louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06016933: Effect of Spirulina on Periodontitis
Official title: Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.

Detailed description: In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.

Eligibility criteria: Inclusion Criteria:

* All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm.

Exclusion Criteria:

* Any systemic disease that affects the periodontium. ·
* Pregnant, postmenopausal women. ·
* People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.
* People who use mouth washes regularly ·
* Participation in other clinical trials.

Primary outcomes:
measure: Clinical attachment level
timeFrame: 3 months
measure: Probing pocket depth
timeFrame: 3 months
measure: Interleukin 6.
timeFrame: 3 months
Secondary outcomes:
measure: Plaque Index
timeFrame: 3 months
measure: Gingival index
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Kafrelsheikh University
Study officials:
References:
Clinical trial NCT03492333: Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status
Official title: The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Keywords: antigliadin, gluten free diet, transit
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention GFD in IBS and HV(controls)
Primary purpose: DIAGNOSTIC

Brief summary: Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria).

Antibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of response to GFD. However, this has not been tested in a prospective study in IBS patients. Identification of predictors of a symptomatic response to GFD within the IBS population would improve the clinical management of these patients.

The purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to their antigliadin antibodies status.

Additional purposes include investigating effects gluten free diet may have on other parameters:

* Improvement of mood
* Quality of life and general well-being
* Changes in gut microbiota


Eligibility criteria: Inclusion Criteria:

* Adult patients
* IBS diagnosis (Rome III)
* Willingness to participate

Exclusion Criteria:

* history of any organic disease including celiac disease
* Immune deficiency
* Major abdominal surgery
* Use of immunosuppressants, glucocorticosteroids or opioids
* Use of antibiotics in the last 3 months

Primary outcomes:
measure: Improvement on gastrointestinal symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Normalization of gastrointestinal transit
timeFrame: 4 weeks
measure: Improvement anxiety and/or depression
timeFrame: 4 weeks
measure: Improvement somatization
timeFrame: 4 weeks
measure: Improvement quality of life and well-being
timeFrame: 4 weeks
measure: Changes in gut microbiota
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Farncombe Institute
state: Ontario
Study officials:
affiliation: McMaster University
name: Premysl Bercik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinto-Sanchez MI, Nardelli A, Borojevic R, De Palma G, Calo NC, McCarville J, Caminero A, Basra D, Mordhorst A, Ignatova E, Hansen S, Uhde M, Norman GL, Murray JA, Smecuol E, Armstrong D, Bai JC, Schuppan D, Collins SM, Alaedini A, Moayyedi P, Verdu EF, Bercik P. Gluten-Free Diet Reduces Symptoms, Particularly Diarrhea, in Patients With Irritable Bowel Syndrome and Antigliadin IgG. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2343-2352.e8. doi: 10.1016/j.cgh.2020.08.040. Epub 2020 Aug 19.
Clinical trial NCT03831633: Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
Official title: A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oncology
Lead sponsor: VIFORFRANCE
Sponsor class: INDUSTRY
First posted: 2019-02-06
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting


Eligibility criteria: Inclusion Criteria:

* Male or female, Age ≥ 18 years
* Have a histological or cytological confirmed solid tumor malignancy
* Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor
* Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's
* Naïve of CT
* ECOG performance up to 2
* Able to read, understand and follow the study procedures
* Patient with Health insurance

Exclusion Criteria:

* Pregnancy and breastfeeding women;
* Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;
* Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Anti-emetic response
timeFrame: 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Avicenne
Study officials:
References:
Clinical trial NCT00802633: Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Official title: Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bladder Cancer
Hemostasis
Keywords: Tissue sealing device
Articulating stapling device
Radical cystectomy
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.


Eligibility criteria: Inclusion Criteria:

* Muscle invasive bladder cancer
* Male/Female gender

Exclusion Criteria:

Primary outcomes:
measure: Estimated Blood Loss
timeFrame: Perioperative
Secondary outcomes:
measure: Operating Room Time in Minutes
timeFrame: Intraoperative time
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sam S Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05838833: Ointment to Prevent Scar After Thyroidectomy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of INV-001 Administration for the Prevention of Scar After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Scar
Lead sponsor: Innovo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to evaluate the efficacy and Safety of INV-001 administration for the prevention of scar after thyroidectomy.

Participants will be asked to apply ointment on their scar for 12 weeks.

Detailed description: to evaluate the efficacy

-investigator check POSAS and VSS

Eligibility criteria: Inclusion Criteria:

* Patient who got thyroidectomy due to Thyroid cancer
* has scar longer than 3 cm

Exclusion Criteria:

* have history about Keloid or Hypertrophic scar
* have infection on surgical site

Primary outcomes:
measure: Observer overall opinion of POSAS
timeFrame: 12 weeks
Secondary outcomes:
measure: Observer overall opinion of POSAS
timeFrame: 3, 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Innovo Therapeutics, Inc.
Study officials:
affiliation: New Drug development Center
name: Minjeong Kim, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT03745833: Medical Mindfulness: Virtual Reality Mindfulness Therapy for Eating Disorders
Official title: Medical Mindfulness: Virtual Reality Mindfulness Therapy for Anxiety and Pain Management in Adolescent and Young Adult Patients With Eating Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorder
Anxiety
Abdominal Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adolescents and young adults with eating disorders undergoing refeeding on an inpatient unit often experience abdominal pain and anxiety either as a result of their medical condition or as an expected side effect of nutritional rehabilitation. The purpose of this study is to assess if VR (Virtual Reality) mindfulness therapy is more or as effective as the standard of care (supportive care such as aromatherapy, heat packs, distraction, and nausea bands) for treating and/or preventing anxiety and pain in patients with eating disorders during the re-nourishment process. The anticipated primary outcome will be reduction of abdominal pain and anxiety with utilization of this intervention.

Detailed description: In this study, investigators hope to 1) assess acceptance of VR mindfulness among inpatient adolescents and young adults with eating disorders 2) assess effects of VR mindfulness on perceived abdominal pain and 3) determine the impact of VR mindfulness on anxiety scores.

This study is designed to test the feasibility, acceptability and effectiveness of VR mindfulness in patients as they undergo various medical and nutritional therapies to treat their conditions.

Eligibility criteria: Inclusion Criteria:

* patients admitted to the inpatient medical unit for refeeding for malnutrition

Exclusion Criteria:

* non-English speakers

Primary outcomes:
measure: Abdominal pain
timeFrame: 1 hour after meals
Secondary outcomes:
measure: Anxiety
timeFrame: 1 hour after meals
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00835133: Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma
Official title: Biospecimen Resource for Familial Pancreas Research, a Data and Tissue Registry (Also Known as a Bio-repository, Bio-bank, Data and Tissue Database, Data and Tissue Bank, Etc.) to Help Advance Research in Familial Pancreas Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Familial Pancreatic Cancer
Keywords: family
history
pancreas
cancer
melanoma
genetic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-02-03
Enrollment: 1122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Familial pancreatic cancer kindred

Brief summary: RATIONALE: Collecting and storing samples of blood and tissue from family members of patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This clinical trial is collecting blood and tissue samples from family members of patients with pancreatic disease, pancreatic cancer, and melanoma.

Detailed description: OBJECTIVES:

* To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma.
* To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.

OUTLINE: Study participants undergo collection of blood and/or tissue samples as well as survey data for inclusion in a familial data and tissue registry. Participants complete two baseline surveys regarding their personal, family, health, and environmental exposure histories and regarding their opinions on cancer and cancer screening. Patients also complete a follow-up survey at 1 year and undergo review of their medical records.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Has at least 2 blood relatives with pancreatic cancer (both must be related)
  * Has at least 1 blood relative with pancreatic cancer and 1 with melanoma (both must be related)

PATIENT CHARACTERISTICS:

* Mentally competent and able to provide informed consent
* Able to understand and read English

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Collection of familial data and biospecimens in a data and tissue repository for familial pancreas research
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shounak Majumder, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00751933: Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis
Official title: A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Vaccines
Oats
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Vest
First posted: 2008-09-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. We hypothesise that an improvement or even normalisation of this balance may be achieved by the use of vaccines and dietary oats. The combined use of oral typhoid vaccine and cholera/ETEC-vaccine is supposed to stimulate mucosal defence factors, while dietary oats modifies the microbial environment inside the intestinal lumen. Or study aim is to show if such treatment brings symptom relief to patients with ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* ulcerative colitis of at least 4 months duration
* disease activity index score (Walmsley) \>5 and \</=13
* patients taking no ulcerative colitis relevant medicine, or stable doses of aminosalicylates or maximum 10mg prednisolon daily the last 2 weeks before study entry. They must remain on the same dose throughout the study (6 months).
* stool examination negative for enteric pathogens, clostridium difficile toxin and parasites

Exclusion Criteria:

* ulcerative colitis disease activity index \>13
* symptoms of bowel obstruction
* other serious medical condition
* use of any of the study vaccines during the last two years
* use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first vaccine dose, or planned use during study period
* pregnant or planning to become pregnant
* breastfeeding
* chronic administration of prednisolone more than 10mg per day or steroids of equivalent dose the last 2 weeks before the first vaccine dose
* treatment with anti-tumor necrosis factor within 3 months prior to the first vaccine dose
* use of other immunosuppressants or immune modifying drugs within 30 days prior to the first vaccine dose

Primary outcomes:
measure: Symptom Score Improvement of 3 or More During or After 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Symptom Score Improvement of 2 or More During or After 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Medicine, Haukeland Universtiy Hospital
Study officials:
affiliation: Department of Medicine,Haukeland University Hospital, Bergen, Norway
name: Gunnar Nysæter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02358733: Use of IMSI in Poor Responders to IVF
Official title: Use of Intra-Cytoplasmic Morphologically Selected Sperm Injection (IMSI) in Poor Responders to In Vitro Fertilization (IVF): a Prospective, Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Female Infertility
Keywords: POR
IMSI
Lead sponsor: Centro de Infertilidad y Reproducción Humana
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 37
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study which aims to determine the role of IMSI in poor responders.

Detailed description: This is a pilot study which aims to determine the role of IMSI over ICSI in poor responders to IVF, without a background of teratozoospermia.

Eligibility criteria: Inclusion Criteria:

* poor ovarian response

Exclusion Criteria:

* body mass index (BMI) ≥ 30 kg/m2
* presence of endocrinopathies (e.g., diabetes, hyperprolactinemia, hypothyroidism)
* altered karyotype or documented genetic defects in one or both partners
* history of chronic, autoimmune or metabolic diseases
* altered meiosis in testicular biopsy or altered sperm-FISH
* teratozoospermia
* participation, simultaneously or within the previous 6 months, in another clinical trial with medication

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: Four to six weeks after embryo transfer
Secondary outcomes:
measure: Number of embryos obtained
timeFrame: Two days after egg retrieval
measure: Percentage of cycles with embryo transfer
timeFrame: Two days after egg retrieval
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro de Infertilidad y Reproducción Humana (CIRH)
Study officials:
affiliation: Centro de Infertilidad y Reproducción Humana (CIRH)
name: Karinna Lattes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06353633: The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease
Official title: The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: PEN
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 44
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.


Eligibility criteria: Inclusion Criteria:

* children aged 4 to 18 years with active Crohn's disease
* Pediatric Crohn's Disease Activity Index (PCDAI) ≥10 and ≤40

Exclusion Criteria:

* Patients who receiving concurrent remission-inducing drugs such as steroids, 5-ASA, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic

Primary outcomes:
measure: PCDAI
timeFrame: 8 weeks
measure: CRP
timeFrame: 8 weeks
measure: ESR
timeFrame: 8 weeks
measure: FC
timeFrame: 8 weeks
measure: Alb
timeFrame: 8 weeks
Secondary outcomes:
measure: Arm Circumferance
timeFrame: 8 weeks
measure: BMI
timeFrame: 8 weeks
measure: Height
timeFrame: 8 weeks
measure: weight
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: NNFTRI
name: Azita Hekmatdoost, MD, PhD
role: STUDY_DIRECTOR
References: