cyrilzakka/clinical-trials huggingface dataset:
Fresh Vs Frozen Surgical Sperm in IVF

The primary objective of this study is to determine if the use of frozen surgical testicular sperm specimens for ICSI lead to different IVF outcomes when compared with the use of fresh surgical testicular sperm for ICSI.

The study seeks to isolate the effect of slow freezing and thawing of surgical sperm specimens on fertilization and embryo blastulation rates by utilizing a randomized controlled split cohort protocol including men with obstructive azoospermia undergoing surgical sperm retrieval and good-prognosis female patients.

Eligibility Criteria:
Inclusion Criteria:

* Females age \< 42 with an indication for IVF
* Females with lowest AMH level 1.2 ng/mL or higher
* Females with FSH \< 13 mIU/mL
* Sperm obtained via Surgical retrieval (any type) for IVF only
* Use of comprehensive chromosome screening (CCS) to screen embryos for aneuploidy
* BMI \< 35
* Baseline antral follicle count of \> 8
* Single embryo transfers only

Exclusion Criteria:

* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
* Contraindication to IVF
* Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring detailed embryo genetic analysis)
* Fewer than 4 mature oocytes retrieved (will not randomize)
* Male partner with non-obstructive azoospermia
* Male partner with any Karyotype other than 46,XY
* Male partner with history of spinal cord injury
* Male partner with Kallman's syndrome
* History of chronic oligomenorrhea
* History of hydrosalpinges or adnexal mass
* History of endometrial insufficiency (max endometrial thickness \< 7mm)
Rheumatic Heart Disease Research and Screening in Nepal: A Feasibility Study

Rheumatic Heart Disease (RHD) remains a significant public health problem in lower and middle-income countries, accounting for over 300,000 deaths world-wide. RHD is a sequela of Acute Rheumatic Fever (ARF) caused by Group A Streptococcus (GAS). Benzathine Penicillin Prophylaxis (BPP), through tri-weekly intramuscular injection of benzathine penicillin G, remains the mainstay of intervention to delay and prevent the sequelae among ARF and RHD patients by preventing repeat GAS infections. Two major obstacles exist to the optimal utilization of this effort. First, despite proven benefits, BPP adherence remains low. Unfortunately, there is very little knowledge on the factors associated with BPP adherence. Even in countries like Nepal, which has a nation-wide free BPP program serving about 6000 patients, there is absence of a robust system to prospectively track and study these patients. Second, largely because RHD is initially asymptomatic, only a fraction of those who would benefit are enrolled in BPP programs. There is a dearth of information and evidence on potentially high-yield approaches like the screening of first-degree relatives (FDRs) of RHD patients to identify asymptomatic, early-stage RHD patients who may benefit from BPP. The investigators will combine the resources and expertise at the University of Washington with those from existing partners at two leading Nepali hospitals (Manmohan Cardiothoracic Vascular and Transplant Center and Dhulikhel Hospital) to first create an easy to use, scalable, comprehensive electronic RHD registry and enroll BPP patients from these sites. In Aim 1, the investigators will examine whether patient socio-demographic, clinical, and health services-related characteristics are associated with BPP adherence. Investigators will use the BPP registry to collect important covariate information and adherence outcomes to address this aim. In Aim 2, investigators will determine the feasibility of screening FDRs of known RHD patients. Investigators will invite FDRs of known RHD patients (enrolled in the BPP registry) for echocardiographic screening for RHD. Investigators will assess the prevalence of RHD in these FDRs. This proposal harnesses one of the largest RHD patient pools in the world for establishing a robust RHD-related quality improvement and research platform that serves as a solid foundation for conducting larger epidemiologic, interventional, and implementation studies on RHD risk, prevention, and treatment.


Eligibility Criteria:
Inclusion Criteria:

* RHD patients

Exclusion Criteria:

-
Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study

The goal of this clinical trial is to determine the efficacy of baclofen for the treatment of alcohol use disorder (AUD) in patients with or without comorbid anxiety symptoms. The main questions it aims to answer are:

* Do we see more abstinent days after the study period in patients with high anxiety symptoms compared to low anxiety symptoms?
* Do we observe additional differences between patients with high- and low anxiety symptoms in: any drinking at the end of treatment (yes/no), number of patients who respond to treatment, anxiety score reduction, autonomic responses, craving scores, drinking motives and side effects?

Participants already taking baclofen as part of routine clinical care for treatment of AUD will be asked to answer several questionnaires over a 6 week study period.


Eligibility Criteria:
Inclusion Criteria:

* Meeting DSM-5 criteria for AUD
* Able to understand and provide written consent
* Already receiving baclofen or started with baclofen at start of hospitalization
* Therapeutic desire towards alcohol abstinence

Exclusion Criteria:

* Concurrent substance use disorder other than nicotine or cannabis
* Clinically significant psychiatric illness that requires pharmacotherapy, unless stable and no changes in medication has been made in the last 30 days
* Clinically significant medical diseases that may pose a risk to continuing baclofen use
* Pregnant or currently breastfeeding women
Analysis of Immunological Reactions to Foods in Birch Pollen-Allergic Patients

A high number of birch pollen-allergic individuals develop hypersensitivity reactions to certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch pollen-related foods contain proteins, e.g. Mal d 1 in apple, that are structurally related with the major birch pollen allergen, Bet v 1. Hence IgE antibodies and T lymphocytes specific for Bet v 1 recognize these food proteins which results in activation of the immune system and, consequently, in clinical symptoms.

In the present study the investigators intend to investigate if and how the consumption of birch pollen-related food allergens affects birch pollen allergy. In other words, the investigators are interested to analyse whether Bet v 1-related food allergens activate Bet v 1-specific memory cells and thus, contribute to the maintenance of the pollen allergy outside the pollen season. Data obtained in this study will help to clarify the immunological and clinical role of cross-reactivity between pollen and food allergies and will reveal whether avoidance of such foods should be recommended for the patients. Finally, novel approaches for diagnosis and therapy of pollen-related food allergens can be developed.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy birch pollen allergic (rhinoconjunctivitis)persons
* Positive SPT and RAST to birch pollen
* Sensitized to Bet v 1

Exclusion Criteria:

* Persons suffering from malignancies, autoimmune and cardiopulmonary diseases
* Anemia
* Hyper-IgE syndrome
* Treatment with ß-blockers, permanent treatment with antihistaminics, leucotriene antagonists, corticosteroids
To Evaluate the Treatment Effect of an Anti-Infective Agent for Complicated Infections (0826-053)

To collect clinical response data with the use of ertapenem in community acquired sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18 years of age or older
* Patients present with at least two of the following signs and symptom:
* fever (temperature\> 38c or \< 36c)
* heart rate \> 90 beats/min)
* respiratory rate\> 20 breaths/min)
* high white blood cell count \> 12,000/ul or \>10% bands)

Exclusion Criteria:

* Patient has a history of allergy or hypersensitivity (anaphylaxis) or serious adverse reaction to ertapenem or any carbapenem
* Patient has a poor chance of survival for more than 14 days.
* Patient has an apache ii score \> 15 (see attachment 3.
* Patient has an infection caused by pathogens resistant to ertapenem
* The patient requires antibiotics other than ertapenem (such as: glycopeptides, macrolides or antifungal agents)
Critical Illness Myopathy and Trajectory of Recovery in AKI Requiring CRRT

The purpose of this study is to determine whether patients with acute kidney injury requiring renal replacement therapy have a higher incidence of muscle wasting than controls and whether the course of recovery is longer compared to controls.

Acute kidney injury (AKI), the abrupt loss of kidney function, is a common complication that affects more than half of all intensive care unit (ICU) admissions, and it is associated with substantially higher rates of morbidity and mortality in both the short- and the long-term. This is especially true in patients with AKI requiring renal replacement therapy (AKI-RRT), also known as dialysis. An understudied mechanism by which AKI-RRT may contribute to poor clinical outcomes, both in the hospital and after discharge, is through its impact on muscle mass and muscle function. AKI of any severity is known to alter tissue utilization of amino acids, and preliminary data suggest that RRT in the ICU may exacerbate muscle dysfunction through the removal of large quantities of amino acids from the patient's plasma. This study will determine whether patients with AKI-RRT have greater lean muscle loss over 1 week than historical critically ill controls, whether patients with AKI-RRT have diminished recovery of muscle mass and function at 1-3 months following discharge compared to controls, and whether changes in plasma levels of amino acids during hospitalization correlate with loss of muscle function or lack of recovery.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* AKI requiring CRRT, with enrollment within 48 hours of CRRT initiation

Exclusion Criteria:

* ICU admission for \>7 days
* RRT of any kind at any time prior to ICU admission
* Chronic kidney disease (CKD) with estimated glomerular filtration rate \<20 mL/min/1.73 m2 as calculated by the 2021 CKD-EPI equation
* underlying muscle disorders or muscle atrophy such as quadriplegia or hemiplegia, stroke with residual motor deficits, end-stage liver disease, active alcohol use disorder, active malignancy (other than non-melanoma skin cancer) within 1 year, burns, or other baseline neuromuscular disease
* pregnancy
* concomitant use of other extracorporeal support devices such as ventricular assist devices or extracorporeal membrane oxygenation
* anticipated inability to engage in weight-bearing testing after discharge (e.g., trauma or orthopedic surgery)
* subjects will be ineligible for outpatient testing if they remain on RRT in the week prior to the research appointment
The Safety and Utility of Skin Testing With XOLAIR® (Omalizumab) and Placebo Omalizumab (Formulation Excipients)

This study enrolled 30 healthy volunteers and 30 patients with atopic asthma, for a total of 60 subjects. The study examined the tolerability of omalizumab and omalizumab excipients in two successive cohorts of subjects, healthy volunteers and patients with allergic asthma without prior exposure to omalizumab, according to a skin test protocol, consisting of a prick skin test and/or intradermal test.


Eligibility Criteria:
Inclusion Criteria:

* (Applicable to healthy subjects only) Healthy subjects not taking any regular prescription medication, without history of allergy, and considered healthy by the physician
* (Applicable to asthma patients only) Patients with atopic asthma diagnosed by a physician with asthma and history of positive skin test(s)
* Physical examination findings within normal limits
* Body mass index (BMI) between 18 and 30, inclusive

Exclusion Criteria:

* Pregnancy and lactation
* Current or previous treatment with a biologic agent (e.g., monoclonal antibody)
* Concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to individuals in this study
* History or symptoms of significant psychiatric disease, including but not limited to, depression, schizophrenia, etc.
* History of drug abuse
* Participation in an investigational drug or device trial within the last 30 days prior to screening
Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia

Vitreoretinal surgery is associated with a considerable incidence of postoperative nausea and vomiting (PONV), which is reported to be as high as 60%. Reasons for this high incidence may be the long duration of surgery and anesthesia and the high degree of manipulation of the eye. Postoperative vomiting after vitrectomy is an important risk factor for the onset of several complications, such as suprachoroidal hemorrhage, with disastrous visual consequences.

To date there is no evidence as to the possible protective effect of anti-emetic therapy with regard to interventions of vitrectomy performed under local anesthesia.

In this prospective, randomized, multicenter, double blind study, we evaluated the efficacy of Ondansetron alone, Dexamethasone alone and in combination in controlling nausea and vomiting in patients undergoing vitrectomy under local anesthesia.

Patients were randomly stratified to receive 1 of 4 prophylactic antiemetic treatments (3 pharmaceutical treatment and 1 placebo) in a double-blind manner at the start of the surgery and 15 minutes before the end of surgery.

The syringes were prepared by a third, neutral person not involved in the perioperative care of the patient, immediately before the start of anesthesia.

All vitrectomy surgeries were performed, in each unit,under local anesthesia by a retrobulbar block.

Each patients was observed and treated during a period of 24 hours after the surgery. For patients who have nausea and vomiting despite the antiemetic prophylaxis, will be given a rescue dose of 4 mg ondansetron IV.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older with an American Society of Anesthesiologists (ASA) physical status of I to II
* Scheduled for vitrectomy under local anesthesia

Exclusion Criteria:

* Hypersensitivity to study drug or rescue medication
* Preoperative score for nausea greater than 4 out of 10 points
* Subjects who suffer from chronic nausea and/or vomiting
* Severe hepatic insufficiency (Child-Pugh score \> 9)
* Other antiemetic within 12 hours prior to surgery
* Patients unable to undergo a local anesthetic
* Subjects with clinically significant or unstable cardiac, respiratory, hepatic, renal, or other major organ system disease
* Psychotic illness or depression
* Addiction to illicit substances or alcohol
* Non-psychotic emotional disorders
* Pregnant or lactating
* Subjects who, in the opinion of the investigator, would experience an unacceptable risk from administration of study drug
Optimizing Influenza Vaccination in Surgical Oncology Patients

Seasonal influenza (flu) is a significant and sometimes serious health issue in the U.S. The Centers for Disease Control (CDC) estimates that over 200,000 people are hospitalized in the U.S each year related to the flu. Public health campaigns advocate widespread vaccination for the flu, and especially for high risk people. People with cancer are high risk, with an increased risk of developing complications from the flu, such as pneumonia, bronchitis, or worsening of other medical conditions. As part of their vaccination campaign, the CDC strongly encourages inpatients to be vaccinated prior to hospital discharge. Accordingly, Stony Brook Hospital has enacted a policy that mandates screening all hospital inpatients for vaccination prior to discharge. While physicians or patients can opt not to vaccinate, the default is to proceed. Surgical oncologists have several concerns about vaccinating their patients after major surgical procedures. Patients with cancer have impaired immunity, and the ability of our patients to mount an effective immune response to the vaccine is unclear. Conversely, due to their immunocompromised state, our patients may be more susceptible to complications from the vaccine, such as influenza-like-illness (ILI), or have higher rates of postoperative complications due to the additional immune challenge of the vaccine. Previous studies have evaluated the flu vaccine in patients receiving chemotherapy, or after organ transplantation, but the combination of cancer and major surgery remains unstudied.

This is a collaborative study with Infectious Diseases and Microbiology to evaluate the response to the flu vaccine in patients with pancreatic or gastric cancer, soft tissue sarcoma or peritoneal surface disease (i.e. carcinomatosis from appendiceal or colon cancers). Patients will be randomly selected to receive the vaccine either 2 weeks preoperatively or postoperatively at the time of discharge. Serum antibody response, rates of ILI and post-op complications will be analyzed. The long term goal of this study is two-fold: to determine the optimal time to vaccinate this group of patients in relation to their surgery, and to improve compliance with vaccination.


Eligibility Criteria:
Inclusion Criteria:Patients with gastric or pancreatic cancer, soft tissue sarcoma or peritoneal surface malignancy who will undergo surgery with curative intent are eligible.

-

Exclusion Criteria:Those with a contraindication to vaccination, patients who have a splenectomy (whether planned or not) and those who have had the flu for the year are not eligible.

-
Effects of Daily Interruption of Sedatives in Critically Ill Children

Critically ill children are often sedated in order to relieve them from anxiety and discomfort, and to facilitate their care. There is little information on the effects of prolonged and continuous use of sedatives and analgesic agents in critically ill children. In adult intensive care unit (ICU) patients, daily interruption of sedative infusions accelerates recovery resulting in a reduction in the average duration of mechanical ventilation of 2.4 days as well as a reduction in average ICU length of stay of 3.5 days. These results were achieved without an increased rate of adverse events potentially linked to less sedation and associated with a reduction of common complications of critical illness and without negative psychological effects.

It is unknown whether these results can be extrapolated to critically ill children. Moreover, the possible risk of complications associated with less sedation, such as accidental self-extubation, is probably higher in children. Also, the need for intermittent bolus administrations in children treated with intermittent sedation could nullify the reduction in the use of sedatives.

It is unknown if daily interruption of sedatives is feasible in critically ill children. The researchers studied the effects of daily interruption of sedatives in critically ill children on the total amount of sedatives used and risks of complications.


Eligibility Criteria:
Inclusion Criteria:

* Intubated and mechanically ventilated for \> 24 hours
* Expect further mechanical ventilation for \> 48 hours
* Receiving midazolam and morphine for sedation
* Written informed consent given by parents

Exclusion Criteria:

* Inclusion in another trial
* Transfer from an outside institution where sedatives had been administered
* Neuromuscular blockers
* Metabolic disease
* Neuromuscular disease
* Encephalopathy
* Epilepsy
* Pulmonary hypertension
* Neurotrauma
* Raised intracranial pressure
* Life expectancy less than a month/infaust prognosis
Use of Acupuncture for Stimulation of Labour

Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia.

A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture.

The women are randomized into to groups.

1. Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)
2. No treatment

The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial.

Inclusion criteria:

1. Normal pregnancy
2. In labour (orificium \< 8 cm), 37th week or thereafter
3. Ruptured membranes
4. Primary or secondary inertia

The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization.

The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration.

Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice:

1. before the randomization and again 1 hour after randomization.


Eligibility Criteria:
Inclusion Criteria:

1. Normal pregnancy
2. In labour (orificium \< 8 cm), 37th week or thereafter
3. Ruptured membranes
4. Primary or secondary inertia -

Exclusion Criteria:

1. Pathological pregnancy
2. Pathological labour
3. Medical diseases
4. Women who do not speak and undrestand danish