cyrilzakka/clinical-trials huggingface dataset:
Fetal CPR at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by GDM

The goal of this observational study is to evaluate fetal cerebroplacental ratio at term and its relation to adverse neonatal outcome in patients with gestational diabetes. The main question\[s\] it aims to answer are:

* To evaluate the efficacy (sensitivity \& specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes
* To evaluate the difference in fetal cerebroplacental ratio in patients treated by insulin \& those on metformin
* to evaluate the incidence of adverse neonatal outcome in patients treated by insulin \& those on metformin.

Participants will undergo ultrasound and doppler study at 37 weeks \& every two weeks thereafter till delivery. Neonatal assessment will be done after delivery to exclude adverse outcomes.

pregnant females in the reproductive age, pregnant ≥37 weeks, who were diagnosed with gestational diabetes by routine screening at 24-28 weeks, and are on metformin or insulin treatment. Informed consent, to share in the study, will be taken from all participants after describing the aim of the study and the potential hazards.

The patients enrolled in our study will be divided into two equal groups according to their treatment regimens:

(Group A): 130 patients who are on insulin treatment

(Group B): 130 patients who are on metformin

\*All participants will be subjected to the following:

A) Full history taking:

Including personal, menstrual, obstetric, present, past \& family history. B) Complete Physical Examination (general \& local).

C) Investigations:

* Routine baseline investigations:

  1. Complete blood picture, Rh typing, liver \& kidney functions.
  2. HbA1C estimation.
  3. Surveillance of maternal diabetes: daily fasting and 2- hour postprandial capillary glucose measurement.
  4. Routine obstetric ultrasound will be done at term (at 37 weeks gestation): to confirm gestational age, assess fetal weight (EFW) and amniotic fluid index (AFI) and to exclude fetal anomalies.
* Doppler ultrasonography assessment:

Doppler study and Cerebroplacental ratio assessment will be done at 37 weeks gestation and repeated every two weeks.To reduce inter-operator variability, a single experienced sonographer will perform all sonograms.

The mode of delivery and the gestational age at delivery will be noted

Early neonatal assessment:

1. 1\&5 minutes APGAR score
2. Neonatal blood glucose
3. Neonatal cord blood PH
4. The need for NICU admission

Eligibility Criteria:
Inclusion Criteria:

* Maternal age: 18-40 years
* Diagnosed with gestational DM and are on insulin or metformin treatment.
* Single living pregnancy.
* Gestational age ≥ 37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).

Exclusion Criteria:

* Fetal anomalies.
* Maternal chronic diseases esp. renal disease, epilepsy or CNS lesion.
* Pregnancy induced medical disorders.
* IUGR (EFW below the 10th percentile for gestational age).
* Rupture of membranes or oligohydramnios (AFI \< the fifth percentile).
SPARK a Healthy and Fit Lifestyle

The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.


Eligibility Criteria:
Inclusion Criteria:

* 18-25 years old
* body mass index 25-45
* willing to be randomly assigned to any of the 3 arms
* available during the time frame of the study
* willing to complete assessment visits at 0, 2, 4 and 6 months

Exclusion Criteria:

* Age or BMI outside of eligible range
* Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe
* Pregnant or nursing within 6 months
* recent weight loss \>10% of body weight
* History of eating disorder
* Substance abuse or dependence
A Study of CT-388 in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Body mass index (BMI) ≥25.0 kg/m\^2
* Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
* Have an HbA1c ≥7% and ≤10.5%
* Management of T2DM with diet and exercise alone or diet and exercise and treatment with metformin or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor as monotherapy or in combination, per approved local label
* At least one self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

* Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
* Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemia unawareness within 3 months prior to screening
* Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, non-proliferative diabetic retinopathy that requires acute treatment
* Have presence of active neuropathy (including resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
* Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
* Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment with these medications during the study
* Self-reported body weight change of \>5 kg within 3 months before screening
* Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very high protein, ketogenic, or intermittent diets, within 3 months of the screening visit, or plan to be on such diets during the study
* Current or recent participation in an organized weight reduction program
* Current or recent use of any treatment that promotes weight loss or glucose metabolism
* Current or recent use of treatment that may cause weight gain
* Prior or planned surgical treatment for obesity
* Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
* History of chronic pancreatitis or acute pancreatitis within 6 months before screening
* Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
* History of major depressive disorder within 2 years of screening
* Family or personal history of medullary thyroid carcinoma
* Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method
Comparison Between Lung Ultrasound and Chest Radiography for Acute Dyspnea

For patients presenting to the Emergency Department with acute dyspnea, emergency physicians will be asked to categorize the diagnosis as acute decompensated heart failure or non-cardiogenic shortness of breath a) after the initial clinical assessment, and b) after performing lung ultrasound (LUS) for LUS arm or after chest radiography (CXR) and natriuretic peptide (NT-pro BNP) results for CXR arm. All patients will undergo CXR, those enrolled in the LUS arm, after sonographic evaluation. After discharge, the cause of patient's dyspnea will be determined by independent review of the entire medical records performed by two emergency physicians. In case of disagreement, a third expert physician will review entire medical records, and adjudicate the case.

Study protocol After the initial standard work-up, which includes past medical history, history of the present illness, physical examination, ECG, and arterial blood gas analysis, the emergency physician responsible for patient care will be asked to categorize the diagnosis as ADHF or non-cardiogenic dyspnea.

Then, the patient will be assigned to one of the experimental arms. In the LUS arm, the same emergency physician will perform LUS, and express the new integrated presumptive etiology ("LUS-implemented" diagnosis). All patients will then undergo CXR.

In the CXR arm, patients will undergo CXR, and the new integrated etiology will be record after CXR and NT-proBNP results will be available.

After hospital discharge, two expert emergency physicians, blinded to LUS results, will independently review the entire medical record, and indicate the final diagnosis. In case of disagreement, a cardiologist will review the medical records, and adjudicate the case.

Statistical analysis The accuracy of each diagnostic tool will be expressed as sensitivity, specificity, predictive values and likelihood ratios obtained using 2 x 2 tables. "Positive" and "negative" results will be considered, for each test, the diagnosis of ADHF or non-cardiac dyspnea, respectively. Receiver operating characteristic (ROC) and area under curve (AUC) statistics will be also shown.

Eligibility Criteria:
Inclusion Criteria:

* acute dyspnea as chief complaint
* presence of an emergency physician skilled in lung ultrasound at evaluation time

Exclusion Criteria:

* mechanical ventilation ongoing at enrolment time
* dyspnea clearly related to a different aetiology (e.g. trauma, anxiety, etc)
Evaluation of the Effectiveness of the Remedee Solution in Fibromyalgia

Fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. These symptoms are due to a dysfunction of the central nervous system, namely increased sympathetic and decreased parasympathetic levels of activity, and a deficit in endogenous pain inhibition.

Remedee Labs is developing a unique technology using millimeter waves to stimulate subcutaneous nerve receptors of the wrist, sending a message to the brain, which in turn releases endorphins. These endorphins induce a hypoalgesic effect and activate the parasympathetic nervous system, which reduces pain, stress, and improves sleep.

The Remedee Solution evaluated in this study is a wristband designed to deliver millimeter wave, a mobile application that allows the patient to follow his treatment sessions and a personalized support which aims to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment.

The hypothesis of this study is that regular use of the Remedee Solution for three months improves the quality of life of fibromyalgia patients.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (Wolfe et al., 2016),
* FIQ score ≥ 39 (moderate and higher forms) on the day of inclusion (D0),
* with a smartphone that runs on Android 8 and iOS 12 or later,
* agreeing the installation of the Fibrepik app on the smartphone,
* agreeing the collection of the number of steps measured by the smartphone,
* agreeing the installation of the Google Fit app for patients whose smartphone runs on Android (necessary for the collection of the number of steps),
* wrist size compatible with the size M or L of the wristband template,
* affiliated to the social security system or beneficiary of such a system,
* who have signed a consent to participate.

Exclusion Criteria:

* with a characterized depressive episode according to the DSM 5,
* substantial change in treatment in the three months prior to inclusion and in the months to come: change in analgesic level, introduction of a new treatment.
* with a chronic inflammatory pathology (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, lupus,...),
* person in civil proceedings,
* having a dermatological pathology on the wrists, such as oozing dermatosis, hyper sweat or an unhealed lesion,
* with a surgical implant, tattoo or piercing on one of the wrists,
* allergic to metals and/or silicone,
* referred to articles L1121-5 to L1121-8 of the French Public Health Code (CSP): Pregnant, parturient or nursing woman; Person deprived of liberty by judicial or administrative decision; Person subject to a legal protection measure or unable to express his/her consent; Person under psychiatric care
* in a period of exclusion from other interventional research.
FMS European Long-Term Study

Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* patient who completed the 3-month F02207 GE 302 study
* patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study

Exclusion Criteria:

* known hypersensitivity to milnacipran
* major depressive episode
* significant risk of suicide
* generalised anxiety disorder
* substance abuse
* clinically significant cardiac disease
* pulmonary dysfunction
* active liver disease
* renal impairment
* autoimmune disease
* current systemic infection
* epileptic
* active cancer
* severe sleep apnoea
* active peptic ulcer
* inflammatory bowel disease
* unstable endocrine disease
* (for men) prostatic enlargement or other genito-urinary disorders
* (for women) pregnancy or breastfeeding
Familial Hypocalciuric Hypercalcemia: Clinical Aspects and Evolution

Familial hypocalciuric hypercalcemia (FHH) is a rare disease (ORPHA#405, www.orpha.net) and most likely underdiagnosed, that clinicians should be aware of in the differential diagnosis of a hypercalcemia. Appropriate identification of the FHH has implications in treatment and also for the family, since it is an automosal-dominant disease, due to mostly a heterozygous loss-of-function mutation of the CASR (calcium-sensing receptor) gene, but also much less freqüent mutations of another two genes (AP2S1 and GNA11). In case of clinical and biochemical suspicion of FHH, a genetic evaluation is mandatory. Nevertheless, an important number of patients, the genetic study is negative. This observational study is intended to perform a descriptive review of cases with clinical and biochemical suspicion of FHH who underwent a genetic study in the usual clinical practice. Clinical, biochemical and radiological characteristics, treatment, follow-up and comorbidities of genotype-negative participants will be compared with genotype-positive cases.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical and biochemical suspicion of FHH who, at the discretion of the physician in routine clinical practice, were asked to perform a genetic evaluation of FHH and whose genetic results are available.

Exclusion Criteria:

* Genetic study of FHH is not available or was not performed despite clinical and biochemical suspicion of FHH.
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with history of immediate hypersensitivity reactions to iodinated contrast media
2. 15-70 years of age

Exclusion Criteria:

1. On antihistamine/ cannot discontinue antihistamine before the test
2. Having asthma exacerbation
3. Being pregnant
4. Suffering from severe systemic disease/ in bad health
The Impact of an Antibiotic (Cefazolin) Before Surgery on the Microbiome in Patients With Stage I-II Melanoma

This phase I trial investigates the impact of cefazolin before surgery on the microbiome in patients with stage I-II melanoma. Antibiotics, such as cefazolin, given at the time of surgery may cause a significant change in the microbes (like bacteria and viruses) found in the stomach and intestines. This trial may help researchers learn if any changes in microbes affect the body's ability to respond to surgery and cancer.

PRIMARY OBJECTIVE:

I. To investigate whether the use of pre-operative prophylactic antibiotics administered during surgical resection substantially alters the patient's gut microbiome.

SECONDARY OBJECTIVES:

I. To characterize the dynamics of the immune response to surgical intervention in the absence and presence of pre-operative prophylactic antibiotics, focusing on the immune profile of the peripheral blood leukocytes as well as the balance of circulating pro- and anti-inflammatory cytokines and metabolomic profiles.

II. To assess surgical site infection (SSI) in the absence and presence of pre-operative prophylactic antibiotics at time of surgical resection.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive cefazolin intravenously (IV) and then undergo standard of care surgical resection within 1 hour.

ARM B: Patients undergo standard of care surgical resection.

After completion of study treatment, patients are followed up at 3 days, 2 weeks, and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with early stage melanoma (stage I-II)
* Patients must be undergoing wide local excision +/- sentinel lymph node biopsy
* Patients must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

* Use of antibiotics within the three months prior to surgery
* Allergy, sensitivity or anaphylaxis to beta-lactam or cephalosporin antibiotics
* Presence of an infection at the time of surgery
* Increased risk of infection due to a co-existing medical condition as determined by the surgical team or principal investigator (PI)
* Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration
* American Society of Anesthesiologists (ASA) grade \> IV
* Refusal to participate in the study
* Patients who are pregnant will not be included in this study
Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension

This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or glaucoma in both eyes
* Require IOP-lowering therapy in each eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Known allergy or hypersensitivity to bimatoprost
Preoperative TAP Block Versus Postoperative TAP Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial

The goal of this clinical trial is to learn if the regional anesthesia technique "TAP block" provide more analgesia when performed before or after the surgery. The main questions it aims to answer are:

Does preoperative TAP block provide greater analgesia than postoperative TAP block? Patients receiving preoperative TAP block will have less pain and take less painkillers than patients receiving postoperative TAP block?

Participants will:

Receive preoperative or postoperative TAP block They will be asked about their pain levels during the hospital stay.

The TAP block is a safe, easy-to-perform, and effective technique for managing postoperative pain. It reduces opioid consumption and increases patient satisfaction. Despite recent studies indicating that postoperative TAP block might be more effective than preoperative TAP block in reducing opioid use within 24 hours, the optimal timing of its administration (before or after surgery) remains unclear.

In this study we will compare preoperative to postoperative TAP block in patients undergoing laparoscopic cholecistectomy.

The primary aim of this study is to determine the difference in postoperative pain control between preoperative and postoperative TAP block administration in patients undergoing laparoscopic cholecystectomy.

The primary objective will be to evaluate the difference in postoperative pain at rest, 24 hours after surgery, between patients receiving preoperative versus postoperative TAP block. Pain will be assessed using the Numeric Rating Scale (NRS) from 0 to 10.

Secondary objectives will be intraoperative and postoperative opioids, postoperative nausea and vomiting, pain at resnt and on movement at 0,6,12,24 hours.

Eligibility Criteria:
Inclusion Criteria

* ASA I-II patients
* Age \>18 years
* Informed consent

Exclusion Criteria

* History of chronic pain
* Beta-blocker therapy
* Allergy to the drugs used in the study
Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)

Irritable bowel syndrome is a common condition affecting 1 in 10 of the population. About a third of these suffer from diarrhoea, which severely impairs their quality of life. Previous studies in Nottingham have suggested that some patients with diarrhoea may have an excess of a chemical called serotonin in their gut. Serotonin stimulates secretion and propulsion in the gut and contributes to diarrhoea. We are interested to see whether a drug, Ondansetron, which blocks the effect of serotonin, would improve symptoms in patients with IBS and diarrhoea. We think the drug may work better in people with a specific gene type so your genetic makeup may be of influence and we would like to test this. Because IBS symptoms fluctuate, one way to determine whether Ondansetron is effective is to perform a randomised placebo controlled trial in which neither the patient nor the doctor knows which medication is being taken in each part of the study.


Eligibility Criteria:
Inclusion Criteria:

* IBS-D patients meeting the Rome III criteria.
* Male or female aged 18-75 years
* Women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study., (e.g. implants, injectables, combined oral contraceptives, sexual abstinence or vasectomised partners)
* Patients who are able to give informed consent.

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Patients that, in the opinion of the investigator, are considered unsuitable.
* Patients who have had abdominal surgery which may cause bowel symptoms similar to IBS (Please note, appendicectomy and cholecystectomy is not an exclusion)
* Patient unable to stop anti-diarrhoeal drugs
* Patients currently participating in another clinical trial or who have been in a trial in the previous three months

Since many patients will be on SSRIs or tricyclics antidepressants these will not be an exclusion criteria, provided they have been on medication at least 3 months and that the dose remains unaltered throughout the study.