cyrilzakka/clinical-trials huggingface dataset:
The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum

In the research planned as a randomized controlled study, the experimental groups will be administered routine hyperemesis gravidarum (HG) treatment as well as chewing mint-flavored gum, while the control group will only receive routine HG treatment and no intervention will be performed. This study aims to contribute to the literature by investigating the effect of chewing mint-flavored gum on the severity of nausea and vomiting, coping with stress, and anxiety levels due to hyperemesis gravidarum in pregnant women.

The data of the research will be collected after the necessary institutional permission and ethics committee approval have been obtained. Women who meet the inclusion criteria for the study will be informed about the method to be followed in the research. Those who want to participate in the research will read and sign the volunteer information form.

1. Intervention Group In data collection, pregnant women will sign an informed consent form before the application. Personal Information Form, VAS Scale, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale will be filled out. In addition to the routine treatment plan, the application will begin at least 4 hours after the antiemetic application (Gökbulut, 2021). The application will continue by chewing mint-flavored gum twice a day for at least 15 minutes for 3 days. The VAS scale will be filled after the morning chewing application, and the VAS Scale, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale will be filled in after the evening application. The forms of patients discharged during this period will be filled in via phone.
2. Control Group In data collection, pregnant women will sign an informed consent form before the application. At least 4 hours after the antiemetic application (Gökbulut, 2021), the Personal Information Form, VAS Scale, PUQE Scale and Stress Coping Styles Scale and State Anxiety Scale will be filled out. Routine treatment and nursing care will be applied to the control group, and no intervention will be performed. 1. After the forms are applied, the forms will continue to be filled for 3 days: VAS Scale in the morning, VAS Scale in the evening, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale. The forms of discharged patients will be filled in via phone.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 18 and over
* At least primary school graduate
* The one who is married
* Pregnant women who are younger than 16 weeks of gestation and diagnosed with hyperemesis
* Those who agreed to participate in the study

Exclusion Criteria:

* Those with a history of chronic disease
* Having a health problem that may cause nausea and vomiting in the current pregnancy
* Those who are allergic to mint
Dose Sparing Intradermal S-OIV H1N1 Influenza Vaccination Device

Primary objective: To evaluate the safety and immunogenicity of low-dose ID S-OIV H1N1 vaccines delivered via a novel microneedle device (MicronJet600) and compare this to the full-dose standard IM injection.

Hypothesis: Low dose (20%) intradermal (ID) S-OIV H1N1 vaccine delivered via a novel microneedle device (MicronJet600) is equally effective as full-dose standard intramuscular (IM) vaccine.

This is a prospective randomised, single-blinded trial in Queen Mary Hospital. We aim to recruit 200 subjects \[with a minimum of 80 subjects per age group (21-65 with chronic diseases and age 65+)\] who would be qualified for the Hospital Authority (HA)/ Centre for Health Protection (CHP) Mass Vaccination Program for S-OIV H1N1. These patients include all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness. Subjects will be randomly assigned to receive either the full-dose (1 dose) standard Panenza vaccine at day 0 (15ug non-adjuvanted monovalent influenza A(H1N1) 2009 vaccine) delivered intramuscularly using a conventional needle (IM group) or a low-dose (1 dose) intradermal injection of Panenza vaccine at day 0 (3ug non-adjuvanted monovalent influenza A(H1N1) 2009 vaccine) delivered with the MicronJet600 (ID group).

Eligibility Criteria:
Inclusion Criteria:

* All participants qualified for the HA/ CHP Mass Vaccination Program for S-OIV H1N1 as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above with chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure.
* All patients give written informed consent.
* Subjects must be available to complete the study and comply with study procedures.
* Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.

Exclusion Criteria:

* Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers.
* Inability to comprehend and to follow all required study procedures.
* History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
* Have received an S-OIV H1N1 vaccination.
* Have a recent (starting May 2009) history (documented, confirmed or suspected) of a flu-like disease).
* Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients.
* Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
* Female of childbearing potential, not using any acceptable contraceptive methods for at least 2 months prior to study entry or that do not plan to use acceptable birth control.
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer

The experimental design is exploratory, single-arm, multi-center, real-world research.

Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC

1. Efficacy and safety;
2. The relationship between molecular mechanism and curative effect;
3. Ensatinib resistance mechanism;

Enrolled patients:

1. stage IIIB or stage IV NSCLC
2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
3. Without any ALK-TKI treatment; Study endpoint

Primary endpoint:

According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;

Secondary endpoint:

According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;

Exploratory endpoint:

The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;

The sample size is determined:

The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:

Eligibility Criteria:
Inclusion Criteria:

1. stage IIIB or stage IV NSCLC by histology or cytology;
2. All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
3. Without any ALK-TKI treatment;
4. Voluntarily and capable of following the trial and follow-up procedures;
5. Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.

Exclusion Criteria:

* 1. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment.

Had a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100mmHg).

6. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.

7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.
Internet-based Cognitive Behavior Therapy for Insomnia for Parents Who Have Lost a Child

The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to evaluate changes in symptoms of complicated grief and depression.


Eligibility Criteria:
Inclusion Criteria:

* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-5
* Enough Swedish language skills

Exclusion Criteria:

* Other sleep disorders that require other treatment (e.g. sleep apnea)
* Somatic or psychiatric conditions requiring acute care
A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants

This study will look at how a single dose of abemaciclib will impact the body's ability to get rid of two other drugs, metformin and iohexol. In addition, this study will evaluate the effect of a single dose of abemaciclib on kidney function by measuring blood and urine markers. Side effects will also be documented.

Each participant will complete four study periods. During each study period, participants will stay in the clinical research unit for nine days and eight nights.

The study will last approximately 10 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Healthy surgically sterile or postmenopausal females and sterile males
* Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m²), inclusive at screening

Exclusion Criteria:

* Have known allergies to abemaciclib, metformin, iodine, iohexol, related compounds, or any components of the formulation
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence and/or positive antibodies of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes

The purpose of the study is to assess the effectiveness of motivational interviewing in promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the completion of a structured exercise program.

Participants with T2D who are new graduates of a supervised exercise program will be randomly assigned to either standard care (SC) or to standard care and in addition, participate in two individual motivational interview (MI) sessions (SC + MI).

The primary outcome will be change in physical activity behavior assessed by the Godin Leisure and Exercise questionnaire. Secondary outcomes will include change in blood glucose control (A1C), BMI, six minute walk-test, QoL, and self-efficacy.

Outcomes will be measured in groups at baseline, end of program, 3 months and 6 months post-program.


Eligibility Criteria:
Inclusion Criteria:

* a) self-reported physician diagnosed T2D, included are those who are treated with diet alone, oral medication and insulin
* b) clearance by Living Well clinical staff to exercise through GXT algorithm and triaged to "Keep Going" level class,
* c) at least 18 years of age,
* d) ability to read and write in English.

Exclusion Criteria:

* a) insulin therapy that began less than 2 years after T2D diagnosis,
* b) changes during the previous 2 months in oral hypoglycemic
Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

This study is an international multicenter, pilot randomized, assessor-blind, controlled trial, which is aimed to preliminarily investigate the efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome (PCOS).

A total of 60 subjects will be recruited and randomly allocated into experimental or control group with 30 subjects respectively. The subjects in experimental group will receive a standardized acupuncture treatment plus usual care, whereas the ones in control group will be managed only with usual care.

Eligibility Criteria:
Inclusion Criteria:

* Oligomenorrhea (menstrual cycle\> 35 days or less than 8 cycles per year) plus at least one of the following two criteria; hyperandrogenism (clinical, biochemical, or both) and/or polycystic ovarian morphologic features \[12 or more antral follicles (2 to 9 mm in diameter) in either ovary, an ovarian volume that is greater than 10 ml in either ovary, or both\]
* 20-40 years of age
* Voluntary agreement to participate in this trial

Exclusion Criteria:

* Pregnancy, labor or breastfeeding within the past 3 months
* Intake of oral contraceptive or ovulation inducing agent within the past 3 months
* Severe oligomenorrhea with menstrual period over 3 months
* Menstruation during more than 8 days
* Premature ovarian failure
* Resistant thyroid disease, Cushing's disease, congenital adrenal hyperplasia, or hyperprolactinemia
* Ovarian tumor or adrenal tumor that cause hyperandrogenemia
* Hemorrhagic disease
* Severe cardiac, pulmonary, hepatic, or renal diseases, central nervous system disorders, or intake of psychoactive drug
* Acupuncture treatment within the past one month
* Participation in other clinical trial within the past 3 months
* Other conditions judged to be inappropriate for the clinical study by the investigators
Insulin Resistance and Resisted Exercise Post Burn

The main objective of the present study is to assess the effect of the resisted exercise on insulin resistance post burn.

A burn injury represents the fourth most common type of trauma globally, though it is associated with the most devastating consequences. Severe burn injuries, encompassing 20% of the total body surface area (TBSA) in adults, present a unique challenge compared with other forms of trauma given the magnitude and persistence of systemic deregulation. Indeed, an extensive inflammatory response develops immediately following a severe burn to promote wound healing. This period, known as the "ebb" phase, is comparable with a fight-or-flight response and lasts for the first 72-96 h post injury .

Moreover, burn-induced muscle catabolism places a significant burden on the recovery process, as a 10%-30% loss impairs immune responses and delays wound healing, thereby increasing the risk of infection, and a 40% loss becomes fatal. Despite a mountainous effort to prevent muscle catabolism and wasting. Therefore, a better understanding of the pathophysiology and consequences of burn-induced skeletal muscle wasting is pivotal to alleviating hyper metabolism and reducing morbidity and mortality patients with severe burns .

Hence, extensive burn injury produce clinical syndromes characterized in part by "insulin resistance, it is unclear if these insulin resistant states are identical. To test if the maximal biological effectiveness of insulin is altered in burned patients

Eligibility Criteria:
Inclusion Criteria:

* Patients ranged from 18-35 years of age.
* Patients has waist hip ratio around 0.8 in female and 0.95 in male.
* Patient has body mass index (BMI around 25 kg/m2) (J Obes Weight Loss Ther ,2015).
* Patients has second degree thermal burn injury (superficial and deep partial thickness).
* Patients with around (20% - 40%) of total body surface area (TBSA) burned.
* Patients who are able to follow verbal commands.
* Patients will have upper limb and trunk burn.
* Patients with normal hemoglobin A1C (5.6 %).
* Patients should take diet rich protein, omega 3 and should have good sleep.
* Patients passed two months post severe burns

Exclusion Criteria:

* - Potential participants were excluded if they reported a leg amputation, anoxic brain injury, psychological disorders, quadriplegia, or severe behavior or cognitive disorders history of heart disease, stroke, diabetes mellitus, or any condition that would prevent them from engaging in an exercise study.
* Patients with liver disease, pancreatic disease or any disease affects metabolism.
* If they were already engaging in 2 or more planned exercise sessions per week.
* Patients with any medication to lower glucose levels. Blood pressure and medications to lower lipid levels
Onset Time of Thiopental Versus Propofol in the Elderly

This study is aimed at increasing the safety of the use of anaesthesia in an elderly population (\> 60 years). Patients with decreased physiological reserve, including all elderly patients, have an increased risk of getting an erroneous induction bolus. This project will investigate how fast elderly patients (\> 60 years) fall asleep during bolus induction of anaesthesia with two of the most used hypnotics, thiopental and propofol, evaluated with BIS-monitoring and clinical signs of anaesthetic depth. The hemodynamic response will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgical patients above 60 years of age, with an indication of general anaesthesia during surgery.
* Informed consent.
* The patient must be legally competent.
* The patient must be able to read and understand Danish.

Exclusion Criteria:

* Known allergic reactions to thiopental, propofol, lidocaine or alfentanil
* "Body Mass Index" (BMI) \<18 and \> 35.
* NYHA-class \> 2.
PERFECT Project - Part 2 - Study 3

The objectives are to test the acute effects of different bagels containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. We hypothesize that consumption of bagels containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. We also hypothesize that consumption of bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.


Eligibility Criteria:
* Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
* BMI of 18.5-29.9 kg/m2

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity)
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
* Those unable to walk for an hour continuously
A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules

The purpose of this study is to actively monitor patients with multiple pulmonary Ground-glass Nodules (GGNs), in order to provide evidence for multiple GGNs treatment.

Multiple pulmonary GGNs are very commonly identified particularly as increasing numbers of CT scans are performed as part of routine lung cancer screening. At the same time, the ideal solution for these cases continues to be debated. This aim of this study is to learn more about the effects of multiple factors on outcome of multiple pulmonary GGNs, such as patients' clinical characteristics, CT features and different pathological types. Furthermore, the optimal timing of surgery and the effect of different surgical choices on the prognosis of patients with multiple GGNs will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Have two or more GGNs on CT imaging
3. Diameter of GGNs \> 5mm and ≤ 3cm
4. GGNs must be greater than half ground glass

Exclusion Criteria:

1. patients who have a history of lung cancer
2. patients who have undergone chemotherapy, radiotherapy or targeted therapy before surgery
3. pregnant women
Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion

This study is the international multicenter registry for drug-coated balloon treatment for de novo coronary lesion.

There is lots of evidence that DCBs result in lower rates of restenosis, thrombosis, and better long-term outcomes when used for PCI of in-stent restenosis (ISR) compared to plain old balloon angioplasty (POBA) or additional stenting with drug-eluting stent (DES). DCB-only approach studies for de novo coronary lesion cases are scarce, but a recent registry data suggested it was a feasible and well-tolerated treatment method if the pre-dilation result is good. Therefore, the aim of this study was to evaluate the safety and efficacy in terms of angiographic and clinical outcomes of a DCB-only approach for de novo coronary lesions.

Eligibility Criteria:
Inclusion Criteria:

- de novo coronary artery disease

Exclusion Criteria:

* unstable hemodynamics at presentation
* life expectancy \<1 year
Exploratory Study of Raised Serum Lactate as a Marker of Necrotizing Fasciitis

The investigators examined the hypothesis that serum lactate is raised in early necrotizing fasciitis to a much greater extent than in other differential diagnoses, such as severe cellulitis, and therefore provides a diagnostic indicator.

A prospective comparison of serum lactate levels at referral to the Plastic Surgery team to the 'gold standard' test of histology at initial surgical debridement, looking at 53 consecutive patients referred with suspected necrotizing fasciitis to a single surgeon at one institution between 2000 and 2010.

Eligibility Criteria:
Inclusion Criteria:

* Referral to one consultant (Mr A Armstrong) at one institution (Wexham Park Hospital) with a suspected diagnosis of necrotizing fasciitis between September 2000 and September 2010

Exclusion Criteria:

* Nil