cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Dental Brushing for Preventing Ventilator-Associated Pneumonia

Poor oral hygiene is associated with respiratory pathogen colonization and secondary lung infection.The possible association between oral care and incidence of VAP, and the role of dental plaque, mouth and tracheal colonization have not been firmly established. The investigators' hypothesis was that improving oral care with electrical toothbrushing might be effective in reducing the incidence of VAP.


Eligibility Criteria:
Inclusion Criteria:

* Adult intubated patients
* Without evidence of pulmonary infection (randomized within 12h of intubation if they were expected to remain ventilated for longer than 48 hours)

Exclusion Criteria:

* Absence of dental pieces
* Current diagnosis of pneumonia or massive bronchoaspiration
* Tracheostomy (or expected within 48 hours)
* Chlorhexidine allergy
The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD

COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD.

The main questions it aims to answer are:

1. Does the training given in COPD affect the level of fatigue?
2. Do the education given and text messages sent regarding COPD affect the level of fatigue?

In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages.

Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance.

The initial information of all groups was taken again at the end of the 8th week.

Main outcomes:

* Dyspnea severity,
* COPD general conditions and
* Fatigue level. The results obtained will be interpreted by comparing between 3 groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD for the last 1 year
* Hospitalized for at least 3 days,
* Voluntary patients

Exclusion Criteria:

* Under 18 years old
* Over 85 years old
* Those with chronic fatigue syndrome
* Those with severe heart failure
* Those who had surgery in the last 6 months
Pharmacokinetic Profile of Vincristine Administered With Imatinib for Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) Compared to That Without Imatinib for Bcr-Abl Negative ALL

This study is characterizing the pharmacokinetics of vincristine using two different cohorts of patients. The first cohort includes patients with acute lymphoblastic leukemia (ALL) that are Bcr-Abl positive. This cohort of patients will receive vincristine along with imatinib in the induction chemotherapy regimen. The second cohort includes patients with ALL that are Bcr-Abl negative. This cohort of patients will receive vincristine without imatinib in the induction chemotherapy regimen. This study involves blood draws beginning on day 7 of the treatment protocol and these samples will be analyzed for pharmacokinetic parameters.

Imatinib and vincristine are both metabolized by the hepatic CYP 450 enzyme system. Imatinib is an inhibitor of the system and co-administration of imatinib and vincristine has the potential to increase the blood level of vincristine. This could explain the increased level of neurotoxicity that is currently being seen with the co-administration of these two agents in the treatment of Bcr-Abl positive ALL.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* New Diagnosis of Bcr-Abl positive ALL or Bcr-Abl negative ALL
* Receiving induction chemotherapy with the standard Princess Margaret Hospital modified DFCI protocol
* Will have a functioning central venous access catheter in-situ
* Agreeing to participate in the study and sign the informed consent form

Exclusion Criteria:

* Concomitant use of other agents that inhibit hepatic cytochrome CYP3A4, as these drugs may alter vincristine and imatinib levels
* Elevated liver function tests: bilirubin \>1.5xULN or AST/ALT \>2.5xULN, or documented history of chronic liver disease.
Correlation Between Serum TK1 and Pathological Remission of Breast Cancer With Neoadjuvant Chemotherapy

The levels and changes of sTK1 among different outcome groups in BCs with different molecular types were compared by stratification to explore whether sTK1 can be used as one of the tumor markers to predict pathological remission of NACT in BC patients.The changes of serum sTK1 level and ADC before surgery were continuously monitored, and combined with other clinicopathological factors, the pathological remission prediction model of NACT in BC patients was constructed and verified.

Female patients diagnosed with breast cancer by breast biopsy and receiving neoadjuvant chemotherapy in our hospital from 2020 to 2024 were selected as the study objects, and their puncture pathology data, general clinical characteristics, hematology test data, imaging data and surgical pathology data were collected, and the data were collated for statistical analysis. The influencing factors of pCR after neoadjuvant therapy were determined by univariate and multivariate logistic regression analysis, and the nomogram and ROC curve were drawn. The model was verified internally through bootstrap resampling 1000 times, and the correction curve was drawn to evaluate the prediction ability of the model.

Eligibility Criteria:
Inclusion Criteria:

① The patient was diagnosed with breast cancer by biopsy, and there were complete pathological data. ② Complete the course of neoadjuvant chemotherapy; ③ After the end of neoadjuvant therapy, the operation was performed and the postoperative pathology was obtained; MRI and serum TK1 data were complete (baseline, after 2 cycles of chemotherapy, 4 cycles of chemotherapy, and 6 cycles of chemotherapy).

Exclusion Criteria:

① Distant metastasis at first diagnosis (stage IV); ② With other primary malignant tumors.
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.


Eligibility Criteria:
Inclusion Criteria:

* Participants who completed the end of treatment visit in Study INS1009-211 (NCT05176951). Participants for whom the OLE study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit.
* Complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in Study INS1009-211, or any other lead-in PH-ILD TPIP study.
* Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous PH-ILD TPIP study, which in the opinion of the Investigator, could indicate that continued treatment with TPIP may present an unreasonable risk for the participant.
* Initiation of parenteral administration of prostacyclin analogues (eg, TRE, epoprostenol) since the completion of Study INS1009-211 or other TPIP studies. Initiation of inhaled prostacyclin analogues (eg, TRE \[Tyvaso\] or iloprost) and oral prostacyclin analogues (eg, TRE \[Orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration.

Pregnant or breastfeeding. Male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug.

- Any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the Investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.
Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease

The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of BIIB037 after single-dose administration.

BIIB037 is an investigational product being developed as a treatment for Alzheimer's disease (AD). BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is selective for the fibrillar form of beta amyloid (Aß).

Eligibility Criteria:
Key Inclusion Criteria:

* Must be ambulatory
* Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the following:

  1. Probable Alzheimer's Disease (AD), according to National Institute of Neurological and Communicative Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria \[McKhann et al. 1984\].
  2. Dementia of Alzheimer's type, according to Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM IV TR) criteria \[American Psychiatric Association 2000\]
* Subject (or subject's permanent caregiver) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or assent) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Must have a Mini Mental State Examination (MMSE) score of 14 to 26 inclusive.

Key Exclusion Criteria:

* Any medical or neurological condition other than Alzheimer's Disease (AD) that in the opinion of the Investigator could be a contributing cause of the subject's dementia (e.g., medication use, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, diffuse Lewy body disease, head trauma).
* History within the past 6 months or evidence of clinically significant psychiatric illness (e.g., major depression, schizophrenia, or bipolar affective disorder).
* Subject currently lives in a nursing home.
* Blood donation (1 unit or more) within the 1 month prior to Screening
* Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half lives, whichever is longer) prior to Screening, and/or participation in any other clinical study involving experimental medications for AD within the 60 days (or 5 half lives, whichever is longer) prior to Screening.
* Any contraindications to having a brain Magnetic Resonance Imaging (MRI) e.g., pacemaker; Non-Magnetic Resonance Imaging (MRI)-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure

The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.

The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.

Each study participant will have up to eight study visits. Topical sulforaphane will be applied for up to 6 months. Photography, clinical assessment, UV light irradiation, Visible light treatment, Skin biopsies, non invasive elasticity measurements such as cutometer and ballistometer, and others will be involved in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be over the age of 18 years old with healthy skin or moderate degree of photoaging/intrinsic aging;
* Must be healthy enough to undergo skin biopsy, light irradiation, and other study procedures in the opinion of the investigator;
* Must be willing to comply with the requirements of the protocol;
* Must have the ability to understand and communicate with the investigator;
* Participant must provide informed consent.

Exclusion Criteria:

* Subjects who are unable to provide informed consent;
* Subject with significant medical history or current skin diseases that the investigator feels is not safe for study participation;
* Subjects who have been treated with systemic retinoids or steroids within the past month prior to entry to the study;
* Subjects who have been treated with topical steroids, retinoids or other topical drugs used within 2 weeks prior to entry to the study;
* Recently treated or current skin diseases that would affect clinical evaluation and biopsy;
* Subjects with a known allergy to broccoli.
* Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy.
* Subjects with a history of excessive scar or keloid formation in the past 10 years.
* Pregnant or nursing subjects (self-reported).
* Subjects with known allergy to anesthetics used.
* Patients with history of investigational drug use in the 30 days prior to entry into the study.
A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18

This is a Phase 3, open-label, multicenter study to evaluate the safety, efficacy, PK, PD, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ERT-experienced and ERT-naïve pediatric subjects with IOPD.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

1. Male or female subjects who are aged 6 months to \< 18 years on Day 1
2. Subject must have documentation of IOPD genotype
3. Subject must have had hypertrophic cardiomyopathy at the time of diagnosis
4. Subject must have received ERT for at least 6 months immediately before enrollment. For subjects whose ERT dosage has been modified, the subject must have been on the modified dosage and regimen for at least 3 months before enrollment
5. Subjects aged ≥ 12 to \< 18 years must perform one valid 6-minute walk test (6MWT) (≥ 75 meters) at screening; Subjects aged ≥ 5 to \< 12 years must perform one valid 6MWT (≥ 40 meters) at screening; Subjects aged 18 months to \< 5 years must be ambulatory and assessed to be likely to be able to perform 6MWT (≥ 40 meters) when they turn 5 years old
6. Subjects must have experienced a clinical decline on their current rhGAA dose and frequency

Cohort 2:

1. Male or female subjects who are aged 0 to \<6 months at Day 1
2. Subject must have documentation of IOPD genotype
3. Subject must have had hypertrophic cardiomyopathy at the time of diagnosis
4. Subject is ERT-naïve

Long-term Extension (Cohort 1 or Cohort 2):

1. Subject must have, in the opinion of the investigator, benefited from therapy with cipaglucosidase alfa/miglustat during the 104-week primary treatment period with no significant safety concerns.

Exclusion Criteria:

Cohort 1 and Cohort 2, unless specified

1. Subject requires invasive ventilation (eg, tracheostomy)
2. Subject is CRIM negative and has not received prophylactic immunomodulation (Cohort 1); Subject is CRIM negative and will not be receiving prophylactic immunomodulation (Cohort 2)
3. Subject has a history of life-threatening IARs/hypersensitivity (eg, anaphylaxis and severe cutaneous reactions) to ERT (eg, alglucosidase alfa, cipaglucosidase alfa, miglustat) or other iminosugars, or to any of the excipients, where rechallenge was unsuccessful
4. Subject has prior history of illness or condition known to affect motor function
5. Female subject is pregnant (or intends to get pregnant) or breastfeeding at screening (Cohort 1)
Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation

The purpose of this study is to confirm the safety profile for long term treatment and maximize doses and the control status on bronchial asthma in daily clinical usage


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Symbicort for the first time possibly at the higher dose due to bronchial asthma

Exclusion Criteria:

-
Comparative Effects of Pendulum Exercise and Serratus Punch Exercises on Rotator Cuff Pain in Badminton Players

This study will compare the effects of two exercise interventions, pendulum exercises and serratus punches, on rotator cuff pain and injury in badminton players. Using a randomized clinical trial with participants from local clubs, the research will evaluate pain levels, range of motion, and shoulder function after a set period of regular, supervised exercises. The results aim to provide evidence-based insights for effective rehabilitation programs tailored to badminton athletes, supporting better recovery and injury prevention.

Rotator cuff pain and disability is typical among badminton players because of the dull movements associated with the game. These wounds can prompt critical torment and practical limits, influencing the players' exhibition and prosperity. The focal point of this exploration project is to think about the impacts of two different activity mediations, pendulum activities and serratus punch works, on rotator sleeve agony and injury in badminton players. Understanding the similar adequacy of these activities will contribute essential knowledge to improving designated restoration programs for badminton competitors, further developing their recuperation results and forestalling future wounds.

This exploration will utilize a randomized clinical preliminary plan to research the similar impacts of pendulum activities and serratus punch practices on rotator sleeve agony and injury in badminton players. Members will be selected from neighborhood badminton clubs, and consideration measures will include people with an analyzed or self-revealed history of rotator sleeve torment. The chosen members will be arbitrarily allotted to the pendulum or the serratus punch practice bunch. The mediation time frame will traverse a predefined span, during which members will routinely participate in their doled-out practice. Result estimates will incorporate torment levels, scope of movement, and practical appraisals of the rotator sleeve. Factual examinations will be directed to consider the viability of the two activity mediations and their effect on rotator sleeve agony and injury in badminton players. The consequences of this study are to illuminate proof-based restoration systems customized explicitly for the badminton populace, adding to the enhancement of player well-being and execution.

Eligibility Criteria:
Inclusion Criteria:

* Badminton players aged 15 to 30 years.
* Individuals with self-reported rotator cuff pain or discomfort
* Clinically diagnosed rotator cuff pain or discomfort.
* Individuals with Rotator Cuff Injury.

Exclusion Criteria:

* Previous shoulder surgeries or fractures.
* Chronic shoulder conditions unrelated to rotator cuff issues.
* Inability to perform the prescribed exercises due to other musculoskeletal or medical conditions.
* Patients with shoulder dislocation.
* Patients with swelling on shoulder.
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients

The purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of subjects with TGCT.

AMB-05X drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (CSF1R).

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥ 18 years
2. A confirmed diagnosis of TGCT
3. Measurable disease based on RECIST v1.1
4. Symptomatic disease
5. Stable prescription of analgesic regimen
6. Agrees to follow contraception guidelines
7. Adequate hematologic, hepatic, and renal function, at Screening
8. Willing and able to complete self-assessment instruments throughout the study

Exclusion Criteria:

1. Prior investigational drug use within 4 weeks or 5 half-lives of Baseline
2. Current or prior radiotherapy within 3 months before Baseline
3. Current or prior active cancer within 3 years before Baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy)
4. Known metastatic TGCT or malignant transformation of diffuse-type TGCT
5. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or chronic infection with human immuno deficiency virus (HIV)
6. Known active tuberculosis (TB)
7. Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history
8. Women who are pregnant or breastfeeding
9. Screening Fridericia-corrected QT interval(QTcF) ≥450ms (men) or ≥470ms (women)
10. MRI contraindications (eg, pacemaker, loose metallic implants)
11. History of hypersensitivity to any ingredient in the study drug
12. History of drug or alcohol abuse within 3 months before Baseline
13. Has any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment, interfere with interpretation of study results, or, in the Investigator's opinion, make the subject inappropriate for this study
14. A person who is held in detention as the result of a judicial or official decision or who is in a subordinate relationship to the Sponsor or Investigator
15. A subject who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the subject's ability to comply with study requirements