cyrilzakka/clinical-trials huggingface dataset:
Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer

This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advanced colorectal cancer. The primary end point is progression free survival (PFS). A total of 42 patients who failed with oxaliplatin, irinotecan and fluorouracil in previous treatment and could not receive the target therapy presently are planned for recruitment. For patients with metastatic colorectal cancer who met admission criteria, oxaliplatin- or irinotecan-based chemo regimen could be used and evaluation was repeated every 6 weeks. The treatment continues until the disease progression or the untolerable adverse reaction.

The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen.

Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent

Eligibility Criteria:
Inclusion Criteria

1. Patients age between 18 and 80 years
2. Histologically confirmed metastatic colorectal cancer (mCRC)
3. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. Treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinotecan); progression free survival (PFS) of prior oxaliplatin or irinotecan-based chemotherapy should be at least four months without any unrecoverable toxicity. Prior target therapy was acceptable
5. For those who received other anti-tumor treatment, the toxicity should have been restored, with the time interval from last dose of cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥3 weeks
6. Life expectancy≥12 weeks
7. At least one measurable lesion as defined by RECIST 1.1
8. Acceptable hematologic, hepatic, and renal function within 7 days from screening: the blood ANC count≥1.5\*10\^9/L; hemoglobin≥9.0 g/dl, the blood platelet count≥80 x 10\^9/L, total bilirubin\<1.5\*upper limits of normal(ULN), ALT and AST\<2.5\*ULN(\< 5 \*ULN for patients with live metastasis), endogenous creatinine clearance rate\>50ml/min
9. Targeted drugs are currently not suitable or affordable

Exclusion Criteria

1. Receiving other systemic anti-cancer treatment within 3 weeks
2. Prior radiation therapy of target measurable lesion
3. Presence of Grade III or IV chemo-related toxicity in previous treatment without recovery to Grade II or less
4. With other malignant tumor in 5 years; except for cured cervical carcinoma in situ or basal cell carcinoma
5. Symptomatic intracranial or meningeal metastasis
6. History of uncontrolled seizures, central nervous system dysfunction or mental disorder
7. Uncontrolled pleural or peritoneal effusion
8. Severe life-threatening concomitant disease that might impair the safety of patients or affect the completion of treatment, according to the researcher's judgment
Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).

BACKGROUND:

MR causes volume overload and hemodynamic burden on the left ventricle. Initial compensatory mechanisms may fail, leading to increased severity. Patients who have had repair of an atrioventricular septal defect (AVSD) are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic, contributing to the likelihood that they might respond to medical therapy.

DESIGN NARRATIVE:

This is a randomized, double-blind, placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD. A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD, who were then evaluated at 6 months for trial eligibility.

Eligibility Criteria:
Inclusion Criteria:

* Children less than 18 years of age and at least 6 months post AVSD repair or reoperation
* At least moderate MR
* Asymptomatic or minimally symptomatic, defined by Ross Heart Failure Class I or II
* Atrioventricular synchrony (paced or intrinsic)

Exclusion Criteria:

* Tetrology of Fallot, total or partial anomalous venous connection
* More than trivial MS or outflow obstruction
* Other sources of LV volume overload
* Hypertrophic obstructive cardiomyopathy
* Significant residual coarctation
Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts

To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy

* Group A: 18 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
* Group B: 18 patients will be treated with bivalent HPV vaccine solution intralesional into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
* Group C: 18 patients will be treated with both agents intralesionally into the largest wart using an insulin syringe at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.

it is thought that candida antigen act through a cell-mediated immune response and bivalent HPV vaccine act mainly through humoral immunity, so we want to study their effect as single or mixed agents

Eligibility Criteria:
Inclusion Criteria:

* patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study

Exclusion Criteria:

* Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine
Effectiveness of Physical Therapy Interventions for Low Back Pain Targeting the Low Back Only or Low Back Plus Hips

Low back pain (LBP) is the leading cause of disability worldwide and has substantial impacts on pain and function for an individual. Some individuals with LBP seek physical therapy for their condition. The purpose of the study is to determine whether individuals with LBP have improved pain and disability following physical therapy targeting either the low back only or low back plus hip(s).

Often, individuals with LBP also have concurrent impairments in strength and/or range of motion of one or both hips. Physical therapists may or may not decide to treat the concurrent hip impairments for an individual with LBP based on their clinical decision making. Currently, it is unknown which approach leads to superior patient outcomes in terms of pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* Modified Oswestry Disability Index (ODI) ≥ 20%
* Numeric Pain Rating Scale (NPRS) of ≥ 2 points
* Primary complaint of low back pain with at least one hip impairment in one or both hips

Exclusion Criteria:

* Contraindications to manual therapy
* Severe trauma to the lumbar spine or hip(s) in the last 6 weeks
* 'Red flag' symptoms including:

  * Tumor
  * Metabolic disease
  * Rheumatoid arthritis or other systemic rheumatologic disorders
  * Acute fracture
  * Bowel/Bladder dysfunction
  * Prolonged history of corticosteroid use
  * Evidence of central nervous system involvement
* Two or more positive neurologic signs consistent with nerve root compression:

  * Diminished muscle stretch reflexes of lower extremity
  * Muscle weakness in any lower extremity myotome
  * Diminished or absent sensation in any lower extremity dermatome
* Spinal surgery in the last 6 months
* Total Hip Arthroplasty
* Currently pregnant or post-partum ≤ 6 months
* Osteoporosis
* History of cancer within the last 12 months
* Inability to understand the English language
Sun Protection Factor Assay (SPF Assay 19008)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)

The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.


