louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02540421: Recurrence in High-grade Lesions After Conization
Official title: Presence of Positive Resection Margins, Hypooestrogenism and Specimen Volume May Influence Risk of Disease Recurrence in Patients With High-grade Cervical Intra-epithelial Neoplasia Undergoing Large Loop Excision of the Transformation Zone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia
Keywords: cervical intraepithelial neoplasia
human papillomavirus
conization
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III).

Brief summary: Objectives: To identify factors associated with disease recurrence in patients with high-grade cervical intra-epithelial neoplasia (CIN) undergoing large loop excision of the transformation zone (LLETZ).

Study Design: A case-control study that included 103 patients. Patients were included in the study if they had a history of surgery for conization by LLETZ for the histopathological diagnosis of cervical intraepithelial neoplasia grades II and III (CIN II and CIN III). Follow-up exams were conducted every six months with Pap smear collection and colposcopic examination with biopsy, when necessary, for a minimum period of twelve months. Cure was defined as a normal follow-up examination within 24 months. During follow-up, relapse occurred when cytology and/or biopsy results showed that CIN had returned after 12 months, at which time a new cervical conization by LLETZ was performed.


Eligibility criteria: Inclusion Criteria:

1. history of surgery for conization

Exclusion Criteria:

1. under 18 years of age,
2. immunosuppressed,
3. Patient with a histopathological diagnosis of low-grade intraepithelial neoplasia
4. Patient with invasion, or surgical margins obtained by LLETZ that were unable to be evaluated.

Primary outcomes:
measure: Recurrence rates after conization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Andre
country: Brazil
facility: Emerson de Oliveira
state: SP
Study officials:
affiliation: FACULTY OF MEDICINE OF ABC
name: EMERSON OLIVEIRA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04690621: Cross-sectional Examination of the Reliability of Oral Implants
Official title: Cross-sectional Examination of the Reliability of Oral Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periimplantitis
Keywords: peri-implant disease prevalence incidence tolerance titanium
Lead sponsor: German Association of Oral Implantology e. V.
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with oral implants inserted after 01.04.2002

Brief summary: Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis.

Detailed description: Aim of the multi centrical, cross-sectional study is the registration of the prevalence and incidence of mucositis and periimplantitis. Additional clinical examination of the tolerance of titanium using cytosine analysis of periimplant sulcus smear and of blood lymphocytes on titanium plates in vitro. In total 10 centers will examine clinical, genetic and microbiological parameters in 200 patients during 12 months.

Study hypothesis: The incidence of mucositis and periimplantitis during a time period of 10 years in patients is less than 30%

Eligibility criteria: Inclusion Criteria:

* Patients with oral implants inserted after 01.04.2002
* Periodical recall

Exclusion Criteria:

* No other titanium implants inside the body

Primary outcomes:
measure: IL-1ß
timeFrame: 6 month
Secondary outcomes:
measure: MMP-8
timeFrame: 6 month
measure: BOP
timeFrame: 6 months
measure: PD
timeFrame: 6 months
Other outcomes:
Locations:
city: Memmingen
country: Germany
facility: Gerhard Iglhaut
Study officials:
affiliation: Academy Member
name: Gerhard Iglhaut, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04853121: Accuracy and Primary Stability of Straight and Tapered Implants in Immediate Implant Placement Using Dynamic Navigation
Official title: Accuracy and Primary Stability of Straight and Tapered Implants Placed Into Fresh Extraction Sockets Using Dynamic Navigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Diseases
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prosthetic-driven immediate implant placement for optimal aesthetic restoration has been increasing in demand during the last decades but requires higher accuracy. Dynamic navigation has been a reported better implant positioning. There are two main choices of implant macrogeometry: straight and tapered implants. One feature of implant design that may influence implants' accuracy is the taper of the implant body. However, their exact role is still needed to be investigated further. Besides, implant macrogeometry may influence primary stability, which is a prerequisite in achieving osseointegration. Therefore, we designed a randomized controlled clinical trial study to verify the clinical efficacy of the implant macrogeometry by comparing straight implants with tapered implants in immediate implant placement using dynamic navigation.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years old and in good health;
2. The maxillary incisor that cannot be retained due to non-periodontitis;
3. The buccal bone plate is complete;
4. No acute infection;
5. The extraction socket have at least 3-5 mm apical bone.

Exclusion Criteria:

1. General contraindications of oral implant surgery (such as immunodeficiency, long-term use of corticosteroids);
2. Treatments or diseases that may affect bone tissue metabolism (for example, taking bisphosphonates or receiving local radiotherapy);
3. Periodontitis history or uncontrolled periodontitis. Bleeding of probing (BOP) positive site ≥ 10%, or probing depth (PD) ≥ 4mm;
4. Heavy smokers or previous heavy smoking history (quit smoking time \<5 years or\> 20 cigarettes per day);
5. Refuse to participate in this trial.

Primary outcomes:
measure: Accuracy
timeFrame: one week
Secondary outcomes:
measure: Insetion torque value, ITV
timeFrame: surgery day
measure: Implant Stability Quotient, ISQ
timeFrame: surgery day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
References:
Clinical trial NCT05237921: Adherence to Exercise and Dietary Intervention in Cancer Patients
Official title: Adherence to a Combined Exercise and Dietary Intervention in Patients With Gastrointestinal Cancer Undergoing Neo-adjuvant Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence
Gastrointestinal Cancer
Keywords: Body composition
Wasting
Malnutrition
Lead sponsor: Hospital Beatriz Ângelo
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 50
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: OTHER

Brief summary: Intervention programs in cancer patients have been proposed with the aim of improving outcome. Bearing in mind that compliance is a limiting factor to the benefit provided from exercise and diet, assessing adherence to these interventions is paramount before pursuing further studies. Therefore the purpose of this study was to study the adherence of gastrointestinal cancer patients to a Combined Exercise and Dietary Intervention (CEDI) during neo-adjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with esophageal, gastric, pancreatic and rectal cancer
* Due to commence neo-adjuvant chemo/ radiotherapy (ChT)

Exclusion Criteria:

-

Primary outcomes:
measure: Number of participants that adhere to a Combined Exercise and Dietary Intervention (CEDI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of participants that meet estimated dietary intake and exercise goals
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
state: Lisboa
Study officials:
affiliation: Hospital da Luz
name: Cravo
role: STUDY_DIRECTOR
References:
Clinical trial NCT01930721: Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees
Official title: Comparison of Incision Angle of Mediolateral Episiotomy at 40 and 60 Degrees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obstetric Labor Complications
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The angle at which an episiotomy can be made is a continuous variable. If the investigators consider midline to be 0 degrees and a lateral episiotomy (never used today) to be 90 degrees, then it is theoretically possible to choose any angle from 0 to 90 degrees.

Detailed description: Episiotomy is a surgical incision to the perineum in order to enlarge the vaginal orifice during the second stage of labor. Although seven types of episiotomy have been described in the literature , the most frequently performed types are the mediolateral and median episiotomies, with the former being the most common one. Despite being a common obstetric practice, the exact definition of a "mediolateral" episiotomy is often unclear. Several studies and reports, however, stated that a significant proportion of the so-claimed mediolateral episiotomy were not actually mediolateral. The current trial compares two angles of mediolateral episiotomy , regarding the risk of third- and fourth-degree perineal tearing, episiotomy-related pain and dyspareunia in primiparous women at a large tertiary maternity center, namely Ain Shams University Maternity Hospital, Cairo, Egypt.

Eligibility criteria: Inclusion Criteria:

1. Primigravida with singleton pregnancy presenting by vertex.
2. Gestational age \> 37 weeks
3. No instrumental delivery.
4. No fetal distress or any emergency

Exclusion Criteria:

1. Women had an episiotomy because of fetal distress and for technical reasons (emergency or episiotomy incised prior to the fetal head crowning the perineum.
2. Inability to understand the informed consent.

Primary outcomes:
measure: and fourth degree perineal tears.
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Unversity Hospitals
Study officials:
affiliation: LECTURER
name: ADEL SH SLAH EL-DIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Din AS, Kamal MM, Amin MA. Comparison between two incision angles of mediolateral episiotomy in primiparous women: a randomized controlled trial. J Obstet Gynaecol Res. 2014 Jul;40(7):1877-82. doi: 10.1111/jog.12432.
Clinical trial NCT04022421: Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis
Official title: The Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behcet's Syndrome, Vascular Type
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients diagnosed with Behcet's disease will be randomized to administeration of hydroxychloroquine. Assessment will be done for the patients at baseline and every one month in the first three months and then quarterly for one year.


Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with Behcet's disease on any DMARDs

Exclusion Criteria:

* Patients with critical conditions
* Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.

Primary outcomes:
measure: Prevention of the recurrence of thrombotic events
timeFrame: 6 months- one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT05520021: The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat
Official title: Comparison of the Effects of Nifedipine and Magnesium Sulfate on Maternal and Fetal Doppler Blood Flow Patterns in Women With Preterm Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Labor Without Delivery
Pregnancy Preterm
Keywords: Nifedipine
Magnesium sulfate
pregnancy
preterm labor threat
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.

Detailed description: In this study, the investigators aim to compare the effect of Nifedipine and MgSO4 therapies on Doppler parameters of the uterine, umbilical, middle cerebral arteries, and ductus venous in the first 48 hours of therapy in pregnancies with preterm labor threat and also compare perinatal outcomes after delivery between the groups.

Eligibility criteria: Inclusion Criteria:

* pregnancies with preterm labor threat between 28-34 weeks gestational ages

Exclusion Criteria:

* Cervical dilatation at \> 4 cm and/or cervical effacement \>80%,
* Multiple pregnancies,
* Pregnancy complications including preeclampsia, ablatio placenta, intrauterine growth restriction, placenta previa, gestational diabetes

Primary outcomes:
measure: Doppler parameters
timeFrame: Gestational age at delivery (weeks)
Secondary outcomes:
measure: Perinatal outcomes
timeFrame: Gestational age at delivery (weeks)
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Hasan Ali Inal
Study officials:
affiliation: Antalya Training and Research Hospital
name: Hasan A Inal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04759521: Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography
Official title: Evaluation of Liver Fibrosis in Chronic Hepatitis B Patients With 2D Shear Wave Elastography With Propagation Map: A Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B
Sonoelastography
Fibrosis, Liver
Keywords: Shear wave elastography
Propagation map
Chronic Hepatitis
Liver fibrosis
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 253 patients with CHB and inactive hepatitis B surface antigen (HBsAg) carriers who presented to the Infectious Diseases outpatient clinic were included in the study. In addition, a healthy control group of 30 people was included.

Brief summary: The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.

Detailed description: A total of 253 patients with CHB and inactive HBsAg carriers as well as a control group of 30 healthy individuals were included in the study between January 2019 and October 2020. Liver stiffness measurements with 2D-SWE, fibrosis-4 (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI) scoring and additional liver biopsy in patients with CHB were performed in all cases with the help of the propagation map. Depending on the degree of fibrosis, liver stiffness was measured again at 24 and 48 weeks in patients who received antiviral therapy. Spearman rank correlation test was used for analysing correlation between variables, and receiver operating curve analysis was used to evaluate diagnostic performance in terms of fibrosis.

Eligibility criteria: Inclusion Criteria:

1. Being infected with the hepatitis B virus,
2. \> 18 years old
3. \< 64 years old

Exclusion Criteria:

1. Co-infection with hepatitis C or D
2. Have chronic or acute fulminant liver disease
3. Have DM disease
4. Hypertriglyceridemia, obesity, grade2 and higher hepatosteatosis,
5. Long-term drug use, alcohol intake that may damage the liver
6. Under the age of eighteen
7. Over sixty-five years old
8. Transplantation patients

Primary outcomes:
measure: Comparison of liver stiffness levels of group 1 and group 2 patients
timeFrame: 1st week, 24th week and 48th week
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Sağlik Bilimleri Üniversitesi Training and Research Hospital
Study officials:
References:
Clinical trial NCT05338021: Intrawound Administration of Vancomycin in TKA
Official title: Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Age between 50 and 80
2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

1. Diminished mental capacity
2. Vancomycin allergy
3. Chronic kidney disease stage III and stage IV

Primary outcomes:
measure: Intra-articular vancomycin concentration
timeFrame: 2 hours, 8 hours and 24 hours postoperatively
measure: Serum vancomycin concentration
timeFrame: 2 hours, 8 hours and 24 hours postoperatively
measure: Renal function
timeFrame: Postoperative Day 1 and Day 3
measure: Blood loss
timeFrame: Postoperative Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The affiliated hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Shuai Xiang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06608121: Upper Limb Muscle Strength Models for Patients With Motor Impairment.
Official title: Study for the Development and Evaluation of Personalised Muscle Effort Generation Models for Patients With Upper Limb Motor Deficits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Multiple Sclerosis
Spinal Cord Injuries
Keywords: muscle strength
modeling
upper limb
motor impairment
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 60
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: BASIC_SCIENCE

Brief summary: Upper limb motor impairments are common. They affect quality of life and can lead to dependency. They are mainly due to neurological conditions such as stroke, multiple sclerosis, and traumatic spinal cord injury. However, the contractile properties of muscle, in particular the maximum force that can be generated voluntarily (MVF) depending on joint angle and motion speed, have been mainly studied and modeled in healthy people. This study aims at developing mathematical models describing residual muscle forces in patients with motor impairments. The knowledge could guide patients' rehabilitation and could be useful for the development of robotic assistance systems that use patients\&#39; residual capacities to control the level of assistance provided.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 85
* A patient who is a member or beneficiary of a social security scheme
* Patients hospitalised at the Saint-Hélier rehabilitation centre for a stroke more than 15 days old, MS or SCI
* Patients with a motor deficit ≤3/5 on the MRC (Medical Research Council) scale in both internal-external shoulder rotation and elbow flexion-extension.
* Patient with voluntary consent to participate in this study.

Exclusion Criteria:

* Spasticity \&gt;3/4 on the Aschworth scale in the shoulder abductor or elbow flexor muscles.
* Cognitive impairment that may interfere with measurements (MOCA \&lt; 20/30)
* Presence of a pressure sore \&gt; stage 2 at the ischial level
* Recent trauma to limbs or spine
* Decompensated heart disease or other unbalanced pathology which contraindicates or may hinder isokinetic testing.
* Persons deprived of their liberty by a judicial or administrative decision
* Pregnant women, women in labour or nursing mothers.

Primary outcomes:
measure: Description of the residuals of the effort generation models, defined as the difference between the actual effort values and the modelled values: o Average residual of the models (mean ± standard deviation) (Main Evaluation Criterion)
timeFrame: From enrollment to the end of the participation at maximum 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Fondation Saint-Hélier
Study officials:
References: