cyrilzakka/clinical-trials huggingface dataset:
Behavioral Weight Loss and Exercise After Treatment (BEAT)

Overweight and physically inactive breast cancer survivors are at increased risk of breast cancer recurrence and mortality. Cancer treatment-related changes that likely mediate weight loss and exercise success include the long term effects such as fatigue, psychological distress and impaired executive (cognitive) function.

This study will explore the variability in how breast cancer survivors respond to a behavioral weight loss intervention. The primary objectives include determining the degree to which success with a behavioral weight loss intervention in overweight breast cancer survivors is explained by measures of executive function as measured with task performance at 6 and 12 months and associated brain function imaging (fMRI), collected at baseline only.Additionally, the study is designed to determine the degree to which selected measures of cancer-related symptoms account for variance in the success of breast cancer survivors at 6 and 12 months following entry into a behavioral weight loss and exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer diagnosis
* Received surgery +/- chemotherapy +/- radiation for treatment of a Stage I, II or III breast cancer. Ongoing treatment with monoclonal antibodies and/or anti-estrogen therapy is acceptable
* Completion of initial therapy 6 weeks prior to study initiation
* BMI of 27-45 kg/m\^2

Exclusion Criteria:

* Prior diagnosis of malignancy other than non-melanoma skin cancer (i.e. prior non-melanoma skin cancer is not an exclusion criteria)
* Medical conditions that limit food choices such as celiac sprue or inflammatory bowel disease
* Inability to walk on flat ground (or a treadmill) at 2.5 mph for 5 minutes
* Age \<21 and \>70
* Presence of body metal
* Psychotic or central nervous system impairment that would limit compliance with study requirements, including dementia
* Evidence of metastatic disease
* Symptomatic heart disease (chest pain or equivalent with activity)
* Exercise limiting pulmonary disease or need for oxygen to exercise
* Individuals taking mood stabilizing medications including: Lithium, valproic acid, also called divalproex sodium (Depakote), carbamazepine (Tegretol), lamotrigine (Lamictal), oxcarbazepine (Trileptal), olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), ziprasidone (Geodon), clozapine (clorazil)
* Participants with an active neurologic disorder that affects the central nervous system, including seizures, and Parkinson's disease
* Weight loss of \>10 lbs in the previous 6 months
* Participation in \> 150 minutes of moderate intensity activity by self report, unless activity level by accelerometer is less than 150 minutes of moderate intensity activity
A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis

This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a female aged between 18 and 41 years
* The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months
* The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis
* The subject has given a written informed consent prior to any study-related procedures

Exclusion Criteria:

* The subject is pregnant
* The subject's surgery results showed evidence of malignancy
* The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude
Rehabilitation by Effort for Patients With Advanced Bronchial Cancer

Bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to pathology (chronic inflammation) and also to treatments (surgery, radiotherapy, chemotherapy); it's considerably alters patients quality of life.

Investigators want to ensured the feasibility of rehabilitation by effort for these patients.


Eligibility Criteria:
Inclusion Criteria:

* General condition according to World Health Organisation 0-1
* Age between 18 and 70 years old
* Non progressive patients according to RECIST criteria 1.1 after chemotherapy treatment whichever line of treatment
* Autonomous patient
* Voluntary written informed consent signed
* Patients with social security insurance

Exclusion Criteria:

* Bone metastasis with fracture risk
* Significant cardiovascular pathology
* Cardiac, vascular, rheumatologic or neurologic contraindication
* Patients living far 60 kms from Toulouse
* Patients under juridical protection guardianship, or tutelage measure
Balloon Cryotherapy vs. Radiofrequency Ablation Pain Study

Barrett's esophagus is a condition in which the normal lining of the lower esophagus is replaced with cells that predispose an individual to development of esophageal cancer. Treatment of Barrett's esophagus reduces the risk of progression to cancer. Treatment is provided endoscopically, via a variety of approved techniques including endoscopic mucosal resection, argon plasma coagulation, radiofrequency ablation (RFA), spray cryotherapy ablation and balloon cryotherapy ablation. A common side effect of ablation treatment is pain, thus making pain an important factor when discussing treatment options. It is speculated that balloon cryotherapy causes less pain than RFA but no head-to-head comparison trials exist to date. This multi-center, prospective cohort study aims to compare pre- and post-procedural pain for balloon cryotherapy versus RFA. Providing both patients and clinicians with data from a well-designed prospective study may help guide future physician/patient treatment discussions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with dysplastic Barrett's esophagus (LGD and HGD) naïve to ablation therapy presenting for ablation
2. Age ≥ 18
3. Ability to sign informed consent

Exclusion Criteria:

1. Prior ablation treatment for Barrett's esophagus
2. Pregnancy
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Scheduled to remove the impacted tooth.
3. Any NRS score reaches the inclusion criteria within 4 hours after the surgery.
4. Willing to comply with the study procedures and requirements.
5. Willing and able to provide written informed consent for this study.

Exclusion Criteria:

1. Subjects who have used other drugs that have the analgesic effect.
2. Subjects who have used any drug that affect the efficacy and safety of study drug.
3. Subjects who have infection or other complications on the planned oral surgical site.
4. Subjects with hypertension or hypotension during screening period.
5. Subjects with severe cardiovascular and cerebrovascular diseases.
6. Subjects with severe gastrointestinal disease.
7. Subjects with Respiratory diseases.
8. Subjects with a history of seizure, or drug or alcohol abuse.
9. Subjects with significant abnormal electrocardiogram result.
10. Subjects with significant abnormal laboratory value.
11. Subject who were allergic to the study drug and ingredients.
12. Pregnancy, lactation or having recent pregnant plan.
13. Subjects who participated in other clinical research study 30 days before entering this study.
14. Other conditions unsuitable for participation in the study.
Effects of Insomnia Treatment on Metabolism in Patients With Depression

This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia Severity Index \> 14
* Meet diagnostic criteria for Insomnia
* Meet diagnostic criteria for Major Depressive Disorder
* Either currently taking an SSRI/SNRI or no antidepressant

Exclusion Criteria:

* BMI \> 30
* Those with unstable medical conditions defined by change in diagnosis or medication in past 2 months
* Those with clinically significant comorbid psychiatric conditions (e.g., Bipolar disorder)
* Those with known untreated sleep apnea or other clinically significant sleep disorder other than insomnia
* Those currently taking medications that affect sleep or metabolism (e.g., stimulants, thyroid meds)
A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of \<115 mg/dL


Eligibility Criteria:
Inclusion Criteria:

* Completion of base study
* Dyslipidemia and at high risk of CHD

Exclusion Criteria:

* Impaired liver function
* Gastrointestinal disease that could limit drug absorption
A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study
Prevention of Unmitigated Chemotherapy-induced Emesis

Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to patient care and continues to decrease quality of life. Despite the addition of medications and antiemetic regimens, doctors' ability to control CINV is still inadequate: even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. In this study, the investigators test a transcranial vibrating system that has shown great promise at reducing nausea and vomiting. .

Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to cancer patient care despite numerous medications being available to prevent and treat CINV.

CINV decreases quality of life in roughly one third of patients receiving highly emetogenic chemotherapy. In addition, roughly half to two thirds of all patients receiving chemotherapy require rescue anti-emetic medications despite being given guideline-based prophylactic anti-emetics.The anti-emesis armamentarium continues to grow with new medications, including olanzapine and fosaprepitant, being studied in recent years. However, despite the addition of these medications and guideline-based antiemetic regimens, the ability to control CINV is still inadequate as even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea.

In this study, the investigators aim to test a new transcranial vibrating system that has shown promise in phase I studies for treating dizziness, motion sickness and nausea.

Eligibility Criteria:
Inclusion Criteria:

* Subject currently receiving chemotherapy known to be emetogenic (i.e subject has already received one round of chemotherapy)
* MASCC Antiemesis Tool score of \> 6 on the nausea severity scale and/or
* One or more episodes of vomiting anytime in the 4 days following receipt of chemotherapy and/or
* The need for three or more uses of rescue antiemetic medications within 4 days of chemotherapy during previous round.

Exclusion Criteria:

* Pregnant women
* Individuals unable to provide informed consent
* Any preexisting condition causing significant nausea or vomiting, or causing reaction to the bone conduction system (e.g. superior canal dehiscence)
* Prisoners
Intermittent Oral-esophageal Tube Feeding in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma

This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* With the history of NPC and radiation therapy.
* With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
* Conscious and with stable vital signs;
* Willing to participate and sign the written informed consent form either personally or by a family member.

Exclusion Criteria:

* Presence of other diseases that might cause dysphagia.
* With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
* Concurrent participation in other treatments that could interfere with the trial.
* Inability to cooperate with treatment due to aphasia, mental health issues, etc.
* Received tube feeding for enteral nutrition support within the past three years.
WATCHMAN for Second Prevention of Stroke (WASPS)

To evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of stroke in the patients with nonvalvular atrial fibrillation

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, affecting an estimated 5 million Chinese. Atrial fibrillation is the primary cardiac abnormality associated with embolic stroke; among patients with AF, there is an annual stroke rate, about 5 times for the same age population in sinus rhythm.

Although warfarin therapy is effective at reducing the risk of stroke, chronic anticoagulation presents problems of safety and acceptability for many patients. Drug and dietary interactions, frequent blood tests, and compliance issues all contribute to difficulties with chronic warfarin therapy. New oral anticoagulant compounds with better therapeutic range and without need for similar monitoring, such as Dabigatran, Rivaroxaban, Apixaban and Edoxaban,have been studied, but there is no direct comparison with left atrial appendage closure(LAAC).

However,the left atrial appendage (LAA) is the major location of thrombi in patients with AF. In patients with nonrheumatic AF and thrombus in the left atrium, the clot was located in the LAA in 90%. And the WATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic thromboembolism in patients with AF.The PROTECT-Af and PREVAIL trails confirmed this device's efficacy and safety, compared with warfarin, for preventing the combined outcome of stroke,systemic embolism, and cardiovascular death. And the device has been approved by China's FDA.

Stroke is the primary cause of death in China, and recurrence of stroke remains a major public health issue.

This cohort study is designed to evaluate the effects of mechanical left atrial appendage (LAA) closure for secondary prevention of ischemic stroke in the patients with nonvalvular atrial fibrillation in China, compared with medicine approach (Warfarin or NOAC),.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* A history of stroke/transient ischemic attack(TIA) over 3 months;
* Paroxysmal, persistent, or permanent nonvalvular AF;
* 4.2 or more CHA2DS2-VASc risk factors
* Eligibility for long-term anticoagulation with warfarin or new oral anticoagulants.

Exclusion Criteria:

* patent foramen ovale with atrial septal aneurysm
* an atrial septal defect
* mechanical valve prosthesis
* left ventricular ejection fraction less than 30%
* mobile aortic atheromata
* symptomatic carotid disease
Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair

Arthroscopic rotator cuff repair often causes significant postoperative pain. An interscalene nerve catheter is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of shoulder surgery. Liposomal bupivacaine (Exparel) was recently approved by the FDA for use around the interscalene brachial plexus, and it has been shown to be an effective option, but its analgesic efficacy has limited data. Both techniques are currently being used at the UNC's Ambulatory Surgery Center (ASC) for analgesia after shoulder arthroscopy. The goal is to ensure that the fairly new Exparel option provides non-inferior analgesia as compared to the prior standard practice of placing a nerve catheter with plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of shoulder arthroscopy at this institution by prospectively and rigorously collecting data during regular follow up.

This is a prospective comparison of patients undergoing rotator cuff repair that receive one of two types of interscalene nerve block, both of which are currently being used at UNC. Group 1 will be comprised of patients with a preoperative interscalene nerve catheter placed with 20 mL 0.25% bupivacaine and a 0.2% ropivacaine infusion by an OnQ pain pump. Group 2 will be comprised of patients with a preoperative interscalene nerve block placed with 10 mL 0.5% bupivacaine and 10 mL 1.3% Liposomal Bupivacaine (Exparel). All patients in both groups will have a similar intraoperative general anesthetic with multimodal analgesic pre-op oral medications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients age \> 18 undergoing arthroscopic rotator cuff repair at the ambulatory surgery center at the University of North Carolina

Exclusion Criteria: the below are simply contraindications to regional anesthesia in general, this is a pragmatic study to evaluate the quality of care for these patients with no additional exclusion criteria.

* Contraindications to regional anesthesia
* Significant peripheral neuropathy or neurological disorder affecting the upper extremity
* Pregnancy
* Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia

This study aims to compare between androgens level (serum total and free testosterone) in women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).

Methodology:

All women in this study will be subjected to:

* All women are candidates for this study according to inclusion and exclusion criteria.
* History taking with special emphases on last menstrual period to determine the exact Gestational age.
* A reliable date is defined as the occurrence of regular menstrual cycles (28±7 days) in patients who have not taken oral contraceptives during the three months before conception and have no irregular bleeding.
* General and abdominal examination for each patient to determine those patients matching with the inclusion criteria.
* Preeclampsia refers to the new onset of hypertension (systolic blood pressure ≥140 mmHg ,or diastolic blood pressure≥ 90 mmHg ,or both, measured on two occasions \> 6 hours apart) and either proteinuria or end organ dysfunction after 20 weeks of gestation in a previously normotensive woman.
* At Ain Shams University Hospitals, the investigator will use ELISA based test system intended for the quantitative measurement of total and free testosterone for patients of both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women (primigravidas) at third trimester i.e. 28-40 weeks.
2. Age between 20 and 35 years old.
3. Live fetus.
4. Having no history of pregestational hypertension.
5. Having no history of diseases associated with hormone disorders (thyroid gland disorders, DM, hyperprolactinemia or polycystic ovary syndrome).
6. During their pregnancy they did not receive antihypertensive medications.
7. Nonsmoker.

Exclusion Criteria:

* 1- First and second trimester pregnant women. 2- Women younger than 20 years old and older than 35 years old 3- Intrauterine fetal death. 4- History of pregestational hypertension. 5- History of hormonal disorders (thyroid gland disorders and hyperprolactinemia).

  6- Smoker. 7- Polycystic ovary syndrome. 8- Signs or symptoms of hyper-androgenism (hirsutism, acne, oily skin, etc.). 9- Diabetes mellitus. 10- Drug use except ordinary supplementation (iron, folic acid).