louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04613466: The Prevelance of Pulmonary Manifestation in Patients With Inflammatory Bowel Disease
Official title: The Prevelance of Pulmonary Manifestations in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Prevelance and Complications of Pulmonary Manifestations in Patients With Inflammatory Bowel Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed IBD either male or female age 18 to 60 years

Brief summary: Bronchopulmonary manifestations signs and symptoms are variable extraintestinal manifestations of IBD.

Detailed description: Several cases like bronchiactsis, bronchitis, tracheobronchitis and broncholitis. None of this complications are specific for either crohns or ulcerative , however the majority of cases are related to ulcerative colitis.

Eligibility criteria: Inclusion Criteria:All patients diagnosed ulcerative colitis and crohns disaese on conventional treatment and biological treatment -

Exclusion Criteria:no exclusion criteria

-

Primary outcomes:
measure: The presence of pulmonary manifestations in IBD patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02017366: Design of the EFECTS Trial
Official title: Design of the EFECTS Trial, Investigating the Influence of Postoperative Enteral Feeding in Esophageal Cancer paTients on Survival
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: Surgery
Malnutrition
Nutrition, Enteral
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: It is well known that there is a considerable postoperative weight loss in patients undergoing esophageal resection for cancer.

We believe that this weigh loss can be limited by administering postoperative enteral feeding (target: 1000 kCal/ day) via feeding jejunostomy for at least 6 weeks postoperatively.

We hypothesize that patients undergoing esophageal resection for cancer will have a better overall survival with postoperative additional enteral feeding than when on regular oral diet alone.


Eligibility criteria: Inclusion Criteria:

* advanced cT2 N+ or cT3 Nx
* all histology
* GEJ or distal esophageal ACC
* proximal or mid SCC
* curative intent with intention to treat
* no M+
* at least two-field lymphadenectomy
* all access: MIE, left thoraco freno or R thoraco + laparotomy with intrathoracic or cervical anastomosis
* all anastomosis (intrathoracic, cervical)

Exclusion Criteria:

* T4
* R2
* transhiatal
* pt in definitive CRT or rescue resection following definitive CRT
* palliative treatment
* tumours in cervical esophagus
* pharyngeal cancer with gastric pull-up

Primary outcomes:
measure: overall survival from day of surgery
timeFrame: 5 years postoperative
Secondary outcomes:
measure: postoperative weight loss
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University hospital Leuven
state: Vl-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Hans Van Veer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Philippe Nafteux, MD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Willy Coosemans, MD, PhD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Johnny Moons, MScN
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Paul De Leyn, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03803826: Cardiac Strains for Optimization of CRT in Non-Responders
Official title: Use of Cardiac Strains for Optimization of Cardiac Resynchronization Therapy in Non-Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: cardiac resynchronization therapy
non-responders
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months from implementation are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap, the interventricular interval iss subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and the use of other strain combinations assessed.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the possibility of optimizing the performance of CRT-D in non-responding patients through utilization of cardiac strain speckle tracking

Detailed description: In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to any improvement of the patients' status.

In this study, an investigation of a possible method of optimization through speckle tracking of cardiac strains is attempted.

Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap and the interventricular interval subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and use of other strain combinations assessed.

Eligibility criteria: Inclusion Criteria:

* patients with symptomatic heart failure with NYHA III/IV, pharmacological treatment options exhausted, LVEF below 30%, and QRS duration over 130ms who did not respond to the implantation of CRT-D

Exclusion Criteria:

* Age below 18
* response to the original CRT implantation

Primary outcomes:
measure: Change in the left ventricular ejection fraction
timeFrame: 6 months from CRT-D implantation, 3 months from optimization
Secondary outcomes:
measure: Change in NYHA Classification
timeFrame: 6 months from CRT-D implantation, 3 months from optimization
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
Study officials:
affiliation: University Hospital Ostrava, Dpt of Cardiovascular Diseases
name: David Sipula, MUDr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041626: Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell
Keywords: Recurrent Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Introgen Therapeutics
Sponsor class: INDUSTRY
First posted: 2002-07-12
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: There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.


Eligibility criteria: * 18 years or older
* Must have had radiation treatment
* Eligible for chemotherapy
* Not eligible for surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Aurora
country: United States
facility: Unversity of Colorado Cancer Center
state: Colorado
city: Miami
country: United States
facility: University of Miami Hospital and Sylvester Comprehensive Cancer Center
state: Florida
city: Louisville
country: United States
facility: Norton Healthcare Pavilion
state: Kentucky
city: Baltimore
country: United States
facility: Center Center of GBMC
state: Maryland
city: Columbia
country: United States
facility: WJB Dorn VA Medical Center
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Houston
country: United States
facility: University of Texas, MD Andersen Cancer Center
state: Texas
Study officials:
name: Kerstin Menander, MD
role: STUDY_DIRECTOR
name: Julie L Sicam, MT (ASCP) MSHS
role: STUDY_CHAIR
References:
Clinical trial NCT00941226: The Quality Of Life Of Cerebral Palsy Child Carers
Official title: Evaluation of the Quality of Life of Cerebral Palsy Child Carers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Caregivers
Quality of Life
Lead sponsor: Centro de Estudos Superiores de Maceio
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 1
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CP child carers attended in the physiotherapy sector of a philanthropic institution on Maceió - AL

Brief summary: Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of muscle tone, posture and voluntary movement. Children who are afflicted need special intense care for their carers

Detailed description: INTRODUCTION: Cerebral Palsy (CP) is characterized by a sensory-motor deficiency, involving disturbance of muscle tone, posture and voluntary movement. Children who are afflicted need special intense care for their carers. OBJECTIVE: The objective of this study was to analyze the quality of life of CP child carers attended in the physiotherapy sector of a philanthropic institution on Maceió - AL. METHODS: 62 carers were assessed in the period from the 18th to the 29th of February 2008, in which 96.7% were female carers and 3.7% male. The form for the collection of data from the carers, elaborated by the researchers and the WHOQOL-26 quality of life questionnaire were utilized as as instruments.

Eligibility criteria: Inclusion Criteria:

* Children who were attended by Associação dos Pais e Amigos dos Excepcionais (APAE), Maceió, Alagoas
* They had cerebral palsy

Exclusion Criteria:

* Child who had not cerebral palsy
* Child under 2 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Estudos Superiores de Maceio
name: Thâmara C. R. B. Calado, Graduated
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01933126: Intrauterine Injection of HCG and Implantation Rate
Official title: The Effect of HCG Injection to the Uterine Cavity on Pregnancy Rate in Women Undergoing IVF Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Rate
Implantation Rate
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to examine the effect of intrauterine injection of HCG on pregnany rate in women undergoing IVF treatment.


Eligibility criteria: Inclusion Criteria:

* Women undergoing IVF treatment

Exclusion Criteria:

* \> 40 years

Primary outcomes:
measure: Pregnancy rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Ya'akov
country: Israel
facility: Assaf Harofeh Medical Center
state: Zerifin
Study officials:
References:
Clinical trial NCT03155126: Different Crystalloids on AKI in Shock
Official title: The Effect of Different Crystalloids on the Incidence of Acute Kidney Injury in Shock Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Keywords: shock
acute kidney injury
crystalloid
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Shock patients who need fluid resuscitation with risk factors of acute kidney injury

Brief summary: The goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

Detailed description: Fluid resuscitation is important to shock patients. Saline is the classical fluids for resuscitation. However, studies showed that resuscitation with saline could increase the incidence of hyperchloremia and acute kidney injury. Thus, the goal is to observe that the incidence of acute kidney injury in patients who need fluid resuscitation when resuscitated with saline or acetated Ringer's sodium.

Eligibility criteria: Inclusion Criteria:

* Shock patients who need fluid resuscitation with risk factors of acute kidney injury

Exclusion Criteria:

* Patients with a history of chronic kidney injury and hemodialysis therapy

Primary outcomes:
measure: Incidence of acute kidney injury
timeFrame: 28 day
Secondary outcomes:
measure: Application of renal replacement
timeFrame: 28 day
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
References:
Clinical trial NCT02945826: uPAR-PET/MRI in Glioblastoma Multiforme
Official title: uPAR-PET/MRI in Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: urokinase plasminogen activator receptor
positron emission tomography
glioblastoma multiforme
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.

Detailed description: 68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/MRI will be applied in patients suspected of glioblastoma multiforme. The uptake of the radioligand 68Ga-NOTA-AE105 will be compared and correlated with expression of the molecular target: uPAR using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. In addition, the semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in tumor tissue will be correlated with overall survival and progression free survival

Eligibility criteria: Inclusion Criteria:

* Patients where imaging with MRI or CT is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery
* The participants must be capable of understanding and giving full informed written consent
* age above 18 years

Exclusion Criteria:

* Pregnancy
* Lactation/breast feeding
* Age above 85 years old
* Weight above 140 kg
* Known allergy towards 68Ga-NOTA-AE105

Primary outcomes:
measure: uPAR PET/MRI imaging of uPAR expression
timeFrame: 1 hour
measure: uPAR PET/MRI prognostic factor for overall survival
timeFrame: 36 months
Secondary outcomes:
measure: uPAR PET/MRI prognostic factor for progression free survival
timeFrame: 36 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Dorthe Skovgaard, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05034965: Dynamic Changes in Some Facial Muscles After Hyaluronic Acid Filler Injection
Official title: Dynamic Changes in Some Facial Muscles After Superficial Versus Deep Hyaluronic Acid Injection: An Electromyographic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Changes in Facial Muscles Following Filler Injection
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: assess electrophysiological changes in some facial muscle dynamics following hyaluronic acid filler injection in superficial versus deep level of injection.

Detailed description: Participants will be subjected to injection of cross-linked hyaluronic acid fillers on both sides of the face in 3 different regions: temples, cheeks and chins.

Each female will undergo:

1. Before injection:

   1. Aesthetic facial clinical analysis.
   2. Baseline quantitative surface electromyography.
   3. Baseline digital photography.
2. Injection:

   Each female will receive the injection in the particular facial region at superficial level to the muscle (subcutaneous) on one side and the same amount at deep level to the muscle (supraperiosteal) on the other side.
3. One week after injection:

   1. Follow up quantitative surface electromyography.
   2. Follow up digital photography.

Eligibility criteria: Inclusion Criteria:

1. Age: 20-60 years.
2. Sex: females.
3. Areas eligible for injection: temples, cheeks and chin.

Exclusion Criteria:

1. Active infection near the site of injection.
2. Pregnant or lactating women.
3. Patients suffering from any neuromuscular disorders.
4. Known allergy/hypersensitivity to hyaluronic acid fillers.
5. History of botulinum toxin injection in the last 4 months.
6. History of injection of fillers in the last 2 years.
7. Patients receiving any muscle relaxants.
8. Coagulation disorder or anticoagulants therapy.

Primary outcomes:
measure: electrophysiological changes in some facial muscles
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT00828165: A Safety Study of ARRY-300 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per subject), designed to test the safety of investigational study drug ARRY-300 in healthy subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male or female (females must be of non-childbearing potential) between the ages of 18 and 50 years, inclusive.
* Body mass index (BMI) of 18 kg/m2 to 35 kg/m2; and a total body weight \> 50 kg (110 lbs) and \< 113 kg (280 lbs).
* Additional criteria exist.

Key Exclusion Criteria:

* Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* A condition possibly affecting drug absorption (e.g., gastrectomy).
* Women who are pregnant or breastfeeding.
* A positive test for drugs or alcohol.
* Use of tobacco- or nicotine-containing products in excess of 5 cigarettes per day, or daily use of pipe, cigar, chewing tobacco or nicotine gum or patches.
* Treatment with an investigational drug within 30 days prior to first dose of study drug.
* Use of prescription or nonprescription drugs, vitamins, grapefruit juice, and dietary or herbal supplements within 14 days prior to the first dose of study drug. As exceptions, acetaminophen may be used at doses of ≤ 1 g/day or ibuprofen may be used at doses of ≤ 800 mg/day until 24 hours prior to first dose of study drug.
* Blood donation of ≥ 1 pint within 30 days prior to first dose of study drug.
* Evidence of hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing.
* Additional criteria exist.

Primary outcomes:
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
timeFrame: Duration of study
measure: Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
timeFrame: Following a single dose
Secondary outcomes:
measure: Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
timeFrame: Duration of study
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: