louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04651647: Bone Graft in Aseptic Subtrochanteric Nonunion
Official title: Is Open Bone Graft Always Necessary When Treating Subtrochanteric Nonunion With a Reamed Intramedullary Nail?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subtrochanteric Nonunion
Keywords: subtrochanteric nonunion; intramedullary nail; bone graft
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: Pusan National University Yangsan Hospital
First posted: 2020-12-03
Enrollment: 37
Sex: ALL
Minimum age (years): 32
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visited our institutions for surgical treatment of subtrochanteric nonunion and underwent surgical intervention in the institutions.

Brief summary: This study aimed to compare the radiologic results between closed nailing without bone graft (BG) and open nailing with BG for subtrochanteric nonunion and to determine when open BG should be considered.

Detailed description: In this retrospective study, we investigated the patients who underwent surgical intervention for subtrochanteric nonunion between January 2008 and March 2018 in two institutions. The cases with infection, large bone defect, pathologic fracture, open fracture, previous surgery using plate, and follow-up less than 1 year were excluded. We compared the demographic details and radiologic results between patients who underwent the open procedure with BG (BG group) and the closed procedure without BG (non-BG group) as a historical control, and risk factors for the failure of revision surgery were evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent surgical intervention using intramedullary nailing for aseptic subtrochanteric nonunion

Exclusion Criteria:

* The cases with infection, large bone defect, pathologic fracture, open fracture, previous and revision surgery using plate, and follow-up less than 1 year

Primary outcomes:
measure: bony union
timeFrame: The time when bone union was achieved after surgery
measure: risk factors for nonunion
timeFrame: One year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
References:
Clinical trial NCT03337347: Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients
Official title: Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Circulating Tumor Cell
Keywords: Prognostic significance
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether the presence of circulating/disseminated tumor cells (CTCs/DTCs) in the blood and bone marrow of colorectal cancer (CRC) patients with localized disease is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.


Eligibility criteria: Inclusion Criteria:

- colorectal adenocarcinoma

Exclusion Criteria:

* prior neoadjuvant chemoradiotherapy
* prior colorectal cancer
* cancer duplicity

Primary outcomes:
measure: CEA mRNA positive circulating tumor cells in colorectal cancer patients
timeFrame: 1 day
Secondary outcomes:
measure: Cancer specific survival in CTC positive CRC patients
timeFrame: 10 years
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc
name: Miloslav Duda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021847: Ozonated Water in Treatment of Denture Stomatitis
Official title: Effect of Ozone Water in Treatment of Denture Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Denture Stomatitis
Keywords: Ozonated water
denture stomatitis
Chlorhexidine mouthwash
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.
Primary purpose: TREATMENT

Brief summary: The effect of Ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to Chlorhexidine mouthwash

Detailed description: Compete denture wearers having oral denture stomatitis were divided into two groups. group I used Ozonated water while group II used Chlorhexidine mouthwash. The growth of Candida albicans, the degree inflammation and pain grade were evaluated before starting the treatment then every week till one month. Also

Eligibility criteria: Inclusion Criteria:

* Completely edentulous male patients wearing heat cured acrylic resin removable prosthesis.
* Patients having denture associated oral stomatitis.
* Healthy patients free of any systemic diseases.

Exclusion Criteria:

* Smoker patients.
* Patients suffering from any auto immune or systemic diseases, Temporo-mandibular joint disorder ( TMJ disorders and parafunctional oral habits.
* Patients with a history of radiotherapy or chemotherapy.
* Patients having oral lesions.

Primary outcomes:
measure: Candida albicans colonies
timeFrame: day one, 7th day, 14th day and 30th day
Secondary outcomes:
measure: -Evaluation of inflammation and pain grade
timeFrame: day 1, and 30th day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
Study officials:
affiliation: National Research Centre, Egypt
name: Asmaa N, Elboraey, Ass,Pro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004347: Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome
Official title: The Effects of Dietary Cholesterol in the Smith-Lemli-Opitz Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Smith-Lemli-Opitz Syndrome
Keywords: Smith-Lemli-Opitz syndrome
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Oregon Health and Science University
First posted: 1999-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Examine the intestinal absorption of dietary cholesterol in patients with Smith-Lemli-Opitz syndrome.

II. Measure the effect of dietary cholesterol on plasma sterol composition. III. Quantify basal cholesterol synthesis, turnover of cholesterol and 7-dehydrocholesterol, and the effects of dietary cholesterol on these parameters.

IV. Identify fecal bile acid excretion quantitatively and qualitatively in these patients.

V. Compare the incorporation of deuterated water into plasma cholesterol, 7-dehydrocholesterol, and other intermediates, and assess the effect of dietary cholesterol on this incorporation.

Detailed description: PROTOCOL OUTLINE:

Patients are treated with 2 dietary regimens for 1 to 3 weeks: high cholesterol and cholesterol-free. Cholesterol is provided in the form of egg yolk. The absorption and metabolism of cholesterol are evaluated with plasma and fecal studies. Deuterated water is given to patients followed by analysis of deuterium in plasma cholesterol and other intermediates, including 7-dehydrocholesterol.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Smith-Lemli-Opitz syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: William Connor
role: STUDY_CHAIR
References:
Clinical trial NCT03787147: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
Official title: Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pain
Keywords: Virtual Reality
Spinal Injection
Adult
Analgesia
Google cardboard
Oculus
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A three-group parallel randomized controlled trial to evaluate the efficacy of virtual reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients undergoing Spinal Injections (SI).


Eligibility criteria: Inclusion Criteria:

* Adult requiring Spinal Injections
* Adult \> 18years
* Adults with intact vision who can attend VR intervention

Exclusion Criteria:

* Anyone \< 18 years
* Adults who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
* Adults who request moderate IV sedation
* Adults with photic-induced seizures

Primary outcomes:
measure: Pain intensity as measured by the Visual Analog Scale
timeFrame: Immediately after receiving spinal injection
Secondary outcomes:
measure: Anxiety Level as measured by the Visual Facial Anxiety Scale
timeFrame: Immediately after receiving spinal injection
measure: Heart rate as measured by the Empatica E4 wristband
timeFrame: Baseline, during and Immediately after the procedure
measure: Systolic Blood Pressure as measured by the Empatica E4 wristband
timeFrame: Baseline, during and Immediately after the procedure
measure: Diastolic Blood Pressure as measured by the Empatica E4 wristband
timeFrame: Baseline, during and Immediately after the procedure
measure: Sympathetic skin response as measured by the Empatica E4 wristband
timeFrame: Baseline, during and Immediately after the procedure
measure: Temperature as measured by the Empatica E4 wristband
timeFrame: Baseline, during and Immediately after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Albert Einstein College of Medicine
name: Sayed Wahezi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03657147: Improving African American Glaucoma Patient Involvement in Visits and Outcomes
Official title: Improving African American Glaucoma Patient Involvement in Visits and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2018-09-04
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a research project about services provided to African American patients with glaucoma. The goal of the project is to improve communication between providers and African-American patients about glaucoma.


Eligibility criteria: Inclusion Criteria:

* African American
* Age 18 or older
* Able to speak and read English
* Mentally competent to participate
* Not blind (are at least 20/400 in their better seeing eye)
* On one or more glaucoma medications
* Report being less than 80% adherent to their glaucoma medications on a Visual Analog Scale

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 12 months
measure: Glaucoma Medication Percent Adherence
timeFrame: 12 months
measure: Glaucoma Medication Adherence Self-Efficacy Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Betsy Sleath, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06682247: A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in Advanced MSS Colorectal Cancer
Official title: A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in the Treatment of Microsatellite Stable Advanced Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer Metastatic
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 200
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: advanced/metastatic MSS colorectal cancer patients

Brief summary: This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.


Eligibility criteria: Inclusion Criteria:

1. Aged≥18 years
2. Histology-confirmed metastatic CRC (mCRC);
3. ECOG 0\~2
4. At least one efficacy evaluation
5. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Lack of follow-up data.
2. Chidamide stopped after less than two cycles.
3. Serious comorbidities that interfere with the efficacy or safety analysis

Primary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 2 years
Secondary outcomes:
measure: Objective Response Rate（ORR）
timeFrame: 2 years
measure: Clinical Benefit Rate (CBR)
timeFrame: 2 years
measure: Disease Control Rate （DCR）
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05772247: Predictive Value of PS Application in Premature Infants With RDS
Official title: Predictive Value of PS Application in Premature Infants With RDS by Different Pulmonary Ultrasound Scores: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 1392
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants \<37 weeks gestational age

Brief summary: A multicenter prospective study was conducted to compare the predictive value of 6-zone, 10-zone, and 12-zone LUS scores for PS application in early and late preterm infants.


Eligibility criteria: Inclusion Criteria:

1. Hospital admission within 2 hours after birth;
2. The diagnosis was RDS;
3. Parents agree to attend

Exclusion Criteria:

1. chromosomal abnormalities or complex congenital malformations;
2. congenital pulmonary disease;
3. severe sepsis, disseminated intravascular coagulation, septic shock and other critical conditions;
4. LUS and blood gas analysis have been examined before the application of alveolar surfactant.

Primary outcomes:
measure: Whether the patient uses ps (pulmonary surfactant)
timeFrame: 2023.2-2023.12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00243347: The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer
Official title: An Exploratory, Open-Lael Study to Assess the Effects of AZD2171 on Tumors and Biomarkers in Patients With Previously Untreated or Recurrent Non-small Cell Lung Cancer (NSCLC) or Patients With Metastatic or Recurrent Head and Neck Cancer (HNC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Non-Small-Cell Lung Carcinoma
Head and Neck Neoplasms
Keywords: RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-24
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable stage IIIb or IV non-small cell lung cancer (NSCLC)
* At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET Scan
* Considered suitable for treatment of NSCLC with no prior biological or immunological therapy for disease
* Or considered suitable for treatment for metastatic or recurrent HNC with no prior biological or immunological therapy for disease

Exclusion Criteria:

* NSCLC: Have received more than 2 previous chemotherapy regimens or have received the last chemotherapy or radiotherapy within 28 days of first dose of AZD2171
* HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of AZD2171
* Untreatable, unstable brain or meningeal metastases.
* Abnormal liver and kidney blood chemistries
* History of poorly controlled hypertension with resting blood pressure of \>150/100
* Recent (\< 14 days) major surgery or a surgical incision not fully healed
* Diabetes patients with type I insulin dependent diabetes or poorly controlled type II
* Significant hemorrhage or hemoptysis
* Presence of necrotic/hemorrhagic tumor or metastases

Primary outcomes:
measure: Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)
timeFrame: Randomisation until Day 22
Secondary outcomes:
measure: Change From Baseline in Mean Arterial Blood Pressure (MAP)
timeFrame: Randomisation until Day 22
Other outcomes:
Locations:
city: Houston
country: United States
facility: Research Site
state: Texas
city: Barcelona
country: Spain
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Oncology Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05518747: Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
Official title: Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized clinical trial with a test and placebo group
Primary purpose: TREATMENT

Brief summary: The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.

Detailed description: The present study is a double-blinded randomized clinical trial with a duration of 12 weeks

. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.

Clinical measurements and sampling will be performed at baseline, week 6 and week 12.

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Eligibility criteria: Inclusion Criteria:

* Periodontitis stage 2-3, Grade B-C, generalized

Exclusion Criteria:

* • Use of systemic antibiotics within the latest three months.

Primary outcomes:
measure: Changes in microbial composition in dental plaque
timeFrame: Baseline vs. week 6 and week 12
Secondary outcomes:
measure: Changes in dental plaque
timeFrame: Baseline vs. week 6 and week 12
measure: Changes in bleeding on probing
timeFrame: Baseline vs. week 6 and week 12
measure: Changes in probing pocket depth
timeFrame: Baseline vs. week 6 and week 12
measure: Changes in clinical attachment level
timeFrame: Baseline vs. week 6 and week 12
measure: Changes in salivary levels of inflammatory cytokines
timeFrame: Baseline vs. week 6 and week 12
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Odontology
Study officials:
References:
Clinical trial NCT01942447: Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clostridium Difficile
Clostridium Difficile Infection
Keywords: Fecal microbiota transplantation
microbiota
clostridium difficile
clostridium difficile infection
Efficacy of FMT
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 30
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 host gastrointestinal microbiota is significantly influenced by antibiotic treatment which might favor Clostridium difficile infection (CDI), a frequent cause of community- and hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in 19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no standardized therapy of recurrent or refractory CDI, but recent studies show remarkable effects of fecal microbiota transplantation (FMT).

In the current project, we aim to ideally match host and donor for FMT success in recurrent or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will evaluate its safety and efficacy, and the patient acceptance and quality of life before and after FMT. We will analyse persistence of the donor microbiota within the recipient, define predictive clinical recipient and donor factors for FMT success and correlate them with microbial host and donor metagenomics.

We hypothesize that our work will yield novel, individualized strategies for recurrent or refractory CDI. In perspective, our results may be expanded to treatment of other inflammory bowel diseases.


Eligibility criteria: Inclusion Criteria:

* recurrent or refractory CDI
* previous antimicrobial therapy includes at least on course of vancomycin 4x125 (or higher doses) for at least 7d
* CDI, defined as: 3 or more loose bowel movements/d AND (presence of C.diff. toxin in stools or toxin producing C. diff. strain) OR (endoscopic or histologic evidence of pseudomembraneous colitis)

Exclusion Criteria:

* no informed consent
* no ability to provide informed consent
* immune suppression (continuous immune-suppressive drugs; steroids: prednisolone-equivalent \> 20 mg for 14d or longer)
* lack of appropriate donor
* pregnancy

Primary outcomes:
measure: Resolution of diarrhea
timeFrame: 2 weeks
Secondary outcomes:
measure: Patient acceptance
timeFrame: 2 weeks
Other outcomes:
measure: Persitence of FMT
timeFrame: 26 weeks
Locations:
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
Study officials:
References: