cyrilzakka/clinical-trials huggingface dataset:
Incidence of Chronic Pain After Video-Assisted Thoracic Surgery

Video-assisted thoracic surgery (VATS) is frequently performed in thoracic surgery. It is widely accepted that VATS causes acute pain. Many factors such as postoperative analgesia treatment plan, operation time, number of chest tubes, and duration of chest tube stay can affect acute pain. This acute pain prolongs the discharge time of the patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Postoperative acute pain may cause chronic pain in the later period, and may adversely affect the quality of life of the patients.

This study, it was aimed to analyze the symptoms of chronic pain in the 1st and 3rd months postoperatively in patients who had undergone VATS.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-35 kg/m2
* Patients undergoing elective VATS

Exclusion Criteria:

* Advanced cancer
* History of chronic analgesic therapy
* Patients with previous thoracic surgery
* Patients who were operated under emergency conditions
Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.

Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers 18-65 years of age.
* Good general health.
* Must sign informed consent form.
* Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental procedures/visits.
* Medical condition which precludes eating/drinking for 12 hrs.
* History of allergy to common dentifrice ingredients.
* Subjects unable or unwilling to sign the informed consent form.
* Moderate or advanced periodontal disease.
* Two or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that can currently affect salivary flow.
* Current use of antibiotics.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 30 days prior to enrollment into this study.
* Use of tobacco products.
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).
Therapeutic Response of Cannabidiol in Rheumatoid Arthritis

The study will randomly assign Rheumatoid Arthritis (RA) patients on stable RA therapy to either placebo or cannabidiol (CBD). The overall goal of this proposal is to examine the efficacy and safety of CBD treatment as adjunctive to the medical management of RA patients.

This is a randomized, placebo-controlled, double-blind clinical trial at the University of California, Los Angeles evaluating the efficacy, safety, and tolerability of oral cannabidiol (CBD) as adjunctive for rheumatoid arthritis (RA) patients on stable therapy. Patients with moderate to severe RA meeting study inclusion criteria will be randomly assigned to one of three treatment groups (CBD 200 mg BID, CBD 400 mg BID, or placebo). Patients in all groups will receive CBD or placebo under observation for 12 weeks with an additional follow-up phone call occurring 4 weeks after.

Eligibility Criteria:
Inclusion Criteria:

* Meet the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 Classification Criteria for Rheumatoid Arthritis
* Disease activity score (DAS28) \>= 3.2
* Age \>= 18
* Stable RA therapy for 12 weeks prior to baseline
* Power Doppler Score \>= 5 (for the PDUS 34 joint score)
* Must use at least one highly effective method of contraception
* Written informed consent

Exclusion Criteria:

* Prior exposure to cannabis \<= 28 days prior to baseline
* Current diagnosed substance use disorders (including Alcohol Use Disorder)
* Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
* Chronic infections
* \>10mg of prednisone daily use
* Daily use of central nervous system (CNS) depressant medications (e.g. sedatives, hypnotics \[zolpidem, temazepam, alprazolam, lorazepam, diphenhydramine etc.\])
* Women who are pregnant, planning to become pregnant, or breast feeding
* Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception
* Deemed unsafe by the investigator
* History of an allergic reaction or adverse reaction to cannabis is exclusionary.
Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and visualization of amastigotes in tissue samples or a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 5 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

Safety concerns:

* Thrombocyte count \<30 x 109/l
* Leukocyte count \<1 x 109/l
* Hemoglobin \<5 g/100 ml
* ASAT, ALAT, AP \>3 times upper limit of normal range
* Bilirubin \>2 times upper limit of normal range
* Serum creatinine or BUN \>1.5 times upper limit of normal range
* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
* Immunodeficiency or antibody to HIV
* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months

Lack of suitability for the trial:

* Negative parasitology (aspirate/smear)or negative Montenegro test
* Any history of prior anti-leishmania therapy
* Any condition which compromises ability to comply with the study procedures
* Concomitant serious infection other than cutaneous

Administrative reasons:

* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures
Sleep Disturbances and Chronic Widespread Pain

Chronic widespread pain (CWP), defined as long-lasting pain in multiple body regions, has a prevalence of 10-14% in Europe and is associated with other physical symptoms such as fatigue and cognitive problems. Individuals with longstanding pain also have a high prevalence of sleep disturbances, and sleep problems can in itself lead to tiredness, lower neurocognitive function and higher pain ratings. However, studies of comorbid sleep problems for individuals with CWP are a lacking, and the primary aim for the present study is to assess the prevalence of sleep disturbances in individuals with CWP, and to see how this covariates with pain, fatigue, activity level, neurocognitive functioning, and biomarkers. As a secondary aim the study will assess a subgroup of the individuals, that has received multimodal pain management treatment, a second time after 6 months to analyze how the prevalence of sleep disturbances and other associated problems covaries over time.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Widespread Pain

Exclusion Criteria:

* Other untreated and or serious psychiatric or somatic conditions
Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients

This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.

To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.

Using mixture of indocyanine green (ICG) with radioisotope (RI) can guide surgeons to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast to the axillary lymph node basin.

Last pilot study, sentinel lymph node was successfully identified by using dual method of ICG and RI in 5 patients. In this study, when radiolabeled colloid is used, a gamma probe identifies radioactivity in the lymph nodes in the axilla. If ICG, RI both used, Near infrared fluorescence camera visualized during surgery.

As investigators measure node detection time from axillary approach moment, investigators are going to compare detection rate. (ICG+RI or RI only). And determine the accuracy.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.The protocol required that 130 patients who receive neoadjuvant chemotherapy.

In this study investigators expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients who receive neoadjuvant therapy (chemotherapy,hormonal therapy, targeted therapy)
* cN1-cN2 or cN3( but must be complete response status)on tumor lymphnode metastasis classification( TNM) after neoadjuvant therapy.
* ECOG Performance status 0 or 1
* consented patients with more than 20 years, less than 70 years

Exclusion Criteria:

* history of breast cancer
* early stage breast cancer
* history of excisional or incisional biopsy or axillary dissection
* inflammatory breast carcinoma
* cN3 on tumor lymphnode metastasis classification(TNM)
* stage 4 breast cancer
* pregnancy
Home Care Needs and Current Nursing Status of Patients With Amyotrophic Lateral Sclerosis

The purpose of this study is to comprehensively investigate and analyze the home care needs and status quo of ALS patients in China, and to clarify their home care needs and status quo, so as to provide reference for the development of home care service planning and policy measures for ALS patients.

Amyotrophic lateral sclerosis (ALS) is the most common type of motor neuron disease. It is common in middle-aged and elderly people. Progressive skeletal muscle weakness, atrophy, fascicular fibrillation, bulbar paralysis and pyramidal tract sign are the main clinical manifestations. The survival time is usually 3-5 years. As the pathogenesis of ALS is not fully understood, there is no specific treatment for ALS. The clinical treatment mode of most patients with ALS is hospitalization at the end of the disease and maintenance treatment at home during the disease progression. At present, there are few reports on the home care needs and nursing status of ALS patients in China. This study is a cross-sectional survey. Based on consulting the relevant literature and consulting experts' opinions, the researchers designed the questionnaire of home care needs and nursing status of ALS patients, The convenience sampling method was used to select 126-252 ALS outpatients, 126-252 ALS inpatients, and 126-252 ALS family members from a third class a general hospital in Beijing. The needs and status of home care of ALS patients in China were comprehensively investigated and analyzed, and the needs and status of home care were clarified, so as to provide reference for the development of home care service planning and policy measures for ALS patients.

Eligibility Criteria:
Inclusion Criteria:

-

The inclusion criteria of ALS patients:

1. They met the diagnostic criteria of Chinese guidelines for the diagnosis and treatment of amyotrophic lateral sclerosis; ② Receiving care at home; ③ No cognitive impairment (if the patient is unable to talk and write due to illness, the family members can express it for the patient);

   ④ Informed consent, willing to participate in this study;

   ⑤ No mental illness.

   The inclusion criteria of caregivers: ① the primary caregiver designated by the patient was responsible for the primary care;
   * They are relatives of patients;

     * No payment for care; ④ Informed consent, willing to participate in this study;

       * No mental illness; ⑥ There was no cognitive impairment.

   Exclusion Criteria:

   -

   Exclusion criteria of ALS patients:

   ① severe physical diseases, such as malignant tumor, liver and kidney dysfunction, etc;

   ② They are participating in other intervention projects.

   Exclusion criteria of caregivers:
   * severe physical diseases, such as malignant tumor, liver and kidney dysfunction, etc; ② They are participating in other intervention projects.
Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)

The purpose of this study is to determine whether a prototype toilet device that we have developed can accurately and automatically track human fluid output from renal and gastrointestinal systems in the hospital. The device includes components that can be outfitted onto existing toilets.

In this study, participants hospital room will be outfitted with the prototype toilet device. Participants will use the toilet as usual throughout the duration of their inpatient stay. Sometimes output will be measured by the device, and other times output will be measured manually by nurses.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo an allogeneic or autologous hematopoietic stem cell transplant for any cancer or non-cancer illness through the Duke ABMT clinic
* Age 18-80 years
* Karnofsky Performance Scale KPS ≥ 70
* Able to read/write English

Exclusion Criteria:

* Inability to use toilet device due to physical constraints, e.g. waste excreted through stoma or catheter
* Physician recommendation that patient does not use standard urine/stool collection hat during days 1-2 of HCT conditioning
Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data

Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.

The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Developmental and Epileptic Encephalopathy
* Registered with or benefiting from a social security scheme.

Exclusion Criteria:

* Opposition of the patient or his/her parents to the re-use of data in the context of this study
* Person subject to a safeguard of justice measure
Prospera Test Evaluation in Cardiac Transplant (ProTECT)

The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.

The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Patients who are enrolled in this study should have blood drawn for Prospera™ testing at regular intervals per routine clinical care. Prospera™ test results and results of surveillance endomyocardial biopsies, laboratory testing, echocardiograms, angiography and hemodynamic monitoring performed to monitor cardiac status and for signs of transplant rejection, as well as medications and post-transplant re-vascularization and surgical procedures will be recorded in the electronic case report form (eCRF). Patient management decisions, even those informed by the Prospera™ test result, are made based on the individual judgment of the healthcare providers participating in the study.

Eligibility Criteria:
Patients must meet all the following criteria to be eligible for the study:

1. Age 18 or older at the time of informed consent.
2. Enrolled within 60 days following heart transplantation.
3. Prospera™ testing is planned as part of standard clinical care to monitor for and assess transplant rejection.
4. Prospera™ testing is planned to be performed within 60 days (inclusive) following heart transplantation.
5. Selected by their healthcare provider to receive or continue receiving Prospera™ testing as part of their routine transplant management.
6. Willing and able to provide written informed consent.
7. Willing and able to comply with study procedures.

Patients are not eligible for the study if they meet any of the following criteria:

1. Pregnant at the time of signing informed consent.
2. Candidate for multiple solid organ or tissue transplant.
3. History of prior organ or cellular transplantation.
4. Ongoing testing with another allograft dd-cfDNA assessment is planned.
Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

How does long term treatment with Soliris affect HAHA in PNH patients?

To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.

Eligibility Criteria:
Inclusion Criteria:

* PNH patients who previously participated in study E05-001;
* Patients who have an eculizumab naive serum sample for comparison;
* Patients who currently used commerical Soliris;
* Patients who are willing and able to gie written informed consent.

Exclusion Criteria:

* There are no exclusion criteria for this study.
Smoking Cessation Program Among Adolescents in Vocational Training Centers

Background: Most of the efforts to fight against young people's tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees), was developed by a team of tobacco addiction specialist physicians. We developed a study to evaluate the efficacy of the program. Its main objective is to compare the efficacy of a smoking cessation program offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC) with that in a control population. The objective of this paper is to present the TABADO study protocol and the results of the pilot study.

Methods: The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC (in Lorraine, France): The intervention group (1000 trainees) benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees) other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months.

The pilot study is a descriptive monocentric cross-sectional study conducted among the whole group of students, completed by a longitudinal prospective study of smoker volunteers.


Eligibility Criteria:
Inclusion criteria:

* All students, males and females, registered in the VTC for at least a 2-year training period
* Aged from 15 to 20 years

Exclusion criteria:

* Subjects with current serious psychiatric disorders or who may be susceptible to decompensation upon quitting smoking (major depression)
* Smokers who are involved in an ongoing attempt to quit, with medical monitoring.
Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID)

The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older,
2. injected heroin, cocaine, or other drugs in the past 90 days.
3. test HCV Ab and RNA positive
4. provide written consent (including consent for researchers to examine their hepatitis C medical records)

Exclusion Criteria:

Persons already in care for hepatitis C, defined as having had at least 2 visits with a hepatitis treatment provider within the past 6 months, will be excluded.

People with decompensated cirrhosis will be excluded.