cyrilzakka/clinical-trials huggingface dataset:
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

The study investigates different adhesive materials on healthy and peristomal skin


Eligibility Criteria:
Inclusion Criteria:

* Has given written consent
* Be at least 18 years of age and have full legal capacity
* Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)

Exclusion Criteria:

* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Having dermatological problems in the abdominal area (assessed by investigator)
* Participate in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol
G-Pola-ZLP in Diffuse Large B-Cell Lymphoma

The goal of this phase 2 trial is to test the safety and efficacy of G-Pola-ZLP as induction therapy in patients with DLBCL.

The investigators will evaluate safety and efficacy of G-Pola-ZLP as induction therapy in Previously Untreated Diffuse Large B-Cell Lymphoma. ORR(Overall response rate, progression-free survival (PFS), Overall survival (OS), Adverse events (AEs) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Patient has not received chemotherapy previously.
* Anticipated life expectancy at least 3 months

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
* Pregnant or lactating women
A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS

This study is aimed to evaluate the efficacy, safety, immunogenicity and pharmkinetics, pharmacodynamics of 6MW3211 as monotherapy and in combination with AZA or AZA plus VEN in patients with AML/MDS.

This study is a phase I/II study to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of 6MW3211 monotherapy or combined with AZA or AZA plus VEN in patients with AML and MDS. There will be 2 parts of this study. The phase Ib is about monotherapy of 6MW3211 and Phase II is designed to evaluate the safety and efficacy of 6MW3211 combined with AZA or AZA plus VEN in patients with relapse/refractory and newly diagnosed AML and MDS.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in the study and sign the informed consent;
* 18≤age≤75，Men or women；
* AML patients (except acute promyelocytic leukemia) : subjects who meet the diagnostic criteria for relapsed/refractory AML according to the diagnostic criteria of 2021 Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory AML ； MDS patients: MDS patients were diagnosed as having moderate risk of recurrence/refractory (IPSS-R score \>3.5) according to WHO diagnostic criteria in 2016
* ECOG:0-2;
* Survival expectation of at least 3 months;
* Adequate organs and hematopoietic functions; only applicable for phase II :
* Newly diagnosed AML with intolerance to standard induction chemotherapy who should meet one of following criterias: age ≥75 years; ECOG 2-3; chronic heart failure requiring treatment or EF≤50% or chronic stable angina pectoris; DLCO≤65% or FEV1≤65%;30ml/min≤CrCl\<45ml/min；1.5 x ULN\<total bilirubin≤3.0 x ULN
* Newly diagnosed intermediate- and high-risk (International Prognostic Scoring System IPSS-R) MDS

Exclusion criteria:

* Myeloid proliferative diseases (MPN), including primary myelofibrosis (PMF), polycythemia vera (PV), chronic myelogenous leukemia (CML), and primary thrombocytopenia (ET); Or have myelodysplastic myeloid proliferative tumors (MDS-MPN), including chronic monocytic leukemia (CMML), atypical chronic myelogenous leukemia (aCML), juvenile granulomatous single-cell leukemia (JMML), and acute promyelocytic leukemia (M3);
* Recurrence after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year;
* Known infiltration of central nervous system leukemia；
* Active or uncontrolled autoimmune diseases；
* Has a history of other malignancies；
* Has known inherited or acquired hemorrhagic disorders；
* Pregnant or lactating women；
Prevention of Gestational Diabetes

Gestational diabetes mellitus (GDM)is a major health problem

* growing prevalence of obesity
* the older age of pregnant women

A randomized controlled trial in 54 pregnant voluntary women at high risk for GDM.

* feasibility of an early intervention
* glucose tolerance at weeks 26-28

1. A 75-g oral glucose tolerance test (OGTT) was performed at weeks 8-12

   1. voluntary women in early pregnancy (n=96)
   2. 54 high risk mothers were randomized

      * lifestyle intervention group (n=27)
      * close follow-up (n=27)
2. An OGTT was performed again at weeks 26-28

   * the lifestyle intervention group (n=27)
   * the close follow-up group (n=27)
   * other high-risk women of the early care group (n=42)who were not randomized
3. An OGTT was also performed at weeks 26-28 in two neighboring municipalities

   * a standard care high-risk group(n=171)who did not undergo early intervention
4. Primary outcomes

   * number of at risk participants developing GDM during pregnancy in the two arms
5. Secondary outcomes

   * the effect of intervention on fetal growth

Eligibility Criteria:
Inclusion Criteria:

* high risk for gestational diabetes
* fasting glucose 4.8-5.5 mmol/l and 2-hour glucose of OGTT \<7.8 mmol/l

Exclusion Criteria:

* normal glucose tolerance at weeks 8-12
* gestational diabetes at weeks 8-12
PPI And Food Effect Study For PF-06463922 In Healthy Volunteers

The current study will be conducted in healthy adult subjects to evaluate the effect of proton pump inhibitor and food on pharmacokinetics of PF-06463922, to evaluate the bioavailability of the oral solution relative to the tablet formulation of PF-06463922.

PF-06463922 is a selective, ATP competitive small molecule tyrosine kinase inhibitor (TKI) of the Anaplastic Lymphoma Kinase (ALK) positive (ALK+) or ROS oncogene 1 (ROS1) positive (ROS1+) receptor tyrosine kinases (RTK) that also potently inhibits ALK kinase domain mutations responsible for resistance to crizotinib. PF-06463922 is being developed as a novel anticancer agent for the treatment of patients with advanced ALK+ NSCLC or ROS1+ NSCLC.

The current study is a Phase 1, randomized, open label, 4 period, 4 treatment, 4 sequence, crossover study conducted in healthy adult subjects. Each subject will receive four single oral doses of 100 mg PF-06463922 as tablets alone, tablets with food, tablets with rabeprazole, and oral solution after overnight fasting with at least a 10 day washout period between each PF-06463922 dose.

Twenty four (24) subjects will be enrolled to obtain at least 20 evaluable subjects who complete all treatments. Subjects who withdraw will not be replaced unless the total number of completed subjects falls below 20.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and/or male subjects
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document.
* Subject must be willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular
* Any condition possibly affecting drug absorption
* A positive urine drug screen.
* Use of tobacco- or nicotine containing products within 90 days of screening or a positive urine cotinine test and history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within 6 months of Screening.
The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety

The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access.

H0.1. Playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels.

H0.2. Applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.

H0.3. Listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.

Design: It is a randomized controlled experimental study. Methods: This study was conducted between February and December 2023 with 126 children between the ages of 4 and 12 who were hospitalized in the pediatric ward of a public hospital in a province in eastern Turkey and had vascular access. The sample consisted of four groups: a music video listening group (n=31), a buzzy group (n=32), a music video listening + buzzy group (n=31), and a control group (n= 32). Children were selected into groups by simple randomization method. Data were collected 60 seconds before starting the vascular access procedure and as soon as the procedure was completed. Introductory Information Form, Child Fear and Anxiety Scale and Wong-Baker Facial Expression Rating Scale were used to collect data.

The data was analyzed on SPSS (Version 25, Chicago, IL, USA). The Gaussian curve and Shapiro-Wilk test were used to assess whether or not the data were normally distributed. Descriptive statistical tests (arithmetic mean, standard deviation, number, and percentage) were also conducted. The conformity of the measurement values to normal distribution was tested with "Shapirow-wilk" analysis. Pearson chi-square test was applied to the dependency relationship of frequency measurement values. One-factor ANOVA test was used to compare whether there was a statistically significant difference between the means of independent groups. Kruskal Wallis H-Test was used to compare groups that did not show normal distribution. Mann Whitney U test was used in further analysis to determine the difference between two independent groups. Wilcoxon test was used to test the significance of the difference between the scores of two related measurements. P values \<0.05 were considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 4-12
* being willing to participate in the study,
* being accompanied by their parents (mother or father).

Exclusion Criteria:

* Failure to establish vascular access on the first try
Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

The purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with aHUS who had not previously used a complement inhibitor.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 12 years of age and weighing ≥ 40 kg at the time of consent.
2. Evidence of thrombotic microangiopathy, including low platelet count, hemolysis (breaking of red blood cells inside of blood vessels), and decreased kidney function.
3. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study drug. Participants who received a meningococcal vaccine less than 2 weeks before initiating ravulizumab treatment must have received treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Participants who had not been vaccinated prior to initiating ravulizumab treatment should have received prophylactic antibiotics prior to and for at least 2 weeks after meningococcal vaccination. Participants \< 18 years of age must have been vaccinated against haemophilus influenzae type b and streptococcus pneumoniae according to national and local vaccination schedule guidelines.
4. Female participants of childbearing potential and male participants with female partners of childbearing potential had to use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.

Exclusion Criteria:

1. A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 deficiency (activity \< 5%).
2. Shiga toxin-related hemolytic uremic syndrome.
3. Positive direct Coombs test.
4. Pregnancy or breastfeeding.
5. Identified drug exposure-related hemolytic uremic syndrome (HUS).
6. Bone marrow transplant/hematopoietic stem cell transplant within last 6 months prior to start of Screening.
7. HUS related to known genetic defects of cobalamin C metabolism.
8. Systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome.
9. Chronic dialysis (defined as dialysis on a regular basis as renal replacement therapy for end-stage kidney disease).
Immune Response in Celiac Disease on In-vitro Gluten Challenge

The main purpose of this study is to see how cells taken from the lining of the intestine behave in the laboratory with exposure to gluten and other substances that act on the immune system. The cells lining the intestine of a person with celiac disease should be different than a person without celiac disease. The study doctors would like to see how the cells react after coming in contact with gluten and if substances that act on the immune system can prevent gluten related inflammation. Examples of these substances include steroids. The cells should produce chemicals of their own in response to the gluten. These other chemicals will be measured and the results compared between those with:

* celiac disease that does not respond to a gluten-free diet (refractory celiac disease)
* celiac disease which is controlled by a gluten-free diet
* uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a gluten-free diet
* gluten-sensitivity
* disorders other than celiac disease.

The primary purpose of this study is to determine the effect of in-vitro introduction of gluten on inflammatory response primarily Interferon-γ and other cytokines, such as IL-15, IL-18 and IL-21, in cultures obtained from small intestinal mucosal biopsy samples of subjects who underwent upper endoscopy.

Secondary goals include comparing the inflammatory response to immunosuppressants and cytokines after exposing the cultures obtained from small intestinal mucosal biopsies taken from RCD I subjects with intestinal mucosal biopsies taken from subjects with CeD controlled on a Gluten-Free Diet (GFD), uncontrolled CeD, Gluten sensitivity and Non-celiac Controls.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* Undergoing a clinically indicated upper endoscopy

Exclusion Criteria:

* Anticoagulation or antiplatelet therapy
* Known active non-celiac intestinal inflammatory disorder
Home Based Peer Support Program for Mothers With Low Breastfeeding Self-efficacy

An online home-based breastfeeding peer support programme is proposed to support mothers who are giving birth to their first-born. This study aims to evaluate the effectiveness of this programme in improving breastfeeding practices among women with low breastfeeding self-efficacy. It is hypothesized that participants who received online home-based peer support will exclusively breastfeed for longer duration, have higher breastfeeding self-efficacy, and lower post-partum depression symptoms when compared to those receiving only standard care.

Primiparous mothers who plan to breastfeed but did not go on to breastfeed often face high levels of emotional and psychological challenges in their transition to parenthood. This can adversely affect their breastfeeding experiences and general well-being, and is associated with stress, anxiety, and postnatal depression. While family psycho-education and other supportive group programmes are available in health services, they require face-to-face education sessions over a long interval, high engagement, and trusting relationships, and thus often result in low attendance and high drop outs.

Mothers have expressed the need for psychological support of peer counsellors, which would allow them to support each other. The first month postpartum is a critical period for sustaining exclusive breastfeeding and the time when mothers are at high risk of postpartum depression. For Chinese mothers in Hong Kong, however, they are often housebound during this period due to the tradition of "doing the month", and thus often find it difficult to attend support groups or seek help. In view of these challenges and the pandemic wave faced by primiparous mothers, they are reluctant with home visits, therefore an online delivery of the home-based peer support programme is proposed.

This randomized control trial adopts a two-arm design to examine the effectiveness of an online home-based peer support programme for women with low breastfeeding self-efficacy. It is hypothesized that those receiving the intervention, when compared to the controls, will have (1) longer period of exclusive breastfeeding, (2) higher postnatal breastfeeding self-efficacy, and (3) lower post-partum depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous mothers
* Intend to breastfeed
* Have low breastfeeding self-efficacy (between 14 to 32)
* Have singleton pregnancy and live birth
* Have term infant (37-42 weeks gestational)
* Cantonese speaking
* Hong Kong resident
* Have no serious medical or obstetrical complications

Exclusion Criteria:

* Infant is \<37 week gestation
* Infant has Apgar score \<8 at five minutes
* Infant has birthweight \<2,500 grams
* Infant has any severe medical conditions or congenital malformations
* Infant is placed in the special care baby unit for more than 48 hours after birth
* Infant is placed in the neonatal intensive care unit at any time after birth
A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).The study includes blood sampling.


Eligibility Criteria:
Inclusion Criteria:

* Male aged 20-55 years (both inclusive) at the time of signing the informed consent.
* Both parents of Japanese descent.
* Body mass index between 20.0 kg/m\^2 and 24.9 kg/m\^2 (both inclusive).
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening.
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation within 14 days prior to the day of screening.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
The Effect of Music on Anxiety in Patients Prior to Gastrointestinal Procedures

This study investigated the effect of listening to self-selected music on anxiety and physiological responses in patients prior to gastroscopy. A randomized controlled trial was conducted, in which patients scheduled for gastroscopy in a medical center located in Taipei, Taiwan, were enrolled. The experimental group listened to self-selected music with earphones for 15 min before the procedure, whereas the control group rested for 15 min. Blood pressure (BP), heart rate, respiratory rate, and anxiety level were measured immediately before and after the intervention.

Potential study patients were referred from physicians. The research assistant described the study's purpose and procedure to the patients and explained their right to refuse or withdraw from the study without jeopardizing their procedure. In addition, the privacy of each patient's data was ensured by storing the data in a file that required a password to access. Personal identification was by no means included in the data file. In addition, the participants were assured that their data would not be used for purposes other than this research.

After obtaining their consent, the participants were randomly assigned into the music group or the control group by drawing lots. We brought the participants to a separate and quiet room in the waiting area to prevent environmental interference. First, the participants completed the study questionnaire; then, the research investigator measured their physiological parameters. The participants in the music group selected the music they preferred from different genres, namely Chinese pop, Taiwanese songs, western classical , light music, western pop, and nostalgic music. If a participant had no particular preference, music with a low tone, regular rhythm (approximately 60-80 beats per minute), and soft melody (light music, 5%) was used, as recommended by a previous study. During the 15-min intervention period before the gastroscopy procedure, the experimental group rested by listening to music and sitting on a comfortable chair, whereas the control group rested only by sitting on a comfortable chair. After the 15-min intervention, the patients' anxiety and physiological parameters were reassessed.

Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* able to respond to questionnaires in Chinese. were excluded from the study.

Exclusion Criteria:

* with hearing loss who did not wear hearing aids
* patients who were unable to communicate verbally
* patients diagnosed with dementia, mental illness defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, or cognitive impairment