louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02884115: Serological Response to Retreatment of Serofast Early Syphilis Cases With Benzathine Penicillin
Official title: Randomized, Clinical Trial to Compare the Serological Response Rates of Serofast Early Syphilis Cases Retreated With Three Doses Benzathine Penicillin and Absence of Any Retreatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Syphilis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A continuing challenge to determining the response to treatment of early syphilis (primary, secondary, early latent syphilis) is exemplified by the substantial proportion of patients who fail to achieve serological cure and remain serofast. Although retreatment is often done in clinical practice, optimal management remains uncertain due to the paucity of data regarding serological response to retreatment and long-term outcomes. Furthermore, the investigators cannot rule out that the gradually increasing seroreversion/serological cure rates may have been due to the natural decline in rapid plasma regain (RPR) titers after initial therapy, rather than due to the additional dose of benzathine penicillin. Thus, the investigators would like to conduct a clinical trial to compare the serological response rates of serofast early syphilis cases retreated with three doses benzathine penicillin and absence of any retreatment (control group).


Eligibility criteria: Inclusion Criteria:

* Early Syphilis Cases Determined to Be Serofast at 6 Months after Initial Treatment

Exclusion Criteria:

* Human immunodeficiency virus (HIV)-infected
* Baseline serology showed a nonreactive RPR test
* follow-up is inadequate
* Allergic to penicillin
* Pregnant woman

Primary outcomes:
measure: Rapid plasma regain titer
timeFrame: 6 months after retreatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Dermatology and Venereology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Study officials:
References:
Clinical trial NCT04704115: The Therapy of Large Endometrioma
Official title: Evaluate the Therapy of Large Ovarian Endometrioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrioma
Endometriosis Ovary
Keywords: Endometriomas measuring 6 cm or more
Ovarian Endometrioma
laparoscopic drainage
recurrence
AMH
GnRH agonist therapy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women presenting at a surgical consultation for the management of an endometrioma of 6cm or more

Brief summary: Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve.

Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve.

In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy.

This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above.

The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone


Eligibility criteria: Inclusion Criteria:

* Endometrioma size ≥ 6cm determined by MRI or ultrasonography
* Women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis.
* Cyst single or bilateral

Exclusion Criteria:

* Cyst with radiographic or macroscopic in laparoscopy atypia
* Pregnancy
* Patient with contraindication to GnRH agonist (Enantone® 3,75 mg et Decapeptyl® 3 mg)
* Patient with contraindication to laparoscopy
* Patient with contraindication to general anesthesia
* Subject refusing to participate in the study

Primary outcomes:
measure: Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
timeFrame: at 3 months
Secondary outcomes:
measure: The impact of the ovarian reserve postoperative
timeFrame: at 3 months
measure: The number of re-operation
timeFrame: at 4 months
Other outcomes:
Locations:
city: Lisle-sur-Tarn
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Chrytèle RUBOD, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748615: The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
Official title: The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous Patients
Atrophic Posterior Mandible With Insufficient Width
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations

Detailed description: Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations.

Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically.

In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption.

As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.

Eligibility criteria: Inclusion Criteria:

* Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Primary outcomes:
measure: Time of the procedure ,pain and edema
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02849015: Combination of Cryosurgery and NK Immunotherapy for Tumors in Transplanted Liver
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Tumor
Evidence of Liver Transplantation
Keywords: liver tumor
cryosurgery
NK immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus natural killer(NK) immunotherapy to tumors in transplanted liver.

Detailed description: By enrolling patients with tumors in transplanted liver adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and NK cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Institute of Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909415: Urodynamic Evaluation in Patients With Anorectal Malformation According to Spinal Cord Abnormalities
Official title: Urodynamic Evaluation in Patients With Anorectal Malformation According to Spinal Cord Abnormalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorectal Malformation
Keywords: patients with anorectal malformation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-05-28
Enrollment: 53
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with anorectal malformation

Brief summary: This study will examine the effects of spinal cord abnormalities on perioperative neurovesical dysfunction in patients with anorectal abnormalities.


Eligibility criteria: Inclusion Criteria:

* Anorectal malformation patients who underwent preoperative and postoperative urodynamic studies

Exclusion Criteria:

* Severe artifacts in urodynamic result graph when the postoperative urodynamic study was done after spinal surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT04194515: Gut Microbiota and Bile Acids in Type 2 Diabetes Mellitus
Official title: Gut Microbiota and Bile Acids Mediate the Clinical Benefits of Metformin and YH1 in Patients With Treatment-naïve Type 2 Diabetes Mellitus: A Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Metformin
YH1
Keywords: Bile acid
Microbiota
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients and treatment-naïve male patients with type 2 diabetes

Brief summary: The investigators will evaluate the stool microbiota, serum and fecal bile acid composition, and changes in blood glucose and lipid profile before and after one month of metformin or YH1 treatment.


Eligibility criteria: Inclusion Criteria:

1. Treatment-naïve male patients with type 2 diabetes;
2. Aged 20-65 years;
3. Body mass index (BMI) ≥ 24 kg/m2; 4.7 % ≤ glycated hemoglobin (HbA1c) \< 9 %;

5.Low-density cholesterol (LDL-C) ≥ 130 mg/dl; 6.Expected to receive metformin 500 mg tid or YH1 6g tid for one month

Exclusion Criteria:

1. type 1,or other specific types of diabetes;
2. female;
3. history of oral hypoglycemic agents (OHAs) treatment or insulin therapy;
4. use of lipid-lowering drugs within the past six months;
5. serious gastrointestinal (GI) tract diseases, including peptic ulcers and GI tract bleeding;
6. hepatic insufficiency with ALT \>72 U/L or renal insufficiency with an eGFR \< 60 mL/min/1.73 m2;
7. history of stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, infectious disease, or surgery in the previous month;
8. mental illness;
9. current smoking status, alcohol or drug abuse;
10. hemoglobin disease or chronic anemia;
11. underlying conditions that could lead to poor compliance;
12. severe organic diseases, including cancer, coronary heart disease, myocardial infarction or cerebrovascular disease;
13. continuous antibiotic or probiotics use for over 3 days within 3 months prior to enrollment;
14. continuous use of weight loss drug for over 1 month;
15. history of YH1 therapy, or Chinese medicine treatment within the past one month.

Primary outcomes:
measure: bile acid profile
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT04952415: the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome
Official title: the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome in Shengjing Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Twin Diseases
Keywords: TTTS
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TTTS after fetoscopic laser surgery.

Brief summary: Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established. Among them, twin-to-twin-transfusion syndrome (TTTS) is serious disease in twin pregnancy, and the factors affecting prognosis after fetoscopic laser surgery are part of the study. Through this study, the investigators expect to achieve better prediction indicators of the prognosis of TTTS.

Detailed description: A better guideline for twin-to-twin-transfusion syndrome are anticipated to be established in China. Fetoscopic laser surgery is applied to treat TTTS. After surgery, better prediction indicators of the prognosis of TTTS are needed.

Eligibility criteria: Inclusion Criteria:

TTTS after fetoscopic laser surgery.

Exclusion Criteria:

Pregnant women who refuse to take part in the study

Primary outcomes:
measure: Weight in kilogram of neonate
timeFrame: At birth of neonate
Secondary outcomes:
measure: Neurodevelopment at early childhood
timeFrame: At age of 1 year old
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
References:
Clinical trial NCT06622915: Cardiac Performance Evaluation in Children With Steroid Dependent vs Steroid Resistant Nephrotic Syndrome
Official title: Cardiac Performance Evaluation in Children With Steroid Dependent vs Steroid Resistant Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nephrotic Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: nephrotic syndrome (NS) is one of the most common pediatric kidney diseases There is an increased incidence of heart disease in patients with primary nephrotic syndrome (PNS) compared to the normal population Conventional Echocardiography is usually utilized to diagnose myocardial dysfunction. Tissue Doppler imaging is a non-invasive cardiac imaging technique which measures the velocity of the longitudinal motion of the mitral annulus, tricuspid annulus and the basal part of interventricular septum


Eligibility criteria: Inclusion Criteria:

* Children with primary nephrotic syndrome.

  * Age: 2 - 14 years.
  * Both males and females

Exclusion Criteria:

* Patients of primary cardiac diseases (e.g., congenital or rheumatic heart disease, cardio- myopathy).

Patients who refuse to give written informed consent to study

Primary outcomes:
measure: cardiac performance evaluation in children with steroid dependent vs steroid resistant nephrotic syndrome
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Banh THM, Hussain-Shamsy N, Patel V, Vasilevska-Ristovska J, Borges K, Sibbald C, Lipszyc D, Brooke J, Geary D, Langlois V, Reddon M, Pearl R, Levin L, Piekut M, Licht CPB, Radhakrishnan S, Aitken-Menezes K, Harvey E, Hebert D, Piscione TD, Parekh RS. Ethnic Differences in Incidence and Outcomes of Childhood Nephrotic Syndrome. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1760-1768. doi: 10.2215/CJN.00380116. Epub 2016 Jul 21.
citation: Correia Pinto J, Henriques-Coelho T, Roncon-Albuquerque R Jr, Leite-Moreira AF. Differential right and left ventricular diastolic tolerance to acute afterload and NCX gene expression in Wistar rats. Physiol Res. 2006;55(5):513-526. doi: 10.33549/physiolres.930845. Epub 2005 Dec 12.
citation: Ozkan G, Adar A, Ulusoy S, Bektas H, Kiris A, Fidan M, Celik S. Presence of fragmented QRS and its correlation with myocardial performance index in patients with nephrotic syndrome. Anadolu Kardiyol Derg. 2014 Aug;14(5):450-5. doi: 10.5152/akd.2014.4886. Epub 2014 Jan 28.
citation: Loscalzo J. Venous thrombosis in the nephrotic syndrome. N Engl J Med. 2013 Mar 7;368(10):956-8. doi: 10.1056/NEJMcibr1209459. No abstract available.
Clinical trial NCT05801315: Non-surgical Treatment of Peri-implant Mucositis: FMUD vs FMUD and Air-Flow Master Piezon®
Official title: Treatment of Peri-implant Mucositis: Adjunctive Benefit of Glycine Powder Air Polishing Device to Professional Mechanical Biofilm Removal. A Randomized Parallel Arm Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implant Mucositis
Keywords: Peri-implant Mucosits
air polishing device
non-surgical treatment
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Both treatments are described in the literature, but few studies are available on their comparison.

Detailed description: 52 patients (132 implants) with peri-implant mucositis were included in this randomized parallel arm clinical study. Following baseline variables assessment, participants received Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP. Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and partial disease resolution were defined as absence of BoP (DR1) or \<2 BoP+ sites (DR2), respectively.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 70 years old;
* presence of one implant loaded at least one year before;
* bleeding on probing and/or suppuration of the peri-implant mucosa;
* pain and/or tenderness of the peri-implant mucosa;
* good general health conditions.

Exclusion Criteria:

* radiographic bone loss ≥ 2mm;
* intake of anticoagulants, antiplatelet, antibiotic or cortisone drugs;
* inability to perform oral hygiene maneuvers.

Primary outcomes:
measure: Bleeding on probing
timeFrame: 12 months
Secondary outcomes:
measure: Probing pocket depth change
timeFrame: 12 months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References:
Clinical trial NCT01017315: Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast
Official title: Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fracture Distal Radius
Keywords: baby talcum
pruritus
cast
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast application in orthopaedic patients.

The investigators will do a randomized controlled trial in patient with fracture distal end of radius treated conservatively.

Pruritus score and satisfaction will be monitor along the entire course of cast retention.


Eligibility criteria: Inclusion Criteria:

* Fracture distal end radius treated conservatively

Exclusion Criteria:

* open fracture
* skin disease and wound under cast area
* Fracture distal end radius needed surgical management
* Allergy to baby talcum

Primary outcomes:
measure: Pruritus score
timeFrame: 2 years
Secondary outcomes:
measure: Satisfaction score
timeFrame: 2 years
measure: Complication rate
timeFrame: 2 years
measure: Number of antihistamine drugs used
timeFrame: 2 years
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: Prince of Songkla university
state: Songkhla
Study officials:
affiliation: Prince of Songkla University
name: Boonsin Tangtrakulwanich, MD.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: