louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06989333: Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis
Official title: A Single-arm Clinical Study of Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pulmonary Alveolar Proteinosis
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to explore a new therapeutic approach: the feasibility, safety and preliminary efficacy of directly spraying GM-CSF into the airway through bronchoscopy for the treatment of aPAP.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 60 years old;
2. A clear diagnosis of aPAP must meet at least one of the following diagnostic criteria:

1) BALF appears "milky white"; Or cytological examination reveals a large amount of PAS-positive protein deposition; 2) HRCT shows typical "paving stone-like changes"; 3) Positive for serum GM-CSF antibody. 3. There are more than one of the following treatment indications: Symptoms such as progressive breathing difficulties, coughing, and shortness of breath after activity occur; 2) Without oxygen inhalation, PaO2 \> 65 mmHg 3) Pulmonary function DLCO accounts for % of the predicted value, ranging from 60% to 80%, including the critical value.

4. No other PAP specific treatments (such as WLL, inhaled GM-CSF, biological agents, etc.) have been received recently (for more than 4 weeks).

5. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Secondary PAP (such as secondary to blood diseases, etc.);
2. Patients with obvious pulmonary fibrosis, emphysema or irreversible lung function impairment;
3. Patients in the acute exacerbation stage;
4. Patients with other lung diseases (such as active pulmonary tuberculosis, bronchiectasis with purulent infection or other chronic infections; Have severe asthma, chronic bronchospasm, etc.
5. Have a history of allergy to GM-CSF antibodies or related drug components;
6. Patients who have participated in other clinical drug trials within the past three months;
7. Patients who have experienced severe complications related to bronchoscopy or are intolerant to bronchoscopy;
8. Concurrent with other serious cardiovascular and cerebrovascular diseases, hematological disorders, malignant tumors, etc.
9. Pregnant or lactating women.

Primary outcomes:
measure: Chest HRCT
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04668833: ALI Post Radiation Therapy in Patients With Lung and Esophageal Canter
Official title: Phase I Study of Autologous Lymphocyte Infusions After Radiation Therapy to Mitigate Radiation Induced Lymphopenia and Enhance Immune Reconstitution in Patients With Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Solid Tumor Malignancies
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective.

Detailed description: The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation. Primary Objective To investigate the preliminary efficacy of autologous lymphocyte infusion (ALI) in improving the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemo-radiation (CRT). Secondary Objectives

1. To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation.
2. To identify lymphocyte clonal populations in the tissue that are specific for tumor cells
3. To identify immune reconstitution in the peripheral blood shaped by ALI.
4. To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.

Eligibility criteria: Inclusion Criteria:

Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18

Exclusion Criteria:

Prior radiotherapy to the chest Life expectancy\<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy

Primary outcomes:
measure: To evaluate the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemoradiation. (CRT)
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: To evaluate the feasibility of ALI in patients who had undergone chemoradiation.
timeFrame: Baseline to 6 weeks
measure: To evaluate the safety of ALI in patients who had undergone chemoradiation.
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson Cancer Center, Houston, Texas
name: Gheath Al-Atrash
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05980533: Portable Ultrasound to Predict Heart Failure Readmission Risk
Official title: Utility and Feasibility of Prehospital Portable Ultrasound to Predict Heart Failure Readmission Risk
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Patient Readmission
Keywords: Ultrasound
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to use a handheld ultrasound to assess patients with congestive heart failure (CHF) to see if the ultrasound can help predict readmission to the hospital. The study will include patients who are admitted to the hospital for CHF. Participants will have two ultrasounds at hospital discharge and at a follow up visit.

Detailed description: The purpose of this research is to see if a portable ultrasound can help predict readmission to the hospital for patients who are admitted to the hospital for CHF. The study will enroll patients who take part in Mobile Integrated Healthcare as part of their routine care. Participants will have two ultrasounds. The first ultrasound will be at hospital discharge.

Between seven to ten days after hospital discharge participants will be visited at their home in follow-up as the usual standard of care for Mobile Integrated Healthcare. At this visit participants will have a second ultrasound. Participants will be followed for one year for hospital readmission.

Eligibility criteria: Inclusion Criteria:

* Primary admission diagnosis is listed as congestive heart failure, with an acute component of decompensation.
* Age greater than 18 years.
* Principal residence within the geographic reach of our MIH program.

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: Hospital Readmission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Guthrie Clinic
name: Zachary Dewar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01589133: Surgiscreen Registration
Official title: A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irregular Antibody Screening
Keywords: Irregular antibody screening
Lead sponsor: Johnson & Johnson Medical, China
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 3109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need transfusion therapy in investigator sites.

Brief summary: The purpose of this study is to assess the consistency of the results of irregular antibody screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent), and the consistency of the results of irregular antibody screening with investigational reagent on serum and plasma from same patients.


Eligibility criteria: Inclusion Criteria:

* Serum or plasma samples left after routine clinical testing;
* Blood sample of the same day, or blood samples stored at 2-8°C for 3 days after collection, or serum or plasma samples stored at -20°C for those separated 3 days after collection.

Exclusion Criteria:

* Samples with severe hemolysis, jaundice or chyle-like samples;
* Small sample size insufficient for completing the testing;
* Samples not collected and processed upon the requirements of the instructions.

Primary outcomes:
measure: The consistency of the results of irregular antibody screening of investigational reagent and control reagent.
timeFrame: baseline
Secondary outcomes:
measure: The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Science
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Blood Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02207933: Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Patients With Step Length Asymmetry After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegic Gait
Keywords: anterioposterior
weight
shifting
training
patient
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of anteroposterior weight shifting training with visual biofeedback on step length asymmetry. Reduced speed and asymmetry of stepping is a specific characteristic of hemiplegic gait. Asymmetry of stepping is characterized by shorter step length of the unaffected limb compared to the affected limb. Causes of this phenomenon are difficulty in weight bearing at the affected limb, weak propulsive force of the affected limb, and decreased strength of hip extensors. To correct these factors. we have developed an anteroposterior weight shifting training system with visual feedback and studied its effects.


Eligibility criteria: Inclusion Criteria:

1. Independent standing
2. Ability to walk 10m without manual assistance
3. Asymmetric ratio of step length \> 1.1
4. No severe perceptual, cognitive or cardiovascular impairments that could affect walking

Exclusion Criteria:

1. Quadriplegia or double hemiplegia
2. Orthopedic or neurologic conditions in addition to the stroke
3. Had more than 1 cerebrovascular accident

Primary outcomes:
measure: change of step Length Asymmetric Ratio
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: change of Step Length Asymmetric Index
timeFrame: baseline, 3 weeks, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Severance Hospital
name: Deog Young Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05584033: Searching of Apraxia of Speech in Children With Specific Language Impairment
Official title: Searching of Apraxia of Speech in Children With Specific Language Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apraxia of Speech
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Searching of Apraxia of Speech in Children with Specific Language Impairment

Brief summary: Searching of Apraxia of Speech in Children with Specific Language Impairment


Eligibility criteria: Inclusion Criteria:

* Children from 4 to 8 years old diagnosed as specific language impairment

Exclusion Criteria:

* 1. Children with mental retardation or hearing impaired . 2. Children with any neurological or psychiatric disorders.

Primary outcomes:
measure: Mansora Arabic test battery for childhood apraxia of speech
timeFrame: one houre
Secondary outcomes:
Other outcomes:
Locations:
city: Sohage
country: Egypt
facility: Sohage University
Study officials:
References:
Clinical trial NCT05339633: Study in Healthy Adult Female Subjects
Official title: An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C]-D-0502 Following Single Oral Dose Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mass Balance Recovery
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-04-21
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of \[14C\] D-0502 Following Single Oral Dose Administration


Eligibility criteria: Inclusion Criteria:

* Healthy adult female volunteers not of child-bearing potential between the ages of 18 and 65. Other inclusion criteria will be reviewed by the Principal Investigator.

Exclusion Criteria:

* History or presence of any condition or prior surgery that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives
* Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG, or laboratory tests
* Other exclusion criteria will be reviewed by the Principal Investigator.

Primary outcomes:
measure: Radiolabel recovery
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Site Location
state: Maryland
Study officials:
References:
Clinical trial NCT02929433: Cycloergometer and Rotator Cuff Tear
Official title: Conservative Treatment of Rotator Cuff Tear: The Role of Cycloergometer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: disability
pain
Rotator Cuff Tear
rehabilitation
range of motion (ROM)
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 38
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. The cycloergometer has been already employed in many fields of medicine.

However, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in Rotator Cuff Tear patients.

Detailed description: To evaluate the effects of cycloergometer on pain during activities (primary outcome) and shoulder functionality, the investigators performed a prospective randomized controlled study (pilot study) in patients with a symptomatic full-thickness RCT.

Since cycloergometer works through a continuous active and passive joint mobilization, the investigators expect it can reduce pain and improve shoulder functionality becoming a useful tool for physicians in the management of RCT patients.

Eligibility criteria: Inclusion Criteria:

* positive imaging diagnosis of full-thickness RCT
* surgery not considered as the first treatment of choice
* willingness to sign the informed consent form.

Exclusion Criteria:

* inflammatory rheumatic diseases
* history of fracture or operations around the shoulder region
* neurological diseases
* infections or tumours
* diabetes
* coagulation diseases
* intra-articular injections of the involved shoulder within the last 12 months.

Primary outcomes:
measure: Visual Numeric Scale (VNS)
timeFrame: Change from Baseline VNS at 6 months after the out-patient rehabilitation
Secondary outcomes:
measure: Constant-Murley scale
timeFrame: Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Change from Baseline HAQ at 6 months after the out-patient rehabilitation
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Bernardo Gialanella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364233: Safety Study of MotifMESH (cPTFE) in Abdominal Surgery
Official title: A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2011-06-02
Enrollment: 10
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 will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

Detailed description: cPTFEi s a mesh-like product designed to reduce associated post surgical complications.

Eligibility criteria: Inclusion Criteria:

Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired

Exclusion Criteria:

Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study

Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction

Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.

For subjects with Diabetes Mellitus, HbA1C \<12%

BMI ≤ 40 kg/m²

Primary outcomes:
measure: Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Division of Plastic Surgery
state: Illinois
Study officials:
affiliation: Northwestern University
name: Gregory A Dumanian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04459533: Sparing in Neuromuscular Blockade in COVID 19 ICU
Official title: The Use of Neuromuscular Blockade Monitor as a Strategy for Neuromuscular Blockade Agents Saving in ICU COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Human Characteristics
Complication of Medical Care
Intensive Care Unit Acquired Weakness
Keywords: neuromuscular blockade agent
neuromuscular blockade monitor
Train of Four (TOF)
critical illness
COVID 19
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included all COVID patients in ICU university hospitals in Lyon who required mechanical ventilation and NMB for at least 48 hours.

Brief summary: This is a retrospective case-controlled study of the effect of the use of a neuromuscular blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.

The use of NMB agents during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of NMB agents. Large amount of such patient admitted in a short time has led to a shortage of NMB agents, particularly cisatracurium.

The use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists.

The aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.


Eligibility criteria: Inclusion Criteria:

* PCR-proven SARS-CoV-2 infection
* Use of VM (mechanical ventilation)
* Use of NMB agents for at least 48 hours

Exclusion Criteria:

* Pregnancy
* extracorporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: NMB agents consumption
timeFrame: ICU discharge an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon
Study officials:
References: