cyrilzakka/clinical-trials huggingface dataset:
Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes

Fetal heart rate patterns are an important parameter in the diagnosis of non-reassuring fetal status. Combined-spinal epidural analgesia is a method of initiating labor analgesia used by approximately 90% of the parturients at Prentice Women's Hospital. Optimizing the variables which could affect fetal heart rate patterns at the time of initiation of analgesia, such as fluid administration and oxytocin management, could help us provide better care for our patients and their fetuses.

Hypotheses: Patients who receive a 1000 mL fluid bolus and lower rates of oxytocin administration will have fewer non-reassuring fetal heart rate (FHR) changes.

Informed, written consent will be obtained. At the time of request for labor analgesia, group assignment will be determined by opening an opaque envelope. Patients will be randomized to one of four groups.

All subjects will receive a maintenance infusion of 125 mL Lactated Ringers (LR) solution throughout the study. For patients in Groups A or B, an intravenous bolus of 1000 mL LR will be initiated when the patient is positioned for epidural placement. The bolus will be administered through a free-flowing wide open intravenous catheter until complete.

Patients in Groups C and D will not receive any additional fluid bolus and will only receive the maintenance infusion of 125 mL LR during the study period. Blinding will be maintained by the Labor and Delivery nurse by covering up the LR bolus fluid bag.

If the patient is randomized to groups B or D, the dose of oxytocin currently being administered will be halved and not increased for the duration of the study period (60 minutes after the initiation of CSE).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Healthy nulliparous or multiparous women
* Term (\>36 week gestation)
* Singleton pregnancy
* Spontaneous labor or spontaneous rupture of membranes
* Receive oxytocin
* Request neuraxial analgesia

Exclusion Criteria:

* Under 18 years old
* Presence of any systemic disease (ex: diabetes mellitus, hypertension, preeclampsia
* Use of chronic analgesic medications
* Prior administration of system opioid labor analgesia
* Non-vertex presentation
* Induction of Labor
* Contraindication to neuraxial analgesia
GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope.

See above. The primary outcome is time to intubation.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient booked for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

1. Any patient with cervical spine abnormalities.
2. Any patients with known or probable difficult airways.
3. Any patient requiring rapid sequence induction.
The Effect of Mucogyne® Gel on Wound Healing

The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the context of postpartum perineal wounds.


Eligibility Criteria:
Inclusion Criteria:

1. Adult women with singleton pregnancy
2. Have a perineal tear or mediolateral episiotomy
3. First (with cutaneous injury) and 2nd-degree perineal tear/episiotomy, whose length and depth are as the following:

   * depth (from the fourchette into the greatest depth of the perineal body) ≤3cm,
   * length of vaginal mucosa (from the fourchette to the apex of the vaginal tear) ≤4cm
   * length of skin (from the fourchette along perineal skin towards the anus) ≤3cm
4. Is able to understand the study related information and to give a written informed consent,
5. Has signed the informed consent form before beginning any study procedure,
6. Has no condition that may interfere with the study assessments,
7. Is able to comply with protocol requirements and respect the conditions of the study,
8. Accept to come to the mentioned hospital 12(+/-2) days after childbirth
9. Affiliated to the Social Security system

Exclusion Criteria:

1. Postpartum complications, or developed early bleeding after delivery
2. Third and fourth degree perineal tear.
3. Previous vaginal/perineal surgery within the year preceding the inclusion in the study
4. Had undergone extended episiotomy (incision size \> 3 - 4 cm)
5. Anal fissures.
6. Known hypersensitivity to any of the medical device ingredients
7. With local infectious lesions in the area to be repaired.
8. Who use drugs known to disturb wound healing (example : anticoagulants during pregnancy (based on self-reports))
9. Had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immune deficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level \< 9 g/dl) and hemophilia)
10. Immunosuppressive treatment.
11. Heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the mothers and their documented records),
12. Patients under legal protection or under guardianship and patients deprived of freedom
13. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents

Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP), including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted at least 3 months following the traumatic event.
* Patients during the screening week must have completed ≥ 4 daily pain scores and have an average daily pain score ≥ 4.
* Female patients of childbearing potential must have a negative urine pregnancy test at Screening and be practicing an acceptable form of contraception.

Exclusion Criteria:

* Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or patients with any other co-existing pain which cannot be differentiate from NeP of peripheral origin.
* Patients who have previously failed to respond to pregabalin at a total daily dose of equal to or greater than 300 mg or are intolerant to those doses.
* Patients who have previously failed to respond to gabapentin at a total daily dose of equal to or greater than 1800 mg.
* Patients with any type or history of malignancy, except either where there has been no ongoing treatment for at least 6 months or all basal cell carcinomas; all patients with a history of brain or spinal tumors will be excluded.
* Patients who currently have ongoing litigation related to any injury affecting their pain symptomatology.
Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors

This is a Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of IO-108 monotherapy and in combination with anti-PD-1 monoclonal antibody pembrolizumab or tislelizumab in adult patients with advanced solid tumors. The study will be conducted in 3 parts, including Part A IO-108 monotherapy dose confirmation; Part B IO-108 + anti-PD-1 dose confirmation, and Part C dose expansion.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18, and \< 75.
2. Part A and Part B Cohort 1: Patients must have histologically or cytologically confirmed advanced or metastatic solid tumor and have failed, or have been intolerant for standard systemic therapy, or for whom no treatment known to confer clinical benefit exists.

   Part B Cohort 2 and Part C: Patient with advanced or metastatic solid tumor who meet the specific criteria.
3. Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
5. Patients must have adequate hematologic function, hepatic function and renal function.

Exclusion Criteria:

1. Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
2. Patients who received chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or other investigational anti-cancer therapy \< 4 weeks prior to their first day of study drug administration.
3. Requires systemic corticosteroids at a dose of \>10 mg daily of prednisone or the dose equivalent to other systemic corticosteroid, or other immunosuppressive agents ≤ 14 days prior to the first dose.
4. History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.
5. Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Duloxetine for Postoperative Analgesia After Modified Radical Mastectomy

The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy.

Inadequate control of postoperative pain is associated with increased length of hospital stay, increased hospital cost, sleep disturbance, depression, functional impairment and affects the quality of life.

Modified is one of the commonly performed procedures which is associated with severe postoperative pain.

Preemptive analgesia is the analgesic treatment initiated before the surgical procedure to prevent central sensitization from the noxious stimuli. Drugs such as gabapentin, pregabalin, serotonin-norepinephrine reuptake inhibitors, dexamethasone, and cyclooxygenase-2 inhibitors have been used for preemptive analgesia.

There are contrary results about the role of duloxetine in mangement of acute postoperative pain.

Arecent meta-analysis was done in 2020 that concluded that the currently available evidence does not support the clinical use of duloxetine for the management of acute postoperative pain,so we will discuss that in this study.

There are many studies that have shown that perioperative use of duloxetine for a few days has a significant effect on reducing postoperative pain and analgesic requirements.

Duloxetine is a dual anti-depressant drug that inhibits the neuronal reuptake of serotonin (5-HT) and norepinephrine (NE) modulating the descending inhibitory pain pathways by increasing the availability of serotonin and norepinephrine. Duloxetine is an approved drug for the treatment of post-traumatic depression, major depression, and generalized anxiety disorder. It is also approved for the treatment of various chronic painful syndromes, including neuropathic pain associated with diabetes, chronic musculoskeletal pain, and fibromyalgia.

The mechanisms of action so far described suggest that duloxetine may be useful as an adjunct in the treatment of acute postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III

Exclusion Criteria:

Known Allergies to duloxetine.

* Abnormal liver or renal function tests.
* Narrow angle glaucoma.
* Being a chronic opioid abuser (more than 3 months)
* Being on chronic gabapentin or pregabalin (more than 3 months)
* Being on Monoamine oxidase inhibitor, tricyclic antidepressant, or fluvoxamine.
* Pregnant female
* Patients with psychiatric disorders or seizure disorders.
Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland

The primary objective of this study is to evaluate the effectiveness of idelalisib and rituximab in adults with chronic lymphocytic leukaemia (CLL) in a real world setting


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CLL documented within medical records
* Individuals who have received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation at the time of starting idelalisib treatment
* Idelalisib and rituximab initiated on or before 31 December 2017

Exclusion Criteria:

* Individuals who received idelalisib as part of an interventional clinical trial
* Individuals who received idelalisib for other indications including follicular lymphoma (FL)
* Individuals who previously received idelalisib in combination with ofatumumab
* Use of idelalisib which is not in accordance with its marketing authorisation at the time of starting idelalisib treatment
Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media

Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. In these cases, especially if a CT-scan shows opacification of the mastoid air cells, a mastoidectomy can be considered as treatment modality. In recent years, obliteration of the mastoid cavity following mastoidectomy is gaining popularity. However, the effectiveness of obliterating the mastoid in comparison to mastoidectomy alone is uncertain for CSOM. In this retrospective cohort study, our aim is to compare mastoidectomy to mastoidectomy + mastoid obliteration in a cohort of patients suffering from CSOM with mastoid involvement. The hypothesis is that obliterating the mastoid cavity will result in a higher frequency of dry ears and in a lower frequency of revision surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from CSOM, as indicated by otorrhea as main complaint preoperatively
* At least one year of follow-up, in order to asses the primary outcome
* Opacification of the mastoid air cells on preoperative CT-scans, as indication for mastoid involvement
* Canal wall up or canal wall down mastoidectomy
* Operated between 2010 and 2022

Exclusion Criteria:

* Patients suffering from middle ear cholesteatoma
The Optimal Dosage of Ropivacaine for Arthroscopic Knee Surgery

Fast-track Surgery (FTS ) refers to the application of various proven effective methods in perioperative period to reduce stress and complications and accelerate the recovery of patients.Nowadays, FTS has been successfully applied in clinical practice."FTS" truly embodies the concept of "patient-centered" and the direction of medical development.

Lower limb joint damage (the meniscus, and patellar ligament, etc.) is the joint movement orthopedic common disease, often characterized by joint swelling, pain, sports relaxation instability, thigh muscle atrophy, most can't continue to pursue the original movement, even unbend and flexor limited activity, result in patients with walking difficulties, serious impact on the patient's quality of life.Practice has proved that minimally invasive surgery under arthroscopy is the best way to treat such injuries. According to literature reports, the average hospital stay after arthroscopy is 5\~7 days, while successful application of FTS can shorten it to 2\~3 days.

Anesthesia plays an important role in the process of FTS.Compared with general anesthesia, intra-spinal anesthesia can effectively reduce the incidence of postoperative complications in patients, such as ventilator-related lung injury, deep vein thrombosis, cardiovascular and cerebrovascular accidents, and acute renal failure.Ropivacaine is a long-acting amide local anesthetic. Compared with bupivacaine, it is more and more widely used in spinal anesthesia due to its advantages of lower degree of motor nerve block and weaker toxicity to central nervous system and cardiac.However, the optimal dosage of ropivacaine for arthroscopic surgery is still unclear. Conventional dosage makes patients unable to move 2-4h after surgery and unable to urinate autonomically. Therefore, this study aims to optimize the dosage of ropivacaine for spinal anesthesia and enable patients to recover motor function at an early stage.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective arthroscopic knee surgery

  * ASA: grade I to III

Exclusion Criteria:

* There are contraindications to spinal anesthesia

  * Allergic to local anesthetics

    * Patient refused
Methods for Objective Selection of Competent Sperm

In spite of the achievements and developement of the assisted reproduction techniques in the last years, there is still an elevated percentage of unsuccessful treatments, needing sometimes repeated attempts to reach pregnancy.

The molecular physiology of sperm is being better characterized, and some reports have demonstrated the implication of different molecular processes in the pathophysiology of male infertility.

Recently, different sperm selection methods have been based on these molecular differences, showing a better quality of the sperm population after selection.

The main objective of this research project is to clinically apply these techniques in order to increase the pregnancy rates per cycle in infertile couples attending assisted reproduction treatments.


Eligibility Criteria:
Inclusion Criteria:

MEN:

- \>3million sperm after swimming process

WOMEN:

* \< 37 YEARS OLD
* NO GYNECOLOGICAL ANOMOLIES
* HORMONAL VALUES WITHIN CLINICAL RANGE

Exclusion Criteria:

* NONE
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study

The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.

A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CRS
* Subject in in need of frontal recess and/or sphenoid sinus dilation

Exclusion Criteria:

* Pregnant or breastfeeding females
* Previous treatment site intervention
* Cystic fibrosis, aspirin sensitivity, steroid dependent asthma, sinonasal tumors, allergic fungal sinusitis, ciliary dysfunction, atrophic nasal mucosa, excessive osteogenesis that might preclude dilation
Effect of Modified Endotracheal Intubation Protocol Combined With Early Oral Intake on Postoperative Recovery Quality in Thyroid and Parathyroid Surgery

The purpose of this study is to assess the effect of modified endotracheal intubation procedure combined with early oral intake on postoperative recovery quality of patients, so as to further optimize the ERAS（enhanced recovery after surgery） program for thyroid or parathyroid surgery.

After being informed about the study and potential risk, all patients giving written informed consent will undergo a screening-period to determine eligibility for study entry. Before operation, patients will be randomly assigned to conventional intubation process group or modified intubation process group before the operation. After the operation, patients will enter the PACU（post-anaesthesia care unit） for further observation. When the anesthesiologists and surgeons agree that patients have no early oral drinking high-risk factors, patients will be randomly assigned to early resumption of oral intake group or late resumption of oral intake group for further observation and evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* American Society of Anesthesiologists (ASA) physical status classification I-II
* Body mass index 18.5-29.9kg/m2
* First operation on operation day

Exclusion Criteria:

* Patients or family members cannot understand the conditions and objectives of this study
* Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration
* The surgeons or anesthesiologists point out that the patient is not suitable for early postoperative drinking (such as considering the injury of recurrent laryngeal nerve or lymphatic vessels during the operation)
* Patients who cannot be intubated under visual laryngoscope(such as difficult airway, loose incisors and so on)
* Exclusion criteria of Quality of Recovery-15\* (\*Quality of Recovery-15 exclusion criteria: 1. Unable to understand words and language; 2. Difficult to cooperate due to mental disorders; 3. History of alcohol or drug abuse; 4. Any serious pre-existing medical condition that can limit the objective evaluation after surgery; 5. Any life-threatening complications; 6. Emergency surgery)
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic Blood Pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.

Clinical diagnosis of AIDS and related anemia.

* Clinical diagnosis of AIDS.
* Clinically stable for 1 month preceding study entry.

Substance abuse.