louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02556411: Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Official title: Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenomyosis
Chronic Pelvic Pain
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.

The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone


Eligibility criteria: Inclusion Criteria:

* Women affected by adenomyosis with pelvic pain \> 4;
* Negative Pap Smear test

Exclusion Criteria:

* Pregnancy or research of pregnancy
* Refusal or inability to sign informed consent
* Severe underlying comorbidities (hepatic, oncological)
* Pelvic inflammatory disease
* Other cervical or uterine pathologies
* Deep venous thromboembolism
* Hormonal therapy contraindications
* Smoke

Primary outcomes:
measure: Change of Pelvic pain as measured by visual analogue scale
timeFrame: Change from baseline pelvic pain at 45 days of treatment
Secondary outcomes:
measure: Change of Pelvic pain as measured by visual analogue scale
timeFrame: Change from baseline pelvic pain at 90 days of treatment
measure: Change of Pelvic pain as measured by visual analogue scale
timeFrame: Change from baseline pelvic pain at 180 days of treatment
measure: Change of Pelvic pain as measured by visual analogue scale
timeFrame: Change from baseline pelvic pain at 365 days of treatment
measure: Quality of sexual life
timeFrame: Cases were administered and fulfilled the questionnaires at the moment of diagnosis of adenomyosis up to 4weeks; Change from baseline were evaluated 45 days after begin of treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04583111: The Effect of Antiemetics on Bowel Preparation Before Colonoscopy
Official title: The Effect of Antiemetics on Bowel Preparation Before Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.


Eligibility criteria: Inclusion Criteria:

* 18-70 years patients scheduled for colonoscopy

Exclusion Criteria:

* intestinal obstruction or hemorrhage;
* allergy to domperidone, sulpiride or PEG;
* pregnancy or breastfeeding;
* previous use of prokinetics within 1 month.

Primary outcomes:
measure: Incidence of the discomforts during bowel preparation
timeFrame: before colonoscopy
Secondary outcomes:
measure: The quality of bowel preparation assessed by Boston Bowel Preparation Scale
timeFrame: during colonoscopy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shengliang Chen
Study officials:
References:
Clinical trial NCT05146011: Clinical Outcomes of Single Stage Versus Two-stage Treatment of Severe Obesity
Official title: Clinical Outcomes of Single Stage Versus Two-stage Laparoscopic Roux-en-y Gastric Bypass in the Management of Super Obesity: a Propensity Score Weighted Analysis'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 155
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: patients, with a BMI≥50 kg/m2 undergoing Bariatric Surgery in Chelsea and Westminster Hospital

Brief summary: Laparoscopic Roux-en-Y gastric bypass (LRYGB) in super obese patients (BMI≥50kg/m2) is a challenging operation. Weight reduction with intragastric balloon (IGB) prior to LRYGB may improve operative outcomes and improves weight loss. We assessed 155 patients, with a BMI≥50 kg/m2 who underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group) in our institution. Two stage procedure was adopted for high-risk individuals.


Eligibility criteria: Inclusion Criteria:

* patients, with a BMI≥50 kg/m2, underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group)

Exclusion Criteria:

* NA

Primary outcomes:
measure: Percentage of total weight loss measured in kilograms following Bariatric Surgery
timeFrame: 24 months after Bariatric Surgery
measure: Length of hospital stay in days following Bariatric Surgery
timeFrame: 90 days following gastric bypass surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00063011: Bone Development in Adolescent Girls: Effects of Calcium and Exercise
Official title: Calcium and Exercise Effect on Pubertal Bone Gain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Osteoporosis
Keywords: Weight-bearing exercise
Calcium-rich diet
Adolescents
Females
Bone mass
Osteopenia
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-06-20
Enrollment: 107
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Osteoporosis is a major public health problem. Prevention of osteoporosis depends in part on good bone development in childhood and adolescence. This study will evaluate a weight-bearing exercise program and high-calcium diet on bone development in adolescent girls.

Detailed description: There are currently few safe and effective methods for restoring lost bone to the osteoporotic skeleton. Therefore, prevention of osteoporosis is crucial. If skeletal development can be maximized during growth, young people will begin adulthood with optimal bone mass and will be less likely to develop osteoporosis in later years. This study will determine the effects of weight-bearing physical activity and a high-calcium diet on bone mass in adolescent girls.

Participants in this study will be randomized to one of three study arms. Girls in Arm 1 will consume their usual diets and will participate in a weight-bearing exercise program that meets 3 times per week. Girls in Arm 2 will also participate in a weight-bearing exercise program that meets 3 times per week and will be given high calcium foods to supply 1500 mg of calcium per day. Girls in Arm 3 will consume their usual diet and maintain their customary activity level. Study visits occur every 6 months; participants will be followed for 4 ½ years. Assessments will include a medical and social history and measurements of spine, hip, radius, and total body bone mineral content (BMC); calcaneal speed of sound (SOS); height; weight; and Tanner stage.

Eligibility criteria: Inclusion Criteria

* Tanner Stage of Development: Stage 1

Exclusion Criteria

* History of lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any other significant health problem
* Body mass index (BMI) \>= 85th percentile for age and gender
* Regularly have more than two practice sessions per week of dance, gymnastics, or organized team sports

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Joan M. Lappe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410111: Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy
Official title: A Pilotstudy on Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
encephalopathy
cerebral perfusion
electroencephalogram
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis, severe sepsis or septic shock admitted to an intensive care unit

Brief summary: Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis develop septic encephalopathy is unknown. We will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic encephalopathy from early measurements of cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular autoregulation is not dysfunctional in septic encephalopathy.


Eligibility criteria: Inclusion Criteria:

* Sepsis
* Admission to ICU

Exclusion Criteria:

* CNS infection
* History of cerebrovascular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Operative Intensivbehandlung, University of Basel Hospital
Study officials:
affiliation: Department of Anesthesia, University of Basel Hospital, Basel, Switzerland
name: Luzius A Steiner, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfister D, Siegemund M, Dell-Kuster S, Smielewski P, Ruegg S, Strebel SP, Marsch SC, Pargger H, Steiner LA. Cerebral perfusion in sepsis-associated delirium. Crit Care. 2008;12(3):R63. doi: 10.1186/cc6891. Epub 2008 May 5.
Clinical trial NCT06524011: Stromal Vascular Fraction Enriched PRP in Treatment of Post-acne Scars
Official title: Split Face Comparative Study of Stromal Vascular Fraction Enriched PRP Versus Each Alone in Treatment of Atrophic Post-acne Scars
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acne Scars - Atrophic
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: in a split face fashion, 30 patients will be randomized into 3 groups: Group A: rt side treated with SVF enriched PRP, lt side treated with prp Group B: rt side treated with SVF enriched PRP, lt side treated with SVF Group C: rt side treated with PRP, lt side treated with SVF


Eligibility criteria: Inclusion Criteria:

* patients with atrophic post acne scars without any previous treatment trials.
* adequate blood picture, no anemia, no bleeding or platelet disorders.

Exclusion Criteria:

* pregnant and lactating females.
* elderly.
* patients with bleeding tendencies.

Primary outcomes:
measure: change in severity of acne scars using Goodman scoring system
timeFrame: 3 monthly sessions and follow up for 3 months after the last visit
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
References:
Clinical trial NCT05714111: Radiology Registry on Pancreatic Malignancies
Official title: Radiology Registry on Pancreatic Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Pancreas Neoplasm
Pancreas Disease
Pancreas Cyst
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic adenocarcinoma, pancreatic neuroendocrine tumors, rare forms of pancreatic cancer (such as ampullary cancer, adenosquamous carcinomas, squamous cell carcinomas, signet ring cell carcinomas, undifferentiated carcinomas, and undifferentiated carcinomas with giant cells) and cystic neoplasms.

Brief summary: The purpose of this study is to collect all radiological data which evaluated with clinical data may help assess malignancy and prognosis of pancreatic disease.This registry aims to collect retrospective data from 2014 and prospective data until 2027 with a maximum follow-up of 3 years per patient.

Detailed description: Single center, observational (retrospective and prospective) will collect all available parameters to assess the clinical outcome of the patients (progression free survival (PFS), overall survival (OS), local progression free survival LTPFS), response to treatment) with pancreatic neoplasms presenting to San Raffaele. Patient assignment to a given diagnostic and/or therapeutic procedure is not related to random assignment methods but is part of the ordinary therapeutic strategy planned for each patient on an individual basis and after multidisciplinary discussion.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Patients with suspect (planned for investigation) or diagnosed pancreatic cancer at any stage.
* able and willing to sign informed consent

Exclusion Criteria:

* Patients with non-primary pancreatic disease

Primary outcomes:
measure: Progression- free survival
timeFrame: From date of intervention until the date of first documented progression, up to a maximum of 3 years
measure: Local progression free survival
timeFrame: From date of intervention until the date of first documented local progression assessed up to a maximum of 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of treatment until the date of death from any cause assessed up to 3 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Radiology, IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT04080011: A Case Series Study of Negative Pressure Platform Wound Device
Official title: A Case Series Study of Negative Pressure Platform Wound Device (NP-PWD) on the Healing of Elective Surgical Incisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisions, Surgical
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This primary case series study will demonstrate the safety and feasibility of the NP-PWD technology and treatment protocol to promote healing of surgical incision healing. In a first use in humans of the NP-PWD's capability to deliver negative pressure wound treatment (NPWT), this project will gather data from patients with elective surgical incisions, with the intention to evaluate the NPWT capability for future use in more tenuous situations of wound closure.

Detailed description: A case series study of 10 subjects will be conducted by enrolling patients who are scheduled for elective surgical incisions. Patients will be screened for inclusion criteria and asked to consent to participate in the study for single application treatment with the NP-PWD for 3-6 days. Initial evaluation of the incision would occur on Day 0, including screening, pre-procedure evaluation, measurement and photography of the closed surgical incision. Follow up data is then gathered Day 3-6 with removal of the NP-PWD, surgical incision assessment and photography, and assessment for adverse effects. Day 9-14 follow up include the same assessments of progression of wound closure. Gathered clinical data of the 10 subjects will be used to evaluate the safety in using the NPWT device for effective wound healing.

Eligibility criteria: Inclusion Criteria:

1. Patients 18-85 years of age.
2. Scheduled for surgical intervention in which an incision will be made and skin closure will be performed.

Exclusion Criteria:

1. Active infection as judged by the Investigator
2. Inability to give informed consent
3. Active malignant disease or subject is less than one year disease-free
4. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
5. Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with wound healing
6. On any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
7. Pregnant at enrollment

Primary outcomes:
measure: Incidence of treatment-related adverse events.
timeFrame: Three to six days post application.
measure: Rate of successful application of the NP-PWD device
timeFrame: Three to fourteen days post application
Secondary outcomes:
measure: Incidence of treatment-related adverse events.
timeFrame: Fourteen days post application.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Northeast Baptist
state: Texas
Study officials:
References:
Clinical trial NCT04468711: Vitamin D in Egyptian Children With Atopic Dermatitis
Official title: The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
First posted: 2020-07-13
Enrollment: 92
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear


Eligibility criteria: Inclusion Criteria:

1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score

Exclusion Criteria:

1. serious skin disorder other than AD.
2. taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation
3. receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment
4. known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.

Primary outcomes:
measure: difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
timeFrame: 12 weeks
measure: the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study
timeFrame: 12 weeks
Secondary outcomes:
measure: Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
timeFrame: 12 weeks
measure: Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score
timeFrame: 12 weeks
measure: Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NHTRMI
Study officials:
References:
Clinical trial NCT00385411: Study of Valproate in Young Patients Suffering From Epilepsy
Official title: Therapeutic Follow-up Observational Study and Population Kinetics Ancillary Study of Valproate Microgranules (Micropakine® SR) in Patients Aged Between 6 Months and 15 Years Suffering From Epilepsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-09
Enrollment: 81
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.

Secondary objectives: Ancillary population kinetics study

* Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data.
* Evaluate the influence of individual characteristics on the pharmacokinetic parameters.
* Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.


Eligibility criteria: Inclusion Criteria:

* Children aged between 6 months and 15 years.
* Suffering from any type of epilepsy.
* Receiving at the time of inclusion valproate in the form Micropakine® SR 20 to 30 mg/kg/d by oral route, in 2 daily administrations and at most two other antiepileptic drugs (an antiepileptic benzodiazepine treatment taken daily or on demand more than 2 times weekly, must be considered as an antiepileptic treatment).
* Followed by hospital paediatricians or neuropaediatricians.
* For whom the consent has been signed by the parents or the holders of parental authority and if possible by the child him/herself.
* For whom the parents or legal guardian do not have any language or cultural obstacle for understanding the study.

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

Primary outcomes:
measure: Clinical and biological safety.
timeFrame: at each visit
measure: Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate
timeFrame: Ancillary population kinetics study
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Marie SEBILLE, Dr
role: STUDY_DIRECTOR
References: