cyrilzakka/clinical-trials huggingface dataset:
Cryopreserved Human Meniscus Transplantation

The purpose of this study is to determine the long-term survivorship and clinical outcomes of all cryopreserved meniscus transplants performed by Dr. Frank Noyes.

All patients receiving cryopreserved meniscus transplants will be followed at 1, 2, 5, 10, and 15 years postoperatively. Study examination will include comprehensive knee examination by Dr. Noyes, x-rays, and potentially MRI. Patients will complete the following forms of the Cincinnati Knee Rating System: Symptom Rating Form, Sports Activity and Function Form, and Occupational Rating Form. All patient identification will be kept confidential. Patient data will be entered into the Knee Registry database according to their unique study number by the clinical research assistant.

Eligibility Criteria:
Inclusion Criteria:

* Patient post-meniscectomy
* Patient symptomatic with activities
* Patient has early articular cartilage degeneration in affected tibiofemoral compartment
* Patient understands goals of operation, willing to undergo lengthy rehabilitation

Exclusion Criteria:

* Patient has no symptoms with activities
* Patient has advanced degeneration in affected tibiofemoral compartment or other compartments
* Patient is obese (BMI \> 30)
* Patient has uncorrected lower limb axial malalignment or knee ligament deficiency
* Patient has active infection
* Patient has pre-existing knee arthrofibrosis or lower limb muscular atrophy
* Patient has symptomatic patellofemoral articular cartilage deterioration
* Patient is unwilling to undergo lengthy rehabilitation after surgery
Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol

At hemodynamic level, the greater affinity of bisoprolol by the beta 1 receptor in theory could improve the peripheral arterial perfusion and could have a greater antihypertensive effect. At the same time, this could carry objectifiable improvements in the vascular tree, such as the level of arterial stiffness.

This study attempts to mark the hemodynamic differences in the same individual with hypertension and metabolic syndrome who will be exposed to both drugs at different moments. Parameters will be objectified with impedance cardiography, pulse wave velocity and central blood pressure assessment before and after taking each one of the drugs. The results will be compared to the baseline data and between themselves.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Metabolic syndrome

Exclusion Criteria:

* Severe hypertension \>180/110
* Secondary hypertension
* Contraindication for betablockers
* Prior treatment with betablockers (up to one month before inclusion)
* History of neoplastic disease
* Patients that do not sign informed consent
The Impacts of Mindfulness on Psychological Wellbeing Among Nursing Students

The aims of this study are to develop a mindfulness-based course for nursing students. As well as, to verify the effects on psychological well-being (mindfulness, stress, and anxiety) and nursing professional related competences (empathy, clinical practicum stress, nursing competency) among nursing students.

A quasi-experimental study design will be used to examine the effects of a new elective course. Convenient sampling will be used to invite nursing students at a university of science and technology in Taiwan. The data will be collected four seven times, including baseline (T0), the end of the course (T1), before and after the nursing practicum (T2, T3).

Participants who enroll in an elective course in mindfulness education constitute the experimental group, while those who do not enroll in the elective form the comparison group. The total number of participants will be 240. Participants will be excluded if they are unwilling to participate in the study or do not complete the consent form.

Intervention: The experimental group will enroll in the elective course named "Mindfulness and Happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. The comparison group will not participate in this course. The elective course is designed using the ADDIE model (Analysis, Design, Development, Implementation, Evaluation) and is based on Mindfulness-based Stress Reduction principles.

Eligibility Criteria:
Inclusion Criteria:

* Nursing students who participated in the elective mindfulness course

Exclusion Criteria:

* under 18 years
SNIFF - Combo INI+EMPA Trial

The proposed pilot study will provide safety and efficacy preliminary data regarding singular and combined effects of two therapeutic approaches, intranasal insulin and treatment with the sodium-glucose cotransporter type 2 inhibitor (SGLT2i) empagliflozin, to correct bioenergetic and vascular dysfunction in adults with preclinical Alzheimer's disease (AD) and amnestic mild cognitive impairment (aMCI) or early AD.

The study will consist of a single site, randomized, double-blind trial comparing the effects of 4 weeks of intranasal insulin(40 International Units four times daily), empagliflozin (10 mg daily) and combined intranasal insulin (INI) and empagliflozin (empa) compared with placebo on cerebrospinal fluid (CSF) biomarkers and cognition.

At study entry, participants will be randomized to one of 4 conditions: INI, empa, INI+empa or placebo. Participants who are cognitively normal but have abnormal elevations of brain amyloid or who have mild cognitive impairment (MCI) or early Alzheimer's disease (AD) will be enrolled.

The primary outcome measure will consist of safety (treatment-related serious adverse events). Secondary outcome measures will consist of cerebrospinal fluid (CSF) biomarkers, cognition, and cerebral blood flow.

Eligibility Criteria:
Inclusion Criteria:

1. Age 55 to 85 (inclusive)
2. Fluent in English
3. Cognitively normal or diagnosis of amnestic mild cognitive impairment (aMCI) or mild Alzheimer's disease (AD)
4. Amyloid positive by positron emission tomography (PET) or cerebrospinal fluid (CSF) criteria
5. Stable medical condition for 3 months prior to screening visit
6. Stable medications for 4 weeks prior to the screening and study visits (exceptions may be made on a case by case basis by the study physician)
7. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

Exclusion Criteria:

1. A diagnosis of dementia other than Alzheimer's disease (AD)
2. History of a clinically significant stroke
3. Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
4. Diabetes (type I or type II) insulin-dependent and non-insulin-dependent diabetes mellitus
5. Current or past regular use of insulin or any other anti-diabetic medication within 2 months of screening visit
6. History of seizure within past five years
7. Pregnancy or possible pregnancy
8. Use of anticoagulants, unless documentation received from prescribing clinician that anticoagulant medication can be held before LP, and approved by study clinician
9. Residence in a skilled nursing facility at screening
10. Use of an investigational agent within two months of screening visit
11. Regular use of alcohol, narcotics, anticonvulsants, anti-parkinsonian medications, or any other exclusionary medications (exceptions may be made on a case by case basis by the study physician)
Scandinavian Olecranon Research in the Elderly

This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting.


Eligibility Criteria:
Inclusion Criteria:

* Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm dislocation of the joint surface) fracture of the olecranon
* Age of patient is 75 years or over at the time of the injury

Exclusion Criteria:

* A delay more than 2 weeks after traumatic event to the day of intervention
* Mayo type 3 fracture
* Fracture continuation distal to coronoideus
* Other acute fracture or nerve damage of the ipsilateral upper limb
* Old fracture (\<6 months) or pseudoarthrosis or unhealed nerve injury of the ipsilateral upper limb
* Open fracture
* Pathological fracture
* History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent
* Patient's inability to understand written and spoken Finnish or Swedish or Danish
* Patient's denial for participation or cognitive incapability to provide consent
* Patient physically unfit for surgery
PS-341 in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic kidney cancer.

OBJECTIVES:

* Determine the efficacy of PS-341 in patients with metastatic renal cell carcinoma.
* Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive PS-341 IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed renal cell carcinoma

  * Metastatic disease
* Unidimensionally measurable disease
* No brain metastases

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Karnofsky 70-100%

Life expectancy:

* More than 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* ALT/AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* No pre-existing neuropathy of grade 1 or greater
* No other malignancy within the past 5 years, except completely resected basal cell skin cancer, unless treated with potentially curative therapy or at low risk for recurrence
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy and recovered
* No concurrent biologic therapy

Chemotherapy:

* No prior cytotoxic therapy
* No concurrent cytotoxic therapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* At least 4 weeks since prior major surgery

Other:

* No other concurrent anticancer therapy
A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa

This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) in treating individuals with Anorexia Nervosa and Bulimia Nervosa. The main objective of this study is to determine the short and long-term efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing eating disorder symptoms (i.e. binging, purging, restricting, intense fear of gaining wait, etc;) in Anorexia Nervosa and Bulimia Nervosa.

The investigators will also be comparing the brain activity patterns of individuals with Anorexia Nervosa and Bulimia Nervosa to healthy controls using electroencephalography (EEG). Further, the investigators would like to examine if the activation patterns in these patients change after receiving rTMS.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening questionnaire

Exclusion Criteria:

* Diagnosis of another psychiatric disorder, except MDD.
* Any rTMS counter-indications:
* History of seizures
* Metal in head
* Currently pregnant
* Having received rTMS for any reason in the past as this would interfere with participant blinding.
Gastrointestinal Tract Disorders: A Prospective Multicenter Registry

The purpose of this prospective registry is to assess long-term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract for various GI tract disorders. Currently, lack enough data evaluate and verify technical feasibility, clinical success and safety of endoscopic suturing in specific gastrointestinal disorders.1-16 Evaluation of these factors would help us compare them to conventional treatment modalities; and consequently help us identify appropriate treatment techniques and improve clinical management of patients.

This study is a prospective, observational, medical chart review for at least six standards of care visits up to 1 year after subject consents for study participation. There will be a retrospective chart review for patients who underwent endoscopic suturing procedures from October 2014 - April 2019. Those subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic suturing procedures from April 2019 to April 2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic suturing procedure and standard of care follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has undergone clinically indicated and/or standard of care endoscopic suturing within the Gastrointestinal tract
* Above or equal to 18 years of age

Exclusion Criteria:

* Any patient who has not undergone endoscopic suturing within the gastrointestinal tract
* Below 18 years of age
Impact of Long Distance Mountain Race on Knee Cartilage.

Long-distance mountain running is increasingly popular among European and North America countries. Long-distance races are organized in various mountains and can reach up to 160 km (100 miles) with several thousands meters of climbing. The pathophysiological consequences of such extreme effort is still a matter a debate. From a muskelo-skeletal perspectives, the potential lower-limb join damage is a major health issue. The present study aims to use objective magnetic resonance imaging (MRI) techniques to describe the consequences of performing long-distance mountain running races on the knee cartilage.

Healthy male runners will perform T2 MRI knee cartilage examination before, immediatly after and 1 month after 3 distinct long-distance mountain races of 40, 55 and 160 km. The physiological responses during the races (speed, heart rate, glycemia) will also be recordered.

Eligibility Criteria:
Inclusion Criteria:

* no cardiac, respiratory or neuromuscular diseases
* more than 2 years of experience in mountain race
* no contre-indication for participating in a mountain race

Exclusion Criteria:

* history of knee surgery
* contre-indication to MRI
Study of Longidaze in the Prevention & Treatment of Pulmonary Fibrosis, Interstitial Lung Diseases Caused by COVID-19

A study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of post-inflammatory pulmonary fibrosis and interstitial lung disease following COVID-19.

The aim of the study is to compare the outcomes associated with postinflammatory pulmonary fibrosis and interstitial lung disease among a cohort of adult patients after complicated pulmonary manifestations of COVID-19 in two groups: in a group of patients who were prescribed Longidaze® for treatment or prevention as part of routine clinical practice, and in the group of patients who underwent dynamic observation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with residual lung changes after complicated COVID-19
2. Residual changes were detected no later than 2 months after the discharge after disease
3. Treatment of COVID-19 was in accordance with the standard of the then current temporary guidelines for the treatment of COVID-19
4. Age of patients over 18 years old
5. Negative polymerase chain reaction (PCR) test COVID-19 at least 2 times in respiratory samples or based on serology results in blood samples
6. Patients in the framework of routine clinical practice, in accordance with the instructions for use before inclusion in the study, were prescribed intramuscular treatment with Longidaze® at a dose of 3000 IU, 1 injection every 5 days for a total course of 15 injections or dynamic observation without the use of active therapy
7. The patient did not participate in other drug clinical trials within 1 month prior to Visit 1.
8. The patient or patient's caregiver agrees to participate in the trial and sign an informed consent form
9. Patient understands and agrees to follow the planned procedures.
10. Women with fertile potential must agree to use at least one method of contraception before completing participation in the study.

Exclusion Criteria:

1. Women during pregnancy and lactation and women planning to become pregnant during the study period
2. Severe background diseases, such as severe heart failure (class IV heart function), severe liver and kidney disease, severe bronchial asthma, severe chronic obstructive pulmonary disease, bronchiectasis, bullous emphysema and previously identified interstitial lung diseases, neurological diseases, tumors.
3. Long-term bed rest, regardless of its cause
4. Increased individual sensitivity to the components of the studied drug
5. Pathological conditions that determine the impossibility of patient participation in the study (by the decision of the investigator)
6. Medical history that, according to the investigator, does not allow the patient to be included in the study
7. A burdened allergic anamnesis, which, according to the investigator, does not allow the patient to be included in the study
Low-Dose Radiation + SBRT + Tislelizumab Plus Platinum-based Chemotherapy in Stage ⅡA-ⅢB Non-small Cell Lung Cancer

This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung cancer.

All eligible patients will receive LDRT combined with partial SBRT, followed by PD-1 inhibitors plus platinum-based chemotherapy, initiated within 7 days after completing radiation. PD-1 inhibitors and chemotherapy will be administered at the recommended doses according to the instruction manual every 3 weeks, with 3 cycles planned as neoadjuvant therapy. Surgery will be performed within 4 to 6 weeks (+7 days) after completing the final cycle of immunochemotherapy.

Main objective and endpoint: the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Patients with untreated stage IIa-IIIB non-small cell lung cancer, diagnosed cytologically or histologically (according to the AJCC 9th edition of thoracic tumor staging);
3. Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;
4. At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
5. Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.

Exclusion Criteria:

1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；
2. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;
3. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;
4. Active infection requiring systemic treatment.
Epigenetic Regulation in Fibrous Dysplasia of Bone: mirDYS Study.

Fibrous dysplasia of bone is a rare congenital but non-hereditary disease caused by a post-zygotic activation mutation of the GNAS gene. Patients with fibrous dysplasia may present pain and bone complications (fractures, deformities..) related to their bone lesions.

For undetermined reasons, severity and disease evolution may vary considerably from patient to patient.

Epigenetic regulation could then be involved, including micro Ribonucleic Acids (miRs).

These small non-coding micro Ribonucleic Acids are involved in the regulation of major steps of cellular processes in different pathologies, in particular in bone diseases. However, micro Ribonucleic Acids have never been studied in fibrous dysplasia.

The aim of this study is to identify micro Ribonucleic Acids significantly associated with the severity of fibrous dysplasia.


Eligibility Criteria:
Inclusion Criteria:

Control population :

* men and women,
* 18 years-old and over,
* consulting a rheumatologist or an orthopedist for arthrosis
* have scheduled surgery for hip or knee replacement surgery or any intervention involving the lower limb or upper limb.

Patients with Fibrous dysplasia:

* men and women,
* 18 years-old and over,
* with a diagnosis of fibrous dysplasia previously established by a rheumatologist.

Exclusion Criteria:

* Refusal to participate in the study
* Long- term corticosteroids treatment (\> 3 months)
* Treated osteoporosis
* Chronic inflammatory rheumatism (rheumatoid arthritis, psoriasic arthritis, spondyloarthropathy)
* Collagen disease (osteogenesis imperfecta...)
* Paget's disease, benign bone tumors
* Uncontrolled hypo/hyper-thyroidism, hypo/hyper-parathryoidism
* Severe renal impairment (GFR \< 30 ml/min/1.73m2)
* Cancer or bone metastases (current or in the past two years)
* Paget disease, benign bone tumor (osteoid osteoma, enchondroma ...)
* Malabsorptive disease (Celiac disease, Whipple's disease, intestinal bypass, short bowel syndrome) and inflammatory bowel disease
* Pregnant women or lactating
* Psychiatric disorders
* Difficulty in understanding French
* Not a beneficiary of french social security
* Patients protected by law