louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04447924: The Effect of a Probiotic Strain on Ibuprofen-induced GI Damage
Official title: The Effect of Daily Intake of Bifidobacterium Breve Bif195 on Small-intestinal Damage Induced by Ibuprofen - a Randomized, Double-blind, Placebo-controlled Trial in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Small Intestinal Ulceration Risk
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule endoscopy in a healthy US population.

Detailed description: This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to daily intake of 800mg of Ibuprofen.

The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and Ibuprofen is co-administered.

Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 visits.

After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. After baseline assessments at Visit 2, subjects will start daily intake of 800mg of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo product in a ratio of 1:1.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Healthy and without any gastrointestinal pain or other significant symptoms
* Age 18 - 40 years
* Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial

Exclusion Criteria:

-

Primary outcomes:
measure: Lewis score area-under-the-curve for Bif195 vs Placebo
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Atlantia Food Clinical Trials
state: Illinois
Study officials:
affiliation: Houston Methodist Gastroenterology Associates
name: Eamonn Quigley, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05416424: Life Study: Lifestyle Intervention in Fibroid Elimination
Official title: Effects of Implementing a Post-surgical Dietary and Lifestyle Protocol on Uterine Fibroid Recurrence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uterine Fibroid
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study will evaluate a lifestyle, nutrition, and exercise program to assess whether this program is acceptable and feasible for patients..Researchers will examine if the LIFE program can modify fibroid recurrence.

Detailed description: This prospective cohort pilot study will enroll asymptomatic, post-surgical patients who underwent a laparoscopic, open, robotic myomectomy, or other procedure ie Sonata, Accessa for fibroid removal. Patients will be offered enrollment into a lifestyle, nutrition, supplement, and exercise program to assess whether this program is acceptable and feasible for patients. Surveys will be collected at 3-6 month intervals.

Eligibility criteria: Inclusion Criteria:

* Participants ages 18-50, who are seeking care at the Center for Fibroid Care at NYU
* Participants who have had a procedure or surgery performed to removed fibroids within the last 3 months and are now considered "fibroid free."
* Be English speaking and be able to read/write in English
* Visit with PCP within the last 3 months with labs

Exclusion Criteria:

* Currently Pregnant
* Use of any medication, hormonal or GNRH agonists, that would affect fibroid growth
* Postmenopausal women
* Non-English speaking
* Fibroid procedure or surgery outside of the 3-month window
* Women who are physically incapable of following a physical activity regimen
* Women with multiple dietary restrictions that would impact their ability to follow recommended dietary plan. (ie. GI disorders)

Primary outcomes:
measure: Acceptability of LIFE program as measured by Self report survey
timeFrame: 12 month visit.
measure: Change in improvement in quality of life as measured by Quality of Life Scale (QOLS)
timeFrame: Baseline, 6 month, 12 month
measure: Change in fibroid recurrence as measured by standard of care ultrasounds
timeFrame: Baseline, 6 month, 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Taraneh Shirazian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05614024: Neurofeedback During Eating for Bulimia Nervosa
Official title: Neurofeedback During Eating: A Novel Mechanistic Treatment for Bulimia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bulimia Nervosa
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two conditions, either the experimental or sham neurofeedback arm.
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using a wearable brain imaging device, functional near-infrared spectroscopy (fNIRS). The investigators will examine how this training may influence inhibitory control and BN symptoms.

Detailed description: The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS. Specifically, the study aims 1) to demonstrate ventrolateral PFC (vlPFC) neurofeedback target engagement in women with BN using fNIRS; and 2) to link changes in PFC activation to changes in inhibitory control and eating-related symptoms.

Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person evaluation, one neurofeedback session, behavioral tasks, online questionnaires before and after the neurofeedback session, and a remote follow-up assessment.

