cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy

The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to undertake all scheduled visits and assessments
* Agreement to use an effective form of contraception for the duration of the study
* Geographic atrophy (GA) at least 0.75 disc areas in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

* Treatment for active systemic infection
* Predisposition or history of increased risk for infection
* Active malignancy
* History of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
* GA in either eye due to non-AMD causes
* Active or history of ocular and intraocular conditions in the study eye (except GA)
* History of vitreoretinal surgery or laser photocoagulation in the study eye
* Prior treatment for AMD (except vitamins and minerals)
* History of intravitreal (ITV) drug delivery
* Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
Histomolecular Profiles of Gliomas in Children and Adolescent/Young Adults

In the last decades, many advances have been made in the field of genetic abnormalities of glial and glioneuronal brain tumors. In the 2016 World Health organization (WHO) Classification of Tumors of the Central Nervous System, the concept of "integrated" diagnosis emerged: histological and genetic/molecular features now define many entities. Since 2016, six updates have been published by the c-IMPACT-NOW (the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy- Not Official WHO) to develop and clarify the "integrated" diagnosis. In the future WHO 2021 Classification of Tumors of the Central Nervous System, "integrated" diagnoses will take up even more importance. Even if they can have similar histological features, gliomas of children are very different from the "adult" gliomas in the molecular mechanism of oncogenesis. The histomolecular features of adolescents/young adults (AYAs) can have similarities with "pediatric-type" or "adult-type" gliomas, but few studies have focused specifically on the histomolecular profiles of gliomas in AYAs.

The investigators would like to study the cohort of patients treated for a glial and glioneuronal tumor diagnosed under the age of 25 in the Amiens University Hospital between 2008 and 2020. The investigators would like to compare the histomolecular profiles of gliomas in children (0-14 years) and AYAs (15-25 years).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient
* Patient treated in the Amiens University Hospital
* Patient treated for a glial or glioneuronal brain tumor according to the 2016 WHO Classification of Tumors of the Central Nervous System ("diffuse oligodendroglia or astrocytoma tumour," "another astrocytic tumor," "another glioma" or a "mixed neuronal or glioneuronal tumour").
* Diagnosis histologically confirmed or formally established by radiologist.
* Diagnosis established between January 1, 2008 and December 31, 2020.
* No patient opposition (from adult patient, or from the holder of parental authority of the minor patient).

Exclusion Criteria:

* Uncertain diagnosis
* Patient opposition (from adult patient, or from the holder of parental authority of the minor patient).
The Use of DHEA in Women With Premature Ovarian Failure

DHEA supplementation has been used in women with infertility and diminished ovarian reserve. There is a small report in 5 women with POF that benefited from the use of DHEA over several months. The investigators aim to evaluate further the use of DHEA in women with Premature ovarian failure (POF).


Eligibility Criteria:
Inclusion Criteria:

* women with POF

Exclusion Criteria:

* women without ovaries
Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma

This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders.


Eligibility Criteria:
Inclusion Criteria

* Patients must have a definite diagnosis.
* Patients must be histologically confirmed CD30 positive within 3 months of enrollment
* Patients with pcALCL must have target lesions present for at least 1 month without spontaneous regression
* pcALCL patients must have failed treatment with local radiation therapy, or failed systemic therapy of a single agent
* Patients must be considered an eligible candidate for systemic therapy as determined by the investigator
* All patients must have a three week wash-out from previous treatments, unless in the opinion of the investigator it is not in the best interest of the patient, at which point the individual case must be discussed with the medical monitor prior to enrollment.
* Patients must have an ECOG performance status of \< 2 (Appendix B) and a life expectancy \> six months.
* Patients must be at least 18 years of age.
* Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
* Females of childbearing potential must have a negative HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study.
* Patients must give written informed consent.
* Required baseline laboratory data: Absolute neutrophil count greater than or equal to to 1,000/mm3, Platelet count greater than or equal to 75,000/mm3, Serum bilirubin less than or equal to 1.5 times ULN, Serum creatinine less than or equal to 1.5 times ULN, BUN less than or equal to 1.5 times ULN, SGOT less than or equal to 2.5 ULN, SGPT less than or equal to 2.5 ULN

Criteria for Exclusion

* Patients with Sezary syndrome, or any type of lymphoproliferative disease other than pcALCL, T-MF or LyP
* Patients with systemic ALCL or extracutaneous involvement of cutaneous ALCL
* Patients with known active systemic viral, bacterial, or fungal infection
* Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive
* Patients who have been treated previously with any anti-CD30 antibody
* Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
* Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ
* Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
* Patients who are pregnant or breastfeeding
* Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment
* Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent
Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux

This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.


Eligibility Criteria:
Inclusion Criteria:

* One or more of the following symptoms present for at least 3 consecutive months: throat clearing, cough, globus, sore throat, or hoarseness.
* Patients must complete a run-in diary card, and this will be looked at to ensure met the inclusion criteria.
* Must have a total score of 5 or more on the Chronic Posterior Laryngitis Index (CPLI) grading system.

Exclusion Criteria:

* A number of diseases / conditions would preclude a patient from taking part in the study, as listed in the protocol.
* If the patient is on certain medications this will also preclude them from taking part.
Clinical Utility Evidence for TissueCypher®

Cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be provided to all participating physicians and submitted to a national journal for publication. The study plans to enroll up to 249 physicians.


Eligibility Criteria:
Inclusion Criteria:

* Board-certified gastroenterologist or GI surgeon for at least two years
* Averages at least 20 hours per week of clinical and patient care duties over the last six months
* performs either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
* practicing in the US
* english speaking
* access to the internet
* informed and voluntarily consented to be in the study

Exclusion Criteria:

* non-English speaking
* unable to access the internet
* not practicing in the US
* not averaging at least 20 hours per week of clinical or patient care duties over the last six months
* does not perform either diagnostic endoscopy, interventional endoscopy, upper GI surgery, or bariatric surgery
* does not voluntarily consent to be in the study
LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy

To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven cervical dysplasia
* colposcopy Prior to conization
* informed consent

Exclusion Criteria:

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate
Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.

OBJECTIVES:

Primary

* To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine.

Secondary

* To determine the toxicity of this drug in these patients.
* To determine the response rate, progression-free survival, and overall survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6-8 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed small cell lung cancer
* Relapsed or refractory disease after 1-2 prior chemotherapy regimens
* Measurable disease
* ECOG - Eastern Cooperative Oncology Group performance status 0-2
* ANC ≥ 1,500/mm³: ANC = Absolute neutrophil count
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Bilirubin normal
* AST/ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN in patients with hepatic metastases; AST/ALT = alanine transaminase (ALT) and aspartate aminotransferase (AST)
* Creatinine clearance \> 40 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study therapy
* No known hypersensitivity to bendamustine
* No other malignancy for which the patient has been treated within the past year except for nonmelanoma skin cancer or carcinoma in situ of the cervix
* No cardiac disease, including any of the following:

  * Unstable angina pectoris
  * Life-threatening cardiac arrhythmia
  * Symptomatic congestive heart failure
* No uncontrolled infection
* No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy
Clinical Follow Up of a Fissure Sealant Placed With Different Adhesive Protocols: 2-Year Randomized Split Mouth Study

The purpose of this study was to evaluate the retention rates of a fissure sealant placed using different adhesive protocols over 24 months.Twenty-four subjects with no restoration and caries received fissure sealants (Clinpro™Sealant, 3M/ESPE) placed with different adhesive protocols. A total of 292 sealants (73 for each group) were placed. The sealants were placed as follows; a-without adhesive (acid-etch only), b-with an etch-and-rinse adhesive (SingleBondTM), c-with a self-etch adhesive (AdperTMEasyBond), d-with acid-etch+self-etch adhesive (AdperTMEasyBond) by two previously calibrated dentists using a table of random numbers. Two other calibrated examiners, independently evaluated the sealants at baseline and at 6-, 12-, 18-, and 24-month recalls. Each sealant was evaluated in terms of caries formation being present or absent and retention using the following criteria: 1=completely retained, 2=partial loss, and 3=total loss. The Pearson χ2 test was used to evaluate differences in retention rates among the sealants for each evaluation period.

Dental caries, which can be encountered by individuals throughout their lives, is one of the most chronic diseases worldwide. Researches have mainly been focusing on the prevention of tooth caries with the awareness of this fact. The use of fluorides as well as pit-and-fissure sealants are the most common preventive applications against caries progression.Modern adhesives combine conventional conditioning, priming and bonding steps (etch-and-rinse adhesives) together into one or two bottle (self-etch adhesives) to ease adhesive protocols. However, it is still suspicious whether modern self-etch adhesives have equal bonding capacity to the conventional etch-and-rinse systems. Therefore, clinical trials are necessary to evaluate long-term adhesive performance of self-etch adhesives compared to the conventional etch-and-rinse ones.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in the current study had good general and oral health and hygiene.
* with no detecatable caries, bruxism, malocclusion, previously placed restorations or sealants on the fissures, or no allergies to resins
* willing to return for follow-up examinations

Exclusion Criteria:

* Third molars
* Uncooperative patients
* Molar teeth with antagonist tooth not present or extracted
* Mentally and physically handicapped patients
Approach to Vascular Access After Renal Transplantation

The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.

Patients after kidney transplantation during a routine visit will be asked to participate to the study. In eligible a number of studies will be conducted:

* detailed clinical examination
* routine laboratory tests
* lung ultrasound
* muscle strength with a dynamometer
* ultrasound assessment of upper limb vessels with assessment of fistula function (in the case of active fistula) and for the possibility of future vascular access
* blood collection and protection (10-15 ml) for biomarkers
* survey EQ-5D-5L and LVD-36
* functional strength test.

The obtained clinical data and test results will be subject to statistical analysis after anonymization. The impact of individual parameters on long-term prognosis will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years old
* kidney transplant
* \>12 months after transplantation
* stable transplanted kidney function
* signed informed consent

Exclusion Criteria:

* GFR \<15 ml / min
* severe infection within 3 months of testing
* increase in creatinine concentration\> 0.5 mg / dl within 3 months before the test
* active cancer
* signs of severe heart failure (NYHA IV)
Folic Acid Clinical Trial: Follow up of Children (FACT 4 Child)

FACT 4 Child is a follow up study of mothers who participated in the Folic Acid Clinical Trial (NCT01355159) and their children at 4-6 years of age to determine the effect of high dose folic acid supplementation on social impairments associated with Autism Spectrum Disorders (ASDs), and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death.

The Folic Acid Clinical Trial (FACT) was developed to conclusively determine the effect of high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a randomized controlled trial (RCT) design.

The primary objective of the FACT 4 Child study is to examine the effect of maternal folic acid supplementation in pregnancy on the risk of social impairments, as well as executive function, emotional and behavioural problems associated with Autism Spectrum Disorders (ASD) and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to the CIHR funded FACT.

The effect of folic acid supplementation throughout pregnancy may potentially have an impact on both the mother and her offspring, which highlights the importance and relevance of this study to the management of women with preeclampsia. Results of this study will allow care providers to have the evidence of potential effects of high dose folic acid that can then be discussed; allowing women to make an informed choice about their management and care.

Eligibility Criteria:
Inclusion Criteria:

1. Capability of participant to comprehend and comply with study requirements
2. Mother participated in FACT

Exclusion Criteria:

1. Confirmed spontaneous termination (miscarriage) or elective termination or stillborn
2. Confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital
Long Term Effect of High-intensity Training After Heart Transplantation

High-intensity training (HIT) has repeatedly been documented to have superior positive effects compared to moderate exercise in patients with coronary heart disease and heart failure. Since heart transplant recipients (HTx), have a denervated heart with different respond to exercise, HIT has previously not been introduced among these patients. Rikshospitalet carried out a RCT to investigate this (the TEX study 2009-2012), and found that this form of exercise also was highly effective and safe in long term HTx with clinically significant improvement in VO2peak, muscular exercise capasity, general HRQoL, and even slower progression of CAV (coronary allograft vasculopathy). Based on these findings we ask the following questions in this follow-up study:

1. Would the effect on VO2peak, HRQoL,muscle capacity and CAV obtained during the study period continue during long term follow up (5 years)?
2. Is the intervention group more physical active after HIT compared to the control group?


Eligibility Criteria:
Inclusion Criteria:

* stable situation
* optimal medical treatment
* written concent

Exclusion Criteria:

* unstable situation,
* infections (open wounds or skin diseases),
* physical conditions that prevents participation,
* or other injuries/ diseases who are contraindicated with training.
Prevention of Post-operative Pneumonia (POPP)

Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It leads to considerable morbidity and contributes to perioperative morbidity. There is evidence in literature that supports the use of strategies for improved oral hygiene and specialized endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically ventilated patients. This study aims at utilizing a combination of these interventions in the perioperative period in patients undergoing planned thoracic surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
2. Patients with poor lung function (FEV1% \<50% or DLCO\<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection).
3. Patients undergoing esophageal resection.

Exclusion Criteria:

1. Patients with ongoing symptomatic dental infections.
2. Patients with recent/ongoing pneumonia (\<15 days from initial surgical patient evaluation).
3. Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
4. Patients with a preexisting tracheostomy.
5. Age\<18
6. Patients with an allergy to Peridex/chlorhexidine solution
The Efficacy and Mechanism of Acupuncture Treatment in Patients With Subjective Cognitive Decline

This study evaluates the efficacy and mechanism of acupuncture treatment in patients with subjective cognitive decline. Half of patients will receive acupuncture treatment for 12 weeks, while the other half will receive sham acupuncture treatment for 12 weeks .


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults aged 55-75;
2. Native Chinese speakers with right-handed and at least a primary school education;
3. Self-reported persistent memory decline, which was confirmed by caregivers;
4. Normal general cognitive function and not meeting the criterion of mild cognitive impairment, as defined by performance within the normal range on both measures within at least one cognitive domain or in each of the three cognitive domains sampled (adjusted for age and education);
5. No or minimal impairment in activities of daily living;

Exclusion Criteria:

1. Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ;
2. treatments that would affect cognitive function;
3. Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression;
4. Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer;
5. History of alcohol or drug abuse/addiction in nearly two years;
6. Any contraindications for magnetic resonance imaging (MRI) scans (e.g., aneurysm clip pacemaker, etc.);
7. Significant visual and/or auditory impairment uncorrected by aids, and unable to perform neuropsychological evaluations;
8. Currently enrolled in another research study;
9. Received acupuncture treatment in the preceding month.