cyrilzakka/clinical-trials huggingface dataset:
Descriptive Study on MRI Contrast of Acute Cerebral Hemorrhage in Different Microangiopathies

Cerebral haemorrhage represents a minority of acute vascular syndromes (less frequent than ischemic stroke, at around 20%), but with a therapeutic impasse, having no specific treatment.

Arterial contrast ("spot sign") within the hematoma has been described in CT scans as a risk factor for further enlargement and poor prognosis.

An equivalent marker has also been described in gadolinium-enhanced MRI.

By studying the radiological appearance of gadolinium "spot signs" on MRI, which has better parenchymal resolution, the researchers propose to retrace the phenomenology of the acute phase of cerebral hemorrhage in order to better estimate the risk of radiological aggravation by subgroup, which could serve as a target population for future therapeutic trials.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute cerebral hematomas from existing databases of cerebral amyloid angiopathy and hypertensive microangiopathy managed at Nîmes University Hospital;
* Patients who have undergone a follow-up cerebral CT scan in the event of worsening or for follow-up.

Exclusion Criteria:

* Patient refusing to participate
Effects of Different Exercise Training Regimens on Visceral Fat Dynamic and Resting Energy Expenditure in Obese Patients

In this project, the investigators will test the hypothesis that predominant (two to three times a week 60 min) strength training is more effective in reducing visceral fat mass than endurance training in obese patients.

Strength training (ST) was shown to be more effective than endurance training (ET) in improving glycemic control in the treatment of type 2 diabetes. However, it is unknown, whether different training strategies have different effects on the preferential visceral adipose tissue reduction and changes in resting energy expenditure in a population with abdominal obesity. We will therefore compare ST and ET (two to three times a week, 60 minutes per training session) in addition to a restricted energy intake of 1500kcal per day for women and 1800kcal per day for men in a prospective study of 200 individuals with abdominal obesity defined by a waist circumference \> 102 cm for males and \> 88 cm for females and a BMI \> 35 kg/m² with regard to:

1. Abdominal visceral adipose tissue area dynamic (MRI studies)
2. Abdominal subcutaneous adipose tissue area dynamic (MRI studies)
3. Total body fat mass changes (bioelectrical impedance analysis)
4. Changes in resting energy expenditure (indirect calorimetry)
5. Changes in parameters of glucose metabolism, insulin sensitivity and lipid profile
6. Changes in circulating adipokines and markers of inflammation In addition, we will search for novel serum parameters, which predict the individual training response by a serum metabolomics/ proteomics approach.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 35 kg/m2
* waist circumference \>102cm (men), \>88cm (women)
* age 18 - 60 years
* written informed consent

Exclusion Criteria:

* type 1 or type 2 diabetes
* fasting plasma glucose \>= 6.0 mmol/l
* 2h-OGTT (oral glucose tolerance test) glucose \>= 11.1 mmol/l
* any chronic inflammatory or malignant disease
* medical treatment which influences glucose metabolism
* drug or alcohol abuse
* psychiatric disorders
* untreated thyroid dysfunction
* cardiac pacemaker or other contraindication for MRI
* attendant therapy with oral antidiabetic medication, GLP-1 mimetics or analoga, Insulin, anti-obesity medication (orlistat, sibutramine), Falithrom, antipsychotic drugs, any chemotherapeutics
* pregnant or nursing women
* expected low compliance
* current participation in another investigational trial
* last exercise training \<= 6 months ago
Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition

The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.


Eligibility Criteria:
Inclusion Criteria:

* WHZ \<-2 but \>-3 without bilateral pedal edema
* Reside within 7 kilometers of study site.

Exclusion Criteria:

* Not permanent resident in vicinity of study site.
* Severe chronic illness such as cerebral palsy.
* History of peanut allergy or anaphylaxis resulting from any food.
* Receiving other supplementary food or participating in other research.
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)

Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis.

Design: Prospective, multicenter, single-arm study with an extended follow-up period.

Sample Size: 204 participants (based on the final number of cases enrolled in the registration trial).

Endpoints:

Primary: Surgical success rate (residual stenosis \<30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively.

Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively.

Inclusion criteria:

All patients participating in this extended follow-up period are sourced from the registered clinical trial.

Ethics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians.

Sponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.

### Detailed Description

This clinical trial evaluates the safety and long-term efficacy of a disposable neurovascular intravascular lithotripsy (IVL) catheter and intravascular lithotripsy treatment device for pre-treatment of calcified lesions in the extracranial segment of the carotid artery. The study is designed as a prospective, multicenter, single-arm trial （extended follow-up period）.

