cyrilzakka/clinical-trials huggingface dataset:
Ozone and Rhinovirus-Induced Disease in Asthmatics

In the U.S., morbidity associated with human rhinovirus (RV) infection represents a major health problem. In asthmatics, up to 80% of asthma exacerbations are associated with upper respiratory infections. Despite evidence that environmental oxidant pollutants, such as ozone, may increase the severity of viral disease, the mechanisms underlying such an effect have not been identified. This study will test the hypothesis that exposure of allergic asthmatic subjects to ambient levels of ozone directly enhances viral disease by increasing infectivity and intensifying virus-induced inflammation.

In mild asthmatics, the study will investigate: (1) if exposure to ozone will enhance the viral infective process in the nasal epithelium, (2) the effect of ozone exposure on RV-induced inflammatory gene expression, mediator release and inflammatory cell influx into the upper and lower airways, and (3) the interactive effects of ozone and RV on airway reactivity. This information will improve our understanding of the risk associated with oxidant pollutant exposure in this population of individuals in whom RV infection may represent a significant health concern.

Eligibility Criteria:
Subjects recruited will be non-asthmatic controls or mild allergic asthmatics using beta-agonists, mostly on an "as needed" basis. Selection criteria will include good general health by medical history and physical examination, no history of smoking, and the absence of respiratory infection in the preceding 6 week period. Subjects will undergo serologic testing and must have a negative test for neutralizing antibodies to RV16 to participate in all but one study of the project.
Osia CPT Code Study

To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent.
* Proficient in English.
* Hearing loss etiology of Conductive or Mixed Conductive loss.
* Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the treatment ear.
* Aged 18 years and older.

Exclusion Criteria:

* Unwilling to wear the treatment device or comply with the surgical and rehabilitation requirements of the study.
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Medical, audiological or psychological conditions, as judged by the investigator that might contraindicate participation in the clinical investigation.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or contractors engaged by Cochlear for the purposes of this investigation.
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
* Prior experience with a surgical bone conduction treatment option
* Insufficient bone quality to support the BI300 implant as determined by the surgeon
Consciousness, Psilocybin, and Well-Being

This study is being done to identify a dosing strategy that will allow IV psilocybin to be administered to sleeping participants without awakening them.

The study commenced with 1 subject receiving 2 mg IV infusion of psilocybin over 2 minutes and 2 subjects receiving 2 mg IV infusion of psilocybin over 10 minutes. Subsequently, the pre-treatment of 0.2 mg of clonidine was added.

This design involves testing up to two psilocybin+clonidine administration protocols in asleep and awake subjects and one of two "IV psilocybin only" administration protocols in awake subjects.

The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or 10-minute psilocybin infusion (plus oral clonidine) protocols allow sleep maintenance, up to 5 subjects will, while awake, receive the same psilocybin infusion protocol administered to sleeping subjects, including clonidine. Subsequently, this same infusion protocol may be administered without clonidine, to evaluate any potential effect of co-administered clonidine on the acute psychedelic experience in awake subjects (Group 1C for 2-minute psilocybin infusion; Group 2C for 10-minute psilocybin infusion), should a significant effect of clonidine on the awake psychedelic experience be suspected. For individual subjects that are dosed first while asleep and then up to twice while awake, each of their visits will be separated by a minimum of two weeks and will include psychosocial support through integration sessions following each dosing visit.

Adaptive Study Design Change per Protocol Amendment Approved 5/21/24

Eligibility Criteria:
Inclusion Criteria:

* Medically healthy
* English-speaking
* Live within 150 miles of Madison, WI for duration of study

Exclusion Criteria:

* Current use of medications that may interact with psilocybin
* Current sleep disorder, including (but not limited to) insomnia, sleep apnea, restless legs syndrome, and/or narcolepsy
* Females with positive urine pregnancy at any time point during screening or study participation
* Current cardiac valve disease
Study to See Whether Breath-Hold Techniques During RT Are Effective in Helping to Improve Sparing of the Heart

The study hopes to determine whether patients with left-sided breast cancer are at an increased risk of cardiac changes due to radiation to the breast +/- Anthracycline-based chemotherapy +/- Herceptin and whether a deep inspiration breath hold (DIBH) technique during radiotherapy treatments would further reduce dosimetric dose to the heart as compared to the conventional free breathing (FB) technique thus reducing cardiac toxicity as measured by cardiac MRI using left ventricular end-diastolic volume (LVEDV) as a metric. Bio fluid samples will also be collected to investigate specific biomarkers of breast cancer: BNP, PIIINP and CITP

Patients with left-sided breast cancer who receive adjuvant breast or chest wall radiation have increased risk of treatment related cardiovascular morbidity. The risk of cardiac morbidity and mortality is increased when a patient receives radiation following adjuvant chemotherapy and Herceptin. The dose-volume histogram (DVH) parameters associated with increased cardiac toxicity include volume of heart irradiated, total radiation dose received by the left ventricle (LV), V25 and mean cardiac dose. Even though modern RT treatments like 3DCRT and IMRT can reduce the mean dose to the heart, the maximum dose to the left side of the heart/LV may not be reduced if the target is close to the heart. The hypothesis is that DIBH RT can safely and effectively reduce the heart dose, especially the dose to the LV, that could lead to reduction in the incidence of radiation induced cardiovascular morbidity and mortality.

Radiotherapy has detrimental effects on cardiac function due to remodeling of the cardiac tissue that receive radiation. We believe that the radiation related acute effects on heart tissue can be detected with cardiac functional MRI. The study will quantify the acute RT related effects. To our knowledge, cardiac MRI has not been explored as a non invasive technique to quantify RT +/- chemotherapy related effects.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with pathologically confirmed left sided breast cancer eligible for adjuvant breast/chest wall plus or minus regional nodal radiotherapy
* Women patients with age group between 18 and 70 years old
* Karnofsky performance score ≥ 70
* Ability to hold breath for at least 20 sec (for DIBH cohorts only)
* Life expectancy \>10 years

Exclusion Criteria:

* For patients with prior Anthracycline based chemotherapy or Herceptin, if there is \< 1.0 cm of heart on at least 3 slices ( 3 mm slices) on the FB scan, the patient will be considered a screen failure.
* Previously irradiated or recurrent breast/chest wall tumours or previous malignancy other than non-melanoma skin cancer unless disease free for a minimum of 5 years prior to study entry
* Patients that require a shell for breast immobilization
* Patients requiring a boost
* Stage IV disease
CANadian Adaptive DBS TriAl

Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS).

This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.


Eligibility Criteria:
Inclusion Criteria:

* PD treated with bilateral STN DBS using Medtronic lead
* Able to provide informed consent and comply with study protocol
* Need to replace the implantable pulse generator (IPG) due to battery end of life
* Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient
* Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off.
* Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one
* Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere

Exclusion Criteria:

* Previous DBS surgery without Medtronic products
* Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS
* Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues)
* Medically unstable
* Severe non-motor problems, such as depression, dementia, etc.
Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late damage after radiotherapy) of the jaw.

Late radiation damage to the lower jaw (osteoradionecrosis (ORN)) is often seen in patients treated with radiotherapy for a tumor in the head and neck region. Part of the lower jaw becomes non-vital and has to be treated. ORN proofs to be a condition difficult to treat and the treatment for this condition varies.

In many countries hyperbaric oxygen therapy (HBOT) is added to the surgical treatment of ORN. Unfortunately there is no consensus whether the addition of hyperbaric oxygen therapy to the treatment of ORN is beneficial or not. This study has the aim to investigate the efficacy and cost-effectiveness of HBOT in the treatment of ORN

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age ≥ 18 jr
* WHO performance status 0-2
* Last radiation treatment ≥ 6 month ago radiotherapy with curative intention and \> 55 Gy. The affected part of the jaw must be in the target volume area of the radiotherapy field.
* Local recurrence must be ruled out
* Necrosis of the jaw with at least one of the following symptoms for over 3 month present:

  * Bone exposition which measures at least 1 cm
  * Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN.
  * Non-healing extraction socket

Exclusion Criteria:

* Former HBO treatment
* Contra indication for HBO treatment (pneumothorax)
* Bisphosphonate treatment in the medical history
* reirradiation in the medical history
* Osteosynthesis material in the affected area
* Distant metastasis
* Primary or recurrent tumor in the affected area
* Malignancies elsewhere
In Vitro Fertilization Outcomes of Two Treatment Protocols in Women With Polycystic Ovary Syndrome

Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol.

Women with PCOS undergoing IVF/ICSI cycles will be evaluated by two different protocols. One arm of the study includes oral contraceptive plus GnRH agonist protocol with 150 IU FSH (standard dose) and second arm includes oral contraceptive plus GnRH Antagonist with 150 IU FSH dose and fixed 6th day starting of GnRH Antagonist.

Eligibility Criteria:
Inclusion Criteria:

* PCOS women undergoing ICSI cycles
* All women will be administered 150 IU rec FSH

Exclusion Criteria:

* Women having other endocrinopathies
* women older than 35
* third IVF/ICSI cycles
* previous and current use of metformin
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.


Eligibility Criteria:
Key Inclusion Criteria

* Patients scheduled for either elective unilateral or same-day bilateral total knee replacement surgery (TKR) or a revision of at least 1 component of a TKR
* Patients willing and able to undergo bilateral ascending contrast venography

Key Exclusion Criteria

* Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or his or her first-degree relative
* Known or suspected history of heparin-induced thrombocytopenia
* Known coagulopathy
* Active bleeding or at high risk for bleeding
* Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
* Active hepatobiliary disease
* Alcohol and/or substance abuse within the past year
* Any condition for which, in the opinion of the investigator, surgery or administration of an anticoagulant was contraindicated
* Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure \>180 mm Hg or supine diastolic blood pressure \>105 mm Hg
* Clinically significant laboratory abnormalities at the enrollment visit:

  * Hemoglobin \<10 g/dL
  * Platelet count \<100,000/mm\^3
  * Creatinine clearance \<30 mL/min, as estimated by the method of Cockcroft and Gault
  * Alanine aminotransferase or aspartate aminotransferase level \>2\*upper limit of normal (ULN) or a total bilirubin ≥1.5\*ULN (unless an alternative causative factor such as Gilbert's syndrome was identified)
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies

The purpose of this study is to determine if two allergy medications are more effective than placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 12 years of age and older
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in protocol
* Must be willing and able to provide informed consent and participate in all study procedures
* 2-year history of PAR
* Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion Criteria:

* On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
* Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
* Nasal surgery or sinus surgery within the previous year
* The use of any investigational drug within 30 days
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
* Women who are pregnant or nursing
* Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
* Respiratory tract infection within 2 weeks of screening
* Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
* Patients with asthma with the exception of mild, intermittent
* Significant pulmonary disease including COPD
* Patients with arrhythmia
* Patients with a known history of alcohol or drug abuse
* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
* Clinically relevant abnormal physical findings within one week of randomization
* Overnight abscences from home for more than 3 nights
* Employees of the research center or private practice and family members are excluded
* Patients who received prohibited medications within specified timepoints in protocol.
Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention.

The investigators hypothesized that the inflation of the blood pressure cuff during the remote ischemic conditioning (RIC) procedure would lead to an increase in stroke volume (SV), cardiac index (CI), and peripheral perfusion index and that these changes would correlate with the hemodynamic changes induced by passive leg raising (PLR).

Furthermore, the clinical relevance of the RIC effect in critically ill patients, particularly in terms of determining their hemodynamic responsiveness, remains uncertain. The investigators hypothesized that the RIC procedure influences hemodynamic changes during PLR.

Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years,
* admitted to the intensive care unit,
* monitored with a transpulmonary thermodilution device with calibrated pulse contour analysis (Pulsion Medical Systems, Munich, Germany),
* decision by the physician in charge to perform passive leg raising.

Exclusion Criteria:

* pregnancy,
* advanced malignancy,
* peripheral artery disease affecting both arms,
* head trauma,
* deep vein thrombosis in the lower limbs,
* intra-abdominal hypertension, defined as an intra-abdominal pressure greater than 12 mmHg.
Energy Regulation and Nutritional Status of Children: A Satiation Study

This is study among children attending child welfare clinics in Greater Accra Region of Ghana. The investigators want to find out if moderately malnourished children regulate the food energy intake similarly to healthy children, using an established method to assess energy compensation.

Malnutrition originates from a complex interplay between genes and environment, manifesting in changes to hormones, metabolism, and behaviour. Energy regulation which determines food intake or avoidance plays a significant role in the cause, prevention and treatment of malnutrition. There is however limited knowledge of how energy regulation develops in children and its effect on their nutritional status in the context of undernutrition in children. A good understanding of energy regulation in children is therefore essential in designing interventions for tackling infant malnutrition.

A standardised energy compensation study will be undertaken in 60 children- 20 moderately malnourished, 20 stunted and 20 healthy. At two visits at least a week apart, the children will be given one of two similar tasting drinks in random order, one with very few calories and another with extra, without them knowing which is which. After 30 minutes they will eat as much as they want of a standardized lunch. All foods and drinks offered will be weighed before and after, to calculate the amount of energy eaten in total after the low energy drink, compared to the high energy drink.

Eligibility Criteria:
Inclusion Criteria:

* moderately malnourished (WHZ between -3 and -2 Z-scores) or stunted (HAZ\<-2SD) or Healthy (WHZ \>-2SD and HAZ \>-2SD) children age 12-36 months.
* Children should be attending child welfare clinics at the selected communities.
* The children should be accompanied by a main caregiver who is actively involved in cooking for and/or feeding the child.
* Children who are able to fast for at least 2 hours prior to the experiment.

Exclusion Criteria:

* Children with congenital disorders, disabilities and diseases requiring specialised care and hospitalisation.
* Children with severe malnutrition with complications that required inpatient care.
* Tube-fed children.
* Children who are both stunted and moderately malnourished
Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery

The objective of this study is to evaluate the hemostatic capacity of two types of collagen hemostatic sponges in nail surgery.

It is a randomized triple-blind clinical trial with two experimental groups (medium porosity collagen and high porosity collagen) and control group ( non collagen).

To evaluate bleeding, all patients with onychocryptosis will be operated on with the same technique.

In the experimental groups, once the surgical procedure has been completed on both edges of the nail, hemostatic collagen will be applied in the experimental groups (experimental group 1- medium porosity collagen and experimental group 2-high porosity collagen) In all groups, including the control, once the intervention was finished, the same bandage was performed with the same number of gauze pads.

At 72 hours, the gauze set will be removed to weigh it using a precision balance and quantitatively evaluate the amount of bleeding.

In this way, a comparative study can be carried out between the 3 groups and determine if there are statistically significant differences or not, and can determine if lyophilized hemostatic collagen is useful in nail surgery and if there are significant differences between both experimental groups, determining if the percentage of porosity in a hemostatic is relevant in the hemostatic effect.

Eligibility Criteria:
Inclusion Criteria:

* STADIUM I, II, or III (Kline classification) without infective onychocryptosis (cellulitis) on both edges of the Hallux
* Susceptible to phenol-alcohol technique with Suppan I modification

Exclusion Criteria:

* Platelet Antiplatelet Therapy
* Oral Anticoagulant Therapy
* History of congenital or acquired Hemorrhagic Syndrome
* Alteration in the following parameters (platelet count, prothrombin time, activated thromboplastin time, and plasma fibrinogen)
OCT in Fuchs' Dystrophy

This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.


Eligibility Criteria:
Inclusion Criteria:

* Damaged or diseased corneal endothelium from Fuchs' or PBK
* Willingness to commit to required study visits

Exclusion Criteria:

* Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery
* Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
* Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome)
* Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment
* Peripheral anterior synechiae in the angle greater than 3 clock hours
* Hypotony
* Uncontrolled glaucoma
* Visually significant optic nerve or macular pathology