cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction With Virtual Postoperative Visit

This is a prospective, randomized study designed to evaluate the effects of different initial postoperative follow-up modalities. Given the nature of the study, it is not possible for either the surgeons or the subjects to be blinded. To reduce bias that may occur due to each surgeon's personal preference for postoperative follow-up modality, the surgeons (rather than individual subjects) will be randomized to one of two postoperative follow-up modality groups (traditional or virtual).


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* \< 60 years old
* Undergoing knee arthroscopy procedure

Exclusion Criteria:

* \< 18 years old
* \> 60 years old
Basiliximab Treating Interstitial Pneumonia of CADM

This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.


Eligibility Criteria:
Inclusion Criteria:

* Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.
* Agreement of contraception.
* Serum creatine Kinase ≤ 1.5 fold of upper normal level.
* Interstitial pneumonia:

(meet at least two in four of following)

1. interstitial pneumonia images in high resolution CT;
2. DLCO (diffusing capacity)≤ 60% predict in lung function test;
3. elevated serum KL-6;
4. serum anti-MDA5 (+).

Exclusion Criteria:

* Previous application of immunosuppressives or any target treatment for dermatomyositis.
* Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.
* Abnormal renal function at screening (serum creatine\>300μmol/L，or eGFR\<60mL/min/1.73m2, or end-stage renal disease).
* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.
* History of any malignancy.
Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong

The proposed study is a randomized controlled trial (RCT) that aims to examine the effectiveness of cognitive behavioural therapy in reducing depressive and anxiety symptoms for youths in Hong Kong. It is to be carried out with 120 youths aged 12 - 24 recruited from a series of community-based LevelMind@JC hubs, funded by the Hong Kong Jockey Club Charities Trust. It is designed to improve the youths' abilities/ skills in handling moods to have better emotional management. A written informed consent will be signed by participants. Researchers will perform cognitive behavioural therapy on youths who agree to join the study.


Eligibility Criteria:
Inclusion Criteria:

* LevelMind@JC users with mild to moderate distress level (n=120);
* have sufficient proficiency in Chinese to understand verbal instructions and give informed consent;

Exclusion Criteria:

* known diagnosis of intellectual disability
* organic brain disorder
* photosensitive epilepsy
* significant visual, auditory or balance impairment
* current or previous use of illicit drugs
* known psychiatric diagnosis (stabilized diagnosis and treatment)
* receiving any psychosocial treatment for social withdrawal such as CBT or;
* current or active suicidal ideation or attempts.
The Professional Peer Resilience Initiative

The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers (HCWs) and mental health consultants (MHCs) in UMN medical school departments

Exclusion Criteria:

* None
Equivalency Study of the TEG and CORA Hemostasis Systems

This study is being performed to obtain data about the CORA system, a new device that is currently being tested and is not yet cleared for sale in the United State by the Food and Drug Administration (FDA). The purpose of the study is to validate the CORA system by comparing the results of this test to that of the standard of care device called the TEG system. Both systems evaluate hemostasis, a highly complex and interactive process involving many protein and cellular elements, especially platelets, occurring in a series of interrelated phases, which results in either normal hemostasis or a tendency toward bleeding or clotting complications.

The study protocol specifies testing using multiple reagents which are similar for both the CORA and TEG systems. Tests are run on blood samples taken from patients undergoing cardiovascular surgery and cardiology procedures, at two times throughout the procedure. The tests may be performed at three different pairs of times: Pre-Operation and Post-Protamine, or During Operation (Post-Heparin) and ICU, or Pre-Operation and ICU. Patients are selected at random for determination of which pair of times will be used, as long as the number of patients for each of the three groups is approximately the same. Following the protocol defined in CLSI Standard EP09-A2, equivalence between the two systems will be demonstrated if the conclusions from the Standard Section 7, Interpreting Results and Comparing to Internal Performance Criteria, are found to be acceptable.

The study protocol also specifies the testing of blood samples from normal, health volunteer subjects for the purpose of determining CORA System Reference Ranges for all of the reagents used in the study. Reference ranges will be constructed following the guidelines specified in CLSI Standard C28-A3c.

All blood samples drawn for this study will use venous blood. Whole blood is not used for these studies; only citrated or heparinized samples are used. All samples are repeated twice (run in duplicate tests). Quality Controls are run on both instruments at a frequency specified by the manufacturers. Results obtained from this testing are not used to make treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over (both groups)
* Age, gender, ace and disease state documented (both groups)
* In good health (Reference Ranges group only)

Exclusion Criteria:

* Subjects/patients under the age of 18 (both groups)
* On medications affecting hemostasis (Reference Ranges group)
* Having conditions or undergoing treatments affecting hemostasis (Reference Ranges group)
Use of Magnetic Imaging to Asses the Efficacy of Cap Assisted Colonoscopy in Reducing Looping and Improving Patient Acceptance for the Colonoscopy Procedure

The aim of this study is to compare the mechanism of loop formation and acceptance of CAC and regular colonoscopy by MEI.

Colonoscopy is widely used for the investigation of lower gastrointestinal tract disease.However,colonoscopy remains a technically difficult procedure. As the colon is a mobile organ, looping may occur when the colonoscope passes through.Hence,reducing looping during procedure is very improtant to achieve succes as well as patient acceptance.Recently,some studies shown that cap-assisted colonoscopy(CAC)allow better visualisation of the colonic folds, thus increase success rate.However, previous studies shown that magnetic endoscope imaging (MEI)is useful as an adjunct to assist endoscopist in performing the procedure and as a modality to look for the mechanism of looping. Because of such concern,our study is to compare the mechanism of looping formation and acceptance of CAC and regular colonoscopy by MEI.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergo first colonoscopy examination
* Signed informed consent

Exclusion Criteria:

* Patient had received colonoscopy examination before.
* Patient had prior colorectal surgery done(apart from appendectomy)
* Known to have colonic stricture or obstructing tumour from the result of other investigations such as CT scan or barium enema.
* Presence of acute surgical conditions such as severe colitis, megacolon, ischaemic colitis and active gastrointestinal bleeding.
* Patient could not provide consent.
A Phase 3 Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥5 to ≤65 Years of Age With Classical Homocystinuria (HCU) (ENSEMBLE)

The goal of this long-term extension (LTE) study is to evaluate the safety and efficacy of pegtibatinase in patients with classical homocystinuria (HCU). Patients who are active in the Phase 1/2 COMPOSE study or those who complete the 24 weeks of treatment in the Phase 3 HARMONY are eligible to participate.

Participants will be in this clinical study for up to about 13 months including:

* a treatment period of up to 104 weeks
* a 4-week safety follow-up period

Overall Design:

This is a global, multicenter, single-arm, open-label study. Participants who meet all eligibility criteria may transition from other pegtibatinase studies and enroll into this LTE study for long-term safety, efficacy, and clinical assessments of pegtibatinase treatment.

All participants will follow a protocol of self-administration of pegtibatinase unless exempted. During the ENSEMBLE study, an optional protein tolerance modification (PTM) sub-study will also be conducted for eligible participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants active in the COMPOSE study or who completed the 24-week blinded period on the full target dose of study intervention in the Phase 3 HARMONY study

Exclusion Criteria:

* Participant permanently discontinued from study intervention treatment in a previous pegtibatinase study due to serious AE (SAE) or intolerance
Effects of Growth Hormone on Exercise Capacity

The purpose of this study was to assess whether Growth Hormone(GH)improves exercise capacity and cardiopulmonary performance in patients with chronic heart failure.

clinical studies have focused the effects of GH on left ventricular function and hemodynamics. Little is known about the impact of GH on cardiopulmonary performance and exercise capacity. Such data would be relevant, given the well-recognized importance of cardiopulmonary performance and exercise capacity as markers of disease progression and predictors of mortality in patients with CHF.Consequently we conducted a randomised double blind placebo controlled trial to investigate the effects of a three month course of GH, adjunctive to background therapy, on cardiopulmonary performance and exercise capacity in patients with dilated cardiomyopathy and CHF.The primary outcome of the study was improvement of peak VO2 assessed by a cardiopulmonary exercise testing. Secondary endpoints were exercise capacity and ejection fraction obtained by echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Ejection fraction \< 40%
* Left ventricular internal dimension \>58 mm
* II-III NYHA class
* Stable hemodynamic condition during the previous three months
* Sinus rhythm

Exclusion Criteria:

* IMA or CABG or PTCA in the previous six months
* Instable angina
* Major arrhythmias (Lown class\> IV)
* Diseases limiting exercise capacity
* Insulin treated diabetes mellitus
Effectiveness of Care in Certified Cancer Centres in Germany

Assessment of the effectiveness of care in certified cancer centres for eight cancer entities via a retrospective cohort study based on secondary data from statutory health insurance funds and population-based clinical cancer registries.

Cancer constitutes the second most frequent cause of death in Germany. To maintain a high quality of treatment, the national cancer plan aims at a unified certification of cancer centres.

The project "Wirksamkeit der Versorgung in onkologischen Zentren" (WiZen) investigates effects of treatments in certified cancer centres across large populations and different cancer entities in comparison to hospitals that do not hold a certificate.

WiZen is a retrospective comparative cohort study that analyzes incident cases of eight types of cancer diagnosed within 2009-2017 based on nationwide health insurance data provided by WIdO (the AOK research institute) and data from regional clinical cancer registries (CCR) for the period 2006-2017. These eight types of cancer are colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors and neuro-oncological tumors.

Eligibility Criteria:
Inclusion Criteria:

* first hospitalization due to diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2009-2017 \[WIdO\]
* hospitalization due to primary diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017 \[CCR\]

Exclusion Criteria:

* prevalent diagnosis of colorectal cancer, pancreatic cancer, breast cancer, gynecologic tumors, lung cancer, prostate cancer, head and neck tumors, or neuro-oncological tumors 2006-2017
* exception: outpatient cancer diagnosis up to 12 months prior to first hospitalization is not regarded as prevalent
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract

The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.

The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.

Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (POAG) in the study eye
* Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
* Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
* Patient must provide written informed consent to participate

Exclusion Criteria:

* Known or suspected allergy or hypersensitivity to medical silicone
* Allergy to fluorescein
* Presence of silicone oil in the study eye
* Individuals under tutorship or trusteeship
* Patient has a condition such that his / her ability to provide personal informed consent is compromised
Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy

The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ eighteen years
* Eastern Cooperative Oncology Group performance status of 0-1
* Normal hematologic, hepatic function and renal values
* Forced expiratory volume 1 \>800 cc

Exclusion Criteria:

* The presence of rash or unhealed wound in the radiation field
* A known allergy or hypersensitivity to EGCG
* Pregnancy or lactation
* History of/current connective tissue disorder
* Prior radiation to the thorax
Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents

The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.

The study aim is to determine if parent mentors can improve adherence to the intensive multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the frequency of blood glucose measurements. Researchers are also trying to determine if the parent mentors can improve glycemic control, which is measured through HbA1c. Diabetic knowledge, responsibility for diabetes care, degree of diabetes related family conflicts, and major complications of diabetes will also be collected during the patient's routine clinic visit. The study hypothesis is that trained parent mentors can help families with children who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their metabolic control.

Eligibility Criteria:
Inclusion Criteria for mentee families:

* Residing within 60 miles of a Parent Mentor
* Child diagnosed with T1DM greater than or equal to 1 year at the start of our study's data collection (February 2015)
* On multiple daily injection regime or insulin pump therapy
* Mean HbA1c between 8.5 - 12.5% over the last 2 clinic visits

Inclusion Criteria for parent mentors:

* Child diagnosed with T1DM greater than or equal to 2 years at the start of our study's data collection
* Compliant with suggestions made by the diabetes care team
* Mean HbA1c less than or equal to 8% over the last 2 clinic visits
* No episodes of diabetic ketoacidosis, aside from initial episode at diagnosis, if applicable
Cyberknife for Early Stage Breast Cancer

This phase II study based on the Cyberknife Society study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the Cyberknife. It will evaluate quality of life (QOL) issues as they relate to treatment-related side effects, cosmetic result and patient convenience. It will evaluate outcome in terms of local control in the treated breast.

Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed with 7 weeks of the lumpectomy and sent/axillary node sampling over the period of five to ten days using the Cyberknife (CK) or within the 7 weeks of the last chemotherapy treatment if given.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 0, I, or II (Tis, Ti, or T2 \<=3cm \& NO) histologically confirmed invasive non-lobular carcinoma or ductal carcinoma in situ of the breast with a lesion \<= 3 cm, treated with wide excision.
* Negative inked histologic margins of excision or reexcision and clear of invasive tumor and DClS by at least 2mm
* Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications; no remaining suspicious microcalcifications in the breast before radiotherapy.
* No involved axillary lymph nodes by routine histologic examination (H\&E) of sentinel node(s) or of nodes identified from axillary dissection.
* Enrollment and initiation of CyberKnife therapy within 42 days of last breast cancer surgery or last chemotherapy treatment.

Exclusion Criteria:

* Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
* Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
* Patients who are pregnant.
* Patients who have any histologically confirmed positive axillary nodes.
* Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a creatine phosphokinase level above normal or with an active skin rash.
Rectovaginal Fistula Repair

This study is a prospective evaluation of quality-of-life after rectovaginal fistula repair at our institution

All patient having undergone rectovaginal fistula repair at Uppsala University Hospital 2003-2018. An invitation to join the study was sent to all patients. Those who answered were then sent Rand 36/SF36 questionnaire as a follow-up together with some general questions concerning whether the rectovaginal fistula was healed or not.

Eligibility Criteria:
Inclusion Criteria:

* Undergone RVF repair at Uppsala University Hospital 2003-2018

Exclusion Criteria:

* Fistula due to gender reconstructive surgery
Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1 to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and debilitating is characterized by erosive areas, ulcerated on an erythematous base with or without a keratinocyte lichenien network.

The literature data moving towards an autoimmune origin, but the pathophysiological mechanisms of OLP remain unknown.

This project represents the first part of a comprehensive project to examine the oral pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on Epstein-Barr Virus (EBV).


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years
* Clinical and/or histological diagnosis of erosive or atrophic OLP
* No signs of severe dysplasia at the sampling

Exclusion Criteria:

o immunosuppressive or anti-inflammatory therapies at the inclusion