louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04742543: Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia
Official title: Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysplasia, Cervix
Keywords: cervical dysplasia; conization; anxiety; pain; virtual reality
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-02-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: : Parallel Assignment
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the effectiveness of virtual reality glasses as a distraction technique in the management of acute pain and anxiety during conization of cervix uterus under local anesthesia

Detailed description: A prospective, open-label, randomized control trial in a tertiary university affiliated medical center between March 2021 to March 2023. Overall, 100 women referred for conization of cervix due to cervical dysplasia will be randomly allocated to undergo conization either with the use of virtual reality glasses (study group) or with standard treatment (control group). The primary outcome measures will include self-reported pain, anxiety scores, and vital signs as an indirect measurement of pain and anxiety, including pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes will be measured as numeric rating scores.

Eligibility criteria: Inclusion Criteria:

Patients over 18 years referred for conization of cervix due to cervical dysplasia

Exclusion Criteria:

* patients under 18 years
* pregnant women

Primary outcomes:
measure: Assessments of pain through pain score parameter
timeFrame: 20 minutes
measure: Assessments of pain through physiological parameters
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT01304043: French Observatory of Rare Malignant Tumors of the Ovary
Official title: Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Tumors
Keywords: ovarian tumors
rare ovarian tumors
germinal tumors
sexual cords tumors
observatory
forum
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 204
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: female with rare ovarian cancer

Brief summary: To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

Detailed description: * to establish prognosis factors for the disease
* to proceed in a centralised examination of histologic laminas
* to reach in the long-term and homogenous follow-up of the patients
* to follow-up the long-term toxicities of the treatments given
* to analyse and follow-up the later fertility of the patients
* to evaluate the interest of setting a multi-disciplinary discussion forum on the Web

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* germinal or sexual cords ovary tumors histologically proven
* first line or relapse treatment
* written informed consent

Exclusion Criteria:

* mental ineptitude to understand and follow the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame
Study officials:
affiliation: GINECO
name: Isabelle Ray-Coquard, Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01497743: Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
Official title: Probiotics in Patients With Moderate-to-severe Distention/ Bloating From Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Scleroderma
Keywords: Scleroderma
gastrointestinal
bloating
reflux
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Organs of the gastrointestinal tract include the mouth, throat, stomach, intestines, and anus. Patients with scleroderma often have GIT disorders. GIT disorders can be severely debilitating and even life-threatening. Some problems associated with GIT disorders may include heartburn, loss of voice or hoarseness, ulcers (open sores), difficulty swallowing, constipation, diarrhea, malabsorption (impaired absorption of nutrients from the GI tract), diminished peristalsis (decreased in the wavelike motion in the muscles of the intestines), and the inability to control your bowel movements.

Probiotics are the "good bacteria" normally found in your digestive tract. Our group is looking at whether or not taking daily probiotics (lactobacillus) can help alleviate some of these symptoms in scleroderma patients that have GIT disorders.


Eligibility criteria: Inclusion Criteria:

1. Adult patient ≥18 years.
2. Patients with SSc with moderate-to-severe distention/bloating on GIT 2. scale (scale score \>1.00).
3. Stable immunosuppressive therapy(ies) for ≥ 1 month.
4. Stable PPI and/or other anti-reflux medications for ≥ 1 month.
5. Stable calcium channel blocker for ≥ 1 month.
6. Stable NSAID for ≥ 1 month.
7. Stable dose of pro-motility agent for ≥ 1 month.

Exclusion criteria:

1. Recent diagnosis for small intestinal bacterial overgrowth (SIBO) during last 1 month.
2. Treatment with antibiotics within last 2 weeks.
3. Currently receiving chemotherapy (pulse cyclophosphamide). It is acceptable to be on methotrexate, mycophenolate mofetil, hydroxychloroquine, or azathioprine.
4. Severe diarrhea (Diarrhea scale score of ≥ 1.01; may suggest untreated SIBO).
5. History of inherited or acquired immunodeficiency

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Primary outcomes:
measure: 1. Proportion of patients with improvement in distention/bloating scale ≥ 0.14 at the end of 4 weeks. A change of 0.14 is the minimally important difference for this scale(9)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02030743: A Study of Visual Attention Training to Improve Balance and Mobility
Official title: A Study of Visual Attention Training to Improve Balance and Mobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Falls
Older adults
Balance
Mobility
Visual attention
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: King Saud University
First posted: 2014-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if training visual attention improves balance and mobility, and reduces falls in older adults.

Detailed description: Visual training in visual attention is compared with activity as usual.

Eligibility criteria: Inclusion Criteria:

* healthy older adults
* Visual acuity 6/12 or better
* able to speak English

Exclusion Criteria:

* No known dementia or cognitive impairment
* not dependent on a walker or cane

Primary outcomes:
measure: Balance on force plate platform
timeFrame: after 4 weeks
Secondary outcomes:
measure: Mini-BESTest (Balance evaluation)
timeFrame: after 4 weeks
Other outcomes:
measure: One Legged Stance Test
timeFrame: after 4 weeks
measure: Sit to Stand test
timeFrame: after 4 weeks
measure: Timed Up and Go test
timeFrame: after 4 weeks
measure: 5 Metre Walking test
timeFrame: after 4 weeks
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Susan J. Leat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03592043: A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy
Official title: A Retrospective Multicenter Canadian Registry of Patients With Mitral Regurgitation Undergoing Percutaneous Mitral Valve Repair With MitraClip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Keywords: MitraClip
Degenerative Mitral Regurgitation
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 1191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who have undergone percutaneous mitral valve repair with the MitraClip Clip Delivery System in Canada.

Brief summary: The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date.

Detailed description: In addition to evaluating efficacy and safety, PREMISE will include a description of patient demographics, etiology of mitral regurgitation, co-morbidities, medication use and functional class. It will also compare re-hospitalization for heart failure 12 months prior and 12 months after the procedure.

Eligibility criteria: Inclusion Criteria:

* Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada

Exclusion Criteria:

* none

Primary outcomes:
measure: Mitral Regurgitation (MR) severity
timeFrame: 12 months
Secondary outcomes:
measure: Hospitalization for Heart Failure
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Population Health Research Institute; McMaster University
name: Shamir Mehta, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital, University of Toronto
name: Neil Fam, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229138: Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients
Official title: A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: De novo kidney recipients,
EC-MPS,
tacrolimus,
efficacy,
safety,
glomerular filtration rate
Treatment in de novo kidney recipients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.


Eligibility criteria: Inclusion Criteria:

* Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
* The renal cold ischemic time (CIT) must be \<30 hours
* The age of the donor must be between 10 and 65 years

Exclusion Criteria

* Patients who have previously received an organ transplant
* Patients who are recipients of a multiple organ transplants
* Recipients of non heart-beating donor organs
* ABO incompatibility against the donor

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: renal function at 6 months posttransplant as measured by glomerular filtration rate
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months
measure: Renal function as measured by calculated creatinine clearance
measure: Cockcroft-Gaultand serum creatinine at 6 months
measure: Gastrointestinal tolerability as measured by gastrointestinal
measure: symptom rating scale (GSRS) at various time points
measure: Safety as measured by incidence of adverse events
measure: Effects on glucose metabolism at months 3 and 6 after transplantation.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Chan L, Andres A, Bunnapradist S, Gugliuzza K, Parasuraman R, Peddi VR, Cassuto E, Hart M. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. J Transplant. 2012;2012:941640. doi: 10.1155/2012/941640. Epub 2012 Nov 25.
Clinical trial NCT01423838: Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
Official title: Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive bladder
Solifenacin
Oxybutynin
Lead sponsor: Adana Numune Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Kocaeli University
name: Akdeniz University
name: Cukurova University
name: Baskent University
name: Ankara University
name: University of Gaziantep
name: Inonu University
name: Gaziosmanpasa University
name: Kahramanmaras Sutcu Imam University
First posted: 2011-08-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder.

Detailed description: In this two-month follow-up study, the patients with overactive bladder will be randomly assigned into two groups (solifenacin or oxybutynin in their usual doses) and will be assessed with respect to baseline characteristics and complaints before treatment. After initiation of the treatment at first and second months follow-up visits the patients will be reassessed with respect to compliance, satisfaction, degree of improvement, reasons for dropouts, number and severity of side effects.

Eligibility criteria: Inclusion Criteria: Women between 18-70 years of age, diagnosed to have overactive bladder (presence of at least two of the following three main criteria: urgency, urge incontinence, frequency and nocturia)

Exclusion Criteria: Presence of stress urinary incontinence, patients who are still using a drug for overactive bladder, pregnant women, women in postpartum period (women on lactation), patients who have closed angle glaucoma, patients with chronic constipation, having allergy to the ingredients of the drugs, patients having the contraindicated conditions listed in the printed instructions of the drugs.

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Primary outcomes:
measure: Degree of improvement in overactive bladder symptoms
timeFrame: 2 months
Secondary outcomes:
measure: To compare the degree of side effects between two study groups
timeFrame: 2 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
Study officials:
affiliation: Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
name: Murat Api, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03438838: Randomised Trial Between LHM Alone Vs LHM With Anterior Fundoplication In Achalasia Cardia
Official title: Randomised Clinical Trial Comparing Relief of Dysphagia Between Laparoscopic Heller's Myotomy Alone Versus Laparoscopic Heller's Myotomy With Anterior Fundoplication In Achalasia Cardia-A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achalasia Cardia
Keywords: Achalasia, LHM, Anterior fundoplication
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2018-02-20
Enrollment: 20
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: Back ground: Achalasia Cardia (AC) manifests with major symptom dysphagia. Surgery as the treatment modality relieves dysphagia in most of the patients. Laparoscopic Heller's myotomy(LHM) is the surgery of choice but is associated with gastroesophageal reflux. Anterior fundoplication (Dor Fundoplication) is usually combined with LHM in patients with AC. It reduces gastroesophageal reflux following LHM. It has been observed that along with reduction of gastroesophageal reflux Dor Fundoplication also affects relief of dysphagia. But it has not been prospectively studied.

Hypothesis:The hypothesis of present study is that "Frequency of dysphagia following Laparoscopic Heller's myotomy with Dor fundoplication is more than that compared to Laparoscopic Heller's myotomy alone in patients with Achalasia Cardia".

Methods: From December2017 to November 2018 minimum of 20 patients with diagnosis of Achalasia cardia will be randomized to receive either Laparoscopic Heller's myotomy (LHM) alone or LHM with Dor fundoplication. Symptomatic outcomes would be assessed using frequency of dysphagia and Eckardt's score. .

Outcomes: Primary outcome is Frequency of dysphagia and secondary outcome is manometry pressure assessment. Statistical analysis would be done using Statistical Package for the Social Sciences (SPSS) soft ware. P value \< 0.05 is considered significant.


Eligibility criteria: Inclusion Criteria:

* All adult patients (18 years or more) with Achalasia cardia

Exclusion Criteria:

* Patients of achalasia with axis deviation
* Patients with history of pneumatic dilatation
* Patient with other associated motility or non motility disorders
* Patients with pseudoachalasia Prior gastric or esophageal surgery

Primary outcomes:
measure: Frequency of Dysphagia
timeFrame: Minimum one month after surgery
Secondary outcomes:
measure: Manometry pressure
timeFrame: Minimum one month after surgery
measure: Gastro esophageal reflux
timeFrame: Minimum after one month
measure: Eckardt's score
timeFrame: Minimum after one month
Other outcomes:
Locations:
city: New Delhi
country: India
facility: GIPMER
Study officials:
affiliation: GIPMER
name: Hirdaya H Nag, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02725138: Efficacy of Probiotics in the Gut Microbiota and H Pylori Density
Official title: The Efficacy of Lactobacillus Acidophilus and Lactobacillus Rhamnosus in the Modification of Gut Microbiota and Reduction of Helicobacter Pylori Bacterial Load- a Double Blind, Placebo Controlled, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Helicobacter
Keywords: Helicobacter pylori
probiotic
bacterial density
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Taiwan Sugar Cooperation Company
First posted: 2016-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aimed to assess the efficacy of Lactobacillus acidophilus and Lactobacillus rhamnosus in the reduction of bacterial load of H. pylori and in the modification of gut microbiotia in this double blind, placebo controlled, randomized trial.

Detailed description: Subjects: Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial. We will screen 150 subjects and it is estimated that 40 H. pylori infected subjects will be eligible. Eligible subjects will be randomized to receive probiotic (Lactobacillus acidophilus and Lactobacillus rhamnosus) or placebo, one pack twice daily, for 28 days. The primary outcome was the reduction in H. pylori load of greater than 20% than baseline. The secondary outcome was the impact of the probiotic on the gut microbiota and the adverse effects.

Eligibility criteria: Inclusion Criteria:

* Adult subjects aged 20 or greater with moderate to high bacterial load of H. pylori defined as a DOB value greater than 10 will be eligible to this trial

Exclusion Criteria:

* history of gastrectomy and colectomy
* severe underlying illness, such as malignancy, ESRD, liver failure, etc
* allergy to probiotics
* symptomatic patients who need PPI, antibiotics, or other probiotics
* pregnancy and lactating women
* unable to cooperate with the protocol

Primary outcomes:
measure: Reduction of bacterial load of H. pylori
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: changes in gut microbiota
timeFrame: after 4 weeks of treatment
measure: adverse effects
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Ming Liou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen MJ, Chen CC, Huang YC, Tseng CC, Hsu JT, Lin YF, Fang YJ, Wu MS, Liou JM; Taiwan Gastrointestinal Disease, Helicobacter Consortium. The efficacy of Lactobacillus acidophilus and rhamnosus in the reduction of bacterial load of Helicobacter pylori and modification of gut microbiota-a double-blind, placebo-controlled, randomized trial. Helicobacter. 2021 Dec;26(6):e12857. doi: 10.1111/hel.12857. Epub 2021 Oct 27.