louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00329667: Observational Study of Prosthetic Tissue Aortic and Mitral Heart Valve
Official title: An Observational, Prospective Evaluation of the SJM Epic Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Disease
Keywords: heart valve
mitral
aortic
valvular disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-05-25
Enrollment: 761
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.

Detailed description: This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:

* adverse effect rates
* clinical status as indicated by NYHA functional classification
* hemodynamic performance

Eligibility criteria: Inclusion Criteria:

* The patient requires replacement of the aortic and/or mitral valve (Note: Patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study).
* The patient (or legal guardian) has signed a study-specific informed consent, agreeing to the data collection and follow-up requirements.
* The patient is of legal age in host country.

Exclusion Criteria:

* Patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time.
* The patient requires replacement of the tricuspid or pulmonary valve.
* The patient is pregnant or nursing.
* Patient has active endocarditis.
* Patient is actively participating in the study of an investigational drug or device.
* Patient has had an acute preoperative neurological event.
* The patient is undergoing renal dialysis.
* Patient is an intravenous drug abuser, alcohol abuser or prison inmate.
* Patient has an inability or unwillingness to return for the required follow-up intervals.
* The patient had the SJM Epic Valve implanted during the clinical study but then had the bioprosthesis explanted.

Primary outcomes:
measure: Adverse effect rates
timeFrame: Ongoing
measure: Clinical status as indicated by NYHA functional classification
timeFrame: At required follow-up visits
measure: Hemodynamic performance
timeFrame: At required follow-up visits
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06892067: Safety Assessment of Over-the-counter Personal Care and Cosmetic Products Ingredients Based on Product Description
Official title: Safety Assessment of Over-the-counter Personal Care and Cosmetic Products Ingredients Based on Product Description and Properties
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cosmetic Product Causing Toxic Effect
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Safety Assessment of Over-the-counter Personal Care and Cosmetic Products' Ingredients Based on Product Description.

Brief summary: "Personal care and cosmetic products maintain hygiene, enhance aesthetics and promote wellbeing. This category includes various formulations for cleansing, grooming and beautification products for skin, hair, nails, lips and teeth.

Detailed description: This study evaluates the safety of ingredients in 100 over the counter personal care and cosmetic products. Stratified sampling selects products from various categories, brands and retailers.

Eligibility criteria: Inclusion Criteria:

* Over the counter personal care products available for consumer purchase,Products from various categories (e.g., skincare, haircare, makeup, eye care),
* Products from different brands and manufacturers,Products with ingredient labels or lists available,Products marketed for general consumer use (not specialized or prescription products).

Exclusion Criteria:

* Prescription-only products or those requiring medical supervision,Products intended for specialized use (e.g., medical conditions, sensitive skin)
* Products without ingredient labels or lists.
* Products from obscure or unreliable manufacturers
* Products with expired or near-expired ingredients.
* Products with unclear or misleading labelling,Products not intended for general consumer use (e.g., professional salon products),Products with ingredients already known to be harmful or banned by regulatory agencies.

Primary outcomes:
measure: Likert scales
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pharmacies (Mehmood Pharmacy, Servaid Pharmacy, Clinix+ Pharmacy), Supermarkets (Hyperstar, Metro cash and carry, Imtiaz supermarket), Departmental stores (AL Fatah, Haji cream bakhsh, Enem store), Online retailers (Saloni.pk, Just4Girls.pk, Daraz.pk)
state: Punjab
Study officials:
References:
Clinical trial NCT03116867: Sonosalpingography After Hysteroscopic Tubal Occlusion
Official title: Sonosalpingography in Assessment of Efficacy of Hysteroscopic Tubal Occlusion by Roller Ball Electrode
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fallopian Tube Occlusion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients requiring tubal occlusion

Brief summary: Sonosalpingography is done to assess the efficacy of hysteroscopic tubal occlusion by roller ball electrode.


Eligibility criteria: Inclusion Criteria:

* Infertile patients with hydrosalpinges requiring in vitro fertilization
* irreversible contraception

Exclusion Criteria:

* Acute pelvic inflammatory disease

Primary outcomes:
measure: The presence of fluid in douglas pouch detected by transvaginal ultrasound after saline infusion through the cervix
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References:
Clinical trial NCT00004667: Phase I Study of Human Von Willebrand Factor for Von Willebrand's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Von Willebrand's Disease
Keywords: hematologic disorders
rare disease
von Willebrand's disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of North Carolina
First posted: 2000-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the effect of a new von Willebrand factor concentrate on bleeding time, in vivo recovery, and circulating half-life of the infused factor in patients with von Willebrand's disease.

II. Assess the safety of von Willebrand factor in these patients.

Detailed description: PROTOCOL OUTLINE: Patients receive 1 dose of von Willebrand factor concentrate. Timed blood studies are performed for the next 96 hours.

Patients are followed every 2 weeks for 16 weeks, and at 24, 36, and 52 weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* von Willebrand's disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina
name: Gilbert C. White
role: STUDY_CHAIR
References:
citation: Menache D, Aronson DL, Darr F, Montgomery RR, Gill JC, Kessler CM, Lusher JM, Phatak PD, Shapiro AD, Thompson AR, White GC 2nd. Pharmacokinetics of von Willebrand factor and factor VIIIC in patients with severe von Willebrand disease (type 3 VWD): estimation of the rate of factor VIIIC synthesis. Cooperative Study Groups. Br J Haematol. 1996 Sep;94(4):740-5. doi: 10.1046/j.1365-2141.1996.d01-1860.x.
Clinical trial NCT06542367: Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
Official title: Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tympanic Membrane Perforation
Keywords: Tympanoplasty
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Eligible participants with chronic tympanic membrane perforation (\>6 month) will be given a detailed description and offered to participate in the study.

the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.


Eligibility criteria: Inclusion Criteria:

* Chronic tympanic membrane perforation (\>6 months).
* Central tympanic membrane perforation.
* Air bone gar of 35 dB or lower at the operated ear.
* No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.
* No evidence of a retraction pocket and no suspicion for a cholesteatoma.

Exclusion Criteria:

* Known ossicular chain dysfunction
* The tympanic membrane perforation edges are not accessible/visualized transcanal
* Pregnancy
* Allergy to lidocaine

Primary outcomes:
measure: closure of tympanic membrane perforation
timeFrame: 1 year following the procedure
Secondary outcomes:
measure: Hearing results following tympanoplasty - Speech recognition threshold
timeFrame: 1 year following the procedure
measure: Hearing results following tympanoplasty - Pure Tone Average
timeFrame: 1 year following the procedure
measure: Hearing results following tympanoplasty - air bone gap.
timeFrame: 1 year following the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04633967: Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.
Official title: Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis
Lead sponsor: Maritime Neurology
Sponsor class: NETWORK
First posted: 2020-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with MS qualifying for Alemtuzumab therapy

Brief summary: To evaluate a Novel infusion protocol in MS patients treated with Alemtuzumab

Detailed description: This observational study will evaluate and anaylse primary data investigating the effects of a novel peri-infusion regimen in MS patients in a Candian clinical setting infused with Alemtuzumab.

This observational study has been developed by a Canadian neurologist with the intent to treat MS patients receiving Alemtuzumab in order to mitigate infusion associated reactions (safety) by utilizing an alternative peri-infusion protocol which is a deviation from the recommendation in the Canadian Product Monograph.

All the patients' recruited for this observational study were informed and consented for this novel peri-infusion regimen and were clinically followed by the neurologist for the two Alemtuzumab infusion cycles and for any subsequent Alemtuzumab infusions for potential mitigation of infusion associated reactions associated with Alemtuzumab.

Eligibility criteria: Inclusion Criteria: Patient s treated with Alemtuzumab as per canadian label -

Exclusion Criteria: Contraindication to Alemtuzumab

-

Primary outcomes:
measure: Number and type of adverse events in Novel versus standard infusion protocol
timeFrame: 2016-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Maritime Neurology
state: Nova Scotia
Study officials:
References:
Clinical trial NCT03591367: The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
Official title: The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Bladder Disease
Bladder Neoplasm
Micro-RNA
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We try to assess the potential role of telomerase reverse transcriptase and MicroRNA (miR-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 years or older.
* Patient with hematuria suspected to be of bladder origin clinically.
* Willing to be participate in the study.

Exclusion Criteria:

* Patient having another malignancy.
* Hematuria of other causes as trauma and stones

Primary outcomes:
measure: sensitivity, specificity and positive and negative predictive values of combined MicroRNA-155 And Telomerase Reverse Transcriptase In diagnosis Of Non-Muscle Invasive Bladder Cancer
timeFrame: 1 year
Secondary outcomes:
measure: correlation between serum Vit D and Non-Muscle Invasive Bladder Cancer
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
affiliation: Urology and nephrology center
name: Ahmed Mosbah, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06525467: Primary Renal Lymphoma on a 48 Year Old Woman
Official title: Primary Renal Lymphoma: a Case Report and Review of the Literature.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Lymphoma
Keywords: neoplasms, renal, primary
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-07-29
Enrollment: 1
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 48 Year old female

Brief summary: A 48-year-old female presented to our hospital with the following medical conditions: Systemic arterial hypertension in treatment. She denies any allergies or surgical history.

She reports a history of asthenia and adynamia for 3 months, accompanied by intermittent pain in the left flank. She denies hematuria, fever or weight loss. She underwent an enhanced CT examination at the local hospital, and a mass (10 x 9 cm in diameter) was noted in the left kidney.

Detailed description: She underwent radical nephrectomy and lymph node dissection. with the following surgical findings: (Figure 3) Kidney measuring 7 x 6 x 5 cm, with a tumor located in the upper pole of approximately 12 cm, with abundant newly formed vessels, loose and firm adhesions tumor-spleen and tail of pancreas, 1 artery, 1 vein, 1 ureter.

Postoperative pathology and inmunohistochemistry indicated DLBCL wich only localized in the kidney. Bone marrow biopsy and CT of the chest region dod not show any evidence of linmphoma invasion. According to the findings, she was diagnosed with PRL. After operation the patient received the R-CHOP regimen.

Eligibility criteria: Inclusion Criteria:

* Patient with renal lymphoma

Exclusion Criteria:

* Patient without renal lymphoma

Primary outcomes:
measure: Cure of the disease
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Mexican Institute Of Social Health
state: Yucatán
Study officials:
References:
Clinical trial NCT00111267: Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
Official title: The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Cognitive Symptoms
Keywords: vitamin B12
cognitive function
oral supplementation
elderly
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-05-19
Enrollment: 165
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin B12 deficiency.

Detailed description: Mild vitamin B12 deficiency is highly prevalent in old age. Reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorption (active) of food-bound vitamin B12. In contrast, the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age. In both healthy and cognitively impaired elderly people, associations between vitamin B12 status and cognitive performance have been observed, and the follow-up of geriatric patients suggests effects of parenteral treatment in early cognitive impairment.

We investigated whether daily oral supplementation with 1,000 μg vitamin B12 or 1,000 μg vitamin B12 combined with 400 μg folate for 24 weeks improves cognitive performance in people over 70 years with vitamin B12 deficiency.

Eligibility criteria: Inclusion Criteria:

* Mild vitamin B12 deficiency:

  * Low plasma vitamin B12 concentration (100 \< B12 \< 300 pmol/L)
  * Elevated methylmalonic acid (MMA) concentration (\> 0.32 umol/L)
  * Creatinine concentration \< 120 umol/L

Exclusion Criteria:

* Severe cognitive impairment
* Anemia
* Gastrointestinal surgery or diseases
* Use of vitamin B12 injections or supplements containing \> 25 ug vitamin B12 and/or 200 ug folic acid
* \< 90% compliance during a 2 week placebo run in period
* No written informed consent
* Participation in other research studies

Primary outcomes:
measure: Cognitive performance in the domains of attention, concentration, memory, executive function, speed
Secondary outcomes:
measure: Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
References:
Clinical trial NCT01476267: A Study of the Metabolic Profile of Dalcetrapib in Healthy Volunteers
Official title: An Open Label, Single Centre Study to Investigate the Metabolic Profile of Dalcetrapib After a Single Oral Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 6
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, 45 to 65 years of age inclusive
* Body mass index (BMI) between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

* Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the subject
* Clinically significant abnormal laboratory values
* Infrequent bowel movements (e.g. less than one movement per 24 h on average)
* An intent to father children within 3 months of dosing
* Any external or internal radiotherapy with open (nuclear medicine) or sealed sources (brachy therapy)
* External irradiation (radiological examination) or internal radiation (diagnostic nuclear medicine procedure) within one year before study drug dosing; dental radiography and plain X-rays of the extremities are allowed before dosing

Primary outcomes:
measure: Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
timeFrame: up to Day 5
Secondary outcomes:
measure: Correlation of Metabolic Profile With Enzyme/Transporter Genotypes
timeFrame: approximately 3 months
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: