louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03819803: Fecal Microbiota Transplantation in aGvHD After ASCT
Official title: Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Graft Versus Host Disease in GI Tract
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
Primary purpose: TREATMENT

Brief summary: Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.

Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.

Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.


Eligibility criteria: Inclusion Criteria:

* first episode of histologically confirmed, steroid-refractory GI-aGvHD
* reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
* eligibility for repeated colonoscopic procedures
* informed consent

Exclusion Criteria:

* complications during a previous colonoscopy
* recurrent episode of GI-aGvHD
* lacking cardiopulmonary fitness for repeated colonoscopic procedures
* septic infection
* acute extraintestinal organ failure (excluding bone marrow)
* mechanical ileus

Primary outcomes:
measure: GI-aGvHD remission
timeFrame: 90 days after first FMT
Secondary outcomes:
measure: GI-aGvHD remission
timeFrame: 45, 180 and 365 days after first FMT
measure: Disease-free survival
timeFrame: 180 and 365 days after first FMT
measure: Recurrence of GI-GvHD
timeFrame: 365 days after remission
measure: Patient survival
timeFrame: 180 and 365 days after first FMT
measure: SUSAR (Suspected Unexpected Serious Adverse Reaction)
timeFrame: within 48 hours after a FMT
measure: SAE (Serious Adverse Event)
timeFrame: within 48 hours after a FMT
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz
state: Styria
Study officials:
affiliation: Department of Internal Medicine, Division of Hematology, Medical University of Graz
name: Peter Prof. Dr. Neumeister
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05932303: A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
Official title: A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986278
Itraconazole
Gemfibrozil
Carbamazepine
Idiopathic pulmonary fibrosis
Drug interaction
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\^2) through 32.0 kg/m\^2, inclusive.

BMI = weight (kg)/(height \[m\])2.

* Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
* Any major surgery within 4 weeks of study intervention administration.

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 33 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 33 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
timeFrame: Up to 33 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 33 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 33 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 33 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 33 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 33 days
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Local Institution - 0001
state: CA
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02944903: Audit of Lung Cancer Screening Practice in Chest Physicians: An Update
Official title: Lung Cancer Screening Practice in Chest Physicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Screening
Keywords: audit
Lung cancer
screening practice
Egypt
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chest physicians, general practitioners, and general internists

Brief summary: The investigators will conduct nationally representative survey in chest physicians in Egypt in 2016-2017. Self-administered questionnaire will be used to assess the physicians' knowledge of lung cancer screening guidelines, beliefs about the effectiveness of screening tests, and ordering of screening chest radiography, low-dose spiral computed tomography, or sputum cytology in the past 12 months.

Detailed description: Although current practice guidelines do not recommend screening asymptomatic patients for lung cancer, physicians may still order lung cancer screening tests. No recent national survey of health care professionals has focused on lung cancer screening

Eligibility criteria: Inclusion Criteria:

* Physicians practising in Egypt (Chest physicians, general practitioners, and general internists)

Exclusion Criteria:

* Other nationalities
* Other specialities

Primary outcomes:
measure: Assessment of the use of guidelines of lung cancer screening
timeFrame: one year
Secondary outcomes:
measure: Self- administrated questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
affiliation: Professor of Pulmonology- Faculty of Medicine-Assiut University
name: Aliae Mohamed-Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914703: MDR EZ Pass and Precision Flexible Reamer
Official title: Post-market Clinical Follow-up Study to Collect Safety, Performance and Clinical Data of the EZPass Suture Passer (Instrumentation) and Precision Flexible Reamers (Instrumentation)- A Retrospective Consecutive Series Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Injury
Rotator Cuff Tear
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 73
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: The study population should be a consecutive series of subjects where the EZPass Suture Passer or Precision Flexible Reamer instrumentation will be used.

Brief summary: The objective of this study is to confirm the safety and performance on the EZPass Suture Passer Instrumentation and the Precision Flexible Reamer Instrumentation. Ultimately, clinical performance will be assessed through survey questions that evaluate the safety and performance of these instruments.

Detailed description: The primary objective of the study is to assess performance, clinical benefits and safety of the EZPass Suture Passer and the Precision Flexible Reamer Instrumentation.

Performance and clinical benefits will be assessed through an operative survey conducted immediately following intraoperative surgery.

Safety will be assessed by recording and analyzing the incidence and frequency of complications, adverse events, and intra-operative revisions.

Eligibility criteria: Inclusion Criteria

* EZ Pass Suture Passer:

  - Intended as an open or arthroscopic instrument utilized in conjunction with a nitinol wire or nylon monofilament to aid in passing suture through soft tissue.
* Precision Flexible Reamer:

  * This device is a hand held, or hand-manipulated device, intended to be used in ACL and PCL reconstruction surgeries and is intended for medical purposes to manipulate tissue, or for use with other devices in these surgeries.

Exclusion Criteria

* EZ Pass Suture Passer:

  - Any use other than the approved uses indicated in the Instructions for Use (IFU).
* Precision Flexible Reamer:

  * Any use other than the approved uses indicated in the Instructions for Use (IFU).

Primary outcomes:
measure: Performance of Instruments based on Patient Questionnaire (EZ Pass Suture Passer and Precision Flexible Reamer)
timeFrame: Intraoperative
measure: Absence of Instrument Related Serious Adverse Events
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
Study officials:
affiliation: Zimmer Biomet
name: Erin Osborn
role: STUDY_DIRECTOR
References:
Clinical trial NCT05980403: Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）
Official title: Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: superficial esophageal squamous cell carcinoma
lymph node metastasis
prediction model
tumor- infiltrating immune cells
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with superficial esophageal squamous cell carcinoma who underwent endoscopic therapy or esophagectomy.

Brief summary: Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. However, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a prediction model that can predict the risk of individual lymph node metastasis to assist in clinical decision-making. In this context, investigators intend to retrospectively collect the clinical and pathological data of 300 patients with superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk prediction model. In addition, investigators are also preparing to prospectively collect tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to further explore the mechanism of lymph node metastasis.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from 2013 to 2022.
2. Histopathological diagnosis was squamous cell carcinoma.
3. T1NxM0.
4. Received endoscopic resection or esophagectomy.

Exclusion Criteria:

1. Patients who received neoadjuvant therapy.
2. Positive surgical margin.
3. Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured.
4. Lack of complete histopathological information.

Primary outcomes:
measure: Lymphatic metastases
timeFrame: Through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin hosptial of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00892203: Efficacy and Safety of BGG492 in the Treatment of Migraine
Official title: A Multi-centre, Randomized, Double-blind, Parallel Group, Active and Placebo Controlled, Proof of Concept Study in Patients With Acute Migraine to Assess the Efficacy, Safety and Tolerability of Single Oral Doses of BGG492
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine
Headache
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of BGG492 used to treat migraine pain.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe migraine for at least 1 year
* At least 1 migraine episode, but not more 15 migraine days per month
* Past use of triptans
* Migraine onset before 50 years of age

Exclusion Criteria:

* Diagnosis of basilar, ophthalmoplegic or hemiplegic migraine.
* More than 6 non-migraine headaches per month
* Patients receiving migraine prophylaxis treatment
* Patients receiving regular treatment with psychoactive drugs
* Smokers
* Patients with a very high or low body weight Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Reduction in migraine pain
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials, 1560 Chevy Chase Drive, Suite 140
state: California
city: Paramount
country: United States
facility: California Clinical Trials, 15625 Lakewood Boulevard
state: California
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Goettingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigator Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koenigstein
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigator Site
city: Wurzburg
country: Germany
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Investigator Site
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Gomez-Mancilla B, Brand R, Jurgens TP, Gobel H, Sommer C, Straube A, Evers S, Sommer M, Campos V, Kalkman HO, Hariry S, Pezous N, Johns D, Diener HC; BGG492 Study Group. Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks. Cephalalgia. 2014 Feb;34(2):103-13. doi: 10.1177/0333102413499648. Epub 2013 Aug 20.
Clinical trial NCT01720303: Efficacy and Safety of Repaglinide Combined With Insulin in Type 2 Diabetes
Official title: A Multi-centre, Open, Randomised, Parallel, Controlled Trial to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime Insulin With Insulin Alone in Type 2 Diabetic Subjects Inadequately Controlled With Sulphonylurea ± Biguanide Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to compare oral anti-diabetic drug (OAD) combined with insulin vs. insulin alone in subjects with type 2 diabetes not adequately controlled on the current OAD therapy.


Eligibility criteria: Inclusion Criteria:

* HbA1c between 7.5 % and 13.0% (both inclusive)
* Fasting C-peptide above or equal to 0.33 nmol/l
* BMI (Body Mass Index) between 25 and 32 kg/m2 (both inclusive)

Exclusion Criteria:

* Medical history of treatment with insulin within the last 6 months
* Impaired renal function, defined as serum creatinine above to 1.7 mg/dl (150 µmol/l)

Primary outcomes:
measure: Change in HbA1c
Secondary outcomes:
measure: Change in FBG (Fasting Blood Glucose)
measure: Change in body weight
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00707603: Chronic Hepatitis C and Insulin Resistance
Official title: Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Insulin Resistance
Keywords: Insulin resistance
Liver fat
Muscle fat
Abdominal fat
Cytokines
Lead sponsor: Garvan Institute of Medical Research
Sponsor class: OTHER
First posted: 2008-07-01
Enrollment: 50
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C patients

Brief summary: Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with \>200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC


Eligibility criteria: Inclusion Criteria:

* Caucasian male
* Age: 25-55 years
* Chronic Hepatitis C (PCR positive) and fibrosis ≤ F2 (if liver biopsy done)
* Genotypes 1 or 3
* Due to commence antiviral therapy
* BMI \< 30

Exclusion Criteria:

* Cirrhosis or F3 fibrosis on liver biopsy (if done)
* \> 20 g ETOH per day
* Type 2 Diabetes (need an OGTT if fasting BGL\> 5.7)
* Concurrent HIV
* Other cause of liver disease

Primary outcomes:
measure: Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures
timeFrame: 2 years
Secondary outcomes:
measure: insulin resistance post treatment of Hep C
timeFrame: 2 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Garvan Institute Of Medical Research
state: New South Wales
city: Sydney
country: Australia
facility: Storr Liver Unit
state: New South Wales
Study officials:
affiliation: Garvan Institute of Medical Research
name: Donald Chisholm, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: Storr Liver Unit
name: Jacob George, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milner KL, van der Poorten D, Trenell M, Jenkins AB, Xu A, Smythe G, Dore GJ, Zekry A, Weltman M, Fragomeli V, George J, Chisholm DJ. Chronic hepatitis C is associated with peripheral rather than hepatic insulin resistance. Gastroenterology. 2010 Mar;138(3):932-41.e1-3. doi: 10.1053/j.gastro.2009.11.050. Epub 2009 Dec 4.
Clinical trial NCT04689503: Study on the Measurement of Retinal Blood Flow in Children
Official title: Study on the Measurement of Retinal Blood Flow in Children Based on Oct Angiography and the Effect of Optical Defocus Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 1200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children volunteers with normal corrected visual acuity

Brief summary: In order to provide reference for clinical application, the normal values of retinal blood flow parameters in Chinese healthy children were measured by oct-angiography. Meanwhile, the repeatability and consistency of retinal blood flow parameters measured by oct-angiography in children were further analyzed, and the correlation of retinal blood flow parameters with eye axis, choroidal thickness, age and diopter was analyzed, so as to provide basis for clinical diagnosis of children's ophthalmopathy. Objective to study the effect of short-term optical defocusing on retinal blood flow parameters, and analyze the correlation between the changes of posterior segment parameters before and after short-term optical defocusing, so as to provide the basis for the possible compensation mechanism of posterior segment optical defocusing, and further understand the possible physiological mechanism of myopia.


Eligibility criteria: Inclusion Criteria:

1. The subjects should be 6-18 years old, with parents' consent and be able to abide by the experimental rules;
2. uncorrected visual acuity or spectacle corrected visual acuity ≥ 1.0, and each eye can fix the target;
3. equivalent spherical lens range + 0.50D \~ - 6.00D, binocular spherical lens anisometropia ≤ 1D, anisometropia ≤ 1.5D;
4. frame glasses can be worn for patients with ametropia, and hard contact lenses can not be worn for at least 4 weeks, and anisometropia can not be worn for 2 weeks
5. intraocular pressure in the normal range (9mmhg-21mmhg)

Exclusion Criteria:

1. Patients with history of ocular trauma and surgery;
2. patients with ocular organic lesions or systemic diseases;
3. patients with dry eye;
4. patients in the treatment period using drugs (such as atropine eye drops);
5. patients with poor cooperation or unqualified image quality

Primary outcomes:
measure: Blood flow density measurement
timeFrame: 2017.05.01-2019.11.11
Secondary outcomes:
measure: Macular avascular area measurement
timeFrame: 2017.05.01-2019.11.11
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The affiliated Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References: