cyrilzakka/clinical-trials huggingface dataset:
Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes

Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes.

Cesarean delivery (CD) is one of the most common surgeries performed worldwide. In the last few decades, its rate has steadily increased worldwide, leading to an increase in maternal morbidity and mortality compared to vaginal delivery (VD)1. In 2014, the American College of Obstetricians and Gynecologists (ACOG) and Society for Maternal Fetal Medicine (SMFM) published an Obstetric Care Consensus for safe prevention of primary cesarean delivery, allowing an additional hour of pushing during the 2nd stage of labor for both nulliparous and multiparous women before diagnosing prolonged 2nd of labor2-4.

Prolonged 2nd stage is especially common among nulliparous women5, and is defined as more than three hours of pushing6, or four hours for women with a regional anesthesia. Prolonged 2nd stage has been shown to be associated with maternal adverse outcomes, such as assisted-vaginal delivery, CD, and postpartum hemorrhage (PPH)7,8, and neonatal adverse outcomes such as low 5-minute Apgar score, and NICU admissions9.

Oxytocin is the primary and the most widely used pharmacological agent for induction and augmentation of labor10. Administrating oxytocin during labor is a common practice and is used to intensify contractions and decrease the chances of a non-progressive labor and associated adverse outcomes11,12. Despite its extensive use, there are several protocols which varies between different countries and obstetric wards. Likewise, there is no consensus regarding the duration or dosage of oxytocin infusion during labor, and especially during the 2nd stage of labor13.

The study will assess the optimal time initiation of Oxytocin during the 2nd stage of labor, and its association to mode of delivery, and adverse maternal and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy
2. Maternal age ≥ 18 years' old
3. Oxytocin administration initiated or renewed during second stage of labor

Exclusion Criteria:

1. Maternal age \< 18 years' old
2. Multiple gestation pregnancy
3. Known fetal malformations
4. Uterine scar
Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis

To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.

Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.

To improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
* Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
* Patients were in good general health.
* Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.

Exclusion Criteria:

* Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
* Patients had a history of allergy to indigo naturalis.
* Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
* Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and/or other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission and to determine how long patients are able to stay in complete radiological remission without treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of HER-2 positive metastatic (Stage IV) breast cancer.
2. Patients in complete radiological remission (CRR), including a stable bone scan, as determined by computed tomography (CT), positron-emission tomography (PET), or PET-CT.

   a. Patients with brain metastasis are allowed to participate as long as their disease has been treated and radiologically stable for at least 36 months.
3. Patients must be on the same or current anti-HER-2 directed therapy for at least 36 months.
4. Archived tumor biopsy available.
5. Patients with no evidence of circulating tumor deoxyribonucleic acid (ctDNA) as determined by the Signatera assay.
6. Patients willing to stop maintenance anti-HER-2 directed therapy with close monitoring.
7. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score from 0 to 2.
8. Patients ≥ 18 years of age.
9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with uncontrolled metastatic disease.
2. Patients whose disease has been controlled for less than 36 months on the same or current anti-HER-2 therapy.
3. Patients who are currently receiving or have received treatment for a secondary cancer other than resected non-melanoma skin cancer lesions or in situ cancer within the past 24 months.
4. Patients positive for ctDNA (which occurs when a patient's blood sample contains ≥2 target markers) with the Signatera assay.
5. Use of investigational drugs ≤ 28 days prior to study enrollment and during the study.
6. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the Investigator.
7. Patients with impaired decision-making capacity.

Patients who are found to be ctDNA+ at study entry will be recorded as a screen failure (Section 5.4). Their Signatera testing results will be provided to their treating physician to aid in clinical decision-making for disease management and treatment.
Evaluation of Surfactant Protein B in the Differential Diagnostics of Dyspnea

Establishing new biochemical markers in the differential diagnostics and risk stratification in heterogeneous patient collectives is becoming more and more important. The markers should be objective, reliable, reproducible, quick and cost effective as well as specific and sensitive. Concerning the differential diagnostics of "dyspnea", NT-pro-BNP plays the most important role for the evaluation of a cardiac origin. However, a corresponding biochemical marker for pulmonary stress is lacking. The aim of the study at hand therefore was the evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac diseases.


Eligibility Criteria:
Inclusion Criteria:

* patients presenting with dyspnea and giving informed consent

Exclusion Criteria:

* outpatients
* lack or doubt of legal competence
* indication for mechanical ventilation
* pregnancy
* palliative patients
* CPAP/LTOT
* BMI \> 30 kg/m2
* sepsis
* anemia
* dialysis
Altruistic Decisions

The study aimed to understand how payoffs for others influence perceptual decision making. The research consists in testing how varying monetary payoffs for another modify the perceptual decision making processes. The use of drift diffusion models on a random dots task enable the characterization of the decision parameter(s) that are modulated when a decision is made to win payoffs for others as compared to decisions for self-benefits. Once the parameter revealed through behavioral experiment, neuroimaging is applied to find the neural correlates of the effects of taking others into account in the decision making process.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 35
* Right-handed
* French
* Normal vision or corrected by contact lenses

Exclusion Criteria:

* Contraindications to the MEG examination
* Presence of a perceptual disorder (vision) or motor impairing the capacity to carry out the tasks requested (including dyschromatopsia and achromatopsia).
* Taking of medical treatment in progress (excluding contraceptive pill).
* Known neurological or psychiatric history or disorders.
* Participants in an exclusion period for any other research.
* Participants who do not benefit from social protection.
* Participants refusing to be informed of the results of the medical examination.
* Participants who refuse to be informed of the possible detection of an anomaly.
* Participants with MRI contraindications
S9910, Collecting and Storing Blood and Bone Marrow Samples From Patients With Hematologic Cancer

RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about diagnosing cancer and how well patients will respond to treatment.

PURPOSE: The purpose of this study is to collect and store blood and bone marrow samples from patients with hematologic cancer to be tested in the laboratory.

Primary objective:

* Maintain and expand tissue repositories of highly characterized samples from patients with acute lymphoblastic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes.

Other objectives as funding permits:

* Develop laboratory assays for rapid and precise diagnosis of leukemia using bone marrow and peripheral blood samples.
* Determine biologic, genetic, and molecular parameters that distinguish different subtypes of human leukemia with differing responses to therapy, and develop "risk-adapted" therapeutic approaches based on these parameters to tailor therapeutic regimens, randomize or stratify patients in clinical trials, or otherwise assist in therapeutic decision-making.
* Develop new automated and standardized laboratory methods for the detection and monitoring of therapeutic responsiveness and minimal residual disease in patients and use this information to design clinical trials.

OUTLINE: Patients receive treatment as directed by the Southwest Oncology Group (SWOG) study to which they are registered.

Patients undergo collection of peripheral blood (myeloid leukemia) or venous blood (lymphoid leukemia) and bone marrow at baseline, at the time of response or remission, and at the time of progression or relapse. Additional collections may take place according to the guidelines of the study in which the patient is registered.

Specimens are stored for use in laboratory research.

PROJECTED ACCRUAL: Samples from a maximum of 1,000 patients will be collected for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently registered on a Southwest Oncology Group (SWOG) treatment study for acute lymphoblastic leukemia, chronic lymphocytic leukemia, acute myeloid leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
PPAR, RXR, and VDR Expressions in Peri-implantitis

ABSTRACT Objective: Periodontitis and peri-implantitis are the irreversible destructive diseases of the periodontal and peri-implant tissues. The present study aimed to determine the receptor expressions of Peroxisome proliferative-activated receptor (PPAR)-γ, Retinoid X receptor (RXR)-α, and Vitamin D receptor (VDR) in the diseased tissues around teeth and dental implants.

Methods: The study consisted of three groups as group 1; healthy controls (C, n=15), group 2; periodontitis patients with stage 3 grade B (P, n=15), and group 3; peri-implantitis patients (PI, n=15). Periodontal clinical parameters as the plaque index (PI), gingival index (GI) and clinical attachment levels (CAL) were recorded. Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing. Hematoxylin-eosin (H\&E) and immunohistochemistry staining were performed. Total inflammatory cell counts and fibroblast cell density were evaluated on H\&E-stained slides while PPAR-γ, RXR-α, and VDR were evaluated via immunohistochemistry.


Eligibility Criteria:
Inclusion Criteria:

* healthy individuals
* periodontitis patients
* periimplantitis patients

Exclusion Criteria:

* smokers,
* systemically compromised patients
The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption

The objective of this study is to examine the effectiveness of mindfulness/meditation using the Headspace App on post-operative pain and opioid consumption in patients after arthroscopic rotator cuff repairs, biceps tenodesis, and Mumford procedures.

The purpose of this study is to examine the effectiveness of mindfulness/meditation on post-operative pain and opioid consumption. Patients will be randomized into one of two standardized groups after shoulder arthroscopy: Control group (CON) and mindfulness/meditation group (MM). All participants will be consented and enrolled into the study before surgery. Both groups will receive the same standardized method of post-operative pain medication for post-operative pain relief. Participants in the MM group will utilize a Headspace application on their smart phone meditate twice a day while the control group will not perform any meditation or mindfulness. Patient reported outcomes will be collected at regular intervals. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis and/or Mumford procedure. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 6 months which will include 3 standard of care post-operative visits and electronic surveys to track patient reported outcome.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure

Exclusion Criteria:

* Less than 18 years old
* Patients undergoing a simultaneous arthroscopic procedure that is not in the inclusion criteria.
* History of shoulder osteoarthritis
An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care.

The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.

Originally registered as OBS17104 by Sanofi; transitioned to REGN 05Jul2023.

The recruitment period will be 48 months. Data will be collected during routine clinical visits approximately every three months while the patient is on cemiplimab treatment and then approximately every six months for up to 24 months after cemiplimab discontinuation. Patients will be followed from cemiplimab treatment initiation until death, loss to follow-up, study withdrawal, or to the end of the study period (72 months after study launch), whichever occurs first.

Eligibility Criteria:
Key Inclusion Criteria:

1. At least 18 years of age at the time of cemiplimab treatment initiation
2. Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC
3. Prescribed a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the Summary of Product Characteristics (SmPC).
4. Can understand and complete the study-related questionnaires
5. Must be legally capable of providing written consent for participation in the study and have signed informed consent prior to any study activities

Key Exclusion Criteria:

1. Has received cemiplimab prior to enrollment
2. Has uncontrolled autoimmune disease
3. Has a contraindication to cemiplimab as noted in the local SmPC
4. Is concurrently participating in any other study of an investigational drug or procedure
5. Has cognitive impairment or other medical condition that, in the opinion of the investigator, would interfere with the ability to complete the study-related questionnaires

NOTE: Other protocol-defined inclusion/exclusion criteria apply
Effect of Sleep on the Recovery of Patients Admitted to the ICU

The investigators plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the ICU.

Critically ill patients are known to suffer from severely fragmented sleep with a predominance of stage I sleep and a paucity of slow wave and REM sleep. The causes of this sleep disruption include the intensive care unit (ICU) environment, medical illness, psychological stress, and many of the medications and other treatments used to help those who are critically ill. Surveys have identified poor sleep as one of the most frequent complaints among patients who have survived a critical illness. Patients in medical, cardiac, and surgical ICUs almost uniformly have fragmented sleep.

Although illness, pain, and medications contribute to sleep disruption in ICU patients, the primary factor causing sleep disruption had been thought to be the ICU environment. Noise from various sources, including ventilators, alarms, television, phones, beepers, and conversation, have all been purported to disturb sleep in the ICU. Patients have reported that noise, specifically talking, is a frequent cause of sleep disruption in the ICU. Several studies have confirmed that peak noise levels in ICUs are far in excess of 45 dB during the day and 35 dB at night, which are the recommendations of the Environmental Protection Agency for peak noise levels in the ICU.

The clinical importance of this type of sleep disruption in critically ill patients, however, is not known. The investigators hope to determine if placing patients in sleep/circadian rhythm friendly rooms will enable them to achieve better sleep, suffer from decreased delirium, and have improved recovery from their critical illness.

Eligibility Criteria:
Inclusion Criteria:

* any adult patient admitted to the MICU with an expected length of stay of at least 3 days

Exclusion Criteria:

* frequent overnight neurological checks or frequent peripheral vascular checks
The Effect of Mobile Health Application Based on Omaha System on Symptoms and Quality of Life in COVID-19 Patients

Purpose: The aim of this study is to evaluate the effects of nursing interventions made with a mobile health application (COVOS) developed based on the Omaha System on the physical, psychosocial and cognitive symptoms and quality of life of patients diagnosed with COVID-19, and continuing treatment at home.

Design: This is a single center, 1:1 randomized, single blind, parallel, active comparator trial.

Method: Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist used in study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will carried out in a family health center, located within the boundaries of İzmit District of Kocaeli province. The patients in the experimental group will be followed up with the COVOS app and nursing interventions (videos, information messages) to manage their symptoms will be directed with the COVOS app. The patients in the control group will not receive any intervention, the standard follow-up and health care provided by the family health center of the patients will continue.

Hypothesis: In patients diagnosed with COVID-19 followed at home with COVOS, symptom management and quality of life will be better in 1st, 2nd and 3rd months compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a positive Polymerase Chain Reaction (PCR) test within the last 24-48 hours
* Patients whose symptoms started within the last 48 hours
* Patients experiencing at least one symptom
* Patients diagnosed with COVID-19 and continuing treatment at home
* Literate patients
* Patients with smartphone

Exclusion Criteria:

* Those who have had a previous COVID-19 infection
* Patients with vision or hearing problems
* Patients with chronic disease
* Patients with mental illness
* Patients who do not have a smartphone
* Pregnant and postpartum patients
* Patients who did not agree to participate in the study
Urinary CA19-9 Level in the Differential Diagnosis of Neurogenic and Non-Neurogenic Lower Urinary Tract Dysfunction in Children

It has been shown in the literature that urinary CA19-9 levels are associated with the degree of hydronephrosis and the anteroposterior diameter of the renal pelvis. Additionally, this marker has been reported as a potential indicator of kidney damage related to obstructive uropathies. A study conducted in our clinic, which has yet to be published, investigated CA19-9 levels in children with hydronephrosis of different etiologies. It found a statistically significant difference in CA19-9 levels between children with neurogenic and non-neurogenic lower urinary tract (LUT) dysfunction (Evaluation of Spot Urine Carbohydrate Antigen 19-9, Sodium, Potassium, and Creatinine Levels as Biomarkers for Differential Diagnosis of Hydronephrosis and Detection of Kidney Damage in Children Aged 0-16: A Prospective Study, Kütükoğlu et al.). Based on this, the hypothesis was formulated that urinary CA19-9 might be a potential biomarker for indicating neurological deficits in children presenting with LUT symptoms. Therefore, this study aimed to compare CA19-9 levels in a larger group of children with neurogenic and non-neurogenic LUT dysfunction.

A total of 25 children with non-neurogenic etiologies and 25 children with neurogenic etiologies who presented to our clinic with LUT dysfunction were prospectively included in the study. A control group of 15 healthy children was also included. Urine samples were collected from the children, centrifuged at 3000 rpm for 4 minutes, and stored at -25°C. Urinary CA19-9 was analyzed using ELISA, and creatinine levels were measured for configuration in the spot urine samples. Additionally, for the neurogenic group, scintigraphy, urinary ultrasonography, voiding cystourethrography, and urodynamic (UD) parameters were recorded. Children with active urinary tract infections, malignancy, or congenital urinary anomalies were excluded from the study. Urinary CA19-9 levels were compared between the groups, and subgroup analysis was performed within the neurogenic group based on urodynamic parameters and the presence of upper urinary tract (UUT) damage. The presence of vesicoureteral reflux, hydronephrosis, or renal scarring was considered as UUT damage.

Eligibility Criteria:
Inclusion Criteria:

* lower urinary tract symptoms
* \<18 years old

Exclusion Criteria:

* active urinary tract infections
* malignancy
* congenital urinary anomalies