cyrilzakka/clinical-trials huggingface dataset:
Reducing Skin Cancer Risk in Childhood Cancer Survivors

The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. This randomized controlled trial uses a three-group design.

Our specific aims are to: (1) Determine the impact of a Patient Activation and Education intervention with and without physician activation and teledermatology on skin cancer early detection practices, (2) Determine the impact of the intervention on time to diagnosis, and (3) Estimate the cost and cost-effectiveness of the intervention as a secondary outcome.

There are currently more than 420,000 Americans who are long-term survivors of childhood and adolescent cancer. While these groups have greatly benefited from recent medical advances, primarily increasing overall survival rates, treatment advances have come at a cost. It is now clear that childhood radiation therapy has caused survivors to be at extremely high risk for non-melanoma skin cancer (NMSC) and increased risk of melanoma. Early detection is crucial to reduce the morbidity caused by NMSCs and the morbidity and mortality incurred due to melanoma. Both patient and provider action are needed to detect and treat early skin cancers and to find new solutions to ensure expedited follow-up care and treatment, especially among those who live where they have little access to dermatologists.

The objective of this study is to determine the impact of a 12-month patient activation and education intervention on skin cancer early detection practices among childhood cancer survivors treated with radiation. All participants will receive text messages encouraging them to examine their skin and request physician examinations while concurrently driving them to a study website that provides education related to the associated skills, and reinforces and expands the text messages. To reduce skin cancers among this young and dispersed patient population, this study will address several key issues: (1) how to provide patients with the skills needed to conduct effective skin self-examinations; 2) how to prompt action from patient's physicians when worrisome moles and lesions are found; and 3) how to ensure rapid access to dermatologic exams, which in some parts of the US can take weeks or months to schedule.

Eligibility Criteria:
Inclusion Criteria:

* treated with radiation for a childhood cancer
* have a regular healthcare provider whom he/she has seen in the previous 2 years, or plans to see in the next year
* have a phone that can receive text messages
* have access to a dermlite compatible smartphone or tablet

Exclusion Criteria:

* personal history of a skin cancer diagnosis
Evaluation of the Safety and Efficacy of Smart Orthopedic Minimally Invasive Surgical Systems for Spinal Surgery

To evaluate the safety and effectiveness of the intelligent orthopedic minimally invasive surgery system developed by Shenzhen Xinjunte Intelligent Medical Equipment Co., Ltd. in spinal surgery.


Eligibility Criteria:
Inclusion Criteria:

- Age 18-65, gender unlimited; In line with the surgical conditions for spinal surgery requiring Kirschner wire implantation, and the treatment plan allows open or minimally invasive surgery; Signed the informed consent and agreed to participate in the study; Complete the filter check and meet all the entry criteria in the filter table.

Exclusion Criteria:

- Subject meeting the exclusion criteria; People with metal allergy; Women who are lactating or pregnant, and the possibility of pregnancy cannot be ruled out; Subjects with coagulation dysfunction; Subjects who have failed spinal surgery and need a second operation; Subjects with spinal tumors, deformities and slippery vertebrae; Candidates who have participated in clinical trials related to other drugs and medical devices within the past 3 months; Any other circumstances in which the Investigator deems it inappropriate to participate in this study.
Treatment of Early Stage Renal Failure With Active Vitamin D or a Phosphate Binder.

Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.


Eligibility Criteria:
Inclusion Criteria:

* Renal failure stage 3B
* 25(OH)vitamin D level above 50 nmol/l
* Age over 18 years
* Written consent

Exclusion Criteria:

* Major surgery during the previous 6 months
* Myocardial infarct during the previous 6 months
* Unstable heart failure
* Ongoing treatment for any malignancy
* History of frequent infections
* Pregnancy
* Ongoing treatment with steroids, lithium or biphosphonates
Saccharomyces Boulardii in Diarrhea Dominant Irritable Bowel Syndrome

Probiotics are friendly bacteria normally present in food products like yogurt whereas irritable bowel syndrome is a longstanding functional disorder characterized by abdominal pain and altered bowel habits either diarrhea or constipation dominant without a definitive etiology.

Study Hypothesis:Does probiotics(Saccharomyces boulardii improves daily bowel symptoms and quality of life in patients with diarrhea dominant irritable bowel syndrome?

Irritable bowel syndrome (IBS) is a common functional disorder and may lead to impaired social and personal function and can diminish quality of life.While the precise pathophysiology of IBS remains to be elucidated, dysmotility and altered visceral sensory perception are currently the most popular hypothesis. There has been a suggestion that some patients with IBS may harbor bacterial overgrowth leading to low grade inflammation, immune activation, and their symptoms may be ameliorated by its eradication.Probiotics, defined as live or attenuated bacteria or micro organism that confer a significant health benefit to the host.

* I. Firstly, probiotic organism exert antibacterial and antiviral effects.
* II. Probiotics could alter the composition of the gut flora, either directly through augmentation of commensal or indirectly through a reduction in pathogen related inflammation or bacterial fermentation.

Trial protocol:

Phase 1: placebo BID (1 week),both arms Phase 2: Randomization by pharmacy, placebo vs. active drug (6 weeks) Phase 3: placebo BID (1 week), both arms

-III. Probiotics have been demonstrated to exert anti-inflammatory effects at mucosal surfaces by reducing mucosal inflammation, decreasing immune mediated activation of enteric motor and sensory neurons and modifying neural traffic between the gut and central nervous system.

Saccharomyces Boulardii is a probiotic yeast and its role for the treatment of IBS has not been extensively investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be recruited from gastroenterology clinic at Aga Khan University hospital with diagnosis of diarrhea dominant irritable syndrome.
* Age between 18- 60 years.
* Male and female both.
* Organic gastrointestinal diseases excluded by baseline laboratory and sigmoidoscopy/colonoscopy and biopsy within last 2 years.
* All Patients need to satisfy ROME III criteria

Exclusion Criteria:

* Age \< 18 and \> 60 years
* Pregnant and lactating females
* Patients on laxatives or antidiarrheal drugs that could influence the motility of gut
* Patient on antibiotics or within 2 weeks of starting protocol.
* Not willing to participate
* Non-compliant in run in period.
* Patients taking Husk.
* Diabetic patients
ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma

Short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (PAAD) after surgeries. Despite the importance of adjuvant treatments for resected PAAD patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. In this study, we aim to examine whether postoperative circulating tumor DNA (ctDNA) could be used as a biomarker for early detection of minimal residual disease (MRD) and predicting relapse in resected PAAD through high-depth targeted next-generation sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed pancreatic adenocarcinoma (stage I-III)
* KRAS mutations identified in resected tumor tissues
* Margin negative (R0) or no imaging recurrence/metastasis and CA 19-9\<37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Receiving adjuvant chemotherapy
* ECOG 0-2
* Signed informed consent

Exclusion Criteria:

* With serious internal medicine diseases, infectious diseases, other solid tumors (except PAAD) or hematologic disorders
* Distant organ metastasis or malignant ascites
* Receiving neo-adjuvant therapy before surgery
* Imaging recurrence/metastasis or CA 19-9\>37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Pregnant or breastfeeding at time of enrollment
* Prior transplantation of bone marrow, stem cell or organ
Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)

Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.


Eligibility Criteria:
Inclusion Criteria:

* Patient has given written informed consent;
* BMI \< 30 kg/m2;
* Age 18 - 42 (upon starting COH);
* \<3 prior ART cycles (IVF, ICSI and related procedures);
* Baseline (day 2-3 of cycling) FSH \<15 IU/L and E2 \<80 pg/mL;
* Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or hysteroscopic exam (i.e. no polyps or protruding submucosal fibroids);
* Patients must have at least three retrieved oocytes.

Exclusion Criteria:

* Intramural uterine fibroids that distort the uterine cavity or polyps \>1 cm;
* Stage III or IV endometriosis (no endometriomas);
* Hydrosalpinges;
* History of past poor response to COH resulting in canceling ART;
* Use of thawed/donated oocytes;
* Use of thawed/donated embryos;
* Gestational carrier;
* Patients affected by pathologies associated with any contraindication of being pregnant;
* Hypersensitivity to study medication;
* Uncontrolled adrenal or thyroid dysfunction;
* History of conditions (i.e. toxic shock syndrome) that would contraindicate use of a vaginal progesterone product;
* History of arterial disease;
* Patients with hepatic impairment (liver function tests \> 2x upper limits of normal);
* Patients with dermatologic disease;
* Patients with renal impairment (estimated creatinine clearance \<60 mL/min/1.73 m2);
* Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
* High grade cervical dysplasia;
* History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages, wherein pregnancy developed to a minimum of a gestational sac on TVUS;
* Participation in a concurrent clinical trial or in another trial within the past 2 months;
* Use of concomitant medications that might interfere with the study evaluation;
* Pre-implantation genetic diagnosis/screening
Exercise Training for the Treatment of Generalized Anxiety Disorder

The purpose of this study is to compare the effects of 6 weeks of endurance or strength training and a wait list comparison condition on symptoms of Generalized Anxiety Disorder (GAD).


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-39 years
* Principal diagnosis of Generalized Anxiety Disorder according to DSM-IV diagnostic criteria (comorbidities will be acceptable as long as Generalized Anxiety Disorder is the principal diagnosis)

Exclusion Criteria:

* A score of less than 45 on the Penn State Worry Questionnaire
* A score of less than 7 on the Generalized Anxiety Disorder section of the Psychiatric Diagnostic Screening Questionnaire
* Expending greater than 250 kilocalories per kilogram body weight per week as measured by a 7-day physical activity recall questionnaire
* Engaging in greater than 6 exercise bouts in the month prior to recruitment
* Pregnancy
* Any medical contraindications (cardiovascular or musculoskeletal) to exercise training according to American College of Sports Medicine guidelines
Neutrophil Gelatinase-associated Lipocalin Concentration in Coronary Artery Disease

Serum NGAL has been described as a biomarker of neutrophil activation and an inflammatory marker which correlates to obesity and its metabolic complications. Since neutrophil activation has been implicated in the pathogenesis of coronary artery disease, the investigators hypothesized that serum NGAL levels would be higher in patients with CAD and that serum concentration would correlate with the extent of CAD as documented by coronary angiography, serving as a potential biomarker of the severity of CAD.

Inflammation is considered to play a major role in coronary artery disease (CAD) which accounts for high morbidity and mortality rates in the western world. Several lines of evidence support a role for neutrophils in the development of atherosclerosis and its progression.

Neutrophil gelatinase-associated lipocalin (NGAL), also known as Lipocalin-2, is a 25-kDa secretory glycoprotein that was originally identified in mouse kidney cells and human neutrophil granules. This protein has been used as a marker of neutrophil activation in several studies, while recently it was found to be an inflammatory marker closely related to obesity and its metabolic complications.

Recently, lactoferrin, a protein which co-localizes with NGAL in the specific granules of human neutrophils has been proposed as a more dynamic marker of neutrophil activation compared to the widely used myeloperoxidase in patients with CAD.

In line with the accumulating evidence, this study is designed to investigate the relationship between serum NGAL concentration and the presence or the severity of coronary artery disease according to coronary angiography.

Eligibility Criteria:
Inclusion Criteria:

* Consenting patients undergoing coronary angiography due to suspected CAD based on clinical history and results from non-invasive testing

Exclusion Criteria:

* Abnormal renal function
* Any known active inflammatory disease
* Receiving medical therapy with antibiotics, corticosteroids, immunosuppressive agents
Point of Care Device Use in the Pediatric Emergency Department

To compare the effect of "point-of-care" (POC) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (PED).

This study was a prospective, randomized controlled study of patients requiring blood work that a POC device was capable of performing. Length of time spent at various timepoints were prospectively recorded by a dedicated research assistant after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Clinically requiring bloodwork capable by the POC device

Exclusion Criteria:

* Requiring other bloodwork such as medication levels, WBC
A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State

A study demonstrates the bioequivalence of DA-1229_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 19 years of age at the time of health examination
* Female patients who were confirmed to be not pregnant at health examination
* Patients without a history of mental illness in the past 5 years

Exclusion Criteria:

* Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial
* Patients with a congestive heart failure which requires medicinal treatment
* Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial
* Female patients who are lactating
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas

This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma(NHL) for whom no treatment of higher priority was available.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, \>=18 years of age;
2. Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Life expectancy \>6 months
5. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 2 months after discontinuation of all study treatments
6. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

1. Prior use of any investigational antibody therapy within 3 months of study start
2. Prior use of any anti-cancer vaccine
3. Prior administration of radioimmunotherapy 3 months prior to study entry
4. Central nervous system lymphoma
5. History of other malignancy
6. Evidence of significant, uncontrolled concomitant disease
7. Abnormal laboratory values
8. Patients with progressive multifocalleukoencephalopathy (PML)
9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
10. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV

The purpose of this study is to determine if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.


Eligibility Criteria:
Inclusion Criteria:

* inpatient rehabilitation in Schön Klinik Berchtesgadener Land
* stable COPD(GOLD severity III and IV with and without respiratory insufficiency)

Exclusion Criteria:

* severe exacerbation in the last four weeks
* acute coronary syndrome
* unability to cooperate
Restorative Treatment of Severe Tooth Wear; Direct vs Indirect

This study compares the survival rates of both direct and indirect resin-based composite restorations in the treatment of severe tooth wear.

Tooth wear can lead to pain, discomfort and unsatisfying dental attractiveness and when severe, it can compromise the dentition's prognosis. Restorative therapies for treatment of severe tooth wear should be preferably minimally invasive and adhesive.

This study compares two different treatment techniques for severe tooth wear. The first technique is regarded as the 'standard' technique. This is a full rehabilitation using only direct composite restorations (AP-X, Kuraray, Japan).

The second technique comprises a full rehabilitation using both direct and indirect resin composite restorations (Estenia C\&B, Kuraray, Japan). 10 indirect restorations are placed on specific elements i.e. first molars and palatal sides of all maxillary anterior teeth. Other elements are restored conform the direct protocol.

An important benefit for the patients is the rehabilitation of their worn dentitions. Functionality (teeth are less sensitive, improved chewing ability, better occlusal stability, etc) and aesthetics will be improved immediately after finishing the treatment.

Indirect techniques have the advantage of a superior control over form of restorations.

Eligibility Criteria:
Inclusion Criteria:

* Patients age of at least 18 years old.
* Generalized moderate to severe tooth wear (Tooth Wear Index (TWI) ≥ 2) with a patient demand for treatment (Smith 1984)
* Full dental arches, but one diastema due to one missing tooth in the posterior area was allowed.
* An estimated need for increase of vertical dimension of occlusion (VDO) of ≥3mm at the location of the first molars.

Exclusion Criteria:

* Limited mouth opening (\<3.5cm).
* (History of) Temporomandibular dysfunction, periodontitis, deep caries lesions or multiple endodontic problems.
* Local or systemic conditions that would contra-indicate dental procedures.

Patients with specific individual risk factors, such as parafunctional habits of grinding/clenching or patients with GORD (Gastro Oesophageal Reflex Disease), were not excluded.
Effect of Fermented Maillard Reacted Whey Protein on Immune Function

To investigate the impact of supplementing fermented Maillard reacted whey protein (F-MRP) on natural killer (NK) cell activity, circulating cytokines and serum protein levels.

A randomized, double-blind, placebo-controlled study was conducted on 80 participant without diabetes and obesity. Over a 8-week testing period, the F-MRP group consumed 6 g of powder containing 4.2 g F-MRP each day, whereas the placebo group consumed the same amount with dextrin. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, or 1.25:1.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* The levels of white blood cells within range 3x10\^3/μL\~8x10\^3/μL
* Males and females
* 20-70 years old
* Without no severe complications

Exclusion Criteria:

* Diabetes
* White blood cell under 3x10\^3/μL or over 8x10\^3/μL
* Pregnancy or breast-feeding
* Hypersensitivity or disease history for milk protein
* Liver disease, inflammation disease, or severe kidney failure disease
* Cancer, lung disease, leukemia, or autoimmune disease
* Psychological or neurological disease
* Myocardiac infarction or cerebrovascular diseases within 6 months before screening
* Consumption of other test products or drugs within 1 month before screening
* Inflammation related disease within 1 month before screening
Accelerated rTMS for the Reduction of Nicotine Craving

The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient Adults aged 18-70
* Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of \>10ppm day of visit.
* Ability to provide informed consent

Exclusion Criteria

* Current treatment with varenicline or bupropion
* Currently making a smoking quit attempt (not currently smoking).
* Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer.
* Current episode of major depression determined by MINI interview.
* Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI.
* Current daily consumption of alcohol or current alcohol use disorder.
* Current substance use disorder except for nicotine or cannabis use disorder.
* Currently pregnant or lactating.
* Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion.
* Unstable medical conditions
* Suicidal ideation or history of suicide attempt within the last six months.
* Inability or unwillingness of subject or legal guardian/representative to give informed consent