louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03448900: Intervention Study for Smoking Cessation in Spanish College Students
Official title: Intervention Study for Smoking Cessation in Spanish College Students: Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: Cessation
College student
Motivational Interview
Self-efficacy
Intention
Beliefs
Young adult
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: University of Navarra
First posted: 2018-02-28
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking.

Detailed description: This study hipotetize that a multicomponent intervention, tailored to college student and conducted by a nurse is more effective than brief advise.

The intervention was a multi-component intervention based on the Theory of Triadic Influence and on previous recommendations made in the Surgeon General's report . The strategies of this program consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The smoking-related Self-efficacy, Belief and Intention scale was used to assess outcomes.

Eligibility criteria: Inclusion Criteria

- Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months

Exclusion Criteria

- Students who are ex-smokers

Primary outcomes:
measure: Smoking cessation
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Mean of smoked cigaretes
timeFrame: 6 month follow-up
measure: Quit attempts
timeFrame: 6 month follow-up
measure: Stages of change according to Prochaska's model
timeFrame: 6 month follow-up
measure: The self-efficacy to avoid smoking, and
timeFrame: 6 month follow-up
measure: Smoking-related beliefs
timeFrame: 6 month follow-up
measure: Intention to quit smoking
timeFrame: 6 month follow-up
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Miren Idoia Pardavila Belio
state: Navarra
Study officials:
affiliation: University of Navarra
name: Miren I Pardavila-Belio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pardavila-Belio MI, Garcia-Vivar C, Pimenta AM, Canga-Armayor A, Pueyo-Garrigues S, Canga-Armayor N. Intervention study for smoking cessation in Spanish college students: pragmatic randomized controlled trial. Addiction. 2015 Oct;110(10):1676-83. doi: 10.1111/add.13009. Epub 2015 Jul 2.
citation: Pardavila-Belio MI, Canga-Armayor A, Duaso MJ, Pueyo-Garrigues S, Pueyo-Garrigues M, Canga-Armayor N. Understanding how a smoking cessation intervention changes beliefs, self-efficacy, and intention to quit: a secondary analysis of a pragmatic randomized controlled trial. Transl Behav Med. 2019 Jan 1;9(1):58-66. doi: 10.1093/tbm/ibx070.
Clinical trial NCT06718400: Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation
Official title: Vascularised Sentinel Skin Flaps to Predict Rejection in Intestinal Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intestinal Transplant
Keywords: Transplant
Sentinel Skin Flap
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Willing participants who will be receiving an intestinal transplantation will receive a sentinel skin flap on their forearm from the same donor
Primary purpose: OTHER

Brief summary: This pilot study aims to validate the use of vascularised donor-derived sentinel skin flaps for diagnosing and monitoring rejection in intestinal transplantation

Detailed description: Intestinal transplantation is the current treatment option for patients with irreversible intestinal failure that has not responded to other methods of treatment. Whilst the majority of patients that have an intestinal transplant will obtain good graft function over many years, some patients suffer from reduced function of their new intestine following transplantation that can progress to the transplant failing completely.

Acute rejection may be the most common cause of transplant failure. Currently, there is not an effective way of monitoring the intestine that can detect rejection before irreversible damage occurs. If there is a more sensitive way of continuously monitoring the intestine transplant for rejection then issues could be earlier detected and early treatment could prevent permanent damage to the transplant.

The reason for this study is to assess a new technique that has been developed to detect early rejection in intestinal transplantation. The name of this technique is called a 'sentinel skin flap' and involves transplanting a patch of forearm skin from the donor at the same time as the intestine

Eligibility criteria: Inclusion Criteria

* Recipient of an intestinal transplant.
* Participant is willing and able to give informed consent for participation in the study
* Male or Female, aged 18 years or above

Exclusion Criteria

* Patient does not have a patent ulnar artery in either forearm or a negative Allen's test.
* Patient is not willing to return to the Institution for all clinical follow-up for 12 months
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant's ability to participate in the study.

Primary outcomes:
measure: Correlation of histological rejection in the skin flap and the transplanted solid organ
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Anil Vaidya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01081652: A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
Official title: An Open, Randomized, Comparative, Phase III Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: Fertilisation, In vitro
Embryo transfer
progesterone
Reproductive technologies, Assisted
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 238
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET.

Detailed description: This was an open-label, randomized, comparative, multicentric, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in Chinese female subjects undergoing IVF/ET. The study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. The progesterone administration was started on the day of ET. Randomisation was performed on the day of ET. If pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. The subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.

Eligibility criteria: Inclusion Criteria:

* Patient has given written informed consent
* BMI \< 25 kg/m2
* Age \< 36 years
* \<3 prior ART cycles (IVF, ICSI and related procedures)
* Infertility
* Regular spontaneous ovulatory menstrual cycles

Exclusion Criteria:

* Habitual abortion
* Hydrosalpinges
* History of past poor response to COH
* Patients with serious arterial, lung, hepatic and renal diseases
* Hepatic and renal impairment

Primary outcomes:
measure: The difference in hCG positive rate in the two arms 14 days after embryo transfer
measure: The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer
measure: The difference in implantation rate in the two arms 30 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hopistal
Study officials:
affiliation: Serono Pharmaceutical Limited
name: Huafei Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT02278952: Tacrolimus Adjustment by NFAT-related Gene Expression in Lung Allograft Recipients.
Official title: Tacrolimus Adjustment by NFAT-related Gene Expression in Lung Allograft Recipients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplantation, Lung
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Astellas Scientific & Medical Affairs, Inc.
First posted: 2014-10-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung transplant recipients

Brief summary: This is a non-interventional cohort study to assess a novel assay to detect excessive or insufficient immunosuppression from the drug tacrolimus in lung transplant recipients. The assay measures mean residual expression (MRE) of genes downstream of nuclear factor of activated T cells (NFAT), a transcription factor regulated by tacrolimus. The investigators will assess whether MRE levels identify subjects at risk for rejection (insufficient immunosuppression) or infection (excessive immunosuppression).


Eligibility criteria: Inclusion criteria:

The study will include lung allograft recipients within 2 months of transplantation at UCSF.

Exclusion criteria:

Subjects will be excluded who are (a) unable to provide consent or (b) if treating clinicians do not anticipate subject will start on tacrolimus. Recruitment and enrollment in this study are targeted equally between women and minorities and the study will not exclude any gender or racial/ethnic group. This study does not involve vulnerable populations.

Primary outcomes:
measure: Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Acute Cellular Rejection
timeFrame: from 1 month up to 18 months post-transplant
measure: Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Infection
timeFrame: from 1 month up to 18 months post-transplant
Secondary outcomes:
measure: Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Weeks Post-Transplant
timeFrame: from 1 month (4 weeks) up to 18 months (82 weeks) post-transplant
measure: Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Tacrolimus Trough Level
timeFrame: from 1 month up to 18 months post-transplant
measure: Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Medication Dosages
timeFrame: from 1 month up to 18 months post-transplant
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Greenland John, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04663152: Integrated Navigation Services for Treatment Adherence, Counseling, and Research
Official title: Integrated Navigation Services for Treatment Adherence, Counseling, and Research
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infection Primary
Keywords: HIV viral suppression
community health worker
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research is to determine whether a Community Health Worker (CHW) intervention including a mobile telehealth (M-Health) component can help achieve long term viral suppression among Black people with poorly controlled HIV.


Eligibility criteria: Inclusion Criteria:

* Ages 18 years or older
* patient from adult HIV outpatient clinic at University of Miami/Jackson Memorial Health System
* self-identify as Black
* uncontrolled viral suppression as determined by treating clinician
* English speaking

Exclusion Criteria:

* Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.

Primary outcomes:
measure: Communication Preferences
timeFrame: 3 months
measure: Number of CHW contacts
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sonjia Kenya, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05595252: Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022
Official title: Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Intraepithelial Neoplasia
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study on patients who were pregnant and have a CIN lesion at the same time, care at the MRUN, the Nancy Régional Maternity between 2014 and 2022

Brief summary: In France, the screening rate for cervical cancer remains too low. Screening is simple and non-invasive.

Pregnant patients are most of the time young and are part of the target population for screening, and for many women, it is the first encounter with a gynecologist.

The cervical smear is therefore an important step of the first consultation during pregnancy In the case of pathological results, colposcopies with biopsies are performed, frequently finding CIN 1 to 3. (cervical intraepithelial neoplasia) These CIN lesions evolve slowly and most of the time, treatment can be withheld until the end of the pregnancy.

Several studies suggest a higher regression rate in pregnant patients. Our study will evaluate the rate of regression, progression or persistence of these lesions in per and post partum patients in Nancy, between 2014 and 2022.

To obtain our results, we will compare the results of per and post partum biopsies in each patient.

In a second step, we will study the risk factors of aggravation or on the contrary the protective factors, allowing a faster regression of the lesions


Eligibility criteria: Inclusion Criteria:

* women who have a CIN lesion during pregnancy
* in Nancy, France, MRUN Center
* between 2014 and 2022

Exclusion Criteria:

* lost of follow up women

Primary outcomes:
measure: progress, persistence or regression of CIN lesion count
timeFrame: up to one year after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: BENOIT Camille
Study officials:
affiliation: CHRU Nancy
name: Camille BENOIT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060952: Calprotectin in Chronic Prosthetic Joint Infection
Official title: Synovial Fluid Calprotectin Lateral Flow Test for the Diagnosis of Prosthetic Joint Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prosthetic Joint Infection
Prosthetic Infection
Arthroplasty Complications
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with painful or failed arthroplasty of the hip or knee joint scheduled for partial or complete arthroplasty exchange.

Brief summary: A bacterial infection of an artificial joint is a serious complication that often requires additional surgery to exchange the arthroplasty. It is also difficult to recognize an infected joint, as the symptoms caused by the infection are very similar to those of other problems with arthroplasties, such as loosening of the implant. To improve the ability to diagnose prosthetic joint infections, this study compares the levels of calprotectin, a specific inflammatory protein, in the joint fluid of infected joints and joints with other complications. The underlying hypothesis is that the level of calprotectin in infected joints is significantly higher, thus facilitating the diagnosis of prosthetic joint infection.


Eligibility criteria: Inclusion Criteria:

* scheduled arthroplasty exchange for any of the following reasons:
* infection
* loosening
* instability
* malalignment
* periprosthetic fracture

Exclusion Criteria:

* acute prosthetic joint infection

Primary outcomes:
measure: Diagnostic accuracy of synovial fluid calprotectin
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Orthopedics and Sports Orthopedics, Klinikum rechts der Isar, Technical University Munich
state: Bavaria
Study officials:
References:
Clinical trial NCT05081752: Preventing Esophageal Stent Migration in Esophageal Strictures
Official title: Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stent Migration
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.


Eligibility criteria: Inclusion Criteria:

1. The study population will include any adult (18 years +) who will undergo standard of care esophageal stent placement for benign or malignant esophageal strictures as either an inpatient or outpatient at NYULH.
2. The participant is able to consent to stent placements with fixation or without fixation and study procedures, verified by signature on the informed consent form.
3. Willing to comply with all study procedures and be available for the duration of the study.
4. English and Non-English speaking participants.

Exclusion Criteria:

1. Patients who have strictures treated with luman apposing stents.

Primary outcomes:
measure: Number of Participants who Experience Stent Migration
timeFrame: Week 48
Secondary outcomes:
measure: Total Procedural Time
timeFrame: 120 minutes
measure: Change in Score on Dysphagia Outcome and Severity Scale (DOSS)
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Gregory Haber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02031952: Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma
Official title: Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
hepatectomy
lymphadenectomy
complication
prognosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.

This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.


Eligibility criteria: Inclusion Criteria:

* age 18 to 65 years;
* Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
* good liver function with Pugh-Child Class A or B;
* indocyanine green retention at 15 minutes (ICG-R15) \<15%;
* without severe cirrhosis;
* the diameter of tumor is equal to or more than 3 cm;
* the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
* absence of extrahepatic metastasis.

Exclusion Criteria:

* the diameter of tumor is less than 3 cm;
* palliative resection of tumor;
* with the history of hepatic encephalopathy, ascites, and variceal bleeding;
* with severe hepatic cirrhosis;
* tumor rupture;
* with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 5 year
Secondary outcomes:
measure: Post-operation complication
timeFrame: 90-d after surgery
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References: