cyrilzakka/clinical-trials huggingface dataset:
Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer

Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of rectal adenocarcinoma;
2. Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);
3. Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
4. R0 surgical results is expected by transabdominal or transanal TME/TSME;
5. 18 \< age (years) \< 71, informed consent;
6. Normal erection function (IIEF-5\>21), ejaculation function grading as I level, FSFI \> 26, normal urinary function (Bladder residual urine\<100ml);
7. Preoperative ASA grade I \~ III, no serious systemic disease;

Exclusion Criteria:

1. Preoperatively confirmed peritoneum or distant metastasis;
2. Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;
3. With other malignant diseases;
4. With acute ileus, perforation or hemorrhage,need emergency surgery;
5. Critical organs dysfunction, unable to tolerate laparoscopic surgery;
6. With severe mental illness, cannot be evaluated;
Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)

Re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. The dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 Gy. The use of unconventional low dose rate pulsed radiotherapy (pLDRT) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. The present study therefore aims at evaluating whether the use of pLDRT in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 Gy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Ability to express appropriate informed consent to treatment;
* Diagnosis of cerebral glioma;
* Histological/radiological confirmation of disease recurrence/relapse;
* Previous brain-level radiation therapy completed a minimum of 6 months;
* Performance status: ECOG=0-2.

Exclusion Criteria:

* Refusal to radiation treatment (i.e., absence of informed consent signed);
* Concomitant chemotherapy;
* Leptomeningeal spread of disease and localization in both cerebral hemispheres;
* Current pregnancy.
A Study of DCC-2701 in Participants With Advanced Solid Tumors

The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.

This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors.

The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy
* The cancer has no proven effective therapy
* The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
* Able to swallow tablets

Exclusion Criteria:

* Have active central nervous system (CNS) metastasis
* Have an active infection of any kind (fungal, viral, or bacterial)
* Are pregnant or breastfeeding
Adiponectin Gene and Coronary Artery Disease

Genetic studies of coronary artery disease, restenosis after angioplasty or stenting, focusing on renin-angiotensin system genes and adiponectin gene, and their interactions.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving angiography

Exclusion Criteria:

* Patients receiving angioplasty and reluctant for the study
Forxiga HF General Drug Use-Results Study

To capture safety when Forxiga is administered to patients with HF in clinical practice after launch.

The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch.

1. ADRs which are unexpected from the precautions for use
2. Understanding of incidence of ADRs during use of Forxiga in the real world setting
3. Factors possibly having an impact on the safety

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 15 years
* Patients who have been prescribed Forxiga for the first time

Exclusion Criteria:

* Patients with a history of hypersensitivity to any ingredients of this drug.
* Patients with severe ketosis, diabetic coma or precoma
* Patients with severe infections, before or after a surgery, or with serious trauma
Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke

The objective of the study is to determine the safely of Human Umbilical Cord Blood mononuclear cells by Intravenous injection in acute ischemic stroke patients.

The study will use Umbilical Cord Blood cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 4 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. Then cells injection by Intravenous in acute ischemic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

1. The age of Subjects between 45 through 80 years.
2. Acute Ischemic Stroke.
3. National Institutes of Health Stroke Scale (NIHSS):6-18
4. Brain MRI shows the middle cerebral artery region (M1 and M2) of cerebral i infarction stroke patients.
5. Subjects have no midline shift or hemorrhagic transformation

Exclusion Criteria:

1. NIHSS score reduced more than 4 within after 24 hours.
2. Female are pregnant or lactating.
3. Subjects with impaired liver function, AIDS, cancer or other significant medical condition (including certifiable diseases, rare disease)
4. Subjects joined other clinical trails or received rt-PA therapy.
5. Immune dysfunction or receiving other immunosuppressive agents.
6. Subjects cannot have MRI test
7. Subjects' HLA typing results match less than 4 out of the 6 genotypes
Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication

Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is the most common clinical feature of PAD.

Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type 5, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication.

For patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment. The experimental drug will be delivered for a 1 month treatment. First follow up visit at month one will focus on tolerance, compliance and eventual side effects. If no major side effect is found the study drug will then be delivered for an additional 2 months. Patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. In parallel focus on tolerance, compliance and eventual side effects will be done. If no major side effect is found, the study drug will be delivered for an additional 3 months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).


Eligibility Criteria:
Inclusion Criteria:

* Grade I cat 2 or 3 claudication despite optimal medical treatment
* Reporting a vascular claudication history for at least 3 months
* Able to achieve a walking treadmill test, Walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes
* Having no cons Sildenafil indication
* Must be on optimal medical therapy (ACE Inhibitors / AT2 Antagonist + Antiplatelet + Lipid Lowering drugs) for at least 1 month

Exclusion Criteria:

* Critical ischemia
* Previous history of myocardial infarction or angina not stabilized
* Amblyopia
* Treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the Sildenafil
* Pregnant woman and woman in labor
* Major Person subject to reinforced protection, deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research
* Being in an exclusion period for another biomedical study
Clinical Status and Bronchial Inflammation in Patients With Bronchiolitis Obliterans

The aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans.

On the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). Further levels of eNO and eCO are determined. A blood sample is drawn to describe the inflammatory status. Bronchial inflammation will be measured in induced sputum. At the second visit, a non-specific bronchial provocation testing (PD20 FEV1 methacholine) is performed.

Objectives:

The aim of this study is the characterization of patients with bronchiolitis obliterans in terms of lung function, bronchial hyperreactivity and the degree of the systemic and bronchial inflammation.

Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. In the conduct of this study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (HRCT) studies of affected patients

Methods and Work Programme:

This study consists of two study visits (V1 and V2)

V1:

* Measurement of nitric oxide in expired air (eNO)
* Measurement of carbon monoxide in the exhaled air (eCO)
* Lung function testing with spirometry and body plethysmography
* Blood test: blood count, CRP, RAST, serum inflammatory mediators, genetic markers of the non-specific pulmonary defense system
* Induced sputum for inflammatory mediators and microbiological investigations

V2:

• Unspecific bronchial provocation test with methacholine (PD20 FEV1 methacholine)

Study population:

Children and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* between 6 and 25 years of age
* Known bronchiolitis obliterans / no bronchiolitis obliterans(depending on the study group)
* Ability to perform lung function tests and inhalation

Exclusion Criteria:

* \<6 and \> 25 years of age on the day of written informed consent
* Acute illness with systemic or bronchial inflammation
* every chronic condition or infection (eg HIV, tuberculosis, malignancy)
* pregnancy
* known alcohol and/ or drug abuse
* Inability to understand the extent and scope of the study
* Participation in another study
MDR - Comprehensive Primary Revision Stems PMCF

The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

The safety of this device will be assessed by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.

The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Eligibility Criteria:
Inclusion Criteria

* Patient must be 18 years of age or older.
* Patient must be willing and able to follow directions.
* Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem

Exclusion Criteria

* Off-label use.
* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
* Patient is unwilling to sign informed consent.
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
Floor Sitting Study

The goal of this clinical trial is to evaluate the impact of different sitting environments on general well-being and movement patterns in healthy young adults aged 18-35. The main questions it aims to answer are:

Does floor sitting lead to increased movement and postural changes compared to chair sitting? Over a month-long period, how does sustained floor sitting influence overall well-being, posture, and movement habits?

Researchers will compare the effects of chair sitting and floor sitting in a controlled lab environment (Aim 1) and observe the longer-term effects of habitual floor sitting in participants natural environments (Aim 2) to see if consistent floor sitting promotes more dynamic movement and comfort.

Participants will:

Undergo two 30-minute experimental sitting sessions, one in a chair and the other on the floor, while engaging in typical desk activities (Aim 1).

Participate in a month-long study where they integrate an hour of floor sitting into their daily routines, recording their experiences and any changes in sitting habits through daily diaries and in-depth interview (Aim 2).


Eligibility Criteria:
Inclusion Criteria:

* age 18-35 years
* English-speaking
* willing and able to complete study procedures.

Exclusion Criteria:

* Any injuries or conditions that would limit participants from sitting on the floor in a safe manner, mental states that would preclude the complete understanding of the protocol and compliance, and prior knowledge of the study hypotheses, as it may potentially influence participant behavior and compromise the integrity of the study.
Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain

The aim of this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain.

Sixty patients with chronic mechanical neck pain were recruited and randomly allocated into stabilization exercise with and without the connective tissue massage program. The study's inclusion criteria were as follows: 18 to 65 years of age, having neck pain for more than 3 months, and being volunteer. The exclusion criteria were as follows: stenosis, traumatic injury history, previous surgery related to cervical spine, hypermobility, cancer, having inflammatory rheumatologic, severe psychological disorders, being pregnant, and intervention including exercise or physical therapy in the last 3 months.The program was carried out for 12 sessions, 3 days/week in 4 weeks. Pain intensity with Visual Analog Scale, pressure pain threshold with digital algometer, the level of anxiety with the Spielberger State Trait Anxiety Inventory, and life quality with Short Form-36 were evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age,
* having neck pain for more than 3 months, and
* being volunteer

Exclusion Criteria:

* Stenosis,
* traumatic injury history,
* previous surgery related to cervical spine,
* hypermobility,
* cancer,
* having inflammatory rheumatologic,
* severe psychological disorders,
* being pregnant, and
* intervention including exercise or physical therapy in the last 3 months
Accessible Mobile Health and Wellness

Can community outreach education help develop self-sustaining wellness and exercise programs, and will associated wellness clinics help persons with a neurological physical disability achieve better well-being?


Eligibility Criteria:
Inclusion Criteria:

* \[for community participants/caregivers/family members\] Ability to demonstrate clear communication and understanding of English.
* \[for participants with neurological physical conditions\] Neurological physical conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis, or similar diagnoses
* \[for educational seminars\] \> 6 years of age.
* \[for wellness/exercise clinic\] 18 65 years of age
* \[for wellness/exercise clinic; participants with neurological physical conditions\] Clearance by primary care or treating physician

Exclusion Criteria:

* \[for participants with neurological physical conditions\] Unstable fractures
* \[for participants with neurological physical conditions\] Uncontrolled hypertension (combined systolic/diastolic \> 140/90 mmHg)
* \[for participants with neurological physical conditions\] Enrollment of individual deemed by study staff to be unsafe
Spontaneous Coronary Artery Dissection anaLysIs of the Brazilian Updated Registry

A retrospective and prospective registry will evaluate demographic and angiographic data in patients with spontaneous coronary artery dissection (SCAD) using medical records, invasive coronary angiography, intravascular imaging and/or computed multislice coronary tomography. The type of treatment applied during index hospitalization (i.e., clinical management, percutaneous coronary intervention or coronary artery bypass grafting) will be evaluated. Long-term follow-up (up to 10 years) will be also reported.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary manifestations due spontaneous coronary artery dissection
* Angiographic findings of SCAD in coronary angiogram or coronary tomography
* Agreement between two or more invasive cardiologists (adjudicated committee) for the diagnosis.

Exclusion Criteria:

* Non-agreement for SCAD diagnosis
* Coronary dissections due other mechanisms: unstable atherosclerotic plaque or trauma-induced.
The Use of Smart Glasses for Environmental Controls

Environmental control systems are a type of assistive technology that can be controlled by a wide variety of different methods (e.g. switches) and can assist people with physical disabilities to control various electronic devices in the home. Communication aids are designed to assist people who have difficulties speaking to communicate. Both systems are designed to provide independence and potentially could have a positive effect on quality of life.

The majority of communication aid and environmental control systems aimed at high end users require a screen to be mounted in front of the user. The limitations with this are that the user is only able to access their device when it has been suitably mounted in front of them. There are occasions when mounting devices in front of the user is difficult due to other considerations for example transfers in and out of a wheelchair. As smart glasses can potentially be worn at all times during the day this could provide an effective alternative solution.

The purpose of this study is to explore with service users the usability and satisfaction provided by smart glasses when operating a communication aid/environmental control system. The study will achieve the above aim by undertaking a satisfaction questionnaire prior and post a 3 week trial of using smart glasses with their device. In addition an interview will be carried out with participants to explore the impact that smart glasses has had on the usability of their device.

Participants will be recruited by contacting eligible patients of the NHS Lothian Environmental Control Service and communication aid service. The end point of the study will be 8 months from the start date (allowing for follow up data to be collected for anyone recruited towards the end of the 6-month recruitment period).


Eligibility Criteria:
Inclusion Criteria:

* Existing environmental control system user (age 18-80).
* Neurological condition.
* Cognitive ability to answer the questions and to give consent.
* Current environmental control system is compatible with smart glasses display.

Exclusion Criteria:

* Current environmental control system or communication aid is not compatible with smart glasses display.
* Rapidly deteriorating condition