Eligibility Criteria:
Inclusion Criteria:

1. The patient should be a male or female, aged between 18 and 60 years old;
2. Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air;
3. The female patients should agree to use birth control methods during the study participation;
4. To be able to meet the study instructions and all the visits required;
5. To give a free consent to participate in the study and sign the informed consent form (ICF).

Exclusion Criteria:

1. Smoking;
2. Secondary hypolactasia;
3. Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias;
4. Colonoscopy or colon cleaning procedure 4 weeks before the start of study
5. Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics;
6. Diagnosis of HIV, immunodepression of any origin, or cancer under treatment.
7. Diagnosis of other comorbidity that, at the investigator's discretion, may compromise the study participation (e.g., systemic infection during the study or use of antibiotics in the last 4 weeks, diabetes mellitus, uncontrolled hypertension or renal failure),
8. Hypersensitivity or previous laboratory or clinical adverse event related to the use of lactase or any of the components of the formulations used in the study;
9. Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF;
10. Pregnancy or lactation;
11. Use of alcohol, exceeding 3 doses daily;
12. Participation in another clinical study on the last 12 months;
13. Patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).
Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

RESOLVE is a pragmatic, cluster-randomised, open-label study designed to evaluate in real-world conditions the comparative effectiveness of two default dialysate sodium concentrations.

Dialysis sites will be randomised in a 1:1 ratio to a default dialysate sodium concentration of 137mmol/l or 140mmol/l. 'Default' is defined as the use of the allocated dialysate sodium for ≥ 90% of delivered dialysis sessions in the unit. All other care will be according to standard local practices as determined by the site.

Outcomes will be assessed on individual patients dialysing at those sites. Sites will be asked to consent to participation while waiver or opt-out consent will be sought for individual patients.

It is anticipated that site accrual will occur over 5-7 years with average study duration expected to be approximately 2-5 years. The actual length of the study will be end-point determined.

Eligibility Criteria:
The site inclusion criteria are:

* Predominantly dialyses adults (≥18 years old) receiving maintenance haemodialysis
* Rates of withdrawal within the first two years of commencing dialysis for social reasons have been less than 15% for the 2 years prior to recruitment and are not expected to increase above 15%
* Has a minimum of 10 dialysis recipients at time of randomisation
* Utilises a default dialysate sodium concentration at the time of recruitment (a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration)
* Is a self-contained unit (i.e. unit patients do not regularly rotate through another unit. Brief trips by patients to a parent or other unit do not exclude a site)
* Willing to accept randomisation to either intervention (as determined by nominated Director of Unit)
* Is not a home dialysis training or support unit. \[Sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site\].

The exclusion criteria are:

* Not able to comply with data collection methods
ITIL-168 in Advanced Solid Tumors

DELTA-2 is a phase 1 clinical trial to evaluate the safety, feasibility, and preliminary efficacy of ITIL-168 with pembrolizumab in participants with advanced cancer whose disease has progressed after standard therapy. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically documented advanced (metastatic and/or unresectable) cervical cancer, HNSCC, or NSCLC.
* Cohort 1: Participants with cervical cancer whose disease progressed during or after at least 1 prior line of chemotherapy.
* Cohort 2: Participants with HNSCC whose disease progressed during or after chemotherapy that must have included a platinum agent and previous CPI.
* Cohort 3: Participants with NSCLC whose disease progressed during or after 1 prior line of platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have progressed on targeted therapy and platinum-based chemotherapy
* Medically suitable for surgical resection of tumor tissue
* Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow and organ function

Key Exclusion Criteria:

* History of another primary malignancy within the previous 3 years
* Neuroendocrine carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the lip, or histopathology with neuroendocrine differentiation
* Previously received an allogeneic stem cell transplant or organ allograft
* Previously received TIL or engineered cell therapy (eg, CAR T-cell)
* Significant cardiac disease
* Stroke or transient ischemic attack within 12 months of enrollment
* History of significant central nervous system (CNS) disorder
* Symptomatic and/or untreated CNS metastases
* History of significant autoimmune disease within 2 years prior to enrollment
* Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, IL-2, of CPI
Using Self-evaluation to Increase Visit Intervals in Juvenile Idiopathic Arthritis

In the THUIS study, JIA patients in clinical remission will skip one 3-monthly hospital control visit and instead monitor their disease activity at home. Outcomes at 6 months will be compared to those from a historical cohort.

Background:

Children with juvenile idiopathic arthritis (JIA) commonly visit their pediatric rheumatologist every 3 months. This costs time and money for the patient, their parents or guardian, the hospital and other stakeholders. Therefore, the THUIS study aims to demonstrate that JIA patients in clinical remission can safely increase their visit interval by home-monitoring disease activity using the EuroQol five-dimensional youth questionnaire with five levels (EQ-5D-Y-5L) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR).

Methods:

JIA patients in remission from the Wilhelmina Children's Hospital in Utrecht, the Netherlands, will skip one 3-monthly control visit and instead complete an online EQ-5D-Y-5L and JAMAR questionnaire at home. The home-monitoring results will be evaluated by a research nurse in consultation with the treating pediatric rheumatologist in order to determine if the patient can safely remain at home or has to be planned in for a short-term control visit at the hospital. Primary and secondary outcomes after 6 months will be compared with a historical cohort of matched JIA patients in order to prove non-inferiority.

Eligibility Criteria:
Inclusion Criteria:

* JIA diagnosis of ≥1 year, all subtypes can participate
* Clinical remission, defined as a cJADAS of ≤3

Exclusion Criteria:

* Insufficient control of the Dutch language
* Not able or willing to use e-mail
Turkish Version of Nijmegen Questionnaire

The study aims to provide Turkish version of Nijmegen Questionnaire for the evaluation of respiratory dysfunction in asthmatic subjects. The incidence of hyperventilation syndrome in asthmatic patients can be determined with the results of the study.

Nijmegen Questionnaire allows to assess and identify respiratory symptoms and dysfunction, and to assess unexplained respiratory symptoms and symptoms of hyperventilation syndrome. Determining whether Turkish version of Nijmegen Questionnaire is a valid and reliable tool in asthmatic individuals will guide researchers for further studies on identifying appropriate treatment approaches for the patient and developing different treatment strategies. Hyperventilation syndrome is a recognized form of respiratory dysfunction associated with biochemical factors. Hyperventilation syndrome is defined as breathing above the body's metabolic requirements. This results in decreased carbon dioxide pressure in the arterial blood, respiratory alkalosis, and increased symptoms. Complex symptoms such as shortness of breath, chest tightness, paresthesia, anxiety, and dizziness may occur. There is no laboratory test which is the gold standard in the diagnosis of hyperventilation syndrome. If it is concluded that the Turkish version of the Nijmegen Questionnaire is a valid and reliable test in individuals with asthma, a new tool will be introduced to the literature for the evaluation of pulmonary dysfunction in asthmatic individuals.

Eligibility Criteria:
Inclusion Criteria:

* Having mild to moderate clinically stable asthmatic patients
* Being able to cooperate
* Being 18 years old or older

Exclusion Criteria:

* Having severe orthopedic, neurological, cardiovascular disorders or cognitive problems
* Unable to cooperte
Optimal Treatment for Poor Efficacy of Entecavir in Chronic Hepatitis B Patients

There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Tenofovir or interferon alfa is the optimal choice right now. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

There are chronic hepatitis B patients with poor antiviral efficacy of entecavir in clinical practice. Poor efficacy is defined as hepatitis b virus DNA is still positive and decreases \> 2 lg from baseline. Sequential therapy by using tenofovir or interferon alfa is the optimal choice right now. 100 patients with poor antiviral efficacy of entecavir will be recruited in this study. They are randomly divided into tenofovir group or interferon alfa group. The aim of this study is to investigate the therapeutic effect of using tenofovir of interferon alfa in these patients.

Eligibility Criteria:
Inclusion Criteria:

1. Hepatitis b virus DNA or HBsAg positive for over half a year;
2. Age from 18 to 65;
3. With poor efficacy of entecavir: Hepatitis b virus DNA is still positive at 24 weeks, and decrease \> 2 lg from baseline .
4. Not be treated with interferon alfa ever before.

Exclusion Criteria:

1. Other active liver diseases;
2. Cirrhosis, hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Patients can not follow-up.
Pancreatic Cancer Registry: For Any Person With a Personal or Family History

The NFPTR was established in 1994 to find the causes of pancreatic cancer. In brief, the investigators are interested in both the genetic and non-genetic causes of pancreatic cancer. The investigators are particularly interested in finding the genes that cause pancreatic cancer to cluster in some families. Up to 10% of pancreatic cancer patients have another close relative who has also developed pancreatic cancer. This clustering of pancreatic cancers in families has yet to be explained; however, the investigators continue to identify new familial pancreatic cancer genes that explain this clustering in subsets of families. For example, in 2009 and 2012 the investigators discovered that mutations in the PALB2 and ATM genes jointly account up to 5% of the clustering of pancreatic cancer in families.


Eligibility Criteria:
Inclusion Criteria:

* personal or family history of pancreas tumors

Exclusion Criteria:

* none
Sacral Nerve Modulation in IPAA Patients With Poor Function

IPAA patients with poor functional outcome where no obvious reason can be detected are identified from our patient registry. These patients are offered a sacral nerve modulation test period of three weeks. They will then be scored on function and physiological testing will be done by a Barostat. After a another 14 days without stimulation the tests will be repeated. Those who respond positively will be offered permanent implantation of the Device..


Eligibility Criteria:
Inclusion Criteria:

* UC With IPAA
* Bad functional outcome

Exclusion Criteria:

* Established treatable cause of malfunction