cyrilzakka/clinical-trials huggingface dataset:
Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions

The purpose of this study is to determine whether a consultation with a Personalized Therapeutics Clinic, or PTC, will help participants lower the risk for side effects (drug-drug interactions and drug-gene interactions) when taking many medications and help providers improve prescribing decisions for participants. A PTC is a clinical that will test your genes to gather information about your health that may help guide prescribing advice and offer you new information about your prescriptions. Doctors leading this study will look for variations (differences) in your genes that may suggest that you are at greater risk of having side effects or a greater chance of benefiting from certain medications. Individuals in this study will participate for roughly 9 months.


Eligibility Criteria:
Inclusion Criteria:

1. Adult participants cared for by a participating provider at University of Chicago Medical Center.
2. Participants must be at least 18 years of age.
3. Participants prescribed 5 or medication medications and taking a perpetrator drug or a drug with actionable pharmacogenomic information.

Exclusion Criteria for Participants

1. Participants who have undergone, or are being actively considered for, liver or kidney transplantation.
2. Participation in another pharmacogenomic study.
3. Participants who have previously received genotyping from another source.
4. Inability to understand and give informed consent to participate.

Inclusion of Women, Minorities, and Other Underrepresented Populations Individuals of all races and ethnic groups and genders are eligible for this trial.
Non-invasive Caries Management: Clinical Study

Clinical trial to compare non-invasive and minimally-invasive therapies on the progression of the caries lesions. Clinical investigation of resin infiltration versus sodium fluoride (5% NaF) varnish application.

Dental caries is the most globally prevalent disease that affects thousands of adults and children. Caries is a biofilm-mediated, sugar-driven, multifactorial, and dynamic disease that results from the imbalance between demineralization and remineralization of the dental hard tissues. Preventing the onset of the disease should be the primary goal; however, once the disease is present efforts should be made by both patient and clinician to successfully reestablish the mineralization balance by the use of preventive and/or minimally-invasive methods when possible. The sodium fluoride (5% NaF) varnish is one of the most common therapies used as a non-invasive approach for caries prevention and remineralization; and, the resin infiltration materials are indicated for the minimal intervention of non-cavitated occlusal and proximal caries. The minimal intervention has been considered the new concept of caries management. Although several studies discussing minimal intervention or non-intervention are available, there is a lack of published randomized controlled trials (RCTs) providing data about the use of non-invasive therapies on incipient lesions, and its correlation with the patient's caries risk. The aim of this study is to evaluate the efficacy non-invasive and minimally-invasive therapies on the progression of the caries lesions considering the patient's caries risk.

This study will be conducted in the province of Ontario, Canada. A total of thirty patients (15 to 50 years old), who present with a minimum of two incipient proximal carious lesions on the proximal surfaces of posterior teeth (non-cavitated lesions identified as small, faint radiolucent areas seen on the intra-oral radiographs) will be asked to participate in this study. The radiologic assessment of incipient lesions will be performed by a dental radiologist, blinded to the selected treatment groups, by comparison of the radiographs imaging over time.

Eligibility Criteria:
Inclusion Criteria:

* Patients must present at least two non-cavitated proximal caries lesions
* Patients must be able to give informed consent in English
* Patients must be resident in London, Ontario, or nearby locales with community fluoridation

Exclusion Criteria:

* Patients presenting proximal caries that are beyond the outer third of dentin
* Patients suffering from a disability that impairs dental hygiene performance
* Patients that are unable to perform her/his own oral hygiene
Prospective, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle

Is there a difference in clinical outcome measures as assessed by the AOFAS, SF-36 and Visual Analogue Scale of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus the proximal chevron osteotomy?

Is there a difference in radiologic outcomes of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in surgical times or surgeon procedure preference in the treatment of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy? Is there a difference in complication rates of adult patients with moderate to severe hallux valgus with increased intermetatarsal angles treated with a proximal open wedge osteotomy with LPS system versus proximal wedge osteotomy?

Eligibility Criteria:
Inclusion Criteria:

* age (\> 16 years of age) moderate to severe hallux valgus angle \[HVA\] of \>30º with increased intermetatarsal angles \[IMA\] of \>13º
* persistent incapacitating symptoms despite non-operative treatment (shoe wear modification, orthoses, non-steroidal anti-inflammatory drugs and restricted activity)

Exclusion Criteria:

* degenerative arthritis of 1st metatarsophalangeal (MTP) joint
* neuropathic patients
* diabetes mellitus
* peripheral vascular disease
* previous 1st metatarsal, hallux or MTP joint surgery
* active or recent foot/toe infection
* currently participation in a another clinical trial
* Worker's Compensation Board patients.
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* seropositive for HIV-1;
* enrolled in an early access program for a new investigational PI;
* naive to Fuzeon, and the investigational PI;
* treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).

Exclusion Criteria:

* females who are pregnant or breast-feeding;
* evidence of active, untreated opportunistic infection;
* malignancy requiring chemotherapy or radiotherapy.
TENS to Alleviate the Effect of Thirty After Surgery Xerostomia (Dry Mouth) After Surgery

Dry mouth of postoperative makes the patient feel thirst, and the pain of the lips is cracked. It will also make the sputum thick and sticky, making it difficult for the patient to cough by himself. Especially the elderly may have sputum accumulation and pneumonia. Dry mouth can easily change the pH value in the mouth, destroy the environment in the mouth, and increase the chance of oral mucosal lesions, ulcers and infections. The physical discomfort can lead to psychological effects such as anxiety, irritability, and irritability. The incidence of dry mouth was 88%, 6-8 hours after abdominal surgery. Although the incidence is high, compared with other complications after surgery (such as: pain, bleeding, etc.), dry mouth after surgery is less important, and is underestimated, unmeasured, unrecorded and untreated. Initiating the motivation of this study, it is hoped that through research to understand the relevant factors causing dry mouth after surgery, and using transcutaneous electrical nerve stimulation (TENS) to improve the symptoms of dry mouth after surgery. The first phase is to describe the relevant studies with the aim of understanding the relevant factors that contribute to dry mouth after surgery. This study will understand and pay attention to the post-operative dry mouth. It is hoped that through this study, the problem of dry mouth after surgery will be improved, and the comfort of the recovery period after surgery will be improved, so that patients can get better care and promote the quality of care.

Introduction A postoperative thirst is one of the major complaints in the recovery room. The purpose of this experimental study was to compare the efficiency of reducing postoperative thirst by transcutaneous electrical nerve stimulation (TENS) and routine care.

Methods Surgical patients under general anesthesia were recruited from a medical center. Each patient was randomly assigned to the experimental group (TENS) or control group (routine care). Experimental group had 53 patients and control group had 52 patients fitted in the inclusion and exclusion criteria and completed data collection. The intensity of thirst was measured pretreatment, immediately after treatment and 30 minutes after treatment. All data were managed by SPSS for Windows (version 21.0). Descriptive and inferential statistics (Chi-square test, t-test, generalized estimating equation regression analysis) were performed to identify the relationships that were proposed.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology (ASA) physical status I-ΙII, elective abdominal surgery, \>20 years old

Exclusion Criteria:

* pregnancy, epilepsy, unconscious
Effect of Different Dosages of Paraxanthine, the Major Caffeine Metabolite, on Energy and Focus

Research has shown that acute ingestion of Paraxanthine (1,7-dimethylxanthine, PXN) can enhance various markers of focus, including memory, reaction time, and attention in healthy adults. To assess these effects, this placebo-controlled crossover trial will compare the effects of 200 and 300mg of PXN to a placebo control. Participants will abstain from caffeine for 3 days, before taking the first test/placebo product for 3 consecutive days. Participants will complete questionnaires at 30, 60, 90, and 120 minutes after ingestion on Day 1 and Day 3 of ingestion. Participants will have a 3-day washout period before trialing the next test product/placebo.

Following enrollment to the study, participants will abstain from any products containing caffeine, for 3 days.

On the night of the 3rd day of caffeine abstinence, participants will fast overnight (\~10 hours) The morning after the fast, participants will complete the Day 1 baseline questionnaire.

Participants will then consume Test Product A and complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Test Products should be consumed in a fasted state, and 1-hour post-ingestion participants will consume a standardized meal (See Section 6.3).

On Day 2, participants will consume Test Product A again but will not complete any questionnaires. The product should be consumed in a fasted state and participants will consume the standardized meal 60 minutes post-ingestion.

On Day 3, participants will consume Test Product A in a fasted state and will again consume the standardized meal 1-hour following ingestion of the product. Participants will complete questionnaires 30, 60, 90, and 120 minutes after ingestion. Participants will then have a 3-day washout period with no products consumed or questionnaires completed.

Following the washout period, the intervention cycle will be repeated with Test Product B and, subsequently, Test Product C.

The questionnaires will consist of study-specific surveys and a cognitive assessment battery.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-35
* Willing to abstain from caffeine-containing beverages and foods during the duration of the study
* Recreationally active; currently performing structured exercise (e.g., running, weightlifting, team-sport activity) at least 2 days per week for the previous 3 months

Exclusion Criteria:

* Body Mass Index: \>29.9kg/m2
* Inability to adhere to protocol guidelines (e.g., caffeine, alcohol, tobacco)
* Regular tobacco use
* Illicit drug use (e.g., growth hormone, testosterone, etc.)
* A diagnosed medical condition under the care of a physician (e.g. type 2 diabetes) Inability to abstain from supplements (e.g. protein, creatine, HMB, BCAA, phosphatidic acid, etc.) at least three weeks before the trial
* Individuals on medications known to affect caffeine metabolism (e.g., corticosteroids, non-steroidal anti-inflammatories, or prescription-strength acne medications)
* Participants who are amenorrheic (females only)
* Inability to comply with the study protocol as judged by the investigators
Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine

This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.

The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
2. Patient can use patient-controlled analgesia (IV PCA)

Exclusion Criteria:

1. History of drug allergy to gabapentinoid and related drug
2. History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
3. Renal disease (Creatinine Clearance \< 60), Liver disease, Seizure disorder and Psychiatric disorder
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. This study will also compare tumor volume before and after neoadjuvant therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is done before surgery to reduce the size of tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with adenocarcinoma of the rectum, who have not started their neoadjuvant treatment yet.

Exclusion Criteria:

* Patients who have started their neoadjuvant therapy already
Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies

This is a monocentric, open-label clinical study, presenting a retrospective part and a prospective part, studying the data of patients with drug-resistant focal epilepsies and treated with the combination of stiripentol (Diacomit®) and Carbamazepine.


Eligibility Criteria:
Inclusion Criteria:

* Retrospective part of the research:

The medical records of CRéER patients with the following criteria will be included in the retrospective part of the research by an investigator:

1. With pharmacoresistant epilepsy, i.e. a history of failure of two well-conducted and well-tolerated antiepileptic treatment regimens, either as monotherapy or as combination therapy,
2. Receiving or having received a treatment combining stiripentol and carbamazepine for a period of at least 15 days,
3. Having at least one evaluation data after the initiation of treatment with stiripentol and carbamazepine (a follow-up visit after the initiation of the study treatment),
4. For which an information note indicating the possibility of opposing the processing of data has been provided.

   * Prospective part of the research:

Among the patients whose medical records are included in the retrospective part of the research, those who meet the following criteria will be able to participate in the prospective part of the research:

1. Currently treated with stiripentol in combination with carbamazepine for at least 15 days and still being followed in the center,
2. Weighing at least 5 kg (minimum weight in accordance with the blood volume taken),
3. Having read, or whose parents have read, the information note and signed the consent form. For children, if their level of understanding allows it, their consent will also be sought,
4. Having sufficient knowledge, or whose parents or legal guardians have sufficient knowledge, of the French language to read, understand and complete the research documents,
5. Members or beneficiaries of a social security scheme. These patients, both children and adults, will be welcomed at the CIC.

Exclusion Criteria:

- Retrospective part of the research : Patients objecting to the collection of their data will not participate in the research.

- Prospective part of the research :

Patients with the following criteria will not be able to participate in the prospective part of the research:

1. Participating simultaneously in another interventional clinical trial or in a period of exclusion following a previous trial,
2. Whose state of health does not allow him to give his consent,
3. Under guardianship or curatorship,
4. Under judicial protection or person deprived of liberty.
Comparison of Two Oxygenation Targets With Two Different Oximeters - Impact on Oxygen Flow Rates and Oxygenation

The investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared SpO2 with SaO2 obtained on arterial gas. Correlations between SaO2 and SpO2 were poor for all oximeters, as previously known, and SpO2-SaO2 bias were different between oximeters. Some oximeters (Masimo, Nellcor) had lower biases but they detected less well hypoxemia. Some oximeters underestimated SaO2 (Nonin) but detected very well hypoxemia, and some overestimated SaO2 (Philips). The investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences.

The assumption is that the SpO2 target AND oximeter used will both have an impact on oxygen flows and that these effects will add up. With a high SpO2 target, oxygen flows will be significantly greater and with the Nonin oximeter, the required flows will be greater than with the Philips oximeter.

NB: the results obtained were in a population with light skin pigmentation (96% of the patients were Fitzpatrick 1-2, reflecting the local hospitalized population).

The oximeters to be evaluated will be the Nonin (Plymouth, MN), and the Philips (Eindhoven, Netherlands). The sensors used will be digital reusable sensors for all oximeters. Because of the impact of the fingers used for SpO2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter).

Two SpO2 targets will be assessed: 90% and 94%. A total of four 10-minute periods will be performed in randomized order: Nonin 90, Nonin 94, Philips 90, and Philips 94.

At the end of each 10-minute period, arterial gas will be collected through the arterial catheter.

The adjustment of the oxygen flow rates will be performed manually. The average oxygen flow of the last 2 minutes of the period will be considered.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Patients admitted to postoperative cardiac surgery intensive care unit
* Presence of an arterial catheter Specific for the extubate patient
* Ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5L/min) with SpO2 between 88 and 100% with the usual oximeter and nasal cannula.
* SpO2 \< 92% ambient air Specific for the intubate patient FiO2 \<= 0.60 with SpO2 between 88 and 100% with usual oximeter SpO2 \< 92% with FiO2 0.21

Exclusion Criteria:

* No SpO2 signal with oximeter in use
* False nails or nail polish
* Methemoglobinemia \>0.015 on last available arterial gas
* Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-CoV-2 ...) Specific for the extubate patient
* Expected to use another respiratory support within one hour of inclusion (NIV or nasal high flow oxygen) Planned extubation within one hour of inclusion
Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients

The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between the ages of 18-65 years old
* BMI ≥ 40 kg/m2, ≤ 60 kg/m2
* Undergoing a primary laparoscopic RYGB by Dr. Murr
* Agree to be followed 24 hours postoperatively
* Normal K+ and Mg++ serum levels

Exclusion Criteria:

* BMI less than 40 kg/m2, \> 60 kg/m2
* Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr
* Allergy to lidocaine
* Allergy to hydromorphone or ketorolac
* Allergy to corn or amide anesthetics
* Use of (thioridizine)
* Pregnancy
* Abnormalities of ALT or AST
* Intra-operative diagnosis of cirrhosis or portal hypertension
* Intraoperative complications per surgeon
* Intraoperative extensive adhesions per surgeon
* Chronic pain syndrome and chronic use of narcotics
* Severe back pain secondary to degenerative joint disease