louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01689103: Therapeutic Alliances in Alcoholism Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorders
Keywords: Alcohol use disorders
Treatment
Outpatient
Therapeutic alliance
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2012-09-20
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders.

Detailed description: This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders. Alliances are assessed over the course of treatment and will be reviewed in the context of posttreatment functioning.

Eligibility criteria: Inclusion Criteria:

* Current Alcohol Dependence diagnosis
* Live within commuting distance of treatment program
* Minimum 6th grade reading level
* Provide consent

Exclusion Criteria:

* Presence of current organic mental disorder, schizophrenia, or another psychotic disorder
* Treatment for an alcohol use disorder in past 12 months

Primary outcomes:
measure: Percent days abstinent
timeFrame: 12 months
Secondary outcomes:
measure: Drinks per Drinking Day
timeFrame: 12 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Research Institute on Addictions
state: New York
Study officials:
affiliation: University at Buffalo
name: Gerard J Connors, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Syracuse University
name: Stephen A Maisto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Ronda L Dearing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230503: Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Official title: Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B, Chronic
Hepatitis B Virus
Pradefovir Mesylate
Adefovir Dipivoxyl
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 220
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: * Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies

Detailed description: * Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
* Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
* Select the dose of pradefovir for Phase 3 studies
* Determine the pharacokinetic profiles of four oral doses of pradefovir

Eligibility criteria: Inclusion Criteria:

* Compensated chronic HBV Infection
* No prior treatment with adefovir dipivoxil
* No interferon or lamivudine treatment for three months prior to enrollment
* HBeAg positive or negative
* HBV DNA viral load greater than 500,000 copies per mL
* ALT between 1.2 and 10 times ULN

Exclusion Criteria:

* Positive HIV, HCV, and/or HDV serology
* History of renal tubular necrosis
* Serum creatinine greater than 2.0 mg/dl
* History of organ transplant or use of immunosuppresive drugs
* Pregnant or breast-feeding females

Primary outcomes:
measure: - Safety: Clinical examinations of laboratory tests
measure: - Efficacy: Change in viral load over time
Secondary outcomes:
measure: - Efficacy: Proportion of patients with undetectable viral load
Other outcomes:
Locations:
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Ralph T. Doyle
role: STUDY_DIRECTOR
References:
citation: Gao Y, Kong F, Song X, Shang J, Yao L, Xia J, Peng Y, Liu W, Gong H, Mu M, Cui H, Han T, Chen W, Wu X, Yang Y, Yan X, Jin Z, Wang P, Zhu Q, Chen L, Zhao C, Zhang D, Jin W, Wang D, Wen X, Liu C, Jia J, Mao Q, Ding Y, Jin X, Zhang Z, Mao Q, Li G, Niu J. Pradefovir Treatment in Patients With Chronic Hepatitis B: Week 24 Results From a Multicenter, Double-Blind, Randomized, Noninferiority, Phase 2 Trial. Clin Infect Dis. 2022 Jun 10;74(11):1925-1932. doi: 10.1093/cid/ciab763.
Clinical trial NCT05979103: Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients
Official title: Music Genre Stereotypes to Boost Relaxation in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 120
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: Social psychological research has demonstrated that internalized stereotypes affect people's attitudes and behaviors. Music-based interventions that rely on stereotypes might have promise for keeping participants engaged in health interventions, reducing stress, and improving wellbeing.

Detailed description: Group Assignments

Participants will be randomized into one of four groups.

1. Group 1 (Reggae): Participants in this group will receive the stereotype and listen to the music over the 4 weeks.
2. Group 2 (Preferred): Participants in this group will listen to preferred music over the 4 weeks.
3. Control Group: Participants in this group will serve as a control and will not receive any intervention until the study is completed. They will complete a baseline survey and a follow-up survey at four weeks, as well as similar daily surveys. Some recordings will be sent to this group after the study is completed, without tracking their usage.

Intervention

All groups will complete a baseline and 4-week follow-up survey.

Participants in Group 1 and Group 2 will engage in daily listening 4-week intervention.They will have access to electronic audio recordings, with the order of listening labeled for each day. It is up to them if they want to listen to the daily recordings.

Eligibility criteria: Inclusion Criteria:

1. Are 18+
2. Live in the US
3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type)
4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week
5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days
6. Have moderate to severe anxiety based on GAD-7

Exclusion Criteria:

1. Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity
2. Have a current cancer diagnosis

Primary outcomes:
measure: Generalized Anxiety Disorder (GAD-7) Score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
References:
Clinical trial NCT01460303: Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Official title: Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Dysfunction
Urinary Retention
Keywords: Transurethral catheterization
Urinary retention
Bladder dysfunction
Patient comfort
Pelvic Reconstructive Surgery
Postoperative bladder dysfunction
Postoperative urinary retention
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.


Eligibility criteria: Inclusion Criteria:

* patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.

Exclusion Criteria:

* inability to provide consent
* \<18 years old
* non-English speaking
* patients using intermittent self-catheterization
* patients sustaining bladder injury during surgery
* prisoners
* pregnant women

Primary outcomes:
measure: Total Catheter Related Pain
timeFrame: 5-10 days postoperatively
Secondary outcomes:
measure: Composite Satisfaction Score (CSS)
timeFrame: 5-10 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: University of Massachusetts, Worcester
name: Michael Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01607203: Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
Official title: Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: ovarian hyper stimulation syndrome (OHSS)
metaphase II oocytes (MII)
good quality embryo's
implantation
pregnancy
Lead sponsor: AZ Jan Palfijn Gent
Sponsor class: OTHER
Collaborators: name: Onze Lieve Vrouw Hospital
First posted: 2012-05-30
Enrollment: 120
Sex: FEMALE
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.


Eligibility criteria: Inclusion Criteria:

* Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
* 1,2 or 3 rd IVF-cycle

Exclusion Criteria:

* polycystic ovary syndrome (PCOS) patients
* patients with endocrinological diseases or problems

Primary outcomes:
measure: MII Oocytes
timeFrame: 3 weeks
Secondary outcomes:
measure: Pregnancy Rate
timeFrame: 12 weeks
measure: Patients With Cryopreserved Embryos
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: A Z Jan Palfijn
state: Oost-vlaanderen
Study officials:
affiliation: IVF Centrum Jan Palfijn Gent
name: Wim Decleer, gynacologist
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642003: To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Official title: To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cirrhosis
Lead sponsor: Sir Ganga Ram Hospital
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.

Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.


Eligibility criteria: Inclusion Criteria:

* Age 18 years to75 years
* Patients of decompensated cirrhosis with CTP ≥6 and ≤ 13
* Liver transplantation not feasible soon (due to financial reasons or unavailability of donors).

Exclusion Criteria:

* Hepatocellular Carcinoma
* Sepsis (Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP): Patients were included after sepsis is controlled.
* Any organ failure
* Grade 3 or 4 Hepatic Encephalopathy, Active Variceal bleed, Hepatorenal Syndrome: Patients might be included after clinical improvement
* HIV seropositivity
* Pregnancy
* Refusal to participate in the study
* Previous known hypersensitivity to G-CSF

Primary outcomes:
measure: Number of participants alive at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Study officials:
References:
citation: Prajapati R, Arora A, Sharma P, Bansal N, Singla V, Kumar A. Granulocyte colony-stimulating factor improves survival of patients with decompensated cirrhosis: a randomized-controlled trial. Eur J Gastroenterol Hepatol. 2017 Apr;29(4):448-455. doi: 10.1097/MEG.0000000000000801.
Clinical trial NCT01257503: Homeopathic Cold Remedy for Children Study
Official title: Randomized Controlled Trial of a Homeopathic Cold Remedy for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Keywords: children
upper respiratory tract infections
homeopathy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Standard Homeopathic Company
First posted: 2010-12-09
Enrollment: 263
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial of a commercially available homeopathic cold remedy will be conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract infection will be randomized to receive either the homeopathic remedy or placebo. Parents of study children will administer 5 ml of the study medication up to 6 times per day as needed to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms (for up to the first 10 doses). In addition, parents will rate their child's overall symptom severity and functional status over the first 3 days of the cold. It is postulated that children receiving the active homeopathic remedy will have better symptom relief and that their symptom severity and functional status will improve more rapidly than those receiving placebo.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of upper respiratory tract infection
* duration of symptoms \< 7 days
* Parent who speaks English

Exclusion Criteria:

* history of asthma
* on any prescribed medication
* prescribed any medication other than acetaminophen or ibuprofen at index visit
* use of homeopathic remedy within 48 hours of index visit

Primary outcomes:
measure: Change in Severity of Cold Symptoms
timeFrame: Parents assessed change in symptom 1 hour after a dose of study medication
Secondary outcomes:
measure: Change in Non-specific Symptoms
timeFrame: Parents assessed change in symptom 1 hour after dose of study medication
measure: Functional Status
timeFrame: 10 days
measure: Health Status
timeFrame: 10 days
measure: Overall Symptom Severity
timeFrame: 10 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center- Roosevelt Pediatric Care Center
state: Washington
Study officials:
affiliation: University of Washington
name: James A Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02497703: Interactive Exoskeleton Robot for Walking - Knee Joint
Official title: Interactive Exoskeleton Robot for Walking - Knee Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2015-07-14
Enrollment: 25
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: An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the gait pattern from the stroke patients and assist the walking and control the knee angle. The clinical trial will use repeated measurements to evaluate the effectiveness of the robotic knee system in gait rehabilitation post stroke.


Eligibility criteria: Inclusion Criteria:

1. Ischemic or hemorrphagic stroke with drop foot problem.
2. Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination \> 20)
3. Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category \> 3, Berg Balance Scale \> 40)

Exclusion Criteria:

1. Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.
2. Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
3. Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the followup.

Primary outcomes:
measure: Functional Ambulation Category
timeFrame: 3-month followup
measure: 6-minute Walk Test
timeFrame: 3-month followup
Secondary outcomes:
measure: Kinematic and Kinetic Gait Motion Capture
timeFrame: 3-month followup
measure: Fugl-Meyer Assessment Lower Extremity
timeFrame: 3-month followup
measure: Timed 10-meter Walk Test
timeFrame: 3-month followup
measure: Modified Ashworth Scale
timeFrame: 3-month followup
measure: Berg Balance Scale
timeFrame: 3-month followup
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Interdisciplinary Division of Biomedical Engineering. The Hong Kong Polytechnic Univesity
Study officials:
References:
Clinical trial NCT00533403: MK0686 in Postsurgery Dental Pain (0686-002)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the pain relieving effect of MK0686 to placebo or ibuprofen after dental surgery.


Eligibility criteria: Inclusion Criteria:

* Men and women ages 18-45 years who are scheduled to have 2 or more third molars (wisdom teeth) removed
* Patients must agree to remain in the clinic for 24 hours after surgery

Exclusion Criteria:

* Patient has history of heart disease, asthma, pulmonary disease
* Patient must discontinue use of certain pain medicines 24-72 hours prior to the surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00686803: Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Official title: A Single-Center, Single-Dose, Placebo-Controlled, Randomized, Double-Blind, Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: hypertension
controlled hypertension
hypertensives
Lead sponsor: Palatin Technologies, Inc
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.

Detailed description: Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.

Eligibility criteria: Inclusion Criteria:

* Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history
* Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history.
* Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg.

Exclusion Criteria:

* Subject weight greater than 100 kg or less than 50 kg.
* Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk.

Primary outcomes:
measure: Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension.
timeFrame: 24 hours
measure: Pharmacodynamics as Measured by cGMP Levels.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Palatin Technologies, Inc
name: Steven Fischkoff, MD
role: STUDY_DIRECTOR
affiliation: Palatin Technologies, Inc
name: Robert Jordan
role: STUDY_DIRECTOR
References: