cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients

The aim of this study is to identify correlations between change from the baseline at Month 24 in Forced Vital Capacity (FVC) (% predicted and mL) and change from the baseline at Month 24 in cough or dyspnoea scores \[points\] as measured in the living with pulmonary fibrosis questionnaire (L-PF) over 24 months of nintedanib treatment in patients with connective tissues disease-associated progressive fibrosing interstitial lung disease (CTD associated PF-ILD) under routine clinical practice conditions in Greece.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years with a confirmed physician diagnosis of connective tissue disease (CTD) associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
* Have been prescribed nintedanib according to the local Summary of Product Characteristics (SmPC) and clinical judgment. Therapy with nintedanib must have been started for clinical reasons independently from the intended patient enrolment into the study at a maximum of 15 days before enrolment into the trial.

Exclusion Criteria:

* Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nintedanib
* Patients at baseline with a known condition or reason that will result in withdrawal from the study before the 24-month time point
* Pregnancy or lactation
Non-Invasive Diagnostic and Functional Evaluation of Cardiac Involvement in Patients With Systemic Sclerosis

The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis patients and to establish whether it reflects the severity of RV overload.

Elevated serum brain natriuretic peptide (BNP) levels released from myocytes of ventricles upon stretch have been found in patients with isolated right ventricular (RV) pressure overload. However, limited data suggest that serum BNP may be elevated in patients with systemic sclerosis (SSc), especially with RV dysfunction. The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in SSc patients and to establish whether it reflects the severity of RV overload.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

* Cardiovascular disorders other than pulmonary hypertension
* Significant pulmonary function abnormalities
* Impaired renal function
Kinematics of Obese Patients Perambulation

The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.

Laparoscopic Sleeve gastrectomy is the standard surgical procedure for the treatment of obese patients. Even the surgery is well described, there is no available study about its influence on the functional parameters of patients perambulation.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 40 and 60 kg/m2 or BMI \> 35 kg/m2 with at least one comorbidity
* no weight loss
* between 18 and 65 years old
* history of obesity \> 5 ans

Exclusion Criteria:

* history of bariatric surgery
* major cardiac insufficiency
* pregnancy or breastfeeding
* no social welfare
Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer

The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression.

The primary objective of this study is to evaluate the safety profile of Cetuximab when used in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC).

Also, the study will determine the response rate in patients with EGFr positive chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in combination with gemcitabine and carboplatin as well as determine the time to progression in patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in combination with gemcitabine and carboplatin.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).
* Have uni-dimensionally measurable and/or evaluable advanced NSCLC.
* Have Stage IV or recurrent disease following radiation therapy.
* Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.
* Have given signed informed consent.
* Be at least 18 years of age.
* Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.
* Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.
* Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.
* Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.
* Agree to use effective contraception if procreative potential exists.
* Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.

Exclusion Criteria:

* Have received prior murine monoclonal antibody or Cetuximab therapy.
* Have disease amenable to curative surgery.
* Have received prior chemotherapy.
* Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.
* Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.
* Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.
* Be pregnant or breast-feeding.
* Have received any investigational agent(s) within 1 month of study entry.
Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients

Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses. Anesthetic requirements and stress hormone response are compared in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil.

Nitrous oxide (N2O) is often used for anesthetic adjuvant, but may be associated with side effects and toxicities. Remifentanil shares characteristics with N2O, including anesthetic-reducing and antinociceptive effects and a rapid recovery. Anesthetic requirements and stress hormone response in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil. Forty-five SCI patients scheduled to undergo pressor sore surgery below the level of the injury are randomly allocated to receive either sevoflurane alone (control, n=15), or combined with 67% N2O (n=15) or target-controlled infusions of 1.37 ng/mL remifentanil (n=15). Sevoflurane concentration is titrated to maintain a Bispectral Index (BIS) value of 40-50. Measurements include end-tidal sevoflurane concentrations, mean arterial blood pressure (MAP), heart rate (HR), and plasma catecholamine and cortisol concentrations.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status II, with chronic, clinically complete cord injuries scheduled for a surgery for pressure sore below the level of the neurologic lesion under general anesthesia.

Exclusion Criteria:

* Cardiovascular, pulmonary, or metabolic diseases. Patients who took medications that would influence autonomic or cardiovascular responses to the surgery
Louisville Cooperative Tissue Biorepository

To provide appropriate collection, storage, and distribution of specimens and medical data to local investigators who have approved IRB protocols for their specific research purposes.

The mission of the Louisville Cooperative Tissue Biorepository is to appropriately collect normal and abnormal tissues that are removed from the human body as a part of standard medical and surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. The LCTB securely stores appropriately collected human samples for research purposes and appropriately allocates these samples to local investigators for research purposes. The LCTB team appropriately documents all points in the process of obtaining informed consent, collection, storage, and allocation of tissues.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery for removal or normal and abnormal tissues as part of standard medical and surgical practice

Exclusion Criteria:

* Patients with known systematic infections including septic patients with bacterial and viral infections, hepatitis, HIV, TB and other defined pathogens will not be included.
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects

This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to understand and provide informed consent.
* Males or females, between 21 and 45 years of age, inclusive;
* Body mass index must be within the range of 18.5 to 32.0 kg/m2;
* 12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator；
* Systolic blood pressure ≤140 mmHg and a diastolic blood pressure of ≤ 90 mmHg after 5 minutes with supine rest；
* non-pregnancy
* meningococcal vaccinations for at least 2 weeks before dosing

Exclusion Criteria:

* Disease or conditions interfere with participating the trial
* Active serious mental illness or psychiatric disorder
* clinically relevant abnormal test results in hepatic function
* unacceptable CBC lab test
* asymptomatic complement deficiency
* Any other clinical safety laboratory test
* HIV, HBV, HCV positive
* Alcohol and drug abuse
* etc.
The Effect of Methylphenidate Versus Placebo on State Anxiety in Children With Attention Deficit Hyperactivity Disorder.

The purpose of the study is to explore the effect of methylphenidate on state anxiety in children with attention deficit hyperactivity disorder.

Patient population: 30 children diagnosed with attention deficit hyperactivity disorder. The subjects will be of all racial, ethnical and gender categories, ranging from 8 to 18 years of age.

Structure: the study is a randomized double blind crossover study. The subjects will complete a continuous performance test, the cambridge neuropsychological test automated Battery, before and after given methylphenidate or placebo on the first day of the study. On the second day of the study, the subjects will receive either methylphenidate or placebo based on what was given on the first day of the study and they will complete the same task.


Eligibility Criteria:
Inclusion Criteria:

* Attention deficit and hyperactivity disorder
* Children aged 8-18 years

Exclusion Criteria:

* Pervasive developmental disorder
* Schizophrenia
* Bipolar disorder
* Current depressive episode
* Current Anxiety disorder
* Drug use during the past 6 months
Effect and Mechanism of Social Interaction Treatment on ASD Children

Current study try to find out whether social interaction treatment is effective for ASD children. ASD children will be divided into three groups, social interaction treatment group, neuronal cognition treatment and routine treatment group. Based on excited recognition training treatment effect on the core symptom of ADHD by tablet computer, the investigators propose that tablet computer social interaction treatment may induce a significant improvement in ameliorating the social disorder of ASD.

Appropriate and effective treatment coupled with home training can help ASD children restore the ability of language, behavior and learning. However, there is no suitable and effective behavior intervention for home training yet. Current study try a 3 months' randomized double-blinded clinical trial to find out whether tablet computer social interaction treatment at home is effective for ASD children. 90 3-6 years old ASD children will be included and divided into three groups, social interaction treatment group, neuronal cognition treatment and routine treatment group respectively. During the treatment days, children in social interaction treatment group will have 30min social interaction each day for 3 months. Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months. Children in routine treatment group will keep the same initial treatment. All ASD children are followed up closely. The primary observed indicator is the score of Childhood Autism Rating Scale (CARS) at the inclusion, one month and 3 month after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children.

Eligibility Criteria:
Inclusion criteria：

* Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R)
* CARS ≥ 34
* Agree to sign the informed consent

Exclusion criteria：

* Children with abnormal gene and chromosome
* Children with neurodevelopmental diseases (like epilepsy, schizophrenia)
* Children with severe sense perception disorder
* Children with weight over 20kg, with electronic metal products in body unsuited for magnetic resonance imaging
Montessori-Based Activities for Elderly Persons With Dementia

This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.

Studies have shown that Montessori-based activities, which focus on developing an individual's unique abilities, are effective in increasing engagement between nursing home residents with dementia and their caregivers. This study will determine whether the positive effects of Montessori-based programming can be replicated in adult day care, assisted living, and nursing homes. Results from this study will be used to create training materials to help staff in different settings implement the intervention within existing schedules, staffing, and programming routines.

This study will be conducted in two phases. During Phase I, participants with mild dementia will be trained to become small group leaders for Montessori-based activities. In Phase II, newly-trained participants will use their skills to assist others. Assessments will be made throughout the study. Participants' engagement with the environment and caregiver burden and satisfaction will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia
* Living in or attending programs at participating sites

Exclusion Criteria:

* Medical conditions that would interfere with study participation
Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.


Eligibility Criteria:
Inclusion criteria:

* Written informed consent
* At least 18 years old
* Confirmed advanced non-small cell lung carcinoma (NSCLC)
* Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
* Presence of either measurable or non-measurable disease by radiologic study or physical examination.
* Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.
* At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
* At least 7 days since prior radiotherapy.
* A probable life expectance of at least 3 months.
* Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.

Exclusion criteria:

* Concomitant malignancies or other malignancies within the last five years.
* Symptoms of brain metastases requiring treatment with steroids.
* Active infection.
* Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk.
* Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
* Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication.
* Women who are pregnant or lactating.
* Subjects of child-bearing potential refusing to practice adequate contraception.
* Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.
* Subjects who cannot receive steroid premedication.
An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee

The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft injection for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection.

It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).

60 subjects will be enrolled in this study. Subjects will be randomized 1:1 in treatment arms.

Each of the patient will be treated with one time injection to the knee. Methods for collecting data will be through validated patient-reported outcome tools (KOOS, VAS and WOMAC questionnaire) that the patient will complete pre-injection and at specified time intervals after injection: 90 days, 180 days and 365 days.

Eligibility Criteria:
Inclusion Criteria:

* Age of 21 to 80 years
* Diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale

Exclusion Criteria:

* Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale
* BMI greater than 40 kg/m2
* Subject has active infection at the injection site
* Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy.
* Subject has rheumatoid arthritis, psoriatic arthritis or has been diagnosed with any other disorder that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor or cancer
* Subject has documented history of gout or pseudo-gout
* Subject has an autoimmune disease or known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
* Subject has received any of the following to the target knee:

  1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening
  2. Intra-articular cortisone (steroid/corticosteroid) injection into the knee joint within 12 weeks of treatment
  3. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening
  4. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
* History of partial or total knee arthroplasty
* Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment
* Subject has a history of immunosuppressive or chemotherapy in the last 5 years
* Subject has had prior radiation at the site
* Subject is currently taking narcotic medication for any reason.
* Subject is pregnant or plans to become pregnant within 365 days of treatment
* Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
* Subject is a worker's compensation patient
* Subject is a prisoner
Effects of Traumeel®S Tablets on Exercise Induced Muscle Damage and Muscle Soreness

To investigate and compare the effects of Traumeel®S tablets versus placebo on exercise induced muscle damage and muscle soreness for 72 hours after strenuous eccentric exercise test on downhill treadmill.


Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age ≥ 18 and ≤ 40 years
* BMI ≥ 18.5 and \< 27,5 kg/m2 (WHO standard for normal range BMI) \[48\]
* Maximum relative oxygen uptake (VO2max) \< 53 ml/kg x min
* General state of good health
* Non-smoker
* Medically approved unrestricted participation in sports as shown by diagnostic performance test conducted on treadmill no longer than 3 months prior to study entry
* Willingness to provide signed informed consent

Exclusion Criteria:

* Regular eccentric exercise training
* Weekly training volume ≥ 6 hours
* Use of dietary supplements (incl. high-dosed vitamins and minerals)
* Chronic immune deficiency
* Current infection
* Heart and/or circulation disorders
* Abnormal findings on exercise ECG
* Musculoskeletal disorders
* Any current clinical condition that requires systemic treatment or might have an impact on study objectives
* Hypersensitivity to botanicals of the Compositae family (e.g. Echinacea)
* Lactose intolerance
* Illicit drug or alcohol abuse
* Participation in another clinical trial within 4 weeks prior to study entry
Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL

Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.


Eligibility Criteria:
Inclusion Criteria:

1. Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction;
2. Enrollment at least 21 days after second eye surgery;
3. Clear intraocular media in each eye.
4. Signed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.

Exclusion Criteria:

1. Concurrent participation in an interventional clinical trial during the time from which the data will be collected;
2. Use of systemic or ocular medication that may affect vision;
3. Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE: Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively within the retrospective analysis window;
4. Ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator;
5. Acute or chronic disease or condition, ocular trauma or surgery that may affect vision in each eye (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus etc.).
6. Amblyopia, strabismus, nystagmus in each eye.