cyrilzakka/clinical-trials huggingface dataset:
Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study

Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.

Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist.

Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.


Eligibility Criteria:
Inclusion Criteria:

* Both ovaries present with no morphological abnormalities
* Normal ovulatory cycle with cycle lengths of between 25 and 35 days
* Basal serum FSH (day 3) level of \< 15 mIU/mL
* Body mass index (BMI) ranging between 18 and 27 kg/m2

Exclusion Criteria:

* History of a poor ovarian response
* Evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome
* Hydrosalpinx
* Severe endometriosis (stage III-IV)
Effect of Abdominal Binder aftEr Laparoscopic Treatment on Postoperative Recovery

There have been no studies exploring the efficacy of incision support using an elastic abdominal binder after laparoscopy to date. The investigators performed therefore a randomized controlled trial to determine the effect of post-laparoscopic abdominal binder use on enhanced recovery after surgery (ERAS) in patients with gynecologic disease.

An abdominal elastic binder (girdles, trusses, abdominal belts, longuette, etc.) is a wide belt that surrounds the abdomen and supports the incision . Abdominal binder is routinely used after open surgery and Cesarean section, because it has been reported, according to a recent systematic review, to facilitate enhanced recovery after surgery (ERAS) such as pain relief, reduced risk of seroma formation, improved respiratory function, and assisted physical function using additional support to the lower abdominal musculature.

However, the routine use of abdominal binder after laparoscopy has been challenged due to a potential risk of postoperative pulmonary complications and deep venous thrombosis due to increased intra-abdominal pressure. Also, abdominal binders after laparoscopy have been criticized for being uncomfortable and hot to wear and for impinging the breast line in females. Therefore, some laparoscopists prefer the use of abdominal binder in patients undergoing laparoscopy, while other laparoscopists did not. However, there have been no studies exploring the efficacy of incision support using an elastic abdominal binder after laparoscopy to date. The investigators performed therefore a randomized controlled trial to determine the effect of post-laparoscopic abdominal binder use on ERAS in patients with gynecologic disease.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* absence of pregnancy at the time of surgery

Exclusion Criteria:

* body mass index (BMI) ≥30 kg/m2
* history of abdominal surgery within 6 months
* history of ventral or incisional hernia
* walking disabilities (or walking with the assistance of crutches or a walker)
* chronic obstructive respiratory disease
* stage IV cancer,
* chronic pain syndrome (defined as daily intake of opioids for chronic back pain, chronic headache, or fibromyalgia)
* inability to fill out the questionnaire
Treatment of Type I Supracondylar Fractures of the Humerus

Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years. Many different treatment options exist to treat this type of fracture. The purpose of this study is to compare three different treatment modalities with regards to pain experienced during treatment, the amount of pain medication needed during treatment, and any short-term complications. We hypothesize that above elbow casting and long-arm splinting will result in less pain and have fewer complications than taping the elbow in flexion.

Patients who meet the inclusion criteria will be enrolled into the study either by the attending physician in the Emergency Department at BC Children's hospital or by one of the study investigators. They will be randomly assigned to one of three treatment groups: above elbow cast, long arm splint, or tape. After being treated, patients will be required to fill in a daily pain diary describing their level of pain and how much analgesia they are requiring. They will also be followed by regular phone calls to track any complications of treatment (e.g. loosening or shifting of cast/ splint/ tape, any skin breakdown, etc.). Patients will be seen for follow-up at three weeks post-injury in the Orthopedics Clinic at BCCH to have radiographs repeated, finish their treatment, and hand in their pain diaries.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 4-12 years who present to the Emergency department at BC Children's hospital with a history of elbow trauma, and are diagnosed by the staff emergency physician to have a Type I supracondylar fracture of the humerus (as seen on AP and lateral radiographs of the elbow)

Exclusion Criteria:

* patients with neurovascular compromise associated with the fracture
* a pre-existing diagnosis of metabolic or structural bone disease that predisposes them to fractures
* presence of other fractures of the ipsilateral upper extremity
The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial

Improving adherence to inhaled corticosteroids (ICS) medication in urban minority pediatric populations is a clinical and population health priority. Financial incentives have been shown as a compelling method to engage a high-risk asthma population in regular ICS use, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.

Investigators propose to initially enroll 125 children into an initial 1-month run-in interval. Participants who successfully complete the run-in interval will be randomized into a six-month intervention with a six month follow-up period. Children will be ages 5-12, and must have two or more visits to any combination of the outpatient, Emergency Department (ED) or hospital setting in the past year for asthma exacerbations at Children's Hospital of Philadelphia (CHOP).

The study intervention will include daily automated medication reminders (either via text message or push reminder), an app to track daily medication use, and nominal incentives to promote daily controller use. Inhaled controller medication adherence and rescue medication use will be measured using electronic monitors affixed to the inhalers. Factors associated with differential adherence will be assessed using surveys administered during enrollment, the experiment interval (months 1 through 3), the observation interval (months 4 through 6), and study completion (months 12-13). Efficacy outcomes will include change in parent-reported asthma control and mean adherence to ICS between study arms during the experiment interval, as well as the observation interval.

Patients will be considered fully enrolled when they fulfill the requirements of the Run-in period (sensor data uploaded to research platform AND text message receipt confirmed by caregiver) and are subsequently randomized.

Eligibility Criteria:
Inclusion Criteria:

* Males or females age 5 to 12 years and their parent or legal guardian.
* Caregiver has an app enabled cellular phone (i.e., smart phone)
* Prescribed inhaled corticosteroid or corticosteroid/long acting beta agonist combination for daily use
* At least 2 asthma exacerbations in the preceding year (Any combination of hospitalizations, ED visits, or outpatient visits where oral steroid courses were administered for asthma)
* Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

* Subjects prescribed a controller medication to which the electronic device cannot affix
* Subjects in which the mobile app is not compatible with their smart phone model
* Subjects with major developmental delays or disabilities
* Subjects with comorbid chronic diagnoses that influence their asthma management such as cystic fibrosis, bronchopulmonary dysplasia, or cyanotic heart disease
* Families with active Department of Human Services (DHS) involvement
* Non-English speaking families
* Parents/guardians or subjects whose medical team recommends against approaching for enrollment in a research study.
Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital

An intensive care unit (ICU) is a specialized unit within the hospital where patients who need immediate medical attention are admitted both during office hours and off hours.1 Literatures report reduced working efficiency because of long working hours, unavailability of 24/7 intensivist staffing and the absence of the same level of hospital services like laboratory investigations during off hours affecting outcome of the patients. 2-6 High intensity staffing model and shorter workhours can improve the outcome.7 However, these are not always feasible in ICUs of low and middle income countries like Nepal. Any variations in outcome depending upon time of ICU admission may impact the workforce planning, medical insurance, and healthcare policy.

The aim of this study was to compare the outcomes of patients admitted to the ICU during office hours and off hours in terms of ICU mortality, duration of mechanical ventilation and length of stay.


Eligibility Criteria:
Inclusion Criteria:

- age \>= 16 years

Exclusion Criteria:

* Patient who were discharged on request, left against medical advice, had withdrawal of active life support
Intrapartum Glucose and Insulin Compared to Glucose Alone in Diabetic Women

This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin infusion; group 2 will receive intravenous glucose alone. The primary outcome is the incidence of neonatal hypoglycemia.

About 2 to 9% of pregnant women are diagnosed with gestational diabetes. Peripartum complications attributed to diabetes include: birth trauma, neonatal hypoglycemia and hyperinsulinemia and neonatal hyperbilirubinemia. The incidence of neonatal hypoglycemia is about 40%. Strict glycemic control may lower the risk of neonatal complications. There is a lack of evidence on how to manage women with diabetes during labor. Previous studies recommended the use of intravenous saline solution boosted with 5% glucose and insulin as needed, glucose 5% with constant insulin infusion and others recommended the use lactated Ringer's solution. Most of these studies are either retrospective or have a small number of participants.

In this study we will examine the effect of 2 different protocols on glycemic control during labor and the immediate neonatal period. Women in group 1, will receive intravenous saline solution boosted with 5% glucose and constant insulin infusion. Women in group 2, will receive intravenous saline solution boosted with 5% glucose alone. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Women in both groups will receive additional insulin infusion in cases of glucose levels above 100 mg/dL. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution in cases of glucose levels above 140 mg/dL.

Intravenous fluid regimens will be assigned according to a computer randomization sequence generation program. Women will randomly assigned to the 2 groups in a 1:1 ratio. The randomization sequence results will be kept in the delivery ward in a closed study box. Site investigators will enroll participants after confirming eligibility. The sequence will be concealed until intervention is assigned (and after obtaining a signed informed consent).

Our hypothesis is that 5% glucose combined with constant insulin infusion will achieve better glycemic control and thus will lead to lower rate of neonatal hypoglycemia. In order to detect a reduction of neonatal hypoglycemia from 40% to 20%, 182 women will be needed in both groups in order to achieve a level of significance of 95% (α, 2-sided = 0.05) and a power of 80% (β = 0.2).

Eligibility Criteria:
Inclusion Criteria:

* \>37 weeks gestation
* gestational diabetes mellitus according to Carpenter and Coustan
* pregestational diabetes mellitus

Exclusion Criteria:

* Intrauterine fetal death
* estimated fetal weight\<10p
* multiple gestation
* major fetal malformations
Lighting Intervention to Improve Sleep

50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance, will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 4 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease and
* Difficulties with sleep or cognition

Exclusion Criteria:

* There is no exclusion criteria
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.


Eligibility Criteria:
The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).
* Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
* Has a life expectancy of at least 3 months.

Exclusion Criteria:

* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Has received prior systemic anticancer therapy for metastatic NSCLC.
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids.
* Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Has an active infection requiring systemic therapy.
* Has a history of human immunodeficiency virus (HIV) infection.
* Has a history of Hepatitis B or C.
* Has not adequately recovered from major surgery or has ongoing surgical complications.
* Has a history of allogenic tissue/solid organ transplant.
Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients

The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.

Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. However, it is not known if this incorporation is essential or merely serves as storage for n-3 free PUFAs to be release during for instance myocardial ischaemia.

The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 PUFAs in plasma.

In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be administered during hemodialysis treatment. The two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs
* End-stage renal failure
* Maintenance haemodialysis treatment \> 3 months

Exclusion Criteria:

* Allergy to fish or egg protein
* Body weight \< 50 kgs
* Chronic supraventricular tachycardia
* Implanted pacemaker
* Myocardial infarction within 6 months
* PCI or CABG within 6 months
* Stroke or TIA within 6 months
* HbA1C \> 10 %
* ALAT \> 100 U/l
* Triglycerides \> 3 mmol/l
* Ongoing infection
* Tendency to severe blood pressure drops during dialysis treatment
* Malignancy
* Psychiatric disorder
* Pregnancy
Dose Individualization of Pemetrexed - IMPROVE-III

Rationale:

Pemetrexed is a multi-targeted folate antagonist, which is primarily indicated for the treatment of advanced non-small cell lung cancer (NSCLC) and mesothelioma. Dosing of cytotoxic agents like pemetrexed requires balancing the dual risk of sub-therapy and toxicity. Administration of pemetrexed to patients with a creatinine clearance \<45 ml/min is currently not advised. Pemetrexed is dosed based on body surface area (BSA), while renal function and dose are the sole determinants for systemic exposure. This causes 3 major issues:

1. In patients with renal dysfunction, BSA-based dosing may lead to haematological toxicity
2. Patients have to discontinue treatment due to declining renal function, and are withheld effective treatment
3. Even in patients with adequate renal function (GFR \>45 ml/min) treatment may be improved by individualized dosing based on renal function, resulting in less toxicity. Also, BSA-based dosing may lead to ineffective therapy in patients with above average renal function.

The investigators aim to address these problems.

Objective: The overall main objective is to develop a safe and effective individualized dosing regimen for pemetrexed.

Study design: IMPROVE-III is an explorative microdosing study to assess the extrapolability of microdose-pharmacokinetics to the pharmacokinetics of a therapeutic dose.

Study population: IMPROVE-III includes 10 patients of IMPROVE-I and/or IMPROVE-II.

Intervention: patients will be administered a microdose with subsequent pharmacokinetic assessment.

Main study endpoints: The predictive performance of microdosing to predict full dose pharmacokinetics


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old
2. Planned for treatment with pemetrexed-based chemotherapy in IMPROVE-I or -II.
3. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
4. Subject is able and willing to sign the Informed Consent Form

Exclusion Criteria:

1. Conditions that affect haemostasis in a way that blood drawing is complicated (to be assessed by physician)
2. Contraindications for treatment with pemetrexed in line with the summary of product characteristics (SmPC) (except for creatinine clearance \<45 ml/min in IMPROVE-I)

   1. Hypersensitivity to the active substance or to any of the excipients
   2. Pregnancy or lactation
   3. Concomitant yellow fever vaccine
3. The presence of clinically relevant pharmacokinetic interactions, according to the current SmPC
Interactive Rehabilitation for Adults With Unilateral Vestibular Weakness

People that have difficulty with balance, such as those with damage to their inner ear, have a higher risk of falling, which may lead to anxiety and reduced quality of life. Some individuals that have lost part of their sense of balance can learn to compensate using information from their vision, their sense of where their limbs are in space, and from other balance organs that are still intact. Our study aims to determine if virtual reality used together with information from footplate sensors can be used to train people with balance problems to compensate for their inner ear deficits.


Eligibility Criteria:
Inclusion Criteria:

* Adult Age 18-80
* Unilateral vestibular weakness confirmed one or more of:

  * Videonystagmography
  * VEMP
* Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)
* Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)
* Symptomatic
* Long-standing/persistent symptoms greater than one year

Exclusion Criteria:

* Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)
* Neurological deficit or proprioception deficit
* Diabetes
* Poor vision or blindness
* Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal deshicsence (SDCS)
* Active benign paroxysmal positional vertigo (BPPV)
* Undergoing treatment which may affect balance or ability to stand
* Cognitive impairment that prevents understanding and responding to instructions required to complete the study
* Inability to provide informed consent