cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)

This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.


Eligibility Criteria:
Inclusion Criteria:

* Must be Chinese
* Must have a diagnosis of bilateral nasal polyps
* Clinically significant nasal congestion/obstruction must be present
* Must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures, or compromise the participant's safety
* Must have negative urine pregnancy test
* Must be using or agree to use a medically accepted method of contraception prior to Screening and during the study

Exclusion Criteria:

* Have a history of seasonal allergic rhinitis within the last two years
* Have had sinus or nasal surgery within the past six months
* Have presumed fibrotic nasal polyps
* Have had three or more nasal surgeries
* Have had any surgical procedure that prevents an accurate grading of the polyps
* Complete (or near complete) nasal obstruction
* Have acute sinusitis, concurrent nasal infection or have had a nasal infection within two weeks
* Have ongoing rhinitis medicamentosa
* Have Churg Strauss syndrome (vasculitis, asthma, fever, and eosinophilia)
* Have dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immobile cilia)
* Have been treated within the last 4 weeks with intranasal steroids
* Have used any investigational drug in the last 30 days
* Have a hypersensitivity to corticosteroids or are allergic to aspirin
* Have an ongoing upper respiratory tract infection or had an upper respiratory tract infection within two weeks
* Have a nasal septal deviation needing corrective surgery
* Have a nasal septal perforation
* Have asthma that required in-patient hospitalization for asthma control within six months, required ventilator support for respiratory failure secondary to their asthma within the last five years, required admission to the hospital for management of airway obstruction on two or more occasions within the past year, or required use of more than 14 days of systemic steroid use in previous six months
Post-transplant Cancer Incidence and Survival in Patients With or Without Pre-transplant Cancer

Patients with previous malignancies have increasingly been accepted for renal transplantation. However, post-transplant malignancy risk and survival rates of these patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily high risk of post-transplant malignant tumours and if the organs as a resource are too limited for investment in this patient group.


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplanted patients from January 1982 through December 2013 with or without a pre transplant cancer.

Exclusion Criteria:

* Simultaneous kidney+pancreas transplantation.
* Islet cell transplanted patients
* Undiagnosed malignancies at the time of transplantation
* Death within a week after transplantation
* First transplantation at another hospital
Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
* Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
* Patients with a baseline pain intensity (categorical) of moderate or severe

Exclusion Criteria:

* Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
* Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
* Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
* Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
* Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study
Type 1 Diabetes Mellitus Effect on Bone Mineral Density

Because the diabetics are fracturing at a younger age than the general population (12), this leads us to believe there are significant factors that lead to fracture in Type 1 diabetes mellitus (DM) other than bone mineral density (BMD). Very little longitudinal data exists on BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data exists on pQCT in adults with Type 1 DM.

Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral density (BMD) as measured by DXA compared to age and sex matched healthy controls.

Because the diabetics are fracturing at a younger age than the general population(12), this leads us to believe there are significant factors that lead to fracture in Type 1 DM other than BMD. Very little longitudinal data exists on BMD in adults with Type 1 DM and the effects of glucose control on BMD. No longitudinal data exists on pQCT in adults with Type 1 DM.

Hypothesis: Adult subjects with diabetes and poor glucose control will lose bone mineral density (BMD) as measured by DXA compared to age and sex matched healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients must have completed Visit 1 of the previous study.
Outlook Quality of Life Intervention Study

The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.

This is a randomized control trial to evaluate the feasibility of the Outlook intervention. 221 veterans with advanced cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or end stage renal disease (ESRD) were randomly assigned to one of three intervention groups and completed a brief battery of pre-test measures. Subjects in the first group ("Outlook Intervention") were randomized to meet with a facilitator three times for a period of 45 min-1 hour. Participants were asked in the first session to discuss issues related to life review. They were asked in the second session to speak in more depth about issues of regret, forgiveness and things left undone. The subject of the final session was heritage and legacy. Participants in the attention control group were randomized to meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation audio disc (CD). Participants in the third group ("treatment as usual") were exposed to no interventional sessions. Participants were assessed with post-test measures administered by a blinded interviewer one week and 3 weeks after the intervention window.

Eligibility Criteria:
Inclusion Criteria:

* Patients with
* Advanced cancer
* Congestive heart failure
* COPD
* End stage renal disease

Exclusion Criteria:

* Cognitive impairment
* inability to speak
* non-English speaking
Corneal Tomographic Parameters in TGD

The current study involved analysis of the corneal tomographic parameters of patients with thyroid gland dysfunction (hyperthyroidism or hypothyroidism), including those with an autoimmune etiology, in comparison to healthy controls without TGD, using pentacam, in an attempt to detect possible early corneal changes and to highlight whether early screening of those patients would be necessary for early detection of KC.

A total of 100 eyes of 50 patients with TGD and 100 eyes of 50 healthy controls were enrolled. Diagnosis of TGD was based on history, clinical examination and laboratory investigations. Exclusion criteria included previous thyroid medications, thyroidectomy, previous ocular surgery, corneal pathology and other risk factors of keratoconus (KC). All eyes were examined by Pentacam, (Oculus Optikgerate GmbH, Wetzlar, Germany). Pentacam parameters were compared between TGD patients and controls. Spearman's correlation coefficient between different pentacam parameters and the level of free T4 and TSH was calculated.

Eligibility Criteria:
Inclusion Criteria:

* For TGD patients: Patients with a recent diagnosis of TGD (the study group) were recruited from endocrinology outpatient clinic of Specialized Medical Hospital, Mansoura University. Diagnosis of TGD was based on précised history, clinical examination and laboratory investigations. In order to avoid bias, patients with history of intake of any thyroid-related medications (antithyroid medications or thyroxine replacement), radioactive iodine or thyroidectomy were excluded from the study. Therefore, we only included patients who did not received treatment yet For the control group, fifty age and gender matched healthy subjects without known personal or family history of thyroid disease or any autoimmune diseases were recruited from candidates of refractive surgery referred to the outpatient clinic of Mansoura Ophthalmology Center for pentacam assessment and who were proved to have normal corneal pentacam parameters. They were further examined by the endocrinologist to exclude thyroid dysfunction; this was supported by normal thyroid function profile (serum TSH and free T4) and negative anti-TPO and antithyroglobulin antibodies.

Exclusion Criteria:

* patients with previous thyroid medications or replacement therapy, thyroidectomy or radioactive iodine intake participants with a history of ocular surgery or trauma, use of any topical medication or contact lens wear, patients with any corneal pathology, Corneal dystrophy, corneal scarring or any concurrent ocular disease. To eliminate other risk factors for KC, we also excluded participants with a history of persistent eye rubbing, vernal keratoconjunctivitis (VKC), atopy, Down syndrome, Turner's syndrome, or congenital rubella. Pregnant or lactating females were also excluded from the study.
Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit

A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.

Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.

All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.

One month after discharge from the ICU, the patients will be randomly assigned to

* either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit
* or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Person who has given oral consent
* Patient 18 years of age or older
* Patient with at least one organ failure
* Patient with a stay of 6 days or more

Exclusion Criteria:

* Person who is not affiliated or not a beneficiary of a social security system
* Patient at the end of his/her life
* Patient who does not speak French
* Minor (\< 18 years old)
* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant, parturient or breastfeeding women
* Patient incarcerated
* Patient with a psychiatric history
NeuroGlove PD Study Clinical

Safety and Feasibility of Peripheral Sensory Stimulation of the Hand in the Treatment of Parkinson's Disease

This is a prospective, homebased, interventional clinical study in which 8 subjects will be enrolled. Eight (8) subjects who suffer from Parkinson's disease will receive treatment using the NeuroGlove.

Up to 8 subjects enrolled and complete study procedures. There will be a single cohort in the study consisting of the subjects with PD who will receive treatment with NeuroGlove.

Eligibility Criteria:
Inclusion Criteria:

1. Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
2. Men and women ≥18 and \<85 years of age.
3. Carry an active diagnosis of PD
4. Suffer from PD symptoms that impact subject's daily activities and quality of life

   Exclusion Criteria:
5. Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
6. Lacks the ability to comprehend or follow instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
7. Currently participating in another interventional clinical trial (observational clinical trial participation is allowed for study enrollment.)
Optical Detection of Peripheral Nerve Bundles During Surgery

Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.

The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.

Primary Objective:

The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.

Secondary Objective:

During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
* Patients that have provided a signed informed consent
* Patients ≥ 18 years old

Exclusion Criteria:

• Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy
A Cardiac Liability Study of Varegacestat in Healthy Participants

This clinical study is designed to study the effect of a single dose of varegacestat on cardiac repolarization in healthy adult participants.

This is a double-blind (with respect to varegacestat and placebo only), single-dose, randomized, placebo- and positive- controlled, 3-way crossover study.

On Day 1 of each period, participants will receive one of 3 treatments: a single dose of varegacestat (Treatment A), a single dose of varegacestat matching placebo (Treatment B), or a single dose of moxifloxacin (Treatment C). In each period, cardiodynamic ECGs will be collected predose and for 24 hours postdose. PK samples will be collected predose and up to 168 hours post-dose for assessments of varegacestat and AL102 MTB, and up to 24 hours post-dose for assessment of moxifloxacin.

