louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01056913: NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery
Official title: Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonic Neoplasms
Rectal Neoplasms
Diverticulitis
Inflammatory Bowel Diseases
Rectal Prolapse
Keywords: anastomotic leakage
bleeding from the anastomotic region
anastomotic stenosis
Lead sponsor: St John of God Hospital, Vienna
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.


Eligibility criteria: Inclusion Criteria:

* benign and malign lesions of the colon and rectum

Exclusion Criteria:

* advanced peritonitis (putrid, feculent)

Primary outcomes:
measure: Anastomotic Leakage
timeFrame: 4-8 weeks
Secondary outcomes:
measure: Clinical Relevant Stenosis
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: St John of God Hospital, Vienna
name: Friedrich Herbst, MD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2.
Clinical trial NCT00400413: Neuroanatomy of Reading in Congenital Deafness.
Official title: Phonological Perception and Learning to Read : the Neuroanatomy of Reading in Congenitally Deaf Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Deafness
Keywords: Neuropsychology
fMRI
Reading
Phonology
Deafness
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre National de la Recherche Scientifique, France
name: Conseil Régional d'Alsace
First posted: 2006-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The aim of the research is to investigate phonological processing in deafness and to examine its influence on the neuroanatomy of reading.The basic hypothesis is that insofar as the ability to read is closely related to the ability to segment and represent speech units, the neuroanatomy of reading in deaf would be different from the one of hearing readers.


Eligibility criteria: Inclusion criteria:

* adult
* full education

Exclusion criteria:

* reading impairment
* fMRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Clinique Neurologique - Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Marie-Noëlle Metz-Lutz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05710913: Development of Machine Learning Models for the Prediction of BMI and Complications After Bariatric Surgery (CABS-Study)
Official title: Development of Machine Learning Models for the Prediction of BMI and Complications After Bariatric Surgery (CABS-Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Body Weight
Post-Op Complication
Anastomosis, Leaking
Hiatal Hernia
GERD
Internal Hernia
Mesenteric Hernia
Intussusception
Diabetes Mellitus, Type 2
Sleep Apnea, Obstructive
Keywords: Bariatric Surgery
Machine learning
Clinical prediction modelling
Artificial intelligence
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: University of Basel
name: GZO Hospital, Zürich, Switzerland
First posted: 2023-02-02
Enrollment: 10000
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: Patients undergoing bariatric surgery

Brief summary: This Study aims to develop machine learning models with the ability to predict patients' BMI and complications after Bariatric Surgery (CABS-Score).

This Study also aims to develop machine learning models with the ability to predict diabetic (DM II)patients' remission rate after Bariatric Surgery.

The service mentioned above will be publicly available as a web-based application


Eligibility criteria: Inclusion Criteria:

* Patients undergoing bariatric surgery
* Patients \>18 years

Exclusion Criteria:

* Patients \<18 years
* Patients who cannot be followed up on for more than 6 month after surgery
* Patients who are unable to provide informed approval to participate according to each centre's rules will be excluded.

Primary outcomes:
measure: Complication after surgery
timeFrame: [Time Frame: From index surgery up to 3 months postoperatively]
measure: Body mass Index (KG/m2) after surgery
timeFrame: [Time Frame: From index surgery up to 1 year postoperatively]
measure: Diabetes mellitus type II remission rate postoperatively
timeFrame: [Time Frame: From index surgery up to 2 year postoperatively]
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel - Department of Biomedical Engineering
Study officials:
References:
Clinical trial NCT01030913: B-type Chronic Lymphocytic Leukemia (B-CLL) Subgroups: Maturation Stage and Gene Expression
Official title: B-CLL Subgroups: Maturation Stage and Gene Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 1248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Lymphocytic Leukemia Community Sample

Brief summary: B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western world. It is a disease that occurs primarily in aging individuals and occurs more frequently in males than females. Although B-CLL was considered a homogeneous condition, recent studies by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.

These sub-groups can be identified by either the presence or the absence of mutations in antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody genes low percentage CD38) follow strikingly clinically different courses. For example, the unmutated/CD38+ group experiences a much more aggressive disease and these patients almost invariably die much sooner than the cases in the other group. In addition, the patients in the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally, surprisingly there is a much higher representation of males in the poor outcome unmutated CD38 group than in the better outcome group. The reasons for these differences in clinical outcome and gender bias are unknown.


Eligibility criteria: Inclusion Criteria:

* 18 years of age,
* Patients must be able to contribute the required amount of blood without compromising their well being,
* Participants must be willing to be contacted again in the future for additional blood drawing.

Exclusion Criteria:

* Patients who are known to be anemic, with a hemoglobin \< 8,
* Patients who are known to be infected with HIV.

Primary outcomes:
measure: differentiating B-CLL cells by the presence or absence of mutations in antibody genes and/or by the percentage of cells expressing CD38 and the difference in clinical disease course and outcome for each group
timeFrame: follow through the clinical disease course for each group
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical research
state: New York
Study officials:
affiliation: Northwell Health
name: Nicholas Chiorazzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936113: Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study
Official title: An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
microbiome
probiotic
commensal Gram-negative bacteria
transdermal water loss
allergic diseases
dermatitis
eczema
skin diseases
skin diseases, eczematous
immune system diseases
Lead sponsor: Forte Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.


Eligibility criteria: Inclusion Criteria:

* Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study
* Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor

Exclusion Criteria:

* Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01
* Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological
* Pregnant (or planning to become pregnant during the period of the study) or lactating females

Primary outcomes:
measure: Number of adverse events
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc
state: Georgia
city: Clarksville
country: United States
facility: DS Research
state: Indiana
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: New Brighton
country: United States
facility: Cyn3rgy Research
state: Minnesota
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
Study officials:
References:
citation: Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.
Clinical trial NCT03161236: Assessing Balance Changes Following an Exercise Program Among Middle-Aged Adults
Official title: Assessing Balance Changes Following an Exercise Program Among Middle-Aged Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance Changes
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 52
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This graduate student research study has two purposes; the first purpose is to examine the criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in healthy middle-aged adults. The second purpose is to examine balance changes using the YBT following a home-based exercise program.

Detailed description: 4. "Subjects will be healthy female or male middle-aged adults who are able to walk and move independently.

5. "Subjects will be between 45 and 64 years of age." 6. "In total, subject participation will last approximately eight weeks. Visit 1 (baseline): 90 minutes, visit 2 (week 4): 30 minutes, and visit 3 (week 8): 60 minutes.

7. "Subjects will be recruited by distributing flyers in the Loma Linda Community, sending emails to school staff, students, and faculty, and word of mouth.

8. "Consent will take place at Loma Linda University, Nichol Hall rooms A620 -A640 by investigators." 9. If Multi-center: N/A 10. If Single center or investigator-initiated: "70 subjects will participate in the study."

Eligibility criteria: Inclusion Criteria:• Healthy adults.

* Age range: 45-64 years.
* Able to walk and move independently

Exclusion Criteria:• Dizziness, visual or neurological disorders that prevent the ability to complete the testing protocol.

* Lower limb injury in the last 3 months.
* Lower limb surgery in the last 6 months.
* Current involvement in a rehabilitation program.

Primary outcomes:
measure: Y Balance Test
timeFrame: change from baseline to 4 weeks
measure: Y Balance Test
timeFrame: change from 4 weeks to 8 weeks
Secondary outcomes:
measure: limits of stability
timeFrame: change from baseline to 4 weeks
measure: limits of stability
timeFrame: change from 4 weeks to 8 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Gurinder Bains, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05282836: Early Hydrogen-Oxygen Gas Mixture Inhalation in Patients With Aneurysmal Subarachnoid Hemorrhage (HOMA)
Official title: Early Hydrogen-Oxygen Gas Mixture Inhalation Therapy for Patients With Aneurysmal Subarachnoid Hemorrhage: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 206
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: This was a randomized, single-center trial. On the basis of standard-of-care, patients in the treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) during a 7-day stay in the intensive care unit. Patients in the control group received standard-of-care (consisting of oxygen therapy) alone. This study intends to apply Hydrogen/Oxygen Generator in clinical patients with aneurysmal subarachnoid hemorrhage (aSAH), exploring the role of hydrogen-oxygen mixed gas inhalation therapy in early brain injury, and the prevention of cerebral vasospasm and delayed cerebral ischemia, finally providing a scientific basis for hydrogen treatment of aSAH.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Signed informed consent
3. Must be admitted within 72 hours after aneurysm rupture

Exclusion Criteria:

1. physical disability caused by any reason before the onset of the disease
2. dementia or mental illness before the onset of the disease
3. more than 72 hours after aneurysm rupture admitted to hospital for treatment
4. do not cooperate with the treatment

Primary outcomes:
measure: In- hospital Cerebral Vasospasm
timeFrame: From baseline to 14 days
measure: In- hospital Delayed Cerebral Ischemia
timeFrame: From baseline to 14 days
Secondary outcomes:
measure: modified Rankin Scale score
timeFrame: 90 days after discharge
measure: Montreal Cognitive Assessment score
timeFrame: 90 days after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00543036: Efficacy and Safety of the Hcoil Deep TMS for the Treatment of Cannabis Addiction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Marijuana Abuse
Keywords: Cannabis
Addiction
Craving
TMS
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2007-10-12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of efficacy and safety of H-coil deep transcranial magnetic stimulation 9 week treatment trial for cannabis addiction as assessed by measures of drug intake and craving.


Eligibility criteria: Inclusion Criteria:

* Male and Female, aged 21-70 years, who meet DSM-IV TR diagnostic criteria for cannabis abuse and are motivated to quit cannabis use as assessed in the screening visit and gave their written informed consent to participate in the study.

Exclusion Criteria:

* History of a primary major psychiatric other then cannabis abuse, or cognitive disorder according to DSM-IV TR criteria.
* Hamilton depression scale rated 25 and above (moderate to severe depression)
* Current alcohol or other substance abuse or dependence
* Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
* History of or evidence of significant brain malformation,neoplasm, head injury, cerebral vascular events,neurodegenerative disorder or brain surgery.
* Severe somatic co-morbidity
* History of seizures Cardiac pace maker or other electronic implants Pregnancy and lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hod-HaSharon
country: Israel
facility: Shalvata Mental Health Center
Study officials:
affiliation: Shalvata MHC affiliated to Tel-Aviv universtiy, Sackler school of medicine
name: Ziv Carmel, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Weizmann Institute, Rehovot, Israel
name: Abraham Zangen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03468036: Intratracheal Suctioning and Oxygenation at Extubation
Official title: Intratracheal Suctioning and Oxygenation at Extubation (INnovATE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extubation
Keywords: critical illness
ICU
extubation
respiratory failure
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients that undergo routine extubation

Brief summary: Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with 100% O2 vs. 35% O2 with/without suctioning.


Eligibility criteria: Inclusion Criteria:

* All adult (≥18 years) ICU patients with routine extubation on the ICU during the 2-month observational interval.

Exclusion Criteria:

* Age \< 18 years
* Patients on comfort therapy and/ or terminal extubation or accidental extubationtracheostomized patients
* Patients with refusal to general consent or withdrawal of general consent (DLF and/or internal database)
* Patients dying without next-of-kin available

Primary outcomes:
measure: Difference in proportion of patients with need for ongoing ventilatory support
timeFrame: 30 days max follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dept. of Intensive Care Medicine, University of Bern,
Study officials:
affiliation: Inselspital, University of Bern
name: Joerg C Schefold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03737136: Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR
Official title: Comparison Between Rituximab + PLX + IVIG With and Without Bortezomib in the Treatment of Antibody Mediated Kidney Transplanted Rejection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antibody-mediated Rejection
Keywords: transplantation
plasmapheresis
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic-active antibody-mediated rejection (cAMR) due to de novo or pre-formed donor specific antibody (DSA) is currently considered the main cause of long-term allograft losses.Based on the aim of reducing or eliminating DSA, some proposed different therapeutic regimens for cAMR treatment. All of these protocols were derived from previous experience using acute antibody-mediated rejection and desensitization protocols, and mainly consisted of steroids, plasma exchange (PE), IVIG and RTX in various modalities. More recently, bortezomib was also proposed.To evaluate the role of a therapeutic regimen with plasma exchange, intravenous immunoglobulins and rituximab with or without Bortezomib in chronic-active antibody-mediated rejection (cAMR) settings this study designed.

Detailed description: 20 kidney transplant recipients (KTRs) with a diagnosis of cAMR in a prospective randomized clinical trial will be recruited in two arms

: ten KTRs treated with plasmapheresis, intravenous immunoglobulins and rituximab (PE-IVIG-RTX group) vs 10 patients receiving the same therapy plus Bortezomib. Differences between transplanted kidney survival and functional outcomes 6 mo after diagnosis and histological features and donor-specific antibody (DSA) characteristics (MFI ) will be investigated between two arms.

Eligibility criteria: Inclusion Criteria:

* All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection

Exclusion Criteria:

* Mixed AMR and T cell rejection
* do not sign the consent

Primary outcomes:
measure: graft survival
timeFrame: at month 6 following diagnosis
Secondary outcomes:
measure: Renal functional tests
timeFrame: at month 6 following diagnosis
measure: Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology
timeFrame: at month 6 following diagnosis
measure: DSAs-MFI
timeFrame: at month 6 following diagnosis
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: SBMU
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Shahid Beheshti MU sbmu
role: PRINCIPAL_INVESTIGATOR
References: