cyrilzakka/clinical-trials huggingface dataset:
Vibration Intervention to Improve Bone and Muscle in Children With Cerebral Palsy

Cerebral palsy is a group of disorders characterized by lack of coordination in the muscles, loss of movement, and speech disturbances. These disorders are caused by injuries to the brain that occur during fetal development or near the time of birth. The purpose of this study is to determine the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy.

The extent of bone mass built up during childhood and adolescence is the most important determinant of osteoporosis later in life. Some disabled children, such as those with cerebral palsy, are particularly vulnerable to low bone mass accumulation due to decreased mobility and weight-bearing. These children also have poor muscle strength and control, which limits function and contributes to the lack of mechanical stimulation needed to build bone mass. The most common treatment for these children is physical therapy, which is time- and labor-intensive and may not be adequately available to them. Whole body vibration has shown promise as an alternative method for stimulating increases in bone mass and improvements in muscle. The purpose of this study is to evaluate the effects of high frequency, low magnitude vibration on bone and muscle in children with cerebral palsy. This intervention may be useful as a noninvasive, nonpharmacological treatment for low bone mass and poor muscle function in these children.

This study will last 1 year. All participants will visit the hospital 3 times, at study entry and Months 6 and 12. At each visit, height and weight will be measured, muscle strength and balance will be tested, and bones and muscles in the spine and lower leg will be imaged with computed tomography (CT), a special x-ray machine. Participants will be randomly assigned to one of two groups. For this study, all participants will be asked to stand for 10 minutes every day for 1 year. For Group 1, a vibrating platform will be used for the 10-minute standing sessions during the first half of the study but not during the second half of the study. For Group 2, this will be reversed and the vibrating platform will not be used during the first half of the study but will be used during the second half of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebral palsy
* Low vertebral bone density
* Able to stand for 10 minutes with handheld support
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* Surgery, casting, or receipt of botulinum toxin in the 12 months prior to study entry
* Planned surgery, casting, or receipt of botulinum toxin in the 12 months after study entry
* Metal rods or plates in tibia or lumbar spine
* Severe scoliosis (greater than 20 degrees) or bowing of tibia
* Medical condition other than cerebral palsy affecting bone or muscle
* Require corticosteroids or seizure medication (phenytoin)
Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

Iron deficiency anaemia is a common condition among colorectal surgical patient. Untreated anaemia would lead to increase in blood transfusion, surgical complications and mortality. Treatment with oral iron sulphate is poorly tolerated due to side effects. Intravenous iron supplement provides an alternative way to rapidly replace iron deficit during the preoperative period among surgical patients. Evidence is growing for its effect in rising hemoglobin level and reducing blood transfusion, at the same time supporting its safety profile.

The investigators plan for a single-centered, randomized controlled trial to examine the effect of intravenous iron compared to standard care in terms of hemoglobin level/serum ferritin increment, need for blood transfusion, duration of hospital stay, quality of recovery and surgical complication rate, as well as safety profile among colorectal cancer surgical patients in Hong Kong. The investigator propose the following pilot RCT for exploring the effect size and study process in conducting the above-mentioned large-scale RCT.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old with written informed consent
* Anaemia defined as: hemoglobin concentration \< 13g/dL (same cut-off for both male and female patients according to the International consensus statement on the perioperative management of anaemia and iron deﬁciency)2
* Laboratory test confirmed iron deficiency: serum ferritin \<30mcg/L alone or serum ferritin 30-100mcg/L with TSAT \< 20%

Exclusion Criteria:

* Pregnancy or lactation
* Other known causes of anaemia apart from iron deficiency: untreated B12/folate deficiency, hemolytic disease, hemoglobinopathy/thalassemia, chronic renal failure on dialysis
* Presence of iron overload (serum ferritin \> 300g/dL or TSAT \> 50%); known hemochromatosis
* Previous or ongoing iron replacement/use of erythropoietin within 12 weeks before recruitment
* Known hypersensitivity towards iron isomaltoside
* Significant liver function derangement (AST/ALP exceeding three times upper limit of normal range)
* Participation in another ongoing interventional clinical trial(s)
* Patients with less than 3 weeks waiting time to surgery
Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme

Experimental study to assess the efficacy of single embryo transfer (SET) with respect to double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be randomized in two groups


Eligibility Criteria:
Inclusion Criteria:

* patients under their first or second cycle of a synchronous donation
* to have a minimum of 5 available embryos to transfer
* patients who accept transfers of frozen-thawed embryos

Exclusion Criteria:

* medical indications to transfer only one embryo (Turner Syndrome, uterine surgical history, uterine myomas,...)
Stocrin Re-examination Study (0831-028)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 Infected Patient
* Patient Who Is Treated With Stocrin 600 Mg Tablet Within Local Label During The Enrollment Period (A Patient Who Changes The Therapy From Stocrin 200 Mg Capsule To Stocrin 600 Mg Tablet Can Be Eligible.)

Exclusion Criteria:

* Patient Who Has A Contraindication To Stocrin According To The Local Label
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start-II Study

Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients.

Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The proposed research will develop and pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients. The specific aim is to:

Aim: Examine effects of psychological risk factor reduction on smoking outcome. We will conduct a pilot trial in which 62 participants are randomized to the multi-component behavioral treatment (9 weekly sessions) or self-guided treatment (mailing of printed self-help materials).The primary outcome is number of days abstinent for 2 weeks post-quit (range = 0-14 days).

Eligibility Criteria:
Inclusion Criteria:

Eligible participants will be males and females who are:

* Diagnosed with COPD (as documented in electronic health record \[EHR\]),
* Daily cigarette smokers (5 or more cigarettes per day over past 30 days),
* Intend to quit smoking within the next 60 days,
* Report at least moderate level of smoking for affective regulation (SMQ-R coping subscale score 30 or greater),
* Have access to a smart phone, tablet, or computer, and
* Are able to communicate fluently in English

Exclusion Criteria:

* Any concurrent medical or psychiatric condition which would preclude ability to provide informed consent or perform study procedures (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia), as determined by the treating physician or study PI.
Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)

Mastocytosis is a rare condition characterized by an accumulation of mast cell cells in one or more organs such as the liver, bone marrow, spleen and intestines. Its prevalence in the general population is 1 in 10,000.

This pathology is due to the proliferation of a mast cell clone and the excessive release of inflammatory mediators which lead to abnormal tissue infiltration.

To date, there are only a few cases reporting ocular and orbital manifestations of mastocytosis.

Our prospective, interventional and single-center study consist in describing the ocular functional manifestations and ocular surface abnormalities of patients with systemic and cutaneous mastocytosis.

Patient with systemic or cutaneous mastocytosis will be included in the study. Data about organ involvement of mastocytosis will be collected. Participants will be screened with a medical and eye disease history. They will also have an eye exam.

Participants will provide a tears sample.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of mastocytosis
* Male or female, 18 years of age and over
* Ability to understand and provide written informed consent.

Exclusion Criteria:

* Disorders that do not allow good visualization of the posterior pole (cataract, intravitreal hemorrhage)
* Patients with another ocular pathology that may bias the results (corneal dystrophy, dysthyroid orbitopathy, retinal pathologies)
* History of refractive surgery
Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients

This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).

In this prospective study, all the eligible patients will be given Pola-R2 regimen(polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of Pola-R2.

The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.

Eligibility Criteria:
Inclusion Criteria:

* The patient volunteered to participate in the study and signed the Informed Consent
* Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
* Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
* Adequate organ function and adequate bone marrow reserve

Exclusion Criteria:

* Coexisting malignancy other than lymphoma
* Active HBV infection
* Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
Cast Immobilization Versus Percutaneous Pinning for Fracture of Radius in an Elderly Patient

Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.

Background: Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.

Methods: This prospective randomized controlled trial enrolled participants aged over 60 years with AO23-A2 or AO23-A3 distal radius fractures and no contraindications for local anesthesia. The participants were randomly assigned to either the cast immobilization or percutaneous pinning group. Follow-up was conducted for 3 months, during which radiological outcomes and clinical outcomes were assessed. Radiological parameters included radial angulation, while clinical outcomes were evaluated using the Disability of Arm, Shoulder, and Hand (DASH) score, range of motion, and grip strength. Additionally, data on complications and pain levels measured using the Visual Analog Scale (VAS) were collected for the percutaneous pinning group under local anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* aged \>60 years
* primary distal end radius fracture type AO23-A2 or AO23-A3

Exclusion Criteria:

* multiple trauma
* onset \> 2 weeks
* systemic diseases such as RA
* steroid user
* contraindication for LA
Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency

Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.

Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP

Elderly patients with bleeding tendency either secondary;

1. Strict antiplatelet intake
2. Strict anticoagulant intake
3. uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.

Laser prostate surery was introduced to overcome this difficulty. However, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients In the current study patients presented for BPH surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by Holmium laser enucleatiuon of the prostate or Greenlight laser vaporization of the prostate Single surgeon will perform all cases

Eligibility Criteria:
Inclusion Criteria:

* BPH patients candidate for transurethral prostate surgery after failure of medical treatment
* Perioperative uncorrected Blleding tendency

  1. patients with naturally induced uncorrectable bleeding tendency;

     1. platelet count less than 100000/mm3
     2. INR more than 1.5
  2. Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist
  3. Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist

Exclusion Criteria:

* Correctable bleeding tendency
Changhai Multimodal Esophageal Cancer Cohort

The burden of esophageal squamous cell carcinoma (ESCC) in China is substantial, with 85% of the cancers being in the progressive stage. The treatment for advanced ESCC are extremely limited, and immunotherapy, represented by PD-1 inhibitors, has demonstrated a promising application potential. However, the effectiveness of PD-1 inhibitors varies significantly among patients with different types of ESCC, and currently, there is no effective method to predict the response to PD-1 inhibitors. In this study, investigators aim to construct a multimodal deep learning-based model to predict the level of immune infiltration and the efficacy of immunotherapy for ESCC, integrating both pathological image features and clinical information of patients with ESCC, thereby enhancing the level of individualized and precise treatment for ESCC.


Eligibility Criteria:
Inclusion Criteria:

1. Availability of Hematoxylin and Eosin (H\&E) stained images, molecular data obtained through RNA sequencing (RNA-Seq, DNA-seq), and comprehensive clinical information including patient age, gender, history of alcohol consumption, history of smoking, AJCC Tumor, Node, Metastasis Stage, specific location of oesophageal cancer occurrence, and history of reflux.
2. The sample collection is restricted to cancerous tissue, encompassing both primary tumor samples and those from metastatic sites.

Exclusion Criteria:

1. Patients diagnosed with adenosquamous carcinoma or presenting with a combination of other types of oesophageal cancers;
2. Cases involving combined adenocarcinoma affecting the gastroesophageal junction;
3. Individuals with high-grade tumors that have not penetrated the basement membrane, as confirmed by postoperative pathological examination;
4. Subjects in whom postoperative pathology confirms an absence of residual malignant tissue.
The Value of Cardiovascular Imaging in Kawasaki Disease

The goal of this observational study is to assess the cardiovascular injury of Kawasaki disease with multi-modal imaging combined with clinical data.

During their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and genetic tests when hospitalization and follow-up, and the baseline data will be collected at the admission. Some patients will undergo coronary computed tomography angiography (CCTA) or DSA due to the disease progress. All the above examination data and changes will be analyzed to assess the value of cardiovascular imaging in the pathogenesis, diagnosis, and prognosis of Kawasaki disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed based on the American Heart Association guideline for Kawasaki disease.

Exclusion Criteria:

* Patients with a history of congenital heart disease, cardiomyopathy.
* Patients with age over 18 years old.
Allopregnanolone for the Treatment of Traumatic Brain Injury

This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.

This is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive, clinical trial study comparing allopregnanolone to placebo when administered intravenously for 5 days beginning within 8 hours after injury. Test products to be administered are low and high dose allopregnanolone (Products L and H, respectively) and placebo (Product P) intravenous solutions. The products are administered during a 4-day treatment period followed by a 1-day dose de-escalation period. Stage 1 of the study will assess safety and confirm that dosing with Products L and H achieve the target steady-state plasma concentrations set for each of these products. Dosing will be adjusted in Stage 1, if necessary. Stage 2 will initially allocate subjects equally to Products L, H and P but will then use adaptive randomization to allocate subjects between Products L and H to optimized the probability of yielding a better 3-month Glasgow Outcome Score Extended (GOS-E) score.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking person
* Moderate to severe closed or blunt traumatic brain injury \[post resuscitation Glasgow Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12\]
* Less than 8 hours from injury to study initiation
* Able to participate for the full term of the study

Exclusion Criteria:

* Subjects with life expectancy of less than 24 hours
* Isolated epidural hematoma
* Hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment)
* Hypotension (systolic blood pressure ≤90 mm Hg on 2 or more reliable measurements before enrollment)
* Cardiopulmonary arrest prior to randomization
* Spinal cord injury with motor deficits
* Bilateral non-reactive pupils with Glasgow Coma Scale 3
* Body weight \>120 kg
* Pregnancy
* Active breast or reproductive organ cancer
* Allergy to progesterone
* History of thromboembolic events
* Receipt of activated Factor VII before enrollment
* Any disease that is unstable or which could jeopardize the safety of the subject including severe renal impairment (creatinine clearance \<50 ml/min)
* Prisoner/ward of the state
* Known treatment with another investigational drug therapy or procedure within 30 days of injury
Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People

An open-label, one-sequence, multiple administration study for exploration of microRNA and metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean people.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations were eligible to participate in the study. Subjects had to be 65 to 84 years of age.

Exclusion Criteria:

* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator