cyrilzakka/clinical-trials huggingface dataset:
The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health

The purpose of this study is to determine whether consumption of the active product affects postprandial changes in metabolic indices, in comparison to the control product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy free-living men aged from 20 to 60 years old, and postmenopausal women aged from 45 to 60 years old, on the day of inclusion
* Able to understand the information sheet and comply with all the trial procedures
* Having given written consent to take part in the study prior to participation.
* Body mass index (BMI): 18.0 - 35 kg/m².

Exclusion Criteria:

* Those diagnosed with Phenylketonuria (PKU)
* Those with known or suspected food intolerances, allergies or hypersensitivity
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study
* Women who are breast feeding
* Participation in another clinical trial
* Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months
* Those with Full Blood Counts and Liver Function test results outside of the normal range
* Pre-menopausal women due to the potential influence of cyclical changes in reproductive hormones on insulin sensitivity
* Current smokers, or reported giving up smoking within the last 6 months
* History of substance abuse or alcoholism
* Reported history of CVD, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function
* Unwilling to restrict consumption of specified high polyphenol foods for 24 h before the study
* Weight loss \>3kg in preceding 2 months and body mass index \<18 or \>35 kg/m²
* Blood pressure ≥160/100 mmHg
* Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
* Medications that may interfere with the study such as alpha-glucosidase inhibitors (e.g. acarbose), insulin-sensitising drugs (e.g. metformin, thiazolidinediones), sulfonylureas, and lipid-lowering drugs. Other medications, should be reviewed by medical representative from KCL on a case by case basis.
* Nutritional supplements that may interfere with the study such as higher dose vitamins/minerals (\>200% RNI), B vitamins, Vitamin C, calcium, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, potassium and zinc. Subjects already taking vitamin or minerals at a dose around 100 % or less up to 200% of the RNI, or evening primrose/algal/fish oil supplements will be asked to maintain habitual intake patterns, ensuring that they take them every day and not sporadically. They will be advised not to stop taking supplements or start taking new supplements during the course of the study.
Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients

Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. The aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.

The study is divided in 4 parts:

Part 1: study of cellular infiltrate (lymphocytes) performed on large primary melanoma and cutaneous metastasis ( fresh samples) Part 2: NK cells study on metastatic regional lymph nodes ( fresh samples) and blood samples Part 3: a retrospective study of macrophages in sentinel lymph nodes and in corresponding primary melanomas Part 4: study of the cellular modulation by the chemotherapy (DTIC or cisplatin or inhibitor of B-raf) which(who) will be made on two cutaneous metastases by patient (one taken before the treatment(processing) and one taken during the evaluation after 2 or 3 cycles of treatment(processing))

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed melanoma-patients informed of the aims of the study , the modalities
* Patients who signed the consent form ou a non opposition form signed by the patient or by a relative

According to study part:

Part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis Part 2: stage IV melanoma patients who shall undergo a regional lymph node dissection Part 3: retrospective study of patients who underwent a sentinel node procedure Part 4: Patients achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment (processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases

Exclusion Criteria:

* Refusal to take part in the study (patient or relative)
* Contraindications known to the xylocaine (groups 1,2, and 4)
* No affiliated to the social security system (groups 1, 2, and 4)
EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy

The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.

This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.

Eligibility Criteria:
Inclusion Criteria:

* Females, 18-75 years of age inclusive.
* American Society of Anesthesiologist (ASA) physical status 1-3.
* Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).
* Physically and mentally able to participate in the study and complete all study assessments.
* Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.

Exclusion Criteria:

* Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
* Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.
* Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.
* Any subject, who in the opinion of the Investigator, is on chronic pain medicine.
* Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.
The Efficacy And Safety Of Lacidipine And Amlodipine Once-Daily Treatment In Hypertensive Adult Patients

The sustained reduction in elevated blood pressure and lower incidence of adverse events of Lacidipine may provide additional benefits for hypertension patients than other CCBs (calcium channel blockers). This study is to compare the efficacy and safety of Lacidipine with Amlodipine, the most widely used CCB in Taiwan, in hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent written prior to the recruit into the study
* Male or female subjects
* Patients with diagnosis of essential, uncomplicated hypertension
* After one to two weeks washout period, patients showing, systolic blood pressure equal or lager than 160mmHg or diastolic blood pressure equal or lager than 90mmHg

Subject could be enrolled in one of the following state:

1. Patients previously untreated for hypertension;
2. Intolerant or not responding to their current therapy;
3. Patients controlled under their previous therapy but who can safely and agree to be switched to the trial therapy could clinically feasible for mono-therapy for hypertension control.

Exclusion Criteria:

* Any form of secondary hypertension
* History of malignant hypertension or evidence of accelerated hypertension
* Myocardial infarction within 3 months
* Unstable angina pectoris
* Congestive heart failure
* Atrial fibrillation
* Life threatening arrhythmia
* History of cerebrovascular accident
* Clinically relevant renal disease; defines if serum creatinine equal or lager than 1.5 mg/dl
* Liver function abnormal: glutamic-oxalacetic transaminase lager than 2 times of upper limit normal or glutamic-pyruvic transaminase lager than 2 times of upper limit normal
* Existence of any serious systemic disease
* Allergic history to the compounds of both study medication
* Can not comply the study protocol or misunderstand the informed consent form
* Other diseases which treated by calcium channel blockers
Treatment of Atrophic Nonunion by Preosteoblast Cells

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields).

Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The percutaneous technique of autologous bone-marrow grafting is a minimally invasive alternative able to produce a good healing of the fracture. The efficacy is dependent of the concentration in progenitor cell reinjected. An optimization of this type of treatment could be achieved using a technique to increase the differentiation of the bone marrow cells in preosteoblasts before the injection in situ by an adequate culture. Therefore we would like to start a pilot open study on the feasibility and the efficacy of implantation of preosteoblasts into nonunion. Two different presentations exist: the atrophic and the hypertrophic pseudarthrosis in relationship with radiological features of bone proliferation at the tip of bone fragments. Some data support that atrophic and hypertrophic nonunion fractures could have different physiopathological factors. So, in a first time we only would evaluate the atrophic form and to determine in an open study the effect of the implantation of preosteoblasts into atrophic nonunion.

We will recruit 30 patients having a atrophic nonunion fracture of long bone present for minimum 6 months.50 ml of bone marrow harvest will be performed under local anaesthesia 3 weeks before the implantation. After three weeks of culture, preosteoblastic cells will be injected into the site of pseudarthrosis under radioscopic control, using percutaneously a 3 mm trephine.

An immobilization and non weight-bearing of the bone will be respected during the first month after the injection. If callus could be observed on radiographs, partial mobilization and weight-bearing will be allowed during the second month.

Eligibility Criteria:
Inclusion Criteria:

* Fracture of a long bone having insufficient healing after minimum 6 months.
* Be able and willing to participate in the study.

Exclusion Criteria:

* Evidence of malignant disorder in the past five year.
* Patient who is positive for an HIV, hepatitis B or C infection.
* Insufficient reduction of the fracture with displaced fragments.
* Evidence of local sepsis by biological parameters and/or positive isotopic scan using leucocytes labelled by Indium.
Weight-bearing of Surgically Treated Acetabular Fractures.

The purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. The study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively.

Both study groups are stratified according to

* Type of fracture (anterior approach vs anterior + additional posterior approach)
* Dislocated dome vs non-dislocated/ non existing separate dome fragment

Patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. This is to examine a potential participation bias in the RCT groups. These patients will not be counted into the target amount of 50 RCT patients.

For the past 20 years, the established treatment of dislocated acetabular fractures has been surgical reduction and stable osteosynthesis. Good long-term results have been reported in these patients. At present, the mobilisation of these patients after surgery is generally restricted for several weeks ranging from 6-12 weeks touch-down- or non-weight-bearing with no uniform protocol. However there is no scientific evidence for limiting post operative weight-bearing. Accordingly the need of studies on weight-bearing surrounding periarticular fractures has been advocated.

Acetabular fractures in the elderly population are becoming more common and pose significant challenges for treatment including postoperative rehabilitation. Our aim is to investigate if patients benefit of a more liberal weight-bearing regime postoperatively. The primary outcome is measured at 1 year, secondary outcomes are followed up to 10 years postoperatively

Eligibility Criteria:
Inclusion Criteria:

* Unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative CT scan)
* The osteosynthesis is performed during 21 days after initial trauma
* The patient is willing to participate in the follow-up

Exclusion Criteria:

* Unwillingness to participate in randomisation
* Bilateral fracture
* Letournel \& Judet type Both column or Posterior column and wall fractures
* Any other injury that prevents the patient from partial weight bearing
* Open fracture of the acetabulum
* Pathologic fracture (fragility fractures are not an exclusion criteria)
* Prior functional disability in the pelvis or lower extremity
* Non-Compliance due to dementia or other mental disability
* Prior daily pain medication due to hip-pain
* Unwillingness to accept one of the two mobilisation protocols
* Prior hip replacement on injured side
* BMI \> 40
Neural Correlates of Tactile Prediction

This project aims to measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. We will perform several behavioral evaluations to analyze the results in view of the quality of development.

We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. Children will be recruited from local schools and institutions. Birth will be considered premature if children were born before 36 weeks of gestational age. Children will be considered as having neurodevelopmental disorder if they receive medical and/or paramedical care at the time of measurement for neurodevelopmental disorder, including autism spectrum disorder, attention deficit with or without hyperactivity, tics, learning disorders, but all participants must be attending school at the time of measurement.

Children will come to the lab for a 2 hours session with their parents, during which they will undergo movement, attention and executive functions evaluations. Parents will fill out questionnaires evaluating their child's executive functioning and sensory profile in home/everyday settings. Children will then be equipped with 128-channels electroencephalography and proposed two tests : a modified attention network task and a tactile prediction task.

We will calculate correlations between evoked potential amplitudes during the tactile prediction trials and inhibitory conflict trials. Results will be analysed in the light of age, gestational age at birth, ecological and psychometric evaluations, and neurodevelopmental status.

Eligibility Criteria:
Inclusion Criteria:

* Age 24 to 35 or 72 to 83 months
* Born prematurely or term, with or without neurodevelopmental disorders (see arms)
* Parental informed consent
* Attending school

Exclusion Criteria:

* Severe IQ deficit or language impairment
* Psychotropic medication
Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention

The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥23 (≥22 in Asians) kg/m2 but \< 45 kg/m2
* HbA1c 5.7-8.0% while not on antihyperglycemic medications

Exclusion Criteria:

* Recent (\<6mos) CVD event
* active malignancy, kidney/liver disease pregnancy/lactation, chronic inflammatory disease, eating disorder, bariatric surgery
* history of acute pancreatitis
* family or personal history of medullary thyroid cancer
* current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)
* heavy alcohol use
* hct \<30, creatinine \> 1.4, ALT\> 3x ULN
* physical activity \>2 hours/day
* inability to come to Stanford CTRU for metabolic testing
The Effect of Bladder Stimulation Technique and Bathing Method on Urine Collection in Term Babies

Purpose of the Study: The aim of this study is to examine the effect of bladder stimulation technique and bathing method on urine collection in term infants hospitalized in the neonatal intensive care unit.

Content of the Study: This study will consist of 3 groups. Babies in the 1st group, the control group, will be fed only with breast milk or formula, and after 25 minutes, a urine bag will be inserted and urination will be expected. The babies in the second group, the bladder stimulation technique application group, will also be placed in a urine bag 25 minutes after feeding. Then the bladder stimulation technique will be applied. This technique; consists of two consecutive maneuvers. In the first maneuver, the bladder (Urine Bag) is stimulated by hitting the suprapubic (lower parts of the abdomen) area for 30 seconds at a frequency of 100 touches per minute. In the second maneuver, a 30-second circular massage is applied to the paravertebral region (located next to the spine). Babies in the 3rd group, the bathing group will be fed formula or pumped breast milk, depending on the baby's age and weight. Babies will be bathed under running water 20 minutes after feeding.The bathing process will take 4 minutes in total. After bath, a urine bag will be inserted at the 25th minute of feeding. In all group, urine urination will be monitored by running the stopwatch immediately after the urine bag is placed on all babies. When the baby urinates, the stopwatch will be stopped and the time and success of urination will be recorded on the observation form by the researcher.


Eligibility Criteria:
Inclusion Criteria:

* Term babies whose gestational age is 37+6 days and above,
* Full-term newborns aged 1-28 days
* Orally fed babies
* Babies with stable health status,
* Babies who do not have urological, neurological diseases, or anatomical anomalies that may affect bladder function,
* Babies of parents who voluntarily agree to participate in the study will be included in the study.

Exclusion Criteria:

* Preterm babies whose gestational age is below 37+6 days,
* Babies fed with an orogastric tube (OGS),
* Babies with serious health problems (such as respiratory distress),
* Babies with urological, neurological diseases or anatomical anomalies that may affect bladder function,
* Babies of parents who do not agree to participate in the study will be excluded from the study.
Eponychial Stent Study

The study design is a prospective, randomized, controlled trial evaluating the cosmetic and functional outcomes of nail bed repairs with and without eponychial stents. Patients presenting to a single institution with a finger tip injury requiring a nail bed repair will be initially evaluated in the emergency department. The purpose of the study will be explained to the patient, and informed consent for participation will be obtained. Patients will be randomly assigned to either the eponychial stent or no eponychial stent group based on the last digit of their assigned medical record number. Even-numbered patients will be randomized to the stent group and odd-numbered patients will be randomized to the no stent group. Demographic data will be obtained and recorded (age, gender, hand dominance, mechanism of injury, and past medical history). All patients will undergo a thorough clinical exam under digital nerve block followed by removal of the nail plate and thorough irrigation and debridement of devitalized tissue. The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, a stent (native nail, suture container foil, or nonadherent gauze) will or will not secured under the eponychial fold with suture depending on randomization. Laceration characteristic and time required to perform the procedure will be recorded. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection. Follow-up evaluation will occur at 1 week, 1 month, 3 months, and 6 months. A each follow-up visit, patient-perceived functional outcome, cosmetic outcome, and level of pain will be assessed using a 10-point analog scale. Cosmetic results will also be evaluated by the examining physician using a validated physician-based outcome tool.


Eligibility Criteria:
Inclusion criteria:

1. Men and women, age \> 18 years.
2. Patients with either nail plate avulsion and/or fracture with associated nail bed injury or subungal hematoma \> 50% with intact nail plate.
3. Presentation within 8 hours of injury.
4. Being treated at NYU Langone Health or Jamaica Hospital Medical Center.
5. Willingness to participate in the study

Exclusion criteria:

1. Nail plate/bed injury secondary to bite wound