louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06966856: This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcting Early-onset Vitamin B12 Deficiency in Adult Patients Using Proton Pump Inhibitors (PPIs). The Primary Outcome is the Change in Serum Vitamin B12 Levels Over a 6-week
Official title: Sublingual Versus Oral Vitamin B12 for Acute Hypovitaminosis B12 Secondary to Proton Pump Inhibitors: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hypovitaminosis b 12
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, clinical trial evaluates the efficacy of oral versus sublingual vitamin B12 supplementation in correcting early-onset vitamin B12 deficiency in adult patients using proton pump inhibitors (PPIs). The primary outcome is the change in serum vitamin B12 levels over a 6-week treatment period. Secondary outcomes include changes in homocysteine levels, hemoglobin levels, and patient-reported satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age 18-70.
* PPI use for 1-6 months (new users).
* Serum B12 between 150-300 pg/mL.
* No known prior B12 supplementation.

Exclusion Criteria:

* History of long-term GI disease (e.g., Crohn's, celiac).
* Previous gastrectomy/bariatric surgery.
* Baseline anemia with hemoglobin \<9 g/dL.
* Severe renal or liver failure.

Primary outcomes:
measure: Change in Serum Vitamin B12 Concentration
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change in Plasma Homocysteine Level
timeFrame: Baseline and Week 6
measure: Change in Hemoglobin Level
timeFrame: Baseline and Week 6
measure: Patient-Reported Satisfaction with Route of Supplementation
timeFrame: Week 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02672956: Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
Official title: Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators selected participants who operated by laparoscopic technique due to any gynecologic indication according to random number table. The ten mm trocar was inserted supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of patients. One month after we evaluated umbilical scar by used vancouver scar scale and compared results of vancouver scar scale.


Eligibility criteria: Inclusion Criteria:

* Participant with eligible for laparoscopic surgery

Exclusion Criteria:

* Participant with umbilical scar due to previous surgery, burn eg.

Primary outcomes:
measure: The results of vancouver scar scale
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study officials:
affiliation: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
name: Mehmet Baki Şentürk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim E, Kim D, Lee S, Lee H. Minimal-scar laparoscopic adjustable gastric banding (LAGB). Obes Surg. 2009 Apr;19(4):500-3. doi: 10.1007/s11695-008-9713-6. Epub 2008 Oct 7.
citation: Park SK, Olweny EO, Best SL, Tracy CR, Mir SA, Cadeddu JA. Patient-reported body image and cosmesis outcomes following kidney surgery: comparison of laparoendoscopic single-site, laparoscopic, and open surgery. Eur Urol. 2011 Nov;60(5):1097-104. doi: 10.1016/j.eururo.2011.08.007. Epub 2011 Aug 12.
citation: Nozaki T, Ichimatsu K, Watanabe A, Komiya A, Fuse H. Longitudinal incision of the umbilicus for laparoendoscopic single site adrenalectomy: a particular intraumbilical technique. Surg Laparosc Endosc Percutan Tech. 2010 Dec;20(6):e185-8. doi: 10.1097/SLE.0b013e3181f70a2a.
Clinical trial NCT02728856: Evaluation of the Irritation Potential of Products in Human Eyes.
Official title: Evaluation of the Irritation Potential of Products in Human Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate the human eye irritation potential of two test sunscreen formulation


Eligibility criteria: Inclusion Criteria:

* Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
* Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
* Willing to report any medications taken during the study.
* Willing to have the test materials instilled into the eyes and follow all protocol requirements.
* Have been informed and have given written consent to participate in the study.

Exclusion Criteria:

* Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
* Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, acquired immune deficiency syndrome (AIDs), severer rheumatoid arthritis. results as determined by the investigator.
* Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
* Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.

Primary outcomes:
measure: Subjective assessment of discomfort in the eyes assessed by 5 point scale
timeFrame: Up to 1 day
measure: Intensity of Lacrimation assessed by 5 grading scale
timeFrame: Up to 1 day
measure: Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale
timeFrame: Up to 1 day
measure: Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale
timeFrame: Up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04444856: Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Study at the University Hospital of Bern
Official title: Clinical Outcomes of NovoSeven® Treatment in Severe Postpartum Haemorrhage - a Retrospective Single-centre Cohort Study at the University Hospital of Bern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Postpartum Haemorrhage
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 225
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with severe postpartum haemorrhage (sPPH) who were treated with NovoSeven® or other standard of care

Brief summary: This non-interventional study will compare the clinical outcomes in women with an event of severe postpartum haemorrhage treated with NovoSeven® to clinical outcomes in women with an event of severe postpartum haemorrhage not treated with NovoSeven®. The study will be a single centre retrospective cohort study of women with an event of severe postpartum haemorrhage, defined as 1.5 L of blood loss within 24 hours of delivery, in the period of 2005-2016.


Eligibility criteria: Inclusion Criteria:

* Females
* sPPH, defined as continuous bleeding of more than 1500 mL within 24 hours after delivery
* Inclusion in one of the four cohorts (historical cohort 1, historical cohort 2, study cohort and new cohort)

Exclusion Criteria:

* There are no exclusion criteria

Primary outcomes:
measure: Occurrence of invasive procedures (yes/no). (Invasive procedures are defined as: uterine or iliac artery ligation, radiological arterial embolisation, uterine compression sutures, or hysterectomy.)
timeFrame: 20 min-24 hours following time 0
Secondary outcomes:
measure: Occurrence of thromboembolic events (yes/no)
timeFrame: From time 0 until 5 days after time 0
measure: Amount of blood products transfused
timeFrame: From delivery to 24 hours after time 0
measure: Estimated blood loss
timeFrame: From delivery to 24 hours after time 0
measure: Occurrence of hysterectomy (yes/no)
timeFrame: 20 min-24 hours following time 0
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00936156: Treatment of High-Risk Cerebral Primitive Neuroectodermal Tumors in Children Aged Over 5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic, Cerebral Primitive Neuroectodermal Tumors
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 68
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years.


Eligibility criteria: Inclusion Criteria:

1. Type of tumor:

   * Metastatic medulloblastoma whatever the quality of the initial resection (radiologically visible metastases by MRI and/or CSF invaded by at least one mass of tumoral cells).
   * Incompletely resected local medulloblastoma with a residue \> 1.5 cm2.
   * Anaplastic, large cell medulloblastoma whatever the risk criteria (localized or metastatic, complete or incomplete resection).
   * Medulloblastoma with amplification of c-myc or N-myc whatever the risk criteria (local or metastatic, complete or incomplete resection).
   * Local and/or metastatic sustentorial PNET.
2. Age at diagnosis of the medulloblastoma of more than 5 years and less than 20 years.
3. Age at diagnosis of S-PNET of more than 10 years and less than 20 years.
4. Nutritional and general status compatible with treatment, Lansky score \> 60.
5. Estimated life expectancy \> 1 months.
6. Radiographs must be available for the second reading in dicom format on a CD-ROM.
7. Hematological function at diagnosis: PMN \> 1.0 x 109/l and platelets \> 100 x 109/l.
8. Hepatic function at diagnosis: serum bilirubin \< 1.5 times normal value; ASAT and ALAT \< 2.5 times normal values; prothrombin time \> 50%; fibrinogen \> 1.5 g/l.
9. Renal function at diagnosis: serum creatinine according to age in a correctly hydrated child: 1 to 15 years \< 65 micromol/l; 15 to 18 years \< 110 micromol/l.
10. No organ toxicity (Grade \> 2 according to NCI-CTC coding, version 2.0)
11. No other concomitant anti-cancer treatment.
12. No prior anti-cancer therapy.
13. No prior irradiation.
14. Written informed consent signed by both parents or legal guardians

Exclusion Criteria:

1. Failure to comply with one of the inclusion criteria.
2. Severe or life-threatening infection.
3. Uncontrolled active or symptomatic intracranial hypertension.
4. Refusal of parents or legal guardian.
5. Patients incapable of undergoing medical follow-up for geographical, social or mental reasons

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
Clinical trial NCT06961656: The Effect of Wound Care Education Using the Jigsaw IV Learning Technique on Nursing Students' Knowledge, Collaborative Learning, and Academic Motivation
Official title: The Effect of Wound Care Education Using the Jigsaw IV Learning Technique on Nursing Students' Knowledge, Collaborative Learning, and Academic Motivation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nursing Students
Nursing Education
Jigsaw Technique
Wound Care
Keywords: Jigsaw IV
Nursing students
Wound care
Collaboration
Motivation
Lead sponsor: Agri Ibrahim Cecen University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate the effects of wound care education given with the jigsaw IV learning technique on the knowledge, collaborative learning and motivation levels of nursing students. Second-year nursing students will be divided into two groups with simple randomization. The intervention group will be given a wound care training program with the jigsaw IV technique. The control group will be given wound care training with traditional education. Pre-test data will be collected before the training and post-test data will be collected after the training.


Eligibility criteria: Inclusion Criteria:

* Not having taken a wound care education before
* Willing to participate in the study voluntarily

Exclusion Criteria:

* Being a nurse who graduated from secondary school and working in the clinic,
* Having previously established an associate degree program related to health,
* Not participating in theoretical lessons, demonstrations and group work, - The student wants to withdraw from the research at any stage,
* Not filling out the data collection forms or filling them incompletely.

Primary outcomes:
measure: Change in Wound Care Knowledge Score
timeFrame: At Baseline, immediately after the training intervention
Secondary outcomes:
measure: Change in Collaborative Learning Level
timeFrame: At Baseline, immediately after the training intervention
measure: Change in Academic Motivation Level
timeFrame: At Baseline, immediately after the training intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06795256: Homework in Retrograde Intrarenal Surgery
Official title: Homework to Help with Stone Dissolution in Retrograde Intrarenal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retrograde Intrarenal Surgery
Stone, Kidney
Lead sponsor: Adiyaman University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effectiveness of this homework on stone clearance rates after retrograde intrarenal surgery (RIRS) by instructing the patient in the home environment and suggesting percussion and movement/position changes to assist in spontaneous stone passage.


Eligibility criteria: Inclusion Criteria:

* Patients with an indication for RIRC

Exclusion Criteria:

* Patients with anatomic abnormalities such as horseshoe kidney, fragments in the calyx diverticulum, infundibular stenosis, pelvi-ureteral junction obstruction or ureteral stenosis.
* Patients with morbid obesity, uncontrolled hypertension, previous cerebrovascular accident, skeletal deformity such as significant coronary artery disease or symptomatic gastro-esophageal reflux disease.
* Patients with lumbar disc herniation who have undergone spinal surgery and are unable to undergo behavioral therapy.

Primary outcomes:
measure: stone free rates
timeFrame: 1 month after the intervention/procedure/surgery
Secondary outcomes:
measure: Number of Patients with complications and Number of Patients with need for secondary surgery after retrograde intrarenal surgery
timeFrame: 1 month after the intervention/procedure/surgery
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman University
Study officials:
References:
Clinical trial NCT06012656: Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay
Official title: Prospective, Multricentre, Non Controlled, Non-randomized, Open Study for the Evaluation of the Cementless Anatomic Femoral Stem MiniMAX
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Osteoarthritis
Secondary Osteoarthritis
Traumatic Arthritis
Rheumatoid Arthritis
Congenital Hip Dysplasia
Avascular Necrosis
Fracture; Femur, Head
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample size of 100 patients has been defined based on the literature data to guarantee a sufficient number of patients for the evaluation of the performance of the prosthesis, taking into account a 10% of lost patients (dead or lost at follow-up).

Brief summary: This is a post-marketing surveillance on MiniMAX Stem


Eligibility criteria: Inclusion Criteria:

1. Patient with a clinical condition requiring THA
2. Patient receiving a MiniMAX® stem
3. Patient aged more than 18 years
4. Patient having a Social Insurance or a similar protection regime
5. Patient eligible for an AMIS procedure
6. Patient able to follow the study requirements
7. Patients who are willing to give informed written consent

Exclusion Criteria:

1. Patient with local or systemic infection
2. Participation to biomedical research
3. Patient whose BMI exceeds 40
4. Patient with less than 18 years
5. Protected adults
6. Vulnerable person according to article L1121-6 of the Code de la Santè Publique.
7. Pregnant or lactating woman
8. Patient unable to express his/ her opinion about the participation to the study

Primary outcomes:
measure: Survival Rate
timeFrame: 10 years
Secondary outcomes:
measure: Functional evaluation
timeFrame: Pre-op, 3 months, 1, 3, 5, 10 years
measure: Evaluation of patient satisfaction
timeFrame: Pre-op, 3 months, 1, 3, 5, 10 years
measure: Evaluation of the stem fixation
timeFrame: Pre-op, 3 months, 1, 3, 5, 10 years
measure: Evaluation of the general and thigh pain
timeFrame: Pre-op, 3 months, 1, 3, 5, 10 years
measure: Incidence of adverse events
timeFrame: Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years
measure: Evaluation of the stability of the stem
timeFrame: Pre-op, 3 months, 1, 3, 5, 10 years
Other outcomes:
Locations:
city: Soyaux
country: France
facility: Centre Clinical Angouleme Soyaux
Study officials:
References:
Clinical trial NCT02773056: Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
Official title: Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: transfemoral
amputation
perspiration
socket
socket comfort
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-05-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.


Eligibility criteria: Inclusion Criteria:

* Unilateral above the knee amputees of non-dysvascular etiology
* 100-275 lbs
* ≥ 1 yr. of prosthetic experience
* Independent community ambulator
* Self-reported ability to walk for 20min consecutively

Exclusion Criteria:

* Above the knee amputees of dysvascular etiologies
* Body weight \<100 or \>275 lbs
* Does not speak English or Spanish
* Use of an assistive device (i.e. canes, walkers)
* Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees
* Known skin issues
* Known cognitive impairment

Primary outcomes:
measure: Skin Temperature
timeFrame: Accommodation with new prosthetic sockets is approximately 10 days
measure: Perspiration
timeFrame: Accommodation with new prosthetic sockets is approximately 10 days
measure: Vertical Interface Movement (Pistoning)
timeFrame: Accommodation with new prosthetic sockets is approximately 10 days
Secondary outcomes:
measure: Balance and Stability
timeFrame: Accommodation with new prosthetic sockets is approximately 10 days
measure: Comfort
timeFrame: Accommodation with new prosthetic sockets is approximately 10 days
measure: Preference
timeFrame: Accommodation with new prosthetic sockets is approximately 10 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Jason Highsmith, PhD, CP, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahle JT, Miro RM, Ho LT, Porter MR, Lura DJ, Carey SL, Lunseth P, Swanson AE, Highsmith MJ. Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial. Prosthet Orthot Int. 2021 Aug 1;45(4):304-312. doi: 10.1097/PXR.0000000000000013.