cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Glucocerebrosidase in Patients With Gaucher Disease

OBJECTIVES:

I. Evaluate the efficacy and toxicity of glucocerebrosidase enzyme therapy in patients with Gaucher disease.

PROTOCOL OUTLINE:

Patients are treated with intravenous glucocerebrosidase every 2 weeks. The dose is based on clinical severity of disease and response to therapy.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Gaucher disease with glucocerebrosidase deficiency confirmed by enzymatic or molecular assay At least 3 organ systems affected, based on the following criteria: Anemia Thrombocytopenia Organomegaly Bone deterioration on radiograph Pulmonary compromise Symptoms compromise daily activities or risk longevity No neurologic disease
The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns

The blinded RCTstudy aims to:

* Determine the effects of HBOT on burns conversion for patients who have fresh thermal burns injury using the LDI.
* Objectively determine the proportion of burns conversion in areas of partial thickness burns for early thermal burns injury in both arms of the RCT.
* Study the effects of HBOT on immunological markers IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α and TGF-β ( comparison between both arms and 2 assessment points).
* Study the effect of HBOT on haematological markers including procalcitonin ,albumin, lymphocyte counts, neutrophil count, and macrophage count.
* Study the effects of HBOT on histology specimens in quantifying P53 protein, leukocyte and macrophage infiltration, burns depth assessment and vascular endothelial growth factor (VEGF) and inducible nitric oxide synthase (iNOS) .
* Study the effects of HBOT on bacteriology of tissue culture in areas of deep dermal burns.


Eligibility Criteria:
Inclusion Criteria:

* Thermal burns injury less than 40% with areas of deep dermal/ full thickness burns.
* Less than 24 hours from time of injury.
* No inhalational injury (Nasoendoscopy and bronchoscopic diagnosis by burns centre medical team/ department of emergency medicine in SGH).
* Age 21 years old and above and less than 60 years old.
* Not intubated and not on inotropic support.
* Understands and agrees to informed consent (approved by IRB SGH).

Exclusion Criteria:

* Untreated pneumothorax
* Medications: Bleomycin, Cis-platin, Doxorubicin, Disulfiram (Chemotherapy)
* Acute uncontrolled medical condition or significant medical condition (eg. Cerebrovascular accident, diabetic ketoacidosis, severe hypertensive 180/ 110 mmHg, end stage renal failure, chest pain, bleeding gastrointestinal tract, coma and acute asthma attack)
* Other surgical emergencies (eg. open fractures, compartment syndrome and acute abdomen)
The ICON Study: Outcomes After FMT for Patients With IBD and CDI

In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or greater
* Confirmed recurrent CDI by positive PCR or EIA toxin test defined at ≥ 2 episodes and vancomycin failure within one year with the most recent being within the past 3 months.
* Confirmed diagnosis of IBD with colonic involvement (ulcerative colitis, Crohn's colitis or ileocolitis or indeterminate colitis) for ≥ 3 months
* Undergoing FMT via colonoscopy for CDI as part of standard medical care

Exclusion Criteria:

* Unable or unwilling to undergo a colonoscopy
* Inpatient status
* Anticipated immediate or upcoming surgery within 30 days
* Need for continued non-anti-CDI antibiotic therapy
* History of total or subtotal proctocolectomy
* Isolated ileal or small bowel disease
* Pregnancy or lactation
* Female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months.
* Patients who are unable to give informed consent
* Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
* Severe food allergy (anaphylaxis or anaphylactoid-like reaction)
* Life expectancy \< 6 months
* Unable to adhere to protocol requirements
* Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from FMT
* Known concurrent HIV, Hepatitis B or C infection
* Concurrent PSC
* Patients with WBC\< 3.0 x109th/L at baseline
* Patients with platelet count \< 100 x109th/L
* Patients with initial elevation of AST or ALT \> 1.5 times above normal limit at baseline
* Non - steroidal anti-inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
* Treatment with vancomycin or metronidazole for more then 60 days prior to enrollment
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study

Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED.

The rationale of this IDEAL study is to provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will be tested in a pilot study first.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients presenting to the ED with suspicion of infection
* Age ≥18 years
* Written Informed Consent obtained

Exclusion Criteria:

* Recent major trauma or surgery
* End stage renal failure requiring dialysis
* Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure
* Patients those source of infection always requires hospital admission or never requires hospital admission.
* Patients who cannot be discharged for other than medical reasons
* Patient participates in any other interventional clinical trial
* Patients with active intravenous drug use
* Pregnant or lactating women
* Patients who are institutionalized by official or judicial order
* Dependents of the sponsor, the CRO, the study site or the investigator
Effect of Suspension Training in the Elderly

This study aimed to analyze the effects of a 12-week suspension exercise training programme on handgrip strength (HG) and anthropometric and bioelectrical impedance parameters in older adults.


Eligibility Criteria:
Inclusion Criteria:

non-hypertensive and not receiving hormonal replacement therapy,

Exclusion Criteria:

performing any regular physical exercise more than once a week over the 6 months preceding the beginning of the study
The Role of Antibiotic Prophylaxis in Lowering Wound Infection Rates Post-Open Repair of Primary Elective Groin Hernias in High-Risk Patients

This study aims to investigate the impact of antibiotic prophylaxis on reducing wound infection rates following open repair of primary elective groin hernias in high-risk patients.

This study will be a randomized controlled trial involving high-risk patients undergoing open repair of primary elective groin hernias. Participants will be randomized into two groups: one receiving antibiotic prophylaxis and the other serving as the control group. The study will assess the incidence of wound infections postoperatively in both groups to determine the effectiveness of antibiotic prophylaxis in lowering infection rates.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study.
* Elderly patients aged over 60 years.
* Patients with Diabetes.
* Or obese patients with a BMI greater than 35.
* Or immunocompromised patients.
* Or American Society of Anesthesiologists (ASA) physical status classification 2 or more, with a history of more than 10 years.

Exclusion Criteria:

* Non-cooperative patients for regular follow-up.
* Therapeutic Indication for.
Prospective Evaluation of Patients With Pleural Effusion

Having a pleural effusion is a common reason for being hospitalized, as it usually requires in-patient care for invasive diagnostic and therapeutic procedures. Specific subtypes of pleural effusion may warrant recurrent admissions, a longer hospital stay and consume more healthcare resources. Despite the recent advancement of pleural medicine, better research is increasingly desired to fill the gaps in establishing an early diagnosis and optimal management of pleural effusion from various causes. Local data on different aspects of pleural effusion is also lacking.

The aetiologies of pleural effusion range from cardio-respiratory diseases, malignancy, infection to systemic inflammatory conditions. However, data on the exact incidence of individual causes of pleural effusion is inadequate. Conflicting results on the aetiologies of pleural effusion were shown in several retrospective and prospective studies based in different geographical regions, which may be explained by the different epidemiology of common diseases in the corresponding areas and patients recruited. Despite a common clinical problem, the incidence and aetiology of pleural effusion have not been examined on a population level in Hong Kong. Therefore, a local study is necessary to inform physicians about the disease burden of pleural effusion.

The management of pleural disease can be heterogeneous, as reflected by a recent multi-institutional questionnaire study in Hong Kong. Infrequent updates of international guidelines of pleural medicine, lack of an established registry reflecting the patient burden, procedure load and complications may contribute. Delayed or suboptimal management of pleural diseases can lead to unnecessary invasive procedures, prolonged hospital stays and even higher mortality rates. A local registry should be established to stocktake and understand diagnostic accuracy and complication rates of pleural procedures and reflects the real-life practice by hospital physicians.

This prospective study aims at evaluating the aetiology and management of pleural diseases prospectively. The management by the attending doctors will not be interfered. Recruited patients will be divided into subgroups based on their characteristics for further analysis. The data collected from this study will guide the planning of subsequent research to overcome the knowledge and service gap in managing pleural diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for pleural effusion.
* Pleural tapping will be performed for pleural fluid analysis.
* Aged 18 years old or above

Exclusion Criteria:

- Failed to obtain informed consent due to the patient's refusal or cognitive impairment
Effects of Sublingual Immunotherapy on Grasspollen Allergy

The objective of the study is to document the objective immunological effects of SLIT on the nasal mucosa. Better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic reaction, with objective parameters, in the nasal tissues showing it to be a true etiological treatment of allergy.

Double blind placebo controlled evaluation of the immunological effects (decrease of IgE specific cells and the decrease of Th2 mediator release, respectively increase of Th1 mediator release) of SLIT on the nasal mucosal tissue of adult humans with severe rhinocunjunctivitis due to grass pollen allergy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older.
2. Patients known in general practice with documented clinical history of grass pollen allergy with moderate disease intensity as retrospectively derived from the use of symptomatic allergy medication during the previous grass pollen season, i.e. regular use of cromoglycates as nasal spray and/or eye drops, and/or regular use of anti histamine tablets or sprays and/or limited use of local acting or systemically administered corticosteroids.
3. Positive (ARTU) grass pollen specific skin prick test (despite negative RAST).

Exclusion Criteria:

1. Clinical history of severe asthmatic symptoms requiring inhalant therapy with daily pulmonary steroids during at least 3 months a year.
2. Symptomatic perennial allergic rhinitis. Meaning perennial allergy is allowed if the allergen is not present in patients' daily life (especially one month prior to provocation) and if they have no apparent symptoms of this perennial allergy.
3. Other seasonal allergic rhinitis are not allowed unless it is asymptomatic during the period of provocation.
4. The intention to subject the patient to surgery of the nasal cavity in the course of the study.
5. Previous immunotherapy.
6. Negative (ARTU) grass pollen specific skin prick test (despite positive RAST).
7. Contraindications to sublingual immunotherapy, i.e.:

   * Malignancies and serious disorders of the oral cavity
   * History of status asthmaticus and anaphylactic shock
   * Aggressively developing asthmatic symptoms
   * Serious chronic inflammations, chronic disorders associated with fever, particularly of the bronchial tubes
   * Irreversible, secondary changes in reactive organs (emphysema, bronchiectasis)
   * Auto immune diseases and immunodeficiency
   * Concurrent therapy involving immunosuppressives
   * Systemic and collagen diseases
   * Tuberculosis of the lung and tuberculosis
   * Serious psychological disorders
   * Documented hypersensitivity to glycerol
   * Pregnancy
   * Serious cardiovascular disease
   * Usage of b -blockers
Nurse Managed Sequential Strength Training and Bicycle Training in Chronic Obstructive Pulmonary Disease (COPD)

This is a 16 week exercise training program for people with severe to very severe chronic obstructive pulmonary disease (COPD). The purpose of this study is to find out if performing strength training prior to initiating exercise training on a stationary bicycle is associated with greater gains in functional status than bicycle training alone or concurrent bicycle and strength training together.

Volunteers are randomly assigned to one of three groups: 1). 8 weeks of resistance (strength) training followed by 8 weeks of bicycle exercise training, 2). 8 weeks of chair exercise followed by 8 weeks of resistance (strength) training and bicycle exercise training, or 3). 8 weeks of chair exercise followed by 8 weeks of bicycle exercise training. The length of the training is 16 weeks for all 3 groups. Volunteers train 3 days per week in our lab located in the Chicagoland area and are supervised by an exercise specialist.

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC \< 70 and FEV1 \< 55%,
* \> 45 years of age,
* experience dyspnea with exertion,
* stable clinical condition (Stable clinical condition is defined as free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy.)

Exclusion Criteria:

* evidence of restrictive lung disease or asthma,
* acute respiratory infection,
* taking oral corticosteroids on a regular basis,
* \>3 exacerbations in the previous year,
* currently participating in pulmonary rehabilitation,
* the presence of a potentially debilitating disease or the presence of a condition that would make it potentially unsafe to exercise.
* We will adhere to the American College of Sports Medicine guidelines and exclude those who do not meet their guidelines for exercise testing and training.
* Pregnant women or women who plan to become pregnant during the study.
Whipples Resection in Octogenarians

Whipples resection is an operation that has a burden of high morbidity and mortality. It is performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when curative surgery has been performed. Short and long term outcomes however, have improved recently and the indications for curative resection have been increasingly extended, including operating on those that previously may have been considered too old to benefit from curative resection.

Little is known about the benefit of performing this procedure in the oldest patients. Performing Whipples resection in patients over the age of 70 has been reported and has been shown to result in satisfactory perioperative results with comparable long term outcomes to those under 70. However the benefit of performing the same procedure in the over 80 age group is less well reported and consistently presents a challenging decision for the clinician.

Whipples resection is an operation that has a burden of high morbidity and mortality. It is performed for a variety of disorders of the pancreas, duodenum and ampulla. The most common indication is pancreatic ductal adenocarcinoma which has a poor long term outcome even when curative surgery has been performed. Short and long term outcomes however, have improved recently and the indications for curative resection have been increasingly extended, including operating on those that previously may have been considered too old to benefit from curative resection.

Little is known about the benefit of performing this procedure in the oldest patients. Performing Whipples resection in patients over the age of 70 has been reported and has been shown to result in satisfactory perioperative results with comparable long term outcomes to those under 70. However the benefit of performing the same procedure in the over 80 age group is less well reported and consistently presents a challenging decision for the clinician.

This study therefore aims to assess the short and long term outcomes of patients undergoing Whipples PD in the over 80 age group in Lothian. This will be combined with data from all the other units in Scotland that perform Whipples resection (Dundee, Glasgow and Aberdeen)

The primary outcome will be overall and disease free survival.

Participants will be identified by using procedure specific codes to identify those patients who underwent Whipples pancreaticoduodenectomy from the ORSOS prospectively collated theatre record database. The other centres in Scotland will identify their subjects via their own methodology.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing Whipples PD from 1998-2018 in Scotland

Exclusion Criteria:

* incorrectly coded as Whipples resection
* Underwent non curative bypass procedures.
Short-term Effects Kinesiotaping (KT) on Balance and Gait in Parkinson's Disease (DP)

To analyze the short-term effect of kinesiotaping in balance and gait on Parkinson's disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage III PD, according to the Hoehn and Yahr scale.
* Subjects who are in the age range of 50 to 80 years.
* Acceptance of informed consent.
* Not present a musculoskeletal disorder or other neurological disease that interferes with balance and / or walking.
* Not having a diagnosed vestibular disorder.

Exclusion Criteria:

* Diagnosis of parkinsonism o Parkison-Like.
* Taking medications that may interfere with the different variables evaluated.
* Allergy to any component of the bandage.
* Being a pacemaker.
Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design

"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).

The "PrEPare for Work" package includes two behavioral intervention components:

1. Strengths-based case management for PrEP initiation, and
2. Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use.

Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.

Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Biological male at birth and current male gender identity
* Exchanged sex for money or drugs with another man in the past 3 months
* Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
* HIV uninfected by antibody test\* Stage 2
* Able to understand and speak English (for consent and counseling)
* Mental competency to provide voluntary informed consent
* Lives in the New England area
* Willing to initiate PrEP

Exclusion Criteria:

* Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
* HIV Positive at baseline
* Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate \< 50) \*Stage 2
* History of or current medical conditions that would preclude taking Truvada for PrEP \*Stage 2
* Currently taking Truvada for PrEP
Effects of Community Health Programs by Nurses for Older Adults

As the aging population increases, preventing and decreasing disabilities become a critical issue for the health care system. Previous researches have shown that preventive community-based nursing services for older adults could achieve important health benefits at a relatively low cost. However, many frail and pre-frail older adults living in communities cannot get enough attention from current health care system. The role and function of nurses should be expanded to provide more comprehensive family-oriented care to improve health outcomes of older adults in Taiwan. The objectives of this study are:

1. Understand the difficulties and solutions for nurses providing community-based services in order to expand their better role and function.
2. Develop a cultural sensitive community advanced nurse service model for Taiwan in health care system.
3. Explore the effectiveness of community health programs by nurses for frail or pre-frail older adults in community.

Focus groups and literature review will be used to achieve the first and second study objectives. A single centre randomized controlled trial will be used in this study to achieve the third study objective. Two hundred and twenty people aged 65 and over who meet the Fried definition of frailty and pre-frailty will be recruited from the clinic of a hospital. Participants will be followed for a 6-month period. Frailty, quality of life, satisfaction to the services, hospitalizations and admissions to nursing care facilities will be measured and compared between experimental group and control group. This research is an important step in the examination of a new approach to the community older people by nurses. The study results will provide the evidence data to recommendation for related policy making in the future.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and above, frail and pre-frail older adults, living in communities

Exclusion Criteria:

* Cognitive impairment.