cyrilzakka/clinical-trials huggingface dataset:
Softened Water for Eczema Prevention Pilot Trial

An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study

A 6-month parallel group assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of eczema in neonates, with an embedded mechanistic study.

The overall rationale is that by installing a domestic water softener around the time of birth, the infant will be exposed to softened water rather than hard water for bathing and that this will be less irritating to the skin than hard water and so associated with a lower risk of eczema development. The primary objective is to determine the feasibility of conducting a subsequent definitive RCT that will investigate whether installation of a domestic water softener around the time of birth can prevent eczema in high-risk babies. The secondary objective is to explore the likely mechanisms by which water softeners might prevent eczema.

Eligibility Criteria:
Inclusion Criteria:

* Participant (i.e. the neonate) must have a parent or sibling with a history of doctor-diagnosed atopy (i.e. at least one of: eczema, asthma, hayfever)
* Mother aged ≥18 years of age at enrolment
* Baby \<36 weeks gestation at screening
* Informed consent from the mother on behalf of the participant
* Mother has the ability to understand English
* Live in a hard water area (\>250 mg/L Calcium Carbonate)
* Consent of landlord for installation on water softener (if appropriate)
* Occupy a property appropriate for installation of a water softener

Exclusion Criteria:

* Preterm birth (defined as birth prior to 37 weeks gestation)
* Significant inflammatory skin disease at birth not including seborrheic dermatitis ("cradle cap")
* Sibling (including twin) previously randomised to this trial. If multiple birth, the first child will be randomised into the trial.
* The child is to be fostered/adopted
* Any immunodeficiency disorder or severe genetic skin disorder
* Child has any other serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial.
* Planned stays away from home for a continuous period of more than 2 weeks or a total of 1 month out of the 6 month follow up period
* Water softening or filtration device already installed
* Concurrent enrolment in any other skin-related intervention study
* Other medical condition that in the opinion of the CI could interfere with the conduct of the trial
Study of T-Regulatory Cells in Asthma

To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.

The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma.

This is an exploratory study to investigate the following:

1. To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma.
2. To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.

Eligibility Criteria:
Inclusion Criteria:

1. Obese asthmatics
2. Normal weight asthmatics
3. Healthy obese
4. Health non-obese

Asthmatic subjects will be recruited:

1. If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18).
2. If they have stable disease without exacerbation, physician or emergency department visits, or change in asthma medication for the past 4 weeks, inhaled steroids will be allowed.

Non asthmatic subjects

1. Will not have had a prior diagnosis of asthma,
2. Have no history of atopy.
3. Have no history of lung diseases.

Exclusion Criteria:

1. \> 10 pack year smoking history, or currently smoking
2. Pulmonary disease other than asthma.
3. History of heart disease
4. Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months.
5. Any agents that could potentially alter the inﬂammatory system such as thiazolidinedione, a statin, or oral steroid therapy.
Dose Escalation and Expansion Study of HM16390 in Advanced or Metastatic Solid Tumors

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.

Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into at each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the potential RP2D to be tested in the Dose-Expansion Part is determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent when administered at the potential RP2D to subjects in indication-specific expansion cohorts.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit.
* Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Age of 18 years or older (or country's legal age of majority if the legal age was \>18 years)
* Adequate renal function.
* Adequate hematologic function.
* Adequate liver function.

Key Exclusion Criteria:

* Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.
* Known active CNS metastases and/or carcinomatous meningitis.
* History of severe toxicities associated with a prior immunotherapy.
* Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
* Has ongoing or suspected autoimmune disease.
* Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.
* History of chronic liver disease or evidence of hepatic cirrhosis.
A Study of RO5458640 in Patients With Advanced Solid Tumors

This multicenter, open-label, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640 intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed malignant solid tumors
* Measurable and/or evaluable disease according to RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Prior chemotherapy, radiotherapy, or hormonal therapy for cancer within 3 weeks of first study treatment, except for short course palliative radiotherapy for pain
* Antibody therapy or other immunotherapy currently or less than 21 days prior to study treatment
* Current immunosuppressive therapy, including those prescribed for organ transplantation and rheumatologic disease
* Corticoid therapy \> 10 mg/day prednisone or equivalent
* Patients who have not recovered from \> grade 1 (NCI CTCAE) prior adverse events from any cancer therapy, except for alopecia
* Pregnant or breastfeeding women
* Known hypersensitivity to any component of RO5458640 or previous severe hypersensitivity reactions to monoclonal antibody therapy
* History of active seizure disorder
* History of CNS or leptomeningeal metastases, except for clinically stable disease for at least 3 weeks prior to first study drug
* Cardiovascular illness: CVA or MI \< 6 months prior to study, CHF \> NYHA Class 2, QTcF \>480 msec.
* Active infection
Comparison of Different Cardiac Output Measurement Methods in Patients Undergoing Right Heart Catheterization

The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC).

The main questions it aims to answer are:

* Are these methods interchangeable?
* Can possible discrepancies influence risk stratification and therapeutic management of PH patients? All consecutive patients aged ≥18 years, referred for RHC for suspected PH, will be included. Exclusion criteria will be contraindications to RHC, cardiac shunts and failure to obtain informed consent. Patients will undergo RHC by a Swan-Ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Suspected pulmonary hypertension at clinical and echocardiographic evaluation

Exclusion Criteria:

* contraindication to Right Heart Catheterization (RHC)
* cardiac shunt
* inability to provide informed consent
Effect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women.

The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit. Output data is collected on a PC. By measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. The study will assess changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.

Medical Device Development

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles.
* Subjects must be void of Female Sexual Disorder.

Exclusion Criteria:

* Pregnant or lactating women
* Postmenopausal subjects
* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.
Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)

The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)
* Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* CD19 negative B-cell leukemia
* Any uncontrolled active medical disorder that would preclude participation as outlined
The Effect of Occupational Therapy on Subthreshold Attention Deficit Hyperactivity Disorder

The purpose of this study is to investigate the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.

Subthreshold attention deficit hyperactivity disorder may occur in a subset of children who are possibly more sensitive to their environment. Therefore, it is very important to target the elimination of symptoms with appropriate preventive therapies before this disorder occurs. One of the promising preventive therapy option may be occupational therapy.

Attention deficit hyperactivity disorder can have a negative impact on occupational performance such as: activities of daily living, education, resting, sleeping, playing and social participation. Occupational therapists are able to provide interventions to improve engagement in daily activities on social skills, play, executive functioning, impulsivity, inattention, and motor coordination.

Although the guidelines about the treatment of ADHD are primarily medically and psychologically based, certain treatment components are useful for occupational therapy practice; for example, behavioural management of the child and psychoeducational programmes for families.

However, treatment recommendations for subthreshold ADHD cases or the population at risk are limited. This study investigates the effectiveness of occupational therapy in subthreshold attention deficit hyperactivity disorder.

Eligibility Criteria:
Inclusion Criteria:

* Subthreshold Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

* Attention Deficit Hyperactivity Disorder
The Effects of Weight Reduction in IgA Nephropathy

The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight reduction. The investigators hypothesized that benefits of weight loss may reduce proteinuria.

This is a prospective randomized study in adult IgA nephropathy. The investigators enrolled 30 patients who have proteinuria exceeds 1 g per day with biopsy proven IgA nephropathy. The experimental arm recieves the non-pharmacological treatment, weight reduction protocol. All patients in this arm must be reduce their body weight in 3-5 % from baseline as protocol. Another arm is control group which recieves standard treatment of IgA nephropathy including ACEIs/ARBs for blood pressure control (target \< 130/80 mmHg). The primary outcome is proteinuria level. The secondary outcome is cytokines and inflammatory markers level including interleukin-6, resistin, adiponectin, leptin and monocyte chemoattractant protein-1.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven IgA nephropathy
* body mass index more than 23 Kg/m2
* 24 hours urine protein more than 1 g
* estimated GFR more than 20 ml/min

Exclusion Criteria:

* pregnancy and lactation
* rapidly renal function decline
* crescent formation in renal biopsy more than 10%
Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified

The principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask).

Randomized, comparative, non inferiority study between two nebulization strategies bronchodilators, one according to the method tested namely the spray - in across the top humidified nasal flow system and the other according to a customary procedure, through a mask. A third arm will be evaluated (control arm) to overcome a possible own bronchodilator effect of high flow nasal humidified.

Eligibility Criteria:
Inclusion Criteria:

* adults
* Patient with chronic obstructive pulmonary disease
* Patients, when performing lung function tests performed outside of the study :

  1. A report FEV / FVC less than 60% prior to bronchodilator treatment AND
  2. A positive reversal test defined by FEV variation of over 12 % and 200 mL after administration of inhaled salbutamol
* Patients affiliated to social security scheme
* Informed consent signed by the patient

Exclusion Criteria:

* Exacerbation of chronic obstructive pulmonary disease during
* Uncontrolled asthma
* Pneumothorax current or recent ( \< 2 months)
* Pleural aspiration or biopsy , trans - bronchial biopsies and / or bronchoalveolar lavage in the preceding 48h
* hemoptysis in progress
* Patient under guardianship or trusteeship safeguard justice
* Pregnant or breastfeeding women or parturient woman
* Known allergy or intolerance to salbutamol
Fractional Flow Reserve-guided Provisional Side Branch Intervention

Study purpose: To evaluate fractional flow reserve-guided side branch intervention strategy Method: Provisional side branch intervention if jailed side branch FFR\<0.75

Patients with de novo, coronary bifurcation lesions with jailed side branches after successful drug-eluting stent implantation at the main branches will be prospectively and consecutively enrolled. Control group patients will be selected from the database.

Jailed side branches need to have an ostial stenosis \>50%, vessel size \>2 mm, vessel length \>40 mm and lesion length \<10 mm by visual estimation.

Study procedure Coronary stenting of the main branch should be performed with standard interventional techniques using drug-eluting stents. In the FFR group, pressure measurement would be performed using a 0.014 inch pressure guide wire (PressureWire, Radi Medical Systems, Uppsala, Sweden)Lesions with an FFR \<0.75 are considered to have functionally significant stenosis and side branch balloon dilatation is allowed only for these lesions. It is recommended to use a smaller balloon than the side branch vessel diameter. After kissing balloon inflation, FFR will be measured again at the same site and further intervention is only recommended when FFR was \<0.75 after kissing balloon dilatation. In the conventional group, the decision to treat the side branch lesion and the method of intervention are all up to the operators' discretion.

Eligibility Criteria:
Inclusion Criteria:

Jailed side branches with an ostial stenosis \>50%, vessel size \>2mm, vessel length \>40mm and lesion length \<10mm by visual estimation.

Exclusion Criteria:

ST elevation myocardial infarction Left main stenosis, totally occluded lesion Angiographically visible thrombus, significant lesion within the main branch proximal to the stented segment, significant distal lesion at a side branch Regional wall motion abnormalities of the stented artery and jailed side branch segments Left ventricular ejection fraction\<40% Primary myocardial disease Serum creatinine \>2mg/dl Predilatation of side branch before the main branch stent implantation Contraindications to adenosine
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis

The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.

An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
* Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
* Physicians Global Assessment score of 3 or 4 at baseline

Exclusion Criteria:

* Has other dermatological conditions that may interfere with clinical assessments
* Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
* History of an adverse reaction to Cortrosyn™ or similar test reagents
* Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP

To select a dose and to make a decision for Phase 3 study

The onset of primary immune thrombocytopenia is thought to be increased platelet destruction and decreased platelet production due to anti-platelet antibodies. HBM9161 is a fully human anti-FcRn monoclonal antibody that can effectively remove pathogenic IgG, thereby relieving platelet destruction and rapidly increasing platelet counts in patients. The study will be conducted in a Phase 2/3 operational seamless design, with group Dose A and Dose B of HBM9161 and a placebo group in Phase 2.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the screening visit, male or female.
2. Persistent or chronic ITP whose average number of platelet at the screening visit and pre-dose (at least 1 day apart) is \< 30 × 10\^9/L, and not \> 35 × 10\^9/L for any of two tests. No severe bleeding within 4 weeks prior to the screening visit.
3. Patients who have received and failed at least 1 first line of ITP therapy (glucocorticoids and/or intravenous gamma globulin), or who are contraindicated, intolerable, or refuse standard therapy.
4. Patients will be allowed to use a stable dose of concomitant drugs for the treatment of ITP. e.g., glucocorticoid, danazol, immunosuppressant (azathioprine, cyclosporine A, mycophenolate mofetil) and eltrombopag.

Exclusion Criteria:

1. Other autoimmune systemic diseases other than ITP.
2. Multi-lineage immune cytopenias, such as Evan's syndrome, autoimmune pancytopenia.
3. Secondary ITP.
4. Received a vaccine within 4 weeks prior to the first dose of the study drug or planned during the study.
5. Use of anticoagulants or any agents that have antiplatelet effect or can affect thrombopoiesis within 3 weeks prior to the first dose of the study drug.
6. Received blood transfusion within 1 week prior to the first dose of the study drug.
7. Received the intravenous gamma globulin, anti-D immunoglobulin, or plasmapheresis within 2 weeks prior to the first dose of the study drug.
8. Received high-dose dexamethasone or high-dose methylprednisolone within 2 weeks prior to the first dose of the study drug.
9. Received recombinant human thrombopoietin (rhTPO) within 4 weeks prior to the first does of the study drug.
10. Received rituximab or other non-rituximab anti-CD20 drugs within 6 months prior to the first does of the study drug.
11. Treated with splenectomy within 4 weeks prior to first dose of the study drug.
12. Any thromboembolic or embolic events within 12 months prior to the first does of the study drug.
13. Serum total IgG \< 700 mg/dL at the screening visit.