louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237366: Study Targeting Affect Regulation
Official title: A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV
AIDS
Substance Use Disorders
Keywords: HIV/AIDS
Methamphetamine
Trauma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This Phase Ib pilot RCT will examine the safety, feasibility, and acceptability of a multi-component intervention to address traumatic stress symptoms among HIV-positive, methamphetamine-using men who have sex with men (MSM). Following a baseline assessment, 56 participants will be randomized to receive either: 1) a 7-session intervention to address traumatic stress related to living with HIV/AIDS; or 2) a 7-session, attention-control condition. Follow-up assessments will be administered at 1 and 3 months post-randomization.

Detailed description: In the multi-component intervention protocol, participants will complete expressive writing exercises where they will be asked to write about difficult life experiences. Following expressive writing, participants will receive stress management skills training to assist them with managing any acute increases in distress that arise from the writing experience. Participants in the attention-control condition will write about neutral topics and complete psychological measures. The overarching goals of this Phase Ib RCT will be to: 1) examine the feasibility and acceptability of the intervention and attention-control; and 2) determine whether intervention participants report reductions in traumatic stress symptoms over the 3 months following randomization. Findings from this Phase Ib trial will inform our efforts to implement a more definitive RCT of this intervention with HIV-positive, methamphetamine-using MSM.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Speak English
* Self-identify as a man who has sex with men
* Have been diagnosed with HIV for at least 3 months
* Provide evidence of HIV-positive serostatus
* Report using methamphetamine during the past 30 days

Exclusion Criteria:

* Do not have the capacity to provide informed consent

Primary outcomes:
measure: Traumatic stress symptom severity
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Psychological reactivity to expressive writing
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Center for AIDS Prevention Studies
state: California
Study officials:
affiliation: University of California, San Francisco
name: Adam Carrico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002066: Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Official title: Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Thymopentin
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Examine the ability of thymopentin (Timunox) to:

Reduce the amount and/or frequency of virus isolation. Stimulate the immune system and alter the clinical findings in patients infected with HIV who do not yet have AIDS.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Aerosolized pentamidine.

Prior Medication:

Allowed:

* Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with an abnormal chest x-ray indicative of active disease (opportunistic infection) within 30 days prior to entry are excluded.

Concurrent Medication:

Excluded within 90 days of study entry:

* Zidovudine (AZT).

Prior Medication:

Excluded within 30 days of study entry:

* Immunomodulatory or experimental therapy.
* Excluded within 90 days of study entry:
* Zidovudine (AZT).

Patients must not have:

* Hemophilia A or B or other hematologic disorders requiring current or previous administration of blood products.
* AIDS as defined by the CDC (except for those with HIV "wasting syndrome").
* Significant hepatic disease.
* Thrombocytopenia (\< 75000 platelets/mm3).

Patient must voluntarily sign consent and be seropositive for HIV-1 (ELISA assay) confirmed by Western blot.

* HIV-1 p24 antigen must be detected in supernatant fluids from co-cultures of patient's peripheral blood monocytes (PBMC) on two separate occasions.
* Patients with HIV "wasting syndrome" are included.

Intravenous drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Annandale
country: United States
facility: Immunobiology Research Institute
state: New Jersey
Study officials:
References:
Clinical trial NCT03755466: Examination of Efficacy and Safety of Baricitinib in RA Patients
Official title: Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Shinshu University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:

1. Baricitinib treatment for 12 months
2. Biologics treatment for 12 months
3. Tofacitinib treatment for 12 months


Eligibility criteria: Inclusion Criteria:

* RA patients

Exclusion Criteria:

* Not RA patients
* RA patients who are allergic to the drugs, refused to do this research, or who are pregnant

Primary outcomes:
measure: Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients.
timeFrame: Change from Baseline Values of DAS28-CRP at 1 year in each group
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Yukio Nakamura
state: Nagano
Study officials:
References:
Clinical trial NCT01402466: Urban Health Study II
Official title: Finding, Testing and Treating High-Risk Probationers and Parolees With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: Drug users
criminal justice
HIV care
HAART
incarceration
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-07-26
Enrollment: 49
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: HEALTH_SERVICES_RESEARCH

Brief summary: The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.

Detailed description: The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design.

HIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants.

The study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* HIV antibody positive
* not currently receiving HIV care

Exclusion Criteria:

* already in care
* unable to provide informed consent

Primary outcomes:
measure: Log10 viral load
timeFrame: Every 3 months for 2 years
Secondary outcomes:
measure: Engagement in HIV Care
timeFrame: Every 3 months for 2 years
measure: Initiation of Highly Active Antiretroviral Therapy (HAART)
timeFrame: Every 3 months for 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: RTI International Urban Health Program
state: California
Study officials:
affiliation: RTI International
name: Alex H Kral, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605666: CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies
Official title: CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Relapsed/Refractory B Cell Leukemia/Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: B Cell Leukemia
B Cell Lymphoma
Keywords: CAR-T
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).


Eligibility criteria: Inclusion Criteria:

* Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* ALT/ AST \<3 x normal
* Bilirubin \< 2.0 mg/dl
* Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
* LVEF\< 45%
* Accept white blood cell collection
* Provide informed consent

Exclusion Criteria:

* Previous treatment with investigational gene or cell therapy medicine products
* Active hepatitis B , hepatitis C or HIV infection
* Uncontrolled active infection
* Presence of grade 2-4 acute or extensive chronic GVHD
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Received non-diagnostic purposes major surgery within the past 4 weeks
* Participated in any other clinical study within the past 4 weeks
* Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
* Pregnancy or breast-feeding women
* Use of prohibited drugs:
* Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion
* Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion
* GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CD19-CAR-T2 Cells infusion
* Any situation that may increase the risk of the test or interfere with the test results

Primary outcomes:
measure: ORR
timeFrame: 3 months
Secondary outcomes:
measure: ORR
timeFrame: 6 months
measure: ORR
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
measure: OS
timeFrame: 1 year
measure: DFS
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qi-fa Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01243866: Effect of Dental Treatment on Children's Growth
Official title: Effect of Dental Treatment on Children's Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dental Decay
Lead sponsor: King Fahad Armed Forces Hospital
Sponsor class: OTHER_GOV
First posted: 2010-11-19
Enrollment: 86
Sex: ALL
Minimum age (years): 72
Maximum age (years): 95
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe dental decay affects children physically, emotionally, socially and thereby impacts on their quality of life. Evidence from developed countries showed that children with severe dental decay weighed less than their peers and following dental treatment children's growth and quality of life improved. This suggests that treatment of severe dental decay may enhance growth and wellbeing. A study was carried out in Saudi to test that hypothesis.


Eligibility criteria: Inclusion Criteria:

Having dental caries with at least 2 teeth with pulpal involvement.

Exclusion Criteria:

1. Children with illness known to adversely affect growth.
2. Children who required urgent dental treatment.
3. Children on regular nutritional supplements.
4. Anaemic children with Hb levels lower than 11.0 g/dl

Primary outcomes:
measure: Children's height and weight (HAZ,WAZ and BAZ)
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life (pain, sepsis, satisfaction and appetite)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: KFAFH
name: Hiba A Alkarimi, PhD
role: STUDY_DIRECTOR
References:
citation: Alkarimi HA, Watt RG, Pikhart H, Jawadi AH, Sheiham A, Tsakos G. Impact of treating dental caries on schoolchildren's anthropometric, dental, satisfaction and appetite outcomes: a randomized controlled trial. BMC Public Health. 2012 Aug 29;12:706. doi: 10.1186/1471-2458-12-706.
Clinical trial NCT06703866: Value-Based Medicine (VBM) for Lung Cancer
Official title: Validation of Predictive Model in Value-based Medicine for Lung Cancer and Analysis of Its Implications for Patient Communication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with first diagnosis of non-small cell lung carcinoma eligible for surgical lung resection and available for follow up

Brief summary: This is a prospective observational monocentric trial. The primary endpoint is the validation of predictive models. These predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.

Detailed description: The goal of this prospective observational monocentric study is to validate a predictive models in patients with diagnosis of non-small cell lung cancer eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy.

Participants will be asked to complete quality of life questionnaires before surgery and then at 30 days, 4 months, 8 months and 12 months post discharge.

The informations collected through questionnaires, along with clinical data will be used to validate the predictive models created.

These models will then be utilized to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients with diagnosis of non-small cell lung carcinoma
* Only patients eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy
* Diagnosis of primary non-small cell lung cancer
* Signed Informed Consent
* Patients must be available for follow-up

Exclusion Criteria:

* Patients with benign lesion
* Patients with recurrence who have already undergone lung surgery
* Conditions/pathologies that prevent the ability to give consent

Primary outcomes:
measure: Creation of a personalized clinical-functional risk profile
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Monica Casiraghi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02485366: Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Official title: Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heart Defects, Congenital
Keywords: Rejuvenated packed red blood cells
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery.

Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.


Eligibility criteria: Inclusion Criteria:

* children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)
* children undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* refusal of blood products
* end-stage renal disease
* planned avoidance of CPB
* use of non- heparin anticoagulants
* participation in an experimental drug or device protocol within 30 days
* existing hemoglobinopathy
* allergy requiring washed RBCs
* immunocompromise requiring special blood product treatment.

Primary outcomes:
measure: Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration
timeFrame: End of Surgery
measure: Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)
timeFrame: 2 hours
measure: Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels
timeFrame: end of bypass
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Univerisity Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew Lodge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01783366: Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
Official title: Nasogastric Tube Insertion Using Cook Airway Exchange Catheter in Anesthetized Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elective Surgery of Gastrointestinal Tract
100 Adults Aged Between 20 and 70 Years Old
ASA Physical Status of I or II
Keywords: nasogastric tube, tube exchange catheter
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: Pusan National University Yangsan Hospital
First posted: 2013-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we first examined whether use of tube exchange catheter during NGT insertion could increase the success rate on the first attempt of NGT insertion compared with conventional technique. We then addressed the question of whether the use of tube exchange catheter might decrease the possible occurrence of complication associated with YOON insertion.


Eligibility criteria: Inclusion Criteria:

* ASA physical status of I or II who were scheduled to undergo elective surgery of gastrointestinal tract with NGT insertion under general anesthesia were enrolled

Exclusion Criteria:

* Patients with maxillofacial trauma, inability to adequately protect airway, and esophageal abnormalities were excluded. Pregnant patients were also excluded from the study.

Primary outcomes:
measure: Number of attempt of NGT insertion
timeFrame: after successful insertion of NGT, within 1 hr
measure: Procedure time of NGT insertion
timeFrame: after successful insertion of NGT, within 1 hr
Secondary outcomes:
measure: presence of bleeding of the larynx, and knotting or kinking of NGT under laryngoscopic view
timeFrame: after successful insertion of NGT within the time of completion of surgery, expected average within 6 hours
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pnuyh Anesthesia
Study officials:
References: