louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03004833: Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Official title: Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Classical Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 110
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: The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD).

The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.


Eligibility criteria: Inclusion Criteria:

* Histologically proven classical HL
* First diagnosis, no previous treatment
* Age: 18-60 years
* Stage I, IIA with risk factors a-d, IIB with RF c-d:

  1. large mediastinal mass
  2. extranodal lesions
  3. elevated ESR
  4. ≥ 3 nodal areas confirmed by central review.

Exclusion Criteria:

* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
* History of other malignancy ≤ 5 years
* Prior chemotherapy or radiation therapy
* Concurrent disease precluding protocol treatment
* Pregnancy, lactation
* Non-compliance

Primary outcomes:
measure: Complete Remission Rate
timeFrame: 4 to 6 weeks after end of treatment
Secondary outcomes:
measure: Treatment related Morbidity
timeFrame: 1 year after end of treatment
measure: Progression Free Survival
timeFrame: 1 and 3 years after end of treatment
measure: Overall Survival
timeFrame: 1 and 3 years after end of treatment
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: University of Cologne, I. Dept. of Medicine
name: Andreas Engert, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerhard-Hartmann E, Goergen H, Brockelmann PJ, Mottok A, Steinmuller T, Grund J, Zamo A, Ben-Neriah S, Sasse S, Borchmann S, Fuchs M, Borchmann P, Reinke S, Engert A, Veldman J, Diepstra A, Klapper W, Rosenwald A. 9p24.1 alterations and programmed cell death 1 ligand 1 expression in early stage unfavourable classical Hodgkin lymphoma: an analysis from the German Hodgkin Study Group NIVAHL trial. Br J Haematol. 2022 Jan;196(1):116-126. doi: 10.1111/bjh.17793. Epub 2021 Sep 14.
citation: Brockelmann PJ, Goergen H, Keller U, Meissner J, Ordemann R, Halbsguth TV, Sasse S, Sokler M, Kerkhoff A, Mathas S, Huttmann A, Bormann M, Zimmermann A, Mettler J, Fuchs M, von Tresckow B, Baues C, Rosenwald A, Klapper W, Kobe C, Borchmann P, Engert A. Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma: The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial. JAMA Oncol. 2020 Jun 1;6(6):872-880. doi: 10.1001/jamaoncol.2020.0750.
Clinical trial NCT03639233: Youth Epilepsy and Successful Self-Management Intervention
Official title: Youth Epilepsy and Successful Self-Management Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed as a pilot test of the YESS! web-based intervention for adolescents with epilepsy. One hundred twenty participants will be given access to the intervention for a period of eight weeks. The investigators are testing the feasibility and acceptability of the the study procedures, measures and of the intervention itself. The study also evaluats the potential for impact on the users.

Detailed description: YESS! is a web-based self management program developed to enhance the motivation and skills of youth with epilepsy.

This clinical trial uses a pre-test, post-test design where all consenting participants are given access to the intervention.

Eligibility criteria: Inclusion Criteria:

* Age as above
* Epilepsy diagnosed by a physician
* Currently taking anti-seizure medications or use device
* Ability to understand and respond to questions about health and epilepsy
* Ability to utilize an internet based intervention website

Exclusion Criteria:

Primary outcomes:
measure: Feasibility of recruiting and enrollment procedures and
timeFrame: 8 weeks after getting access to the web intervention
measure: Acceptability of intervention website users
timeFrame: 8 weeks after getting access to the web intervention
Secondary outcomes:
measure: Participant Well-being
timeFrame: 8 weeks after getting access to the web intervention and 8 weeks after that.
measure: Participant Quality of Life
timeFrame: 8 weeks after getting access to the web intervention and 8 weeks after that.
measure: self-management behavior profile
timeFrame: 8 weeks after getting access to the web intervention and 8 weeks after that.
measure: self-management motivation profile
timeFrame: 8 weeks after getting access to the web intervention and 8 weeks after that.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Peter Scal, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06908551: Pylorus Distensibility Measurement
Official title: Pylorus Distensibility Measurement in Overweight and Obese (BMI 27-40) Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Overweight or Obesity
Lead sponsor: BariaTek Medical
Sponsor class: INDUSTRY
First posted: 2025-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese (BMI 27-40)

Brief summary: The present study aims at characterizing the pylorus functionality in overweight and obese patients (BMI 27-40) using a systematic measurement approach by using an impedance planimetry technology.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects aged between 20 and 60 years inclusive
2. A BMI between 27.0 and 40.0 kg/m2
3. Willing and able to provide written informed consent
4. Willing and able to comply with the study procedures

Primary outcomes:
measure: Calculation of pylorus Cross Sectional Area
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00563251: Effectiveness of Azithromycin Therapy in Improvement of Symptoms and Lung Function in Patients With Bronchiolitis Obliterans After Bone Marrow Transplantation
Official title: Azithromycin Therapy for Bronchiolitis Obliterans Syndrome After Allogenic Bone Marrow Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis Obliterans
Bone Marrow Transplantation
Keywords: Bronchiolitis obliterans in bone marrow transplant recipients
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
name: Pfizer
First posted: 2007-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bronchiolitis obliterans syndrome (BOS), an obstructive airway disease as a result of chronic rejection, is one of the major causes of morbidity and mortality in long-term survivors of allogeneic bone marrow transplantation (BMT). Although augmentation of immunosuppressive treatment might help but the only effective treatment for BOS is by lung transplantation.

Macrolide antibiotics, which have been licensed to use as antibacterial agents for decades, have been found to have immunomodulatory properties in addition to their antibacterial activity. Low dose Azithromycin, an antibiotic of the macrolide family, has been shown to have promising result in a pilot study in treating BOS associated with lung transplantation. We propose to perform a prospective, randomised, double blind study to test the efficacy of Azithromycin in treating BOS after BMT. Patients with proven BOS after BMT will be randomised into two groups based on lung function parameters. One group will receive low dose Azithromycin while placebo will be provided for the other group. Lung function will be serially monitored at 3 month, 6 months and 12 months after commencement of treatment with drug/placebo. If Azithromycin was proven effective in treating BOS then all patient with proven BOS should be treated with this drug.


Eligibility criteria: Inclusion Criteria:

* Confirmed BOS post BMT
* Informed consent

Exclusion Criteria:

* Women currently pregnant or nursing
* Allergy to macrolide

Primary outcomes:
measure: Quality of life assessment by questionnaires
timeFrame: 3 months after treatment
measure: Spirometry
timeFrame: 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
name: Albert Lie, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03259451: Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain
Official title: Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Neuropathic Pain: Retrospective Study on a Cohort of 149 Patients at Rennes University Hospital, From January 2014 to December 2015
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Neuropathic Pain
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 0
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: Patient with chronic neuropathic pain

Brief summary: A retrospective, monocentric, observational, descriptive, open study of a cohort of 149 patients from January 2014 to December 2015

Detailed description: Neuropathic pain is a public health problem because of its prevalence reaching nearly 7% of the general population and the effectiveness of current treatments often remains incomplete: only 30-40% of patients are relieved of 50% of their pain by a pharmacological approach.

As early as the 1990s, stimulation of the motor cortex by implanted electrodes made it possible to successfully treat certain chronic refractory neuropathic pain. In 1995 it was reported that the application of repeated shocks by transcranial magnetic stimulation of the motor cortex could induce an analgesic effect in a patient suffering from neuropathic pain.

This technique has proved its analgesic efficacy after an induction treatment over 5 days, in the context of chronic pain (neuropathic or fibromyalgia), but all the patients are not responders and there is currently, Of predictive criteria for response. It seems important to continue studies on this non-medicinal, non-invasive therapy with no significant adverse effects.

Eligibility criteria: Inclusion Criteria:

- patient older than 18 years old with chronic neuropathic pain who are resistant to drug therapy for which treatment with rTMS is indicated between January 2014 and December 2015

Exclusion Criteria:

* Patient less than 18 years old
* Pregnant woman
* Non-neuropathic pain
* Pain \<6 months
* Unbalanced epilepsy
* Patient with a contraindication for cerebral MRI (cochlear implant, ocular metallic foreign bodies, patient with a pacemaker, mechanical valve)
* Psychiatric pathology
* Person subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Primary outcomes:
measure: Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term
timeFrame: Day 7
measure: Evaluation of the efficacy of rTMS in the treatment of chronic neuropathic pain in a short term (≤ 1 month)
timeFrame: Month 1
Secondary outcomes:
measure: Evaluate the effectiveness of rTMS in the treatment of long-term chronic neuropathic pain (> 6 months)
timeFrame: Month 6
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT00948051: Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants
Official title: A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Lead sponsor: Syral
Sponsor class: INDUSTRY
First posted: 2009-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.


Eligibility criteria: Inclusion Criteria:

* infants aged of 4 months at randomization
* not breast-fed infants

Exclusion Criteria:

* infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria
* infants suffering from a disease associated with gastro-intestinal disorder
* infants who have taken antibiotic during the 2 months preceding randomization

Primary outcomes:
measure: To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination
timeFrame: 1 month
Secondary outcomes:
measure: To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dr Tormo
Study officials:
References:
Clinical trial NCT00538551: Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Cases
Official title: Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin Disease
Lymphoma, Non-Hodgkin
Keywords: HD
NHL
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 350
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphoma database

Brief summary: Prospective Data Collection of Newly Diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma Cases

Detailed description: Prospective Data Collection of Newly Diagnosed HD and NHL.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed Hodgkin's Disease and Non-Hodgkin's Lymphoma

Exclusion Criteria:

* Patients with diagnosis other than HD and NHL.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH & RC
name: Syed Akhtar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01418651: Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population
Official title: Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia in an Elderly Population: an Open-label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Banner Health
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2011-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Participants will undertake a 12-week, open-label study of milnacipran in a well-characterized cohort of patients with fibromyalgia syndrome (FMS) who are 65 years and older to investigate the short-term efficacy and safety of this drug in the elderly population. The investigators hypothesize that milnacipran will be effective in treating fibromyalgia syndrome (FMS), and will be prove to be safe when patients are selected for the absence of pre-existing blood pressure abnormalities and other serious medical conditions.


Eligibility criteria: Inclusion Criteria:

* Male or female patients.
* Age 65 years or older.
* Fibromyalgia diagnosed according to ACR 1990 criteria.
* Pain Score ≥ 10 on Gracely scale at screening and baseline assessments.
* Discontinuation of other dual-acting antidepressant medications, including duloxetine, venlafaxine, and tricyclic antidepressants for a period not less than 4.5 times the drug half-life as of the baseline evaluation.

Exclusion Criteria:

* Uncontrolled hypertension (BP ≥ 140/90) at screening or baseline evaluations.
* Baseline orthostasis (documented drop in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg within 3 minutes after standing) at screening or baseline evaluations.
* Psychosis, active suicidality, current episode of major depression or other severe psychiatric illness, or current alcohol/substance abuse or dependence as assessed by the MINI.
* Significant cardiovascular disease, including atrial fibrillation or other dysrhythmia, congestive heart failure, valvular heart disease, or QTc prolongation on baseline EKG (\> 450 msec).
* Uncontrolled narrow angle glaucoma.
* History of seizures.
* Use of MAO inhibitor drugs within the last 14 days.
* Abnormal baseline liver or renal function tests.
* Dementia or other syndrome of cognitive impairment that could interfere with the subject's ability to participate fully in the assessment protocol.
* Obstructive uropathy in males.

Primary outcomes:
measure: Change in self-reported severity of pain over 12 weeks of treatment in persons aged 65 and older
timeFrame: 14 months
Secondary outcomes:
measure: Determine the effects of milnacipran on cognition
timeFrame: 14 months
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
Study officials:
affiliation: Banner Health
name: Sandra Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01494051: High Protein Diet in Patients With Long-chain Fatty Acid Oxidation Disorders
Official title: Fatty Acid Oxidation and Body Weight Regulation in Long-chain Fatty Acid Oxidation Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Very Long-chain Acyl-CoA Dehydrogenase Deficiency
Trifunctional Protein Deficiency
Carnitine Palmitoyltransferase 2 Deficiency
Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency
Keywords: fatty acid oxidation disorders
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 13
Sex: ALL
Minimum age (years): 7
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study also determines if eating a diet higher in protein alters body composition, energy balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.

Detailed description: At baseline, the amount of muscle and fat in the whole body and inside the liver and muscle will be measured. All subjects will complete a moderate treadmill exercise test and a test to determine how they use sugar (oral glucose tolerance test). The amount and type of energy burned by each subject will be measured. Subjects will be randomly assigned to follow either a high carbohydrate diet or a reduced carbohydrate, high protein diet for 4 months. At the end of 4 months, the tests will be repeated.

Eligibility criteria: Inclusion Criteria:

* diagnosis of a long-chain fatty acid oxidation disorder including VLCAD, CPT2, LCHAD or TFP deficiency
* 7 years old or greater
* able to comply with diet guidelines

Exclusion Criteria:

* pregnant
* enrolled in another study that alters diet composition
* cannot complete treadmill exercise study

Primary outcomes:
measure: Energy Expenditure
timeFrame: change from baseline after 4 months of treatment
Secondary outcomes:
measure: Body Composition
timeFrame: change from baseline to 4 months of treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05841251: Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
Official title: Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Bleeding
Coblation Turbinoplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 80
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: Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy

Exclusion Criteria:

* Known allergy to study drugs.
* History of coagulopathy or bleeding disorders.
* Patients with hypertension or ischemic heart disease.
* patients on anticoagulants, antiplatelets or NSAIDs
* history of deep vein thrombosis, stroke or peripheral vascular disease.

Primary outcomes:
measure: surgical field scale
timeFrame: intraoperativel
Secondary outcomes:
measure: Volume of Blood loss
timeFrame: intraoperative
measure: Duration of surgery
timeFrame: the duration from induction of anesthesia till extubation
measure: Avoidance of postoperative nasal packing
timeFrame: immediately after the surgey
measure: Intra-operative and Postoperative complications
timeFrame: intraoperative and 24 hours postoperative
Other outcomes:
Locations:
Study officials:
References: