cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid

This study will evaluate the therapeutic effect and safety of adjunctive AKST4290 in subjects with bullous pemphigoid (BP).

This is a randomized, double-blind, placebo-controlled study to assess the therapeutic effect and safety of adjunctive AKST4290 in subjects with bullous pemphigoid (BP). Subjects will receive topical mometasone furoate cream (MFC) therapy concurrently with study agent (placebo or AKST4290) in an inpatient setting until disease control is reached (duration of inpatient stay is dependent upon individual disease course, but is estimated between 1-3 weeks).

Subjects will receive rescue therapy at any time if their clinical condition worsens or if their clinical condition fails to improve by the completion of Week 1 on study treatment, as assessed by the investigator. Rescue therapy will consist of whole-body clobetasol propionate cream (CPC) (15-50g) and/or oral prednisone (0.5 mg/kg per day), as determined by the investigator. Subjects who receive rescue therapy will remain in the study until disease control, unless they are withdrawn or withdraw from participation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to moderate BP at screening.
* Treatment naïve or initiation of whole-body high potency topical steroid treatment ≤ 7 days of screening (lesion-only treatment for any amount of time with any topical steroids prior to screening is allowed without restriction).
* Provide a signed and dated informed consent form in accordance with local regulations and/or IRB/IEC guidelines.

Exclusion Criteria:

* Severe BP.
* Initiation of gliptins and other treatments (e.g., etanercept, sulfasalazine, furosemide, penicillin) that can trigger BP if this treatment was started within 4 weeks prior to screening and is considered possibly related to the onset of BP.
* Any concomitant medications in the last 3 months prior to screening and assessed by the investigator as possibly related to the development of BP.
* Planned use of intravenous immunoglobulin or other concomitant treatments for BP (i.e., doxycycline, dapsone) during the study period.
* Use of systemic immunosuppressants (i.e., mycophenolate, azathioprine, methotrexate) within 4 weeks prior to screening.
* Treatment with rituximab within 1 year prior to screening.
* Subjects taking warfarin.
* Use of systemic steroids (\>10 mg prednisone or equivalent/day) within 14 days of first dose of study agent or known diseases (other than BP) that could require the use of systemic steroids within the study period.
* Clinically relevant abnormal laboratory value at screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the screening phase).
* Participation in studies of investigational drugs must have been discontinued within 30 days or 5 half lives of the drug (whichever was longer) prior to screening.
Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism

The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to measure the effect of HBOT on specific chemicals in their blood that may play a role in the child's behavior.

During the study's 20-week duration, all children will receive Hyperbaric Oxygen Treatment (HBOT) for two eight-week sessions, with a four week session between. Therefore, all children will participate in the study for 20 weeks, and will receive HBOT for 16 weeks. This is an open label study. This means that there will not be a placebo group in the study. All study participants will receive the same treatment of HBOT in a hard shell chamber. Normal air contains about 24% oxygen at a pressure of about 1 atmosphere absolute (ATA). The chamber will contain 100 percent oxygen at a pressure of 1.5 ATA, which is equivalent to the pressure at a depth of 15 feet in sea water. Each subject will complete the first 40 treatments during one hour sessions on 5 separate days in each of the first 8 weeks. They will then take a 4-week break before they begin their next 40 treatments, which will also occur during one hour sessions on 5 separate days in each of the last 8 weeks. The entire study will last 20 weeks. The child's behavior will be measured and evaluated at the MIND Institute at the beginning of the study, at week 8, and at week 20.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of DSM-IV defined autism and meets cut off for autism on the Autism Diagnostic Inventory-Revised (ADI-R) or Social Communication Questionnaire (SCQ) and the Autism Diagnostic Observation Scale (ADOS).
2. Age 3 to 8 years.
3. Nonverbal IQ of 50 or above.
4. Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention.

Exclusion Criteria:

1. Clinical evidence of seizure disorder
2. Active infection with fever
3. Fragile X or other known genetic cause of autism
4. Perinatal brain injury (e.g. cerebral palsy)
5. Previous adequate trial (at least 20 session) of HBOT
6. Inability to clear ears in the HBOT chambers
Expiratory Airflow Limitation in Subjects With Obesity

The purpose of this study is to investigate posture dependent small airway obstruction in subjects with obesity, and to study the capacity of FOT as a measurement tool for small airways obstruction.

Obesity is a cause of dyspnea due to mechanical impairment of pulmonary ventilation. One of the causes of this impairment is expiratory flow limitation, which is related to decreased lung volume. As a result, obesity can cause an asthma-like symptoms. Therefore, some patients with obesity are misdiagnosed as asthma-patients, and treated with asthma medication. The effects of bronchodilators on the mechanical airway obstruction in obese subjects have not been well established.

Posture also has effect on lung volumes: they are decreased in supine position. Therefore, the interaction of obesity and supine posture might result in a larger decrease in lung volumes, and thereby a more increased airflow limitation. It has been suggested that both obesity and supine posture result in an obstruction of peripheral airways. Such an obstruction can be measured by spirometry, using the ratio of forced expiratory flow between 25 and 75% and vital capacity. This measure is highly variable, however.

The forced oscillation technique (FOT) is a non-invasive method to measure the resistance and reactant of the respiratory system. Particularly the reactance has been shown useful in the measurement of airflow limitations.

The investigators hypothesize that obesity causes a posture dependent end- expiratory airflow limitation due to a mechanical compression of lung tissue, resulting in increased resistance and reactance in the airways. Therefore, the investigators expect no protective effect of bronchodilation by salbutamol. The investigators expect that reactance measured by FOT detects differences in airflow limitation and correlates with airflow limitation as measured by spirometry.

Eligibility Criteria:
Inclusion Criteria obese population:

* Male/female, age 25-60
* BMI (body mass index) 30-40 kg/m2
* Non or ex smokers with \< 10 packyears

Inclusion Criteria control population:

* Male/female, age 25-60
* BMI (body mass index) 18.5-25 kg/m2
* Non or ex smokers with \<10 packyears

Exclusion Criteria obese population:

* Asthma
* COPD (FEV1/FVC\<0.70)
* Reversibility \>9% in FEV1 (400 microgram salbutamol)
* Other significant neuromuscular, cardiac or lung disease

Exclusion Criteria control population:

* Asthma
* COPD (FEV1/FVC\<0.70)
* Other significant neuromuscular, cardiac or lung disease
* Reversibility \>9% in FEV1 (400 microgram salbutamol)
Special Survey on PD Patients With Renal Dysfunction

The survey is conducted to collect safety and effectiveness information targeting patients who have both Parkinson's disease and renal dysfunction treated with Pramipexole in the daily clinical settings in Japan.


Eligibility Criteria:
Inclusion Criteria:

Patients with Parkinson's disease who have renal dysfunction with pretreatment creatinine clearance =\<70mL/min or whose renal dysfunction was determined by the physician

Exclusion Criteria:

None
Concor® Bioequivalence Study in Chinese Participants (Darmstadt-Nantong)

The purpose of this study is to assess is the bioequivalence (BE) of Concor 5 milligram (mg) tablets manufactured by Merck/China Nantong (test product) and Concor 5 mg tablets manufactured by Merck/Germany Darmstadt (reference product) in Chinese healthy participants under fed or fasted condition.


Eligibility Criteria:
Inclusion Criteria:

* Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests and cardiac monitoring
* Participant must have a body weight within 50-90 kilogram (kg) and body mass index (BMI) within the range 19-26 kilogram per meter square (kg/m2) (inclusive)
* Participant must have negative screen for alcohol and drugs of abuse at screening and on admission
* Both male and female participants. The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable
* Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participant must not have any condition, including any uncontrolled disease state, that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
* Participant should not have positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, and treponema pallidum antibodies
* Participant must not have received any prescription or non-prescription medication within 28 days before the first study intervention administration, including multivitamins and herbal products (example, St John's Wort, or traditional Chinese medicines)
* Participant must not have participation in a study trial within 90 days prior to first drug administration; Blood donation (equal or more than 400 milliliter \[mL\]) or significant blood loss within 90 days prior to first drug administration
* Other protocol defined exclusion criteria could apply
Aprepitant to Mitigate Opioids' Cognitive Side Effects

Morphine and similar substances (called opioids) are often prescribed for moderate to severe pain, such as after a surgery, thus allowing for minimal pain and a better recovery. Unfortunately various, non-dangerous side effects from opioids occur often that limit the way patients feel and can take of themselves, despite otherwise good pain control and minimal limitations from the surgery itself.

In this proposed study the investigators want to examine if the drug aprepitant can decrease the so called "cognitive impairments" opioids may cause, such as drowsiness, loopiness and feeling "high".

This would allow for a better recovery period, in which patients can be more "themselves", participate in activities around them and move forward.

Subjects scheduled for elective surgeries with expected opioid medication for moderate to severe pain and good functional status shortly after surgery will be randomized to receive either aprepitant or placebo shortly before their surgery and for two more days thereafter.

A telephone interview for cognitive status and several specific questions will be used to assess the effect of aprepitant on the subjects' cognitive and functional status.

Eligibility Criteria:
Inclusion Criteria:

* healthy English speaking, opioid-naive consenting adults

Exclusion Criteria:

* current or very recent (\< 3 months) opioid therapy
* morbid obesity
* liver disease
* therapy with pimozide, terfenadine, astemizole, cisapride, vitamin K antagonists (warfarin), hormonal contraceptives
* acute or chronic infections
* immunocompromised status
* hemodynamically unstable, hemorrhage (bleeding)
* recent surgery
* pregnancy, nursing
* younger than 18 years old
* not proficient of the English language
Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

This is a small pilot randomized controlled trial which will enroll both subacute (\<6 mos) and chronic (\>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 75 years
* Minimum of 2 wks from a first clinical non-hemorrhagic or hemorrhagic stroke
* Medically stable
* Unilateral lower extremity hemiparesis
* Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council scale, while seated
* NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
* Full voluntary ROM of the contralateral ankle
* Skin intact on bilateral lower extremities
* Able to don the NMES system or caregiver available to assist with device if needed.
* Able to hear and respond to stimulator auditory cues
* Able to follow 3-stage commands
* Able to recall 2 of 3 items after 30 minutes
* Cognition and communication adequate for safe use of the device based on neurological assessment by physician principal investigator

Exclusion Criteria:

* Severely impaired cognition and communication
* History of peroneal nerve injury
* History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis
* Uncontrolled seizure disorder
* Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
* Edema of the paretic lower extremity
* Absent sensation of paretic lower extremity
* Evidence of deep venous thrombosis or thromboembolism
* History of cardiac arrhythmias with hemodynamic instability
* Cardiac pacemaker or other implanted electronic system
* Botulinum toxin injections to any lower extremity muscle in the last 3 months
* Pregnancy
* Symptomatic peripheral neuropathy
* Current use of psychoactive medications (except selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants)
* Acetylcholinesterase inhibitor usage
* Unstable asthmatic condition
* Metallic implants (including clips and/or wires)
* Prosthetic heart valves
* Cardiac, renal or other stent
* History of claustrophobia
* Low visual acuity
* Body weight or body habitus not compatible to MRI machine
* Medical, psychological, or social concern identified by the principal investigator or co-investigator which suggests inappropriateness of subject participation
Control of Iatrogenic Endobronchial Bleeding by Tranexamic Acid, Adrenalin and Hemagglutinase

A prospective national multi-center study will be conducted to evaluate the effectiveness of hemocoagulase in iatrogenic airway bleeding in a large class III hospital, such as the Second Affiliated Hospital of Harbin Medical University, the First Affiliated Hospital of Nanchang University, and to compare it with topical epinephrine and tranexamic acid in a prospective double-blind cluster randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* During diagnostic bronchoscopy, patients with bronchial bleeding that was not successfully controlled with cold (4°C) saline (3 times within 60 seconds, 5ml each time).

Exclusion Criteria:

* 1: Patients with contraindications for diagnostic flexible bronchoscopy.

  2: Coagulopathy (PV INR \>1.3).

  3: Thrombocytopenia (\<50x10\^9) or anemia (hgb \<80 g/L).

  4: Direct oral anticoagulant, low molecular weight heparin, or antiplatelet therapy.

  5: Thrombophilia, history of pulmonary embolism or deep vein thrombosis.

  6: Contraindications for the use of epinephrine in the bronchus.

  7: Coronary artery disease, cerebrovascular disease, history of rapid arrhythmias.

  8: Uncontrolled pulmonary hypertension.

  9: Cardiovascular decompensation.

  10: Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90%, FiO2 \>=60%).
Quality of Life and Supportive Care Preferences Following Radiation Therapy in Prostate Cancer Survivors

This pilot clinical trial studies quality of life and supportive care preferences following radiation therapy in prostate cancer survivors. Studying quality of life and supportive care preferences in patients undergoing radiation therapy may help identify the effects of treatment on patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To develop an understanding of the impacts of prostate cancer on aspects of psychological stress, physiological stress and health related quality of life (HRQL) for men who are being treated with some level of radiation therapy (RT).

II. To gain insight into the perceived needs of survivors depending on their disease stage, treatment regimen and side effects.

SECONDARY OBJECTIVES:

I. To explore whether biomarkers of stress, inflammation and autonomic control (heart rate variability \[HRV\]) can confirm or dispel the self-reported measures of psychological distress and HRQL of a unique population of aging men with prostate cancer.

OUTLINE:

Participants complete questionnaires about quality of life and preferences for supportive care treatment, undergo heart rate variability testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week, and undergo a single intelligent dual-energy X-ray absorptiometry (iDXA) scan over 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Diagnosis of prostate cancer
* Treatment with primary radiation (brachytherapy or external beam therapy), radiation + androgen deprivation therapy (ADT) or salvage prostatectomy
* Body mass index (BMI) (26 - 40 kg/m\^2)
* Treating oncologist consent
* Ambulatory or able to engage in walking for at least 45 minutes per intervention visit
* Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week

Exclusion Criteria:

* Poor diagnosis or other cancer
* Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension
* Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
* Non-ambulatory
* Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit
* Major mental illness (e.g., schizophrenia, major depressive disorder)
* Unwilling to give consent
Acceleration of Recovery From General Anesthesia - Efficacy of Isocapnic Hyperpnoea in Obese Patients Undergoing Isoflurane Anesthesia

Faster recovery from anesthesia is important for obese patients because they are at high risk of respiratory complications following tracheal extubation. Isoflurane has several properties that make it a preferable agent for anesthesia in obese patients. Its main limitation is a longer recovery time due to slower elimination in comparison to other agents. Elimination of isoflurane from the lungs can be accelerated by increasing in patient's minute ventilation, which decreases the level of CO2 in blood (hypocapnia).Isocapnic Hyperpnoea (IH) is a method allowing increased ventilation and therefore enhancement of the elimination of inhalation agents while maintaining a normal blood CO2 level. The investigators will compare recovery time from isoflurane anesthesia in obese patients during standard anesthesia management protocol (control) to a group treated with IH.


Eligibility Criteria:
Inclusion Criteria:

Elective gynecological or urological procedure,

* BMI \> 35 kg/m²,
* ASA I-III,
* Signed informed consent.

Exclusion Criteria:

* Lack of informed consent,
* ASA IV-V,
* Contra-indications to isoflurane anesthesia or other anesthetics included in the protocol,
* History of cardiac or respiratory disease,
* Alcohol or drug abuse,
* Psychiatric illness and/or medications.
Evaluation of the Evolution of Quality of Life in Relation to Naso-sinus Symptomatology Under Treatment With CFTE Modulators in Children Aged 6 to 11 Years With Cystic Fibrosis With Compatible Mutation

Cystic fibrosis is a multi-organ disease. It most often results from a genetic mutation, the delta F508 mutation, which prevents the expression of the CFTR 'régulateur de conductance transmembranaire de la fibrose kystique) protein. If the poor prognosis of the disease is correlated to the pulmonary damage, we observe, at the naso-sinus level, a significant functional impact, with chronic rhino-sinusal damage that can alter the quality of life of patients. In addition to this functional impact, some studies suggest that these chronic naso-sinus attacks are involved in the creation of a bacterial reservoir that is secondarily responsible for pulmonary colonization and therefore partly responsible for the poor prognosis of the disease.

The clinical and paraclinical examinations can be used to determine the extent of these disorders. Their functional impact can be assessed using quality of life questionnaires such as the SN-5 scale.

Treatment with CFTR modulators in patients with mutations compatible with the treatment seems to transform their vital prognosis. The scientific rationale of this treatment consists in restoring the activity of the CFTR protein, allowing the recovery of the hydro-electrolytic balance of the mucous secretions, and thus reducing the viscosity of the biological fluids. The various studies carried out all prove a dramatic improvement in pulmonary parameters under treatment, with very limited toxicity.

A marketing authorization for this treatment has been issued on the European market for patients over 18 years of age in 2020, for children over 12 years of age in 2021, and will soon be issued for children aged between 6 and 11 years.

Since the pathophysiology of pulmonary and nasosinus involvement are similar, and since this treatment will be marketed for children between 6 and 11 years of age, we expect an improvement in rhino-sinus symptomatology. To date, clinical studies have focused primarily on pulmonary outcomes. There are only few publications dealing with the evolution of nasosinus symptomatology under treatment, and none concerning the pediatric population.

The aim of our study is to evaluate the evolution of naso-sinusal symptomatology under treatment with CFTR modulators in children aged 6 to 11 years. This will allow us to confirm or deny the interest of these treatments in the extra-pulmonary manifestations of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Children between 6 and 11 years of age
* Compatible genotype and patient treated with KAFTRIO (treatment initiation is independent of this study)

Exclusion Criteria:

* Refusal of the child or the holder of parental authority to participate in the study.
* Child not affiliated to a social security system and under legal protection
* Holder of parental authority who does not master the French language

Secondary Exclusion Criteria:

* Sinus surgery during the observation period
* Poor tolerance of the treatment (pneumological opinion)