cyrilzakka/clinical-trials huggingface dataset:
Roentgen Stereophotogrammetric Analysis (RSA) and Dual Energy X-ray Absorptiometry (DEXA) to Evaluate Fixation of Periapatite Coated Triathlon Total Knee Arthroplasty (TKA) Components

The purpose of this study is twofold: 1) to use RSA to determine the migration patterns of the PA coated Triathlon Total Knee Arthroplasty components during the first 2 years postoperatively and thus determine the proportion of cases where adequate fixation is achieved, and 2) to use DEXA scanning to document peri-prosthetic bone mineral density changes in response to the PA coated Triathlon Total Knee arthroplasty over the first two postoperative years.

In addition, gait assessment and validated outcome questionnaires will be utilized to quantify changes in functional status of subjects after surgery and migration patterns will be compared to results obtained from previous studies of uncemented total knee arthroplasty components conducted at this centre. Questions to be asked are: 1. Do the components achieve adequate fixation to the underlying bone? 2. What are the migration patterns (translations and rotations) of the PA coated arthroplasty components during the first two years postoperatively and are they different from that seen for other implants that have been studied with RSA at this institution? 3. For what proportion of implants does migration continue to increase during the two year follow-up? 4. Are inducible displacements, measured at weight-bearing follow-ups, consistent over time and do they indicate that adequate fixation has been achieved? 5. Are there changes over time in bone mineral density of peri-prosthetic bone in the PA coated Triathlon total knee arthroplasty? 6: Where do changes in bone mineral density occur? 7: Is there a significant difference in health status and functional outcome before and after total knee arthroplasty using PA coated Triathlon total knee arthroplasty components? 8: Are there changes in gait symmetry and centre of mass (COM) displacements as assessed with the Walkabout Portable Gait Monitor pre- and post-operatively and how does study gait data compare to asymptomatic gait? and finally, Question 9: Are there differences in the micromotion patterns between the when compared to other samples of knee implants in our RSA database?


Eligibility Criteria:
Inclusion Criteria:

* symptomatic osteoarthritis of the knee indicating surgical intervention
* ability to give informed consent

Exclusion Criteria:

* significant co-morbidity affecting ability to ambulate
* range of motion measurements that are beyond the realm of normal
* a BMI \> 40 (morbid obesity)
* severe osteoporosis or osteopenia or neuromuscular impairment
* women who are pregnant will also be excluded due to the risks of the surgery
Cognition in Patients With Hypoglycemia, Without Diabetes

The purpose of this study is to determine if there are differences in cognitive function (thinking) in individuals who have recurrent hypoglycemia (low blood sugars) following Roux-en-Y gastric bypass, compared with individuals who have also had a Roux-en-Y gastric bypass but do not have hypoglycemia.

This study will test the hypothesis that a history of recurrent hypoglycemia following gastric bypass is associated with differences in cognition (thinking), by analyzing results of cognitive testing in post-gastric bypass individuals with a history of hypoglycemia as compared to those without known hypoglycemia.

This pilot study will identify cognitive domains of interest, as well as inform the development of a future battery of assessments, which could be replicated in a larger sample. Cognitive domains which will be assessed include: premorbid intelligence, memory, language, executive function, and psychomotor speed.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years of age, inclusive, at screening.
2. Willingness to provide informed consent and attend one study visit.
3. For hypoglycemia after upper GI surgery group: Males or females diagnosed with ongoing post upper GI surgery hypoglycemia, with prior episodes of neuroglycopenia, unresponsive to dietary intervention.
4. For hypoglycemia without a history of upper gastrointestinal surgery group: Males or females diagnosed with ongoing hypoglycemia with prior episodes of neuroglycopenia, and without a history of prediabetes, diabetes, or upper GI surgery.
5. For post-bariatric without hypoglycemia group: Males or females with history of bariatric surgery, and no history of symptomatic hypoglycemia.
6. For non-surgical controls only: Males or females with no history of upper GI surgery and no history of hypoglycemia, prediabetes, or diabetes.

Exclusion Criteria:

1. Active treatment with any diabetes medications, except for acarbose.
2. History of cerebrovascular accident.
3. History of a traumatic brain injury not related to hypoglycemia.
4. Active depression.
5. Active alcohol abuse or substance abuse.
6. Known insulinoma, gastrinoma or other neuroendocrine tumor.
7. Having undergone same / similar cognitive assessments within the last calendar year.

There will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China

This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 - 65;
* Weight ≥ 40 kg to ≤ 125 kg;
* Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months;

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
* Significant fibrosis or cirrhosis;
* History or evidence of drug or alcohol abuse;
* History of intolerance to SC injection;
* History of chronic liver disease from any cause other than chronic HBV infection;
* History of hepatic decompensation;
An Investigation to Evaluate the Function of a New Silicon Cover Film and an On-top Suction Device to be Used in a NPWT System in the Treatment of Acute and Chronic Wounds

The aim of the investigation is to evaluate the function of two new device parts to be used in a NPWT system; an on-top suction device intended to transport exudate from the wound and a silicon cover film intended to fixate the wound filler and seal tight to the skin in order to keep a moist environment.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
2. 1cm2 ≤ wound size ≤ 200cm2
3. Male or female, 18 years and above
4. Signed Informed Consent Form
5. Subject understands the written Patient Information

Exclusion Criteria:

1. Need for frequent dressing changes, i.e.\<48 hours between the changes
2. Critical ischemia (for wound healing) according to investigator's judgement
3. Malignancy in the wound and/or wound margin
4. Target ulcer previous not successfully treated with NPWT within 48 hours
5. Poorly controlled diabetes according to investigators judgement.
6. Osteomyelitis which has been left untreated
7. Infection which has been left untreated
8. High risk for bleeding complications
9. Exposed blood vessels, organs or nerves
10. Current or within 3 months treatment with chemotherapy or irradiation
11. Known hypersensitivity to the dressing material
12. Expected technically impossible to seal the film to achieve a vacuum treatment
13. Expected non compliance with the Clinical Investigation Plan (CIP)
14. Pregnancy
15. Subjects not suitable for the investigation according to the investigator's judgement
16. Subjects previously included in this investigation
17. Subjects included in other ongoing clinical investigation at present or during the past 30 days
Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
2. Aged 18 to 70 years old，male or female
3. Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA\> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA\> 105 copies/ml.
4. 1.3 times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
5. Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
6. Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
7. WBC ≥ 3.5 × 109 / L, PLT ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
8. Creatinine (Cr) ≤ 1.5 × ULN.
9. If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
10. Patients signed an informed consent form and compliance was good.

Exclusion Criteria:

1. Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
2. Patients with cirrhosis or liver cancer.
3. Patients have participated in another therapeutic clinical trial in 3 months.
4. Granulocyte count \<1.5 × 109 / L, hemoglobin (HB)\<100g / L, sera alpha-fetoprotein(AFP)\> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
5. Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
6. Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
7. Pregnant woman, lactating women or those who wre allergic for study drug.
To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

Prevention of COVID-19 infection to severe pneumonea or ARDS


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female age 19 years or older
* Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia

Exclusion Criteria:

* Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia
* Pregnant or nursing at the time of signing informed consent
* Known sensitivity to any study medication
* Unwilling or unable to complete study diary
* Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol
IF-MCT 16:8: Investigating the Influence of Intermittent Fasting With and Without MCTs in Patients With Drug-resistant Epilepsy

The objective of the prospective monocentric pilot trial is to investigate the influence of intermittent fasting with or without a once-daily intake with medium chain triglycerides (MCTs) on the frequency of seizures in patients with therapy-refractory epilepsy. The effects of 12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared to 12 weeks intermittent fasting with additional intake of exogenous MCTs (IF MCT 16:8) in a within-subject-crossover-design in 28 patients with drug-resistant epilepsy.

One in three patients suffering epilepsy does not become seizure-free with conventional pharmacotherapy. The chance of seizure freedom with each additional medication is only in the single-digit percentage range. For this reason, additive therapies such as the ketogenic diet play an important role. By means of a ketogenic diet, a significant reduction in the frequency of seizures has been shown in various studies for children. The main goal is the body's own production of ketone bodies in the liver, which are used instead of glucose to produce the energy carrier ATP. This metabolic change results in biochemical, metabolic and hormonal changes that may reduce the severity and frequency of epileptic seizures, although the exact mechanisms are not yet understood. Common to all forms of ketogenic diets (e.g. classic kKD, modified Atkins diet, low glycemic index diet) is a specific preparation of each meal with plans for meals and often an initiation of additive therapy in the inpatient setting or by trained staff. Especially in adulthood, the lack of treatment adherence seems to play an important role in the effectiveness of the ketogenic diet. A form of ketogenic diet which might be more suitable for everyday use is intermittent fasting.

The primary aim of the prospective monocentric pilot trial is to investigate the effect of intermittent fasting with and without a once-daily intake of medium-chain triglycerides (MCTs) on the frequency of seizures in patients with therapy-refractory epilepsy. The effects of 12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared to 12 weeks intermittent fasting with additional intake of exogenous medium chain triglycerides (IF MCT 16:8) in a within-subject-crossover design in 28 patients with drug-resistant epilepsy. Secondarily, the influence of this diet on the composition of the gut microbiome, the T-cell mediated innate immune system and neuronal signalling pathways and networks will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects able to provide informed consent
* Drug-resistant epilepsy
* At least 3 seizures per month

Exclusion Criteria:

* Pregnancy
* Breast feeding period
* Metabolic disorder (e.g. diabetes, liver cirrhosis, kidney disease)
* Eating Disorder (e.g. anorexia, bulimia)
* Chronic inflammatory gut disease
* Active cancerous disease
* Antibiotics within the last 3 months
Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults

The purpose of this study is to test whether deposit contracts, wherein individuals invest their own money with the study to serve as the incentive, with or without daily feedback about progress help individuals to increase step counts and more often meet a step goal compared to self-monitoring only.

Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness. Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive.

This study will last for 16 weeks. Each participant will invest $42 with the study, and be exposed to to each of three interventions. All participants will have the use of a FitBit for ongoing self-monitoring and a step-count goal of 10,000 steps per day. In one condition, these will be the only interventions you receive. In one condition, you will receive a monetary consequence for meeting or not meeting the goal. Each day during the incentive conditions, you will be eligible to lose $0.75 of your own money for not meeting the goal, or to earn back $0.75 of your money plus $0.75 from the study (i.e., a total of $1.50) for meeting the goal. In the third condition, you will have daily feedback mid-afternoon about your distance from the goal and the money you stand to gain or lose. You will be made aware of what condition you are in.

Eligibility Criteria:
Inclusion Criteria:

* 25 kg/m2 ≤ BMI ≤ 45 kg/m2
* Age 18-70
* Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week, confirmed by FitBit at baseline)
* Able to engage in moderate amount of walking
* Able to receive email/text messages from study staff

Exclusion Criteria:

- medical or psychiatric conditions that would make it difficult to comply with study protocols
Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.

This study population was chosen from a non-probability sample

Eligibility Criteria:
Inclusion Criteria:

* Subjects with active luminal and/or fistulizing CD.

Exclusion Criteria:

* Per summary of product characteristics.
Kryptonite - a Novel Osteosynthesis Method for Median Sternotomy

The aim of this study was to investigate the beneficial effect of bone cement in combination with wire cerclage on the stability of the sternum following median sternotomy.

One half of the patients received only wire cerclage the other both bone cement and wire cerclage.

The aim of this study was to investigate the beneficial effect of bone cement in combination with wire cerclage on the stability of the sternum following median sternotomy.

It has been shown previously that wire cerclage alone does not provide a stabile osteosynthesis following median sternotomy. The hypothesis is that if a stabile osteosynthesis can be achieved patient recovery can be hastened and patient discomfort and pain reduced.

One half of the patients received only wire cerclage the other both bone cement and wire cerclage.

The stability of the sternum was evaluated using radiostereometric analysis, PET-CT and patient reported outcomes in the form of SF-36 and VAS.

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective Heart surgery

Exclusion Criteria:

* none
Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation

Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use warfarin will be given an approved new oral anticoagulant agent instead of warfarin for 3 weeks.

If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be performed. Other patients in the both groups will undergo electrical cardioversion. After the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion

Exclusion Criteria:

* Urgent cardioversion
* Patients who have implanted pace-makers or other metal devices
* Claustrophobia
* Hematological disorders disabling patients to receive anticoagulant agents
* Atrial fibrillation secondary to temporary causes.
* Serious rheumatic heart valve disease
* Hyperthyroidism
* History of malignancy
* Left atrium diameter \> 55 mm
* Ejection fraction \< 0.25
Botulinum Toxin (BOTOX) for Cerebral Palsy

This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.

This trial will test the effectiveness of BTX injections versus placebo to reduce plantar-flexor spasticity and improve function and mobility in children with spastic diplegia, a common form of cerebral palsy. The study will evaluate the effects of the treatment across five domains that relate to disability: pathophysiology, impairment, functional limitation, disability, and societal limitation.

Forty children, ages 4 to 12 years, will be recruited and randomized into one of two groups. Group A will receive BTX. Group B will receive a placebo injection. Participants will be assessed at the beginning of the trial and at Weeks 3, 8, 12, and 24. Assessments include quantitative electromyographic kinesiology measurements, electromechanical measurement of joint torque across the ankle joint using the Spasticity Measurement System, Gross Motor Function Measure, physical exam parameters, energy expenditure using the Energy Cost Index, kinematic gait analysis, and the Canadian Occupational Performance Measure.

Participants are followed for a total of 6 months. Participants initially randomized to Group B will have the opportunity for BTX treatment after 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Spastic diplegic cerebral palsy
* Community or independent ambulators
* Expressive communication skills at age 3 or above
* Stable social environment
* Reasonable proximity to the medical center
* Physical therapy at least once per week
* No other serious health problems that would interfere with the study

Exclusion Criteria:

* Other forms of cerebral palsy
* Previous treatment with botulinum toxin
* Musculoskeletal contractures greater than 15 degrees
* Unstable social environment
Infusional Fluorouracil and Weekly Docetaxel for Gastric Cancer With Bone Marrow Involvement and DIC

A distinctive subtype of gastric adenocarcinoma with extensive bone marrow metastasis and DIC has been described. Few patients have been treated properly due to the lack of standard care. We designed this phase II study to evaluate a dose-dense regimen for this kind of highly aggressive gastric cancer (HAGC).

5-fluorouracil 200mg/square metre/day continuously venous infusion on days 1-21; Docetaxel 25mg/square metre, on days 1, 8 and 15; This regimen repeats every 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* ECOG PS 0-3;
* Pathologically confirmed adenocarcinoma in stomach or esophagogastric junction;
* Bone marrow metastasis confirmed by aspiration, biopsy or PET/CT scan;
* overt DIC according to the International Society on Thrombosis and Haemostasis (ISTH) criteria;
* Treatment-naive after the diagnosis of metastasis;
* Platelet ≤ 50 \* 10E9/L;
* ALT≤5×ULN, AST≤5×ULN, Bilirubin≤5×ULN, Creatinine≤3×ULN;
* Written informed consent.

Exclusion Criteria:

* Concurrent aggressive malignancy;
* Docetaxel containing perioperative treatment within 6 months;
* Allergic to the study drugs;
* Serious medical conditions, including severe heart disease, severe cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection,etc.
* HIV positive;
* MSI-H;
* Her-2 gene overexpression;
* Inadequate contraceptive measures.