There will be a washout of at least 14 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female (of non childbearing potential), 18 to 55 years of age, inclusive, at the screening visit.
* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, and vital signs, as deemed by the PI or designee

Exclusion Criteria:

* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
* Have taken an investigational drug or participated in a clinical trial evaluating an investigational drug or device within 30 days (or 5 half-lives) prior to the study drug dose, whichever is longer.
Case Series Study to Detect SARS-CoV-2 in Semen of COVID-19 Patients

A descriptive, clinical series, single-centre, national, biomedical study to determine the presence of SARS-CoV-2 in sperm samples from positive PCR patients for COVID-19 and to evaluate the presence of the virus in the sperm samples after a negative PCR for COVID-19

In late December 2019, a new coronavirus strain emerged in China causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). Different organizations including the American Society of Reproductive Medicine have recommended a precautionary approach. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended in many countries. The decision to resume the In vitro fertilization (IVF) treatment make us to question if virus could be in gametes affecting couples and reproductive outcomes. The presence of the virus in sperm have contradictory results.

The present study aims to describe if there could be presence of virus in sperm samples of patients with positive diagnosis for COVID-19, and if so, if the virus turns negative on the sperm after the patient recovers and have a negative result for COVID-19. Also it aims to assess the presence of the virus in the seminal plasma and discern if it possible to disseminate it by sexual transmission.

An interim analysis is expected to be carried out once the 50% of the expected recruitment is achieved.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
* Male age: 18 - 65 years, both included.
* COVID-19 positive result by PCR (including symptomatic and asymptomatic subjects).

Exclusion Criteria:

* Patients with severe symptoms or any other medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and his compliance in the study
* Known medical history of azoospermia or anejaculation
Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior

The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DM2,
* Over 18 years,
* Low educational level (no college to GBS or ESO),
* Inadequate glycemic control (glycosylated hemoglobin levels above 7%)

Exclusion Criteria:

* Physical or mental condition that prevents the completion of the intervention - complications arising from severe DM2 altering routine medical monitoring.
Equivalence Test of Two Different Inspiratory Muscle Training Protocols: a Randomised Controlled Trial

The objective of this study is to investigate if six weeks of high intensity Inspiratory Muscle Training (IMT) performed two times a week has the same effect as five times a week in hospitalized patients with first time Spinal Cord Injury (SCI).

Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced Maximal Inspiration Pressure (MIP) will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on Rating Perceived Exertion (RPE), voice performance, Quality Of Life (QOL)and sleep quality. Furthermore, long term follow-up at 12 months after start of intervention will also be performed.

Background: SCI may result in various disabilities including both physical, cognitive, emotional and social domains. Motor function and function of the respiratory muscles are often decreased and may influence the patient's activities of daily activities and QOL. IMT is training to improve the strength and endurance of diaphragm and the external intercostal muscles. Various training protocols of IMT have shown efficient to increase lung function. Although, a recent meta-analysis suggest that high intensity training may be more efficient it is less clear at what weekly frequency IMT should be performed.

Thus, the objective of this study is to investigate if six weeks of high intensity IMT performed two times a week has the same effect as five times a week in hospitalized patients with first time SCI.

Design/ methods: A Randomised controlled trial (RCT) including 60 patients, with reduced MIP will be recruited at two specialized SCI centers in Denmark. Primary outcome is MIP after six weeks of training. Secondary outcome will be reported on end of treatment and long term follow-up (12 months after start of intervention) in RPE, voice performance, QOL and sleep quality. The two intervention arms will consist of one arm training two times a week and the other arm training five times a week. The training protocol in both arms will include five rounds of IMT with 12 repetitions at 60 % of MIP. MIP will be increased 10 % every week if tolerated by the patient until 80 % of MIP is reached. After six weeks patients are motivated to continue training by themself up to 12 months after start of intervention.

Eligibility Criteria:
Inclusion Criteria:

* First time SCI within 0-6 months
* Age ≥ 18 years
* Neurological level: C4 -TH12 and C1-C4 (AIS D only)
* Severity/ AIS: A, B, C or D
* Able to give informed concent and understand and read Danish
* Mental able to understand and participate in a lung function assessment
* Decreased MIP according to normal gender and age adjusted MIP values

Exclusion Criteria:

* Lung disease or lung infection at the time of inclusion
* Co-morbidity or other contra indications
* Injury that hinder mouth shutting
* Respirator or tracheal tube use
* Experience of severe dizziness or vomiting during training
* Not expected to be hospitalised for at least 6 weeks