louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01079754: 0.05 Versus 0.1 mg Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy
Official title: The Comparison of 0.05 vs. 0.1 Milligram Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy With/Without Anterior and Posterior Vaginoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Vaginal Hysterectomy
Keywords: Spinal morphine 0.05 mg
Spinal morphine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 72
Sex: FEMALE
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 aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty.


Eligibility criteria: Inclusion Criteria:

* Female ASA physical status 1-3
* Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty
* Be able to operate patient-controlled analgesia (PCA)

Exclusion Criteria:

* Allergy to the study drugs
* History of bleeding tendency
* Infection at the back
* Refuse to spinal anesthesia
* History of CAD or CVA

Primary outcomes:
measure: The total amount of morphine that the patient required during the first 24-h postoperative.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine, Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00841854: Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
Official title: Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Infection
Keywords: Helicobacter pylori
Bismuth
Salvage treatment
Metronidazole
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Inje University
name: Pacific Pharmaceuticals
First posted: 2009-02-11
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.


Eligibility criteria: Inclusion Criteria:

* H. pylori infection
* Aged between 18-80 years
* Are willing to received eradication therapy for H. pylori

Exclusion Criteria:

* Children and teenagers aged less than 18 years or over 80 years
* Previous eradication therapy for H. pylori
* History of gastrectomy
* Previous allergic reaction to antibiotics
* Use of prompt pump inhibitors and antibiotics in the recent 4 weeks
* Active upper GI bleeding in the recent 1 week
* Contraindication to treatment drugs
* Pregnant or lactating women
* Severe concurrent disease or malignancy

Primary outcomes:
measure: Whether the two week group yield a higher eradication rate comparing to the one week group.
timeFrame: At least four week after completion of treatment
Secondary outcomes:
measure: side effect
timeFrame: four weeks after completion of medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hwoon-Yong Jung, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung JW, Lee JH, Jung HY, Yun SC, Oh TH, Choi KD, Song HJ, Lee GH, Kim JH. Second-line Helicobacter pylori eradication: a randomized comparison of 1-week or 2-week bismuth-containing quadruple therapy. Helicobacter. 2011 Aug;16(4):289-94. doi: 10.1111/j.1523-5378.2011.00844.x.
Clinical trial NCT06706154: Exercise Capacity in Kidney Transplant Recipients
Official title: Determinants of Exercise Capacity in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Transplantation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with kidney transplantation will be included.

Brief summary: This study aimed to determine the determinants of 6 minute walk test distance in patients with kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Patients with kidney transplantation
* At least 6 months after the kidney transplant
* Being aged 18-65
* Not having regular exercise habits
* Voluntary participation in the study

Exclusion Criteria:

* Having a musculoskeletal problem that may interfere with the tests
* Having neurological impairment
* Having chronic lung disease
* Having had any cardiovascular event in the last 6 months

Primary outcomes:
measure: Exercise capacity
timeFrame: 1st day
measure: Respiratory function
timeFrame: 1st day
measure: Respiratory muscle strength
timeFrame: 1st day
measure: Musle function
timeFrame: 1st day
Secondary outcomes:
measure: Physical activity
timeFrame: 1st day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01230554: Product Performance of a Daily Disposable Contact Lens
Official title: A Study to Assess the Product Performance of a Daily Disposable Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: contact lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-29
Enrollment: 212
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch \& Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.


Eligibility criteria: Inclusion Criteria:

* Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects who have any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or are using any ocular medication.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who are aphakic or amblyopic.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who currently wear monovision, multifocal, or toric contact lenses.

Primary outcomes:
measure: Market Research Survey
timeFrame: 1 week
Secondary outcomes:
measure: Lens Evaluation - Centration
timeFrame: Over all study visits through 1 week
measure: Lens Evaluation - Movement
timeFrame: Over all study visits through 1 week
measure: Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).
timeFrame: Over all study visits for 1 week
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Bausch & Lomb
Study officials:
References:
Clinical trial NCT04245254: GutMe!: IBS and Collagen Protein Powder an Interventional Study
Official title: GutMe!: IBS and Collagen Protein Powder an Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Irritable Bowel
Irrit
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Qina
First posted: 2020-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm interventional study.
Primary purpose: TREATMENT

Brief summary: In this study we would like to understand how or if a food-based supplement affects gut symptoms such as bloating, stomach cramps and irregular bowel habits. Through using a digital symptom tracking app for a few weeks, you may just learn more about exactly what is triggering your symptoms!


Eligibility criteria: Inclusion Criteria:

* US based
* self report bloating

Exclusion Criteria:

* vegan or vegetarian diet
* suffering from any skin disorders
* kidney disease
* treated medical issues
* glutamine sensitivity

Primary outcomes:
measure: Change in self-reported IBS symptoms
timeFrame: Baseline, Week 4 and Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot (Virtual Study: https://p.proofpilot.com)
state: New York
Study officials:
References:
citation: Abrahams M, O'Grady R, Prawitt J. Effect of a Daily Collagen Peptide Supplement on Digestive Symptoms in Healthy Women: 2-Phase Mixed Methods Study. JMIR Form Res. 2022 May 31;6(5):e36339. doi: 10.2196/36339.
Clinical trial NCT00345254: Severing Nuchal Cord at the Time of Delivery.
Official title: Study That Clarifies Whether Cord Around the Neck Should be Severed at Delivery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Outcome
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-27
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the practice of severing the cord, which was encircled once around the neck of the fetus, after delivery of the anterior shoulder and prior to extraction of the body. The study and the control groups will include 30 women, each one. After diagnosis of cord around the neck during labor by ultrasound, the women will inter a randomization process. After delivery of the head, it will be cut intentionally in the study group and left intact in the control group. Neonatal outcome will be assessed.

Detailed description: Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the practice of severing the cord, which was encircled once around the neck of the fetus, after delivery of the anterior shoulder and prior to extraction of the body. The study and the control groups will include 30 women, each one. After diagnosis of cord around the neck during labor by ultrasound, the women will inter a randomization process. After delivery of the head, it will be cut intentionally in the study group and left intact in the control group. Neonatal outcome will be assessed.

Eligibility criteria: Inclusion Criteria:

single loop cord around the neck active labor spontaneous vaginal delivery

Exclusion Criteria:

instrumental delivery cesarean section false positive finding of cord around the neck multiple loop cord around the neck

Primary outcomes:
measure: Umbilical Cord pH
timeFrame: immediately after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Deliveery Ward, Edith Wolfson Medical Center,
Study officials:
affiliation: E Wolfson Medical Center, Holon, Israel
name: Oscar Sadan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06153654: Role of the Nasal Environment in Obesity
Official title: Role of the Nasal Microbiota in Obesity - the microNASA Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adiposity
Keywords: Adiposity
Olfactory Function
Microbiome
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female participants between the age of 18-55. 50 participants with obesity, 50 lean participants (age- and sex-matched), 50 patients with schedueled bariatric surgery

Brief summary: The primary aim of this study is to investigate the nasal environment in obese and lean individuals.


Eligibility criteria: Inclusion Criteria:

N=50 adult male and female patients with obesity will be included in this study.

Inclusion criteria:

Inclusion criteria:

* Age 18-55 years
* Written informed consent
* BMI \> 30 kg/m2

N=50 adult lean patients age- and sex-matched to the group of obese patients will be included in this study.

Inclusion criteria:

* Age 18-55 years
* Written informed consent
* BMI 18-25 kg/m2

N=50 adult male and female patients with obesity with scheduled bariatric will be included in this study

Inclusion criteria:

* Age 18-55 years
* Written informed consent
* BMI \> 35 kg/m2

Exclusion Criteria:

* Smoking
* Chronic or acute sinusitis
* Surgical intervention of the nasal cavity or the paranasal sinus
* Use of antibiotics within the last 31 days18
* Current illicit drug abuse including daily marijuana or CBD consumption (≤ 24 g of alcohol per day allowed)
* Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
* Use of any kind of decongestant more than twice a week
* Use of cortisone-containing nasal spray within the last 3 months
* Acute allergic rhinitis
* History of neurodegenerative diseases
* History of severe head trauma
* Severe renal impairment (e.g. estimated glomerular filtration rate \<30 ml/min/m2)

Primary outcomes:
measure: Difference in nasal microbiota composition
timeFrame: 6 Months
Secondary outcomes:
measure: Change in nasal microbiota Composition after bariatric surgery
timeFrame: 24 Months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Katharina Timper, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333254: A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients
Official title: A Randomised Controlled Trial Comparing Different Methods for Short-Term Bladder Drainage in Patients With Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: urinary tract infections
urinary catheterisation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 170
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the project is to evaluate differences between intermittent and indwelling catheterisation in patients with hip surgery.

Specific objectives are to determine whether:

* frequencies of urinary tract problems in hospital and up to one year after discharge differ between patient groups treated with intermittent and indwelling catheterisation respectively.
* costs and health-effects differ between the patient groups.
* experiences of urinary catheterisation differ between the patient groups


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hip fracture surgery or hip replacement due to arthrosis
* Age 50 years and above

Exclusion Criteria:

* Patients with an indwelling catheter in situ
* Cognitive impairment

Primary outcomes:
measure: Nosocomial urinary tract infection
timeFrame: Urine culture will be collected at admission and before discharge from the orthopaedic ward (about 5-10 days after admission)
Secondary outcomes:
measure: Time to normal bladder function
timeFrame: Hours after surgery (participants will be followed for the duration of hospital stay, about 5-10 days)
measure: Costs for material and labour related to urinary catheterisation and nosocomial UTI during the first year after hip surgery
timeFrame: During time in hospital and up to 1 year after discharge
measure: Health effects during the first year after hip surgery
timeFrame: Before discharge, 4 weeks, 4 months and 1 year after discharge
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Dept of Orthopaedic Surgery at Örebro University Hospital
Study officials:
affiliation: Örebro University Hospital, Sweden
name: Maria Hälleberg Nyman, RN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03411954: Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients
Official title: Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients:an Open, Prospective,Non-randomized Phase III Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: hippocampus avoidance
cognitive changes
intensity modulated radiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100

Brief summary: This is a prospective, non-randomized phase III study observing the cognitive function changes with conformal hippocampus avoidance during intensity modulated radiotherapy for T4 nasopharyngeal carcinoma patients.

Detailed description: All patients received intensity modulated radiotherapy or Tomotherapy with or without chemotherapy. Before radiotherapy, the patients will receive brain MRI scanning and the brain MRI images will be fused with the head and neck CT scan images. The investigators develop the treatment plan with hippocampus avoidance. Cognitive function are evaluated before,during and after radiotherapy. Dose-volume Histograms are got to analyze the associated factors.

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologic confirmed nasopharyngeal carcinoma
2. ECOG performance scale 0-2
3. Tumor stage is T4N0-3M0-1 according to 8th American Joint Commission on Cancer edition
4. Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10\^9/L, neutrophils ≥ 1.5×10\^9/L, serum transaminase \< 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase\< 5×the ULN), creatinine clearance rate \> 60ml/min.
5. Informed consent signed.

Exclusion Criteria:

1. History of malignant tumors.
2. Any severe complications contraindicated chemotherapy or radiotherapy.
3. Medical history of central nervous system, cognitive or psychological diseases;
4. Pregnant or nursing women.
5. Patients with mental disease cannot complete the questionaire.
6. MRI contraindication -

Primary outcomes:
measure: the dose-volume relationship between hippocampus and cognitive function
timeFrame: 1 year
Secondary outcomes:
measure: cognitive function changes
timeFrame: 1 year
measure: memory function changes
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: yuanyaun chen, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01291654: Paracetamol and Patent Ductus Arteriosus (PDA)
Official title: Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Patent Ductus Arteriosus
Keywords: PDA
Paracetamol
Indomethacin
Ibuprofen
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2011-02-08
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.

Detailed description: Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.

Eligibility criteria: Inclusion Criteria:

* Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus

Exclusion Criteria:

* Major congenital anomalies
* Life-threatening infection
* Active NEC and/or intestinal perforation
* Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4
* Urine output \<1 ml per kilogram per hour during the preceding 8 hours
* Serum creatinine concentration of \>1.6 mg %
* Platelet count of \<60,000 per cc.

Primary outcomes:
measure: Closure of the Ductus
timeFrame: 3 days
Secondary outcomes:
measure: Absence of peripheral vasoconstriction
timeFrame: 48 hours
measure: Absence of hepatotoxicity
timeFrame: 1 week
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Hebrew University Faculty of Medicine
name: Cathy Hammerman, MD
role: PRINCIPAL_INVESTIGATOR
References: