louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04214925: Effectiveness of Tai Chi Exercise Program in Scleroderma Patients
Official title: Investigation of the Effectiveness of Tai Chi Exercise Program on Trunk Endurance, Balance, Sleep, Fatigue, Anxiety and Depression in Scleroderma Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tai Chi
Keywords: Scleroderma
Tai Chi
sleep
fatique
depression
anxiety
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled parallel group
Primary purpose: TREATMENT

Brief summary: Because of multiple system involvement, patients with Scleroderma have complaints such as fatigue, sleep disturbances, functional limitations, skin deformations, pain, swollen hands and joint pain. The aim of this study is to investigate the effect of Tai Chi exercise program on trunk endurance, balance, sleep, fatigue, anxiety and depression in patients with scleroderma.

Detailed description: In the study, which will be planned as a randomized controlled parallel group, the effects of Tai Chi in SS patients are compared with the home exercise group. Evaluations before and after the treatment will make by a physiotherapist. Training of Tai Chi will supervised by an experienced and certified physiotherapist.

Lateral Bridge Test , Berg Balance Scale, Pittsburg Sleep Quality Index , Fatigue Severity Scale and Fatigue Impact Scale , Hospital Anxiety and Depression Scale will be used evaluation before and after training.

Eligibility criteria: Inclusion Criteria:

* have been diagnosed with scleroderma,
* have been sedentary (have not routinely participated in exercise activities during the past 3 months)
* have been using a fixed dose of medication for at least 6 months
* no communication problems
* having stable disease

Exclusion Criteria:

* a diagnosis of pulmonary hypertension
* a history of active infection, cardiac involvement, psychiatric disorder, a history of active myositis, renal failure, metastatic cancer, pregnancy
* Data of the participant whose changes were made during the study are not included in this study and participation is terminated.

Primary outcomes:
measure: Pittsburg Sleep Quality Index
timeFrame: ten weeks
measure: Fatigue Severity Scale
timeFrame: ten weeks
measure: Fatigue Impact Scale
timeFrame: ten weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: ten weeks
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Kinikli
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ayse Ayan, Dr
role: STUDY_DIRECTOR
References:
citation: Mitropoulos A, Gumber A, Crank H, Akil M, Klonizakis M. The effects of upper and lower limb exercise on the microvascular reactivity in limited cutaneous systemic sclerosis patients. Arthritis Res Ther. 2018 Jun 5;20(1):112. doi: 10.1186/s13075-018-1605-0.
Clinical trial NCT00348725: Acceptability of a Fixed Combination of Fenofibrate and Metformin
Official title: An Open Label, Parallel-Arm, Multicenter Trial Assessing the Acceptability of 4 Dosages of a New Fixed Dose Combination of Fenofibrate and Metformin in Patients With Type 2 Diabetes and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia/Glucose Metabolism Disorder
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-06
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective was to assess the acceptability of a 4-week treatment of 4 new fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus and dyslipidemia.

Exclusion Criteria:

* Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose \> 300 mg/dL - Triglycerides \> 500 mg/dL

Primary outcomes:
measure: Quotation by Visual Numeric Rating Scale before and after 4-week treatment
Secondary outcomes:
measure: Assessment of safety by reporting of Adverse Events
Other outcomes:
Locations:
city: Anzin
country: France
facility: Site 24
city: Bachant
country: France
facility: Site 23
city: Baune
country: France
facility: Site 21
city: Bersee
country: France
facility: Site 32
city: Briollay
country: France
facility: Site 34
city: Denain
country: France
facility: Site 27
city: Denain
country: France
facility: Site 28
city: Le Temple de Bretagne
country: France
facility: Site 5
city: Nantes
country: France
facility: Site 29
city: Nantes
country: France
facility: Site 2
city: Nantes
country: France
facility: Site 8
city: Nantes
country: France
facility: Site 9
city: Nort sur Erdre
country: France
facility: Site 1
city: Parcay les Pins
country: France
facility: Site 13
city: Quarouble
country: France
facility: Site 26
city: Saint Aignan le Grand
country: France
facility: Site 7
city: Saint Herblain
country: France
facility: Site 4
city: Saint-Amand
country: France
facility: Site 30
city: Sautron
country: France
facility: Site 11
city: Segre
country: France
facility: Site 17
city: St Etienne de Montluc
country: France
facility: Site 10
city: Thiant
country: France
facility: Site 33
city: Thouars
country: France
facility: Site 12
city: Vieux Conde
country: France
facility: Site 25
city: Vihiers
country: France
facility: Site 20
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT01682525: Ovarian Tissue Cryopreservation for Fertility Preservation
Official title: Ovarian Tissue Cryopreservation for Fertility Preservation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Keywords: Fertility preservation
Ovarian Tissue
Cryopreservation
Assisted Reproductive Technology
Lead sponsor: Boston IVF
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. To determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation

The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.


Eligibility criteria: Inclusion Criteria:

* Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy which are likely to result in permanent loss of subsequent ovarian function or diminished fertility
* Have a medical condition or malignancy that requires removal of all or part of one or both ovaries
* Patients may have newly diagnosed or recurrent disease
* Be in good health so as to be able to undergo laparoscopic surgery as determined by history and physical examinations, and consultation with the medical oncologist, reproductive endocrinologist, surgeon and anesthesiologist

Exclusion Criteria:

* Moderate to high-risk of ovarian failure due to treatment
* Documented ovarian metastasis
* HIV or hepatitis (B, C)-positive serology
* Absolute surgical contraindications
* ECOG performance status of 0 or 1
* Pregnancy
* Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent

Primary outcomes:
measure: Safety
timeFrame: 10 years
Secondary outcomes:
measure: Efficacy
timeFrame: 10 years
Other outcomes:
Locations:
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
Study officials:
affiliation: Boston IVF
name: David Ryley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725425: The Effect of Portion Sizes on Mood
Official title: The Impact of Portion Size of Foods on Mood in Normal Weight Adults 18-35
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mood
Eating Patterns
Keywords: snack food (chips)
fruit (red grapes) consumed in each condition
mood
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether different portion sizes will effect overall mood.

Detailed description: The objective of this investigation is to determine whether participants will have a change in mood based on the portion size of foods served. The specific aims of the study are:

1. Determine the effect of increasing portion sizes on mood.
2. Determine the effect of decreasing portion sizes on mood.

Eligibility criteria: Inclusion Criteria:

* Age 18-35
* have a body mass index of 18.5 and 24.9 kg/m\^2
* be an unrestrained eater( scoring less than 12 on the Three Factor Eating Questionnaire)
* Report Being a non-smoker

Exclusion Criteria:

* currently pregnant or nursing
* report being an athlete in training
* currently taking any medications that affect appetite or food intake
* Have a medical condition affecting eating or are currently following a therapeutic diet
* Report disliking foods used in the investigation
* Report having allergies to foods used in the investigation

Primary outcomes:
measure: Total grams of snack food consumed
timeFrame: 1 year
Secondary outcomes:
measure: Total grams of fruit consumed
timeFrame: 1 year
Other outcomes:
measure: Relative Reinforcing Value of Foods
timeFrame: 1 Year
Locations:
city: Knoxville
country: United States
facility: The University of Tennessee-Knoxville
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Hollie Raynor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184925: Ventilator Associated Pneumonia and Late Complications of Percutaneous Tracheostomy
Official title: The Development of Ventilator Associated Pneumonia and Late Complications of Two Different Percutaneous Tracheostomy Techniques
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pneumonia
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the incidence of ventilator associated pneumonia and late complications by comparing two different cannulas and two different percutaneous tracheostomy techniques.

Detailed description: This study did not generate the expectations's we've expected, therefore, the analysis was prematurely stopped...

Eligibility criteria: Inclusion Criteria:

* all patients on the intensive care unit who receive a tracheostomy.

Exclusion Criteria:

* HIV/AIDS
* use of immunosuppressive
* with regard to the MRI-scan patients who have a pacemaker and/or who are claustrophobic

Primary outcomes:
measure: Clinical Pulmonary Infection Score first week on day 0-2-4-6 and after the first week on indication.
timeFrame: 1 year
Secondary outcomes:
measure: Two weeks and three months after decannulation: Forced oscillation technique.
timeFrame: 1 year
measure: Three months after decannulation ENT-specialist control and MRI-scan to see whether there are signs or symptoms of tracheal stenosis.
timeFrame: 1 year
measure: Peri-operative complications: procedure-related complications occurring within 24 hours of the procedure.
timeFrame: 1 year
measure: Post-operative complications: divided into 'complications while cannulated' and 'late complications'.
timeFrame: 1 year
measure: - Complications while cannulated: complications occurring after 24 hours until removal of the tracheostomy tube.
timeFrame: 1 year
measure: -Late complications: complications occuring after removal of the tracheostomy tube.
timeFrame: 1 year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: UMC st Radboud
state: Postbus 9101
Study officials:
affiliation: Radboud University Medical Center
name: B G Fikkers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: J G van der Hoeven, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fikkers BG, Fransen GA, van der Hoeven JG, Briede IS, van den Hoogen FJ. Tracheostomy for long-term ventilated patients: a postal survey of ICU practice in The Netherlands. Intensive Care Med. 2003 Aug;29(8):1390-3. doi: 10.1007/s00134-003-1824-x. Epub 2003 Jul 22.
Clinical trial NCT06990425: CLOSM Trial: Groin Closure Using Layered Option for Suture Material
Official title: CLOSM Trial: Groin Closure Using Layered Option for Suture Material
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Diseases
Keywords: surgical site complication
vascular surgery
wound healing
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 259
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: This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl suture versus PDS (polydioxanone) suture. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.

Detailed description: Previous research has provided insights into the properties of various suture materials, yet there remains a gap in our understanding of their relative effectiveness in groin closure specifically within the context of vascular surgery. The lack of definitive evidence on whether Vicryl or PDS (polydioxanone) sutures offer superior outcomes necessitates further investigation. This study aims to address this gap by conducting a head-to-head comparison of these sutures, focusing on their impact on postoperative groin complications.

This is a randomized controlled trial comparing groin closure after vascular intervention with Vicryl versus PDS. This will be a single center trail performed at CCF main campus. Patients will be enrolled in a prospective fashion and will be randomized 1:1 to either PDS or Vicryl closure. Patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.

The primary objective of this randomized controlled trial (RCT) is to evaluate the effectiveness of Vicryl versus PDS sutures in reducing groin complications following vascular surgery.

Eligibility criteria: Inclusion Criteria:

* All patients \> 18 years who undergo ELECTIVE vascular surgery that would require groin incisions
* Patients with to undergo ELECTIVE bilateral groin incisions will be matched to receive closure with PDS in one groin and Vicryl in the other groin

Exclusion Criteria:

1. Age 17 or younger
2. Prisoners
3. Pregnant patients
4. Emergent cases
5. Active groin infection prior to intervention
6. History of prior surgical groin access (re-operative groin)
7. Groin closure after extracorporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: Rate of groin complication
timeFrame: 30 days and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Francis Caputo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02186925: A Prospective Study of Clinical Factors Affecting Disease Progression and Treatment Results of Patients With Tumors of the Prostate, Bladder and Kidney.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Cancer
Prostate Cancer
Bladder Cancer
Keywords: Kidney Cancer
Prostate Cancer
Bladder Cancer
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 1000
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 suffering from kidney, bladder or prostate cancer who are being treated at the Meir Medical Center.

Brief summary: Identifying clinical factors such as medication, background diseases and blood tests that effect the course of disease in cancer patients can help physicians to better decide on the patient's treatment plan. The study seeks to identify and analyze relevant clinical factors that effect the course of the disease and the results of treatment in patients with cancers of the prostate, bladder and kidney.


Eligibility criteria: Inclusion Criteria:

* All patients with prostate, bladder or kidney cancer that are being treated at the Meir Medical Center and are over 18 years of age.

Exclusion Criteria:

* Patients under the age of 18

Primary outcomes:
measure: Progression Free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Patient overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Kvar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Daneil Kejzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01566825: The Influence of Amitriptyline on Learning in a Visual Discrimination Task
Official title: The Influence of Amitriptyline (Amitriptylin-CT 25 mg®) on Learning in a Visual Discrimination Task (Karni-Sagi-paradigm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: amitriptyline
sleep dependent memory consolidation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether 75 mg amitriptyline affect the sleep dependent consolidation of procedural memory (visual discrimination task, Karni-Sagi-paradigm).

Detailed description: Rapid eye movement (REM) sleep is considered critical to the consolidation of procedural memory - the memory of skills and habits. Many antidepressants strongly suppress REM sleep, however, and procedural memory consolidation has been shown to be impaired in depressed patients on antidepressant therapy. As a result, it is important to determine whether antidepressive therapy can lead to amnestic impairment. We thus investigate the effects of the anticholinergic antidepressant amitriptyline on sleep-dependent memory consolidation in 32 healthy men in a double-blind, placebo-controlled, randomized parallel-group study.

Eligibility criteria: Inclusion Criteria:

* male gender
* age 18 through 40 years
* ability to communicate effectively in German

Exclusion Criteria:

* shift work within the past 24 months
* any sleep disorder as measured by the Pittsburgh Sleep Quality Index
* irregular sleep/wake patterns or extreme chronotype as measured by the Morningness-Eveningness Questionnaire
* history of any neurologic or psychiatric disorders
* regular medication intake within the past four weeks
* contraindications for amitriptyline
* abnormal electrocardiogram (ECG)

Primary outcomes:
measure: changes in the visual discrimination task's perception threshold
timeFrame: The visual discrimination task's perception treshold is assessed before sleep (day 10 at 6 pm) and after sleep (day 11 at 6 pm).
Secondary outcomes:
measure: amount of rapid eye movement (REM) sleep (sleep period time percentage)
timeFrame: night from day 10 to day 11
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Department of Physiology CBF
Study officials:
affiliation: Charite University, Berlin, Germany
name: Dieter Kunz, MD
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Dieter Kunz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goerke M, Cohrs S, Rodenbeck A, Kunz D. Differential effect of an anticholinergic antidepressant on sleep-dependent memory consolidation. Sleep. 2014 May 1;37(5):977-85. doi: 10.5665/sleep.3674.
Clinical trial NCT04885725: Association Between Knee Isokinetic Testing and Lower Limb Functional Performance and Limb Symmetry
Official title: Association Between Knee Isokinetic Testing and Lower Limb Functional Performance and Limb Symmetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proprioceptive Disorders
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 20
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young healthy adults who volunteered to participate in this study

Brief summary: This study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional Hop-tests and Y-balance test.

This study included 20 healthy individuals who performed an isokinetic assessment of knee proprioception (joint position sense, JPS and threshold to detection of passive motion, TDPM) and flexors/extensors strength. At the same time, they performed a functional testing consisting of three Hop-tests (single, triple and cross-over) and the Lower Quarter Y-Balance Test (YBT-LQ). We tested the correlation between the isokinetic and functional performances, and limb symmetry indexes.


Eligibility criteria: Inclusion Criteria:

* individuals under 45 years of age who performed at least 4 hours of physical activity per week.

Exclusion Criteria:

* individuals unable to perform isokinetic muscle tests
* individuals with a current or recent lower limb injury with time loss from sport participation within the previous month
* individuals with previous severe knee injury (eg. Severe ligament tear, knee fracture)
* individuals taking medications with potential balance/coordination side effects.

Primary outcomes:
measure: Strength
timeFrame: one evaluation at a single point in time through study completion, an average of 4 months
measure: Knee proprioception, JPS1
timeFrame: one evaluation at a single point in time through study completion, an average of 4 months
measure: Knee proprioception, JPS2
timeFrame: one evaluation at a single point in time through study completion, an average of 4 months
measure: Knee proprioception, TDPM
timeFrame: one evaluation at a single point in time through study completion, an average of 4 months
measure: Functional testing, Hop tests
timeFrame: one evaluation at a single point in time through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References: