louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02876536: Effect of Transcutaneous Electrical Nerve Stimulation on Cognition in Multiple Sclerosis Patients
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Cognitive Disorders in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Disorders
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate whether the Transcutaneous Electrical Nerve Stimulation (TENS) is effective on improvement of cognitive disorders in Multiple sclerosis patients.

Detailed description: Multiple sclerosis (MS) is one of the most common autoimmune diseases in the world. One of the complications of MS, is cognitive disorder.

In some studies on rats, stimulation of somatosensory neurons has improved the hippocampus activity by increasing the amount of acetylcholine. Hippocampus has a major role in cognition and behavior.

TENS is a non-invasive method in which the electrical pulses are sent to the body trough skin by electrodes. This device can stimulate the somatosensory neurons by electrical impulses. In several studies, the effect of TENS has been proved on short term memory and verbal fluency in patients with mild stages of Alzheimer disease. Also it has been effective on some aspects of cognition on old people suffering from forgetfulness.

Eligibility criteria: Inclusion Criteria:

* patients with confirmed multiple sclerosis by McDonald criteria;
* score 25 or less in mini mental state examination (MMSE)

Exclusion Criteria:

* MMSE score greater than 25;
* the history of psychiatric problems;
* addiction to alcohol; head trauma; cerebrovascular disease; hydrocephalus; neoplasm; epilepsy; renal or respiratory diseases; impaired consciousness

Primary outcomes:
measure: change in the level of cognition measured by Addenbrooke's cognitive examination
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra Hospital
Study officials:
affiliation: Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran
name: Vahid Shaygannezhad, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02721836: Yoga for Patients With Irritable Bowel Syndrome
Official title: Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to nutrition counselling. Further, the potential of both interventions to influence the gut microbiome will be inquired.


Eligibility criteria: Inclusion Criteria:

* Patients with irritable bowel syndrome (IBS) diagnosed by physician and confirmed by Rome III diagnostic criteria

Exclusion Criteria:

* inflammatory bowel diseases (IBD)
* total abdominal colectomy
* no sonographie or colonoscopy as diagnostic criterion
* stool lactoferrin \> 7mg/g
* pregnancy or breast feeding
* simultaneous participation in further clinical intervention trials
* Regular yoga practice or nutrition counselling in the past 12 months
* Planned surgery in the study period
* Serious illness that would interfere with the ability to practice yoga

Primary outcomes:
measure: Irritable Bowel Syndrome Symptoms
timeFrame: Week 12
Secondary outcomes:
measure: disease specific quality of life
timeFrame: Week 12
measure: disease specific quality of life
timeFrame: Week 24
measure: Generic Health-related Quality of life
timeFrame: Week 12
measure: Generic Health-related Quality of life
timeFrame: Week 24
measure: Emotional distress
timeFrame: Week 12
measure: Emotional distress
timeFrame: Week 24
measure: Subjective Stress
timeFrame: Week 12
measure: Subjective Stress
timeFrame: Week 24
measure: Subjective improvement of symptoms
timeFrame: Week 12
measure: Subjective improvement of symptoms
timeFrame: Week 24
measure: Gut microbiome
timeFrame: Week 12
measure: Adverse Event
timeFrame: Week 12
measure: Adverse Event
timeFrame: Week 24
measure: Irritable Bowel Syndrome Symptoms
timeFrame: Week 24
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universität Duisburg-Essen
Study officials:
References:
citation: Schumann D, Anheyer D, Lauche R, Dobos G, Langhorst J, Cramer H. Effect of Yoga in the Therapy of Irritable Bowel Syndrome: A Systematic Review. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1720-1731. doi: 10.1016/j.cgh.2016.04.026. Epub 2016 Apr 22.
Clinical trial NCT03952936: Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study
Official title: Vestibular Rehabilitation for Chronic Central Vestibular Deficits Due to Cerebellar Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Fall
Coordination and Balance Disturbances
Lead sponsor: Methodist University, North Carolina
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.

Detailed description: The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.

Investigators will test the subject initially at 4 weeks, 8 weeks and 6 months post start date to assess for symptom improvement.

Eligibility criteria: Inclusion Criteria:

* Central vestibular deficits

Exclusion Criteria:

* None

Primary outcomes:
measure: Activity Specific Balance Confidence Scale
timeFrame: 2-6 months
Secondary outcomes:
measure: Dizziness handicap inventory
timeFrame: 2-6 months
measure: Functional Gait Assessment
timeFrame: 2-6 months
measure: Motion Sensitivity Quotient
timeFrame: 2-6 months
measure: Modified Clinical Test for Sensory Integration in Balance
timeFrame: 2-6 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Methodist Universtiy
state: North Carolina
Study officials:
References:
Clinical trial NCT04956536: Anterior Tibial Subluxation in the Setting of ACL-injury and After ACL Reconstruction
Official title: A Retrospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Injury and After Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior tibial subluxation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ACL-injured patients that had suffered from ACL injury and underwent primary ACL reconstruction between January 1, 2013 and December 31, 2015.

Brief summary: To identify the related factors for anterior tibial subluxation (ATS) on anterior cruciate ligament-injured MRI images.

Detailed description: Demographic data and MRI images of anterior cruciate ligament-injured patients were retrospectively analyzed. Anterior tibial subluxation was measured and factors were examined via univariate and multivariate analysis.

Eligibility criteria: Inclusion Criteria:

* Diagnosed anterior cruciate ligament injuries
* Available preoperative MRI images at our hospital

Exclusion Criteria:

* Patients were excluded in the case of under 18 years of age
* Bilateral anterior cruciate ligament injuries
* Concomitant posterior cruciate ligament injuries
* Concomitant collateral ligament injuries
* No access to the preoperative MRI scan at our hospital

Primary outcomes:
measure: Anterior tibial subluxation
timeFrame: Preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Cheng Wang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02136836: Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stomach Neoplasms
Keywords: Genes, erbB-2
Prognosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 860
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: gastric cancer patients in Gangnam Severance Hospital

Brief summary: The objective of this study is to investigate the proportion of HER2 overexpression in gastric cancer patients group, to evaluate the relation of HER2 overexpression with prognosis, and to analyze the proportion of herceptin applied to patients in clinical field. Furthermore, the investigators are going to reevaluate the clinical benefit of Herceptin for survival prolongation compared to chemotherapy only.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed gastric adenocarcinoma
2. Patients were diagnosed during 2006-2013
3. HER2 expression status was evaluated in primary gastric cancer or metastatic lesion.

Exclusion Criteria:

* Patients with second primary cancer within 5 years

Primary outcomes:
measure: The proportion of HER2 overexpression in gastric cancer patients
timeFrame: 8 years
Secondary outcomes:
measure: Gastric cancer specific survival according to HER2 expression in each stage
timeFrame: 5 years
Other outcomes:
measure: The practice pattern of Herceptin use in stage IV gastric cancer
timeFrame: 3 years
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital, Yonsei University
name: Jae Yong Cho, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04729036: Mandibular Angle Fracture and Interframents Gap
Official title: Interfragmentary Gap Discrepancy After Intraoral One-plate Fixation in Mandibular Angle Fracture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mandibular Fractures
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: . All the patients suffered from minimally displaced mandibular angle fracture which needed intervention via reduction and fixation

Brief summary: Twenty-five patients with mandibular angle fracture were subjected to reduction and fixation through intra-oral open reduction and semi-rigid min plate fixation near the superior border of the mandible at Champy's osteosynthesis line. The linear inter-fragmentary gap was measured at the inferior border of the mandible after fixation of the fractured bony segments in the final aligned position immediately postoperative on a panoramic radiograph for the mesio-distal plane and a cone beam computed tomography for the bucco-lingual plane to assess any lingual splay. The healing process was clinically followed for 3 months postoperatively for any complications and/or patient complains


Eligibility criteria: Inclusion Criteria:

* minimally displaced mandibular angle fracture which needed intervention via reduction and fixation \*medically free

Exclusion Criteria:

* - Patients with multiple mandibular fractures or patients with concomitant maxillary fracture.
* Patients with severely displaced mandibular angle fracture needing extra-oral open reduction and fixation.
* Medically compromised patients and patients with abnormalities that impair bone healing

Primary outcomes:
measure: interfragment gap
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT03806036: The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovary
Official title: The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study included 100 female diagnosed with polycystic ovary syndrome. They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Detailed description: The study included 100 female diagnosed with polycystic ovary syndrome diagnosed by by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003): oligoovulation and/or an ovulation , excess androgen activity (clinical or biochemical) and polycystic ovaries (by pelvic ultrasound "vaginal route").They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Eligibility criteria: Inclusion Criteria:

1- BMI: more than 25.0 kg/m2

2- PCO was diagnosed by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003)

1. oligoovulation and/or an ovulation
2. excess androgen activity (clinical or biochemical)
3. polycystic ovaries (by pelvic ultrasound "vaginal route")

3- Anovulatory patient resistant to induction with clomiphene citrate alone

Exclusion Criteria:

-1) BMI: more than 35.0 kg/m2

2) Infertile women due to any factor other than PCO

Primary outcomes:
measure: Ovulation
timeFrame: 14 days after menses
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03756636: "Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis.
Official title: "Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colo-rectal Polyps
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 40
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: All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract.

Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure.

Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication".

A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years.
* Signing of informed consent.
* Possibility of being subjected to the diagnostic and therapeutic procedures of the study.
* Presence of colo-rectal polypoid lesions ≥ 15mm presenting macroscopic aspects of fibrosis as a consequence of previous incomplete treatments or biopsies or relapses after previous removal.

Exclusion Criteria:

* Highly indicative morphological characteristics of carcinoma with submucosal invasion (Ulceration, Pit Pattern Vn according to Kudo et al.18)
* Pregnancy or breastfeeding
* ASA\> 3
* Unstable personality or unable to adhere to the protocol procedures.
* Inability to provide informed consent.
* Injury not reachable endoscopically.

Primary outcomes:
measure: Macroscopically complete resection rate
timeFrame: 6 Months
measure: 6-month recurrence rate;
timeFrame: 6 Months
measure: Rate of adverse events (according to the lexiconA ASGE).
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT03913936: Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot
Official title: Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Intervention Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2019-04-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is piloting a new internet-based research tool (YES portal). The main purpose of this pilot study is to test the web-based interface.

Detailed description: This study is being done to pilot a web-based research intervention tool. The investigators hope that by piloting it with the participants they can improve the tool and the other processes. The main purpose of this pilot study is to test the web-based interface, the participant's engagement with the platform, and the recruitment procedures. This initial pilot study will inform the design of a larger study intended to monitor common symptoms and behavior, and to provide supportive care information and research opportunities in an iterative manner for young women who have been diagnosed with breast cancer using the YES portal, built for smartphones, tablets, and computers.

Eligibility criteria: Inclusion Criteria:

* Female
* Between the ages of 18-44 years
* A history of breast cancer; we will pilot in 3 separate cohorts consisting of 10 patients each: newly diagnosed patients receiving care at DFCI, prevalent survivors who have completed early active therapy (surgery, chemotherapy and/or radiotherapy) and are being followed at DFCI, and women living with advanced breast cancer receiving care at DFCI
* Be fluent in and able to read English
* Have internet access on a regular basis at the time of consent that can support the web-based platform

Exclusion Criteria:

N/A

Primary outcomes:
measure: Frequency of logging into the portal.
timeFrame: 2 years
measure: Time spent in the portal.
timeFrame: 2 years
measure: Time spent responding the survey.
timeFrame: 2 years
measure: Frequency of information downloads.
timeFrame: 2 years
measure: Participant-reported utility of the portal.
timeFrame: 2 years
measure: Participant-reported recommendations for improving the portal.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ann H. Partridge, MD
role: PRINCIPAL_INVESTIGATOR
References: