cyrilzakka/clinical-trials huggingface dataset:
Comparing Biopsy Needles for Endoscopic Ultrasound Guided Samples for Pancreatic Masses

This is a randomized prospective clinical study comparing a fine needle biopsy device and an aspiration needle.

At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G FNA or FNB needle. All patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. Subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. However, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. The number of passes needed to achieve diagnostic adequacy using both needles will documented.

Four dedicated passes will then be performed using the initial randomization sequence for cell block. Two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing.

If the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. This will also be a maximum of 8 passes. Information about the number of needles used, how many passes were performed, any problems with the needles will be collected. If there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo EUS
* Patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction
* Able and willing to provide written or verbal consent

Exclusion Criteria:

* Unable to safely undergo EUS for any reason
* Coagulopathy (Prothrombin time \> 18 secs, platelet count \< 80,000/ml)
* Active alcohol or other drug use or significant psychiatric illness
* Pregnancy
* Unable or unwilling to provide consent
Acute Metabolic and Endocrine Responses of Glucose and Fructose in Healthy Young Subjects

The purpose of this study is to investigate the metabolic and endocrine responses during 3 hour after taking 75g fructose or glucose in young Chinese.

The study was a double-blinded, randomized, crossover trial. Twenty healthy volunteers were randomized to two groups: group A (300ml of 22.5% glucose) and group B (300ml of 22.5% fructose).Volunteer was randomized into either group A or B, after an 8-h overnight fasting, took 300ml of solution at 0830 within 5 minutes. After one-week washout period, volunteer was crossed over for either group B or A. each intervention, venous blood was collected at 0h, 0.5h, 1h, 2h, and 3h and blood pressure was tested at 0h, 1h, 2h, and 3h.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were aged 19-39 years, with BMI between 18-24 kg/m 2.

Exclusion Criteria:

* Subjects pregnant or having a history of hepatic or renal disease, fructose intolerance, gout, hypoglycemia, or diabetes mellitus were excluded.
* Subjects taking any drugs, botanicals, or nutraceutical known to influence blood pressure also were rejected either.
Exploring the Immunology of Sarcoidosis

In sarcoidosis, over activity of parts of the immune system drives the accumulation of granulomas (collections of immune cells) in affected parts of the body. To facilitate development of effective and safe treatment options in the future it will be vital to understand how and why the immune system becomes over active. The aim of this research is to work towards this goal by studying cells of the immune system and the molecular pathways inside these cells that control how they behave. This will be achieved by analysing patterns of proteins and RNA (the code used to tell cells which proteins to produce) in immune cells present in blood samples and tissue biopsies from people with sarcoidosis.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, of any race, between 18 and 85 years of age, inclusive
2. Able to provide written informed consent
3. Clinician diagnosis of sarcoidosis
4. Treatment-naïve or receiving immunomodulatory therapy.

Exclusion Criteria:

1. Evidence of acute bacterial infection or other condition likely in the opinion of the investigator to significantly impact results of blood assays.
Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery

The aim of this pilot study is to investigate effectiveness, tolerability and safety of an oral nutritional supplement (PreOP Booster), given to rectal tumour patients prior to low anterior resection.


Eligibility Criteria:
Inclusion Criteria:

* rectal tumour with indication for elective low anterior resection (open surgery, not laparoscopic surgery) or abdominoperineal resection (APR)
* preoperative radiotherapy (5x5 Gy) or chemoradiation
* loop ileostoma or colostoma;

Exclusion Criteria:

* severe malnutrition
* severe renal insufficiency
* diabetes mellitus I or II
* concomitant thyroid medication
* corticosteroids
* diuretic medication and antihypertensive medication
* known or suspected allergy to any component of the investigational product(s)
Feasibility of a Bedtime Variability Protocol

The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol.

The purpose of this study is to find out if parents and children 6-10 years old are willing and able to follow a protocol to be used to study the effects of short and/or variable sleep in children. Children with medical conditions or taking medications affecting sleep, or children who do not have a regular bedtime, will be excluded. During each of three, one-week long periods, parents will have their child follow one of the following bedtime schedules: 1) habitual bedtime; 2) 1 hour later bedtime; or 3) variable bedtime (+/- 1 hour of habitual bedtime each day). Children will wear a sleep tracker and parents will complete daily diaries. Participants will answer questions about their experiences completing the protocol. Participants will attend an initial enrollment visit to complete consent and receive instruction on the protocol. Participants will then complete the three experimental conditions in a randomized, counterbalanced order. Participants will complete a phone or Zoom check in at the end of the first two conditions, and an in-person or Zoom visit at the end of the third condition where their opinions about the protocol feasibility and acceptability will be assessed, answer any questions, and provide them instruction for the next condition (when applicable).

Eligibility Criteria:
Inclusion Criteria:

* Child age 6-10 years
* Parent age 18 years or older
* Child has a regular bedtime (goes to bed within 30 minutes of the same time on 5 or more days per week)

Exclusion Criteria:

* Child has a medical condition impacting sleep (e.g., narcolepsy, sleep apnea)
* Child has a developmental disorder or delay (e.g., autism, Down syndrome)
* Child regularly takes supplements or medications (prescription or over the counter) for sleep, such as melatonin or antihistamines
* Not English speaking
* Not willing to follow bedtime protocol
* Residing in the same household as a current or previous participant (i.e., only 1 child per household may complete study)
Drug Utilisation and Lifestyle Intervention Study in Patients Attending Cardiac Outpatient Clinic

This study has two parts: A drug utilization study and a Health-related quality of life study.

This study has two parts: A drug utilization study and a Health-related quality of life study.

Drug utilisation study is an open label, cross sectional, descriptive drug utilization analysis of the primary cardiovascular drug classes prescribed to coronary artery disease patients attending cardiology OPD of a North India hospital.

Quality of life study intended to evaluate impact of a mobile based patient education program on the health related quality of life, physical activity and body mass index of coronary artery disease patients. It is a two arm study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults 18 - 75 years of age
* Diagnosed cased of coronary artery disease
* Agreeing after informed consent to participate

Exclusion Criteria:

* High risk cardiac patients
* Systemic, orthopedic and/or neurological problems restricting physical activity
Postpartum Pelvic Floor Rehabilitation and Information Provided by the Health Care Providers

The aim of this work is to evaluate the experience of Postpartum Pelvic Floor Rehabilitation (PPFR) according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the patient.

Postpartum Pelvic Floor Rehabilitation is an important central stage of the postpartum period. It allows, if it is well done, to reduce complications related to childbirth, (pelvic floor disorders: urinary, sexual or anal disorders ) and to increase quality of life of women in postpartum period.

But, what about the woman's opinion and experience of PPFR? Previous studies have evaluated the effectiveness of PPFR but not the woman's experience.

It is interesting to evaluate the experience of PPFR according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the women

Eligibility Criteria:
Inclusion Criteria:

* All women undergoing postpartum pelvic floor rehabilitation at the Departmental Hospital Center of Vendee

Exclusion Criteria:

* Refusal to participate in the study
* Patient did not complete all her PPFR sessions at the Departmental Hospital Center of Vendee
* Patient unable to understand the protocol, read the information note and answer the questionnaires
* Patient under tutelage, curatorship, mandate of future protection, family habilitation
Capsaicin in Digital Osteoarthritis Versus Control

The objective of this multicentric, randomized controlled double-blind clinical trial is to demonstrate the efficacy of transdermal application of capsaicin in patients with painful digital osteoarthritis with a neuropathic pain component.

Participants will receive either a transdermal patch of capsaicin 179 mg (8%) or the control treatment (capsaicin 0.04%).

Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8% group versus capsaicin 0.04% (control arm)

Visit 0 : Screening visit (D0 - 30 days): Screen for eligibility

Visit 1 :Inclusion visit (D0): Randomization and blinded patch application of capsaicin 8% or 0.04%

Visit 2: Follow-up visit 1 (D60 + 7 days): Assessment +/- Patch renewal. Patients with finger pain still greater than 4/10 may receive an open application of a capsaicin 8%

Visit 3:Follow-up visit 2 (D120 +/- 7 days): Final assessment.

For the duration of the study, the patient will record in a notebook: analgesics, anti-inflammatories, corticoids and daily hand pain VAS.

Blood samples will be taken at V1 and V2 for subsequent measurement of pro-inflammatory cytokines (IL6, IL8, TNFa) and markers of cartilage degradation, in order to build up a serum library.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of digital osteoarthritis fulfilling the American College of Rheumatology criteria;
* Presence of finger pain of ≥ 40 mm on a visual analogue scale (VAS);
* Presence of finger pain with a neuropathic pain component (DN4 score ≥ 4/10)
* Inadequate response, adverse reactions, and/or contraindications to conventional analgesics and NSAIDs;

Exclusion Criteria:

* Patient with isolated rhizarthrosis;
* Patient with other joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis);
* Patient with upper extremity pain syndrome that may interfere with the assessment of finger pain;
* Patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's tunnel syndrome, cervicobrachial neuralgia, brachial plexitis);
* Patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis);
* Patient with poorly controlled high blood pressure;
* Patient with hypersensitivity to capsaicin;
* Patient who had 8% capsaicin patch use in the year prior to the study;
* Patient who has received intramuscular, intra-articular or intravenous corticosteroid therapy, another disease-modifying anti-rheumatic therapy (methotrexate, salazopyrine) or an intra-articular injection into the joints of the fingers within the previous 3 months;
* Patient wearing wrist or finger orthoses in the previous month;
* Patient with fibromyalgia;
Anesthesia Type on Percutaneous Nephrolithotomy in Aging Male

The aim of this study is to compare the anesthesia methods in percutaneous nephrolithotomy in terms of safety and effectiveness in elderly men.

Data recorded since 2003 will be analyzed retrospectively. Elderly men with PNL will be divided into two groups according to the type of anesthesia. The results determined in both arms will be compared with appropriate statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Renal Stone Disease
* Above 65 years of age
* Male sex

Exclusion Criteria:

* Having low hemoglobin level before surgery
* Presence of hematology disease causing bleeding diathesis
* Presence of stones in an ectopic or transplanted kidney
Pilot Digital Follow-up of Lung Cancer

In the pilot study, 30 patients with metastatic lung cancer (stage IV) will be recruited at the start of their stage IV treatment from February 2019. The study period per patient will last six months, from the start of the stage IV treatment. Patients are eligible if they are diagnosed with stage IV lung cancer, speak sufficient Dutch, and are willing to participate. Patients are randomly assigned to two arms by simple randomization. In the intervention arm, 15 patients will receive a weekly questionnaire. Alerts will be sent to the multidisciplinary care team, who will undertake follow-up actions. In the control arm, 15 patients will receive the standard care pathway without weekly questionnaire and without automatic alerts to the care team. The standard care pathways and the care team are the same in both groups. In this pilot study, the weekly follow-up will be evaluated by a validation questionnaire, semi-structured interviews with patients (n=5) and the care team (n=5), and workload registration of the care team during a six-month period for all included patients in the pilot.


Eligibility Criteria:
Inclusion Criteria:

* stage IV lung cancer,
* speak sufficient Dutch
* willing to participate

Exclusion Criteria:

-
Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)

A consequence of chronic RV pacing is a process of electrical remodeling that alters myocardial repolarization to reflect the altered depolarization induced by the RV lead. When RV pacing is discontinued, the altered repolarization persists for several weeks. This phenomena is traditionally described as "T-wave memory" based upon the 12-lead ECG appearance of inverted T-Waves. The investigators are using the ECGI technique to produce three dimensional electroanatomical images of this phenomena in patients with dual chamber pacemakers. Echocardiography will also be used to image the mechanical effects of RV pacing and T-wave memory. The images will show the spatial distribution of altered repolarization and allow us to correlate any mechanical consequences of this phenomena that may exist.


Eligibility Criteria:
Inclusion Criteria:

* Implanted dual chamber pacemaker for sick sinus syndrome with no history of complete heart block.

Exclusion Criteria:

* Persistent atrial fibrillation that is not suppressed by medications.
Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol for Freeze-all Cycles

Stimulation protocols for IVF underwent several cycles of upgrading aiming to achieve reasonable outcomes with low-cost cycles. Antagonist protocols have been introduced as effective and comparable to long agonist regarding the outcomes. However, these protocols are still costly. Alternative protocols using progestin suppressions appear options for consideration.


Eligibility Criteria:
Inclusion Criteria:

1. Women age of ≥ 18 to ≤ 40;
2. BMI of ≤ 31;
3. All indication for freeze-all
4. PCOS;
5. Women who have ≥ 1 year of primary or secondary infertility;
6. Tubal factor (unilateral, bilateral obstruction or salpingectomy);
7. Fresh ejaculate sperm of any count provided they have ≥ 1% normal forms and a motile fraction;
8. Women undergoing their first ICSI cycle or following a previous successful attempt;
9. Women undergoing only frozen-thawed embryo transfer;
10. Women with \> 8 mm endometrial thickness at the day of progesterone supplementation in the transfer cycle;
11. Women with no detected uterine abnormality on transvaginal ultrasound (e.g. submucosal myomas, polyps or septa).

Exclusion Criteria:

1. Unilateral oophorectomy;
2. Uterine pathology or abnormality;
3. Abnormal karyotyping for them or their male partners;
4. History of repeated abortions or implantation failure;
5. Uncontrolled diabetes;
6. Liver or renal disease;
7. History of malignancy or borderline pathology;
8. Endometriosis;
9. Plan for PGD-A;
10. Severe male factor includes surgical sperm retrieval or cryopreserved sperm.
Black Women's Wellness Project

The proposed randomized controlled trial will evaluate an educational self-management intervention in 450 African American women and weight management. It will be the first to use a culturally tailored in-person and telephone approach to address all aspects of wellness and social determinants for African American women to achieve optimal long term wellness for both self and family.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American woman, aged 20-59
* BMI 27.5-57.4
* Ability to walk unrestricted for \> 3 min
* Caretaker of a child -providing a meal at least 50% of days/week
* Caretaker of at least one child aged 5 -12 years
* Resides in Jackson, Saginaw, Ypsilanti, Lansing, Detroit (All cities in Michigan)
* Speaks English fluently

Exclusion Criteria:

* \<12 months postpartum
* Active pregnancy
* Prior or anticipated bariatric surgery
* Non-ambulatory
* History of a severe cardiovascular event (including cerebrovascular accident or myocardial infarction)
* Severe mental illness, neurologic disease and/or cognitive impairment
Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases

The purpose of this study is to evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).


Eligibility Criteria:
Inclusion Criteria:

* histologically diagnosed as NSCLC, stage IVb \[ (American Joint of Cancer Committee(AJCC), 2002) \], Brain metastasis
* no history of hypertension or diabetes.

Exclusion Criteria:

* the brain tumor diameter \>5cm; RPA class =3; pregnancy.
High Cardiovascular Risk Management and Salt Reduction in Rural Villages in China

Cardiovascular disease is the leading cause of death in China. At the village level, strategies for the control of cardiovascular disease are mostly absent. National clinical guidelines for the management of hypertension and cardiovascular disease are rarely disseminated to, or implemented by, the village primary care providers. Salt reduction has greater potential in rural China than almost anywhere else in the world. Very high levels of salt consumption, very little use of processed food and most dietary salt deriving from home cooking makes the removal of salt from the diet easier, cheaper and more worthwhile than in almost any other setting. The two large-scale cluster-randomized controlled trials proposed here will precisely and reliably define the effect of two highly plausible intervention strategies on important clinical outcomes. The evidence provided by the project will form the basis for policy setting that has the potential to greatly reduce the occurrence of vascular disease in rural China and take an important step towards balancing the rural urban divide in health and healthcare.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed history of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or
* Older age (50 years or older for men; 60 years or older for women) and having physician-diagnosed Type I or Type II diabetes
* Older age (50 years or older for men; 60 years or older for women) and systolic blood pressure 160 mmHg (note that for simplicity, diastolic blood pressure is not included in the criteria)

Exclusion Criteria:

* none