louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04735679: Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients
Official title: Multi-omic Longitudinal Characterization of Pulmonary Microbiome in Cystic Fibrosis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: MICROBIOLOGY
MULTI-OMIC
SPUTUM
PULMONARY MICROBIOTA
CYSTIC FIBROSIS
COHORT
ANTIBIOTHERAPY
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cystic fibrosis patients

Brief summary: The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy.

All patients followed at the Montpellier CF center will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up

Detailed description: The composition and role of the pulmonary microbiota is not yet well described in cystic fibrosis patients.

According to our hypothesis, the lung microbiota shapes the lung environment of cystic fibrosis patients and modifies the effectiveness of antibiotic treatments and the course of the disease. The objective of our longitudinal follow-up of primary colonised patients is to show the presence of a link between the composition of the microbiota and the effectiveness of antibiotic therapy. Finally, the management of first colonisations could justify the characterisation of the microbiota in order to develop innovative diagnostic tests for the follow-up of patients suffering from cystic fibrosis and possibly the identification of new therapeutic agents based on the microbiota.

All patients followed at the Montpellier CF centre will be asked to participate in this cohort. All patients have a regular follow-up every 1 to 6 months and will be asked at each visit to keep their sputum sample in excess of the analyses requested for their follow-up.

Eligibility criteria: Inclusion criteria:

- Cystic fibrosis patient

Exclusion criteria

- Refusal to participate in this research

Primary outcomes:
measure: to determine a characterisation of the microorganisms of the lung microbiota
timeFrame: 1 day
measure: to determine a ink between the Composition of the microbiota
timeFrame: 1 day
measure: to determine a Effectiveness of antibiotic therapy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Raphael CHIRON, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01468779: Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms
Official title: Effect of the Probiotics Use in Patients Undergoing Surgery for Periampullary Neoplasia - A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periampullary Carcinoma Nos
Keywords: Periampullary cancer
Surgery
Dietary supplementation
Nutritional assessment
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: FIPE - Fundo de Incentivo a Pesquisa do Hospital de Clínicas de Porto Alegre
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2011-11-09
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.


Eligibility criteria: Inclusion Criteria:

* Patients in need of surgery for periampullary cancer

Exclusion Criteria:

* Patients submitted to periampullary surgery without pathologic confirmation of cancer
* Patients unwilling to be a part of the trial

Primary outcomes:
measure: Mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 15 days
Secondary outcomes:
measure: Postoperative infection rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 15 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT02424084: Bone Microcirculation After Extracorporeal Shock Wave Therapy
Official title: Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intact Scaphoid Bone
Intact Metacarpal Bone
Fractured Scaphoid Bone
Fractured Metacarpal Bone
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of extracorporeal shock wave therapy on scaphoid bones and metacarpal and metatarsal in a human in-vivo setting for the first time.


Eligibility criteria: Inclusion Criteria:

* Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid.
* Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
* Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid.
* Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.

Exclusion Criteria:

* below 18 years of age
* scar tissue above scaphoid or metacarpal bone
* osteoporosis or comparable bone disease
* medication that influences bones

Primary outcomes:
measure: Change in microcirculation (composite outcome measure)
timeFrame: Baseline and 1 minute post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Tobias Kisch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819584: Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism
Official title: Long Term Glucose Metabolism in Conservatively Treated Patients With Congenital Hyperinsulinism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Conservatively Treated CHI Patients
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-03-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include conservatively treated CHI patients who are in remission for at least one year

Brief summary: The purpose of this study is to continue follow up of conservatively treated CHI patients and to focus on their metabolic outcome, including frequency of hypoglycemia after discontinuing treatment and incidence of diabetes mellitus in the long term.


Eligibility criteria: Inclusion Criteria:

* conservatively treated CHI patients who are in remission for at least one year

Exclusion Criteria:

* none

Primary outcomes:
measure: presence and frequency of hypoglycemia and hyperglycemia.
timeFrame: one year
Secondary outcomes:
measure: incidence of diabetes mellitus
timeFrame: 5 years
Other outcomes:
measure: presence of metabolic syndrome
timeFrame: 5 years
Locations:
Study officials:
References:
Clinical trial NCT00649584: A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies
Official title: A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Keywords: Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
monomethyl auristatin E
Combined Modality Therapy
Drug Therapy
Immunotherapy
Lymphoma, Non-Hodgkin
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hematologic Diseases
Lymphoma
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed CD30-positive hematologic malignancy.
* Patients with HL must have failed systemic chemotherapy.
* Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
* Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria:

* Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
* History of allogeneic stem cell transplant.
* Patients who have had previous treatment with any anti-CD30 antibody.

Primary outcomes:
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: 1 month after last dose
Secondary outcomes:
measure: PK profile
timeFrame: 2 months after last dose
measure: Immunogenicity (anti-SGN-35 antibodies)
timeFrame: 1 month after last dose
measure: Anti-tumor activity
timeFrame: 1 month after last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Seagen Inc.
name: Dana Kennedy, PharmD
role: STUDY_DIRECTOR
References:
citation: Fanale MA, Forero-Torres A, Rosenblatt JD, Advani RH, Franklin AR, Kennedy DA, Han TH, Sievers EL, Bartlett NL. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012 Jan 1;18(1):248-55. doi: 10.1158/1078-0432.CCR-11-1425. Epub 2011 Nov 11.
Clinical trial NCT04972084: 3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion
Official title: Three-dimensional Evaluation of the Efficacy of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion: A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion, Division 1
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 12
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is aiming to evaluate the efficacy of Powerscope appliance in treatment of skeletal Class 2 malocclusion by three-dimensional image. Powerscope appliance is a hybrid fixed functional appliance used for treatment of Class II malocclusion with a retruded mandible.


Eligibility criteria: Inclusion Criteria:

1. Healthy post pubertal female patients of age range 14 to 16 years old, manifesting features of post pubertal cervical vertebrae maturational stages 4, 5 and 6 (deceleration, maturation, and completion).
2. Skeletal class 2 malocclusion of ANB angle greater than 4° with retrognathic mandible.
3. Class II division 1 malocclusion with at least an end-on Class II molar relationship.
4. Presence of all permanent dentition excluding third molars.
5. Good oral hygiene.

Exclusion Criteria:

1. History of previous orthodontic treatment.
2. Any systemic disease that could affect the orthodontic treatment.
3. Patients with periodontal diseases.
4. Patients with temporomandibular disorders.

Primary outcomes:
measure: The Condylar head volumetric changes
timeFrame: six months
Secondary outcomes:
measure: Mandibular length
timeFrame: six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university, Faculty of oral and dental medicine
state: Naser City
Study officials:
References:
Clinical trial NCT05416684: Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
Official title: A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skull Defect
Keywords: Skull Defect
Epilepsy
Infections
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with skull defect

Brief summary: The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and neurological function recover following cranioplasty. Complication events after cranioplasty are investigated within 6 months after surgery and neurological function is evaluated at 3, 6 and 12 months after cranioplasty.


Eligibility criteria: Inclusion Criteria:

* Skull defect with a diameter greater than 3cm
* No intracranial hemorrhage, intracranial hypertension or hydrocephalus (or treated) occurred more than 1 month after the previous operation
* Cranioplasty is feasible according to doctor's evaluation
* Patients must agree to participate in this clinical trial and the informed consent is signed by patients themselves or next of kin on behalf of the patient.

Exclusion Criteria:

* Manifestations of intracranial hypertension or untreated hydrocephalus
* Poor healing of skin wound
* Intracerebral infection or intracerebral hematoma is not cured
* Patients with operational contradictions, for example, poor general condition

Primary outcomes:
measure: Implant Failure
timeFrame: Within 12 months
Secondary outcomes:
measure: Length of stay in hospital
timeFrame: Within 2 months post-operation
measure: Detailed Economic Evaluation
timeFrame: Within 6 months post-operation
measure: Complications Rates
timeFrame: 3, 6, and 12 months
measure: Glasgow coma scale (GCS)
timeFrame: 3, 6, and 12 months
measure: Glasgow outcome scale (GOS)
timeFrame: 3, 6, and 12 months
measure: Mini-Mental State Examination score (MMSE)
timeFrame: 3, 6, and 12 months
measure: Appearance Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT06195384: Anti-cancer Neoantigen mRNA Vaccine to Treat Solid Tumors
Official title: Anti-cancer Neoantigen mRNA Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Keywords: mRNA Vaccine
Solid Tumor
Immunotherapy
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate mRNA sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the mRNA vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the mRNA vaccine immunotherapy on human cancers will firstly be evaluated.

Detailed description: 1. Choose appropriate patients with advanced solid cancers, with written consent for this study;
2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
3. Produce high quality mRNA vaccine and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.

Eligibility criteria: Inclusion Criteria:

1. Patients with advanced cancer; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

-

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate.

Primary outcomes:
measure: Number of Patients with Dose Limiting Toxicity
timeFrame: Six months
Secondary outcomes:
measure: Percent of Patients with best response as either complete remission or partial remission.
timeFrame: Six months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Zhenfeng Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176084: Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction
Official title: The Efficacy of a Low Carbohydrate Diet, With and Without Exercise, on Cardiovascular Disease Risk in Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: low carbohydrate diet
obesity
moderate exercise
men
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2010-08-05
Enrollment: 56
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are:

To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat.

To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men.


Eligibility criteria: Inclusion Criteria:

* male
* 21-65 years
* body mass index (BMI) 27-40kg/m2
* not currently losing weight
* physically able to exercise at moderate intensity

Primary outcomes:
measure: insulin levels
Secondary outcomes:
measure: body composition
measure: lipid profile
measure: body weight
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Faculty of Health and Medical Sciences, University of Surrey
state: Surrey
Study officials:
affiliation: University of Surrey
name: Rebecca Hiscutt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Helen D Truby, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06667284: Gastroduodenal Intussusception: Two Cases of Gastroduodenal Intussusception Following Gastric Plication, Each Managed with a Different Approach.
Official title: Gastroduodenal Intussusception: Two Cases of Gastroduodenal Intussusception Following Gastric Plication, Each Managed with a Different Approach.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bariatric Surgery
Intussusception
Keywords: case report
gastric plication
Lead sponsor: Ibn Al Nafees Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Damascus University
First posted: 2024-10-31
Enrollment: 2
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: The investigators received two female patients in the hospital who developed gastroduodenal intussusception following gastric plication procedure, requiring surgical treatment. Both patients presented with non-specific, atypical abdominal pain several months after the gastric plication. Both patients required surgical intervention, which included manual reduction of the plication followed by subtotal gastrectomy en bloc with Roux-en-Y reconstruction. In the second case, an Omega Brown anastomosis was performed, and a jejunostomy was created after the anastomosis in both patients.


Eligibility criteria: Inclusion Criteria:

- Patients with gastro-duodenal intussusception following a gastric plication procedure.

Exclusion Criteria:

* children

Primary outcomes:
measure: Comparison of management strategies for gastro-duodenal intussusception following gastric plication.
timeFrame: 12 weeks following end of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Coco D, Leanza S, Fiume I. Small bowel obstruction: a prognostic score index for surgery - a review. Prz Gastroenterol. 2022;17(3):177-182. doi: 10.5114/pg.2022.118454. Epub 2022 Aug 3.