cyrilzakka/clinical-trials huggingface dataset:
Registry Measuring Impact of RNA Expression Testing on Treatment Decisions in Early Stage Lung Cancer and Assessing the Disease-free Survival With Long-term Follow-up (ONC006)

This registry is intended to measure the effect of myPlan Lung Cancer™ test has on influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC.

The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006). This registry is specific to Oncologists (ONC006).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of early stage non-small cell lung adenocarcinoma
* Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site
* Resection of tumor within previous 2 months of enrollment
* ECOG performance of 0-2
* A minimum life expectancy of six months

Exclusion Criteria

* Previous myPlan Lung Cancer test performed
* Pre-operative radiation or chemotherapy for NSCLC
* Post-operative radiation or chemotherapy for NSCLC
* Enrollment in a separate clinical trial restricting treatment options
* Unable to provide informed consent
Attitudes Towards Buprenorphine and Methadone

Main intention of this study is to find out whether there is a difference between the attitudes towards opioid- substitution of opioid dependent patients under substitution with methadone, buprenorphine or without substitution and their therapists

Attitudes of patients and therapists can influence therapy success in both directions. Not much is known about patients' and their therapists' attitudes towards substitution medication. Our hypothesis is that the attitude towards buprenorphine is more positive than towards methadone even in patients taking methadone. Better knowledge about the influence of attitudes on treatment success could facilitate to adapt therapy to the patients' needs.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Opioid-dependent with substitution with buprenorphine,
* methadone or without substitution
* Sufficient knowledge of German language

Exclusion Criteria:

* Inability to give informed consent
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug

This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed and dated the informed consent.
* Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent.
* Patient agrees to follow-up schedule.
* Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess.
* Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device.

Exclusion Criteria:

* Patient is not medically fit enough for surgery under general or spinal anesthesia.
* Patient is a "mature minor" as defined by Ugandan law.
* Patient is pregnant, breastfeeding or planning further pregnancy during the study period.
* Patient has physical allergies or cultural objections to the receipt of porcine products.
* Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing.
* Patient has spina bifida or other neural tube defect.
* Patient has interstitial cystitis or other chronic pelvic pain syndrome.
* Patient has signs of acute or chronic pelvic inflammation, active urinary tract infection not responsive to antibiotic treatment, vaginal infection, or abscess of the fistula tract.
* Patient presents with clinically diagnosed sepsis (for whatever reason).
* Patient has concomitant ureterovaginal fistula.
A Trial of SHR-1701 in Subjects With Advanced Solid Tumors

This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.

This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed (histologically or cytologically) with solid tumors
* ECOG Performance Status of 0 or 1 at both the screening and baseline visits
* Life expectancy ≥12 weeks
* Adequate laboratory parameters
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent

Exclusion Criteria:

* Known history of hypersensitivity to the study drug
* Prior malignancy active within the previous 2 years
* Any investigational or concurrent cancer therapy
* History of immunodeficiency including seropositivity
* Systemic antibiotics treatment for ≥ 7 days before the first dose
* A known history of allogeneic organ transplantation
Clinical Feasibility of the IMES Transradial Prosthesis

This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis

The study assesses the feasibility of an implantable myoelectric prosthesis control system to control a transradial prosthesis. Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles of three transradial amputee subjects. These devices wirelessly transmit electrical muscle signals to an electromechanical prosthetic wrist and hand.

Following a two-week recovery from implantation of up to 16 IMES into residual forearm muscles, subjects will begin a two week training phase. When they receive their custom-fit IMES Transradial Prosthesis (including electromechanical wrist and hand) subjects initiate approximately four months of home use. Subjects will be offered up to five post-study follow-up visits. The usability and functionality of the prosthetic system will be evaluated throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* (unilateral acquired transradial) amputation
* residual limb size requirements to fit investigational device componentry
* at least 6 residual muscle locations available for implantation
* good compliance with health service (rehabilitation)
* willing to undergo surgical implantation of IMES Sensor implants
* experience with myoelectric upper limb prostheses
* using own myoelectric device approximately 6-8h/day
* able to provide informed consent and attend the study visits

Exclusion Criteria:

* any condition which in the opinion of the investigator poses a risk to health
* neurological disorder that may prohibit accurate control
* major injury proximal to the level of amputation
* neuromuscular disorder
* nerve transection or palsy that may cause de-innervation of muscles planned for implantation
* allergy to implanted materials
* existing active implant
Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant Patients

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant,
* treated with cyclosporine and corticosteroids as primary immunosuppression.

Exclusion Criteria:

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ
* Patients who have received an investigational drug within four weeks prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply.
Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health Network

Pregnant women who live in rural area have fewer prenatal consultations. It has been demonstrated that maternal and neonatal morbidity and mortality increase if time travel to a maternity ward is longer than 30 min.

Home visitation in isolated area may improve prenatal follow-up as it gives full access to women to health care professionals as well as biological and ultrasound exams without travelling.

Our aim is to assess the impact of home visitation on prenatal follow-up as compared to prenatal follow-up in maternity ward and in primary care.

Isolated areas will be randomized, for women living in areas included in the intervention group, home visitations will be planned for prenatal follow-up. Ultrasound screening as well as blood exams will be performed during home visitations. For women living in control areas, they will be free to choose prenatal follow-up modalities.


Eligibility Criteria:
Inclusion Criteria:

* At the first antenatal consultation, confirming the pregnancy.
* Pregnant women who live in an area of geographic vulnerability covered by a perinatal network
* The women must be informed about the study, understand, read, and speak French, and must be able to consent to participate in medical research

Exclusion Criteria:

* Pregnant women who live outside an area of geographic vulnerability covered by a perinatal network
* Women who give birth in a maternity ward outside Auvergne
* Women from another region giving birth in a maternity ward in Auvergne
PICU Patient Diary

The PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use in the PICU, using mixed methods. We will assess the feasibility of assessing the impact of a patient diary on PICU outcomes and psychological distress in critically ill children, 1 month following PICU discharge.

There is considerable need for research dedicated to exploring interventions to improve the psychological and functional effects of critical care admission on patients and families. Patient diaries are one approach that has been used in several adult critical care groups and has been shown to positively impact patient care by helping patients better understand their illness, acting as a therapeutic tool and debriefing aid, and providing an outlet for caregivers to participate in care plans. However, to date, there is minimal research available in the pediatric population.

The specific objectives of this study are to evaluate the acceptability and impressions of a patient diary as a supportive measure for critically ill children in the PICU. Our secondary objective is to evaluate the feasibility of measuring the impact of a patient diary on psychological distress in critically ill children, following discharge from the PICU.

The purpose of this diary is to support the recovery of critically ill children and their family members by:

1. Helping patients understand visually and in written form as age appropriate, what has happened to them during their PICU stay, how ill they were, and in so doing, reduce anxiety and post-traumatic stress symptoms; AND
2. Serving as an engagement tool to help families take on an informed, active role in their child's care plan.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients admitted to the PICU will be screened for eligibility to participate in the evaluation component of the PICU Diary study
* We will offer a PICU Diary to families of any critically ill children admitted to the PICU for at least 72 hours and who are fluent in the English language
* Eligible patients and their families will be approached for consent to participate, by a member of the investigator team (MB, KC, SB or CC). For those who consent to participate, they will be oriented to the diary and its use.

Exclusion Criteria:

* Stay less than 72 hours
* Not fluent in the English language
Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy

The purpose of study is to investigate if yoga exercise improve life quality and immune status in breast cancer patients after complete treatment (including surgery and / or radiotherapy and / or chemotherapy)

It is well-known that exercise promote immune regulation for better life quality. However, the mechanism for better immunity and life quality is not clear. We postulate that Ayurveda yoga might benefit breast cancer women with completion of operation and/or chemotherapy and radiotherapy. The benefits could be due to immune modulation, and improve health perception and life quality, and even potential decrease of cancer relapse.

The study patients will do yoga twice a week for 12 weeks. The study primary endpoints are 1) to improve personal health perception, 2) to improve life quality and 3) to enhance human immunity. The study secondary endpoint will follow up the immunity changes 3 months after the intervention.

We anticipate to reach the primary endpoints and to publish the primary results in one year, the secondary endpoint will complete in the second year.

Eligibility Criteria:
Inclusion Criteria:

* Able to attend yoga program weekly, and fill out inform consent.
* Patients with breast cancer after complete treatment for at least 3 months (including surgery and / or radiotherapy and/or chemotherapy).

Exclusion Criteria:

* male
* overweight
* unable to do yoga exercise.
Study on the Value of Three DWI Scanning Sequences in Staging of Gastric Cancer

Accurate staging is critical for effective gastric cancer treatment planning. Conventional DWI (C-DWI) has limitations in image quality due to magnetic field inhomogeneity, which hampers precise T staging.

This study aims to compare the image quality and T staging accuracy of C-DWI, TSE-DWI, and ZOOMit-DWI (Z-DWI) sequences in MRI examinations of gastric cancer patients.

A prospective study plan to enroll 72 gastric cancer patients undergoing preoperative MRI with C-DWI, TSE-DWI, and Z-DWI sequences using a 3.0 T scanner. Quantitative metrics (ADC, SNR, CNR) and image quality were evaluated. T staging accuracy was assessed by comparing MRI results with postoperative pathological staging using ROC analysis.


Eligibility Criteria:
Inclusion Criteria:

1. The patient was diagnosed with gastric cancer by pathological biopsy
2. No biopsy was taken within 1 week before MR Examination to rule out the effect of bleeding on the image
3. No contraindications for MRI examination; And exclude serious heart, liver, kidney, cerebrovascular diseases.

Exclusion Criteria:

1. The image quality cannot meet the diagnostic criteria;
2. Patients could not tolerate MRI examination, resulting in incomplete MR-related sequence image data.
Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring

This study is a randomized, controlled, prospective trial with a 6-month follow- up. A newly developed psychoeducational treatment and education programme for diabetic patients on an insulin therapy who use flash glucose monitoring (FGM) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are: time-in-range, frequency and duration of hypo- and hyperglycemic episodes, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes self-efficacy, self-care behavior, and hypoglycemia awareness.

The investigators developed a new psychoeducational treatment and education program - called FLASH - for diabetic patients on an intensive insulin therapy who use flash glucose monitoring (FGM).

FLASH is a self-management-based treatment and education program. It is designed to empower patients to adequately use FGM in daily life and to train patients how to analyze their glucose data. FLASH consists of four lessons (90 minutes each).

FLASH is tested in a randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for FGM exists.

This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of FLASH will take place at the respective practice.

Baseline measurement will take place prior to the beginning of FLASH. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of FLASH, follow-up measurements will be conducted at the respective study center.

HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Time-in-range and the frequency and duration of hypo- and hyperglycemic episodes will be assessed via stored glucose data on patients FGM devices. The other secondary outcome measures will be assessed via psychometrically tested questionnaires or via patient files.

Eligibility Criteria:
Inclusion Criteria:

* Intensified insulin therapy / insulin pump therapy
* previous participation in a structured diabetes education program
* HbA1c ≥ 7,5% but ≤ 14%
* Reduction of HbA1c as therapeutic goal
* Indication for using FGM
* Ability to understand, speak and write German language
* informed consent (if necessary, informed consent of the parents)

Exclusion Criteria:

* Diabetes duration \< 1 year
* Type 2 diabetes without insulin or non-intensified insulin therapy
* severe organic disease preventing a regular participation in the training course
* pregnancy
* severe cognitive impairment
* current treatment of psychiatric disorder
* renal disease requiring dialysis
External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain

The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.

Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Opioid addiction.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Drug abuse.
* Pregnancy.
* Severe liver and/or renal failure.
* Uncontrolled hypertension.
* Severe cardiovascular problems.
* Diabetes mellitus.
Post-Market Clinical Follow-up of WOVEX (Wovex® Polyester Vascular Prostheses) Bifurcated Prostheses From LEMAITRE VASCULAR Society in the Treatment of Aneurysms or Occlusive Diseases of the Abdominal Aorta.

The Wovex bifurcated dacron vascular prostheses have been available on the French market since 2008. They are mainly used to treat aneurysmal or occlusive aortic diseases. To date, they have not been the subject of a specific clinical efficacy/safety study, unlike other Dacron prostheses used in the same field.

We purpose a monocentric, retrospective, consecutive study based on medical data, including all the patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between 2013 and 2017 and who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses).

The objective is to explore the safety (short-term postoperative morbidity and mortality at 5 years) and efficacy (primary permeability, secondary permeability and dilatation of the prosthesis at 5 years) of the WOVEX prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is volontarily agree to participation
* Patients operated for aneurysms or occlusive disease of the abdominal aorta at Dijon Bourgogne University Hospital between January, 1st 2013 and December 31, 2017 who received a WOVEX bifurcated prosthesis (Wovex® Polyester Vascular Protheses) from LEMAITRE VASCULAR Society

Exclusion Criteria:

- Deceased patients who have expressed their refusal of post-mortem processing of their personal health data
Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery and Heart Transplant

Pre-habilitation programs that combine physical training, nutritional support and emotional reinforcement have demonstrated efficacy as presurgical optimization strategies in the context of digestive surgery. The experience in patients at risk for cardiac surgery, one of those associated with higher morbidity and mortality, is anecdotal. Main objective: to evaluate the feasibility, efficacy and cost-effectiveness of a pre-habilitation program for the improvement of preoperative functional capacity in high-risk and intermediate risk groups for cardiac surgery and its impact on the reduction of postoperative complications (primary endpoint). Secondary objectives: (i) in-hospital stay; (ii) symptoms, quality of life, (iii) evaluation of information and communication technologies (ICT) as a support for the pre-habilitation, and (iv) design and validation of indicators for a future large-scale implementation of this type of intervention.

Design: Subproject: #1: Prospective study of the efficacy of prehabilitation in heart transplant candidates during the study period. The results will be compared with historical records; #2: Randomized controlled trial with a 1:1 ratio to assess the efficacy of prehabilitation in patients undergoing elective coronary revascularization or valve replacement surgery. Subjects: Subproject #1: 40 patients candidates for heart transplantation. Subproject #2: 80 patients in the prehabilitation group and 80 controls in which a conventional treatment will be performed. Intervention: (i) personalized supervised resistance training, and (ii) program to promote physical activity and healthy lifestyles. The overall duration of the intervention is estimated to be at least 4-6 weeks (variable in each subproject). The support with ICTs will be a significant aspect of the program in which the adaptation of the personal health folder of Catalonia (Cat@SalutLaMevaSalut) will be fundamental.


Eligibility Criteria:
Inclusion Criteria:

* Subproject #1: Heart transplant candidates
* Subproject #2: Patients awaiting for coronary artery bypass or valve surgery with an expected waiting time for surgery of 8-12 weeks

Exclusion Criteria:

* Dynamic left ventricular outflow tract obstruction (\> 40 mmHg)
* Arrythmia induced by exercise
* Emergent surgery
* Unstable cardiac disease
* Unstable severe co-morbid disease
* Disabling orthopedic and neuromuscular disease
* Cognitive impairment
* Refusal to participate in the study