cyrilzakka/clinical-trials huggingface dataset:
Continuous Versus Interrupted Sutures for Repair of Episiotomy or Second Degree Tears: a Randomised Controlled Trial

The best technique for this repair would be that which requires least time in realisation, least consumption of material for the repair and that which produces less pain at short and long-term permitting the resumption of intercourse quicker and with less pain thereby requiring less necessity to take out the stitches and less frequency of re stitching. The investigators research is looking for a technique for repairing the perineum more advantageously.

445 women who participated in the project had undergone normal deliveries with episiotomy or second-grade tearing of the perineum. One group was repaired with continuous non-locking suture in the vagina, perineum and subcutaneous tissue. The other group used continuous locking suture of the vagina, interrupted sutures in the perineum muscle and interrupted transcutaneous suture. The threads used for stitching were identical in both groups. The same questions were asked concerning the sensation of pain and the use of painkillers, the second and the tenth day and at the three months.

Eligibility Criteria:
Inclusion Criteria:

* vaginal childbirth
* at least 37 weeks of gestation
* assistance by one of the 4 matrons who participated in the project
* have been subjected to an episiotomy or the appearance of tearing that affected skin and muscle
* The newborn child had to be alive, viable

Exclusion Criteria:

* instrumentation
* produce injury in the anal sphincter or in the rectum.
* serious congenital malformations.
Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy

With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia.

The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.

Our study consists of analyzing the calcium (mmol/l) and PTH (pmol/l) levels on the first postoperative day. Postoperative treatment with calcium and vitamin D and the length of hospital stay is also taken into consideration.

We also analyze post-operative complications.

Eligibility Criteria:
Inclusion Criteria:

• Total thyroidectomy

Exclusion Criteria:

* concomitant parathyroidectomy for primary hyperparathyroidism
* lobectomy only
* completion thyroidectomy
* central and lateral neck dissection
* patients with calcium and/or vitamin D supplementation prior surgery
* patients with known and significant osteoporosis and renal failure
Temporamandibular Joint Functions and Parafunctional Habits

Headache is the most common type of pain in children and adolescents with effects on health-related quality of life (HrQoL), school attendance, and social functioning. The International Headache Society recognizes that secondary headaches can be attributed to temporamandibular joint (TMJ) problems. The primary aim of the study is to evaluate temporamandibular joint functions and parafunctional habits in adolescents with headache. The second aim is to examine the relationship between temporamandibular joint functions and parafunctional habits and headache.

24 individuals under the age of 18 diagnosed with headache and 24 healthy controls will be included in the study. Age, height, weight characteristics and parafunctional habits of individuals will be recorded. The severity of headache and its effect on daily life, temporamandibular joint pain severity will be evaluated. Temporamandibular joint dysfunction severity will be determined and mouth openings will be measured.

Participants who meet the inclusion criteria will be included in the study group. Healthy volunteers without headache complaints will also be included in the study as a control group.In this study, which is planned to include those who meet the inclusion criteria and agree to participate in the study, written informed consent form will be obtained from all individuals and from their parents for those under the age of 18. The study will be carried out in accordance with the ethical principles of the Declaration of Helsinki. The study will be done through a questionnaire form and with anthropetric measurements. No invasive procedure will be applied. A p value of ≤0.05 will be considered significant in all statistics.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with headache according to the ICDH-II (International Classification of Headache Disorders 2nd edition) criteria published by IHS (International Headache Society) in 2004
* Having a headache complaint in the last 3 months
* Having a HIT-6 score of 50 or higher

Exclusion Criteria:

* Being on any analgesic, anti-sedative, myorelaxant medication
* Those with mental and psychiatric problems
Utility of Placental/Umbilical Cord Blood in Early Onset Neonatal Sepsis in Very Low Birth Weight Infants

This study evaluates the utility of placental/umbilical cord blood (PUCB) to perform the baseline workup testing for EONS in Very Low Birth Weight Infants: CBC (Complete Blood Count) with differential, Immature/Total ratio (I/T ratio), and blood culture along with CRP and IL-6 levels. A cohort (63 subjects) of preterm infants will be recruited. All the participants will be evaluated for sepsis using placental/umbilical cord blood (PUCB) and subject blood sample during the first 12 hours of life (after birth).

Early Onset Neonatal Sepsis (EONS) is common in preterm infants, and it is associated with high morbidity and mortality, especially if not diagnosed early. Currently the baseline workup is done using blood samples from the infant to perform Blood culture, CBC, I/T ratio. These tests have shown to have low sensitivity and specificity to diagnosis EONS.

PUCB can be another safe source of blood which is useful, painless and simple to collect. As CBC, I/T ratio and blood culture may not be enough to diagnose EONS we will add IL-6 and CRP which will increase sensitivity and specificity to diagnose EONS in preterm infants without collecting blood from the infants.

This study may be a step to decrease iatrogenic blood loss to diagnose EONS. The primary outcome of the current research will be to find out the utility of PUCB in diagnosing EOS in preterm infants (\<30 weeks and \<1250 grams birth weight). Using PUCB can increase the accuracy to diagnose Sepsis in Preterm infants, and it will also conserve blood in the extremely premature infants while reducing hemodynamic instability due to acute blood loss.

Eligibility Criteria:
Inclusion Criteria:

* Infants \<34 weeks' gestational

Exclusion Criteria:

* Known congenital or chromosomal anomalies
* Congenital heart disease (other than Patent Ductus Arteriosus, Patent Foramen Ovale or Atrial Septum Defect)
* Vaginal bleeding at admission
Improving Care After Chemotherapy

The main purpose of this study is to examine changes in patient-reported symptoms during the first two cycles of neoadjuvant or adjuvant chemotherapy for non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer, among patients who receive standard care plus a proactive nursing intervention relative to patients who receive standard care alone. Interventions to improve symptom management and prevent urgent care needs in both the clinic and hospital for patients receiving chemotherapy with curative intent are needed to enhance the quality of cancer care.

* Participants with NSCLC, CRC or breast cancer undergoing neoadjuvant or adjuvant chemotherapy will be asked to fill out self-report questionnaires at their first chemotherapy administration visit, in order to measure patient-reported symptoms, psychological distress, and satisfaction with oncology care.
* Participants will then be randomized into one of the two study groups: standard care with proactive phone calls from nurse practitioners or standard care alone.
* Participants assigned to the standard care group will be treated by their care team as would any other cancer patient.
* Participants assigned to the intervention group will receive four proactive phone calls from nurse practitioners designed to discuss symptom burden and management. Proactive phone calls will occur 2-4 days after chemotherapy administration and 5-7 days after chemotherapy administration, during cycles 1 and 2.
* Participants will be asked to fill out the same set of questionnaires during their second and third chemotherapy administration visits, to assess patient-reported symptoms, psychological distress, and satisfaction with oncology care.
* Medical records will be reviewed at 24-weeks following the first chemotherapy administration visit, to evaluate frequency of urgent outpatient cancer center visits, emergency department visits, and hospital admissions that occurred during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 or older)
* Newly diagnosed stage I-III colorectal cancer, non-small-cell lung cancer, or breast cancer
* Scheduled to receive neoadjuvant chemotherapy (i.e. pre-surgical cancer-directed therapy with curative intent) or adjuvant chemotherapy (i.e. post-surgical cancer-directed therapy with curative intent)
* Able to respond to questions in English

Exclusion Criteria:

* Already received 1 or more cycles of chemotherapy for the current regimen
* Unwilling or unable to participate in the study
Maternal Use of Antibiotics and the Risk of Congenital Malformations

Antibiotics are widely used during pregnancy to prevent or treat infections, yet concerns remain regarding their fetal safety. Drawing on data from spontaneous reporting databases and cohort studies, this study aims to explore potential associations between exposure to various antibiotic classes during pregnancy and congenital malformations.

Data were collected from publicly available reports in the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS), the Canada Vigilance Adverse Reaction (CVAR) database, and a population-based retrospective cohort in Xiamen, China. By applying multiple signal detection methods, we identified potential risk signals linking different antibiotic classes to organ-system-specific congenital malformations. For antibiotics showing positive signals, we further utilized a pregnancy medication cohort in Xiamen and applied causal inference techniques to estimate the adjusted relative risk of congenital malformations associated with first-trimester exposure to these antibiotics. Several sensitivity analyses-including both negative- and positive-control analyses-will also be performed.


Eligibility Criteria:
Inclusion Criteria:

* For the spontaneous reporting data study, all adverse reactions reported by mothers were included.

For the cohort study, all Xiamen pregnant women registered in the cohort were included

Exclusion Criteria:

* For studies using spontaneous reporting data, all adverse reaction reports unrelated to pregnant or postpartum women-including those occurring during the lactation period-were excluded.

For cohort studies, pregnant women who were lost to follow-up were excluded, and pregnant women who were exposed to factors known to be associated with congenital malformations were excluded.
Effect of Hyaluronic Acid on Tissue Healing After Removal of Impacted Mandibular Third Molars (LM3)

Hyaluronic acid (HY) is used in dentistry to improve wound healing after oral and periodontal surgical interventions. After the application of HY, a positive effect on the wound healing of extraction sockets and periodontal defects has been described. The removal of a mandibular wisdom tooth (LM3) often leads to remaining residual defects with increased probing depths distal to the second molar. To date, the influence of HY on periodontal healing of the distal aspect of the second molar after removal of the LM3 has not yet been investigated. Accordingly, the aim of this double-blind, controlled and randomized clinical study is the influence of the application of HY Gel or HY Gel in combination with an absorbable collagen sponge on the periodontal healing of the second molar after surgical removal of the LM3 compared to the standard procedure (blood clot). A total of 102 patients with an impacted LM3 and a pre-existing bone defect of at least 5 mm distal to the second molar will be included. In the HY test group (n = 34), HY gel is applied to the LM3 extraction socket, and in the HY + C test group (n = 34) HY gel and an absorbable collagen sponge, while the control group (n = 34) does not receive any additional treatment. Patients are followed up for 12 months and the presence of an increased probing depth (≥ 5mm) on the distal side of the second molar is defined as the main parameter. A more stable blood clot and thus improved wound healing including periodontal healing is expected through the use of HY.


Eligibility Criteria:
Inclusion Criteria:

1. Patients elder than 18 years;
2. uni- or bilateral vertical or mesioangular complete impaction of the LM3 classified to:
3. group II- or III- B or C according to Pell-Gregory (1933);
4. a distance ≥ 5 mm from the CEJ to marginal bone level at the distal aspect of the second molar.

Exclusion Criteria:

1. Patients with chronic diseases and/or
2. taking any medication, influencing hard and soft tissue healing;
3. acute pain/infection of the surgical region;
4. untreated periodontal disease;
5. patients smoking \> 10 cigarettes per day;
6. pregnancy;
7. history of hypersensitivity or allergy to HY;
8. absence of an adjacent second molar;
9. presence of caries or restoration on the distal aspect of the adjacent second molar; and
10. inability to attend the follow-up appointments.
Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood

The study is a combination of outpatient and inpatient monitoring. During the 27-day inpatient portion of the study, the individual's sleep-wake schedule will be varied daily. Volunteers will be randomized to a regular or irregular inpatient schedule.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI between 18.5 and 29.5

Exclusion Criteria:

* medications
* recent night-work, shift-work, or travel across \>2 time zones
* use of medications
* pregnant or within 6 months post-partum
Biomarkers to Predict and Monitor Response to Infliximab

The aim of the study is to generate novel minimally-invasive serum protein signatures and biomarkers in children and adolescents with Crohn's Disease (CD) that correlate with and can predict and monitor patients who will have a prolonged response to Infliximab so that personalized medicine can be applied to patients with CD.

Prospective, observational study will enroll 120 unique pediatric Crohn's disease patients between the ages of 3-20 years among multiple sites. Patients will be naïve to TNF inhibitor. If patient is going to start infliximab or infliximab biosimilar, patient may be enrolled in study. Study length will be from commencement of infliximab until the infusion visit given at least 1 year after initiation. During the study, if the patient fails infliximab or biosimilar, they will be complete study once failure is indicated and discontinued on infliximab or biosimilar. Patients may be on concurrent IBD therapy such as antibiotics, mesalamines, immunomodulators and may continue in study if non-standard induction schedule or changes made during induction or maintenance to dose or frequency. Excluded patients will be those receiving infliximab or biosimilar infusions at home due to need for blood collection at time of infusion, on systemic corticosteroids (topical preparations such as budesonide are allowed), and those who have already undergone significant bowel surgery relating to their Crohn's.

Study visits will take place in conjunction with previously scheduled routine clinic visits or infusion visits. At initial study visit, demographics, medical and surgical history, PARIS classification, PCDAI, weight and height, fecal calprotectin, labs, EGD and colonoscopy report and pathology report, cross-sectional imaging reports and concurrent medications will be obtained and entered. Parameters measured at each study visit will include any obtained labs, weight and height, PARIS classification, PCDAI, infliximab dose (mg/kg) and dose interval. There will be four study visits throughout the course of 1 year after initiating infliximab. At these four visits, blood will be obtained in PAXgene tubes for RNA analysis and serum for banking for SOMAscan analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 3-20 years old
* Patient starting infliximab or infliximab biosimilar,
* Patients naïve to TNF inhibitor

Exclusion Criteria:

* Patients receiving infliximab or biosimilar infusions at home
* Patients already undergone significant bowel surgery relating to their Crohn's.
The Role of P-glycoprotein in Sitagliptin Clinical Pharmacology

The purpose of this study is to determine the pharmacogenetics, pharmacokinetics, and drug-drug interactions of sitagliptin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between 21 to 60 years of age will be recruited to participate in this study.
* Subjects will be eligible if metabolic, renal, hepatic, and hematological laboratory tests are within normal limits.

Exclusion Criteria:

* Subjects will be excluded from the study if they have a current or past history of cardiovascular, hepatic, endocrine (e.g., diabetes), renal, pancreatic, gastrointestinal, pulmonary, immunologic, hematologic, or neurologic disease.
Can Acupuncture be Used as Preparation for Induction of Labour

The purpose of the study is to evaluate whether acupuncture can be used to ripen cervix before medicinal induction of labor or even be used as method for induction, and thereby eliminating other and more potentially harmful methods.

Acupuncture has become a natural part of the range of treatments in obstetric departments in Denmark, but there is only little evidence to the effect of acupuncture.

Many of the induction procedures currently in use in Denmark also have a little risk of side effects. to mention a few: There is a increased risk of maternal and neonatal infection, bleeding, ruptured membranes and placental disruption as result of the use of endocervical balloon catheter. In connection with manual rupture of membranes there is an increased risk of umbilical prolapse, maternal and neonatal infection, affected fetal heart rate, scratches on the scalp and placental bleeding. By using misoprostol there has been seen hyperstimulation of uterus causing affected fetal heart rate.

Many women are asking for alternatives to the existing methods used in obstetric dept.s.

In order to assess the effect, or lack of, acupuncture might have, we want to use acupuncture in the study group on acupuncture points on hands, feet, ankles and back of the head. The control group will get placebo acupuncture needles on same locations. The included women will be treated with the kind of acupuncture that counts for the group to which shes been allocated on gestational age 41+6 at 8:00 am and 2:30 pm.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 41+6
* Normal pregnancy, expecting a healthy baby
* Verified due date

Exclusion Criteria:

* Women who do not speak or understand Danish
* Multiple pregnancy
* In active labour
* Previous sectio
* Maternal diseases (i.e. Diabetes, preeclampsia, heart diseases)
* Fetal diseases (i.e. foetus mors, IUGR, hydrocephalus)
* Previous complicated delivery i.e. low Apgar score
* Allergic to metal
* Anticoagulatory treatment
Health-related Quality of Life in Korean Patients With Rheumatic Diseases

To compare the health related quality of life of patients with systemic sclerosis with other rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus and Sjogren's syndrome.

Systemic sclerosis (SSc) is a connective tissue disease characterized by vasculopathy, fibrosis, and autoimmunity. The prognosis of the disease depends on the nature and severity of organ involvement. Patients with SSc suffer from digital ulceration, arthritis, progressive skin tightening, and joint contractures that cause pain and limitation of limb function. The cardiopulmonary system may also be severly affected by SSc in the form of interstitial lung disease and pulmonary arterial hypertension, which leads to reduction in exercise capacity and symptomatic dyspnea. Gastrointestinal involvement by SSc may cause malnutrition, and SSc renal crises may result in renal failure. In addition, cosmetic disfigurement resulting from facial and limb skin involvement may lead to social isolation, mood problems, and significant work disability.

It has been reported that health related quality of life (HRQoL) is significantly impared in SSc patients compared to the general population. Moreover, the degree of impairment in SSc patients was comparable to those who suffered from other chronic illnesses such as heart and lung disease, hypertension, diabetes mellitus, and depression. However, there were no studies yet comparing the HRQoL of SSc patients with other rheumatic diseases, such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Especially, information regarding the impact of SSc on functioning and HRQoL in Korean patients is lacking.

Therefore, the investigators plan to compare the functioning and HRQoL of patients with SSc with other rheumatic diseases, such as RA, SLE, and Sjogrens's syndrome, and healthy controls. A validated Korean version of the Medical Outcomes Study Short Form 36 (SF36) questionnaire and the EuroQol five dimensions questionnaire (EQ-5D) will be used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females \> 18 years at time of consent
* Patients able to understand written and spoken Korean
* Patients who have been informed about the research
* Patients with SSc meeting the 1980 ACR criteria or 2013 ACR/EULAR criteria for SSc
* Patients with RA meeting the 2010 ACR/EULAR criteria
* Patients with SLE meeting the 1997 ACR criteria or 2012 SLICC criteria
* Patients with Sjogren's syndrome meeting the 2002 AECG criteria or 2012 ACR criteria
* Controls : without any rheumatic diseases

Exclusion Criteria:

* Severe mental retardation
* Any impairment of ability to understand making self-evaluation impossible (using a validated Korean version of the SF36 and EQ-5D)
* Anyone with other rheumatic diseases