louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00894049: A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation
Official title: A Multicenter Prospective Randomized Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allograft
Allogeneic Cell Transplantaion
Hematological Malignancy
Solid Tumor
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 148
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: This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC).

Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).

Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI).

A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches.

Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB).

Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent.

Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).


Eligibility criteria: Inclusion Criteria:

* hematological malignancy or solid tumor,
* eligible for non myeloablative allogenic transplantation,
* aged between 18 and 65,
* with a suitable HLA identical sibling

Exclusion Criteria:

* contra-indication to allogenic transplantation
* pregnant women or breast feeding
* active infection

Primary outcomes:
measure: one year overall survival (OS)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux Pessac
country: France
facility: CHU
city: Clermont Ferrand
country: France
facility: CHU
city: Lyon
country: France
facility: CHU
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier
country: France
facility: CHU
Study officials:
affiliation: Institut Paoli-Calmettes
name: Didier BLAISE, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06170749: Prediction Model for Anemia After Bariatric Surgery
Official title: Prediction Model for Anemia After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anemia
Bariatric Surgery
Keywords: Anemia
Bariatric surgery
Prediction model
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: The Third Xiangya Hospital of Central South University
name: Jining First People's Hospital
name: The Second Hospital of Shandong University
First posted: 2023-12-14
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: This study aims to include patients with obesity who will undergo bariatric surgery.

Brief summary: To develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.

Detailed description: This study aims to develop and validate a prediction model for estimating the probability of anemia for patients with obesity one, three, and five years after sleeve gastrectomy and Roux-en-Y gastric bypass, using preoperative clinical and laboratory data.

Eligibility criteria: Inclusion Criteria:

* aged between 16-70 years;
* body mass index (BMI) ≥ 27.5 kg/m2;
* complete preoperative and follow-up data.

Exclusion Criteria:

* vegetarian;
* other bariatric procedures;
* renal failure at baseline;
* postoperative bleeding (it was defined as a drop in hemoglobin levels \> 3 g/dL or a confirmed blood loss requiring treatment after surgery);
* incomplete preoperative and follow-up data.

Primary outcomes:
measure: AUCs of the prediction model at 1, 3, 5 years
timeFrame: 5 years
Secondary outcomes:
measure: Brier score
timeFrame: 5 years
Other outcomes:
measure: AUCs of the prediction model in different subgroups
timeFrame: 5 years
Locations:
city: Beijing
country: China
facility: Yuntao Nie
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yuntao Nie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02812849: Somatostatin Receptor Imaging in Cardiac Sarcoidosis
Official title: Somatostatin Receptor Imaging in Cardiac Sarcoidosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiac Sarcoidosis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected or known cardiac sarcoidosis or with myocarditis/dilated cardiomyopathy

Brief summary: The purpose of the trial is to determine the accuracy of Cu-64 labelled DOTATATE for diagnosing cardiac sarcoidosis using PET/CT or PET/MRI.


Eligibility criteria: Inclusion Criteria:

Group A: Suspected cardiac sarcoidosis Group B: Known cardiac sarcoidosis, clinical follow-up Group C: Myocarditis or dilated cardiomyopathy (Non-cardiac sarcoidosis)

Exclusion Criteria:

Infection Pregnancy Severe claustrophobia Weight \>140 kg

Primary outcomes:
measure: Sensitivity to detect cardiac sarcoidosis
timeFrame: 1 day at PET/CT examination
measure: Specificity to detect cardiac sarcoidosis
timeFrame: 1 day at PET/CT examination
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Rasmus S Ripa, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05412849: Radiation Field, Dose and Fractionation Related to Mandibular Complications
Official title: Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Neoplasms
Osteoradionecrosis
Radiotherapy; Complications
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutively included patients treated for head and neck neoplasms with a combination of surgery and radiotherapy.

Brief summary: Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation.

Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion.

The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of the head and neck malignancy
* Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery

Exclusion criteria

* less than 12 months follow up
* Under 18 years of age

Primary outcomes:
measure: Complications related to dose, time and position of radiotherapy
timeFrame: The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Lund University Hospital
name: Martin Bengtsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02155049: Treatment of Soft Tissue Expansion in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues
Official title: Phase 3 Study of Treatment of Soft Tissue Expansion and Exophthalmos in Inactive Thyroid Eye Disease Patients Using Drops of Prostaglandin Analogues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid Associated Ophthalmopathies
Keywords: TED
Prostaglandin Analogues
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-06-04
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: TREATMENT

Brief summary: Prostaglandin analogues eye drops are common and effective treatment for decreasing Intra-Ocular Pressure (IOP) in Glaucoma patients. A number of recently published case reports have documented periorbital fat atrophy following treatment by prostaglandin analogues. In this study the investigators want to use this side-effect of prostaglandin analogues for the treatment of orbital and periocular fat proliferation in inactive Thyroid eye disease (TED) patients, as a conservative substitute for surgical intervention.


Eligibility criteria: Inclusion Criteria:

* Inactive TED (Clinical Activity Score below 3)
* Significant exophthalmos or orbital fat expansion.

Exclusion Criteria:

* Previous prostaglandin analogues treatment due to glaucoma
* Known prostaglandin analogues sensitivity.

Primary outcomes:
measure: Bimatoprost effect on soft tissue amount and exophthalmos in inactive TED patients.
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with adverse events.
timeFrame: 9 months
Other outcomes:
measure: Bimatoprost effect reversibility after treatment cessation.
timeFrame: 3 months
Locations:
city: Petach Tikva
country: Israel
facility: Ophthalmology clinics, Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Maya Eiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04345549: Ayurveda Self-Management for Flu Like Symptoms During the Covid-19 Outbreak
Official title: Ayurveda Self-Management for Flu Like Symptoms in People Self-Isolated for 7 Days During the Coronavirus Disease 2019 (COVID-19) Outbreak
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flu Like Symptom
Flu Like Illness
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: From the end of January 2020, Coronavirus disease 2019 began to spread in United Kingdom (UK). During the same time, seasonal flu continued to circulate across the UK. With similar course of management at early stages, flu like symptoms were self-isolated to prevent the spread and further complications of infection. Present study aimed to evaluate the effect of self-managed Ayurveda on flu like symptoms in people who self-isolated at home for 7-days in March 2020 during the Covid-19 outbreak in UK.


Eligibility criteria: Inclusion Criteria:

* Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
* Willing to consent and follow up

Exclusion Criteria:

* Pregnant/lactating
* Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
* Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances

Primary outcomes:
measure: Time to achieve afebrile
timeFrame: From Baseline to 3rd and 7th-days of intervention
Secondary outcomes:
measure: Severity of influenza symptom score
timeFrame: Twice daily from Day 1 to Day 7
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00782249: Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Official title: Prospective Randomized Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2008-10-31
Enrollment: 31
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 3 arms with different vagus nerve stimulation paradigms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* 16 years or older
* At least 1 seizure/month with alteration of consciousness
* Documented seizure diary, at least 3 months prior to implantation (baseline)
* No change in anti-epileptic drugs 1 month before implantation
* At least one or more AEDs

Exclusion Criteria:

* Active cardiac, pulmonary or gastrointestinal disease
* Vagotomy
* Concomitant use of an investigational drug
* Unstable medical condition
* Unstable psychiatric condition

Primary outcomes:
measure: Efficacy of vagus nerve stimulation: responder rates and mean monthly seizure frequency reduction, mean seizure free interval, seizure severity and seizure type
timeFrame: After 6 and 12 months
Secondary outcomes:
measure: VNS-related side effects
timeFrame: After 6 and 12 months
measure: Battery life
timeFrame: After 6 and 12 months
measure: Quality of life: changes in QOLIE 89 score
timeFrame: After 12 months
measure: Mood assessment: changes in Beck depression scale scores
timeFrame: After 12 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Paul Boon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
name: Vijay Thadani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00250549: A Theory Based HIV Prevention Video For Rapid HIV Testing: A Randomized Trial
Official title: A Randomized Control Trial Evaluating the Educational Effectiveness of a Rapid HIV Post-Test Counseling Video.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Prevention
Rapid HIV testing
Lead sponsor: North Bronx Healthcare Network
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: OraQuick is a safe, rapid test that accurately identifies HIV in as little as 20 minutes. By providing an accurate, quick method for detecting a person's serostatus and access to immediate post-test counseling, rapid testing has a crucial role in identifying HIV status and improving post-test counseling rates in populations who are at high risk of HIV infection and high failure to return rates. This prospective randomized control trial compared the educational effectiveness of a fifteen-minute post-test counseling video with the normal practice of a session with an HIV counselor.

Detailed description: A convenience sample of stable patients presenting to the walk-in section of the Jacobi Medical Center Adult ED were recruited for rapid HIV testing. After consenting for the rapid HIV test and completing measures on condom intention and condom use self-efficacy, participants were randomized to either a fifteen-minute HIV post-test educational video available in English or to an HIV counselor for post-test counseling. Afterwards, both groups completed a measure of HIV knowledge assessing relevant testing information and level of satisfaction. An equivalence analysis was carried out to assess whether the video was at least as good as counseling, measured by total score on the knowledge questionnaire, with a lower equivalence bound of -5%.

Eligibility criteria: Inclusion Criteria:

* All adult patients presenting to the Urgent Care Area at Jacobi Medical Center

Exclusion Criteria:

* Patients that were in to much pain, unable to understand the consent process or spoke another language other than the languages offered via the video or were HIV tested with in 6 months.

Primary outcomes:
measure: Mean Knowledge Score within both groups.
timeFrame: One year
Secondary outcomes:
measure: Overall condom intention measures and Condom Self efficacy measures
timeFrame: One year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Jacobi Medical Center
name: Yvette Calderon, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06147349: Kidney Cancer Observational Protocol
Official title: 2007 - Rene: Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Radical Nefrectomy/Tumorectomy Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cancer
Keywords: Renal cancer
Radical Nephrectomy
Partial Nephrectomy
Relapse
Renal cancer diagnosis
Renal cancer treatment
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with kidney cancer who underwent radical or partial nephrectomy

Brief summary: The aim of this observational study is to gather pre and post surgery clinical data belonging to patients who underwent radical or partial nephrectomy and to evaluate the impact of the surgery on the quality of life of the patients, as well as possible relapses within a 10 year period.

Detailed description: A databasa was created with the intention of collecting data related to patients who underwent radical or partial nefrectomy surgery in an electronic case report form.

Each patient will be followed for 10 years approximately starting from the date of surgery for a total of 2 yearly visits for the first 5 years which could then be diluted in 1 visit per year for the remaining 5 years. At each visit control exams forseen by the standard care for post surgery patients will be evalued and tha data will then be transferred into the database. Yearly, a follow up questionnaire will be sent to the patients' home in order to obtain the information relative to possible relapses. The data collected will be handled following the most strict GCPs and privacy norms. The main objectives of the study are the collection and interpretation of the scientific data with the scope of: obtaining health benefits for the patients involved and for future patients with the same type of cancer, improving the scientific knowledge on the pathology and implementing new strategies for diagnosis and therapy and evaluating the epidemiologic changes of renal neoplasia.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Kidney cancer diagnosis
* Indication to cancer removal through surgery
* Ability to read and sign the informed consent

Exclusion Criteria:

* Age \< 18 years
* Absence of kidney cancer
* Inability to read and sign the informed consent

Primary outcomes:
measure: Clinical parameter collection
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Francesco Montorsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172049: Incidence of Colorectal Cancer in Southwest China: Based on SCC Database
Official title: Incidence of Colorectal Cancer in Southwest China: Based on SCC Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 5838
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were diagnosed with CRC were included

Brief summary: To evaluate recent trends in CRC incidence, treatment, and survival in the Southwest China.

Detailed description: The epidemiological feature of colorectal cancer (CRC) showed different trends among countries. Studying the epidemiological and management characteristics between China and the US has important implications for understanding the current status of cancer occurrence, treatment and survival. we established the Southwest China Colorectal (SCC) database, aiming to provide reference information on the diagnosis and management of CRC in China.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of colorectal cancer;
2. Received treatment in medical institutions;
3. Regular follow-up after the diagnosis.

Exclusion Criteria:

Patients who lost to follow-up

Primary outcomes:
measure: Survival
timeFrame: From inclusion until date of death from any cause, or untile the 2023-10-31
Secondary outcomes:
Other outcomes:
Locations:
city: Chendu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ziqiang Wang
role: STUDY_CHAIR
References: