louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02968667: The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial
Official title: The Effectiveness of Hopelessness and Helplessness on Recovery Rate Among People Diagnosed With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychotic Disorders
Lead sponsor: Fakeeh College for Medical Sciences
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 102
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.

Detailed description: A randomized controlled trial was conducted from November 2015 and May 2016 with 112 participants of people diagnosed with schizophrenia. Participants aged 18 years or older with DSM-V schizophrenia or schizoaffective disorder from outpatient mental health clinics in Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment as usual \[TAU\] (intervention, n = 56), or TAU (control, n = 56). Participants were assessed at baseline, immediately post-intervention (post-treatment1) and at three months follow-up. The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric symptoms, recovery rate and quality of life.

Eligibility criteria: Inclusion Criteria:

* Adult aged 16 years or more
* Able to read and write in an Arabic
* Able to consent
* Diagnosed with schizophrenia
* Volunteers

Exclusion Criteria:

* Learning disability
* Not able to read or write

Primary outcomes:
measure: Modified Learned Helplessness
timeFrame: Up to 6 months
Secondary outcomes:
measure: Psychiatric symptoms
timeFrame: Up to 6 months
measure: recovery assessment scale
timeFrame: Up to 6 months
measure: Empowerment level
timeFrame: Up to 6 months
measure: Quality of life
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01225367: The Use of a Ultra-sound of the Lung to Diagnose Lung Diseases
Official title: Detection and Characterization of Cardio-pulmonary Patho-physiological States and Diseases by Ultrasound Transthoracic Doppler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Pathologies
Cardio-pulmonary Diseases
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The study is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system.

The system is a noninvasive non-imaging device designated to monitor flow and movement velocity and display the data continuously.


Eligibility criteria: Inclusion Criteria:

* Age 18y or older
* patients who are clinically suspected of having a significant pulmonary or cardio-pulmonary disease
* Patients with CHF
* Patients with pulmonary hypertension
* Patients with COPD
* Patients with Asthma
* Signed informed consent
* Normal subjects

Exclusion Criteria:

* Patients with unstable conditions: unstable angina, uncontrolled CHF, etc
* Inability to assume a sitting or supine position
* Patients with severe chest wall deformity

Primary outcomes:
measure: Diagnose specific pattern of LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Elisha hospital
Study officials:
affiliation: Elisha Hospital
name: Moshe Person, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198367: Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
Official title: Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: operable and resectable stage IIIA (T1-3, N2) NSCLC
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.

Detailed description: These results justify the choice of the study design currently suggested, testing the preoperative feasibility

1. chemotherapy: cisplatin-Gemzar (arm A) or
2. chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C).

The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.

Eligibility criteria: Inclusion Criteria:

* Operable and resectable stage IIIA (T1-3, N2) NSCLC
* World Health Organization (WHO) performance status of 1 or less

Exclusion Criteria:

* Severe cardiac, respiratory, renal or hepatic failure

Primary outcomes:
measure: percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
timeFrame: at week 22
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
Study officials:
affiliation: Hospices Civils de Lyon
name: Francoise Mornex, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Bernard Milleron, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Girard N, Mornex F, Douillard JY, Bossard N, Quoix E, Beckendorf V, Grunenwald D, Amour E, Milleron B. Is neoadjuvant chemoradiotherapy a feasible strategy for stage IIIA-N2 non-small cell lung cancer? Mature results of the randomized IFCT-0101 phase II trial. Lung Cancer. 2010 Jul;69(1):86-93. doi: 10.1016/j.lungcan.2009.10.003. Epub 2009 Oct 29.
Clinical trial NCT02438267: Preterm Infants and Nephrocalcinosis
Official title: Preterm Infants and Nephrocalcinosis: Diagnosis and Pathogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Nephrocalcinosis
Hypercalciuria
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
First posted: 2015-05-08
Enrollment: 56
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants admitted to the newborn intensive care unit.

Brief summary: Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born prematurely and with very low birth weight (\<1500 gm) seem to be at the highest risk of developing NC. Recent changes in recommendations for nutrition for the preterm infant such as higher intakes of protein, calcium, and vitamin D may also play a factor in the pathogenesis of NC.

Currently, diagnosis of NC often occurs incidentally during ultrasound evaluation for other issues. Because there is no acute symptom or pattern of symptoms in the preterm population associated specifically with NC, it is possible that many cases of NC may not be diagnosed. Presently, it is impractical and costly to screen all infants for NC with renal ultrasound, therefore there is no standard of care regarding screening for NC.

NC may have long-term effects. Studies have shown that preterm infants with NC had shorter kidneys and a lower rate of tubule resorption of phosphorus (TRP) than preterm infants without NC.

This study will analyze weekly urinalysis for all enrolled subjects prospectively and then look at the incidence of NC at discharge of the enrolled subjects.


Eligibility criteria: Inclusion Criteria:

* Infants whose gestation less than or equal to 32 weeks and/or birth weights less than 1800 gm

Exclusion Criteria:

* Infants with congenital abnormalities of the heart, lung, GI, or kidneys that will affect renal function.

Primary outcomes:
measure: Urinary calcium to creatinine ratio (UCa/Cr)
timeFrame: 3 months
measure: Urinary crystals
timeFrame: 3 months
Secondary outcomes:
measure: Serum Vitamin D levels
timeFrame: 3 months
measure: Vitamin D intake
timeFrame: 3 months
measure: Calcium intake
timeFrame: 3 months
measure: Protein intake
timeFrame: 3 months
measure: Total bone density per DXA
timeFrame: 3 months
measure: Tibial bone density per tibial ultrasound
timeFrame: 3 months
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: University of Utah
name: Sabrina Malone-Jenkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04823767: Single Anastomosis Sleeve Iejenal Bypass in Obese Patient With Hiatus Hernia
Official title: Single Anastomosis Sleeve Iejenal Bypass With Crural Repair in Obese Patient With Hiatus Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations

Detailed description: preoperative endoscopy was done and if hiatus hernia was present the patient is undergo single anastomosis sleeve jejunal bypass with hiatal repair for morbid obesity with reflux manifestations

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures

Primary outcomes:
measure: the effect of sleeve jejunal bypass on reflux manifestations
timeFrame: 2 months
Secondary outcomes:
measure: EWL
timeFrame: one year
measure: treatment of comorbidities
timeFrame: one year
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT01493167: Study on Wood-plastic Composite for Circumferential Casting
Official title: Study on Circumferential Casting Techniques With WOODCAST
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Fracture
Radius Fracture
Ankle Fracture
Keywords: cast
splint
circumferential casting
casting techniques
fracture in extremity
Lead sponsor: Onbone Oy
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 97
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.

Detailed description: An ecologically friendly and biodegradable wood-plastic composite-cast is studied. The purpose of the study is to verify that WOODCAST Circular system performs safely and effectively in its intended use. Patients, who need immobilization of extremity (including for example scaphoid fracture of the wrist or ankle fracture) will be participating in the study. Various casting techniques with novel WOODCAST material will be studied.

Eligibility criteria: Inclusion Criteria:

* patient treatment involves circular casting;
* age 0-90 years;
* mother tongue finnish or swedish

Exclusion Criteria:

* open fracture;
* other fractures or a previous fracture;
* a previous or simultaneous tendon-, nerve-, or vascular injury to the extremity yo be treated;
* a multiple injured extremity;
* decreased co-operation of the patient;
* malignancy;
* an illness affecting the general health.

Primary outcomes:
measure: Efficient Casting With Woodcast Circular System
timeFrame: 1 - 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Nina C Lindfors, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02144467: The Establishment of Large-sample Database of "Multiple-MRI/Gene/Cognition"
Official title: The Establishment of Large-sample Database of "Multiple-MRI/Gene/Cognition"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Multiple-MRI, Gene, Cognition
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 5000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of Hangzhou, China.

Brief summary: Aim to establish a large-sample database of "Multiple-MRI/Gene/Cognition" for healthy Chinese (sample number, 5000; age, 6-70 years). This is a fundamental but very necessary work for future researches such as development, aging, relation of gene and behavior, relation of gene and neuroimaging, relation of behavior and neuroimaging. Importantly, this work will provide a norm for researches on psychological or neurological patients. This large-sample will be shared with world-wide researchers.

Detailed description: A part of data have been used in a publication which is preparing to submit.

Eligibility criteria: Inclusion Criteria:

* Healthy Chinese
* Age: 6-70 years old
* Right handed
* No smoking or alcoholic addiction

Exclusion Criteria:

* Psychological or neurological patients
* Hypertension or cardiopathy patients
* Pregnant woman
* Take medicine or drink tea/coffee before scanning-

Primary outcomes:
measure: The distribution of the amplitude of blood oxygenation level dependent(BOLD) signal in healthy subjects
timeFrame: up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Normal University,Center for Cognition and Brain Disorder
state: Zhejiang
Study officials:
affiliation: Hangzhou Normal University, Center for Cognition and Brain Disorder
name: Yu-Feng ZANG, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jing Y, Zhao N, Deng XP, Feng ZJ, Huang GF, Meng M, Zang YF, Wang J. Pregenual or subgenual anterior cingulate cortex as potential effective region for brain stimulation of depression. Brain Behav. 2020 Apr;10(4):e01591. doi: 10.1002/brb3.1591. Epub 2020 Mar 8.
Clinical trial NCT01662167: Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy
Official title: Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy: a Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy, Ectopic
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 87
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.


Eligibility criteria: Inclusion Criteria:

* unruptured tubal EP
* gestational mass of less than or equal to 3.5 cm in ultrasonography report

Exclusion Criteria:

* hemodynamic instability
* contraindications related to the use of MTX
* hepatic
* renal and active pulmonary diseases
* peptic ulcer
* immune deficiency status
* alcohol abuse
* blood dyscreasia

Primary outcomes:
measure: hCG level decrease
timeFrame: 4 days after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Shariaty Hospital
state: Hormozgan
Study officials:
References:
Clinical trial NCT00566267: A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
Official title: A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
First posted: 2007-12-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.


Eligibility criteria: Inclusion Criteria:

* Moderately obese with hyperlipidemia

Exclusion Criteria:

* Recent unstable heart or lung condition
* Current use of other lipid modifying drugs
* Hepatic disease
* Pregnancy or lactation

Primary outcomes:
measure: LDL cholesterol
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: Other lipid measures
timeFrame: 8 weeks of treatment
measure: Safety and tolerability
timeFrame: 8 weeks treatment
Other outcomes:
Locations:
Study officials:
affiliation: Philadelphia VAMC
name: Frederick F Samaha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chirinos JA, Williams MM, Bregman DB, Ashfaq H, Khayyam U, Iqbal N. Efficacy of cholesterol uptake inhibition added to statin therapy among subjects following a low-carbohydrate diet: a randomized controlled trial. Am Heart J. 2010 May;159(5):918.e1-6. doi: 10.1016/j.ahj.2010.02.010.
Clinical trial NCT05090267: The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Official title: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognition
Gut Microbiome
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: University of Miami
name: University of Louisville
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Exegi Pharma, LLC
name: Soterix Medical
First posted: 2021-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a 2 x 2 factorial, longitudinal design (tVNS/Sham, Probiotic/Placebo) across three time points (baseline; 30days and 90days).
Primary purpose: BASIC_SCIENCE

Brief summary: This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.


Eligibility criteria: Inclusion Criteria:

* Age 35-70 years
* English or Spanish speaking
* Alcohol users
* Cognitive impairment
* Current CD4\>350

Exclusion Criteria:

* Diagnosed major psychiatric illness
* Consumption of over 300 drinks in the past 30 days
* Recent opioid use
* Lifetime history of medically-assisted alcohol detoxification
* Inpatient or intensive treatment for addictive behaviors in the past 12 months
* MRI contraindications
* Current antibiotic treatment
* Current probiotic use
* Physical impairment precluding motor response or lying still.

Primary outcomes:
measure: Improved cognition from day 1 to day 90
timeFrame: Baseline up to 90 days
measure: Reduction of dysbiosis from day 1 to day 90
timeFrame: Baseline up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Florida
name: Eric Porges, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Robert L Cook, MD
role: STUDY_DIRECTOR
References: