cyrilzakka/clinical-trials huggingface dataset:
Adherence to Lifestyle Changes for Age-related Macular Degeneration

The AMD-Life study investigates which strategies (personalized risk-profiling including genetic testing and/or coaching) motivate AMD patients to change their lifestyle.

Age-related macular degeneration is a frequent eye disease in the elderly affecting the center of retina, i.e., the macula. Despite current treatments for the wet form of this disease, it is still the most frequent cause of blindness in the Western world. The disease is the result of the interplay between genetic and environmental factors such as smoking, unhealthy diet, and lack of physical activity. The current clinical recommendations are aimed towards these lifestyle factors: a healthy diet, no smoking, regular physical exercise, and use of antioxidant supplementation. Although assumed to be low by clinicians as they feel patients find it difficult to actually alter their lifestyle, the adherence and feasibility to these recommendations in clinical ophthalmology practice is unclear. Individualizing the patients' risk of blindness and lifestyle changes, as well as coaching may positively influence adherence strategies. This pilot study aims to gain knowledge and experience in a relatively small study comparing adherence to these strategies through a healthier lifestyle. Additionally, the trial investigates blood and gut microbiome biomarkers: which molecules in blood directly relate to the supplemented nutrients as well as those related to the pathogenesis of AMD, and which biomarkers in blood and eye best correlate with supplement intake and lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Early/Intermediate AMD or unilateral late AMD with minimal vision 0.8

Exclusion Criteria:

* Participation in other intervention studies for AMD
* Living in retirement homes (difficulty in implementation of diet)
* Diagnosis of dementia (because of unreliable dietary recall)
* Persons with macular pathology other than AMD hindering appropriate grading of the macula
* Persons who are illiterate and have no independent trusted person with them to explain the informed consent form.
* Persons diagnosed with liver and kidney insufficiency.
Clinical Study of Pediatric Acute Liver Failure

The goal of this observational study is to understand the etiology, prognosis and influencing factors of acute liver failure in children, evaluate the predictive value of children's SOFA score, PELD score and LIU score for the short-term mortality rate of children's liver failure and the infection of children's acute liver failure; analyze the bleeding and kidney damage of children's acute liver failure, and evaluate the quality of life of children's acute liver failure.

PALF is a seriously life-threatening acute disease with a rapid onset, rapid progression and high mortality rate. Especially under the influence of multiple organ dysfunction syndrome (MODS) or other serious complications, clinical prognosis evaluation and treatment decision-making face great challenges.It aims to accurately evaluate the survival probability or liver transplantation needs of patients based on clinical data and biological indicators, and deeply reveal the impact of different factors on the prognosis of PALF from the perspective of etiology, treatment mode (such as mechanical ventilation and plasma replacement) and complications (such as MODS and its score), so as to provide a scientific basis for identifying high-risk groups, optimizing personalized treatment strategies and early diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* （1) The age is less than 18 years old; (2) Acute onset (≤8 weeks), no liver disease basis in the past; (3) Biochemical evidence of severe liver injury ; (4) Coagulation dysfunction that cannot be corrected by vitamin K: prothrombin time (PT) ≥15s or international standardized ratio (INR) ≥1.5, and accompanied by hepatic encephalopathy at the same time; or meet any of PT≥20s, INR≥2.0, may not be accompanied by hepatic encephalopathy; (5) Provide complete clinical data and treatment records. (6) Agree to participate in this study and obtain informed consent.

Exclusion Criteria:(1) Multiple organ failure caused by non-hepatic diseases; (2) Missing data or incomplete follow-up information.

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Optimal Fluid Resuscitation for Trauma Patients

The purpose of this study is to determine if the overall fluid requirements for the first 24 hours after admission will be reduced with Hextend versus a standard of care crystalloid resuscitation fluid.

Following severe multi-system traumatic injury, the first 24 hours of standard resuscitation fluid will be either Hextend or crystalloid depending upon attending preference. No tests or interventions will be performed for research purposes.

Data will be collected prospectively from patient medical records and attending clinicians to monitor fluid requirements, hemodynamics and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years old and less than 65 years old
* Admission with multi-system traumatic injury
* Admission to the intensive care unit

Exclusion Criteria:

* Less than 18 or greater than 65 years old
* Pregnant or lactating
* No fluid resuscitation
Autologous Cytokine-induced Killer Cell Adoptive Immunotherapy for Acute Myeloid Leukemia and Myelodysplastic Syndrome

A phase I/II study to explore the feasibility and efficacy of autologous CIK cells in patients with acute myeloid leukemia (AML)/ high grade myelodysplastic syndrome (MDS)

1. Group 1: As adjuvant therapy in minimal residual disease state after autologous PBSCT.
2. Group 2: As an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable

This is a Phase I /II study on the feasibility / efficacy of adoptive immunotherapy with autologous CIK cells for the following 2 groups of patients who have AML or high grade MDS :

1. Group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant ( PBSCT ), and
2. Group 2 patients with untreated high grade MDS or AML, who are not fit for standard curative intent chemotherapy.

The CIK cells will be generated by leukapheresis from patients and cultured in GMP facilities. Four repeated infusions will be given for a target dose of 1x10e10 T cell per infusion.

Efficacy will be assessed by

1. Disease free survival compared to historical control in group 1 given CIK cells post autologous PBSCT as adjuvant immunotherapy (n=20 over 3 years), and
2. Effect on the peripheral or marrow leukemia cell load in group 2 patients given CIK cells as alternative therapy in place of chemotherapy (n=10).

Eligibility Criteria:
Inclusion Criteria:

1. For Group 1: AML or MDS post autologous peripheral blood or marrow stem cell transplant.
2. For Group 2: High grade MDS ( RAEB or RAEBIT ) or AML, whom the haematologist in charge has assessed and deemed unfit for chemotherapy with curative intent.Patients must have fairly stable white cell count requiring only low dose or no myelosuppressive medication
3. Patients must understand the trial nature of this treatment and accept the possible absence of benefit.

Exclusion Criteria:

1. uncontrolled infection
2. life expectancy less than 6 weeks.
3. Contraindication to undergo one session of leukapheresis for PBMNC harvesting
FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department

Non-Profit Prospective Observational Pilot Study

The study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval.

In this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department will be considered. A registry will be created with the patients\&#39; data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy.

This observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the Emergency Department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.


Eligibility Criteria:
Inclusion Criteria:

All adult patients who access the Emergency Department with a diagnosis of aspiration pneumonia and for whom the referring physician determines the need for aspiration of secretions or ingesta. Patients must have at least one of the following criteria

* Radiological evidence of pneumonia (Chest X-ray/CT scan/Chest ultrasound)
* Clinical diagnosis of aspiration pneumonia
* Presence of secretions in the upper airways
* Respiratory distress in a dysphagic patient
* Need for oxygen therapy or need to increase FiO2 in patients already on home oxygen therapy

Exclusion Criteria:

* Lack of consent
* Age \&amp;lt; 18 years
* Pregnancy
* Hemorrhagic diathesis
* Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
* Severe airway obstruction
Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition

This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.

This study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.

Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. Caregivers in the monthly visit group will receive additional instruction at admission regarding home-based MUAC measurement and clinical surveillance.

Regardless of intervention assignment, all children with uncomplicated SAM will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. Additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.

Eligibility Criteria:
Inclusion Criteria:

* age from 6 to 59 months
* MUAC \< 115 mm and/or grade 1-2 edema
* Absence of current illness requiring inpatient care

Exclusion Criteria:

* History of allergy to peanuts
* Any other condition in which, in the judgment of the Field Investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent
Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution


Eligibility Criteria:
Inclusion Criteria:

* subject is a habitual wearer of a silicone hydrogel or group IV contact lens
* VA correctable to 0.3 LogMar or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings
Speech Motor Learning and Retention (Master Protocol)

The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well.

Aim 1 involves tests of speech motor memory retention following disruption of left hemisphere brain activity in either auditory, somatosensory or motor cortex or to a control site (hand area motor cortex right hemisphere). Continuous theta-burst stimulation (cTBS) is delivered following adaptation to altered auditory feedback to assess its effects on the retention of new learning.

Aim 2 assesses the temporal order in which plasticity occurs in cortical motor and sensory brain areas during speech motor learning.

In Aim 3, resting-state fMRI will be interleaved with speech motor adaptation. For information specific to each aim, please refer to the below corresponding, separate, clinicaltrials.gov records: unique IDs: 2000037622_a for Aim 1, 2000037622_b for Aim 2 and 2000037622_c for Aim 3.

Eligibility Criteria:
Inclusion Criteria:

* Fluent English speakers
* Right-handed
* Normal hearing
* No speech disorder or reading disability

Exclusion Criteria:

* Cardiac pacemaker
* Aneurysm clip
* Heart or Vascular clip
* Prosthetic valve
* Metal implants
* Metal in brain, skull, or spinal cord
* Implanted neurostimulator
* Medication infusion device
* Cochlear implant or tinnitus (ringing in ears)
* Personal and/or family history of epilepsy or other neurological disorders or history of head concussion
* Psychoactive medications
* Pregnancy
Enhanced Cognitive Rehabilitation to Treat Comorbid TBI and PTSD

This study will test a modification of Cognitive Processing Therapy (CPT) for Post-Traumatic Stress Disorder, (PTSD) in which CPT is augmented with compensatory cognitive rehabilitation principles from the Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) intervention to create a hybrid treatment, SMART-CPT. This study investigates the efficacy of SMART-CPT in improving PTSD and post-concussive symptoms, cognition, quality of life, and treatment compliance in those with a history of mild to moderate TBI and persistent cognitive complaints.


Eligibility Criteria:
Inclusion Criteria:

1) OEF/OIF veteran; 2) Current diagnosis of PTSD; 3) History of mild-to-moderate TBI; 4) Subjective cognitive complaints; 5) No anticipated/pending medication changes; 6) Written informed consent to participate in the study. -

Exclusion Criteria:1) Active substance dependence, 2) Suicidal intent or attempt within the previous month; 3) Current psychotic disorder; 4) Dementia; 5) Non-English speaking; 6) Participation in other intervention studies.

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Exercise: Improving Compliance and Long-term Weight Loss

The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program. Participants are randomized to one of three groups: in-class yoga, yoga by digital video disk (DVD), stretching by DVD. Changes in weight loss and stress levels are monitored.

The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program. The 6-month study includes a 3-month randomized, controlled trial using in-person yoga, a yoga DVD, and a stretching DVD (control group) followed by a 3-month post-intervention follow-up. The study will be conducted to test the hypotheses that both in-person yoga classes and DVD yoga participation will result in 1) greater compliance with the Profile program, 2) greater weight loss during the yoga intervention, and 3) greater weight loss 3 months following completion of the intervention compared to the stretching intervention. Compliance will be investigated using percent of days that dietary intake was entered online and percent of days that online records indicate that the program was followed. Changes in weight will be measured using data transmitted from electronic scales that are provided as part of the Profile program. In order to assess weight change after participation in the intervention we will ask participants to continue weighing themselves daily for 3 months following completion of the intervention regardless of whether they completed the Profile program or not. Participants will complete online questionnaires on behavioral and appetite perceptions related to eating, food intake, stress levels, compliance with diet recommendations given to them by Sanford Profile, and perceived benefits of their intervention. We will use these measures to determine the effect of yoga participation on eating behaviors and stress levels.

Eligibility Criteria:
Inclusion Criteria:

* Must be participants in the Sanford Profile Program (weight loss program)

Exclusion Criteria:

* Must have physician approval if answers yes to Physical Activity Readiness Questionnaire (PARQ) questions
Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements

The aim of this study is to investigate the amino acid kinetics in blood after a bout of strength training and ingestion of different milk protein supplements (native whey, whey protein concentrate 80, hydrolysed whey, microparticulated whey and milk) The investigators hypothesize that native whey will give a faster and higher rise in blood concentrations of leucine compared to the other milk protein supplements.

Increasing or maintaining muscle mass is of great importance for populations ranging from athletes to patients and elderly. Resistance exercise and protein ingestion are two of the most potent stimulators of muscle protein synthesis. Both the physical characteristic of proteins (e.g. different digestion rates of whey and casein) and the amino acid composition, affects the potential of a certain protein to stimulate muscle protein synthesis. Given its superior ability to rapidly increase blood leucine concentrations to high levels, whey is often considered the most potent protein source to stimulate muscle protein synthesis. Native whey protein is produced by filtration of unprocessed milk. Consequently, native whey has different characteristics than WPC-80, which is exposed to heating and acidification. Because of the direct filtration of unprocessed milk, native whey is a more intact protein compared with WPC-80. Of special interest is the higher amounts of leucine in native whey.

The aim of this double-blinded randomized 5-arm cross-over study is to compare amino acid kinetics in blood after a bout of strength training and ingestion of 20 grams of high quality, but distinct, dairy protein supplements (native whey, whey protein concentrate 80, hydrolysed whey, microparticulated whey and milk). Furthermore, the investigators investigate whether differences in amino acid kinetics affect acute blood glucose and urea response, as well as recovery of muscle function after a bout of strength training.

The investigators hypothesize that native whey will give a faster and higher rise in blood concentrations of leucine compared to the other protein supplements.

Eligibility Criteria:
Inclusion Criteria:

* Healthy in the sense that they can conduct training and testing
* Able to understand Norwegian language written and oral

Exclusion Criteria:

* Diseases or injuries contraindicating participation
* Use of dietary supplements (e.g. proteins, vitamins and creatine)
* Lactose intolerance
* Allergy to milk
* Allergy towards local anesthetics (xylocain)
The Combination of Sitagliptin and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of Sitagliptin and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 120 adults with steroid-resistant/relapse ITP in China. Patients were randomized to Sitagliptin plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia; Platelet count of less than 30×109/L at enrollment; Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation; 18 years older;

Exclusion Criteria:

Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus) Congestive heart failure Severe arrhythmia Nursing or pregnant women Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria Creatinine or serum bilirubin levels each 1•5 times or more than the normal range Active or previous malignancy Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
Safety and Efficacy of Simultaneous or Staged Surgery on Complicated Hepatolithiasis

For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed.

For some complicated hepatolithiasis, it is difficult to decide whether to perform surgery on biliary stone and portal hypertension simultaneously or separately by staged surgery.There's a high risk of intraoperative bleeding, postoperative liver failure and variceal bleeding for these patients.How to develop a optimized algorism of simultaneous and staged surgery is highly needed. In this protocol, we will assign the eligible cases into two group. And then perform surgery as simultaneously or separately.By long-term follow-up,to examine the safety and advantages of each procedure.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 years old
* Without gender restriction
* With a favorable liver function of Child-Pugh A to B
* No contraindications to surgery and anesthesia
* Diagnosed with Hepatolithiasis and portal hypertension
* Signed informed consent.

Exclusion Criteria:

* Diffused type of Hepatolithiasis
* Impairment in liver function
* Severe disorders in vital organ
* Accompanied with tumors.