louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05591833: Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass
Official title: Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 180
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: to compare the results of SASI to SAS-J in treatment of morbid obesity

Detailed description: 200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures

Primary outcomes:
measure: nutritional deficiency
timeFrame: 12 months
Secondary outcomes:
measure: comorbidities
timeFrame: 1 year
measure: complications
timeFrame: 1 year
measure: weight loss
timeFrame: 12 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university hospital
Study officials:
References:
Clinical trial NCT02062333: The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
Official title: The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia; Adverse Effect
Reflex, Abnormal
Tinnitus, Spontaneous Oto-Acoustic Emission
Keywords: dexmedetomidine
esmolol
stapes reflex
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission.

Detailed description: This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic emission are of considerable diagnostic significances in otolaryngology this are objective methods for the assessment of auditory function.

Eligibility criteria: Inclusion Criteria:

* 18-65 age
* American Society of Anaesthesiologists physical status classification (ASA)1-2
* tympanoplasty surgery
* patients with normal stapes reflexes

Exclusion Criteria:

* hypertension
* drug allergy
* cardiac problems
* pregnancy

Primary outcomes:
measure: distortion product auto acoustic emission
timeFrame: postoperative 1 day
Secondary outcomes:
measure: stapes reflex
timeFrame: postoperative 1 day
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Education and Research Hospital
Study officials:
affiliation: M.D
name: Gunhan Gokahmetoglu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04312087: Lateral Neck Lymph Node Mapping in Thyroid Cancer
Official title: Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Keywords: thyroid cancer
lateral neck lymph node
lymph node mapping
neck dissection
sentinel lymph node
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study includes papillary thyroid cancer patients who have unpalpable lateral neck lymph nodes but suspicious on ultrasound and/or CT. Carbon nanoparticles is used as the tracer for lateral neck lymph node mapping.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed papillary thyroid cancer
* The maximum diameter of the thyroid cancer \<3 cm with enough normal thyroid tissue for tracer injection
* Unpalpable lateral neck lymph nodes
* Ultrasound and CT showed suspected lateral neck lymph nodes \<2 cm

Exclusion Criteria:

* Previously treated thyroid cancer
* High risk thyroid cancer (e.g. with severe extra-adenial invasion or extensive lymph node metastasis or poorly differentiated thyroid cancer)
* Patients with distant metastasis

Primary outcomes:
measure: Lymph node counts
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Lymph node metastasis rate
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT02798887: Ridge Preservation Comparing the Healing With or Without a Barrier Membrane
Official title: Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Keywords: Regeneration
Bone regeneration
Grafting, Bone
Allograft
Xenograft
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 24
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: Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.

Detailed description: Thirty patients will be treated using the principles of bone grafting for ridge preservation. Fifteen test patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft without a membrane where only the exposed intrasocket allograft will be covered with a piece of Alloderm GBR. The positive control group of fifteen patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR membrane. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Eligibility criteria: Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID or steroid therapy.
10. Pregnant patients.

Primary outcomes:
measure: Change in post-extraction site to 4 month change in crestal osseous width
timeFrame: 4 months
Secondary outcomes:
measure: Change in Soft tissue thickness
timeFrame: 4 months
measure: Percent osseous tissue
timeFrame: 4 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Graduate Periodontics Clinic University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Henry Greenwell, DMD, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02454387: A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers
Official title: A Double-blind, Single and Multiple Ascending Dose, Randomised, Placebo-controlled Study, in Healthy Adult and Elderly Subjects Exploring Safety, Tolerability, Pharmacokinetics of ONO-4474 and Pharmacology of ONO-4474 in NGF-hyperalgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in healthy volunteers.

Detailed description: A Double-blind, Multi-centre, Single Dose, Single and Multiple Ascending Dose, Four-part, Randomised, Placebo-controlled Study in Healthy Adult and Elderly Subjects Exploring the Safety, Tolerability, Pharmacokinetics of ONO-4474 in Fed and Fasted Conditions, and Pharmacology of ONO-4474 in NGF-hyperalgesia.

Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects aged 18-55 years inclusive (Parts A and C); healthy male and female subjects aged 18-55 years inclusive (Part B); healthy male and female subjects aged 65 and over (Part D)
2. Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive

Exclusion Criteria:

1. Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
2. Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit

Primary outcomes:
measure: Safety and tolerability of ONO-4474 across ascending single and multiple doses using number of adverse events
timeFrame: Up to Day 28
Secondary outcomes:
measure: Maximum plasma concentration of ONO-4474 (Cmax)
timeFrame: Day 1 and at Day 7
measure: ONO-4474 Plasma Area Under the Curve from Time Zero to 24 hour after dosing (AUC24)
timeFrame: Day 1 and at Day 7
measure: Time to Reach Maximum Observed Plasma concentration (Tmax) of ONO-4474
timeFrame: Day 1 and at Day 7
measure: Plasma Decay half life (T1/2) of ONO-4474
timeFrame: Day 1 and at Day 7
measure: Part C only - Evaluation of ONO-4474 vs. placebo on walking soreness using a Likert scale
timeFrame: 3hr and 24hr after NGF injection
measure: Part C only: Assessment of pharmacology of ONO-4474 using change in pressure pain threshold after NGF injection.
timeFrame: 3hr and 24hr after NGF injection
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Clinical Site
city: Nottingham
country: United Kingdom
facility: Nottingham Clinical SIte
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Drug Development Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT03112187: FLIPS: Ferfer Liposomal Iron Performance Study
Official title: FLIPS: Ferfer Liposomal Iron Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Keywords: IDA
iron deficiency anemia
iron supplements
Pakistan
Liposomal iron
Lead sponsor: PharmEvo Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2017-04-13
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin and Haematocrit levels

Detailed description: Anemia, described as a low blood Haemoglobin concentration, has been shown to be a public health problem that impacts low-, center- and high-earnings nations and has great unfavorable health results, as well as unfavorable influences on social and monetary development . even though the most dependable indicator of anemia on the populace stage is blood Haemoglobin attention, measurements of this attention by myself do now not determine the cause of anemia. Anemia may additionally result from a number of causes, with the maximum great contributor being iron deficiency. approximately 30%- 50% of instances of anemia are taken into consideration to be because of iron deficiency.

Doctor will evaluate on the basis of inclusion or exclusion criteria, lab values and overall assessment and then enroll in this clinical trial. During the study patient will visit the Doctor four times, Day 0 week 4, week 8 and week 12. Doctor will investigate the Hemoglobin level and Hematocrit level and also evaluate the adverse effects and tolerability of Ferfer® at week 2 and week 8. Doctor also instructed to take the food supplements, twice daily, once in a morning and once in evening independently by food intake as Ferfer® has no interaction with food.

Eligibility criteria: Inclusion Criteria:

* Iron deficiency anemia (Hemoglobin \<8 to \>5 g/dl)
* Subjects able to provide written informed consent;
* Subjects already treated with other iron supplements or drugs that experienced side effects (not including allergy) related to iron administration.
* Wash out period will be a week

Exclusion Criteria:

* Had a history of iron intolerance
* Hypersensitivity and allergic of Vit C and Vit B12
* Not willing to take informed consent

Primary outcomes:
measure: Efficacy of a novel food supplement, Ferfer® to raise the capacity of Haemoglobin levels
timeFrame: Week 12
Secondary outcomes:
measure: Adverse Event
timeFrame: upto 12 weeks
measure: Efficacy of a novel food supplement, Ferfer® to raise the capacity of ferritin levels
timeFrame: Week 12
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lubna Shahzad,Al-raheem surgical and Maternity Hospital, Daroghwala
state: Sindh
Study officials:
affiliation: PharmEvo Pvt Ltd
name: Masood Jawaid, MRCS,FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06237387: Association of Acne Vulgaris With Oral Hygiene and Gingivitis
Official title: Association of Acne Vulgaris With Oral Hygiene and Severity of Plaque-Induced Gingivitis in Puberty
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acne Vulgaris
Gingivitis
Dental Plaque
Oral Hygiene
Puberty
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in puberty between the ages of 13-18.

Brief summary: The goal of this observational study is to learn about in the relationship between acne vulgaris and oral hygiene and gingivitis. The main questions it aims to answer are:

* Is there a relationship between the severity of acne vulgaris lesions and the severity of plaque-related gingivitis?
* Could oral hygiene or the severity of plaque-related gingivitis have an impact on the treatment of acne lesions?

Participants will;

* First be examined at the dermatology clinic.
* Then be examined at the periodontology clinic.
* Participants with severe acne vulgaris lesions will be examined a second time at the dermatology clinic. (1.5 months after the first examination)
* Regularly use the antibiotic containing 100 mg doxycycline prescribed in the dermatology clinic for acne treatment. (Patients deemed suitable by the dermatologist)


Eligibility criteria: Inclusion Criteria:

* Being systemically healthy
* Not using any medication regularly
* Not having received acne treatment before
* Not having a known allergy to Doxycycline/Tetracycline antibiotics
* Not having received periodontal disease treatment in the last 6 months
* Not having taken antibiotics or anti-inflammatory drugs in the last month
* Not having used antiseptic mouthwash in the last month
* Being between the ages of 13-18
* No radiographic bone loss or clinical attachment loss
* Absence of any diagnosed psychiatric disease

Exclusion Criteria:

* Smoking
* Using antibiotics and anti-inflammatory drugs
* Having significant psychological problems
* Mouth breathing

Primary outcomes:
measure: The relationship between acne vulgaris and the severity of gingivitis depending on the amount of plaque
timeFrame: Baseline
measure: The relationship between acne vulgaris and oral hygiene
timeFrame: Baseline
measure: Relationship between acne vulgaris and gingival index
timeFrame: Baseline
Secondary outcomes:
measure: The relationship between response to medical treatment and severity of gingivitis depending on the amount of plaque
timeFrame: At the end of 1.5 months from the beginning
measure: The relationship between response to medical treatment and oral hygiene
timeFrame: At the end of 1.5 months from the beginning
measure: The relationship between response to medical treatment and gingival index
timeFrame: At the end of 1.5 months from the beginning
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03620487: Detection of Dengue Virus in Plasma of Patients in Nepal
Official title: Pathogen Detection and Host Response in Plasma of Patients With Dengue and Dengue Fever Like Illnesses in Nepal.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue Fever
Keywords: NGS
Sequencing
Lead sponsor: Karius, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tribhuvan University, Nepal
First posted: 2018-08-08
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Dengue or Dengue Fever-like illnesses in Nepal.

Brief summary: To test whether Karius Infectious Disease Diagnostic Sequencing assay can detect Dengue Virus in plasma from suspected cases of Dengue or Dengue Fever like-illnesses from samples collected as part of a hospital-based multi-site study conducted in Nepal.

Detailed description: Blood samples will be obtained from consented subjects as part of a hospital-based multi-site study conducted in Nepal and will be shipped to Karius, Redwood City, CA.

The investigators will test whether the Karius test can detect Dengue Virus in plasma from those suspected cases and measure the performance of the Karius test against standard tests (PCR, ELISA test and neutralization assays) used to determine a final diagnosis of Dengue Fever.

Eligibility criteria: Inclusion Criteria:

* 18 years and older, suspected of having Dengue or Dengue Fever-like illnesses.

Exclusion Criteria:

* Inability to understand instructions and comply with study-related procedures, inability to understand and/or sign informed consent, any condition that will prevent the subject from completing the study.

Primary outcomes:
measure: Sensitivity and Specificity of the Karius Test in detecting the Dengue Virus in plasma.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kirtipur
country: Nepal
facility: Tribhuvan University
Study officials:
affiliation: Tribhuvan University
name: Krishna Manandhar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04338087: The Effect of Assisted Reproductive Technology on Male Sexual Function.
Official title: The Correlation Between Assisted Reproductive Technology and Male Erectile Dysfunction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 734
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients participating in fertility treatments.

Brief summary: Men participating in assisted reproductive technology treatments will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth.

Detailed description: Men participating in fertility will be recruited to a study involving filling erectile function questionnaires throughout fertility treatments, pregnancy and up to 1 year after birth. In addition, participants will be questioned regarding marital life, sexual intercourse frequency, medical history and treatments for erectile dysfunction in relevant cases. Thes control group will be comprised of male subjects who did not require fertility treatments to conceive.

Eligibility criteria: Inclusion Criteria:

* Participation in fertility treatments.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Changes in International index of erectile function score
timeFrame: From recruitment up to 3 years.
Secondary outcomes:
measure: Sexual intercourse rate.
timeFrame: From recruitment up to 3 years.
measure: Use of phospho-di-esterase 5 inhibitors
timeFrame: From recruitment up to 3 years.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam healthcare campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150787: Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.
Official title: A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy, Tonic-clonic
Keywords: Monotherapy, epilepsy
Levetiracetam
Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs


Eligibility criteria: Inclusion Criteria:

* Subjects with a confirmed diagnosis of epilepsy.
* Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
* Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion Criteria:

* Need for an additional AED.

Primary outcomes:
measure: Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ; Levetiracetam Monotherapy Study Group. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology. 2007 Feb 6;68(6):402-8. doi: 10.1212/01.wnl.0000252941.50833.4a.