louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05054946: The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types
Official title: The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cysts
Keywords: ovarian reserve
anti-mullerian hormone
ovarian cyst
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare the effect of laparoscopic ovarian cystectomy on ovarian reserve in terms of different cyst types.

Detailed description: Participants who will be treated surgically for ovarian cysts will be included in the study. Anti-Mullerian Hormone (AMH) levels of the participants will be investigated before the surgery and 6 months after the surgery. All surgeries will be performed under general anesthesia laparoscopically. After histopathological evaluation, the participants will be divided into three groups; Group 1: Endometrioma, Group 2: Mature cystic teratoma (Dermoid cyst) and Group 3: Serous or mucinous cystadenoma.

A total of fifty-five women will be included in the study.

Eligibility criteria: Inclusion Criteria:

* no ovarian surgery before

Exclusion Criteria:

* Endocrinological pathologies
* Suspicion of malignancy in preoperative laboratory and ultrasonographic evaluations
* Detection of malignancy in histopathological examination

Primary outcomes:
measure: Change in AMH Level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Hospital
Study officials:
affiliation: Ege University
name: Sabahattin Anil Ari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560846: Perioperative Nutrition in Upper Gastrointestinal (GI) Cancer Surgery
Official title: Perioperative Nutrition in Upper GI Cancer Surgery (Oesophagectomy or Gastrectomy)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stomach Neoplasms
Esophageal Neoplasms
Keywords: Gastric cancer
Esophageal cancer
Surgical complications
Immunonutrition
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 43
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: The aim of this study is to demonstrate the influence of peri-operative nutrition on the post-operative complications, preservation of lean body mass and length of stay after gastrectomy or oesophagectomy.


Eligibility criteria: Inclusion Criteria:

* Surgery for Upper GI cancer
* Age over 18
* Informed consent

Exclusion Criteria:

* Major swallowing disorders
* Dementia or other psychological state precluding compliance and understanding of research protocol
* Pre-existing enteral or parenteral nutrition

Primary outcomes:
measure: Rate of post-operative complications
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
measure: Body composition
timeFrame: 1 year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires Genève
Study officials:
affiliation: University Hospital, Geneva
name: Dan E Azagury, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03830346: Instrument-assisted Soft Tissue Mobilization in CrossFitters
Official title: Instrument-assisted Soft Tissue Mobilization and Stretching in CrossFitters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Instrument Assisted Soft Tissue Mobilization
Manual Therapy
Muscle Stretching Exercises
Range of motion
Shoulder Joint
CrossFit
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective. To determine the effectiveness of instrument assisted soft tissue mobilization and horizontal adduction stretch in CrossFit practitioners' shoulders.

Setting: Acero CrossFit center, city of Toledo (Spain) Design: Randomized, single-blind pilot study, with follow-up period. Participants: Twenty-one subjects of both sexes, being regular CrossFitters and in the age range of 18 to 40 years.

Intervention: The experimental group (n = 11) received 30 seconds of stretching with isometric contraction of 5 seconds and instrument assisted soft tissue mobilization. The control group (n = 10) received only 40 seconds of instrument assisted soft tissue mobilization. Each session lasted 2 to 5 minutes, 2 days a week, over a period of 4 weeks, prior to each workout.

Main Outcome measures: Shoulder internal rotation and horizontal adduction (digital inclinometer), and posterior shoulder stretch perception (Park scale) were evaluated.


Eligibility criteria: Inclusion Criteria:

* Subjects of both sexes
* Being regular CrossFitters (workouts at least two days a week)
* In the age range of 18 to 40 years

Exclusion Criteria:

* Had suffered a shoulder injury in the 3 months prior to the study
* Had undergone shoulder surgery in the previous six months
* Had a non-attendance rate of over 15% of the intervention sessions (2 sessions)
* Had not signed the informed consent document

Primary outcomes:
measure: Change from baseline internal rotation and horizontal adduction of the shoulder after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes:
measure: Change from baseline perception of stretch after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Real Fundación Victoria Eugenia
Study officials:
affiliation: Universidad Europea de Madrid
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04458246: Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic
Official title: Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Chronic Diseases in Adolescence
Chronic Disease of Immune System
Chronic Kidney Diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 140
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of chronic diseases among adolescents has increased in the last years. About 20% of the adolescents have some chronic disease, resulting in increased morbidity and mortality. In march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical appointments for adolescents with chronic disease were temporarily suspended. To mitigate the deleterious effect of the social isolation on physical and mental health among these patients, this study aims to test the effects of an online, home-based, exercise training program.


Eligibility criteria: Inclusion Criteria:

Diagnosed with either one of the following chronic conditions:

* Inflammatory bowel disease;
* autoimmune hepatitis;
* liver transplant;
* renal transplant;
* systemic lupus erythematosus;
* juvenile dermatomyositis;
* juvenile idiopathic arthritis.

Exclusion Criteria:

* Patients with physical limitations that preclude exercise.
* Patients diagnosed with COVID-19.
* Patients diagnosed with mental disorders.

Primary outcomes:
measure: Safety and efficacy of a home-based exercise training program
timeFrame: From baseline to 3 months of follow-up
Secondary outcomes:
measure: Patients perceptions during social isolation
timeFrame: From baseline to 3 months of follow-up
measure: Adolescents quality of life
timeFrame: From baseline to 3 months of follow-up
measure: Disease activity
timeFrame: From baseline to 3 months of follow-up
measure: Disease overall assessment
timeFrame: From baseline to 3 months of follow-up
measure: Strengths and difficulties
timeFrame: From baseline to 3 months of follow-up
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Univsersity of Sao Paulo
Study officials:
References:
Clinical trial NCT03532646: Endoscopic Complications After Gastric Bypass
Official title: Endoscopic Complications After Roux-en Y Gastric Bypass Versus Mini/One Anastomosis Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All patients who underwent RYGB and MGB/OAGB readmitted for complications in our centre of excellence are getting observed
Primary purpose: DIAGNOSTIC

Brief summary: Endoscopic complications such as gastro-esophageal reflux disease, ulcera, gastritis, bile reflux, anastomotic stricture and so on are described after gastric bypass surgery. The incidence of these complications after RYGB versus MGB/OAGB are getting observed.

Detailed description: All patients who were readmitted to our centre of excellence for obesity and metabolic surgery (October 2014 - March 2018) are observed regarding endoscopic complications in s.a. RYGB and MGB/OAGB.

Eligibility criteria: Inclusion Criteria:

* all patients who underwent RYGB or MGB/OAGB as a primary surgery and were readmitted to tho hospital undergoing upper endoscopy are included

Exclusion Criteria:

-

Primary outcomes:
measure: Complication
timeFrame: Up to 15 years post surgery
Secondary outcomes:
measure: Weight Loss since Surgery
timeFrame: Up to 15 years post surgery
measure: toxic status
timeFrame: Up to 15 years post surgery
measure: toxic status II
timeFrame: Up to 15 years post surgery
measure: Revisional Surgery
timeFrame: Up to 15 years post surgery
Other outcomes:
Locations:
city: Remscheid
country: Germany
facility: Sana obesity center
Study officials:
affiliation: Sana Klinikum Offenbach/Sana Klinikum Remscheid
name: Christine Stier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.
citation: Abd Ellatif ME, Alfalah H, Asker WA, El Nakeeb AE, Magdy A, Thabet W, Ghaith MA, Abdallah E, Shahin R, Shoma A, Dawoud IE, Abbas A, Salama AF, Ali Gamal M. Place of upper endoscopy before and after bariatric surgery: A multicenter experience with 3219 patients. World J Gastrointest Endosc. 2016 May 25;8(10):409-17. doi: 10.4253/wjge.v8.i10.409.
Clinical trial NCT04373746: Accuracy of the NICCI™ Monitor in Children and Adolescents
Official title: Accuracy of the NICCI™ Monitor in Providing Beat-to-beat Non-invasive Blood Pressure Readings in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anesthesia
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 82
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective study that will compare the blood pressure readings from an arterial cannula with those obtained non-invasively by the NICCI device. The study will enroll 50 patients into each of three weight ranges: 10-20 kg, 20-40 kg, and 40-80 kg.

The NICCI, Pulsion/GETINGE uses novel technology to provide a continuous estimation of BP displayed as a waveform similar to that seen with an invasive arterial cannula, but is totally non-invasive by using the fingers. The patient rests their hand on the device, which is about the size of a computer mouse, and then a blood pressure cuff goes around their upper arm.


Eligibility criteria: Inclusion Criteria:

* Patients requiring anesthetic care and in whom an indwelling arterial cannula will be placed for the surgical procedure.

Exclusion Criteria:

* Patients with history of a peripheral neurologic or neuropathic disorder
* Patients in whom the upper extremity cannot be used for blood pressure monitoring
* Patients in whom an invasive arterial cannula cannot be placed
* Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)
* Edematous patients

Primary outcomes:
measure: Difference in Blood Pressure
timeFrame: 2-8 hours (average length of major surgery)
Secondary outcomes:
measure: Percentage of BP Values From the NICCI Device That Were ≤ 5 mm Hg the Values Obtained From the AC
timeFrame: 2-8 hours (average length of major surgery)
measure: Percentage of BP Values From the NICCI Device That Were ≤ 10 mm Hg the Values Obtained From the AC
timeFrame: 2-8 hours (average length of major surgery)
measure: Percentage of BP Values From the NICCI Device That Were > 10 mm Hg From the Values Obtained From the AC
timeFrame: 2-8 hours (average length of major surgery)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00004646: Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Duchenne Muscular Dystrophy
Keywords: Duchenne muscular dystrophy
genetic diseases and dysmorphic syndromes
muscular dystrophy
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Rochester
First posted: 2000-02-25
Enrollment: 20
Sex: MALE
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients with Duchenne muscular dystrophy.

II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth hormone, and insulin.

III. Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin.

IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to prednisone or placebo. Therapy is administered daily for 12 weeks; prednisone is then tapered.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Ambulatory males with Duchenne muscular dystrophy
* No medical/psychiatric contraindication to protocol therapy
* No requirement for regular use of prescription medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Robert Griggs
role: STUDY_CHAIR
References:
Clinical trial NCT04479046: Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
Official title: Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decay, Dental
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of PMMA pediatric crowns

Detailed description: The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:

I. Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to zirconia crowns and stainless steel crowns after 6 months, and 12 months.

II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.

III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's satisfaction regarding the appearance and clinical performance of PMMA crowns when compared to stainless steel crowns and zirconia crowns through a given questionnaire.

Eligibility criteria: Inclusion Criteria:

* Children included in the study should conform to the following criteria:

  1. Aged 5-8 years old
  2. Medically free
  3. Patient should suffer from extensively decayed primary lower second molar that will undergo pulpotomy.
  4. The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.

     Exclusion Criteria:

     Children with the following criteria will be totally excluded from the study:

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  1. Children who are extremely uncooperative and difficult to manage.
  2. Children suffering from any medical conditions that can't be managed in the clinic.
  3. Teeth with decay extending beneath the free gingival margin.
  4. Teeth that were grossly broken down, that cannot be restored.
  5. Presence of uncontrolled bleeding.
  6. Clinical or radiographic evidence of non-vitality such as presence of an abscess or a sinus, obvious discoloration, and premature hypermobility.

Primary outcomes:
measure: Gingival health
timeFrame: 6 months
measure: Crown survival
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heliopolis
country: Egypt
facility: Faculty of Dentistry, Ain Shams University
state: Cairo
Study officials:
References:
Clinical trial NCT01110746: To Evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
Official title: A Double-blind Study of the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin During Subcutaneous Insulin Pump Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Biodel
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.


Eligibility criteria: Inclusion Criteria:

1. Males or females diagnosed with type 1 diabetes mellitus for at least 6 months
2. Current usage of subcutaneous insulin pump treatment with one of the following pumps:

   * Medtronic Paradigm®
   * Animas®
   * OmniPod®
   * ACCU-CHEK Spirit®
3. Age 18-75 years
4. HbA1c of 6.0 - 9.0% at screening visit.
5. Willingness to attend 9 clinic visits.

Exclusion Criteria:

1. Pregnancy or Lactation
2. Renal insufficiency (serum creatinine of 2.0 mg/dL or greater).
3. Anemia
4. Congestive heart failure.
5. Visual impairment preventing reading of glucose meter values or the ability to use an insulin pump or continuous glucose monitoring device.
6. Active coronary artery disease or heart procedure within the past 4 months.
7. Active foot ulceration.
8. Severe peripheral arterial disease.
9. Stroke within the past 6 months.
10. Active alcohol abuse, substance abuse, or severe mental illness.
11. Active cancer, except basal cell or squamous cell skin cancers.
12. Major surgical operation within 30 days prior to screening.
13. Seizure disorder (epilepsy).
14. Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
15. Currently use of corticosteroids.
16. History of major non-compliance.
17. Use of an investigational drug within 30 days prior to screening.
18. Bleeding disorder, treatment with warfarin, or low platelet count.
19. Any insulin allergy
20. Current complaints of major infusion site problems with commercially- available insulin preparations, such as frequent occurrence of infections, marked swelling or marked erythema.
21. History of gastroparesis.

Primary outcomes:
measure: 3 hour incremental area under the glucose curve after a standardized high glycemic index meal.
timeFrame: 3 hours
Secondary outcomes:
measure: Draize scores at insulin infusion site at 24 hour and 72 hour follow-up visits, frequency of discomfort with insulin infusion, and severity of discomfort with insulin infusion (ratings of mild, moderate, or severe).
timeFrame: 72 hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University/Legacy Health System
state: Oregon
Study officials:
References: