cyrilzakka/clinical-trials huggingface dataset:
Support for Cancer Patients Awaiting News

This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and/or protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).

Advanced cancer patients repeatedly undergo routine scans that inform their disease status and treatment. While awaiting the results, anxiety and uncertainty are elevated, which can negatively impact quality of life. Evidence-based stress management strategies have the potential to be useful during this unique time period, but require tailoring for this population and context.

The goal of this study is to pilot test an adapted stress management program to help patients manage their anxiety while awaiting scan results. The program is a behavioral intervention that includes psychoeducation and stress management activities, delivered via a web platform to promote dissemination. In the Open Trial phase, the program will be field tested in a single-arm trial, using feedback to refine materials and procedures as needed before formal piloting. In the Pilot RCT phase, a small RCT will be conducted to test the intervention's feasibility and acceptability and to examine preliminary effects on anxiety and cancer-related intrusive thoughts.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (ages 18 and older)
2. Comfortable speaking, reading, and writing English without an interpreter
3. Established diagnosis of Stage III-IV lung cancer (or extensive stage small cell lung cancer)
4. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
5. Receiving ongoing care from collaborating clinics with regular scans
6. Receiving systemic treatment for lung cancer
7. Endorse appointment- or scan-related stress on 4-item screen (using a modified Distress Thermometer item, a Fear of Progression scale item, an Impact of Events scale item, and an item from our prior study)
8. Willingness to use the study website

Exclusion Criteria:

1. Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen)
2. Requires an interpreter for medical visits
3. Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)
4. Currently enrolled in hospice
5. Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)
Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection

The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in the patients with pediatric acute upper respiratory tract infection with bacterial infection.

Upper respiratory tract infection is the most common respiratory disease in childhood, and the incidence rate accounts for more than 60% of pediatric outpatients, ranking first in pediatric diseases. At present, antibiotics are commonly used to treat children with upper respiratory tract infections. However, due to the large amount of clinical use of antibiotics in recent years, the resistance of various pathogens has become stronger and stronger, which has caused the majority of clinicians and researchers to turn their attention to traditional Chinese medicine. Qingfei Granule is composed of six common herbal medicines such as Schizonepeta (Jing-Jie),Radix Scutellariae (Huang-qin),Forsythia (Lian-Qiao), etc. After upper respiratory tract infections with bacterial infections, chills, fever, runny nose, red and sore throat may occur, and may be accompanied by mild cough, thin red tongue, yellow moss, floating pulse,which is considered as the exogenous wind-heat Zheng in Chinese medicine. The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in the patients with pediatric acute upper respiratory tract infection with bacterial infection.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with the acute upper respiratory tract infection;
2. Diagnosis with wind-heat Zheng according to Chinese medicine;
3. Age: 5-14 years old;
4. Body temperature ≥ 37.5 ℃;
5. White blood cell count\> 12 × 10\^9 / L, and / or neutrophil ratio over than 70%;
6. The informed consent process complies with the regulations, and the legal agent or the child (≥8 years old) jointly sign the informed consent

Exclusion Criteria:

(1) Acute bacterial otitis media; (2) Patients with periodontitis or periodontal abscess (3) Candidiasis; (4) Patients with positive mycoplasma; (5) Taking antibiotics, anti-inflammatory drugs, and antihistamines; (6) Patients with severe comorbidities of heart, liver and kidney; (7) Other patients with acute infectious diseases and mycoplasma pneumoniae infections with symptoms similar to upper respiratory tract infection; (8) Children with a history of epilepsy or convulsions; (9) Patients with mental illness; (10) Those who are allergic to treatment drugs; (11) Participated in other clinical trials in the past month; (12) The investigator evaluates that it is not suitable to participate in this clinical trial or according to the investigator's judgment, who is likely to loss to follow-up.

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Development and Validation of a Multidimensional Score to Predict Long-term Kidney Transplant Outcomes

To further develop personalized medicine in kidney transplantation and improve transplant patient outcomes, attention has been given to define early surrogate endpoints that might aid therapeutic interventions, clinical trials and clinical decision-making.

Despite a clear pressing need, no population-scale prognostication system exists that will combine traditional factors and biomarker candidates to represent the complete spectrum of risk predicting parameters. To adequately predict transplant patients' individual risks of allograft loss, this would require a complex integration of data, including: donor data, recipient characteristics, transplant characteristics, allograft precision phenotypes, ethnicity, immunosuppressive regimen monitoring, allograft infections, acute kidney injuries, and recipient immune profiles.

This project aims:

1. To develop a generalizable, transportable, mechanistically and data driven composite surrogate end point in kidney transplantation;
2. To validate several risk scores to predict kidney allograft survival and response to treatment of individual patients;

Eventually, it will provide an easily accessible tool to calculate individual patients' risk profiles after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.

Background The field of kidney transplantation currently lacks robust models to predict long-term allograft failure, which represents a major unmet need in clinical care and clinical trials. This study aims to generate and validate an accessible scoring system that predicts individual patients' risk of long-term kidney allograft failure.

Main Outcome(s) and Measure(s)

A score based on classical statistical approaches to model determinants of allograft and patient survival (Cox model, multinomial regression). These models will be further completed with statistical approaches derived from artificial intelligence and machine learning.

Eligibility Criteria:
Inclusion Criteria:

* Kidney recipient transplanted after 2002
* Kidney recipient over 18 years of age

Exclusion Criteria:

* Combined transplantation
Validation of the Transport of Biological Material by Drone

The Hospital Group of Territory Somme Littoral Sud, through its biology sector and in partnership with the company DELIVRONE, aims to engage in the experiment of transporting biological samples by means of a drone platform. Transport by air will be between the CHAM, the Abbeville Hospital and the CHU Amiens-Picardie by flying as much as possible over the waterways via the Somme. With a flight speed of around 100km/h at an altitude between 80 and 120 m, drones will be able to connect sites in less than an hour by transporting packages between 2 and 3 kg. Powered by propellers connected to rechargeable batteries, these drones do not emit CO2. This type of transport has not been validated in France by measuring the analytical impact of transport constraints for medical biology, and has never been evaluated according to the criteria of ISO 15189 standard allowing the certification of medical biology laboratories. Validation steps of this transportation method are therefore necessary on pathological samples prior to routine use.

The aim of the project is to validate the transport of biological samples by drone under defined flight conditions between CHAM and CHU Amiens-Picardie


Eligibility Criteria:
Inclusion Criteria:

* participants of legal age
* No contraindication to blood collection
* Voluntary
* informed and consenting participants

Exclusion Criteria:

* Impossible to collect sufficient blood volume
* Refusal to participate in the study
Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue

This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment and Group B which receives sham treatment and will serve as a control to verify the treatment outcomes. Subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). All of the study subjects will receive the treatment (either active or sham) with the subject device.

At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* Voluntarily signed an informed consent form
* BMI ≤ 35 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study.
* Willingness to abstain from partaking in any treatments other than the study procedure
* Willingness to comply with study instructions, to return to the clinic for the required visits and to undergo punch biopsies in the abdominal area.

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Metal implants in the treated area
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Injured or otherwise impaired muscles in the treated area
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations in the treated area
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Application during pregnancy, postpartum period, nursing, and menstruation
* Graves' disease
* Skin related autoimmune diseases that may contradict the biopsy
* Poor healing and unhealed wounds in the treatment area
* Any disease or condition contradicting the skin tissue biopsy
* Any disease or condition that may compromise the histologic observation at the pathologist discretion
Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)

Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged between 18 - 45 years
* Gestational age between 24.0 and before 33.6 gestational weeks
* Singleton pregnancy
* Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)
* Ultrasound cervical length at discharge \< 25 mm
* Signed patient consent form (CI)

Exclusion Criteria:

* Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.
* Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.
* With known allergy to progesterone or peanuts (excipient).
* Grade 2 (or upper) renal or liver laboratory abnormalities
* Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)
* With Diabetes mellitus or insulinized gestational diabetes
* Treated with heparin
* Drug abuse
* Inadequate treatment compliance
Validation of Transvaginal Tactile Imaging

The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the outcome of reconstructive surgery.

1. The device will detect significant differences in tissue elasticity and anatomy for women with normal pelvic floor versus women with prolapse stage 1.
2. The device will detect significant differences in tissue elasticity and anatomy for patients before and after reconstructive surgery.
3. The device will detect significant differences in tissue elasticity and anatomy among 3 groups of patients with prolapse stages 1, 2 and 3.
4. The device will detect significant differences in tissue elasticity among 3 control groups with normal pelvic floor conditions (nulliparous women at age 21-30, parous women at age 31-40, and postmenopausal women).

Eligibility Criteria:
Inclusion Criteria:

* Subject is female of 21 years or older AND HAS AT LEAST ONE OF THE FOLLOWING
* No evidence of pelvic organ prolapse and no prior pelvic surgery
* Stage 1 or greater pelvic organ prolapse affecting one or more vaginal compartments and no prior pelvic surgery
* Stage 2 or greater pelvic organ prolapse affecting one or more vaginal compartments and reconstructive surgery is scheduled

Exclusion Criteria:

* Active skin infection or ulceration within the vagina
* Presence of a vaginal septum;
* Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
* Ongoing radiation therapy for pelvic cancer;
* Impacted stool
* Recent (less than three months) pelvic surgery;
* Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia;
* Severe hemorrhoids
* Surgically absent rectum or bladder
* Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone

After tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed. Bone resorption occurs specially in incisors and premolar area of jaw in region of thin buccal bone that may lead to change in contour. Total clinical bone loss height approximately 2-5 mm at first 6 months may be observed in vertical dimension , after 12 months alveolar ridge may lose up to 50 % of its width.

Recently augmentation with bone grafting became one of the most common techniques surgically ; progressive bone resorption may be prevented by using augmentation procedures with use of graft materials. The gold standard in regenerative procedures is autogenous bone graft because of osteoinduction , osteoconduction and osteointergration properties required in regeneration. In autogenous bone graft there is need for a second surgical site , donor site morbidity and limited availability will lead to challenge for alternative bio-materials.

Extracted healthy non functional teeth from human are considered to be a dental waste all over the world. High proportion of extracted sockets are left untreated for physiological healing. Inadequate or failure of bone healing in sockets has been seen due to absence of bone graft material. Stem cells, matrix , trace metal ions and growth factors are rich in human tooth. Bone and dentin tissue structure are different but ratio of components is similar (mineral 70% , collagen 20% and body fluid 10% by weight). Dentin after demineralization is mainly composed of type 1 collagen 95% and non collagenous proteins as growth factors.

Eligibility Criteria:
Inclusion Criteria:

* Patient related :

  * Patient who only need to restore this single tooth.
  * Good oral hygiene
  * Systemically healthy (free from any systemic diseases)

Site related :

* Hopeless tooth (nonrestorable, badly broken, endodontically treated) indicated for extraction and immediate implant placement
* Esthetic area with thin buccal bone
* Having periapical bone more than 3mm for primary stability

Exclusion Criteria:

* Patient related :

  * Smokers
  * Pregnant woman

Site related

* Teeth that have to be extracted due to advanced periodontal bone loss
* Trauma in aesthetic area
* Periapical infection.
Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells

To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.

* Validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types
* Characterize and identify these circulating tumor cells and demostrate cell viability with this capture method
* Apply this technology in clinically relevant settings and correlate to response to treatment and disease progression
* Elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed metastatic disease planned for palliative chemotherapy
* Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer
* Informed consent given for the purposes of blood sampling for this study
* Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual

Exclusion Criteria:

* N/A
An Alternative Dosing Schedule of Varenicline for Smoking Cessation

The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.

This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

* currently smoking at least 15 cigarettes daily
* in good health
* able to read and speak English fluently
* have a home telephone and plan to reside in Western New York for 6 months
* willing to make quit attempt
* signed informed consent
* who planned quit attempt.

Exclusion Criteria:

* serious medical condition
* depression or mental health condition requiring treatment in the past year
* history of panic disorder, psychosis, bipolar disorder
* alcohol or drug abuse in the past year
* use of tobacco products other than cigarettes
* current use of other cessation pharmacotherapies
* pregnancy/planned pregnancy.
Barriers and Breakthroughs in IMPlementing Split Regimen OVEr Single Dose

The split-dose regimen (SpD) has demonstrated its superiority over the day-before regimen (DB) in determining a better colon cleansing and is considered the standard bowel preparation for colonoscopies by the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. However its application is still suboptimal due to concerns about patient acceptability, fluid aspiration due to residual gastric contents and challenging viability for early morning colonoscopies. Barriers precluding the prescription of SpD have been explored in few studies mainly in the setting of auditing of current practice, while corrective measure aiming at changing this practice have been prospectively tested in very few, small and selected, cohorts. The present study has the aim of surveying split-dose regimen adoption rate among several endoscopic centres before and after an improvement phase following a plan-do-study-act approach, in order to analyse and correct factors preventing its adoption. A multivariate analysis was planned in order to use collected data to infer factors favouring and limiting split-dose regimen adoption.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing colonoscopy with full bowel cleansing

Exclusion Criteria:

* Incapacity to give informed consent
* Partial colonoscopy
Social Facilitation of Alcohol Effects and Alcohol Misuse in Young Adults

The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 250 young adults who drink alcohol frequently will take part in the study. This research is being funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Participation involves one in-person screening session with a same-sex platonic friend. Then participants will complete four in-person laboratory sessions where they will drink beverages containing alcohol or no alcohol. After completion of the laboratory sessions, participants will complete smartphone surveys for 28 days. Lastly, they will complete follow-up surveys 6 months and 12 months post-study enrollment.


Eligibility Criteria:
Inclusion Criteria:

* 21-28 years of age
* Drink regularly (1+ times/week) with a same-sex platonic friend that also meets eligibility and is willing to participate
* Regular alcohol use (3+ times/week) with at least one binge drinking episode (5+ drinks \[male\] or 4+ drinks \[female\] in about 2 hours) in the past month
* BMI of 18-30
* Own a smart device operating on the iOS or Android operating system
* Fluent in English

Exclusion Criteria:

* Pregnancy or breastfeeding or intent to get pregnant in the next 60 days (females)
* medical conditions counter-indicated for alcohol administration
* seeking treatment for alcohol use