Eligibility criteria: Inclusion criteria:

* Female
* Aged 18 to 45 years
* Meet diagnostic criteria for bulimia nervosa
* Current body mass index greater than or equal to 18.5kg/m2 but under 30kg/m2
* English-speaking

Exclusion criteria:

* Ongoing medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
* Current psychotherapy focused primarily on eating disorder symptoms
* Pregnancy or planned pregnancy, or lactation during the study period
* Allergy to ingredients in the standardized meal or in the shake

Primary outcomes:
measure: Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
timeFrame: approximately 1 hour
measure: Go/no-go task performance
timeFrame: 2 weeks
measure: Number of loss-of-control eating and purging episodes
timeFrame: 2 weeks
measure: Severity of loss-of-control eating scale
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Computational Psychiatry at the Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Laura A Berner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644124: Aflibercept and Standard Chemotherapy (R-CHOP) in First Line of Non Hodgkin B-cell Lymphoma
Official title: A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non Hodgkin's B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Keywords: Non-Hodgkin's lymphoma
angiogenesis inhibitors
CHOP protocol
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2008-03-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to determine how the body handles aflibercept when it is administered with R-CHOP.


Eligibility criteria: Inclusion Criteria:

* Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated

Exclusion Criteria:

* Contraindication to any drug contained in the R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)
* Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
* Cerebral or leptomeningeal involvement.
* History of another neoplasm (Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for \> 5 years are allowed)
* Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
* Any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
* Uncontrolled diabetes mellitus
* Uncontrolled hypertension
* Abnormal kidney function
* Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
* Pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
* History of hypersensitivity to any Trap agents or recombinant proteins

Primary outcomes:
measure: selected dose of aflibercept based on Dose Limiting Toxicities observed
timeFrame: cycle 1 +/- 2
Secondary outcomes:
measure: Adverse events
timeFrame: treatment period
measure: Response rate
timeFrame: cycle 2, 4 and 8
measure: Progression free survival
timeFrame: study period
measure: Biomarkers
timeFrame: Study period
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Groupe d'Etudes du Lymphome de l'Adulte
name: Corinne Haioun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088724: Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)
Official title: Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-transplant Lymphoproliferative Disease (PTLD)
Non Burkitt
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fludarabine may be of benefit to prevent rejection of grafted solid organs in children during chemo-immunotherapy treatment for post transplant lymphoproliferative diseases (PTLDs).

Detailed description: Eligible to this study were patients less than 18 years old, presenting with non Burkitt, aggressive, CD20 positive PTLD, after solid organ transplants.

Induction therapy consisted of two cycles of a combination of Fludarabine(30mg/sqm/day, days 1,2,3), Cyclophosphamide (750 mg/sqm/day, day 1), Doxorubicin (30 mg/sqm/day, day 1)and Rituximab (375 mg/sqm/day, day 4).

Thereafter consolidation therapy was given as follows: two blocks for stage II or III with LDH less than 500 IU/L; three blocks for stage III with LDH \>500 and \< 1000 IU/L or stage IV with LDH \< 1000 IU/L; four blocks for stage III or IV with LDH \> 1000 IU/L. Blocks given were modified BFM blocks used for treatment of non Hodgkin B-lymphomas, as follows:

Block 1: High Dose Methotrexate (HDMTX) 1.5 gr/sqm; Vincristine (VCR,1.5 mg/sqm); Cytarabine (from 120 to 150 mg/sqm x4); Ifosfamide (600 mg/sqm/day x5); VP-16 (80 mg/sqm/day x2); Dexamethasone (DXM,10 mg/sqm/day for 5 ays); Intrathecal Methotrexate-Cytarabine-Methylprednisolone(TIT).

Block 2:HDMTX (3 gr/sqm); VCR (1.5 mg/sqm); Daunomycin (20 mg/sqm/day x2); Cyclophosphamide (160 mg/sqm/day x5); DXM (10 mg/sqm/day x5); TIT

Block 3:Vindesine (3 mg/sqm); Cytarabine (3000 mg/sqm q 12 hours x4); VP-16 (100 mg/sqm q 12 hours x4); DXM (20 mg/sqm/day x5);

Block 4 as Block 1.

Outcome measures are: achievement of complete remission after induction therapy; incidence of infectious episodes; neurological toxicity; incidence of graft rejection; duration of complete remission.

Eligibility criteria: Inclusion Criteria:

* Children less 18 years old and
* Non Burkitt, CD20 positive aggressive PTLD and
* Solid organ transplant

Exclusion Criteria:

* Burkitt PTLD

Primary outcomes:
measure: Complete remission rate
timeFrame: 6 months
measure: graft rejection rate
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Continuous complete remission rate
timeFrame: five years after the diagnosis
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
state: BG
Study officials:
affiliation: Department of Pediatrics, Ospedali Riuniti di Bergamo
name: Valentino Conter, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05788224: The Management of Complicated Colo-rectal Cancer in Older Patients in the Emergency Setting: the CO-OLDER Study
Official title: The Management of Complicated Colo-rectal Cancer in Older Patients in the Emergency Setting: the CO-OLDER Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Colorectal Cancer in Elderly Patient
Keywords: elderly; oldest; colorectal cancer; perforation; bleeding; obstruction; emergency; surgery; laparotomy; laparoscopy; futility; frailty
Lead sponsor: Poissy-Saint Germain Hospital
Sponsor class: OTHER
Collaborators: name: Fausto Catena
name: World Society of Emergency Surgery
First posted: 2023-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All older (aged 75 years old and over) patients who were admitted to the surgical department with acute abdominal pain due to a complication of colorectal cancer.

Brief summary: This is a multicenter observational study aimed to investigate the management of older patients aged 75 years old and over admitted to the emergency department with complicated colorectal cancer.

The final endpoint is to report morbidity and mortality in this group of frail individuals according to the shift of incidence of colorectal cancer in geriatric patients, over 2 periods: before the COVID pandemic outbreak (11th March 2020) and after the 11th March, during the ongoing pandemic.


Eligibility criteria: Inclusion Criteria:

* Patients aged 75 years old and over;
* Admission to the emergency department with acute abdominal pain;
* Diagnosis of obstructed and/or perforated colorectal cancer.

Exclusion Criteria:

* Patients aged\< 75 years old;
* Patients aged \>=75 years old admitted with acute abdomen, not due to complicated colorectal cancer.

Primary outcomes:
measure: mortality and morbidity correlated with the management of older (=>75 years old) patients admitted to emergency department with a complicated colorectal cancer
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: World Society of Emergency Surgery
Study officials:
affiliation: World Society of Emergency Surgery
name: Belinda De Simone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03453424: Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA
Official title: Analgesic Efficacy of Dexmedetomidine Added to Patient Controlled Epidural Analgesia for Patients Undergoing Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Abdominal Pain
Abdominal Cancer
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

Detailed description: The aim of modern anaesthetic practice is to insure the rapid recovery of patients with fewer complications and earlier hospital discharge.

Thoracic epidural anesthesia (TEA) has been established as a cornerstone in the perioperative care after thoracic and major abdominal surgery providing most effective analgesia. beyond its analgesic properties, TEA's effects on the postoperative neurohumoural stress response, cardiovascular Pathophysiology, and intestinal dysfunction have been in the focus of both clinical and experimental investigations for years.

dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

Eligibility criteria: Inclusion Criteria:

* adult patients (21 years old or more),
* classified as American Society of Anesthesiologists (ASA) grade II and III,
* scheduled for elective major abdominal cancer surgery.

Exclusion Criteria:

* patients with coagulopathy,
* active neurological disease,
* cutaneous disorders at the epidural insertion site,
* allergy to the study medication
* and patients refusal.

Primary outcomes:
measure: Change in pain scores (dynamic VAS)
timeFrame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Secondary outcomes:
measure: Change in post operative MAP
timeFrame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Study officials:
affiliation: Lecturer in Assuit university
name: Alaa M. Elzohry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00365924: A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo
Official title: A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: 12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with osteoporosis

Exclusion Criteria:

* Any therapies or products affecting bone turnover within 12 months of Screening.
* Bisphosphonate treatment \>1 month in total duration at any time in the past.
* In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.

Primary outcomes:
measure: Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
timeFrame: 12 months
Secondary outcomes:
measure: Changes in BMD and bone biomarkers following 12 months of therapy with Forteo
timeFrame: 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Capital Federal - Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: