louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04506476: Trial Evaluating the Benefit of a Fitness Tracker Based Workout During Adjuvant Radiotherapy of Breast Cancer
Official title: Randomisierte Studie Zum Nutzen Des Fitnesstracker Basierten Aktivitätstrainings während Einer Adjuvanten Bestrahlung Des Mammakarzinoms (OnkoFit I)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Fatigue
activity tracker
Radiotherapy
Exercise
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 201
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized three-arm trial will test the benefit in terms of cancer related fatigue of an activity tracker based exercise training during adjuvant radiotherapy in breast cancer patients.

Detailed description: This monocentric, three-arm, randomized, controlled clinical trial evaluates the effect of an activity tracker based exercise program in breast cancer patients on the fatigue syndrome during adjuvant radiotherapy. Quality of Life and the intensity of fatigue will be documented with the fatigue subscale of the FACIT Questionnaire three months after adjuvant radiotherapy.

Eligibility criteria: Inclusion Criteria:

* Capacity for consent
* Minimum age 18
* Presence of breast cancer
* ECOG 0-2
* Indication for adjuvant radiotherapy of breast cancer after breast-conserving surgery or Ablatio mammae

Exclusion Criteria:

* Participation in any other interventional study
* Pregnancy
* Contraindication against physical activity/sport and others
* Severe cardiovascular pre-existing conditions (after myocardial infarction, apoplexy in the last 6 months, congestive heart failure NYHA \> I°)
* preexisting diseases with are relevantly accompanied by a limited mobility in patients (e.g. paraparesis of the lower limbs)
* ECOG Status 3-4
* prior use of activity trackers

Primary outcomes:
measure: Evaluation of the impact of an activity tracker based fitness programme on the fatigue syndrome
timeFrame: 3 Months after completion of adjuvant radiotherapy of breast cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Radiation Oncology
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tübingen
name: Cihan Gani, MD, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hauth F, Gehler B, Niess AM, Fischer K, Toepell A, Heinrich V, Roesel I, Peter A, Renovanz M, Hartkopf A, Stengel A, Zips D, Gani C. An Activity Tracker-Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials). JMIR Res Protoc. 2021 Sep 22;10(9):e28524. doi: 10.2196/28524.
Clinical trial NCT04642976: Prospective Evaluation of CT Guided Ablation of Cardiac Ganglionated Plexi
Official title: Prospective Evaluation of Computed Tomography Guided Ablation of Cardiac Ganglionated Plexi in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Ganglionated Plexus
Cardioneural Ablation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with atrial fibrillation planned to undergo catheter ablation

Brief summary: Despite progress made in treating atrial fibrillation with catheter ablation, outcomes remain suboptimal with pulmonary vein isolation alone. Ablation of ganglionated plexi (GP) has been shown to be beneficial in patients with atrial fibrillation although optimal strategies of localization of these regions have yet to be determined. The investigators aim to develop a novel strategy of CT guided GP localization to guide ablation in patients with atrial fibrillation. The investigators also aim to clarify the network of innervation between GP to clarify the optimal ablation strategy. This is an observational, single-center study evaluating feasibility and efficacy of CT and high frequency stimulation (HFS) guided GP mapping and ablation in patients with AF undergoing catheter ablation with pulmonary vein isolation. Patients will undergo HFS and CT guided mapping of GPs followed by allocation into one of 8 different GP ablation approaches in a non-randomized fashion.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years
4. History of AF with plan to undergo catheter ablation

Exclusion Criteria:

1. Contraindication or unwillingness to undergo CT imaging or catheter ablation.
2. Pregnancy or lactation

Primary outcomes:
measure: Correlation Between HFS (High Frequency Stimulation) Response and CT Identified Epicardial Adipose Tissue.
timeFrame: During Procedure
Secondary outcomes:
measure: HFS (High Frequency Stimulation) Response Elimination
timeFrame: during procedure
measure: Global Vagal Response Elimination
timeFrame: This will be assessed during the procedure.
measure: Ablation Site Changes - Amplitude of Signals
timeFrame: This will be assessed during the procedure.
measure: Ablation Site Changes - Duration of Signals
timeFrame: This will be assessed during the procedure.
measure: Ablation Site Changes - Fractionation of Signals
timeFrame: This will be assessed during the procedure.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Saman Nazarian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01435876: Surgery and Convergence Insufficiency Intermittent Exotropia
Official title: Treatment for Convergence Insufficiency Intermittent Exotropia; A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications
Lead sponsor: Sudhalkar Eye Hospital
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial aims to determine which treatment modality is better for treatment of the convergence insufficiency subtype of intermittent exotropia.

Detailed description: Surgery can give better results,

Eligibility criteria: Inclusion Criteria:Convergence Insufficiency Type Intermittent Exotropia

* No stereopsis
* Good visual acuity

Exclusion Criteria:

* Amblyopia
* Anisometropia \> 2.5D
* Vertical deviations

Primary outcomes:
measure: Postoperative gain of stereopsis
timeFrame: 1month-1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Aditya Sudhalkar
state: Gujarat
city: Ahmedabad
country: India
facility: M & J Institute Of Ophthalmology
state: Gujarat
city: Ahmedabad
country: India
facility: M & J Institute
state: Gujarat
Study officials:
affiliation: Consultant
name: Aditya A Sudhalkar, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914276: Lymphedema in Endometrial Cancer
Official title: A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Extremity Lymphedema
Endometrial Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 100
Sex: FEMALE
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: (1) women older than 18 years old, (2) endometrial cancer, (3) suitable candidates for surgery, (4) scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC), (5) no severe physical or mental comorbidity

Brief summary: Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery.

Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.


Eligibility criteria: Inclusion Criteria:

1. women older than 18 years old,
2. endometrial cancer,
3. suitable candidates for surgery,
4. scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC),
5. no severe physical or mental comorbidity

Exclusion Criteria:

1. metastatic disease,
2. laparotomy

Primary outcomes:
measure: change in incidence of lower-extremity lymphedema
timeFrame: 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer
Secondary outcomes:
measure: change in lymphedema-related morbidity
timeFrame: 1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer
Other outcomes:
measure: change in quality of life in women with endometrial cancer who undergo staging surgery
timeFrame: pre-operatively, 1 month post-op, 6-9 months and 12-18 months post-op
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Laura Havrilesky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01641276: Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma
Official title: Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis
Hepatocellular Carcinomas
Keywords: biofeedback response
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.

Detailed description: Patients will be exposed by different specific amplitude-modulated frequencies of low intensity electromagnetic fields for 30 min. During the exposure, autonomic response with be recorded in order to identify biofeedback response. Differences in group of frequencies is expected in patients with hepatitis B carries with or without hepatocellular carcinoma.

Eligibility criteria: Inclusion Criteria:

* hepatitis B carriers patients
* hepatitis B carriers patients with hepatocellular cancer patients

Exclusion Criteria:

* other tumor types
* other hepatitis types

Primary outcomes:
measure: Identification of different group of specific frequencies of modulation in hepatitis B carriers with and without hepatocellular carcinoma associated with biofeedback response
timeFrame: within 10 min of exposure
Secondary outcomes:
measure: Characterization of differences biofeedback response in hepatitis B carriers with and without hepatocellular carcinoma
timeFrame: within 10 minutes of exposure
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio Libanês
Study officials:
affiliation: Hospital Sirio-Libanes
name: Frederico P Costa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02456376: Balance Control in Children With Cerebral Palsy
Official title: Sensor Fusion for Balance Control in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Sensor Fusion
Stochastic Resonance Stimulation
Sensory deficits
Postural Control
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
name: University of Delaware
First posted: 2015-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate how sensory information processing affects balance ability in children with cerebral palsy (CP). An additional goal is to determine if a subsensory electrical stimulation called Stochastic Resonance (SR) Stimulation, can improve balance in children with CP. Children with CP and children with typical development will participate and complete a series of clinical and balance assessments. They will also be tested in a sensor fusion paradigm to investigate potential deficits in the dynamic integration of visual, vestibular and proprioceptive information during upright stance. SR stimulation will then be used to potentially improve these deficits and subsequently their balance ability.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of spastic diplegia CP (GMFCS I- III)\*
* Ability to stand independently for approximately 2 min

Exclusion Criteria:

* Lower extremity surgery or fractures in the year prior testing
* Joint instability or dislocation in the lower extremities
* Botulinum toxin injections in the lower extremities within the past 6 months\*
* Marked visual or hearing deficits
* Uncontrolled seizure disorder
* Implanted medical device that may be contraindicated with application of SR stimulation

  * Asterisk indicates the eligibility criteria that should be met only by children with CP

Primary outcomes:
measure: Gain response
timeFrame: 1 day
Secondary outcomes:
measure: Gain response
timeFrame: 1 day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Shriners Hospital for Children
state: Pennsylvania
Study officials:
affiliation: Temple University
name: John Jeka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zarkou A, Lee SCK, Prosser LA, Hwang S, Jeka J. Stochastic resonance stimulation improves balance in children with cerebral palsy: a case control study. J Neuroeng Rehabil. 2018 Dec 10;15(1):115. doi: 10.1186/s12984-018-0467-7.
Clinical trial NCT01655576: Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial
Official title: Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Management of Delivery
Keywords: drainage
pregnancy
active management
postpartum hemorrhage
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.

Detailed description: The study aims to compare the effectiveness of placental drainage versus maintenance of maternal cord clamped end in the third stage of labor to reduce postpartum blood loss.

Eligibility criteria: Inclusion Criteria:

* Low risk pregnant women
* Pregnancy at term
* Women at low risk for assisted labor / delivery and postpartum care.
* Live Fetus

Exclusion Criteria:

* Women under 18, mentally handicapped and indigenous;
* Women who agreed to participate signed the Informed Consent, but evolved to cesarean section or instrumental delivery by forceps;
* Instrumental Delivery by forceps or c-section

Primary outcomes:
measure: Duration of the third period of labor
timeFrame: Six hours
Secondary outcomes:
measure: Postpartum blood loss
timeFrame: 24 hours
measure: PPH
timeFrame: 24 hours
measure: Need of uterotonics
timeFrame: 24 hours
measure: Need of blood transfusions
timeFrame: until discharge
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: IMIP
state: Pernambuco
Study officials:
References:
citation: Vasconcelos FB, Katz L, Coutinho I, Lins VL, de Amorim MM. Placental cord drainage in the third stage of labor: Randomized clinical trial. PLoS One. 2018 May 2;13(5):e0195650. doi: 10.1371/journal.pone.0195650. eCollection 2018.
Clinical trial NCT01959776: Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery
Official title: Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Hole
Keywords: cone outer segment tips line, foveal displacement
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after macular hole surgery


Eligibility criteria: Inclusion Criteria:

* The patients with macular hole

Exclusion Criteria:

* The patients with follow-up less than 6 months

Primary outcomes:
measure: Optical coherence tomography
timeFrame: one year
Secondary outcomes:
measure: Visual recovery
timeFrame: one year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
References:
citation: Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.
Clinical trial NCT02885376: Study of Dentoxol® Mouthrinse for Oral Mucositis
Official title: Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: Mucositis
Lead sponsor: Ingalfarma SpA
Sponsor class: INDUSTRY
First posted: 2016-08-31
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy.
* Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity

Exclusion Criteria:

* Unable to give written informed consent
* Known allergy/intolerance to any component of the study rinse or placebo
* Planning to use any contraindicated medications during the study period (pain medications are allowed)
* Age below 18 years
* Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)

Primary outcomes:
measure: Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale
timeFrame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Secondary outcomes:
measure: Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.
timeFrame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
measure: Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
timeFrame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
measure: Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
timeFrame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
measure: Weight loss, as measured by the difference between weight on first and last day of radiation therapy.
timeFrame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
measure: Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.
timeFrame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica IRAM
city: Santiago
country: Chile
facility: Fundación Arturo López Pérez
city: Santiago
country: Chile
facility: Instituto Nacional del Cáncer
Study officials:
affiliation: Clinica IRAM
name: Sebastián Sole
role: PRINCIPAL_INVESTIGATOR
References: