cyrilzakka/clinical-trials huggingface dataset:
Difference Between Monofilament Versus Multifilament Suture Material in Isthmocele Formation

This thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section.

The difference between monofilament and multifilament sutures and the special properties of each one .

The primary outcome of the study is to know which material conducts more scar niche formation .

Secondary outcomes are the extent of blood loss , the need of extra hemostatic sutures


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-45 years old

  * Singleton pregnancy.
  * Gestational age between 37 completed weeks to 42 weeks.
  * Patients undergoing elective primary caesarean section

Exclusion Criteria:

* History of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section). (to be able to differentiate between the recent CS scar and the old scar)

  * Abnormal placental invasion (placenta previa and accrete ) ( more liable to undergo Cesarean hysterectomy)
  * Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids). (may be localized at the suture line and therefore affect the scar)
  * Drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative)
  * Any medical Co-morbidity (diabetes mellitus, Hypertension and Thyroid abnormalities) (more liable to affect the healing)
A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.

The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .


Eligibility Criteria:
Inclusion criteria:

* Ability to sign a written Informed Consent Form consistent with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial (i.e., prior to any study procedures, including any pre-study washout of medications).
* Age of 40 years or older.
* Smoking history of ≥10 pack-years.
* A diagnosis of relatively stable chronic obstructive pulmonary disease with an Forced expiratory volume in one second (FEV1) ≤60% of predicted normal and FEV1 ≤70% of Forced vital capacity (FVC).
* Ability to perform technically acceptable pulmonary function tests, and ability to maintain records during the study period as required in the protocol.
* Ability to inhale medication from the HandiHaler® and from a metered dose inhaler.

Exclusion criteria:

* Clinically significant diseases other than Chronic obstructive pulmonary disease (COPD). A clinically significant disease was defined as a disease or condition which, in the opinion of the investigator, could have put the patient at risk because of participation in the study or may have influenced either the results of the study or the patient's ability to participate in the study.
* Known moderate or severe renal insufficiency.
* A recent history (i.e., six months or less) of myocardial infarction.
* Unstable or life-threatening cardiac arrhythmias, including newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed on Visit 1. Unstable arrhythmias included arrhythmias that required an intervention (i.e., hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the year preceding study enrollment.
* Hospitalization for heart failure during the past three years.
* History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
* Other exclusion criteria apply.
Violence Against Women in Patients With Alcohol Substance Addiction Training

This study was planned as a randomized controlled trial in order to determine the effect of creative drama training for alcohol-substance dependent male patients on their attitudes towards violence against women.

This study was planned as a randomized controlled trial in order to determine the effect of creative drama training for alcohol-substance dependent male patients on their attitudes towards violence against women.

The study was planned to be fully experimental. The participants to be included in the study will be selected from men who are followed up with a diagnosis of addiction in a mental health hospital. In the experimental group, male patients will be given violence against women training supported by creative drama five days a day. It will be used as an improved scale-measuring tool for women before and after the training. In the control group, the trainings applied in the service operation will be applied. It will be used as an improved scale-measuring tool for women before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Literate,
* Male inclusion,
* Have reached the age of 18,
* do not have an acute psychotic illness,
* Patients without symptoms of delirium tremens or intense withdrawal made up the study group of this study.

Exclusion Criteria:

* Illiterate,Woman,
* Have an acute psychotic illness,
* Delirium tremens or those with symptoms of intense withdrawal,
* Patients who did not agree to participate in the study were not included in this study.
Rebooting Infant Pain Assessment: Using Machine Learning to Exponentially Improve Neonatal Intensive Care Unit Practice

A multi-national multidisciplinary team will be working collaboratively to build a machine learning algorithm to distinguish between preterm infant distress states in the Neonatal Intensive Care Unit.

Unmanaged pain in hospitalized infants has serious long-term complications. Our international team of knowledge users and health/natural science/engineering/social science researchers have come together to build a machine learning algorithm that will learn how to discriminate invasive and non-invasive distress. A sample of 400 preterm infants (300 from Mount Sinai Hospital and 100 from University College London Hospital \[UCLH\]) and their mothers will be followed during a routine painful procedure (heel lance). Pain indicators (facial grimacing \[behavioural indicators\], heart rate, oxygen saturation levels \[physiologic indicators\], brain electrical activity) during the painful procedure will be used to train the algorithm to discriminate between different types of distress (pain-related and non-pain related).

Eligibility Criteria:
* QUALITATIVE INTERVIEWS
* Inclusion Criteria:
* parents of a child currently in the NICU or
* health professionals currently working in the NICU.
* Exclusion Criteria:
* Participants who cannot communicate fluently in English
* QUANTITITATIVE DATA CAPTURE (video, eeg, ecg, SPo2)
* Inclusion Criteria:
* Infants born between 28 0/7 weeks 32 6/7 weeks gestational age
* Infants who are within 6 weeks postnatal age
* Infants who are undergoing a routine heel lance
* Exclusion Criteria:
* Infants with congenital malformations
* Infants receiving analgesics or sedatives at the time of study (aside from sucrose),
* Infants with history of perinatal hypoxia/ischemia at the time of study.
* Infants with diaper rash or excoriated buttocks
Syngery-Evaluating the Impact of Decision Aid

The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)
Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
* Body Mass Index (BMI) of ≥18 and ≤30 kg/m2;
* History or symptoms consistent with motion sickness

Exclusion Criteria:

* Chronic nausea due to condition other than motion sickness;
* A positive test for drugs of abuse at the screening or evaluation visits;
* Clinically significant deviation from normal clinical laboratory results
The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes

The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section

The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section on the following post-operative outcomes:

1. Post-operative nausea, vomiting, abdominal distention and abdominal cramps.
2. Return of intestinal movements.
3. Duration of intravenous fluid administration.
4. Duration of hospital stay.
5. Participant satisfaction

Eligibility Criteria:
Inclusion Criteria:

* • Uncomplicated pregnancy.

  * Uncomplicated elective or emergency Caesarean section under regional anesthesia

Exclusion Criteria:

* • Having medical disorders in the form of: hypertension, DM, and Hepatic disorders.

  * Having bleeding disorders.
  * Having intraoperative bowel or bladder injury.
  * Having intraoperative or immediate postoperative severe bleeding.
  * Having chronic gastrointestinal problems, like chronic constipation, peptic ulcer, esophagitis, hiatus hernia or irritable bowel syndrome.
  * Having abdominal adhesions
ICNBs for Post-op Pain in Breast Surgery

The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Classification (ASA Class) 3 and below.
* Bilateral or unilateral breast surgery including cancer extirpation, reconstruction (implant and expander), oncoplastic surgery (\<200 gm), breast augmentation and breast reduction, etc.

Exclusion Criteria:

* Patients who refuse local anesthesia.
* Patients who cannot receive local anesthesia.
* Below the age of 20 and above the age of 70.
* Patients requiring reoperation due to complications of mammoplasty or another breast surgery.
* Poorly controlled diabetics, uncontrolled hypertension, heart disease, arrhythmias, diagnosed with bipolar and generalized anxiety disorders.
Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics

This is a randomized, parallel group comparison of the immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in patients with Type 1 Diabetes Mellitus

To evaluate and compare the Immunogenicity safety of Wockhardt's Insulin analogue Lispro and lispro Mix with Eli Lilly's Insulin analogue Humalog® and Humalog® Mix in Type I Diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who understand the nature of the study and are willing to provide written informed consent.
2. Patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year
3. Male or Female Patients ≥ 18 and \< 55 years of age.
4. Patients with body mass index (BMI) of 18.0 to 30.0 kg/m2
5. Patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures.
6. Ability to use the self glucose-monitoring device and to self inject insulin.

Exclusion Criteria:

1. Females who are pregnant or lactating, or not practicing adequate contraception.
2. A Patient with compromised hepatic or renal function
3. A Patient who is an employee of the Investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the Investigator.
4. A Patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously randomized in this trial.
5. A Patient with history or evidence of allergy to insulin preparations.
6. A Patients who is currently receiving or has received, within the last year, any immunomodulator medications.
7. Patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.
8. Patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1

The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 80 years of age;
* Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification; of the acute arthritis of primary gout;
* At least 2 gout flares in the year prior to the screening visit;
* Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;

Exclusion Criteria:

* Acute gout flare within 2 weeks of the screening visit or during screening;
* Persistent chronic or active infections;
* History of an allergic reaction to allopurinol;
* History or presence of cancer within 5 years of the screening visit;
* Previous exposure to Rilonacept;
* Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.
90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers

The purpose of this study is to investigate steady-state cobalt levels following dietary supplementation for 90 days with 1 mg cobalt/day (as cobalt chloride in solution) in healthy adult volunteers.

Over the counter cobalt (Co) dietary supplements are available for sale in the United States, but little is known regarding their clinical effects and biokinetic distribution and body burden with long-term use. This study assessed blood kinetics, steady-state levels, biochemical responses, and clinical effects in five adult males and five adult females who voluntarily ingested approximately 1.0 mg Co/day of a commercially available Co supplement over a three month period. Volunteers were instructed to take the Co-dietary supplement in the morning according to the manufacturer's label. Blood samples were collected and analyzed for a number of biochemical parameters before, during, and after dosing. Hearing, vision, cardiac, and neurological functions were also assessed in volunteers before, during, and after dosing.

Eligibility Criteria:
Inclusion Criteria:

* Subject ≥ 18 years old.
* Subject able to understand and willing to sign a written informed consent form for the study.

Exclusion Criteria:

* Subject is unwilling to discontinue current multivitamins or other types of dietary supplements while on study
* Subject has a documented history of an allergy to cobalt
* Subject has a documented history of severe cardiac problems (e.g., congestive heart failure, myocardial ischemia within past 12 months, cardiomyopathy)
* Subject has a documented history of thyroid, kidney, or liver disease
* Subject has insulin-dependent diabetes
* Subject has a concurrent illness or personal stressor which in the opinion of the investigator may interfere with the subject's ability to perform the study's requirements.
* Subject has a total joint replacement (e.g., knee, hip, shoulder)
* Subject is pregnant or breastfeeding
* Subject is unwilling to follow protocol requirements
* Subject weight is less than 45 kg
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe PsA
* Inadequate response to DMARD therapy
* Corticosteroid stable dose \<=10 mg QD
* DMARDs must have been taken for 3 months and stable dose for 4 weeks
* MTX maximum dose = \<=30 mg/week
* Active chronic plaque PS or documented history of chronic plaque PS

Exclusion Criteria:

* No other active skin disease
Drug Use Investigation for LAMICTAL

The purpose of this study is to grasp actual status of usage of lamotrigine tablet and to collect information for using lamotrigine tablet effectively and safely as well as to grasp onset status of adverse events in pediatric subjects, geriatric subjects, pregnant women, subjects with poor renal and hepatic functions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with epilepsy having the following seizure types.
* Partial seizures (including secondary generalized seizures)
* Tonic-clonic seizures
* Generalized seizures of Lennox-Gastaut syndrome

Exclusion Criteria:

- None
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets

In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. Besides semaglutide, the current version of the tablet contains 300 mg SNAC and 3 helping agents, while the new version of the tablet contains 300 mg SNAC and only one helping agent. Both are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. Semaglutide cannot yet be prescribed as a tablet. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. Participants will get semaglutide in the current tablet formulation and in a new formulation - in which order they receive the two different formulations is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment for a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, they must take their breakfast 30-45 minutes after dosing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
* Use of tobacco and nicotine products, defined as any of the below:
* Smoking more than 5 cigarettes or the equivalent per day
* Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s)
* History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject).
* History (as declared by the subject) or presence of pancreatitis (acute or chronic).
Comparing Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone for Caudal Block in Supra - Umbilical Surgeries

dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically or combined to local anesthetics during regional blocks. Investigators studied the combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in pediatric patients undergoing supra - umbilical surgeries.

Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared to caudal bupivavaine alone for analgesia following upper trunk surgery

Eligibility Criteria:
Inclusion Criteria:

* supra - umbilical surgeries

Exclusion Criteria:

* allergy to the drug or coagulopathy
Diagnostic Performance of Antenatal Ultrasound in the Localization of Intestinal Structures Involved in Malrotation With a Higher-risk of Volvulus

The aims of this study are:

* To assess the performance of third-trimester ultrasound scan in the localization of intestinal structures (small bowel, gut, mesenteric vessels..) involved in malrotations with a higher-risk of volvulus compared to a gold standard based on fetal MRI.
* To describe normal meconium progression (ultrasound and MRI), prenatal anatomical variants of the fetal digestive tract, and interobserver agreement on prenatal ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over the age of 18
* Good understanding of French
* Gestational age greater than or equal than 31 weeks
* Fetal MRI indication validated in multidisciplinary staff at weekly meetings of the Multidisciplinary Prenatal Diagnosis Center in Montpellier or Nimes
* Affiliation or beneficiary of a social security scheme
* Declaration of free and enlightened opposition

Exclusion Criteria:

* Complex fetal abdominal malformations responsible for difficult interpretation of imaging: heterotaxis with asplenia or polysplenium, diaphragmatic hernia, omphalocele, gastroschisis, digestive pathology, abdominal tumor, bladder exstrophy or megavessia.
* Fetal chromosomal abnormality
* Request for termination of pregnancy validated by a Multidisciplinary Pre-natal Diagnosis Center