#### Study Population:

All patients participating in this extended follow-up period are sourced from the registered clinical trial.（The registered clinical trial:Participants aged 18-80 years with symptomatic (≥50%) or asymptomatic (≥70%) calcified carotid artery stenosis confirmed by CT angiography (CTA) and digital subtraction angiography (DSA) are eligible. Patients who have failed conventional balloon dilation and are planned for carotid artery stenting (CAS) will be included.）

#### Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. Assessments will include clinical evaluations, imaging studies (CT angiography or carotid ultrasound), and recording of adverse events.

* Endpoints:

  * \*\*Primary Endpoint\*\*: Surgical success rate defined as residual stenosis \<30% after stenting.
  * \*\*Secondary Endpoints\*\*: Target lesion re-narrowing rate, target lesion revascularization rate, MAE (major adverse events) rate, ipsilateral stroke rate, and MACCE (major adverse cardiovascular and cerebrovascular events) rate at 3 and 6 months postoperatively.
* Ethical Considerations:

Informed consent will be obtained from all participants or their legal guardians. The study will be conducted in accordance with the Helsinki Declaration and local regulatory requirements.

Eligibility Criteria:
Inclusion criteria:

All patients participating in this extended follow-up period are sourced from the registered clinical trial.

Exclusion criteria:

none
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)

This study will assess the efficacy, safety, and tolerability of EN3835 compared to placebo in the treatment of PFI (also known as Ledderhose disease).


Eligibility Criteria:
Key Inclusion Criteria:

* Be an ambulatory male or female ≥18 years of age.
* Have a diagnosis of PFI.
* Have current foot pain due to PFI.
* Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol.
* If female, be of non-childbearing potential (history of hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study and for 28 days after any active treatment period.
* Be capable of providing consent, are adequately informed, and understand the nature and risks of the study.

Key Exclusion Criteria:

* Has the presence of non-PFI-related nodules on the foot (for example, neurofibroma, rhabdomyosarcoma, liposarcoma, neurilemmomas, rheumatoid nodules, desmoid tumors, or malignant soft tissue lesions of the foot or ankle).
* Has any musculoskeletal, neuromuscular, neurosensory, other neurological or related disorder that affects the participant's use of his or her foot and/or would impair his/her completion of study assessments as determined by the investigator.
* Has any significant medical history or examination findings related to the participant's plantar nodule(s), which in the investigator's opinion, would make the participant unsuitable for study intervention administration or required assessments and evaluations.
* Has a known bleeding disorder which would make the participant unsuitable for enrollment in the study.
* Has a clinically significant laboratory abnormality.
* Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results or endanger the participant's well-being, or any significant hematological, endocrine, cardiovascular, respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for greater than 1 year and is judged by the investigator not to interfere with participation in the study, the participant may be included, with the documented approval of the medical monitor.
* Has any other significant medical condition(s), which in the investigator's opinion, would make the participant unsuitable for enrollment in the study.
* Is pregnant or plans to become pregnant.
* Is breastfeeding or is providing or plans to provide breast milk in any manner during the study.
Examination of Balance, Vestibular, and Ocular Functions and Activity Following Concussion

Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. However, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in physical and cognitive activities post-concussion may affect recovery. While limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations.

The proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.

To address study hypotheses, the investigators plan to recruit subjects who have been diagnosed with a concussion by participating sports medicine physicians at the Boston Children's Hospital Sports Concussion Clinic. If patients elect to participate, they will undergo their regularly scheduled clinical examination along with two testing components requiring less than 15 minutes of additional time to complete: an instrumented gait balance assessment, a vestibular-ocular motor screen, and a weekly activity survey. Participants with concussion will be matched with control subjects who meet similar demographic characteristics and report to the clinic for other orthopedic injuries that do not affect brain function, gait, or either lower extremity.

During the assessment, participants will complete a protocol which measures balance control while walking and simultaneously completing a cognitive task, a vestibular-ocular motor ability, and physical and cognitive activity levels. As a need exists to develop protocols which utilize inexpensive, objective, and sensitive measurements to track concussion recovery, this study seeks to incorporate innovative and clinically feasible methods into the clinical examination of concussion.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 12 and 40 years
2. No history of concussion in the past year, and no lifetime history of more than 3 concussions
3. Diagnosed with concussion within the past 21 days (concussion group only)

Exclusion Criteria:

1. Lower extremity deficiency or injury, which may affect normal balance or gait
2. History of permanent memory loss
3. Diagnosis of Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), learning disability, Down syndrome, or developmental delay
Evaluating of Role of Myeloperoxidase in Prediction of Outcomes of Cardiac Surgery Procedures.

The main objection is to investigate molecular biology of myocardial damage during cardiac surgery procedures.

To assess outcomes after cardiac surgery procedures. To investigate serum level of myeloperoxidase, morphology of left atrium appendage, to perform genetic analysis and cell biology.

Eligibility Criteria:
Inclusion Criteria:

* ischemic heart disease with indications for operation
* valve disease with indications for operation
* ischemic heart disease combined with valve disease with indications for operation

Exclusion Criteria:

* patient refusal
Lifestyle Modification Intervention in Pre-diabetic Subjects

The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.

The study is a 2-parallel groups' randomized controlled trial. Participants with elevated fasting plasma glucose concentrations (FPG 100-125 mg/dl) or glycated hemoglobin (HbA1C 5.7-6.3%) are enrolled. All study subjects are randomized to receive a lifestyle intervention (intervention group) or regular prevention education (control group). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (3th months, 6th months and 12th months). All participants complete a structured questionnaire, including basic information, disease history, physical activity, food-frequency, stage of change, and social support situation.

Eligibility Criteria:
Inclusion Criteria:

* 40 years old or over
* elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)

Exclusion Criteria:

* having received a diagnosis of diabetes or receiving treatment for diabetes in 3 years
* having a history of cardiovascular disease, stroke, liver disease, kidney disease, cardiopulmonary disease, malignancy or cancer and musculoskeletal impairment
* receiving corticosteroids, androgens, estrogen containing compounds
* who had dietary problem
* pregnant women
* who joined other health intervention study in one year.
Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure

Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.


Eligibility Criteria:
Inclusion Criteria:

* The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study
* Birth gestational age between 27w0d-36w6d
* Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation

Exclusion Criteria:

* Unable to obtain lung ultrasound between 1-2 hours of life
* Infants already intubated or received surfactant before the point of care lung ultrasound
* Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations
* Infants born with chromosomal abnormalities
* Infants with APGARs ≤ 5 at 10 minutes of life
* Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life
A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
* The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory.
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

* Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3,000 cu.mm. Absolute neutrophil count \<1,200 cu.mm; 4. Platelet count \<100,000/L
* History of any other autoimmune rheumatic disease other than Sjogren's syndrome
* No malignancy or history of malignancy.
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
* Patients who have previously received adalimumab therapy for any reason.
* Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
* Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy)
* Willingness and capability to comply with all study tests, procedures, and assessment tools
* Capability of providing informed consent.

Exclusion Criteria:

* History of, or evidence of, gynecologic malignancy within the past five years
* Pace maker, internal defibrilator/cardioconverter
* Impaired coagulation parameters
* Unwillingness to be randomized to treatment
* History of median laparotomy
* Intraabdominal adhesions
* Requirement for open laparoscopy
A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms

The goal of this observational study is to evaluate if Danning Tablets are effective in alleviating dyspepsia in patients with any of the following digestive symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux or constipation.

The main questions it aims to answer are:

How effective are Danning Tablets for patients with indigestion symptoms? What are the impact factors (e.g. severity of conditions, demographic features, dose and length of treatment etc.) of the efficacy of Danning Tablets for indigestion patients?

Participants already taking Danning Tablets as part of their regular medical care for indigestion will take questionnaires by the end of two weeks and four weeks respectively from the start of their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 75 years old
* Patients with at least one of the following symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux or constipation
* Patients already taking Danning Tablets as part of their regular medicine treatment for dyspepsia
* Patients agree to sign the informed consent form

Exclusion Criteria:

* Past history or comorbidity of malignant tumor
* Comorbidity of severe systemic condition including cardiovascular, cerebrovascular, renal and hematopoietic system diseases
* Past history of abdominal surgery (post pancreatic surgery, post subtotal gastrectomy; incomplete intestinal obstruction) or mental illness, mobility difficulty (e.g. long-term bed ridden)
* Comorbidity of any unstable chronic or acute disease,which may impact the evaluation of treatment efficacy as determined by the research physician
* Pregnancy or breastfeeding
* Participation in other clinical trials within the past 3 months
* Other circumstances determined as ineligible by the research physician
Detection of Postoperative Respiratory Depression in High Risk Patients Utilizing Minute Ventilation Monitoring

Respiratory volume monitor (RVM) (ExSpiron) is superior to continuous pulse oximetry in detection of postoperative respiratory depression in high risk patients.

Aims are to: 1) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous pulse oximetry 2) Estimate the incidence of postoperative respiratory depression in high risk patients as detected by continuous respiratory volume monitor (RVM) (ExSpiron) 3) Assess the agreement between the continuous pulse oximetry and continuous respiratory volume monitor (RVM) (ExSpiron) in detection of postoperative respiratory depression in high risk patients

Eligibility Criteria:
Inclusion Criteria:

* Patients who suffered rib fractures or patients who are weaned from mechanical ventilation and recently extubated.

Exclusion Criteria:

* Have known contraindication/allergy to neuroaxial/paravertebral nerve block anesthesia
* Patients allergic to morphine.
* Have an ASA class \> IV