louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01154309: Group CBT for Depression and AOD Disorders
Official title: Group Cognitive Behavioral Therapy for Depression and Alcohol and Other Drug Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Substance Use
Keywords: Depression
Substance Use
Group Cognitive Behavioral Therapy
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Behavioral Health Services, Inc.
First posted: 2010-06-30
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will adapt and test an existing treatment (group CBT for depression) for use in outpatient substance use treatment settings as delivered by trained substance use counselors. The investigators expect that treatment will lead to improved depression and substance use outcomes.

Detailed description: Aim 1. To adapt an existing group therapy (CBT for depression), creating a manualized treatment and accompanying implementation measures and tools for use with clients with persistent depressive symptoms and AOD disorders and to obtain preliminary assessments of the treatment from patient and provider perspectives.

Aim 2. To conduct a pilot test of the revised treatment in which we (a) demonstrate that when the therapy is implemented with fidelity, clinically significant reductions in depressive symptoms and AOD use occur; (b) estimate the likely effect size; and (c) investigate the underlying mechanisms of change, including both cognitive-behavioral and group processes and their relationship to depression and AOD treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* Enrolled in outpatient substance abuse program
* BDI II score \>13
* Probable alcohol or substance use problem

Exclusion Criteria:

* Cognitive impairment (Short Blessed \> 10)
* Probably bipolar or schizophrenic disorder

Primary outcomes:
measure: Reductions in depressive symptoms as measured by the BDI II
timeFrame: Post treatment
measure: Reductions in AOD use
timeFrame: Post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Gardena
country: United States
facility: Behavioral Health Services, Inc
state: California
Study officials:
affiliation: RAND
name: Katherine E Watkins, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002209: Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy
Official title: Multiple Ascending Dose Pharmacokinetics of CPI-1189 (LU 02-584) in Fasted, HIV Infected, Male Volunteers on Combined Reverse Transcriptase and Protease Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AIDS Dementia Complex
HIV Infections
Keywords: Dose-Response Relationship, Drug
Drug Therapy, Combination
AIDS Dementia Complex
Zidovudine
Lamivudine
Indinavir
Reverse Transcriptase Inhibitors
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe to give multiple doses of CPI-1189 to HIV-infected, otherwise healthy, males. The study will also look at how CPI-1189 affects the levels of HIV, T cells (cells in the body that help fight infection), and three anti-HIV drugs (zidovudine, lamivudine, and indinavir) in the blood.

Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

Detailed description: Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

In this randomized, double-blind study, 48 HIV-infected, otherwise healthy, male volunteers receive either multiple-dose CPI-1189 or placebo by mouth for 15 consecutive days. Each dosing group begins 6 weeks following the start of the preceding group. Volunteers enter the study site the night before dosing on Days 1 and 15 and remain at the study site for 72 hours following dosing. Throughout the study, volunteers have physical exams and donate samples of blood, urine, cerebrospinal fluid, and sperm.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are an HIV-positive man who is otherwise in good health.
* Are 18-50 years old.
* Have a CD4 count of 75-500 cells/mm3.
* Are currently taking zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Harris
state: Arizona
Study officials:
References:
Clinical trial NCT03457909: Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach
Official title: A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outpatients
Keywords: string
capsule endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases.

Detailed description: Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.

This study is a prospective, single-centered, self-controlled pilot study.Outpatients who have esophagus symptoms will take conventional endoscopy examination and DS-MCE successively.

Eligibility criteria: Inclusion Criteria:

* outpatients who have esophagus symptoms.

Exclusion Criteria:

* known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
* dysphagia or delayed gastric emptying.
* known or suspected possibility of active bleeding of digestive tract.
* a history of abdominal operation.
* pacemaker implantation and gastrointestinal pacemaker users.
* patients who are allergic to simethicone or pronase.
* pregnant women,mental patients.
* other circumstances that doctors consider inappropriate for the study.

Primary outcomes:
measure: Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Number of DS-MCE Associated Adverse Events
timeFrame: up to 2 weeks
measure: Duration of Time Capsule is Within the Esophagus
timeFrame: up to 2 weeks
measure: Z-line Visualization
timeFrame: up to 2 weeks
measure: Quality Score of Z-line Images
timeFrame: up to 2 weeks
measure: Degree of Comfort
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao
role: STUDY_CHAIR
References:
Clinical trial NCT03331809: Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion
Official title: Influence of Two-handed Jaw Thrust on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Surgery
Keywords: intubation
pharyngitis
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing double-lumen endotracheal intubation.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Patients scheduled for double-lumen endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Mallampatti scores greater than 3
* Recent sore throat
* Cervical spine disease
* History of head and neck surgery

Primary outcomes:
measure: Number of participants with postoperative sore throat for postoperative 24 h
timeFrame: At 24 hr
Secondary outcomes:
measure: Number of participants with postoperative sore throat
timeFrame: At 1, 6, and 24 hr
measure: Postoperative sore throat scores
timeFrame: At 1, 6, and 24 hr
measure: Number of participants with postoperative hoarseness
timeFrame: At 1, 6, and 24 hr
measure: Number of participants with postoperative shivering
timeFrame: At 1, 6, and 24 hr
measure: Wound pain scores
timeFrame: At 1, 6, and 24 hr
measure: Jaw discomfort scores
timeFrame: At 1, 6, and 24 hr
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University
state: Non-US/Canada
Study officials:
References:
citation: Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.
Clinical trial NCT06002009: SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
Official title: SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orthopedic Disorder
Keywords: Rotator cuff tear
Suprascapular nerve function
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from the University Hospitals of North Midlands outpatient clinic

Brief summary: The primary objective of the study is to determine in adult patients with a rotator cuff tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular nerve.

The secondary objectives are

1. To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired.
2. To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged.
3. To determine factors that are protective against SSN injury.
4. Can the patient data gathered be used to optimise operative procedures.


Eligibility criteria: Inclusion Criteria:

• All patients age ≥18 years presenting to a UHNM shoulder clinic with a confirmed diagnosis of a rotator cuff tear (affecting one or both shoulders).

Exclusion Criteria:

* Bony pathology (such as significant shoulder arthritis that would exclude isolated rotator cuff repair)
* Grossly abnormal shoulder anatomy
* Motor Neurone Disease
* Cervical cord disease affecting the SSN nerve roots
* Patients unable to undergo MRI scan
* Previous surgery at the affected glenohumeral joint
* Patients unable to tolerate NCS
* Acute fracture affecting the glenohumeral joint
* Recent glenohumeral joint dislocation (past 12 months)
* Patients unable or unwilling to give full informed consent
* Patients unable or unwilling to comply with the study procedures

Primary outcomes:
measure: Assess suprascapular nerve funaction
timeFrame: 36 months
Secondary outcomes:
measure: Shoulder scores
timeFrame: 36 months
measure: Nerve recovery
timeFrame: 24 months
measure: Machine learning
timeFrame: 24 months
measure: Nerve conduction studies
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of North Midlands NHS Trust
name: Damian McClelland
role: STUDY_CHAIR
References:
Clinical trial NCT03268109: COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Official title: COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Memory Impairment
HIV/AIDS
Cognitive Impairment
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-08-31
Enrollment: 330
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cART-treated PLHIV ≥65 years old having a memory complaint and virologically controlled for at least 1 year and to compare PLHIV to HIV-uninfected individuals matched for age, sex and educational level

Brief summary: Despite combined antiretroviral therapy (cART), milder forms of HIV-associated neurocognitive disorders (HAND) persist in 20-50% of persons living with HIV (PLHIV). Since more PLH are at risk for HAND due to aging, the frequency of HAND in PLHIV ≥ 65 years old is important to quantify for planning early intervention to attenuate both functional and occupational disabilities due to cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Personal or familial cognitive complaints
* Individual aged ≥ 65 years old and \< 81 years old
* Instrumental activities of daily living (IADL) score between 3-4
* French speaking individual
* Informed consent signed For PLHIV
* HIV infection
* Undetectable HIV viral load ≥ 1 year
* Current cluster of differentiation (CD4) cell count \> 100/mm3 For controls
* negative HIV serology ≤ 6 months

Exclusion Criteria:

* Opportunistic infection \< 5 years
* Contraindications to MRI

Primary outcomes:
measure: cognitive impairment
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild /URC
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Antoine Moulignier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00855309: Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Official title: Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Simplex
Keywords: chemotherapeutic agent toxicity
renal toxicity
infection
neutropenia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-03-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia.

PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.

Detailed description: OBJECTIVES:

* To determine the difference in nephrotoxicity between low-dose and weight-based intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients with neutropenia.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
* Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment continues for approximately 2 weeks unless clinical herpes simplex virus infection is confirmed or the patient is no longer neutropenic.

Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or older.
* Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
* Receiving chemotherapy or have received chemotherapy within the past 2 weeks
* Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
* Creatinine clearance ≥ 50 mL/min
* Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption)

Exclusion Criteria:

* Pregnant or nursing
* Hypersensitivity to acyclovir sodium
* High tumor burden (i.e., WBC \> 50,000/mm\^3 at admission)
* Neutropenic, defined as one of the following:
* ANC \< 500/mm\^3
* ANC \< 1,000/mm\^3 with a predicted decrease to 500/mm\^3
* Active HSV infection, as evidenced by any of the following:
* Positive HSV cultures
* Oral lesions
* Receiving 5 mg/kg acyclovir sodium every 8 hours

Primary outcomes:
measure: Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: M. Jay Brown, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270009: Role of BCL-B in Multiple Myeloma
Official title: Implication of the Antiapoptotic Protein BCL-B in the Pathogenesis of Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2011-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Multiple Myeloma and MGUS newly diagnosed at the Service de Medecine Interne-Cancerologie department of the Nice CHU

Brief summary: MM accounts for 10% of hematopoietic malignancies. Despite the use of various drug combinations in chemotherapy, life expectancy of MM patients does not exceed 7 years. Until now, lack of specific markers of the disease has not allowed efficient specific molecular targeting. In view of our preliminary results, the antiapoptotic protein Bcl-B could be a novel diagnostic and pronostic marker of MM. Therefore, our main objective will be to confirm that Bcl-B is indeed a novel diagnostic and pronostic marker and a new potential therapeutic target of MM. Targeting Bcl-2 family member's is a promising strategy for the treatment of hematopoietic malignancies. In this context, specific targeting of Bcl-B could improve the treatment of patients suffering MM. Of note, this could be achieved by converting the antiapoptotic function of Bcl-B to a proapoptotic one thanks to the use of small mimetic peptides derived from Nur77 one of its interactors.


Eligibility criteria: Patients with Multiple Myeloma and MGUS newly diagnosed at the Service de Medecine Interne-Cancerologie department of the Nice CHU

Primary outcomes:
measure: To determine whether BCL-B is a survival factor in malignant plasmocytes, we will analyse the level of expression of Bcl-B at the both mRNA and protein levels in a cohort of MGUS and MM patients.
timeFrame: 6 months
Secondary outcomes:
measure: To determine whether deregulation of BCL-B expression is associated to chimioresistances commonly observed in Multiple Myeloma, We will compare Bcl-B expression in MM patients either sensitive or resistant to conventional therapies.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Service de Médecine interne et cancérologie - Hôpital de l'Archet
Study officials:
affiliation: CHU de Nice Service de Médecine Interne et Cancérologie Hôpital de l'Archet
name: Jean-Gabriel FUZIBET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00449709: A Study To Assess The Pharmacokinetics Of Different Modified Release Formulations Of GSK221149 In Healthy Adult Subjects
Official title: A Two-part, Open-label, Cross-over Study to Assess the Pharmacokinetics of GSK221149 Following Single Oral Doses of Various Modified Release Formulations and a Solution in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Obstetric Labour, Premature
Premature Ejaculation
Keywords: Pre-term labor,
modified release formulation
pharmacokinetics,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149 is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, the pharmacokinetics of various modified release formulations of GSK221149 will be investigated in healthy non-pregnant adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy males and non-pregnant female
* Between the ages of 18 and 50 years old.
* Females may be of child-bearing or non-child-bearing potential.
* Non-smokers
* BMI of between 19 and 30 kg/m2 (weight of greater than 110lbs).

Exclusion Criteria:

* History of smoking within past 6 months
* Regular alcohol consumption averaging 7 drinks or more per week
* Subject is positive for hepatitis C antibody, hepatitis B surface antigen, or HIV
* Use of prescription or non-prescription drugs within 14 days of study start

Primary outcomes:
measure: Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
timeFrame: over a 24 hour period during each study session.
Secondary outcomes:
measure: Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..
timeFrame: over a 24 hour period during each study session.
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: