louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03507127: Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
Official title: Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Tobacco Dependence
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 5
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: BASIC_SCIENCE

Brief summary: Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a cigarette rating task session. Participants will then undergo a 72-hr abstinence period in which they will come to the laboratory twice per day and receive high-value cash reinforcement contingent upon meeting a strict breath CO abstinence criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of the abstinence period, they will repeat the cigarette rating task. Participants will return to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their CO samples for one week. Date and time of smoking relapse will be measured from these samples.


Eligibility criteria: Inclusion Criteria:

1. Men and women
2. Ages 18-65
3. Have schizophrenia or schizoaffective disorder
4. Would like to quit smoking within the next 6 months
5. Have smoked at least 10 cigarettes per day in the past year
6. Have breath CO level \> 10 ppm
7. Able to speak, read and comprehend English well enough to complete study procedures

Exclusion Criteria:

1. Pregnant, breast-feeding, or unwilling to use medically-approved contraception
2. Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
3. Medical disease that would preclude participation
4. Unstable psychiatric conditions
5. Body mass index (BMI) \< 15 or \> 38 kg/m2
6. Past-month suicidal intention, with or without a specific plan
7. Positive urine drug screen or breath alcohol level \> 0.01% at screening

Primary outcomes:
measure: Questionnaire on Smoking Urges - Brief Form
timeFrame: 72 hrs abstinence
measure: Minnesota Nicotine Withdrawal Scale - Negative Affect Scale
timeFrame: 72 hrs abstinence
Secondary outcomes:
measure: Modified Cigarette Evaluation Questionnaire - Satisfaction Scale
timeFrame: 72 hrs abstinence
measure: Modified Cigarette Evaluation Questionnaire - Reward Scale
timeFrame: 72 hrs abstinence
measure: Latency to Smoking Relapse
timeFrame: 1 week
Other outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: 72 hrs abstinence
Locations:
city: Providence
country: United States
facility: Brown University, 121 South Main Street
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer Tidey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02191527: Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique
Official title: Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services and Their Impact on Mother and Child Health Outcomes in Cabo Delgado Province, Mozambique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Syphilis
Anemia During Pregnancy
Keywords: PMTCT
HIV
Syphilis
Anemia during pregnancy
Point of care diagnostics
Lead sponsor: Elizabeth Glaser Pediatric AIDS Foundation
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Mozambique
First posted: 2014-07-16
Enrollment: 1673
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Before and after intervention study design
Primary purpose: DIAGNOSTIC

Brief summary: The general goal of the proposed study is to evaluate the cost-effectiveness of POC technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting performed within MCH services to improve maternal and infant health.

A prospective, quasi-experimental study will be done in Cabo Delgado province, where health facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and infant health will be measured.


Eligibility criteria: Inclusion Criteria:

* First antenatal care visit
* Able to provide informed consent and signed consent form
* Minimum 18 years of age
* Diagnosed HIV positive at antenatal care visit
* Living in the catchment area of the health facility

Exclusion Criteria:

* Age \<18 years
* No consent form signed
* Being on ART at time of first antenatal care visit

Primary outcomes:
measure: The proportion of HIV positive pregnant women initiating antiretroviral therapy among eligible women.
timeFrame: Within 1 month
Secondary outcomes:
measure: Proportion of women at first ANC visit tested and treated for syphilis
timeFrame: Within 1 month
measure: The proportion of pregnant women tested and treated for anemia
timeFrame: Within 1 month
measure: Number of HIV infections in infants averted
timeFrame: 1-3 months of age
Other outcomes:
Locations:
Study officials:
affiliation: Elizabeth Glaser Pediatric AIDS Foundation
name: Caroline DeSchacht, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Saúde, Mozambique
name: Ilesh V Jani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06927427: Evaluation of Swallowing Impairment After Tonsillectomy
Official title: Evaluation of Swallowing Impairment After Tonsillectomy: A Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Swallowing Impairment After Tonsillectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: the investigator will evaluate the swallowing pattern of the patients pre-operative and will follow them up at day 15 after tonsillectomy by using Careful history taking and Fiberoptic endoscopic evaluation of swallowing (FEES).

Detailed description: All patients will be evaluated pre-operative by history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES). All patients will be operated by the same surgical technique. Patients will be directed to return back on the 15th day post-operative after tonsillectomy and they will be subjected to history taking using the Arabic version of Eating Assessment Tool (EAT-10) questionnaire and they will be examined by Fiberoptic endoscopic evaluation of swallowing (FEES).

1. Careful history taking The history of the patients will be taken using the Arabic version of the Eating Assessment Tool (EAT-10) questionnaire. The patient will rate the problem on a scale of 0 to 4 (0 means no problem; 4 means severe problem). A score of 3 or more on the EAT-10 is considered dysphagia.
2. Fiberoptic endoscopic evaluation of swallowing (FEES). Using flexible endoscopy (the flexible nasopharyngeal video-fiberscope Henke-Sass-Wolf, 4.3mm in diameter connected to Lemke video camera). The patient will be given a colored thin fluid to keep in their mouth and then swallow following the instructions of the examiner, then the examination will be repeated using semisolids (1 teaspoon of yogurt) and using solids (piece of bread). The evaluation of swallowing will involve four items: early spill of food (delayed triggering), aspiration, penetration, and retention (residue). And the results will be recorded.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing tonsillectomy.
2. Age group (from 7-18 years).
3. Patients of either gender.

Exclusion Criteria:

1. Patients younger than 7 years or older than 18 years.
2. Patients with neurological diseases and genetic syndromes.
3. Patients with history of swallowing disorders prior to tonsillectomy.

Primary outcomes:
measure: evaluation of swallowing impairment after tonsillectomy
timeFrame: 15 days after tonsillectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: OtoRhinoLaryngology, head and neck surgery resident, Ain Shams University
name: Alaa A Mansour, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01499927: Early Reassessment of Intravenous Antiinfective Therapy Due to "Antiinfective Reminders" (AIR Study)
Official title: Early Reassessment of Intravenous Antiinfective Therapy Due to "Antiinfective Reminders" (AIR Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection as Complication of Medical Care
Keywords: Early reassessment of intravenous antiinfective therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 74766
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Switching from intravenous application of antiinfective agents to oral therapy is often performed late including high costs and risk of complications. This study will investigate the impact of displayed reminders in the electronic patient chart after 60h of intravenous therapy with an antiinfective agent.

Detailed description: Switching from intravenous application of antiinfective agents to oral therapy is often performed late including high costs, risk of complications as well as higher workload on nursing. This study will investigate the impact of displayed reminders in the electronic patient chart after 60h of intravenous therapy with an antiinfective agent.

Eligibility criteria: Inclusion criteria:

* all in-patients in treatment with an intravenous antiinfective for \>60h,
* hospitalized in a ward with computerized physician order entry (cpoe)

Exclusion criteria:

* outpatients,
* ward without cpoe,
* no intravenous antiinfective treatment

Primary outcomes:
measure: duration of intravenous antiinfective therapy until switching
timeFrame: 1 year
Secondary outcomes:
measure: costs (per year, per day and patient)
timeFrame: 1 year
measure: defined daily doses (per 100 days)
timeFrame: 1 year
measure: duration of hospitalization
timeFrame: 1 year
measure: ratio of narrow to broad-spectrum antibiotics
timeFrame: 1 year
measure: requests for consultations
timeFrame: 1 year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Center for Clinical Research
state: ZH
Study officials:
affiliation: University Hospital Zurich, Center for Clinical Research
name: Juerg Blaser, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beeler PE, Kuster SP, Eschmann E, Weber R, Blaser J. Earlier switching from intravenous to oral antibiotics owing to electronic reminders. Int J Antimicrob Agents. 2015 Oct;46(4):428-33. doi: 10.1016/j.ijantimicag.2015.06.013. Epub 2015 Jul 21.
Clinical trial NCT03201627: Study of Lithium Carbonate to Treat Niemann-Pick Type C1 Disease
Official title: a Single-center, Prospective, Open, and Non-randomized Case-control Study of Lithium Carbonate Effect on Niemann Disease C1 Type
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Niemann-Pick Disease, Type C1
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 18
Sex: ALL
Minimum age (years): 7
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is planned to study whether lithium carbonate has protective effect on the brain of Niemann-Pick disease type C1.


Eligibility criteria: Inclusion Criteria:

1. aged from 7 years to 40 years
2. onset of neurological symptoms prior to 15 years of age
3. confirmed diagnosis of NPC1 determined by either two NPC1 mutations or one NPC1 mutation with elevated plasma 7-ketocholesterol
4. ability to walk either independently or with assistance
5. Subject or parent/guardian able to communicate with investigator, understand and abide the rules of this clinical trial.
6. parent/guardian able to accompany the subjects to participate in the clinical trial
7. Subject or parent/guardian must provide written informed consent

Exclusion Criteria:

1. One NPC clinical severity scale score reached 5
2. Female in pregnancy or breastfeeding
3. The predicted life span less than 1 year
4. Severe liver insufficiency (defined as hepatic laboratory parameters, AST and/or ALT greater than three-times the upper limit of normal
5. Renal insufficiency, with the serum creatine greater than 1.5 times the upper limit of normal
6. Free with neurological symptoms
7. Take antidiuretic hormone

Primary outcomes:
measure: NPC clinical severity score
timeFrame: 52 weeks
Secondary outcomes:
measure: 7-ketocholesterol
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital
state: Shanghai
Study officials:
References:
citation: Han S, Zhang H, Yi M, Liu X, Maegawa GHB, Zou Y, Wang Q, Wu D, Ye Z. Potential Disease-Modifying Effects of Lithium Carbonate in Niemann-Pick Disease, Type C1. Front Pharmacol. 2021 Jun 9;12:667361. doi: 10.3389/fphar.2021.667361. eCollection 2021.
Clinical trial NCT00822627: Influenza Vaccination in the Emergency Department
Official title: Influenza Vaccination in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
vaccination
Emergency Department
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?

Detailed description: This study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the Emergency Department. Subjects are either offered vaccination or education regarding vaccination and a list of community providers. At a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.

Eligibility criteria: Inclusion Criteria:

* Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute:
* Age 6-59 months or \>50 years
* Pregnant
* Health care worker
* Aged 6 months-18 years on chronic aspirin therapy
* Comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year)
* Household contact or caregiver of someone with at least one high risk attribute

Exclusion Criteria:

* Prior vaccination
* History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination
* Allergy to influenza vaccination or eggs
* Age \< 6 months old
* Fever with more than minor illness
* Hospitalization

Primary outcomes:
measure: Vaccination status
timeFrame: 4 months
Secondary outcomes:
measure: Influenza rate
timeFrame: 4 months
measure: Influenza-like illness rate
timeFrame: 4 months
measure: Visits to medical providers
timeFrame: 4 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona Department of Emergency Medicine
name: Katherine M Hiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06228027: External Validation os the ACME Scoring System
Official title: Prediction of the Mortality in Acute Calculous Cholecystitis. The ACME Project.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Cholecystitis
Keywords: Acute Cholecystitis
Cholecystectomy
Tokyo Guidelines
Postoperative Complications
Mortality
High-risk patient
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 10000
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: All the consecutive admisions with an acute calculous cholecystitis, independent on the treatment indicated, during 2025 and 2026.

Brief summary: Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is \<1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.

Detailed description: This is a prospective multicenter observational study of 10.000 adults with ACC during 2 consecutive years (2025/2026), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification and the new ACME Scoring system. The primary outcome is to study the prediction of mortality of ACME score. Secondary outcomes include complications following Clavien-Dindo's classification, C-statistic, and ROC Curves.

Eligibility criteria: Inclusion Criteria:

* Acute Calculous Cholecystitis

Exclusion Criteria:

* Acute Cholangitis
* Chronic Cholecystitis
* Neoplasia
* Acute Pancreatitis
* Pregnant

Primary outcomes:
measure: Mortality
timeFrame: Jan 2025- Dec 2026
measure: Complications
timeFrame: Jan 2025- Dec 2026
measure: ACME's prediction of mortality
timeFrame: Jan 2025- Dec 2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital del Mar
name: Ana María González Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00203827: Pediatric Sleep Questionnaire: Use for Collection of Clinical Data
Official title: Pediatric Sleep Questionnaire: Use for Collection of Clinical Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Keywords: Sleep Disorders
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 300
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Problems or habits children experience with sleep

Brief summary: The purpose of this study is to develop a questionnaire that can be used for standardized patient information gathering in the clinical setting. This will serve as the information source for a pediatric sleep database.

Detailed description: A sleep questionnaire will be administered to patients who present to the Pediatric Neurology Clinic and the Pediatric Sleep Clinic in the DCAM as well as LaRabida Children's Hospital complaining of sleep problems. The questions asked are those routinely obtained in clinical practice of sleep medicine. Medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. The database will be maintained in Filemaker Pro program for future research purposes. Collection of the data will require approximately 15 minutes. A database file number not related to the patient medical record number will be assigned to each patient. The investigator will keep a separate log linking patient database number and patient medical record number. The logbook will be kept under lock and key by the investigator.

Eligibility criteria: Inclusion Criteria:

* All patients seen in the Pediatric Neurology Clinic and at La Rabida Children's Hospital

Exclusion Criteria:

* Adults

Primary outcomes:
measure: Pediatric Sleep Questionnaire
timeFrame: When data from clinic patients becomes available
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Michael Kohrman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: