple physical wellness measurements in a 60 +/- 15 minute period of time.

Eligibility Criteria:
Inclusion Criteria:

* Health care providers practicing at Mayo Clinic.
* Able to speak English and complete surveys.
* Able to read, understand and sign inform consent.

Exclusion Criteria:

* Unable to sign inform consent.
* Pregnant women. (As verbalized by participant).
* Unable to ambulate without assistance.
* Not currently involved in another formal program or research study involving wellness coaching.
The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients

The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:

Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom.

Orthostatic Hypotension is common in Parkinson's Patients. The goal of this clinical trial is to explore raise-bed training Orthostatic Hypotension in Parkinson's Patients. The main question it aims to answer is:

Can raise-bed training improve Orthostatic Hypotension in Parkinson's Patients. Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given raise-bed training. The study lasts 21 days for each patient. Researchers will compare Orthostatic Hypotension Questionnaire, Orthostatic Grading Scale, Composite Autonomic Symptom Scale 31 to see if raise-bed training can help improve the symptom.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Parkinson's disease
* Presence of orthostatic hypotension, defined as a decrease in systolic blood pressure of at least 20 mmHg or a decrease in diastolic blood pressure of at least 10 mmHg within three minutes of standing up
* Age 40 years or older
* Willingness to participate in the study and provide informed consent

Exclusion Criteria:

* Severe cardiovascular disease or other medical conditions that would make head-up tilt treatment unsafe or inappropriate
* Use of medications that affect blood pressure or heart rate, such as beta-blockers or vasodilators, and inability or unwillingness to discontinue these medications for the study period
* History of syncope or falls within the past six months
* Inability to stand or sit up independently or tolerate changes in body position
* Cognitive impairment or inability to provide informed consent
Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)

Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents.

Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents. The consent will have a check box to indicate if they consent to the additional test.

Echocardiographic measurements will be performed on all infants at 12 hours +/- 6 hours of age by our research sonographers who are blinded to infant randomization. Measurements will be taken according to a standard operating procedure to assess systemic blood flow, by superior vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular output (LVO) (ml/kg/min), measures of left and right ventricular tissue Doppler and strain imaging. These measurements will be performed offline at a later time. Data will be entered into REDCap.

If any structural abnormalities are found, the attending pediatrician will be notified of the abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic purposes. Any additional studies including an official complete echocardiogram and or cardiology consultation will be left to the discretion of the attending pediatrician, as he/she deems necessary

Eligibility Criteria:
Inclusion Criteria:

• Non-vigorous newborns born between 35-42 weeks gestation.

Exclusion Criteria:

* Known major congenital or chromosomal anomalies of newborn.
* Known cardiac defects other than small atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA).
* Complete placental abruption/cutting through the placenta at time of delivery.
* Monochorionic multiples
* Cord anomaly (i.e. cord avulsion or true knot)
* Presence of non-reducible nuchal cord
* Perinatal providers unaware of the protocol
* Incomplete delivery data
* Infants born in extremis, for whom additional treatment will not be offered.
Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK

The therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. The treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. Targeted therapies are indicated for BRAF mutated melanomas.

The mutation BRAF leads activation of MAP Kinases pathway and the proliferation of melanoma cell in the body . About 50% of metastatic melanoma is BRAF mutated. The most frequent mutation is the V600E. The targeted therapy by anti BRAF and anti MEK allows the double bloking of the MAP Kinases pathway. This treatment is more efficient than that of the anti BRAF alone. The association of anti BRAF and anti MEK have a global survival global rate of 41% at the 1 year, against 9% for the anti BRAF .

In 2014, a program of extended access to the association of anti BRAF and anti MEK (dabrafenib and trametinib) started in many french hospitals (Protocol Mekinist, Novartis laboratory). Patients who were included in this program and followed in Poitiers Hospital, had frequent abnormalities of albumin level without any sign of undernutrition.

Hypoabuminemia is a poor prognosis factor described in many cancers, including metastatic melanoma.

The only prognostic factor in metastatic melanoma is the rate of LDH . The level of albumin and its prognostic impact have not been studied for patients with a metastatic melanoma and treated by anti BRAF and anti MEK.

The objective of this studie was to analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated in our Center by dabrafenib and trametinib


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 ans
* the patients with unresecable stage IIIc or IV melanoma with BRAF V600 E or K mutation,
* treated by dabrafenib and trametinib by the program of extended access (research protocol Mekinist)

Exclusion Criteria:

* Age \< 18 ans
* patients who had less than 3 months of treatment,
* patients for which the albumin level could not be carried out before starting treatment, and after the first month
Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.

Intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) is one of the pillars of malaria prevention in pregnancy in sub-Saharan Africa, in addition to prompt case management and use of long lasting insecticide treated bednets. However, mounting resistance to SP by Plasmodium falciparum increasing renders IPTP-SP ineffective.

Two exploratory trials in Uganda and Kenya demonstrated that IPTp with DP was superior to IPTp-SP for the prevention of malaria infection in pregnancy. However, neither study was adequately powered to look at adverse birth outcomes. This study is a confirmatory efficacy trial in Malawi, Tanzania and Kenya to determine the efficacy and safety of IPTp with DP alone or in combination with AZ.

This will be a 3-arm trial, superiority, partial blinded, placebo controlled, randomized trial comparing IPTp with SP, versus IPTp with DP alone, and IPTp with DP+AZ with the following hypotheses:

* IPTp with DP is superior to IPTp with SP in preventing adverse pregnancy outcomes.
* The combination of DP with AZ further reduces adverse pregnancy outcomes compared to IPTp with DP alone.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 16-28 weeks' gestation
* Viable singleton pregnancy
* Resident of the study area
* Willing to adhere to scheduled and unscheduled study visit procedures
* Willing to deliver in a study clinic or hospital
* Provide written informed consent

Exclusion Criteria:

* Multiple pregnancies (i.e. twin/triplets)
* HIV-positive
* Known heart ailment
* Severe malformations or non-viable pregnancy if observed by ultrasound
* History of receiving IPTp-SP during this current pregnancy
* Unable to give consent
* Known allergy or contraindication to any of the study drugs
Burst Crossover Trial

Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.

'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.

The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.

The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
* Minimum pain intensity of 5/10 on the leg pain NRS at baseline
* Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
* Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital
* Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period

Exclusion Criteria:

* Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
* History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
* Abnormal pain behavior and/or unresolved psychiatric illness.
* Unresolved issues of secondary gain or inappropriate medication use.
Lead Mobilization & Bone Turnover in Pregnancy/Lactation

We are examining the role of maternal bone lead turnover during pregnancy and lactation as a potential source of lead exposure for the fetus and the infant (via breast milk). A cohort, ascertained at entry to care, consists of \>1000 women to be followed through pregnancy. In the postpartum subjects are recruited for a nested case control study to assess the influence of lactation on maternal bone density, maternal blood lead and breast milk lead.


Eligibility Criteria:
1. Positive pregnancy test, age 12-35 and informed consent;
2. Gestation \<28 weeks at entry to prenatal care;
3. No history of serious chronic or metabolic diseases, which could affect maternal growth or bone density;
4. Not corticosteroid user or diagnosed use of illicit drugs;
5. Eligible for lactation study: Ascertainment during or participation in the pregnancy study and a negative pregnancy test.
Asian Phase I Study Of PF-03446962

This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose \[MTD\] and the Recommended Phase 2 Dose \[RP2D\].


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of stomach cancer
* advanced/metastasis solid tumor refractory or intolerant to established therapy
* adequate blood chemistry, blood counts and kidney/liver function
* willing to participate to study requirements and sign an informed consent document

Exclusion Criteria:

* Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
* excessive toxicities related to prior therapies
* pregnant or breastfeeding patients
Total Versus Partial Arytenoidectomy in Bilateral Vocal Fold Paralysis

Total arytenoidectomy is claimed to increase risk of aspiration and cause more voice loss than other operations performed for bilateral vocal fold paralysis (BVFP). However, objective evidence for such conclusion is lacking. There is no study comparing swallowing and voice after total and partial arytenoidectomy.

Design: Prospective, randomized, double-blind, case-control Setting: Tertiary, referral, university Patients: Twenty patients with BVFP Intervention: Endoscopic total and partial arytenoidectomy

Eligibility Criteria:
Inclusion Criteria:

* Bilateral vocal fold paralysis

Exclusion Criteria:

* Previously operated patients
A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic and early triple-negative breast cancer (TNBC).


Eligibility Criteria:
Inclusion Criteria

Cohort A:

* Metastatic or locally advanced unresectable, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
* Only patients with metastatic TNBC tumors that are centrally tested and found to be programmed death-ligand 1 (PD-L1) positive will be enrolled
* No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease, as assessed by the investigator according to RECIST v1.1
* Adequate hematologic and end-organ function

Cohort B:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically documented TNBC (negative HER2, ER, and PR status)
* Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
* Primary breast tumor size of greater than (\>) 2 centimeters (cm) by at least one radiographic or clinical measurement
* Stage at presentation: cT2-cT4, cN0-cN3, cM0
* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
* Adequate hematologic and end-organ function

Exclusion Criteria

Cohort A:

* Formalin-fixed, paraffin-embedded (FFPE) tumor tissue that is PD-L1 negative, as determined on the SP142 PD-L1 immunohistochemistry assay, with positivity defined as immune cells greater than or equal to (\>/=) 1%
* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>2 weeks prior to initiation of study treatment
* Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
* Leptomeningeal disease

Cohort B:

* History of invasive breast cancer
* Stage IV (metastatic) breast cancer
* Prior systemic therapy for treatment and prevention of breast cancer
* Previous therapy with anthracyclines, platinum, or taxanes for any malignancy
* Synchronous, bilateral invasive breast cancer
* Cardiopulmonary dysfunction
Safety Study of Elvucitabine in HIV-1 Subjects

The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected, clinically stable, adults
* HIVRNA 5000 -150,000, CD4 100
* Genotypically documented M184V variant
* Receiving stable ART.

Exclusion Criteria:

* Hep B
* HIV-1 genotype for 4 protease inhibitors
* HIV-1 genotype positive for 2 NNRTI mutations
* Previous therapy with system myelosuppressive potential within 3 months of study start
* Use of Epogen or Neupogen
* History of cirrhosis
* Alcohol or drug dependence
* Inability to tolerate oral medication
* Women who are pregnant or breast feeding
Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.

The CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.

Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately 20g CLA per day. A control group is not needed. If three subjects or more show one or more blood values for liver and kidney function above predefined limits the study will be terminated.

Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* serum total cholesterol \< 8.0 mmol/L
* serum triglycerides \< 3.0 mmol/L
* ALAT \< 45 IU/L
* ASAT \< 41 IU/L
* amylase 35-130 U/L
* alkaline phosphatase 40-125 U/L
* bilirubin \< 17 µmol/L
* gamma-glutamyltranspeptidase \> 75 U/L (men) and \< 40 U/L (women)
* lactate dehydrogenase 230-485 U/L
* creatinine clearance \>= 90 mL/min
* fasting glucose levels 70-115 mg/dL
* fasting insulin levels 5-30 mU/L

Exclusion Criteria:

* use of cholesterol lowering medication
* high alcohol intake
* BMI \> 30
* chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
* pregnancy