louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06412068: A Prospective Study: Sintilimab and R-CHOP in PMBCL Treatment
Official title: A Prospective, Single-arm, Multi-center Exploratory Study on the First-line Treatment of Primary Mediastinal Large B-cell Lymphoma ( PMBCL ) With Sintilimab Combined With R-CHOP Regimen
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Primary Mediastinal Large B Cell Lymphoma
Keywords: primary mediastinal large B cell lymphoma
sintilimab
R-CHOP
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this multi-center, single arm, phase Ⅱ clinical trail is to evaluate the efficacy and toxicity of sintilimab combined with R-CHOP regimen as first-line treatment for primary mediastinal large B-cell Lymphoma (PMBCL)


Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of PMBCL , and did not receive any previous treatment for PMBCL ;
* Predicted survival time ≥ 6 months ;
* 18-75 years ;
* IPI score 0-3；
* ECOG performance status 0-2 ;
* Clinicians judge that the patient is suitable for the treatment of primary mediastinal large B-cell lymphoma ;
* After the patient was enrolled in the trial, other drugs that may have therapeutic effects on primary mediastinal large B-cell lymphoma were not acceptable ;
* WBC ≥ 3 × 109 / L, NE ≥ 1.5 × 109 / L, PLT ≥ 100 × 109 / L ;
* Serum creatinine ≤ 1.5mg / dL, creatinine clearance rate ≥ 50mL / min ;
* ALT, AST ≤ 3 × ULN ( normal upper limit ) ; total bilirubin ≤ 2 × ULN ;
* Sign the informed consent.

Exclusion Criteria:

* Other malignant diseases except PMBCL were diagnosed within 5 years；·Participating in other interventional clinical studies, or has received chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
* Known allergies to test drugs or any excipient component of these products；·Allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation has been performed；
* Women in pregnancy or lactation；
* Severe infectious diseases, such as HIV infection, untreated active hepatitis B, active hepatitis C；
* The researchers believe that there are other potential risks that are not suitable for participation in this study.

Primary outcomes:
measure: complete remission (CR)
timeFrame: 2years
measure: overall response rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2 years
measure: progression survival (PFS)
timeFrame: 2 years
measure: bio-marker analysis
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00278668: ECT Schizophrenia Serotonin Study
Official title: Serotonin Uptake to Lymphocytes and Citalopram Platelets Binding of Treatment-Resistant Schizophrenia Patients Before and After Electroconvulsive Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Lead sponsor: Sha'ar Menashe Mental Health Center
Sponsor class: OTHER
First posted: 2006-01-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT

Detailed description: We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT

Eligibility criteria: Inclusion Criteria:

Participants must meet DSM-IV criteria for schizophrenia, as assessed by the Structured Clinical Interview - Patient Version (SCID) (First et al., 1995).

Ages 18 -55 Men and/or women -

Exclusion Criteria:

1. History of neurological disorders, active substance abuse in the previous 3 months.
2. Estimated IQ less then 70.
3. SSRIs treatment 4 weeks prior to the study.
4. Any subject suffering from inflammatory fever disease will be excluded from the study.

   -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shaar Menashe MHC
name: Avi Peled, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaar Menashe
name: Ilan Modai, M.D. MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: TAU
name: Moshe Rehavi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018668: Antipsychotic Response in Schizophrenia
Official title: Psychopharmacologic Aspects of Motor Slowing in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Antipsychotics
schizophrenia
motor retardation
bradykinesia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Motor slowing is a hallmark, clinical sign in mental illness. Slowness can be related to a specific disease process, as in negative schizophrenia or depression or it can be the result of medications used to treat forms of mental illness. Prior research has lead to a novel instrumental approach for distinguishing subtypes of motor slowing - one type related to cognitive processes and another related to parkinsonism. The purpose of this study is to test whether new medications used to treat schizophrenia improve the cognitive or parkinsonian components of motor slowing. Patients will be studied in the laboratory before and 8-weeks after starting a new antipsychotic. The n of this study = 60 patients. The results of this study will improve our understanding of the complex interactions between cognitive processing and motor behavior in patients with psychotic illnesses and how drugs work to treat these problems.


Eligibility criteria: Schizophrenia diagnosis currently treated with conventional antipsychotic willing to be switched to an atypical antipsychotic.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Department of Veterans Affairs
state: California
Study officials:
References:
Clinical trial NCT00671268: Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
Official title: Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-hydroxide in Patients With IgE-mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinoconjunctivitis
Keywords: Grass pollen allergy
specific immunotherapy
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2008-05-05
Enrollment: 256
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: Efficacy and Safety from a high-dosed subcutaneous recombinant preparation


Eligibility criteria: Inclusion Criteria:

* Allergic rhinoconjunctivitis attributable to grass pollen
* Positive SPT
* Positive EAST
* Positive provocation test

Exclusion Criteria:

* serious disease
* other perennial allergies

Primary outcomes:
measure: Change of Symptom and Medication score
timeFrame: during the baseline and the following two pollen seasons
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Margitta Worm, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00866268: Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty
Official title: "Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty: a Double Blind Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Knee Arthroplasty
Keywords: Blood loss
Total knee arthroplasty
Adults
Drain
Drainage system
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2009-03-20
Enrollment: 169
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: Principal hypothesis:

A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmHg) following total knee arthroplasty.

Detailed description: Secondary's hypothesis:

* It don't expect differences in:

  1. Incidence of hematomas
  2. Incidence in surgery wound infection
  3. Time of immobilization
  4. Duration of hospitalization
* The low suction drainage (-50 mmHg) will be more cost-effective than the standard closed drainage (-700 mmHg)

Eligibility criteria: Inclusion Criteria:

* Adult knee replacement patients who agreed to participate in the study

Exclusion Criteria:

* People that not accomplished the inclusion criteria

Primary outcomes:
measure: total post-surgical blood loss (mL)
timeFrame: from the moment after surgery until drainage catheter removal
Secondary outcomes:
measure: blood loss (mL) in the recovery unit
timeFrame: 24-48 h
measure: Blood loss in the ward
timeFrame: 5-10 days
measure: need for a blood transfusion according to the surgeon's criteria
timeFrame: 10 days
measure: number of blood units required for transfusion
timeFrame: 10 Days
measure: post-surgical pain (using a 100mm visual analogue scale)
timeFrame: 10 days
measure: incidence of hematomas
timeFrame: 10 days
measure: infections
timeFrame: 10 days
measure: suture dehiscence
timeFrame: 10 days
measure: re-intervention due to complications in the surgical wound
timeFrame: 10 dasy
measure: venous thrombosis
timeFrame: 10 days
measure: hypotension
timeFrame: 10 days
measure: mortality
timeFrame: 10 days
measure: adverse reactions
timeFrame: 10 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya
city: Barcelona
country: Spain
facility: Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau.
state: Catalunya
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Calvo Rafael, Rn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02219568: Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding
Official title: Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Bleeding
Keywords: obscure gastrointestinal bleeding, CT enterography
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 52
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 study is to compare the efficacy between video capsule endoscopy and CT enterography in diagnosis of obscure gastrointestinal bleeding.

Detailed description: All adult patients with obscure gastrointestinal bleeding will undergo both video capsule endoscopy and CT enterography. The interval between two tests will be less than 1 month. The capsule reading gastroenterologist and the CT reading radiologist are blinded to each others' results.

Eligibility criteria: Inclusion Criteria:

* patients who present with passing melena or hematochezia or have iron deficiency anemia
* no lesion found on both esophagogastroduodenoscopy and colonoscopy
* age at least 18 years

Exclusion Criteria:

* allergy to iodinated intravenous contrast
* chronic kidney disease stage at least 3 patients who do not on regular dialysis
* suspected small bowel obstruction

Primary outcomes:
measure: number of significant gastrointestinal lesions detected
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Julajak Limsrivilai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03792568: ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
Official title: ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: ALK mutation
ALK inhibitor
Metastatic Colorectal Cancer
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 30
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 clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.


Eligibility criteria: Inclusion Criteria:

Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria:

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.

Primary outcomes:
measure: Objective Respone Rate(ORR)
timeFrame: up to 36months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03812068: Parent-mediated Developmental Behavioral Intervention
Official title: The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD
Early intervention
Development
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study explores the effectiveness of two intervention programs: "Long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple developmental delays.


Eligibility criteria: Inclusion Criteria:

* Child's age between 30-84 months old.
* Children have a diagnosis of autism spectrum disorder or multiple developmental delays.
* Children without physical disabilities or major health problems, such as congenital limb defects.
* One of the fathers or mothers involved in the study shall be the primary caregiver of the child.
* The father or mother participating in the study has at least 9 education years and can read and understand Chinese.
* The father or mother participating in the study is willing to allow the child to undergo a comprehensive development assessment and is willing to video during the training process.

Exclusion Criteria:

* Absence of chromosome abnormalities, congenital anomalies, and major neurological or sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus, severe brain damage, uncorrected vision, or hearing loss).

Primary outcomes:
measure: The Autism Diagnostic Observation Schedule
timeFrame: 3 months
measure: Child Behavior Checklist Ages 1.5-5
timeFrame: 3 months
measure: Pediatric Evaluation of Disability Inventory
timeFrame: 3 months
measure: Mullen Scale of Early Learning
timeFrame: 3 months
measure: Movement Assessment Battery for Children
timeFrame: 3 months
measure: 3D Gait Assessment Foot-worn Inertial Sensor
timeFrame: 3 months
measure: Peabody Developmental Motor Scales, Second Edition
timeFrame: 3 months
Secondary outcomes:
measure: Parenting Stress Index
timeFrame: 3 months
measure: Parenting Sense of Competence Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, National Taiwan University
Study officials:
References:
Clinical trial NCT00144768: A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients
Official title: A Multicenter, Multinational, Open-Label Study of Anti-Laronidase Antibody Formation and Urinary GAG Levels in Patients With Mucopolysaccharidosis I (MPS I) Being Treated With Aldurazyme® (Laronidase).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mucopolysaccharidosis I
Hurler's Syndrome
Hurler-Scheie Syndrome
Scheie's Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: BioMarin/Genzyme LLC
First posted: 2005-09-05
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the development of antibodies to laronidase in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.


Eligibility criteria: Inclusion Criteria:

* Have a documented diagnosis of MPS I confirmed by measurable signs and symptoms and deficient α-L-iduronidase activity (\<10% of the lower limit of normal).
* For a patients receiving Aldurazyme therapy prior to study entry: Have available as baseline data the results of urinary GAG levels and IgG antibody titers collected prior to the patient's first Aldurazyme infusion.
* Provide signed, written informed consent prior to any protocol-related procedures being performed. Consent of a legally authorized guardian(s) is (are) required for patients under 18 years.

Exclusion Criteria:

* Have previously received Aldurazyme without the collection of baseline samples as specified.
* Have a suspected hypersensitivity to Aldurazyme or a know hypersensitivity to components of infusion solution.
* Have received a Hematopoietic Stem Cell Transplantation, injection fibroblast therapy, or major organ transplant.
* Are receiving chronic immunosuppressant therapy.
* Have a medical condition, serious intercurrent illness, or other extenuating circumstances that may interfere with study compliance including all prescribed evaluations and follow-up activities.
* Are pregnant or lactating
* Have received investigational drug within 30 days prior to study enrollment

Primary outcomes:
measure: Urinary GAG (glycosaminoglycans)
timeFrame: Up to 4 years
measure: Immunogenicity Testing
timeFrame: Up to 4 years
Secondary outcomes:
measure: Safety
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Los Angles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03186768: Soap on a Rope Trial
Official title: Evaluation of Soap on a Rope Hall Pass Behavior Intervention: a School-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Disinfection
Lead sponsor: Syracuse University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: School-randomized controlled trial
Primary purpose: OTHER

Brief summary: The soap on a rope behavioral trial is a school-randomized trial to determine if a disruptive cue (the soap on a rope hall pass) can influence hand washing behavior for students in Namwala District, Zambia.


Eligibility criteria: Inclusion Criteria:

* Students in study schools who use the latrine on the day of observation

Exclusion Criteria:

-

Primary outcomes:
measure: Change in hand washing behavior
timeFrame: Handwashing behavior will be monitored at three time points: baseline, 3 weeks following the intervention, and 8 weeks following the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Namwala
country: Zambia
facility: Namwala District
Study officials:
affiliation: Syracuse University
name: David A Larsen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: