louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05436782: Effects of Core Strengthening and PNF Pattern on Balance and Plantar Pressure in Chronic Stroke
Official title: Effects of Core Strengthening and Proprioceptive Neuromuscular Facilitation Pattern on Static Standing Balance and Plantar Pressure in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke; Paralysis
Keywords: Stroke, Static Balance, PNF, Plantar Pressure, PoData
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 73
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients

Detailed description: The effects of different exercise regimes and PNF techniques on balance and plantar pressure had been studied. This study focuses on determining the effects of CSE and PNF techniques on developing static standing balance and plantar pressure in stroke patients using PoData

Eligibility criteria: Inclusion Criteria:

* • Age 45-60

  * Score of 9 or higher on the static component of Berg Balance Scale
  * Both genders will be recruited.
  * First ever episode of stroke
  * Duration of stroke greater than 6 months.
  * Having a score of equal to or less than 2 on the Modified Ashworth Scale
  * Having a score of greater than or equal to 24 on the Mini-mental state examination in order to understand the commands.

Exclusion Criteria:

* • Concurrent orthopedic (for e.g. amputation ) that may hamper standing

  * Relevant psychiatric disorders that may prevent from following instructions.
  * Other medical drugs that may influence our intervention
  * Condition contraindicating physical activity
  * Use of cardiac pacemakers.

Primary outcomes:
measure: Static Standing balance
timeFrame: 6 months
Secondary outcomes:
measure: Plantar pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
state: Punjqb
Study officials:
affiliation: The University of Lahore
name: Sameed Liaqat, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06771882: Effect of Breast Milk Olfactory Stimulation
Official title: Effect of Breast Milk Olfactory Stimulation Based Intervention on Preterm Infants' Feeding Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preterm Infant Feeding Outcomes
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The researcher obtained 5cc soaked in a 2cm×2 cm piece of sterilized gauze for every intervention administration.

* The preterm neonates were positioned in the supine position and the head turned to one side
* The gauze was placed near the head, 2cm away from the nose for 2 minutes before feeding to stimulate an olfactory sense of preterm neonates 3 times per day (11 am, 2 pm, and 5 pm).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast milk olfactory stimulation will improve preterm infants' outcomes.

Detailed description: The researcher will explain the aim of the study and the components of the tools to the studied nurses.

* The researcher will distribute questionnaire to studied nurses for assessing their knowledge and the researcher will observe their practices regarding breast milk olfactory stimulation for premature infants.
* The researcher will be divided preterm infant randomly into two equal groups (control and study). While intervention will be directed to study group only before feeding. Both groups will be subjected to same routine care of the NICU.
* The researcher will be used PIBB scale and neonatal behavioral responses Sheet to assess the premature infants at 1st day of admission as pre intervention after routine care as "change diaper, eye care, cord care, feeding" at morning shift at ten o'clock and one o'clock in the afternoon for study and control group (pre intervention).
* The researcher will apply breast milk olfactory stimulation technique for study group only before feeding but, both groups will be subjected to same routine care of the NICU.
* The researcher will assess the effect of used olfactory stimulation technique to study group at 5th and 6th day of admission post intervention.

Eligibility criteria: Inclusion Criteria:

* Preterm infant has gestational of 30 \>37.
* Birth weight 1000 \> 2500 gm.
* Preterm infant fed oral or gavage feeding or both of them.

Exclusion Criteria:

* Preterm infants on mechanical ventilation or complicated case

Primary outcomes:
measure: enhance preterm infant feeding outcomes
timeFrame: after one week from use breast milk olfactory stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: القاهرة
country: Egypt
facility: Children's Hospital and Maternity & Gynecological Hospital affiliated to Ain Shams University
Study officials:
References:
Clinical trial NCT04634682: Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
Official title: Assessing the Effect of the MYODM Food Supplement on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myotonic Dystrophy 1
Lead sponsor: Myogem Health Company, S.L.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 30
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: The purpose of this study is to determine whether MYODM (formulated composition containing Theobroma cacao supplemented with caffeine (caffeine/theobromine ratio1/1.85, w/w) is effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1 (DM1) and improves the quality of life of these patients.

Detailed description: Detailed Description:

Myotonic Dystrophy type I (DM1) is the most common form of adult muscular dystrophy, affecting 1 in 8000 individuals. It is an autosomal dominant disorder with multisystemic involvement of multiple organs and tissues, mainly brain, heart, endocrine system, eyes and both smooth and skeletal muscles.

Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities. The present project is a 6 month randomized study to assess the effect of MYODM on fatigue, hypersomnia and quality of life in DM1 patients.The patients will be randomized to one of the two study arms. The active arm will receive the MYODM treatment and the control arm will not but both will follow the same evaluation program.

Patients will come to the center every 3 months for evaluations.

Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Genetically proven DM1
* Able to walk independently

Exclusion Criteria:

* Regular intake of plant stanols or other nutritional supplement
* Co-morbidity interfering with the interventions or possibly influencing outcomes.
* Participation in another clinical trial at the same time
* Unable to complete study questionnaires.

Primary outcomes:
measure: Change in Individualized Neuromuscular Quality of Life (INQoL) Mean Scores
timeFrame: Screening, Month 3, Month 6
measure: Change in Individualized Short Form-36 (SF-36) Mean Scores
timeFrame: Screening, Month 3, Month 6
measure: Change in Epworth Sleepiness Scale (ESS) Scores
timeFrame: Screening, Month 3, Month 6
Secondary outcomes:
measure: Change in Physical activity and daytime sleepiness measured with GeneActiv actometer
timeFrame: Screening, Baseline, Month 6
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Guipuzkoa
Study officials:
References:
Clinical trial NCT03491982: Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation
Official title: Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Referred by Cardiologist for Phase 2 Cardiac Rehabilitation
Keywords: Cardiac Rehabilitation
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the compliance of patients in a Phase 2 (outpatient clinic based) cardiac rehabilitation program, who are offered the opportunity to perform the rehab remotely (e.g. at home, not at the clinic), using a remote monitor and smart-phone application.

Detailed description: In spite of the fact that cardiac rehabilitation has been shown to be beneficial to patients who have had a cardiac event, such as a heart attack, only 5% of eligible patients complete this program. Some of the reasons cited include limited facility access, travel time and cost.

We are testing the hypothesis that cardiac rehab compliance will be greater if patients are offered the opportunity, and associated technology, to perform cardiac rehab anywhere.

Eligibility criteria: Inclusion Criteria:

* referred to SLU cardiac rehab facility

Exclusion Criteria:

* does not own app compatible smart phone
* dementia
* syncope
* valvular disease
* life expectancy \< 1 year
* non-English speaking
* unstable angina
* decompensated congestive heart failure
* ventricular arrhythmia

Primary outcomes:
measure: Percentage of patients completing remote rehab program compared to case controls
timeFrame: Immediately after cardiac rehab completion or stoppage
Secondary outcomes:
measure: Six minute walk test compared to case controls
timeFrame: Immediately after cardiac rehab completion or stoppage
measure: depression score vs case controls
timeFrame: Immediately after cardiac rehab completion or stoppage
measure: Average number of minutes in exercise rehab compared to case controls
timeFrame: Immediately after cardiac rehab completion or stoppage
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis University - SLUCare
state: Missouri
Study officials:
affiliation: St. Louis University
name: Lisa Alderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03104582: Best Biliary Drainage Option in Advanced Klatskin Tumor
Official title: Best Biliary Drainage Option in Type II、III、IV Klatskin Tumor：ERCP or PTBD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangitis
Keywords: ERCP
PTBD
EBD
Cholangitis
Complication
Klatskin tumor
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To investigate the biliary drainage-related cholangitis and other complications of percutaneous transhepatic biliary drainage (PTBD) in the management of Klatskin tumor (KT) compared with endoscopic biliary drainage (EBD).

Detailed description: Operative treatment combined with preoperative biliary drainage (PBD) has been established as a safe management strategy for KT. Preoperative cholangitis was an independent risk factor for patients undergoing resection for KT. However, controversy exists regarding the preferred technique for PBD.

Eligibility criteria: Inclusion Criteria:

* Type II、III、IV Klatskin tumor patients;
* 18-90 years old

Exclusion Criteria:

* Unwillingness or inability to consent for the study;
* Coagulation dysfunction (INR\> 1.3) and low peripheral blood platelet count(\<50×109 / L) or using anti-coagulation drugs;
* Previous endoscopic sphincterectomy (EST) or endoscopic papillary balloon dilatation (EPBD);
* Any type of GI reconstruction;
* Combined with Mirizzi syndrome and intrahepatic bile duct stones;
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, primary sclerosing cholangitis (PSC), septic shock;
* Biliary-duodenal fistula;
* Pregnant women

Primary outcomes:
measure: Acute cholangitis
timeFrame: 2 weeks
Secondary outcomes:
measure: Abdominal pain
timeFrame: 2 weeks
measure: Length of hospital stay
timeFrame: 6 months
measure: Overall procedure related complication rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Xun Li, M.D., Ph. D.
role: STUDY_DIRECTOR
References:
citation: Ba Y, Yue P, Leung JW, Wang H, Lin Y, Bai B, Zhu X, Zhang L, Zhu K, Wang W, Meng W, Zhou W, Liu Y, Li X. Percutaneous transhepatic biliary drainage may be the preferred preoperative drainage method in hilar cholangiocarcinoma. Endosc Int Open. 2020 Feb;8(2):E203-E210. doi: 10.1055/a-0990-9114. Epub 2020 Jan 22.
Clinical trial NCT04201782: Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-T
Official title: Long-Term Follow-up of HIV-Infected Subjects Treated With Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T or SB-728mR-T)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV-1-infection
Keywords: HIV
gene editing
CCR5
Lead sponsor: Sangamo Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 38
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: HIV-Infected Subjects who received SB-728-T under BB-IND 14129 or SB-728mR-T under BB-IND 16082.

Brief summary: Long-term follow-up of HIV-infected subjects who received SB-728-T or SB-728mR-T. Enrolling subjects will be followed for a total of 12 years.

Detailed description: Subjects infected with HIV who have received therapy with SB-728-T or SB-728mR-T will be eligible to participate in this trial. There will be no treatment in this long-term follow-up study. Subjects who choose to enroll into this extension study will be evaluated for a total of 12 years.

Eligibility criteria: Inclusion Criteria:

Subjects who have, in previous Sangamo clinical trial received SB-728-T or SB-728mR-T, autologous T-cells genetically modified at the CCR5 gene by zinc finger nucleases and give consent to participate in the long-term follow-up study.

Exclusion Criteria:

There are no exclusion criteria for this study.

Primary outcomes:
measure: Long-term safety of treatment with SB-728-T or SB-728mR-T
timeFrame: 12 years
Secondary outcomes:
measure: Long-term effects of SB-728-T or SB-728mR-T on CD4+ T-cell counts and on the viral load and tropism of HIV in blood.
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Norwalk
country: United States
facility: Circle CARE Center, LLC
state: Connecticut
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
Study officials:
affiliation: Sangamo Therapeutics, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02652182: Short-term Air Pollution Exposure and In-hospital Outcomes in Patients With Acute Myocardial Infraction
Official title: Short-term Air Pollution Exposure and In-hospital Outcomes in Patients With Acute Myocardial Infraction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Air Pollution
Acute Myocardial Infarction
Percutaneous Coronary Intervention
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First posted: 2016-01-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute ST (S- and T-wave)-segment elevation myocardial infarction who received emergent percutaneous coronary intervention

Brief summary: The aim of this study is to investigate whether or not short-term expose to air pollution is associated with in-hospital outcomes, such as mortality and morbidity.


Eligibility criteria: Inclusion Criteria:

* Less than 12 hours after the onset of myocardial infarction symptoms
* Documented acute ST (S- and T-wave)-segment elevation myocardial infarction
* Received emergent percutaneous coronary intervention

Exclusion Criteria:

* Age under 18-year old

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: in the phase of hospital stay, up to 30 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: in the phase of hospital stay, up to 30 days
measure: ST (S- and T-wave) segment decreasing
timeFrame: within an hour after primary percutaneous coronary intervention
measure: left ventricular function
timeFrame: in the phase of hospital stay, up to 30 days
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Huai'an First People's Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT06431282: Hyaluronic Acid Delivery: CO2 Laser Versus Thulium Laser Treatment
Official title: In Vivo Visualisation of Hyaluronic Acid After CO2 Laser Compared to Thulium Laser Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging Skin
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: * Weakly crossed-linked hyaluronic acid (HA) can be delivered through multiple injections into the dermal and subnormal layer to improve skin quality. However, this treatment comes with multiple bumps for several days.
* Alternatively, HA can be delivered after CO2 laser or thulium laser pretreatment. As microscopic analysis after this treatment is limited, the object of the present study is to investigate the morphological cellular changes after CO2 laser and thulium laser delivered HA into human skin.


Eligibility criteria: Inclusion Criteria:

- healthy male and female patients

Exclusion Criteria:

* pregnancy, breast feeding
* open wounds at the area to be treated

Primary outcomes:
measure: Size of intercellular spaces
timeFrame: 30 minutes and 30 days after treatment.
measure: Size of keratinocytes
timeFrame: 30 minutes and 30 days after treatment.
measure: Size of hyaluronic acid granules
timeFrame: 30 minutes and 30 days after treatment.
measure: Distribution of Hyaluronic Acid
timeFrame: 30 minutes and 30 days after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical-Center Hamburg-Eppendorf
Study officials:
References:
citation: Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25.
Clinical trial NCT03647982: Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers
Official title: Open-Label, Active Controlled, Single-Center, Phase 1 Study to Determine the Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anhidrotic Area
Hyperhidrosis
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 13
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the anhidrotic area and safety of MEDITOXIN


Eligibility criteria: Inclusion Criteria:

* Male adults aged between 20 and 45 years

Exclusion Criteria:

* Subjects not appropriate for participating in this study according to the investigator's opinion

Primary outcomes:
measure: anhidrotic area
timeFrame: week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic University St. Paul Hospital
state: Dongdaemun-gu
Study officials:
References:
Clinical trial NCT04785482: The PaTHS Descriptive Correlational Longitudinal Study
Official title: Parents Post-traumatic Stress Before and After Their Infant's Second Palliative Heart Surgery: The PaTHS Descriptive Correlational Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Single-ventricle
Posttraumatic Stress Disorder
Psychosocial Impairment
Keywords: remote monitoring
nursing
parents
transition
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Missouri, Kansas City
First posted: 2021-03-08
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of infants with single ventricle congenital heart disease participating in the Cardiac High Acuity Monitoring Program (CHAMP)

Brief summary: The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease. The investigators will use the posttraumatic stress disorder checklist for the DSM-V (PCL-5) to measure levels 2-4 weeks before and after the infant's second heart surgery. The investigators aim to describe the levels at the two-time points, compare the scores, and identify demographic information that correlates with the scores.


Eligibility criteria: Inclusion Criteria:

* Parent who is 18 years or older of an infant with SVCHD
* Following with CHAMP through Children's Mercy Hospital. Any person personally identifying as a parent of the child, who lives in the same household as the infant, and who will provide primary care after discharge from the hospital is eligible to participate.

Exclusion Criteria:

* Parents of an SVCHD infant who is undergoing end-of-life care, determined by the primary care team.

Primary outcomes:
measure: Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgery
timeFrame: on average at 4-6 months of age
Secondary outcomes:
measure: Measure the level of parental post-traumatic stress two to four weeks after discharge following their infant's second palliative heart surgery.
timeFrame: On average 5-6 months of age
Other outcomes:
measure: Examine the relationship of parental post-traumatic stress level before and after their infant's second palliative heart surgery.
timeFrame: through study completion, an average of 1 year
measure: Examine what demographic variables are the mediators and moderators of the correlations.
timeFrame: through study completion, an average of 1 year
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Advanced Practice Registered Nurse
name: Melissa Elliott
role: PRINCIPAL_INVESTIGATOR
References: