cyrilzakka/clinical-trials huggingface dataset:
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)

This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Bilateral nasal polyps
* Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)

Exclusion Criteria:

* Polypectomy within the last 6 months
* Unhealed nasal surgery/trauma
* \>5 previous polypectomies
* Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
* Nasal infection
* Pulmonary tuberculosis
* Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease
* Immunocompromised
* Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants)
* Known hereditary mucociliary dysfunction
* Significant nasal structure abnormalities
* Asthmatic attack within the past 30 days
* Asthmatic patients requiring \>1000 mcg beclomethasone or equivalent
* Asthmatic patients not stable on corticosteroid therapy
Effect of TEAS Combined With Oxycodone on Postoperative Visceral Pain in Gynecologic Laparoscopic Patients

To investigate the effect and feasibility of percutaneous acupoint stimulation combined with oxycodone on postoperative visceral pain in laparoscopic patients, and provided a clinical basis for optimizing perioperative pain management in laparoscopic patients.

Patients aged 18-65 years old, BMI 18-30kg/m2, ASA grade I or II were selected for gynecologic laparoscopic surgery (laparoscopic ovarian tumor stripping, laparoscopic uterine fibroid stripping, laparoscopic total hysterectomy) under general anesthesia from May 2024 to July 2024. Exclusion criteria: Patients who were allergic to the drugs used in the study, had confusion or cognitive impairment, contraindicated percutaneous acupoint electrical stimulation, abnormal cardiopulmonary and liver and kidney function, history of analgesic drug use within one week, history of diabetes, myocardial infarction, or cerebrovascular accident. Exclusion criteria: patients dropped out of the experiment midway or the data was not completely collected, the surgical method changed midway, the operation duration was less than 30 minutes or more than 2 hours, and patients with opioid and addictive drug dependence

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* American Society of Anesthesiologists grade I-II
* Body mass index (BMI) 18.5-30 kg/m2;
* No ulceration or infection at the acupuncture stimulation site.

Exclusion Criteria:

* Allergic to the drugs used in the study;
* People with unclear consciousness or cognitive dysfunction;
* There are contraindications of percutaneous acupoint electrical stimulation;
* Abnormal cardiopulmonary and liver and kidney function;
* History of analgesic drug use within one week;
* History of diabetes, myocardial infarction or cerebrovascular accident.
Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity.

Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed melasma in adult patient
* signed inform consent

Exclusion Criteria:

* Pregnant women
* Other pigmentary disorder of the afce
* Use of depigmentant agent in the month before the inclusion
* Use of topical steroid, tretinoin, hydroquinone in the month before the inclusion
* Coeliac disease or allergy to gluten
Brain Stimulation for Patients With Parkinson Disease

The aim of this crossover study is to investigate the efficacy of non-invasive brain stimulation (transcranial pulse stimulation; TPS) in adults with Parkinson Disease (PD). Participants will receive 6 sessions of TPS and Sham-TPS, respectively, in random order. Motor manifestations of PD and manual dexterity will be the primary outcome measures. Outcomes will be assessed immediately post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable PD with fine skilled and/or gross motor deficits (e.g. right arm with a clinical force level \>2)
* Signed written informed consent
* Monthly pregnancy test for women in childbearing years
* Age \>= 18 years

Exclusion Criteria:

* Non-compliance with the protocol
* Pregnant or breastfeeding women
* Relevant intracerebral pathology unrelated to the disease (e.g. Brain tumor)
* Hemophilia or other blood clotting disorders
* Cortisone treatment within the last 6 weeks before first treatment
* Thrombosis
A Study to Assess the Efficacy and Safety of Namilumab in Participants With Chronic Pulmonary Sarcoidosis

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

This is a randomized, double-blind, placebo-controlled study with an OLE.

Participants will be randomized to receive namilumab or placebo in the 26-week Double-blind Treatment Period of the study. Namilumab, or placebo, will be administered subcutaneously (SC) every 4 weeks through Week 22 after the initial dosing period.

All participants who complete the 26-week Double-blind Treatment Period, may be eligible to participate in the 28-week OLE.

Further details are in the protocol.

Eligibility Criteria:
Inclusion Criteria :

* Male or female age ≥18 years
* Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
* Greater than or equal to 6-month history of documented sarcoidosis including histological confirmation in the subject's medical records
* Evidence of sarcoidosis as indicated by: a) HRCT consistent with Pulmonary Sarcoidosis AND; b) Medical Research Council Dyspnea scale \>1 (i.e., Grade 2 or more) AND; c) One or more of the following is present: i) Screening FDG-PET scan consistent with active pulmonary sarcoidosis AND SUVmax ≥ 3; ii) Recent history of worsening sarcoidosis; iii) Recent history that tapering OCS and/or ISTs resulted in an increase of pulmonary disease
* Body Mass Index (BMI) ≤ 40 kg/m2 at Screening
* Vaccinations for COVID-19 with completion of the primary series at least 2 weeks prior to randomization

Exclusion Criteria

* Hospitalized for any respiratory illness ≤ 30 days prior to or during Screening
* Greater than or equal to 20% fibrosis as indicated on HRCT-scan assessed by central read prior to randomization
* Hemoglobin ≤ 9.5 g/dL
* Participation in another interventional clinical trial (IP/Device) within 6 months prior to Screening, during screening and throughout the duration of the study
* ECG abnormalities that warrant further clinical investigation or management at Screening
* Systolic blood pressure (SBP) \<90 or \>180mm Hg; Diastolic blood pressure (DBP) \<60 or \>110 mm Hg at Screening
* Has documented laboratory-confirmed SARS-CoV-2 infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing ≤ 6 months prior to randomization
* Other significant pulmonary disease or conditions that prevent subject from performing acceptable spirometry
* Females who are pregnant or breastfeeding or intend to be during the course of the study
* Any other acute or chronic medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study
* Subjects who are treatment naive

Other protocol-defined inclusion/exclusion criteria apply.
Thyroid Function in Term Infants With Respiratory Distress

This study was designed to evaluate the level of certain hormones (thyroid hormones and cortisol) in full term or close to full term infants who have respiratory distress severe enough to require respiratory support. The purpose of this study is to determine if there is a relationship between these hormone levels and how sick these infants are who require help with breathing following birth.

Hypothesis: Infants who are born full term or near full term and who have low hormone levels will have higher severity of illness.

Transient hypothyroxinemia, as demonstrated by low T4 and free T4 levels with normal levels of TSH, in preterm infants has been associated with increased severity of illness and adverse outcomes. Effects of thyroid function in term infants is less well studied. Previous research in the Special Care Nursery at Christiana Hospital has indicated that transient hypothyroxinemia in intubated term infants was associated with increased severity of illness and the need for more intensive rescue therapies. However, free T4, the biologically active substance was not measured in our previous study.

Infants who meet criteria for the study will begin participation after parental informed consent is obtained. Infants who are enrolled will have serial measurements of thyroid stimulating hormone (TSH), T4, free T4, free T3, and cortisol. These measurements will be obtained at four specific time intervals throughout the first week of the infant's life. The medical team will be blinded to the results of the hormone testing. The results will be reviewed by an unblinded study investigator and an endocrinologist will be consulted if abnormal results are reported.

These hormone levels will be compared with severity of illness and level of respiratory support needed in order to establish an association between thyroid function and illness severity. Illness severity will be quantified by using the Score for Neonatal Acute Physiology (SNAP). SNAP scores require collecting data from vital signs and results of labs that are considered standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Infants born \> or = to 35 weeks gestation
* Infants admitted to the neonatal intensive care unit at Christiana Hospital
* Respiratory distress requiring use of mechanical ventilation or nasal CPAP (continuous positive airway pressure)
* Parental informed consent

Exclusion Criteria:

* Infants born \< 35 weeks gestation
* Infants with documented congenital abnormalities which directly impact the cardiorespiratory system
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery

The purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.

Patients in the Time-Restricted Feeding (TRF) group will follow a daily TRF regimen consisting of an 8h ad libitum eating period and a 16h water fasting period during the last two weeks before surgery, followed by routine preoperative fasting before surgery.

Patients in the CarboHydrate Loading (CHL) group will follow their usual diet in the pre-surgical weeks and will receive a maltodextrin beverage on the evening before surgery, as well as two hours before induction of anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective orthopaedic surgery;
* Intermediate, major or complex surgery according to the Surgical Outcome Risk Tool (SORT; http://www.sortsurgery.com/) severity of surgery classification;
* Scheduled for surgery at least 17 days from the date of screening;
* Motivated to follow a time restricted feeding regimen.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* History of diabetes mellitus;
* History of feeding or eating disorders;
* History of delayed gastric emptying or gastro-oesophageal reflux
* Active malignancy
* Patients classified as ASA IV by the attending anaesthetist;
* BMI \< 18.5 or ≥ 35;
* Outpatient or day case surgery;
* Palliative surgery;
* Participation in another clinical trial that is interfering with the procedures or outcomes of the PRINCESS trial;
* Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch).
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed participation in the TR02 study
* Subject is currently receiving in-center hemodialysis at the time of consent

Exclusion Criteria:

* Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
* Subject received opiates on a daily basis during the 1 week prior to screening
* Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening
* Subject is a pregnant or lactating female
Pain in America: A Randomized Controlled Trial

Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native English speakers

Exclusion Criteria:

* Patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. Patients with a severe mental, visual, auditory or tactile impairment.
Chemotherapy in Treating Patients With Sarcoma of the Uterus

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus.

OBJECTIVES: I. Estimate the antitumor activity of doxorubicin HCl liposome in patients with recurrent or advanced uterine sarcoma. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1-1.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent or recurrent uterine sarcoma with documented disease progression after appropriate local therapy Leiomyosarcoma Malignant mixed mullerian tumor (mixed mesodermal tumor, mixed heterologous mesenchymal sarcoma) Mixed malignant Muellerian tumor (carcinosarcoma, homologous mesenchymal sarcoma) Endometrial stromal sarcoma Other uterine sarcomas Considered incurable Bidimensionally measurable disease consisting of abdominal, pelvic, chest, or other masses by palpation, x-ray, computed tomography, or ultrasound

PATIENT CHARACTERISTICS: Age: Over 21 Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: LVEF normal by MUGA scan Other: No clinically significant infection No other malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior therapy with cytotoxic drugs No prior doxorubicin HCl liposome No prior doxorubicin greater than 360 mg/m2 No other concurrent antineoplastic agents Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy No prior radiotherapy for any other malignancy Surgery: Recovered from prior surgery Other: No other concurrent investigational agents
A Comparison of Conventional Adult Out-of-hospital Cardiopulmonary Resuscitation Against a Concept With Mechanical Chest Compressions and Simultaneous Defibrillation - LINC Study

The primary objective is to show superiority in survival of the modified method with the LUCAS Chest Compression System, compared to the conventional manual resuscitation method in patients suffering from out of hospital sudden cardiac arrest.

Every year 300 000 to 400 000 people suffer from sudden cardiac arrest outside of the hospital in Europe. Only 5 - 7 % of these patients survive and are discharged from hospital. In spite of massive education, research and new methods the survival rate has not improved. In the latest international guidelines for CPR, published in 2005, there is a strong emphasis on chest compressions with as little interruptions as possible. Manual chest compressions during CPR result in only 20-30% of normal blood flow and are difficult to perform for a long period of time. Mechanical chest compressions with the LUCAS device have shown increased blood flow in experimental studies. Defibrillation during ongoing mechanical compressions is a new method of treatment that showed promising results in increased short time survival in out of hospital cardiac arrest in a recently completed pilot study.

The LINC trial is a prospective randomised multicenter study where LUCAS according to a concept will be used with simultaneous defibrillation compared to manual chest compressions according to 2005 guidelines for advanced CPR. The study will be conducted in first tier systems, where LUCAS always will be placed in the first arriving ambulance.

Eligibility Criteria:
Inclusion Criteria:

* Unexpected adult out-of-hospital cardiac arrest where an attempt of resuscitation is considered appropriate.

Exclusion Criteria:

* Traumatic cardiac arrest, including hanging
* Age believed to be less than 18 years (no upper limit)
* Known pregnancy
* Defibrillated before LUCAS Chest Compressions System arrives at scene
* Patients body size not fitting the LUCAS Chest Compression System
The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases

This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.

Introduction- Implantation failure after IVF may be due to endometrial function, embryo quality or a combination of both. The prevalence of minor intracavitary pathology in cases with an apparent normal transvaginal sonography (TVS) observed at hysteroscopy has been recorded to be 25-40%. Treatment of such pathology prior to initiating IVF/ICSI has been advocated without high-quality evidence.

Objective- To evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.

Material \& methods- Patients, indicated for their first IVF/ICSI treatment cycle at the UMC Utrecht and AZ-VUB Brussels, initially underwent TVS. In case of a normal TVS these patients were scheduled for hysteroscopy in the early-mid follicular phase of the cycle, one to three months before starting IVF/ICSI treatment. Vaginoscopic hysteroscopy was performed in an ambulatory office setting. During the hysteroscopy a biopsy was taken, to diagnose chronic endometrial inflammation. In case of finding a predefined intra uterine abnormality (polyp, myoma, adhesion, septum, endometrial inflammation) randomisation took place if prior to hysteroscopy informed consent had been obtained for endoscopy treatment versus no treatment. Shortly after the hysteroscopy, IVF/ICSI treatment was initiated and outcome during one year treatment period will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Normal Transvaginal Ultrasound
* No prior hysteroscopy
* Regular menstrual cycle
* Single embryo transfer
* BMI between 18 and 29
* Presence of both ovaries
* Primary or secondary infertility
* Women indicated for a first IVF/ICSI cycle

Exclusion Criteria:

* Recurrent miscarriage
* Prior hysteroscopic treatments
* Endometriosis \> AFS Stage II
* Meno-metrorrhagia (defined as any intermenstrual loss of blood)
* Submucosal/Intracavitary Fibroids taking more than 50% of the cavity
* Hydrosalpinx
* FSH/LH \> 12IU/L on day 3
* Polyps taking more than 50% of the cavity
* Severe adhesions \> grade II
Characterization of Myeloproliferative Neoplasia With a Mutated IDH, SRSF2 or SF3B1 Allele (CARPEDIEM)

Retrospective study assessing the impact of IDH1/2, SRSF2 or SF3B1 mutations on event free survival of MPN patients

Patients with a diagnosis of MPN and a mutation of IDH1/2, SRSF2 or SF3B1 will be included. Clinical and biological characterisation at diagnosis, as well as evlution will be recorded. Event free survival will be assessed in each group (event = thrombosis, transformation to mylofibrosis/acute leukemia, death).

Eligibility Criteria:
Inclusion Criteria:

* Patients with MPN diagnosis
* Mutation in IDH1/2, SRSF2 or SF3B1

Exclusion Criteria:

* Unable to consent
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading

The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75
* Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
* Willing to give informed consent

Exclusion Criteria:

* Bone height \< 5 mm, in the planned implant area
* Bone width \< 5 mm, in the planned implant area
* Previous bone augmentation procedure in the planned implant area
* Previous failures of endosseous implants
* Untreated caries and/or periodontal disease of residual dentition
* History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Current alcohol or drug abuse
* Unable or unwilling to return for follow-up visits for 3 years