louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06969131: Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
Official title: The Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pentafecta
Laparoscopic
Partial Nephrectomy
Renal Tumors
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 70
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: This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy.

Detailed description: Partial nephrectomy (PN) is widely considered the preferred treatment for clinical T1 (cT1) renal masses, primarily because it preserves kidney function more effectively than radical nephrectomy.

The trifecta metric includes three components: warm ischemia time (WIT) of ≤ 25 minutes or cold ischemia time (CIT) of ≤ 60 minutes, negative surgical margins, and the absence of perioperative major complications. The pentafecta expands upon these criteria by adding two additional parameters: preservation of ≥ 90% of the estimated glomerular filtration rate (eGFR) and no progression in chronic kidney disease (CKD) stage within 12 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients who diagnosed with clinical T1 or T2a N0M0 renal tumors who were suitable candidates for partial nephrectomy

Exclusion Criteria:

* Severe and irreversible coagulopathy.
* Anatomically unfavorable tumor location.
* Extensive encasement of the renal pedicle.
* Diffuse invasion of the renal vein or central collecting system.
* Adjacent organ invasion consistent with stage cT4 disease.
* Regional lymphadenopathy (stage cTxN1), or anticipated retention of less than 20% of total nephron mass.

Primary outcomes:
measure: Predictor of pentafecta achievement
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Amount of blood loss
timeFrame: Intraoperatively
measure: Surgery duration
timeFrame: Intraoperatively
measure: Length of hospital stay
timeFrame: Till discharge from hospital (Up to one week).
measure: Intraoperative complications
timeFrame: Intraoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Analgesic requirements
timeFrame: 24 hours postoperatively
measure: Incidence of complications following surgery
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
city: South Valley
country: Egypt
facility: South Valley university
state: Qena
Study officials:
References:
Clinical trial NCT03287531: Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients With Temporomandibular Joint Dysfunction
Official title: Effect of Conventional Therapy and Low Level Laser Therapy on Pain and Function in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Level Laser Therapy
Temporomandibular Joint Dysfunction
Keywords: conventional therapy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was to determine the effect of conventional therapy and low level laser therapy on pain and function in patients with temporomandibular joint dysfunction. sixty patients with myofascial pain syndrome of TMJ are randomly classified into two groups with thirty patients in each group; Group I received traditional exercise. Group II received low level laser therapy in addition to traditional exercise. All outcome measures including Pain and function, were evaluated before and after the treatment program.

Detailed description: METHODOLOGY

Subjects: This prospective study was conducted on thirty patients of both genders with myofascial pain syndrome of TMJ in the department of physical therapy at October 6 university Hospital from December 2016 to October 2017. The Patients were selected to be enrolled into this study according to the following criteria:

Eligibility criteria: Inclusion Criteria:

* All patients are diagnosed as myofascial pain syndrome of TMJ.

Exclusion Criteria:

* Presence of systematic musculo-articular pathologies.
* Pregnant women.
* History of facial trauma.
* Facial palsy.
* Fractures of the facial bones.

Primary outcomes:
measure: Pain algometry
timeFrame: 4 weeks
Secondary outcomes:
measure: Jaw Functional questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04850131: Desarda Repair Compared to Lichtenstein Repair for the Treatment of Inguinal Hernias
Official title: Mesh Free Desarda Repair Compared With Lichtenstein Repair for the Treatment of Primary Inguinal Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Recurrence
Wound Complication
Keywords: Desarda Repair
Comparison
Lichtenstein Repair
Randomized Controlled Trial
Lead sponsor: Benazir Bhutto Hospital, Rawalpindi
Sponsor class: OTHER_GOV
First posted: 2021-04-20
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 82 patients with inguinal hernias were selected randomly to participate in this study. They were subjected to either Lichtenstein hernioplasty or Desarda herniorrhaphy. A follow-up was conducted to analyze the hospital stay, return to work, recurrence rate, chronic pain, postoperative complications, and cost-effectiveness.
Primary purpose: TREATMENT

Brief summary: The Lichtenstein technique for hernia repair is safe and simple, but the underlying mesh prosthesis has its setbacks, as it acts as a mechanical barrier5. The mesh does not provide mobile and the physiologically dynamic posterior wall. The most dangerous complication associated with the mesh prosthesis is its migration from the abdominal cavity's primary implantation site. The relatively knew technique developed by Dr. Desarda does not utilize the synthetic mesh rather it uses a strip of external oblique aponeurosis to strengthen the posterior wall. Our study has compared the two methods regarding various aspects.


Eligibility criteria: Inclusion Criteria:

1. Patients of age between 20 to 70years
2. A primary inguinal hernia
3. Consented to participate in the research.

Exclusion Criteria:

1. Age below 20,
2. Recurrent and pantaloons hernia
3. Patients who did not give the informed consent
4. Patients who lose the follow-up

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours after the surgery
measure: Postoperative pain
timeFrame: 3 months after the primary surgery
measure: Recurrence
timeFrame: Within 01 year of the primary surgery
Secondary outcomes:
measure: Wound complication
timeFrame: Complications occuring within 30 days after the surgery
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Benazir Bhutto Hospital Rawalpindi
state: Punjab
Study officials:
affiliation: BENAZIR BHUTTO HOSPITAL
name: MUHAMMAD USMAN GHANI, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05180331: Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Trial
Official title: Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide and Self-harm
Suicide, Attempted
Suicidal Ideation
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention (AFSP)
First posted: 2022-01-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - Mobile Application to Prevent Suicide (MAPS) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).


Eligibility criteria: Inclusion Criteria:

* Suicidal ideation and/or suicidal behavior in the past month verified by the C-SSRS
* Between the ages of 18 and 26
* English proficiency
* Comfortable with smartphone technology
* Deemed by the treatment team to be stable enough to complete study procedures

Exclusion Criteria:

* Current psychotic or manic symptoms severe enough to interfere with study procedures

Primary outcomes:
measure: Acceptability of Research (Recruitment)
timeFrame: Baseline
measure: Acceptability of Research (Dropout)
timeFrame: 1 month
measure: Acceptability of Research Procedures
timeFrame: 1 month
measure: Patient Satisfaction
timeFrame: 1 month
measure: Acceptability of MAPS Intervention
timeFrame: 1 month
measure: Satisfaction with MAPS Intervention
timeFrame: 4 weeks
measure: Ecological Momentary Assessment (EMA) Adherence
timeFrame: 4 weeks
Secondary outcomes:
measure: Suicidal Ideation and Behavior
timeFrame: 1 month
measure: Rehospitalization
timeFrame: 1 month
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT01652131: Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia
Official title: Colloid Volume Kinetics in Morbidly Obese Patients Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Obesity, Morbid
Keywords: general anesthesia
volume kinetics
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: There is no objective evidence of how long intravenous solutions remain inside venous blood vessels after they have been administered, therefore there is no definite guideline of how to administer them in the preoperative setting. Besides, obese patients represent a particular group of subjects as they theoretically with-hold a constant inflammatory response and that would modify the way solutions behave intravenously, that is how long they remain inside.

Having said this, we wish to describe the way colloid solutions behave in this group of patients by taking serial blood samples in 12 obese patients after a colloid infusion, to calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it remains intravascularly.

All this in the hope this information will help, in the near future, to establish a more objective way to use these solutions and avoid possible complications due to over-administration.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of obesity (IMC \>35kg/m2) that will be treated with gastrojejunal laparoscopic bypass

Exclusion Criteria:

* Renal failure KDOQI \>3
* Cardiac failure NYHA III-IV
* Sepsis
* Allergy to tetrastarch
* Allergy to any of the anesthetic medication that is to be used in the protocol previously established
* Patients in which vasoactive drugs are used
* Patients in which the blood samples are completed.

Primary outcomes:
measure: description of colloid volume kinetics in obese patients after the infusion of Tetrastarch (130/0.4)
timeFrame: 90 minutes after beginning of the infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Medical Sciences, Salvador Zubiran
state: Distrito Federal
Study officials:
affiliation: National Institute of Medical Sciences, Salvador Zubiran
name: Miguel F Herrera Hernandez, MD MSc PhD
role: STUDY_DIRECTOR
affiliation: National Institute of Medical Sciences, Salvador Zubiran
name: Maria V Hernandez Martinez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03797131: Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
Official title: An Open Label Pilot Study to Evaluate the Effect of KB195, a Novel Prebiotic Gluco-Oligosaccharide Mixture, in the Diet of Patients With Urea Cycle Disorders on Gut Nitrogen Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urea Cycle Disorders
Keywords: KB195
Urea Cycle Disorders
UCD
microbiome
Kaleido
ammonia
Lead sponsor: Kaleido Biosciences
Sponsor class: INDUSTRY
First posted: 2019-01-09
Enrollment: 4
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs). This will be done using a stable isotope to assess nitrogen metabolism in the blood, urine, and stool. The study will also assess the safety and tolerability of KB195 in patients with UCDs.


Eligibility criteria: Inclusion Criteria:

* Confirmed UCD patient at any age ≥ 14 years
* Parental/legal guardian permission or patient's written informed consent or assent, as applicable
* Be willing and able to comply with study requirements

Exclusion Criteria:

* Any medical condition unrelated to the sequelae of UCD
* Patient has N-acetylglutamate synthase (NAGS) deficiency
* Recent hospitalization or risk for metabolic decompensation
* Liver transplantation
* Systemic antibiotics, probiotics or prebiotics that do not align with study guidances
* Change in dose or frequency of any drug or other compound to modulate GI motility
* Contraindications or known allergy/sensitivity to the use of the study products
* Use of an investigational drug, product or device within 30 days prior to Screening Visit, or current enrolment in another investigational drug, product, or device study
* Considered to be at risk for noncompliance or unlikely for any reason to be able to comply with the study procedures

Primary outcomes:
measure: Change in labelled (15N-nitrogen) and total nitrogen excretion in urine
timeFrame: Baseline to Day 25
measure: Change in labelled (15N-urea) and total urea excretion in urine
timeFrame: Baseline to Day 25
measure: Change in labelled (15N-ammonia) and total ammonia excretion in urine
timeFrame: Baseline to Day 25
Secondary outcomes:
measure: Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires
timeFrame: Baseline to Day 32
measure: Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires
timeFrame: Baseline to Day 32
Other outcomes:
measure: Incidence of adverse events
timeFrame: Baseline to Day 32
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: Kaleido Biosciences
name: Mark Wingertzahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT06512831: Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients
Official title: Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients: A Retrospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Tuberculosis
Isoniazid Toxicity
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 1348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tuberculosis (TB) is a major and severe opportunistic infection among solid organ transplant recipients. Chemoprophylaxis is advised for those with latent tuberculosis infection (LTBI). However, the effectiveness of an isoniazid (INH) prophylactic approach based on TB risk factors, without relying on tuberculin skin test (TST) or interferon-gamma release assay (IGRA), remains uncertain. Therefore, the investigators conducted this retrospective study to evaluate the safety and efficacy of a 6-month INH prophylaxis regimen guided by TB risk factors in kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

1. living-donor kidney transplant recipients
2. receiving standard triad immunosuppressive regimen

Exclusion Criteria:

1. active TB infection
2. multiorgan transplantation
3. liver cirrhosis
4. malignancy history in the donor and recipient
5. human immunodeficiency virus infection
6. those who had received a nine-month course of INH.

Primary outcomes:
measure: The incidence of post-transplant active TB
timeFrame: from transplant to post-transplant for up to 5 years
Secondary outcomes:
measure: The incidence of side effects of INH
timeFrame: Within 6 months of INH regimen
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT01132131: Management of Urinary Tract Infections in Primary Care Facilities.
Official title: Use of Standardized Delegation Form in Diagnosing and Treating Acute Cystitis in Primary Care Facilities.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: Urinary tract infection
Cystitis
Bacteruria
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 443
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Emergency Ward Center in Oslo has the last two years used a questionnaire to identify patients who qualify for treatment of acute cystitis by the use of a delegation form.

The aim of the study is to evaluate this practice, the primary objective being to evaluate if in a selected patient group the treatment outcome after identifying patients with probable acute cystitis by delegation form will be as good or better than the treatment received after a regular doctor's consultation.

The planned study will also investigate which symptoms, signs and laboratory findings that coincide with significant bacteruria.

The reference standard will be a microbiological culture of every patients urine.


Eligibility criteria: Inclusion Criteria:

* Females 16-55 years
* Dysuria
* Increased frequency of urination

Exclusion Criteria:

* Pregnant
* Breastfeeding child \< 1 month of age
* Diabetes
* Kidney disease
* Fever
* Poor general condition
* Backpain
* Abdominal pain
* Increased amount of vaginal secretions
* Vaginal itching or pain
* Urinary tract infection in the last four weeks
* Use of urinary catheter in the last four weeks
* Symptoms lasting more than seven days
* Ongoing antibiotic treatment
* Allergy to penicillin
* Use of the medicine Probecid

Primary outcomes:
measure: Number of patients who are clinically and bacteriologically free of symptoms of urinary tract infection.
timeFrame: 6 days after start of treatment.
measure: Number of patients who are clinically and symptomatologically free of symptoms.
timeFrame: 10 days after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Legevakten i Oslo
Study officials:
affiliation: University of Oslo
name: Morten Lindbaek, Md PhD
role: STUDY_DIRECTOR
References:
citation: Bollestad M, Grude N, Lindbaek M. A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. Scand J Prim Health Care. 2015 Jun;33(2):57-64. doi: 10.3109/02813432.2015.1041827. Epub 2015 May 11.
Clinical trial NCT02800031: IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses
Official title: The Diagnostic Value Of International Ovarian Tumour Analysis (IOTA) Simple Rules Versus the Pattern Recognition Method In Differentiating Between Malignant And Benign Adnexal Masses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecology
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 396
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses


Eligibility criteria: Inclusion Criteria:

* Ovarian mass more than 5 cm in size (confirmed by transvaginal or transabdominal ultrasonography in gynecology clinic)
* The patient is candidate for abdominal exploration for ovarian Cystectomy or oophorectomy.

Exclusion Criteria:

* Complicated ovarian masses.
* Unfit for surgery.

Primary outcomes:
measure: comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina MR Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dakhly DMR, Gaafar HM, Sediek MM, Ibrahim MF, Momtaz M. Diagnostic value of the International Ovarian Tumor Analysis (IOTA) simple rules versus pattern recognition to differentiate between malignant and benign ovarian masses. Int J Gynaecol Obstet. 2019 Dec;147(3):344-349. doi: 10.1002/ijgo.12970. Epub 2019 Sep 26.
Clinical trial NCT06228131: Detection of hCG in Early Pregnancy Clinical Samples
Official title: Detection of hCG in Early Pregnancy Clinical Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Pregnancy
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 241
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 241 subjects who planned to conceive but did not conceive participating in the clinical trial. Of these, 73 women successfully conceived and provided a full cycle of urine samples(10 days, from day -8 to day +1 relative to the expected period) .

Brief summary: To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system.


Eligibility criteria: Inclusion Criteria:

* Female；
* 18-55 years of age；
* In a state of preparing for pregnancy;
* Voluntary and sign informed consent form.

Exclusion Criteria:

* Within 8 weeks of childbirth or abortion；
* The investigator has reason to believe that it is inappropriate for subjects to participate in the study.

Primary outcomes:
measure: To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.
timeFrame: 10day
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: First Teaching hospital of Tianjin University of Traditional Chinese Medicine
city: Tianjin
country: China
facility: Internet Hospital of Tianjin Medical University General Hospital
Study officials:
References: