louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03880279: Autologous TAC T Cells Targeting CD19 in R/R Large B-Cell Lymphoma
Official title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting CD19 in Relapsed or Refractory Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Lymphoma, B-Cell
Lead sponsor: Triumvira Immunologics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-19
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: TREATMENT

Brief summary: Phase I/II study to evaluate TAC01-CD19 in subjects with relapsed or refractory B-cell lymphomas. TAC technology is a novel way to genetically modify T cells and to redirect these T cells to target cancer antigens by co-opting the natural T cell receptor. The dose finding portion of this study will evaluate the safety and tolerability of increasing dose levels of TAC01-CD19 to identify a Maximal Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D). The dose expansion portion of the study will further evaluate the safety, efficacy and pharmacokinetics of TAC01-CD19 at the RP2D.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed CD19+ Large B-Cell Lymphoma including Diffuse Large B-cell Lymphoma (DLBCL) not otherwise specified (including de novo and transformed lymphoma), Primary Mediastinal Large B-cell Lymphoma, High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangement per WHO 2016 classification.
* Relapsed or refractory disease after greater than 2 lines of therapy including anthracycline and anti-CD20 therapy and either having failed autologous stem cell transplant (ASCT) or being ineligible for ASCT.
* ECOG 0-1.
* Adequate organ function.

Exclusion Criteria:

* Prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, adoptive cell transfer of any kind, including CAR T cells.
* Active central nervous system (CNS) lymphoma involvement.
* History or presence of clinically relevant CNS pathology.
* Active inflammatory neurological disorders, autoimmune disease, or infections.

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: First 28 days after dosing
measure: Incidence of adverse events (AEs)
timeFrame: Informed consent through 2 years after dosing
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00618579: Effects of LMWH in Healthy Subjects Treated With TB-402 and Effects of TB-402 in Healthy Subjects Treated With Warfarin
Official title: A Randomised, Controlled Study Investigating the Safety and Anticoagulant Activity of Administration of Low-molecular-weight Heparin in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402 and the Safety and Anticoagulant Activity of Administration of TB-402 in Healthy Male Subjects Treated With Warfarin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Interaction with LMWH or warfarin
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
Collaborators: name: BioInvent International AB
First posted: 2008-02-20
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Administration of LMWH in healthy male subjects treated with TB-402 and administration of TB-402 in healthy male subjects treated with warfarin


Eligibility criteria: Inclusion Criteria include:

* Males 18 to 45 years of age
* Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion Criteria include:

* Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
* History of important bleeding episodes
* Previous allergic reaction to immunoglobulin
* Present or previous history of severe allergy, for example asthma or anaphylactic reactions
* FVIII:C \<50% at screening
* Clinically significant out of range values for any coagulation test during screening
* Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402

Primary outcomes:
measure: Anticoagulant activity assessed by aPTT, PT, TGAs and FVIII:c
timeFrame: To study end
Secondary outcomes:
measure: Changes in safety parameters over time, PK parameters estimated by NCA, effect of LMWH in TB-402 treated subjects assessed by anti factor Xa (LMWH arm)
timeFrame: To study end
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Cyncron CRU
Study officials:
affiliation: Cyncron CRU
name: Thomas J Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083979: Intravesical Liposomes for Ulcerative Cystitis
Official title: Intravesical Liposomes for Ulcerative Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Cystitis
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (IC).

Detailed description: A physician sponsored Investigation New Drug (IN) has been acquired from the FDA for compassionate use of this non-approved treatment in one patient from Dr. Peters' private practice. Since this treatment has not been used previously in the US, we propose to evaluate the safety and efficacy of the treatment in this one patient by comparing pre and post treatment symptom changes.

Prior to treatment (visit 1) baseline measures will be assessed: vital signs,pelvic/bladder pain on a visual analog scale (VAS; "0" being none and "10" being severe), concomitant medications, Serum pregnancy test and Antiphospholipid Antibody Panel, Urine cytology, urinalysis (dipstick), and culture.

At visits 2-5 (4 treatment visits) questionnaires will be completed and vital signs, pain VAS, post void residual (measured by bladder scan or catheter), unanticipated events, and voiding history (voiding diary) will also be assessed. Additionally, cystoscopy will be done prior to the first treatment to view the bladder lining. At each treatment visit, the patients will have a solution of liposomes instilled in the bladder with a catheter, retained for 30 minutes, and be carefully monitored for at least 1 hour after the liposomes are drained.

After treatment, visits 6 and 7 (follow up) will include vital signs with VAS pain assessment, post void residual (PVR), urinalysis (dipstick), unanticipated events assessment, questionnaire completion and review of voiding diary. Visit 8 (study exit) will include the same parameters measured at follow up visits 6 and 7 with the addition of cystoscopy and Antiphospholipid Antibody Panel testing.

Eligibility criteria: Inclusion Criteria:

* Ulcerative IC for at least 6 months documented,
* Negative urine cytology,
* Able to independently complete self administered questionnaires and voiding diaries.

Exclusion Criteria:

* Pregnant or lactating,
* History of bleeding diathesis,
* On anticoagulant therapy,
* Active peptic ulcer disease,
* Obvious neurological impairment,
* Known allergy to liposomes.

Primary outcomes:
measure: Change in Symptom and Problem Severity
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Bladder Appearance
timeFrame: Baseline to 12 Weeks
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth M Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156779: Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: SR-Exenatide
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-07-05
Enrollment: 31
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects

Detailed description: This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.

Eligibility criteria: Inclusion Criteria:

1. Age : 20 \~ 45 years old
2. Healthy Male
3. Body weight : ≥50kg and Ideal body weight ± 20%
4. Informed consent

Exclusion Criteria:

1. Clinically significant medical history
2. Acute or Chronic pancreatitis
3. Clinically significant hypersensitivity of Drugs
4. Clinically significant cutaneous disorder
5. History of administration of exenatide
6. Disorder of blood pressure
7. History of drug abuse

Primary outcomes:
measure: Assessment of safety
timeFrame: 84 days
Secondary outcomes:
measure: Pharmacokinetics and Pharmacodynamics
timeFrame: PK : 84 days / PD : 42days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01015079: The Association Between Cervical Cancer Screening and Cancer Occurrence
Official title: The Association Between Cervical Cancer Screening Participation and Corresponding Results and Subsequent Cancer Occurrence and Death
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Cancer
Keywords: Pap smear screening
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2009-11-17
Enrollment: 6000000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The entire Taiwan women with their information obtained from several national registries.

Brief summary: To investigate the protective effect of cervical cancer incidence and mortality by screening attending frequency or screening pattern, and to evaluate the possible risk of developing malignancies among women with cervical lesions, inflammation or infection.


Eligibility criteria: The eligibility criteria in the proposal are specified in different part of analyses respectively, which are briefly listed below:

Part I:

* Include women covered by national screening program and they did not have previous cervical cancer history before the study initiate date.

Part II:

* Include women ever participated cervical cancer screening and exclude women with previous cervical cancer history before screening attending.

Part III:

* Include women without previous cervical cancer history before the follow-up initiation.

Part IV:

* Include women without previous cervical cancer history before the follow-up initiation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taiwan Cervical Cancer Screening Task Force
Study officials:
affiliation: National Taiwan University Hospital
name: Chi-An Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng WF, Chen YL, You SL, Chen CJ, Chen YC, Hsieh CY, Chen CA. Risk of gynaecological malignancies in cytologically atypical glandular cells: follow-up study of a nationwide screening population. BJOG. 2011 Jan;118(1):34-41. doi: 10.1111/j.1471-0528.2010.02769.x. Epub 2010 Nov 4.
Clinical trial NCT05854979: Effects of GLP-1 Agonists on Gastric Volume
Official title: Ultrasound Assessment of Preoperative Gastric Volume in Fasted, Diabetic Surgical Patients: A Prospective Observational Cohort Study on the Effects of GLP-1 Agonists on Gastric Emptying
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Gastric Content Aspiration
Glucagon-like Peptide 1
GLP-1
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will consist of patients with a diagnosis of diabetes who are or are not taking a GLP-1 medication, have appropriately fasted, and scheduled for an elective surgery with general anesthesia.

Brief summary: This study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a GLP-1 receptor agonist medication, or 2) not taking a GLP-1 receptor agonist medication. The patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. The primary goal is to assess the effect of subcutaneous injectable GLP-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.


Eligibility criteria: Inclusion Criteria

* Age greater than or equal to 18 years old
* Diagnosed with diabetes (listed on medical record, Hgb A1C greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dL, and/or on medical treatment for diabetes)
* One of the following groups:
* Taking a GLP-1 Medication
* Not taking a GLP-1 Medication
* ASA Physical Classification Status 1-3
* Scheduled for elective surgery under general anesthesia
* Appropriately fasted per ASA Fasting Guidelines 201712

Exclusion Criteria

* BMI greater than 40
* Previous gastric/esophageal surgery
* Abnormal gastric anatomy
* Pregnancy
* Inability or unwillingness of subject to give informed consent
* Non-English Speaking

Primary outcomes:
measure: Gastric Volume in RLD Position
timeFrame: From time of enrollment until the start of surgery, assessed up to 4 weeks
Secondary outcomes:
measure: Gastric antrum CSA in RLD position
timeFrame: From time of enrollment until the start of surgery, assessed up to 4 weeks
measure: Perlas antral grade
timeFrame: From time of enrollment until the start of surgery, assessed up to 4 weeks
measure: Incidence of aspiration
timeFrame: From the time surgery begins until the end of scheduled surgery, assessed up to 24 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Christopher Wolla, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06065579: Efficacy of Well-Being Promotion Program for Management of Emotional and Behavioural Problems Among Adolescents
Official title: Efficacy of Well-Being Promotion Program for Management of Emotional and Behavioural Among Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-being, Emotional and Behavioral Problems, Adolescents
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of the study are given as under;

1. To examine the efficacy of the Well-being Promotion Program in enhancing subjective well-being, positive affect, life satisfaction and reducing emotional /behavioral problems , negative affect among adolescents with emotional and behavioral problems.
2. To examine the differences in terms of subjective well-being, emotional / behavioral problems , positive / negative affect and life satisfaction between the treatment and control group after intervention.
3. To examine the differences in terms of subjective well-being, emotional / behavioral problems, positive / negative affect and life satisfaction in the intervention group at (T1) before and at (T2) after intervention.

Detailed description: In this study, adolescents within age range ( 14-19years) will participates in the study because this study focus on the emotional and behavioral problems and their low level of well-being and life satisfaction among adolescents. Adolescence is a developmental period in which dramatically emotional changes occur which may be the result of biological changes such as secretions of hormones. Chances of psychological distress are increased due to emotional changes. Depression and anxiety are most common psychopathology in adolescents (Ma \& Fang, 2019). Child turns out to be independent, gradually deals with the external world and starts taking his/her decisions such as selection of subjects, peer pressure and so on. Thus , it is important to focus on mental health and management of emotional and behavioral problems.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria Only those participants who meet the category of moderate level of emotional and behavioural problems through Strength and difficulty Questionnaire (SDQ; Urdu Version) (Samad et al., 2005) will be selected for the study.

Exclusion Criteria:

* Exclusion Criteria Those participants who meet high levels of emotional and behavioural problems through Strength and difficulty Questionnaire (SDQ; Urdu Version) (Samad et al., 2005) will not be selected for the study.

Primary outcomes:
measure: Emotional and Behavioural Problems Among Adolescents
timeFrame: 2.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sukkur
country: Pakistan
facility: Madiha Arshad
Study officials:
References:
Clinical trial NCT04083079: Cost-Effectiveness Study of PEG-rhG-CSF in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
Official title: Cost-Effectiveness Study of Pegylated Recombinant Human Granulocyte Colony-stimulating Factor(PEG-rhG-CSF) in Prophylactic Treatment of Neutropenia After Chemotherapy in Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lymphoma, Non-Hodgkin
Granulocyte Colony-Stimulating Factor
Cost-Benefit Analysis
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pharmacoeconomic research to explore the cost-effectiveness of PEG-rhG-CSF and rhG-CSF in prophylactic treatment of neutropenia in lymphoma patients. It should provide more scientific basis for clinical decision-making.


Eligibility criteria: Inclusion Criteria:

* 18-65 years
* histologically confirmed de novo Non Hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and Burkitt lymphoma)
* plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) ± Rituximab (R)
* KPS ≥70
* plan continuous PEG-rhG-CSF or rhG-CSF adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment
* absolute neutrophil count≥1.5×109/L，platelet count ≥100× 109/L，hemoglobin≥90g/L，while blood cell count≥3.0×109/L，without bleeding signs
* adquate liver and renal function as protocol discribed
* no serious cardiovascular disease as protocol discribed
* under good mental conditions and informed consented
* potential benefit for subjects based on investigators' decision

Exclusion Criteria:

* history of hematopoetic stem cell transplantationor organ transplantation
* uncontrollable infection
* allergic to study drugs or ingredients
* accepted any other investigational drug or participated another interventional study within 30 days during screening period
* other uncontrollable conditions judged by the investigator
* breast-feeding , pregnant or plan to be pregnant during study observation period

Primary outcomes:
measure: Incremental Cost-Effectiveness ratio
timeFrame: 1 year
Secondary outcomes:
measure: Cost-Effectiveness ratio
timeFrame: 1 year
measure: Sensitivity analysis
timeFrame: 1 year
measure: Incidence of febrile neutropenia
timeFrame: 1 year
measure: Duration time of febrile neutropenia
timeFrame: 1 year
measure: Incidence of grade 3-4 neutropenia
timeFrame: 1 year
measure: Duration time of grade 3-4 neutropenia
timeFrame: 1 year
measure: Relative dosage intensity
timeFrame: 1 year
measure: Usage rate of antibiotics
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05181579: Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction
Official title: Efficacy of Manual Therapy and Sacroiliac Joint Injection in the Treatment of Patients With Sacroiliac Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Somatic Dysfunction
Keywords: Sacroiliac joint dysfunction
Manuel therapy
Sacroiliac joint injection
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 30
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: The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction


Eligibility criteria: Inclusion Criteria:

* Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
* Pain score greater than 3 according to NRS
* Unresponsiveness to conservative treatment (such as exercise, NSAID)
* At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive

Exclusion Criteria:

* Refusing to participate in the study
* Pregnancy
* History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
* Infective sacroiliitis
* Malignancy
* Osteoporosis
* Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
* Neurological finding in the lower extremity
* Pain spreading below the knee
* History of spinal surgery
* History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)

Primary outcomes:
measure: Numeric Rating Scale, NRS
timeFrame: Change from baseline NRS at 3 months
Secondary outcomes:
measure: Oswestry Disability index
timeFrame: Baseline, Month 1, Month 3, Month 6
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
state: Cankaya
Study officials:
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Umut Guzelkucuk, MD
role: STUDY_DIRECTOR
References: