louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05237180: Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension
Official title: Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension in Noise in Bi-implanted Subjects With Post-lingual Deafness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Cochlear
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hearing comprehension under complex listening conditions is considered to be the central complaint of everyday life for patients with cochlear implants. Localization is one of the cues for listening comprehension. However, only few studies have investigated the effect of spatial localization training on listening comprehension performance in noise. None of these studies correspond to the desire to purpose training by speech therapists while using affordable equipment.

The main objective of this study is to evaluate the effect of a spatial localization training protocol in cochlear bi-implanted subjects with post-lingual deafness on their ability to understand in noise.

2 groups of 10 subjects each will be recruited: a patient group and a control group. The patient group will undergo 8 sessions of spatial localization rehabilitation lasting an average of 45 minutes each.

After this programme, the pre-test and post- test results obtained will be compared.


Eligibility criteria: Inclusion Criteria:

* post-lingual deafness
* implanted bilaterally for at least 1 year
* score ≥ 70 at LAFON scale
* score ≥ 70 at MBAA scale
* score ≥ 5/9 at CAP scale
* good command of the French language
* accepts to participate in the study

Exclusion Criteria:

* do not realize speech reeducation (spatial localisation and speech perception) during the study
* no change in setting of cochlear implants

Primary outcomes:
measure: Change of Hearing comprehension performance in noise
timeFrame: 10 weeks after inclusion
measure: Change of Hearing comprehension performance in noise
timeFrame: 10 weeks after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Sainte Clotilde
country: Réunion
facility: Gcs Crcsi
Study officials:
affiliation: GCS CRCSI
name: Justine MAISSON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01339780: Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Metastases
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2011-04-21
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prostate and breast cancer continues to be the most common cancer among men and women, respectively. The exact assessment of the cancer spread with detection of possible bone metastasis is crucial for treatment decision. In the current study 50 patients with prostate cancer and 50 patients with breast cancer at high risk for bone metastases or with know metastatic disease will be studied with multiple imaging modalities. Patients will be recruited from the Department of Oncology, Turku University Hospital. Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is to calculate the sensitivities and specificities of the four imaging modalities on a patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal imaging protocol for detection of prostate and breast cancer bone metastasis will be developed and validated.


Eligibility criteria: Inclusion Criteria:

* Age: 40 to 80 years
* Language spoken: Finnish or Swedish
* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
* Diagnosis: Histologically confirmed prostate or breast cancer
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
* strong suspicion of first bone metastatic disease (already diagnosed metastases in other organs, elevated tumor markers, destruction of bone in plain x-ray or otherwise specified reasons
* adjuvant chemo- or endocrine therapy is allowed

Exclusion Criteria:

* Ongoing treatment for metastatic disease
* Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
* Infections: Patient must not have an uncontrolled serious infection
* Claustrophobia

Primary outcomes:
measure: Number of participants with bone metastases
timeFrame: at least 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Kiinamyllynkatu 4-8
Study officials:
References:
Clinical trial NCT01478880: Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations
Official title: Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for the Treatment of Auditory Hallucinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Auditory Hallucinations
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 16
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: First clinical studies indicate an effect of repetitive transcranial magnetic stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size, optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.


Eligibility criteria: Inclusion Criteria:

* auditory hallucinations at least once a week
* Schizophrenia (DSM-IV)
* stable treatment setting (in- or out-patient)
* no change of antipsychotics during and at least 1 week before treatment initiation

Exclusion Criteria:

* epilepsy
* benzodiazepines \> 1,5mg lorazepam / d
* pregnancy
* metal parts in the brain
* cardiac pacemaker
* deep brain stimulation

Primary outcomes:
measure: Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
timeFrame: 3 weeks
Secondary outcomes:
measure: Hallucination change score (HCS)
timeFrame: 3 and 6 weeks
measure: Positive and Negative Symptom Scale (PANSS)
timeFrame: 3 and 6 weeks
measure: PSYRATS subscale for auditory hallucinations
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen, Department of Psychiatry and Psychotherapy
Study officials:
affiliation: Universtity of Tuebingen
name: Christian Plewnia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06819280: Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Advanced Colorectal Cancer
Official title: A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adult
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 18
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
Primary purpose: TREATMENT

Brief summary: This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with Advanced Colorectal Cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Eligibility criteria: Inclusion Criteria:

1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
2. Age 18 to 70 years old;
3. Advanced Colorectal Cancer that progresses after first-line chemotherapy；
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Expected survival time of ≥ 12 weeks;
6. Good function of vital organs;
7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

1. Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
2. Known mental illness, alcoholism, drug use or substance abuse;
3. Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
4. Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
5. The investigators determine that other conditions that make the patient not suitable for enrollment

Primary outcomes:
measure: Incidence and severity of adcersed events per CTCAE 5.0
timeFrame: 3 years
measure: Objective response rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medcine, Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT07027280: Noninvasive Intratumor Heterogeneity Evaluation in HNSCC
Official title: Noninvasive Intratumor Heterogeneity Evaluation in HNSCC With Multi-omics Insights and Therapeutic Targets
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 700
Sex: ALL
Minimum age (years): 15
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathologically confirmed HNSCC were collected from the Department of Otolaryngology, the First Affiliated Hospital of Chongqing Medical University.

Brief summary: This study focuses on tumor heterogeneity, a core challenge in the field of oncology, and innovatively utilizes patient imaging data to deeply mine and analyze intratumoral heterogeneity. By constructing an imaging analysis model for tumor heterogeneity and associating this model with clinical, pathological, transcriptomic, and metabolomic data of patients, a multi-omics decoding of tumor heterogeneity is achieved. The main questions it aims to address are:

Can the ITH model stratify patients' treatment efficacy and prognosis assessment? Can pathological and multi-omics sequencing map the mechanisms behind the ITH model?


Eligibility criteria: Inclusion Criteria:

Pathologically confirmed head and neck squamous cell carcinoma (HNSCC). Complete clinical, imaging, and pathological data. Available complete follow-up information.

Exclusion Criteria:

Patients who received chemotherapy or radiotherapy before surgery. Poor image quality. Tumors too small to be easily identified. History of other concurrent malignant tumors.

Primary outcomes:
measure: AUC
timeFrame: through study completion, an average of 1 year
measure: C-index
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
References:
Clinical trial NCT03759080: Mental Practice Versus Proprioceptive Neuromuscular Facilitation on Strength of Upper Limb
Official title: Mental Practice Versus Proprioceptive Neuromuscular Facilitation on Strength of Upper Limb
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Motor Activity
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2018-11-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: there are two arms :1. proprioceptive neuromuscular facilitation (PNF) group ,2 mental practice (MP) group.

PNF group: 30 individuals, these subjects received PNF training. PNFMP: 30 individuals, these subjects receivedMP. training program has been administered for every group for 12 sessions over 4 weeks with 3 x 45 min training sessions per week.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effects of mental practice combined with proprioceptive neuromuscular facilitation on muscle strength of upper limb were measured in 60 healthy students Subjects were randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or mental practice (MP) group. PNF group: 30 individuals, these subjects received only PNF training. MP: 30 individuals, these subjects received mental practice.

Detailed description: The effects of mental practice on muscle strength of upper limb were measured in 60 healthy female students with right dominant hand,. Their age ranged from17 to 23 years old. Subjects were randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or mental practice (MP) group. PNF group: 30 individuals, these subjects received only PNF training. MP: 30 individuals, these subjects received MP. training program has been administered for every group for 12 sessions over 4 weeks with 3 x 45 min training sessions per week. Pre-post test design was used. EMG device was used to measure the electrical activity of muscles. Measurements conducted at pre-intervention, during intervention and post-intervention testing with 20 days.

Eligibility criteria: Inclusion Criteria:

1.Absence of a prior injury of arm

Exclusion Criteria:

1.History of a neurological disease.

Primary outcomes:
measure: Strength Evaluation of coracobrachialis Muscle
timeFrame: 2 minutes.
measure: Strength Evaluation of teres minor muscle
timeFrame: 2 minutes.
measure: Strength Evaluation of Brachialis muscle
timeFrame: 2 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Jazan University
state: Jazan
Study officials:
References:
Clinical trial NCT03163680: Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers
Official title: Efficacy of Low Dose of Proton Pumb Inhabitor in Treatment Upper Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroduodenal Ulcer
Marginal Ulcer
Peptic Ulcer Hemorrhage
Keywords: Gastroduodenal Ulcer
Marginal Ulcer
Peptic Ulcer Hemorrhage
Peptic Ulcer
Lead sponsor: Damascus Hospital
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the gastrointestinal department of damascus hospital

Brief summary: Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding

Detailed description: Determining the efficacy of low dose meaning 40 mg of omeprazole twice in management acute peptic ulcer bleeding

Eligibility criteria: Criteria:

Inclusion Criteria:

High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata, active bleeding was defined as a continuous blood spurting (Forrest IA) oozing (Forrest IB) from the ulcer base. A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).

An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion Criteria:

ulcer was malignant non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear

Primary outcomes:
measure: Morality
timeFrame: within 1 week
Secondary outcomes:
measure: Rebleeding
timeFrame: within 1 week
measure: need for surgery
timeFrame: within 1 week
measure: Length of hospital stay
timeFrame: within 1 month
measure: Blood transfusions
timeFrame: within 1 week
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus Hospital
Study officials:
References:
Clinical trial NCT01467180: Myoglobin Removal by High Cut-off CVVHD
Official title: Myoglobin Reduction by High Cut-off (HCO) Continuous Veno- Venous Hemodialysis (CVVHD) in Patients With Rhabdomyolysis and an Increased Risk for Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhabdomyolysis
Renal Failure
Keywords: septeX
CVVH
CVHD
myoglobin
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Dialysatoren GmbH
name: Baxter Healthcare Corporation
First posted: 2011-11-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.

Detailed description: Excess myoglobin in the circulation is a causative pathogenetic factor of rhabdomyolysis associated with acute kidney injury (AKI). The rapid elimination of myoglobin by standard dialysis membranes is limited to its molecular weight of 17.8kDa, although some removal can be achieved when a convective therapy is applied.

Significant clearance for myoglobin has been reported for high flux membranes from \< 8 mL/min (5) up to 22 mL/h (CVVH) (10) and for high cut-off (HCO) membranes a mean clearance rate of 36.2 mL/min in HD mode (7) and 39.2 mL/h in CVVH mode (5). The use of high cut-off (HCO) continuous veno- venous hemodialysis (CVVHD) may constitute a novel therapeutic strategy for effectively reduction of myoglobin in the patient's serum to ameliorate the course of AKI.

Previously, a case study of the removal of myoglobin by HCO-CVVH in one single patient with severe rhabdomyolysis was published.

Eligibility criteria: Inclusion Criteria:

* Acute Rhabdomyolysis
* placed central venous catheter
* Indication for RRT due to Serum CK level \> 5000 u/L
* Age ≥ 18 years
* Signed ICF

Exclusion Criteria:

* End stage CKD (dialysis dependent) renal failure before manifestation of rhabdomyolysis
* Pregnancy or lactation
* Palliative treatment
* Participation in other clinical studies

Primary outcomes:
measure: Myoglobin plasma level
timeFrame: 24h
Secondary outcomes:
measure: eGFR
timeFrame: at 3 and 6 month after treatment
measure: Duration of hospital stay (days)and Duration of ICU stay (days)
timeFrame: 6 month
measure: Duration of dialysis dependence (days)
timeFrame: 6 month
measure: Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria
timeFrame: 6 month
measure: patient survival
timeFrame: 6 month
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum
state: Hessen
Study officials:
References:
Clinical trial NCT02368080: Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults
Official title: Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults: a Comparison of Two Commercially Available Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Healthy
Keywords: Lung Clearance Index
Cystic Fibrosis
Multiple Breath Nitrogen Washout
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF : primary care clinic HC : community sample

Brief summary: This study compares the lung clearance index (LCI) in cystic fibrosis and healthy adults obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.

Detailed description: Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the "EasyOne Pro Lab" (ndd Medical Technologies, Zürich, Switzerland) and the "Exhalyzer D" (Eco Medics AG, Duernten, Switzerland).

Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis diagnosis

Exclusion Criteria:

* Respiratory infection within 3 weeks
* Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia

Primary outcomes:
measure: Lung Clearance Index (LCI)
timeFrame: 1 hour
Secondary outcomes:
measure: Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device)
timeFrame: 1 hour
measure: Functional residual capacity (FRC) ( the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)
timeFrame: 1 hour
Other outcomes:
measure: Subject's preference
timeFrame: 1 hour
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Patrick Lebecque, MD, PhD
role: STUDY_DIRECTOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: William Poncin, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Anne-Sophie Aubriot, PhD student
role: STUDY_CHAIR
References: