louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00399191: A Test of Iron Malabsorption in Patients With Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Iron Deficiency Anemia
Keywords: anemia
iron deficiency anemia
iron deficiency
absorption
iron absorption
iron uptake
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2006-11-14
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to develop a simple, noninvasive test for evaluation of iron absorption as a tool to determine the cause of iron deficiency anemia. Healthy, premenopausal women with iron deficiency with or without anemia will be recruited for the study. Participants will, over the course of two months, ingest an iron solution three times; after each iron ingestion, participants will collect their stool and bring it to the study investigators for assessment of iron content.


Eligibility criteria: Inclusion Criteria:

* ferritin \<40

Exclusion Criteria:

* pregnant,
* post-partum,
* s/p GIT surgery,
* known malabsorption,
* coeliac disease,
* Helicobacter pylori

Primary outcomes:
measure: initial mucosal uptake of iron
measure: intra- and inter-individual variability
measure: red cell incorporation of iron
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: BioChemAnalysis Corp.
name: Morteza Janghorbani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04441229: Mobile Attentional Bias Modification Training in Pediatric MS
Official title: A Prospective, Observational Study of Mobile Attentional Bias Modification Training (ABMT) in the Pediatric Multiple Sclerosis (MS) Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the feasibility of using a mobile ABMT application as a treatment modality in the Pediatric Multiple Sclerosis population. Participants will be asked to undergo one hour-long baseline evaluation, followed by at-home ABMT application sessions. Subjects will complete online REDCap or MyCap surveys weekly and at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Age 12-24 years
* Confirmed Diagnosis of Multiple Sclerosis with onset \< 17 years and 11 months (defined by the 2013 International Pediatric MS Study Group (IPMSSG) criteria (Krupp, Tardieu, Amato, Banwell, Chitnis, Dale, Ghezzi, Hintzen, Kornberg, Pohl, Rostasy, Tenembaum, Wassmer, \& Sclerosis, 2013) and the 2010 McDonald criteria (Polman et al., 2011).)
* Followed at NYU Multiple Sclerosis Comprehensive Care Center
* Access to a mobile device with iOS (devices will be provided to subjects if this criteria is not met, see section 4.4)
* Active or concurrently enrolled in the ongoing US Network of Pediatric MS Centers Study Consortium

Exclusion Criteria:

* Previous report of an IQ \< 70
* Wide-Range Achievement Test-Fourth Edition (Wilkerson, 2006) Reading Subtest standard score \<85
* Non-English speaking, learned English in the past three years, or learned English after the age of 12 years
* Not willing to comply with all study procedures
* Insufficient visual and motor ability to operate the intervention and assessments

Primary outcomes:
measure: Proportion of "compliant" participants
timeFrame: 30 days
Secondary outcomes:
measure: Preliminary efficacy composite score
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03172429: Cerebral Tissue Oxygenation in Highlanders/Lowlanders
Official title: Cerebral Tissue Oxygenation in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Altitude Pulmonary Hypertension
Keywords: pulmonary hypertension
cerebral tissue oxygenation
disease progression
hypoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2017-06-01
Enrollment: 79
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Highlanders with high altitude pumonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of \<1000 m.

Brief summary: The purpose of the current study is to evaluate the cerebral tissue oxygenation of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participated in the study in 2012 to undergo follow-up examinations in 2017, in order to allow comparisons of current results with baseline data from 2012.


Eligibility criteria: Inclusion Criteria:

* high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure \>30 mmHg measured by echocardiography at altitude of residence.
* healthy subjects (high altitude controls)
* Both genders
* Age \>16 y
* Kyrgyz ethnicity
* born, raised and currently living at \>2500 m
* healthy subjects currently living at \<1000 m (low altitude controls)

Exclusion Criteria:

* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
* Excessive erythrocytosis
* Other coexistent disorders that may interfere with the cardio-respiratory system and sleep
* Regular use of medication that affects control of breathing
* Heavy smoking

Primary outcomes:
measure: Changes in cerebral tissue oxygenation
timeFrame: Year 2012 to 2017
Secondary outcomes:
measure: Changes in cerebrovascular response to hyperoxia
timeFrame: Year 2012 to 2017
measure: Changes in cerebrovascular response to hypocapnia
timeFrame: Year 2012 to 2017
measure: Arterial oxygen saturation
timeFrame: Year 2012 to 2017
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: NCCIM
name: Talant M Sooronbaev, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04697329: Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy
Official title: Laparoscopic Cholecystectomy: Use of Infiltration With Levobupivacaine and Postoperative Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Cholecystectomy
Postoperative Pain
Local Infiltration
Levobupivacaine
Keywords: Laparoscopic cholecystectomy
Postoperative Pain
Local Infiltration
Levobupivacaine
Randomized controlled trial
Lead sponsor: Hospital Universitario de Móstoles
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 233
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: Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration.

Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.


Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patient refusal
* Open surgery
* Reintervention surgery
* Drain tube placement
* Cognitive impairment
* Allergic reactions to local anesthetics

Primary outcomes:
measure: Postoperative pain assessed by visual numeric scale.
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative administration of analgesics
timeFrame: 24 hours
measure: Postoperative nausea and vomiting episodes
timeFrame: 24 hours
Other outcomes:
Locations:
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
Study officials:
affiliation: H. U. REY JUAN CARLOS
name: MANUEL DURÁN POVEDA, MD
role: STUDY_DIRECTOR
affiliation: H. F. ALCORCÓN
name: GIL RODRÍGUEZ CARAVACA, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04286529: Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
Official title: Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pre-Diabetic
Keywords: Pre-menopausal women
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of \>24kg/m2
* Fasting serum glucose \<126 mg/dL

Exclusion Criteria:

* BMI\</=24 kg/m2
* Fasting serum glucose \>/=126 mg/dL
* Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
* Serum Calcium \>10.2 mg/dL
* Serum inorganic phosphorous \>4.5mg/dL
* Pregnancy or breastfeeding
* Diagnosis of Diabetes Mellitus
* Diagnosis of Rheumatoid Arthritis
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Renal in sufficiency/failure ( serum creatinine \>1.5 mg/dL men, \> 1.3 mg/dL women)
* Chronic active liver disease (bilirubin \>1.2 mg/dL, AST\>144IU/L, or ALT \>165 IU/L)
* History of chronic hepatitis
* Active coronary artery disease ( unstable angina, myocardial infarction, stroke and revascularization of coronary, peripheral or carotid artery within the last 3 months)
* Oral warfarin group medications or history of blood clotting disorders
* Platelet count \<100,000 per uL within the last 7 days
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L)
* Debilitating chronic disease (at the discretion of the investigators)
* The presence of infections, highly communicable diseases ( AIDS, active tuberculosis, venereal disease, hepatitis)
* Any malignancy

Primary outcomes:
measure: Glucose Levels
timeFrame: Baseline and 8 weeks
measure: Insulin Level
timeFrame: Baseline and 8 weeks
measure: C-Peptide Level
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: PROMIS 10 Questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rajiv Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909129: Interactions of Hepatitis C Viral (HCV) Dynamics and Immune Activation in HIV Coinfected Patients During HCV Treatment
Official title: Hepatitis C Virus Dynamic and Immune Activation in HIV-1 Coinfected Patients Treated With Pegylated Interferon Alfa-2a and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Chronic Hepatitis C
Keywords: HIV-1
Chronic hepatitis C
Immune activation
HCV kinetics
IP-10
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Hoffmann-La Roche
First posted: 2009-05-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate T-cell mediated immune responses to HIV-1 and HCV and determine how these responses are affected by HCV treatment and correlates to response. Furthermore, to study Interferon-inducible protein-10 (IP-10) dynamics during HCV treatment, and correlate this to treatment outcome.


Eligibility criteria: Inclusion Criteria:

* HIV-1 Hepatitis C coinfected adult patients
* Hepatitis C treatment naive
* Stable HIV-1 infection with or without cART
* \> 300 CD4+ cell count

Exclusion Criteria:

* Decompensated liver disease
* Ongoing depression
* Ongoing drug abuse
* Other contraindications for interferon or ribavirin treatment

Primary outcomes:
measure: Sustained virological response
timeFrame: 24 weeks end of treatment (EOT)
Secondary outcomes:
measure: T-cell mediated immune responses
timeFrame: baseline to 24 weeks EOT
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
affiliation: Infectious Diseases Unit, Dept of Medicine Solna, Karolinska Institutet Stockholm
name: Annette Alaeus, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez VD, Falconer K, Michaelsson J, Moll M, Reichard O, Alaeus A, Sandberg JK. Expansion of CD56- NK cells in chronic HCV/HIV-1 co-infection: reversion by antiviral treatment with pegylated IFNalpha and ribavirin. Clin Immunol. 2008 Jul;128(1):46-56. doi: 10.1016/j.clim.2008.03.521. Epub 2008 May 20.
citation: Falconer K, Askarieh G, Weis N, Hellstrand K, Alaeus A, Lagging M. IP-10 predicts the first phase decline of HCV RNA and overall viral response to therapy in patients co-infected with chronic hepatitis C virus infection and HIV. Scand J Infect Dis. 2010 Dec;42(11-12):896-901. doi: 10.3109/00365548.2010.498019. Epub 2010 Jul 7.
Clinical trial NCT06735729: Attitudes and Technical Maneuvers Regarding Enterostomy Management and Stoma Creation Among Surgeons
Official title: Attitudes and Technical Maneuvers Regarding Enterostomy Management and Stoma Creation Among Surgeons: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Colorectal Surgery
Keywords: surgeon attitude
surgical procedure
stoma
enterostomy
colorectal cancer
cross-sectional study
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 401
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the surgeons were coming from either general surgery, gastrointestinal surgery, surgical oncology, emergency, and other departments involved stoma creation. their concepts and attitudes regarding to enterostomy management were investigated by a electronic questionnaire which comprised of five parts: personnel qualification and training, attitude toward stoma-related complications, preoperative siting, process of acquiring ostomy-related surgical skills, and awareness and adoption of relevant techniques (37 items in total).

At the end of the study, a total of 401 participants participated including 188 hospitals of different grades across 26 provinces or municipalities directly under the Central Government.

Brief summary: This study was aiming to investigate Chinese surgeons' attitudes toward and technical preferences for stoma creation.

Detailed description: The survey comprised five parts: personnel qualification and training, attitude toward stoma-related complications, preoperative siting, process of acquiring ostomy-related surgical skills, and awareness and adoption of relevant techniques (37 items in total). The questionnaire was distributed to Chinese hospitals by Sojump, a professional online platform. Finally, about 401 surgeons had responded including 188 hospitals of different grades across 26 provinces or municipalities directly under the Central Government.

Eligibility criteria: Inclusion Criteria: General or gastrointestinal surgeons involved in general surgery, gastrointestinal surgery, surgical oncology, emergency, and others involved in managing enterostomies who had completed their degree and were licensed, or at least resident surgeons were included.

-

Exclusion Criteria: Surgeons who did not provide consent to participate in this study were excluded.

-

Primary outcomes:
measure: attitude, technical preferences
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Haidian district
Study officials:
References:
Clinical trial NCT04378829: Platelet Count, Platelet, Mean Platelet Volume and Platelet Distribution Width in COVID-19
Official title: Does the Platelet Count, Mean Platelet Volume and Platelet Distribution Width Change in COVID-19 Pandemic, ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Mean Platelet Volume
Platelet Destruction
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group will be selected from patients followed up in the 1-month period from the hospital online COVID-19 monitoring system.

Brief summary: The study will aim to investigate the relation of platelet count (PLT), mean platelet volume (MPV) and platelet distribution width (PDW) with other acute phase reactant c-reactive protein(CRP) in Coronavirus(COVID-19).

As a methodology, patients will be selected in records in one month from the online hospital system. Two groups will be divided before as need for mechanical ventilation or not. The latter comparison will be about three groups as an ambulatory follow-up, hospital follow-up, and intensive care unit follow-up. Parameters will be analyzed according to the groups.

Detailed description: In this study, as a methodology, patients diagnosed with PCR test through the online system created for COVID-19 patients will be included in the study. These patients will be divided into 3 groups as outpatient follow-up, hospital follow-up and follow-up with a mechanical ventilator in intensive care. In addition, patients who have completed the 14-day treatment period, which is considered as the turning point time of the world health organization by looking at the patients 3 times, every 5-7 days, which is the accepted incubation period, will be included in the study. In these patients, hemoglobin, leukocyte, platelet, MPV, PDW and CRP values will be examined for 3 weekly measurements. Changes in COVID-19 disease follow-up and treatment of MPV and PDW values, which have not been studied so far, will be investigated.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with COVID-19, both PCR tests and computed tomography, as well as control hemogram and CRP tests at one week intervals will be included.

Exclusion Criteria:

* Those with suspicion of COVID-19, those who do not perform hemogram and c-reactive protein tests 3 times with one week intervals, those who do not have standard drug treatment will be excluded from the study.

Primary outcomes:
measure: Change in PDW and MPV parameters
timeFrame: 3 weeks totally tests.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Yasin Tire
Study officials:
References:
Clinical trial NCT05690529: Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation
Official title: Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Radiofrequency ablation
Lead sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing radiofrequency AF ablation guided by 3D mapping

Brief summary: Determine echocardiographic predictors of atrial fibrillation recurrence post radiofrequency Ablation and evaluate markers of low voltage areas on 3D mapping.


Eligibility criteria: Inclusion Criteria:

* paroxysmal or persistent ablation

Exclusion Criteria:

* previous AF ablation
* previous left atrial ablation
* refusal to give informed consent
* congenital cradiomiopathy

Primary outcomes:
measure: Recurrence
timeFrame: 1 year
Secondary outcomes:
measure: Low voltage areas
timeFrame: At procedure
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
Study officials:
References: