louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03222947: New Variants Involved in Taybi-Linder Syndrome
Official title: Identification of New Genes Involved in the Taybi-Linder Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Taybi Linder Syndrome
Genetic Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with a Taybi-Linder or Taybi-Linder like syndrome and their blood relatives.

Brief summary: Taybi-Linder syndrome (TALS, OMIM 210710) is a rare autosomal recessive disorder belonging to the group of microcephalic osteodysplastic primordial dwarfisms (MOPD). This syndrome is characterized by short stature, skeletal anomalies, severe microcephaly with brain malformations and facial dysmorphism, and is caused by mutations in RNU4ATAC. Although RNU4ATAC-associated TALS is a recognizable phenotype, an atypical presentation is sometimes observed, thus expanding the clinical spectrum (TALS-like phenotype).

This study aims to identify new variants involved in Taybi-Linder syndrome and associated phenotypes (i.e.TALS-like).

This non interventional study will be performed on patients with no proven mutation of RNU4ATAC and their blood relatives (19 samples total) by high throughput sequencing and genetic analysis of already collected deoxyribonucleic acid samples.

Altogether, such a study will allow a better understanding of the molecular mechanisms responsible for the Taybi-Linder syndrome and Taybi-Linder syndrome-like phenotypes as well as the pathophysiology of these devastating forms of microcephalic dwarfism.


Eligibility criteria: Inclusion Criteria:

* foetus or young children diagnosed with a Taybi-Linder or Taybi-Linder like syndrome, with no RNU4ATAC mutation (index case)
* aged 20 weeks pregnant to 18 years old
* parents or sibling of the index cases, with informed consent for the analysis of both their DNA sample and the one of the index case.

Exclusion Criteria:

* no informed consent for the use of genetic samples for medical research

Primary outcomes:
measure: Identification of new variants involved in the Taybi-Linder syndrome
timeFrame: Collection at time of diagnosis = less than one day
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Génétique Clinique, Groupement Hospitalier Est, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00208247: KATHY:Cognitive-behavioural Therapy for Hypochondriasis
Official title: Cognitive-behavioural Therapy Versus Short-term Psychodynamic Psychotherapy: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypochondriasis
Lead sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2005-09-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to examined if psychotherapy is an effecitive treatment for hypochondriasis.

Detailed description: Background: The central feature of hypochondriasis is preoccupation or fear of having a serious disease based on misinterpretation of bodily signs. Psychotherapeutic treatments have developed with focus on different aspects of the condition. Several controlled trials have examined the effectiveness of different treatment strategies.

Hypothesis: Hypochondriasis is accessible for treatment. Specific cognitive treatment focused on misinterpretation of bodily sensations is more effective than short-term non-specific psychodynamic psychotherapy.

Method: Patients with hypochondriasis were randomisation to cognitive behavioural therapy (CBT), psychodynamic psychotherapy, or waiting list. Patients on waiting list were subsequently randomised to CBT or dynamic psychotherapy. The patients received six-teen sessions over a period of six month. Follow-up assessments were made six and twelve month after treatment.

Eligibility criteria: Inclusion Criteria:

(1) age between 18 and 65 years, (2) Danish as native language, (3) fulfilment of the ICD-10 research criteria for hypochondriasis (3), (4) health anxiety to a significant degree: a score more than 17 on the health anxiety inventory (HAI) (5).

-

Exclusion Criteria:

(1) current psychotic condition, (2) current substance abuse, (3) a medical condition which demanded immediate treatment, (4) psychopharmacological treatment initiated or increased during the last 6 weeks before treatment, and (5) previous cognitive behavioural treatment.

-

Primary outcomes:
measure: Two primary outcome measures were included 0, 6 and 12 month after treatment: the Health Anxiety Inventory (HAI), which is an 18-item, self-report questionnaire and the Hamilton Anxiety Rating Scale (HAM-A).
Secondary outcomes:
measure: Several secondary outcome measures were included 0, 6 and 12 month after treatment: Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hamilton Rating Scale for Depression (HAM-D) and Global Assessment Functioning (GAF).
Other outcomes:
Locations:
Study officials:
affiliation: Liaison Psychiatric Unit, Bispebjerg Hospital, 2400 NV Copenhagen, Denmark
name: Morten Birket-Smith, DMSc
role: STUDY_DIRECTOR
affiliation: Liaison Psychiatric Unit, Bispebjerg Hospital, 2400-NV Copenhagen, Denmark
name: Per Sorensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566547: GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
Official title: Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-22
Enrollment: 116
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: All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.


Eligibility criteria: Inclusion Criteria:

* 1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be measurable by central laboratory assessment: Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or

Light chain multiple myeloma without measurable disease in the serum or the urine:

Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.

Exclusion Criteria:

* 1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.

Primary outcomes:
measure: ORR evaluated by IRC
timeFrame: 2 years
Secondary outcomes:
measure: ORR evaluated by investigator
timeFrame: 2 years
measure: Progression-free survival (PFS) evaluated by IRC
timeFrame: 2 years
measure: MRD negative rate
timeFrame: 2 years
measure: AE
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: he First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Jie Jin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06990347: A Study on the Efficacy and Safety of IPyC for HER2+ MBC
Official title: A Retrospective Multicenter Cohort Study on the Efficacy and Safety of Inetetamab and Pyrotinib Combined With Chemotherapy for HER2-positive Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 301
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from five centers, clinical oncology school of fujian medical university, fujian provincial hospital, the first affiliated hospital of xiamen university, zhangzhou zhengxing hospital and the third affiliated people's hospital of fujian university of traditional chinese medicine

Brief summary: Between July 2020 and August 2024, 301 HER2-positive MBC patients from five tertiary centers received the regimen until disease progression or unacceptable toxicity. Efficacy endpoints included progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR).


Eligibility criteria: Inclusion Criteria:

* patients who underwent a biopsy of the metastatic site and were confirmed as having MBC
* patients who received inetetamab + pyrotinib + chemotherapy as metastasis therapy.

Exclusion Criteria:

* male patients or individuals with prior malignancy
* patients with prior or current enrollment in interventional clinical trials for MBC
* patients who received less than 2 cycles of treatment (6 weeks of inetetamab or 8 weeks of pyrotinib)
* patients who were lost to follow-up during the therapeutic process

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
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
Study officials:
References:
Clinical trial NCT06604247: The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients
Official title: The Association Between CBT-I Dose and Innate Immunity in Insomnia and Fatigue in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this project is to test the association between Cognitive Behavioral Therapy for Insomnia dose (number of sessions), severity of cancer related fatigue, and levels of innate immunity biomarkers. Ultimately, this research will help to develop a better understanding of the underlying mechanisms of cancer related fatigue.

Detailed description: Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to decreases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of organ-confined breast cancer or prostate cancer
* Received radiation treatment
* Willing and able to provide informed consent
* Endorse problem with both insomnia and cancer-related fatigue, as measured by the insomnia severity index, Multidimensional Fatigue Symptom Inventory (short form) and the Brief Fatigue Inventory

Exclusion Criteria:

* History of obstructive Sleep Apnea
* History of narcolepsy
* Night shift work
* Distant metastatic disease at presentation
* Active drug/alcohol dependence

Primary outcomes:
measure: Fatigue
timeFrame: From enrollment to three months post-treatment
measure: Insomnia Severity
timeFrame: From enrollment to post-treatment, and 3 months post-treatment
Secondary outcomes:
measure: Sleep Continuity
timeFrame: From enrollment to post-treatment, and 3 months post-treatment.]
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University Of Pennsylvania, Behavioral Sleep Medicine Program
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03061747: Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored
Official title: Italian Multi-centre Observational Registry on Patients With impLANTable Devices Remotely monitorED
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Defibrillators, Implantable
Heart Failure With Reduced Ejection Fraction
Arrythmia
Pacemaker
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients underwent ICD or pacemaker implantation from January 2009 to September 2016 for any indication and followed by remote monitoring at enrolling hospitals

Brief summary: Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.


Eligibility criteria: Inclusion Criteria:

* ICD of pacemaker implantation fo any indication
* Followed by remote monitoring
* Age \>18 years

Exclusion Criteria:

* life expectancy of less than one year

Primary outcomes:
measure: Death for any cause
timeFrame: an average of 2 years
Secondary outcomes:
measure: Atrial arrhythmias
timeFrame: an average of 2 years
measure: Hospitalizations for any cause
timeFrame: an average of 2 years
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: University Hospital "Umberto I - Lancisi - Salesi"
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Catanzaro
country: Italy
facility: AO Pugliese-Ciaccio
city: Lecce
country: Italy
facility: Vito Fazzi Hospital
city: Napoli
country: Italy
facility: Monaldi Hospital
city: Novara
country: Italy
facility: Dell'Era Gabriele
Study officials:
affiliation: Card. G. Panico Hospital - Tricase - Italy
name: Pietro Palmisano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113047: Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine
Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Single Pill (SPC) Combination of Aliskiren 300 mg / Amlodipine 10 mg in Hypertensive Patients Not Adequately Respond to an Uptitrated 4 Week Therapy With the SPC of Olmesartan 40 mg / Amlodipine 10 mg, With a Potential Extension if Patients Still Not Adequately Respond With a 4 Week Therapy With the SPC Aliskiren 300 mg / Amlodipine 10 mg / HCTZ 12,5 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Hypertension
Aliskiren
Amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-29
Enrollment: 347
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 will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine.

Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.


Eligibility criteria: Inclusion Criteria:

* Essential hypertension stage II
* Male and female patients
* Age \>= 18 years old

Exclusion Criteria:

* Severe hypertension (systolic BP \>= 180 mmHg, diastolic BP \>= 110 mmHg
* Poorly controlled diabetes mellitus or type 1 DM
* History of myocardial infarction, stroke
* Presence of heart failure
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in mean sitting diastolic blood pressure after 4 weeks of treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in mean sitting systolic blood pressure reduction after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
timeFrame: 4 weeks
measure: Change in mean sitting diastolic blood pressure after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
timeFrame: 4 weeks
measure: Change in heart rate, pulse pressure, responder rates, normalization rates after 4 weeks of treatment with Aliskiren/Amlodipine or after 4 weeks of treatment with Aliskiren/Amlodipine/HCT
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Pirna
country: Germany
facility: Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Axthelm, Dr. med.
role: STUDY_DIRECTOR
References:
citation: Axthelm C, Sieder C, Meister F, Pittrow D, Kaiser E. Aliskiren/amlodipine as a single-pill combination in hypertensive patients: subgroup analysis of elderly patients, with metabolic risk factors or high body mass index. J Drug Assess. 2012 Dec 25;2(1):1-10. doi: 10.3109/21556660.2012.762367. eCollection 2013.
Clinical trial NCT00690547: Force Enhancement of Musculus Quadriceps Femoris During and After Excentric Muscle Activity in Vivo
Official title: Force Enhancement of m. Quadriceps Femoris During and After Excentric Muscle Activity in Vivo by Maximal and Sub-maximal Deliberately Activation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Quadriceps Femoris
Healthy
Keywords: Functionality
Deliberately
Activated
Quadriceps
Femoris
During
After
Active
Extension
Lead sponsor: German Research Foundation
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: males without previous muscular or neurophysiological diseases at an age between 20 and 40 years

Brief summary: Force enhancement (FE) describes the phenomenon of strength potentialization of a muscle cell or the complete muscle during and after active extension compared to the strength of an isometric contraction with same muscle length. The underlying physiological mechanism of this phenomenon is not completely known today. In vitro trials indicate that the interaction of an active and a passive component on the cellular level are responsible for the higher strength measurements. So far FE could be shown in vitro and in vivo on muscle fibers and small human muscles. Further research is needed for verification of the existence of FE in voluntary motor activity in everyday life. In order to approach this objective the investigators will scrutinize the functionality of the deliberately activated musculus (m) quadriceps femoris during and after active extension on the basis of in vivo studies.

Detailed description: The research proposal is resubmitted with no amendments made regarding content.

Eligibility criteria: Inclusion Criteria:

* Males without previous muscular or neurophysiological diseases
* Age between 20 and 40 years

Exclusion Criteria:

* Previous muscular or neurophysiological diseases

Primary outcomes:
measure: Identification of a potential Force enhancement by complex muscle activity with a high relevance for everyday life, for example more agile leg stretching (knee bend).
timeFrame: 12 months
Secondary outcomes:
measure: Evidence of existence of the force enhancement by deliberately activated, great human muscle by sub-maximal activation
timeFrame: 12 months
measure: Correlation between typ of muscle fiber and force enhancement in vivo
timeFrame: 12 months
measure: Analysis of the alternation of length of the muscle fiber during and after excentric extension for the differentiated explanation of in vivo mechanism excentric and post-excentric strength
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technical University of Munich, Department of Biomechanics in Sports
Study officials:
affiliation: Technical University of Munich, Department of Biomechanics in Sports
name: Ansgar Schmirtz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: