cyrilzakka/clinical-trials huggingface dataset:
Postoperative Nausea and Vomiting: to Estimate the Incidence and Risk Factors in a Tertiary Teaching Hospital

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia.

The aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia, in the literature it reaches up to 70% of the surgical patients and it occurs after local and general anesthesia with surgery.

Locally in Jordan there was no proper clinical study to estimate PONV among surgical patients, the aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Eligibility Criteria:
Inclusion Criteria:

* Patients who undergoes anesthesia and surgery.
* Patients who suffer from postoperative nausea and vomiting for 24 hours.

Exclusion Criteria:

* Patients who suffer from postoperative nausea and vomiting after 24 hours.
* Patients who undergoes Day-case surgery.
Calcific Tendinitis: Comparing Minimally Invasive Modalities

Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current standard of care at the Thunder Bay Regional Health Sciences Centre is referral for treatment by either needle decompression therapy by a radiologist or shockwave therapy by a physiotherapist. The purpose of this study is to compare the efficacies of these treatment options.

Calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. The chronic and variable course of the condition can lead to dissatisfaction with conservative management. Current guidelines recommend conservative management initially and failing this, a variety of minimally invasive options exist. These include subacromial steroid injection (SSI), needle decompression (ND), and Shock wave therapy (SWT).

Few trials of these methods exist, but generally a benefit is seen with all minimally invasive methods. Most promising results have occurred with needle decompression and shockwave therapy. To date, no direct trials comparing SWT and ND have been published.

The purpose of this trial is to preliminarily establish the comparative efficacies of NDSSI and SWT using a number of outcome measures. Secondarily, the investigators aim to determine prognostic factors for success of minimally invasive therapies. The results of this study will serve as a foundation for more rigorous trials in this area.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of symptomatic calcific tendinitis of the shoulder
* Seeking treatment for diagnosis
* ≥ 18 years of age

Exclusion Criteria:

* Pre-existing diagnosis of rotator cuff tear or arthropathy
* Previous minimally invasive or surgical therapy
* Systemic Inflammatory disease
* Blood dyscrasia
* Peripheral neuropathy
* Active Workplace Safety \& Insurance Board (WSIB) claim for shoulder injury
Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

(MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable pulmonary metastases from colorectal cancer.
* diagnosis by CT, and confirmed by percutaneous puncture biopsy.
* Age range 18-70 years old.
* Eastern Cooperative Oncology Group performance status 0-1.
* Life expectancy of more than 3 months.
* Adequate organ function.

Exclusion Criteria:

* Resectable lung metastases.
* Life expectancy less than 3 months
* Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials.
* Coagulopathy with platelet count less than 50000.
* Active infectious disease.
* Age below 18 years.
* Pregnancy of breastfeeding.
Sorafenib, Tamoxifen, and Cisplatin in Treating Patients With High-Risk Stage III Melanoma

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as tamoxifen and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with tamoxifen and cisplatin after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib together with tamoxifen and cisplatin works in treating patients with high-risk stage III melanoma.

OBJECTIVES:

* Compare relapse-free and overall survival of patients with high-risk stage III melanoma receiving adjuvant sorafenib tosylate, tamoxifen citrate, and cisplatin vs historical data from patients treated with tamoxifen citrate and cisplatin.
* Compare the toxicity of these regimens in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to number of positive lymph nodes identified during surgery.

Patients receive oral sorafenib tosylate twice daily on days 1-28, oral tamoxifen citrate twice daily on days 1-7, and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for at least 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of melanoma

  * High-risk, stage III disease
* No measurable metastatic disease
* Has undergone surgery within the past 8 weeks

  * Surgically rendered disease free

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Creatinine clearance ≥ 50 mL/min OR creatinine ≤ 1.5 mg/dL
* Liver function tests ≤ 3 times the upper limit of normal
* ANC ≥ 1,200/mm³
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No myocardial infarction within the past 6 months
* No congestive heart failure requiring medication
* No pulmonary disease requiring supplemental oxygen
* No dyspnea at rest
* No active infection
* No chronic underlying immunodeficiency disease
* No other serious illness that, in the physicians' opinion, may compromise the safety of the patient
* No other cancer within the past 5 years except for nonmelanoma skin cancer and cervical cancer
* No thromboembolic disease within the past 6 months

PRIOR CONCURRENT THERAPY:

* No prior tamoxifen citrate, sorafenib tosylate, or cisplatin
* No concurrent radiotherapy or surgery
Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases

With this cross-sectional study of adult subjects with neuromuscular disease in the French-speaking part of Switzerland, we aim to explore MI-E adherence using self-report questionnaires and device data in order to identify the factors that influence the pattern of MI-E use and satisfaction with the treatment. Determining potential barriers to regular long-term home use of MI-E could help in identifying the patients who would benefit most from this therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Diagnosis of neuromuscular disease
* Active prescription of MI-E for more than 3 months

Exclusion Criteria:

-Invasive airway
Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. The present exploratory clinical trial aims to advance our understand of the mechanisms of in situ GSH synthesis control through assessment of the response of brain GSH and plasma markers of oxidative stress to different doses of NAC in comparison to placebo, as a potential treatment for ME/CFS that would provide neuroprotection against oxidative stress by restoring cortical GSH reserves. If successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto the mechanisms of action of NAC in brain GSH restoration, which could open a new avenue for the development of potentially effective treatments for a disorder, ME/CFS, that currently has none.

This phase two, single-site study will utilize a double-blind, placebo-controlled, randomized, pre-/post-treatment design to investigate the effect of NAC dosing on brain GSH levels and measure temporally concordant plasma levels of several established circulating markers of oxidative stress. Three study groups, of 20 subjects each (for a total of 60 who completed all components of the study), will each be administered a different dose (0 mg/day, 900mg/day, 3600mg/day) of the study intervention over a four week period; N-acetylcysteine (NAC) treatment. Subjects receiving 0 mg/day dose will be administered a placebo. Baseline visit assessments will include blood collection, survey questionnaires, MRI and MRS imaging. Subjects whose initial screening confirms low GSH level at baseline will be provided with a 4-week supplement of anonymized NAC or placebo caplets. After 4 weeks, subjects will then undergo a follow-up visit to repeat the baseline assessments.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, ages 21 to 60 years (inclusive).
* Baseline GSH levels at or less than a predefined cutoff value.
* Primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
* Willing and capable of providing informed consent.

Exclusion Criteria:

* Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders.
* Any significant neurological illness or impairment.
* Other unstable medical conditions (asthma, hypertension, endocrine or metabolic disease, etc).
* History alcohol abuse.
* Positive urine toxicology at screening and on days of assessments.
* Positive pregnancy test at screening or on days of assessments.
* Contra-indication for clinical MRI scan (e.g., pacemaker, metallic prosthesis).
* Baseline GSH levels higher than a predefined cutoff value.
Intrauterine Antibiotic Infusion in Treating Chronic Endometritis and Restoring Reproductive Dynamics

Chronic Endometritis (CE) is related to infertility and entails a challenging management. This study investigates the treatment of off-label intrauterine antibiotic infusion (IAI) combined with oral antibiotic administration (OAA), and it assesses respective performance against the gold standard treatment of OAA. Data sourced herein reports on treatment efficiency and fertility restoration for both patients aiming to conceive naturally or via In Vitro fertilization (IVF).


Eligibility Criteria:
Inclusion Criteria:

* Positive diagnosis of CE
* Recurrent Pregnancy Loss (RPL) or Recurrent Implantation Failure (RIF)
* No previous live birth
* FSH and LH levels -evaluated on day 2 of the menstrual cycle- \<12 IU/ml
* AMH levels \>1.1ng/ml
* Progesterone levels -evaluated on day 21 of the menstrual cycle- \> 2 and \<25 ng/ml
* 18.5\<BMI\<29.9
* 18\<Patients' age\<40

Exclusion Criteria:

* Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID)
* Current or previous cancer diagnosis
* Auto-immune, genetic or reproductive disorders
* Reproductive history of pregnancy loss due to genetic abnormalities
* Male factor infertility diagnosis
Evaluation of Leg Muscular Activity Using MRI and 11C-acetate PET/MRI. Pilot Study

The present study is conceived as a pilot study aimed to determine the efficiency of the newly available Positron Emission Tomography (PET) - Magnetic Resonance Imaging (MRI) hybrid scan technique for muscular activity evaluation, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle.


Eligibility Criteria:
Inclusion Criteria:

MRI exam inclusion criteria

* Male volunteer aged in the range 18 to 35 years.
* Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.
* Volunteers that could undergo 1h15 to 1h30 immobilization (MRI exam duration in time).

PET/MRI exam inclusion criteria

* Male volunteer aged in the range 18 to 35 years.
* Acceptance of the research protocol: signature of the informed consent form after oral and written information about the protocol through the patient information document.
* Volunteers that could undergo 1.5 to 2.0 hours immobilization (PET/MRI exam duration in time).
* Volunteers should practice regular physical activity, defined as 50 min per day (in a single session), 2 days per week of physical activity as a minimum (no maximum is fixed).

Exclusion criteria MRI exam exclusion criteria

* Pre-existing neurological or muscular lesions on the legs.
* Co morbidities impeding on the protocol comprehension or fulfilment.
* Illnesses that do not allow to lay down on an examination table.
* Pacemaker holder.
* Metal implants that would preclude MRI imaging
* Claustrophobia: Subjects will be questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.

PET/MRI exam exclusion criteria

* Medical radiation exposure within the last five years (normal population should not be exposed to medical radiation higher or equal to 1 mSv per year).
* Pre-existing neurological or muscular lesions on the legs.
* Co morbidities impeding on the protocol comprehension or fulfilment.
* Illnesses that do not allow to lay down on an examination table.
* Pacemaker holder.
* Metal implants that would preclude MRI imaging
* Claustrophobia: Subjects will be questioned about possible discomfort with being in an enclosed space (e.g., MRI scanner). Those who report such problems will be excluded.
Pelvic Ultrasound Pessary Study: Changes in Pelvic Anatomy After Placing a Pessary

In the past, the impact of pessaries was mostly assessed by questionnaires on Quality of Life (QoL) and sexual dysfunction. This research project primarily aims to objectify the effects of the currently available pessaries in a different way. To accomplish this, the investigators choose transperineal ultrasound and uroflowmetry. Additionally, this project aims to describe the impact of pessaries on the symptoms and QoL.

First, the investigators will carry out a small feasibility study with inclusion of 20 patients with pelvic organ prolapse (POP) already using a pessary to check if it is possible to perform adequate measurements of the pelvic floor on transperineal ultrasound with the pessary in situ. By doing this cross-sectional study, the investigators want to refine our technique to optimize data collection.

The study will be designed as a monocentric prospective longitudinal study. Patients presenting to our gynecology outpatient department with symptomatic POP, who choose to try a pessary after thorough counseling, will be recruited. The follow-up will continue for 1 year after the insertion of the pessary. Regular check-ups at 2 weeks, 3, 6, and 12 months will be performed to document patient-reported outcome measures (PROMs), perform a clinical examination. Transperineal ultrasound (TPUS) and uroflowmetry will be added to the examinations at the check-up at 3 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic POP
* start of pessary therapy
* patient must master Dutch, French or English

Exclusion Criteria:

* active pelvic infection
* severe vaginal ulceration
* vaginitis
* allergy to silicone and/or latex
* non compliant patients
* pregnancy
Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging

The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.


Eligibility Criteria:
Inclusion Criteria:

Male right-handed\*, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form

Exclusion Criteria:

Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.

History of obstructive voiding symptoms, including urinary retention.
A Drug Interaction Study of LY3871801 in Healthy Participants

The main purpose of this study is to determine the effect of LY3871801 when administered orally on the levels of methotrexate (part 1), drug cocktail (warfarin, dextromethorphan, and midazolam) and repaglinide (part 2) in the blood stream when administered orally in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 25 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
* Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 40.0 kilograms per meter squared (kg/m²)
* Male or female participants not of childbearing potential (both parts) and for part 2, female participants of child bearing potential are eligible.

Exclusion Criteria:

* Have known allergies to LY3871801, related compounds, or any components of the formulation, or history of significant atopy.
* Have known allergies to drugs including methotrexate, folic acid, repaglinide, warfarin, dextromethorphan, and midazolam that would pose an unacceptable risk to the participant.
* Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator
* Have used or intend to use prescription or nonprescription medication
* Have a positive (not indeterminate) QuantiFERON®-TB Gold test
Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab

The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to eculizumab. Patients will be treated with RA101495 for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PNH by flow cytometry
* Inadequate response to eculizumab defined as having received eculizumab for at least 6 months plus a documented LDH level ≥ 1.5 x the upper limit of normal (ULN) and/or the presence of a known C5 mutation conferring resistance to eculizumab

Exclusion Criteria:

* History of meningococcal disease
* Current systemic infection or suspicion of active bacterial infection
German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation

This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores.

This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores. Adverse effects and adverse events without a clear causal relationship will be documented in terms of frequency and severity. Furthermore, the progression of improvement in Alzheimer's symptoms as a result of TPS treatment is summarized in various neuropsychological scales.

Eligibility Criteria:
Inclusion Criteria:

i. Age = 18 to 85 ii. N\>=100, clinical Alzheimer's syndrome, defined by a gradually progressive change in memory function (for severity using the MMSE as a screening tool) and impairment of activities of daily living for more than six months iii. MRI scan, in vivo evidence from CSF and/or PET using the NIA-AA criteria, which categorize the underlying pathological processes based on biomarkers, should be added if possible, but are optional. These biomarkers are categorized as ß-amyloid deposition, pathological tau and neurodegeneration \[AT(N)\], which can be detected on imaging and in biofluids. If possible, patients with Alzheimer's disease (AD) or Alzheimer's continuum should be included.

iv. TPS treatment in a center of a neurological or psychiatric specialist and performed under supervision of a specialist

Exclusion Criteria:

i. Relevant intracerebral pathologies not related to Alzheimer's disease, such as vascular encephalopathy Fazekas grade 3, tumors, vascular malformations, pregnancy, metal implants, CAA according to Boston criteria, Z.n. or during antibody therapy ii. Blood coagulation disorders or oral anticoagulation iii. Epilepsy iv. Medical conditions leading to non-compliance with the protocol
Melphalan, Prednisone and Thalidomide Versus Melphalan and Prednisone in Elderly Myeloma Patients

The purpose of this study is to determine whether the association of Thalidomide to Melphalan and Prednisone is effective in the treatment of newly diagnosed elderly multiple myeloma.

Intermittent courses of Melphalan and Prednisone (MP) have been the first line therapy in multiple myeloma, for many years.

Advances in systemic and supportive therapy increased remission rates and overall survival, but multiple myeloma still remains an incurable haematological malignancy. Several preliminary studies demonstrate the efficacy of thalidomide in refractory and relapsed multiple myeloma with an overall response rate of 30 to 60%.

Due to its activity, Thalidomide will be evaluated in association with MP in a randomized study for newly diagnosed myeloma patients not eligible for high-dose chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* untreated myeloma patients
* age \>65 years of age or younger but excluded from transplant procedure
* Durie \& Salmon stage II or III myeloma and measurable disease.
* Patients agreed to use contraception

Exclusion Criteria:

* other cancer
* psychiatric disease and any grade 2 peripheral neuropathy