cyrilzakka/clinical-trials huggingface dataset:
Integrative Nutrition Care Plan for the Patient With Liver and Colorectal Cancer

At present, the families of cancer patients are lack knowledge and experience of nutritional care after discharge. As a result, cancer patients often suffer from low nutritional status after being discharged from the hospital.

This study intends to design a home nutrition care plan to explore the effect of a home nutrition care plan on the nutritional status of patients with liver cancer and colorectal cancer at risk of malnutrition. Malnutrition or side effects often lead to natural food intake for patients. It is not enough to meet the nutritional requirements, so it is matched with dietary products to help patients more easily meet their nutritional requirements. Supplements are used to alleviate patients' side effects. It is hoped that they can help patients improve their nutritional status.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with liver cancer or colorectal cancer stage I to III
2. Not suffering from other carcinomas in situ at the same time
3. Will undergo surgery or non-surgical cancer treatment
4. Can move, read and answer questions by itself
5. At least one social support (family or friend) to assist and support the patient to complete the trial
6. According to the aPG-SGA, the assessment score is between 4 \~ 9
7. The patient or caregiver can cooperate with the dietitian to track and answer related questions asked by the dietitian in a remote way through communication software or telephone every week.
8. Able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist
9. Be able to cooperate with doctors and the beginning of the study and monthly return visits and blood tests for health insurance items

Exclusion Criteria:

1. Perform organ transplantation or palliative care
2. Hepatic encephalopathy
3. History of cardiovascular and cerebrovascular diseases
4. Severe organ failure of the heart, breathing, or kidneys
5. History of digestive tract inflammation or ulcer
6. Severe mental illness
7. An active infectious diseases
8. Those who can only use intravenous nutrition and cannot use enteral nutrition
9. People who are allergic to product ingredients (milk, soy, or mango and their products)
10. Unwilling to cooperate with dietitians to make dietary adjustments or supplement nutrition and supplements
11. Unwilling to actively treat cancer
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease

This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 or older
2. Multivessel coronary artery disease patients requiring coronary intervention

   * Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization
   * Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm
3. Capable of understanding the risks and benefits of participating in the study and providing informed consent

Exclusion Criteria:

1. Incapable of voluntarily providing informed consent
2. Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
3. Cardiogenic shock or cardiac arrest patients
4. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
5. Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
6. Patients with severe valvular heart disease requiring open heart surgery
7. Pregnant or lactating women
Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning.

The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD.

The specific aim of this study is to determine whether acute calcitriol (vitaminD) administration (compared to placebo) enhances the neurocognitive effects of of current stimulant medications as measured by tasks of vigilance/attention, spatial working memory, and reversal learning in individuals with (attention deficit hyperactivity disorder (ADHD) using a randomized, double-blind, placebo controlled, within-subject, two-day study design.

Primary Hypothesis: It is hypothesized that calcitriol (versus placebo) administration will enhance positive neurocognitive effects of current stimulant medications in individuals with ADHD.

Secondary (Exploratory) Hypothesis: It is hypothesized that calcitriol (versus placebo) administration alone will also enhance neurocognitive performance on tasks of attention/vigilance and/or spatial working memory.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years
* Voluntary, written, informed consent
* Physically healthy by medical and psychiatric history
* DSM-5 diagnosis of ADHD
* Point of Care Test results for Vitamin D equal or higher than 20 ng/ml
* English speaking

Exclusion Criteria:

* Medical contraindication to calcitriol administration (e.g., history of hypersensitivity to calcitriol or any component of the formulation, hypercalcemia or vitamin D toxicity)
* History of substance dependence (e.g., alcohol, opiates, sedative hypnotics), except for nicotine
* A primary major DSM-V psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-V (SCID), except ADHD
* A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness
* Current use of psychotropic and/or potentially psychoactive prescription medications, except prescribed stimulants
* Use of any prescription medications and/or over-the-counter medications, vitamins (including vitamin D) and/or herbal supplements which could have a negative clinical interaction with calcitriol or which could confound scientific results of the study, within 2 weeks prior to each test day (e.g., thiazide diuretics, Mg based antiacids, digoxin, etc,).
* Levels of 25(OH)D3 below 20 ng/ml .
* History of kidney stones within the past 5 years
* History of renal failure
* History of parathyroid disorder (hyper or hypoparathyroidism)
* History of osteoporosis or any pathologic fractures
* Vitamin D supplementation in any form in the past 3 months
* Known hypersensitivity to calcitriol
* Malabsorption syndromes (i.e. Celiac sprue)
Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.

* The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.
* The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.
* Follow up for pain levels will be done during the first week.
* clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.
* Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.
* The 3 materials will be compared in terms of clinical and radiographic outcomes.
* demographic data of the three groups will be also compared
* predictive factors of success will be also analyzed
* tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Mature permanent tooth with carious lesion exposing the pulp,
* Positive response to cold test
* Clinical Diagnosis of reversible or irreversible pulpitis
* Restorable tooth by direct restoration or crown
* Healthy patient

Exclusion Criteria:

* Non vital teeth
* Teeth without pulp exposure
* Inability to achieve hemostasis within 10 min after pulpotomy
* Non restorable teeth or teeth that require post and core restoration
Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes

Subjects that participate in the practical workshop will improve their quality of life and will stay longer in remmision , in compare to the participants that will continue their regular threatment

Participants will be randomly assigned to a regular threatment (control group) or to a lifestyle changing workshop. The workshop will consist of 11 meetings with behavioral lessons in nutrition, cooking, stress realese and physical activity. The study population will include 100 crohn's disease patients in remmision that will be recruited and will be randomly divided into two groups: an intervention group of 50 will commence the workshop during 2007 and a control group of 50 who will continue their regular threatment. an IBDQ , CDAI and blood samples for metabolic index will be taken from the participant in the staudy before entering the study and every half a year for three years.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* diagnosed with CD
* Crohn's Disease Activity Index (CDAI) of under 170
* a minimum of 75% of the meetings

Exclusion Criteria:

* patients with a stoma
* and patients with a planned admission to the hospital for surgery or other treatment.
An Adult Spasticity Registry of OnabotulinumtoxinA Treatment

This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with onabotulinumtoxinA according to the decision of the physician for spasticity
* Willingness to complete study questionnaires and answer study questions by phone or internet

Exclusion Criteria:

* Concurrent participation in a clinical trial for spasticity
Measurement of Viscoelastic Properties of Bronchopulmonary Secretions.

The study is experimental and aims to (a) compare the viscoelastic properties of bronchial secretions obtained in patients suffering from obstructive respiratory disease, and (b) to compare the viscoelastic properties of bronchial secretions obtained in patients before and after application of a respiratory physiotherapy or exercise as usually prescribed.

After agreement, the sputum of the participants will be collected according to the method used in clinical routine.Experiments (collection and analysis of sputum) will be conducted at the Saint-Luc University Clinic.


Eligibility Criteria:
Inclusion Criteria:

* obstructive pulmonary disease

Exclusion Criteria:

* none
Pedometer Intervention and Health Effects for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy

Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity.

There is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. However, the most frequently studied diagnosis group is women with breast cancer. Until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy

The purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy.

The hypothesis of the study are: 1. That both interventions will show a positive association between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy.

Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week).

Benefits and risks of participating: Possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. At participation in the interventions minor sports injuries may occur.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with colorectal cancer in adjuvant chemotherapy
* Age 18+ years
* WHO performance status of 0 or 1
* Undergone surgery at least 6 weeks ago
* Do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week.

Exclusion Criteria:

* Myocardial infarction within the past six months
* Symptomatic heart failure
* Known angina pectoris
* Contraindication for moderate to strenuous physical activity
Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study

This longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Age, sex, education-level matched healthy controls will also be enrolled. The initial scan will performed within 7 days post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1 month, 3 month, 6-12 months.


Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Score of 13-15;
* one or more of the following: loss of consciousness (if present) \< 30 min, post-traumatic amnesia (if present) \< 24 h, and/or other transient neurological abnormalities such as focal signs, seizure, and intracranial lesion not requiring surgery.
* no contraindications to MRI;
* injury within 7 days;
* agreement to communicate by telephone or e-mail for 1, 3 to 6-12 months after enrollment and come back to the hospital for follow-up

Exclusion Criteria:

* history of neurological disease
* head injury, or history of substance or alcohol abuse, intubation and/or presence of a skull fracture
* administration of sedatives on arrival in the emergency department
* spinal cord injury, manifestation of mild TBI due to other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury.
Xarelto on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study

This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.

3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation
* Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator's routine treatment practice

Exclusion Criteria:

* NA
EPISPOT Detection of Circulating Prostate Cells Among Adenocarcinoma Patients

The primary objective of this study is to evaluate the predictive value (in terms of remission) of a new technique for detecting circulating, functional, prostate cells among patients with localized adenocarcinoma of the prostate, and prior to any treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Histologically proven presence of prostate adenocarcinoma
* Localized disease on digital rectal examination
* Cancer without extensions
* Acceptance of a curative treatment by the patient

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is taking a hormone-modifying treatment
* Patient taking adrogenic supplements
Recombinant Human Bone Morphogenetic Protein-2(rhBMP-2) in Patients With Osteoporosis After Lumbar Fusion

rhBMP-2 has been used to promote spinal fusion. Despite potential risk of complications, satisfied results could be obtained with low dose of rhBMP-2. Effect of early bone formation has been validated using rat ovariectomy osteoporosis model. However, whether it functioned in patients with osteoporosis remained unknown. In this study, the investigators intend to investigate whether rhBMP-2 promotes early bone formation in patients with osteoporosis after transforaminal lumbar interbody fusion (TLIF).

Pseudoarthrosis and many complications associated with iliac crest bone graft (ICBG) has prompted the spine surgeons to seek alternative methods to promote rate of spinal fusion. The rhBMP-2 received FDA approval in 2002 for use as an alternative to autograft for single-level anterior lumbar interbody fusion (ALIF). Many studies reported equivalent or better fusion rates. Recent studies, however, identified complications related to rhBMP-2 use such as osteolysis, graft subsidence, and retrograde ejaculation and other urological complications. Overdose of rhBMP-2 in patients may lead to complications mentioned above. A recent randomized controlled trial in 2022 confirmed a low dose usage of rhBMP-2 promoted fusion after TLIF (21.mg per fusion level) without increase in complications.

Current fusion methods achieve interbody fusion by filling the cage in the central region of the intervertebral space with bone graft material. However, the early fusion rates (at 3 and 6 months postoperatively) are often unsatisfactory. According to present literatures, the 3-month and 6-month fusion rates have ranged from 2.9% to 43.1% and 30% to 68.8%, respectively. Although a lack of fusion may be asymptomatic, it may potentially lead to complications, even a reoperation. In addition, failure to achieve early fusion may result in a delayed return to work, and reduced patient satisfaction, especially in patients with osteoporosis. Whether rhBMP-2 may lead to higher and early fusion rate in osteoporosis patient remains unknown.

In this study, the investigators intend to compare the time it takes to achieve osseous union/fusion and the clinical efficacy of using rhBMP-2 to control group in TLIF. The rhBMP-2 in the study is produced by a domestic enterprise (HANGZHOU JIUYUAN GENE ENGINEERING CO .,LTD., Hangzhou, China).

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with degenerative lumbar diseases.
* patients underwent one-level TLIF
* osteoporosis (DXA T≤-2.5)
* complete preoperative and follow-up data (imaging and health-related quality of life)

Exclusion Criteria:

* history of previous spinal surgery
* inflammatory and neoplastic diseases
PoC Study of OBE022 in Threatened Preterm Labour

This is a proof-of-concept study in 2 parts.

In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks.

Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks.

All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.


Eligibility Criteria:
Key Inclusion Criteria:

Part A

* Pregnant females aged ≥ 18 years
* Patients with a singleton or twin pregnancy
* Gestational age between 28 0/7 and 33 6/7
* Administered or prescribed atosiban for the treatment of preterm labour

Part B

* Pregnant females aged ≥ 18 years
* Patients with a singleton or twin pregnancy
* Gestational age between 24 0/7 and 33 6/7
* Administered or prescribed atosiban for the treatment of preterm labour
* ≥4 uterine contractions per 30 minutes
* Cervical dilatation of 1 to 4 cm inclusive
* At least one of the following signs of preterm labour:

  1. positive IGFBP-1 or fœtal Fibronectin test
  2. cervical length ≤ 25mm
  3. progressive cervical change

Key Exclusion Criteria:

* Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days
* Oligohydramnios
* Known pathological Doppler ultrasound of the umbilical artery
* Any contraindications for the mother or the fœtus to stop labour or prolong pregnancy or any maternal or fœtal conditions likely to indicate iatrogenic delivery in the next 7 days, including but not limited to:

  1. Premature rupture of membranes
  2. Evidence or suspicion of abruptio placenta
  3. Signs and/or symptoms of chorio-amnionitis
  4. Pre-eclampsia, eclampsia or HELLP-syndrome
* Use of cervical cerclage in the current pregnancy or a pessary in situ
* Current use of anti-hypertensive medication
* Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions