cyrilzakka/clinical-trials huggingface dataset:
Aflibercept With and Without Micropulse Laser in Diabetic Macular Edema

prospective study evaluating the impact of subthreshold micropulsed laser on the number of Aflibercept injections when used as an adjuvant therapy in eyes with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* diagnosed with DME with central macular thickness (CMT) more than 250 µm measured by OCT
* best corrected visual acuity (BCVA) between 20/400 and 20/40.

Exclusion Criteria:

* patients with intra-ocular surgery as cataract surgery within 6 months
* prior intravitreal injection of any drug within the preceding 6 months
* panretinal photocoagulation (PRP) within the former 4 months.
* Patients with previous macular laser
* patients with vitreo-macular traction (VMT) syndrome
* severe glaucoma
* other retinal vascular diseases
* conditions that impede the OCT interpretation
Prospective Controlled Study Evaluating Cryocontact Therapy of Infantile Hemangiomas of Preterm Infants

Prospective controlled study evaluating cryocontact therapy of infantile hemangiomas of preterm infants

Principal investigator: Rangmar Goelz, MD Coworkers: M Möhrle, M Moll, HM Häfner, W Schippert, C Meisner, M Röcken, CF Poets

Background Despite their frequent occurrence, there is no established therapeutic procedure for localized infantile hemangioma in preterm infants. A PubMed search with the key words hemangioma, controlled study, infant or childhood revealed five studies (1-5), none of them included preterm infants, even though low birth weight and prematurity have been described as the most significant risk factors

Aim:

To evaluate cryocontact therapy of infantile hemangioma (IH) of 1 - 10 mm diameter in preterm infants \<=34 weeks of gestational age (GA) using a liquid nitrogen cooled metal at the Department of Neonatology at the Tuebingen University Hospital.

Method:

In a prospective controlled study, preterm infants \<= 34 weeks GA with at least 2 IH should be randomized to have one treated with cryocontact therapy using a liquid nitrogen cooled metal (-196°C), while the other one is left untreated. Primary endpoint is an intact skin at the site of the hemangioma at 1 year corrected age . The study starts at August 1st, 2004. Cryocontact is done by 3 trained dermatologist (MM, HMH, WS), outcome documentation, including photodocumentation, by 2 neonatologist (RG, MoMo).

Statistical Analysis: A sample size of 25 intrapersonal pairs of treated and untreated IH is needed to show a significant difference with alpha=0.05 and beta=0.9 between treated IH and controls, assuming that 5% of the treated IH and 40% of the controls have an unsuccessful primary outcome. Documentation will be made on standardized forms and the data will be transferred to Excel. Biometric calculations will be handled with SAS 9.1.3. for Windows using Fisher´s Exact Test for difference in proportions.

Ethics:

The study is approved by the Ethics Committee of Tuebingen University Hospital; all parents must give written informed consent.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants \<=34 weeks GA with hemangioma

Exclusion Criteria:

* no hemangioma
Safety Study of Immune System Modulator for Autoimmune Diseases

The purpose of this study is to determine the toxicity, tolerability and safety of single ascending doses of AX-024.HCl in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / \[Height (m)\]2.
* In good health as determined by medical history, physical examination, and clinical judgment of the investigator
* Subject with no history of autoimmune disease or cardiac disease
* Subjects must be available to complete the study (including follow-up visit).
* Subjects must satisfy a medical examiner about their fitness to participate in the study.
* Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

* A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
* Receipt of regular medication within 21 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator's discretion).
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
* Subjects who are smokers, or ex-smokers who have smoked in the last 3 months (determined by negative urine cotinine at screening visit).
* A clinically significant history of hypersensitivity (anaphylaxis, angioedema) to any drug.
* A clinically significant history of drug or alcohol abuse.
* Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
The Study of Clinical Value of Acute Physiologic and Chronic Health Evaluation (APACHE) Scoring System in Medical Intensive Care Unit

Objective: To evaluate and compare the outcome predictive power of Acute Physiologic and Chronic Health Evaluation (APACHE) Ⅳ、Ⅲ、Ⅱ scoring systems for intensive ill patients in an independent medical intensive care unit (MICU), and explore the best time point when they can most accurately predict outcome.

Design: Retrospective analysis of medical records. Methods and Materials: Collect data of patients admitted between July 2010 and July 2013 to the medical intensive care unit of the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China. Patients with an ICU stay less than 4 hours and age less than 16 years were excluded. Calculate the APACHE Ⅳ、Ⅲ、Ⅱ scores and corresponding predictive mortality risks in the first 24 hours of ICU admission and the 3th, 5th, 7th, 14th, 21 th, 28th day or the day of transferred out of ICU or death. The predictive power of each model was assessed through the ratio of observed death rates and predictive death rates (Standardized mortality ratios, SMR), the calibration of observed and predictive death rates and the discriminative ability between survivors and non-survivors. Hosmer-Lemeshow test was employed for assessing the calibration and the discriminative ability was assessed by the area under the receiver operating curve. Compare the predictive power of the three models at different time points and explore the the best time point when they can most accurately predict outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an ICU stay more than 4 hours and age older than 16 years.

Exclusion Criteria:

* Patients with an ICU stay less than 4 hours and age less than 16 years.
Establishing Video Decision Aids for Geriatric Patients With Frailty to Promote Advance Care Planning

The goal of this observational study aimed to develop and assess a video decision aid for advance care planning in geriatric patients with frailty. The main question it aims to answer is:

The video decision aid comprehensibility, usability, feasibility? The video includes an introduction to geriatric frailty (3 minutes) and advance care planning (5 minutes). Advance care planning includes three levels of medical care: life-prolonging care, limited care, and comfort care.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1 - Patients

  1. Aged 65 or older.
  2. Have not completed an advance directive (AD) document.
  3. Able to communicate in Mandarin or Taiwanese.
  4. Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
  5. Willing to participate in the study after explanation.
* Phase 1 - Family Members

  1. Aged 18 or older.
  2. Have not completed an advance directive (AD) document.
  3. Able to communicate in Mandarin or Taiwanese.
  4. Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
  5. Willing to participate in the study after explanation.
* Phase 1 - Healthcare Providers

  1. Have not completed an advance directive (AD) document.
  2. Able to communicate in Mandarin or Taiwanese.
  3. Willing to participate in the study after explanation.
* Phase 2 - Patients

  1. Aged 65 or older.
  2. Have participated in shared decision-making (SDM) using decision aid tools.
  3. Have experience in advance care planning (ACP) consultation or have completed related written advance directive documents.
  4. Able to communicate in Mandarin or Taiwanese.
  5. Have adequate vision and hearing to watch a video in Mandarin or Taiwanese on a tablet.
  6. Willing to participate in the study after explanation.
* Phase 2 - Healthcare Providers

  1. Have professional knowledge and practical experience in advance care planning (ACP).
  2. Have experience caring for frail elderly populations.
  3. Able to communicate in Mandarin or Taiwanese.
  4. Willing to participate in the study after explanation.

Exclusion Criteria:

1.Cognitive impairment, unable to communicate clearly.
Treadmill Stress Test With and Without Mask

The purpose of this study is to assess if wearing a surgical mask affects the results of a standard treadmill test.

The persons interested to participate will be informed of the implication and potential risks associated with the study. The participants that accept and meet the eligibility criteria will give written consent and be randomized into two groups. One group will first perform a treadmill test with a surgical mask and then repeat the test without a mask. The second group will do the first treadmill test without a mask and the second one with a surgical mask.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-65 years old)
* Healthy
* Vaccinated against COVID-19

Exclusion Criteria:

* Any cardiac or respiratory condition
* Walking difficulty
* Waiting for a stress test for a medical reason
* Abnormal resting ECG
* Inability to wear a mask
* Inability to understand or follow the instructions
* Medical contraindication to performing a treadmill stress test
Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment

This randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. Additionally, investigate the impact of these treatments on health-related quality of life. The investigators selected patients who, after scraping and planing procedures, presented at least 2 teeth meeting the following inclusion criteria: presence of gingival recession without or with a periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile stimulus. and evaporative. Subjects were randomized into 3 groups: Placebo Group (GP) - Placebo Gel application followed by Placebo solution (distilled water); GPG- Placebo Gel application followed by application 5% aqueous glutaraldehyde solution; GSG - Application of 37% phosphoric acid followed by 5% aqueous glutaraldehyde solution. The sensitivity of the dental elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a Visual Analog Scale (VAS). A questionnaire was applied to patients with the objective of capturing psychosocial experiences, prior to treatment and one month after its completion, to assess the impact of desensitizing treatment on health-related quality of life. Data will be collected and appropriate statistical tests will be applied.


Eligibility Criteria:
Inclusion Criteria:

- Presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli.

Exclusion Criteria:

* Systemic diseases;
* Pulpitis;
* Carious lesions;
* Presence of restorations in selected teeth;
* Cracked enamel;
* Noncarious cervical lesions;
* Use of medication with analgesics and/or anti-inflammatories;
* Pregnant or lactating women;
* Desensitizing treatment and periodontal treatment received during three months prior to study recruitment.
Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt

One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19 (Refs. 1-4). Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARSCoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic (Refs. 5-7).

Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID19 convalescent plasma in clinical trials. This guidance provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. This guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma..

laboratory-confirmed patients using qRT-PCR will be enrolled in the study. Eligibility criteria for recipients are ; laboratory-confirmed SARS-CoV-2, Severe or immediately life-threatening. Severe disease defined as one or more of the following; shortness of breath( dyspnoea), respiratory frequency≥ 30/min, blood oxygen saturation ≤93%, a partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300, and lung infiltrates \>50% within 24-48 hours. While a life-threatening disease is defined as one or more of the following; respiratory failure, need for mechanical ventilation, septic shock and multiple organ dysfunction or failure.

Intervention: All patients included in the study provided will be administered with two plasma units (each unit is 200cc).

Primary measure is the degree of clinical improvement among the COVID-19 patients who receive CPT within seven days as compared with the patients who receive after seven days. Case Fatality will be assessed among the enrolled cases

Eligibility Criteria:
Inclusion Criteria:

Laboratory confirmed COVID-19. Severe or immediately life-threatening COVID-19,

Exclusion Criteria Not fitting inclusion criteria
Transcranial Direct Current Stimulation Acute Stroke Walking

16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham.

Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week.

Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks.

The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up \& Go and the 10 meter walking test.


Eligibility Criteria:
Inclusion Criteria:

* First Ever Stroke
* Motor or sensory deficit
* Understands and follows orders
* Signed inform consent

Exclusion Criteria:

• One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program

This study is aimed to investigate whether mobile app-based human coaching program for 6 months is effective for reducing BMI in breast cancer survivors with overweight and obesity.


Eligibility Criteria:
Inclusion Criteria:

1. breast cancer survivors who have completed acute treatment of breast cancer
2. Age: 18 \~ 70 year old
3. stage: I, II, III
4. BMI≥25.0 Kg/m2
5. breast cancer survovrs who can use mobile application program
6. breast cancer survovrs who agree with this study's consent

Exclusion Criteria:

1. Stage IV, carcinoma in situ
2. breast cancer survivors who don't use smartphone
3. breast cancer survivors with previous other malignant disease
4. breast cancer survivors with multiple malignancies
5. breast cancer survivors with uncontrolled chronic comorbid disease
6. breast cancer survovrs who disagree with this study's consent
Validation of a Novel Oxygen Consumption Measurement Technique in Neonates

The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming. Currently, there is no device which measures either oxygen consumption, or another variable that depends on oxygen consumption - resting energy expenditure - in neonates or infants. Our group has developed a new device which can attach to any ventilator and measures these two variables with accuracy in the preclinical setting, including in rodents as small as severely preterm infants. The purpose of this study is to compare measurements of oxygen consumption and energy expenditure in neonates using this device and comparing it with a gold standard which is rarely used, a Douglas bag method in which expired gas is collected and later analyzed.


Eligibility Criteria:
Inclusion criteria.

1. Mechanically ventilated neonates and infants (\<1 year of age).
2. Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital.
3. Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes.
4. Written parental informed consent.

Exclusion criteria.

1. Hemodynamic or respiratory instability.
2. Patients on extracorporeal membrane oxygenation support.
3. Clinically significant tracheo-esophageal fistula
4. Measured endotracheal tube leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
Effect of Quetiapine on Negative Symptoms and Cognition

The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* men and women aged 18 to 65 years with diagnosis of schizophrenia
* score of at least 4 CGI, PANSS negative subscale score \> 21
* fulfil the criterion to be right-handed for inclusion in the fMRI investigations

Exclusion Criteria:

* Substance or alcohol dependence
* female patients who are pregnant, lactating or at risk of pregnancy
* history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions
* risk of suicide or aggressive behaviour
* history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor

For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as:

* existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.
A Geriatric Home Visit Program to Reduce Post-Hip Fracture Complications

The overall goal of the project is to reduce the incidence of post hip fracture morbidity and mortality by conducting geriatric fellow periodic home visits.The assessment will be multidisciplinary and will include assessments of functional status, depression, environmental risks and medical conditions. This group will be compared against a group followed by the usual standard of care post hip fracture.

All patients post hip fracture on the hospital's rehabilitation service that will be discharged to home will be enrolled after obtaining consent. Patients will be randomized into the intervention group and the usual standard of care group.We will be recruiting a total of 100 patients , with equal numbers for each group.All patients will undergo an initial assessment by a Geriatric fellow prior to discharge . The intervention group will be seen at the time of discharge in the hospital and at home at 1, 3, and 6 months post hip fracture. The control group will be seen at the time of discharge in the hospital and then again at 6 months for follow up. The two groups will then be compared for multiple known complications post hip fractures well as mortality.

Eligibility Criteria:
Inclusion Criteria:

* All post hip fracture patients on the hospital's rehabilitation service being discharged to home .

Exclusion Criteria:

* Patients discharged to nursing homes or rehabilitation facilities.
Association Between Cancer and Anti-synthetase Syndrome

Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions.

Idiopathic inflammatory myopathies area heterogeneous group of disease involving mainly muscles, which paraneoplastic feature has been well characterized, specifically in some subgroups such as dermatomyositis. In contrast, antisynthetase syndrome is thought to be rarely associated with cancer. However, clinical observations of the association of those diseases led us to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions, describing the type of cancer observed as well as clinical features of patients and diagnostic work-up leading to the diagnosis of cancer.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* positive antisynthetase antibodies (JO-1,PL12, PL17, EJ, OJ, KS, RS, YRS)

Exclusion Criteria:

* age under 18
* opposition to data collection
* no positive antisynthetase antibodies
* absence of clinical involvment