cyrilzakka/clinical-trials huggingface dataset:
Glycemic Durability After Metformin Failure

Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c) of \<7%.

AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.

* Source data verification: paper or electronic medical records.
* Statistical analysis: All analyses will compare the randomly assigned treatment groups under the intention- to-treat principle

Eligibility Criteria:
Inclusion Criteria:

* Newly-diagnosed, type 2 diabetic patients, failing to diet

Exclusion Criteria:

* Suspected type 1 diabetes or secondary diabetes resulting from specific causes
* Current or previous (within past 3 months) treatment with any investigational drug
* Any major cardiovascular event in previous year
* Plans for pregnancy during the course of the study for women of childbearing potential
* Serum creatinine level \>1.3 mg/dL in women and \>1.4 mg/dL in men
* History of cancer, other than nonmelanoma skin cancer, that required therapy in the 5 years before randomization
* Treatment with oral, loal, systemic glucocorticoids 14. Treatment with atypical antipsychotics
A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time

The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
* Women and men must agree to follow specific methods of contraception, if applicable.

Exclusion Criteria:

* History of a clinically significant drug rash or Stevens-Johnson Syndrome
* History of Gilbert's Syndrome
* Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment
* Any major surgery within 4 weeks of study treatment administration
* Any gastrointestinal surgery that could impact upon the absorption of study treatment

Other protocol-defined inclusion/exclusion criteria apply
The Efficacy Of Complete Mesocolic Excision With Central Vessel Ligation Technique On Lymph Nodes And Safety Margins Compared With Conventional Surgery For Colon Cancer Treatment

Cancer Colon is one of the major public health problems worldwide. Complete eradication of the tumor with no recurrence or residual masses is a challenge which faces all the surgeons and medical staff all over the world. A lot of techniques were used to ensure 100 % eradication of the tumor and to cure the patients from cancer. Total Mesocolic Excision with Central Vessel Ligation is one of the recent techniques used for colon cancer surgeries. Here in the research the investigators answer the question of how this technique is superior and more beneficial in complete eradication of the tumor than the conventional surgery for colon cancer


Eligibility Criteria:
Inclusion Criteria:

* • Adult male and female Age of or above 18 years.

  * Tumor localization at the caecum, ascending colon, transverse colon, descending colon, sigmoid colon or rectosigmoid on preoperative endoscopy and radiographic imaging \[barium enema or computed tomography (CT)\]
  * No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease
  * Written informed consent

Exclusion Criteria:

* • Contraindications to major surgery and American Society of Anaesthesiologists (ASA) Physical Status scoring 4 which means extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment.

  * Infectious disease requiring treatment.
  * Pregnant women
  * Use of systemic steroids.
  * Severe pulmonary emphysema or pulmonary fibrosis
Enhancing Life Quality in Community-Dwelling Older Omanis by Telling Their Life Story

This study investigates whether sharing life stories and creating life-story books can enhance the quality of life and life satisfaction and reduce depression in older adults. The primary research question is:

Did the quality of life, life satisfaction, and levels of depression improve more for participants in the intervention group compared to those in the control group?

Participants will be divided into two groups:

* Intervention group: These participants will share life stories and create life-story books.
* Control group: These participants will not share life stories or create life-story books.

Background: The main goal of this study is to investigate whether telling their life stories and developing a life-story book intervention affects a group of Omani older adults' quality of life, life satisfaction, and depression symptoms.

Methods: In Oman, a randomized controlled trial with repeated measures was conducted to evaluate the impact of the intervention. 75 older individuals were randomly assigned to either the intervention group (n = 38) or the control group (n = 37). Baseline demographic data were collected as an initial reference point. To comprehensively assess changes over time, participants' depression levels, life satisfaction, and overall quality of life were measured at multiple time points: weeks 1, 2, 3, 4, and 8. This longitudinal design allowed for a nuanced analysis of intervention effects across different implementation phases.

This study believes that participants in the 8-week trial of the life-story review intervention were successful in reducing depression and improving life satisfaction and quality of life in the older population. Healthcare professionals can use such interventions to enhance older persons' mental health and well-being.

Eligibility Criteria:
Inclusion Criteria:

* aged 60-90;
* depressive symptoms score between 5 and 10;
* able to sign the consent form;
* able to speak Arabic or English;
* able to communicate without the need for a hearing aid.

Exclusion Criteria:

* using hypnotics, sedatives, antidepressants, anticholinergics, antihistamines, tranquilizers, or melatonin for sleep;
* having a medical diagnosis of Parkinson's, dementia, Alzheimer's disease, or a serious mental problem;
* Participants assigned to the intervention group who did not want to be audio recorded.
Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography

Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography (PSG).

The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after initiation of continuous positive airway pressure (CPAP) therapy is important to verify the therapeutic success. In clinical practice, the internal records of CPAP devices are utilized to determine the therapeutic success, during either medical consultations or telemetric observation.

This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded by the CPAP device (Prisma, Löwenstein Medical Technology).

The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be compared with the simultaneously recorded events of the CPAP device.

This shall lead to recommendations regarding the situations, and in which degree the event detection of the CPAP devices may be meaningful to determine the therapeutic success of home sleep apnea therapy.

Eligibility Criteria:
Inclusion Criteria:

* PSG diagnostic not older than 3 month,
* AHI\>15, CPAP indication,
* age \>18,
* nasal CPAP mask,
* written informed consent

Exclusion Criteria:

* CPAP contraindication,
* participation in another clinical trial
The Effect of Progressive Muscle Relaxation Exercises on Premenstrual Syndrome, Anxiety, and Tendency to Violence in Young Women

This study results will provide evidence on the effectiveness of Progressive Muscle Relaxation Exercises (PMRE) as a complementary method in improving Premenstrual Syndrome (PMS), an important women's health issue. Additionally, it will contribute to the literature by shedding light on irritability and anxiety, which are common side effects of PMS.


Eligibility Criteria:
Inclusion Criteria:

* Female students studying at Istanbul Aydın University, Faculty of Health Sciences, Those who score 111 or above on the Premenstrual Syndrome Scale (PMSS), Female students aged 18-24 will be included in the study.

Exclusion Criteria:

* Non-Turkish speakers, Individuals who cannot communicate normally, Students who are unable to comply with the exercise program will be excluded from the study.
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.

This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 days of one treatment (IPX066 or IR CD-LD) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (IR CD-LD or IPX066). During the approximate 7-day washout period, subjects took their prestudy CD-LD regimen. Pharmacokinetic and efficacy/pharmacodynamic measurements were done on Days 1 and 8. Safety measures (electrocardiograms \[ECGs\], clinical laboratory tests, vital signs, adverse events \[AEs\], and concomitant medications) were evaluated over the course of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
2. If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
3. At least 30 years old at the time of diagnosis of PD.
4. Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
5. A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.
6. Must have predictable fluctuations between "on" and "off" states.
7. Hoehn and Yahr Stage I-IV when "on".
8. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
9. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

Exclusion Criteria:

1. Pregnant or breastfeeding.
2. Diagnosed with atypical parkinsonism.
3. History, physical findings or laboratory results suggesting a diagnosis other than PD.
4. Allergic or nonresponsive to previous CD-LD therapy.
5. Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.
6. Exposure to any investigational agent within 30 days prior to Visit 1.
7. Donated blood or plasma within 28 days.
8. Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).
A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts

To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine therapeutic activity against Plantar Warts

* Clinical Tolerance
* Clinical Recovery
* Evaluate Safety

Plantar Warts occur on the soles (plantar surface of feet) and can be severely debilitating for patients even for normal walking. The severity and magnitude of the warts can vary, but they are the cause of much pain and discomfort for all age groups. Nowarta 110 has been evaluated for the therapy of plantar warts caused by the HPV virus, (HPV infection). Clinical experience in a totals of 124 patients receiving Nowarta 110 for 5 weeks treatment in multiple clinics overseas has demonstrated the potential of Nowarta110 with absolutely no side effect.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory or recurrent Plantar Warts.
* No wart treatment for the last 12 weeks
* Healthy male or non-pregnant, non-lactating female aged ≥ 18 years or greater
* If female of childbearing potential, use an acceptable form of birth control during the study
* Provide written informed consent or (HIPAA consent/authorization, as applicable

Exclusion Criteria:

* Concurrent medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe
* Female subjects who are breast-feeding or planning to become pregnant
* Patients with a history of allergy to silver or fruits
* Subjects with clinically significant unstable medical disorder, life threatening disease, or current malignancies
* Subjects with History of Alcohol abuse or other drug abuse within 2 years prior to Randomization
* Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment
* Concomitant Medications: any other wart therapy is prohibited during the study.
Impact of Thermal Stress on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds. Exposure to heat induces physiological responses that help maintaining a stable body temperature. Those changes can affect organ functions implicated in absorption and metabolism. According to literature, those changes could lead to increased concentrations of chemical compounds in the body and their toxicity. Therefore, the aim of this study is to evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress conditions in volunteers exposed in a inhalation chamber. Results will then be used to develop PBPK models that will allow to predict organic solvent kinetics when coexposed with heat.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18,5 et 25 kg/m3

Exclusion Criteria:

* Smoking
* Respiratory, cardiovascular and neurological problems
* History of exposure to solvents
* Chronic medication
* Abusive and/or chronic alcohol consumption
* Alcohol consumption 24h before or 18h following exposure
Change in Body Weight During Treatment of Advanced Colorectal Cancer

Colorectal cancer (CRC) is a significant and growing health burden in Hong Kong. According to data from Hong Kong Cancer Registry, CRC ranked the first in incidence and the second in mortality, with around 5,000 new cases diagnosed and more than 2,000 cancer-related mortality in 2014. The investigators aim to evaluate the association between serial weight change during first line treatment and outcomes in patients with metastatic CRC.

Studies have suggested that exposure to a greater number of chemotherapeutic agents is associated with better survival in metastatic colorectal cancer.

Multiple factors might affect body weight during treatment. Cancer-related symptoms can impair quality of life and appetite. Cachexia syndrome affects around 50% of colon cancer patients and is characterized by cancer-induced catabolism with involuntary weight loss (fat and muscle), patients have increased lipolysis and change in skeletal muscle metabolism, including increased energy expenditure at rest and protein degradation, and decreased protein synthesis. Besides these disease factors, treatment related side effects are common causes of weight loss, such as inability to ingest or digest food effectively due to nausea, vomiting, and malaise. Based on these factors and the hypotheses between tumour control and weight gain, monitoring the serial weight change can have practical value.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of colorectal origin
* Stage IV disease with systemic treatment
* Estimated life expectancy \>3 months
* Adequate organ functions

Exclusion Criteria:

* Eastern Cooperative Oncology Group performance status 3 or above
* Pregnancy
* Human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS)
* Past medical history of another cancer
Effect of Exercise on the Disease Activity of Rheumatoid Arthritis

This study will evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weightlifting.

The goal of this study was to evaluate the effect of exercise on the number of swollen and tender joints associated with rheumatoid arthritis. It was hypothesized that persons would have less inflammation associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking and weighlifting. Immune parameters were measured to determine potential mechanisms responsible for changes in inflammation with exercise.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of RA according to the ACR 1989 Criteria at least 6 months prior to enrollment in the study, but not longer than 12 years
* age 19 to 65 years old
* stable regimen of medication for 2 months with less than 10 mg/day of oral corticosteroids
* currently exercise \< 2x/week for less than 30 minutes at less than 60% of his/her age predicted maximum heart rate
* Subjects must pass the Physical Activity Readiness Scale Questionnaire (PAR-Q)

Exclusion Criteria:

* other serious health problems
* intra-articular injection within 6 weeks
* total joint replacement of the large joints
* use of beta-blockers
* inability to complete the submaximal exercise test
Efficacy of Heat-shock Protein (HSP) Inhibitors in Myeloproliferative Syndromes (MPS)

Heat-shock proteins (HSP) have been very highly conserved throughout the evolution of species and are characterized by their chaperone function, thanks to their ability to prevent aggregation and to promote the renaturation/break down of damaged proteins. Among other targets, they also chaperone JAK2, a key step that is deregulated in signalling in myeloproliferative syndromes (MPS) because of the JAK2V617F mutation. These HSP also have a potent cytoprotective action through their multiples inhibiting effects on apoptotic processes.

Little is known about levels of HSP expression, in particular for HSP70 and HSP27, in MPS cells.

However, in vitro studies of different cell models have shown the interest of HSP90 inhibitors in slowing cell proliferation in MPS. These results have been confirmed in animal models with results in terms of blood counts and overall survival. In addition, it seems that the V617F mutated form of JAK2 is more sensitive than the wild-type to HSP90 inhibitors. Finally, inhibitors of HSP90 remain efficacious with regard to the inhibition of cell growth, even in cases of resistance to JAK2 inhibitors. Nonetheless, HSP90 inhibitors are known to stimulate the expression of other HSP, notably HSP27 and HSP70, which are, through their properties, tumorigenic and could lead to an escape phenomenon. Thus the combined use of several HSP inhibitors could be beneficial, and eventually present synergistic effects on the inhibition of tumour processes.


Eligibility Criteria:
Inclusion Criteria:

MPS Patients:

* Patients with MPS
* Patients who have been informed and not objected to the tests
* Patients over 18 years old
* Patients whose samples have been preserved at the CRB in the "Haemopathies" collection

Control patients:

* Patients over 18 years old
* Pregnant patients
* Patients who have been informed and not objected to the collection of their cord blood after the delivery

Exclusion Criteria:

* Adults under guardianship
CArotid Robotic Procedure Evaluation

This study aims to evaluate the use of R-One in the peripheral vasculature.

This is a prospective, single-arm, monocenter study to evaluate the R-one use in carotid artery stenting procedures. Up to 8 patients will be included and followed at 30 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Candidate for CAS
3. Presence of a WEB-diaphragm lesion at carotid artery ostium, proved by non-invasive imaging (CTA or MRA)
4. No minimum delay between previous stroke therapy (IMT) is required
5. Double antiplatelet therapy the day before the procedure and 1 month after the procedure is required
6. The patient provides written informed consent as approved by the applicable Ethics Committee and is willing to comply with all study requirements including 30 days follow-up.
7. The patient is affiliated with a social security scheme

Exclusion Criteria:

1. Target lesion has atherosclerotic or dissection stenosis or occlusion;
2. Treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion;
3. CAS performed at the end of intracranial mechanical thrombectomy
4. Contra-indications of double antiplatelet therapy the day before the procedure and 1 month after the procedure
5. Patients under judicial protection, tutorship or curatorship
6. Any patient participating in another clinical study valuating a drug or a medical device (except registries for which the primary endpoint has not been evaluated);
7. Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.