cyrilzakka/clinical-trials huggingface dataset:
Mapping Health-related Quality of Life in Pregnant Women With Thyroid Disease.

Natural thyroid function changes during pregnancy. In up to tens of percent of pregnant women, these changes can lead to pathological fluctuations in hormone and antibody production. Although the effects on pregnancy and child development are well described, none has determined their influence on mother's emotional well-being and the quality of life.

At present, universal thyroid screening in pregnancy in the Czech Republic is not covered by health insurance. The aim of the project is to change this situation by providing quality of life estimate for the cost-effectiveness model.

This is a project of three specialized institutions aimed at mapping various aspects of the quality of life of pregnant women and describing the impact of thyroid disease on their lives. The project is a parallel study to a larger project Early screening for thyreopathy in pregnancy (CZ.03.2.63/0.0/0.0/15_039/0009643) supported by the European Fund Operational Programme Employment through the National screening centre. The data will be collected through online questionnaire from women enrolled in the Early screening for thyreopathy in pregnancy (CZ.03.2.63/0.0/0.0/15_039/0009643) who were screened for TSH, TPOAb and FT4.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* screened for laboratory signs of thyreopathy anytime during pregnancy
* willing/able to participate in online survey

Exclusion Criteria:

* women whose laboratory results were not available or inconclusive
* already participated in this survey by filling the online questionnaire
* not able to complete the entire questionnaire
The Effects of Mindfulness Meditation on Sleep Quality and Perceived Stress

Higher education students 18 years or older will participate in 8- virtual mindfulness meditation sessions over 3 to 4 weeks (minimum of 3 sessions per week). Each session will be 30 minutes long, 15 minutes for guided mindfulness meditation run by researchers, followed by a short discussion period to understand mindfulness meditation better. Before starting the mindfulness meditation session, baseline data will be collected.

Sleep consider a restorative occupation that affects other daily activities, such as academic performance. Mindfulness meditation may improve sleep quality and decrease perceived stress in higher education students. There is limited research on virtual mindfulness meditation involving sleep quality and perceived stress in higher education students. The researchers will measure changes in sleep quality and perceived stress after participants completed 8- virtual mindfulness meditation sessions using PSQI, PSS, and the Fitbit Inspire 2™.

Eligibility Criteria:
Inclusion Criteria:

* Must be a student at the University of the Sciences
* 18 years or older and fluent in English
* Students must have access to a device with internet connection and Zoom capabilities
* Students must have a smartphone to download the Fitbit®: Health \& Wellness application.

Exclusion Criteria:

* Students who do not attend the University of the Sciences
* Students do not have access to an internet connection and an electronic device
* Students do not comprehend and speak English
* Students under the age of 18 years old
Facioscapulohumeral Dystrophy in Children

This study will focus on the symptoms, natural history and clinical impact of facioscapulohumeral muscular dystrophy (FSHD) in children.

Symptoms of classical FSHD start in adulthood. However, a small subgroup of FSHD patients have an early, childhood onset. This early onset is associated with faster progression and other symptoms like hearing loss and epilepsy.

The symptoms, natural history and clinical impact of FSHD in children are largely unknown.

The results of this study will be vital for adequate symptomatic management and trial-readiness.

FSHD is a hereditary muscle disease with slowly progressive muscle weakness. In children it is a very heterogenic disease ranging from severely affected infants to mildly affected adolescents. Symptoms can include muscle weakness, pain, fatigue, epilepsy, hearing loss, vision loss, mental retardation and spinal deformities. The prevalence of these symptoms and the adequate follow-up of these symptoms is unknown. Moreover the clinical impact and social functioning of children with FSHD is under exposed.

Therefore this study will focus on the total spectrum of FSHD in children.

In addition, an extensive genetic screening will be conducted, searching for (epi)genetic disease modifiers and severity predictors.

Eligibility Criteria:
Inclusion Criteria:

* aged 0-17 years
* symptoms of facial, scapulohumeral or peroneal weakness
* genetically proven FSHD1 or FSHD2
* living in the Netherlands

Exclusion Criteria:

* no informed consent
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Breast Surgery

Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* 25-70 years of agge
* ASA I-II
* Undergoing elective breast cancer surgery

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs
Palatability and Postprandial Sensations

Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical composition (350 Kcal) and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability will be studied on a cross over-design. The responses to the meals will be tested on 2 different days.

Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility Criteria:
Inclusion Criteria:

* non obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria

This is a multicenter, single-arm, open-label study to characterize long-term safety and tolerability of MY008211A tablets and to provide access to MY008211A tablets to patients with PNH who have completed Phase 2 or 3 studies with MY008211A tablets.

The purpose of this open-label, single arm, multicenter study is to evaluate the long-term safety, tolerability and efficacy of MY008211A tablets in patients with PNH and to provide access to patients who have completed (without tapering down) Phase 2 and Phase 3 trials and derived benefit from MY008211A treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have previously received and completed MY008211A study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of MY008211A.
2. Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections.

Exclusion Criteria:

1. History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus.
2. Known or suspected hereditary complement deficiency.
3. Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data.
A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache

The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a history of migraine of at least 1 year prior to enrollment.
* Migraine onset prior to age 50.

Exclusion Criteria:

* Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
* Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
* History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.
* Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.
* Failure to respond to more than two adequately dosed effective migraine prevention treatments.
* Evidence of significant active psychiatric disease, in the opinion of the investigator.
* Women who are pregnant or nursing.
Safety Study of Second Intraperitoneal (I.P.) Infusion Cycle of Catumaxomab in Patients With Malignant Ascites

This phase II single arm, open-label study investigate the safety of a second cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study.

Up to 30 evaluable patients from the CASIMAS study will be enrolled. Catumaxomab will be infused intraperitoneally with 3hour constant-rate infusions 4 times within 11 days with ascending dosages (10 - 20 - 50 - 150 µg).

Eligibility Criteria:
Inclusion Criteria:

* patients who have completed 4 infusions of catumaxomab in the CASIMAS study
* age \>= 18 years
* Karnofsky index \>= 60 %
* patients with malignant ascites requiring their first therapeutic ascites paracentesis after at least 60days following last catumaxomab infusion in the CASIMAS study
* Patients where standard therapy is either not available or no longer feasible

Exclusion Criteria:

* acute or chronic infection
* concomitant treatment with investigational products other than catumaxomab, cancer, chemo- or radiotherapy
* previous treatment with entirely murine monoclonal antibodies other than catumaxomab
* liver metastases with volume \>70 % of liver metastasized tissue
Safety and Effectiveness of Regorafenib

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice
Patient-centered Breast Cancer Teleprehabilitation

Surgery, the cornerstone of most cancer treatments, is associated with considerable postoperative complications. Adjusting patients' health behavior before surgery may have beneficial effects on postoperative outcomes.

Women (n=50) who will undergo breast surgery because of stage I-III breast cancer are eligible. All participants will receive multimodal patient-centered teleprehabilitation comprising of motivational interviewing, education, exercise therapy, and stress management.

Feasibility, participation rate, patient satisfaction, intervention safety, and treatment adherence will be monitored as primary outcomes. Fatigue, pain, quality of life (QoL), physical activity levels, perceived injustice, self-efficacy, and healthcare use are secondary outcomes and will be assessed by self-reported questionnaires at baseline, 0-, 2-, and 6 months post-intervention.

Proof of concept for using telecommunication and exercise therapy in prehabilitation prior to breast cancer surgery is available. We expect the proposed intervention to be feasible and effective at reducing fatigue, pain, perceived injustice, and healthcare use, and at improving treatment adherence, QoL, physical activity levels, and self-efficacy.

Effective prehabilitation interventions can reduce the long-term symptoms that arise/persist beyond treatment completion, improving patients' QoL. By using telecommunication technologies, socio-economic barriers can be reduced, making care accessible to all.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Scheduled for primary breast surgery because of stage I-III breast cancer
* Able to speak and read Dutch fluently

Exclusion Criteria:

* Stage IV breast cancer
* A medical contra-indication for physical activity
* Not being able to access a computer or mobile device at home
Efficacy and Safety of CO2 vs Room Air Insufflation During ESD for Gastric Tumor

Insufflation is essential procedure to observe the lumen of gastrointestinal tract in gastroscopy or colonoscopy Currently, most of hospital in Korea are using room air for insufflation According to recent clinical studies have shown that carbon dioxide have better safe and reduce stomachache than room air when endoscopy and endoscopic procedure is performed.

However, there was still no research data or study in Korea. In this study, the investigators will try to make comparison between Carbon dioxide and room air insufflation for endoscopic submucosal dissection for Gastric Tumor and investigate the efficacy and safety


Eligibility Criteria:
Inclusion Criteria:

* Patients who have gastroscopy and colonoscopy or ESD for gastric tumor under sedation in department of gastroenterology, Gachon University Gil Medical Center

Exclusion Criteria:

* Age : \< 19 years old
* Underlying disease : COPD requiring O2
* Known CO2 retention
* Opiate abuse for chronic pain
* Nonreader or short in understanding
* Pregnancy
* Any medical instabilities expected to not be in safe
Effects of Iloprost on Pulmonary Oxygenation in Obese Patients During One-lung Ventilation

One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. In this prospective, randomized, double blind study, the investigator is planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc) in obese patients.


Eligibility Criteria:
Inclusion Criteria:

1. scheduled for VATS lobectomy
2. 40 \< age \< 80
3. American Society of Anaesthesiologists(ASA) physical status classification I\~III
4. BMI \> 30 kg /m2

Exclusion Criteria:

1. American Society of Anaesthesiologists(ASA) physical status classification IV or more
2. NYHA class III\~IV
3. Severe obstructive lung disease and/or restrictive lung disease patients
4. patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
5. arrhythmia
6. pregnant women
7. pulmonary edema or pulmonary arterial hypertension
8. cerebrovascular disease
9. unstable angina or myocardial infarction within 6 months
10. patients with allergic reaction at iloprost
A Study of JMKX003948 Tablets in Patients With Renal Cell Carcinoma

This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Has the ability to understand and willingness to sign a written informed consent form.
2. Male or female from 18 years of age or older.
3. Histologically confirmed locally advanced or metastasis clear cell renal cell carcinoma.
4. Has at least one measurable lesion per RECIST v1.1.
5. Has a life expectancy of ≥ 12 weeks.
6. Adequate organ function.

Exclusion Criteria:

1. Patients with known active CNS metastases and/or cancerous meningitis.
2. Has received any type of systemic anticancer monoclonal antibodies or other immunosuppressants within 4 weeks prior to the first dose. Has received prior chemotherapy, targeted therapy, or other investigational therapy within 2 weeks prior to the first dose.
3. Has failed to recover from a ≥ grade 2 adverse event due to prior anti-tumor therapy.
4. Has impaired heart function,or clinically significant cerebrovascular and cardiovascular disease.
5. Subjects with dysphagia or known drug absorption disorders.
6. Has a history of any other malignancy within 5 years.
7. Has severe oncological complications.
8. Is currently participating in other clinical studies.
9. Subjects with be unsuitable for participation in the trial evaluated by investigator.
A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors

This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years at the time of signing informed consent form
* Measurable disease per RECIST 1.1
* Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography.
* ECOG Performance status of 0 or 1
* Life expectancy of at least 3 months
* Adequate organ and marrow function
* Contraception during study participation, as applicable

Exclusion Criteria:

* Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose.
* Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose.
* Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose.
* Treatment with another IL-18 therapy.
* Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed.
* Certain clinically significant intercurrent disease.
* Primary immune deficiency.
* Active untreated brain or spine metastasis or leptomeningeal metastases.
* Known HIV seroposivitiy, although patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted.
* Active hepatitis A or acute or chroming hepatitis B or C infection.
* Received a live virus vaccine within 30 days of enrollment or a COVD vaccine within 14 days.
Immunological Markers Screening for Colorectal Cancer

Colorectal cancer incidence is increasing at an alarming rate in China. Recent reports concluded aberrant immunological function was associated with colorectal cancer outcome, however, the influence of immunocyte subgroup and immunologic factors on cancer outcome in colorectal cancer survivors is largely unknown.The investigators will explore the impact of immunocyte subgroup and immunologic factors on colorectal cancer disease-specific, disease-free and overall survival. The investigators will recruit approximately 5,000 patients as a prospective study cohort. During follow up, the investigators will explore the association of these factors with outcome of patients. The investigators believe that this project will improve the understanding of the impact of immunocyte subgroup and immunologic factors on colorectal cancer outcome.


Eligibility Criteria:
Inclusion Criteria:

Patient must have a histologically proven adenocarcinoma of colon or rectum cancer.

* Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
* Patients must have recovered from any effects of surgery.
* Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
* Patients must provide a signed consent to participate in the study.
* Patients must complete all questionnaires.

Exclusion Criteria:

Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.

* History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
* Unresolved bacterial infection requiring treatment with antibiotics.
* Pregnant or lactating women may not participate in the study.
* Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
* Gilbert's disease.
* Other serious concurrent infection
* Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Danish Carvedilol Study in Portal Hypertension

Patients with large esophageal varices who have not yet experienced bleeding, are normally treated with propranolol, a beta blocking agent that reduces the portal pressure and thereby diminish the risk of bleeding. 20-40% of the patients do not respond to this treatment or have to discontinue the treatment because of side effects. The aim of this study is to evaluate if carvedilol (a combined alfa -beta blocker) has better efficacy and safety than propranolol in lowering the portal pressure in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* HVPG \> 12 mmHg

Exclusion Criteria:

* Respiratory disease that contradict endoscopy
* Hepatic encephalopathy
* Hepatorenal syndrome
* COPD or Asthma
* Treatment with vasoactive drugs within 1 week of inclusion
* Heart disease that contradict treatment with beta-blocking agents
* IDDM
* Pregnancy