louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02725320: Rotator Cuff Surgical Outcomes in Women
Official title: Rotator Cuff Surgical Outcomes in Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Injury of Shoulder Region
Rotator Cuff Syndrome
Keywords: rotator cuff
shoulder reconstruction
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 192
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants for this study will be selected from the practice of three shoulder reconstruction surgeons in their embedded clinical research practice.

Brief summary: The overall purpose of this work is to use a prospective cohort study to examine patient-specific but shoulder-extrinsic factors and how they influence the results of rotator cuff surgery. There are undoubtedly many factors that play a role in patient outcome, however, this project will focus on three: the effect of gender on outcome, the effect of mood disorders and coping style on outcome, and the effect of patient height and reach on outcome after rotator cuff surgery. It is hypothesized that these factors will have a significant influence over outcomes.


Eligibility criteria: Inclusion Criteria:

* Referred for surgical treatment of predominantly unilateral rotator cuff syndrome

Exclusion Criteria:

* unable to speak or read English
* unable to complete 12 month follow-up
* significant cervicogenic arm and shoulder pain in the affected arm
* significant chronic pain diagnoses felt at least as likely to be the cause of the symptoms as the rotator cuff condition as evaluated by the surgeon

Primary outcomes:
measure: Western Ontario Rotator Cuff score (WORC)
timeFrame: 1 year
Secondary outcomes:
measure: Overall change in WORC (male versus female)
timeFrame: 1 year
measure: Rate of change in WORC (male versus female)
timeFrame: 1 year
measure: Rate of change in visual analogue scale (VAS) (male versus female)
timeFrame: 1 year
measure: Rate of change in SF-36 (short-form 36) response scores (male versus female)
timeFrame: 1 year
measure: Rate of change of satisfaction with surgical outcome (male versus female)
timeFrame: 1 year
measure: Prevalence of anxiety and depression at baseline
timeFrame: Baseline data
measure: Prevalence of catastrophizing at baseline
timeFrame: Baseline data
measure: Improvement in HADS
timeFrame: 1 year
measure: Height (males versus females)
timeFrame: baseline
measure: Change in reach over time
timeFrame: 1 year
measure: WORC score by HADS score
timeFrame: 1 year
measure: WORC score by PCS score
timeFrame: 1 year
measure: WORC score by forward reach
timeFrame: 1 year
measure: WORC score correlated to gender, PCS, HADS
timeFrame: 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: University of Calgary
name: Marlis Sabo, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06413420: SUNOSI® (Solriamfetol) Pregnancy Registry
Official title: SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Narcolepsy
Obstructive Sleep Apnea
Pregnant Women and Their Offspring
Keywords: Solriamfetol
SUNOSI
Axsome
Narcolepsy
Obstructive Sleep Apnea
Non-stimulant therapy
Dopamine norepinephrine reuptake inhibitor
Pregnancy outcomes
Infant outcomes
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 1731
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include pregnant women of any age who reside in a country where solriamfetol is available for the treatment of narcolepsy or OSA, provide consent to participate as well as medical releases for their healthcare providers (HCPs) to provide data to the registry, and meet the criteria for inclusion into 1 of the 5 cohorts.

Brief summary: The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).

Detailed description: The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions.

The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.

Eligibility criteria: Inclusion Criteria:

* Pregnant women of any age
* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy
* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
* Provides written informed consent to participate in the study
* Authorization for her HCP(s) to provide data to the registry

Exclusion Criteria:

* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
* Inclusion of a prior pregnancy in the main analysis population

Primary outcomes:
measure: Long-term Safety
timeFrame: Baseline up to 12 months after pregnancy outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Evidera, a PPD business unit
state: North Carolina
city: Wilmington
country: United States
facility: PPD, Inc.
state: North Carolina
Study officials:
References:
Clinical trial NCT06638320: Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
Official title: Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatitis Delta With Hepatitis B Carrier State
Chronic Hepatitis b
Lead sponsor: Tam Anh Research Institute
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 2452
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 16 years old with chronic hepatitis B, with hepatocellular carcinoma and cirrhosis or not, should be examined and treated at the Gastroenterology - Hepatobiliary Center of Bach Mai Hospital, Tam Anh General Hospital and Tam Anh TP. Ho Chi Minh General Hospital.

Brief summary: The goal of this observational study is to determine the prevalence of hepatitis D virus (HDV) and the distribution of the HDV genotype in patients with chronic hepatitis B infection. It will also identify factors related to hepatitis D virus infection, such as characteristics of the study sample, vaccination history, drug use affecting hepatitis, family factors, environment, and lifestyle.

This study will be conducted at Tam Anh General Hospital, Bach Mai Hospital and Tam Anh TP. Ho Chi Minh General Hospital.

Participants will be interviewed directly through a questionnaire to collect some information related to epidemiological risk factors. A blood sample will also be collected.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 16 years old undergo testing at the Testing Center of Tam Anh General Hospital or Tam Anh TP. Ho Chi Minh General Hospital, with chronic hepatitis B HBsAg (+) standards for six months or over or HBsAg (+) combined with HBcAb total (+) and HBcAb-immunoglobulin M (-).
* Patients ≥ 16 years old with chronic hepatitis B come to be examined or are inpatients at the Gastroenterology - Hepatobiliary Center of Bach Mai Hospital, diagnosed with hepatocellular carcinoma, and cirrhosis

Exclusion Criteria:

* Patients do not agree to participate in the study or refuse to sign a written informed consent.

Primary outcomes:
measure: Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection
timeFrame: Day 0 after recruitment
Secondary outcomes:
measure: Distribution of the HDV genotype in patients with chronic hepatitis B infection
timeFrame: Day 0 after recruitment
measure: Factors related to hepatitis D virus infection
timeFrame: Day 0 after recruitment
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: VNVC Tan Phu
Study officials:
References:
Clinical trial NCT03479320: Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation
Official title: Efficacy of Perioperative Intravenous Lidocaine Infusion on Postoperative Analgesia in Patients Undergoing Oral and Maxillofacial Surgeries Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 40
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: This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request


Eligibility criteria: Inclusion Criteria:

* Adult patients 18-60 years of age
* Patients of ASA (American Society of Anesthesiologists) Class I or Class II (I- healthy with no systemic disease, II- mild systemic disease with no functional limitation) who require oral and maxillofacial surgeries under general anesthesia

Exclusion Criteria:

* Refusal to give consent.
* Hypersensitivity or allergy to the study medication.
* ASA physical status III or more.
* Subjects with known severe hepatic or renal dysfunction or cardiac dysrhythmia or atrioventricular block.
* History of taking opioids or antiarrhythmic drugs within 1 week of surgery.
* History of drug or alcohol abuse
* History of psychiatric disorders.
* Patients requiring emergency surgery.
* Patients unable to comprehend pain assessment

Primary outcomes:
measure: Postoperative Numeric Rating Scale(NRS)
timeFrame: 24 hours
Secondary outcomes:
measure: Total opioid consumption
timeFrame: 24 hours
measure: Time to first analgesic request
timeFrame: 24 hours
measure: Side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: B. P. Koirala Institute of Health Sciences
Study officials:
affiliation: B.P. Koirala Institute of Health Sciences
name: Vivek Kr Mahato, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00182520: Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)
Official title: A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Keywords: Treatment Refractory Obsessive Compulsive Disorder
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Janssen-Ortho Inc., Canada
name: Hamilton Health Sciences Corporation
First posted: 2005-09-16
Enrollment: 23
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: SRI's are considered first-line treatments for OCD, however many patients continue to have significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown that the glutamate neurological system is involved in OCD. This study will test the safety and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where the OCD has been un-responsive, or partially responsive to regular SRI treatment.


Eligibility criteria: Inclusion Criteria:

* Outpatient with primary DSM- IV OCD
* Completion of a 14-week open label trial of one the following SRI's: fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day and demonstrating a non or partial responses to SRI treatment (CGI-I of 3 or 4, Y-BOCS reduction of \< 35%)
* Stable (8 wks or longer) concurrent medications including benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants.

Exclusion Criteria:

* Any other primary DSM-IV diagnosis; DSM-IV criteria for body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse.
* A previous adequate trial of topiramate
* Comorbid major depressive disorder diagnosis which predates OCD diagnosis
* Cognitive behavioural therapy or additional psychotherapy in past four months
* Allergy or hypersensitivity to topiramate
* BMI \< 20
* History of kidney stones

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: 12 weeks
measure: Clinical Global Impression - Improvement ≤ 2
timeFrame: 12 weeks
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: 12 weeks
measure: Sheehan Disability Scale
timeFrame: 12 weeks
measure: Beck Depression Inventory
timeFrame: 12 weeks
measure: PI-SWUR Hoarding Scale
timeFrame: 12 weeks
measure: Self Report Y-BOCS
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: MacAnxiety Research Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Michael VanAmeringen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058720: Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
Official title: A Pilot Study to Evaluate the Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Supplementation
Adolescence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.

Detailed description: Twenty normal weight adolescents between ages 12-18 that are age and gender would receive vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and other demographic variables will be assessed.The primary endpoint in this study is the 25 OH Vitamin D level at 12 weeks.

Eligibility criteria: Inclusion criteria:

* Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.

Exclusion Criteria:

* Subjects with 25 (OH)- D levels \>80 ng/mL
* Serum calcium \>10.8 mg/dL
* Serum phosphorus \> 5.5 mg/dl
* Pregnancy or nursing
* Current cancer
* Patients on multivitamin supplementation
* Dietary calcium intake exceeding 1500 mg/day
* Hepatic or renal disorders
* Type 1 or Type 2 diabetes mellitus
* Those receiving insulin, metformin, or oral hypoglycemic medications
* Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)

Primary outcomes:
measure: Increment in 25(OH)vitamin D level
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum Calcium
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Seema Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00251420: Writing About Disease: Effect on Rehabilitation?
Official title: Writing About Disease: Effect on Rehabilitation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Asthma
Keywords: copd
asthma
QoL
Perceived health status
Trait anxiety
Lead sponsor: LHL Helse
Sponsor class: OTHER
Collaborators: name: The norwegian association for heart and lung patients
First posted: 2005-11-10
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Therapeutic writing about one's emotions has been described previously (J Pennebaker: Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare the effects (if any) of writing about the emotional versus the physical consequences of lung disease on anxiety, perceived quality of life, and perceived health status.

Detailed description: Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age 20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in the project - are randomly assigned to one of three conditions:

* Writing about emotional consequences of their disease before the program starts
* Writing about physical consequences of their disease before the program starts
* Not writing

All patients are measured (completing questionnaires at home) on: perceived quality of life, perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the program and 6 months after the program. FEV1 and 6 min walking distance are measured at the beginning and by the end of the program.

In addition to questionnaires, all patients are asked to:

* Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation clinic; and
* Write in their own words (6 months after) about how the disease affects their life at that point.

Both quantitative and qualitative data will be used for analysis purposes.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD (age between 35 and 70)
* Clinical diagnosis of asthma (age between 20 and 60)

Primary outcomes:
measure: Quality of life
timeFrame: prospective
measure: Perceived health status
timeFrame: prospective
measure: Trait anxiety
timeFrame: prospective
Secondary outcomes:
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: prospective
measure: 6-minute walking distance
timeFrame: prospective
Other outcomes:
Locations:
city: Hakadal
country: Norway
facility: Glittreklinikken
state: Akershus
Study officials:
affiliation: LHL Helse
name: Einar Haave, Cand Psychol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05338320: Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia
Official title: A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Elective Lumbar Fusion Operations Under General Anesthesia: Ultrasound Guided Erector Spinae Plane Block Versus Intrathecal Morphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It was proven that intrathecal opioids are considered as an effective means of pain control in several major surgical interventions including spine surgeries. Intrathecal morphine added to a spinal anesthesia reduces acute pain after spine surgeries but has side effects, including dose dependent respiratory depression, nausea, vomiting, pruritus, and sedation. Ultrasound guided Erector Spinae Plane Block (ESPB) was first described in 2016.Recent case reports suggest a positive effect of ultrasound guided ESPB on pain for multiple indications including lumbar spine fusion and scoliosis surgery, with a very low risk of complications as there are no structures in close proximity at risk of needle injury.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) 25 to 35 kg/m².
* American Society of Anesthesiologist (ASA) physical status I or II.

Exclusion Criteria:

* patient's refusal
* Altered mental status
* Known allergy to study drugs (bupivacaine or morphine)
* Local infection at site of puncture.
* Known case with any pulmonary disease
* Known case with Obstructive sleep apnea (OSA)
* Coagulopathy and /or thrombocytopenia
* Severe hepatic or kidney impairment

Primary outcomes:
measure: Time to first requested rescue analgesia (Minutes).
timeFrame: First 24 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT00005920: Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole
Official title: A Multiclinic, Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety, Tolerability, and Efficacy of L-743,872 in the Treatment of Fluconazole-Unresponsive Oropharyngeal Candidiasis in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Candidiasis, Oral
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Dose-Response Relationship, Drug
Fluconazole
Antifungal Agents
Candidiasis, Oral
Pharyngeal Diseases
MK 0991
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.

Detailed description: Patients are randomized to treatment with L-743,872 at one of two doses administered intravenously by a peripheral line once-daily. Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. Each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. Liver enzymes are drawn at the 14-day follow-up visit.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Have thrush that has not responded to fluconazole treatment.
* Are 18-65 years old.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rahway
country: United States
facility: Carol Sable
state: New Jersey
Study officials:
References: