louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04923698: Effect of Yoga on Postpartum Depression
Official title: Yoga on Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Keywords: Yoga
Postpartum
depression
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 40
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A (Control group): It consisted of 20 women and treated by antidepressant drugs only for 12 weeks. Group B (Study group): It consisted of 20 women and treated by the same antidepressant drugs as in group A and yoga program, 50 minutes daily,7 days per week for 12 weeks (Total 84 sessions).
Primary purpose: TREATMENT

Brief summary: This study was conducted to investigate the effect of yoga on postpartum depression. Subjects: Forty primipara women with postpartum depression (PPD) selected randomly from Kasr El Ainy University Hospital in Cairo complaining of postpartum depression at least one month after childbirth shared in this study.

Detailed description: This study was conducted to investigate the effect of yoga on postpartum depression. Subjects: Forty primipara women with postpartum depression (PPD) selected randomly from Kasr El Ainy University Hospital in Cairo complaining of postpartum depression at least one month after childbirth shared in this study. Group A (Control group): It consisted of 20 women and treated by antidepressant drugs only for 12 weeks. Group B (Study group): It consisted of 20 women and treated by the same antidepressant drugs as in group A and yoga program, 50 minutes daily,7 days per week for 12 weeks (Total 84 sessions).

Eligibility criteria: Inclusion Criteria:

* Their ages were ranged from 20-35 years
* Their body mass index was less than 30 kg/m2

Exclusion Criteria:

* cardiac arrhythmia,
* respiratory problems,
* uncontrolled Type I diabetes

Primary outcomes:
measure: BMI assessment
timeFrame: three months
Secondary outcomes:
measure: Zung self-rating depression scale
timeFrame: three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ghada Ebrahim Elrefaye
Study officials:
References:
Clinical trial NCT02896998: Routine Versus on Demand Removal of the Syndesmotic Screw
Official title: Routine Versus on Demand Removal of the Syndesmotic Screw
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anke Fracture
Syndesmotic Injury
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 197
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 objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.


Eligibility criteria: Inclusion Criteria:

* Over 17 years of age
* Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury
* Syndesmotic screw placed within two weeks of the trauma
* Being in such condition that one is able to possibly undergo a second procedure

Exclusion Criteria:

* ISS score \>15
* Injuries to the ipsi- and contralateral side which might hamper rehabilitation
* Other medical conditions which hamper physical rehabilitation
* Incomprehensive understanding of the Dutch language

Primary outcomes:
measure: Functional outcome through the Olerud-Moland score
timeFrame: 1 year following initial treatment
Secondary outcomes:
measure: Functional outcome through the OAFAS
timeFrame: 1 year following initial treatment
measure: Pain through the Visual Analog scale
timeFrame: 1 year following initial treatment
measure: Range of motion
timeFrame: 1 year following initial treatment
measure: Surgical complications
timeFrame: 1 year following initial treatment
measure: Quality of Life through the EQ-5D-5L
timeFrame: 1 year following initial treatment
measure: Health care consumption through the iMCQ
timeFrame: 1 year following initial treatment
measure: Loss of productivity through the iPCQ
timeFrame: 1 year following initial treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
References:
citation: Dingemans SA, Birnie MFN, Sanders FRK, van den Bekerom MPJ, Backes M, van Beeck E, Bloemers FW, van Dijkman B, Flikweert E, Haverkamp D, Holtslag HR, Hoogendoorn JM, Joosse P, Parkkinen M, Roukema G, Sosef N, Twigt BA, van Veen RN, van der Veen AH, Vermeulen J, Winkelhagen J, van der Zwaard BC, van Dieren S, Goslings JC, Schepers T. Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial). BMC Musculoskelet Disord. 2018 Jan 31;19(1):35. doi: 10.1186/s12891-018-1946-5.
Clinical trial NCT05119998: A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
Official title: A Phase I, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed, locally advanced unresectable or metastatic tumors.
2. At least one evaluable or measurable lesion per RECIST 1.1
3. Male or female subject at least 18 years old and no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function
6. Be able to provide archived or fresh tumor tissues-

Exclusion Criteria:

1. Previous exposure to any anti-CD73 monoclonal antibody
2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
3. Unstable central nervous system netastases
4. Known active autoimmune disease or inflammatory disease
5. Known active infectious disease
6. Other uncontrolled systematic disease that may increase the risk of participating the study-

Primary outcomes:
measure: Number of patients with DLT
timeFrame: 28 days post first dose
measure: Number of patients with treatment related AEs
timeFrame: Up to 90 days post last dose
Secondary outcomes:
measure: Number of patients with response
timeFrame: Every 6 weeks until progressive disease or up to 24 months after treatment
measure: The area under the curve (AUC)
timeFrame: Up to 90 days post last dose
measure: Maximum concentration (Cmax)
timeFrame: Up to 90 days post last dose
measure: Time at which maximum concentration (Tmax)
timeFrame: Up to 90 days post last dose
measure: The half-life (t1/2)
timeFrame: Up to 90 days post last dose
measure: Positive rate of ADA and Nab
timeFrame: Up to 90 days post last dose
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Province Cancer Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT01713998: Treatment of the Face and Neck With Lower Ulthera System Energy Settings
Official title: Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 47
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed description: This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Eligibility criteria: Inclusion Criteria:

* Male or female, age 30 to 65 years.
* Subject in good health.
* Skin laxity on the face and neck

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face or neck.
* Excessive skin laxity on the face or neck.
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Severe or cystic acne on the area to be treated.

Primary outcomes:
measure: Subjects' Assessment of Pain During Treatment With Lower Energy Settings
timeFrame: Participants were assessed for the duration of study treatment, an average of 75 minutes
measure: Overall Improvement in Skin Laxity on the Face and Neck
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Quantitative Assessment of Brow Lift at 90 Days Post-treatment
timeFrame: 90 days post-treatment
measure: Subject Assessment of Improvement at 90 Days Post-treatment
timeFrame: 90 days post-treatment
measure: Subject Assessment of Improvement at 180 Days Post-treatment
timeFrame: 180 days post-treatment
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Ulthera, Inc.
state: Arizona
Study officials:
affiliation: Ulthera, Inc
name: Steven H Gitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02304198: Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH
Official title: A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-01
Enrollment: 59
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: This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).

Detailed description: Pulmonary arterial Hypertension is characterized by a progressive incerease in pulmonary vascular resistance(PVR) leading to right ventricualar failure.

Udenafil inhibits PDE 5, an enzyme that metabolizes cGMP, enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells, including those in the lung.

Eligibility criteria: Inclusion Criteria:

* Patients who completed the initial study(DA8159_PAH_II), 12-week, double-blind, placebo-controlled trial

Exclusion Criteria:

-

Primary outcomes:
measure: Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc)
timeFrame: during 48-weeks
Secondary outcomes:
measure: 6-MWD
timeFrame: 24, 48-week
measure: BORG dyspnea score
timeFrame: 24, 48-week
measure: WHO class
timeFrame: 12, 24, 36, 48-week
measure: Time to clinical worsening(TTCW)
timeFrame: during 48-weeks
measure: NT-pro BNP
timeFrame: 24, 48-week
measure: Echocardiography
timeFrame: 48-week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-Gu, Irwon-Dong 50
Study officials:
affiliation: Samsung Medical Center
name: Duk-Kyung Kim, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Samsung Medical Center
name: Sung-A Jang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Jun-Bin Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Hyung-Kwan Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Hyuk-Jae Jang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul St. Mary's Hospital
name: Hae-Ok Jung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Hospital
name: Jung-Hyun Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Jae-Seung Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Kye-Hun Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Jin-Ok Jeong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: Sang-Yeub Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05802498: Rehabilitation in Parkinson Disease Cyclone in Life
Official title: IR3MA Parkinson Cyclone in Life: Innovation, R3 Rehabilitation - Resonance - RTD Fluxgate Sensor, Multidisciplinary Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Physical Disability
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

* Improved joint function and gait pattern
* Reduction of the risk of falling or reduction of energy expenditure during physiological gait

Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

Detailed description: rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

Eligibility criteria: Inclusion Criteria:

* Hoehn \& Yahr between 2.0 and 3.0;
* No need for a walking aid;
* Mini-Mental State Examination (MMSE) score \>24;
* Effective dopaminergic pharmacological control;
* Absence of other relevant neurological comorbidities;
* Absence of postural deformities (and/or Pisa syndrome);
* Absence of severe cardiological pathologies (exertional angina, severe decompensation).
* Ability to travel to the rehabilitation treatment site independently or with support

Exclusion Criteria:

* presence of Deep Brain Stimulation (DBS);
* presence of severe heart and/or lung disease;
* presence of therapeutic regimen in the definition phase;
* impaired joint and/or motor function to follow a proposed rehabilitation treatment programme
* contraindications to performing MRI scans
* undergoing rehabilitation therapy in the 3 months preceding enrolment.

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi "Bonino-Pulejo"
Study officials:
References:
Clinical trial NCT05780398: Long Term Follow up in Pediatric Supracondylar Humeral Fracture
Official title: Long Term Follow up in Pediatric Supracondylar Humeral Fracture After Surgical Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Supracondylar Humerus Fracture
Elbow Fracture
Keywords: long term follow up
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 634
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019

Brief summary: The goal of this clinical trial is to learn about long term outcomes in Supracondylar Humeral Fracture in children after surgery.

The main questions it aims to answer are:

* how good is the elbow function
* what are the post-operative complication
* what is the time before return to sport
* what is the aesthetic prejudice of the scar for the patient Participants will answer questionnaries and send photographs of their elbows to the examinator

Detailed description: Elbow fractures represent 5% of total fracture in children. Supracondylar humeral fractures compound half of them.

As distal humerus is responsible for only 20% of humeral growth, bone remodelage her is less important compared to other sites in children..

Many different attitudes are possible : orthopedic reduction, open reduction, percutaneous pinning ... No methode as clearly demontrated a superiority.

Percutaneous pinning as been widely used the last years though We haven't find any study evaluating long term outcomes regarding functionnal and aesthetic outcomes in supracondylar humeral fracture treated by percutaneous pinning.

Eligibility criteria: Inclusion Criteria:

* Children operated for a supracondylar humeral fracture in university hospital of Grenoble from July 2011 to December 2019

Exclusion Criteria:

* Opposition from patient or parents to participate
* Children who did not effectively suffered a supracondylar humeral fracture

Primary outcomes:
measure: functional outcome after supracondylar humeral fracture
timeFrame: 1 day
measure: functional outcome after supracondylar humeral fracture
timeFrame: 1 day
measure: functional outcome after supracondylar humeral fracture
timeFrame: 1 day
Secondary outcomes:
measure: post operative complication
timeFrame: 1 day
measure: time before return to sport
timeFrame: 1 day
measure: aesthetical prejudice
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00342498: Estrogen Receptor Gene Mutations
Official title: Estrogen Receptor Gene Mutations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mutations
Hormones
Keywords: DNA
Hormone
Resistance
Skeleton
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient who appears insensitive to estrogen hormone treatment.

Detailed description: We propose to analyze a DNA sample for mutations in the estrogen receptor gene from a patient who appears insensitive to estrogen hormone treatment.

Eligibility criteria: * INCLUSION CRITERIA:

Patient is individual with estrogen insensitivity.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: NIEHS, Research Triangle Park
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01850498: Epilepsy Motion Sensing
Official title: Motion Sensing Study in Epilepsy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Seizure
Motor
Motion
Accelerometer
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 19
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 with epilepsy referred to epilepsy monitoring unit.

Brief summary: Evaluate patient motion during seizures.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
* Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
* Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
* Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary \[idiopathic\] or secondary \[symptomatic\] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures.
* Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study
* Male or non-pregnant female
* English speaking

Exclusion Criteria:

* Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable
* Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings
* Have a movement disorder that may affect GT3X+ recordings

Primary outcomes:
measure: To identify and evaluate seizure characteristics derived from an accelerometer that can be used in development of a seizure detection algorithm (compared to EEG readings).
timeFrame: While patients are being evaluated in an epilepsy monitoring unit.
Secondary outcomes:
measure: Evaluate the accuracy of an accelerometer in identifying seizures (compared to EEG readings).
timeFrame: While patients are being evaluated in an epilepsy monitoring unit.
measure: Evaluate whether certain seizure types are more capable of being identified by the accelerometer (compared to EEG readings).
timeFrame: While patients are being evaluated in an epilepsy monitoring unit.
measure: Evaluate heart rate and rhythm changes associated with seizure onset (compared to ECG readings).
timeFrame: While patients are being evaluated in an epilepsy monitoring unit.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: