cyrilzakka/clinical-trials huggingface dataset:
Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome

The investigators have hypothesized that dietary flavonoids reduce insulin resistance and subclinical inflammation secondary to reductions in intestinal inflammation and permeability and that these events are mediated through alterations in gut microbiota composition. To test this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53% en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6 weeks each in a randomized cross-over design with endpoints determined in duplicate during the last week of each diet period.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 35 kg/m2

Exclusion Criteria:

* Documented presence of atherosclerotic disease;
* Diabetes mellitus
* Uncontrolled hypertension
* Renal, hepatic, endocrine, gastrointestinal or other systemic disease
* For women, pregnancy, breast feeding or postpartum \< 6 months
* History of drug or alcohol abuse
* History of depression or mental illness requiring hospitalization within the last 12 months
* Use of antibiotics within the last 6 months
* Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
* Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
* Lifestyle or schedule incompatible with the study protocol
* Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol.
Investigating Hereditary Cardiac Disease by Reprogramming Skin Cells to Heart Muscle

Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. Due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in detail and therefore in many cases remain untreatable. The investigators propose to study heart cell electrical function from such patients by reprogramming skin cells to become stem cells and then differentiating them to heart muscle cells.

The hypothesis of the study is that the differentiated cardiac cells will display electrical abnormalities dependent on the mutation causing the disease. These abnormalities can therefore provide a clue as to the nature of the mutation causing the disease or information about its effective management


Eligibility Criteria:
Inclusion Criteria:

* Clinical features of Brugada Syndrome (ECG findings)
* mutation positive or mutation negative
* Idiopathic ventricular fibrillation

Exclusion Criteria:

* not able to give informed consent
* Age less than 18 years
* clinical diagnosis ambiguous
Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.

The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK data, the clinical trial has been designed to include a pharmacodynamic read-out by incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or electromyographic (EMG) activity.

Part 3, 4 and 5: Phase 1, randomised, multi part study to evaluate the safety, tolerability, PK, relative bioavailability and food effect of single and multiple ascending doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment with Itraconazole.

Part 1 will study safety, tolerability, PK of single ascending doses (SAD) of XPF-008 as well as the impact and variability of single ascending doses of XPF-008 on TMS.

Part 2 will study the safety, tolerability and PK of multiple ascending doses (MAD) of XPF-008

Part 3 will explore dose proportionality of XPF-010 and confirm dosing for subsequent cohorts, and the food effect and relative bioavailability of XPF-010 compared to XPF-008.

Part 4 will explore multiple dose PK.

Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.50 and 30.00 kg/m2
* Must agree to use effective methods of contraception, if applicable
* Able to swallow capsules
* Able to provide written, personally signed and dated informed consent form (ICF)

Key Exclusion Criteria:

* Any history of epileptic seizures
* Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
* Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale
* Mental incapacity or lingual barriers precluding adequate understanding, cooperation, and compliance with the study
* No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end
* No smoking 60 days prior to dosing to study end
* No soft drugs 3 months prior to Screening and hard drugs 2 years prior to Screening
Strengthening Maternal Neonatal and Child Health Services in a Rural District of Pakistan

The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a dismal pictures and after the floods of 2010-2011 the health infrastructure of this district was badly affected. Aga Khan University Pakistan is intending to implement a service delivery project for the improvement of Maternal Neonatal and Child health situation through evidence based MNCH interventions.

The Aga Khan University is implementing together with its local partners a MNCH project in five Union Councils (UC) in Dadu District in Sindh Province. The project will scale up the already existing health services for MNCH in the district referral hospital and the five Basic Health Units (BHUs), one in each UC. Institutional based services as well as their scope for outreach to pregnant women, mothers and children in the communities with the aim to promote safe deliveries as per WHO guidelines and Government policy will be enhanced. In order to deliver quality services, the facilities will be renovated and equipped and the capacity of the existing staff will be strengthened through different training courses in MNCH. In addition professionally trained Lady Health Visitors will be introduced in the BHUs, who will conduct all maternal services including deliveries in the BHU and the communities. The health staff is furthermore responsible to establish and facilitate community support groups and raise communal awareness for the importance of mother and child health care as well as safe deliveries with skilled attendants. Operational research is an integral part of this pilot project. The research validates the progress and improvement of maternal and child health indicators. The results will be used to lobby the scale up of MNCH interventions with the Ministry of Health in Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Be a resident of target areas and consent to participate in the study

Exclusion Criteria:

* Do not fulfill the residence and consent criteria
Study of DS-5141b in Patients With Duchenne Muscular Dystrophy

This is a phase I/II study to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD) amenable to exon 45 skipping and to determine the dosage for subsequent studies.


Eligibility Criteria:
Inclusion Criteria:

* Confirmation of out-of-frame deletion(s) that could be corrected by dystrophin gene exon 45 skipping.
* Intact muscles of adequate quality for biopsy to allow evaluation of the efficacy of the study drug.
* Boys aged from 5 years to \<11 years.
* Patients able to walk at least 325 meters in the 6-minutes walk test.
* Glucocorticoid-naive patients, or patients who have used glucocorticoids for at least 6 months prior to enrollment in this study with no dose changes for at least 3 months prior to enrollment.

Exclusion Criteria:

* A genetic mutation that can not be expected the expression of dystrophin protein by dystrophin gene exon 45 skipping.
* A concurrent illness other than DMD that can cause muscle weakness and/or impairment of motor function.
* Current or history of severe disorder.
* Left ventricular ejection fraction (LEVF) \<55%.
* Corrected QT interval (QTc) \>0.45 sec.
Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients

This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks


Eligibility Criteria:
1. Inclusion Criteria:

1. Patients who show positive HBsAg
2. Patients who show positive or negative HBeAg

2. Exclusion Criteria:

1. Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
2. Patients with a history of allergic reaction to Tenofovir
3. Patients who are unable to participate in clinical trials based on investigator's decision.
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer with presence of bone metastases
* Pain score over 4 on the VAS

Exclusion Criteria:

* Patients with pathological fractures or medulla compression or neuropathic pain
* Patients with infection or corticosteroid treatment
* Pregnant or lactating patients
Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.

Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a single center, prospective, randomized trial to be held in the ICU of " Universitarian hospital La Fe" in collaboration with the service of Neurophysiology of the hospital. All patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the Methodology section will be included in the study. The intervention will consist of a muscular electrostimulation with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. We will evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel scale and Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. The process of extubation will be performed following an established protocol, the duration will be collected as the same manner as ICU.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Sedated and mechanically ventilated critically ill patients, more than 48 hours.

Exclusion Criteria:

* Body mass index \> 45 or \< 20 kg/m2.
* Pregnant.
* Epilepsia.
* Use muscular blocks.
Continued Early Intervention for Recent-onset Schizophrenia

The purpose of this study was to determine whether outreach integrated treatment of first episode schizophrenia was more effecive than standard outpatient treatment.

Early intervention for schizophrenia has spawned considerable enthusiasm among clinicians without solid research evidence to suport its benefits and costs. The present study is a random-controlled study of integrated biomedical and psychosocial treatment on a population of recent-onset cases.

Comparison(s): 50 consecutive referrals with schizophrenic disorders of less than two years duration were allocated randomly to a comprehensive model of integrated treatment or standard care for two years. Main outcome measures was psychopathology, psychosocial functioning and hospital admissions.

Eligibility Criteria:
Inclusion Criteria:

* first-episode schizophrenia

Exclusion Criteria:

* acute psychosis
The Safety and Effect Study of Acupuncture for Anorexia in Patients With Gastrointestinal Tract and Lung Cancers

This trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.

Acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. The 160 eligibilities will be randomly divided into 3 groups(Acupuncture and Placebo group, Megestrol acetate and Sham Acupuncture group, Placebo and Sham Acupuncture group).The effect will be investigated baseline, the 2,5,8 and 15days. The safety issue will be recorded every section during the acupuncture.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed gastrointestinal tand lung cancers;
2. Age ≥18 years;
3. Appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening;
4. Had a history of weight loss ≥5% within 6 moths;
5. Maintained oral intake;
6. Signed the informed consent.

Exclusion Criteria:

1. Patients with dementia, delirium, intestinal obstruction, pregnancy or lactation;
2. Had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(The score of the symptoms≤ 3, 0= worst) ;
3. Patients with untreated vitamin B12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism);
4. Patients on melatonin supplements or medications with potential appetite-stimulating activity(Chinese herb,thalidomide)
5. Less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture;
6. Lifetime expected less than 3 months.
A Study to Evaluate the Effects of Renal Function on Pharmacokinetics and Safety of DA-8010

This Study will evaluate the effects of renal function on pharmacokinetics and safety of DA-8010


Eligibility Criteria:
Inclusion Criteria:

\[Healthy Volunteer\]

* Adult male or female, 19 years to 75 years
* eGFR ≥ 90 mL/min/1.73m\^2
* Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0 kg/m\^2
* The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire

\[Renal Impairment Patient\]

* Adult male of female, 19 years to 75 years
* eGFR \< 90 mL/min/1.73m\^2, not on dialysis
* Body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0kg/m\^2
* The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire

Exclusion Criteria:

* The subjects with acute illness
* The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
* The subjects hypersensitive to any of the Investigational Product components or other drug components
* The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
* The subjects who have history of drug abuse
* The subjects who are pregnant or lactating
* The subjects who do not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the Investigational Product until the 4 weeks after the last administration
Interactive Hand-grip Strength Game in Critically Illness Patients

Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigators aim to design an interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care.

Patients admitted to the intensive care units (ICUs) are an unexpected event that consequently causes physical and psychological problems, including ICU acquired weakness, delirium, sleep disruptions, anxiety, depression, and post-traumatic stress disorder (PTSD). Such consequences may lead to prolonged ICU stay, increased health care, and elevated medical costs. Therefore, mitigating physical and psychological distresses by providing timely effective interventions has become a top concern to optimize critically ill patients' recovery. Investigaters aim to design a interactive hand-grip game to improve patients' upper limbs activities and psychological health in patients requiring intensive care. This will be a two-arm, parallel randomized controlled trial which randomly assign patients into the game group and usual care group.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 20 years
* Having clear consciousness
* Independently able to mobilize to complete the intervention and communicate in Chinese
* Richmond Agitation-Sedation Scale (RASS) 24 between +1 to -1 if using sedatives

Exclusion Criteria:

* Suspect neurological deficits
* Neuromuscular disease
* Orthopedic injuries with contraindications to mobilize
Genome Sequencing in Refractory Breast Cancer to Molecular Targeted Therapy and Young Breast Cancer

The purpose of this study is to investigate and analyse genomic profiles in patient with breast cancer who failed standard treatment, refractory and young breast cancer.

The hypothesis is that genomic profiling measured by CancerSCAN, cfDNA, Whole exome sequencing (WES), Whole transcriptome sequencing (WTS), FACS(Fluorescence-Activated Cell Sorting), cytokine and immunologic signature analysis would be helpful to find out tolerance for chemotherapy and innovate new therapeutic strategies.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed breast cancer that is either metastatic or young breast cancer(≤ 40 years of age).
2. HER2 positive patient who failed HER2 target therapy including trastuzumab with feasible biopsy site.
3. Triple Negative Breast Cancer patient who failed standard therapy with feasible biopsy site.
4. Hormone Receptor positive patient who failed standard therapy with feasible biopsy site.
5. Age ≥ 21 years
6. Written informed consent

Exclusion Criteria:

1. No feasible biopsy site
2. No written informed consent
Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration

200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).

In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.

Eligibility Criteria:
Inclusion Criteria:

* any subtype of neovascular age-related macular degeneration
* age of 50 years or older
* initial treatment with intravitreal bevacizumab between August 2005 and June 2006

Exclusion Criteria:

* previous vitrectomy
* presence of cystoid macular edema without choroidal neovascularization
* Uncontrolled systemic disease