cyrilzakka/clinical-trials huggingface dataset:
BGJ398 for Patients With Tumors With FGFR Genetic Alterations

The purpose of this signal seeking study was to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study.


Eligibility Criteria:
Inclusion Criteria:

Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma multiforme) or hematologic malignancies and is in need of treatment because of progression or relapse.

Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic alteration. The qualifying alteration must be assessed and reported by a CLIA-certified laboratory.

Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.

Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate hematological response criteria.

Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

Patient has received prior treatment with BGJ398

Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis

Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

Patients with acute or chronic pancreatitis

Patients with impaired cardiac function or clinically significant cardiac diseases

History and/or current evidence of extensive tissue calcification

Use of medications that increase serum levels of phosphorus and/or calcium

Current evidence of corneal or retinal disorder/keratopathy

History and/or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis

Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
Demonstration of Broncholytic Effects in Subjects With Obstructive Airway Diseases by Low Frequency Ultrasound

This study is aiming at evaluating whether low frequency ultrasound spectroscopy is a sensitive tool to detect broncholytic effects in patients with obstructive airway diseases.


Eligibility Criteria:
Inclusion Criteria:

* • 18 - 70 years

  * for the healthy cohort:

    * FEV1 \> 80 % pred, FEV1/FVC ≥ 70 % pred., no history of allergies or asthma
    * nonsmokers, with a history of less than 1 packyear having been nonsmokers for at least the last five years
  * for the COPD cohort: COPD GOLD I to IV according to current guidelines (2)
  * for the asthma cohort: history of asthma GINA I to IV according to current guidelines (3)
  * BMI ≤ 30 kg/m2
  * Able and willing to give written informed consent
  * Available to complete all study measurements

Exclusion Criteria:

* • medical conditions which prohibit the use of salbutamol

  * recent exacerbation of COPD or asthma or lower respiratory tract infection (four weeks previous to informed consent visit)
  * past or present disease, which as judged by the investigator, may affect the outcome of the study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, psychiatric disease, endocrine disease or pulmonary disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic fibrosis)
  * history of drug or alcohol abuse which would interfere with the subject's proper completion of the protocol assignment
  * risk of non-compliance with study procedures
  * suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population

The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type II diabetes
* Between the age of 18-64
* BMI ≥ 27
* Individual annual income less than $47,520 \[Covered CA income guidelines and salary restrictions\]
* Hispanic and/or Latinx origin
* Monitors blood glucose regularly
* Owns or has access to a bathroom weight scale
* Owns a smartphone and willing to download mobile apps

Exclusion Criteria:

* Does not check blood glucose at least once per day
* On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.

Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay
Smoking Cessation Program in the Construction Sector

The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.


Eligibility Criteria:
Inclusion Criteria:

Company leaders:

* ≥ 18 years
* Involved in decision making
* Willing to participate in the implementation development and evaluation

Safety Managers:

* ≥ 18 years
* Be a safety manager
* No plans to leave the company within the next year
* Bilingual
* Willing to receive training in smoking cessation treatment
* Willing to deliver the smoking cessation treatment to workers

Construction Workers:

* Be a construction worker
* ≥ 18 years
* Have smoked on average 5 or more cigarettes daily for the past year
* Willing to make a serious quit attempt in the next 30 days
* Planning to stay in the company for the next 6 months
* Own a telephone and plan to keep it active for the next 12 months

Exclusion Criteria:

Safety Managers:

- Current cigarette smoker
Safety of Hyaluronan Thiomer i.o. Implant During Combined Phacoemulsification - Non Penetrating Deep Sclerectomy

The study is designed to assess the safety of Hyaluronan Thiomer i.o. implant in patients with primary open angle glaucoma undergoing a combined phacoemulsification - non penetrating deep sclerectomy procedure.

In this study, Hyaluronan Thiomer i.o. will be implanted during a combined surgery of cataract and non - penetrating deep sclerectomy in a group of 16 patients with primary open angle glaucoma and clinically significant cataract. Given that a considerable number of glaucoma patients also suffer from cataract, it is reasonable to test Hyaluronan Thiomer i.o. during a combined procedure of phacoemulsification and deep sclerectomy. This is also of importance because a combined procedure avoids the need of a second operation in this group of patients. Finally, it has been shown that combined phacoemulsification - deep sclerectomy does not induce a further risk compared to deep sclerectomy alone(open phase I study).

Safety will be assessed based on the occurrence of adverse events.

Efficacy assessments will be performed at every visit and efficacy analysis will include:

* Proportion of subjects at each study time point which will need additional IOP lowering drug therapy to achieve an IOP reduction to values \< 21 mmHg. If a subject needs more than one drug to achieve target IOP, the number of drugs needed to achieve adequate IOP reduction will be recorded.
* Proportion of subjects at each time point which will need Neodymium:YAG goniopuncture to achieve an IOP reduction to values \< 21 mmHg.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Primary open angle glaucoma with uncontrolled IOP (IOP \> 21 mmHg or more) despite maximally tolerated topical medication
* Clinically significant cataract as judged by the investigator
* Scheduled for combined cataract/glaucoma surgery

Exclusion Criteria:

Any of the following will exclude a subject from the study:

* Participation in a clinical trial in the 3 weeks preceding the study
* Presence or history of a severe medical condition as judged by the clinical investigator
* Wearing of contact lenses
* Loss of mean deviation of visual field testing of 15 dB or more
* Diabetic retinopathy
* Dysgenetic glaucoma, secondary glaucoma or any type of angle closure glaucoma
* Previous argon laser trabeculoplasty
* Severe dry eye syndrome as judged by the investigator
* Ocular infection or clinically significant inflammation as judged by the investigator
* Ocular surgery in the 12 months preceding the study
* History of glaucoma surgery in the study eye
* Neovascular form of age related macular degeneration
* The following lenses will not be implanted during cataract surgery Multifocal lenses Toric lenses PMMA lenses
* Ametropy \>/= 6 Dpt
* Patients in which the surgical procedure cannot be performed or completed according to the protocol for any reason will be excluded and replaced.
* Pregnancy, planned pregnancy or lactating
Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain

Our study aims to determine postoperative pain outcomes when comparing port site \> 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Pain outcomes will be measured using the visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older.
* Any patient undergoing laparoscopic gynecologic surgery with one left upper quadrant port site \> 10 mm via either robotic or traditional laparoscopic techniques for any indication including abnormal bleeding, pelvic pain, gynecologic cancer, uterine fibroids, etc. Procedures performed will include but not be limited to hysterectomy, bilateral or unilateral salpingoophorectomy, ovarian cystectomy, and pelvic floor support procedures.
* Patients willing and able to give informed consent.
* Patients capable and willing to return for follow up and complete pain diaries.

Exclusion Criteria:

* Patients unable to return for follow up.
* Patients undergoing laparoscopic surgery that requires conversion to laparotomy.
* Patients undergoing laparoscopic surgery that does not require a port site \>10 mm.
Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD

The goal of this study is to determine how non-invasive brain stimulation (delivered through the ear called vagus nerve stimulation) affects fear learning processes in people who have experienced psychological trauma. To answer these questions, we measure bodily responses (heart rate, sweat, startle) and questionnaires. The main questions it aims to answer are:

Does non-invasive vagus nerve stimulation help reduce anxious arousal? Does non-invasive vagus nerve stimulation help dampen learned fear?

This study aims to determine how non-invasive brain stimulation (delivered through the ear) affects learning processes. During this study, participants who have experienced a trauma will be asked to complete surveys and come to the lab for about 7 hours across four lab visits. Researchers will measure body responses (heart rate, skin conductance, startle), while the ear is stimulated. Participants also will be asked to complete a startle task. The study is at the Wayne State University Tolan Park Research Clinic. Participants will be compensated for their time. To be eligible, participants must be 18-70 years old, have experienced or witnessed a traumatic event, be able to commit 7 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer.

Aim 1. Establish feasibility and acceptability of taVNS in a diverse sample of Detroit metro residents with symptoms of posttraumatic stress. It is hypothesized that taVNS delivery will be feasible and acceptable for individuals with trauma exposure and PTS symptoms, and that there will be no difference in acceptability/tolerability between the active and sham conditions.

Aim 2. Establish the effects of active versus sham taVNS on physiological indicators during fear extinction. It is hypothesized that active compared to sham taVNS will a) result in facilitation of fear extinction, and b) show greater modulation of physiological responding. Exploratory Aim: Data will be explored for individual differences (affective blunting, hyperarousal, impaired discrimination of conditioned stimuli) which moderate taVNS effects.

This proposed project will determine how taVNS delivered at higher doses than have been previously administered influence the course of adaptive posttraumatic processing in a sample with trauma exposure, while evaluating the psychophysiological profile in multiple contexts.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-80
2. Fluent in English
3. Experience with a DSM-5 Criterion A trauma (LEC-5)
4. Probable PTSD (PCL-5 ≥ 32)

Exclusion Criteria:

1. Visual or Auditory impairment
2. Major injury at time of screen or study procedures
3. Taking ≥20 mg morphine per day
4. Current substance use or intoxication (12-panel drug test)
5. Intellectual disability (MoCA)
6. Self-inflicted injury
7. Occupational injury
8. Prisoner
9. Ongoing domestic violence
10. Pregnant or breastfeeding
11. Contraindications for taVNS
Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage

To delineate the effect of MSM on osteoarthritis

Objective: To delineate the effect of MSM on osteoarthritis of large joints. Design: Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA to be divided in 2 groups. Intervention is either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured are the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC), patient and physician assessments and SF-36 (overall health-related quality of life).

Eligibility Criteria:
Inclusion Criteria:

* Knee and hip OA
* men and women \>45 years of age

Exclusion Criteria:

* any other type of arthritis
* chronic pain syndrome
* arthroscopic surgery in the past 8 months
* intra-articular corticosteroidsin the past 8 months
* hyaluronic acid injections in the past 8 months
* narcotic pain killers use
* renal or hepatic disease
* body mass index (BMI) \>45 kg/m2
* cancer
CARD for Community Pharmacy Vaccinations - Phase 2

This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in pharmacies randomized to Control (usual care) in phase 1 of the trial. Both groups will use CARD for delivery of vaccinations during the 2024-2025 fall/winter vaccination season.

This study is a continuation of a previous cluster trial. Pharmacies that participated in the original trial will be asked if they want to volunteer for the present study. They will all use the CARD system as the vaccination delivery system for their community pharmacies during the 2024-2025 fall/winter vaccination season. They will collect feedback from vaccine clients using a paper survey that tracks experiences, including symptoms, during vaccination. The responses will be compared between groups.

The sample size is limited by the number of pharmacies that volunteer. We expect 8 pharmacies will participate in a 1:1 ratio (about 1/3 of all pharmacies in original cluster trial), with a total of at least 500 vaccination clients. We will collect data for all vaccinations that are conducted and for which client feedback data are available. Thus, the sample size is expected to deviate from the estimated sample size of 500.

Eligibility Criteria:
Inclusion Criteria:

* clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies

Exclusion Criteria:

* able to speak and write in English
Pilot Study of Text Message Brief Interventions for Problem Drinkers

This study will provide a pilot test of two different text message interventions for problem drinkers. Participants will be recruited using a general population telephone survey. Participants in a control group (who will not receive text messages) will be compared to participants who receive one of two different types of text message packages (12 text messages sent once per week in each) - a series of personalized feedback text messages or a series of consciousness raising test messages (i.e., messages that keep the thought of cutting down on their drinking in the participants' mind). Participants in the three different conditions will be followed-up in three months time to assess changes in drinking. It is predicted that participants who receive either of the text message packages will report reduced drinking as compared to those participants in the control condition who do not receive any text messages.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Ontario
* 19 years of age or over
* Have consumed alcohol in the one month prior to the telephone survey.
* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
* Are willing to participate in follow-up at three months

Exclusion Criteria:

•None
Frequency of Vascular Events With Short-term Thromboprophylaxis in Fast-track Hip and Knee-arthroplasty.

There are many different views regarding ideal duration and type of thromboprophylaxis after hip or knee surgery.

An important factor in Fast-track surgery is early mobilization, which in itself is thought to prevent clotting.

The investigators hypothesize that there is no increase with regards to thrombosis in patients receiving fast-track surgery with early mobilization and chemical thrombosis prophylaxis only during hospitalization.

Major orthopaedic surgery is related to development of thrombosis. It is well known that pharmacological prophylaxis reduces the risk of thrombosis after surgery but there are still doubt about the best type of prophylaxis and duration of treatment. The American College of Chest Physicians recommend thromboprophylaxis with either Low molecular weight heparin, factor Xa-inhibitors or Vitamin-K-antagonists for up til 10 days after total knee replacement (TKR) and 35 days after total hip replacement(THR). However whether these recommendations are applicable in fast-track patients receiving early mobilisation is uncertain.

Studies on fast-track patients receiving early mobilisation and thrombosis prophylaxis only during hospitalisation showed very small incidence of symptomatic thromboembolic events. Therefore we conduct a quality-cohort-study on all patients receiving fast-track TKR/THR with short-term anti-thrombotic treatment, in order to investigate frequency of symptomatical deep vein thrombosis, pulmonary embolus, acute myocardial infarction and stroke.

Eligibility Criteria:
Inclusion Criteria:

* primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days.

Exclusion Criteria:

* not a danish citizen
The HeartRunner Trial

The study will assess 30-day survival for cases where volunteer citizen responders ('heart runners') were activated through a smartphone app to retrieve an AED in case of suspected out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The study will randomize emergency medical dispatch center incoming calls which are suspected out-of-hospital cardiac arrest, such that half will be randomized to activation of heart runners and half to no activation of heart runners (standard care). The study will also assess physical or psychological risks involved for the activated heart runners.

Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until defibrillation. Activating volunteer citizens through the emergency medical dispatch center can potentially increase rates of bystander defibrillation and survival. The HeartRunner trial will investigage the effect of activating registered volunteer citizens through a mobile app integrated with the emergency medical services on 30-day survival following out-of-hospital cardiac arrest. Both arms will receive standard care by the Emergency Medical Services. The intervention arm will additionally receive the activation of volunteer citizen responders. The randomization will take place independently in 3 different strata according to heart runner distance to OHCA (\< 3 min, 3-9 min, \> 9 min). The trial will also assess whether it is safe, both physically and psychologically, to activate volunteer citizen responders to respond to out-of-hospital cardiac arrests.

Eligibility Criteria:
Inclusion Criteria:

* All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.
* Non-traumatic etiology, this excludes intoxication, drowning or suicide.
* Age \> 7 years

Exclusion Criteria:

* Caller is not in direct contact with the patient
* If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.
* OHCAs not treated by the EMS due to ethical reasons or obvious signs of death
* OHCAs with no heart runners within 1800 meters
* Not true cardiac arrest (suspected, but not verified)
* EMS-witnessed OHCAs

Emergency medical dispatchers are instructed not to activate heart runners in case any of the exclusion criteria above. However, since it can be challenging for emergency medical dispatchers to gather sufficient information about the patient within the first few minutes, heart runners will admittedly be activated even though they should not have been. Since randomization will occur for all cases in which a heart runner is activated, cases with any of the exclusion criteria will be secondarily excluded.

These cases will be accounted for but not included in analyses of outcome. Our pilot study showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore, we expect 40% of cases for which heart runners were dispatched not to be true cardiac arrests.