cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC affecting up to 80% of patients with advanced stage disease, and it has been related with higher risk of complications, length of hospital stay, and worst overall survival. During cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has been associated to higher treatment related toxicity, loss of functional status, shorter progression free survival and overall survival in different types of cancer under various treatments. Hence, preservation of muscle mass and function should be an important focus of the multidisciplinary treatment of patients with LC.

Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue and improve exercise tolerance in patients with LC undergoing curative surgery. However, few studies have focused on the efficacy of PR on patients with advanced cancer undergoing palliative care with chemotherapy or targeted therapies.

The main objective of this study is to determine the effects of a pulmonary rehabilitation program on the pulmonary function and muscle mass. Moreover, the effects on exercise tolerance, inflammatory response, quality of live and overall survival will be explored.

Patients will be randomized into intervention group (IG) or control group (CG). Patients in the IG will be scheduled to receive 12 sessions of PR over a period of 4-6 weeks (2-3 session/week). CG will receive information and recommendations on physical activity. Both groups will receive nutritional assessment and intervention as needed.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of advanced non-small-cell lung cancer
* Good performance status (ECOG 0-1)
* Life expectancy \>12 weeks
* Eligible to receive treatment with chemotherapy or tyrosinkinase inhibitors
* Recent electrocardiogram without evidence of arrythmia

Exclusion Criteria:

* Symptomatic brain metastasis
* Uncontrolled pain (Visual Analog Scale \>5)
* Uncontrolled hypertension (\>140/100mmHg)
* Practice of regular moderate to intense physical activity at least 3 day/week
* Not residents of Mexico City or unable to attend to therapy sessions
Biomarker for Cystic Fibrosis

International, multicenter, observational, longitudinal study to identify biomarker/s for Cystic fibrosis and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

Cystic fibrosis (CyFi) is a progressive hereditary disease with the prevalence of 1 in 2500. CyFi is an autosomal recessive disease caused by pathogenic variant/s in the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene encoding Cftr protein.

CyFi causes chronic respiratory damage. Pulmonary findings occur already in infancy, which raises questions whether obstruction might be congenital. Thick, sticky mucus clogs the airways, reduces muco-ciliary clearance and leads to problems with breathing and recurrent bacterial (Pseudomonas aeruginosa) infections, which causes over time the formation of scar tissue (fibrosis) and cysts in the lungs.There is no cure for CyFi; however, symptomatic treatment can help relieve symptoms.

The aim of this study is to identify biomarkers for Cystic fibrosis disease and to explore their clinical robustness, specificity, and long-term variability. An ideal biomarker plays an essential role in the early diagnosis, prediction and therapeutic monitoring of a specific disorder.

Eligibility Criteria:
INCLUSION CRITERIA:

* Informed consent is obtained from the participant or the parent/ legal guardian
* The participant is aged between 2 months and 50 years
* The diagnosis of Cystic fibrosis is genetically confirmed by CENTOGENE

EXCLUSION CRITERIA:

* Informed consent is not obtained from the participant or from the parent/ legal guardian
* The participant is younger than 2 months or older than 50 years
* The diagnosis of Cystic fibrosis is not genetically confirmed by CENTOGENE
Pelvic External Combined With 252-Cf Neutron Intracavitary Radiotherapy With or Without Platinum in Treating Advanced Cervical Cancer

The objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.


Eligibility Criteria:
Inclusion Criteria:

* 1. To be aged from 18 (including 18) to 65 (including 65), female patient;
* 2. Expected survival ≥6 months
* 3. Pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to FIGO(International Federation of Gynecology and Obstetrics) staging, appropriate stage for protocol entry, including IIA2, IIB,IIIA,IIIB;
* 4. No patients with distant metastases;
* 5. Measurable target lesions (satisfying the criteria in RECIST 1.1);
* 6. ECOG PS status of 0-2;
* 7. No prior treatment;
* 8. No
* 9. No surgery
* 10. Major organ function has to meet the following criteria:

  1. Bilirubin \<1.5 times the upper limit of normal (ULN)
  2. ALT , AST and APL≤2.5 × ULN
  3. NEUT≥2.0 × 10\^9 / L
  4. PLT ≥ 100 × 10\^9 / L
  5. HB≥60g/L
  6. Serum Cr and urea nitrogen ≤ 1.5 × ULN
* 11. Favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled.

Exclusion Criteria:

* 1. Serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance;
* 2. Allergic to platinum;
* 3. Rejecte to join the study in other conditions.
The Learning and Memory of the Experience of Pain

This study investigates the learning and memory of pain.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female healthy volunteers.
2. 18-65 years of age.
3. Right-handed.
4. Fluency in English. Ability to read and understand English; English can be a second language provided that the participant feels that he/she is able to understand all the questions used in the assessment measures.

Exclusion Criteria:

1. Any previous experience with conditioned analgesia/hyperalgesia paradigms.
2. Presence of any illness or medication use that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids.
3. Unwillingness to receive brief pain stimulation administered by a heat probe on the hand.
4. Instability of responses to experimental heat pain
5. Any contraindications to fMRI scanning for subjects in Experiment 2 (including metal implants, claustrophobia, history of head trauma, and pregnancy).
6. Peripheral neuropathy.
PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer

The purpose of this study is to learn more about how a new study agent works inside the body. The study agent is a protein called 64Cu-trastuzumab. This is a radioactive tracer that was developed at MSKCC to target HER2 protein on cancer cells. A radioactive tracer is a small amount of radioactive dye that follows something else that is not radioactive In this study the study agent, 64Cu-trastuzumab, is the tracer and what's being followed is trastuzumab (Herceptin™). By giving you this tracer after you have treatment with trastuzumab (Herceptin™), we will be able to use PET scans to show us which parts of your body and tumor sites the Herceptin goes to. This will help us to understand better how Herceptin works in the body to fight cancer.


Eligibility Criteria:
Inclusion Criteria:

* Registered patient at MSKCC
* Age ≥18 years
* Patients with HER2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (\>2.0) by fluorescence in situ hybridization (FISH))
* Measurable or evaluable disease
* Currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care
* Karnofsky Performance Score ≥ 60
* Signed informed consent

Exclusion Criteria:

* Previous Grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
* Claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure.
* Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
* Inability to provide written informed consent.
* Patients with liver metastases as the only site of distant disease
* Patients with known sensitivity or contraindication to Herceptin.
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in a clinical practice setting among patients who are TNF IR.

Eligibility Criteria:
Inclusion Criteria:

1. Psoriatic arthritis meeting CASPAR criteria;
2. Active psoriatic arthritis defined by at least 1 swollen joint;
3. cDAPSA score ≥ 10; See also Exclusion #4 - cDAPSA must be \> 14 in patients without psoriasis.
4. Using a TNFi or previously used a single TNFi historically and either never responded or lost response (TNF IR) and planning to switch to a new biologic therapy;
5. If using an oral small molecule/csDMARD (i.e., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, or apremilast), must be on a stable dose for 4 weeks and remain on a stable dose during the study; Use of up to two OSM/csDMARDs is allowed.
6. If using NSAIDs, glucocorticoids (\<10 mg daily) or topical medications for psoriasis, must be on a stable dose for 4 weeks prior to Screening/Baseline 1 and remain on a stable dose during the study;
7. Age 18-80 (patients older than 80 may be more likely to have concomitant osteoarthritis which may make it difficult to assess whether symptoms are related to PsA vs OA).

Exclusion Criteria:

1. Prior exposure to golimumab or another non-TNFi biologic (IL12/23i, JAKi, an IL17i, or an IL23i); prior exposure to a TYK2i is acceptable, but cannot be used during course of the study;
2. An adverse event that precludes use of another TNFi (development of drug-induced SLE, allergic reaction, serious infection, heart failure symptoms, demyelination at any point during use of therapy) or any other contraindication or substantial intolerance to a TNFi;
3. Use of moderate to high dose glucocorticoids (\>10 mg);
4. Already meets the primary endpoint at Baseline; \[cDAPSA low disease activity ≤ 14; IGA of psoriasis 0/1\] In patients with psoriasis, cDAPSA can be 10-14 IF the Investigator Global Assessment of Psoriasis ≥ 2.

   In patients without psoriasis, cDAPSA must be \> 14 to meet eligibility requirements.
5. Currently pregnant or actively trying to conceive.
Stem Cells for Treatment of Bronchopleural Fistula

Bronchopleural fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.

The investigators will conduct endoscopic injection of umbilical cord mesenchymal stem cells to fistula, observe the recovery of bronchopleural fistula and systemic reactions, to investigate the application of umbilical cord mesenchymal stem cells in the treatment of bronchopleural fistula.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with bronchopleural fistula by imaging or bronchoscopic examination
* typical symptom of bronchopleural fistula, such as fever, cough, purulent sputum, weight loss...
* patients present compromised conditions, who can only accept a conservative treatment.

Exclusion Criteria:

* absolute contraindication of bronchoscopic examination and treatment
* with previous treatment of cell therapy, including stem cells.
Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections

to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.

100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment, whereas no treatment was conducted in control group.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 65 years of age with the sex life of female patients;
* HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.

Exclusion Criteria:

* Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer;
* Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients;
* Associated with acute, severe bacterial or viral infection;
* Autoimmune diseases;
* Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs;
* Allergies or allergy to the drug known ingredients;
* History of suffering CNS diseases, epilepsy and/or psychological disorder;
* Pregnant and lactating women;
* The researchers do not consider it appropriate clinical trials.
Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis

The primary objective of the present multicentre, prospective, non-interventional study (NIS) is gathering knowledge on the actual use and effectiveness of Elidel® in Chinese patients with mild to moderate AD affecting sensitive skin areas in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients of Chinese ethnicity
* Patients at least 2 years old
* Signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements
* Patients with mild to moderate AD and depending on the age:
* Patients 2-12 years must have:

  - SCORAD Index \< 50
* Patients 13 years and older must have:

  * Affecting sensitive skin areas (e.g. face, intertriginous sites, anogenital area)
  * SCORAD Index \< 50 and IGA in sensitive skin areas ≤ 3

Exclusion Criteria:

* Patients for whom Elidel® is not recommended accordingly to the Package Insert
* Patients with severe atopic dermatitis (SCORAD Index ≥ 50 or IGA in sensitive skin \> 3)
* Receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion;
* Receiving any topical AD-effective drugs within the last 2 weeks before inclusion;
* Pregnant and/or breastfeeding women
* Patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to physician's opinion
* Patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study
PMMHRI-Pitavastatin Registry

The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of Endocrinology, as well as outpatient cardiology and endocrinology clinics who are prescribed pitavastatin.

The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI), the second-largest supra-regional hospital in Poland. The registry was initiated in January 2024 to systematically collect real-world data on patients prescribed pitavastatin, aiming to assess its effectiveness, safety, and impact on lipid and cardiovascular risk management.

The registry has included all patients from the Departments of Cardiology and Endocrinology, as well as outpatient cardiology and endocrinology clinics, who have been prescribed pitavastatin. The inclusion of a broad patient population allows for a comprehensive evaluation of treatment patterns and outcomes in routine clinical practice.

Patient data are extracted from electronic medical records and include:

Demographic parameters (age, sex, BMI, etc.) Relevant comorbidities (e.g., hypertension, diabetes, chronic kidney disease) Concomitant medications, including: Lipid-lowering therapy status (monotherapy vs. combination therapy), Anticoagulation status Lifestyle factors, such as smoking status Post hoc calculated cardiovascular risk scores, to stratify patients based on their predicted risk of major adverse cardiovascular events (MACE) Laboratory parameters, including lipid profiles, inflammatory markers, and metabolic indicators.

Eligibility Criteria:
Inclusion Criteria:

* patient takling pitavastatin based on the 2021 Polish Lipid Guidelines

Exclusion Criteria:

-
Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy

Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)

Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.

Eligibility Criteria:
Inclusion Criteria:

* The patient who is first prescribed and administered Telostop plus Tab.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* The patients to the "Do not administer to the next patient" section of the approved instructions for use
A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Between 19 aged and 50 aged in healthy male adult
2. Body weight more than 55kg
3. Body Mass Index more than 18.5 and under 25

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history that can effect drug absorption or surgery.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product, additives or benzimidazole family.
Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma

The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.

Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced or metastatic endometrial carcinoma
* Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
* At least one measureable tumor lesion
* Adequate bone marrow, hepatic and renal function
* Performance status ECOG 0 or 1

Exclusion Criteria:

* Prior exposure to trabectedin
* Known hypersensitivity to dexamethasone or to any of the components of trabectedin
* Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
* History of another neoplastic disease unless in remission for more than 5 years
* Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
* Current pregnancy, lactation, or childbearing potential without adequate method of contraception.
Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults

This is a phase II, open label, randomized-controlled pilot study designed to study both the efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is that salsalate will reduce inflammation and therefore endothelial cell activation and insulin resistance. The sample size will be 40, with an equal number of people being randomized to one of two groups. The first arm will be randomized to salsalate therapy. The second arm will act as a control group. The study duration will be 13 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. HIV-infected
3. Evidence of durable virologic suppression, i.e., must have HIV-1 RNA \< 400 copies/ml at study entry and for at least 12 weeks prior to entry
4. On a stable antiretroviral (ARV) regimen, i.e., on the same ARV for at least 12 weeks prior to study entry
5. No intention to stop or modify ARV regimen during the study period

Exclusion Criteria:

1. Current pregnancy or breast feeding, or women of child bearing age who refuse or are unable to use appropriate methods for contraception during the study period
2. Any of the following conditions: diabetes (2 fasting glucose levels \> 126 mg/dL or confirmed random glucose level \> 200), creatinine clearance \< 50, aspirin-sensitive asthma, COPD, history of bleeding gastric or duodenal ulcer, hepatic dysfunction, active hepatitis B or C, and any active infectious or inflammatory condition
3. Need for regular use of any of the following medications: salsalate, aspirin, non-steroidal antiinflammatories (NSAIDS), corticosteroids, warfarin or other anticoagulation therapy, phenytoin, valproic acid, carbonic anhydrase inhibitors, lithium, probenecid or sulfinpyrazone
4. Consumption of alcohol on a daily basis
5. Active use of illicit drugs
6. Unable to attend follow-up appointments
7. Allergy to any salicylic acid-containing medication or salsalate
8. AST or ALT \> 2 upper limit of normal (ULN) within 6 months prior to study entry