louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03031106: Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease
Official title: Multidisciplinary Follow-up of Patients Treated for Malignant Hematological Disease; Focus on the Patient's Preferences and Life Situation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Hematologic Neoplasm
Keywords: Patient-reported outcomes, Health-related QoL, Internet-based tool
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with chemotherapy for primary hematological disease and patients followed in a Wait \& Watch regimen

Brief summary: The aim of this study is to adjust and test an existing internet-based tool for collecting patient-reported outcome measures and to use the internet-based tool in an multidisciplinary follow-up of patients treated for malignant hematological diseases. The patient-reported outcome measurements will be used in describing the patients' health-related quality of life (HRQoL) and to investigate whether the HRQol will increase due to participation in multidisciplinary follow-up.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with malignant hematological disease; Morbus Hodgkin and B- and T-cell disease
* patients followed before or after 1. line treatment
* patients in stable phase \> 6 months after 1. line treatment
* the patients participation in the study must be assessed and decided by the doctor responsible for the patient's course of treatment

Exclusion Criteria:

* Health conditions which demands close medical monitoring
* conditions which compromise the ability to understand the study and submit informed consent (ex.: dementia and severe mental illness / disability)
* lack of capability to fill out electronic questionnaires
* poor self-care and/or compliance

Primary outcomes:
measure: Health-Related Quality of Life (HRQoL) - General
timeFrame: HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
measure: Health-Related Quality of Life (HRQoL) - Disease specific
timeFrame: HRQoL is assessed every 2, 3, 4 or 6 months, up to 18 months.
Secondary outcomes:
measure: Symptoms of depression and anxiety
timeFrame: Symptoms of depression and anxiety will be assessed every 2, 3, 4 or 6 month, up to 18 months
measure: Symptoms of hematological disease
timeFrame: Symptoms of disease will be assessed every 2, 3, 4 or 6 month, up to 18 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital, Department of Hematology
Study officials:
affiliation: Aalborg University Hospital
name: Mia Sommer, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01415206: The Total Health Study
Official title: Extended Care Treatment of Multiple Risk Behaviors in Complex Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction Behavior
Keywords: Behavioral changes
Multiple risks
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-08-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, controlled, multiple risk intervention pilot study evaluated with clients recruited from VA Medical Center Substance Abuse Programs. The intervention combines an innovative online system with interpersonal MI-based coaching delivered in 4 sessions over 12-months time.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are: at least 18 years of age, enrolled in the San Francisco Veteran Affairs Medical Center (SF VAMC) Substance Abuse Programs, residing in the San Francisco Bay Area and not planning to relocate out of the area in the next 18 months. For patients in the Day Hospital, we will wait until they have completed one week of treatment before approaching for study involvement, as the first week is the most intensive for services.

Exclusion Criteria:

* Exclusion criteria are: unstable psychiatric disorder and severe cognitive impairment.

Primary outcomes:
measure: Client engagement with behavior change service referrals
timeFrame: Up to18 months follow-up.
Secondary outcomes:
measure: Behavioral changes in multiple risks
timeFrame: up to 18 months follow-up.
measure: Improvements in health-related quality of life at 3, 6, 12, and 18 months follow-up.
timeFrame: up to 18 months follow-up.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Judith J Prochaska, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376206: Drug Use Investigation for ALLERMIST
Official title: Drug Use Investigation for ALLERMIST
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have allergic rhinitis for which the indication of ALLERMIST has been approved and who are using ALLERMIST for the first time.

Brief summary: To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray in Japanese subjects with allergic rhinitis under the practical use conditions


Eligibility criteria: Inclusion Criteria:

* Diagnosis of allergic rhinitis
* Use ALLERMIST for the first time
* Expected to use ALLERMIST for long-term (1 year)

Exclusion Criteria:

* Subjects with infection which fluticasone is not effective
* Subjects with deep mycosis
* Subjects with hypersensitivity to fluticason

Primary outcomes:
measure: The number of adverse events in Japanese subjects with allergic rhinitis treated with fluticasone nasal spray
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06467006: AI PREDICTION FOR PROXIMAL HUMERAL FRACTURES
Official title: ARTIFICIAL INTELLIGENCE-BASED PREDICTION OF CLINICAL OUTCOMES IN PATIENTS SUSTAINING PROXIMAL HUMERAL FRACTURES
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Proximal Humeral Fracture
Lead sponsor: Consorci Sanitari de l'Anoia
Sponsor class: OTHER
Collaborators: name: Parc de Salut Mar
name: Parc Taulí Hospital Universitari
First posted: 2024-06-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients sustaining proximal humeral fractures, nonoperatively treated

Brief summary: Our smartphones can recognize the pictures of our family, loved ones and friends. Face recognition software leverages artificial intelligence (AI), image recognition and other advanced technology to map, analyze and confirm the identity of a face.

We humans do a poor job when classifying the injury related to a patient sustaining a proximal humeral fracture. In consequence, there is great heterogeneity in the treatment of proximal humerus fractures. Moreover, offering relevant information to patients regarding the risk of complications or fracture sequelae is challenging, given that the current series are based on obsolete classifications, and the published series bring together just over hundreds of patients analyzed. With these limitations, patients have few opportunities to participate in decision-making about their injury.

The present project aim is to integrate new technologies for the prediction of relevant clinical results for the patients presenting a proximal humeral fracture. In brief, AI can help identify similar fracture patterns without human inference, while humans can feed the algorithm with variables of interest such as the functional outcomes and complications related to this particular type of fracture.


Eligibility criteria: Inclusion Criteria:

Patients sustaining a proximal humerus fracture treated nonoperatively under the criteria of the treating surgeon and patients' preference.

Subjects evaluated within the first 3 weeks after the injury. Patients between 18 and 90 years of age. Patients who have been studied with simple shoulder radiographs in anteroposterior and scapular outlet projections.

Participants who accept 1-year time follow-up.

Exclusion Criteria:

Patients with dementia or difficulty completing the evaluation after one year of follow-up.

Patients who have previously received surgical treatment on the affected limb. Patients who have suffered a previous fracture in the affected limb. Surgically treated patients.

Primary outcomes:
measure: Constant-Murley Score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01287806: Ulinastatin in Inhalation Lung Injury
Official title: Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Inhalation Injury
Keywords: ulinastatin
inhalation injury
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Southwest Hospital, China
name: General Hospital of Beijing PLA Military Region
First posted: 2011-02-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe inhalation lung injury
* Within 48hours after inhalation injury
* Age 18 to 70 years old
* Burned area not more than 70% TBSA
* Signed the informed consent form

Exclusion Criteria:

* Pregnancy or lactation
* Allergy for ulinastatin
* Received an investigational drug or device within 90 days prior to entering study

Primary outcomes:
measure: all cause mortality
timeFrame: until death or discharge from hospital, data reviewed every 3 months
Secondary outcomes:
measure: length of mechanical ventilation
timeFrame: from admission to 90 days
measure: length of ICU stay
timeFrame: until death or discharge from hospital, data reviewed every 3 months
measure: length of hospital stays
timeFrame: until death or discharge from hospital, data reviewed every 3 months
measure: blood inflammatory mediator
timeFrame: 0days,5days and 10days
measure: Bronchoscopy morphological evaluation
timeFrame: 0days,5days and 10days
Other outcomes:
Locations:
city: Beijin
country: China
facility: 304 hospital of PLA
state: Beijin
Study officials:
affiliation: First Hospitals affiliated to the China PLA General Hospital
name: sheng zhiyong, MD
role: STUDY_CHAIR
affiliation: First Hospitals affiliated to the China PLA General Hospital
name: Jia chiyu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Xia zhaofan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southwest Hospital, China
name: Pang yizhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Jinan PLA Military Region
name: Chen tunhu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Beijing PLA Military Region
name: Zhu jinmin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Lanzhou PLA Military Region
name: Liu yi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaonin People's Armed Police Corps Hospital
name: Cui xiaolin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 187 Central Hospital of the Chinese PLA
name: Sheng guanyu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 251 Central Hospital of the Chinese PLA
name: Lu qinjun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 322 Central Hospital of the Chinese PLA
name: Shi shengfu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02768506: Prospective Comparison Between SADI-S and Gastric Bypass
Official title: Non-randomized Prospective Comparison Between SADI-S and Gastric Bypass for the Treatment of Morbid Obesity and Its Associated Co-morbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Diabetes
Keywords: obesity, malabsorption, gastric bypass, SADI-S
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbid obesity patients asking for surgery

Brief summary: Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a variable limb length between 250 cm and 300 cm or gastric bypass.

Results on weight loss, comorbidities resolution, complications, re-operations, need of supplements are registered.

Detailed description: Morbid obese patients and patients with an initial BMI over 35 with associated comorbidities - as diabetes mellitus - are evaluated for bariatric surgery. Candidates are offered a standard gastric bypass or a single anastomosis duodeno-ileal bypass with sleeve gastrectomy. Patients with higher BMI and those with worse metabolic condition are encouraged to accept the malabsorptive option.

Gastric bypass is performed with a 150 cm alimentary limb and a calibrated pouch and anastomosis over a 14 mm bougie. SADI-S is performed with a sleeve gastrectomy over a 54 French (18 mm) gastric bougie and a 250 cm common limb.

Patients are managed equally during admission: 6 hours to initiate oral intake, 2 days to remove abdominal drain and 3 days to discharge unless contraindicated. Follow up is performed through visits every 3 months the first 2 postoperative years and every 6 months from the 3rd to the 5th year.

Eligibility criteria: Inclusion Criteria:

* Morbid obesity

Exclusion Criteria:

* Drug addiction
* Alcoholic
* Neoplasms
* Immunosuppression
* Mental diseases

Primary outcomes:
measure: Weight loss
timeFrame: 5 years
Secondary outcomes:
measure: Diabetes remission
timeFrame: 5 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
References:
Clinical trial NCT05823506: Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction
Official title: Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this trial is that using tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) is more effective than using tadalafil alone in improving erection rigidity and sexual function. The efficacy of the combination of li-ESWT and tadalafil has been confirmed by a number of studies, including in patients after radical prostatectomy. However, this method is still not a "first-line" method in young primary patients and its benefits in combination with drugs for these patients are not obvious.

The investigators assume that the combination of tadalafil plus low-intensity extracorporeal shockwave therapy (li-ESWT) will improve the subjective state of patients assessed by points of validated questionnaires and Number of successful intercourse per week.

Detailed description: The aim of the study is to test the hypothesis that using tadalafil plus shockwave in primary patient with ED treatment in more effective in improving erection rigidity and sexual function, then using tadalafil alone.

Eligibility criteria: Inclusion Criteria:• Age 20 to 45;

* Married or have had a permanent sex partner for at least 3 months;
* IIEF-5 questionnaire scores below 20

Exclusion Criteria:

* History of previous use of PDE-5 inhibitors or fSWT;
* Patients with diabetes mellitus;
* Patients after the radical prostatectomy or major pelvic surgery;
* Patients with a confirmed neurological disease that may have caused the ED (Multiple Sclerosis, Parkinson's Disease, spinal cord injury);
* Patients with contraindications to the use of PDE-5 inhibitors and/or fSWT;

Primary outcomes:
measure: IIEF-5
timeFrame: 60 days
Secondary outcomes:
measure: PGI-I
timeFrame: 14 days,30 days, 60days.
measure: Likert scale (7-point preferably) satisfaction questionnaire
timeFrame: 14 days,30 days, 60days.
measure: Therapy comfort survey
timeFrame: 14 days,30 days, 60days.
measure: Number of successful intercourse per week
timeFrame: 14 days,30 days, 60days.
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: SBPSU
Study officials:
References:
Clinical trial NCT02838706: Elderly With Hip Fracture and Perioperative Hemoglobin and Perfusion Index Levels
Official title: Contionuous Perioperative Hemoglobin and Perfusion Index Measurements in Elderly Patients With Hip Fracture and Post Operative Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Delirium
Keywords: postoperative anemia
perfusion index
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects are patients age ≥ 65 years requiring surgery for a hip fracture.

Brief summary: The overall aim of the study is to investigate the time difference in the diagnosing of anemia among elderly with hip fracture, between measurements with standard blood samples and non-invasive SpHb-measuring. Another aim is to investigate the relationship between perfusion index and prolong perioperative anemia and the potential impact on perioperative complications.

Detailed description: Immediately after admission and diagnosis of a hip fracture the patients will be monitored with Masimo SpHb. The Patients will be continuously measured until the third day after surgery. The Monitors Hb and PI data but not the SpO2% will be blinded to all participating healthcare personnel.The first three postopertive days the patiens will daily be examined to determined it they have developed delirium.

All perioperativ complications in that period will be monitored.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Primary hip fracture requiring surgery
* Patients able to give informed consent
* Patients who are able to undergo the Hospitals standardized fast track
* Perioperative care regimen for hip fracture including are pre operative placed epidural

Exclusion Criteria:

* Patients who can not co-operate to have a sensor attach to the finger continuous for 4 days.
* Patients who has allergy to the bandage that is used to attach the sensor.

Primary outcomes:
measure: Delay in diagnosting perioperative anemia
timeFrame: From admission up to and including the 3 postopertive day
measure: Perfusion index, periopertive anemia and delirium
timeFrame: From admission up to and including the 3 postopertive day
Secondary outcomes:
measure: Perfusion index as a predictor of early warning score (EWS)
timeFrame: From admission up to and including the 3 postopertive day
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre, department of anesthesiology
Study officials:
References:
Clinical trial NCT03213106: Cerebellar Non-invasive Stimulation in Ataxias
Official title: Effects of Cerebellar Transcranial Magnetic Stimulation in Cerebellar Ataxias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebellar Ataxia
Keywords: TMS
Transcranial Magnetic Stimulation
Cerebellar Ataxia
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 5 sessions of active and sham rTMS separated by at least 4 weeks washout.
Primary purpose: TREATMENT

Brief summary: Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. Some limited studies verified the effects of cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. So far it is not known which patients could benefit. Our hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients.

Detailed description: Thirty patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. Patients will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. After that, participants will be randomly assigned to 5 active or 5 placebo sessions of 1Hz TMS over the located area. After the first 5 sessions and a period of at least 4 weeks washout, patients will cross over and receive other 5 sessions, active or sham. Clinical and video evaluations will be conducted before and after active and sham cluster of sessions.

Eligibility criteria: Inclusion Criteria:

* identification of cerebellar ataxia based on neurologic examination
* no improvement after rehabilitation
* symptoms onset of at least 6 months

Exclusion Criteria:

* Younger than 18 months
* Pregnant or breastfeeding women
* Participation in other clinical trials
* Epilepsy

Primary outcomes:
measure: Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
timeFrame: Day 1 (baseline), day 5 (after 5th TMS session, active or sham), day 33 (new baseline after TMS wash out) and day 38 (after 10th TMS session, active or sham)
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Rubens G Cury, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franca C, de Andrade DC, Silva V, Galhardoni R, Barbosa ER, Teixeira MJ, Cury RG. Effects of cerebellar transcranial magnetic stimulation on ataxias: A randomized trial. Parkinsonism Relat Disord. 2020 Nov;80:1-6. doi: 10.1016/j.parkreldis.2020.09.001. Epub 2020 Sep 6.