louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02521337: PreTerm RNA in Maternal Serum
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Birth
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy pregnant women

Brief summary: Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation. The incidence of preterm birth in Israel in the last years is around 7-8%.

Despite various diagnostic modalities as well as newly therapeutic approaches the incidence of preterm birth remains unchanged and is considered to be the leading cause of neonatal morbidity and mortality.

In the last decade, small RNAs have emerged as an important player in both physiological and pathophysiological responses. These single strands, non-coding regulatory RNA molecules are responsible for post transcriptional regulation of target genes. Hence, may provide a new opportunity for biomarkers discovery in the field of preterm birth.

The main objective of this study is to identify a distinctive expression profile of maternal circulating RNAs that will be used as biomarkers for preterm birth.


Eligibility criteria: Inclusion Criteria:

1. Women with singleton pregnancy at 26-32 week of gestation with no clinical symptoms of preterm labor.
2. Women with singleton pregnancy 24-34 week of gestation who present to the labor suite with symptoms suspected for preterm labor.
3. Women with singleton pregnancy in term active labor (weeks 37-40).

Exclusion Criteria:

Exclusion criteria will include:

1. multiple gestation,
2. major fetal anomalies,
3. IUFD,
4. severe preeclampsia,
5. chronic steroid or immunosuppressive drug use,
6. active immunological illness,
7. and/or pregestational and gestational DM.

Primary outcomes:
measure: Number of women with preterm labor that present a unique RNA cluster
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00707837: Nutritional Study in Preterm Infants
Official title: Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 206
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk


Eligibility criteria: Inclusion Criteria:

* Birthweight 500-1800 g
* Less than 33 wks gestational age
* Enteral feeding initiated by 21 days of life
* Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
* Singleton or twin births only
* Infant is 21 days of age or less at time of randomization

Exclusion Criteria:

* Serious congenital abnormalities that may affect growth and development
* Grade III or IV intraventricular hemorrhage (IVH)
* Maternal incapacity
* History of major surgery
* Extracorporeal membrane oxygenation (ECMO)
* Asphyxia
* Confirmed NEC or positive blood cultures at the time of randomization

Primary outcomes:
measure: The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants
timeFrame: variable
Secondary outcomes:
measure: Measures of eye function, ROP, measures of skin lipid soluble compound concentration
timeFrame: variable
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: St. Petersburg
country: United States
facility: West Coast Neonatalogy, All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Vahalla
country: United States
facility: Maria Fareri Children's Hospital at Winchester Medical Center
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Abbott Nutrition
name: Bridget Barrett-Reis, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00000437: Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
Official title: Nalmefene in Nicotine and Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Smoking
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 60
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 purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

Detailed description: Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence and nicotine dependence.
* Expresses a desire to cut down or stop drinking and smoking.

Exclusion Criteria:

* Currently meets criteria for dependence on substances other than alcohol and nicotine.
* Any history of opiate dependence or evidence of current opiate use.
* Significant medical disorders that will increase potential risk or interfere with study participation.
* Liver function tests more than 3 times normal or elevated bilirubin.
* Females who are pregnant, nursing, or not using a reliable method of birth control.
* Meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy.
* Inability to understand and/or comply with the provisions of the protocol and consent form.
* Treatment with an investigational drug during the previous month.
* Chronic treatment with any narcotic-containing medications during the previous month.
* Sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists.
* Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.
* More than 6 weeks of abstinence.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Department of Psychiatry, University of Miami School of Medicine
state: Florida
Study officials:
affiliation: University of Miam
name: Barbara Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103037: Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma
Official title: A Randomized, Double-blind, Parallel Group Study to Compare the Pharmacodynamics/Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: Mild
Moderate
Asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 8
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 study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma


Eligibility criteria: Inclusion Criteria:

* Patients with moderate persistent asthma

Exclusion Criteria:

* Smokers
* Any significant disease or illness, other than asthma

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry
timeFrame: 28 days
Secondary outcomes:
measure: FEV1 assessments at various timepoints including time of peak drug concentration
timeFrame: 28 days
measure: Measure the change in exhaled Nitric Oxide (FeNO)
timeFrame: 28 days
measure: Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.
timeFrame: 28 days
measure: Total serum IgE levels
timeFrame: 28 days
measure: Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.
timeFrame: 28 days
Other outcomes:
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials
state: California
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06108037: DHL Survey on Generative AI for MyChart Messaging
Official title: Duke Health Listens Survey on Generative Artificial Intelligence (AI) for MyChart Messaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: Artificial Intelligence
Generative Artificial Intelligence
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 1454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Participants will be randomly allocated to one of six arms.
* Over the course of the study period, there will be multiple rounds of surveys, which will consist of a clinical scenario, a response (human or AI generated), and a disclosure statement (none, human, or AI).
* All respondents within an arm will be assigned to a sequence of response-disclosure pairs prior to the first round of surveys.
Primary purpose: OTHER

Brief summary: The purpose of this study is to understand how patients feel about the use of computer programs to create responses when they send electronic messages to their doctors.

Detailed description: * The investigators will create short surveys online to ask patients how they feel about using computer programs that create messages in their medical records.
* The surveys will show fictional situations where patients ask questions and get answers from either real people or computer programs, with or without a disclosure about how the response was written.
* The investigators will ask the people taking the survey to share what they think about these situations using tools like rating scales, comparison scales, or written responses.
* If patients want to, they can provide their contact information to be part of future discussion groups. Participants do not have to give any personal information to complete the survey.

Eligibility criteria: Inclusion Criteria:

* Member of the Duke Health Listens patient advocacy community

Exclusion Criteria:

* Age \< 18

Primary outcomes:
measure: Patient satisfaction, as measured by survey
timeFrame: Up to 2 weeks
measure: Patient attitudes towards utility, as measured by survey
timeFrame: Up to 2 weeks
measure: Patient empathy, as measured by survey
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Anand Chowdhury, MD, MMCi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayers JW, Poliak A, Dredze M, Leas EC, Zhu Z, Kelley JB, Faix DJ, Goodman AM, Longhurst CA, Hogarth M, Smith DM. Comparing Physician and Artificial Intelligence Chatbot Responses to Patient Questions Posted to a Public Social Media Forum. JAMA Intern Med. 2023 Jun 1;183(6):589-596. doi: 10.1001/jamainternmed.2023.1838.
Clinical trial NCT04247737: Gluten Free Diet in IBS
Official title: Effect of a Gluten Free Diet in Patients With IBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gluten Sensitivity
Keywords: non-celiac glutensensitivity
irritable bowel syndrom
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 25 healthy individuals and 150 patients with irritable bowel syndrome keep a gluten-free diet for six weeks
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. The effect of a gluten-free diet (GFD) on clinical symptom improvement and psychological well-being will be checked in patients with IBS. In addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. Responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.

Detailed description: Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. Since it has been shown that a gluten free diet (GFD) often alleviates the clinical symptoms, an overlap between patients with IBS and non-celiac glutensensitivity is assumed. The study includes 25 healthy individuals and 150 patients with IBS taking a six week GFD. Participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. Patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of NCGS.

In addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.

Eligibility criteria: Inclusion Criteria:

* healthy controls without gastrointestinal Symptoms
* patients with irritable bowel Syndrome (Rome IV criteria)

Exclusion Criteria:

* inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
* celiac disease
* wheat allergy
* pregnancy

Primary outcomes:
measure: Determination of inflammatory Stimulation of monocytes after gluten exposure
timeFrame: six weeks
measure: Differences in Stimulation of inflammatory Parameters between healthy controls and patients with irritable bowel disease (IBD)
timeFrame: six weeks
Secondary outcomes:
measure: Effect of a gluten free diet on improvement of gastrointestinal symptoms
timeFrame: six weeks
measure: Effect of the gluten free diet on Quality of life
timeFrame: six weeks
measure: Determination of a subgroup of Patients with NCGS in IBS cohorte
timeFrame: six weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
References:
Clinical trial NCT01520337: Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy
Official title: Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyp and Adenoma Detection During Colonoscopy
Lead sponsor: CosmoTech
Sponsor class: UNKNOWN
First posted: 2012-01-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for screening or surveillance colonoscopy.

Brief summary: Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets

Detailed description: Polyp detection rate in colonoscopy following oral administration of methylene blue MMX modified release tablets in subjects undergoing colonoscopy as outpatients.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for screening or surveillance colonoscopy. Written informed consent.Practising reliable contraception or sterile.Ability to understand and comply with the protocol.

Exclusion Criteria:

* Pregnancy or lactation known or suspected hypersensitivity GI obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.

Primary outcomes:
measure: Polyp and adenoma detection rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02647437: Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia
Official title: Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy of low-dose LEV in reducing hippocampal activity in schizophrenia. The investigators also hypothesize that LEV will improve neurocognition in participants with schizophrenia.

Detailed description: LEV is typically administered in twice-daily doses of 500-1500 mg for the treatment of epilepsy; these doses are generally well tolerated (Patsalos, 2000). Most relevant to the proposed study, LEV (125 mg twice-daily, two week administration) has been shown to reduce hippocampal hyperactivity and improves cognition in patients with mild cognitive impairment (MCI).

The proposed study will administer 125 mg of immediate release LEV twice-daily for two weeks. This dose was chosen to potentially maximize efficacy while minimizing side effects. The proposed dose is substantially lower than the most common dose used clinically for epilepsy treatment of 3000 mg/day.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Good general health
* Normal vital signs (blood pressure, pulse, cardiac, pulmonary, abdominal, neurological exam)
* Normal renal function (as assessed by a metabolic panel at screening if results current within three months are not already available)

Exclusion Criteria:

1. Substance abuse
2. Significant neurological disorders
3. Significant head trauma/injury
4. Left-handedness
5. Pregnancy
6. MRI-specific exclusion criteria (e.g., claustrophobia, weight \> 450lbs, metal in the body)

Primary outcomes:
measure: Resting-state neuronal response
timeFrame: 2 weeks
Secondary outcomes:
measure: Neurocognitive function
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason Tregellas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06091137: Appendectomy and Colorectal Cancer
Official title: Altered Gut Microbiome Composition by Appendectomy Contributes to Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Appendicitis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 180000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60000 appendectomy cases and 120000 controls

Brief summary: Colorectal cancer (CRC) is one of the most common cancer worldwide. Initiation and progression of CRC involve complex interactions among genetic, epigenetic and environmental factors. Given that hereditary and familial CRC only accounts for 2% to 5% of cases, environmental factors are the key triggers of CRC. Emerging evidence has indicated that gut microbes are an important environmental factor promoting CRC development. Gut dysbiosis has been shown to promote colorectal carcinogenesis in mice. Several individual bacterial species, such as the enterotoxigenic Bacteroides fragilis (ETBF), Fusobacterium nucleatum and Peptostreptococcus anaerobius, could exert carcinogenic effects by inducing direct DNA damage, oxidative damage and activating oncogenic signaling pathways. Recent studies have shown that the appendix plays an important role in maintaining homeostasis and biodiversity of gut microbiome by providing an ideal ecological niche for commensal bacteria and production of immunoglobulin A. Considering the key role of microorganisms in gastrointestinal pathophysiology, absence of appendix may result in disruption of microbiome homeostasis, which could potentially influence the risk of developing CRC. In terms of epidemiological evidence, the association of appendectomy with the risk of CRC development has been controversial, and to date no consensus has been attained. Although gut microorganisms could be a crucial pivot between appendectomy and risk of subsequent CRC development, the direct contribution of appendectomy and the underlying mechanisms are still largely unexplored. In this study, we aim to study

1. the association between appendectomy and colorectal cancer, and
2. the role of appendectomy in CRC risk through causing gut microbial dysbiosis.


Eligibility criteria: Inclusion Criteria:

* Individuals underwent appendectomy from January 2000 to December 2020

Exclusion Criteria:

1. patients with the age ≤18 years at enrollment;
2. Patients with any malignant diseases or inflammatory bowel disease history before enrollment;
3. Patients with hereditary syndromes of colorectal adenomas or polyps (familial adenomatous polyposis, Lynch syndrome, etc.);
4. Patients that underwent appendectomy for appendiceal neoplasms.

Primary outcomes:
measure: Appendectomy is associated with risk of subsequent CRC incidence
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Institute of Digestive Disease, The Chinese University of Hong Kong
Study officials:
References: