cyrilzakka/clinical-trials huggingface dataset:
MyGeneMyDiet Trial for Weight Management

The study aims to determine if genotype-based nutrition and lifestyle advice is effective for the management of overweight and obesity among Filipino adults compared to the usual standard of care.

The primary objective of the study is to determine if providing a nutrition and lifestyle advice with genetic information can promote the attainment of 5-10% weight loss, and improvements on body mass index, waist circumference, and body fat percentage among Filipino adults with overweight and obesity. Additionally, changes in dietary intake, eating behaviour, physical activity level, biochemical parameters (HbA1c and blood lipid profile), motivation for weight loss, and knowledge and perceptions on nutrigenomics and genetic testing will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese Filipino adults who signify a willingness to participate in the study
* With BMI equal to 25.0 but not more than 40 kg/m2
* Apparently healthy (fasting blood glucose, lipid profile, and blood pressure within the normal range to pre-disease state)
* Normal thyroid hormone levels in the blood
* Normal blood cortisol level
* Carriers of at least one of the risk alleles of FTO rs9939609, UCP1 rs1800592, and TCF7L2 rs7903146

Exclusion Criteria:

* Elevated levels of fasting blood glucose, blood lipids, and blood pressure
* Elevated levels of thyroid hormones, and cortisol level
* Self-reported/history of heart disease
* Participation in a weight loss program or adherence to restrictive /therapeutic diet in the past 3 month
* Self-reported of recent weight changes greater or less than 3.0 kg
* Planned or recent bariatric surgery
* Consumption of weight-altering medications and/or nutritional supplements that promote weight gain/loss in the past 6 months
* Clinical diagnosis of any mental disorder and current use of any mental health medications
* Pregnant, nursing, or with self-declared intention to become pregnant
* Any health condition that may put the participant at risk
* Current and anticipated enrolment in another research study during the course of the trial
Isocaloric Dietary Restriction vs. Bariatric Surgery for Obesity Treatment

This is a prospective, randomized, two-armed study to assess the efficacy and safety of isocaloric dietary restriction in the treatment of obese without diabetic for a period of 4 weeks.

This is a randomized, open-label, two arms trial. Based on inclusion and exclusion criteria, 72 eligible patients, who are 18-45 years old, with BMI between 35 to 45kg/m2 are assigned to one of two intervention groups: isocaloric dietary restriction; bariatric surgery. Both groups were given a dietary intervention for a period of 4 weeks (in rigorous supervision confined in inpatient department). The main purpose of this study is to clarify the efficacy of isocaloric dietary restriction, compared to bariatric surgery, in losing weight and improving metabolic factors. This is an investigator-initiated study performed by department of endocrinology and metabolic disease, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 45 years old
* 35 ≤ BMI ≤ 45 kg/m2

Exclusion Criteria:

* Obesity induced by other endocrinologic disorders
* Severe gastrointestinal diseases or contraindication for surgery
* History or newly known of diabetes
* Use of hypoglycemic medications, antibiotic in the preceding 2 months, or yogurt within 5 days
* Weight change more than 5% of body weight within the past 3 months
* Severe or unstable cardiovascular, liver or renal diseases or known cancer
* History of drug or alcohol abuse or other substance abuse
* Any mental disorders or current use of antidepressantsPregnancy or lactation or consideration of pregnancy
* Allergies to specific food ingredients in the intervention
Pictou County PEP: A 6-Month, Home-Based, Personal Empowerment Program for Adults With a Chronic Medical Condition Living in Pictou County

The Pictou County Personal Empowerment Program is a comprehensive health promotion program aiming to improve the quality of life as well as both physical and mental health in Adults living with chronic medical conditions. The program includes daily email communications over 6 months that encourage a range of self-management and health promoting activities, including strength and aerobic exercise, yoga, stress reduction techniques, dietary improvements, relationship/intimacy education and more.


Eligibility Criteria:
INCLUSION CRITERIA:

* Age \>18;
* Diagnosed with one or more chronic medical conditions, as per the participant's report, including but not restricted to the following (complete list in protocol appendix):

  * Heart disease / cardiovascular disease / stroke
  * High blood pressure
  * Diabetes including a diagnosis of pre-diabetes
  * Chronic respiratory disease
  * Chronic neurologic disease
  * Chronic kidney disease
  * Chronic liver disease
  * Immunodeficiency
  * Overweight or Obese (BMI \>25)
  * Psychiatric or mental health issue - e.g., depression and anxiety
  * Substance-related and addictive disorders (e.g alcohol, smoking, etc.);
* Resident of Pictou County, Nova Scotia;
* Existing (or willingness to create) email account and willingness to access email daily;
* Ability to follow website links to watch YouTube videos;
* Ability to understand and speak English;
* Ability to participate in low to moderate levels of physical activity and strength training;
* Ability and willingness to fill out an online survey at baseline, and 6, 12 months, and fill in a weekly compliance survey for the six months of the program.

EXCLUSION CRITERIA:

* Diagnosed with cancer in the last 5 years and/or received treatment for cancer in the last 5 years;
* Myocardial infarction or stroke within the last year AND without written approval from their Family Physician, Cardiologist, or Study Physician that they are safe to exercise;
* Unable to access the internet daily during the intervention;
* Lack of access to a computer or smartphone to receive emails required for study intervention.
Split Face Study of the Duration of Local Anesthetics

This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. This study will compare a short-acting anesthetic, lidocaine with epinephrine, to one of two long-acting anesthetics (ropivacaine or bupivacaine). This study will also directly compare the duration of actions of ropivacaine and bupivacaine. The investigators hypothesize that the duration of anesthesia of short-acting anesthetics will not differ significantly from long-acting anesthetics at a single site and there will not be a significant difference between the two long-acting anesthetics at a single site.

This study will compare the relative durations of local anesthetics within the same subject at a highly vascularized anatomic region of skin, the nasal ala. This study will test and compare the relative durations and efficacy of commonly used long acting (ropivacaine or bupivacaine) and short acting local anesthetics (lidocaine with epinephrine), delivered via local anesthesia. This study will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthetic.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Normal skin sensation at both nasal ala assessed by pinprick
* Ability to provide informed consent

Exclusion Criteria:

* Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated
* Pregnant or breastfeeding volunteers (assessed by self-report)
* Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
An Approach to "Move a Little & Often" With Health Conditions

People with long term conditions such as diabetes and arthritis, and who also have depression spend a lot of time sedentary during the day. This is because they face many barriers to being active, such as pain and fatigue. Being sedentary is problematic because it is associated with poorer health in the long term.

Common sedentary behaviours are watching television and using the computer; these behaviours are labelled as screen-based sedentary behaviours. An intervention to reduce these behaviours could improve mental and physical wellbeing. The aim of the study is to explore the acceptability of an intervention to "Move a Little and Often" in people with depression symptoms and long term conditions. The investigators will explore the intervention's acceptability using interviews and will examine if the intervention is associated with a reduction in time spent sedentary. Results will help refine the intervention further.

The feasibility study is part of a PhD project funded by the National Institute of Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRC) Greater Manchester

There is a growing focus in research on the need to reduce sedentary behaviours. Studies have shown that independently of moderate to vigorous physical activity, the amount of time spent sedentary predicts poorer health outcomes. This means that in addition to exercising, it is important to reduce prolonged periods of sedentary behaviours to improve health. For people with depression and long term conditions, milder forms of physical activity may be more appropriate due to higher levels of pain and fatigue resulting from exercise. Reducing sedentary behaviours by substituting them with mild physical activities such as walking is a potential avenue to improve health outcomes in this population group.

To date, no intervention has been developed to reduce prolonged periods of sedentariness in people with depression and long term health conditions within the UK. This feasibility study aims to refine a behaviour change intervention to reduce sedentary time in this population group. The intervention has been developed through reviewing the literature on interventions to increase physical activity (a systematic review), an interview study to explore sedentary and physical activity behaviours within this population group, and through patient and public involvement.

Eligibility Criteria:
Inclusion Criteria:

* be aged ≥18 years,
* self-report a clinical diagnosis of a long term physical health condition;
* score 8 or more on the depression subscale of the Hospital hospital anxiety and depression scales (Zigmond \& Snaith, 1983) suggesting the presence of depression;
* speak English fluently;
* live within Greater Manchester

Exclusion Criteria:

* are not registered with a GP practice,
* in receipt of palliative care,
* report a diagnosis of severe mental health problems such as schizophrenia or bipolar disorder,
* have had a recent bereavement
Fecal Microbiota Transplant for Recurrent Clostridium Difficile Infection

The purpose of this research is to investigate the efficacy of transplanting screened donor fecal material in treating patients with recurrent Clostridium difficile infection. Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema and their response will be evaluated by symptom questionnaire and stool testing for Clostridium difficile at 4 weeks after the treatment.


Eligibility Criteria:
Inclusion Criteria for Recipient:

* Between the age of 18 and 100
* Have positive Clostridium difficile polymerase chain reaction (PCR) or toxin
* Have symptoms of \> 3 watery loose stools a day for at least 2 consecutive days
* Have failed at least one prior standard course of antibiotic therapy.

Examples of standard therapy are:

* Metronidazole 500 mg three times a day for 10 to 14 days
* Vancomycin 125 mg four times a day for 10 to 14 days
* Not be pregnant and have negative urine and/or serum human chorionic gonadotropin (hCG) test
* Not be taking oral or intravenous steroids in the past three months.
* Not on biologic agents, anti-tumor necrosis factor (anti-TNF) agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding 3 months
* Not have profound immunosuppression: Chemotherapy the preceding 3 months, HIV/AIDS, decompensated cirrhosis
* Not be in the Intensive Care Unit
* Not be a transplant recipient

Exclusion Criteria for Recipient:

* Not between the age of 18 and 100
* Does not have positive Clostridium difficile PCR or toxin
* Does not have symptoms of \> 3 watery loose stools a day for at least 2 consecutive days
* Has not failed at least one prior standard course of antibiotic therapy. Examples of standard therapy are:
* Metronidazole 500 mg three times a day for 10 to 14 days
* Vancomycin 125 mg four times a day for 10 to 14 days
* Is pregnant
* Has taken oral or IV steroids in the past three months.
* Has taken biologic agents, anti-TNF agents, cyclosporine, mercaptopurine, azathioprine, methotrexate or chemotherapy in the preceding 3 months
* Has profound immunosuppression: Chemotherapy the preceding 3 months, HIV/AIDS, decompensated cirrhosis
* In the Intensive Care Unit
* Is a transplant recipient
Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy

Postictus hyperglycemia is associated with an accelerated transformation of the ischemic penumbra into an infarct area, with increased infarct size, worse recanalization, reduced cerebral perfusion, increased ischemia reperfusion damage, and worse outcome. Furthermore, when perfusion is reinstated, hyperglycemia causes secondary tissue damage through an increase in ischemic reperfusion damage. Thus, those patients with glycemia values \< 155 mg/dL during mechanical thrombectomy, and especially at the time of reperfusion, will have greater ischemia-reperfusion damage, showing a different profile in miRNA expression, with better neurological and functional outcomes and higher risk of hemorrhagic transformation and cerebral edema.

The main objective of the study is to evaluate the association between glycemia values at the time of reperfusion and stroke recovery at 3 months in patients with acute cerebral infarction treated with mechanical thrombectomy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years of age
* Neuroimaging studies such as computed tomography (CT), angio-CT or angio-MRI compatible with the diagnosis of acute cerebral infarction due to occlusion of a large vessel of the anterior circulation, including the internal carotid artery (intra- or extracranial) or middle cerebral artery (M1 or M2 segments).
* Indication of mechanical thrombectomy according to clinical practice.
* Inclusion of the patient in the study before the endovascular procedure.
* Modified Rankin Scale (mRS) score prior to stroke of 0-1.
* Signature of informed consent.

Exclusion Criteria:

* CT, angio-CT or angio-MRI showing posterior circulation occlusion.
* Severe or life-threatening concomitant disease that precludes follow-up for 3 months after stroke,
* Alcohol or drug abuse
* Participation in a therapeutic clinical trial.
The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection

This double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic HIV infection. The effects of the combination and single AZT therapy on immune function and viral replication will also be evaluated. Study participants will be monitored for evidence of toxicity or intolerance to concurrent AZT / ACV administration and AZT therapy alone.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Early AIDS related complex (ARC).
* Willingness to be followed by the original study center for the duration of the trial (96 weeks).
* Ability to give informed consent.
* Patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
* Fever \> 102 degrees F persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry.
* Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).

Concurrent Medication:

Excluded:

* Acyclovir (ACV) therapy for chronic or recurrent herpes simplex.

Patients with an AIDS-defining indicator disease as outlined by the CDC surveillance definition for AIDS which includes opportunistic infections or neoplasms, HIV neurologic disease, AIDS dementia or the "wasting syndrome" are excluded.

Prior Medication:

Excluded within 4 weeks of study entry:

* Any other experimental therapy.
* Drugs which cause significant bone marrow suppression.
* Rifampin or rifampin derivatives.
* Cytolytic chemotherapy.
* Drugs which cause significant nephrotoxicity or hepatotoxicity.
* Immunomodulating agents, including steroids, interferon, Isoprinosine, immunoglobulin or interleukin 2.
* Excluded within 8 weeks of study entry:
* Antiretroviral agents.
To Evaluate the Efficacy of Mobile Applications in Tailoring and Enhancing Rehabilitation Interventions for Pediatric CP

The world of technology is changing and becoming more advanced. Children with cerebral palsy can benefit from the technology to enhance their mobility, balance, and coordination through mobile applications. A lot of applications are made to offer games and interactive therapy activities that focus on balance, coordination, and motor skills.

They may find these activities entertaining as well as helpful, which makes their rehabilitation more pleasurable. This work builds on previous studies by making a mobile application that may be accessed from any location, giving therapeutic treatments more distribution flexibility. This is especially helpful for those with cerebral palsy who might have mobility issues that make it challenging to consistently attend in-person therapy sessions. Cerebral palsy children can perform organized exercises at home with the help of mobile application made for therapeutic activities and rehabilitation. Therapeutic activities may be customized to meet the unique demands of each patient, guaranteeing that the treatment plan is in line with their capabilities and objectives. Caregiver's involvement in the treatment process is a common element of app created specifically for people with cerebral palsy. This might involve providing tools to enhance home-based care, educating caregivers through resources, and monitoring progress in order to promote a team-based approach to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children with cerebral palsy
* Children aged between 5 to 16 years

Exclusion Criteria:

* Children with unstable epilepsy, chronic heart abnormalities , asthma , anemia and other medical conditions
* undergone botulinum neurotoxin A (BoNT-A)injections or surgery in the previous 2 months or 6 months respectively. "
OctavaColon Cancer Blood Tests OctavaGold and OctavaSilver - Blood Tests for the Help in Diagnosis of Colon Cancer Clinical Study Protocol

The OctavaColon tests are qualitative plasma tests that are indicated to people above 18 years of age suspected with colon abnormality. The blood tests will provide additional information to the doctor in the course of colon cancer diagnosis for both normal population and high risk population

The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -

1. Highly specific (OctavaGold) - provides additional information to doctors during evaluation of normal population.
2. Highly sensitive (OctavaSilver) - provides additional information to doctors during evaluation of high risk population.

The study will be considered successful it can achieve at least one of the following sets of performances -

1. For the OctavaGold - 95% specificity with at least 50% sensitivity.
2. For the OctavaSilver - 95% sensitivity with at least 50% specificity. The biological objective of this study is to find the best set of antigens, that when combined with the appropriate algorithm will support each of the above clinical objectives

Eligibility Criteria:
Inclusion Criteria:

Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery

Exclusion Criteria:

* Subjects less than 18 years of age
* Previous or concurrent synchronous cancers other than previous malignancies of the colon and recovered melanoma
* Autoimmune disorders diagnosed subjects
* Hematological malignancies
* Subjects under active chemotherapy treatment or chemotherapy in the past 6 months
* Steroid treatment in the past 3 months
* Subject undergoing immunosuppressive treatments
* Subject with verified melanoma colon cancer
* Subject with verified sarcoma colon cancer
Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation

Chronic constipation is one of the risk factors of inadequate bowel preparation, which could influence the effect of colonoscopy. The risk factors associated with inadequate bowel preparation in constipated patients remains unclear. Here the investigators investigated the high risk factors which might have influence on bowel preparation quality in a prospective cohort of patients with functional constipation.


Eligibility Criteria:
Inclusion Criteria:

* 18-90
* Patients undergoing colonoscopy;
* Patients meeting the criteria of chronic constipation of Rome Ⅳ;

Exclusion Criteria:

* history of colorectal surgery;
* known of suspected colonic stricture or obstructing tumour;
* ulcerative colitis;
* Crohn's disease;
* irritable bowel syndrome;
* toxic colitis or megacolon;
* known or suspected bowel obstruction or perforation;
* pregnancy or lactation;
* unable to give informed consent;
* haemodynamically unstable.
INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems

It's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (ICD) or ICD with cardiac resynchronization therapy (CRT-D).

The personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups.

All patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals


Eligibility Criteria:
Inclusion Criteria:

* Indication for implantation (new, boxchange, upgrade) of ICD/ CRT-D
* Written informed consent
* Ejection Fraction \<= 35%
* New York Heart Association (NYHA) Class I-III
* Age \>=18 and \<=80 years
* In patient's home environment sufficient infrastructure (analog phone line or sufficient strength of GSM (Global System for Mobile communication) mobile phone network) for running a Merlin@home transmitter is available

Exclusion Criteria:

* Arterio ventricular (AV) Block III / AV Block II Type Mobitz
* Severe renal insufficiency
* Coronary angiology intervention within previous 3 months
* Myocardial infarction within previous month
* Life expectancy \< 1 year
* Expected poor data quality / compliance
* Pregnancy
* Patient is already participating to another study with active therapy arm