cyrilzakka/clinical-trials huggingface dataset:
Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

The current study investigates colesevelam as add-on therapy to pioglitazone to improve glycemic control in subjects with type 2 diabetes mellitus not adequately controlled with pioglitazone monotherapy or pioglitazone in combination with either metformin or a sulfonylurea. The study will evaluate if colesevelam add-on to pioglitazone therapy for type 2 diabetes mellitus will be safe, well tolerated, and efficacious.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 diabetes mellitus
* Inadequate glycemic control on a stable dose (at least 2 months prior to screening) of pioglitazone at 30 or 45 mg/day, with or without one or two other oral antidiabetic medications \[metformin or a sulfonylurea, or dipeptidyl peptidase (DPP-IV) inhibitor\]
* Hemoglobin A1c (HbA1c) \>= 7.5% and =\< 9.5% at screening
* Fasting plasma glucose =\<240 mg/dL at randomization (Week 0/Day 1).
* Male or female \>= 18 years of age.
* Women of childbearing potential must be using an adequate method of contraception as detailed per-protocol
* Fasting C-peptide level \>0.5 ng/mL at screening
* Clinically stable in regards to medical conditions other than type 2 diabetes
* Concomitant medications are at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period

Exclusion Criteria:

* History of Type 1 diabetes and/or history of ketoacidosis
* History of bowel obstruction
* History of hypertriglyceridemia-induced pancreatitis
* Fasting serum triglyceride concentration \>500 mg/dL
* History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal motility disorders, major gastrointestinal surgery
* History of insulin use \>= 2 weeks duration during the previous 3 months or a total of \>2 months insulin therapy at any time prior to screening
* Treatment with bile acid sequestrants, including colesevelam within 3 months prior to screening
* Female subject who is pregnant or breastfeeding
* History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack, or any revascularization within 6 months prior to screening
Assessment of Motivity in People Aged 65 to 86 Years

The ability to walk is one of the fundamental attributes of human beings. However, with advancing age this ability is modified by a combination of physiological and pathological aging.These changes mainly involve an irregularity of the pitch, reducing the length of the stride, instability and a decrease in walking speed (Beauchet et al., 2002). Tinetti, Speecheley, Ginter (1988, from Ch Wider, F. Vingerhoets, J Bogousslavsky, 2005) show that 20-30% of heathly older fall each year and state that one of these falls, 25% result in injuries with significant effect and 5% a fracture. In addition to the risk of fracture fear of falling exists in many older people even before a drop in effective (Recommandation of HAS, 2005).In France, about 9 000 deaths of people aged over 65 are associated each year with a fall and this association increases rapidly with advancing age in both sexes. It is therefore important in terms of public health, learn to recognize the gait disturbance, to prevent and to make adequate assessments to reduce the risk of falls. Tools exist to assess the risk of falling. Some are comprehensive but time-consuming and are generally discarded in favour of other simpler tests (test of Tinetti or get up and go test). However, the listing of these lacks precision, particularly in terms of duration single timer.To overcome these biases, innovative technology solutions seem to be a good way. In this study, the investigators will use the motorized go-cart developed by INRIA, entitled ANG (for Assisted Navigation Guide), to obtain more reliable and accurate measurements of parameters such as walking speed and direction. Thus, the investigators set the main objective, to compare a standard evaluation of the process to a technology assessment, in participants aged 65 to 86 years. And as secondary objectives : evaluate the acceptance of using go-cart ANG in the elderly, develop an index of walking and test the feasibility of detecting a weakness of the knee joint by ANG undetected at clinic.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged between 65 and 86 years
* participants with no locomotor disability hindering the implementation of the protocol
* participants with no global cognitive impairment (MMSE score \<24) (Folstein et al. 1975), or arguments in favor of the following diagnoses : probable Alzheimer's disease according to the criteria of the NINCDS-ADRDA, major depressive episode according to DSM-IV-R
* participant with no apathy according to diagnostic criteria for apathy (Robert, Onyike et al. 2009)
* participants recipients of social security
* signature of informed consent.

Exclusion Criteria:

* impossibility of carrying out the experimental protocol because of a mobility impairment
Molecular Pathways Involved in Cardiac Remodeling in Patients With Chronic Heart Failure With Preserved Ejection Fraction by New Omics Technologies

Heart failure with preserved ejection fraction nowadays affects about half of all patients with heart failure. In the general population, the prevalence of this subclass of heart failure (HFpEF, ed.) increases as the age of patients increases, especially in those over 65 years of age, and it has a significant gender. The study is to investigate the molecular pathways, predominantly protein patterns, involved in cardiac remodeling peculiar to heart failure with preserved ejection fraction (HFpEF) by comparing them with remodeling pathways and protein pattern alterations in patients with HFrEF. In addition, the study aims to identify molecular alterations that would allow early identification of the development of PH-HFpEF and PH-HFrEF, affecting the female gender more

The study, placing itself within the framework of Translational Research, aims to gain a greater understanding of the different phenotypes of patients with HFpEF, to expand knowledge of the specific immune profile, and to identify new therapeutic targets for a heterogeneous clinical syndrome, to date lacking effective medical therapy. It is also proposed to find potential biomarkers with which to distinguish early between the two subclasses of decompensation and protein alterations related to the possible development of pulmonary hypertension in patients with HFpEF and HFrEF (PH-HFpEF and PH- HFrEF, respectively).

Patients who will take part in the study, following enrollment carried out on an inpatient or outpatient basis (being inpatients and control group subjects, respectively), will have follow-up visits at two times (at 1 month and at 6 months), in conjunction with regularly scheduled medical checkups, according to Good Clinical Practice.

Eligibility Criteria:
Inclusion Criteria:

* heart failure patients

Exclusion Criteria:

* patients suffering from infectious diseases and serious infectious diseases
Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia

The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty acid supplementation on the vascular structure and function in hypertensive patients with hypertriglyceridemia.

Hypertensive patients aged 40-65 years, both genders, presenting serum triglycerides levels higher than 150 mg/dl will be randomized into two groups. The first group will be receiving ciprofibrate 100mg/day and the second group will be receiving fish oil 1800mg/day. All patients will be evaluated with brachial flow-mediated dilation and with EndoPAT to assess endothelial function before and after supplementation. SPHYGMOCOR and pulse wave velocity (PWV) measurements will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of hypertension
* Patients with serum triglycerides levels ≥ 150 mg/dl and \<500 mg/dl
* Patients on stable antihypertensive medication for at least 4 weeks
* Patients with food consumption maintained for at least 4 weeks

Exclusion Criteria:

* Smoking
* Secondary hypertension
* Hormone replacement therapy
* Diabetes mellitus
* Chronic kidney disease
* Known coronary artery disease
* Previous stroke
* Dyslipidemia severe, with LDL cholesterol\> 160 mg/dL or triglycerides ≥ 500 mg/dl
* Use of statins or beta blockers
Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients

This study is a cross-sectional observational study to evaluate the prevalence of HLA-B\*5701 in the European area and in major European ethnotypes.

Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B\*5701. Patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B\*5701 status by local and central laboratories.

In selected sites patients may be asked to provide an additional blood sample. This sample will be used to develop and validate different methodologies for assessing HLA-B\*5701 status.


Eligibility Criteria:
Inclusion criteria:

* HIV-1 infected patients over the age of 18 years
* Patient is willing and able to understand and provide written informed consent

Exclusion criteria:

* None
Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine

Removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients. Antibiotics, analgesics and mouthwashes are prescribed for the treatment of complications encountered. When using postoperative antibiotics in surgery of impacted third molar teeth, lower surgical area infection, pain, swelling and trismus are seen. Based on this information, in this study, it is aimed to evaluate the effects of rifamycine intraoperatively on the postoperative pain, swelling and trismus.


Eligibility Criteria:
Inclusion Criteria:

* absence of any systemic disease
* having bilateral impacted mandibular third molar teeth in a similar position
* absence of allergy to any of the drugs used in the study,
* absence of pregnancy/lactating state,
* no history of any medication use during at least 2 week before the operation.

Exclusion Criteria:

* not regularly coming to the controls,
* not using their medicines regularly
* using any additional medication that may affect the outcome of the study
A Study of AK112 in Advanced Malignant Tumors

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117（Anti-CD47 Antibody）with or without chemotherapy in advanced malignant tumors


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old.
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Phase Ib:Histologically or cytologically confirmed advanced solid tumor.
5. Phase II:

   cohort 1 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma.

   cohort 2 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic Biliary Tract Cancers, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer.

   cohort 3 : Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic pancreatic ductal adenocarcinoma.

   cohort 4 : Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \[AJCC\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;Have previously received EGFR-TKI treatment and have progressed on or following.
6. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.

Exclusion Criteria:

1. Undergone major surgery within 30 days prior to the first dose of study treatment.
2. Active central nervous system (CNS) metastases.
3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
4. Active Hepatitis B or Hepatitis C.
5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
6. History of severe bleeding tendency or coagulation disorder.
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain

The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants.

This is an open label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic low back pain. All participants start treatment with 12.5 micrograms (µg) per hour patch. The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose increases will be considered based on rescue medication consumption and pain assessment. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. The duration of the treatment will be 30 days. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be at Day 0 (baseline), on Day 15 and Day 30 (trial end). At the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by investigator and participants. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria: -Chronic low back pain with moderate to severe pain at least 3 months -Participants needed to be treated with strong opioid and haven't been treated with strong opioid in the past -Participants who still had moderate to severe pain (Visual Analog Scale \[VAS\] \>= 4), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 120 milligram \[mg\] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days

-Participants who failed from other treatments such as operation or lack of efficacy of current treatment -Participant who has signed the informed consent form Exclusion Criteria: -Skin disease that prevent the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability -History or suspicion of alcohol or drug abuse within the past 5 years -History of cardiac, nervous system or respiratory disease which in the investigator's judgment precludes participation in the study because of the potential for respiratory depression -Concomitant use of Non Steroidal Anti-Inflammatory Drugs (NSAIDs), Cyclooxygenase - 2 (COX-2), muscle relaxant, topical analgesic during the previous week (unless on stable drug dose for at least 1 month before study entry) -Pregnancy or breast-feeding female; female participants of childbearing potential without adequate contraception
Maternal and Neonatal Outcomes After Membrane Sweeping

This study aim to estimate maternal and neonatal outcomes after membrane sweeping in different group of patients.

Sweeping of the membranes is a simple technique usually performed during vaginal examination, in order to initiate labour by increasing local production of prostaglandins.

Eligibility Criteria:
Inclusion Criteria:

* Women with a singleton pregnancy and confirmed cephalic presentation at or after 37 weeks of gestation who are candidate for vaginal delivery were eligible for the study

Exclusion Criteria:

* Women with a multiple pregnancy, nonreassuring cardiotocogram, meconium stained amniotic fluid, major fetal anomalies, HELLP (hemolysis, elevated liver enzymes, and low platelets) syndrome, or severe preeclampsia and signs of intrauterine infections were not eligible.
* women who are not candidates for vaginal delivery: placenta previa, breech presentation, planned repeat cesarean.
Autologous Muscle Fiber Fragment Injections

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

The Study hypothesizes that efficient re-assembly of injected fragments within host muscle tissue along the fiber direction of native muscle will be induced. It is anticipated that these fiber fragments would integrate into the host vascular and neural network.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* participants must experience 4 or more Fecal Incontinence (FI) episodes per 2 week period
* participants must score \>10 on Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)
* participants must have had symptoms for at least 12 months
* participants who have failed standard medical and surgical treatments for FI
* participant will undergo anorectal manometry (ARM) testing
* participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees
* women of childbearing potential must use acceptable contraceptives during this study

Exclusion Criteria:

* participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage
* participants with pre-existing ano-rectal pain of any cause
* participants with incontinence of flatus only
* chronic watery diarrhea which is the primary cause for fecal incontinence
* acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae)
* presence of anorectal tumors
* active proctitis or inflammatory bowel disease
* previous injection of internal anal sphincter (IAS) with bulking agents
* participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment
* participants with a defined bleeding disorder diagnosed and treated by a hematologist
* other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids
* participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction
* women who are pregnant, breastfeeding, or have had a child within the last year
* participants with a history of unstable cardiac function (New York Heart Association Functional Classification III or IV) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (Cr \>1.5 mg/dl or on dialysis) or uncontrolled diabetes (Hemoglobin A1C \> 8 mg/dl)
* participants with anemia (hemoglobin \<10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2 times normal) or increased bilirubin \>1.5mg/dl
* participants with Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2
* rectal prolapse
* vaginal prolapse beyond the hymen
* unable to understand informed consent information even with provision of a medical translator
Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery

To asses ocular discomfort symptoms and signs and inflammatory biomarkers after preoperative topical cyclosporine 0.1% eye drops therapy in high risk elder population after a specific insult such as cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Postmenopausal women for whom cataract surgery has been scheduled
* Stage N2-3; C1-2 according (Lens Opacities classification System) LOCS
* Willing to sign informed consent and fully participate to all length of the study
* Patients without any previous medical history of ocular and/or systemic inflammatory, autoimmune or auto inflammatory disease
* Patient with no history of ocular surgery
* Patients without any previous or concomitant ocular diseases

Exclusion Criteria:

* Patients under topical or systemic anti- inflammatory drugs Patients with a concomitant diagnosis of glaucoma, or on therapy with antiglaucoma drugs
* Patients on systemic or local therapy with drugs that alter the secretion of the tear film (beta blockers, antidepressants and psychotropics)
* Patients with a history of allergic, congenital, autoimmune systemic diseases
* Patients who have undergone previous eye surgery
* Ocular or peri-ocular malignancies or premalignant conditions
* Active or suspected ocular or peri-ocular infection.
* Complicated Cataract Surgery
* Patients with a positive pregnancy testAllergy or reaction history to study drug
* Patients who participated in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug
Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement

The purpose of this research is to determine if using a surgical drain after surgery lowers the risk of complications. Both approaches - using a drain or not using a drain - are currently common in Anterior Cervical Discectomy and Fusion (ACDF) procedures.

Up to 360 participants will be randomly assigned to one of two groups. Those signed to the drain group will have a surgical drain placed on the surface of the wound during closure. The drain will be removed within 24 hours. Those in the no-drain group will have their wound closed without a drain. All other aspects of participants' care before and after surgery will be the same. No additional visits are required for this study.

Basic information will be collected from participants' medical records, such as age, gender, type of surgery. For 180 days following surgery, participants' health will be monitored through clinical visit notes, phone calls with their doctor or clinic staff, and records of any hospital visits due to complications.

Eligibility Criteria:
Inclusion Criteria:

* Between 19 -75 years of age
* Having elective anterior cervical discectomy and fusion (ACDF) surgery

Exclusion Criteria:

* On anticoagulation medication and cannot stop
* Cervical (neck) cancer or tumor
* Have combined anterior cervical discectomy and fusion, and posterior cervical fusion
* Active infection or trauma