louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05590208: Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
Official title: Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
GERD
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction

Detailed description: in this study the patients that have morbid obesity concomitant GERD will managed by sleeve gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around the gastroesophageal junction

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures

Primary outcomes:
measure: the effect on GERD
timeFrame: 6 months
Secondary outcomes:
measure: weight loss
timeFrame: 12 months
measure: comorbidities
timeFrame: 12 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university hospital
Study officials:
References:
Clinical trial NCT00453908: Alfuzosin Versus Placebo in Acute Urinary Retention
Official title: Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Urinary Retention
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-29
Enrollment: 160
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization.

Furthermore is investigated the safety of the medical treatment and self-catheterization.


Eligibility criteria: Inclusion Criteria:

* Men with acute urinary retention and catheterized
* Benign hypertrophia of prostate
* Patient is diagnosed in Emergency room or at a acute hospitalization

Exclusion Criteria:

* Known prostate cancer
* Prior urinary retention within 30 days
* Urinary retention occurring in relation to surgery
* Blood in urine
* Difficult or impossible catheterization
* Fever \> 38 degree Celsius
* Decreased kidney function
* Permanent catheter \> 14 days
* Treatment with alfa 1 blocker within 30 days
* Meeting contraindications to treatment with Alfuzosin
* Treatment with other drugs for urinary problems

The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.

Primary outcomes:
measure: Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
Secondary outcomes:
measure: Number of days until termination of self catheterization
measure: Number of patients with urinary infection requiring treatment
measure: Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.
Other outcomes:
Locations:
city: Hoersholm
country: Denmark
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Henning Andersen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02102308: Exercise Improves Executive Function and Dual-task Decrements
Official title: A Multicomponent Exercise Improves Executive Function and Dual-task Decrements in Gait Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 12-week multicomponent exercise is effective in improving executive function and gait performance in dual-task conditions.


Eligibility criteria: Inclusion Criteria:

* age more than 65 years old
* ability to walk outdoor independently without assistive devices

Exclusion Criteria:

* unstable medical conditions interfering with participation in the study
* diagnosis of dementia, psychosis, neurological disease, and depression
* unable to receive external information for finishing the neuropsychological tests

Primary outcomes:
measure: spatial and temporal gait parameters
timeFrame: 12 weeks
Secondary outcomes:
measure: Executive Interview
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Therapy and Assistive Technology
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Yea-Ru Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05462808: ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars
Official title: ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Teeth Retained
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that releases fluoride, in the following years, the deciduous teeth were removed with a minimally invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without preparation for treatment, has come to the fore.

Detailed description: Many restorative materials, especially GIC, have been used for ART procedures, and with the advancing technology, high-viscosity glass ionomer cements with improved mechanical and chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled resin-modified HVGICs have been introduced.

The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed to stop the progression of caries by covering the carious deciduous molars with SSC and cutting their relationship with the oral environment, without the need for local anesthesia and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral environment, the number of bacteria in the environment will also decrease.

Eligibility criteria: Inclusion Criteria:

* children with no systemic disease,
* children who had a Frankl Behavioral Scale score 2,
* children who have no occlusal problems or bad habits,
* children presenting between 2-5 caries lesion in primary molars.

Exclusion Criteria:

* teeth with presence of radyolusens in furcation and/or periradicular areas,
* teeth with pathologic resorption and internal/external resorption

Primary outcomes:
measure: Hall technique
timeFrame: up to 18 months
Secondary outcomes:
measure: Atraumatic restorative treatment
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Study officials:
affiliation: Suleyman Demirel University Pediatric Dentistry
name: Esra Oz
role: STUDY_DIRECTOR
References:
Clinical trial NCT01609608: Whole-Body Vibration for Functional Constipation
Official title: Whole-Body Vibration for Functional Constipation: A Single-Center, Single-Blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced via a non-invasive oscillation platform could improve symptoms and health-related quality of life (HRQOL) in patients with chronic functional constipation.
2. Methods: A single-blinded, randomized, control trial was performed in a single Hospital in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III diagnostic criteria were included and randomized to either the WBV treatment or no treatment (control) group. The treatment group received six 15-minute sessions of WBV therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a frequency of 12 Hz. The primary outcome was assessed by the constipation severity instrument (CSI). The secondary outcome was improvements in HRQOL.


Eligibility criteria: Inclusion Criteria:

* met the Rome III criteria of constipation

Exclusion Criteria:

* pregnant
* cardiovascular disease
* cerebrovascular disease
* recently undergone major surgery
* hypothyroidism
* depressive disorder.

Primary outcomes:
measure: change from baseline in constipation severity instrument (CSI) at 2 weeks
timeFrame: baseline (day 1), the completion of the trial (day 14)
Secondary outcomes:
measure: change from baseline in health-related quality of life (HRQOL) at 2 weeks
timeFrame: baseline (day 1), the completion of the trial (day 14)
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian hospital
Study officials:
References:
citation: Prisby RD, Lafage-Proust MH, Malaval L, Belli A, Vico L. Effects of whole body vibration on the skeleton and other organ systems in man and animal models: what we know and what we need to know. Ageing Res Rev. 2008 Dec;7(4):319-29. doi: 10.1016/j.arr.2008.07.004. Epub 2008 Aug 12.
citation: Wu TJ, Wei TS, Chou YH, Yang CP, Wu CL, Chen YC, Liu SY. Whole-body vibration for functional constipation: a single-centre, single-blinded, randomized controlled trial. Colorectal Dis. 2012 Nov;14(11):e779-85. doi: 10.1111/codi.12021.
Clinical trial NCT06097208: BMI Development and Risk of Overweight and Obesity in Children
Official title: BMI Development and Risk of Overweight and Obesity When Attending a Community-based Health Promotion and Obesity Prevention Intervention in Kindergartens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Child Obesity
Body Weight
Keywords: Obesity
Body Mass Index
Children
Kindergarten
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present study is based on data from a total of approximately 3000 children (six-year-olds) at school entrance in the period 2021-2022, of whom approximately 2000 children attended the community-based health promotion and obesity prevention intervention in kindergartens (intervention group), from Viborg Municipality, and approximately 1000 children attended usual care kindergarten (no-intervention group), from Skive Municipality, both municipalities located in The Central Denmark Region. Further, a subset of approximately 700 children from the intervention group have been measured with height and weight in kindergartens (three- to four-year-olds).

Brief summary: The goal of this observational study is to investigate differences in attained BMI and the proportion of overweight/obesity at school entrance in children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention compared to children who attended usual care kindergartens. Further questions it aims to answer are:

* Explore the prevalence of attainted overweight/obesity in children at six years of age, who attended kindergartens delivering intervention compared with usual care kindergartens.
* Explore the development of obesity, overweight and normal weight in children from three-, four- to six years of age, who attended kindergartens delivering intervention.


Eligibility criteria: Inclusion Criteria:

* All children with eligible information on one measure of BMI after school entrance

Exclusion Criteria:

* \<7 years of age

Primary outcomes:
measure: BMI after school entrance at 6 years of age
timeFrame: 2018-2023
measure: Proportion of children with overweight/obesity at 6 years of age
timeFrame: 2018-2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00482508: Safety and Tolerability of Omalizumab in Poorly Controlled Moderate to Severe Asthma Patients
Official title: A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
anti immunoglobulin E
omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2007-06-05
Enrollment: 95
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice


Eligibility criteria: Inclusion Criteria:

* Patients who completed core study and extension study CIGE24IA05E1 up to and including visit 15, without experiencing any significant drug-related adverse events
* Patients who have given written informed consent

Exclusion Criteria:

* Patients who had not received study medication for greater than 84 days since visit 15 of study CIGE24IA05E1
* Pregnant females or nursing mothers
* Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety assessed by adverse events, serious adverse events, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT00002008: An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Official title: An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Cytopenias
Keywords: Leukopenia
Drug Evaluation
Granulocyte-Macrophage Colony-Stimulating Factor
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Serum antibody to HIV with or without evidence of HIV.
* Antigenemia.
* Anticipated survival of at least 6 months.
* Allowed:
* Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Malignancy other than Kaposi's sarcoma.
* Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
* Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.
* Primary hematologic or infectious disorders unrelated to AIDS virus infection.
* Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Patients with the following are excluded:

* History of malignancy other than Kaposi's sarcoma.
* Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.

Prior Medication:

Excluded within 3 weeks of study entry:

* Marrow suppressive medication.
* Excluded within 4 weeks of study entry:
* Any investigational drug.

Prior Treatment:

Excluded within 4 weeks of study entry:

* Systemic cytotoxic chemotherapy.
* Irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

* Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA CARE Ctr
state: California
city: Boston
country: United States
facility: Beth Israel Deaconess - West Campus
state: Massachusetts
Study officials:
References:
Clinical trial NCT02414308: Management of Peyronie's Disease With Adipose Tissue Stem Cell
Official title: The Role of Adipose Tissue Stem Cell Injection Through Corpora Cavernosa and Intra Dorsal Penile Artery in Management of Erectile Dysfunction Associated With Peyronie's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Peyronie' Disease
Keywords: Erectile dysfunction, Peyronie's disease, stem cell
Lead sponsor: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Erectile dysfunction is growing in prevalence all over the world and one of the most existing disease in old age patients There is many lines of treatment concerning the status of patient like psychosexual, medical, and surgical treatment But Pyronie's disease is common now among people especially diabetics, and the role of treatment still controversial in results We can start conservative treatment and then surgical treatment if fail but the outcome still not convinced Many patients refuse to fix penile prosthesis and to make operation like nesbite for probability of shortening of penis We start to use stem cell in patients have erectile dysfunction and Peyronie's disease The injection of stem cell will be at corpora cavernosa and intra dorsal penile artery under Doppler device guidance

Detailed description: Peyronie's disease associated with erectile dysfunction nan be treated by different methods We start to treat such patients with adipose tissue stem cell Harvesting stem cell from adipose tissue and injected into corpora cavernosa and penile artery and we assess quality of erection through patient history and penile duplex and also assess plaque size and other symptoms related to Peyronie's disease

Eligibility criteria: Inclusion Criteria:

* erectile dysfunction associated with Peyroni's diseas

Exclusion Criteria:

* nil

Primary outcomes:
measure: sexual function questionnaire
timeFrame: 2-3 months
Secondary outcomes:
measure: Penile plaque assessment
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Man clinic
city: Cairo
country: Egypt
facility: Man clinic for andrology and male infertility
Study officials:
affiliation: Man clinic
name: Khaled A Gadalla, MD, ABS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04811508: Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use
Official title: Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed Multiple Myeloma
Keywords: relapsed multiple myeloma
Carfilzomib
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France

Brief summary: This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).


Eligibility criteria: Inclusion Criteria:

* Male or female patients over the age of 18 years
* Patients beginning carfilzomib treatment in the framework of expanded access or compassionate use in France (KRd or Kd regimen)
* Patients who received carfilzomib in first or second MM relapse
* Patients receiving at least one complete course of carfilzomib

Exclusion Criteria:

* Patients already included in an interventional research protocol using carfilzomib at the time of treatment initiation
* Patients refusing to allow the computerization of their data
* Patients for whom hospital medical records are not accessible

Primary outcomes:
measure: Duration of carfilzomib treatment
timeFrame: 31 august 2021
Secondary outcomes:
measure: Time to next treatment
timeFrame: 31 august 2021
measure: Progression Free survival (PFS)
timeFrame: 31 august 2021
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References: