cyrilzakka/clinical-trials huggingface dataset:
Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture

Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with considerable morbidity and mortality. Recent cohort studies have demonstrated a high incidence of PPF in elderly patients treated with two commonly used polished, tapered, collarless stems in elderly patients. The aim of this study was to compare the rate and characteristics of PPF in a consecutive cohort of patients treated either the polished tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of age with femoral neck fracture.


Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral neck fracture
* Treated with a primary hip arthroplasty

Exclusion Criteria:

* Secondary arthroplasty due to sequel after femoral fracture
The Reliability and Validity of Perioperative Cognitive Test Network Platform for Monitoring Neurocognitive Changes

This study aimed to analyze the reliability and validity of the results of the new designed perioperative cognitive test network platform, and to judge the reliability and scientific nature of the perioperative cognitive test. And then to explore whether the perioperative cognitive test network platform can be used to evaluate the changes of perioperative cognitive function of patients.

Two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery will be included in this study. The cognitive function of the patients was tested one day before and seven days after operation. Healthy volunteers had two cognitive function tests at the same interval. The normality test is used to evaluate whether the test results accord with the normal distribution. The internal consistency of the test was evaluated by calculating the Cronbach coefficient, the content validity was evaluated by experts and the content validity index was calculated, and the construct validity of the test was evaluated by exploratory factor analysis and confirmatory factor analysis. The validity of the test was evaluated by calculating the effect scale.

Eligibility Criteria:
Inclusion Criteria:

* Age over 65
* Scheduled for abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade)
* Informed consent has been obtained
* Healthy volunteer groups are listed as age-and sex-matched community groups

Exclusion Criteria:

* Unable to follow instruction and finish the firtst procedure
* Has severe visual or auditory problems
* History of drug or alcohol abuse (drinking more than 5U daily in the past 3 months, 1U equals 10ml or 8g pure alcohol, equivalent to \>50 liquor over 100ml, two two
* Are diagnosed neuropsychological disease that needs treatment
* Clear history of severe cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), Parkinson's syndrome, schizophrenia, bipolar disorder, depression, dementia, Alzheimer's disease, etc
* Severe head trauma, carbon monoxide poisoning and other loss of consciousness more than 30 minutes
* MMSE score ≤23
* Participated this study or being participating other clinical research
Effect of Epidural Analgesia on the Length of Labor and Delivery and Fetal Outcomes

The purpose of this study is to determine if there is a difference in the duration of the first and second stage of labor in nulliparous women , with or without epidural analgesia. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients, while the duration of the second stage will be longer in patient with analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* \> 18 years old
* term (\>37 weeks gestation)
* singleton
* vertex pregnancies

Exclusion Criteria:

* Non-vertex presentation
* cervical dilation \> 4.0cm
A Research Study Looking at Specific Tissue of the Umbilical Cord

The purpose of this study is to isolate Umbilical cord Wharton's jelly matrix to be used as a scaffold for tissue regenerative applications, including avascular necrosis.

Our working hypothesis is that umbilical cord blood Wharton's Jelly matrix has all the biochemical and biomechanical characteristics needed in an ideal scaffold for tissue engineering. Accordingly, we expect matrix to support the growth and differentiation of transplanted mesenchymal stem cells. The first step in this effort is to isolate Wharton's Jelly matrix by decellularization. The second step will be to test the ability of this matrix to support the growth and differentiation of transplanted mesenchymal stem cells. The third step will be to pursue preliminary animal testing to study the ability of this matrix to support bone tissue regeneration in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women
* 18 years of age or older
* willing to donate umbilical cord units

Exclusion Criteria:

* less than 18 years of age
* Has Hepatitis or HIV
* Considered High Risk
* Scheduled for C-Section due to complications during current pregnancy
* Delivered prior to Full Term
SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks. Patients will be instructed to follow treatment recommendations (either LMWH or oral treatment, at physician discretion) and to come back to the surgeon after that period. At that visit, the Treatment Satisfaction Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures compliance with medication) will be answer by the patient. TSQM is an self administered validated scale (validated also in spanish) that measures in a generic way the treatment satisfaction to a treatment. Morinski-Green test will be used to measure the compliance degree on medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients in antithrombotic prophylaxis treatment after total knee/hip replacement. This is an epidemiological study where the patients to be included will be those that are treated with antithrombotics as out-patients in real life conditions.

Exclusion Criteria:

* Patients who has been previously treated with injectable antithrombotic treatments.
* Diabetic patients treated with insulin.
* Patients who do not sign Informed Consent Form.
Association of Perceived Occupational Performance and Satisfaction, Balance, Gait, and Fear of Falling in Older Adult With Mild Cognitive Impairment

This study was designed to investigate the occupational performance and balance, gait, and fear of falling in older adults with MCI. Balance and gait of the older adults were assessed with the Tinetti balance and gait test, fear of falling with the Tampa Scale for Kinesiophobia and occupational performance with the Canadian Occupational Performance Measure (COPM). The relationship between COPM and other parameters was analysed by Spearmen's test.


Eligibility Criteria:
Inclusion Criteria:

* people over 65 with mild cognitive impairment who could understand and follow instructions

Exclusion Criteria:

* Individuals who were unable to participate in the study due to a chronic condition or the use of assistive devices such as wheelchairs or crutches
Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis

This study compared the efficacy of different dosages of long-term iloprost treatment on Raynaud's phenomenon, ulcer healing, skin thickening, and progression of internal organ sclerosis in systemic sclerosis (SSc).

Methods. 50 SSc patients were 1:1 randomised either for maximally tolerated dose up to 2 ng/kg body weight \[bw\] per minute or low dose (0.5 ng/kg bw per minute) intravenous iloprost administration, for six hours daily over 21 days. The effect on RP, ulcer healing, skin thickness, oesophagus function, lung involvement as assessed by lung function parameters FVC and DLCO, and side effects were measured.

Conclusions. The efficacy of prolonged administration of iloprost is also achieved with low dose iloprost by long term treatment. The effects suggest a disease-modifying capability of iloprost, but further studies are needed to proof this hypothesis.

50 SSc patients (23 patients with limited SSc; 15 patients with diffuse SSc, and 12 patients with overlap syndromes fulfilling the ACR criteria for systemic sclerosis) and suffering from severe Raynaud's phenomenon were included into the study after written informed consent to participate in this study. Severe Raynaud's phenomenon was defined by a high burden of disease, by trophic skin changes, or the presence of digital ulcers.

Patients suffering from SSc related RP and/or digital ulceration were randomized 1 : 1 to one of the following groups that received either high or low dose infusions of iloprost for 21 consecutive days given once or twice a year. High dose patients (n=25) started on 0.5ng per kg bw and min over 6 hours a day. Depending on the tolerability the dosages were increased in increments gradually every two days for 0.5 ng/kg x min. The maximum dose administered was 2.0ng/kg bw and min. Low dose patients (n=25) were permanently treated with 0.5ng/kg bw over 6 hours per day for 21 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* patients with secondary Raynaud's phenomenon suffering from severe Raynaud-'s phenomenon with trophical changes or from digital ulcers with written informed consent. Patients had to be stable for their systemic disease and were on stable medication concerning immunosuppression or vasoactive therapies for three months.

Exclusion Criteria:

* Current smokers, patients with a history of gastric ulcers in the last three months, a cardiac ejection fraction below 25%, patients with severe organ involvement or other uncontrolled diseases such as instable angina pectoris, severe anaemia, coagulopathies, azothaemia, cerebral stroke in the last 6 months or malignant diseases were excluded from the study. The last iloprost therapy had to be finished at least 6 months ago. Participation in other studies during the last 4 weeks was also not allowed. For fertile women, a negative pregnancy test was required.
Chromium's Effect on Insulin Resistance in Obesity

This research is to investigate the nutritional supplement chromium picolinate. A large number of people use chromium picolinate from health food stores to improve the function of the hormone insulin. The investigators are testing how effective this supplement is and are also monitoring its safety. In patients with diabetes, chromium has been shown to increase sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to insulin, the investigators are studying obese individuals with documented insulin resistance. The investigators would like to know if chromium is also effective in treating the insulin resistance associated with obesity.


Eligibility Criteria:
Inclusion Criteria:

1. age \> 18 years;
2. a BMI greater or equal to 30; AND
3. an abnormal 2 hour postprandial glucose (greater than 140 mg/dl but less than 200 mg/dl) following 75 grams of a glucose load.

Exclusion Criteria:

1. positive pregnancy test (all women must have a negative pregnancy test before beginning protocol);
2. diagnosis of cancer;
3. acute illness of any sort, however, patients may be enrolled once they are stable;
4. hemoglobin less than 11.0 g/dl or hemodynamically unstable;
5. creatinine greater than or equal to 1.5 mg/dl;
6. liver dysfunction as evidenced by elevations in transaminases 2-fold higher than upper limit of normal;
7. use of certain medications within the past month (e.g., glucocorticoids).
8. untreated hypertension (systolic BP \> 150 mmHG, diastolic BP\>IOO mmHG);
9. patients with diabetes mellitus;
10. hypogonadism;
11. abnormal thyroid function (serum T4 \< 4 or \> 12; TSH \< 0.35 or \> 5.5) (12) any chronic liver or kidney disease; OR
12. polycystic ovarian syndrome.
Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation

The present study aims to compare the pre-emptive analgesic efficacy of parecoxib 40 mg IV/IM versus placebo on reducing postoperative acute pain following submuscular breast augmentation. Additionally this study is being conducted to evaluate the safety and tolerability of parecoxib in this kind of procedure.


Eligibility Criteria:
Inclusion Criteria:

* Female patients of any ethnic origin aged 18 years or over.
* The patient is post-menopausal, surgically sterile, or using adequate contraception, not lactating, with a negative urine pregnancy test at screening, prior to administration of study medication.
* The patient's preoperative health is graded as a class I or II according to the ASA physical status classification and on the basis of medical history and physical examination.

Exclusion Criteria:

* The patient has significant clinical signs and symptoms suggestive of renal or hepatic morbid conditions
* The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.
* The patient used analgesics or other agents (antidepressants, sedating antihistamines or other sedatives, muscle relaxants, narcotics, or corticosteroids) during the four hours preceding the procedure that could confound the analgesic responses.
* Subjects with a history of established ischemic heart disease (e.g. myocardial infarction, stable angina, unstable angina), peripheral arterial disease and/or cerebrovascular disease (e.g. ischemic or hemorrhagic stroke, transient ischemic attack), as well as subjects with previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature
Arthroscopy Simulator Training vs OR Training Knee

The purpose of this study is to compare between two groups of residents with basic arthroscopic skills in diagnostic knee arthroscopy. The first group will train on a knee arthroscopic simulator in a lab, and the second group will perform diagnostic knee arthroscopy in the operating room. Both groups will be assessed by senior arthroscopy surgeon in the operating room based on selected competencies following the Global Rating System.


Eligibility Criteria:
Inclusion Criteria:

* Orthopedic residents

Exclusion Criteria:

* none
Use of Extracorporeal Blood Purification Therapies for Acute Poisoning

Extracorporeal blood purification therapy, including intermittent hemodialysis (HD), continuous renal replacement therapy (CRRT), plasma exchange (PE), and hemoperfusion (HP) are potentially life-saving treatments for some poisonings. This study aimed to determine extracorporeal blood purification's effect on clinical outcomes in critically poisoned patients in Jiangsu Province, China.


Eligibility Criteria:
Inclusion Criteria:

* 12 years of age and older
* history of acute poisoning

Exclusion Criteria:

* missing records in survival outcome
A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator
* Body weight between 80 kg and 110 kg (both inclusive)
* Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive
* Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Previous participation in this trial (randomisation)
* The receipt of any investigational medicinal product within 3 months prior to this trial
* Subjects who have had a clinically relevant illness within 4 weeks of dosing
* History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
* Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period
fNIRS in the Evaluation of Cognitive-motor Interference in Post-stroke Patients

This study evaluates cognitive-motor interference in stroke patients who is responsible an alteration of spatio-temporal gait parameters. It's proved in the literature but the underlying pathophysiological mechanisms remain poorly understood. fNIRS is a functional imaging technique that evaluates this interference under optimal conditions. The purpose of this study is to evaluate the hemodynamic activity of the CPF in walking post-stroke patients under different DT conditions.

Walking is a motor task that involves cognitive functions. The parameters of walking and brain activity are modified in situations requiring significant attentional and cognitive demand. fNIRS is an interesting functional neuroimaging technique for studying cortical activity when performing a Dual Task (DT). To our knowledge, no studies have examined cerebral oxygenation levels in post-stroke patients based on different cognitive loads during walking. Understanding cognitive contributions in a dual-task walking situation is necessary to providing targeted interventions and preventing falls.

Patients included in the study will be evaluated in single cognitive task, with two levels of difficulty, single walking motor task, and dual task with two levels of cognitive difficulty. The fNIRS will record the hemodynamic activity of the prefrontal cortex for the cognitive slope and the GAITRite will record the walking parameters.

Eligibility Criteria:
Inclusion Criteria:

* patient between 55 and 75 years old
* First stroke
* ischemic sylvian or hemorrhagic lobar deep respecting the frontal lobe, subacute phase (J15-J90),
* patient walking 10 meters.

Exclusion Criteria:

* Heminegligencia,
* a history of neurological pathologies, orthopedic pathologies, aphasia, cognitive disorders preceding stroke (dementia, head trauma), acute cardiovascular or respiratory pathologies.
Quality of Life After Stroke Using a Telemedicine-based Stroke Network

To study the effect of a telemedicine model of stroke care on patient-based outcomes.

Approximately 750,000 patients suffer from ischemic stroke (AIS) annually in the United States. AIS is a a leading cause of long-term disability and the third-leading cause of mortality. Effective therapies exist to ameliorate the disability associated with AIS, but implementation of these therapies is time-sensitive. Currently, there is a shortage in health care professionals with expertise in the treatment of stroke and such expertise tends to be concentrated in large community-based or academic medical centers. To respond to this shortage, stroke networks are being organized in a "hub-and-spoke" model to facilitate the rapid delivery of time-sensitive interventions such as intravenous (i.v.) tissue plasminogen activator (tPA) or rapid evaluation for AIS. Some networks are also using telemedicine to facilitate this approach and bring the needed expertise via robotic tele-presence (RTP). Though the accuracy of stroke diagnosis and i.v. tPA utilization may be higher in RTP based networks, the impact of this model on patient's outcomes has been difficult to elucidate. To this end, meaningful validated outcome assessments are crucial to understand the impact of stroke interventions including telemedicine or RTP based networks. The objective of this study is to translate evidence-based practice of healthcare, patient-centered outcome assessments, and patient-family perceptions of delivery of care into meaningful data. This will aid in the validation of the role of interventions such as "hub-and-spoke" RTP based models in stroke care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected acute ischemic stroke (AIS)
* Age \>17 years

Exclusion Criteria:

* Hemorrhagic strokes (ICH or SAH)
* Transient ischemic attacks (TIA)
* Trauma
* Inability to obtain informed consent
* Participation in another study
Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Dilation and evacuation (D\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D\&E.


Eligibility Criteria:
Inclusion Criteria:

* \>18 Years Old
* Viable, Singleton pregnancy
* Voluntarily seeking abortion between 14-19 weeks gestation
* Able to give informed consent and comply with study protocol
* Fluent in English or Spanish

Exclusion Criteria:

* Allergy to study drugs
Outcome of Platelet Rich Plasma in ICSI Patients, a Randomized Controlled Trial

2 groups randomized to PRP injectioninto uterine cavity at mock embryo transfer, and a control group with only mock embryo transfer.

Participants are allocated in two groups ( randomized). Study is conducted in Dar El Teb infertility and IVF centre, Egypt. Normoresponder patients (9-15 mature follicles on day of HCG administration) and candidates for fresh embryo transfer are recruited to the study. 788 patients will be randomized on the day of ovum pick up in a 1 to 1 ratio to platelet rich plasma (PRP) group and control group. Patients wee randomized using computer generated randomization list and sequentially numbered sealed envelopes containing allocation information written on a card. The embryologist and doctors responsible for follow up after ovum pick up aew blinded to received treatment. Ovarian stimunlation is achieved by highly purified urinary FSH (Fostimon, IBSA, Switzerland)started on the 2nd or 3rd day of menstruation. The initial dose ranged between 150-300IU/d depending on expected ovarian response and serum E2 level. GnRH antagonist (Cetrotide, Serono international, Geneva, Switzerland) 0.25mgSC/day will be give when the leading follicle is 14mm and continued till day of HCG. 10,000 IU HCG will be given when 3 or more follicles are 18mm on mean diameter. Oocyte retrieval will be performed 34-36 hours after HCG administration. In PRP group, 1 ml autologous PRP prepared from blood of participants and injected under ultrasound guidance inside the uterus while performing the mock embryo transfer. In control group, mock embryo transfer was performed without injecting anything inside the uterus. All participants will receive progesterone vaginal pessaries (Prontogest, Marcyrl, Egypt) 400 mg twicw daily, starting on day of oocyte retrieval till 12weeks gestation or negative pregnancy test. No more than 3 embryos will be transferred2-5 days after oocyte retrival. B HCG levels will be measured in blood 14 days after HCGadministration. Transvaginal ultrasound will be performed 4 weeks after embryo transfer to confirm clinical pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Normoresponder patients (i.e. patients with 9 to 15 mature follicles on the day of HCG administration ) with expected good reproductive outcomes of IVF-ET and candidates for fresh embryo transfer

Exclusion Criteria:

* Age less than 18 years and more than 35 years Body mass index more than 30kg/m2 Serum progesterone level less than 1.5 ng/ml on the trigger day Smoking Moreover, patients with previous IVF cycle, PCOS ( polycystic ovarian syndrome), pelvic inflammatory disease, endometriosis, uterine anomalies, Ashermann syndrome, chronic endometritis, chromosomal anomalies, increased peripheral NK cells, hereditary thrombophylia and antiphospholipid syndrome were excluded from the study