cyrilzakka/clinical-trials huggingface dataset:
Gender and Opioid Consumption

Opioids are widely used for pain relief after major abdominal surgeries\[1\]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, Opioid related complications (respiratory depression, Nausea \& vomiting, itching, over-sedation, delayed intestinal motility).


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II Cases scheduled for elective intraabdominal surgeries

Exclusion Criteria:

* diabetes,
* postmenopausal females,
* laparoscopic surgery,
* regional anesthesia emergency procedures,
* sepsis,
* hepatectomy,
* Renal impairment, and
* hepatic impairment,
* mental and psychiatric disorders.
The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome

This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.

We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:

  * abdominal obesity
  * elevated fasting blood sugar (110 mg/dL\< glucose \< 126 mg/dL)
  * low HDL
  * elevated fasting blood triglycerides (\> 150 mg/dL)
  * hypertension (BP \> 140/90 mm HG)
* Normal cardiovascular examination

Exclusion Criteria:

* Diabetes mellitus
* Untreated hypercholesterolemia (LDL \> 75th percentile for age)
* Cigarette smoking within 1 year
* Renal insufficiency (creatinine \> 1.4 mg/dl)
* Blood dyscrasia
* Hepatic dysfunction (ALT \> 2x normal)
* Evident coronary/peripheral atherosclerosis
Paired Integrative Exercise Program for People With Dementia and Caregivers

Preventing Loss of Independence through Exercise (PLIÉ) is a unique, multimodal movement program for people with dementia (affected individuals) that is taught by trained instructors and combines physical, mental and social activities. The Paired PLIÉ Program is an adapted version designed for pairs of affected individuals and care partners. The goal of this study is to perform a randomized, controlled trial (RCT) with a delayed start design to examine the effects of the Paired PLIÉ Program on function and quality of life in affected individuals and care partners.

Study participants are 30 pairs of individuals with mild-to-moderate dementia and their primary care partners (N=60 total) who are randomly assigned to Group 1 (immediate start) or Group 2 (delayed start). Pairs randomized to Group 1 participate together in the Paired PLIÉ program 2 days/week for 12 weeks (24 classes total) while pairs randomized to Group 2 continue with their usual activities. Then Group 1 transitions into a maintenance phase, and Group 2 participates in the Paired PLIÉ program 2 days/week for 12 weeks. Outcome data are collected in all study participants at baseline, mid-point and end-point so that we can examine the initial impact of the program as well as whether effects are maintained in Group 1. Outcome measures include cognitive function, physical performance, quality of life and caregiver well-being.

Eligibility Criteria:
Inclusion Criteria: Person with Cognitive Impairment

* diagnosis of cognitive impairment or dementia
* mild to moderate severity, defined as Clinical Dementia Rating of 0.5, 1 or 2
* willing and able to engage in study procedures
* English language fluency

Inclusion Criteria: Care Partner

* provide care for person with cognitive impairment
* willing and able to engage in study procedures
* English language fluency

Exclusion Criteria: Person with cognitive impairment

* planning to miss more than 2 weeks during the study period
* behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues)
* unable to take 2 steps independently without cane or walker
* terminal illness (life expectancy \< 1 year)
* currently participating in another research study that could impact current study
* changes to dementia medications 3 months prior to baseline or changes planned during the study period

Exclusion Criteria: Care Partner

* planning to miss more than 2 weeks during the study period
* behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., drug abuse, severe mental health issues)
* unable to take 2 steps independently without cane or walker
* terminal illness (life expectancy \< 1 year)
* currently participating in another research study that could impact current study
A Study of ALKS 5461 in Healthy Volunteers

This is a study to test the safety of ALKS 5461 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Be in good physical health
* Body mass index of 18-30 kg/m2
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Currently pregnant or breastfeeding
* History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
* Current or history of any clinically significant medical or psychiatric condition
* Current abuse or dependence on alcohol or any illicit drugs
* Have used nicotine within 90 days
* Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
* Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
* Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
* Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Additional criteria may apply
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients

The Mindful Breathing Laboratory under the direction of Dr. Benzo will complete a randomized controlled trial to evaluate the mindful breathing module. This rigorous study will evaluate home-based PR system compared to the home-based PR system plus mindful breathing module for its effects on breathlessness and emotions. The investigators hypothesize that the intervention will decrease breathlessness while increasing emotional perception, emotional intelligence, and mindfulness.

A total of 50 adults diagnosed with COPD will be enrolled in this study. Half of the subjects will be randomized to receive home-based pulmonary rehabilitation with the mindful breathing module (intervention group) and half will receive home-based pulmonary rehabilitation (control group). Each subject will be consented and trained and then participate in either the intervention or control group. Both groups entail one week of baseline and twelve weeks of home-based pulmonary rehabilitation (health coaching plus activity monitoring). The intervention group will also receive the mindful breathing module during the twelve weeks of home-based pulmonary rehabilitation. The Chronic Respiratory Disease Questionnaire (CRQ) will be administered at baseline, week 12 (after the intervention) and week 24 as the investigators will follow the patients for 3 months after the intervention to document the sustainability of the effects (behavior change).

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥40 years old
* Patients must have a diagnosis COPD documented by pulmonary function testing; breathlessness of score 2 or higher by the Medical Research Council Score
* Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking

Exclusion Criteria:

* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state; or are not living in the healthcare area
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition)
* Patients with an inability to do mild exercise (patients who have orthopedic-neurologic problems; patients who have severe heart failure, characterized by an ejection fraction of \<20% or by New York Heart Association Class IV disease; patients who should be at complete rest, confined to a bed or chair; or patients in whom any physical activity brings on discomfort and in whom symptoms occur at rest).
Sun Protection Factor Assay (SPF Assay 18676)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing.
* Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of Phenylketonuria

For individuals with Phenylketonuria (PKU), the investigators hypothesize that glycomacropeptide will provide an acceptable form of low-phenylalanine dietary protein that will improve dietary compliance, blood phenylalanine levels, cognitive function, and ultimately quality of life compared with the usual amino acid based diet. The study is funded by the Food and Drug Administration (FDA) Office of Orphan Products Development Grants Program, R01 FD003711.

Individuals with phenylketonuria (PKU) lack the enzyme phenylalanine hydroxylase that is needed to metabolize the essential amino acid phenylalanine (phe). When eating a normal diet they show an elevated level of phe in blood that is toxic to the brain. In order to prevent brain damage and cognitive impairment, individuals with PKU must follow a lifelong, low-phe diet that is restricted in natural foods and requires ingestion of a phe-free amino acid (AA) formula. Most adolescents and adults with PKU find the AA formula unpalatable and go off the diet resulting in elevated blood phe levels and neuropsychological deterioration. Glycomacropeptide (GMP), an intact protein produced during cheese making, is uniquely suited to a low-phe diet because it is the only known dietary protein that contains minimal phe. Foods and beverages made with GMP are a palatable alternative to AA formula. The long term goal is to assess the safety, efficacy and acceptability of GMP for the nutritional management of PKU. The specific aim is to conduct a randomized, two-stage, 11-wk, crossover trial comparing the GMP diet with the AA diet in 30 subjects with PKU ≥12 years of age treated since birth with a low-phe AA diet. The sites are: University of Wisconsin-Madison, Waisman Center (primary) and Harvard University, Children's Hospital Boston. Subjects will be recruited and randomized to begin the first 3-wk of the study with either a low-phe diet in which the majority of dietary protein is provided by GMP or AA medical foods and then, after a 3-wk washout with intake of their usual diet, begin the second diet for 3-wk. Dietary education will be provided in a 1-wk base period preceding initiation of each diet.

Eligibility Criteria:
Inclusion Criteria:

* Identified PKU by newborn screening; started diet treatment before 1 mo age
* Diagnosis of classical or variant PKU with documented phenylalanine level of greater than 600 umol/L at 7-10d of age
* Follows or willing to follow PKU diet and consume amino acid medical formula providing more than 50% of protein needs
* Acceptance of glycomacropeptide foods determined prior to enrollment

Exclusion Criteria:

* Females who are pregnant or planning pregnancy
* Individuals with mental deficits due to untreated or poorly controlled PKU
* Individuals with any health condition deemed to interfere with participation
The Combiotic-Study

The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term infants
* Female or male gender
* Gestational age between 37 and 41 weeks completed (= 41 weeks + 6 days)
* Age at time of V1 visit : 4 +/- 7 days
* Birth weight between 2500 ans 4200g, with regular weight gain (≥ 150g / week)
* Two legal representatives (parent(s) / guardian(s)) who are capable of and willing to comply with the protocol and have signed the informed consent in accordance with legal requirements.
* at least one of the legal representatives is affiliated to with a social security scheme.

Additionnaly , criteria of inclusion in one of the formula-fed groups or in the breast-fed group, respectively, are the following:

* To be included in one of the formula arm, infants will have to be exclusively formula-fed (no breast milk meal) at the time of V1 visit (randomization).

or

* To be included in the breastfeeding arm, infants will have to be exclusively breast-fed (no more than one formula meal per day) at V1 visit (randomization) and its mother will have to be willing to pursue exclusive breastfeeding at least until the infant will be 4-month old.

Exclusion Criteria:

* Intensive care during at least the first 14 days of life
* Neonatal health problems, such as: respiratory distress, asphyxia, hypoglycemia, sepsis, NEC (necrotizing enterocolitis),...
* Clinical evidence of chronic illness or gastrointestinal disorders such as : GER (Gastrooesophageal Reflux), gastroenteritis,...
* Known metabolic disorders, such as diabetes, lactose intolerance,....
* Known immune deficiency
* Subjects recommended to receive formula with hydrolized protein (e.g. children with allergy risk)
* Subject under oral antibiotic treatment at V1 visit
* Participation in another biomedical study
* Whose legal representatives have psychological or linguistic incapability to sign the informed consent form
* Reasons to presume that parents are unable to meet the study plan requirements (e.g. impossibility to contact study representatives in case of emergency, drug addiction etc)
Everolimus in de Novo Kidney Transplant Recipients

The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.


Eligibility Criteria:
Key Inclusion criteria:

* Patients who are willing and able to participate in the study and who provide written informed consent before performing any study related procedure;
* Men or women ≥18 years at transplant;
* Recipients of 1st or 2nd single kidney transplant from deceased donor or living unrelated/related donor \> 14 years;

Key Exclusion criteria:

* Patients who are recipients of multiple organs transplant, including two kidneys;
* Historical or current peak PRA \> 50%. Patients with already existing antibodies against the donor;
* Thrombocytopenia (platelets \< 75,000/mm³), absolute neutrophil count \<1,500/mm³, leucopenia (leucocytes \< 2,500/mm³) or hemoglobin \< 7 g/dL;
* Body mass index (BMI) \> 30 Kg/m2;
Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery

The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.

The main question(s) it aims to answer are:

\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods.

This prospective, randomized study was conducted at Başakşehir Çam and Sakura City Hospital in accordance with the Declaration of Helsinki. After ethics committee approval (decision no: 2023-596, date: 22.11.2023) and written consent from all patients, the study was conducted according to Consolidated Standards of Reporting Trials (CONSORT) guidelines. In the study, which included a total of 50 patients, the patients were divided into two groups: subcostal transversus abdominis plane block (STAPB) or rectus sheath block (RSB). Postoperative 24-hour VAS values, opioid demand and administration amounts in intravenous patient-controlled analgesia, presence of nausea and vomiting, surgical complications and length of hospital stay were evaluated (6th hour, 12th hour, 24th hour).

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* ASA II-III

Exclusion Criteria:

* Those who are allergic to local anesthetics
* BMI\> 40 kg/m2
* Those with chronic pain
* Those with a history of previous abdominal surgery
* Patients who refuse the use of postoperative patient-controlled analgesia
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)

This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females who are 10 - 17 years of age
* History of type 2 diabetes
* Nonsmoker
* No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

Exclusion Criteria:

* History of diabetic ketoacidosis
* History of stroke, chronic seizures or major neurological disorder
* Consumes alcohol
* Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other beverages containing caffeine per day
* Unable to swallow tablets
* Has had surgery, donated or lost 1 unit of blood, or participated in another investigational study within a minimum of 4 weeks prior to starting the study
* History of multiple and/or severe allergies or has had an allergic reaction to or significant intolerability to prescription or non-prescription drugs or food
* Currently a regular user of any illicit drugs or has a history of drug or alcohol abuse
* History of clinically significant endocrine, gastrointestinal,

cardiovascular, hematological, hepatic, immunological, renal, respiratory, or

genitourinary abnormalities or diseases

* Has an estimated creatinine clearance of less than or equal to 80 mL/min
Clinical and Biologic Effects of Metformin in Early Stage Breast Cancer

The study will be testing metformin in patients with breast cancer who are about to undergo surgery. Patients will take metformin 3 times daily for about 2-3 weeks prior to their surgery date. It is hypothesized that metformin will reduce cell proliferation rates in tumour tissue.


Eligibility Criteria:
Inclusion Criteria:

1. invasive T1-4 (if T1, ≥ 1cm), NX operable breast cancer confirmed on core biopsy
2. \< 70 years of age
3. breast surgery scheduled at least 2 weeks after study entry at one of the participating institutions (metformin will be started no more than 3 weeks prior to scheduled surgery) for the current breast cancer
4. patient and physician consent

Exclusion Criteria:

1. on metformin for any reason during the preceding 4 weeks
2. recent (within 4 weeks) antiestrogen or estrogen therapy
3. prior or concurrent systemic neoadjuvant BC therapy of any type (chemotherapy, hormone therapy, biologic therapy)
4. known diabetes or baseline fasting glucose \> or = 7.0 mmol/L (specific treatment is required)
5. current or recent (within 4 weeks) use of drugs that may influence insulin or insulin sensitivity including oral corticosteroids, insulin sensitizers, exogenous insulin or oral hypoglycemic agents
6. serum creatinine above upper limit of normal for the institution
7. history of lactic or other metabolic acidosis
8. consumption of \> 3 alcoholic beverages per day (on average)
9. AST \> 1.5 times upper limit of normal for the institution
10. known hypersensitivity or allergy to metformin
11. current or past congestive heart failure
12. coagulopathy (including use of anti-coagulants) precluding biopsy
13. pregnancy or lactation within 3 months.
14. Serious psychiatric illness

    * Note: Women with childbearing potential will be required to use an effective form of birth control (condom or other barrier method, tubal ligation or vasectomy - oral contraceptives are contra-indicated in breast cancer) and to have a negative pregnancy test prior to starting metformin.