cyrilzakka/clinical-trials huggingface dataset:
Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer

The goal of this clinical trial is to explore the feasibility and outcome of fertility-sparing therapy in Stage IA G1-G2 Endometrial Cancer with less than 1/2 myometrial invasion. Researchers will render participants indication-extended fertility-sparing therapy. Researchers will compare the myometrial invasion group with the no myometrial invasion group to see if it is possible to propose an extension indication of fertility-sparing therapy for endometrial cancer.

The study population is patients with Stage IA endometrial adenocarcinoma with no myometrial invasion or less than 1/2 myometrial invasion. The sample size is 57 cases (Myometrial invasion group : No myometrial invasion group = 1 : 2). Follow up every 3-6 months until the end of the fifth year of treatment. The primary outcome measure is the complete remission rate after 9 months of treatment. Secondary outcome measures include complete remission rate (6 months/12 months after initial treatment), complete remission time, recurrence rate (1 year/2 years after complete remission), recurrence time, pregnancy rate (1 year after complete remission), pregnancy outcome, blood molecular biomarkers, pathological markers, adverse reactions, etc.

Eligibility Criteria:
Inclusion Criteria:

* Stage IA (FIGO 2009) ;
* Pathological diagnosis: endometrial adenocarcinoma G1-G2;
* MRI or ultrasound: tumor limited to endometrium or invading less than 1/2 of myometrium；
* 18 years old ≤ Age ≤ 45 years old;
* With a strong desire for fertility preservation；
* Sign the informed consent.

Exclusion Criteria:

* Complicated with any other malignancy；
* Contraindications to conservative treatment；
* Contraindications to progestin use;
* Contraindications to pregnancy, or judged by the researcher to be unfit for pregnancy or delivery.
Effects of Health Education Programs on the Health of Rural Pregnant Women in China

The aim of this study is to design, introduce, conduct, and evaluate health education programs to improve maternal health literacy, health-promoting behaviors, and empowerment of pregnant women in China.

After being informed about the study and potential risks, the quasi-experimental study will be conducted. All the pregnant women who meet the inclusion criteria will be marked as numbers in the first inspection time of the second trimester. And then the odd number will be assigned to an intervention group, while the even number will be distributed to the control group which ensures that they have an equal chance of receiving the intervention.The interventions of the control group will receive the routine health education proposed by relevant experts in China which are chosen by the Chinse Medical Association. The interventions of the intervention group will receive routine health education and individual counsel on health-promoting behaviours based on the health promotion model .

Eligibility Criteria:
Inclusion Criteria:

1. Adult pregnant women;
2. Basic reading and comprehension skills;
3. Can use WeChat app;
4. Can complete all evaluations;
5. Willing to receive guidance and change.
6. The home address shown on the identification card is in a rural area.

Exclusion Criteria:

1. Threatened abortion;
2. Premature rupture of membranes;
3. Serious complication;
4. Be absent from health education more than 2 times;
5. Have psychic or mental problems.
Volume Outcome Relationships and Effects

This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities.

This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities.

The relationship between volume and outcomes has been proven in pancreatic cancer. Similar to pancreatic cancer, esophageal cancer historically has a bad prognosis. Esophageal cancer is typically asymptomatic, resulting in an advanced stage at the time of diagnosis. Additionally, it also has a significantly high morbidity and mortality. Therefore, it is crucial to determine volume-outcome relationships in esophageal cancer. This study aims to elucidate what these findings may entail by evaluating the impact that the volume-outcome relationship has on treatment assessment in esophageal cancer patients.

The purpose of the study is to evaluate the outcomes of esophageal cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities. Furthermore, this paper will assess the outcomes of neoadjuvant and adjuvant therapy in esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* esophageal cancer

Exclusion Criteria:

* No esophageal cancer
Self-help Book for Shift Work Related Problems

The aim is to assess whether a self-help book for coping with shift work will reduce complaints in relation to shift work.

This study is a randomized controlled trial evaluating the effect of a self-help book for shift work related problems compared to the effect of sleep hygiene advice in participants with shift work disorder. 300 participants will be randomized to receive either the book or the sleep hygiene advice. Participants complete questionnaires about sleep, sleepiness and health at baseline and after 6 months after receiving the written material. The main aims are to assess whether the book is more effective to reduce sleep and sleepiness problems in relation to shift work, and to reduce the prevalence of shift work disorder, to increase knowledge about sleep and circadian rhythms, improve health, and reduce turnover intention.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms suggesting shift work disorder
* Health care worker

Exclusion Criteria:

* Below 18 years
Safety and Feasibility of Endovascular Cooling Device in Patients With Hypothermic Cardiopulmonary Resuscitation

Hypothermic resuscitation is proven to be benefit to the cardiac origin cardiac arrest patients for it improve brain recovery dramatically. However, traditional cooling devices and methods, most external cooling methods, include ice blanket, cooling helmet, or ice packing lower the body temperature slowly or inefficiently which make many emergency physicians hesitate to perform hypothermic resuscitation. To improve and promote the practice of hypothermia resuscitation, more efficient temperature control method is necessary. We conduct this clinical trial to evaluate the safety and feasibility of internal cooling catheter and temperature regulatory device, which is approved by FDA in neurologic ICU for temperature control, in the cardiac arrest patients.

We recruited successful resuscitated nontraumatic cardiac arrest adult patients in the emergency department to evaluate the safety and feasibility of application those invasive internal temperature regulator devices. Internal cooling catheter, "ICY" , and thermal regulator device, "Coolguard 2000" are applied to the patients from femoral vein. WE definite 4 stages according to the temperature during the clinical trial: "The Cooling Phase", "Hypothermia phase", "Rewarming phase", and "Postrewarming phase". The temperature is lowed or elevated by the rate 0.5C/hr during the Cooling and Rewarming Phase, and it is maintained 33 +/- 1 C during hypothermia phase for 12 hours according to the comment of ACLS. To understand the safety and feasibility, regular blood sampling, bedside EEG and vital monitors, and special sheets are designed to document the every reasons, time points or every clinical events during hypothermia therapy. The patients is observed until rewarming finish for 48 hours or till death if expired during post-resuscitation hypothermia therapy.

Eligibility Criteria:
Inclusion Criteria:

* Non-traumatic collapsed patients, whose pulsation continues and persists more than 5 minutes after return of spontaneous circulation from cardiopulmonary resuscitation and consciousness level is less than GCS 5 points.

Exclusion Criteria:

* 1. Age \> 78 y/o or \< 18 y/o 2. Core temperature\< 34℃or \> 38 ℃ after resuscitation 3. Pregnancy 4. Underline terminal malignancy disorder or refuse aggressive treatment cancer patient 5. Massive bleeding, known coagulopathy, or received regular anticoagulant medication 6. Persisted hypotension ( mean arterial BP \< 60 mmHg) after resuscitation even under inotropic agents 7. No bed available in ICU
Post-operative Pain Management In Patients Undergoing Hullax Valgus Surgery

The purpose of this study is to investigate the efficacy and cost analysis of intravenous fentanyl combined with either local anesthesia infiltration or peroneal nerves block in patients with Hallux Valgus undergoing orthopedic corrective surgery and compared with patients without local anesthetics administration perioperatively.


Eligibility Criteria:
Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring local anesthesia and PCA use
4. No severe cardiac or pulmonary diseases
5. BMI \<35 kg/m2

Exclusion Criteria:

1. BMI ≧35 kg/m2
2. age \> 65years
3. allergy to opioid or local anesthetics
A Study of Rocbrutinib in Participants with Relapse or Refractory Mantle Cell Lymphoma

This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.


Eligibility Criteria:
Inclusion Criteria:

1. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
2. At least one measurable lesion.
3. Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20.
4. ECOG≤2.
5. Adequate hematologic function.
6. Adequate hepatic and renal function.
7. Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control.

Exclusion Criteria:

1. Received non-covalent BTK inhibitor treatment.
2. Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.
3. Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.
4. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
5. Disease affects the central nervous system.
6. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
Registry for Pulmonary Hypertension in China

1. To characterize the demographics and clinical course of the patient population diagnosed as having WHO group I pulmonary arterial hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic pulmonary hypertension
2. To describe real-world outcome of Chinese patients with WHO group I pulmonary arterial hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic pulmonary hypertension
3. To evaluate differences in patient outcomes according to classification subgroup
4. To identify clinical predictors of long-term survival
5. To assess the relationship between targeted therapies for pulmonary arterial hypertension and patient outcomes

Data describing the natural history of idiopathic and familial pulmonary arterial hypertension were derived from a registry conducted at our institution prior to 2006. Since then, targeted therapies for pulmonary arterial hypertension have been introduced in China. It is probably that the prognosis of Chinese patients with WHO group I pulmonary arterial hypertension and WHO group IV pulmonary hypertension due to chronic thromboembolic pulmonary hypertension has also been improved as western countries. Therefore, the aim of the present study was to describe real-world outcome of Chinese patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension and identify factors that may predict outcome. Our study will provide an updated picture of the clinical course of a more broadly defined scope of pulmonary hypertension and the effects of current therapy on survival, enabling the collection of data on demographics, clinical course, treatments, and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Signed patients'consent
* Diagnosed by right heart catheterization one month within study enrollment
* patients who were firstly diagnosed as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension

Exclusion Criteria:

* Not meeting inclusion criteria
Investigating the Effectiveness of Telepsychiatry for Treating Major Depression in a Chinese American Nursing Home

The current use of telepsychiatry, or psychiatric care using videoconferencing, is very limited. The present study investigates the use of this method with a depressed Chinese American population in a nursing home. It is believed that this population can benefit from telepsychiatric treatment when used in collaboration with the primary care they receive in the nursing home.

Individuals at the South Cove Manor nursing home will be referred to this study if they are experiencing depression. After meeting with the Principal Investigator (a psychiatrist), he will collaborate with the primary care physician and the nursing home staff to establish a treatment plan for the patient. Videoconferencing will be used by the P.I. for regular psychiatric visits with the patient as well as meetings with the nursing home staff to coordinate care for the patient. After collaboration between the two groups, treatment suggestions will be given to the patient's primary care physician (PCP) to implement in the primary care setting. The patient's symptomology, mood, satisfaction of life and side effects of medication will be recorded regularly to measure the effects of treatment for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder
* Patient at South Cove Manor Nursing Home
* Referred by nursing staff for psychiatric consultation

Exclusion Criteria:

* Not competent to participate in psychiatric interviews
Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

Nurse-administered propofol sedation has become the standard procedure for colonoscopy in Germany. Although patient satisfaction with this method is high, there is little data about the satisfaction of the examiner and factors that might negatively influence this satisfaction. Often due to the fact that the sedated patient usually expresses pain by movements of the body and paralinguistic sounds the examination has to pause until the next propofol bolus induces a deeper sedation. In order to measure the correlation of examiner satisfaction and negative factors the investigators initiated this prospective observational study. During this study examiner satisfaction and the correlation with observer reported pain (movements and paralinguistic sounds) will be measured. Additionally different biopotentials (electromyography, skin conductance level, body temperature, pulse) of the patient will be recorded during the examination and feature pattern will be correlated to the observer reported pain in order to detect pain before the expression of pain leads to a pause in the colonoscopy examination. Other factors that might influence examiner satisfaction, like duration to reach the caecum and duration of polypectomy will additionally be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18
* ASA classification I to II
* Indication for colonoscopy with propofol sedation
* Written informed consent

Exclusion Criteria:

* Pregnancy
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)

The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent and HIPAA
* Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a body weight \>50 kg
* General good health
* Ability to use oral inhaler

Main Exclusion Criteria:

* Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
* Participation in any investigational drug trial within the 30 days before Screening Visit and thereafter
* History or current clinically relevant allergies or idiosyncrasy to drugs or food
* History of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations
* Any contraindication to nasally administered corticosteroids
* History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)\] within the 30 days before Screening Visit, or development of a respiratory infection during the Screening Period
* History or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years
* Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding Screening Visit
Are There Changes in the Nerve Fiber Layer (NFL) After Lowering of Eye Pressure?

The aim of this study was to evaluate structural and functional improvement after lowering intraocular pressure (IOP) in patients with glaucoma using Spectral Domain Optical Coherence Tomography (SD-OCT), Visual Field (VF) testing, and Visual Evoked Potential (VEP).

Glaucoma exhibits characteristic changes to the optic nerve in the back of the eye. The optic nerve is formed when fibers that overlay the retina come together. This layer is called the retinal nerve fiber layer (RNFL).

Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers in the retina and RNFL. This provides important anatomical information.

VEP (visual evoked potential) is an imaging system that measures electrical signals from the eye to the brain by using electrodes placed on the forehead and back of head. This is similar in principal to an electrocardiogram of the heart.

Visual field testing is done to evaluate the extent of side vision loss caused by various diseases of the eye, including glaucoma. This testing is performed as you stare at a small light directly in front of your eye while lights flash one at a time in every direction on a screen surrounding the central light. You push a button each time you see a flash out of the corner of your eye.

Lowering intraocular pressure (IOP) in the eye has been shown to result in reversal of glaucoma changes of the optic nerve in some patients. It has also been suggested that improvement in function (visual field) has been associated with improved optic nerve appearance.

This study seeks to provide evidence for reversal of disc appearance and visual function following IOP lowering interventions.

Eligibility Criteria:
Inclusion Criteria:

* All patients with glaucoma (primary open-angle glaucoma, angle recession glaucoma, exfoliation syndrome glaucoma, pigmentary glaucoma and chronic angle closure glaucoma) in whom a pressure-lowering intervention was conducted

Exclusion Criteria:

* Inability to obtain reliable field or optical coherence tomography pre-intervention
* Visual acuity less than 20/40,
* Age \<18 or \>90 years,
* Other cause for visual field loss not glaucoma, that is, visual field loss due to cataract optic neuropathies, retinal disease
* Spherical equivalent refractive error \> +5.00 Diopters and \> 3.00 Diopters cylinder
* Concomitant cataract and glaucoma surgery
A Phase 2, Open-label Study of AMG 706 to Treat Subjects With Locally Advanced or Metastatic Thyroid Cancer

The purpose of the study is to determine if AMG 706 will have clinically meaningful anti-tumor activity in subjects with locally advanced or metastatic thyroid cancer who are not candidates for radioactive iodine therapy or local therapies.


Eligibility Criteria:
Inclusion Criteria: - Histologically confirmed locally advanced or metastatic thyroid cancer - Measurable disease - Normal blood pressure (if history of hypertension, blood pressure must be controlled with medication) - Evidence of disease progression within 6 months before starting study (for differentiated thyroid cancer subjects) - Evidence of disease progression within 6 months before starting study OR symptomatic disease (for medullary thyroid cancer subjects) - Not a candidate for surgical resection, external beam radiotherapy, radioiodine therapy, or other local therapy - At least 18 years of age Exclusion Criteria: - Undifferentiated/anaplastic thyroid cancer - Untreated or symptomatic brain metastases - Prior malignancy, unless cured with treatment and no evidence of disease for greater than or equal to 3 years before starting study (history of thyroid cancer, in situ cervical cancer, or basal cell cancer of skin are exceptions) - Myocardial infarction or any unstable cardiac condition (e.g., congestive heart failure, unstable angina) within 1 year before starting study - Arterial thrombosis or deep vein thrombosis within 1 year before starting study