cyrilzakka/clinical-trials huggingface dataset:
Diagnosis of Pelvic Endometriosis in MRI

Purpose： Evaluate the feasibility of R2 star multiple fast gradient recalled echo (R2\*MFGRE) imaging in the diagnosis of pelvic endometriosis.

One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2\*MFGRE imaging. Clinical diagnosis was pathologically confirmed one month after MRI examination. Three radiologists who were blinded to the pathological results evaluated the numbers of ovarian endometriomas (OMAs) and deep in-filtrating endometriosis (DIE) lesions using routine MRI and its combination with R2\*MFGRE. MRI changes of lesion size before and after estrogen therapy.

This prospective study was approved by the Ethics Committee of the local hos-pital, and informed consent was obtained from all the patients in this study (3701027061515). All procedures performed in studies involving human participants were in accordance with the ethical standards of our institutional and national re-search committee and with the Declaration of Helsinki.

Study population One hundred and Sixty-five patients with suspected endometriosis underwent pelvic MRI with R2\*MFGRE imaging from Decemberr 2017 to December 2023. Of those, One hundred and forty patients were submitted to surgical (either laparotomy or laparoscopy) treatment for endometriosis. The diagnosis was confirmed by pathology within one month after the initial MR exam. Additionally, 20 out of 160 patients were excluded from the study. Of these, 11 were due to non-surgical treatment, and the other 8 were due to prominent susceptibility artifacts caused by colonic overdistention, limiting the vis-ibility of the pelvis. Finally, One hundred patients were included in the study.

All 100 patients were aged ranging from 24 to 54 years, with an average age of 37.8 years. Their clinical symptoms included dysmenorrhea, bulging in the lower abdomen or anus, heavy menstrual bleeding, dyspareunia, and infertility. Some of these patients had multiple symptoms

Eligibility Criteria:
Inclusion Criteria:

* patients who proven endometriosis by pathology Patients who wish to be treated

Exclusion Criteria:

* Received any treatment (radiotherapy, chemotherapy, surgery or chemoradiotherapy) before undergoing imaging studies poor-quality MR images with any severe motion or artifacts
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM.

Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 18 to 75 years of age, inclusive.
2. Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).
3. Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, at screening and visit 3.

Exclusion Criteria:

1. Have type 1 diabetes mellitus.
2. Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range at screening.
4. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
5. Have serum calcitonin ≥20 ng/L at screening.
6. Fasted triglycerides \> 5.7 mmol/L at screening.
Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

The primary objective of this study is to evaluate the efficacy of Phenoptin™ (sapropterin dihydrochloride) in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria.


Eligibility Criteria:
Inclusion Criteria:

* 8 years of age and older
* Received at least 7 out of 8 scheduled doses in Study PKU 001
* Responsive to Phenoptin™ in Study PKU-001, defined as a reduction in blood Phenylalanine level of \>/=30% compared with baseline
* Blood Phenylalanine level \>/=450 μmol/L at screening
* Willing and able to provide written informed consent or, in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained
* Negative urine pregnancy test at screening (females of child-bearing potential)
* Male and Female subjects of childbearing potential (if sexually active) must be using acceptable birth control measures, as determined by the investigator, and willing to continue to use acceptable birth control measures while participating in the study
* Willing and able to comply with study procedures
* Willing to continue current diet unchanged while participating in the study

Exclusion Criteria:

* Perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable
* Use of any investigational agent other than Phenoptin™ within 30 days prior to screening, or requirement for any investigational agent or investigational vaccine prior to completion of all scheduled study assessments
* Pregnant or breastfeeding, or considering pregnancy
* ALT \>5 times the upper limit of normal (i.e., Grade 3 or higher based on World Health Organization Toxicity Criteria) at screening
* Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes, or organ transplantation recipient)
* Serious neuropsychiatric illness (e.g., major depression) not currently under medical management
* Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)
* Concurrent use of levodopa
* Clinical diagnosis of primary BH4 deficiency
Anesthesia and EEG Discontinuity in Infants

This study is a randomized controlled trial to evaluate whether EEG-guided calibration of inhalation agents can reduce occurrence of EEG discontinuity in infants during general anesthesia.

This is a study for comparison of incidence of EEG discontinuity during general anesthesia using sevoflurane. EEG guidance group will receive calibration of fraction of inhalational sevoflurane according to components of slow wave and delta wave of raw EEG. Control group will receive conventional management of anesthesia according to vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Infants who were born as full-term (\>37 weeks postconception) and are equal to or less than 12 month old who were scheduled to undergo surgery under general anesthesia using inhalation agents.
* Belongs to American Society of Anesthesiologists Physical Status 1 or 2

Exclusion Criteria:

* Infants who were born less than 37 weeks postconception or has history of mechanical ventilation immediately after birth
* Presence of any genetic disease, chromosomal anomaly or congenital anomaly that can affect brain development
* Presence of any disease or disability in central nervous system
* History of trauma at head or surgery on brain
* History of hypersensitivity to any anesthetic agents
* Status of sedation or endotracheal intubation before induction of anesthesia
* Inability to attach probes for EEG monitoring
* Expectation of operation time as less than 5 minutes
* Other conditions that researchers regard as inappropriate for enrollment
Diet Quality and Diabetes Risk in Overweight and Obese Adults

The goal of this observational study is to learn about the relationship between diabetes risk with sociodemographic characteristics, lifestyle and diet quality in overweight and obese individuals. The main question it aims to answer is:

Is there a relationship between diabetes risk and diet quality in overweight and obese individuals?

Participants who are overweight and obese will answer survey questions about sociodemographic characteristics and lifestyle behaviors. 24 hour dietary recalls will be taken to evaluate diet quality. FINDRISC questionnaire will be applied to assess diabetes risk.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥25 kg/m²

Exclusion Criteria:

* Diabetes mellitus
* Psychiatric disorders
* Pregnant and lactating
Metabolic Syndrome and Gen-polymorphs Influence on Weightloss Among Children in Treatment for Overweight

Definition:

the overall objective is to examine childhood obesity with focus on NAFLD and its treatment. Further, we aimed to investigate the impact of genetic variation on obesity.

The specific aims are to;

* describe the degree of NAFLD among overweight and obese, Danish children. (hypothesis; the degree for pediatric NAFLD among Danish Children was equal that found in other Caucasian paediatric study populations).
* investigate the effect of a multidisciplinary intervention treatment of 1 year on liver fat content.

(hypothesis; the intervention could reduce the liver fat percentage and a reduction in BMI SDS would associate with a reduction in liver fat content) - Analyze changes in liver fat content in relation to changes in levels of fasting blood variables to see if any of them could be used as a clinical tool for monitoring hepatic steatosis in the clinic.

(hypothesis; serum aminotransferases (separately and their ratio, respectively), serum insulin, and HOMA-IR could predict improvement in liver fat content

- Investigate the association between genetic variants and obesity.


Eligibility Criteria:
Inclusion Criteria:

* 5- 20 Years old.
* Adipose. BMI \> 90 % percentile
* New patient in the Children's Obesity Clinic, Paediatric Department, University Hospital Holbaek,Region Zealand, Denmark
* Informed Consent

Exclusion Criteria:

* Drop-outs
0.15 mg Spinal Morphine vs. no Treatment for Morphine Requirement After VATs.

Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 year or over
* Patient ASA physical status I-III.
* Scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion
* Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

* Known hypersensitivity to morphine
* History of bleeding tendency.
* Known case of infection at the back
* Patient refuse for spinal anesthesia
* History of cerebrovascular disease.
* Need mechanical ventilatory support during postoperative period
99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

99mTc-ABH2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-ABH2 SPECT/CT in the detection of HER2-positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-ABH2 SPECT/CT in stratifying breast cancer.

Eligibility Criteria:
Inclusion Criteria:

Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female

Exclusion Criteria:

Pregnancy Breastfeeding Renal function: serum creatinine \> 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance
AD109 Dose Finding in Mild to Moderate OSA

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.

Eligibility Criteria:
Inclusion Criteria:

* AHI between 5 and 20 events/h
* PGI-S equal to or higher than 1, or one or more of the following symptoms:

  * Snoring or nightime gasping/choking
  * Daytime sleepiness, fatigue or decreased concentration
  * Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
  * Irritability, decreased mood or libido

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
* CPAP should not be used for at least 2 weeks prior to the study
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
Smoking Cessation Intervention Development for Homeless Youth

This trial develops a contextually tailored and optimized smoking cessation intervention and studies smoking motivations and motivations to quit smoking in homeless youth. Identifying motivations for smoking and motivations to quit smoking may help researchers build a program to help homeless young people quit smoking cigarettes if desired.

PRIMARY OBJECTIVES:

I. Establish a theoretical framework for cessation among homeless youth incorporating phase-specific capabilities and opportunities impacting motivation to engage in cessation. (Multiphase Optimization STrategy \[MOST\] Step 1) II. Guided by the theoretical framework for cessation among homeless youth, identify a set of cessation intervention components and assess their implementation feasibility. (MOST Step 2)

OUTLINE:

MOST STEP Ia: Participants attend a semi-structured interview over 60 minutes to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

MOST STEP Ib: Participants complete a survey to help establish theoretical model of contextually tailored smoking cessation for homeless youth.

MOST STEP II (FOCUS GROUPS): Participants attend focus groups to help identify a set of cessation intervention components for homeless youth and determine component acceptability and feasibility.

MOST STEP II (FEASIBILITY STUDY): Intervention components are identified and selected from Focus Groups. Participants take part in a study to assess these components for feasibility in implementing in coordination with homeless youth services, as well as determining main effect estimates for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Youth who report having smoked some or every day in the past week.
* Youth who meet criteria for homelessness defined by the 2002 McKinney-Vento Act including those who lack a fixed, regular, and adequate nighttime residence; live in a welfare hotel, or place without regular sleeping accommodations; or live in a shared residence with other persons due to the loss of one's housing or economic hardship.
Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry

The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice. Also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

All consecutive patients suitable for treatment with DES according to hospital routine practice in centres across the world that agree to participate in the e-ULTIMASTER registry will be treated with Ultimaster DES.

Secondary objectives Evaluation of worldwide utilization of DES, Detection of rare events in representative patient population, identification of predictors of major advers events, assessment of radial access site utilization and its impact on bleeding and vascular complications, assessment of procedural particularities and patients pathology in wide geographic area, assessment of duration and type of DAPT, assesment of the performace of Ultimaster DES is patients lesions subsets, assessment of possible benefits of biodegradable polymer in lager complex patiets/lesions subset and assessment of sirolimus efficacy in different races.

Data will be collected in a e-CRF and online monitoring will be done. Audits will be allowed by sponsor or qualified designees.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* eligible for percutaneous coronary intervention using DES (and RVD matches available Ultimaster DES sizes)
* informed about the nature of the study and agreess to its provisionss and has provided written informed consent as approved by the Institutional Review Board / Ethics committee of the respective clinical site, wherever such requirement exists.

Exclusion Criteria:

* following instruction for use
Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.

Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion.

Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced.

Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24 hours.

In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a visual analogue score. Vomiting was registered.

Eligibility Criteria:
Inclusion Criteria:

* Females younger than 50 years
* ASA I-II
* Scheduled to gynaecological laparotomies or laparoscopies

Exclusion Criteria:

* Medication known to act anti-emetic
* ASA status greater than II
* Malignant hyperthermia
* Allergy to the drugs used.
Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

To assess the efficacy of treatment with sitagliptin or dapagliflozin or lobeglitazone in type 2 diabetes mellitus patients, who had inadequate glycemic control even though use of two drug combination therapy with glimepiride and metformin.

Dual combination therapy with metformin and sulphonylurea is the most commonly used combination regimen to treat patients with type 2 diabetes. But, treatment with the dual combination therapy is often unsuccessful at achieving glycaemic control in patients with type 2 diabetes.

Recently, various oral hypoglycemic agents were developed including dipeptidyl peptidase (DPP)-IV inhibitor, sodium-glucose cotransporter 2 (SGLT2) inhibitor and new peroxisome proliferator-activated receptors (PPARs) agonists.

But, there have been few studies about the glucose lowering effect of these drugs in Type 2 diabetes patients on the dual combination therapy with a sulfonylurea agent and metformin.

Hence, the researchers plan to investigate the efficacy and safety of these drugs in combination with a sulfonylurea agent and metformin in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* 20 ≤ Age \< 80 years
* HbA1c ≥ 7 %
* combination therapy with glimepiride and metformin over 2 months.
* dosage of glimepiride : 1-8mg/day
* dosage of metformin : 500-2550mg/day

Exclusion Criteria:

* Type 1 diabetes, gestational diabetes, or secondary forms of diabetes
* Contraindication to sitagliptin or dapagliflozin or lobeglitazone
* Pregnant or breast feeding women
* Medication which affect glycemic control (ex. steroid)
* Disease which affect efficacy and safety of drugs
* Any major illness (Liver disease, Renal failure, Heart disease, Cancer, etc)
* Not appropriate for oral antidiabetic agent
The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )

The investigators planned to investigate the effect of close monitoring on compliance and the factors affecting compliance among patients receiving PAP treatment due to OSA.This study was a single-center, prospective, randomized, controlled study approved by the hospital's ethics committee.One hundred twenty-eight patients were randomized as group one or two as group 1 is the study and group 2 is the control group. The first group was called by phone on the 15th day to ask if there were any complaints or problems with the device. Sequentially, they were called for controls at the end of the first, third, and sixth months.

The second group was accepted as the control group, following our clinic's standard procedure in the first and sixth months. The patients who came to the control were asked if there were any problems with the device and any difficulties in use, and they were again informed about the devices and masks.


Eligibility Criteria:
Inclusion Criteria:, .newly diagnosed OSA with PSG , and underwent PAP titration

Exclusion Criteria:

. unfollowed patients
Age-related Differences in Response to Pituitary Stimulation Tests

The purpose of this study to age-related differences to the response of a combined pituitary stimulation test with TRH, LHRH and ACTH.

Participants will be recruited in three different age intervals: 18-45 years, 55-80 years and 80+ years. These participants will all undergo the same stimulation test with 0.1 mg LHRH, 0.2 mg TRH, and 0.25 mg ACTH (Synachten). The tests will be perfomed at the same time of day for all particpants (between 08:15 and 08:45) and participants will be fasting for the test. Blood samples will be taken just before and at 10, 20, 30, 45, 60, 90 and 120 minutes following the stimulation test. Serum from blood samples will be stored at -20 degrees until analysis.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18-45 or above 55.
* Healthy Volunteers

Exclusion Criteria:

* Medication or conditions affecting pituitary response (such as hormonal birth control, steriod use, thyroid disorders)
* Pregnancy or birth within the last year
* inability to give informed consent