louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01388829: Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532
Official title: A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of 2 Different Formulations Of PF-04991532
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: formulation comparison
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to compare the pharmacokinetics of two different lots of tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement \[confirmed by a single repeat, if necessary\] following at least 5 minutes of rest.
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Plasma AUClast
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
measure: Plasma Cmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
Secondary outcomes:
measure: Plasma Tmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00191529: Growth Hormone Treatment in Short Children Born Small for Gestational Age
Official title: Optimization of Growth Hormone Treatment in Short Children Born Small for Gestational Age Based on a Growth Prediction Model-The OPTIMA Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infant, Small for Gestational Age
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.


Eligibility criteria: Inclusion Criteria:

* Born small for gestational age
* actual body height less than or equal -3 SDS
* chronological age greater than 3 years

Exclusion Criteria:

* Growth hormone deficiency
* any defined syndromal disease
* Diabetes mellitus

Primary outcomes:
measure: The 2 different doses used are non-inferior to each other
Secondary outcomes:
measure: Safety profiles
measure: Compare absolute height velocity
Other outcomes:
Locations:
city: Koln
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_CHAIR
References:
citation: Jung H, Land C, Nicolay C, De Schepper J, Blum WF, Schonau E. Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study. Eur J Endocrinol. 2009 Feb;160(2):149-56. doi: 10.1530/EJE-08-0301. Epub 2008 Nov 27.
Clinical trial NCT05817929: Angiopoietin and Adverse Outcomes in Cardiac Surgery
Official title: Angiopoietin Dysregulation to Predict Adverse Outcomes in Cardiac Surgery: the Prospective
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Acute Kidney Injury
Keywords: angiopoietin
endothelial injury
MACCE
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Cardiac surgery and cardiopulmonary bypass can lead to systemic organ failure trough excess inflammation and endothelial injury. The angiopoietin family represented by angiopoietin 1 and 2 can reflect endothelial injury by a decrease in angiopoietin 1 and an increase in angiopoietin 2. The investigators hypothesized that angiopoietin dysregulation could reflect organ failure related to cardiac surgery.

The purpose of this project is to assess the association between angiopoietin dysregulation and adverse outcomes on cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* adult patient scheduled for cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* patient less than 18 years old,
* redo surgery,
* urgent surgery,
* endocarditis,
* aortic root repair surgery
* aortic dissection
* heart beating surgery,
* heart transplantation

Primary outcomes:
measure: Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of major cardiovascular event
timeFrame: 28 days
measure: correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and occurence of major cardiovascular event
timeFrame: 28 days
Secondary outcomes:
measure: Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of postoperative pulmonary complications
timeFrame: 28 days
measure: Correlation between abnormal angiopoietin 2 concentration (ng/ml) and number of postoperative pulmonary complications
timeFrame: 28 days
measure: Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 3 months
timeFrame: 3 months
measure: Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality at 3 months
timeFrame: 3 months
measure: Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 6 months
timeFrame: 6 months
measure: Correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and mortality at 6 months
timeFrame: 6 months
measure: Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality rate at 12 months
timeFrame: 12 months
measure: Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality rate at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT04424329: Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
Official title: Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota Perturbation by an Environmental Challenge
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress


Eligibility criteria: Inclusion Criteria:

1. Informed consent signed
2. Adult men and women aged 18 to 45 years
3. Healthy based on the medical screening visit and medical questionnaire
4. BMI in the range of 18.5 to 29.9 kg/m2.

Exclusion Criteria:

1. Known food allergy and intolerance
2. Currently participating in another clinical trial or research project
3. Fewer than 5 spontaneous bowel movements per week on average
4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
5. Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
6. Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
7. Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
8. Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
9. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
10. Artificially sweetened beverage intake higher than 1000 ml/ per day
11. Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
12. Subject having a hierarchical or family link with the research team members.

Primary outcomes:
measure: Minimizing microbiota composition change
timeFrame: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)
Secondary outcomes:
measure: Increased intestinal microbiota diversity
timeFrame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
measure: Increased microbiota gene richness
timeFrame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
measure: Gut comfort
timeFrame: Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Société des produits Nestlé/Metabolic Unit
Study officials:
affiliation: Société des produits Nestlé
name: Sami Damak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01698229: Collection of Cerebrospinal Fluid in Healthy Children
Official title: Collection of Cerebrospinal Fluid in Healthy Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Late Infantile Neuronal Ceroid Lipofuscinosis
Batten Disease
Keywords: Cerebrospinal fluid
Lumbar puncture
Spinal tap
Late infantile neuronal ceroid lipofuscinosis
Batten disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be healthy controls (children ages 2 years to 8 years) undergoing a lumbar puncture at New York Presbyterian Hospital, for clinical care purposes. They will be inpatients and outpatients.

Brief summary: The purpose of this study is to obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.

Detailed description: obtain cerebrospinal fluid from healthy children already undergoing a lumbar puncture procedure at New York Presbyterian Hospital, to act as healthy controls when compared to children with late infantile neuronal ceroid lipofuscinosis (LINCL), a fatal neurodegenerative disease.

Eligibility criteria: Inclusion Criteria:

* Males and females, ages 2 yrs to 8 yrs
* Children already undergoing a lumbar puncture procedure for clinical or diagnostic purposes

Exclusion Criteria:

* Presence of any significant neurological diseases, as judged by the co-investigators
* Presence of any significant medical conditions including cancer

Primary outcomes:
measure: Cerebrospinal fluid (CSF)
timeFrame: 1 time point (once)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College / New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ronald G Crystal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05305729: Metabolic FingerPrinting
Official title: Metabolic FingerPrinting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Genetic Disease
Keywords: Metabolic Fingerprint
Lead sponsor: Arcensus GmbH
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 10000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects with a confirmed genetic disease as well as their first degree family members can participate in the study.

Brief summary: The MetaPrint study aims to characterize the metabolic fingerprint of genetic diseases in order to enhance knowledge on the physiological disease status and establish so new tools for diagnosing, monitoring and personalizing treatment of genetic diseases.


Eligibility criteria: Inclusion Criteria:

* Informed consent is obtained from the participant or from the parent/ legal guardian
* The participant is 2 months or older
* The participant is diagnosed with a genetic disease
* The participant is a first degree relative of a subject diagnosed with a genetic disease

Exclusion Criteria:

* Informed consent is not obtained from the participant or from the parent/ legal guardian
* The participant is younger than 2 months
* The participant is not diagnosed with a genetic disease
* The participant is not a first degree relative of a subject diagnosed with a genetic disease

Primary outcomes:
measure: Number of newly identified, disease-specific Metabolic Fingerprints
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: University Hospital Center Mother Teresa
city: Lahore
country: Pakistan
facility: The Children's hospital & Institute of child health
state: Punjab
city: Islamabad
country: Pakistan
facility: Pakistan Institute of Medical Sciences (PIMS)
city: Multan
country: Pakistan
facility: Children's Hospital & The Institute of Child Health
city: Peshawar
country: Pakistan
facility: Khyber institute of Child Health and Children Hospital (KICH)
Study officials:
References:
Clinical trial NCT02562729: Complete Nerve-Sparing Radical Hysterectomy for Cervical Cancer
Official title: A Simplified Approach of Complete Nerve-sparing Type C1 Radical Hysterectomy for Cervical Cancer, a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Squamous Cell Carcinoma
Cervical Adenocarcinoma
Malignant Neoplasm of Cervix Stage IB1
Stage IIA1 Cervical Cancer
Keywords: Cervical cancer; Nerve-sparing hysterectomy; simplified
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Fudan University
First posted: 2015-09-29
Enrollment: 62
Sex: FEMALE
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility of complete nerve-sparing type C1 radical hysterectomy in cervical cancer.

Detailed description: The primary objective of this study is to evaluate the rate of postvoid residual urine volume (PVR) \<50ml on postoperative day 4 in patients with stage IB1 and IIA1 cervix cancer underwent complete nerve-sparing type C1 radical hysterectomy.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years to \<= 70 years.
* Women with histologically confirmed, primary adenocarcinoma or squamous cell carcinoma of the uterine cervix.
* Stage IIA1, or IB1 disease.
* Karnofsky performance status \>70.
* Patients who comply with follow-up.
* With written informed consent.

Exclusion Criteria:

* Age\>70
* History of lower urinary tract damage or surgery.
* With abnormal urodynamic study results.
* Karnofsky performance status \<70.
* Patients who have uncontrolled psychological disorders.
* Unwilling to or unable to comply with protocol.
* Prior treatment with pelvic radiotherapy

Primary outcomes:
measure: Proportion of patients with fully pelvic nerve plexus preserved
timeFrame: up to 30 days
measure: Proportion of patients removing indwelling catheter
timeFrame: up to 30 days
Secondary outcomes:
measure: The rate of 36-month local control
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University Shanghai Zhongshan Hospital
name: Rongyu Zang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Shi T, Yin S, Ma S, Shi D, Guan J, Xiang L, Liu Y, Ren Y, Tan D, Zang R. An improved nerve-sparing radical hysterectomy technique for cervical cancer using the paravesico-vaginal space as a new surgical landmark. Oncotarget. 2017 Jul 5;8(52):90413-90420. doi: 10.18632/oncotarget.19011. eCollection 2017 Oct 27.
Clinical trial NCT06646029: Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion
Official title: Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Proximal Interphalangeal Joint Stiffness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 64
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: The purpose of this feasibility pilot study is to determine the effectiveness of Relative Motion Orthosis (RMO) in regaining finger range of motion compared to standard care in patients diagnosed with Proximal Interphalangeal (PIP) stiffness with an extension lag secondary to finger injury. Participants will be enrolled and randomized into groups receiving either standard conservative interventions or standard interventions in addition to the RMO. The primary endpoint is to evaluate the efficacy of relative motion orthosis in PIP ROM using clinical scoring and physical exam findings.


Eligibility criteria: Inclusion Criteria:

* Age range 18-80
* Any gender
* Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension
* Right or left hand injury
* Level of Chronicity (4 weeks - 6 months)
* Able to follow instructions

Exclusion Criteria:

* PIP with hard end feel (feels they need serial casting) - level of chronicity
* Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis
* Severe arthropathy
* Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.

Primary outcomes:
measure: Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score
timeFrame: Baseline, End-of-treatment (~Month 3)
Secondary outcomes:
measure: Change in Active Range of Motion (AROM)
timeFrame: Baseline, End-of-treatment (~Month 3)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Natalia Ruiz, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05667844: Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
Official title: Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Mind-body Exercise
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study case
Primary purpose: OTHER

Brief summary: The interoception capacity may be changed with mind-body intervention. This study case investigated the interoceptive capacity, measured by MAIA scale of a pacient with mood disorders and if it can be influenced through of a 7 weeks intervention of interoceptive exercises and the impaction in the patient´s daily life. The aim was analyse the effects of mind-body exercise program with interoceptive approach in the anxiety and depression symptoms, interoceptive capacity, as well your impact in paitient's daily activities. M.S is 47 years old, was forwarded from University Hospital Clementino Fraga Filho to extension project named as "corpo\&mente" (body-mind), an anamnesis was performed including patient's life story, interoceptive scale, anxiety and depression scale from Hamilton and a risk stratification to realize physical activities (it was also performed post-intervention). The exercise program lasted 1h 15 min and it was performed once a week.


Eligibility criteria: Inclusion Criteria:

* Participants with anxiety or/and depression clinical diagnosis
* Participants who do not do formal meditation practices

Exclusion Criteria:

* Participants with other diagnosis
* Patients with cognitive conditions

Primary outcomes:
measure: Mnteroceptive capacity
timeFrame: Day 1
measure: Anxiety symptoms
timeFrame: Day 1 and after 7 weeks
measure: Depression symptons
timeFrame: Day 1 and after 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Federal University of Rio de Janeiro
Study officials:
References: