cyrilzakka/clinical-trials huggingface dataset:
A Virtual Cardiometabolic Health Program for African Immigrants: The Afro-DPP Program

A pilot study titled "A Virtual Cardiometabolic Health Program for African Immigrants (The Afro-DPP Program) will be conducted to address the cardiometabolic of community-dwelling African immigrants who have multiple cardiometabolic risk factors including hypertension, Type 2 Diabetes, high cholesterol, and overweight/obesity. The proposed study will recruit a total of 60 participants and will use a non-equivalent control group design to test the effectiveness of the intervention at two African churches in the Baltimore, Washington, D.C. area. The two churches will be randomly assigned to the intervention or delayed intervention group. At the end of a 6-month follow-up period, the control church will receive the intervention (delayed control group). All participants will receive a Bluetooth-enabled digital scale (Omron Model: BCM-500) that measures body composition including Body Weight, Body Fat percentage, Visceral Fat, Skeletal Muscle percentage, Resting Metabolism and Body Mass Index. A Bluetooth-enabled blood pressure monitor (Omron Model: BP7250) will also be distributed to all participants. All participants will download the Omron Connect app which will allow the participants to sync participants' blood pressure readings and body composition readings into the app. The research team will access these readings to monitor study outcomes and participants progress during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* African immigrants who are aged 25-75 years
* Participants who report being uninsured or have no access to a healthcare provider
* Have at least two of the following chronic conditions:
* Body-mass index ≥ 25 kg/m2
* Self-reported fasting plasma glucose of 95 to 125 mg/d or HbA1c of 5.7-6.5% in the past 6 months
* Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg

Exclusion Criteria:

* Participants who cannot communicate in English
* Participants who have cognitive challenges that would restrict them from participation
* Participants who have any serious illness that would interfere with participation
* Participants who are not members of the churches that are involved in this study
Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin

The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce the size of the cancer in your bladder before surgery and can also help to reduce the chance that your bladder cancer will come back (metastasize) in other parts of your body after bladder surgery.

This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose of this study is to test the effects, good and bad, of low dose weekly cisplatin and gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed muscle-invasive urothelial (transitional cell) carcinoma of the bladder or upper genitourinary tract.
2. Stage T2-T4a. Patients may have nodal disease but there must be no evidence of distant metastases and patients must be candidates for radical cystectomy as determined by urologic surgeon (note from/confirmation by surgeon required).
3. No prior systemic therapy for urothelial carcinoma. Prior intravesical therapy is allowed.
4. Patients are determined by their treating oncologist to not be a candidate high dose cisplatin (\> 70mg/m2) due to medical comorbidities.
5. Creatinine Clearance (CrCL or eCCr)) \> 25 mL/min calculated using the Cockcroft-Gault formula
6. Patients without serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive the protocol treatment of this study with gemcitabine and weekly fractionated cisplatin.
7. Preexisting neuropathy \< grade 2.
8. No prior invasive malignancy within the prior two years. However, prior history of non-muscle invasive bladder cancer and patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer, or asymptomatic prostate cancer) are eligible.
9. ECOG performance status 0 or 1.
10. Age ≥ 18 years of age.
11. Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment. Post-menopausal women (surgical menopause or lack of menses \>12 months) do not need to have a pregnancy test, please document status.
12. Required Initial Laboratory Values:

    * Neutrophils ≥ 1,000/μl
    * Platelet count ≥ 100,000/μl
    * Total bilirubin ≤ 1.5 x ULN.
    * AST (SGOT) \& ALT (SGPT) ≤ 3.0 x ULN

Exclusion Criteria:

1. Metastatic disease.
2. Prior hypersensitivity to platinums that in the investigators opinion would put the patient at risk if re-exposed
3. Small cell cancer of the bladder or pure adenocarcinoma. Patients with mixed histologies such as urothelial carcinoma with sarcomatoid features, squamous differentiation or adenocarcinoma are allowed as long as transitional cell cancer is the predominant pathologic subtype.
Accelerated Intermittent Theta Burst Stimulation in Unipolar Versus Bipolar Depression

The goal of this interventional study is to learn if accelerated Intermittent Theta Burst Stimulation can improve symptoms of 30 participants with Unipolar depression in higher manner than symptoms of 30 participants with bipolar depression

We will apply stimulatory TMS protocol for participants with Unipolar depression and participants with bipolar depression using MagVenture MagPro R30 stimulator with the Cool-B65 coil

Eligibility Criteria:
Inclusion Criteria:

* Age:18_65 years
* Sex:male and female
* Patients with Unipolar depression and bipolar depression diagnosis confirmed by SCID according to DSM5
* No pharmacological change in the last 4 weeks before the beginning of the stimulantion cycle
* Pharmacological resistance

Exclusion Criteria:

* Patients complaining of psychosis.Substance Use Disorder.current suicidal ideation.major medical and neurological disorder
* Patients complaining of epilepsy
* pregnancy and breastfeeding
* peacemaker spinal or bladder stimulator
* History of skull surgery and trauma
* presence of metallic foreign body
Varenicline Observational Investigation In The Cessation of Smoking

The purpose of this study is to determine the safety and efficacy of varenicline in the real-world environment of smokers attending primary care in routine clinical practice with the addition of being offered behavioral support "Life REWARDS"TM. This is a non-interventional study.

Sampling Method Details: Patients as they come to surgeries for smoking cessation treatment.

Eligibility Criteria:
Inclusion Criteria:

* The patients enrolled should be of legal adult age who regularly smoke and of which the main tobacco product is cigarettes.
* The patients must be willing to make an attempt to stop smoking.

Exclusion Criteria:

* All patients enrolled should meet the usual prescribing criteria for varenicline as per SmPC and should be entered into the trial at the Investigators discretion.
Ovarian Reserve in Crohn's Disease

Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian tubes and ovaries and indirectly through surgical interventions and tubal adhesions associated with disease treatment. Anti-mullerian hormone (AMH) is a reliable indicator of ovarian reserve in women. The aim of this study was to compare serum AMH levels in women with Crohn's disease and healthy controls. In this study, the investigators aimed to investigate AMH and ovarian capacity in the study group with crohn's disease and in the control group without disease.


Eligibility Criteria:
Inclusion Criteria:

* crohn's disease;
* reproductive age women

Exclusion Criteria:

* Over 40 years old,
* a previous ovarian resection;
* renal failure (serum creatinine levels N1.2 mg / dL);suspicion of malignancy;
* the presence of hereditary or acquired hematological disease;
* pregnancy;
* current lactation;
* the presence of a serious comorbid chronic disease;
* cirrhosis originating from chronic liver disease;
* abnormal thyroid function tests;
* a known serious psychological problem;
* presence of alcoholism and male sex.
Study of Therapeutic Effect of Electret Static Physiotherapy Film on Acute Soft Tissue Closed Injury

The aim of this study was to evaluate the efficacy and safety of electret static physiotherapy film developed by Beijing Youshilin science and Technology Development Co., Ltd., to treat acute soft tissue injury by sticking to the affected area

Design of randomized, open, parallel controlled non inferiority clinical trial.A total of 60 patients were included in the trial, including 30 subjects in the experimental group and 30 subjects in the control group. The experimental disease was acute soft tissue closed injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute soft tissue injury diagnosed by Western Medicine
* Ability to communicate well with the researcher and comply with the requirements of the validation
* Participants agreed to participate in the clinical validation and follow the validation program requirements, and signed the informed consent form

Exclusion Criteria:

* There are important organs (heart and lung) serious disease history, or have autoimmune disease history, such as rheumatism, SLE, or have a history of immune dysfunction, such as suffering from aids
* Patients with cardiac pacemaker
* Patients with open wounds
* Pregnant and lactating women
* Patients with history of mental illness
* Participants participated in other medical device trials or drug clinical trials within three months
* The researchers believe that the participants who are not eligible for clinical validation should be considered
* Patients who need to be treated with drugs
* Patients requiring physical therapy
Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo

Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant psychosocial impact on patients and society. Different treatment modalities with variable success rates are available.

Phototherapy is among the successful treatments but gives modest results. Some reports documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.

Adding GB to phototherapy, especially the most commonly used one; Narrow-Band UVB (NBUVB) might give better results than using either one alone. This might improve repigmentation as well as patients' quality-of-life. (QOL).

This will be a prospective double-blind randomized controlled clinical trial. One-hundred-sixty Vitiligo patients will be randomly divided into 2 groups( 80 patients per group).

One group will receive oral GB (2 tablets of 60 mgs twice daily) with NBUVB twice weekly.

The other group will receive placebo tablets( identical in size, shape and color) to GB twice daily with NBUVB twice weekly.

Both groups will be treated for 6 months. Standard protocol of phototherapy will be used for both groups.

Our aim here is to see whether adding GB to NBUVB will lead to better repigmentation than placebo or not.

Eligibility Criteria:
Inclusion Criteria:

* Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.
* Body surface area (BSA) involvement ≥ 3%.

Exclusion Criteria:

* Unable to consent
* Any topical, systemic or phototherapy for Vitiligo in the previous 2 months.
* Pregnancy, breast feeding.
* Liver or kidney disease.
* Epilepsy
* Bleeding disorder or anticoagulant treatment
Medtronic Treat to Range (TTR) Closed-Loop Control

The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.

The purpose of this study is to demonstrate the safety and efficacy of a closed-loop "treat-to-range" (TTR) system in an inpatient clinical research center setting. The TTR system only effects insulin delivery when the glucose is projected to be above or below specified target ranges. These initial studies will assess the safety of this algorithm (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal over-insulinization. This is a "hybrid" system, which allows the research team to deliver insulin boluses manually with the TTR controller only becoming active when blood glucose levels are projected to be out of the specified range.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year.
2. Age 15 years to less than 30 years old.
3. HbA1c \< 10%.
4. Subject has used a downloadable insulin pump for at least 3 months.
5. Parent/guardian and subject understand the study protocol and agree to comply with it.
6. Subject comprehends written English.
7. Subject has a home computer with email access.
8. For females, subject not intending to become pregnant during the study.
9. No expectation that subject will be moving out of the area of the clinical center during the study.
10. Informed Consent Form signed by the subject or guardian.
11. Subjects cannot have had a severe hypoglycemic event described as a seizure, loss of consciousness requiring an emergency department visit or hospitalization within 6 months of enrollment.

Exclusion Criteria:

1. Asthma if treated with systemic or inhaled corticosteroids in the last 6 months; Subject has taken oral or injectable corticosteroids within the last 30 days; Current use of oral/inhaled Glucocorticoids
2. Cystic fibrosis
3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
4. Use of non-insulin medications that may affect blood glucose (eg Symlin),
5. Systolic blood pressure \>140 on screening; Diastolic blood pressure \>90 on screening
6. History of seizure or loss of consciousness in the last 6 months.
7. Adhesive allergies; Active skin condition that would affect sensor placement
8. History of heart disease
9. Active Graves disease;
10. Currently on beta blocker medication;
11. Unwilling or unable to follow the protocol;
12. History of diagnosed medical eating disorder;
13. History of known illicit drug abuse or prescription drug abuse;
14. History of current alcohol abuse;
15. History of visual impairment which would not allow subject to participate
16. Currently participating in an investigational study (drug or device);
17. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
Gastrectomy, Eating Behaviour and GLP-1

Patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer are known to have a significantly reduced quality of life. To date, there is very little information on the physiological causes of this. The investigators suspect that overproduction of a hormone (chemical) called glucagon like peptide-1 (GLP-1) released by the lining of the gut may play a role in the reduced appetite, weight loss and low blood sugar symptoms seen in this group. To investigate this, the investigators will study the response of 16 patients who have previously had a gastrectomy to a glucose drink, and a meal, while receiving an infusion of a specific blocker of GLP-1 or placebo. The investigators will examine the levels of sugar and associated hormones in the blood, food consumption and food reward behaviour using standard tools.

Participants will be invited to attend the Clinical Research Facility at Addenbrooke's Hospital for a screening visit, and two whole day study visits. The study has been designed to assess the role of overproduction of GLP-1 by completely blocking its actions, rather than assess the use of the blocking compound as a medication, and is therefore regarded as a physiological study, not a clinical trial.

The goal of this study is to demonstrate the magnitude of effect of GLP-1 on blood sugar and appetite derangement in patients who have had a gastrectomy. This will guide future work on the development of novel treatment paradigms for the post-gastrectomy patient group.


Eligibility Criteria:
Inclusion Criteria:

* • At least 3 months post completion of treatment for gastric cancer, or prophylactic gastrectomy

  * Aged at least 18 years
  * Able to tolerate an oral glucose tolerance test
  * Able to understand and retain all information regarding the study and give informed consent.
  * Willing to receive an infusion of human albumin solution

Exclusion Criteria:

* • Have a diagnosis of diabetes

  * Have a history of untreated anaemia in the last 3 months
  * Be aged under 18 years
  * Have active gastric cancer
  * Be pregnant or attempting to conceive
Modulating Speech Perception With Current Stimulation

This study aims to further develop tACS as a tool to improve speech perception, by manipulation of brain-speech synchronisation ("entrainment"), thereby transforming a promising approach into a technique that can benefit to society on a large scale.

Neural oscillations align their phase to the rhythm of speech. This phenomenon is termed neural entrainment and associated with successful speech comprehension. Importantly, we have demonstrated that transcranial alternating current stimulation (tACS) can be used to manipulate how neural activity aligns to speech rhythm, leading to changes in speech perception. The aim of Experiment 1 is to understand how tACS operates on the neural level. This aim will be reached by testing whether tACS produces rhythmic electroencephalography (EEG) responses that outlast the stimulation, indicating an involvement of endogenous oscillatory activity. The aim of Experiment 2 is to increase efficacy of tACS and, consequently, its potential to play an important role in research and everyday life applications. This aim will be reached by using brain imaging (fMRI) to predict optimal stimulation protocols for individual participants. The aim of Experiment 3 is to reveal how tACS can boost speech perception in a multi-speaker scenario. This aim will be reached by using tACS to enhance attended speech or suppress distracting speech, and by comparing these two approaches in their efficacy to boost speech perception. The aim of Experiment 4 is to combine established techniques to create novel opportunities to improve speech perception. This aim will be reached by using neurofeedback to teach participants to enhance their own neural entrainment, applying tACS to support them in this process.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged between 18 and 50 years old
* informed written consent
* Absence of pro-epileptogenic drugs
* Absence of visual or hearing impairment incompatible with participation in the study

Exclusion Criteria:

* Pregnant or breastfeeding women,
* Persons protected by law adults under guardianship or curatorship
* Persons not affiliated to a Social Security scheme
* Subjects with progressive psychiatric or neurological pathology
* Subjects with a contraindication to tCS or MRI (history of epilepsy, severe head injury or brain/spinal cord surgery, cardiac pacemaker/defibrillator, implanted equipment activated by electrical, magnetic or mechanical system, hemostatic clip carriers of intracerebral aneurysms or carotid arteries, orthopedic implant carriers, claustrophobic, pregnancy).
Surgical Treatment of Mild Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is one of the most common sleep disorder. There are numerous conditions that are related to OSA, such as diabetes, cardiovascular diseases, and metabolic syndrome. If the patient with OSA have large tonsils, soft and largened uvula or flacid soft palate, one might benefit from operative treatment of OSA. The aim of our study is to find out whether an operative treatment is effective in mild OSA patients with carefully assessed anatomical predispositions. Our ultimate goal is to evaluate the effects of operative treatment in mild OSA itself and in the diseases related to OSA. We measure the cardiovasculary functions, symptoms, postoperative recovery, antropometry, laboratory tests, the quality of life, the quality of sleep and the inflammatory system in sleep apnea before and after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* BMI \<35
* AHI 5-30 events/h
* Largened tonsils Grade ≥1

Exclusion Criteria:

* Age \<18 or \> 65
* BMI \>35
* AHI \<5 or \>30
* Tonsil size \< 1
* Severe nasal polyposis
* Pregnancy
* Chronic kidney, liver or thyroid disease
* Active treatment of OSA of any kind
Single Port Endoscopic Breast Conserving Surgery

The center plans to carry out a prospective clinical study of single hole total endoscopic breast conserving surgery for early breast cancer compared with open breast conserving surgery, to provide high-level evidence-based medical evidence for the development of endoscopic breast conserving surgery for early breast cancer.

Data show that breast cancer has surpassed lung cancer asthemost prevalent malignant tumor in the world, and traditional open surgery is highly invasive and has poor cosmetic results. This study investigates the results of endoscopic breast- conserving surgery(E-BCS) versus conventional breast-conserving surgery(C-BCS) in the treatment of patients with early-stage breast cancer and to compare the advantages and disadvantages of the two surgical procedures, so as to provide the best evidence for the rational choice of the procedure by both doctors and patients.

Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer confirmed by pathology；
2. Tumor \<5 cm, TNM stage 0-II；
3. Single Port Endoscopic or traditional open surgery; (4)20 to 70 years old female patients.

Exclusion Criteria:

1. Bilateral breast cancer;
2. Reconstruction after breast conserving surgery ;
3. Basic information is not complete；
4. Breast conserving surgery was converted to modified radical resection or subcutaneous adenoidectomy.
Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace

The purpose of the study is to examine the effectiveness of telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace, in comparison with treatment-as-usual (TAU) (which is minimal contact through Employers Assistance Program (EAP)).


Eligibility Criteria:
Inclusion Criteria:

* Age 20-57 at study entry \[because the retirement age is usually 60, we have to recruit the patients well before 60 in order to allow time for follow-up\]
* Men and women
* Currently employed full-time (either regular or temporary) by the business company
* Expected to be employed full-time for 2 years after screening
* K6 scores greater than or equal to 9 (or 10) at screening
* BDI2 scores greater than or equal to 10 at 2nd screening (Composite International Diagnostic Interview (CIDI) interview)

Exclusion Criteria:

* Part-time employees
* Sick leave for 6 or more days for a physical or mental condition in the past month
* Expected to be on pregnancy leave, maternity leave or nursing leave within 2 years after screening
* Current treatment for a mental health problem from a mental health professional
* Major depressive episode in the past month, as ascertained by CIDI \[We do not exclude dysthymia or major depression in partial remission\]
* Lifetime history of bipolar disorder, as ascertained by CIDI
* Any substance dependence in the past 12 months, as ascertained by CIDI. \[We do not exclude substance abuse.\]
* Any other current mental disorder if it constitutes the predominant aspect of the clinical presentation and requires treatment not offered in the project
* Those who have already received the telephone CBT in the pilot runs