cyrilzakka/clinical-trials huggingface dataset:
A First-in-human Study Using BDC-1001 As a Single Agent and in Combination with Nivolumab in Advanced HER2-Expressing Solid Tumors

A first-in-human study using BDC-1001 as a single agent and in combination with nivolumab in HER2 expressing advanced malignancies

This study has four parts. Part 1 is a dose escalation of BDC-1001 as a single agent to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 3. In Part 3, the selected dose will be administered as monotherapy to patients with selected advanced malignancies. Part 2 is a dose escalation of BDC-1001 in combination with nivolumab to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), or maximum protocol dose (MPD) recommended for Part 4. In Part 4, the selected dose will be administered in combination with nivolumab to patients with selected advanced malignancies.

Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.

Eligibility Criteria:
Key Inclusion Criteria:

* Patient must have an advanced solid tumor with documented HER2-protein expression or gene amplification for which approved therapies have been exhausted or are not clinically indicated.
* Measurable disease as determined by RECIST v.1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Tumor tissue (archival or collected prior to the study start) available for exploratory biomarker evaluation.

Key Exclusion Criteria:

* History of severe hypersensitivity to any ingredient of the study drug(s), including trastuzumab or other monoclonal antibody.
* Previous treatment with a TLR 7, TLR 8 or a TLR 7/8 agonist.
* Impaired cardiac function or history of clinically significant cardiac disease
* Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* Active SARS-CoV-2 infection
* Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis.

Other protocol defined inclusion/exclusion criteria may apply.
The Experiences of Erotic and Sexual Risk of Transgender Men: Exploratory Research Design

Transgender male (TM) is the minority and difficult to reach-up group. Therefore, there is a lack of research on private issues involving TM, such as sex, eroticism, and sexual risk behavior. This study focuses on TM as the research participant, based on Milton Mayeroff's caring theory, to understand the TM's erotic culture and the sexual risks behavior, to evaluate the need for subsequent sexual health care. The research method is a mixed methods research of explanatory design, which recruits participants through purposive sampling and respondent-driven sample (RDS) methods. The first stage is an online questionnaire survey. A total of 321 TMs were recruited. The time of online questionnaire is about 10-15 minutes to get a preliminary understanding of the erotic and sexual risk experience of TM in Taiwan. In the second stage, focus groups and in-depth interviews will be conducted, 2 hours of each group and interview. A total of 29 transgender man and women, and non-binary participants were recruited. The recruitment will be stop when the data are saturated. The analysis of both quantitative and qualitative data can get an in-depth understanding of sex, eroticism, and sexual risk, and violence experiences of the participants. The research results are important for improving the awareness and identification of sexual risk and the assessment of sexual health care needs of TM in health care profession. The results also serve as a reference guide for the development of care needs on sexual health care and anti-violence of transgender people, and for the implement of a gender-friendly environment for medical care.


Eligibility Criteria:
First stage:

Inclusion Criteria:

1. People who used to or currently self-identified as transgender men, regardless of whether they have sex reassignment surgery.
2. Be over 20 years old.
3. Citizen and live in Taiwan.

Exclusion Criteria:

1. Not self-identify as transgender men
2. Younger than 20 years old
3. Not citizen and not live in Taiwan.

Second stage

1. People who used to or currently self-identified as transgender men, transgender woman or non-binary, regardless of whether they have gender-affirming surgery.
2. Be over 20 years old.
3. Citizen and live in Taiwan.

Exclusion Criteria:

1. Not self-identify as transgender men, transgender woman or non-binary.
2. Younger than 20 years old
3. Not citizen and not live in Taiwan.
Prognostic Significance of Lymph Node Yield and Lymph Node Ratio Prospective Observational Study

It is still unclear if Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) may have a prognostic role in patients affected by carcinoma of the oral cavity and the oropharynx. Only retrospective studies are available. For this reason, this prospective, multi center, observational study should provide indications in this regard. Proper stratification by patients characteristics will allow to understand if LNY and LNR may enter in the future TNM staging system

Lymph node involvement is a fundamental prognostic factor in head and neck squamous cell carcinoma (SCC). Lymph node yield (LNY), which is the number of lymph nodes retrieved after neck dissection, and lymph node ratio (LNR), which is the ratio of positive lymph nodes out of the total removed, are measurable indicators that may have the potential to be used as prognostic factors. The present study is designed to define the exact role of LNY and LNR regarding the overall and specific survival of patients affected by oral cavity and oropharyngeal SCC.

This is a multicenter study involving tertiary care referral centers in Europe and North America. Patients affected by oral cavity, HPV+ and HPV- oropharyngeal SCC undergoing neck dissection will be consecutively enrolled and followed-up for up to 5 years. Patients and disease characteristic will be properly recorded and centrally analyzed. The primary end-point is to define reliable cut off- values for LNY and LNR which may serve as prognosticators of survival. This will be achieved through the use of ROC curves. Secondary outcomes will be the Overall survival (OS), Disease Specific Survival (DSS), and Progression Free Survival Hazard Ratios (HR) at 2-, 3- and 5 years, which will be evaluated through the Kaplan-Meier method and the difference in survival attested by the log-rank test. Univariate and multivariate analysis will be performed to understand the association of various outcomes with LNY and LNR.

Eligibility Criteria:
Inclusion Criteria:

* patients affected by oral cavity, oropharynx, larynx squamous cell carcinoma

Exclusion Criteria:

* patients affected by other cancers
Pitolisant in Refractory Restless Legs Syndrome

This is an open-label trial in Restless Legs Syndrome (RLS) patients inadequately treated with standard therapy, defined by an IRLS score greater than 15. Investigators hypothesize that the study drug, Pitolisant (Wakix), may improve RLS symptoms.

This is an open-label trial in RLS patients who have been inadequately treated with standard therapies, defined by an IRLS \> 15. This trial consists of four study center visits (weeks 0, 4, 8, and 16) and four telephone visits (weeks 1, 3, 11, and a post safety phone call at week 17).

Subjects will titrate pitolisant for three weeks, starting with a dose of 8.9 mg at week 1, then increase to 17.8 mg at week 2, and a final increase to maximum dosage of 35.6 mg at week 3. If subjects are unable to tolerate the highest dose, they may reduce their dose to 17.8 mg. Titration of the drug will be monitored via telephone visits. During weeks 0-8, subjects will continue to take their current RLS medications. From week 8-16, subjects may either reduce or stop their other RLS medications as mutually agreed upon with investigator.

Several questionnaire assessments will be conducted throughout the study to monitor the subjects. Subjects will complete the International RLS Rating Scale (IRLS), Restless Legs Syndrome - 6 Scale (RLS-6), RLS Quality of Life Questionnaire (RLSQoL), Fatigue Severity Scale (FSS), Hamilton Depression Scale (HDS), Montreal Cognitive Assessment (MoCA), Epworth Sleepiness Scale (ESS), Clinical Global Impressions (CGI), and Clinical Global Impressions-Change (CGI-C).

Eligibility Criteria:
Inclusion Criteria:

* RLS diagnosed by standard criteria with an IRLS \> 15 while taking at least 1 RLS medication
* Stable RLS medications for at least 2 weeks prior to study entry

Exclusion Criteria:

* MoCA \< 24
* Concurrent untreated sleep disorders, not felt to be stable
* Subjects with any significant, unstable cardiovascular, liver, lung, renal, psychiatric, or neurological diseases (not including RLS)
* Intravenous iron within 4 weeks of study entry
* Breast feeding or pregnancy determined by urine pregnancy test in subjects where pregnancy is possible (pre-menopausal, sexually active women)
* Subjects with previous allergic reaction or lack of tolerability to Pitolisant
Study to Evaluate the Efficacy, Safety, and Tolerability of Topical VDA-1102 Ointment in Subjects With Actinic Keratosis

This is a Phase 2 clinical study in patients with actinic keratosis involving daily application of 1 of 2 strengths of VDA-1102 topical ointment for approximately 12 weeks (84 days). This study has no placebo and the subjects enrolled in the study will know exactly what they are receiving. The objectives of the study are to evaluate the safety and benefit of these two strengths.

This Phase 2 clinical trial is a 3-part, open-label, multi-center study involving a non-occluded, daily topical dermal application of 1 of 2 strengths of VDA-1102 ointment for approximately 12 weeks (84 days) to an initial 2 cohorts of subjects. The first 40 eligible subjects will be enrolled into Cohort 1 (Part A). Cohort 1 subjects will be assigned to receive approximately 200 mg of 10% VDA-1102 twice-daily (BID). Once approximately 40 subjects have been enrolled in Cohort 1, Cohort 1 will be closed to enrollment and Cohort 2 (Part B) will be opened for enrollment. Cohort 2 subjects will be assigned to receive approximately 200 mg of 20% VDA-1102 once-daily (QD). Once approximately 40 subjects have been enrolled in Cohort 2, an additional 70 subjects will be randomly assigned to Cohort 1 or Cohort 2 (Part C) in a 1:1 ratio.

To qualify for the study, subjects aged 18 (inclusive) or older must have signed informed consent and met the study enrollment criteria that include having 4-8 actinic keratosis (AK) lesions within an approximate 25 cm2 area on the cheek, forehead, or hairless scalp (the "Treatment Field").

Eligibility Criteria:
Inclusion Criteria:

* 4-8 grade 1 or grade 2 AK lesions in Treatment Field on face or scalp

Exclusion Criteria:

* Subject has no clinically significant findings at Baseline
* Subject is unable to demonstrate adequate precision applying the study drug to the Treatment Field at Baseline
* Subject has in the opinion of the Investigator (a) an unstable medical, psychiatric, social problem
* Subject has at any time been given a diagnosis or treatment associated with immunosuppression
* Subject has received VDA-1102 in the past
Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization

It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.


Eligibility Criteria:
Inclusion Criteria:

* Affiliate or beneficiary of social security
* Age\>18 years
* Pregnant women or man
* Presenting primary response under golimumab induction and in loss of response during maintenance therapy
* Patient with an ulcerative colitis
* Treated with golimumab
* Signature of consent

Exclusion Criteria:

* Trying to become pregnant
* Mental or emotional disorders
* Patients with crohn's disease or indeterminate colitis
* cancer(\<5)
* Patients not in agreement with this study protocol
* Patients with crohn's disease or indeterminate colitis
* Patients non primary responder to golimumab
Online Education to Improve the Management of Rotator Cuff Related Shoulder Pain

A randomized controlled trial: Conservative treatments including physiotherapy and rehabilitation in the management of rotator cuff-related shoulder pain (RCRSP) are generally accepted as the first-line treatment approach, however, it is known that the disease-specific physiotherapy methods used by physiotherapists are highly variable. This may be caused by the insufficient knowledge of therapists about evidence-based interventions to RCRSP. The aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group.

Shoulder pain is one of society's most common musculoskeletal problems, with a prevalence defined between 16-26%. Almost 70% of shoulder pain complaints are caused by pathologies associated with the rotator cuff. Conservative treatments including physiotherapy are widely accepted as a first-line treatment approach in the management of shoulder pain and on the other hand, the variety of physiotherapy practice is conspicuous. Despite the majority of physiotherapists provide treatment in line with current evidence, passive modalities are still highly preferred by some physiotherapists. The gap between research evidence and practice could be slightly due to the lack of an up-to-date undergraduate physiotherapy curriculum about the RCRSP. Therefore, the aim of this study is to develop the '' Rotator Cuff Related Shoulder Pain E-learning Program'' and evaluate its effect on students' knowledge and clinical reasoning skills related to evidence-based RCRSP interventions and their levels of confidence to have this knowledge compared with a control group. A randomized controlled trial including 146 4th grade physiotherapy students will be conducted. Students will be randomized into an e-learning group (n=73) or wait-list control group (n=73). The primary outcome will be the RCRSP achievement test, and the secondary outcome will be the self-reported confidence in knowledge and clinical reasoning skills related to RCRSP. All data will be collected through an online survey, which will be applied in two different time periods: pre-intervention and post-intervention. All groups will first answer the questionnaire at the beginning (week 0) and after the study group's e-learning activity (4-5 weeks).

Eligibility Criteria:
Inclusion Criteria:

* 3th or 4th grade physiotherapy students

Exclusion Criteria:

* Students who are not currently enrolled in 3th or 4th grade
Online Lapse Management Intervention

The purpose of the trial is to test the adjunctive effect of adding a lapse management system to a best practices web- and mobile smoking cessation program.

Background: Web- and mobile phone health behavior change interventions, including smoking cessation programs, offer great promise, but little is known about the components that may add to their effect.

Objectives: To assess tobacco abstinence associated with an adjunctive lapse management system combined with a best-practices web- and mobilephone based smoking cessation intervention. The investigators hypothesize that a program that includes the lapse management system will yield greater efficacy than a program that does not include such a component.

Methods: The investigators propose a 3-arm RCT with 1500 adult study participants that all receive a best practices web-based smoking cessation program designed for use on snart phones (web-app). Participants are randomized to either the web-app only, the web-app plus a web-based lapse management system, or web-app plus a SMS-based lapse management system.

The lapse management system will be based on the day-to-day logging of target behavior and providing just-in-time therapy to clients reporting a lapse. In the two versions of the lapse management system the logging of target behavior is done by asking a question about smoking status by web or SMS.

Measures: The primary outcome is 7-day point prevalence tobacco abstinence (as assessed at the 1- and 6-months follow-up). Potential predictors, moderators, and mediators of abstinence will also be examined.

Benefits: This protocol describes the first RCT that assesses the incremental efficacy of adding a lapse management system to an online smoking cessation intervention. These interventions constitute a cost-effective means to reach smokers who want to quit. By seeking to identify beneficial adjunctive mechanisms, their efficacy may be improved, which can make a substantial public health impact.

Eligibility Criteria:
Inclusion Criteria:

* 18 year or older
* beeing a current smoker
* determined to or considering to quit smoking
* provide valid e-mail address
* provide valid norwegian cell phone number
* complete a baseline questionnaire
* complete a ten day run-in period (preparation phase)
* reporting an initial quit attempt ("yes, today I have quit smoking")

Exclusion Criteria:

-
Evaluating a Digital Intervention for Overactive Bladder

Overactive Bladder is characterised by (I) Urgency: the sudden and compelling desire to pass urine with or without accidental leakage; (II) Frequency: the need to pass urine far more regularly than is considered normal; and (III) Nocturia: the need to pass urine several times during the night. This study aims to investigate the feasibility, acceptability and preliminary efficacy of a digital intervention (the NUIG OAB App) for overactive bladder. Furthermore, this study will help determine the most appropriate outcomes for use in the future definitive RCT and the effect size for future sample size calculations. Participants will complete an 8-week intervention designed to reduce the symptoms of OAB, delivered through the NUIG OAB App. Participants will be asked to complete online surveys at baseline, 4 weeks and 8 weeks and an in-app Bladder Diary at weeks 1 and 8. There will be no in-person contact with participants by the study team.


Eligibility Criteria:
Inclusion Criteria:

1. On waiting list for Urogynaecologist at participating hospital
2. Referred for Overactive bladder from GP
3. Symptoms of Overactive bladder to include at least one of the following: urgency of urination, frequency of urination or urge incontinence.
4. Female
5. 18 years or older
6. Own a smartphone

Exclusion Criteria:

1. Active/Recurrent urinary tract infection
2. Urinary retention
3. Bladder Pain Syndrome/ interstitial cystitis
4. Pelvic/gynae cancer
5. Pregnant
6. Dementia
7. Kidney problems
8. Stroke
9. Have/had a neuro-stimulation implant for treatment of OAB
KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with myelofibrosis (MF) who no longer benefit from treatment with a JAK inhibitor. Inhibition of MDM2 is a novel mechanism of action in MF.

This study will be conducted in 2 phases. Phase 2 will determine the KRT-232 recommended dose and dosing schedule; Phase 3 will test KRT-232 vs Best Available Therapy (BAT). Patients in the Phase 3 part of the study will be randomized 2:1 to receive either KRT-232 (Arm 1) or BAT (Arm 2). The BAT administered will be determined by the treating physician, with the option to "cross-over" to KRT-232 treatment after 6 months of BAT or if the disease worsens at any time.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
* High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
* Failure of prior treatment with JAK inhibitor
* ECOG ≤ 2

Exclusion Criteria:

* Prior splenectomy
* Splenic irradiation within 3 months prior to randomization
* History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
* History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
* Prior MDM2 inhibitor therapy or p53-directed therapy
* Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
* History of major organ transplant
* Grade 2 or higher QTc prolongation (\> 480 milliseconds per NCI-CTCAE criteria, version 5.0)