cyrilzakka/clinical-trials huggingface dataset:
A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis

Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and can obstruct the airway or become malignant. The cause has been related to specific types of Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness of a trial drug, SGN-00101, in children with RRP and also assess its safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 2 and 18 yrs old, inclusive, who has documented RRP.
* Patients with documented RRP
* Subject is surgically debulked within 7 days before the first dose of SGN-00101.
* Subject has had at least 4 debulking surgeries for RRP, had no intersurgical intervals greater than 84 days during the period of the last 4 surgeries.
* Subject is free of life threatening or serious concomitant disorders other than the disease under study.
* Females of childbearing potential must have a negative pregnancy test and must be practicing an effective/appropriate method of birth control as determined by the Investigator.

Exclusion Criteria:

* Subject has disease or status that causes compromise of the immune system.
* Subject has a history of ionizing radiation therapy to the respiratory tract.
* Patient has used concomitant medications that may suppress the immune system.
* Subject has received any specific or non-specific immunotherapy intended as treatment for their RRP (i.e. mumps vaccine injected intralesionally) within 9 months prior to Week 0 of this study.
* Subject has participated in a past study with SGN-00101
* Pregnancy and lactation.
Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

Aim: the aim of this study is to investigated whether the combination of alflutinib with cytotoxic chemotherapy might hold additive efficacy, as well as tolerability .

alflutinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that is active in the central nervous system (CNS) and which potently and selectively inhibits mutant forms of EGFR with both TKI-sensitising (activating) mutations and the T790M resistance-conferring mutation. However, resistance to alflutinib inevitably emerges. One promising strategy to further improve patient prognosis and to approach a cure is combination therapy with alflutinib and other agents such as cytotoxic chemotherapeutic drugs.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically diagnosed non-squamous NSCLC of stage IIIB or IV (based on the 7th edition of the TNM classification) or recurrent;
* an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;
* WHO performance status of 0 or 1;
* no prior neoadjuvant or adjuvant chemotherapy in the 12 months preceding study enrollment;
* adequate bone marrow reserve and organ function.

Exclusion Criteria:

* treatment with an EGFR-TKI within 7 days of the first dose of the study treatment;
* symptomatic CNS metastases;
* evidence of interstitial pneumonia, pulmonary fibrosis, or radiation pneumonitis requiring steroid treatment as revealed by a computed tomography (CT) scan.
Surgical Evaluation of Fixation of Hand Metacarpals Fractures With K-wires

different techniques have been described forfracture fixation ofmetacarpals fracture withk-wires being the most described technique as it is minimally invasive methodsfor metacarpals fractures in this research ,we are aimingto evaluate k-wire fixation of metacarpal fracture to optimize the clical outcome as regardsto the degree of stiffnessas avouding the impairment of the gluding tissue of the fingers

hand fractures is about 19%of all fractures k-wires fixation is the most frequently method operative procedure which provide operative stability,early mobilization and excellent functional results primary option for fixation of theses fractures include k-wires ,plateand screws and more recently headless intramedullay compression scres and Bouquet k -wire technique Aim of work fir evaluation of the clinical,functional and radiological outcome of metacarpals fractures fixed by k -wires with variious techniques as antigrade intramedullay k-wires,transverse pinning of unstable displaced shaft and neck fractures.

also direct orif for intra articular head fractures Materials and Methods we are analyzing all patients with metacarpals fractures except patients abnormal hands fuctions before injury procedure done under general anesthesia ,brachial plexus block and wrist block outcome and evaluation handgrip strength 3 month after surgery Geniometer for range of motion AP ,Lateral and oblique radiograph

Eligibility Criteria:
Inclusion Criteria:

* all patients with metacarpal fracture

Exclusion Criteria:

* patients with abnormal hand function before surgery
Concomitant Chemoradiotherapy (CCRT) With Weekly Docetaxel and Cisplatin for Locally Advanced Head and Neck Cancer

This phase II trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.

Many studies have shown the superiority of concurrent chemoradiotherapy over radiotherapy only in locally advanced head and neck cancer. Concurrent chemoradiotherapy with high dose cisplatin has been universally used regimen. In a large-scaled phase II trial, however, conducted by the European Organization for the Research and Treatment of Cancer (EORTC), docetaxel (100mg/m2) plus cisplatin (75mg/ m2) every three weeks regimen produced improved survival, nonetheless there was significant limitation to deliver full doses of treatment due to significant hematologic and non-hematologic toxicities. Previously, we showed the safety of the combination regimen of weekly docetaxel and cisplatin in concurrent chemoradiation treatment in a phase I study. We determined the MTD of docetaxel to be 20mg/m2 weekly when concurrently administered with conventional fractionation RT and weekly 20mg/m2 of cisplatin.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx
2. Unresectable Stage III - ⅣB disease
3. previously untreated for head \& Neck cancer with chemotherapy or radiotherapy
4. 18 and over
5. Performance status ECOG 0-1
6. Absolute neutrophil count ≥ 1,500/mm3
7. Platelet count ≥ 75,000/mm3
8. Hemoglobin \> 9.0 g/dL
9. Bilirubin ≤ 1.5 times upper limit of normal (ULN)
10. AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:Alkaline phosphatase ≤ 1.5 times ULN AND AST or ALT ≤ 5 times ULN Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN
11. serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min

Exclusion Criteria:

1. Distant metastatic disease (M1)
2. Prior chemotherapy or RT for Head and neck cancer
3. Synchronous or concurrent head and neck primary tumors
4. Lip, nasopharynx, nasal cavity, salivary gland, or sinuses
5. No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer
6. Other concurrent illness that would preclude study participation
7. Other concurrent physical condition (e.g., infectious disease) that would preclude study participation
8. pregnant or nursing
9. Fertile patients must use effective contraception during and for 3 months after study participation
Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)

This study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group. The intervention is performed by an Advanced Practice Nurse and International Board Certified Breastfeeding Consultant (IBCLC), with high expertise in breastfeeding problems. It is a combination of face-to-face, home care and telephone attention to improve the adherence to breastfeeding. The intervention lasts 6 months.

Will be included moderately premature infants to the Neonatal Unit of the Hospital Clínic who achieve with the inclusion criteria of the study. The sample calculation includes 162 subjects to increase breastfeeding rates to 70% at discharge, 50% at 3 months and 40% at 6 months of the babies. Mothers who wish to exclusively breastfeed up to 6 months and sign the informed consent, will be randomized into the experimental group or control group. The control group will receive usual care and the experimental group will receive 1 pre-discharge face-to-face session, 8 home care sessions up to 4 months and 3 telephone follow-up sessions up to 6 months of baby.

Eligibility Criteria:
Inclusion Criteria:

* Moderate premature
* Late premature babies
* Admitted to the NICU of Hospital Clínic
* Single pregnancy
* Families residing in the Barcelona Metropolitan Area (AMB)
* Families with a good mental health
* Families with a desire for Exclusive Breastfeeding up to 6 months

Exclusion Criteria:

* Maternal diseases that contraindicate breastfeeding
* Mothers with a history of breast surgery
* Mothers with a history of severe hypogalactia
* Premature babies with severe complications
* Premature babies diagnosed with severe CIR
Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery

Globally, cataract is the major cause of blindness accounting for 51% of total blindness and there are regional variations in it. Today, cataract surgery is a highly successful and cost-effective procedure, which enhances both the vision and quality of life of patients.

Visual acuity alone should not be used as a criterion for planning cataract surgery, since visual acuity and function do not necessarily correlate. Therefore, there is a need to review our criteria for management.

Based on recent studies, at least 90% of the patients undergoing cataract surgery obtain a postoperative visual acuity of 6/12 or better in the absence of coexisting ocular pathology.

A number of previous studies have looked at the effect of risk factors on visual outcomes following cataract surgery. Risk factors commonly associated with worse visual outcomes include: age-related macular degeneration, diabetic retinopathy, corneal opacity/pathology, older age, female sex, previous vitrectomy, previous retinal detachment surgery, alpha-blockers, complex surgery, intraoperative complications and refractive surprise.


Eligibility Criteria:
Inclusion Criteria:

* Patients with any type of cataract.

Exclusion Criteria:

* Patients with diabetic retinopathy.
* Patients with previous ocular surgeries or pathologies.
* Patients with pre-operative visual acuity (no perception of light)
Trial to Evaluate the Efficacy of a Manualized Reflective Writing Program for Clinical Phase Physician Assistant (PA) Students.

The following will be an open label controlled efficacy trial of the effects of longitudinal participation in an existing reflective writing program for medical students on burnout in physician assistant students.

The pilot of the reflective writing workshop for PA students will follow the existing curriculum used for the MD program. The workshops will run for 75 minutes with additional time at the end of the session to complete a post-intervention assessment survey. Planning and adaptation of the program materials will be conducted by a group of PA students and the current MD-student leaders of the reflective writing program under the guidance of Dr. Anna Reisman.

All PA student participants will be split up into 1-2 groups of 6-10 students based on the number of participants. Sessions are expected to be held in-person pending COVID-19 guidance and will be held in reserved classroom space in the PA program building (100 Church Street South) or in reserved conference rooms at the Cushing-Whitney Medical Library. Trained PA and/or MD student facilitators will then use prepared materials to guide each group through a series of prompts, each eliciting written reflections of varying lengths. While all participants are encouraged to reflect, write, and share their responses, participation at all levels remains optional. Facilitators will not solicit any participants for a response. All program participants will be asked to complete a brief post-assessment survey consisting of short-answer and Likert scale questions about their attitudes towards program participation. Responses collected will be used to assess the feasibility and acceptability of the program for PA students and as feedback to guide potential future implementation of the program.

Eligibility Criteria:
Inclusion Criteria:

* able to offer consent
* able to speak and read English.
* must be a student in Yale Physician Associate Program Class of 2024

Exclusion Criteria:

-
Dilated Perivascular Spaces in the Dentate Nucleus on MRI in Patients with Hypertensive Angiopathy or Cerebral Amyloid Angiopathy

Hypertensive arteriopathy (HA) and cerebral amyloid angiopathy (CAA) are the two most common forms of cerebral small vessel disease. On MRI, chronic small vessel disease-related abnormalities include white matter hyperintensities, dilated perivascular spaces (DPVS), lacunar infarction, and hemorrhagic features (e.g. cerebral microbleeds, CMB). In the cerebellum, deep CMB involving the dentate nucleus (DN) is associated with HA, whereas the presence of superficial cerebellar CMB are associated with CAA. DPVS are observed in both diseases, predominant in the subcortical white matter (especially in the centrum semiovale) in CAA whereas HA-related DPVS are predominant deep in the brain inside or nearby the basal ganglia.

To the best of our knowledge, DN-DPVS have never been studies systematically in small vessel disease. The researchers want to study DN-DPVS on T2-weighted 3T MRI in patients with HA or CAA and to compare both groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient registered in the CHU de Nîmes (France) stroke database with lobar intracerebral hemorrhage \[ICH\], subarachnoid hemorrhage or cortical superficial siderosis for CAA or basal ganglion ICH for HA
* Patient managed at the CHU de Nîmes (France) between 01/1/2015 and 31/12/2024
* Patient with T2-weighted MRI performed with a 3T magnet

Exclusion Criteria:

* Refusal to participate
Versatile Ampification Single-Molecule Detection in Liquid Biopsy

The trial will test a paradigm-changing in vitro diagnostic device for Liquid Biopsy enabling facile simultaneous detection of protein and nucleic acid analytes with sensitivity at single-molecule level, e.g. not achievable with any alternative technology. A novel affinity-mediated transport amplification (AMT) method will be tested allowing for the multiplexed quantification of rare biomarkers circulating in blood. The Versilib AMT photonic biosensor will test two analytes: the known actionable DNA mutation BRAF p.V600E, and a melanoma-restricted protein antigen. The results will be compared to digital PCR and ELISA methods.


Eligibility Criteria:
Inclusion Criteria:

* age: ≥ 18
* PFS≤2
* Patients willing to sign an informed consent;
* Confirmed (cytologically or histologically) cutaneous melanoma diagnosis
* Confirmed BRAF p. V600E tumor status
* Eligible for BRAFi/MEKi treatment or Immune checkpoint blockade in either the adjuvant or advanced settings (the latter typically stages III/IV, high risk).

Exclusion Criteria:

* Life expectancy \<8 weeks
* Other clinical conditions preventing blood drawing compliance, as per physician's choice.
A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene

This study will assess changes in oral malodor and other factors in response to using a two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have an average hedonic score of at least 6.5;
* Have at least 16 gradable teeth;
* Have at least 10 bleeding sites;
* Have a Lobene composite stain score of ≥1 on at least 1 tooth;
* Have at least one test tooth with recession and a score of 6 or greater on the nine-point comfort/discomfort sensitivity scale;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to refrain from tongue brushing for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;
* Agree to abstain from eating, drinking, chewing gum, using tobacco products, and any oral hygiene at least eight hours prior to evaluation of oral malodor; and
* Agree to refrain from using deodorant, body lotion/powder/spray, hair products, perfume/cologne, lipstick/gloss, or any other scented products on the mornings of the evaluation days prior to their visit to the clinic.

Exclusion Criteria:

* Oral malodor of systemic origin as determined by health history or examination;
* Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* Active treatment for periodontitis;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Antibiotic use within four weeks of the Screening visit;
* Any disease or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.
Ovarian Rejuvenation for Premature Ovarian Insufficiency and Poor Ovarian Response

The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to establish a pregnancy.

Patients will be randomized to either receive the intra-ovarian PRP injection procedure or not. Regardless of randomization patients will be re-assessed at the same time points for ovarian reserve parameters. If antral follicles are detected at follow up, patients will undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per protocol.

Eligibility Criteria:
Inclusion criteria

1. POI according to ESHRE criteria (patient must fit both criteria):

   1. presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
   2. biochemical confirmation as evidenced by an elevated FSH level \>25 IU/L on two occasions \> 4 weeks apart
2. POR defined by at least two prior cycles with POR (≤3 oocytes retrieved with a conventional stimulation protocol, or a cancelled cycle due to poor response)
3. Patients declining ovum donation treatment

Exclusion criteria

1. Age \<18yo or \>38yrs
2. Autoimmune or sex chromosome etiology of POI
3. Ongoing malignancy
4. Previous ovarian surgery
5. Previous gonadotoxic treatment
6. Anticoagulant use for which plasma infusion is contraindicated
7. FMR1 mutations
8. If the duration of the amenorrhea is more than 2 years, patients are discouraged to participate, although it is not an exclusion criterion.
9. Patients with only 1 ovary
10. BMI \> 35
11. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
12. Surgically obtained sperm
13. Presence of hydrosalpinges that communicate with endometrial cavity
14. Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
15. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
16. Use of a gestational carrier
17. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
18. Known ovaries that are not accessible transvaginally.
19. Ovarian endometrioma(s) or dermoid cyst(s) identified via transvaginal ultrasound
20. FSH \> 40iu/l
Survey of Non-resuscitation Fluids in Septic Shock

The objective of this study is to survey the type and the amount of non-resuscitation fluids that patients with septic shock receives during their first 5 days of ICU admission.

Background: Several studies indicate that a large part of the fluid intake in intensive care patients consists of fluids that are given for indications other than volume expansion. However, the type of non-resuscitation fluids that hemodynamically unstable ICU patients receive has not been well characterized.

Methods: A multicenter observational cohort study. Baseline data including, sex, age, physiological data at admission, source of sepsis, illness severity, and ICU and hospital mortality will be collected.

Fluids administered during the first five days of ICU admission will be registered. Fluids used as vehicle to administer drugs will be regarded as non-resuscitation fluids and will be characterized in detail. All glucose solutions will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of \< 5 ml/kg/h will be considered as non-resuscitation fluids. Parenteral nutrition will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of ≥ 5 ml/kg/h will be considered to be resuscitation fluids. Blood products and colloids will be regarded as resuscitation fluids.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock per SEPSIS-3 criteria within 24 hrs of ICU admission
* Informed consent from patient or next of kin if required by local ethical review Board

Exclusion Criteria:

• Lack of informed consent (see above)
A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants

This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy participants.

This is a randomized, double-blind, placebo controlled, single and multiple ascending dose study in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females ≥ 18 to ≤ 55 years of age
* Body mass index ≥ 18.0 to ≤ 30.0 kg/m2
* Body weight ≥ 50 kg at screening and Day -1

Exclusion Criteria:

- Positive pregnancy test or currently breastfeeding.
GV 1001 Immunotherapy in Patients With Non-small Cell Lung Cancer (NSCLC)

To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the immune system) in patients with NSCLC after having been treated with conventional therapy with radiotherapy and docetaxel as a radiosensitizer.

Survival in patients with locally advanced, inoperable NSCLC may be improved if local control can be achieved with concurrent chemo radiotherapy .After completed standard chemo-and radiation therapy; the safety and efficacy of vaccination therapy will be measured as time to progression after treatment with GV1001. Analysis of changes in T-cell subpopulations and cytokines in peripheral blood will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inoperable NSCLC, disease stage IIIA and stage IIIB, who has received concurrent chemoradiotherapy( typically docetaxel 20 mg/m2 and 3D radiotherapy, 2Gy x 30 within the last 4 weeks.
* No sign of brain metastasis( excluded by MRI of the brain)
* Male or female above the age of 18 years.
* Normal lab. values