cyrilzakka/clinical-trials huggingface dataset:
Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear

To explore whether there is a difference in the rate of tendon tear after hyperlipemia in tennis elbow patients and those with normal blood lipids after closed treatment, which provides clues for further exploration of its mechanism. 1. Collect data from 108 cases of tennis elbow patients treated at the Institute of Sports Medicine, Peking University Third Hospital from January 2010 to December 2018 at the Institute of Sports Medicine, Peking University Third Hospital. Statistics included the sex, age, BMI, number of closures, total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein. 2. Retrieve the MRI imaging data of the above-mentioned patients, and use the extensor tendon at the humerus to see if there is a tear as an observation indicator. Analyze the difference of tendon tear after closed treatment in patients with high blood fat and normal blood fat.


Eligibility Criteria:
Inclusion Criteria:

* All patients with tennis elbows in our hospital

Exclusion Criteria:

* none
Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization

The primary goal of the study is to see if the PET/CT will be able to determine the precise location of the Y-90 particles within the liver and within the tumors. We hope to use this information in order to see if these particles distribute evenly throughout large tumors or if the particles go into the tumor which is located in the portal vein.

The secondary goals are threefold. First correlate the distribution of Y90 particles (as demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a difference in the Y90 particle's distribution when a low particle load (1-3 million particles) is used compared to when a high particle load (6-8 million particles) is used. Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production PET research imaging.


Eligibility Criteria:
Inclusion Criteria:

1. UWMC patients over 18 years of age
2. Presence of hepatocellular carcinoma greater than 5 cm OR presence of tumor-associated portal vein thrombosis.
3. Currently undergoing treatment with Yttrium-90 Radioembolization
4. Able to sign informed consent

Exclusion Criteria:

1. Patients who are not undergoing treatment with Yttrium-90 Radioembolization
2. Patients unable to provide informed consent
Alveolar Ridge Preservation Using Different Bone Substitutes

The primary objective of this study was to compare the efficacy of using allograft, autogenous tooth graft, and beta-tricalcium phosphate for alveolar ridge preservation (ARP) by examining the alveolar ridge height and width at baseline and 3 months after the ARP both clinically and radiographically. The secondary objective was to evaluate the quality of the newly formed bone using histomorphometric analysis.

This randomized controlled clinical trial included thirty patients. ARP was performed using either Allograft (Allograft group n=10), Tooth graft (Toothgraft group n=10), and beta tri-calcium- phosphate (beta tri-calcium group n=10). Changes in alveolar ridge dimensions were evaluated clinically and radiographically using cone beam computed tomography at baseline and 3 months. Core bone biopsy samples were obtained 3 months post-extraction during implant placement for histomorphometric analysis.

Eligibility Criteria:
Inclusion Criteria:

1. seeking implant-based restorations after tooth extraction.
2. exhibited no evidence of any significant medical history, measured using Burket's Oral medicine health history questionnaire.
3. exhibited Type I and II sockets

Exclusion Criteria:

1. nonsmokers.
2. Pregnant and breast-feeding females
3. patients with known contraindications to dental implant surgery (e.g., increased bleeding tendency, history of treatments such as radiotherapy,
Care Bundle Containing Chlorhexidine Dressing on Port Catheter and Central Venous Catheters

In order to provide treatment in pediatric hematology-oncology patients, in some cases a central venous catheter is required in children. The most important situation to pay attention to when using a central venous catheter is "Central line-associated bloodstream infections".

These infections are infections that develop after admission to the hospital and are not in the incubation period at the time of admission, or although they usually develop in the hospital 48-72 hours after hospitalization, they can sometimes appear after discharge. Central line-associated bloodstream infections significantly increase morbidity and mortality. In this context, the effect of using a care bundle containing chlorhexidine dressing on port catheter and central venous catheter-related bloodstream infections in pediatric cancer patients was examined.

This study was designed as a prospective, cross-sectional, and randomized controlled study to examine the effect of a care package containing chlorhexidine dressing on port catheter and central venous catheter-related bloodstream infections in pediatric cancer patients.

Hypotheses of the Research H1: Care bundle approach including chlorhexidine dressing in pediatric cancer patients reduces port catheter and central venous catheter-related bloodstream infections.

H2: Care bundle approach including chlorhexidine dressing in pediatric cancer patients reduces port catheter and central venous catheter-related complications.

Randomization A stratified randomization scheme was used to distribute the sample into groups. Stratification randomization was made according to port catheter stay duration, age group, hematological/oncological cancer type and hematopoietic stem cell transplantation unit / pediatric hematology and oncology clinic.

Eligibility Criteria:
Inclusion Criteria:

* The child is receiving inpatient treatment at the Hematology and Oncology unit and hematopoietic stem cell transplantation unit
* The child has a diagnosis of hematological or oncological cancer
* The child's age range is between 1 and 17
* Having a port catheter inserted and no early complications have occurred
* The child agrees to participate in the study voluntarily
* The parent agrees to participate in the study voluntarily
* Obtaining the consent form from the child and parent
* He has been in the hospital for more than 48 hours

Exclusion Criteria:

* Have a systemic infection.
Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults

The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in Australia.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of the vaccination
* Written informed consent has been obtained

Exclusion Criteria:

* Evidence of confirmed pertussis disease within the previous 5 years
* History of diphtheria or tetanus vaccination within the past 5 years Females must not be pregnant or lactating They must either surgically sterilized or one year post-menopausal or if they are of childbearing potential, they must be abstinent or have used adequate contraceptive precautions (or one month prior to the booster vaccination, and must agree to continue such precautions for 2 months after completion of the vaccination.
* History of diphtheria or tetanus disease
* History of allergic disease likely to be stimulated by the vaccination
* Major congenital defects or serious chronic illness
* History of progressive neurological disease
* Immunosuppressive therapy
* Any suspected or confirmed immune disorder
* Immunoglobulin therapy or administration of any blood products within the previous three months or during the study period
* Acute febrile illness (\>37.5°C, axillary or oral temperature) at the time of planned vaccination
* Administration of an investigational or non registered drug or vaccine within 30 days prior to the start of the present trial
* Simultaneous administration of a vaccine not foreseen by the study protocol, within 30 days prior to the start of the present trial
* Any severe or serious adverse experience having occurred after previous administration of DTP vaccine i.e:

  * an immediate anaphylactic or unacceptable reaction to the investigator's opinion, to a previous dose of diphtheria tetanus pertussis whole-cell vaccine, i.e. :
  * encephalopathy
  * fever \> 40.5°C (105°F), rectal temperature, occurring after vaccination with diphtheria tetanus pertussis whole-cell vaccine and not due to another identifiable cause.
  * collapse or shock-like state
  * persistent, inconsolable crying lasting \> 3 hours
  * seizures with or without fever
  * systemic allergic or neurologic reactions following a previous dose of tetanus and diphtheria toxoids vaccine
* Exclusion from long term follow-up of antibody persistence : Evidence of confirmed pertussis, diphtheria or tetanus disease or vaccination against these diseases since previous study visit
Reversal of General Anesthesia With Methylphenidate

The aim of this study is to investigate whether methylphenidate (Ritalin) can actively induce emergence from general anesthesia in patients having a pancreaticoduodenectomy (Whipple procedure), a pancreatectomy, or a prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* American Society of Anesthesiologists classification 1 or 2
* Scheduled to undergo a pancreaticoduodenectomy or distal pancreatectomy at Massachusetts General Hospital

Exclusion Criteria:

* American Society of Anesthesiologists physical status classification of 3 or beyond.
Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections

This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment.


Eligibility Criteria:
Inclusion Criteria: - Moderate to end-stage renal impairment - A diagnosis of complicated skin and skin structure infection known or suspected to be due to susceptible Gram-positive bacteria based on positive Gram stain - A diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor Exclusion Criteria: - Known bacteremia, osteomyelitis or endocarditis
Extended Postoperative Oral Tranexamic Acid in Knee Replacement

A comparison of outcomes between use of oral tranexamic acid as compared to oral placebo in the first days after total knee replacement will be made to determine impact on clinical indications and patient reported outcomes.

Significant blood loss occurs during total knee arthroplasty (TKA) which can lead to adverse outcomes including need for blood transfusion as well as increased local tissue swelling and ecchymosis which can inhibit post-operative recovery. Tranexamic acid (TXA), an inhibitor of fibrinolysis, has been shown to be a safe and effective drug for reducing blood loss during and after TKA. The use of TXA intraoperatively has been associated with higher postoperative hemoglobin levels and a reduction in postoperative blood transfusion rates. Administration of TXA in TKA has also been associated with improved clinical outcome measures including decreased rate of periprosthetic joint infection, decreased length of stay, and increased postoperative range of motion and early ambulation distances. However, there remains a wide variance in the route of administration, dosage, and timing of TXA use among treatment protocols in TKA. Previous studies have evaluated outcomes with the addition of post-operative TXA dosing to standard pre-operative and intra-operative intravenous (IV) doses. This study will investigate patient outcomes following a standardized post-operative oral TXA protocol as compared to oral placebo for three doses over day of surgery, postop day one and postop day two after TKA.

Following written consent documentation, Subjects will be randomized and blinded to randomization assignment until completion of study to either the oral TXA group or oral placebo group. The study medication will be distributed with the Subject's name with instructions for use in the post-anesthesia unit (PACU). The first dose will be administered in PACU with subsequent doses to be taken at home on postop day one and postop day two. TKA will be completed in an ambulatory surgery center with discharge same day of surgery to home.

Outcome measures include: Hemoglobin, visual analog score, KOOS Jr (Knee injury and osteoarthritis outcome score), range of motion, and incidence of treatment-emergent adverse event at postoperative (POD) day 3, POD week 2, POD week 6, and POD week 12. KOOS Jr. will be collected at one year post-op.

Eligibility Criteria:
Inclusion Criteria:

* Primary total knee replacement in ambulatory setting
* Willing to participate
* Physical therapy on site at Campbell Clinic Wolf River
* Fluent in oral and written English

Exclusion Criteria:

* Unwilling to participate
* Revision total knee replacement
* Preoperative use of anticoagulants other than 81 mg aspirin
* Previous history of thromboembolic event
* Previous history of cancer other than non-melanoma skin cancers
NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications

Aims: To investigate the incidence of bleeding complications during oral surgical procedures in patients medicated with DOACs.

To investigate the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs.

To examine whether increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.

Previous studies have shown that the incidence of healthcare-consuming bleeding complications following oral surgical procedures in patients who are prescribed warfarin is approximately 4% (9). To investigate whether the incidence is higher or lower by the intake of DOAC it is considered to be sufficient with 100 patients in each group. The groups consist of patients who are prescribed warfarin, DOACs, as well as a control group.

Hypothetical outcomes: The incidence of bleeding complications and the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs are higher compared to patients medicated with warfarin and patients taking no anticoagulants. Increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time.

Clinical relevance: The study will serve as a basis for the development of treatment guidelines for patients who medicate with DOACs. If it turns out that the oral surgery procedure presents no increased risk of complications and that the bleeding volume does not complicate the surgery significantly, it may be recommended that patients who medicate with DOACs whom are in need of oral surgical procedures seek ordinary dental care.

The continuous variables (amount of bleeding during surgery) will be analyzed with linear regression if they show normal distribution patterns.

The ordinal variables (postoperative bleeding complications) will be analyzed with ordinal logistic regression.

Dichotomous variables (presence of other postoperative complications) will be analyzed with logistic regression.

Eligibility Criteria:
Inclusion Criteria:

Need of dental extraction / oral surgery, and medication with:

1. warfarin or
2. DOACs or
3. no treatment or AK-platelet therapy and age-matched to group a) and b).

Exclusion Criteria:

Medication with the combination of anticoagulants and antiplatelet Ongoing drug abuse
Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

A randomized, double-blind, placebo-controlled, dose-ranging study to examine the safety, tolerability and effect on body weight of a range of doses of metreleptin and pramlintide, each administered by a separate subcutaneous (SC) injection in obese and overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old.
* Is obese (Body Mass Index \[BMI\]\>=30kg/m\^2 and \<=35kg/m\^2); or overweight (BMI\>=27kg/m\^2 and \<30kg/m\^2.
* Has stable body weight, i.e., not varying by \>3% within 3 months prior to study.
* Has not been treated over the past 3 months or is currently treated with any of the following medications: Oral contraceptives (female subjects); Hormone replacement therapy (female subjects); Metformin for the treatment of polycystic ovary syndrome (female subjects); Antihypertensive agents; Lipid-lowering agents; Thyroid replacement therapy; selective serotonin reuptake inhibitors (SSRIs).
* Is comfortable with having repeated telephone contacts with a lifestyle counselor during the study.
* Is a nonsmoker (has not smoked for at least 6 months prior to the study).

Exclusion Criteria:

* Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics suggestive of genetic obesity or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet-Biedl syndrome).
* Is currently enrolled or plans to enroll in a diet, weight loss, or exercise program with the specific intent of losing weight (subjects who have been following an exercise regimen resulting in stable weight maintenance for at least 2 months prior to enrollment are eligible for study inclusion)
* Has been treated over the past 2 months, is currently treated, or is expected to require or undergo treatment with \*antiobesity agents (prescription or over-the-counter), \*antipsychotic agents, \*antiepileptic agents, \*antidepressant agents, \*drugs that directly affect gastrointestinal motility, \*antidiabetic medications.
* Has previously received treatment with metreleptin or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®).
* Has received any investigational drug within 30 days or within a period corresponding to 5 half-lives of that drug, whichever is greater, prior to this study starting.
* Has had a major surgery or a blood transfusion, or has donated blood over the past 2 months or is planning to donate blood during the study.
* Has had liposuction, abdominoplasty, or similar procedure over the past year or is planning to have such a procedure during the study.
Study of the Clinical Scoring System and Cytokines for Prediction of Inflammatory Response in Major Surgery

Cardiac surgery with cardiopulmonary bypass (CPB) and hepatic surgery are major operations, associated with a systemic inflammatory response syndrome. The aim of this study is to assess the effectiveness of clinical scoring systems and inflammatory cytokine levels for predicting systemic inflammation. This correlation might identify peri-operative clinical outcomes, then forecast further systemic inflammation in cardiac and hepatic surgical patients.

Systemic inflammatory response syndrome (SIRS) is commonly found in most major surgery. Early detection of SIRS will lead to early treatment. Serum cytokines levels are reliable markers for SIRS detection but with high cost and inconvenience. Clinical Scoring Systems are commonly used for assessment of patients with SIRS. If they have good correlation with cytokine levels, they might be used to predict peri-operative clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult patients who had undergone elective cardiac surgery with CPB

Exclusion Criteria:

* under 18 years of age
* needing emergency surgery
* needing intra-aortic balloon pump
French Cohort of Patients With Rotator Cuff Lesions

The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment.

This is a non-interventional, prospective, longitudinal, multicentre cohort study.

The research procedure involves recruiting patients during their first consultation for the management of a rotator cuff injury. Patients will then be contacted by telephone or e-mail every year to monitor the progress of their disease and their treatment. Patients will be asked to complete self-questionnaires assessing shoulder function, quality of life and satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years of age.
* Patient with a transfixing (total) rotator cuff lesion confirmed by imaging.
* A patient who has been informed and has expressed no oral objection to taking part in the research.
* Patient affiliated to or benefiting from a social security scheme.

Exclusion Criteria:

* Patients over 75 years of age.
* Patients with a history of shoulder surgery.
* Patients unable to receive emails and/or answer online questionnaires.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Life expectancy \>=3 months, in the investigator's judgment
* Adequate hematologic and end-organ function
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy that has progressed after available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care
* Measurable disease per RECIST v1.1
* Tumor specimen availability, for certain cohorts

Exclusion Criteria:

* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to C1D1, with certain exceptions
* Active hepatitis B or C
* Active tuberculosis
* Positive test for HIV infection
* Administration of a live, attenuated vaccine (e.g., Flumist) within 4 weeks prior to RO7566802 infusion
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Active or history of autoimmune disease
* Prior allogeneic stem cell or organ transplantation
* Uncontrolled tumor-related pain
* Significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria may apply.