cyrilzakka/clinical-trials huggingface dataset:
A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.


Eligibility Criteria:
Inclusion Criteria:

* Complement Factor I (CFI) profile biomarker-positive result
* Women of child bearing potential and men should remain abstinent or use contraceptive methods

Exclusion Criteria:

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
* Previous subfoveal focal laser photocoagulation in study eye
* Laser photocoagulation in the study eye
* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
* Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
* Previous cell-based intraocular treatment in study eye
* Intraocular surgery in study eye
* Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
* History of corneal transplant in study eye
* GA in either eye due to causes other than AMD
* Proliferative diabetic retinopathy in either eye
* Active or history of neovascular (wet) AMD in either eye
* History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
* Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
* Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle
* Previous expression vector mediated intraocular treatments
* Uncontrolled blood pressure and atrial fibrillation
* Medical conditions associated with clinically significant risk for bleeding-
* Predisposition or history of increased risk for infection
* Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (\>/=) 12 months
* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection
* Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment
* Previous participation in other studies of investigational drugs
Study to Evaluate Effectiveness and Tolerability of OROS Hydromorphone for Cancer Pain Treatment in Korean Patients

The purpose of this study is to evaluate the effectiveness and tolerability of Once-Daily OROS ("Osmotic Release Oral System" \[a controlled release oral medication delivery system in the form of a tablet\]) hydromorphone for cancer pain treatment in Korean cancer patients.

This is a prospective (expected to happen), open-label (type of clinical study in which both the researchers and participants know which treatment is being administered), multicenter (conducted at multiple centers), single-arm (only one group), study to evaluate the effectiveness and tolerability (capable to tolerate) of Once-Daily OROS hydromorphone for cancer pain treatment. This is a 14-week study consisting of 2-week efficacy evaluation period (1st evaluation on Day 1 and 2nd evaluation on Days 15±2) and a 12-week extension phase. 99 patients will receive Once-Daily OROS hydromorphone for 2 weeks .After 2 weeks, if a patient has continuous cancer pain and the investigator deems it necessary to administer the same medicine as the study medication then the patient may participate voluntarily in the 12 weeks extension phase. At the extension phase, other continuous-type strong opioid analgesics (painkiller) may be administered at the same time for the adjustment of cancer pain based on the discretion of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Cancer pain and require opioid analgesics
* Average pain intensity measured at the baseline (patient's medical status before any treatment or research is done) for the past 24 hours over Numeric Rating Scale (NRS) is 4
* Never taken continuous-type strong opioid analgesics
* Must be post-menopausal or if pre-menopausal, must use an acceptable method of birth control

Exclusion Criteria:

* Acute digestion related disease, such as dysphagia (difficulty in swallowing), vomiting, no enterokinesia (movements of intestine), intestinal obstruction, acute intestinal stricture (narrowing of a passageway)
* Expected to undergo radioactive treatment (radiation therapy) between Day 1 and Day 15 of study
* Being administered with monoamine oxidase inhibitor (eg, moclobemide, selegiline, toloxatone, etc) or within 2 weeks of administration thereof
Achieving My Potential: A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System

The proposed project is a randomized controlled trial of a telephone-based early childhood developmental care coordination system, in partnership with 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals for developmental evaluation, increasing the numbers of children deemed eligible for services, and increasing the number of children actually receiving interventions.

The trial will enroll 662 children ages 1-3 years who receive well-child care at one of 10 partner clinic sites (belonging to 4 partner clinic systems). The research study team will conduct developmental screening on all children using the Parental Evaluation of Developmental Status (PEDS) Online system, and randomize children 1:1 into intervention (connection to 211LA for developmental care coordination + usual care) or control (usual care alone, with developmental care coordination conducted by clinic staff).

Primary outcomes will include referrals to early intervention evaluations, eligibility for intervention services, and receipt of services. The investigators will measure these outcomes through parent report, medical record review, and 211LA data, at 6 months after enrollment. For children with elevated developmental risk based on the PEDS Online results, the study will assess development using the PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level), conducted at baseline as well as 12 and 24 months after enrollment. For all children, research study team personnel will administer the language subscale of the PEDS:DM-AL at baseline, 12 months and 24 months, to evaluate development over time in the two groups. The investigators will measure behavioral outcomes for all children using the externalizing behavior subscale of the Child Behavior Checklist.

Expected findings include higher rates of referrals, eligibility, and receipt of intervention services among intervention group participants, and greater developmental gains among children in the intervention group. The study will also examine the costs of the program in relation to these outcomes, to estimate the costs and potential long-term benefits of this model. If effective, the model has the potential to disseminate rapidly throughout the 2-1-1 network and transform developmental care coordination in the US.

Eligibility Criteria:
Inclusion Criteria:

* A patient in one of the four partner community clinic systems (ChapCare, Kaiser Permanente LA Medical Center, South Central Family Health Center, and Via Care)
* A patient with an upcoming one- to three-year old well child appointment scheduled
* Child aged 11-42 months

Exclusion Criteria:

* Parent who does not speak English or Spanish
* Child with history of developmental and/or behavioral diagnosis or having been referred to or received developmental and/or behavioral services.
* Child has a sibling already enrolled in the study.
Eecentric Exercise on Cardiopulmonary Fitness and Quality of Life with Chronic Obstructive Pulmonary Disease

This study aims to investigate the effects of elliptical exercise on the six-minute walk test and quality of life in patients with chronic obstructive pulmonary disease (COPD) to identify the most efficient exercise training method.

Background： Chronic respiratory diseases, including COPD, are leading causes of chronic illness and mortality worldwide. However, limitations in ventilation and muscle function restrict COPD patients from engaging in higher-power exercise therapies. Compared to concentric exercise, eccentric exercise can effectively improve health-related fitness and quality of life at lower cardiopulmonary and metabolic loads. Pulmonary rehabilitation programs have been shown to effectively improve symptoms of chronic respiratory diseases, increase exercise capacity, enhance quality of life, delay disease progression, prevent and treat acute exacerbations, and reduce mortality. Therefore, it is hoped that a "safe and effective" eccentric exercise strategy can be designed for COPD patients to comprehensively improve their cardiopulmonary/muscle fitness and quality of life, thereby improving the course of their disease.

Study Design： This is a one-year, single-center, prospective randomized controlled trial. Methods： This study plans to enroll 60 participants who will be randomly assigned to control and experimental groups. The intervention will take place in the pulmonary rehabilitation room on the sixth floor of Fu Jen Hospital. Each group will undergo a functional fitness test and complete a quality of life questionnaire before and after 24 sessions (over 12 weeks) of exercise training.

Effect： It is anticipated that after 24 sessions of elliptical exercise training, there will be an improvement in the functional fitness and in quality of life related to physical activity function.

Key words： Pulmonary rehabilitation; eccentric exercise; chronic obstructive pulmonary disease; cardiopulmonary fitness; functional fitness

Eligibility Criteria:
Inclusion Criteria:

* Having undergone pulmonary rehabilitation for more than 3 months
* Sign the written informed consent form
* FEV1/FVC \< 0.70
* Approval for exercise training granted by a specialist physician's assessment
* Specialist physician's approval for exercise training

Exclusion Criteria:

* Existing of tracheostomy
* Those who use oxygen therapy or ventilator at home
* Severe heart failure (NYHA III-IV)
* Neuromuscular disease
* Acute exacerbation within the past three months
* Those who are unable to cooperate with the cardiopulmonary exercise test
Serious Illness Communication Project

The purpose of the study is to evaluate the impact of implementing a "Serious Illness Conversation Guide" to guide patient/family-clinician discussions and planning about end-of-life care decisions. The goal of the intervention is to improve achievement of patient care priorities and peacefulness at the end of life for patients with serious and life-threatening illness and their families. We hypothesize that patients whose physician is trained to use and adheres to the elements of the Serious Illness Conversation Guide will demonstrate enhanced consistency between documented key priorities and care received, and will experience greater peace in the final month of life; similarly, their families will experience higher satisfaction with care.


Eligibility Criteria:
The subjects of this study will be the clinicians (physicians and nurse practitioners) conducting the SICG conversations, their patient with high-risk cancers, and a friend or family member of the patient.

Clinician Inclusion Criteria:

1. Dana-Farber Cancer Institute medical oncology clinician
2. Care for patients with selected high-risk cancers

Clinician Exclusion Criteria:

1. DFCI Gynecology-Oncology specialist
2. Seeing patients only in the Phase I clinical trial disease center

Patient Inclusion Criteria

1. Over 18 years of age
2. English speaker
3. Patient at Dana-Farber Cancer Institute, including satellite sites at Milford Regional Medical Center and South Shore Hospital
4. Diagnosis of one of the following high mortality or advanced cancers: breast, gastric, intestinal, esophageal, pancreatic, biliary, colorectal, hepatocellular, head and neck, renal, bladder, prostate, acute myeloid lymphoma (AML), acute lymphoblastic lymphoma (ALL), lymphoma, melanoma, glioblastoma multiforme (GBM), sarcoma, and lung.
5. Ability to provide consent

Patient Exclusion Criteria

1. Diagnosis of advanced obstetric-gynecological cancer
2. Cognitive impairment

Family Member Inclusion Criteria

1. Over 18 years of age
2. English speaker
3. Friend or family member of study patient (Health care proxy, or close friend or family member who is involved in helping the patient think about decisions related to their health care)
4. Ability to provide consent
Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease

The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.

Although guidelines exist for immunization of patients with inflammatory bowel disease, few studies exist demonstrating vaccine efficacy in this population. In patients with inflammatory bowel disease, lower than normal humoral responses have been shown with the tetanus toxoid booster, oral cholera, and influenza vaccinations. It is currently uncertain whether women with inflammatory bowel disease (IBD) have an increased risk of cervical dysplasia and cancer. Gardasil, a vaccine against human papilloma viruses (HPV) 6, 11, 16, and 18, has been approved for the prevention of cervical dysplasias and cancers in women ages 9-26 years. However, its immune response in immunocompromised or immunosuppressed patients is unknown.

Young women with inflammatory bowel disease who have not received the HPV vaccine will receive the vaccine. The vaccine is given in 3 doses over 6 months. Response to the vaccine will be measured 6 months after completing the vaccine series.

Eligibility Criteria:
Inclusion Criteria:

1. Women 9-26 years of age
2. Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)

Exclusion Criteria:

1. Pregnancy
2. Taking corticosteroids
3. Allergy to yeast aluminum component of the HPV vaccine
4. Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18
Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.

60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.

The primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male/females aged between 40-80 years
* Previous diagnosis of COPD
* Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids
* Symptoms of increased breathlessness, cough, sputum volume or sputum purulence
* Acute exacerbation of COPD hospitalised within 24hrs of study participation.
* On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
* Known history of cigarette smoking at least 10 pack yrs
* Willing and able to comply with study procedures
* Able to provide written informed consent to participate

Exclusion Criteria:

* Acute exacerbation of COPD within 8 weeks prior to inclusion
* Arterial blood gas on admission \< pH 7.26
* Currently on treatment with mucolytics
* Patients suffering from post nasal drip, or gastro-oesophageal reflux disease
* Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
* On long-term oxygen therapy
* Known or suspected hypersensitivity to erdosteine
Impact of a Mobility Program

After hospitalization, many older adults experience more difficulty getting around in the community and performing one or more of their basic activities of daily living (ADLs) like bathing or dressing. The goals of this study are to test the effectiveness of a mobility intervention, compared to usual care, on change in mobility after hospitalization, to determine the impact on one-year outcomes such as nursing home placement and to identify which Veterans benefit the most from the intervention. Ultimately, the goal is to improve recovery after hospitalization and reduce disability in hospitalized Veterans.

For this high impact study the investigators propose to use a stepped wedge cluster randomization design on five VA hospital wards to compare a mobility program (MP) to usual care (UC) among a cohort of Veterans age 50 years. The investigators will examine pre to post-hospital mobility and adverse outcomes including functional decline, nursing home admission, emergency department (ED) visits, hospitalization and death in the MP and UC groups in the year after hospital discharge. The primary outcome of mobility will be measured by the University of Alabama at Birmingham (UAB) Life-Space Assessment (LSA).10-13 Secondary measures of mobility will include self-reported ability to walk mile and drive a car, as described by Gill, et al.14 The investigators will identify patient specific characteristics that modify the effect of the mobility intervention on post-hospital mobility and adverse outcomes to determine which hospitalized patients are most likely to benefit from this intervention.

Note, Secondary outcome measures were curtailed as the original PI, Dr. Brown, retired.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 years admitted to one of the five hospital wards of the Birmingham VA Medical Center (VAMC) for any medical illness, e.g.:

  * Pneumonia
  * Heart failure
  * Chronic obstructive pulmonary disease (COPD) exacerbation
  * Or other medical (versus surgical) indication for hospitalization
* Patients will be recruited within 48 hours of hospitalization, followed throughout their hospitalization and for one year after hospital discharge.

Exclusion Criteria:

* Patients admitted for brief observation will be excluded, e.g.:

  * 23-hour observation for possible myocardial infarction
  * Additional exclusion criteria will include:
  * Inability to walk across a small room 2 weeks prior to admission
  * Inability to walk safely with assistance, based on a strength and balance screen (see Training of Walkers, below for details)
  * Having a pulmonary embolus, unstable angina or other medical diagnosis deemed by the primary physician to be a contraindication to walking
  * Being on hospice or comfort care
  * Being in a semi-private room with another currently enrolled participant
  * Non-English speaking, blind, or deaf
Probiotics to Treat "Inflammatory Depression"

The main aims of this project are to test if: i) Specific probiotic lactobacilli (added to stabilized ongoing treatment) are efficacious in treating depressive symptoms in individuals with low-grade inflammation, defined using high sensitivity C-reactive protein (hs-CRP) and BMI. ii) This effect is mediated through decrease of inflammation, estimated by treatment-associated changes in blood and faeces biomarkers. Secondary aims are to investigate the relationship between specific depressive symptoms and inflammation and if there is a correlation between certain pro-inflammatory or metabolic markers and depression.


Eligibility Criteria:
Inclusion Criteria:

1. Age, 18-85
2. Depressive episode according to the DSM-V
3. MADRS-M score \>18
4. All subjects will be stable on an antidepressant medication or in Cognitive Behavioural Therapy (CBT) for \>4 weeks
5. Subjects will be willing not to significantly alter their diet during the period of the study
6. A hs-CRP value ≥1mg/L and BMI \>25

Exclusion Criteria:

1. Serious or unstable medical illness that in the investigator's opinion could compromise response to treatment or interpretation of study results.
2. Known or suspected allergy to the study compounds.
3. Ongoing infection.
4. A diagnosis of psychotic disorder, bipolar disorder, personality disorder mental retardation, dementia, or individual whom, due to other causes, lack the ability to make an informed decision.
5. Ongoing ECT.
6. Patients who, in the investigator's judgment, pose a current, serious suicidal.
7. A diagnosis for any Substance Use Disorder (except nicotine or caffeine) in the 3 months prior to the screening visit.
8. Any medications (within 1 week of baseline or during the trial) that might confound the biomarker findings, including: Regular ingestion of NSAIDs or COX-2 inhibitors, or any use of oral steroids, immunosuppressants, interferon, chemotherapy (Patients will be instructed not to take an NSAID, COX-2 inhibitor or Aspirin in the 24 hours prior to a biomarker assessment visit).
9. Antibiotic treatment/consumption within four (4) weeks before baseline visit.
10. Patients who have taken foods or supplements with Probiotics later than two (2) weeks before baseline visit.
11. Active participation in other clinical studies with ongoing study visits.
12. Pregnancy.