cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Assess COM503 in Participants with Advanced Solid Malignancies

The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors.

The primary objectives of this study are:

* To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors.
* To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy
* Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical benefit.
* Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC.
* Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment

Exclusion Criteria:

* History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence \[e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar\] which are allowed to enroll).
* Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses \>10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration
* Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
* Ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration.
* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV).
* Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.
Description of Treatment Management of Patients With Major Depressive Disorder and Inadequate Response

The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in patients with MDD who had an inadequate disease control with antidepressant medication.

A cross-sectional observational study to describe treatment management of patients with Major Depressive Disorder (MDD) and inadequate response to antidepressants in Greece

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MDD as per DSM-IV
* Patients with an inadequate disease control during antidepressant therapy
* Patients who already receive add-on therapy and have completed 4-5 weeks of treatment at the time of their enrolment in the study.

Exclusion Criteria:

* Patients fulfilling criteria for diagnosis of any other psychiatric condition (except for MDD), as per DSM-IV Axis I,
* Concomitant organic mental disorder or mental retardation Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria Participation in another study
Prevalence of HPV (Human Papilloma Virus) and HPV Vaccination Among Victims of Sexual Violence

By a prospective single center cohort study in the Sexual Assault Care Center (SACC) of the CHU (Centre Hospitalier universitaire) Saint Pierre in Brussels, we would like to :

* to evaluate the prevalence of HPV infections in the population of women over 15 years old admitted for rape
* to determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients

The investigators will conduct a prospective single center cohort study in the SACC of the CHU Saint Pierre in Brussels.

Population:

the investigators will include all women over 15 years admitted to the SACC of Brussels between 5/02/2024 and 05/02/2024 for rape (vaginal and/or oral and/or anal penetration) after signing the consent.

PCR (polymerase chain reaction) smears for HPV testing will be performed after obtaining consent from the victims. These smears will be performed at the oral, vaginal and anal site. The smears will be taken either by the patient or by the legal nurse, according to the victim's wishes. Ideally, 3 smears should be taken : oral, vaginal and anal.

It will be carried out at the same time as all other sexual transmitted deseases tests and should therefore not be perceived as more invasive or time-consuming.

These smears will be performed two times: at the first visit of the patients to the SACC and after 12 at 18 months.

Appointment reminders will be sent by phone contact.

The test used is a swab analyzed by PCR via the AML laboratory. They confirmed that this is the most sensitive method for detecting HPV in vaginal and anal areas, and probably also in oral areas.

The HPVs obtained via PCR are: 16 18 45 33 58 31 52 35 59 39 51 56 68 67 53 66 6 and 11. Results will therefore be classified as low-risk, high-risk or HPV-negative.

Patients will be notified if a high-risk HPV test is detected, and treatment will be offered depending on the type of follow-up required according to the international recommendations.

Outcomes:

* Define high-risk HPV carriage in the SACC population.
* Define the proportion of SACC patients vaccinated for HPV.

Secondary objectives:

* To characterize HPV subtypes, according to the type of assault and infected sites (vaginal-cervical, anal, oral).
* To determine the prevalence of HPV and the clearance in HPV-vaccinated and unvaccinated patients (itself assessed by the presence of one type of HPV in the first smear and its absence in the followed smears).

Eligibility Criteria:
Inclusion Criteria:

* women over 15 years admitted for rape speaking in french, dutch or english (and therefore able to sign an inform consent in french, dutch or english)

Exclusion Criteria:

* tourist or other people who will not in belgium one year after their first test
Evaluation of the Teen Outreach Program in Hennepin County, Minnesota

This study tested the extent to which TOP®, when replicated with fidelity, produced impacts on sexual risk-taking behaviors in the short term and the longer term.

This is a cluster randomized controlled trial. Teachers were randomized within schools to the treatment and control conditions. To assess the impact of offering TOP®, students were surveyed three times: at baseline, before the intervention began for the treatment group; 12 months after baseline (short-term impacts); and 24 months after baseline (long-term impacts). Baseline data and subsequent follow-up data were collected using a Web-based survey. Paper surveys were used as back-up for baseline data collection. The pooled survey data from two school-year cohorts (school years 2011-2012 and 2012-2013) were used to estimate program impacts using an intent-to-treat (ITT) analysis. Program fidelity and interview data were used to describe program implementation.TOP® was delivered in middle schools, high schools, alternative schools, and public charter schools in Hennepin County. It was implemented during school hours in classes that spanned an entire school year with the same cohort of students. The subject of the class in which TOP® was placed differed across schools (for example, social studies, study hall, health).

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a study teacher's class at the time of the baseline survey
* Active parental consent and youth assent

Exclusion Criteria:

* Inability to complete survey in the languages provided
* Prior participation in TOP
18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial

The material under investigation will offer the patient a high strength and high durability restoration with the advantage of having anti-bacterial properties.

There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Cervical carious lesions in anterior teeth and premolars
2. Small to moderate class V carious lesion (ICDAS 3 \& 4).
3. Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
4. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion Criteria:

1. Cervical carious lesions in molars.
2. Deep carious defects (close to pulp, less than 1 mm distance).
3. Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
4. Non-vital teeth, Fractured or cracked teeth.
5. Endodontically treated teeth.
6. Periodontally affected teeth
VVC Sampling Study for Analysis Validation

This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.

The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.

Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome.

Samples from a total of 10 women are planned to be taken.


Eligibility Criteria:
Inclusion Criteria:

1. Adult women aged 18 years or older
2. Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:

   1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
   2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
3. Having decisional capacity and providing written informed consent
4. Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria:

None
Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer

To test the feasibility of supportive-expressive group intervention (SEGT) for women with primary breast cancer and to provide a preliminary test of its efficacy.

This study aims to compare the efficacy of a 16-sessions group intervention (Supportive-Expressive group therapy) versus control group (no intervention) in women with primary breast cancer.

This study tries to evaluate the efficacy of SEGT on breast cancer patients' emotion regulation, social support, caregiving, and marital satisfaction, and its improvement on breast cancer patients' life quality. This study also intents to explore the moderating role of attachment on these associations.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary breast cancer

Exclusion Criteria:

* attendance at a cancer support group or individual psychotherapy
* diagnosis of recurrent breast cancer
* severe psychiatric disorder
* history of drug or alcohol abuse
The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

The clinical difference (mean IOP, success rate, and complications) on using S2 and FP7 models of Ahmed Glaucoma Valve that had similar dimensions and different materials used for their construction in one year follow up was evaluated.

Refractory glaucoma is a difficult subject; many glaucoma devices are tried to reduce IOP. Glaucoma devices is now an integral part of glaucoma surgery. AGV is commonly used. The investigators need to compare the efficiency and failure rate of two models of AGV. The point that is the biological reaction around capsule can affect the efficiency.

Eligibility Criteria:
Inclusion Criteria:

1. primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery.
2. patients had secondary glaucoma known to have a high failure rate with trabeculectomy such as neovascular, uveitis, post keratoplasty glaucoma or iridocorneal endothelial syndrome-associated glaucoma.

Exclusion Criteria:

1. patients lacked light perception, unwilling or unable to give informed consent, lived out of the area and were expected to be unavailable for follow-up visits,
2. patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
3. patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
4. patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis.
5. patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.

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Milking Versus Delayed Cord Clamping in Full Term Neonates

To compare the short term risks and benefits of cord milking 5 times toward the neonate with delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.

Abstract Context: milking of the umbilical cord toward the neonate 5 times and delayed cord clamping both are good procedures to prevent anemia in neonates .

Objective: To investigate the effects of delayed umbilical cord clamping for 120 seconds, compared with milking of the cord 5 times toward the neonate on hemoglobin level after 6 weeks, Intubation,Respiratory distress,Clinical jaundice,Neonatal Intensive Care unit (NICU) admission,Apgar score (after 5 minutes of delivery).

-Maternal,Need for blood transfusion,Additional need for therapeutic uterotonics,Post postpartum hemorrhage (blood loss \> 500cc),Intensive Care unit admission.

Design: Randomized controlled trial. Setting: Ain Shams university maternity hospital. Participants:300 full term infants born after a low risk pregnancy by cesarean section delivery.

Intervention: Infants were randomized to delayed umbilical cord clamping (≥120 seconds after delivery) or cord milking (5 times to ward the neonate).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females going for cesarean section that completed 37 weeks of gestation
* Medically free

Exclusion Criteria:

* Known congenital anomalies of fetus.
* Rhesus sensitization.
* Fetal hydrops.
* Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE).
* Need for urgent resuscitation.
* Multiple pregnancies.
Study on the Correlation Between Tracheotomy Tip Pressure and Esophageal Pressure in Patients Weaned from Tracheotomy

Whether the correlation between gas incision tip pressure fluctuations (ΔPtt) and esophageal pressure fluctuations (ΔPes) is a potential measure of spontaneous respiratory effort in patients undergoing gas incision offline.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old), regardless of gender
* Tracheostomized patients with spontaneous breathing;
* Weaning criteria: under the condition of mask oxygen inhalation at 5L/min, SPO2 \> 94%, PaO2/FiO2 \> 150 - 200.
* The patient has stable hemodynamics and pH ≥ 7.32;
* Agree to participate in this trial and sign the informed consent form.

Exclusion Criteria:

* Patients with contraindications for esophageal catheter insertion and unable to monitor esophageal pressure;
* Patients with bleeding risks: severe coagulation disorders, esophageal varices；
* Local injuries: basilar skull fracture, maxillofacial fracture;
* Pregnant women;
* Patients considered not suitable by the researcher.
Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma

Most ESCC received NAC in China without supportive evidence from local RCTs. The negative conclusion about NAC originated from Western countries in the 1990s. Whether two-field extensive mediastinal lymphadenectomy and paclitaxel/platinum-based chemotherapy results in better survival should be determined. As the highest ESCC incidence area worldwid, we tried to analyze this top with big data by using a single-center case-control retrospective PMS study. Paclitaxel- and platinum-based NAC combined with two-field of the extensive mediastinal lymphadenectomy might provide better survival benefits than primary esophagectomy for stage II/III SCC.

Treatment Neoadjuvant Chemotherapy Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1.

Surgical Procedure At approximately 6-8 weeks after NAC, open (McKeown, left thoracic incision left cervical anastomosis) or MIE via thoracoscopy and/or laparoscopy was performed in the patients. Bilateral laryngeal recurrent nerve lymph node dissection was requested for every patient.

Comparisons between the NAC and primary surgery groups were performed using the chi-square test, Mann-Whitney U test and Fisher's exact test for categorical parameters after PMS. Kaplan-Meier curves and a Cox proportional hazards regression model were adopted to perform OS analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018 and the data was prospectively collected in the hubble of the LinkDoc data company
* Surgery performed in the thoracic surgery department
* No previous cancer treatment

Exclusion Criteria:

* Patients with secondary cancer were excluded
Breast Cancer Tumor Heterogeneity

Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.


Eligibility Criteria:
Inclusion Criteria:

1. Women \> age 18 with capacity to consent
2. Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
3. IHC biomarkers performed on original CNB (including HER2)
4. Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
5. Multifocal or multicentric tumors

Exclusion Criteria:

1. Men
2. Women with HER2 positive tumors detected on CNB specimens
3. Women receiving neoadjuvant chemotherapy
4. Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
5. Women whose IHC marker results were inconclusive on CNB or not performed -
Recovery of Serum Creatinine at Discharge Impacts Mortality

The aim of our study is to assess the mortality in the in-hospital patients who have elevated serum creatinine. A registry of patients with increased serum creatinine during hospital was conducted at the Guangdong General Hospital from January 1st, 2007 to December 30th, 2013. The primary clinical outcome is all-cause mortality, followed from the date of hospital discharge to Dec 30th 2018. Patients were divided into three groups, according to the serum creatinine recovery ratio (discharge/max serum creatinine). All-cause mortality, including the date of death, was identified from the electronic hospitalization data, phone follow-up, and confirmed by the household registration (HUKOU) system, a record of registration required by law in China. Baseline characteristics, including primary disease diagnosis, blood pressure, major treatment, drug use and et al, were collected. Demographic data were collected from the electronic hospitalization data and electronic hospital discharge records. All co-morbid conditions were identified using International Statistical Classification of Diseases, Tenth Revision (ICD-10), coding algorithms applied to electronic physician claims and electronic hospital discharge records.


Eligibility Criteria:
Inclusion Criteria:

* In-hospital patients in Guangdong General Hospital in 2007
* Age\>=18y
* Patients with increased serum creatinine during hospital

Exclusion Criteria:

* Death during hospital
* Diagnosed with End-stage renal disease
* given the renal replace therapy during hospital
Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy

The purpose of this pilot study is to gather the data needed to do a larger research study to determine whether children with cerebral palsy print better sitting at an ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.

This pilot study will allow us to gather information for a high-quality randomized controlled trial to study the efficacy of ergonomic school furniture as a remedial handwriting intervention for young students with cerebral palsy. We will conduct the study in two parts. In the first part, 30 children with Gross Motor Function Classification System (GMFCS) Level I and II cerebral palsy will each provide manuscript handwriting samples using two different school furniture configurations. A blinded assessor will score the legibility of handwriting samples using the Minnesota Handwriting Assessment (MHA) as a primary outcome measure. In the second part, seven occupational therapy experts will attend a focus group to help us determine the minimal clinically important difference score for the MHA. We will use the data collected to determine the sample size requirements for a proposed randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of cerebral palsy
* functional status of Gross Motor Function Classification System Level I or II

Exclusion Criteria:

* genetic disorder;
* attention-deficit hyperactivity disorder; or,
* pervasive developmental disorder