louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02227511: Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects
Official title: Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: fruit, nuts, liver fat, insulin, glucose
Focus of the study is to compare the often given advice to eat fruit, containing large amount of glucose and fructose, with nuts that are more rich in fat.
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic rate, liver steatosis and physical activity are investigated ahead of start of the study and at the end of the trial period och two months. Participants will be allowed to buy fruits or nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed for the costs of the snacks.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* significant diseases that can affect outcomes, mental disorders that can affect participation.

Primary outcomes:
measure: amount of fat in the liver by magnetic resonance imaging
timeFrame: two months
Secondary outcomes:
measure: cardiovascular risk factors
timeFrame: two months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Fredrik H Nystrom
Study officials:
References:
citation: Agebratt C, Strom E, Romu T, Dahlqvist-Leinhard O, Borga M, Leandersson P, Nystrom FH. A Randomized Study of the Effects of Additional Fruit and Nuts Consumption on Hepatic Fat Content, Cardiovascular Risk Factors and Basal Metabolic Rate. PLoS One. 2016 Jan 20;11(1):e0147149. doi: 10.1371/journal.pone.0147149. eCollection 2016.
Clinical trial NCT02033811: MitraClip® Registry
Official title: MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Keywords: mitral regurgitation
MitraClip system
percutaneous mitral valve repair
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 200
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 percutaneous mitral valve repair (PMVR) with the MitraClip® system

Brief summary: Percutaneous mitral valve repair with the MitraClip® system has emerged as a therapeutic alternative to surgical valve repair (PMVR) in high risk patients.

The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PMVR with the MitraClip® system. This registry is an open-end observational study to assess the characteristics and outcomes patients with severe mitral regurgitation undergoing PMVR.


Eligibility criteria: Inclusion Criteria:

* severe mitral regurgitation
* percutaneous mitral valve repair (PMVR) with the MitraClip® system

Exclusion Criteria:

* \< 18 years
* Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure

Primary outcomes:
measure: Major cardiac adverse events
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Malte Kelm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
citation: Herbrand T, Eschenhagen S, Zeus T, Kehmeier E, Hellhammer K, Veulemans V, Kelm M, Balzer J. Acute reverse annular remodeling during MitraClip(R) therapy predicts improved clinical outcome in heart failure patients: a 3D echocardiography study. Eur J Med Res. 2017 Sep 20;22(1):33. doi: 10.1186/s40001-017-0273-x.
citation: Rammos C, Zeus T, Balzer J, Veulemans V, Hellhammer K, Niebel S, Kelm M, Rassaf T. Left Atrial and Left Ventricular Function and Remodeling Following Percutaneous Mitral Valve Repair. J Heart Valve Dis. 2016 May;25(3):309-319.
citation: Hellhammer K, Zeus T, Balzer J, van Hall S, Rammos C, Wagstaff R, Kelm M, Rassaf T. Safety and efficacy of percutaneous mitral valve repair using the MitraClip(R) system in patients with diabetes mellitus. PLoS One. 2014 Nov 6;9(11):e111178. doi: 10.1371/journal.pone.0111178. eCollection 2014.
Clinical trial NCT05161611: Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit
Official title: The Effect of Oral Zinc Sulfate on Jaundice in Neonates Admitted to Neonatal Intensive Care Unit: A Randomized, Double-Blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serum Bilirubin
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized double-blind clinical trial will be performed in the neonatal intensive care unit of Makassed General Hospital in Beirut, Lebanon from December 2021 till August 2022. Randomized opaque envelopes to allocate the treatment will be used. The study will include neonates aged between 26 and 42 gestational weeks, who require phototherapy in the neonatal intensive care unit. Patients will be randomized into two groups.Both groups will receive standard conventional phototherapy, but the intervention group will receive 10 mg per day oral zinc sulfate until discharge.


Eligibility criteria: Inclusion Criteria:

* Infants (post-menstrual age ≥ 26 weeks) delivered by Cesarean section or vaginal delivery.
* Diagnosed to have hyperbilirubinemia:

Hyperbilirubinemia is defined as:

* for term and near-term neonates (neonates less than 35 weeks' gestation): Serum Total Bilirubin (STB) level that would qualify for phototherapy requirement as described in American Academy of Pediatrics 2004's guidelines or absolute STB level L 15 mg/dL;
* for preterm neonates (\< 35 weeks' gestation): STB level \> 1% of body weight

Exclusion Criteria:

* Infants less than 26 weeks postmenstrual age
* Allergy to zinc sulfate
* Any reaction seen after administration of first dose of zinc sulfate.
* Any contraindication to oral medication
* Infants with a history of taking phenobarbital by their mother

Primary outcomes:
measure: Phototherapy duration
timeFrame: Within one week
Secondary outcomes:
measure: Total serum bilirubin level
timeFrame: Within one week
measure: Occurrence of side effects
timeFrame: Within one week
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Mariam Rajab, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04451811: A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers
Official title: A Pharmacokinetic Dose Proportionality Study of OPL-002 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Oppilan Pharma Ltd
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2020-06-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a single center, randomized, open-label, three-way crossover, single dose, pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male or female (of non-childbearing potential only) between 18 and 55 years of age.
* Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:

  1. hysteroscopic sterilization;
  2. bilateral tubal ligation or bilateral salpingectomy;
  3. hysterectomy;
  4. bilateral oophorectomy, or;
  5. be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per investigator judgment.
* Male subjects must use reliable forms of contraception from screening to 30 days after the end of dosing.
* Good general health as determined by medical history, and by results of physical examination, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administration.

Exclusion Criteria:

* History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
* pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic, heart rate 60-100 beats/min.
* 12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS \>= 110 milliseconds (msec), QT/QTcF interval of \> 450 msec for men or \>470 msec for women, or PR \> 200 msec.
* Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.

Primary outcomes:
measure: AUC of OPL-002
timeFrame: 0 to 48 hours
Secondary outcomes:
measure: Dose proportionality of 5 and 20 mg
timeFrame: 0 to 48 hours
measure: Absolute lymphocyte count
timeFrame: 0 to 48 hours
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Celerion
state: Northern Ireland
Study officials:
affiliation: Oppilan Pharma Ltd
name: Richard Gregg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04778111: Segmental Exclusion of the Upper Limb and Peri-personal Space
Official title: Segmental Exclusion of the Upper Limb and Peri-personal Space
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Musculoskeletal Disorders of the Upper Limb With Symptoms of Exclusion
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients included in this study are patients with upper extremity musculoskeletal disorders of traumatic origin. To these disorders is added a segmental exclusion syndrome, which is defined as the under-use or non-use of part of the upper limb.

Brief summary: This study is based on previous studies on the search of the limit of the peri-personal space. In a previous study, Gouzien et al. (2017) evaluated the peri-personal space of action of patients with upper limb amputations and sought a link between this space and the level of integration of their myoelectric prosthesis. We have decided to implement part of this protocol to evaluate the peri-personal space for another population with upper limb patholog: segmental exclusion of the upper limb.

Exclusion is a phenomenon that is very little studied but known to orthopedic surgeons and physical medicine and rehabilitation physicians. It is characterized by the non-use or underuse of a limb segment in the absence of central nervous system involvement. This phenomenon is compared to peripheral neglect. Most of the time, the patient is unaware of his disorder "he forgets his finger without realizing it", but this phenomenon can be reversible under verbal exhortation from a third party.

The aim of this study is to observe if there is a change in peri-personal space in patients with unilateral segmental exclusion.


Eligibility criteria: Inclusion Criteria:

* Adult (age greater than or equal to 18 years old).
* Person with a symptom of unilateral exclusion.
* Person with no contraindication to hard work in activities of daily living due to the lesions.
* Person who has given informed consent.

Exclusion Criteria:

* Person under 18 years of age.
* Person with visual impairment
* A person with a central neurological pathology.
* A person with cognitive impairment related to a brain injury, psychiatric illness or intellectual disability.
* A person who has difficulty understanding instructions.
* A person of full age who is subject to a legal protection measure or who is unable to give consent.

Primary outcomes:
measure: Delta-MRD
timeFrame: During one evaluation session
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
Study officials:
References:
Clinical trial NCT03834311: The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
Official title: The Effectiveness of Upper Extremity Isokinetic Strengthening in Post-stroke Hemiplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Hemiplegia
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 24
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: This randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients.


Eligibility criteria: Inclusion Criteria:

* Active motion in upper extremity
* Brunnstrom's Scale above 3

Exclusion Criteria:

* Unstable medical conditions
* Cognitive problems

Primary outcomes:
measure: upper extremity strength
timeFrame: 0, 4, 8 weeks (change from baseline upper extremity strength at 4 weeks and at 8 weeks will be assessed)
measure: pik torque
timeFrame: 0, 4, 8 weeks (change from baseline pik torque at 4 weeks and at 8 weeks will be assessed)
Secondary outcomes:
measure: hand grip strength
timeFrame: 0, 4, 8 weeks
measure: Fugl-Meyer Assessment scale for upper extremity
timeFrame: 0, 4, 8 weeks
measure: Disabilities of the arm, shoulder and hand questionnaire (Part 1)
timeFrame: 0, 4, 8 weeks
measure: Stroke Impact Scale version 3.0
timeFrame: 0, 4, 8 weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: İlke COŞKUN BENLİDAYI
Study officials:
References:
citation: Kerimov K, Coskun Benlidayi I, Ozdemir C, Gunasti O. The Effects of Upper Extremity Isokinetic Strengthening in Post-Stroke Hemiplegia: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2021 Jun;30(6):105729. doi: 10.1016/j.jstrokecerebrovasdis.2021.105729. Epub 2021 Mar 23.
Clinical trial NCT00594711: Monoamine Transporter Function and Autonomic Regulation During Psychodynamic Psychotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Psychotherapy
depression
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2008-01-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiens of clinic

Brief summary: Outcome of psychodynamic psychotherapy measured by \[123I\] nor-B-CIT SPET imaging

Background Psychodynamic psychotherapy is a widely practised form of psychotherapy in the treatment of depression. There is evidence that serotonin transporter (SERT) densities are altered in depression. Preliminary observations have suggested that SERT function may recover in connection with dynamic psychotherapy.

The objective was to determine whether SERT densities change in relation to clinical recovery during psychodynamic psychotherapy.

Detailed description: N=26

Method Twenty six drug-naïve currently depressed (moderate/severe) patients with no previous treatment were recruited for the study. The baseline study included a group of 18 healthy controls. The patients were randomised into psychotherapy and waiting-list control groups. For controls, psychotherapy was started after a 6-month waiting period. \[123I\] nor-B-CIT SPET imaging was performed at baseline and after 12 months of psychotherapy. For the controls, additional imaging was performed after the 6-month waiting period.

Eligibility criteria: Inclusion Criteria:

* depression

Exclusion Criteria:

* antidepressive medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kuopio University Hospital
name: Pirjo Saarinen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuopio University Hospital
name: Johannes Lehtonen, Ph.D
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Lehto Soili, MD
role: STUDY_CHAIR
affiliation: Kuopio University
name: Minna Valkonen-Korhonen, Ph.D
role: STUDY_CHAIR
affiliation: Kuopio University
name: Pasi Ahola, MD
role: STUDY_CHAIR
affiliation: Kuopio University Hospital
name: Mikko Joensuu, MD
role: STUDY_CHAIR
affiliation: Kuopio University Hospital
name: Tommi Tolmunen, Ph.D.
role: STUDY_CHAIR
References:
citation: Joensuu M, Ahola P, Knekt P, Lindfors O, Saarinen P, Tolmunen T, Valkonen-Korhonen M, Vanninen R, Jaaskelainen T, Virtala E, Kuikka J, Tiihonen J, Lehtonen J. Baseline symptom severity predicts serotonin transporter change during psychotherapy in patients with major depression. Psychiatry Clin Neurosci. 2016 Jan;70(1):34-41. doi: 10.1111/pcn.12335. Epub 2015 Sep 22.
Clinical trial NCT04683211: Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes
Official title: Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: Iodine intake
iodine supplementation
gestational diabetes
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with gestational diabetes

Brief summary: Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

Detailed description: Physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. The iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. The general French population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. However, according to French studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. To maintain euthyroidism, the mother must increase her T4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d The thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. Our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.

Eligibility criteria: Inclusion Criteria:

* pregnant woman with gestational diabetes
* age ≥ 18 years
* subject informed of the study and not having opposed it.

Exclusion Criteria:

* already known pathology of the thyroid

Primary outcomes:
measure: Iodine supplementation
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Corbeil-essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References:
Clinical trial NCT03605511: TTP and aHUS in Complicated Pregnancies
Official title: A Observational Study to Determine the Prevalence of Pregnancy-related Thrombotic Thrombocytopenic Purpura and Atypical Haemolytic Uraemic Syndrome in Women Affected by Specific Obstetric Complications
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombotic Thrombocytopenic Purpura
Atypical Hemolytic Uremic Syndrome
Pre-Eclampsia
HELLP Syndrome
Thrombocytopenia
IUGR
Stillbirth
Thrombotic Microangiopathies
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women receiving obstetric care at University College Hospitals London NHS Trust over the study period

Brief summary: A single site observational study aiming to:

(i) Identify cases of previously undiagnosed thrombotic thrombocytopenic purpura (TTP) and atypical haemolytic syndrome (aHUS) in a cohort of women with complicated pregnancies (ii) Characterise the clinical features of these cases and (ii) Identify clinical features or biomarkers which may help distinguish TTP/aHUS from other complications of pregnancy such as preeclampsia


Eligibility criteria: Inclusion Criteria:

- Women, either currently pregnant or recently postpartum, and affected by one or more of the following complications in the index pregnancy: (i) Preeclampsia with evidence of end organ damage (renal/ liver/ haematological/ neurological) or uteroplacental dysfunction (FGR/IUFD) (ii) HELLP syndrome (iii) Fetal growth restriction (FGR) (growth \<10th centile) that is unexplained (ie not due to infection, fetal structural anomaly, fetal chromosomal or pre-existing maternal medical problem) (iv) Intrauterine fetal demise (IUFD) after 20 weeks' gestation that is unexplained (v) Unexplained new onset renal impairment (defined by serum creatinine \>85umol/L 1st trimester, or \>80umol/L 2nd trimester, or \>90 umol/L 3rd trimester\[32\]; OR an increase in serum creatinine by (i) at least 1.5 times the baseline or (ii) of equal or greater than 26.5umol/L (as per KDIGO criteria) (vi) Unexplained new onset thrombocytopenia (platelets \<75x10\^9/L)

Exclusion Criteria:

* Previous diagnosis of TTP or aHUS
* Known disorder of complement dysregulation
* Patients not wishing to participate
* Patients aged less than 16
* Patients lacking capacity to provide informed consent

Primary outcomes:
measure: Frequency of TTP and aHUS in the cohort
timeFrame: At study completion, approximately 18 months after recruitment of first patient
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
References: