louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02288065: Predictive Factors and Outcome in Medical Thoracoscopy
Official title: Predictive Factors and Outcome in Medical Thoracoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleuritis
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pulmonary or extrathoracic malignancy

Brief summary: Retrospective survey for factors predicting the outcome of medical thoracoscopy

Detailed description: Retrospective survey for factors predicting the outcome of medical thoracoscopy in patients with malignant pleuritis

Eligibility criteria: Inclusion Criteria:

* progressive malignancy
* pleuritis

Exclusion Criteria:

* respiratory failure
* unable to consent

Primary outcomes:
measure: Chest X-ray
timeFrame: 3 months
Secondary outcomes:
measure: time interval
timeFrame: 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Jonas Yserbyt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05605665: Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome
Official title: Therapeutic Effect of Low Dose IL-2 Combined With Rapamycin in on sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sjögren's Syndrome
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 30
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: The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome

Detailed description: A randomized, open clinical trial was designed. Patients will be randomly divided into three groups，including Ld-IL2 group, rapamycin group, Ld-IL2+rapamycin group. The improvement of clinical and laboratory indexes will be evaluated. Changes of immune cell subsets and cytokines will be monitored.

Eligibility criteria: Inclusion Criteria:

1. Male or female, and aged 18-70 at the time of screening visit.
2. Patients with Sjogren's syndrome who meet the 2002 EULAR classification criteria.
3. If the standardized treatment is not effective or relapses, it is clinically necessary to give additional immunomodulatory treatment.
4. Disease activity: ESSDAI≥4 points.
5. The pregnancy test results of female subjects of childbearing age should be negative at screening and baseline.
6. The written informed consent form approved by the Ethics Committee of Peking University People's Hospital was signed and dated by the subject or legal representative.

Exclusion Criteria:

1. Severe chronic liver, kidney and heart dysfunction.
2. Severe drug-resistant bacterial infections, such as bacteremia and septicemia.
3. Patients with tumor and tumor history.
4. Chronic respiratory failure.
5. Patients who are ineffective in high-dose hormone pulse therapy.
6. Those who use rituximab or other biological agents within 3 months.
7. Patients with active tuberculosis infection or potential tuberculosis infection.
8. There are obstacles that can't cooperate or cause interference in completing this research: such as mental patients.

Primary outcomes:
measure: Proportion of Treg cells in peripheral blood
timeFrame: week 12
Secondary outcomes:
measure: ESSDAI [potential score 0 - 123]
timeFrame: week 12
measure: Physician's Global Disease Activity VAS, (potential score 0 - 10)
timeFrame: week 12
measure: Patient's Global Disease Activity VAS, (potential score 0 - 80)
timeFrame: week 12
measure: Rate of Participants with adverse effects associated with experimental drugs
timeFrame: week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
state: Beijing
Study officials:
affiliation: Peking university peoples hospital
name: Zhanguo Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT04400565: The Effectiveness of a Recovery Program for People With Mental Illness.
Official title: The Effectiveness of a Recovery Program for People With Mental Illness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recovery-oriented approach has been the main trend in mental health field. However, few recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental illness don't understand the concepts of recovery. A program which provides recovery knowledge and assists in setting recovery goals is beneficial for Taiwanese people with mental illness. Hence, this study aimed to investigate the effectiveness of a recovery program for people with mental illness.

Detailed description: This is a randomized control trial. Participants will be recruited from the psychiatric rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5 hour per class and one class per week. We will introduce concepts of recovery and personal strengths in phase 1. Then, we will help participants to set goals and implement their plans in phase 2. Participants will fill out five questionnaires during the recruitment meeting, including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six months later, participants will receive a follow-up interview and fill out the questionnaires again. The control group will receive a spiritual book and complete the questionnaires at the same time as the intervention group.

Eligibility criteria: Inclusion Criteria:

* diagnosis of mental illness
* lived in community

Exclusion Criteria:

-

Primary outcomes:
measure: Stages of Recovery Scale (SRS)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Secondary outcomes:
measure: Medical Outcomes Study Social Support Survey (MOS-SS)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
measure: The Hope Scale (THS)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
measure: Rosenberg Self-Esteem Scale (RSE)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
measure: Brief Symptom Rating Scale-50 (BSRS-50)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Other outcomes:
measure: Qualitative data
timeFrame: At 10 weeks, 20 weeks and 44 weeks
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT04317365: Counseling of Pregnant Women During Corona
Official title: Effect of Counseling Between Pregnant Women During Corona Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Corona virus is known as covid 19 And is transmitted through droplet infection

Detailed description: Symptoms of Corona include cough Fever and dyspnea

Eligibility criteria: Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* non pregnant women

Primary outcomes:
measure: The number of pregnant women who know the exact symptoms of the disease
timeFrame: Within one month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algezeera hospital
name: Mahmoud Alalfy
role: STUDY_CHAIR
References:
Clinical trial NCT00343265: Vaginal Progesterone Versus Placebo in Multiple Pregnancy
Official title: Pilot Randomized Trial of Vaginal Progesterone to Prevent Preterm Birth in Multiple Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Preterm birth
Multiple pregnancy
Vaginal progesterone
Preterm birth in multiple pregnancy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Calgary Health Region
name: Juniper Pharmaceuticals, Inc.
First posted: 2006-06-22
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
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 see if daily use of vaginal progesterone will prevent preterm birth in women carrying 2 or more babies.

Detailed description: Women who are pregnant with twins or any higher order multiple will be approached to take part. Women will be randomized to get either vaginal progesterone gel or a placebo gel daily from study entry until 35 6/7 weeks. Women can enter the study between 16 - 20 6/7 weeks. Two hundred women will be recruited to take part. Data will be collected on the women and their infants to see if the active medication prolongs pregnancy.

Eligibility criteria: Inclusion Criteria:

* Confirmed multiple pregnancy
* Ultrasound confirmed minimum of 2 live fetuses
* Gestational age 16-20 6/7 weeks

Exclusion Criteria:

* Placenta previa
* Pre-existing hypertension
* Major fetal anomaly
* Monoamniotic, monozygotic multiples
* Maternal seizure disorder
* History of, or active, thromboembolic disease
* Maternal live disease
* Breast malignancy or pathology
* Progesterone dependent neoplasia
* Plans to move to another city during pregnancy
* Sensitivity to progesterone
* Participation in other clinical trials during the pregnancy

Primary outcomes:
measure: Gestational age
timeFrame: Delivery
Secondary outcomes:
measure: Proportion of women delivering < 35 weeks
timeFrame: Delivery
measure: Proportion of women delivering < 37 weeks
timeFrame: Delivery
measure: Proportion of women having spontaneous preterm delivery
timeFrame: Delivery
measure: Proportion of women having tocolytic therapy
timeFrame: During pregnancy
measure: Treatment compliance
timeFrame: Delivery
measure: Length of stay for mother and infants
timeFrame: Discharge
measure: Infant morbidity and mortality
timeFrame: Discharge
measure: Birth weight
timeFrame: Birth
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Health Region
state: Alberta
Study officials:
affiliation: University of Calgary
name: Stephen Wood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Sue Ross, PhD
role: STUDY_DIRECTOR
References:
citation: Wood S, Ross S, Tang S, Miller L, Sauve R, Brant R. Vaginal progesterone to prevent preterm birth in multiple pregnancy: a randomized controlled trial. J Perinat Med. 2012 Nov;40(6):593-9. doi: 10.1515/jpm-2012-0057.
Clinical trial NCT01539265: A Dose-finding Study of Silodosin in Patients With Urinary Calculi
Official title: A Randomized, Double-blind, Placebo-controlled, Phase II Study of Silodosin in Patients With Urinary Calculi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Calculus
Keywords: urinary calculus
ureteral stones
medical expulsive therapy
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 300
Sex: ALL
Minimum age (years): 20
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 the safety of silodosin in urinary calculi patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have a unilateral ureteral calculus with ≥ 5 mm and ≤ 10 mm at Week 0.
* Patients who are able to visit the site continually as out-patient during the study

Exclusion Criteria:

* Patients who have multiple urethral stones.
* Patients who have or have history of a ureteral stricture or other structural passage obstruction of the ureter on affected side.
* Patients who have been diagnosed with myasthenia gravis, myopathy, spina bifida, spinal cord injury, or fibromyalgia syndrome.
* Patients who have a clinically significant hepatic or renal disorder.
* Patients with postural hypotension or with a history of postural hypotension.
* Patients with a history of sever drug allergy, or patients with a history of hypersensitivity to silodosin.
* Patients who are pregnant, nursing, or desire pregnancy during the study period, or patients who cannot strictly comply with a physician's contraception directions.

Primary outcomes:
measure: Spontaneous stone passage rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to spontaneous stone passage
timeFrame: 4 weeks
measure: Analgesic use
timeFrame: 4 weeks
measure: Pain severity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
facility: Japan
Study officials:
affiliation: Clinical Development Department, Kissei pharmaceutical Co., Ltd.
name: Tatsuro Takei
role: STUDY_DIRECTOR
References:
Clinical trial NCT03711565: Oscillatory Versus Non-oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
Official title: Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neonatal Respiratory Distress Related Conditions
Keywords: Nasal CPAP
High Frequency NCPAP
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 0
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controlled randomized trial looking at Standard nasal continuous airway pressure (CPAP) respiratory support versus High Frequency CPAP in neonates who require respiratory support or who are being extubated and require support post extubation. Patients will be evaluated for need to be reintubated and oxygen requirement and PaCO2 levels

Detailed description: This study is a randomized controlled trial comparing High Frequency nasal CPAP versus standard nasal CPAP. The patient population includes preterm newborns who require respiratory support but do not need to be initially intubated and preterm or term infants who are being extubated and will require support for the continued lung disease. After obtaining parental consent the patient will be randomized to one of the two treatments. Patients will be followed for requirement of level of oxygen and blood gases looking at acidity (pH) and PaCO2 and Bicarbonate(HCO3). A respiratory index score will be measured. Attending physician will determine the need for the patient to be intubated or reintubated depending on the patient selected. Additionally, frequency, duration and severity of Apnea, Bradycardia and Desaturation events will be recorded. Also safety issues to include pulmonary airleak, nasal injury, facial edema and scalp edema due to straps holding the device in place will be recorded. Also gaseous distension of the stomach and intestines will be assessed and compared between treatment arms. This study is not powered to look at long term outcomes.

Eligibility criteria: Inclusion Criteria:

* Newborn (0-28 days of age) admitted to Neonatal Intensive care unit (NICU)
* Ordered Respiratory treatment of Nasal Continuous Airway Pressure (NCPAP) respiratory support

Exclusion Criteria:

* Major congenital defect
* Known or suspected chromosomal disorder

Primary outcomes:
measure: Respiratory Index Score (RSI)
timeFrame: 72 hours after initiation of support
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
Study officials:
References:
Clinical trial NCT03469765: (TIMP-2)x(IGFPB7) to Predict Acute Kidney Injury (AKI) in Aortic Surgery
Official title: (TIMP-2)x(IGFPB7) as Early Renal Biomarker for the Prediction of Acute Kidney Injury in Aortic Surgery - an Observational Study (TIGER)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure
Dialysis
Aortic Surgery
Biomarker
Acute Kidney Injury
Keywords: AKI
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with need for aortic operation/ repair

Brief summary: New biomarkers that predict the development of renal dysfunction in patients with aortic surgery are urgently needed. The investigators investigate whether urinary (TIMP-2)x(IGFBP7) predicts postoperative Acute Kidney Injury and/or need for Renal Replacement Therapy (RRT) in patients after aortic surgery (including EVAR).


Eligibility criteria: Inclusion Criteria:

* Patients in need of emergency or elective abdominal aortic surgery (infra- or suprarenal clamping or EVAR) are eligible for study inclusion.

Exclusion Criteria:

* Patients unable to give informed consent
* Age \< 18
* Patients not speaking German or French.

Primary outcomes:
measure: Statistically significant difference in mean total (TIMP-2)x(IGFBP7) values of patients with/ without AKI (as defined along Kidney Disease Initiative for Improvement of global outcomes (KDIGO) definitions: stages 1-3) at the first postoperative day.
timeFrame: 24 hours following ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
References:
citation: Waskowski J, Pfortmueller CA, Schenk N, Buehlmann R, Schmidli J, Erdoes G, Schefold JC. (TIMP2) x (IGFBP7) as early renal biomarker for the prediction of acute kidney injury in aortic surgery (TIGER). A single center observational study. PLoS One. 2021 Jan 7;16(1):e0244658. doi: 10.1371/journal.pone.0244658. eCollection 2021.
Clinical trial NCT03281265: A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China
Official title: A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Failure, Acute on Chronic
Liver Injury
Keywords: pre-acute-on-chronic liver failure
hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 1178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HBV-related compensated liver disease and acute liver injury or decompensation.

Brief summary: The definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well established by EASL CANONIC study. However, patients with high risk to develop ACLF has not been determined, yet. The aim of current study is to establish a preliminary pre-ACLF definition, and to demonstrate the corresponding risk factors.


Eligibility criteria: Inclusion Criteria:

1. Chronic hepatitis B virus infection;
2. Any of the followings: Alanine aminotransferase (ALT)≥3 upper limit of laboratory reference (ULN); Aspartate aminotransferase (AST)≥3 ULN; Serum bilirubin≥2 ULN; Acute decompensation (ascites, hepatic encephalopathy, variceal hemorrhage and/or bacterial infections)

Exclusion Criteria:

1. Previous decompensation;
2. those who had hepatocellular carcinoma or other types of malignancies;
3. those who combined with severe chronic extra-hepatic disease;
4. pregnant;
5. received liver transplantation or kidney transplantation before or after admission;
6. readmission;
7. death within 24 hours.

Primary outcomes:
measure: 28-day ACLF progression
timeFrame: 28-day
measure: 28-day mortality
timeFrame: 28-day
Secondary outcomes:
measure: 90-day mortality
timeFrame: 90-day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04539665: Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
Official title: Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Recurrence
Crohn's Ileocolitis
Lead sponsor: Montreal General Hospital
Sponsor class: OTHER
Collaborators: name: Jewish General Hospital
First posted: 2020-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.

Detailed description: The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.

Eligibility criteria: Inclusion Criteria:

* adults \>18 years old
* diagnosis of CD limited to the distal ileum/ileocolic region
* no previous ileocolic resection
* all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.

Exclusion Criteria:

* previous ileocolic resection
* other sites of CD
* intraabdominal sepsis

Primary outcomes:
measure: Number of participants with endoscopic recurrence at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with endoscopic recurrence at 18 months
timeFrame: 18 months
measure: Rates of recurrence requiring surgery by 2 years
timeFrame: 24 months
measure: Rates of post-operative complications compared between study groups
timeFrame: 30 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: