cyrilzakka/clinical-trials huggingface dataset:
Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection

Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in tumour to that of normal tissue in patients with non-small cell lung cancer and to measure human anti-human antibody (HAHA) concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary or secondary advanced non-small cell lung cancer
* Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material
* Karnofsky performance status of ≥ 70
* Expected survival of ≥ 3 months
* Greater than or equal to 18 years of age
* Absolute granulocyte count ≥ 2.5 x 10\*\*9/L
* Lymphocyte count \> 0.7 x 10\*\*9/L
* Platelet count ≥ 100 x 10\*\*9/L
* Serum Creatinine ≤ 2.0 mg/dl (0.20 mmol/L)
* Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 3x upper limit of normal
* Total bilirubin \< 2 mg/dl or 34µmol (SI unit equivalent)
* Ability to provide written informed consent

Exclusion Criteria:

* Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases
* Exposure to an investigational agent within four weeks of the BIBH 1 infusion
* Patients that are not fully recovered from surgery. Because of the potential binding of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as evidenced by incomplete granulation, infection or localized edema are excluded
* Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for nitrsoureas and/or mitomycin-C.)
* Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment
* Serious illness: e.g., active infections requiring antibiotics, bleeding disorders or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
* Women who are breast-feeding or pregnant
* Men and women of childbearing potential who are unwilling to utilize a medically acceptable method of contraception
* Previous participation in this study
* Patients who have autoimmune disease or hypertopic skin conditions that possibly over-express Fibroblast Activation Protein and may be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis and keloids.
* Patients with unstable angina pectoris. Patients prescribed medication to control their angina pectoris must be on a fixed dose for at least 1 month prior to screening to be eligible for the trial.
* Patients who experienced a myocardial infarction within 3 months of Screening.
A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999

The purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential

Exclusion Criteria:

* Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption
Effects of Dual-site Anodal Transcranial Direct Current Stimulation on Attention, Decision-making and Working Memory During Sports Fatigue in Elite Soccer Athletes

Investigation of the effects of dual-site anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex or primary motor cortex on attention, decision-making and working memory during sports fatigue in elite soccer athletes


Eligibility Criteria:
Inclusion Criteria:

* elite soccer athletes

Exclusion Criteria:

* goalkeepers
* pregnancies
* family history of epilepsy
* metallic head implants
* neurological, psychiatric, or musculoskeletal disorders
* severe sports injuries
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.

The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18-65 years of age
* Has the ability to understand and has signed a written informed consent form and HIPAA authorization
* Females of childbearing potential must agree to use an adequate birth control
* Fitzpatrick (1988) skin type I, II, or III.

Exclusion Criteria:

* History of severe reactions from exposure to sunlight
* Known allergies or sensitivities to adhesives in patches, medical tape, or ingredients found in the test articles
* Inability to evaluate the skin in and around the test sites
* Diabetes requiring medication
* Clinical significant skin diseases which may contraindicate participation
* Asthma or any other severe respiratory disease requiring chronic medication
* Known immunological disorders such as HIV, AIDS, SLE and/or RA
* History, within the last six months, of current cancer, including skin cancer
* Mastectomy for cancer removal of lymph nodes draining test sites
* Epilepsy
* Pregnancy, lactation, or planning a pregnancy during the test period
* Chronic use of systemic antihistamine medication, or use within 14 days prior to Screening Visit
* Use of anti-inflammatory drugs (exception: acetaminophen and \< 81 mg.day aspirin are permitted) within 2 days of Screening Visit
* Currently receiving allergy injections
* Currently taking or expecting to take any photosensitizing medications
* Use of immunosuppressive drugs
* Topical drugs used at the test sites within the last 7 days prior to screening
* Current participation in any clinical trial
* Participation in any patch test for irritation or sensitization or any test involving UV exposures within 4 wees of study start
* Use of any investigational therapy within the past 4 weeks.
Internet-based Exposure-based Therapy for Fibromyalgia: A Randomized Controlled Trial.

The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing Fibromyalgia symptoms and impact amongst patients with Fibromyalgia.

Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of Fibromyalgia symptoms and impact. Secondary objectives are to 1) investigate the treatment's ability to reduce degree of a) quality of life b) function c) insomnia and fatigue d) pain-related fear and negative thoughts e) depression and anxiety, cost-effectiveness of this treatment; and 2) to study if any variables could moderate/mediate the treatment outcome, such as a) degree of covert avoidance, b) degree of reactivity to inner sensations

Trial Design: Randomized controlled trial with waitlist control, who also will receive treatment after the first group has finished.

Duration: Ten weeks

Primary Endpoint: Change in Fibromyalgia symptoms and impact from baseline to Week 10. Long term follow-up is also investigated (potential changes from post-treatment to 6- and 12 months after treatment completion)

Efficacy Parameters: the Fibromyalgia Impact Questionnaire (FIQ)

Description of Trial Subjects: Patients \> 18 years old, Fibromyalgia diagnosis, residing in Sweden.

Number of Subjects: 140

Sample size estimation: Sample size is based on a estimated effect size (measured by Cohen's d) of 0.5, based on a power of 0.8 and with room for a 10 % dropout rate.

Recruitment: Self-referral. Advertising will be made through national newspaper, social media and on patient organisations' websites.

Safety parameters: Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements.

Data collection: Data will be collected electronically via the treatment platform.

Plan for missing data: Last-observation carried forward (LOCF).

Main statistical analysis: Hierarchical linear mixed modelling.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia diagnosis
* Swedish resident
* Internet connection before, under and after treatment
* Willing to refrain from other concurrent psychological treatment during the study
* Agreement to keep psychotrophic medication constant during the study

Exclusion Criteria:

* Severe depression (≥30 points on Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S) or risk of suicide (≥4 points on the suicide item on MADRS-S)
* Ongoing alcohol or substance abuse
* Psychosis
* Other severe illness that require immediate treatment and/or was considered the participants primary concern other than FM, or bodily condition that makes treatment unfeasible (such as late pregnancy; \>29 weeks gestation
* Illiteracy or poor skills in Swedish language
* Insufficient computer or language skills to manage a text-based treatment.
* Other concurrent psychological treatment
* Recent changes in psychotrophic medication (\<6 weeks prior to randomization)
The Therapeutic Effects of Intermittent Theta Burst Stimulation in Autism Spectrum Disorder

The investigator would like to investigate the impact of theta burst stimulation over right inferior frontal gyrus in autism spectrum disorder


Eligibility Criteria:
Inclusion Criteria:

* autism spectrum disorder, confirmed by ADOS

Exclusion Criteria:

* current and past systemic disease
* current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder
* current and past brain injuries
* intelligence \< 70
* seizure history
* pregnant
Efficacy and Safety in Transfusion Independent Non-severe Aplastic Anemia

Aplastic anemia (AA) is a rare bone marrow failure disease characterized by bone marrow hypocellularity and peripheral blood pancytopenia. AA is divided into severe AA (SAA) and non-severe AA (NSAA) based on the degree of cytopenia. The first line therapy for SAA or transfusion dependent NSAA is either immunosuppression therapy (IST) or hematopoietic stem cell transplantation (HSCT). Little attention has been paid to patients with anemia but not transfusion dependent, whose quality of life is significantly impaired due to the anemia and other complications.

Recombined human erythropoietin (rhEPO) has been shown to increase the erythroid response and response rate when combined with IST for patients with newly diagnosed AA, either SAA or NSAA. Different from rhEPO, luspatercept is a recombinant fusion protein that binds to select transforming growth factor β superfamily ligands and enhances late-stage erythropoiesis, and has been shown the promising efficiency in the erythropoiesis in patients with lower risk myelodysplastic syndrome (MDS) in the phase II and III clinical trials. This randomized control study aimed to compare the 6-month efficacy and safety of the combination of luspatercept and ciclosporin versus ciclosporin monotherapy in patients with newly diagnosed transfusion independent NSAA.

Eligibility Criteria:
Inclusion Criteria:

1. age≥18 year-old;
2. hemoglobin level between 60g/L\~10 g/dL;
3. newly diagnosed patients have at least one of the followings: #absolute neutrophil count \<1.5×109/L, #platelet count \< 30×109/L, # hemoglobin level \< 100g/L;
4. with normal baseline liver and kidney function;
5. with no active infection; are not pregnant or nursing;
6. agree to sign consent forms;
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

1. Congenital aplastic anemia;
2. Presence of chromosomal aberration;
3. Evidence of a clonal hematologic bone marrow disorder (MDS, AML) on cytogenetics;
4. Presence with PNH clone ≥50%;
5. Patients received HSCT before;
6. Uncontrolled infection or bleeding with standard treatment;
7. Allergic to luspatercept CsA or accessories;
8. HIV, HCV or HBV active infection or liver cirrhosis or portal hypertension;
9. Patient with QTcF (Fridericia's QT correction formula) at screening \<450 msec, or\<480 msec with bundle branch block, as determined via the mean of a triplicate ECG and assessed at site, unstable angina pectoris, uncontrolled hypertension(\>180/100mmHg)#pulmonary artery hypertension;
10. Have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin;
11. Past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants;
12. Pregnant or nursing (lactating) woman;
13. Have attended other clinical trials within 3 months
Comparing Multicomponent and Isometric Multicomponent Training: Impact on Fitness, Health, and Life Quality in Heart Patients

The goal of this clinical trial is to evaluate if a multicomponent training program (MCT), including aerobic and resistance exercises, or an isometric multicomponent training program (IMCT) can improve physiological, physical fitness, mental well-being, and quality of life in adults and elderly with a history of cardiovascular diseases (CVDs) currently stabilized. The main questions it aims to answer are:

Does MCT or IMCT improve physiological parameters, physical fitness, mental well-being, and overall quality of life compared to a waitlist control group (WLCG)? Does IMCT provide superior physiological improvements compared to MCT?

Researchers will compare:

* MCT (a combination of aerobic, mobility, and resistance training exercises)
* IMCT (a combination of aerobic, mobility, and isometric exercises) to see if these interventions improve health and quality of life outcomes compared to WLCG (participants not engaging in structured physical activity during the study), and if there will be significant physiological differences between MCT and IMCT .

Participants will:

* Complete assessments of anthropometric, hemodynamic, physical fitness, and psychological parameters at baseline (T0) and after 24 weeks (T1).
* Be randomly assigned to one of three groups (MCT, IMCT, or WLCG).
* Engage in a 24-week structured training program (MCT or IMCT) supervised by exercise professionals, including:
* Warm-up sessions (10 minutes, low-intensity walking).
* Main sessions (40 minutes): aerobic, mobility, resistance (MCT), or isometric (IMCT) exercises.
* Cool-down sessions (10 minutes): breathing and stretching exercises.

This study will provide insights into the efficacy of tailored physical activity interventions for individuals with a history of cardiovascular conditions.


Eligibility Criteria:
Inclusion Criteria:

* Women/Men
* Aged 45-80 years
* Absence of severe medical conditions (unstable coronary artery disease, decompensated heart failure, severe pulmonary hypertension) or acute onset conditions that would prevent safe participation in physical activity, according to guidelines from the American College of Sports Medicine (ACSM), American Heart Association (AHA), and European Society of Cardiology (ESC).
* History of cardiovascular dysfunctions currently stabilized.
* Sedentary lifestyle (individuals who have not followed WHO guidelines for aerobic and resistance exercise in the past 3 months).

Exclusion Criteria:

* Smokers
* Expected absence of more than one week during the intervention period
* Lack of a medical certificate for non-competitive sports fitness
* Severe musculoskeletal or joint disorders with significant mobility limitations
* Presence of joint pain, dizziness, chest pain, or angina during physical activity
* High blood pressure: PBP ≥ 160/100 (untreated)
A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease

This is a study to evaluate the safety, tolerability and blood levels of PF-03654746 in subjects will mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Probable Alzheimer's disease
* Mini Mental State Examination score 18-26 inclusive
* Aged 55-85

Exclusion Criteria:

* Dementia other than Alzheimer's disease
* Clinically significant cardiovascular disease in the past 6 months prior to screening
* Creatinine clearance \<30 mL/min
Intravenous Plasma Treatment for Parkinson's Disease

This study will do a preliminary evaluation of a possible treatment for mild-to-moderate Parkinson's disease. Patients will be treated with either transfusions of plasma from young donors. or with placebo transfusions. In the following several months, Parkinson's symptoms will be monitored and compared for the two groups.

This is a double-blind placebo controlled trial, designed to evaluate the efficacy of plasma from volunteer donors of ages 18-25. This young fresh frozen plasma (yFFP) will be given intravenously in two doses of 12.5 ml/kg each, with 40-56 hours between doses. In the following 24 weeks, Parkinson's symptoms will be monitored using the short version of the Stanford Presenteeism Scale (SPS-6), and a modified version of the UPDRS scale.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease
* Disease duration of 1 to 5 years
* Willingness to confirm the use of adequate birth control while on the trial will be required in premenopausal women without evidence for an inability to become pregnant.
* Willingness to not start any other treatment for Parkinson's or Multiple Sclerosis during the parallel part of the trial.

Exclusion Criteria:

* Other significant disease, which in the view of the study doctor may make assessment of the efficacy of yFFP difficult.
* Unstable medical conditions.
* Must weigh at least 45.5 kg. Cannot weigh more than 130 kg.
* A severe disease state diagnosis
* Litigation. Patients in litigation will be excluded only if conclusion of that litigation is imminent during the course of the study.
* If patient is pregnant or breastfeeding.
* Complete IgA deficiency.
* Rare contraindications to yFFP therapy as per summary of product characteristics.
* Receiving yFFP for other reasons.
* Ongoing drug or alcohol abuse.
* Psychiatric disorder that could, in the judgement of the site investigator, interfere with successful study participation.
* Unwillingness or inability to complete the study or an inability to understand the questionnaires being used.
* Cancer other than basal cell carcinoma within the last 5 years. However, those patients who have received definitive treatment, such as curative surgery more than 6 months ago, with no known recurrence can be included.
* A history of hypercoagulable or thrombophilic clotting abnormalities.
* A history of thromboembolic events: ischaemic stroke, confirmed myocardial infarction, pulmonary embolism; deep venous thrombosis except where immobility related (for example, after injury or operation).
* Unstable angina pectoris.
* Medications that might react with yFFP such as blood thinners
* Renal failure or serum creatinine greater than 1.5 times the upper limit of normal at screening.
* Any medical condition that, in the opinion of the investigator, would make it unsafe for the patient to participate or which would interfere with assessment of the outcome measures.
* Participation in another interventional trial within 3 months of randomization. Participation in non-interventional studies is not a reason for exclusion.
Treatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy

The aim of this randomized controlled trial is to compare partial pulpotomy treatments with Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate root developments with Image J Software Program. The null hypothesis of this study is Biodentine® will promote healing with high success rates and induce root development more than CH and MTA.

The purpose of this study was to evaluate clinical and radiographical success of three different materials in partial pulpotomy treatment. 50 patients with 54 asymptomatic, cariously exposed young permanent mandibular molar teeth were included to the study. The teeth were randomly divided into three main groups which were; calcium hydroxide, MTA and Biodentine® and finally restorated with stainless steel crowns. Pain, percussion sensitivity, palpation sensitivity of soft tissue around the tooth, root development, presence of lesion, integrity of lamina dura were evaluated clinically and radiographically during 12 months and recorded for each. Also, Image J Program with Turbo-Reg plug in was used for standardization of the radiographs and to determine the increase in root length.

Eligibility Criteria:
Inclusion Criteria:

* Deep dentine caries with pulp exposure

Exclusion Criteria:

* Pulp exposure without hemorrhage control
Surgical Correction of Moderate Ischemic Mitral Regurgitation

The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

Exclusion Criteria:

* etiology of mitral regurgitation other than ischemic, degree of regurgitation other than moderate.
Impact of Different Electric Pumping Modalities on Milk Volume Production in Mothers of Preterm Infants

Initiating and sustaining breastfeeding are common challenges in neonatal units.

It is known that hindmilk expressed at the end of the expression session has a higher fat content.

Previous studies have shown that simultaneous pumping is more effective at producing milk than sequential pumping. However this approach is often felt uncomfortable by the mothers, and sequential pumping is preferred.

The purpose of this study is to determine which modality of milk expression by electric pump is the most efficient and productive when sequential pumping is used.This is done by assessing the milk volume expressed per expression and its macronutrients content.

The study will last for 6 days. Each mother will express breast milk following two designed modalities in a random fashion, for two days each.

The two designed modalities are:

1. Complete pumping of one breast (first left) for 15 min, followed by complete pumping of the right breast for 15 min, until the breast is empty.
2. Pumping both breast simultaneously for 15 min.

At day one of the study, the mothers will follow the standard pumping modality in practice at our department.

In between the two studied procedures at day 4 of the study, the mothers will again follow the standard pumping modality.

On each day of the study, in the morning after the first expression of the day, a sample of 2 ml of pumped breastmilk will be taken, and the total volume of the daily expressed milk will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Mothers of Preterms

Exclusion Criteria:

* HIV infected mothers