louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05546060: Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in HLH
Official title: Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in the Treatment of Hemophagocytic Lymphohistiocytosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hemophagocytic Lymphohistiocytosis
Keywords: Hemophagocytic Lymphohistiocytosis
Venetoclax
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy and safety of venetoclax combined with dexamethasone and etoposide as a salvage therapy for hemophagocytic lymphohistiocytosis.

Detailed description: Hemophagocytic lymphohistiocytosis (HLH) is a rare and aggressive disease with high mortality and poor prognosis. The HLH-94 and HLH-04 regimens are most commonly used, but approximately 30% of the patients remain unresponsive. Currently, there is no unified evidence-based salvage treatment. There is no unified salvage regimen. This study plans to enroll 20 patients with refractory and recurrent hemophagocytic lymphohistiocytosis. Subjects will receive venetoclax combined with dexamethasone and etoposide for 8 weeks.The safety was evaluated once a week, and the efficacy was evaluated once every 2 weeks. Overall response rate will be evaluated at 8 weeks. Patients were followed up every 3 months thereafter.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years old, expected survival time more than 3 months;
* met HLH-2004 diagnostic criteria；
* ECOG score 0-2；
* ECG QTcF interval: male ≤450ms, female ≤470ms;
* AST and ALT ≤3.0 ULN, TB ≤1.5×ULN；serum creatinine≤1.5×ULN，or CrCL ≥ 50mL/min；INR、APTT、PT ≤1.5×ULN；
* without pregnancy or lactation, and agree to contraception during and for at least 6 months after the study；
* signed informed consent.

Exclusion Criteria:

* patients with malignancies unrelated to HLH, except for fully recovered non-melanoma skin cancer and carcinoma in situ;
* patients participated in other clinical trials within 4 weeks；
* previously treated with Bcl-2 inhibitors；
* unable to take oral medication；
* history of substance abuse or patients with mental illness；
* severe infection；
* cardiovascular disease，NYHA II-IV；
* allergic to venetoclax or etoposide.

Primary outcomes:
measure: Overall response rate
timeFrame: 1 year
measure: Incidence and severity of adverse effects
timeFrame: 1 years
Secondary outcomes:
measure: Overall survival
timeFrame: 1 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05129176: Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin
Official title: Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Eradication
Allergic
Penicillin
Tetracycline
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 106
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: The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Detailed description: Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of levofloxacin-tetracycline -containing and metronidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients with previous H. pylori eradication therapy.
* Patients treated with Histamine-receptor antagonist, proton pump inhibitor, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute gastrointestinal bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent

Primary outcomes:
measure: Eradication rates in 2 groups
timeFrame: 12 months
Secondary outcomes:
measure: The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
timeFrame: 12 months
measure: The rate of adverse events happening
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04891276: Impact of COVID-19 Infection and Confinement on Diabetic Ulcer Management and Amputation Risk
Official title: Impact of COVID-19 Infection and Confinement on Diabetic Ulcer Management and Amputation Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Subjects With Hospital Stays
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 3300000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic subjects with hospital stays in France, 2017 to 2020.

Brief summary: In the context of the COVID-19 pandemic, a number of factors, including the lockdown that was imposed to limit the spread of infection, the fear of being contaminated during hospital consultations and the difficulty in accessing general practitioners may have led to delays in the referral of patients to facilities specialized in the management of diabetic ulcers. Since the beginning of the coronavirus pandemic and during the first lockdown, we observed a clear decrease in hospitalizations and consultations for diabetic ulcers. Patients who had regular follow-up for the management of their diabetic ulcers cancelled their scheduled appointments for fear of being contaminated in the hospital. It is feared that the current epidemic context has favored the delay of referral of patients with diabetic ulcers to specialized facilities, with consequences on the prognosis of these patients and the risk of lower limb amputation.

In this context, this project aims to evaluate the impact of confinement on emergency hospitalizations for foot wounds and the effects on the risk of amputation during the lockdown and the three months following the end of the lockdown.

Our hypothesis is that the lockdown led to a decrease in hospitalizations for foot wounds, resulting in a delay in the management of these patients, and potentially leading to an increase in the number of amputations in the three months following the end of the lockdown.

In parallel, we will also study the impact of confinement on deferrable hospitalizations (glycemic imbalance, assessment of diabetic complications...) or theoretically non-deferrable (diabetic comas, ketoacidosis, diagnosis of type 1 diabetes, acute coronary syndrome, stroke...) of diabetes mellitus. This will allow us to evaluate whether our findings relative to diabetic ulcers could be extended to other complications of diabetes.


Eligibility criteria: Inclusion Criteria:

Diabetic subjects with hospital stays in France, 2017 to 2020.

Exclusion Criteria:

Absence of diabetes

Primary outcomes:
measure: Frequency of lower limb amputations
timeFrame: 3 months after the end of the spring 2020 lockdown
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT00176176: Investigation of Cognitive Function Before and After Induced Ventricular Fibrillation in Electrophysiological (EP) Study
Official title: Change of EEG Activity and Cerebral Circulation During Induced Ventricular Fibrillation and Investigation of Cognitive Function Before and After Induced Ventricular Fibrillation in EP Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventricular Fibrillation
Ventricular Tachycardia
Keywords: cerebral circulation
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, changes in electroencephalogram (EEG) and the hemodynamic state during ventricular fibrillation or induced ventricular tachycardia are investigated.

Detailed description: Patients with a high risk of malignant tachyarrhythmia are routinely investigated by programmed electrophysiological study (EPS). To investigate the hemodynamic effects of ventricular arrhythmia to cerebral circulation an EEG and transcranial ultrasound are conducted simultaneously during the EPS. Before and after the EPS a neuropsychological test and an investigation of a specific blood sample (Neuron Specific Enolase, NSE) is done.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Positive agreement
* EPS for primary and secondary prophylaxis of a malignant ventricular tachyarrhythmia:

  * primary prophylaxis: Brugada syndrome, long QT syndrome, cardiomyopathy, short QT syndrome
  * secondary prophylaxis: Multicenter Automatic Defibrillator Implantation Trial (MADIT) criteria, syncope, documented ventricular tachycardia

Exclusion Criteria:

* Severe neurological deficit
* Cardiopulmonary resuscitation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Fakultät für Klinische Medizin Mannheim Universitätsklinikum Mannheim der Ruprecht-Karls-Universität Heidelberg
Study officials:
affiliation: I.Medizinische Klinik, Universitätsklinikum Mannheim
name: Martin Borggrefe, Prof., MD
role: STUDY_DIRECTOR
affiliation: Neurologische Klinik Universitätsklinikum Mannheim
name: M Hennerici, Prof., MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05287776: E-cadherin and Integrin Alpha v Beta 1 in Vitiligo
Official title: The Effect of Narrow Band UVB on E-cadherin and Integrin Alpha v Beta 1 in Non-segmental Vitiligo: A Novel Proposed Mechanism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to study the effect of Narrow Band UVB on E-cadherin and integrin alpha v beta 1 as representatives of adhesion molecules in non-segmental vitiligo in a trial to verify a novel proposed mechanism of Narrow Band UVB. Additionally, specific melanocyte marker (Melan A) will be done to settle the localization of adhesion molecules in relation to melanocytes.


Eligibility criteria: Inclusion Criteria:

* All clinically diagnosed cases of non-segmental vitiligo .
* Patients with VIDA +1 or more (new/expanding lesions active in time period of 6-12 months ago) will be included in the trial. Activity of vitiligo will be evaluated through Vitiligo Disease Activity (VIDA) Score.

Exclusion Criteria:

* Patients who have stable disease at the time of study i.e. no progression of existing disease or appearance of new lesions in the last six months.
* Patients receiving treatment for vitiligo 3 months prior to the study.
* Patients with contraindications for phototherapy.
* Patients with current/history of any systemic and/or dermatological diseases affecting the immune system as autoimmune diseases and malignancy.

Primary outcomes:
measure: Melanocyte marker (Melan A) for staining of melanocytes
timeFrame: 4 months
measure: E-cadherin expression as a cell adhesion molecule between melanocytes and keratinocytes
timeFrame: 4 months
measure: Integrin alpha v beta 1 expression as a cell adhesion molecule between melanocytes and keratinocytes
timeFrame: 4 months
Secondary outcomes:
measure: Vitiligo Area and severity index (VASI)
timeFrame: 4 months
Other outcomes:
measure: Vitiligo Disease Activity score (VIDA)
timeFrame: 4 months
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy university hospital, Faulty of medicine,Cairo university
state: El Manial
Study officials:
References:
Clinical trial NCT06283576: Pancreatic Cancer Initial Detection Via Liquid Biopsy
Official title: Pancreatic Cancer Initial Detection Via Liquid Biopsy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pancreatic Cancer
IPMN, Pancreatic
Individuals at Risk
Chronic Pancreatitis
Keywords: diabetes mellitus
smoking
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2024-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults capable of giving informed consent to give blood for liquid biopsy coming to the University Hospitals of Stockhol (Karolinska) and Umeå

Brief summary: The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas \[N0M0\]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM).


Eligibility criteria: Inclusion Criteria:

* Suspicion of or elevated risk for pancreatic ductal adenocarcinoma (PDAC); intraductal papillary mucinous neoplasias (IPMN); individuals at risk (IAR) for pancreatic cancer

Exclusion Criteria:

* other malignant condition

Primary outcomes:
measure: Cancer detection
timeFrame: Up to 4 weeks after surgery
Secondary outcomes:
measure: Overall survival
timeFrame: 1 month - 24 months after surgical resection of the tumor
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Gastrocentrum, KarolinskaUniversity Hospital
Study officials:
References:
Clinical trial NCT02378376: In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon
Official title: In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon After Consumption of Different Cereal Fractions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: During this project the amount of SCFA produced in the colon after consumption of 2 different 13C-labelled wheat fiber fractions will be quantified.


Eligibility criteria: Inclusion Criteria:

* Regular diet with 3 meals a day (minimal 5 times a week)
* BMI between 18.5 and 27 kg/m2

Exclusion Criteria:

* Calorie restricted diet or other special diet during the study or during the last month prior to the study
* Antibiotics in the month prior to the study
* Former surgeries on the gastrointestinal tract, with the exception of an appendectomy
* use of the following types of medications with effects on the gastrointestinal tract during the last 2 weeks prior to the study (spasmolytica, anti-diarrhea, anti-constipation, probiotics)
* Chronic disease of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation, chronic frequent diarrhea, clinically relevant lactose intolerance
* Pregnancy, pregnancy desire or breastfeeding
* Diabetes (type 1 and 2)
* Blood donation in the past 3 months prior to the study
* Abnormal hemoglobin (Hb) levels in blood, men must have a Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL
* Participation in studies in the past year in which radiation was used.

Primary outcomes:
measure: Quantification of acetate, propionate and butyrate production in the colon after consumption of each wheat derived fiber fraction
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02179476: A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome - DUET
Official title: A Multi-Site Study of the Zyga GlyDer Facet Restoration Device In Subjects With LUmbar FacET Pain Syndrome (DUET)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Facet Joint Pain
Keywords: Facet joint
facet joint pain
facet joint disease
lumbar pain
back pain
Lead sponsor: Zyga Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-01
Enrollment: 2
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-randomized, multi-site feasibility study to evaluate the safety of the Glyder Device in subjects with a history of lumbar facet joint disease (L2 to the sacrum) and successful neural ablation in which the facet joint is confirmed as the source of pain.


Eligibility criteria: Key Inclusion Criteria:

1. Confirmed bilateral facet joint disease demonstrated by a successful facet rhizotomy (neural ablation) within 18 months prior to enrollment
2. Facet pain is limited to one to two levels from L2 to the sacrum and pain is bilateral
3. Two diagnostic injections (MBBs) both resulting in 80% relief to confirm back pain is facetogenic
4. VAS back pain of ≥ 60 mm on a 100 mm scale, and VAS back pain is greater than or equal to the highest VAS leg pain score
5. ODI ≥ 20 points
6. At least six (6) months of non-operative conservative management (Analgesic therapy for a minimum of 2 weeks and a minimum of 4 weeks of NSAID therapy; Supervised exercise and/or physical therapy program-minimum of 12 sessions)
7. At least 22 years of age and skeletally mature

Key Exclusion Criteria:

1. Pain is from a spinal structure other than facet joints (i.e., disc, hip and SI joint pain are excluded)
2. Osteoporosis or severe osteopenia
3. Lumbar fusion
4. Symptomatic spinal stenosis requiring surgical intervention
5. Prior total disc replacement, fusion, decompressive laminectomy, facetectomy, or placement of a posterior spinous process device
6. Disc herniation requiring surgical intervention
7. The subject has a Body Mass Index (BMI) of greater than 35
8. Planned elective surgery within 12 months

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: The Spine Institute
state: California
city: Tampa
country: United States
facility: Laser Spine Institute
state: Florida
city: Edmond
country: United States
facility: Clinical Radiology of Oklahoma
state: Oklahoma
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists
state: Washington
Study officials:
References:
Clinical trial NCT06078176: Stimulation for Bowel Emptying
Official title: Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurogenic Bowel Dysfunction
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.


Eligibility criteria: Inclusion Criteria:

* Suprasacral spinal cord injury
* Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
* Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
* Neurologically stable
* At least 18 years old
* At least 12 months post neurological injury or disease diagnosis

Exclusion Criteria:

* Active sepsis
* Open pressure sores on or around pelvis
* Significant colon trauma or colostomy
* Crohn's disease
* Colonic obstruction or gastrointestinal surgery within last 3 months
* Significant history of autonomic dysreflexia

Primary outcomes:
measure: Time required to complete bowel emptying
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
Study officials:
affiliation: Syracuse VA Medical Center, Syracuse, NY
name: Cesar Colasante-Garrido, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Dennis Bourbeau, PhD
role: PRINCIPAL_INVESTIGATOR
References: