cyrilzakka/clinical-trials huggingface dataset:
Treating Binge Eating and Obesity Digitally in Black Women

More than 30% of Black women with obesity binge eat. Binge eating may increase the risk for the development of metabolic syndrome and binge-eating-disorder (BED), which is associated with severe obesity. Though several effective treatments for binge eating exist, Black women have not fared well. Not only has their inclusion in treatment trials been limited, but when participating, they are more likely to drop out, and/or lose less weight, compared to their White counterparts. Furthermore, treatment for binge eating is often not available in primary care and community-based settings places where Black women are more likely to receive treatment for their eating and weight-related concerns. Currently, there is scant intervention research to treat binge eating in Black women. With the highest rates of obesity (57%) nationally, Black women are in need of culturally-relevant treatments for binge eating and weight gain prevention. Given the established relationship between frequent binge eating and subsequent weight gain, addressing binge eating among Black women with obesity is imperative.

Aim 1. Modify and adapt a validated program to be a culturally-relevant digital health tool for binge eating and weight management for Black women (BMI \> 30 kg/m\^2) who binge eat.

Aim 1a. Identify the barriers and facilitators to detecting and treating binge eating in Black women with obesity, and identify strategies for optimizing digital health tools to engage and retain this population.

Aim 1b. Conduct usability testing with a group of stakeholders to guide content and design refinements; refine tool.

Aim 2. In a randomized clinical trial, examine the feasibility and preliminary efficacy of the digital health appetite awareness + behavioral weight program in primary care.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* BMI ≥ 30 kg/m\^2,
* have and regularly use a Bluetooth-enabled smartphone,
* report at least one binge eating episode weekly,
* work or live within 30 miles of Kannapolis, NC,
* complete the screening questionnaire

Exclusion Criteria:

* currently pregnant,
* in substance abuse treatment,
* involved in another weight reduction program,
* have a history of anorexia,
* are purging,
* currently in treatment for eating difficulties,
* are concurrent intravenous drug users
* consume \>4 alcoholic beverages/day
Dexmedetomidine in Seizure Patients

Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. The investigators clinical experience suggests that these patients are resistant to the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic interaction between the anticonvulsant medications and dexmedetomidine or the higher dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic and pharmacodynamic differences of dexmedetomidine between patients receiving and not receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for these differences.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65, BMI 20-25 kg/m2
* Anticonvulsant Group: Diagnosis of seizure disorder taking carbamazepine or phenytoin for a minimum of 2 weeks
* Control Group: Healthy volunteers taking no medications

Exclusion Criteria:

* Positive urine pregnancy test or lactating
* History of allergy to dexmedetomidine or alpha -2 agonists
* History of liver, renal or thyroid disease
* History of cardiovascular disease including history of arrhythmia or congestive heart failure
* History of drug or alcohol abuse
Investigation of Clinical Outcome of ACL Reconstruction Utilizing Two Tibial Fixation Techniques, Concentric Tapered Interference Screws and Interference Screw and Sheath

Tibial fixation is the weak link when using soft tissue grafts and interference screws for fixation in a bony tunnel in ACL reconstruction. The Objective is to study two groups of patients undergoing double loop hamstring autograft ACL reconstruction and compare between the two tibial fixation devices: the tapered Deltascrew and the Intrafix screw and sheath .


Eligibility Criteria:
Inclusion Criteria:

* Males and females between ages 21 and 40 years.
* Primary ACL tears.
* Signed Informed consent.
* Availability during follow up period.

Exclusion Criteria:

* Additional meniscal injury requiring suture.
* Articular cartilage injury requiring surgical management.
* Concomitant ligament injuries to the same knee requiring surgery.
* Bilateral ACL injury.
* Revision ACL surgery.
* Concurrent fractures of the lower limbs caused by the same accident.
* Post operative wound infection.

  • Post operative nerve injury
* Cardiovascular compromise.
* Professional sports people.
* Soldiers on active military service.
* Patients actively seeking compensation for injury.
* Patients on other research protocols.
* Patients receiving medications which alter bone metabolism: corticosteriods, Calcitonin, Flourides, Biphosphonates, Vitamin D and its derivatives, Cytotoxic drugs.
* Non compliance. • Pregnancy
Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.

A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, no gender limit.
2. The patient was diagnosed as cerebral arteriovenous malformation .
3. The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
4. Spetzler Martin, grade I-IV .
5. The patient voluntarily signed the informed consent.

Exclusion Criteria:

1. History of heparin allergy.
2. The patient is allergic to contrast media.
3. Severe hepatic and renal insufficiency (serum creatinine ≥1.5 times the upper limit of normal value, alanine aminotransferase ≥3 times the upper limit of normal value, aspartate aminotransferase ≥3 times the upper limit of normal value).
4. Patient has irreversible coagulopathy (INR \> 1.5).
5. Intracranial hemorrhage 1 week before treatment.
6. MRS ≥4 due to neurological dysfunction.
7. Patients with planned malformation resection after embolization.
8. Blood flow related aneurysms of supplying artery that need to be treated by other methods.
9. Complicated with severe cerebral artery stenosis.
10. Brain tumors that require recent surgery.
11. Complicated with proliferative cerebrovascular disease.
12. Pregnant or lactating women.
13. Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
14. The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
15. Subjects deemed unsuitable for this study by the investigator.
RCT Study on the Therapeutic Effect of Escitalopram Loaded With XingpiJieyu Formula on Resting State EEG Energy Abnormalities in Severe Liver Depression and Spleen Deficiency Type MDD

To compare the clinical efficacy of XingpiJieyu formula or its placebo combined with Escitalopram (ESC) in the treatment of moderate and severe MDD, and to explore a new method of integrated traditional Chinese and western medicine for the treatment of moderate and severe MDD with severe liver depression and spleen deficiency, as well as its neurological mechanism for regulating the relative power (RP) of resting-state EEG spectra.

MDD patients, especially severe MDD patients have heavy burden of disease, high risk of suicide, difficulty in single drug treatment, and poor compliance with combined western medicine treatment. It is urgent to explore new methods of integrated traditional Chinese and western medicine in the treatment of moderate and severe MDD to enhance efficacy and reduce toxicity. A double-blind, randomized, controlled Trial (RCT) was conducted to compare the efficacy of XingpiJieyu formula or its placebo combined with escitalopram in the treatment of MDD with severe liver depression and spleen deficiency. We aim to explore the clinical efficacy of XingpiJieyu formula combined with escitalopram and its possible multi-target neural mechanism.

Eligibility Criteria:
Inclusion Criteria:

1. outpatient/inpatient, age 18-45 years old, right-handed;
2. western medical diagnosis meets the diagnostic criteria of MDD in DSM-5, without psychiatric features;
3. In accordance with the diagnostic criteria of depression and liver-stagnation and spleen-deficiency in the "Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine" issued by the China Association of Chinese Medicine in 2008;
4. 17-item Hamilton Depression Scale score ≥18;
5. educational experience ≥5 years;
6. The current episode has not used antidepressants, antipsychotics, mood stabilizers, or other medications that can act on the central nervous system for at least 4 weeks;
7. Have not received physical therapy, such as MECT, rTMS, etc., in the past 6 months;
8. The total duration of the disease ≤10 years.

Exclusion Criteria:

1. Any current or previous mental disorder other than MDD according to DSM-5;
2. Diagnosis of syndromes other than depression and liver-stagnation and spleen-deficiency in the "Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine" issued by the China Association of Chinese Medicine in 2008;
3. Suicidal ideation or suicidal behaviour (HAMD-17 item 3 \> 2);
4. Drinking alcohol in the week prior to the enrollment;
5. Patients with neurological disorders, somatic disorders, organic brain diseases, and tumour;
6. Sleep disorders other than insomnia disorders currently diagnosed according to DSM-5, such as obstructive sleep apnea syndrome, periodic limb movement disorder, restless legs syndrome, etc.
Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia

Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 25 and 75
* Patients who signed informed consent forms of their own volition;
* Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);
* Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal

Exclusion Criteria:

* Patients with uncompensated liver cirrhosis.
* Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.
* Patients who had taken antiviral drugs for viral hepatitis.
* Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).
* Patients whose triglyceride(TG) levels were 400mg/dL or higher.
* Patients with uncontrolled hypertension (DBP≧100mmHg)
* Patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dL)
* Patients whose CK levels were over 2.5 times higher than the upper limit of normal.
* Patients with uncontrolled hypothyroidism although drug treatment (TSH≧ULN×1.5)
* Female patients who were nursing or being pregnant or were planning on becoming pregnant.
* Patients judged to be unsuitable by investigators.
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor/ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with cystic fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in Part B, if they meet the eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who weigh ≥8 kilogram (kg) without shoes and wearing light clothing at the Screening Visit
* Subjects with confirmed diagnosis of CF at the Screening Visit
* Subjects who are homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation

Exclusion Criteria:

* Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
* A standard 12-lead ECG demonstrating QTc \>450 millisecond (msec) at the Screening Visit.
* History of solid organ or hematological transplantation.
* Ongoing or prior participation in an investigational drug study (including studies investigating LUM and/or IVA) within 30 days of the Screening Visit.
* History of cataract/lens opacity or evidence of cataract/lens opacity determined to be clinically significant by a licensed ophthalmologist during the ophthalmologic examination at the Screening Visit
Pattern of Microbial Infection in AECOPD Patients and Its Sensitivity to Antibiotics

Measurement of bacterial species causing AECOPD and their Sensitivity pattern to antibiotics.

Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality worldwide.

Acute exacerbation is a common problem during the natural course of COPD, which is characterized by an increase in the patient's daily symptoms of dyspnea, cough, and/or sputum beyond normal day-to-day variability and severe enough to require an additional therapy.

The most common cause of acute exacerbations of COPD (AECOPD) is an infection of the tracheobronchial tree and air pollution. As many as one-third of AECOPD causes are never identified. The microbial aetiology of AECOPD includes bacteria and viruses with more than 50% of cases being caused by bacterial infection.

The bacterial etiologies of AECOPD keep changing from time to time and the choice of antimicrobial depends upon on local prevalence of bacterial etiologies and their resistance pattern.

Antibiotics are the main form of treatment for AECOPD which are often initiated empirically based on healthcare provider's previous experiences , which often lead to the inappropriate use of antibiotics , thereby contributing to Antimicrobial Resistance.

Early diagnosis and knowledge of the predominant bacterial etiologies and antimicrobial resistance patterns will also help to correct treatment protocol for the management of AECOPD.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age and less than 80 years of age for both genders
* Confirmed diagnosis of COPD by spirometry
* Must be an AECOPD patient (with increased grade of dyspnea, increased purulence and amount of sputum) and admitted to the chest department or ICU
* Positive sputum culture

Exclusion Criteria:

* Age less than 18 years old
* Any associated pulmonary co-morbidity
Cyclization of Motor Cortex Stimulation

Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest.

The strength of stimulation can be individually adjusted by changing the voltage of stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control.

The aim of this study is to analyze the optimal stimulation timing parameters in patients already implanted with MCS and have received good pain relief. The investigators wish to cyclize on/off MCS in order to save the battery life of the stimulator and also decrease stimulus habituation. The investigators hope to determine these timing parameters while maintaining optimal pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient more than 18 years of age
* Chronic neuropathic pain effectively treated with motor cortex stimulation
* Stable medication during the trial
* Willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent.

Exclusion Criteria:

* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
* Technical malfunction of the MCS device
* History of seizures
* Unable to provide informed consent
Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)

Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Subject with well-characterized Epilepsy according to the 1989 International League Against Epilepsy (ILAE) classification
* Subject with Epilepsy who the investigator expects will benefit from Levetiracetam (LEV) but for whom the investigator has decided to discontinue due to nonpsychotic behavioral side effects following the introduction of LEV
* Subject is currently receiving LEV at the recommended therapeutic dose (dose ranging from 1 g/day to 3 g/day)
* Subject currently treated with minimum 2 and maximum 3 Anti-Epileptic Drugs (AEDs) including LEV. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
* Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method

Exclusion Criteria:

* Subject has a lifetime history of suicide attempt (including an actual, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
* Subject whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
* Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
* Subject has history or presence of known psychogenic nonepileptic seizures
* Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease, and/or severe renal impairment) which impair reliable participation in the study or necessitate the use of medication not allowed by protocol
* Subject is pregnant or lactating
Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder

RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue, may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and find out how far the disease has spread.

PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach, small intestine, or gallbladder.

OBJECTIVES:

Primary

* Evaluate the safety and feasibility of visceral lymphatic mapping using isosulfan blue in patients with adenocarcinoma of the pancreas, colon, stomach, small bowel, or gallbladder.
* Evaluate the ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes in the basin are involved with the tumor in these patients.

Secondary

* Compare the results obtained from the sentinel lymph node (i.e., positive or negative for metastatic disease) with the results obtained from the other nodes in these patients.
* Compare immunohistochemical analysis with standard analysis of the sentinel lymph nodes in these patients.
* Evaluate the value of intraoperative touch prep analysis of sentinel lymph nodes in these patients.

OUTLINE: This is a pilot study.

During surgical resection of the primary tumor, patients receive isosulfan blue subcutaneously 5 minutes before undergoing sentinel lymph node identification/excision and radical lymphadenectomy. Tissue samples are analyzed by IHC for cytokeratins and CEA.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of adenocarcinoma of 1 of the following sites:

  * Pancreas
  * Stomach
  * Colon
  * Small bowel
  * Gallbladder
* Patients with highly suspicious pancreatic lesions without definitive tissue biopsy are eligible
* No prior uncontrolled visceral malignancy

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No medical comorbidities that would preclude definitive resection
* No known allergies to isosulfan blue

PRIOR CONCURRENT THERAPY:

* Not specified