louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05080699: Evaluating Benefit of Peptide Based Diet in Obese HEN Patients
Official title: Effect of Hypocaloric, High-protein Enteral Formula on Body Weight and Health Outcomes in Obese HEN Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Keywords: Tube feeding
Obesity
Body mass
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
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 assess the effects of a low energy, high protein tube feeding formula on body weight in tube fed patients who are obese. It will also assess study formula tolerance as well as impact of the study formula on lean body mass, blood pressure, blood sugar and lipids.


Eligibility criteria: Inclusion Criteria:

* Home Enteral Nutrition (HEN) patient receiving at least 90% of energy needs from enteral nutrition.
* BMI \> 30.
* History of stroke.
* Weight stable over the past month.

Exclusion Criteria:

* Diagnosis of cancer undergoing active treatment (chemotherapy, radiation, immunotherapy).
* Life expectancy of less than 6 months.
* Stage IV or higher kidney disease (GFR \< 30).

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in lean body mass
timeFrame: Baseline, 12 weeks
measure: Change in systolic and diastolic blood pressure
timeFrame: Baseline, 12 weeks
measure: Change in HbA1c
timeFrame: Baseline, 12 weeks
measure: Change in c-peptide
timeFrame: Baseline, 12 weeks
measure: Change in total cholesterol
timeFrame: Baseline, 12 weeks
measure: Change in HDL
timeFrame: Baseline, 12 weeks
measure: Change in LDL
timeFrame: Baseline, 12 weeks
measure: Change in triglycerides
timeFrame: Baseline, 12 weeks
measure: Change in percent goal calories provided with enteral nutrition
timeFrame: Baseline, 12 weeks
measure: Change in percent goal proteins provided with enteral nutrition
timeFrame: Baseline, 12 weeks
measure: Change in tube feeding tolerance
timeFrame: Baseline, 12 weeks
measure: Change in hand grip strength
timeFrame: Baseline, 12 weeks
measure: Change in diabetes medications
timeFrame: Baseline, 12 weeks
measure: Change in anti-hypertensive medications
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manpreet Mundi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03759899: hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation
Official title: Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2018-11-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: leukemia patients with allogeneic HSCT

Brief summary: hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Detailed description: Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation

Eligibility criteria: Inclusion Criteria:

* leukemia patients with allogeneic HSCT
* KFS score \>90
* after transplantation, the patient was implanted (peripheral blood neutrophil absolute value \>500/ul for 3 consecutive days)
* no uncontrolled infection after transplantation
* activity II above aGVHD
* patients agreed to participate in the study

Exclusion Criteria:

* patients refused to participate in the study
* patients have poor compliance
* has received hormone therapy
* patients had serious heart, lung, liver, kidney and other vital organs damage
* researchers believe that patients who are not suitable for observation study

Primary outcomes:
measure: Cell counts of T cells, NK cells, B cells and monocytes
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Institute of Hematology
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiaojun Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01192542: Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens
Official title: Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.


Eligibility criteria: Inclusion Criteria:

* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
* The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
* Any cylinder power must be ≤ -0.75D.
* The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
* The subject must read and sign the Statement of Informed Consent.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

* Ocular or systemic allergies or disease which might interfere with contact lens wear.
* Systemic disease or use of medication which might interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation.
* Diabetes.
* Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
* Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Primary outcomes:
measure: Monocular Visual Acuity Assessment
timeFrame: Post lens insertion (baseline)
measure: Binocular Visual Acuity
timeFrame: Post lens insertion (baseline)
Secondary outcomes:
measure: Limbal Redness of Grade 3 or Above
timeFrame: After 6-8 days of lens wear
measure: Bulbar Redness of Grade 3 or Above
timeFrame: After 6-8 days of lens wear
Other outcomes:
Locations:
city: Pismo Beach
country: United States
state: California
city: Warwick
country: United States
state: Rhode Island
city: Fincastle
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT04529642: Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment?
Official title: Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment? A Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Physical Therapy Modalities
Gait Analysis
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke Group:

Post stroke subjects who were referred to the centre for rehabilitation, and were able to independently walk with or without an assistive device.

Healthy Group:

Healthy controls age-matched with the subjects in the stroke group

Brief summary: This Observational study aims at the evaluation of stroke subjects with an inertial measurement unit (IMU) during the execution of a 6-Minute Walking test, to evaluate the associations between the kinematic parameters retrieved trough an IMU and the classical outcome scales. Moreover compare the stroke subjects with age-matched healthy subjects, and detect the differences of gait kinematic.


Eligibility criteria: Stroke Group

Inclusion Criteria:

* Age \>= 18;
* Mini-Mental State Examination ≥ 24;
* Ability to provide written informed consent and to understand the test instructions;
* Presence of a single stroke.

Exclusion Criteria:

* More than one stroke;

  . Stroke area other than the cerebral cortex;
* Concomitant neurological disease and pathology of the locomotor system.

Healthy Group

Inclusion Criteria:

- Volunteers with age similar to the Stroke group subjects

Exclusion Criteria:

- Any disease that could affect the performance in terms of metres walked and quality of gait.

Primary outcomes:
measure: Temporal parameters of gait
timeFrame: 1 day
measure: Canadian Neurological Stroke Scale
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: Baseline
measure: Motricity Index
timeFrame: Baseline
measure: Gait speed
timeFrame: 1 day
measure: Meters walked
timeFrame: 1 day
measure: Step Cadence
timeFrame: 1 day
measure: Symmetry
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
References:
Clinical trial NCT02853942: Autologous Adipose Mesenchymal Stem Cell Transplantation in the Treatment of Patients With Hemifacial Spasm
Official title: The Research of Autologous Adipose Mesenchymal Stem Cell Transplantation for Treatment of Facial 、Auditory Nerve Dysfunction of Patients With Hemifacial Spasm After Microvascular Decompression.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Injury of Facial Nerve, Unspecified Side, Initial Encounter
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 100
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: Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous adipose stem cell transplantation in the treatment of makes the acceptance micro vascular decompression hemifacial spasm patients to nerve function to obtain a better recovery.

Secondary purpose ：To clarify the efficacy of stem cells in the treatment of cranial nerve dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.

Cases in group：Appearing on the surface of microvascular decompression for hemifacial spasm to decrease neural electrophysiological index of patients research design：Single center, prospective, randomized, double-blind, controlled Observation index：Facial nerve clinical score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal fluid index Evaluation of therapeutic effect：Facial nerve function evaluation (House-Brackmann classification, facial nerve function classification scale SFGS), facial nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric measurement Safety evaluation：Clear evaluation of hemifacial spasm and micro vascular decompression were listening to nerve in intracranial segment wrapped around the autologous fat stem cell therapy overall safety and evaluation methods including adverse events, laboratory tests, vital signs, electrocardiogram.


Eligibility criteria: Inclusion Criteria:

1. the age of 18 \~ 80 years old;
2. no surgical contraindications, accept facial nerve microvascular decompression surgery;
3. to enter into the group's informed consent and sign the consent form for clinical research.
4. patients with preoperative facial nerve electrophysiology examination without facial paralysis
5. patients with preoperative electrical testing without hearing impairment

Exclusion Criteria:

1. patients with poor compliance;
2. major surgical complications and interruption of treatment;
3. brain magnetic resonance examination or blood test results abnormal and clinical significance;
4. clinical trials of other drugs within 30 days;
5. the unintended side effects;

Primary outcomes:
measure: House-Brackmann facial nerve grading scale
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03372642: Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot
Official title: Valutazione Dell'Efficacia Dell'Endortesi Senotarsica Nella Correzione Della Sindrome Pronatoria Nel Bambino (Flatfoot)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flatfoot
Pediatric ALL
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We retrospectively review 60 consecutive patients who underwent surgical treatment with subtalar arthroereisis for pediatric flexible flatfoot at the authors' institution from January 2011 to March 2015.

Brief summary: Pediatric flexible flatfoot is sometimes asymptomatic but it can also cause physical impairment, pain, and difficulty walking. We evaluate the radiographic effectiveness of intervention of subtalar arthroereisis with endorthesis for pediatric flexible flatfoot with final follow-up at skeletal maturity.


Eligibility criteria: Inclusion Criteria:

* Males and females
* age ≥ 14 years at the time of the visit
* patients who underwent subtalar endothesis for the treatment of the pediatric flexible flatfoot from January 2011 to March 2015.

Exclusion Criteria:

* age \<14 years at the time of the visit
* patients with comorbidities that make it difficult to return to the hospital for consultation or who have removed the device for discomfort
* female patients who do not exclude (by self-declaration, as clinical practice) a state of pregnancy

Primary outcomes:
measure: lateral talocalcaneal angle
timeFrame: 1 day
Secondary outcomes:
measure: AOFAS
timeFrame: 1 day
measure: SEFAS
timeFrame: 1 day
measure: SF-12
timeFrame: 1 day
measure: Meary's angle
timeFrame: 1 day
measure: Calcaneal pitch angle
timeFrame: 1 day
measure: Anteroposterior talonavicular coverage angle
timeFrame: 1 day
measure: Talonavicular uncoverage percent
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05160142: Diabetes Inspired Culinary Education
Official title: Diabetes Inspired Culinary Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type I Diabetes
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pretest-poshest study design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to assess the feasibility and efficacy of a community-based culinary nutrition education program (Diabetes Inspired Culinary Education, DICE) on improving the diabetes management and dietary intake of 6-14 year old children with type I diabetes mellitus (TIDM).


Eligibility criteria: Inclusion Criteria:

* Children: 6-14 years old; diagnosed with type I diabetes within the past 5 years; English speaking
* Adults: primary caregiver of a 6-14 year old child diagnosed with type I diabetes within the past 5 years; English speaking

Exclusion Criteria:

-

Primary outcomes:
measure: % Change in Hemoglobin A1c
timeFrame: Baseline/pretest, 3 months/posttest
Secondary outcomes:
measure: Change in daily servings of fruit
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in daily servings of vegetables
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in daily servings of whole grains
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in daily servings of sugar-sweetened beverages
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in daily total caloric intake
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in primary caregiver body mass index (kg/m2)
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in child body mass index z-score
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in child blood pressure z-score
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in child food preparation attitude, self-efficacy and frequency of involvement
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in child adherence to TIDM management regimen score
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in child quality of life score
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in primary caregiver self-efficacy for diabetes management score
timeFrame: Baseline/pretest, 3 months/posttest
measure: Change in primary caregiver self-efficacy for healthy meal planning and eating score
timeFrame: Baseline/pretest, 3 months/posttest
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Dave's Grocery Store and Teaching Kitchen
state: Ohio
Study officials:
References:
Clinical trial NCT04907942: Ecological Momentary Assessment and Text Message Intervention for Stress Management
Official title: Click's Ecological Momentary Assessment (EMA) and Text Message Intervention for Stress Management (FACE STRESS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Loneliness
Covid19
Stress
Keywords: Stress
Anxiety
Ecological Momentary Assessment
Automated Text Message Intervention
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 81
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management

Detailed description: The purpose of this study is to evaluate feasibility and acceptability of an Ecological Momentary Assessment (EMA) compared with an EMA plus automated text message intervention for stress management in participants with higher-than-average perceived stress conducted in a remote setting.

Study details include:

Study Duration: 7 months Intervention Duration: 3 weeks

Eligibility criteria: Inclusion Criteria:

1. Age 22 years or older
2. Must reside in an Eastern Standard Time or Central Standard Time zone
3. Able to read and write in English as demonstrated by review and completion of an Informed Consent Form
4. Own an SMS enabled smartphone
5. Scoring \>5 on the 4-item Perceived Stress Scale (reflecting higher-than-average perceived stress)

Exclusion Criteria:

1. Reported cognitive impairment and/or psychiatric disorders of the psychotic spectrum
2. Enrolled in another support study
3. Currently receiving psychotherapy through telehealth
4. PHQ-9 score of 20 or greater.

Primary outcomes:
measure: Number of Participants Who Completed EMA and EMA Plus Text Message Intervention or EMA Intervention Alone.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan, MDPhD, FAAN
role: STUDY_CHAIR
References:
Clinical trial NCT00649142: Predisposing Factors for Chronic Postherniotomy Pain
Official title: Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Postherniotomy Pain
Keywords: Groin hernia
Chronic postsurgical pain
open mesh repair
laparoscopic mesh glue fixation
Sensory changes after groin hernia repair
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aesculap AG
name: Baxter Healthcare Corporation
First posted: 2008-04-01
Enrollment: 455
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method.

The current study will assess the above factors in a prospective study.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years)
* Male
* Primary unilateral groin hernia
* Ability to use pain scales

Exclusion Criteria:

* Neurological disease
* Diabetes with late stage complications

Primary outcomes:
measure: Frequency of chronic pain
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Changes in sensory function
timeFrame: 6 months
measure: Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Hørsholm
country: Denmark
facility: Ambulatory Surgical Clinic, Hørshom Sygehus
city: Stuttgart
country: Germany
facility: Marienhospital, Viszeralchirurgie
Study officials:
affiliation: Rigshospitalet, Copenhagen, section for surgical pathophysiology
name: Henrik Kehlet, Professor, Ph D, M.D
role: STUDY_CHAIR
affiliation: Marienhospital Stuttgart, Viszeralchirurgie
name: Reinhard Bittner, Prof. Ph D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. doi: 10.1002/bjs.5103.