louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00319033: Open-label Study With Bosentan in Interstitial Lung Disease
Official title: Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Interstitial Lung Disease
Scleroderma
Keywords: interstitial lung disease
scleroderma
bosentan
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.


Eligibility criteria: Inclusion Criteria:

* To have completed the 12-month treatment period of the AC-052-330/BUILD 2.
* Women should not be pregnant
* Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception
* Signed informed consent prior to initiation of any study-mandated procedure

Exclusion Criteria:

* Any major violation of the protocol AC-052-330.

Primary outcomes:
measure: Change from baseline to all assessed time points in 6-minute walk test distance.
measure: Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value).
measure: Transition Dyspnea Index at all assessed time points.
measure: Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 ≥ 4%), trough SpO2 and area under the curve during 6-minute walk test.
Secondary outcomes:
measure: Adverse events; serious adverse events.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01738633: Quality of Life After Esophagectomy for Cancer - Step 2
Official title: Quality of Life After Esophagectomy for Cancer - Step 2
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Quality of Life
Keywords: Esophageal Cancer
Quality of Life
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Fondazione Guido Berlucchi
name: Veneto Institute of Oncology I.O.V.-I.R.C.C.S.
First posted: 2012-11-30
Enrollment: 80
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: Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.

The study is divided into two steps.

This is step 2.

At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.


Eligibility criteria: Inclusion Criteria:

* age above 18 years old
* scheduled for esophagectomy for cancer

Exclusion Criteria:

* age below 18 years old
* incapability to autonomously fill in questionnaires
* primary language not italian

Primary outcomes:
measure: items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
timeFrame: 1 month after surgical operation
Secondary outcomes:
measure: item EA (eating) of OES18
timeFrame: 1 month after surgical operation
measure: items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
timeFrame: 3 months after surgical operation
measure: item EA (eating) of OES18
timeFrame: 3 months after surgical operation
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto (IOV-IRCCS)
Study officials:
References:
Clinical trial NCT03657433: Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
Official title: Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia of Pregnancy
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: AMAG Pharmaceuticals, Inc.
First posted: 2018-09-05
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial includes pregnant women with anemia. They are randomized to IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.

Detailed description: This is a randomized controlled trial aimed at assessing whether IV Iron administration (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of iron-deficiency anemia in pregnancy.

140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will receive medication to take at home during their pregnancy.

Patients will have iron studies performed at study entry, and again at presentation for delivery. Cord blood will also be sampled for iron studies.

Eligibility criteria: Inclusion Criteria:

* Maternal age \>/= 18
* Singleton gestation
* \>/=20 weeks gestation, \<37 weeks gestation
* Hemoglobin \<11g/dL and/or hematocrit \<33%
* Able to read/speak English or Spanish

Exclusion Criteria:

* Maternal age \<18
* Multiple gestation
* \<20 weeks gestation, \</= 37 weeks gestation
* Hemoglobin \>/=11g/dL and/or hematocrit \>/=33%
* Unable to read or speak English or Spanish
* Incarcerated patients

Primary outcomes:
measure: Change in hemoglobin
timeFrame: 1 day - 22 weeks
Secondary outcomes:
measure: Change in other laboratory values
timeFrame: 1 day - 22 weeks
measure: Blood loss at delivery
timeFrame: 1 day - 22 weeks
measure: Hemoglobin change after delivery
timeFrame: 1 day - 22 weeks
measure: Blood transfusion
timeFrame: 1 day - 22 weeks
measure: Iron infusion
timeFrame: 1 day - 22 weeks
measure: Concentration of substances in cord blood (iron studies)
timeFrame: 1 day - 22 weeks
measure: Preterm delivery
timeFrame: 1 day - 22 weeks
measure: Indication for delivery
timeFrame: 1 day - 22 weeks
measure: Birth weight
timeFrame: 1 day - 22 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
References:
Clinical trial NCT01612533: Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals in China
Official title: A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Coronary Heart Disease
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 20000
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: An anticipated sample size was caculated in this study, about 20000. Patients using Shenmai injection from 2012 to 2014 in 15 hospitals.

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Detailed description: Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.

A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use Shenfu injection in selected hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients using Shenfu injection from 2012 to 2014

Primary outcomes:
measure: Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction.
timeFrame: The registry procedure will last 3 years only for patients using Shenfu.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06135233: Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:
Official title: Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe: A Critical Appraisal of the First 3 Years of the E-MIPS Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Disease
Keywords: registry
minimally invasive surgery
robot-assisted
laparoscopy
pancreatoduodenectomy
pancreatic surgery
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 1336
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: Data from all patients who underwent R-MIPD and L-MIPD between January 1st 2019 and December 31st 2021 were included

Brief summary: A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Detailed description: The European registry for Minimally Invasive Pancreatic Surgery (E-MIPS) is an E-AHPBA endorsed registry with the aim to monitor and safeguard the introduction of MIPD in Europe. International multicenter audit-based studies focusing on outcomes of minimally invasive pancreatoduodenectomy (MIPD) are lacking.

A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

Eligibility criteria: Inclusion Criteria:

- Data from all patients who underwent R-MIPD and L-MIPD between January 1st 2019 and December 31st 2021 were included

Exclusion Criteria:

* Other pancreatic procedures
* Hybrid approaches (reconstruction phase open)
* Procedures with insufficient baseline data / missing primary outcome data.

Primary outcomes:
measure: Major morbidity
timeFrame: 30 days
measure: 30-day/in-hospital mortality.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC
state: Noord-Holland
Study officials:
References:
Clinical trial NCT03871933: Autonomic Function in COPD and Risk for Atrial Fibrillation
Official title: Characterization of Autonomic Function in Patients With Chronic Obstructive Pulmonary Disease - Potential Relevance for Increased Risk of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: atrial fibrillation
autonomic function
cardiopulmonary interaction
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive pulmonary disease, exacerbated or stable

Brief summary: In the presented study, autonomic function as well as risk for atrial fibrillation will be assessed to characterize the relation between risk of atrial fibrillation and autonomic function.

Detailed description: Atrial fibrillation (AF) has been suggested as relevant comorbidity in patients with chronic obstructive pulmonary disease (COPD). The evaluation of the total atrial conduction time via tissue Doppler imaging (PA-TDI interval) can be used to identify patients with increased risk of new onset AF. Autonomic function can be assessed by different non invasive clinical investigations.

The investigators hypothesise that PA-TDI interval is increased in acutely exacerbated COPD (AECOPD) compared within stable COPD and that increased PA-TDI is related to impairment of autonomic function. For this purpose, 25 patients with AECOPD and 25 patients with stable COPD were characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and autonomic function.

Eligibility criteria: Inclusion Criteria:

* patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave informed written consent

Exclusion Criteria:

* Inability to give written consent, acute myocardial infarction with ST-segment elevations in last 30 days, severe acute or chronic renal dysfunction, severe heart failure, atrial fibrillation, severe valve disease, severe hypotension, active malignant disease, active rheumatic disease

Primary outcomes:
measure: total atrial conduction time
timeFrame: Baseline
Secondary outcomes:
measure: Heart rate variability
timeFrame: Baseline
measure: Baroreflex sensitivity
timeFrame: Baseline
measure: Chemoreflex sensitivity
timeFrame: Baseline
measure: Deep breathing test
timeFrame: Baseline
measure: Ewing test
timeFrame: Baseline
measure: Cold pressure test
timeFrame: Baseline
measure: Cold face test
timeFrame: Baseline
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References:
Clinical trial NCT01045733: A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
Official title: A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Astigmatism
Keywords: Cataract
Toric
IOL
AcrySof
LRI
Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.


Eligibility criteria: Inclusion Criteria:

Ocular criteria must be met in both eyes.

* Willing and able to understand and sign an informed consent;
* Willing and able to attend postoperative examinations per protocol schedule;
* Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
* Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
* Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
* Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Ocular disease and/or condition that may compromise study results;
* Pregnant or planning pregnancy during course of study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Corneal Aberration
timeFrame: Month 6 postoperative
Secondary outcomes:
measure: Visual Acuity
timeFrame: Month 6 postoperative
measure: Corneal Cylinder
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT00997633: Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy
Official title: Single-photon Emission Computed Tomography for Prediction of Treatment Results in Sequential Intraperitoneal Chemotherapy at Peritoneal Carcinomatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Carcinomatosis
Keywords: Intraperitoneal volume
peritoneal carcinomatosis
cytoreductive surgery
SPECT
intraperitoneal chemotherapy
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 51
Sex: ALL
Minimum age (years): 14
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had undergone cytoreductive surgery and intraperitoneal chemotherapy (SPIC) at the Dept of Surgical Sciences, Uppsala University Hospital in the time period between May 1991 and August 2004.

Brief summary: SPECT was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. SPECT data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Cytoreductive surgery and intraperitoneal chemotherapy
* Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment

Primary outcomes:
measure: Detected volume measured by SPECT compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses
Secondary outcomes:
measure: The relationship between SPECT, feasibility of SPIC (intraperitoneal chemotherapy), and clinical variables
Other outcomes:
Locations:
city: S-751 85 Uppsala
country: Sweden
facility: Dept of Surgical Sciences, Section of Surgery
Study officials:
affiliation: Dept of Surgical Sciences, University Hospital, Uppsala, Sweden
name: Haile Mahteme, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05862233: A Phase Ⅲ Clinical Study of MIL62 in Primary Membranous Nephropathy
Official title: A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Primary Membranous Nephropathy
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).


Eligibility criteria: Inclusion Criteria:

1. Age 18-80;
2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;
3. 24 hours urinary protein \> 3.5g at initial screening and confirmation assessment;
4. Epidermal growth factor receptor (EGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2;
5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
6. Sufficient organ function;
7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

1. Participants with a secondary cause of MN;
2. Cyclosporine resistance;
3. Received treatment drugs for membranous nephropathy;
4. Concomitant with other serious diseases；
5. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;
6. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA );
7. Subjects with CD4+ T lymphocyte count \< 300 cells/μL;
8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
9. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62，or Cyclosporine；
10. Breastfeeding or pregnant women;
11. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method
12. Other conditions unsuitable for participation in this study determined by the Investigator.

Primary outcomes:
measure: Overall Remission rate (CR+PR) at Week 52.
timeFrame: Week 52
measure: Overall Remission rate (CR+PR) at Week 76.
timeFrame: Week 76
Secondary outcomes:
measure: Complete Remission rate at Week 52.
timeFrame: Week 52
measure: Complete Remission rate at Week 76.
timeFrame: Week 76
measure: Overall Remission rate (CR+PR) at Week 24
timeFrame: Week 24
measure: Overall Remission rate (CR+PR) at Week 104
timeFrame: Week 104
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: