cyrilzakka/clinical-trials huggingface dataset:
Effects of Reducing Indoor Air Pollution on the Adult Asthmatic Response

This study is about asthma and how the environment affects asthma. Scientists know that air pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms worse. This research is being done to study how the health of a person with asthma responds to an air cleaner. The investigator hypothesize that an air cleaner will improve the health of persons with asthma.

The investigators seek to determine the effect of placing air cleaner devices in the homes of adults with asthma on the adults' asthma health. To this end, the investigators aim to study 40 adults with asthma that are 18-50 years of age and live in Baltimore. Participants will receive either true air cleaners or sham cleaners in a blinded, randomized manner for one month, and then, after a washout period, participants will cross over and receive the other intervention (sham or true cleaner). All participants will have environmental monitoring (personal and in-home) to determine participants' particulate matter exposure, and be followed repeatedly during the 3 month study period for markers of asthma disease, including respiratory symptoms, medication and health care utilization, pulmonary function, systemic markers of inflammation, and bronchoscopic evidence of airway inflammation or epithelial cell dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years of age
* Non-smoker (\<100 cigarettes in lifetime)
* Physician diagnosis of asthma
* Symptoms of asthma and/or reliever medication use in the past 6 months
* Living in the current residence \>= 6 months within Baltimore
* Enrollment in, and completion of, the observational environmental asthma study "Inhale 1"

Exclusion Criteria:

* Current diagnosis of another major pulmonary disease, other significant morbidity
* Pregnancy (as defined by a positive urine pregnancy test at screening of all women of child-bearing potential)
* Planning to relocate residence or activity that necessitates travel away from home for prolonged period of time during the study period
* Current use of an air cleaner in the home
Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)

This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged more than or equal to (\>=) 18 years and less than or equal to (\<=) 60 years at the time of Rebif introduction
* Subjects diagnosed with RMS according to the revised McDonald criteria (2010)
* Treatment naïve or subjects on other DMDs who will switch to Rebif.
* Subjects will receive 1st Rebif 44 mcg dose after signing informed consent
* Subjects willing and able to provide signed informed consent.

Exclusion Criteria:

* Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information
* Subjects participating in other clinical studies/trials
* Any female subject of childbearing potential who is not on contraceptives
* Subjects refusal to participate in the study.
An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin.

Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China.

Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents (body weight \>= 40 kg at the Baseline Visit for patients between \>= 12 and \< 18 years of age) and adults at the time of enrollment.
* Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
* UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC.
* The decision to prescribe UPA is made prior to and independent of study participation.
* The participant should not be treated with UPA prior to this study.
* Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps.
* The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted.

Exclusion Criteria:

* The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation).
* Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.
Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients

Pediatric patients pose challenges in airway management due to anatomical and physiological changes. Using recommended predictive tests for predicting difficult airway can be improved by combining them with ultrasound measurement of the anterior soft tissues of the neck. In this study, the investigators aim to evaluate the ultrasound measurement of anterior neck soft tissues in paediatric patients before anesthesia induction, to anticipate difficult laryngoscopy.

Eligible participants for this study will be patients aged 2-8 years scheduled for elective surgery under general anesthesia who have provided informed consent. During the preoperative evaluation, demographic data and airway physical examination results (Mallampati score) of the patients will be recorded. Patients who have received preoperative sedation will be positioned supine on the operating table, and ultrasound-guided measurements of soft tissue distances will be taken using a linear probe with a frequency range of 6-13 Hz. The distance between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure and skin (DSAC), and distance between the epiglottis and skin (DSE) will be measured. The A/E (Anterior Commissura/Epiglottis) ratio will be calculated after measurements.

After standard monitoring and anesthesia induction, difficult laryngoscopy will be evaluated using the Modified Cormack Lehane Score, which grades the visibility of vocal cords and glottic structures. A grade of 3 or 4 on this scale will be considered as difficult laryngoscopy and recorded as such. Tracheal intubation will be performed by an anesthesiologist with at least two years of experience who is unaware of the ultrasound measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned to undergo general anesthesia for elective surgery
* American Anesthesiology Association physical classification (ASA) status I-III
* Body mass index (BMI) above 30

Exclusion Criteria:

* Patients with a history of difficult airway or with conditions that are known to be associated with a difficult airway, such as syndromic or metabolic diseases.
* Patients with congenital maxillofacial defects.
* Patients with tracheal or laryngeal pathology.
* Patients with pulmonary diseases such as bronchial asthma or airway hyperreactivity.
* Patients with allergies to ultrasound gel.
* Patients with weight percentile outside the range of 10-90 percentiles.
* Patients undergoing emergency surgery.
PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.

This is an European multi-center observational study. Treatments and follow-up visits will be done as per standard of care.

The objective of this study is to evaluate the efficacy and safety of the PHIL® device in the treatment of intracranial dural ArterioVenous Fistula (dAVF). The PHIL® device, a non-adhesive liquid embolic agent, has been CE marked since July 2014. It is intended for use in the embolization of lesions in the peripheral and neurovasculature, including arteriovenous malformations and hypervascular tumors.

All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL® are eligible for this study. A maximum of 70 patients will be enrolled in this study in 16 European Institutions.

The expected approximate study duration is 38 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
2. Patient has an intracranial dAVF that can be treated by embolization with PHIL® used with or without other embolization products except other non-adhesive liquid embolic agents (i.e. Squid, Onyx).
3. Patient is at least 18 years of age.

Exclusion Criteria:

1. Patient has multiple dAVFs to be treated.
2. Patient participates in a study evaluating another medical device, procedure, or medication during the course of dAVF treatment and follow-up per the study protocol.
3. Patient does not give consent to the collection and processing of data required for centralized monitoring

3. Any condition that could prevent patient follow up.
Follow-up Study After Bankart Repair Using MG-1

Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.


Eligibility Criteria:
Inclusion Criteria:

* Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic Hospital and who don't withdraw the consent
* Patient who understand the contents of the study and from whom a written consent can be obtained

Exclusion Criteria:

* Patient with dementia
* Patient who cannot undergo CT examination
* Patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial
* Patient who is pregnant or lactating
* Patient judged to be inappropriate for the study by the (sub)investigator
A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation

This randomized phase II trial compares how well adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant works in treating patients with multiple myeloma. Chemotherapy drugs, such as melphalan, are given to prepare the bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as XMO2 Filgrastim (Granix), may help multiple myeloma cells move from the patient's bone marrow to the blood where they may be more sensitive to treatment with melphalan. It is not yet known whether adding XMO2 Filgrastim (Granix) to melphalan before a stem cell transplant will work better than melphalan alone in treating multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic multiple myeloma requiring treatment
* Received at least two cycles of any regimen as initial systemic therapy for multiple myeloma and are within 2-12 months of the first dose of initial therapy
* At least 18 years of age
* Adequate autologous stem cell collection, defined as an unmanipulated, cryopreserved, peripheral blood stem cell collection containing at least 2 × 10\^6 CD34+ cells/kg based on patient body weight.
* Adequate organ function as measured by:

  * Cardiac function: Left ventricular ejection fraction at rest ≥40%
  * Hepatic function: Bilirubin ≤2 × ULN and aspartate amino transferase/alanine amino transferase (AST/ALT) ≤3 × ULN
  * Renal function: Creatinine clearance ≥40 mL/minute (measured or calculated/estimated)
  * Pulmonary function: Carbon monoxide diffusing capacity (DLCO; corrected for hemoglobin \[Hgb\]), forced expiratory volume in 1 second (FEV1), forced expiratory vital capacity (FVC) ≥50% of predicted value
  * Oxygen saturation ≥92% on room air
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Evidence of multiple myeloma disease progression (as defined by IMWG) any time prior to ASCT
* Prior stem cell transplant (autologous or allogeneic)
* Smoldering MM not requiring therapy
* Plasma cell leukemia
* Systemic amyloid light chain amyloidosis
* Active bacterial, viral, or fungal infection
* Seropositive for human immunodeficiency virus (HIV)
* Known, active hepatitis A, B, or C Infection
* Pregnant or breastfeeding.
* Receiving other concurrent anticancer therapy (including chemotherapy, radiation, hormonal treatment, or immunotherapy, but excluding corticosteroids) within 7 days prior to the ASCT or planning to receive any of these treatments prior to the last study visit on Day +100.
* Hypersensitive or intolerant to any component of the study drug(s) formulation
* Receiving growth factors (filgrastim, XM02-filgrastim, peg-filgrastim, plerixafor, etc) or undergoing apheresis \< 14 days prior to the start of treatment on protocol (Day -7).
Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain

The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.

As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy.

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Opioid addiction.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Drug abuse.
* Pregnancy.
* Severe liver and/or renal failure.
* Uncontrolled hypertension.
* Severe cardiovascular problems.
* Diabetes mellitus.
A Study of PM8002 in Combination With Chemotherapy in Patients With NEN

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET).

This is a phase II, single arm study assessing the efficacy and safety of PM8002 in combination with FOLFIRI as second line treatment for neuroendocrine neoplasm (NEC and Ki-67≥55% G3 NET) who failed first-line platinum-based chemotherapy

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form before any trial-related processes;
2. Aged ≥ 18 years;
3. Ki-67≥55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study;
4. Subjects failed first-line platinum-based chemotherapy;
5. Adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Expected survival ≥ 12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1;

Exclusion Criteria:

1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
2. Evidence and history of severe bleeding tendency;
3. History of severe cardiovascular diseases within 6 months;
4. Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months);
5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. Pregnant or lactating women;
10. Other conditions considered unsuitable for this study by the investigator.
Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy

The aim of the study is to examine the suitability, the so-called validation, of a questionnaire, with which one can grasp the reasons why injections of growth hormones are omitted by patients ("non-adherence"). Participants are treated with growth hormone and are therefore eligible to take part in the study. Study doctor will ask participants to answer questionnaires. two times within 14 days. The first time participants answer during the routine visit to the practice / clinic and the second time at home. There are no risks associated with participating in the study as it does not affect participant's medical treatment.


Eligibility Criteria:
Inclusion Criteria: - Children/adolescents, male or female, aged 8 to 18 years who self-inject GH as well as their parents/legal guardians or Parents/Legal guardians who administer GH to a child/adolescent, male or female, from birth to 18 years - The child/adolescent is on prescribed daily GHT due to idiopathic growth hormone deficiency (GHD), multiple pituitary hormone deficiency (MPHD/organic GHD), small for gestational age (SGA) or Turner syndrome (TS) for at least 6 months before screening visit - Signed informed consent obtained by parent/legal guardian and child/adolescent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) Exclusion Criteria: - Mental incapacity, unwillingness or language barrier of participant precluding adequate understanding or cooperation - Previous participation of participant in this study. Participation is defined as having given informed consent in this study - Treatment of child/adolescent with any investigational drug within 30 days prior to enrolment into the study
C-Reactive Protein as a Predictor for Airway Hyper-Responsiveness

Background: Increased serum high sensitivity C-reactive protein (hs-CRP) has been associated with airway inflammation in asthma and may serve as a surrogate marker for the presence of airway hyper-responsiveness (AHR) in this set-up. This study was designed to evaluate the predictive value of hs-CRP for AHR assessed by metacholine challenge test (MCT), in adults with suspected Asthma.


Eligibility Criteria:
Inclusion Criteria:

* subjects that were referred to Metacholine challenge test

Exclusion Criteria:

* age \< 18
Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot

This is a randomized controlled monocentric study on 114 diabetic patients with the aim of evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that are candidates for a minor amputation in the foot. In particular, it will be evaluated whether the lipofilling will be able to shorten the healing times and to reduce the number of major amputations, with consequent positive impact on the quality of life. Patients will be randomized to the treatment group with Lipogems® (local injection of autologous micro-fractured adipose tissue) or to the control group, thus, treatment according to standard clinical practice.

Primary objective of this study is the evaluation of the time of the healing of the lesions resulting from minor amputations (digital or forefoot) treated with Lipogems® technique.

Secondary objectives are: 1) assessment of the safety of the lipofilling; 2) evaluation of the intensity of pain (VAS); 3) assessment of the skin tropism; 4) calculation of the relapse rate (defined as the occurrence of local infections, dehiscence and suffering of skin flaps that lead to a revision of the amputation stump or amputation at a higher level); 5) evaluation of the time of hospitalization and quality of life (QoL).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with diabetes (diabetes mellitus type 1 and type 2) of both sexes over the age of 18 years.
2. Presence of irreversible gangrene digital or localized at forefoot (with X-ray of the foot negative or positive for osteolytic lesions at phalanges and/or metatarsus).
3. Patients with vascular problems absent or resolved (evaluated with Eco Color Doppler and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure measured at the ankle and the systolic pressure in the arm, both measured in supine position using wave continue Doppler. If assessable, it has to be greater than/equal to 0.7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has to be greater than/equal to 0.6) and/or by the determination of the transcutaneous oxygen pressure (TcPO2 that needs to be equal to or greater than 30mmHg).

Exclusion Criteria:

1. Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
2. Patient under steroid therapy
3. Active vascular issues