louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06780956: Simplified vs Conventional Drilling Protocol for Implant Placment
Official title: Peri-implant Tissue Stability of Simplified vs Conventional Drilling Protocol Randomized Trial With 24-month Follow-up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: MBL
Bone Loss
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the growing interest in these alternative drilling protocols, there is a lack of robust clinical evidence evaluating their long-term effects on MBL. The aim of the present study was therefore, to evaluate the effect of implant site preparation technique (conventional drilling versus simplfied) on change in the marginal bone level and insertion torque.


Eligibility criteria: Inclusion Criteria:

* Patients without any systemic pathologies that could be considered grounds for absolute contraindication.
* Adult patients who agreed to participate in the study and signed the informed consent form.
* Patients who smoked fewer than ten cigarettes per day.
* Patients who were not completely edentulous.
* Patients who were partially edentulous in the posterior maxillary or mandibular area and did not require the use of regenerative techniques.
* Patients with an area of healed, mature bone at least three months post-extraction.

Exclusion Criteria:

* Patients missing teeth in the esthetic zones 13-23 and 33-43 (second and fifth sextants).
* Patients who smoked more than ten cigarettes per day.
* Patients with a bleeding index greater than 30%.
* Patients with dental caries or periodontal disease.
* Pregnant or lactating women.

Primary outcomes:
measure: Marginal bone loss (MBL)
timeFrame: 24 month
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM
Study officials:
References:
Clinical trial NCT03217656: The Jiaxing Birth Cohort in China
Official title: The Jiaxing Birth Cohort in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Obesity
Anemia
Pregnancy Complications
Pregnancy; Hypertension
Feeding Behavior
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jiaxing Maternity and Child Health Care Hospital
name: Qingdao University
name: Westlake University
First posted: 2017-07-14
Enrollment: 500000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between 1999 and 2013, 363 416 pregnancies were followed from initial registration to the end of the pregnancy, with 25 003 children born to the above women having no further information (registration) after the birth. Therefore, a total of 338 413 live mother-child pairs registered at local clinics, and were enrolled in the Jiaxing Birth Cohort.

Among the 338 413 children, there were 332 532 singletons, 2883 pairs of twins (n = 5766), 37 pairs of triplets (n= 111), and 1 pair of quadruplets (n = 4).

Brief summary: The Jiaxing Birth Cohort (JBC) is the largest prospective cohort study to explore prenatal risk factors, early life feeding practice and growth pattern/ adiposity in Chinese children.Between 1999 and 2013, 338 413 mother-child pairs were recruited in Jiaxing area in south-east China.Children of the recruited women were followed up at 1-2, 3, 6, 9 and 12 months of age, and subsequently followed up every 6 months to 36 months of age (toddler stage), and every year to 6-7 years of age before they went to school (pre-school stage). Follow-up rate was 70.8% at the toddler stage and 68.9% at the pre-school stage up to June 2013.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women came to clinic visit at one of the local hospitals during pregnancy at Jiaxing area
2. Pregnant women were followed up during pregnancy and their children were born alive at local hospital or clinics

Exclusion Criteria:

1. Those who did not want to participant
2. The infant was dead at the birth
3. Those pregnant mothers who dropped out during follow-up at pregnancy or moved out of the Jiaxing area

Primary outcomes:
measure: overweight and obesity
timeFrame: Up to 6-7 years old for these children
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang University
state: Zhejiang
Study officials:
References:
citation: Zheng JS, Liu H, Jiang J, Huang T, Wang F, Guan Y, Li D. Cohort Profile: The Jiaxing Birth Cohort in China. Int J Epidemiol. 2017 Oct 1;46(5):1382-1382g. doi: 10.1093/ije/dyw203. No abstract available.
Clinical trial NCT04729556: Safety Evaluation of Sericin-chitosan Cream in Healthy Volunteers
Official title: Safety Evaluation of a Film-forming Cream Containing Sericin and Chitosan for Pressure Sore Treatment in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Sore
Safety Issues
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, randomized, active-controlled clinical trial was conducted to evaluate safety of sericin-chitosan cream in healthy volunteers.

Detailed description: A prospective, randomized, active-controlled clinical trial was conducted to initially evaluate safety of sericin-chitosan cream in comparison with a commercially available cream containing dimethicone for pressure sore treatment in healthy volunteers. The results of this study provided preliminary safety profile of sericin-chitosan cream before conducting the further clinical trial in specific population (pateints with early-stage pressure sore).

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers at the age of 20 - 65 years
* voluntarily sign inform consent

Exclusion Criteria:

* Diagnosed with chronic skin conditions (e g. eczema and psoriasis) and immunocompromised diseases
* Allergic to silk sericin and chitosan, and dimethicone
* Received immunosuppressive therapy, antihistamine, and corticosteroid drugs two weeks before study enrollment.

Primary outcomes:
measure: Skin erythema index
timeFrame: 17 days
measure: Skin melanin index
timeFrame: 17 days
Secondary outcomes:
measure: Visual skin irritation
timeFrame: 17 days
measure: Self-report topical side effects: rash, edema, vesicles, and itching
timeFrame: 17 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
References:
Clinical trial NCT01924156: DC Vaccine Combined With CIK Cells in Patients With Renal Cell Carcinoma
Official title: Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Renal Cell Carcinoma: a Phase I/II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Renal Cell Carcinoma
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells (DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with renal cell carcinoma. Experimental recombinant adenovirus-transfected DC, which engineered to express MUC1 and Survivin are used for DC-based immunotherapy. Based on the results of our previously performed preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years at time of consent
* Histopathologically confirmed diagnosis of renal cell carcinoma
* Received standardized treatment of renal cell carcinoma
* Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
* KPS (Karnofsky performance scale) \>60
* Patient's written informed consent
* Predicted survival \>3 months
* No severe viral or bacterial infections

Exclusion Criteria:

* Receiving chemotherapy, radiotherapy or other therapy
* Patients with other malignancies and infectious diseases
* Pregnant and breast-feeding patient
* Currently participating in another clinical trial
* Unfit for participating in this clinical trial in investigators' opinions

Primary outcomes:
measure: objective tumor response (CR+PR) as measured by RECIST criteria
timeFrame: 4 weeks after DC/CIK treatment
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: 3 days within DC/CIK treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hematopoietic Stem Cell Transplantation
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Hu Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang D, Zhang B, Gao H, Ding G, Wu Q, Zhang J, Liao L, Chen H. Clinical research of genetically modified dendritic cells in combination with cytokine-induced killer cell treatment in advanced renal cancer. BMC Cancer. 2014 Apr 10;14:251. doi: 10.1186/1471-2407-14-251.
Clinical trial NCT05207956: App for Strengthening Services In Specialized Therapeutic Support
Official title: App for Strengthening Services In Specialized Therapeutic Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Data collection
autism
Behavioral Health Technician (BHT)
behavioral economics
implementation
implementation strategy
implementation science
Therapeutic Support Staff (TSS)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.
Primary purpose: TREATMENT

Brief summary: In partnership with a digital health software company, the University research team created two versions of a mobile application to help behavioral health technicians (BHT's) who work with students with autism collect data. The first version comprises a basic electronic platform for data collection. The second version has the same basic electronic platform for data collection, plus additional features designed to increase motivation to collect data and ease the burden of data collection.


Eligibility criteria: Inclusion Criteria:

* Participants must be working as a paraprofessionals or behavioral health technicians
* Currently providing individual support to children with autism
* Currently providing services in Philadelphia preschools, schools, day cares, or homes.

Exclusion Criteria:

* n/a

Primary outcomes:
measure: The Difference in Data Collection Consistency Between Groups Across Three Weeks
timeFrame: Three-week trial period
measure: The Difference in Data Collection Completion Between Groups Across Three Weeks
timeFrame: Three-week trial period
measure: The Difference in Data Collection Timeliness Between Groups Across Three Weeks
timeFrame: Three-week trial period
Secondary outcomes:
measure: Intentions for Implementors
timeFrame: Assessed at baseline and end of 3-week trial period
measure: System Usability Scale
timeFrame: Three-week trial period
measure: Attitudes for Implementors
timeFrame: Assessed at baseline and end of 3-week trial period
measure: Perceived Norms for Implementors
timeFrame: Assessed at baseline and end of 3-week trial period
measure: Descriptive Norms for Implementors
timeFrame: Assessed at baseline and end of 3-week trial period
measure: Self-Efficacy for Implementors
timeFrame: Assessed at baseline and end of 3-week trial period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06285656: Femoral Blood Gas and Prediction of Postoperative Bleeding
Official title: Can Femoral Blood Gas Analysis Predict Early Bleeding and the Need for Blood Products After Abdominal Major Surgery: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Hemorrhage
Blood Transfusion
Keywords: Abdominal Surgery
Postoperative Hemorrhage
Blood Transfusion
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will have surgery at Ankara Bilkent City Hospital's General Surgery Clinic and then be transferred to the critical care unit.

Brief summary: Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible.


Eligibility criteria: Inclusion Criteria:

* Patients with major abdominal surgery
* Postoperative intensive care unit following
* Accepting to participate in research

Exclusion Criteria:

* Age under 18 years old
* Pregnant patients
* Do not accept to participate of study

Primary outcomes:
measure: Eritrocyte replacement
timeFrame: 6 months
Secondary outcomes:
measure: Postoperative Hemmorhagea
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04629456: Physical Therapy for Liver Cirrhosis
Official title: Neuromuscular Electric Stimulation and Exercises Effect on Functional Exercise Performance and Quality of Life in Cases of Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cirrhosis, Biliary
Keywords: liver cirrhosis
exercises
neuromuscular electric stimulation
exercise capacity
quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with liver cirrhosis have severe physical deconditioning. Aim: To compare between the effect of neuromuscular electric stimulation(NMES) and exercises (EX)on treatment of patients with liver cirrhosis.

Detailed description: 70 patients have been chosen from department of internal medicine, Cairo university hospitals, Egypt. 5 patients refused to participate .65 patients divided randomly into 2 groups. All the procedures were explained to patients.2 patients refused to sign informed consent and excluded from the study. 31 patients in group1 and 32 patients in group2. 1patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed.

Thirty patients in each group signed an informed consent and complete the treatment program.

Eligibility criteria: Inclusion Criteria:

* Positive for anti-HCV.
* Not under antiviral therapy at entry.
* Positive for chronic hepatitis or compensated cirrhosis.
* Negative for hepatitis B surface (HBs) antigen.
* Free of co-infection with HIV.
* Not pregnant.
* Systolic blood pressure of less than 180 mmHg or diastolic blood pressure of less than 110 mmHg.
* (viii)No ischemic heart disease or severe arrhythmia

Exclusion Criteria:

* Significant cardiac disease (ejection fraction \<60% or history of coronary artery disease).
* Chronic renal failure on dialysis.
* Hemoglobin \<11.0 g/L.
* Human immunodeficiency virus infection.
* Hepatocellular carcinoma.
* Active non-hepatocellular carcinoma related malignancy.
* Myopathy.
* Any physical impairment or orthopedic abnormality preventing EX, or post-liver transplantation

Primary outcomes:
measure: Sitting standing test
timeFrame: 12 week
measure: Balance
timeFrame: 12 weeks
measure: Time up and go test
timeFrame: 12 weeks
measure: 6 Minutes walk distance
timeFrame: 12 weeks
measure: 2 Minutes steps test
timeFrame: 12 weeks
measure: Chronic liver diseases questionnaire (CLDQ)
timeFrame: 12 week
measure: SF-36
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Manal K. youssef
Study officials:
affiliation: Cairo university, Egypt
name: Manal K Youssef
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05584956: Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of L- Carnitine and Sildenafil in Children Having Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the possible efficacy and safety of L_Carnitine and Sildenafil on patient with Beta thalassemia complicated with increased Tricuspid Regurgitant Jet Velocity


Eligibility criteria: Inclusion Criteria:

* Children with Beta thalassemia major who have increased TRJV more than 2.5m/s.
* Children age from 6-18 years

Exclusion Criteria:

* Others hemolytic anemia

  * Young age before 6 years of age
  * Allergy to Sildenafil or L-carnitine
  * Patient with documented causes of pulmonary hypertension rather than caused by Beta thalassemia.
  * Hepatic dysfunction: serum Alanine Aminotransferase (ALT) 3X.
  * Renal dysfunction: Creatinine level greater than or equal to 1.2 mg/dl.

Primary outcomes:
measure: Cardiopulmonary functions
timeFrame: 3 months
Secondary outcomes:
measure: Biochemical parameters
timeFrame: 3 months
measure: Biochemical parameters
timeFrame: 3 months
measure: Biochemical parameters
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: Gharbia
Study officials:
affiliation: Tanta University
name: Sahar Kamal Hegazy, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771156: Ketorolac in Palatoplasty
Official title: Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cleft Lip and Palate
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively


Eligibility criteria: Inclusion Criteria:

-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral

Exclusion Criteria:

* Syndromic Cleft Palate patients
* Previous palatoplasty
* Major unrepaired cardiac malformation
* History of GI complications (GI Bleed, Gastric Ulceration)
* History of Renal disorder
* History of coagulopathy (As contraindication to NSAID use)
* Feeding tube dependency
* Patients whose parents refuse to consent to randomization

Primary outcomes:
measure: Volume of oral intake
timeFrame: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery
Secondary outcomes:
measure: Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
timeFrame: immediately upon arrival at PACU
measure: Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
timeFrame: 24 hours post surgery
measure: Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
timeFrame: 48 hours post surgery
measure: Pain as assessed by the Faces scale
timeFrame: 7 days post discharge
measure: Time to first oral intake
timeFrame: within 24 hours post surgery
measure: Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room
timeFrame: 24 hours and 48 hours after surgery
measure: Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)
timeFrame: 7 days post surgery
measure: Number of participants who need narcotic prescription at discharge
timeFrame: at discharge(24-48 hours post surgery)
measure: Renal function measured in mL/kg of urine output
timeFrame: from arrival to PACU to discharge (24-48 hours post surgery)
measure: Number of participants with post operative complications
timeFrame: 30 days post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Matthew R Grieves, MD,MS,FACS
role: PRINCIPAL_INVESTIGATOR
References: