cyrilzakka/clinical-trials huggingface dataset:
Oral Propionate to Treat and Prevent Diabetes

The aim of these studies is to firstly determine the pharmacokinetic profile of orally administered enteric coated sodium propionate. Subsequently, the most efficacious dose at improving glucose tolerance following an oral glucose challenge will be determined. The investigators will then determine the mechanism of action of propionate, whether it acts by altering beta cell function directly or by augmenting the incretin effect or both

The NHS spends £1M per hour, 10% of its yearly budget, treating diabetes. In the UK cases of diabetes are expected to top 4 million by 2025. There is an urgent need for new therapies. The short chain fatty acid propionate is a natural substance produced by digestion of fermentable carbohydrates. Preclinical and early human data demonstrate it improves pancreatic function and glucose control. The investigators aim to conduct proof of principle studies to determine if oral delivery of propionate improves glucose control in patients at risk of developing diabetes.

Eligibility Criteria:
Inclusion Criteria:

Study 1: Healthy men and women aged between 18 and 70 years with BMI between 20-25 kg/m2 and with normal fasting blood glucose (below5.5mmol/l and HbA1C less than 5.7% will be eligible to volunteer.

Study 2: As for Study 1. Study 3: Cohort 1: Volunteers aged between 30 to 70 with a BMI between 25-35 kg/m2 who do not have impaired fasting glucose and have HbA1c below 5.7%.

Cohort 2: Volunteers aged between 30 to 70 years with a BMI between 25-35 kg/m2 who have impaired fasting glucose (between 5.5-7mmol/l) and HbA1C between 5.7% and 6.5%,

* Exclusion Criteria:• Type 1 or Type 2 Diabetes

  * Gained or lost ≥ 3kg weight in the past three months
  * Taken prescription medicines having an impact on metabolism, appetite regulation, glucose homeostasis and hormonal regulation
  * Taken any dietary supplements in the last 6 months
  * Any chronic illness
  * Cardiovascular disease
  * Excess alcohol intake
  * Current smokers
  * Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
  * A history of drug or alcohol abuse in the last 2 years
  * Pregnancy (all women of child bearing age will undergo a pregnancy test).
  * Pancreatitis
  * Use of medications likely to interfere with glucose metabolism, appetite regulation, hormonal balance.
Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion

The objective of this retrospective chart review is to evaluate drug utilization, usage patterns and indication of effectiveness Eylea in the routine clinical (real-life) management of patients who suffer from ME (Macular Edema), secondary to CRVO (Central Retinal Vein Occlusion), and who started treatment with Eylea for this indication.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patients who suffer from visual impairment due to ME secondary to CRVO
* Anti-VEGF treatment-naive patients who started reimbursed Eylea treatment between the 1st of June 2014 and the 28th of February 2015

Exclusion Criteria:

* Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.
Family Networks Project Study One: An Efficacy Study of Stepping Stones Triple P for Children Under Age Two

The purpose of the project is to assess the initial efficacy of Stepping Stones Triple P-Positive Parenting Program (SSTP) with parents of children below age two with developmental disabilities to strengthen families and prevent child maltreatment.

This study is an initial efficacy trial of SSTP for parents of children below age 2. The target population consists of 50 families of young children ages 11-23 months with developmental disabilities who are eligible to receive IDEA Part C (Individuals with Disabilities Education Act Part C) services in one region of South Carolina. Families will be randomly assigned to one of two conditions (1) IDEA Part C services as usual or (2) IDEA Part C services plus SSTP. Project goals are to strengthen parent competence, enhance parent confidence, and strengthen child social, emotional and behavioral functioning. Ultimately, this should result in a reduced likelihood of child maltreatment

Eligibility Criteria:
Inclusion Criteria:

* child age between 11 and 23 months of age
* child eligible for IDEA Part C Services
* parent english speaking
* parent willing to allow in-home services

Exclusion Criteria:

* disability requiring extensive out of home treatment
Phase I Dose Finding Study of SSR97225 Given in Patients With Refractory Cancer

The purpose of this study is to determine the maximally tolerated dose and the dose limiting toxicity of this antimitotic, tubulin binding investigational drug for those patients who have failed standard anticancer treatments.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic or locally advanced non-hematological cancer
* Patients with solid tumors refractory to therapy or for whom no therapy exists

Exclusion Criteria:

* Five or more prior chemotherapy lines for metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Patients having discontinued previous specific anti-cancer treatment
* Patients who have not recovered from all toxic effects from previous specific anti-cancer treatment (excluding alopecia)
* Patients with abnormal biological/hematological parameters, cardiac abnormalities or serious infection/intercurrent illness likely to jeopardize the patient's safety or the course of the protocol treatment
* No adequate birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Treatment of Orthostatic Intolerance

This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.


Eligibility Criteria:
Inclusion Criteria:

* Chronic symptoms (\> 6 months) with standing upright

Exclusion Criteria:

* Obvious cause of hypovolemia or drugs that could worsen tachycardia
* Chronic severe medical conditions such as cancer or ischemic heart disease
BI 44370 TA in Acute Migraine Attack

The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.


Eligibility Criteria:
Inclusion Criteria:

* Adult migraine patients with or without aura, diagnosed according to the ICH.
* Established migraine diagnosis greater than or equal to 1 year.
* Age at first migraine onset latest at 50 years of age.
* Medical history of migraine with headache of moderate to severe intensity and migraine frequency of 2-8 times/ month.
* Patient has provided written informed consent in accordance with ICH-GCP and local legislation.

Exclusion Criteria:

* History of hemiplegic, ophthalmoplegic or basilar migraine, or cluster headache.
* History of treatment-resistant migraine attacks.
* Other pain syndromes possibly interfering with study assessment or use of any pain medication \> 10 days / month.
* Use of migraine and other restricted medication, or other restrictions as per protocol.
* Pregnancy or breast-feeding. Female of childbearing potential who do not use contraception.
* Clinically significant cardiovascular, peripheral vascular, hepatic, respiratory, haematological, gastrointestinal, renal, metabolic, immunological, hormonal, neurological and psychiatric disorders.
* Patients in whom unrecognised coronary artery disease is likely, or who are at risk of coronary artery disease indicated by the presence of risk factors.
* Persistent liver enzyme elevation such as ALT, AST or AP \> 2x ULN.
* Known history of HIV, or history of cancer within the last 5 years.
* DSM-IV-defined-history of substance abuse or dependence within the past 6 months, excluding nicotine and caffeine, but including alcohol or benzodiazepines.
Effects Of Perturbation Based Balance Training in Reactive Balance Control Among Chronic Stroke Patients

Chronic stroke patients often have impaired balance on reactive balance control. Task specific exercises are important part of the fall intervention in daily activities of life should be incorporated during the rehabilitative services Objective: Effects of perturbation based balance training in reactive balance control in chronic stroke patients.

RCT (Randomized Control Trail) study was conducted. Stroke patients who have impaired balance and reactive control were determined on inclusion \& exclusion criteria. Stroke patients with impaired balance control were arbitrarily allocated into two groups with one control and one interventional group ages ranged from 45 to 50 years. The sample size was 20 patients. Group 1 (control group) received tradional balance training and Group 2 (interventional group) received perturbation based training for balance control. The interval of treatment was 6 weeks. Data is collected from Azra Naheed Medical college (Ch Muhammad Akram teaching \& research hospital) Lahore and Physiotherapy department of Social security hospital manga mandi Lahore. Tinetti performance oriented mobility assessment (POMA),Time up and go (TUG) and Activity specific balance confidence (ABC) was used to evaluate the pre and post values of balance control.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who was not obese and BMI was \<28
* Individuals at chronic stroke level (\>6 months post stroke).
* The patients who can walk with or without a gait aid (but without assistance of another

Exclusion Criteria:

* • Different neurological diseases and problems that can impaired balance control (e.g. Parkinson's disease); upper or the lower body parts amputation; cognitive, language, or social impairments which can affect the following of instructions.

  * Patients who were attending any perturbation based training
  * Patients who were visually impaired, having orthostatic hypotension or dizziness
Girls First - India (2013-2015)

The purpose of this study is to determine the social, emotional, physical, and educational effects of Girls First, a combined resilience and adolescent health program, vs. its components and a control group, among adolescents in India.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled at schools or present at sites selected for study
* Must complete consent/assent process

Exclusion Criteria:

* None
Costs and Effects of Three Modes for Disease Management of Chronic Obstructive Pulmonary Disease in General Practice

In this randomized controlled trial, three contemporary modes for chronic obstructive pulmonary disease (COPD) management in Dutch general practices are compared for costs and effects:

* usual general practitioner (GP) care (at patient's initiative);
* regular practice nurse review; and
* integrated self-management education.

All three interventions are based on existing guidelines, materials, and field experiences.

Considering the ageing of the Dutch population and the current and increasing shortage of general practitioners (GPs), the capacity of primary healthcare is a major and growing concern. Delegation of care normally provided by GPs with care provided by trained practice nurses is now rapidly emerging for patients with chronic respiratory disease, i.e. asthma and chronic obstructive pulmonary disease (COPD). However, most general practices still provide care at initiative of the patient self, because of the lack in scientific evidence and the costs of implementing a regular care structure. Self-care by patients may be an alternative to alleviate the growing load on primary health care.

The following two main research questions are addressed in this study.

* Does an integrated self-management education intervention for patients with COPD in general practice contribute to attaining long-term treatment targets, compared to regular monitoring by a practice nurse and usual GP care?
* What is the cost-effectiveness of an integrated self-management education intervention for patients with COPD, compared to regular monitoring by a practice nurse and usual GP care?

Eligibility Criteria:
Inclusion Criteria:

* Registered in one of the general practices participating in the study
* Diagnosis of COPD, with Global Initiative for Chronic Obstructive Lung Diseases (GOLD) stage I, II or III
* Age ≥35 years
* Willing to provide written informed consent

Exclusion Criteria:

* Very poor prognosis with regard to respiratory condition (GOLD stage IV)
* Severe co-morbid conditions with a reduced life expectancy
* Unable to communicate in the Dutch language
* Objections to one or more of the disease management modes in the study
Galectin-3 Binding Protein in Cardiovascular Disease and Chronic Heart Failure

The purpose of this study is to determine whether galectin-3 binding protein plasma levels can predict adverse cardiovascular events in patients with coronary artery disease and/or heart failure.

Chronic heart failure represents an important cause of disease burden in Western countries. Heart failure can be either caused by vascular disease (i.e. cardiomypathy (CMP) due to coronary artery disease ("ischemic/ICMP")) or by myocardial conditions (i.e. dilated cardiomyopathies (DCMP) resulting from other causes like familial disposition, drug toxicity, etc.). Gold standard for the diagnosis of CMPs is the coronary angiography in conjunction with left ventricular angiography and myocardial biopsy, non-invasive markers include C-reactive protein (CRP) for ICMP and brain natriuretic protein (BNP) for DCMP. We have previously identified G3BP to be overexpressed in foam cells and plasma-derived microparticles, both potentially important in formation of atherosclerotic plaque. Galectin-3 binding protein (G3BP) is a secreted protein that is involved in cell adhesion and immune activation. The purpose of the current study is to test, whether G3BP plasma levels (a) are able to non-invasively differentiate causes of CMP and (b) are a suitable means for future risk assessment in CMP patients.

Eligibility Criteria:
Inclusion Criteria:

* impaired ventricular function

Exclusion Criteria:

* neoplastic disease
* infections with hepatitis C or HIV
Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study

This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide written informed consent, understand and comply with the requirements and evaluation schedule
2. ≥18, ≤75 years old
3. Histologically confirmed rectal adenocarcinoma
4. immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS
5. The distance from the lower edge of the tumor to the anal verge is ≤5 cm through colonoscopy, digital anal examination or MRI
6. clinical stage cT1-3N1M0 or cT2-3N0M0 (the 8th UICC/AJCC; T and N is evaluated by MRI)
7. Resectable primary tumor assessed by the Investigator
8. Have not received any anti-tumor treatment for rectal cancer
9. ECOG PS ≤ 1
10. Adequate organ function
11. Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose.

Exclusion Criteria:

1. Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma
2. Have received any treatments for rectal cancer, or evidence of distant metastasis
3. Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d
4. Presence or in high risk of obstruction, perforation or bleeding;
5. Not suitable for long-course radiotherapy
6. Cannot tolerate surgery
7. ≥2 colorectal cancer lesions at the same time
8. Contraindications for MRI examination
9. Other malignant tumors in the past or at the same time
10. Have an active autoimmune disease requiring systemic therapy within the past 2 years
11. HIV infection
12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \&amp;gt; 500 IU/mL) or active HCV carriers with detectable HCV RNA;
13. Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container
14. Other conditions judged by the researcher that do not meet the enrollment requirements
Efficacy and Safety of 500mg of Fulvestrant

Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.

* Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29 and then every 28 days thereafter.
* Participants will have a physical examination and blood work performed on each treatment date. After teh study treatment has been completed, the physical examinations will be done every three months for the first 2 years, every 6 months for years 2-5, and annually after 5 years.
* Participants may remain on study treatment until disease progression or until they experience serious side effects.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Histologically confirmed adenocarcinoma of the breast progressing local-regional or metastatic disease that is not considered amenable to curative treatment
* Evidence of hormone sensitivity of primary or secondary tumor tissue
* Postmenopausal as defined by criteria listed in protocol
* May have had adjuvant endocrine therapy if discontinued at least 12 months prior to inclusion. Subjects who have had minimal exposure to adjuvant or first line metastatic endocrine treatment during the 12 months prior to study enrollment can be eligible with overall PI and sponsor permission
* Prior trastuzumab and biologic therapy is allowed, but must be discontinued more than 2 weeks prior to inclusion
* Presence of measurable or evaluable, nonmeasurable, disease. Any x-rays and scans for assessment of measurable disease must be performed with 28 days prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2

Exclusion Criteria:

* Presence of life-threatening metastatic disease
* Endocrine therapy the advanced disease setting
* Systemic chemotherapy, whether as adjuvant therapy or for advanced disease, within previous 4 weeks
* Trastuzumab or biologic therapy within previous 2 weeks
* Extensive radiation therapy within the last 2 weeks
* Prior adjuvant or neoadjuvant treatment with fulvestrant is not allowed
* Concomitant anticancer treatments
* Chronic bisphosphonates for hypercalcemia or prevention of bone metastases
* Subjects receiving long-term anticoagulant therapy with warfarin
* Estrogen replacement therapy within 6 months of trial entry
* Previous or current systems malignancy within the past 3 years
* Treatment with non approved or investigational drug within 2 weeks before study entry
* Any evidence of severe or uncontrolled systemic disease
* History of bleeding diathesis
* Any severe concomitant condition which makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the study protocol
A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)

To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who have had an unsatisfactory response or intolerance to prior or ongoing DMARDs


Eligibility Criteria:
Inclusion Criteria:

* Active psoriatic arthritis defined by \>= 3 tender or painful joints and \>= 3 swollen joints despite standard psoriatic arthritis therapy
* Has had an unsatisfactory response or intolerance to at least two prior or ongoing DMARDs (one of which has to be methotrexate)

Exclusion Criteria:

* Has a history of cancer or other than certain skin or cervical cancers
* Has a history of, or current acute inflammatory joint disease of origin other than PsA, e.g., systemic lupus erythematosus etc.
* Has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk
* History of active tuberculosis, history of histoplasmosis or listeriosis
* Latent TB or risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment
FFRangio Accuracy vs. Standard FFR

This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, \>18 years of age.
* Patients with stable angina or unstable angina or NSTEMI, and in whom invasive FFR is being assessed in a non-culprit stenosis in at least one coronary artery.
* Subject is undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
* Provides written, informed consent (where required)

Exclusion Criteria:

* Contraindication for FFR examination or administration of vasodilators.
* Subject is presenting with acute infarct (STEMI) OR has documented prior STEMI on same side (right/left).
* CTO in target vessel.
* Prior CABG, heart transplant or valve surgery, or prior TAVI/TAVR.
* Known LVEF ≤45%.
* Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
* TIMI Grade 2 or lower at baseline.
* Target lesion involves Left Main (stenosis \>50%).
* PCI with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis.
* Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
* Target coronary vessel is supplied by major collaterals.