cyrilzakka/clinical-trials huggingface dataset:
A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001
* The patient has a diagnosis of idiopathic PD
* The patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments
* The patient has provided written informed consent to participate in the follow-up study

Exclusion Criteria:

* The patient has been included or participates in another clinical study after participation in Study sNN0031-001
* The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation).
* Patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study
Hydroxychloroquine for Thrombosis Prevention and Antiphospholipid Antibody Reduction in Primary Antiphospholipid Syndrome

This is an interventional drug study designed as a pilot for a randomized clinical trial, aimed at assessing the effect of hydroxychloroquine on the incidence rate of thrombosis in patients with primary antiphospholipid syndrome as the main outcome, as well as the safety of hydroxychloroquine administration in this population. In addition, the effect of hydroxychloroquine on antiphospholipid antibody titers will be assessed.

Patients with primary antiphospholipid syndrome (either thrombotic or obstetric) on regular follow-up at our outpatient rheumatology department and being treated with standard care (systemic anticoagulants and/or antiplatelet agents), are randomized to receive either hydroxychloroquine plus standard care, or standard care alone, on a 1:1 ratio using block size 2 randomization, after exclusion of patients with contraindications to hydroxychloroquine or prior hydroxychloroquine use within 12 months of consideration for enrollment. Patients are monitored clinically every 3 months and the development of thrombosis and/or adverse effects attributable to hydroxychloroquine is recorded. Antiphospholipid antibody titers (anti-cardiolipin immunoglobulin G (IgG)/Immunoglobulin M (IgM) and anti-beta2-glycoprotein I IgG/IgM isotypes) are measured semi-annually. Intention-to-treat survival analysis is applied for assessing the effect of hydroxychloroquine on the incidence of thrombosis. Longitudinal mixed linear models are applied for assessing the effect of hydroxychloroquine on longitudinal titers of antiphospholipid antibodies.

Eligibility Criteria:
Inclusion Criteria:

Adult patients diagnosed with primary antiphospholipid syndrome (PAPS) \[updated Sapporo criteria: Miyakis et al, J Thromb Haemost. 2006 Feb;4(2):295-306. PubMed 16420554\]

Exclusion Criteria:

1. ≥4 American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)
2. ACR classification criteria for other systemic autoimmune disorders
3. active malignancy
4. treatment with Hydroxychloroquine (HCQ) in the previous 12 months
5. history of serious adverse events or contraindication to HCQ including a history of HCQ allergy, HCQ eye toxicity, or glucose-6-phosphate dehydrogenase deficiency, uncontrolled seizure disorder, liver enzyme elevation \>2-fold the upper normal limit, and creatinine clearance \<30ml/min
Neuroinflammation/Oxidative Stress/Cardiac Surgery

The prospective observational study delves into the complex relationship between neuroinflammation and oxidative stress in post-cardiac surgery complications, focusing on postoperative cognitive dysfunction.

The prospective observational study meticulously examines the interplay between neuroinflammation and oxidative stress in the realm of post-cardiac surgery complications, specifically targeting postoperative cognitive dysfunction. Its primary objective is to comprehensively assess the sustained influence of these intricate processes on cognitive function and overall well-being, extending beyond the immediate aftermath of surgery. The research endeavors to probe deeply into the molecular mechanisms and clinical ramifications associated with neuroinflammation and oxidative stress, centering on their pivotal role in shaping the onset and trajectory of postoperative cognitive dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing cardiosurgical operation
* Absence of previous neurological disease
* Signed informed consent document

Exclusion Criteria:

* Presence of neoplasms
* Neurological Disease
* Refusal to participate in the clinical trial
Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients

Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.

In prior work, investigators conducted a study in which sound and light levels were recorded at one-minute intervals within an inpatient room on the SCT unit at Boston Children's Hospital using noise and light meters. Results showed that pediatric SCT recipients were consistently exposed to disruptive noise and light. Nighttime noise levels always exceeded World Health Organization recommendations for sleep, with recipients regularly exposed to multiple noise spikes associated with night wakings. While light levels were frequently dim enough to be conducive to sleep at night, participants were rarely exposed to light bright enough to preserve a healthy circadian rhythm during the day, which has the potential to dysregulate sleep at night. As a child's circadian rhythms may be affected by evening light to a greater extent than adults, such light spikes may be particularly disruptive to circadian rhythms in pediatric participants. The relatively low and afternoon-skewed daytime light, combined with the brighter than recommended light during the evening and early night, has been associated with longer hospitalizations and higher morbidity among adults.

This is a single-arm pilot study to evaluate the acceptability and feasibility of the DREAMS intervention program in stem cell transplant pediatric participants to help support families during this critical phase in a participant's SCT recovery. The data collected from this study will help understand the practicality of delivering the program to a greater number of participants and conducting clinical research about the program in the setting in which it will be implemented.

The research study procedures include screening for eligibility and surveys.

Participation in this research study is expected to last for about 2 weeks.

It is expected that about 10 children will take part in this research study.

The American Cancer Society is supporting this research study with grant funding.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 9-17 years.
* Patient scheduled to receive a stem cell transplant at Boston Children's Hospital.
* English speaking child and primary caregiver (parent/guardian).

Exclusion Criteria:

-Primary team declines permission to approach.
Effect of Incentive Spirometery on Asthmatic Pregnant Women

The purpose of this study is to determine the effect of the incentive spirometer on asthma during pregnancy.

This study will provide an evidence basis for obstetricians and physical therapist for women's health about the effect of spirometry on asthma during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

The patients will have the following criteria:

1. Their age will range from 30 to40years old.
2. Body mass index (BMI) will range from 25-29.9 kg/m2.
3. All patients will be clinically and medically stable.

Exclusion Criteria:

Patients will be excluded from the study if they have the following:

1. Diabetes mellitus.
2. Severe hypertension.
3. Neurological and neuromuscular disorders.
4. Blindness.
5. Developed moderate and severe degree of pleural effusion.
6. Cardiovascular instability.
7. Chronic chest disease.
Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy

Primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by CEUS, can predict initial objective response to therapy, defined by current standard-of-care

Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (CEUS or conventional power Doppler or LEAD ultrasound) or optimal time point to predict initial objective response and to assess the correlation of tumor perfusion parameters with change in overall tumor burden, change in diameter on a per-lesion basis, and with 12-month progression-free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* pathology-confirmed diagnosis of cancer
* at least one solid tumor lesion greater than 1 cm in diameter (primary tumor and/or at metastatic site), amenable to ultrasound imaging
* planned to be treated with ICI therapy (single agent or in combination with any other drug)
* written informed consent.

  * prior use of any ICI is not necessarily excluded, and patients may be included with the approval of the Protocol Director

Subjects may participate in the study more than once at the discretion of the Protocol Director, for example, if they receive different lines of treatment that all qualify for the study.

Exclusion Criteria:

* known hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG)
* any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study

  * Examples: any mental condition that compromises the ability to follow a consent discussion, or to make informed decisions (except if represented by a Legally Authorized Representative \[LAR\]), or to have ultrasound exams.
a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy.

The study is being conducted to evaluate the efficacy and safety of QL1706 versus QL1604 monotherapy as consolidation treatment in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy.

QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.
* Pathologically confirmed LS-SCLC \[I-III stage SCLC (any T, any N, M0)\], according to the American Joint Committee on Cancer (AJCC, 8th edition) staging manual.
* Received 4 cycles of chemotherapy concurrent or sequential with radiotherapy. Chemotherapy must contain platinum and etoposide. Radiotherapy must be either total 60-70 Gy over 6 weeks for the QD regimen or total 45 Gy over 3 weeks for BID schedules.
* Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry.

Exclusion Criteria:

* Mixed SCLC and non-small cell lung cancer (NSCLC).
* Extensive-stage SCLC.
* Active or prior documented autoimmune or inflammatory disorders.
* Received other chemotherapy regimens besides etoposide and platinum-based therapy.
* Active or prior documented autoimmune or inflammatory disorders.
* Presence of interstitial lung disease or active non-infectious pneumonia (excluding grade 1 radiation pneumonitis not treated with corticosteroids).
Clinical Trial on Pharmacokinetics and Tolerability of AP707

Brief Summary:This study aims to investigate the uptake of AP707, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.

Pharmacokinetic parameters and tolerability of AP707 is studied over 24 hours after single dose administration in healthy volunteers in a prospective and open-label manner at a single study center.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent form
2. Male at the age of 30 - 60 years at study start
3. Body mass index of 18 to 30 kg/m2
4. Non-smoker, no use of any tobacco products,
5. Good general health status (Karnofsky Score = 100; see Annex 1, page 59)
6. Current ECG without abnormal findings (no significant alterations from normal values, especially with regard to the QT interval (QTcF \< 450 ms)
7. Physical examination, medical history without exclusionary findings
8. Pulse rate between 50 and 90 bpm
9. Blood pressure between systolic 90 - 140 mmHg, diastolic 50 - 90 mmHg
10. Lab values for liver function (ALT, AST, AP, Bilirubin total) within normal ranges
11. Lab value for renal function (S-Creatinine, eGFR according to CKD-EPI) within normal range
12. Negative test result on HIV I, HIV II, hepatitis B cell surface antigen, hepatitis C antibody
13. Negative test result of urine screening for Cannabis and substance abuse

Exclusion Criteria:

1. Medical history of hypersensitivity or intolerance to the investigational product or its ingredients or to ingredients of similar chemical structure
2. Use of Cannabis products within the last 8 weeks
3. Use of opioids
4. Former or present dependency (e.g. to alcohol, medicinal products, drugs)
5. Participation in another clinical trial within the last four weeks prior to study inclusion
6. Former or present mental illnesses such as severe depression, psychosis, bipolar disorder, mania, obsessive compulsive disorder, and anxiety disorder
7. Acute severe somatic disease (e.g. gastrointestinal diseases, influenza)
8. Body temperature ≥ 38°C
9. Present cardiovascular, respiratory, diabetic, or cancer disease
10. Hepatitis A, B, C or other liver and renal disease
11. Other diseases or conditions that do not allow the participant to assess the nature and scope, and possible consequences of participating in this clinical trial
12. Indications that the participant is unlikely to comply with the study protocol (e.g. lack of cooperation)
13. Taking any pharmaceutical products (including any medication interacting with metabolism of THC, e.g. St. John's wort)
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels

The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a first heart or bilateral or single lung transplant
* Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated.

Exclusion Criteria:

* Multi-organ transplants or previously transplanted organs
* Patients with the need of more than two cyclosporine microemulsion dosages per day

Other protocol-defined inclusion/exclusion criteria may applied
Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.

A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must be female.
* Age ≥ 18 years old.
* Histologically proven carcinoma of the breast.
* Estrogen receptor and/or Progesterone positive disease.
* Metastatic or locally advanced disease.
* Patients on a preexisting endocrine agent for at least 3 months before enrollment.
* Have residual measurable disease after

  1. maximal response to endocrine therapy or
  2. no response to endocrine therapy or
  3. progressive non-visceral disease on endocrine therapy.
* Must be able to provide a tumor block from either the primary or metastatic site, if available.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
* Adequate organ function.

Exclusion Criteria:

* Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
* Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
* Prior use of anti-angiogenic agents.
* As judged by the investigator, uncontrolled intercurrent illness.
* Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
* Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
* Known or suspected allergy to sorafenib or any agent given in the course of this trial.
* A serious non-healing wound or ulcer.
* Evidence or history of bleeding diathesis or coagulopathy.
* Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
* Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug.
* Pregnancy
* Any condition that impairs patient's ability to swallow whole pills.
* Documented malabsorption problem.
Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD

This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.


Eligibility Criteria:
Inclusion Criteria:

1. male or female, age 18 to 70 years of age, inclusive;
2. must have a calculated body mass index (BMI) from 18 to 28 kg/m2 at study screening;
3. Glomerular filtration rate must be \< 15 mL/min /1.73 m2 for End-stage renal disease without hemodialysis group, and ≥ 90 mL/min for Normal Renal Function group(using MDRD method);
4. matched for age (±5 years) ,gender and BMI(±15%) with a subject in the End-stage renal disease without hemodialysis group;

Exclusion Criteria:

1. allergies constitution ( multiple drug and food allergies);
2. Use of \>5 cigarettes per day during the past 3 months;
3. A positive test results for HbsAg, Hepatitis C antibody, HIV-1 antibody, or Treponema pallidum antibody；
4. History of alcohol abuse；
5. Donation or loss of blood over 400 mL within 3 months prior to the first dose of study drug；
6. Subjects deemed unsuitable by the investigator for any other reason.
Impact of Anxiety on the Decision-making Processes of Anesthesiologists

Except for exaggerated situations in which aspiration risk seems obvious (or absent), the choice of a rapid sequence induction protocol for general anesthesia is often made under uncertainty, according to the individual assessment of the balance between the aspiration risk on one hand and the anaphylaxis risk induced by short-acting curares on the other hand.

The impact of anxiety and impulsivity on the choice of induction protocols under uncertainty has never been studied before.

In order to investigate this issue, an online anonymous survey has been designed and will be sent to the anesthesiologists of the Bourgogne Franche-Comté and Grand Est regions in France.

The primary objective of this study is to assess the impact of trait-anxiety using the STAI-Y2 form on the decision-making process of anesthesiologists during the choice of an induction protocol for patients at risk of aspiration.

The secondary objectives are to characterize decision-making profiles, to measure the implicit dimension of anxiety using an Implicit association test, to study the impact of impulsivity on decision-making processes under uncertainty using the short version of UPPS-P scale and to study the role of socio-demographic data and professional history in these decisions.


Eligibility Criteria:
Inclusion Criteria:

* all anesthesiologists who have completed their PhD
* working in France
* in a public or private healthcare facility

Exclusion Criteria:

* residents
* retired anesthesiologists