cyrilzakka/clinical-trials huggingface dataset:
Aspire2B Personalization Pilot Study Program

This non-randomized pilot study program is focused on assessing the technical characteristics of the Aspire2B mobile device application.

Aspire2B is a mobile wellness app that uses non-invasive measurements to predict various physiological states and estimate biological age. Users are then enrolled in nutrition, fitness, or sleep challenges within the app that are aimed at improving overall wellness and thus helping to reduce biological age. Mobile health (mHealth) interventions require numerous decisions that integrate behavioral theory, user feedback, and technical and practical feasibility considerations. The main purpose of this research program is to test if the application works as intended. This pilot study program is managed internally by Pepsico clinical researchers.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in reading and understanding English or Spanish
* Smartphone users

Exclusion Criteria:

* Cannot proceed to onboarding without downloading the app, consenting to participate, and agreeing to app Terms of Use
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
* Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study

Exclusion Criteria:

* Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication.
* Patients exhibiting treatment non-compliance in the preceding study (A0081163)
Dosimetric Limitation of Pelvic Bone and Peritoneal Space in Rectal Cancer Patients During Chemoradiotherapy

This project first retrospectively analyzes the intestinal dose indicators related to the concurrent radiotherapy and chemotherapy of rectal cancer and gastrointestinal toxicity, and the pelvic dose indicators related to hematological toxicity, and then prospectively conducts radiotherapy based on the dose indicators most closely related to toxicity. The dose is limited when the plan is made to reduce the gastrointestinal and hematological toxicity of rectal cancer with concurrent radiotherapy and chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with rectal adenocarcinoma
2. Clinical staged T3/4 or any node-positive disease
3. Age of 18-75 years
4. Karnofsky Performance Status \> 80
5. Adequate bone marrow reserve, renal and hepatic functions
6. Without previous antitumoural chemotherapy
7. No evidence of metastatic disease
8. Written informed consent before randomization
9. UGT1A1's genotype of 6/6 or 6/7

Exclusion Criteria:

1. Clinical staged I or IV
2. Age of \<18 or \>75 years
3. Karnofsky Performance Status \< 80
4. Previous pelvis radiotherapy
5. Previous antitumoural chemotherapy
6. Clinically significant internal disease
7. Refuse to write informed consent before randomization
8. UGT1A1's genotype of 7/7
Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure \>95 mm Hg

Exclusion Criteria:

* Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks
Effect of Succinylcholine on Patients Using Statins

Based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. Design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. So statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. The investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery
* ASA Physical Status 1-3

Exclusion Criteria:

* History of liver failure
* History of renal failure
* History of neuromuscular disease
* Increased intraocular pressure
* Recent major burn
* Multiple trauma
* Susceptibility to or family history of malignant hyperthermia
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery

The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent;
* Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
* Women aged 18 years or older;
* Candidate for pharmacological induction of labor;
* Single, live vertex fetus;
* Baseline modified Bishop score ≤ 4;
* Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
* Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

* Women in active labor;
* Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
* Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
* Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
* Fetal malpresentation;
* Diagnosed congenital anomalies, not including polydactyly;
* Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
* Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
* Ruptured membranes ≥ 48 hours prior to the start of treatment;
* Suspected chorioamnionitis;
* Fever (oral or aural temperature \> 37.5°C);
* Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
* Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
* Any condition urgently requiring delivery;
* Unable to comply with the protocol.
Real-Time Assessment of Stress and Stress Response

Stress is a complex natural phenomenon, frequently related to a physiological response, including heart rate, heart rate variability, respiratory rate, skin conductance and temperature. The subjective experience varies greatly; broadly, it may be conceived as a freeze, flight, fight, fright or faint response. Many studies have demonstrated the negative influence of psychological stress on health and well-being. Through the digital phenotyping of physiological and psychological stress reactions, in a controlled laboratory setting (Trier Social Stress Test- TSST) and real-life situations, in a population of healthy participants and patients with a major psychiatric disorder, we expect to find reliable and valid digital biomarkers. The results of this study will, therefore, not only contribute to a better understanding of stress and stress response but also have the potential to improve diagnostic and treatment approaches.


Eligibility Criteria:
Inclusion Criteria:

* Participants are competent to give informed consent.
* Participants are right handed
* German language proficiency as a native speaker or level B1
* Diagnosis of a cluster C personality disorder according to ICD-10; or
* Diagnosis of depressive disorder according to ICD-10; or
* Diagnosis of schizophrenia or schizoaffective disorder according to ICD-10; or
* Without a current psychiatric disorder.

Exclusion Criteria:

* Low Intelligence as confirmed by failure to complete regular compulsory education.
* Pregnancy or over two weeks delay in the menstrual cycle.
* Previous participation in a psychological trial involving psychosocial stress assessment.
* Current neurological disorder.
* Current cardiovascular disorder.
* Current respiratory disorder.
* Current substance use or withdrawal.
* Any change in medication in the previous week.
Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year

Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.

The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery.
* Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately.
* Patients accepting and able to update a questionnaire in French.
* Informed patients who agree to computerised processing of their medical data and their right of access and rectification.

Exclusion Criteria:

* Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress.
* Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc).
* Patients not wishing to become pregnant.
* Patients participating or having participated during the previous month in a gynaecological clinical trial.
General Practitioners' Felt With Their Patients' Death (REGIDAQ)

Very few studies are dealing with the way general practitioners feel the death of their patients. Main studies about that subject are qualitative. It needs quantitative studies to analyse how is felt general practitioners' patients' death. This is an epidemiologic quantitative cross-sectional study. The Studied population is the whole of the general practitioners of the region Nouvelle-Aquitaine. The primary endpoint is the percentage of the general practitioners which have hard time living with their patients' death. The secondary endpoints are to evaluate the general practitioners' help needing after their patients' death, to evaluate the personal and professional impact of the patient's death, the percentage of general practitioners using chemical aid after their patients' death and to determinate the existence of support facilities to help general practitioners to stand patients' death. The results of that study could help general practitioners to improve their medical practice in the patient's death situation.


Eligibility Criteria:
Inclusion Criteria:

* General practitioners from the Nouvelle-Aquitaine region.
* Exclusive or joint exercise of general medicine.
* None retired

Exclusion Criteria:

* Retired patricians
* Students, Residents
* General practitioners from another region
* General practitioners with no general medicine activity
Single Dose Pharmacokinetics of Egalet® Hydrocodone

The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* ≥18 and ≤55 years of age
* BMI ≥19 and ≤30.0

Exclusion Criteria:

* Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
* History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
* Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
* Pregnant or breast-feeding
Optimization of Human Cortical Stimulation

We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. We propose to do a limited, low-level brain stimulation to show that the signatures of local activity in the target area change as an effect of brain stimulation. The goal of this study is to understand the feasibility of a novel recurrent brain-computer interface that could eventually promote targeted functional recovery in subjects who have had a brain injury.

The subject will have already been scheduled for placement of the ECoG electrodes on the surface of the brain and who will, for all clinical purposes, subsequently receive stimulation for mapping of function of the ECoG sites. The decision to place the electrodes on the brain, the location of the electrodes and the length of time the electrodes are in are all part of clinical care.

There will be two types of testing, motor and language. Motor will involve inducing stimulation to the thumb cortex and the wrist cortex. There will be a conditioning of this over 4-12 hours. Language will involve showing pictures on a computer screen and the subject will be observed whether speech is disrupted with stimulation or not.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Male and Female
* Able to understand English for consenting and testing
* Referred for surgical implantation of electrodes

Exclusion Criteria:

* Under 18 years of age
* Pregnant women
* Prisoners
* Mentally disabled IQ \< 70
* Non English Speaking
* Not candidates for surgical implantation of electrodes
Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy

The purpose of this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy.

For diagnosis, staging and grading of chronic liver disease, liver biopsy is the gold standard to date. Unfortunately, being an invasive diagnostic method, liver biopsy has a significant morbidity. Furthermore, due to the small sample size, sampling error (over- or underestimating severity of liver disease) is a serious problem in diagnostic of chronic liver disease.

The objective of this study is to evaluate non-invasive diagnostic methods (MRI, elastography, ultrasound and serum parameters) in comparison to the gold standard to establish criteria for diagnostic in liver disease and reduce the necessary amount of liver biopsies in the future and allow regular follow up.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatopathy and necessity of liver biopsy

Exclusion Criteria:

* metal implants preventing MRI
Association Between Neck Pain and Quality of Sleep

A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic neck pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.


Eligibility Criteria:
Inclusion Criteria:

* patients with nonspecific neck pain of more than 14 days duration
* seen in health centers participating in the study
* patients who accept to participate and sign the consent form
* without age limits and regardless of gender

Exclusion Criteria:

* inability to complete the questionnaires (illiteracy, dementia)
* inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years
Chromium and Insulin Action

The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect on blood glucose levels and insulin sensitivity

The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities.

One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations (4). As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes, and over a 10 month period of observation, used established techniques to assess changes in insulin sensitivity, body composition and glycemic control.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes on diet therapy or low dose oral agent -

Exclusion Criteria:

Significant cardiovascular, hepatic or renal disease

-
Comparative Analysis of Biomarkers in Response to Acute Moderate-Intensity Activity

The purpose of this study is to understand how college students' biomarkers change with a relatively short bout of moderate-intensity physical activity. The investigators are comparing biomarkers in between self-reported physically active and sedentary students in terms of their percent difference and change. The investigators are also studying physically active versus sedentary college students' mental health. This is a mentored student research project in the investigator's lab (not part of a thesis, dissertation, or other coursework requirements), where multiple students have developed research questions using the same study design.

This study will use a two-group (sedentary versus active) pre-test, post-test study design. Following the informed consent process, participants will complete the pre-test data collection protocol including the first venipuncture blood draw for ammonia, insulin, cortisol, and c-reactive protein, first finger stick blood sample for glucose measurement, reporting of food eaten for the day as well as transportation methods to the study site. Resting heart rate will be measured.

Following a 15-minute waiting period to minimize potential effects from the blood draw, participants will walk with a study team member to a reserved elliptical machine. For the exercise component, the lab member will emphasize to the participant about maintaining the desired heart rate for moderate intensity exercise. The participant will use the elliptical for 12 minutes, without music, conversation, or general entertainment. Appropriate warm-up and cool-down is added in to the exercise time (the first two minutes and last two minutes) with preference of moderate intensity exercise lasting 8 minutes.

Participants will then walk with the study team member back to the Lab for post-test data collection. Post-test data collection follows the same procedures as pre-test data collection. Participants also will take a mental health questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* This study will enroll full-time students at the investigator's university who are aged 18-34 years.
* Participants will be generally healthy participants, assessed using the 2020 Physical Activity Readiness Questionnaire (first 7 questions) as a screening tool. Individuals who answer "no" to all of the 7 questions will be deemed healthy enough to take part.
* Two balanced groups will be created based on self-reported current activity level, either sedentary (\<30min/week of exercise) or meeting exercise guidelines (\>=150min/week of exercise).
* Potential participants should be willing to complete the blood draws and the 12 minutes of moderate-intensity exercise on an elliptical machine.
* Potential participants should be able to speak and read the English language. This is so they will be able to understand the study protocols clearly.

Exclusion Criteria:

* Are allergic to nuts because the snacks provided following the blood draw may contain nut products.
* Do not have transportation and parking (if needed) to lab.