louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00950586: Safety, Blood Levels, Drug Interaction and Effects of Repeated Doses of GSK1034702
Official title: A Placebo-controlled, Single-blind, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Drug Interaction of GSK1034702 After Repeat Doses in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Disorders
Keywords: Drug interaction
Saftey
Pharmacokinetics
Cognition
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men and women of no child beading potential to investigate repeated doses of the study medicine. The study will investigate the following questions, do repeated doses of the study medicine have any important side effects when taken by mouth? How much of the study medicine gets into the bloodstream, and how quickly does the body get rid of it? Does the study medicine affect memory, attention and problem-solving skills? What are the effects when the study medicine and dextromethorphan are taken together.


Eligibility criteria: Inclusion Criteria:

* Male or female of non childbearing potential
* Generally healthy
* Body mass index 19 - 29.9 kg/m2 (inclusive), body weight greater than or equal to 50 kg for males and greater than of equal to 45 kg for females
* Normal Laboratory test results

Exclusion Criteria:

* Abuse of drugs or alcohol
* Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months
* ECG abnormality (personal or family history)
* Psychiatric disorder
* Asthma or a history of asthma
* Medical illness

Primary outcomes:
measure: Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.
timeFrame: Up to 28 days
measure: GSK1034702 PK parameters: Cmax; tmax; AUC(0-t)
timeFrame: Up to 28 days
measure: Dextromethorphan PK parameters: Cmax; tmax; AUC(0-t).
timeFrame: Day -2, 1 and 14
measure: Effects on Cognitive tests.
timeFrame: Up to day 28
measure: Effects on salivary secretion
timeFrame: up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06388486: Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy
Official title: Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 63
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: Depressed inpatients, admitted for multimodal treatment, including psychotherapy.

Brief summary: The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:

* Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?
* Are subjects with these psychological traits affected differently by psychotherapeutic intervention?

Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Detailed description: Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of current depression

Exclusion Criteria:

* inadequate knowledge of the German language
* unable to give informed consent
* severe psychiatric comorbidities, such as drug abuse and psychotic diseases
* deemed critically unstable by their treating physician

Primary outcomes:
measure: Change in depression
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01769586: Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
Official title: Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Endoscopy
Keywords: Sedation
Endoscopy
Diphenhydramine
Midazolam
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2013-01-16
Enrollment: 200
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: Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.

Detailed description: Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine (up to 3 incremental doses of 25 mcg each) vs. continued midazolam (up to 3 incremental doses of 1.5 mg each). the level of sedation will be assessed using the MOAA/S scale 2-3 minutes after each administration to determine if they are sufficiently sedated to begin colonoscopy. The patient, the healthcare team involved in performing the endoscopy, and the investigator assessing sedation will be blinded to the therapy. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.

Eligibility criteria: Inclusion Criteria:

* Patients \>18 years-old who are undergoing elective colonoscopy with conscious sedation

Exclusion Criteria:

* allergy or prior adverse reactions to diphenhydramine
* medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma)
* pregnancy

Primary outcomes:
measure: Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)
timeFrame: Approximately 10 minutes or less
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Loren Laine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sachar H, Pichetshote N, Nandigam K, Vaidya K, Laine L. Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial. Gastrointest Endosc. 2018 May;87(5):1297-1303. doi: 10.1016/j.gie.2017.01.028. Epub 2017 Jan 31.
Clinical trial NCT00967486: Selective Versus Routine Shunting in Carotid Endarterectomy Patients
Official title: Selective Shunting in Appropriately Selected Patients Undergoing Carotid Endarterectomy Based on Stump Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenoses, Carotid Artery
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op complications and occurence rates. Patients will be randomized to Routine shunt vs selective groups.

Detailed description: The significance extends to all surgeons who perform Carotid endarterectomy because of their desire to improve patient care by decreasing the overall perioperative complication rate of the procedure by selectively not shunting those patients who ideally do not require it and thus eliminating the attendant morbidity associated with it.

The hypothesis is that there will be no difference in patient outcomes (death, minor strokes, major strokes, transient ischemic attack (TIA)) for patients undergoing a Carotid endarterectomy with a SP of \> 50 mm Hg using selective shunting.Patients will be randomized to Routine shunt vs selective groups. In Selective shunt, there will be subgroup analysis to measure % stenosis if the systolic pressure is \< 40mmHg calling it as Shunt group. All patients in the study, irrespective of treatment group will be followed post-operatively from 24 hours to 30 days. The patient will be monitored and the following outcomes documented - death, minor stroke, major stroke, trans-ischemic attack (TIA).

Eligibility criteria: Inclusion Criteria:

* Patients with a SP \>= 50 mmHg will be randomized to receive a shunt or not receive a shunt.

Exclusion Criteria:

* Patients that will be excluded are those who present for a redo CEA, have had a coronary artery bypass graft (CABG), permanent stroke, and or a contralateral artery total occlusion of \> 30%.
* Finally, consented patients with a stump pressure of \<= 50 mm Hg will be excluded from the study and receive standard of care.

Primary outcomes:
measure: Overall Perioperative Complications Between Selective vs. Routine Shunting.
timeFrame: Within 30 days of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: (Vascular Center of Excellence)
state: West Virginia
Study officials:
affiliation: CAMC Medical Staff - with admitting privileges
name: Ali F AbuRhama, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02527486: Seoul National University Airway Registry
Official title: Airway Registry for Chronic Airway Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Asthma
Asthma With Chronic Obstructive Pulmonary Disease
Bronchiectasis
Inactive Tuberculosis of Lung
Chronic Obstructive Airway Disease
Keywords: COPD
Asthma
ACOS
Bronchiectasis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD Asthma ACOS Bronchiectasis TB-destroyed lung Other chronic airway diseases

Brief summary: This is a multicenter, prospective observational cohort study, in which patients with chronic airway diseases including chronic obstructive pulmonary disease(COPD), asthma, asthma-COPD overlap syndrome (ACOS) will be recruited.


Eligibility criteria: COPD

Inclusion Criteria:

* Postbronchodilator FEV1/FVC \< 0.7 AND chronic respiratory symptom

Exclusion Criteria:

-

Asthma

Inclusion Criteria:

* Never smoker or \<5PY of smoking history AND Recurrent episodes of asthma symptoms (wheezing, dyspnea, chest tightness, cough) AND (either Positive BDR OR positive metacholine/mannitol/exercise provocation test)

Exclusion Criteria:

-

ACOS

Inclusion Criteria:

* COPD AND Asthma (regardless of smoking status)

Exclusion Criteria:

-

Primary outcomes:
measure: Death (time to death)
timeFrame: upto 20 years
Secondary outcomes:
measure: post-bronchodilator FEV1 change rates
timeFrame: upto 20 years (at least 3 years)
Other outcomes:
measure: Time to 1st exacerbation (definition of exacerbation is described below)
timeFrame: upto 20 years
measure: Annual rate of exacerbation (definition of exacerbation is described below)
timeFrame: upto 20 years
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Gyu Yoo, M.D.
role: STUDY_CHAIR
References:
citation: Jo YS, Park S, Kim DK, Yoo CG, Lee CH. The cutoff point of clinical chronic obstructive pulmonary disease questionnaire for more symptomatic patients. BMC Pulm Med. 2018 Feb 27;18(1):38. doi: 10.1186/s12890-018-0601-0.
citation: Jo YS, Lee J, Yoon HI, Kim DK, Yoo CG, Lee CH. Different prevalence and clinical characteristics of asthma-chronic obstructive pulmonary disease overlap syndrome according to accepted criteria. Ann Allergy Asthma Immunol. 2017 Jun;118(6):696-703.e1. doi: 10.1016/j.anai.2017.04.010.
Clinical trial NCT02931786: Effects of Propofol and Ketofol on Core Body Temperature in MRI
Official title: Does Magnetic Resonance Imaging Increase Core Body Temperature in Anesthetized Children? Evaluating the Effects of Propofol and Ketofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Keywords: core body temperature
magnetic resonance imaging
propofol
ketofol
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigators researched the effect of two different types of drugs on core body temperature during magnetic resonance imaging. The hypothesis is in ketamine group, thermo disregulation is not as distinct as in propofol group, due to its positive effect on thermo regulation

Detailed description: Intravenous anesthetics may impair thermoregulation. Absorption of radiofrequency waves by the body surface may result in heating, especially in small children during magnetic resonance imaging (MRI). Investigators applied two different intravenous anesthetics as propofol and ketamine and studied the effect of these drugs on core body temperature.

All patients aged between 6 months-10 years were administered midazolam and atropine. After that 1 mg/ kg of propofol was applied in group I, and 0,1 ml/kg of propofol ketamine mixture ( 10 mg/ml each) was applied in group II. Core body temperatures were taken before and after MRI and compared.

Eligibility criteria: Inclusion Criteria:

* children aged between 6 months-10 years,
* underwent MRI under anesthesia
* ASA I-II

Exclusion Criteria:

* History of drug allergy
* Severe pulmonary and cardiac disease
* Intracranial hypertension

Primary outcomes:
measure: Change in core body temperature
timeFrame: during magnetic resonance imaging (MRI) procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03973086: To Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-04
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program.

This study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.


Eligibility criteria: Inclusion Criteria:

1. Male and female participants with the age of ≥18 and ≤ 60 years of age.
2. BMI of ≥25 - ≤ 35 kg/m2
3. Waist circumference:India: Men: \> 94 cm (37 inches), Women: \>80 cm (31.5 inches) USA: Men: \> 102 cm (40 inches), Women: \>89 cm (35 inches)
4. Triglycerides \>150 mg/dL
5. Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg
6. Fasting blood glucose ≥ 100 mg/ dl
7. Low HDL level: Men: \< 40 mg/dL, Women: \< 50 mg/dL
8. Ready to give voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the trial:

1. Current smoker.
2. Inability to walk independently.
3. Presence of unstable, acutely symptomatic, or life-limiting illness.
4. Neurological conditions causing functional or cognitive impairments
5. Unwillingness or inability to be randomized to one of three intervention groups.
6. Bilateral hip replacements.
7. Exposure to any non-registered drug product within 3 months prior to the screening visit.
8. Unable/unwillingness to complete study specific diaries (digital/paper-based).

Primary outcomes:
measure: Change in body fat percent Body Mass Index (kg/m2)
timeFrame: 16 weeks.
measure: Change in Lean Body Mass (g)
timeFrame: 16 weeks
measure: Change in Body Fat (%)
timeFrame: 16 weeks
measure: Change in Fat Free Mass (g)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Reveal
state: Florida
Study officials:
References:
Clinical trial NCT06127186: Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections
Official title: Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections - a Cross-sectional Study in Primary Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Respiratory Tract Infections
Lead sponsor: Swiat Zdrowia
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with upper respiratory tract infection.

Brief summary: The goal of this longitudinal study is to assess headache and facial pain features in patients with upper respiratory tract infections (URTI). The main question it aims to answer are:

1. What is the phenotype of headache / facial pain in URTIs
2. Does the above mentioned phenotype is associated with:

   1. aetiologic factor (virus),
   2. type of URTI
   3. headache/facial pain experienced by patients in the past.

Participants will:

* answer standardized questions,
* undergo physical examination,
* have a swab test performend for antigens of common viruses causing URTI.


Eligibility criteria: Inclusion Criteria:

* URTI confirmed by primary care physician
* Informed consent to participate in the study

Exclusion Criteria:

* chronic or recurrent upper respiratory tract disorders
* neoplasms
* signs or symptoms of a serious neurologic or psychiatric disorder.

Primary outcomes:
measure: Percentage of patients with one of the specified pain phenotypes
timeFrame: A single assessment during primary care physician office 1 day visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Dzwierzuty
country: Poland
facility: Marcin Straburzyński
state: Warmińsko-mazurskie
Study officials:
References:
Clinical trial NCT03684486: Rehabilitation by Effort for Patients With Advanced Bronchial Cancer
Official title: Rehabilitation by Effort for Patients With Advanced Bronchial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Cancer
Malignant Mesothelioma
Keywords: bronchial cancer
rehabilitation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to pathology (chronic inflammation) and also to treatments (surgery, radiotherapy, chemotherapy); it's considerably alters patients quality of life.

Investigators want to ensured the feasibility of rehabilitation by effort for these patients.


Eligibility criteria: Inclusion Criteria:

* General condition according to World Health Organisation 0-1
* Age between 18 and 70 years old
* Non progressive patients according to RECIST criteria 1.1 after chemotherapy treatment whichever line of treatment
* Autonomous patient
* Voluntary written informed consent signed
* Patients with social security insurance

Exclusion Criteria:

* Bone metastasis with fracture risk
* Significant cardiovascular pathology
* Cardiac, vascular, rheumatologic or neurologic contraindication
* Patients living far 60 kms from Toulouse
* Patients under juridical protection guardianship, or tutelage measure

Primary outcomes:
measure: patients who completed at least 6 sessions of rehabilitation
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Julien Mazières, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: