louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01367483: Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX
Official title: An Open-Label, Phase I, Single Dose Study of the Pharmacokinetics, Mass Balance and Disposition of Intravenously Administered 14C-Methylnaltrexone in Normal, Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.


Eligibility criteria: Inclusion Criteria:

1. Males between 18-45
2. Subject weight between 70 and 90 kg
3. In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation

Exclusion Criteria:

1. History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
2. Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
3. History of or predisposition to erratic or abnormal bowel function.

Primary outcomes:
measure: Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX
timeFrame: 5.5 days
Secondary outcomes:
measure: Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX
timeFrame: 5.5 Days
measure: Clearance of IV MNTX
timeFrame: 5.5 days
measure: Half-life of IV MNTX
timeFrame: 5.5 days
measure: Volume of Distribution of IV MNTX
timeFrame: 5.5 days
measure: Urinary Clearance of IV MNTX
timeFrame: 5.5 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02094183: The Interaction Between Appetite Hormones
Official title: The Interaction Between Appetite Hormones and Their Importance for Maintenance of Weight Loss After a Low Calorie Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2014-03-21
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change

Detailed description: Many obese people have had several successful weight losses, however very few can maintain the weight loss over a longer period (e.g. one year) Therefore, we want to investigate the metabolic response and the importance for maintenance of weight loss in obese people, who lost at least 7, 5 % body weight by low calorie diet followed by 52 weeks of diet weight maintenance with or without supplement of GLP-1.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30 and \< 40 (kg/m2)
* Healthy

Exclusion Criteria:

* Other known illness
* Medicine that affects glucose- and lipid metabolism, appetite or food intake
* Pregnancy
* Breast feeding

Primary outcomes:
measure: Change in hormone level corrected for weight change
timeFrame: Baseline and week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: University of Copenhagen
name: Jens Holst, DMSCi
role: STUDY_CHAIR
References:
citation: Akawi N, Checa A, Antonopoulos AS, Akoumianakis I, Daskalaki E, Kotanidis CP, Kondo H, Lee K, Yesilyurt D, Badi I, Polkinghorne M, Akbar N, Lundgren J, Chuaiphichai S, Choudhury R, Neubauer S, Channon KM, Torekov SS, Wheelock CE, Antoniades C. Fat-Secreted Ceramides Regulate Vascular Redox State and Influence Outcomes in Patients With Cardiovascular Disease. J Am Coll Cardiol. 2021 May 25;77(20):2494-2513. doi: 10.1016/j.jacc.2021.03.314.
citation: Iepsen EW, Lundgren JR, Hartmann B, Pedersen O, Hansen T, Jorgensen NR, Jensen JE, Holst JJ, Madsbad S, Torekov SS. GLP-1 Receptor Agonist Treatment Increases Bone Formation and Prevents Bone Loss in Weight-Reduced Obese Women. J Clin Endocrinol Metab. 2015 Aug;100(8):2909-17. doi: 10.1210/jc.2015-1176. Epub 2015 Jun 4.
Clinical trial NCT01762683: Influence of Preconceptional Obesity on the Myometrial Cells Differentiation Toward a Contractyl Phenotype
Official title: Study of Role of Mononuclear Cells of Maternal Peripheric Blood in Human Myometrial Primar Cell Lines Differentiation Toward a Contratyl Phenotype: Influence of Preconceptional Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complication
Keywords: pregnancy
obesity
differentiation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to improve the understanding of cellular mecanism involved in delivery disorders in obese women, first by characterizing the hyperplasia phenomenon of myometrail cells induced by inflammatory stimulation (Il-1B), then by studying the role of blood mononuclear cells, of leptine and of obese women sera to interfere with the transition of myometrial cells toward hyperplasia phenotype.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed
* Patient affiliated with a social security scheme
* In front of for obstetrical reasons to give birth by caesarean section (scheduled caesarean section)
* Or a woman who is not obese in labour and needs to undergo a cesarean section
* No obvious infectious context
* Age \> 18 years old

Exclusion Criteria:

* Obvious inflammatory or autoimmune diseases
* Suspected or confirmed infectious context, including virale infection VIH, VHC, VHB
* Coagulation disorders

Primary outcomes:
measure: Measuring the expression level of markers (Gama actine, Desmine, Connexine-43, and Ocytocine receptor) by Westernblotting
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Maternité du CHU de Dijon
state: Bourgogne
city: Dijon
country: France
facility: Clinique Sainte Marthe
Study officials:
References:
Clinical trial NCT01259583: Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warm Water
CO2 Colonoscopy
Unsedated Colonoscopy
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.


Eligibility criteria: Inclusion Criteria

* adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent

Primary outcomes:
measure: number of patients undergoing complete unsedated colonoscopy
timeFrame: 6 months
Secondary outcomes:
measure: evaluation of pain and tolerability scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Como
country: Italy
facility: Valduce Hospital - Gastroenterology Department
Study officials:
References:
citation: Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.
Clinical trial NCT06024083: Skills Video Intervention for Chinese/Chinese Americans
Official title: Dialectical Behavior Therapy Skills Video Intervention for Chinese and Chinese American College Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotion Regulation
Self Efficacy
Acceptability of Health Care
Keywords: Dialectical Behavior Therapy
Ecological Momentary Assessment
Psychotherapy, Brief
Culturally Competent Care
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study that aims to test a coping skills intervention delivered via brief animated videos for Chinese and Chinese American college students.

Detailed description: We are interested in seeing whether a brief video-based Dialectical Behavior Therapy skills training intervention that incorporates Western psychotherapy components and Eastern philosophies would be perceived as relevant and useful for this culturally unique yet diverse group. During the study, participants will (1) complete a 20-min online baseline questionnaire; (2) complete a brief survey each day using a phone App for up to four weeks; and may (3) receive a video each day during the intervention.

Eligibility criteria: Inclusion Criteria:

* age 18 or older
* identifying as Chinese or Chinese American
* interested in learning coping skills to regulate emotions
* having a smart-phone compatible with the research mobile phone app
* matriculated at the local University for the current semester

Exclusion Criteria:

* currently receiving routine mental health services
* not able to read or write English
* not able to provide informed consent

Primary outcomes:
measure: Emotion regulation measured by a combination of questions
timeFrame: daily for up to 4 weeks
measure: General self efficacy measured by Patient-Reported Outcomes Measurement Information System General Self-Efficacy Short-form 4a
timeFrame: daily for up to 4 weeks
measure: Acceptability/usability of intervention measured by a combination of Likert-scale and open-ended questions
timeFrame: daily following the delivery of each video for up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Qingqing Yin, M.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01618383: Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
Official title: Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
gut
colon
biopsies
LRRK2
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for the development of Lewy bodies disease, and a careful look at discrepancies between these two conditions may provide insight into the pathogenesis of PD. The early involvement of the enteric nervous system (ENS) during PD led to theories that an as yet unidentified external agent entering the ENS causes PD . If lesions of the ENS are found in patients who present with a genetic form of parkinsonism would go against this notion, and thus provide insight to the pathophysiology of the disease.


Eligibility criteria: Inclusion Criteria:

* Patients aged 30-80, both genders
* Parkinson's disease patients
* Parkinson's disease patients with G2019S mutations
* Controls: patient at risk of colic cancer for whom a coloscopy is required

Primary outcomes:
measure: Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
timeFrame: 3 months
Secondary outcomes:
measure: Analysis of intestinal permeability in biopsies using Ussing's chambers
timeFrame: 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Tiphaine ROUAUD, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760783: The Effects of Microgravity on Human Sperm
Official title: The Effects of Microgravity on Human Sperm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Semen Quality
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de Catalunya
name: Dexeus Clinic Woman
First posted: 2018-11-30
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: It has been described that microgravity affects cellular and molecular structures. Cell membrane, cytoskeleton, cytoplasm and nucleus have been found to be sensible to gravitational changes. Alterations in the male and female reproductive systems have also been reported in mouse and other animals. The effects of microgravity on human reproductive cells remain unknown.

The main objective of this experimental study is to investigate the effect of simulated microgravity in human male reproductive cells under in vitro conditions. Induced microgravity conditions will be obtained with a smaller single-engine aerobatic aircraft that can provide parabolic flights.

The main parameters to be analyzed are: sperm motility, vitality, DNA fragmentation and apoptosis.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men)
* Who accepted to take part in the study
* Who gave their written informed consent

Primary outcomes:
measure: Change in Sperm motility
timeFrame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
measure: Change Sperm Morphology
timeFrame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
measure: Change Sperm Vitality
timeFrame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
measure: Change in Sperm DNA Fragmentation
timeFrame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
measure: Change Sperm APOPTOSIS (Annexin V )
timeFrame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Women's Health Dexeus Departament d'Obstetrícia, Ginecologia i Reproducció
Study officials:
References:
citation: Boada M, Perez-Poch A, Ballester M, Garcia-Monclus S, Gonzalez DV, Garcia S, Barri PN, Veiga A. Microgravity effects on frozen human sperm samples. J Assist Reprod Genet. 2020 Sep;37(9):2249-2257. doi: 10.1007/s10815-020-01877-5. Epub 2020 Jul 18.
Clinical trial NCT03245983: Spirituality, Experience of Disease and Quality of Life in Cancer Patients
Official title: Spirituality, Experience of Disease and Quality of Life in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychology and Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The general aim of research is to identify and analyze the impact and role of spirituality (as a search for meaning and understanding of the meaning of existence) in the experience of cancer. For this purpose, the main objective of this study is to measure the "existential" component in the trajectory of the disease. It is a question of observing its potential contribution to the improvement of the quality of life of the patients and to define if this variable can be translated into a strategy of adjustment for the patients. This research has a double interest: (a) clinical interest in better managing patients' needs; (B) an interest in research in the field of health by combining a measure of spirituality with other psycho-social variables.

The project is a prospective non-randomized mono-centric study by questionnaire and research interview. It is a study that seeks to identify the role of spirituality in the experience of illness (i.e. representations, adjustments, emotional distress) and as a determinant of the quality of life of subjects with cancer pathology.

The interviews will be conducted by a psychologist to qualitatively collect the elements of the lived experience of the disease in connection with the spiritual elements of the "quest for meaning" type.

The population covered by the project is in and out patients coming to the Department of Medical Oncology and Palliative Care at the CHU de la Timone.

The realization of this project will allow investigators to explore the specificity of the existential / spiritual dimensions of patients confronted with cancer, to assess the patients' needs for this type of approach within the hospital, to link the existential component / Spiritual with psycho-social variables


Eligibility criteria: Inclusion Criteria:

* patient undergoing chemotherapy

Exclusion Criteria:

* patient presenting psychiatric or neurological disorders

Primary outcomes:
measure: Descriptive analysis of quality of life in patient cancer
timeFrame: 36 months
measure: Descriptive analysis of spirituality role in cancer patient
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique -Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT04153383: Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Official title: Milrinone on Cardiac Performance in Patients Undergoing Off-pump Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Heart Disease
Keywords: Milrinone
diastolic function
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: valvular heart disease

Brief summary: The purpose of this study is to analyze the changes in cardiac performance before and after milrinone administration in order to find out whether milrinone improves LV performance in patients undergoing coronary artery bypass surgery.


Eligibility criteria: Inclusion Criteria:

* patient agree and provide written informed consent.
* patient undergoing elective coronary artery bypass graft surgery
* preoperative LV EF\>50% (TTE)

Exclusion Criteria:

* preoperative cardiac dysrhythmia
* preoperative IABP
* use of other inotropic agents

Primary outcomes:
measure: TMAD of ticuspid annulus during early relaxation
timeFrame: 15 mini after milrinone administration
Secondary outcomes:
measure: global longitudinal strain of the right ventricle
timeFrame: 15 mini after milrinone administration
measure: left ventricular ejection fraction
timeFrame: 15 min after milline administration
measure: global longitudinal strain of the left ventricle
timeFrame: 15 min after milline administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01455883: A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes
Official title: A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* HbA1c between 7.5% - 10.5%
* on metformin monotherapy
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

* on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis

Primary outcomes:
measure: Change in HbA1c
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hayward
country: United States
facility: Intarcia Therapeutics, Inc
state: California
Study officials:
References: